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2014 -1370

d
IN THE

United States Court of Appeals


FOR THE FEDERAL CIRCUIT

ETHICON ENDO-SURGERY, INC. and ETHICON ENDO-SURGERY, LLC,


Plaintiffs-Appellants,
v.
COVIDIEN, INC. and COVIDIEN LP,
Defendants-Appellees.
ON APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION IN CASE NO. 11- CV-871
JUDGE TIMOTHY S. BLACK

BRIEF FOR PLAINTIFFS-APPELLANTS

WILLIAM F. CAVANAUGH, JR.


CHAD J. PETERMAN
R. JAMES MADIGAN III
HELEN P. OREILLY
JEREMY A. WEINBERG
PATTERSON BELKNAP WEBB & TYLER LLP
1133 Avenue of the Americas
New York, New York 10036
( 212) 336-2000
Attorneys for Plaintiffs-Appellants

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CERTIFICATE OF INTEREST
Counsel for Plaintiffs-Appellants Ethicon Endo-Surgery, Inc. and Ethicon
Endo-Surgery, LLC certify the following:
1. The full name of every party or amicus represented by me:
Ethicon Endo-Surgery, Inc. and Ethicon Endo-Surgery, LLC
2. The name of the real party in interest (if the party named in the caption is not
the real party in interest) represented by me is:
Not Applicable.
3. All parent corporations and any publicly held companies that own 10 percent
or more of the stock of the party or amicus curiae represented by me are:
Johnson and Johnson; Ethicon, Inc.; Ethicon, LLC; Ethicon PR
Holdings
4. The name of all law firms and the partners or associates that appeared for the
party or amicus now represented by me in the trial court or agency or are
expected to appear in this court are:
William F. Cavanaugh, Jr., Chad J. Peterman, R. James Madigan III,
Helen P. OReilly, Jeremy A. Weinberg
PATTERSON BELKNAP WEBB & TYLER LLP
Charles D. Hoffman
HOFFMANN MARSHALL STRONG LLP
David Edward Schmit
FROST BROWN & TODD, LLC

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TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES.................................................................................... iii
STATEMENT OF RELATED CASES ......................................................................1
STATEMENT OF JURISDICTION ..........................................................................1
INTRODUCTION .....................................................................................................2
STATEMENT OF THE ISSUES ...............................................................................5
STATEMENT OF THE CASE...................................................................................6
STATEMENT OF FACTS .........................................................................................7
I.

THE PARTIES .................................................................................................7

II.

THE PATENTS-IN-SUIT ................................................................................8


A.

The 501 Patent .....................................................................................8

B.

The 275 Patent ...................................................................................10

C.

The Design Patents..............................................................................12

III.

THE ACCUSED SONICISION DEVICE.....................................................15

IV.

THE DISTRICT COURTS GRANT OF SUMMARY JUDGMENT..........18

SUMMARY OF ARGUMENT................................................................................19
STANDARD OF REVIEW .....................................................................................20
ARGUMENT ...........................................................................................................21
I.

THE DISTRICT COURT ERRED IN GRANTING SUMMARY


JUDGMENT OF INDEFINITENESS ON THE 501 PATENT ...................22

II.

THE DISTRICT COURT ERRED IN GRANTING SUMMARY


JUDGMENT OF NON-INFRINGEMENT ON THE 275 PATENT ...........29
A.

The District Court Erred In Its Construction of Configured to


Loosely Contact the Transmission Rod.............................................30

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TABLE OF CONTENTS
(CONTINUED)
Page
B.

Even Under Its Construction, the District Court Erred In


Granting Summary Judgment of Non-Infringement...........................32

C.

The District Court Erred In Finding That Sonicisions Sleeve Is


Not Adapted to Absorb Undesired Vibrations.................................36
1.

2.
III.

Covidien Admitted That Sonicisons Sleeve Was


Designed To Prevent Metal-to-Metal Contact, a Form of
Undesired Vibrations.................................................................36
Covidiens Droplet Tests Demonstrated Undesired
Vibrations ..................................................................................38

THE DISTRICT COURT ERRED IN GRANTING SUMMARY


JUDGMENT OF INVALIDITY AND NON-INFRINGEMENT ON
THE DESIGN PATENTS ..............................................................................39
A.

The District Court Erred In Granting Summary Judgment of


Invalidity .............................................................................................40
1.
2.

B.

Whether the Patented Designs Are Dictated by Function


Is a Disputed Issue of Fact ........................................................41
The District Court Erred In Its Application of the Other
Factors Identified In Berry........................................................47

The District Court Erred In Granting Summary Judgment Of


Non-Infringement of the Design Patents.............................................50
1.
2.

The District Court Erred In Factoring Out Elements of


the Design Patents Based On Functionality..............................50
The District Court Erred In Failing to Consider the Prior
Art In Its Infringement Analysis ...............................................52

CONCLUSION........................................................................................................57

ii

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TABLE OF AUTHORITIES
Page(s)
CASES

Anderson v. Liberty Lobby, Inc.,


477 U.S. 242 (1986)................................................................................20, 29, 44
Apple, Inc. v. Samsung Elecs. Co.,
11 Civ 1846, 2011 U.S. Dist. LEXIS 139049 (N.D. Cal. Dec. 2, 2011)............51
Arminak & Assocs. v. Saint-Gobain Calmar, Inc.,
501 F.3d 1314 (Fed. Cir. 2007) ..........................................................................56
Aventis Pharma SA v. Hospira, Inc.,
675 F.3d 1324 (Fed. Cir. 2012) ..........................................................................30
Avia Grp. Intl, Inc. v. L.A. Gear Cal., Inc.,
853 F.2d 1557 (Fed. Cir. 1988) ....................................................................46, 49
Banks v. Wolfe Cnty. Bd. of Educ.,
330 F. 3d 888 (6th Cir. 2003) .......................................................................20, 22
Berry Sterling Corp. v. Pescro Plastics, Inc.,
122 F.3d 1452 (Fed. Cir. 1997) ..............................................................41, 46, 47
Bright v. Westmoreland Co.,
380 F.3d 729 (3d Cir. 2004) ...............................................................................21
Crocs, Inc. v. Intl Trade Commn,
598 F.3d 1294 (Fed. Cir. 2010) ..........................................................................49
Crown Packaging Tech., Inc. v. Ball Metal Bev. Container Corp.,
635 F.3d 1373 (Fed. Cir. 2011) ..............................................................29, 34, 39
DiLeo v. Ernst & Young,
901 F.2d 624 (7th Cir. 1990) ..............................................................................21
Egyptian Goddess, Inc. v. Swisa, Inc.,
543 F.3d 665 (Fed. Cir. 2008) (en banc) .....................................................passim

iii

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TABLE OF AUTHORITIES
(CONTINUED)
Page(s)
Ergo Licensing, LLC v. CareFusion Inc.,
673 F.3d 1361 (Fed. Cir. 2012) ..........................................................................29
Fla. Prepaid Postsecondary Educ. Expense Bd. v. Coll. Sav. Bank,
527 U.S. 627 (1999)............................................................................................35
Good Sportsman Mktg. LLC v. Li & Fung Ltd.,
07 Civ 395, 2010 U.S. Dist. LEXIS 65458 (E.D. Tex. June 29, 2010)..............51
Gorham Co. v. White,
81 U.S. 511 (1871)..............................................................................................52
High Point Design LLC v. Buyers Direct, Inc.,
730 F.3d 1301 (Fed. Cir. 2013) ........................................................39, 40, 41, 45
HIL-ROM v. Stryker,
___ F.3d ___, 2014 U.S. App. LEXIS 12105 (Fed. Cir. June 27, 2014) ...........30
Hilgraeve Corp. v. McAfee Assocs., Inc.,
224 F.3d 1349 (Fed. Cir. 2000) ....................................................................34, 39
Honeywell Intl Inc. v. ITC,
341 F.3d 1332 (Fed. Cir. 2003) ....................................................................27, 28
Hupp v. Siroflex of Am., Inc.,
122 F.3d 1456 (Fed. Cir. 1997) ..............................................................40, 45, 47
In re GPAC Inc.,
57 F.3d 1573 (Fed. Cir. 1995) ............................................................................26
L.A. Gear, Inc. v. Thom McAn Shoe Co.,
988 F.2d 1117 (Fed. Cir. 1993) ....................................................................46, 51
Lexion Med., LLC v. Northgate Techs., Inc.,
641 F.3d 1352 (Fed. Cir. 2011) ..........................................................................20
Lighting Ballast Control LLC v. Philips Elecs. N. Am. Corp.,
744 F.3d 1272 (Fed. Cir. 2014) (en banc) ..........................................................21

iv

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TABLE OF AUTHORITIES
(CONTINUED)
Page(s)
Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co.,
730 F.2d 1452 (Fed. Cir. 1984) ..........................................................................21
Med. Inst. Of Minn. v. Natl Assn of Trade & Technical Schools,
817 F.2d 1310 (8th Cir. 1987) ............................................................................20
Metro. Life Ins. Co. v. Bancorp Servs., L.L.C.,
527 F.3d 1330 (Fed. Cir. 2008) ..............................................................29, 34, 39
Nautilus, Inc. v. Biosig Instruments, Inc.,
572 U.S. ___, 2014 U.S. LEXIS 3818 (June 2, 2014).................................passim
Nordock, Inc. v. Sys., Inc.,
927 F. Supp. 2d 577 (E.D. Wis. 2013) ...............................................................51
Orthokinetics, Inc. v. Safety Travel Chairs, Inc.,
806 F.2d 1565 (Fed. Cir. 1986) ..........................................................................26
Pac. Coast Marine Windshields Ltd. v. Malibu Boats, LLC,
739 F.3d 694 (Fed. Cir. 2014) ............................................................................53
PHG Techs., LLC v. St. John Cos.,
469 F.3d 1361 (Fed. Cir. 2006) ..............................................................41, 44, 46
Phillips v. AWH Corp.,
415 F.3d 1303 (Fed. Cir. 2005) (en banc) ..........................................................30
Revision Military, Inc. v. Balboa Mfg. Co.,
700 F.3d 524 (Fed. Cir. 2012) ......................................................................52, 55
Richardson v. Stanley Works,
597 F.3d 1288 (Fed. Cir. 2010) ....................................................................50, 51
Rosco, Inc. v. Mirror Lite Co.,
304 F.3d 1373 (Fed. Cir. 2002) ........................................................40, 41, 45, 49
Savage v. Gee,
665 F.3d 732 (6th Cir. 2012) ..............................................................................20

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TABLE OF AUTHORITIES
(CONTINUED)
Page(s)
Seiko Epson Corp. v. Nu-Kote Intl, Inc.,
190 F.3d 1360 (Fed. Cir. 1999) ..........................................................................40
Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.,
655 F.3d 1364 (Fed. Cir. 2011) ..........................................................................28
Thorner v. Sony Computer Entmt Am. LLC,
669 F.3d 1362 (Fed. Cir. 2012) ..........................................................................30
Wellman, Inc. v. Eastman Chem. Co.,
642 F.3d 1355 (Fed. Cir. 2011) ..........................................................................28
STATUTES

28 U.S.C. 1295(a)(1)...............................................................................................1
28 U.S.C. 1331........................................................................................................1
28 U.S.C. 1338(a) ...................................................................................................1
35 U.S.C. 171........................................................................................................40
OTHER AUTHORITIES

FED. CIR. R. 32(b).....................................................................................................59


FED. CIR. R. 47.5 ........................................................................................................1
FED. R. APP. P. 4(a)(1)(A)..........................................................................................1
FED. R. APP. P. 32.....................................................................................................59
FED. R. CIV. P. 56(a).................................................................................................20

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STATEMENT OF RELATED CASES


Pursuant to Federal Circuit Rule 47.5, counsel for Plaintiffs-Appellants
states there are no related cases to this case and there are no other cases that will be
directly affected by the Courts decision in this case.

STATEMENT OF JURISDICTION
The district court had jurisdiction in this action pursuant to 28 U.S.C.
1331 and 1338(a). The Notice of Appeal from the Final Judgment entered on
March 4, 2014 was timely filed on March 19, 2014 in accordance with FED. R.
APP. P. 4(a)(1)(A). This Court has appellate jurisdiction under 28 U.S.C.
1295(a)(1).

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INTRODUCTION
Ethicon Endo-Surgery, Inc. and Ethicon Endo-Surgery, LLC (collectively
Ethicon) appeal from the district courts decisions granting Covidien, Inc. and
Covidien LP (collectively Covidien) summary judgment of: (1) invalidity on
U.S. Patent No. 8,182,501 (501 Patent), (2) non-infringement on U.S. Patent
No. 5,989,275 (275 Patent), and (3) invalidity and non-infringement on U.S.
Design Patent Nos. D661,801 (801 Patent), D661,802 (802 Patent),
D661,803 (803 Patent), and D661,804 (804 Patent) (collectively, the Design
Patents).
The patents at issue in this appeal cover important advances in the field of
ultrasonic surgical instruments. In granting summary judgment of invalidity and
non-infringement, the district court ignored disputed issues of material fact and
failed to view the evidence in the light most favorable to Ethicon.
First, the district court erred in granting summary judgment that the asserted
claims of the 501 Patent are invalid as indefinite. The 501 Patent relates to
surgical devices that apply ultrasonic energy and force/pressure through a clamping
arm that clamps down on blood vessels. The inventors unexpectedly found that,
when the clamping arm is fully engaged, a particular range of clamping
forces/pressures produces more reliable vessel sealing. The 501 Patent claims
devices/methods operating within those ranges.

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The district courts ruling is at odds with the Supreme Courts recent holding
in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. ___, 2014 U.S. LEXIS 3818
(June 2, 2014). In granting summary judgment of invalidity, the district court
ignored relevant portions of the specification when it stated that the patent provides
no guidance as to the method of measuring clamping forces/pressures for
purposes of the claims. (A0099, A0101) In fact, the specification provides the
guidance that the district court said was missing. The district court also ignored
Ethicons experts opinion that the scope of the claimed invention would have been
reasonably clear to a person of skill in the art. At a minimum, there are disputed
fact issues that make summary judgment of invalidity inappropriate under
Nautilus.
Second, the district court erred in granting summary judgment that the
accused Covidien Sonicision device does not infringe the 275 Patent. The 275
Patent relates to a damping sheath configured to loosely contact the transmission
rod to absorb undesired vibrations along the rod during use of the ultrasonic
surgical device. The district court erred by reading into its claim construction a
requirement that the sheaths loose contact with the transmission rod must be at
points other than at so-called fixed support points. That requirement is not part
of the ordinary meaning of the claim term and is not justified by any re-definition
or disclaimer by the patentees.
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After adopting this erroneous construction, the district court compounded its
error on summary judgment by ignoring disputed issues of material fact on
whether the accused Sonicision product meets the elements of the claim as so
construed. For example, CT scans taken by Ethicons expert show the contact
necessary under the district courts claim construction. Covidiens expert
disagreed with that interpretation of the scans. The district courts failure to treat
this evidence as creating a triable issue of fact is reversible error.
Finally, the district court erred in granting summary judgment that Ethicons
Design Patents are invalid and not infringed. The four Design Patents claim the
design of the trigger (handle), rotation knob, and activation button of ultrasonic
devices. The district court invalidated these patents by finding that they were all
dictated by function. In doing so, the district court again failed to view the
evidence in the light most favorable to Ethicon. In finding that the designs were
dictated by function, the district court rejected fact and expert evidence showing
that the designs were not dictated by function, including evidence of alternative
designs that could function as well as the patented designs.
The district court also erred in its infringement analysis. Having found the
designs functional in its invalidity analysis, the district court repeated that error in
its infringement analysis by factoring out the shape and placement of the handle,
rotation knob and trigger, thereby distorting the proper analysis of whether the
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accused devices are substantially similar to the patented designs. The district court
also erred by failing to consider the patented designs and accused designs in the
context of the prior art. Ethicons patented designs, which Sonicision sought to
reproduce, represent a departure from prior art designs of triggers, rotation knobs,
and activation buttons.
For all of these reasons, the grants of summary judgment should be reversed.
STATEMENT OF THE ISSUES
1.

As to the 501 Patent: Did the district court err in granting summary

judgment that the 501 Patent is invalid as indefinite where there are disputed
issues of material fact under Nautilus, Inc. v. Biosig Instruments, Inc. as to whether
the scope of the asserted claims would be reasonably clear to a skilled artisan at the
time of the patent application?
2.

As to the 275 Patent: Did the district court err in granting summary

judgment of non-infringement where: (a) the district courts claim construction


erroneously imported a limitation into the asserted claim, and (b) there are disputed
issues of material fact as to whether the accused product meets the requirements of
the claims, even under the district courts incorrect claim construction?
3.

As to the Design Patents: (a) Did the district court err in granting

summary judgment of invalidity where there are disputed issues of material fact on
whether the claimed designs are dictated by function; and (b) Did the district court

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err in granting summary judgment of non-infringement when it factored out


elements that it erroneously considered to be functional and failed to consider the
patented and accused designs in the context of the prior art with which an ordinary
observer would reasonably be familiar?
STATEMENT OF THE CASE
Ethicon filed this patent infringement action on December 14, 2011. The
district court issued its claim construction ruling on April 25, 2013. (A0001A0024)
On October 21, 2013, Covidien filed the three summary judgment motions at
issue here. (A1975; A2435; A2784) In response, Ethicon presented evidence,
including declarations from experts in the relevant art, that presented disputed
issues of material fact warranting the denial of summary judgment. (See, e.g.,
A0177-A0180; A3595-A3606; A3617-A3618; A3649-A3651; A3659; A3684A3688; A4281-A4282; A4356; A4394-A4427; A4807-A4818; A5570-A5576)
On January 22, 2014, the district court granted summary judgment. Copying
Covidiens opening briefs almost word-for-word and without addressing much of
the evidence that Ethicon presented, the district court granted summary judgment
that: (1) the asserted claims of the 501 Patent are invalid as indefinite; (2) the
asserted claims of the 275 Patent are not infringed; and (3) the asserted claims of

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the Design Patents are invalid and not infringed. (A0025-A0051; A0052-A0109;
A0110-A0143)
Final Judgment was entered on March 4, 2014. (A0150-A0152) Ethicon
timely filed a Notice of Appeal on March 19, 2014. (A6147)
STATEMENT OF FACTS
The patents-in-suit involve energy-based instruments, in particular, devices
that use ultrasonic energy to cut tissue and blood vessels, and seal those blood
vessels to prevent bleeding.1 (A0154-A0214)
I.

THE PARTIES
Ethicon develops, manufactures, and sells innovative medical devices,

including ultrasonic surgical instruments, which it markets under the HARMONIC


brand. (A0230; A4656) Ethicon has been the market leader in ultrasonic surgical
devices for decades. (A3652/131:5-18; A4235; A4664/63:18-A4665/64:6) In
2011, Covidien launched its Sonicision brand, a competing ultrasonic surgical
instrument. (A3520; A3639/17:25-A3642/20:14, A3643/30:12-A3646/33:6;
A4661/57:1-16)

Ultrasonic instruments use a blade vibrating at very high frequencies of


approximately 55,000 times per second to cut and coagulate tissue. (A2481/31;
A2545/38)
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II.

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THE PATENTS-IN-SUIT
The patents-in-suit reflect some of Ethicons pioneering work in the field of

ultrasonic surgical instruments.


A.

The 501 Patent

Prior art devices typically used low clamping forces, corresponding to low
clamping pressures, to cut and seal blood vessels. (A0177/1:27-52) Conventional
wisdom was that using higher clamping forces would lead to a degradation in
coagulation performance (i.e., the seal on the end of the coagulated blood vessel
would be weaker and more susceptible to bursting open). (Id.)
Defying conventional wisdom, Ethicon engineers discovered that the use of
higher clamping forces, corresponding to higher clamping pressures, actually
resulted in superior performance. (A0177/2:23-54) The 501 Patent claims
Ethicons novel method of using the higher clamping forces/pressures and devices
capable of operating at such forces/pressures. (A0179-A0180)
Claim 17 is a representative claim. Italics have been added to indicate the
portions of the claim that the district court held were indefinite:
17. An ultrasonic surgical shears comprising:
a) an ultrasonic surgical blade;
b) a clamping arm operable to open and close toward the blade;
c) a tissue pad attached to the clamping arm, wherein the blade and
tissue pad define a clamping surface area so that the applied clamp

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force does not exceed a clamping pressure of 210 psi at the


clamping surface area; and
d) means for limiting a user applied clamping force on the clamping
arm creating an average predetermined clamping pressure between
and including 60 psi and 210 psi on tissue disposed between the
tissue pad and the blade.
(A0180/7:15-26)
The specification provides guidance sufficient to allow a person of skill in
the art to determine the forces and pressures (e.g., clamping pressure . . . at the
clamping surface area and the average . . . clamping pressure) recited in the
asserted claims. In particular, the specification states:
Ultrasonic surgical instruments are known which include ultrasonic
surgical shears having an ultrasonic surgical blade, a clamping arm
operable to open and close toward the blade . . . and a device for
exerting a 1.5 pound clamping force on the clamping arm which
creates a clamping pressure of 45 psi (pounds per square inch) on a
blood vessel which is positioned between the clamping surface area of
the tissue pad and the blade. It is noted that the clamping surface area
is the area where the blade and the tissue pad are in close proximity
when the clamping arm is in a closed position.
***
The ultrasonic surgical shears also includes a device for exerting a
clamping force on the clamping arm creating an average clamping
pressure between and including 60 psi and 210 psi on tissue
positioned between the tissue pad and the blade.
Applicants experimentally found that applying an ultrasonic surgical
shears coaptation pressure ranging from 60 psi to 210 psi
(corresponding to a fully-engaged clamping surface area of 0.033
square inches and a clamping force ranging from 2 to 7 pounds) on
4.5 mm to 5 mm diameter blood vessels resulted in successful bloodvessel sealing . . . .
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***
It is noted that pressure is force per unit area . . . . The pressures
discussed herein are pressures seen by tissue when the entire clamping
surface area is in contact with the tissue. As previously mentioned, a
clamping surface area is the area where the blade and the tissue pad
are in close proximity when the clamping arm is in a closed position.
(A0177/1:27-38, A0177/2:10-14, A0177/2:32-37; A0178/4:17-27; A4424A4427 (emphasis added))
B.

The 275 Patent

When ultrasonic cutting devices are operated, energy is generated at the


transducer and transmitted to the blade by a transmission rod. The transmission of
energy generates ultrasonic vibrations that travel in many directions around the
rod. Only some of the vibrations are desirable, specifically, axial or longitudinal
vibrations (i.e., vibrations that move directly forward and backward along the
transmission rod toward the surgical blade). (A0162/1:17-25) Vibrations moving
in other directions lead to non-optimal performance and potential damage to the
device. (A0162/1:17-30; A0166/9:60-64)

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Prior to the 275 Patent, various methods were used to reduce undesirable
vibrations from the transmission rod, including the use of dampening fluids or Orings placed on the transmission rod. (A0162/1:31-59) The prior art methods had
limitations and drawbacks, including generating too much heat and being
inconvenient or impractical. (Id.)
The 275 Patent improves on the prior art by using a dampening member
that loosely contacts a portion of the transmission rod. This allows the desirable
vibrations to move to the blade while reducing the undesired vibrations.
(A0162/2:1-60) Claim 1 is the sole asserted independent claim. Italics have been
added to indicate the limitations that the district court held were not present in the
accused device:
1. An ultrasonic surgical device comprising:
a transducer assembly adapted to vibrate at an ultrasonic frequency
in response to electrical energy;

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a mounting device having a first end and a second end, the


mounting device adapted to receive ultrasonic vibration from the
transducer assembly and to transmit the ultrasonic vibration from
the first end to the second end of the mounting device, the first end
of the mounting device coupled to the transducer assembly;
a transmission rod having a first end and a second end, the
transmission rod adapted to receive ultrasonic vibration from the
mounting device and to transmit the ultrasonic vibration from the
first end to the second end of the transmission rod;
a damping member surrounding at least a portion of the
transmission rod, the damping member configured to loosely
contact the transmission rod over a portion of the transmission rod,
the damping member adapted to absorb undesired vibrations along
the transmission rod without the use of a fluid; and
an end effector having a first end and a second end, the end effector
adapted to receive the ultrasonic vibration from the transmission
rod and to transmit the ultrasonic vibration from the first end to the
second end of the end effector, the second end of the end effector
being disposed near an antinode and the first end of the end effector
coupled to the second end of the transmission rod.
(A0169/16:50-A0170/17:10)
C.

The Design Patents

In 2005, Ethicon redesigned its flagship HARMONIC ACE product. The


design team set out to improve upon the ergonomics of the predecessor ACE
device and to create a new signature look for Ethicons HARMONIC line of
products. (A4567/42:7-10) As the projects lead industrial designer described it,
the team sought to create a design that would reposition the whole [HARMONIC]
brand and create a brand look that was compelling and unique.

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(A4567/42:5-19; see also A4576/69:5-8; A4582/93:14-16 ([W]e spent a lot of


time on really trying to come up with a beautiful device.))
The new design, like the old one, had to include three elements: (i) a means
to open and close the jaws of the device; (ii) a means to activate ultrasonic energy;
and (iii) a means to rotate the devices blade and clamp arm. The team considered
numerous different design approaches to these three elements and to the device as
a whole. (A5023-A5029) The end result of a two-year long process was the
HARMONIC ACE-E line of products. The ACE-E features a trigger shaped like a
shepherds hook or an inverted U to open and close the device, immediately
beneath a rounded activation button, which itself is beneath a rotation knob with
six rounded flutes. All three of these elements are placed in a line at the distal end
of the devices housing.

As shown in the images below, and as further discussed below (infra pp. 5253), prior to the invention of the Design Patents, the clamping arm of almost all
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ultrasonic surgical devices was controlled by a thumb-ring or a loop-shaped trigger.


(A5573/20, A5575/28-30; A4656-A4657; A4662/61:8-24; A5008-A5009;
A5361-A5363)

Ethicon sought design patent protection for its unique designs. Recognizing
that Ethicons designs were original, non-obvious, and ornamental, the United
States Patent Trademark Office (USPTO) issued the Design Patents. A figure
from the 804 Patent, which is representative of each of the Design Patents, is
shown below:

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(A0211)
The solid lines in the drawing represent the claimed elements while the dotted lines
are unclaimed elements. As shown in the drawing, the 804 Patent claims the
trigger handle, activation button, and rotation knob.2
III.

THE ACCUSED SONICISION DEVICE


In 2011, Covidien introduced the accused Sonicision ultrasonic energy

device.

The three other Design Patents use the same drawing, just with a different
combination of claimed elements. The 801 Patent claims the trigger only
(A0181-A0188); the 802 Patent claims the trigger and rotation knob (A0189A0196); and the 803 Patent claims the trigger and activation button (A0197A0205).
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Relevant for purposes of the appeal of summary judgment of noninfringement of the 275 Patent, Sonicision has a transmission rod (or waveguide)
for transmitting ultrasonic vibrations to the surgical blade. (A1985-A1986; A1999A2000; A2173/49:18-A2174/50:8; A3544-A3545; A3560; A3595-A3602) That
rod has four raised nodes along its length and is surrounded by a clear (Teflon)
damping sheath or sleeve, all shown below. (A1985-A1986; A3560; A3595A3602; A3649/49:3-13) The sheath is not tightly fitted to any portion of the
transmission rod. (A3561; A3595-A3601; A3604)

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The difference in diameter between the sleeve and the non-raised nodal
portions of the transmission rod is quite small (0.015 inches), and both the sleeve
and transmission rod are flexible. (A3560-A3561; A3599-A3602) The sleeve
makes contact with both the raised nodes and points on the transmission rod other
than the raised nodes. (A3595; A3599-A3604; A3617-A3618)
Relevant for purposes of the appeal of summary judgment of noninfringement of the Design Patents, Covidien designed Sonicision to have a Ushaped trigger, activation button, and rotation knob like the patented design rather
than the prior art designs shown above.

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804 Patent
IV.

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Sonicision

THE DISTRICT COURTS GRANT OF SUMMARY JUDGMENT


After the close of discovery, Covidien moved for summary judgment on

various issues. Ethicon opposed the motions by presenting detailed evidence,


including fact and expert witness testimony, which demonstrated that there are
disputed issues of material fact. (See, e.g., A3595-A3606; A3617-A3618; A3649A3651; A3659; A3684-A3688; A4394; A4356; A4395-A4396; A4807-A4818;
A5570-A5576)
The district court did not address much of this evidence. Instead, the district
courts opinions on summary judgment are virtually word-for-word copies of
Covidiens opening summary judgment briefs,3 with little or no discussion of the
evidence that Ethicon presented in opposing summary judgment. (Compare
3

As to the 275 Patent, the district courts opinion also copied Covidiens reply
brief. (Compare A0043-A0045, A0046-A0050 with A5585-A5587, A5589A5593)
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A0099-A0109 with A2462-A2471 (501 Patent); compare A0041-A0043, A0045A0046, A0050-A0051 with A1988-A1990, A1990-A1991, A1991-A1992 (275
Patent); and compare A0126-A0131, A0131-A0143 with A2812-A2816, A2818A2830 (Design Patents))
SUMMARY OF ARGUMENT
Rather than identify triable issues of fact, the district court used Covidiens
summary judgment motions to resolve disputed issues of fact and conflicting
expert opinions in Covidiens favor. The district courts opinions largely ignore
Ethicons evidence.
As described below, Ethicons argument and supporting expert opinion on
indefiniteness, at a minimum, create a disputed issue of fact as to whether a person
of ordinary skill would have understood how to determine whether the clamping
arm was providing the force/pressure required by the claims of the 501 Patent.
For this reason, the district courts holding of indefiniteness should be reversed.
The district court also erred in its claim construction of claim 1 of the 275
Patent by improperly importing a claim limitation. Even under the district courts
erroneous claim construction, Ethicon provided sufficient evidence of infringement
to warrant a trial on the merits.
Finally, the district court erred in its approach both to invalidity and
infringement on the Design Patents. On a summary judgment record containing

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conflicting expert opinions and ample evidence that there were equally effective
alternative design options, the district court nonetheless found that Ethicons
Design Patents were dictated by function. This error infected both its invalidity
and infringement analysis.
STANDARD OF REVIEW
This Court reviews the grant of summary judgment under the law of the
regional circuit. Lexion Med., LLC v. Northgate Techs., Inc., 641 F.3d 1352, 1358
(Fed. Cir. 2011). The Sixth Circuit reviews an order granting summary judgment
de novo. Savage v. Gee, 665 F.3d 732, 737 (6th Cir. 2012).
A court should only grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the movant is entitled to
judgment as a matter of law. FED. R. CIV. P. 56(a). In considering a summary
judgment motion, the court must view the factual evidence and draw all
reasonable inferences in favor of the nonmoving party. Banks v. Wolfe Cnty. Bd.
of Educ., 330 F. 3d 888, 892 (6th Cir. 2003) (citations omitted); Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). The courts role on summary
judgment is not . . . weigh[ing] the evidence and determin[ing] the truth of the
matter, but determin[ing] whether there is a genuine issue for trial. Anderson,
477 U.S. at 249; see also Med. Inst. Of Minn. v. Natl Assn of Trade & Technical
Schools, 817 F.2d 1310, 1315 (8th Cir. 1987) (A judge does not sit as a trier of

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fact when deciding a motion for summary judgment even if the case is scheduled
to be heard without a jury.).
This Court reviews claim construction de novo. Lighting Ballast Control
LLC v. Philips Elecs. N. Am. Corp., 744 F.3d 1272, 1276-66 (Fed. Cir. 2014) (en
banc).
ARGUMENT
The district court largely copied Covidiens opening briefs without further
analysis.4 As a result, it failed to address much of the evidence that Ethicon
presented in response. As discussed below, the evidence that the district court
ignored creates disputed issues of material factparticularly when viewed in a
light most favorable to the non-movant, Ethicon.

This Circuit and others have questioned this practice. See, e.g., Lindemann
Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1457-1458
(Fed. Cir. 1984) (reversing district courts factual findings as clearly erroneous
where the findings adopted by the district court were proposed by a party before
trial, warning that an apparent absence of personal attention [by the district
court] need not be disregarded and the language in an opinion . . . may indicate
that numerous harmful errors of law produced an erroneous conclusion); Bright
v. Westmoreland Co., 380 F.3d 729, 732 (3d Cir. 2004) (When a court adopts a
partys proposed opinion as its own, [it] vitiates the vital purposes served by
judicial opinions.); DiLeo v. Ernst & Young, 901 F.2d 624, 626 (7th Cir. 1990)
(Judicial adoption of an entire brief . . . withholds information about what
arguments, in particular, the court found persuasive, and why it rejected contrary
views. Unvarnished incorporation of a brief is a practice we hope to see no
more.).
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THE DISTRICT COURT ERRED IN GRANTING SUMMARY


JUDGMENT OF INDEFINITENESS ON THE 501 PATENT
The district courts grant of summary judgment of invalidity of the 501

Patent is error under the Supreme Courts recent decision in Nautilus, Inc. v. Biosig
Instruments, Inc., 572 U.S. ___, 2014 U.S. LEXIS 3818 (June 2, 2014). Under
Nautilus, the definiteness inquiry trains on the understanding of a skilled artisan at
the time of the patent application, not that of a court viewing matters post hoc.
2014 U.S. LEXIS 3818, at *23. Applying the standard that the Supreme Court
adopted in Nautilus, summary judgment of indefiniteness is improper unless the
undisputed evidenceviewed with all reasonable inferences [drawn] in favor of
the nonmoving party, Banks, 330 F. 3d at 892establishes that [the] claims, read
in light of the specification delineating the patent, and the prosecution history, fail
to inform, with reasonable certainty, those skilled in the art about the scope of the
invention. Nautilus, 2014 U.S. LEXIS 3818, at *6. As the Court concluded, the
certainty which the law requires in patents is not greater than is reasonable, having
regard to their subject matter. Id. at *22.
Under Nautilus, the understanding of those skilled in the art, in view of the
claims and the specification, is central to the indefiniteness inquiry. Id. at *23.
Here, the evidence from experts on that subject was very much in dispute.
Each claim of the 501 Patent requires the method/device to operate within a
range of clamping forces/pressures. (A0179-A0180) The district court held that
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the claims were indefinite because there is: (1) ambiguity of . . . [the answer to]
the question of where along the length of the clamping arm the force measurements
should be made (A0101) and, (2) ambiguity of the proper distance between the
clamp and blade when the force measurement is taken (A0103). The district court
found that, depending on how these questions are answered, the measurements will
yield[] significantly different results. (A0102)
The district courts finding of ambiguity ignores the language in the
specification, the prior art, and the opinion of Ethicons expert on how a skilled
artisan would understand the scope of the claims of the 501 Patent at the relevant
time period. Quoting from Covidiens opening summary judgment brief, the
district court stated that there was no disclosed method of measurement [of
clamping forces/pressures] in the patent and no guidance as to whether the value
determined was applicable to the patent claims. (A0099) This is incorrect. The
specification provides the guidance that the district court said was missing. A
skilled artisan reading the specification and claims would understand that
measurements are to be taken: (1) when the clamp arm and blade are in a closed
position, and (2) in a manner that reflects the average pressure or force of the
clamping surface area, such as the midpoint of the clamping arm.
The specification expressly states that the force/pressure is measured when
the clamping arm is in a closed position:
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The pressures discussed herein are pressures seen by tissue when the
entire clamping surface area is in contact with the tissue. As
previously mentioned, a clamping surface area is the area where the
blade and the tissue pad are in close proximity when the clamping
arm is in a closed position.
(A0178/4:23-27 (emphasis added))
Ethicons engineering expert, Mark Schafer, Ph.D., testified that a skilled
artisan, reading the intrinsic record, would understand that the measurements under
the 501 Patent are to be taken when the clamp arm and blade are in a closed
position. (A4281-A4282; A4394/145-46; A4395-A4396/149; A4400/158) Dr.
Schafer also testified that a skilled artisan would understand how to measure the
force/pressure in order to calculate the average pressure or force of the clamping
surface area,5 by using the midpoint of the clamping arm:
The claim and descriptions tell one of skill in the art that the pressure
of interest is the average pressure applied across the clamping surface
area when the clamping arm is in its closed position. A recognized
method for determining average force is to measure the clamping
force at the middle of the clamp arm (e.g., Whipple, Col. 13:7-12).
Average pressure is determined by dividing average force by the
clamping surface area. (501 Patent, Col. 4:17-18).
(A4427/247-48) In his opinion as to how one of skill in the art would
understand the claims, Dr. Schafer relied on the references to average
pressure and closed position in the patent. He also relied on the Whipple
Patent cited by Dr. Schafer refers to U.S. Patent No. 5,947,984 (984
5

Pressure is force divided by area. (A0178/4:17)


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Patent), prior art to the 501 Patent, which discloses the use of the midpoint
of the clamping arm for measuring force/pressure. (A4427/247) Dr.
Schafer, relying on the 984 Patent and the laws of physics, opined that:
[O]ne of skill in the art knows that the force measurement is generally
linear with distance along the lever arm, thus taking the force at the
midpoint of the active portion of the clamping arm would be
representative of the average forces delivered by the clamping arm.
Thus, it makes common sense to take the force measurement and
calculate pressure based on measurements at the midpoint.
(A4356/102)
In response, Covidiens expert argued that there were numerous ways
to measure clamping force/pressure and that these different ways would
lead to varying results. But as Dr. Schafer explained:
I do not dispute that there are a number of different ways to measure
clamping force in general, but the 501 [P]atent is directed towards a
specific inquiry of finding average clamping pressure at the clamping
surface area when the clamp jaw is in the closed position. Most of the
methodologies that he identifies are not relevant to that inquiry. For
example, measuring force with the clamp jaw open at an angle (
494, 496, 497, 499, 500) provides a clamping force, but does not lead
to the average pressure as required under the patent. One of skill in
the art would also understand th[at] taking a measurement at the tip of
the clamp arm does not provide the average clamping pressure ( 495,
Covidiens method).
***
[T]he specific words of the claims and specification make clear that
the average pressure is the average pressure seen at the surface area
when the clamp arm is closed.
***
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The midpoint of the clamping arm is a point that has been recognized
by those of skill in the art as an appropriate place to measure force to
determine average clamping pressure. . . . [T]he use of the midpoint
will provide information about the average of the pressures seen
across the clamping surface area.
***
[Covidiens expert Dr.] Durfees tests, which show variable results,
are based on parameters which are outside of the bounds of the patent,
which focuses specifically on average clamping pressures with the
clamp arm fully closed.
(A4427/248-49, A4431/261, A4432/264)
The district court improperly resolved disputes on these issues between the
two experts in Covidiens favor rather than Ethicons, and in doing so ignored
much of Ethicons evidence. For example, the district court completely ignored
Dr. Schafers reference to the 984 Patent as being reflective of what a skilled
artisan would understand about determining the average. The omission of any
discussion of the 984 Patent indicates the district courts failure to evaluate
definiteness from the perspective of a skilled artisan fully informed of all relevant
art within the field. See Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d
1565, 1576 (Fed. Cir. 1986) (Whether a claim is invalid . . . for indefiniteness
requires a determination whether those skilled in the art would understand what is
claimed.); see also In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (The

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person of ordinary skill in the art is a hypothetical person who is presumed to know
the relevant prior art.).
In addressing Dr. Schafers opinion regarding the use of the midpoint, the
district court stated:
[W]hen asked to point to where in the 501 patent this midpoint
measurement appeared Plaintiffs expert, Dr. Schafer had no
answer. This attempt to interject a measurement at the midpoint in the
claims when no location is disclosed in the patent is improper. See
Honeywell, 341 F.3d at 1340-41 (rejecting experts use of a single
method when the intrinsic evidence cannot be construed to eliminate
all other known methods applicable to obtaining the claimed
measurements).
(A0106 (some citations omitted))
But this ignores Ethicons evidence that a skilled artisan would understand,
based on the teaching of the prior art such as the 984 Patent, where to measure
clamp pressure. The indefiniteness inquiry is not limited to what is specifically
disclosed in the specification, but encompasses the knowledge of the skilled artisan
as well. See Nautilus, 2014 U.S. LEXIS 3818, at *6.
The district courts reliance on Honeywell International Inc. v. ITC, 341 F.3d
1332, 1341 (Fed. Cir. 2003), also is misplaced. In Honeywell, which did not
involve a dispute of material facts,6 this Court held that a patent must specify the

Honeywell is premised on undisputed facts. Honeywell, 341 F.3d at 1339 (The


[lower court made] a finding of fact that the choice of sample preparation method
is critical to discerning whether a particular product is made by a process that
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appropriate standard or method of measurement ifwithout such instructions in


the patenta skilled artisan would otherwise be unable discern the proper
methodology for practicing a claimed invention. Honeywell, 341 F.3d at 1340-43.
Importantly, this Court does not require invalidation of a patent simply because a
patent fails to fully delineate a method of measurement. The omission of details
about how to implement the method will invalidate the claim only if a skilled
artisan could not infer those details from industry standards or professional
judgment.7
Nautilus recognized how fundamental the understanding of the skilled
artisan is in assessing definiteness. Here, Dr. Schafer provided a detailed, reasoned
opinion grounded in the intrinsic record and the common knowledge of a skilled
artisan. The fact that Covidien and its expert disagreed with Dr. Schafers opinion
is a conflict in [expert] declarations [which] created a genuine issue of material
infringes the 976 patent claims. Honeywell does not challenge that finding on
appeal.); id. at 1336 (No one challenges those findings on appeal.).
7

This Court has repeatedly reversed district courts that rely on Honeywell to
invalidate patents without considering whether a person of ordinary skill in the art
can discern how to take measurements specified in a claim. See Wellman, Inc. v.
Eastman Chem. Co., 642 F.3d 1355, 1367 (Fed. Cir. 2011) (reversing a ruling of
indefiniteness where it determined that industry guidance would have indicated
to a person of ordinary skill how to conduct measurements specified in the
patent); Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1374
(Fed. Cir. 2011) (upholding the validity of a claim even though the patent did not
specify quantitative limits because a person of ordinary skill would possess
adequate understanding to manipulate these variables to practice the claimed
invention).
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fact that made summary judgment inappropriate. Metro. Life Ins. Co. v. Bancorp
Servs., L.L.C., 527 F.3d 1330, 1338-39 (Fed. Cir. 2008); see also Crown Packaging
Tech., Inc. v. Ball Metal Bev. Container Corp., 635 F.3d 1373, 1384 (Fed. Cir.
2011) (Where there is a material dispute as to the credibility and weight that
should be afforded to conflicting expert reports, summary judgment is usually
inappropriate.).
In sum, the district court ignored the disputed issues of material fact and
failed to draw reasonable inferences in Ethicons favor. See Anderson, 477 U.S. at
255. As this Court has recognized, all close questions of indefiniteness . . . are
properly resolved in favor of the patentee. Ergo Licensing, LLC v. CareFusion
Inc., 673 F.3d 1361, 1367 (Fed. Cir. 2012) (internal quotation marks omitted). For
these reasons, the holding of indefiniteness should be reversed.
II.

THE DISTRICT COURT ERRED IN GRANTING SUMMARY


JUDGMENT OF NON-INFRINGEMENT ON THE 275
PATENT
The district court held that Sonicision does not infringe the sole asserted

independent claim of the 275 Patent because it failed to meet the limitation that
the damping member [is] configured to loosely contact the transmission rod over
a portion of the transmission rod. (A0169/16:64-A0170/17:2 (emphasis added))
The district courts non-infringement finding was based on an erroneous claim
construction. Even under the erroneous construction, summary judgment was

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improper in light of disputed issues of material fact. The district court also found
no infringement because Sonicision did not meet the limitation of having a
damping member adapted to absorb undesired vibrations along the transmission
rod without the use of a fluid. (A0045, A0051) The existence of disputed issues
of material facts makes this finding erroneous as well.
A.

The District Court Erred In Its Construction of


Configured to Loosely Contact the Transmission Rod

The district court erroneously imported a limitation into the construction of


configured to loosely contact the transmission rod. It is a bedrock principle of
patent law that the claims of a patent define the invention to which the patentee is
entitled the right to exclude. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.
Cir. 2005) (en banc) (citation omitted). This Court will only interpret a claim
term more narrowly than its ordinary meaning under two circumstances: 1) when
a patentee sets out a definition and acts as his own lexicographer, or 2) when the
patentee disavows the full scope of a claim either in the specification or during
prosecution. Aventis Pharma SA v. Hospira, Inc., 675 F.3d 1324, 1330 (Fed. Cir.
2012) (quoting Thorner v. Sony Computer Entmt Am. LLC, 669 F.3d 1362, 1365
(Fed. Cir. 2012)); see also HIL-ROM v. Stryker, ___ F.3d ___, 2014 U.S. App.
LEXIS 12105, at *4 (Fed. Cir. June 27, 2014).
Instead of adopting a construction of configured to loosely contact that is
consistent with its ordinary meaningsuch as Ethicon proposed: [c]ontacting or
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capable of contacting portions of the transmission rod, but not tightly fitted
(A1625-A1626)the district court read in an extraneous requirement. Accepting
Covidiens construction, the district court construed configured to loosely
contact to mean structured to have contact other than at fixed support points, but
not tightly fitted. (A0014-A0015 (emphasis added)) This requirement excludes
portions of the transmission rod that are in contact with the sheath. However, this
is not part of the ordinary meaning of the phrase configured to loosely contact,
nor is such a limitation supported by any redefinition or disclaimer by the two
patentees.
The specification distinguishes between loose contact of the invention in the
275 Patent and the prior arts use of silicon rings attached to the transmission rod
at the nodes (locations on the transmission rod which the district court refers to as
fixed support points). (A0166/10:7-17) What the district court failed to
recognize is that the prior art silicon rings are distinguished in the 275 Patent
specification based on the type of contact involved (the rings were tightly fitted or
attached) rather than where on the transmission rod the contact occurs. The
following quotes make this clear: Compare A0162/1:31-40 (Isolation mounts,
such as O-rings, may be mounted around the periphery of the acoustic assembly at
positions of minimal axial ultrasonic activity (i.e. nodes) . . . . The shaft . . . has . .
silicone rings disposed near nodes of the shaft . . .) with A0166/9:58-60 (The
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damping sheath 160 is preferably in light contact with the transmission rod 86 to
absorb unwanted ultrasonic energy from the transmission rod 86.); see also
A0166/10:7-13 (The damping sheath 160 is more effective than using silicone
rubber rings located only at nodes of longitudinal vibration because the damping
sheath 160 can dampen transverse motion occurring near multiple antinodes of the
unwanted vibration which are located randomly along the length of the
transmission rod 86 relative to the nodes and antinodes of the desired longitudinal
vibration.))
The intrinsic record simply does not limit where the loose contact can
occur. The district courts construction confuses the concept of type of the contact
(attached/tight versus loose) with the location of the contact (fixed support points).
Absent this imported claim limitation, it is undisputed that Sonicisions
sleeve is configured to loosely contact the transmission rod. It contacts the
transmission rod and is not tightly fitted. (A1988; A3561/73-78; A3595/57A3602/61, A3604/67) Covidien admitted and the district court found that the
sleeve is structured to have contact with the waveguide . . . at the nodal ribs.
(A0043; A1988; A5586)
B.

Even Under Its Construction, the District Court Erred In


Granting Summary Judgment of Non-Infringement

Even under the district courts incorrect claim construction, there are
genuine issues of fact that preclude summary judgment as to whether Sonicisions
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sleeve is structured to have contact other than at fixed support points, but not
tightly fitted.
Ethicons expert Dr. Schafer opined that Sonicisions sleeve is structured to
have contact other than at fixed support points, but not tightly fitted, as required
by the district courts construction. (A3600-A3602; A3604/67) Dr. Schafer
relied on, among other things, two sets of high-resolution CT scans. In his
opinion, both sets showed loose contact between Sonicisions sleeve and
transmission rod at both the raised nodal points (the fixed support points) and at
points other than the fixed support points. (A3562-A3563; A3602/61A3603/65; A3617-A3618; A3684/5-A3687/12)
Dr. Schafer explained in his report that the first set of CT images showed
that Sonicisions sleeve made contact with the transmission rod at several places
on the transmission rod, including at points . . . where the transmission rod was a
nominal diameterthat is, at points other than the fixed support points. (A3603;
A3617-A3618) As to the second set of CT scans he performed, Dr. Schafer
explained that [t]hese scans confirm the contact [he] saw and reported in [his]
initial report. (A3687/12)
Covidiens expert, Dr. Durfee, corroborated Dr. Schafers finding of contact
in CT image 9(e), one of the images in Dr. Schafers first set of scans, admitting
that the sheath touches in one location other than a fixed support point.
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(A3671/107; see also A3618; A3526-A3527; A3562) Dr. Durfee tried to explain
away this infringing contact, arguing that, in his opinion, it resulted from a
wrinkled sleeve, a nonconforming component that resulted from misassembly or
mishandling. (A3671-A3672) Yet Dr. Durfee admitted in his deposition that he
had no evidence supporting his wrinkle theory. He never discussed it with any
of Covidiens engineers, never gathered any information concerning Covidiens
manufacturing quality control procedures, and never gathered any data concerning
the frequency with which Sonicision devices are produced with wrinkles.
(A3630/81:13-A3631/82:11)
Dr. Durfee also took CT scans. In his opinion, they do not show the
requisite contact. But, Dr. Schafer disagreed, testifying that some of Dr. Durfees
images show contact. (A3687/11) This is a classic battle of the experts
making summary judgment improper. Hilgraeve Corp. v. McAfee Assocs., Inc.,
224 F.3d 1349, 1352-53 (Fed. Cir. 2000) (vacating grant of summary judgment of
no infringement when conflicting allegations of experts le[ft] material factual
questions unanswered); see also Metro. Life, 527 F.3d at 1338-39; Crown
Packaging, 635 F.3d at 1384.
The district court ignored Dr. Durfees admission that one of the scans
showed the requisite contact and failed to consider the second set of scans from Dr.
Schafer, stating without explanation that they were not material to the Courts
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resolution of the relevant dispositive motions. (A6146) To the contrary, the


scans were highly material evidence that provided additional visual proof of the
contact between the sleeve and transmission rod.
The district court also relied on Covidiens self-serving assertion that the
sleeve in Sonicision was specifically designed to avoid contact at locations other
than the fixed support points. (A0042; A0044) Therefore, the district court found
it was not structured to be in loose contact with the transmission rod.
What Covidien supposedly intended to do has no bearing on the actual
structure and performance of its accused device. See Fla. Prepaid Postsecondary
Educ. Expense Bd. v. Coll. Sav. Bank, 527 U.S. 627, 645 (1999) (Actions
predicated on direct patent infringement . . . do not require any showing of intent to
infringe . . . .). The question is, as configured, does the sleeve contact the
transmission rod. Ethicon submitted credible expert testimony that the structure of
the sleeve resulted in the required contact.
As Ethicon demonstrated, the Sonicision is designed with a flexible sleeve
into which a flexible, vibrating transmission rod is placed and the clearance
between the two is very small (0.015 inches). (A3529; A3561/72-78; A3599A3602/61, A3604/67) As Ethicons expert explained, given the structure of
Sonicision, the requisite contact is not just possible, but inevitable. (Id.) Indeed,
the requisite contact was found in every Sonicision that Ethicon tested. (A352635

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A3527; A3562-A3563; A3602-A3604; A3617-A3618; A3684/5-A3687/12)


Based on this record, summary judgment should not have been granted.
C.

The District Court Erred In Finding That Sonicisions


Sleeve Is Not Adapted to Absorb Undesired Vibrations

The district court also erred in finding that Sonicisions sleeve is not
adapted to absorb undesired vibrations as required by claim 1 of the 275 Patent.
Ethicon presented substantial evidence that the sleeve in Sonicision is adapted to
absorb undesired vibrations.
1.

Covidien Admitted That Sonicisons Sleeve Was


Designed To Prevent Metal-to-Metal Contact, a Form
of Undesired Vibrations

Covidiens own witnesses confirmed that Sonicisions transmission rod


experiences undesired vibrations, which in the absence of the sleeve would result
in metal-to-metal contact. According to Patrick Dumbauld, a Covidien engineer,
the Teflon sleeve is designed to contact the waveguideor transmission rodin
order to prevent the waveguide from touching the inner diameter of the inner
tube. (A3649/49:9-16) Metal-to-metal contact occurs when the transmission rod
vibrates into the inner tube. (A3531; A3564/93-94; A3604/69-A3606/73;
A3649/49:9-A3651/51:24; A3659/42:6-11) As Mr. Dumbauld explained, this is
because the waveguide vibrates and its made of titanium, and the inner tube is
made of steel, the sleeve is necessary to reduce the probability of any squealing
associated with those two touching each other. (A3649/49:17-25 (emphasis
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added)) This explanation was confirmed by Robert Stoddard, another Covidien


engineer, who testified that the purpose of the sleeve is [p]rimarily to prevent
contact of the nodal ribs directly with the inner tube to prevent squealing or
rubbing of those two parts where it became an audible -- an audible nuisance to the
user. (A3659/42:6-11; see also A3650/50:18-A3651/51:14 (confirming that
squealing results from the metal-to-metal contact caused by the waveguide
vibrating into the inner tube))
Covidien also admitted that the express purpose of the sleeve in Sonicision
is to act as a buffer that prevents direct metal-to-metal contact between the
waveguides [transmission rod] raised nodal ribs and the surrounding inner tube.
(A5586; A2006/57; A2172/42:6-11) This is an admission that the sleeve is
adapted to absorb undesired vibrations.
Echoing Covidiens witnesses, Dr. Schafer confirmed that, absent the sheath,
undesired vibrations would cause metal-to-metal contact: [m]etal to metal contact
between the vibrating transmission rod and the stationary inner tube would be
caused by the transmission rod vibrating in an undesired way (i.e., vibrating into
the inner tube). (A3606; see also A3564/73) From this, Dr. Schafer concluded
that Covidiens use of the damping sheath absorbs these unwanted vibrations.
(A3606)

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The district court erred in completely ignoring Ethicons evidence that


showed the Sonicisions transmission rod produced undesired vibrations.
2.

Covidiens Droplet Tests Demonstrated Undesired


Vibrations

In an effort to prove non-infringement, Covidien performed tests in an effort


to show the absence of any undesired vibrations. (A1991; A2004/50; A2167A2168) Droplets of water or glycerin were placed on Sonicisions transmission
rod while it vibrated. (A2167-A2168) According to Covidiens expert, the theory
behind the tests was that if the droplet did not splatter off of the transmission rod,
then Sonicision did not experience undesired vibrations. (Id.) If the droplet did
splatter, then Sonicision did experience undesired vibrations. (Id.)
Covidiens expert claimed that none of these tests showed signs of undesired
vibrations. (Id.) Ethicons expert, Dr. Schafer disagreed. Dr. Schafer noted that
Covidiens expert had overlooked a portion of one of the videos that clearly
showed the test fluid splattering off of the transmission rod. (A3565/102;
A3688/16) Dr. Schafer observed that the videos of Dr. Durfees droplet tests
show that there are undesired vibrations in Sonicision since they show[] the test
fluid flying directly off of the transmission rod. (A3688/16) Thus, as Dr.
Schafer opined, [t]his is evidence of the existence of undesired vibrations in
Sonicision. (Id.) But Dr. Schafer did not stop there. He repeated Dr. Durfees

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droplet tests, and again observed the test fluid flying off tangentially from the
transmission rod. (A3688/17)
Here, as elsewhere, the district court resolved a basic fact dispute in
Covidiens favor when it stated that Defendants water droplet testing[]
demonstrates that Sonicision does not experience significant unwanted transverse
vibrations to be absorbed. (A0050) The district court ignored Dr. Schafers
testimony regarding Covidiens tests and also ignored the results of Dr. Schafers
own droplet tests. This evidence creates issues of material fact making summary
judgment inappropriate. See Hilgraeve, 224 F.3d at 1352-53; Metro. Life, 527
F.3d at 1338-39; Crown Packaging, 635 F.3d at 1384.
III.

THE DISTRICT COURT ERRED IN GRANTING SUMMARY


JUDGMENT OF INVALIDITY AND NON-INFRINGEMENT
ON THE DESIGN PATENTS
The district court also erred in granting summary judgment that the Design

Patents are invalid and not infringed. Essentially, the district court confused the
fact that the designs have functions (a requirement for design patentability) as
meaning that they are dictated by function (and are therefore invalid). See High
Point Design LLC v. Buyers Direct, Inc., 730 F.3d 1301, 1316 (Fed. Cir. 2013)
([T]he fact that the article of manufacture serves a function is a prerequisite of
design patentability, not a defeat thereof. (citation omitted)) (reversing a judgment
of invalidity). This error infected both the validity and infringement analysis.

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In addition, the district courts infringement analysis improperly applied the


ordinary observer test as articulated by Egyptian Goddess, Inc. v. Swisa, Inc.,
543 F.3d 665 (Fed. Cir. 2008) (en banc), by neglecting to compare the patented
and accused designs in the context of the prior art. As described below, for both
validity and infringement, the district court ignored Ethicons evidence and
improperly resolved disputed fact issues.
A.

The District Court Erred In Granting Summary Judgment


of Invalidity

A design patent may be granted to [w]hoever invents any new, original and
ornamental design for an article of manufacture. 35 U.S.C. 171. To be
protectable, the design must not be governed solely by function, i.e., that this is
not the only possible form of the article that could perform its function. Rosco,
Inc. v. Mirror Lite Co., 304 F.3d 1373, 1378 (Fed. Cir. 2002) (quoting Seiko Epson
Corp. v. Nu-Kote Intl, Inc., 190 F.3d 1360, 1368 (Fed. Cir. 1999)). A design
patent is invalid if the design is dictated by the utilitarian purpose of the article.
High Point, 730 F.3d at 1315; see also Hupp v. Siroflex of Am., Inc., 122 F.3d
1456, 1460 (Fed. Cir. 1997) (A design or shape that is entirely functional, without
ornamental or decorative aspect, does not meet the statutory criteria of a design
patent.).

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[V]arious factors may help determine whether a claimed design, as a


whole, is dictated by functional considerations. High Point, 730 F.3d at 1315.
Relevant factors include:
[1] whether the protected design represents the best design,
[2] whether alternative designs would adversely affect the
utility of the specified article; [3] whether there are any
concomitant utility patents; [4] whether the advertising touts
particular features of the design as having specific utility; [5]
and whether there are any elements in the design or overall
appearance clearly not dictated by function.
Id. (quoting PHG Techs., LLC v. St. John Cos., 469 F.3d 1361, 1366 (Fed. Cir.
2006), in turn quoting Berry Sterling Corp. v. Pescro Plastics, Inc., 122 F.3d 1452,
1456 (Fed. Cir. 1997)).
A paramount consideration is whether alternative designs exist that would
function as well as the patented design. [I]f other designs could produce the same
or similar functional capabilities, the design of the article in question is likely
ornamental, not functional. Rosco, 304 F.3d at 1378.
As described below, Ethicon submitted ample evidence that the patented
designs were not dictated by function.
1.

Whether the Patented Designs Are Dictated by


Function Is a Disputed Issue of Fact

In granting Covidien summary judgment of invalidity, the district court


ignored Ethicons evidence that alternative designs would work as well as the
Design Patentsevidence that the Design Patents are not dictated by function.
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Ethicons expert, Alan Ball, a practicing industrial designer with experience


designing hand-held medical devices, opined that there are many different designs
that would function just as well as the patented designs. (A4807-A4808; A4812A4813; A4817; see also A4809-A4812; A4814-A4816; A4818) In fact, Mr. Ball
opined that he was confident that either [he] or [Covidiens expert] Mr. Kemnitzer
could design a better trigger for a handheld surgical device with improved
functionality and an entirely different appearance than the asserted design.
(A4810 (emphasis added))
For example, Mr. Ball opined that the following designs would work better
than Ethicons patented trigger design by providing a surer grip and more surface
area against which to apply force in a distal direction:

(A4808, A4811-A4812)
Mr. Ball also identified the following prior art designs for hand-held surgical
device triggers, which function just as well as the claimed designs:

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(A4809, A4811)
There are also many other alternative designs for hand-held surgical devices
featured in the prior art, some of which feature a U-shaped trigger of the type the
district court found functional. For example:

(A4808, A4814, A4828-A4829/70.a)


The lead inventor of the Design Patents, Dan Price, agreed that there are
alternative designs that have functional advantages over the patented designs. He
stated that some of the design concepts [Ethicon] did not choose work better in
certain respects than the concepts [Ethicon] chose. (A5573) Specifically, Mr.

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Price identified the perceived or actual advantages of other designs related to the
shape of the trigger (A5573-A5574), the size and location of the rotation knob
(A5574-A5575), and the nature of the activation button (A5575).
Even Mr. Kemnitzer, Covidiens expert, pointed out that theres always
options to make changes in the way something looks (A5185/92:19-21), admitting
that its possible to make -- to design another handle that would work, that would
work well, would function well yet look different (A5214/199:21A5215/200:25), and in fact that there are a number of examples of different
looking triggers having the same functional aspects as the patented design
(A5209/182:17-A5210/183:12).8
Whether a design is entirely functional and lacking any ornamental or
decorative aspect typically is a question of fact. PHG Techs., 469 F.3d at 1365.
The issue is not suitable for resolution on summary judgment where, as here, there
are disputed fact issues as to functionality when viewing the evidence in the light
most favorable to Ethicon. Anderson, 477 U.S. at 255.
Ignoring the alternative designs identified by Ethicons expert, the district
court instead compared the various features covered by the Design Patents (the

Market research showed that some consumers thought alternate designs worked
better than the patented designs. (A5496) For instance, Covidiens pre-market
prototype testing indicated that some users did not like the U-shaped trigger and
preferred a loop trigger. (A4896, A4911; A4925)
8

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trigger, rotation knob, activation button) to a single alternative (each found in a


prior Ethicon device), and then concluded that the asserted designs worked better.
(A0127-A0128)
But the mere fact that the asserted designs function better than a particular
device does not prove that the patented designs are dictated by functional
considerations. Rosco, 304 F.3d at 1378 (The mere fact that the invention
claimed in the design patent exhibited a superior field of view over a single
predecessor mirror . . . does not establish that the design was dictated by
functional considerations . . . .).
By ignoring the evidence that alternative designs could achieve the same
function, the district court committed an error that this Court has cautioned against:
confusing the fact that a design has a function with the idea that the design itself is
dictated by its function. High Point, 730 F.3d at 1316; Hupp, 122 F.3d at 1460
([T]he fact that the article of manufacture serves a function is a prerequisite of
design patentability, not a defeat thereof. The function of the article itself must not
be confused with functionality of the design of the article.). Although the
Design Patents show a design for a useful objectfor example, a trigger that can
be used to open and close the jaws of a handheld ultrasonic surgical devicea
distinction exists between the functionality of an article or features thereof and the
functionality of the particular design of such article or features thereof that perform
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a function. Avia Grp. Intl, Inc. v. L.A. Gear Cal., Inc., 853 F.2d 1557, 1563
(Fed. Cir. 1988).
As Ethicons evidence and alternative designs demonstrated (see supra pp.
40-43), even though the components shown in the Design Patents have functions,
this does not mean that they could not be designed to look different and yet have
the same functionality. L.A. Gear, Inc. v. Thom McAn Shoe Co., 988 F.2d 1117,
1123 (Fed. Cir. 1993) (the fact that elements of a design perform functions does
not mean that the specific design of each element, and the combination of these
elements into the patented design, is dictated by primarily functional
considerations).
Moreover, Covidiens reliance on the functionality of a few components of
the design in advertising does not render the entire design incapable of design
patent protection. What matters is the overall appearance. See PHG Techs., 469
F.3d at 1366 ([T]he determination of whether the patented design is dictated by
the function of the article of manufacture must ultimately rest on an analysis of its
overall appearance. (quoting Berry, 122 F.3d at 1455)). Ethicons advertising
emphasizes the aesthetics of the patented designs through multiple large, close-up,
high-resolution color photographs of the device. (A3192-A3204) Referring to
functional advantages of certain elements of the product does not demonstrate that
the overall design is dictated by function.
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The district courts finding that each and every aspect claimed in the
Design Patents is clearly dictated by function (A0131) ignores Ethicons
evidence. For example, Ethicon demonstrated that the use of curves in the design
of the trigger is not dictated by function. As Mr. Price testified, many of the
curved forms on the trigger were chosen because they lent a more graceful look
to the design, giving it a more aesthetic, artistic gracefulness. (A4603/271:22-23)
Moreover, he acknowledged that other approaches are possible without sacrificing
ergonomics. (A4603/271:24-A4604/272:13 ([M]y feeling was that a very, you
know, curvy device fits better in your hand and it has more of a graceful look to it,
it has a more aesthetic, artistic gracefulness quality to it. But theres other
designers that would take a different approach. And you can have some very nice
designs that are, you know, a lot more linear. And you can . . . make that
ergonomically good.); A4611/279:20-A4612/280:18 (noting that many of the
curves were added to the design to create a unity of design, more of a friendly,
welcoming kind of overall feel, and a visual impression of the aesthetics [that] is
inviting)) In sum, conflicting evidence on whether the designs in question are
dictated solely by function should not have been resolved on summary judgment.
2.

The District Court Erred In Its Application of the


Other Factors Identified In Berry

The district court also erred in its analysis of the other factors identified in
Berry, 122 F.3d at 1456. For example, the district court concluded that the Design
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Patents embody the optimal design for an ultrasonic surgical product. (A1027)
But Covidiens own expert conceded there is no best design for a product such
as this. (A5172/33:13-A5173/34:2 ([O]ne of the misunderstood concepts of
ergonomics is that there is one solution that is ideal . . . .); A5177/38:15A5178/39:2 (I dont think theres an ultimate design for anything . . . .);
A5213/186:2-23; A5223/276:10-22; see also A4806-A4807; A4999/273:18A5000/274:13)
The fact that Ethicon preferred the patented designs over other designs it
tested does not make the chosen design objectively the best design or make the
alternative designs identified by Ethicons expert irrelevant. Ethicon selected the
designs reflected in the Design Patents not because no other design could work as
well, but rather because Ethicon concluded that surgeons may prefer the selected
designs, visually and ergonomically. (A4596/214:17-A4597/215:25; A5573A5574/19-22)
This does not make other design alternatives irrelevant nor does it make the
design selected the best. As noted above, Ethicons expert testified that the
alternative designs he identified would not adversely affect the utility of the device.
In his view, the alternative designs would have performed better than the patented
designs. (See supra Section III.A.1.; A4808, A4811-A4812; see also A5574/24)
Rather than grapple with this evidence, the district court simply concluded that the
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Design Patents are more functional than Ethicons predecessor design. (A0127A0128) This Court addressed a nearly identical scenario in Rosco and reversed the
district courts finding of invalidity. 304 F.3d at 1378 (holding that a design is not
dictated by function merely because it has functional advantages over a single
predecessor).
The district court also relied on the fact that Ethicon sought utility patents on
its devices. But the existence of a pair of utility patent applications does not make
the Design Patents entirely functional. (A1028) In fact, it is common for a
product to be covered by both a utility patent and a design patent. See Avia, 853
F.2d at 1563 ([A] distinction exists between the functionality of an article or
features thereof and the functionality of the particular design of such article or
features thereof that perform a function. Were that not true, it would not be
possible to obtain a design patent on a utilitarian article of manufacture, or to
obtain both design and utility patents on the same article.) (citations omitted); see
also Crocs, Inc. v. Intl Trade Commn, 598 F.3d 1294, 1297 (Fed. Cir. 2010)
(noting utility and design patent protection for same article).
An invention can be protected by both utility and design patents so long as
its usefulness can be achieved via different looking designs. The alternative
designs identified by Ethicons expert show that different designs could achieve
the same functionality. Moreover, the claims of the utility patent applications do
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not describe the particular proportions or specific design of the elements claimed in
the design patents. There are many different looking designs that would fit the
language of the utility applications that the district court cited. (A3018/124
(describing one embodiment of the claimed invention; A3019/128 (same);
A3020/131 (same))
B.

The District Court Erred In Granting Summary Judgment


Of Non-Infringement of the Design Patents
1.

The District Court Erred In Factoring Out


Elements of the Design Patents Based On
Functionality

The district courts errors, discussed above, regarding the functionality of


the Design Patents also infected its infringement analysis. Having found the
shape and placement of the trigger, knob, and button (essentially, the entirety of
the patent claims) functional, the district court factored out these elements of the
claimed design for infringement purposes.
This was an error. Akin to the invalidity analysis, elements should not be
read out of the claim for infringement analysis unless those design elements are
dictated by some functional requirement. In Richardson v. Stanley Works, 597
F.3d 1288 (Fed. Cir. 2010), this Court made clear that it is only the portions of a
design patents drawings that are dictated by function that can be excluded in an
infringement analysis. The Richardson court described the factored out elements
of the patented tool design as driven purely by utility, dictated by their
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functional purpose, and purely functional. Richardson, 597 F.3d at 1294.


Furthermore, Richardson approvingly cited L.A. Gear, the seminal case for the
proposition that just because an element of a design serves a useful function does
not mean that it is ineligible for design patent protection. Id. at 1294.
The district court, however, applied a dramatically different standard by
factoring out any features of the patent that were informed by or based on
functional considerations. (A0133 (emphasis added)) That standard has no basis
in this Courts precedents. See Nordock, Inc. v. Sys., Inc., 927 F. Supp. 2d 577,
604-05 (E.D. Wis. 2013) (An aspect of a design patent is non-ornamental only if
the design is dictated by its functionality (de jure functional) and there are not
alternative designs that could perform the same function.); Apple, Inc. v.
Samsung Elecs. Co., 11 Civ 1846, 2011 U.S. Dist. LEXIS 139049, at *31 (N.D.
Cal. Dec. 2, 2011) (Richardson instructs the district court to identify the aspects
of the design that are dictated by function . . . .); Good Sportsman Mktg. LLC v.
Li & Fung Ltd., 07 Civ 395, 2010 U.S. Dist. LEXIS 65458, at *10 (E.D. Tex. June
29, 2010) (While the identified components may have functions, they need not be
excluded simply because they perform functions.).
As described above (supra pp. 40-43), Ethicon showed that alternative
designs could meet the functional needs of the user. This same evidence creates an
issue of material fact as to infringement. The elements of the Design Patents
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identified by the district court are not dictated by function and therefore should be
considered in analyzing whether the accused devices infringe. The judgment of
non-infringement should be reversed.
2.

The District Court Erred In Failing to Consider the


Prior Art In Its Infringement Analysis

Infringement of a design patent exists where in the eye of an ordinary


observer, giving such attention as a purchaser usually gives, [the] two designs are
substantially the same. Revision Military, Inc. v. Balboa Mfg. Co., 700 F.3d 524,
526 (Fed. Cir. 2012) (quoting Gorham Co. v. White, 81 U.S. 511, 528 (1871)). In
applying this test, the background prior art, provides . . . a frame of reference and
therefore often is useful in the process of comparison. Id. (quoting Egyptian
Goddess, Inc. v. Swisa, Inc., 543 F.3d 665, 677 (Fed. Cir. 2008) (en banc)).
Considering whether the patented and accused designs are substantially the
same should have been done in the context of the prior art with which an ordinary
observer would reasonably be familiar. See Egyptian Goddess, 543 F.3d 665. The
district courts failure to do so is error and requires reversal of the noninfringement ruling.
In Egyptian Goddess, this Court, sitting en banc, explained that
consideration of the prior art is necessary to the ordinary observer test because
if the accused design has copied a particular feature of the claimed design that
departs conspicuously from the prior art, the accused design is naturally more
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likely to be regarded as deceptively similar to the claimed design, and thus


infringing. Id. at 677. As this Court explained, the prior art provides a useful
frame of reference for the infringement analysis. Id. at 676-77; see also Pac.
Coast Marine Windshields Ltd. v. Malibu Boats, LLC, 739 F.3d 694, 701 (Fed. Cir.
2014) (stating that infringement analysis in design patent cases focuses on the
perspective of one familiar with the prior art).
The district court held that the patented and accused designs at issue here are
so plainly dissimilar that the court need not consider the frame of reference
provided by the prior art. This was error. The designs (shown below) are not so
manifestly different to justify ignoring the prior art.

804 Patent

Sonicision

Using the prior art as context would be particularly important in this case.
As discussed above (supra pp. 12-13), before the invention of the design that led to
the Design Patents, the clamping arm of almost every ultrasonic surgical device
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was controlled by a thumb-ring or a loop-shaped trigger. (A5573/20,


A5575/28-30; A4656-A4657; A4662/61:8-24; A5008-A5009; A5361-A5363)
For example:

The prior art here shows how closely Covidien sought to mirror the patented
design and distinguish Sonicision from the prior art.
It is exactly in cases like this, where the patented design was unique in the
field until the accused product launched, that the frame of reference provided by
the prior art is so crucial. Under these circumstances, infringement is more likely
because the accused design has copied a particular feature of the claimed design
that departs conspicuously from the prior art. Egyptian Goddess, 543 F.3d at 677.
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In Revision Military, the district court took the same erroneous approach that
the district court followed here. In that case, as here, the district court did not
consider the prior art context in which the ordinary observer test is applied,
because, in its view, the accused product and asserted design were too dissimilar to
require it to view the designs in the context of the prior art. Revision Military, 700
F.3d at 527. This Court reversed and remanded the case to the district court for
reconsideration of the infringement question.9 Id. The same result is appropriate
here.
The district court also erred in concluding that a surgeon is not an ordinary
observer for purposes of infringement because surgeons are not involved in
purchasing negotiations, and [are] not expending any money. (A0134)10 This
was error. One need not be the person who pays for the accused product to be an
ordinary observer for an infringement analysis: one must merely be sufficiently
interested in the item and have the capability of making a reasonably discerning
9

Egyptian Goddess is not confined to cases where there are no perceptible


differences in the protected and the accused design. In such instances, resort to
prior art would be unnecessary, because substantial similarity would be so
abundantly clear.

10

The district court never actually identified who the ordinary observer was. It just
noted that a number of entities were involved in the purchasing process, stating:
While the surgeon may have some input to a hospital into which devices he or
she prefers, the surgeon is not involved in purchasing negotiations, and is not
expending any money. As it is the hospital or supply company that is ultimately
putting out the money for these devices, they will heavily scrutinize the details of
the purchase process. (A0134-A0135)
55

Case: 14-1370

CASE PARTICIPANTS ONLY Document: 23

Page: 64

Filed: 07/21/2014

decision when observing the accused items design whether the accused item is
substantially the same as the item claimed in the design patent. Arminak &
Assocs. v. Saint-Gobain Calmar, Inc., 501 F.3d 1314, 1323 (Fed. Cir. 2007). In
fact, Covidiens proffered expert agreed that surgeons qualify here as ordinary
observers. (A5216/268:17-18)
Once again, the district court improperly resolved disputed fact issues on
summary judgment. The grant of summary judgment of infringement of the
Design Patents should be reversed.

56

Case: 14-1370

CASE PARTICIPANTS ONLY Document: 23

Page: 65

Filed: 07/21/2014

CONCLUSION
For all of the above reasons, this Court should reverse the orders granting
summary judgment for the patents-in-suit.
July 21, 2014
Respectfully submitted,

/s/ William F. Cavanaugh, Jr.


William F. Cavanaugh, Jr.
Chad J. Peterman
R. James Madigan III
Helen P. OReilly
Jeremy A. Weinberg
PATTERSON BELKNAP WEBB & TYLER LLP
1133 Avenue of the Americas
New York, New York 10036
Tel. 212-336-2000
Fax 212-336-2222
wfcavanaugh@pbwt.com
cjpeterman@pbwt.com
jmadigan@pbwt.com
horeilly@pbwt.com
jweinberg@pbwt.com
Attorneys for Plaintiffs-Appellants

57

Case: 14-1370

CASE PARTICIPANTS ONLY Document: 23

Page: 66

Filed: 07/21/2014

CERTIFICATE OF SERVICE
I hereby certify that on July 21, 2014, I caused the foregoing BRIEF FOR
PLAINTIFFS-APPELLANTS to be electronically filed with the Clerk of the
Court using the CM/ECF system, which will send notification of such filing to the
registered attorney(s) of record that the document has been filed and is available
for viewing and downloading.
In addition, two copies of the brief will be sent via express mail on the same
date as above to the following:
Drew M. Wintringham, III, Esq.
DLA Piper LLP (US)
1251 Avenue of the Americas
New York, New York 10020
212-335-4520
drew.wintringham@dlapiper.com
Attorneys for Defendants-Appellees

July 21, 2014


By:

58

/s/ Helen P. OReilly


Helen P. OReilly

Case: 14-1370

CASE PARTICIPANTS ONLY Document: 23

Page: 67

Filed: 07/21/2014

CERTIFICATE OF COMPLIANCE
This brief complies with the type-volume limitation of FED. R. APP. P.
32(a)(7)(B). The brief contains 11,499 words, as calculated by the word count of
the word processing system used in preparing it, excluding the parts of the brief
exempted by FED. R. APP. P. 32(a)(7)(B)(iii) and FED. CIR. R. 32(b).
This brief complies with the typeface requirements of FED. R. APP. P.
32(a)(5) and the type style requirements of FED. R. APP. P. 32(a)(6). The brief has
been prepared in Microsoft Word 2010 in Times New Roman 14 point font.
July 21, 2014

/s/ William F. Cavanaugh, Jr.


William F. Cavanaugh, Jr.

59

2014-1370
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
ETHICON ENDO-SURGERY, INC and ETHICON ENDO-SURGERY, LLC.,
Plaintiffs-Appellants,
v.
COVIDIEN, INC. and COVIDIEN LP,
Defendants-Appellees.

Appeal from the United States District Court for the Southern District of Ohio
in No. 11-cv-00871, Judge Timothy S. Black.

RESPONSE BRIEF FOR DEFENDANTS-APPELLEES

Drew M. Wintringham, III


Francis W. Ryan
Stanley J. Panikowski
Melissa A. Reinckens
Matthew N. Ganas
DLA Piper LLP (US)
1251 Avenue of the Americas
New York, NY 10020-1104
Telephone: (212) 335-4520
Facsimile: (917) 778-8520
Attorneys for Defendants-Appellees
Covidien, Inc. and Covidien LP
EAST\86892369.1

CERTIFICATE OF INTEREST
ETHICON ENDO-SURGERY, INC. and ETHICON ENDO-SURGERY, LLC v.
COVIDIEN, INC. and COVIDIEN LP
No. 14-1370
Counsel for Defendants-Appellees certifies the following:
1.

The full name of every party or amicus represented by me is:


COVIDIEN, INC. and
COVIDIEN LP

2.

The name of the real party in interest (if the party named in the caption is not
the real party in interest) represented by me is:
N/A

3.

All parent corporations and any publicly held companies that own 10 percent
or more of the stock of the party or amicus curiae represented by me are:
Covidien PLC (Covidien, Inc. and Covidien LP)

4.

The names of all law firms and the partners or associates that appeared for
the party or amicus now represented by me in the trial court or agency or are
expected to appear in this court are:
DLA Piper LLP (US): Drew M. Wintringham, Francis W. Ryan, Mark
Rueh (deceased), Stanley J. Panikowski, Darius C. Gambino, Edward H.
Sikorski, Erica Pascal, Melissa Reinckens, Matthew Ganas, and Joanna
Sykes-Saavedra of DLA Piper LLP (US); and
James Francis McCarthy, III and Robert Alexander Pitcarin, Jr. of Katz
Teller Brant & Hild

Dated: November 18, 2014


/s/ Drew M. Wintringham
Drew M. Wintringham
EAST\86892369.1

TABLE OF CONTENTS
Page
STATEMENT OF RELATED CASES .................................................................... 1
I.

INTRODUCTION .......................................................................................... 2

II.

STATEMENT OF THE ISSUES ................................................................... 4

III.

STATEMENT OF FACTS ............................................................................. 5


A.

B.

The Patents on Appeal.......................................................................... 5


1.

The 501 Clamping Force and Pressure Patent.......................... 5

2.

The 275 Unwanted Vibration Damping Patent ........................ 8

3.

The Design Patents...................................................................12

The Sonicision Surgical Instrument ...................................................14

IV.

SUMMARY OF THE ARGUMENT ...........................................................17

V.

STANDARD OF REVIEW ..........................................................................19

VI.

ARGUMENT ................................................................................................21
A.

B.

C.

The District Court Correctly Granted Summary Judgment of


Invalidity Based on Indefiniteness of the 501 Patent .......................21
1.

The Patent Does Not Disclose the Use of Any Method of


Measuring Clamping Force and Pressure that Would
Inform a Skilled Artisan of the Boundaries of the Claims ......22

2.

Ethicons Conclusory and Unsubstantiated Expert


Testimony Does Not Create a Disputed Issue of Material
Fact ...........................................................................................25

The District Court Correctly Granted Summary Judgment of


Noninfringement of the 275 Patent ...................................................30
1.

The Sonicision Sleeve Does Not Practice the


Configured to Loosely Contact Claim Limitation ...............30

2.

The Sonicision Sleeve Is Not Adapted to Absorb


Undesired Vibrations .............................................................40

The District Court Correctly Granted Summary Judgment of


Invalidity of the Design Patents Based on Functionality ...................47

-i-

TABLE OF CONTENTS
(continued)
Page

D.

1.

The District Court Adequately Considered Alternative


Designs in Its Analysis.............................................................48

2.

The Undisputed Evidence Shows The Claimed Design Is


the Best Design and Alternative Designs Would
Adversely Affect Utility ..........................................................50

3.

The Remaining Berry Sterling Factors Also Show


Functionality as a Matter of Law .............................................53

The District Court Correctly Granted Summary Judgment of


Noninfringement on the Design Patents ............................................57
1.

The District Court Correctly Factored Out the Functional


Aspects of the Claimed Design ................................................57

2.

The District Courts Alternative Analysis, Which


Considered All Aspects of the Claimed Design, Also
Supports the Summary Judgment of Noninfringement ...........59

3.

The District Court Did Not Need to Consider the Prior


Art in Ruling on the Infringement Claim Because the
Claimed Design and Accused Device Are Plainly
Dissimilar .................................................................................65

4.

The District Court Correctly Noted the Sophistication of


the Ordinary Observer Who Purchases Surgical
Instruments ...............................................................................68

VII. CONCLUSION.............................................................................................69

- ii -

TABLE OF AUTHORITIES
Page
CASES
Abbott Labs. v. Sandoz, Inc.,
566 F.3d 1282 (Fed. Cir. 2009) .......................................................................... 31
Am. Calcar, Inc. v. Am. Honda Motor Co., Inc.,
651 F.3d 1318 (Fed. Cir. 2011) .......................................................................... 31
Anderson v. Kimberly-Clark Corp.,
570 Fed. Appx. 927 (Fed. Cir. 2014) ................................................................ 66
Anderson v. Liberty Lobby, Inc.,
477 U.S. 242 (1986) ................................................................................19, 20, 39
Arminak & Assocs. v. Saint-Gobain Calmar, Inc.,
501 F.3d 1314 (Fed. Cir. 2007) .......................................................................... 68
Aspex Eyewear, Inc. v. Marchon Eyewear, Inc.,
672 F.3d 1335 (Fed. Cir. 2012) ....................................................................46, 47
Avia Grp. Intl, Inc. v. L.A. Gear Cal., Inc.,
853 F.2d 1557 (Fed. Cir. 1988) .......................................................................... 55
Berry Sterling Corp. v. Pescor Plastics, Inc.,
122 F.3d 1452 (Fed. Cir. 1997) ...................................................................passim
Biogen, Inc. v. Berlex Labs., Inc.,
318 F.3d 1132 (Fed. Cir. 2003) .......................................................................... 31
Braun v. Ann Arbor Charter Twp.,
519 F.3d 564 (6th Cir. 2008) .............................................................................. 19
Crocs, Inc. v. Intl Trade Commn,
598 F.3d 1294 (Fed. Cir. 2010) .......................................................................... 55
Dynacore Holdings Corp. v. U.S. Phillips Corp.,
363 F.3d 1263 (Fed. Cir. 2004) ....................................................................43, 45
Egyptian Goddess, Inc. v. Swisa, Inc.,
543 F.3d 665 (Fed. Cir. 2008) .....................................................................passim
- iii -

TABLE OF AUTHORITIES
(continued)
Page
Fromson v. Advance Offset Plate, Inc.,
755 F.2d 1549 (Fed. Cir. 1985) .......................................................................... 20
Gart v. Logitech, Inc.,
254 F.3d 1334 (Fed. Cir. 2001) .......................................................................... 40
Gorham Co. v. White,
81 U.S. 511 (1871) ........................................................................................60, 65
High Point Design LLC v. Buyers Direct Inc.,
730 F.3d 1301 (Fed. Cir. 2013) ..............................................................48, 52, 58
Honeywell Intl. Inc. v. Intl Trade Commn,
341 F.3d 1332 (Fed. Cir. 2003) ....................................................................23, 24
In re Becton, Dickinson and Co.,
675 F.3d 1368 (Fed. Cir. 2012) .......................................................................... 55
Interactive Gift Exp., Inc. v. Compuserve Inc.,
256 F.3d 1323 (Fed. Cir. 2001) .......................................................................... 26
Interval Licensing LLC v. AOL, Inc.,
766 F.3d 1364 (Fed. Cir. 2014) .......................................................................... 28
Invitrogen Corp. v. Clontech Labs., Inc.,
429 F.3d 1052 (Fed. Cir. 2005) ...................................................................passim
Krippelz v. Ford Motor Co.,
667 F.3d 1261 (Fed. Cir. 2012) ..............................................................25, 27, 28
Lighting Ballast Control LLC v. Phillips Elecs. N. Am. Corp.,
744 F.3d 1272 (Fed. Cir. 2014) (en banc) .......................................................... 20
McLean v. 988011 Ontario, Ltd.,
224 F.3d 797 (6th Cir. 2000) .............................................................................. 28
Moore U.S.A., Inc. v. Standard Register Co.,
229 F.3d 1091 (Fed. Cir. 2000) .......................................................................... 43

- iv -

TABLE OF AUTHORITIES
(continued)
Page
MRC Innovations, Inc. v. Hunter Mfg., LLP,
747 F.3d 1326 (Fed. Cir. 2014) .......................................................................... 19
Nautilus, Inc. v. Biosig Instruments, Inc.,
134 S. Ct. 2120 (2014) ........................................................................................ 21
Oddzon Prods., Inc. v. Just Toys, Inc.,
122 F.3d 1396 (Fed. Cir. 1997) .......................................................................... 57
PHG Tech. v. St. John Companies,
469 F.3d 1361 (Fed. Cir. 2006) ....................................................................47, 53
Phillips v. AWH Corp.,
415 F.3d 1303 (Fed. Cir. 2005) .......................................................................... 31
Revision Military, Inc. v. Balboa Mfg. Co.,
700 F.3d 524 (Fed. Cir. 2012) ......................................................................66, 67
Richardson v. Stanley Works, Inc.,
597 F.3d 1288 (Fed. Cir. 2010) .......................................................................... 57
Rosco, Inc. v. Mirror Lite Co.,
304 F.3d 1373 (Fed. Cir. 2002) .......................................................................... 51
SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc.,
242 F.3d 1337 (Fed. Cir. 2001) .......................................................................... 34
Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.,
537 F.3d 1357, 1372 (Fed. Cir. 2008) ..........................................................24, 25
Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.,
No. 13-854 .......................................................................................................... 20
TrafFix Devices, Inc. v. Marketing Displays, Inc.,
532 U.S. 23 (2001) .............................................................................................. 56
Typhoon Touch Techs., Inc. v. Dell, Inc.,
659 F.3d 1376 (Fed. Cir. 2011) .......................................................................... 38

-v-

TABLE OF AUTHORITIES
(continued)
Page
Unidynamics Corp. v. Automatic Prods Intl Ltd.,
157 F.3d 1311 (Fed. Cir. 1998) ....................................................................57, 67
Walker Digital, LLC v. Microsoft Corp.,
484 F. Appx 496 (Fed. Cir. 2012) ..................................................................... 31
Wavetronix LLC v. EIS Elec. Integrated Sys.,
573 F.3d 1343 (Fed. Cir. 2009) .......................................................................... 20
Wellman, Inc. v. Eastman Chem. Co.,
642 F.3d 1355 (Fed. Cir. 2011) .......................................................................... 24

STATUTES AND RULES


35 U.S.C. 171 ........................................................................................................ 47
Fed. R. Civ. P. 56 ..................................................................................................... 19

- vi -

STATEMENT OF RELATED CASES


No appeal in or from this case was previously before this or any other
appellate court. Counsel for Defendants-Appellees knows of no case pending in
this or any other court that will directly affect or be directly affected by this
Courts decision in this appeal.

-1-

I.

INTRODUCTION
Ethicon launched a barrage of various patents against Covidiens novel and

successful Sonicision surgical instrument. But the undisputed facts showed that
none of these patents covers the Sonicision device, and several were ruled invalid
as a matter of law. Ethicon has given up on three of the originally-asserted patents
entirely. It now presses on appeal various issues relating to two utility patents and
a group of design patents.
Ethicon mischaracterizes this case as one where the district favored one
version of the facts over another. In reality, the district court favored the
undisputed material facts over Ethicons legally insufficient attempts to
manufacture a competing view, including with conclusory expert testimony. The
judgment should be affirmed in its entirety.
The 501 Patent
The district court ruled that one of the utility patents, U.S. Patent No.
8,182,501 (the 501 patent), was both invalid as indefinite and not infringed.
Abandoning any appeal of the noninfringement judgment, Ethicon challenges only
the invalidity ruling. But the asserted claims are invalid as indefinite because the
patent fails to identify any method for measuring the clamping force and
clamping pressure that are at the heart of the claims. Ethicons own witnesses
and documents showed, without dispute: (1) there are various ways to measure
-2-

clamping force and pressure; (2) the results will vary significantly depending on
the particular method used; (3) the patent did not disclose the use of any of these
measurement methods, much less a particular one; and (4) there was no known
industry standard for the measurement of clamping force and pressure.
The 501 patent thus does not inform a skilled artisan of the claim scope
with reasonable certainty. Because the patent fails this basic test for allowing the
public to discern its boundaries, the district court correctly ruled the asserted
claims are indefinite as a matter of law.
The 275 Patent
The district court also ruled that no reasonable fact-finder could find
infringement of U.S. Patent No. 5,989,275 (the 275 patent). First, the district
court correctly construed the configured to loosely contact term in light of the
claim language and specification. In doing so, the court properly rejected
Ethicons attempt to divorce that term from the claim language and specification.
Second, the district court correctly ruled that the undisputed facts showed Ethicon
could not prevail on infringement. Two independent grounds support this ruling:
the accused Sonicision device is neither configured to loosely contact the
transmission rod over a portion of the transmission rod nor adapted to absorb
undesired vibrations along the transmission rod without the use of fluid.

-3-

The Design Patents


The district court also ruled that, as a matter of law, U.S. Des. Pat. Nos.
D661, 801 (the 801 Patent), D661,802 (the 802 Patent), D661,803 (the 803
Patent) and D661,804 (the 804 Patent) (collectively, the Design Patents) are
invalid as functional and not infringed. Regarding invalidity, the district court
correctly determined that the claimed design was dictated by function and hence
ineligible for patent protection. Regarding noninfringement, the district court
properly recognized that no reasonable fact-finder could find Covidiens design
substantially similar to the claimed design given the many plain dissimilarities
between them. The district court correctly rejected Ethicons attempt to expand the
coverage of the Design Patents far beyond the drawings that limit their scope.
II.

STATEMENT OF THE ISSUES


1.

Did the district court correctly rule the asserted claims of the 501

patent are invalid as indefinite as a matter of law because a skilled artisan cannot
be reasonably certain of the boundaries of the clamping force and clamping
pressure claim terms?
2.

Did the district court correctly grant summary judgment of

noninfringement of the 275 patent because the undisputed evidence shows


Covidiens accused devices do not practice the properly construed claims?

-4-

3.

Did the district court correctly grant summary judgment of invalidity

of the Design Patents because the claimed features are dictated by function?
4.

Did the district court correctly grant summary judgment of

noninfringement of the Design Patents because Covidiens accused designs are


plainly dissimilar from Ethicons claimed designs?
III.

STATEMENT OF FACTS
Ethicon asserted numerous patents against Covidiens Sonicision device.

(A226-55.) The parties agreed that any trial of the case would be a bench trial.
(A226-55.) Ethicon dropped one of those patents after claim construction and
dismissed another patent after discovery. (A1770; A1892-99; A257-82; A1603;
A1612; A301-14.)
The district court then granted Covidiens motions for summary judgment of
noninfringement, invalidity, or both on all of the remaining patent infringement
claims. (A25-51; A52-109; A110-143; A6068-94; A144-52; A6095-116.) Ethicon
appealed only some of the district courts rulings. In doing so, Ethicon also
abandoned further proceedings regarding another patent. Only the patents that
remain on appeal are discussed below.
A.

The Patents on Appeal


1.

The 501 Clamping Force and Pressure Patent

Ethicon asserted infringement of 17 claims of the 501 patent. (A4259-306;


A4261; A2049-50.) The 501 patent describes ultrasonic surgical shears for
-5-

cutting and sealing a blood vessel. (A4261-62 6-7; A2509-17; A2511.) The
shears have a movable clamp arm and blade at the distal end. (A4261-62 6-7;
A2509; A2511.) An example of the clamp and blade (together referred to as the
jaw) of the 501 ultrasonic device is shown below.

(A2511/Fig. 2.)
The 501 patent claims particular numeric ranges of clamping force and
clamping pressure applied by the clamp arm to tissue. (A2516-17.) The claimed
instrument is activated ultrasonically to cut and coagulate tissue placed in the jaw.
(A2509/Abstract; A2514/1:40-46, 2:4-5.) Coagulation (or sealing) occurs as the
surgeon squeezes on the handle of the device to close the clamp toward the blade
and against the tissue. (A2607-12.) As the surgeon continues to squeeze the
-6-

handle, the force exerted by the clamp arm increases. (A4275-76 43-44; A2543;
A2574-77; A2687-89.)
The force exerted by the clamp is not evenly distributed across the clamp
arm. (A2697-98.) The distal end experiences less force and the proximal end
(near the pivot point of the clamp) experiences greater force. (A4286-87 70-71;
A2695-703; A2697-98; A2675-93; A2679.) Accordingly, the pressure (i.e., force
divided by surface area (A2515/4:17)) is also different depending on where along
the jaw it is measured. (A4277 46-47; A2678; A2697.)
Despite claiming specific numeric ranges for clamp force,1 the 501 patent
does not disclose how to measure clamp force or determine whether a device exerts
the recited force. Yet there are many methods to measure clamp force. Sarah
Noschang, an inventor of the patent and employee at Ethicon, testified to at least
four different measurement methods that the company utilized internally to
measure clamp force. (A4279 49-50; A2676-77.) None of these different
methods is disclosed in the 501 patent. (A2509-17; A4282 57; A2684; A10001.) Nor is there any evidence that they were publicly available.
Ms. Noschang testified that different methods of measuring clamp force do
not provide the same result. (A4279-81 51-54; A2680; A2685-87; A2689-91.)
1

Notwithstanding Ethicons assertion that its engineers discovered that higher


clamping forces and pressures could improve performance, the claimed
force/pressure ranges overlap with values disclosed in the prior art. (See A723-50;
A744/8:13-15.)
-7-

When asked which method applied to the 501 patent, she did not know. (A2684.)
Ethicons expert testified that, without knowing specifically how the force
measurement is taken, it is improper to rely on a cited value of clamp force.
(A4278 48; A2706-07.)
2.

The 275 Unwanted Vibration Damping Patent

Ethicon asserted independent claim 1 and dependent claim 3 of the 275


patent, titled Damping Ultrasonic Transmission Components. (A3536-A3559;
A3538-39 7-8; A2015; A2049-50; A2066-67.) The ultrasonic surgical
instrument described in the 275 patent converts electrical energy into mechanical
motion. (A3537 2-4; A2023/1:12-17; A2024/3:51-65; A2025/6:53-55.) This
conversion produces high-frequency longitudinal waves of ultrasonic energy that
propagate down the length of the instruments transmission rod (or waveguide) to
the end effector (or blade) at the distal end. (A2023/1:12-17; A2024/3:51-65;
A2025/6:53-55.) The longitudinal waves of ultrasonic energy result in axial (i.e.,
longitudinal) vibrational motion of the blade. (A2024/3:51-65; A3537 39;
A2023/1:23-25.)
During surgery, the rapidly vibrating blade is placed in contact with the
tissue of the patient. (A2024/3:51-65; A2025/6:53-55; A3538 5; A2024/4:9-11.)
Ultrasonic energy from the blade causes cutting and sealing of the tissue.
(A2024/3:65-4:11.)
-8-

The asserted 275 patent claims relate to an ultrasonic surgical instrument


comprising a damping member or sheath that loosely surrounds at least a portion of
the transmission rod to dampen or absorb undesired vibrations. (A3539 10-11;
A2030-31/Claim 1; A2027/9:34-45; A3542 20; A3548-49 40-43; A2027/9:5862; A2023/2:1-5.) The specification characterizes these undesired vibrations as
unwanted transverse vibrations (i.e., non-longitudinal vibrations). (A2027/9:6062.) Sheaths were used to dampen such unwanted vibrations in ultrasonic surgical
instruments before the 275 patent. (A3540 13; A2023/1:46-55.) The 275 patent
purports to claim a specific configuration that supposedly provides certain
advantages over prior art systems. (A2023/1:46-55; A3540 14; A2027/10:7-17.)
Claim 1 requires that the damping member be configured to loosely contact
the transmission rod over a portion of the transmission rod and adapted to absorb
undesired vibrations along the transmission rod without the use of fluid. (A3541
17; A3547 32; A2030-31/16:49-17:2.) Figure 5 shows the damping sheath (160)
relative to the transmission rod (86):

-9-

(A3559 66; A2019/Fig. 5 (colored labeling added).)


The 275 patents written description explains how the damping sheath
interacts with the transmission rod, through loose contact, to supposedly absorb
unwanted transverse vibrations:
the damping sheath 160 of the surgical instrument 150
loosely surrounds at least a portion of the transmission rod 86.
The damping sheath may be positioned around the transmission
rod 86 to dampen or limit transverse side-to-side vibration of
the transmission rod 86 during operation.
***
The damping sheath 160 is preferably in light contact with the
transmission rod 86 to absorb unwanted ultrasonic energy from
the transmission rod. The damping sheath 160 reduces the
amplitude of non-axial vibrations of the transmission rod 86,
such as, unwanted transverse vibrations.
(A2027/9:34-45, 58-64.)
The 275 patent distinguishes undesired transverse vibrations, which the
damping sheath is designed to absorb, from desired longitudinal vibrations.
(A3548-50 36-45; A2023/1:20-25, 53-55; A2027/9:36-39, 58-62, 9:65-10:1,
10:7-13; A2023/2:1-5; A3555 59; A2308-310.) Longitudinal ultrasonic vibration
is desired because it causes the high-speed axial (forward and backward) motion of
the transmission rod and blade required for the blade to cut and seal tissue as
intended. (A2025/6:53-55; A2024/4:9-11; A3547 35; A2053; A2023/1:23-25,
53-55.) In contrast, transverse vibrations occur perpendicular to the longitudinal
- 10 -

axis of desired motion and can disrupt the devices operation. (A3547 34; A2053;
A2023/1:22-25; A2027/9:60-62.)
Thus, the 275 patents damping sheath is designed to minimize or dampen
the undesired transverse vibrations that occur along the transmission rod of the
claimed instrument and disrupt effective operation of the device. (A2027/9:36-39,
58-62, 9:65-10:1, 10:7-13; A2023/2:1-5.) By contrast, the damping sheath is
constructed to avoid interruption of the desired longitudinal vibrations.
(A2027/9:65-10:1, 10:7-13; A2023/2:1-5; A2308-10.)
The 275 patent also distinguishes the loose contact between the damping
sheath and transmission rod required by claim 1 from physical support or
attachment of the damping sheath to the transmission rod. (A15; A3542-43 2122; A2027/9:38-41; A2028/11:8-26.) The 275 patent disclosure teaches physical
support or attachment at nodal points of longitudinal vibration. (A2027/9:38-41;
A2028/11:8-26.) The patent defines a node as [a] minimum or zero crossing in
the vibratory motion standing wavewhere axial motion is usually minimal.
(A3543 23-24; A2025/5:57-60; A2043.) The specification explains it is
preferable to physically support the damping sheath at nodes of the transmission
rod to avoid unnecessary interruption of desired longitudinal vibration and axial
motion of the transmission rod. (A2028/11:8-26.)

- 11 -

3.

The Design Patents

All of the asserted Design Patents are titled User Interface For A Surgical
Instrument. (A181-214.) All provide a specific design for a hand-held surgical
device that Ethicon used for its Harmonic ACE products. (A181-214.)
Figure 1 of the 804 design patent is reproduced below. (See A211.) The
three elements claimed in the 804 patent (in solid lines) are: (1) a U-shaped
trigger with a short front portion and longer rear portion (the U-Shaped Trigger),
(2) a rounded activation button disposed directly above the U-shaped trigger (the
Rounded Button), and (3) a fluted torque knob disposed above both the rounded
activation button and the U-shaped trigger (the Torque Knob). (A211-14.)

The other three Design Patents claim subsets of these elements. (A181-205.)
Ethicon filed two utility patent applications, both titled Ergonomic Surgical
Instruments, on the same device claimed in the Design Patents: (1) U.S. Ser. No.
- 12 -

12/245,158, filed October 3, 2008; and (2) U.S. Ser. No. 13/426,232, filed March
21, 2012. (A4532 4-5; A2934-3037; A2039-49; A4533 7; A3089-190.) Just
like the Design Patents, the utility patent applications relate to the configuration of
a hand-held surgical device. These utility patent applications specifically disclose
the functional aspects of the U-Shaped Trigger, Rounded Button, and Torque Knob
features claimed in the Design Patents. (A2934-3037; A3089-3190; A3018-19;
A3021.) These utility patent applications also have claims directed to the specific
designs claimed in the Design Patents. (A2934-3037 0008-18, 0111-0113, 0116,
0118, 0124-26, 0128, 0131-32, 135, 0138-39, Claims 1, 8, & 35; A3038-3049;
A3088-3190 Claims 1, 2, 5, & 16.)
Ethicon believed the Harmonic ACE was an optimal design and that
alternative designs would have adversely impacted performance. Ethicon
specifically touted the utility of features claimed in the Design Patents. (A4533-34
8; A3192-204; A3194; A3200.) Ethicon created marketing materials that
specifically mentioned the functional benefits of the U-Shaped Trigger, Rounded
Button and Torque Knob. (A4534 9; A3206.) Ethicons witnesses also testified
to the functional benefits of the features claimed in the Design Patents. (A3051-52;
A3058-61; A3081; A3086.)

- 13 -

B.

The Sonicision Surgical Instrument

Covidiens Sonicision device is the worlds first cordless, hand-held


ultrasonic surgical instrument. (A383-89.) The battery-operated generator and
transducer supply ultrasonic energy to the waveguide and blade to cut and
coagulate tissue. (A384.) While ultrasonic energy is activated, the user fires the
trigger on the handle to close the clamp, thereby applying pressure to tissue
placed in the jaw of the device to facilitate coagulation. (A384; A1603; A1619;
A2611.)
On summary judgment, the district court ruled that the Sonicision does not
infringe the 501 patent because it does not meet two means-plus-function
limitations relating to certain structures for applying and limiting clamping force
and pressure. (A87-99.) As noted, Ethicon no longer contends the 501 patent
covers the Sonicision device.
Regarding the 275 patent, Ethicon contends that the Sonicisions sleeve
component used to avoid metal-to-metal contact within the device but not to
dampen unwanted vibrations constitutes the damping member of claim 1. The
Soncision sleeve is placed between the transmission rod (i.e., waveguide) and inner
tube of the device.

- 14 -

(A2072 (color labeling added); A2070-74; A3544-45 28; A3540 12; A2051.)
There is no dispute that there is a clearance between the sleeve and waveguide.
(Ethicons Opening Brief (EB) 35; A3541 16; A2061 60.) There is also no
dispute that the sleeve is specifically designed to contact the waveguide at its
raised nodal ribs. (A3546 29, 31; A2062 64; A2165 106.)
By design, the nodal ribs have an increased diameter compared to the
remainder of the waveguide. (A3544 27; A2061 60; A2165 106.) Thus, the
clearance between the sleeve and waveguide is greatest at locations on the
waveguide other than the nodal ribs, thereby avoiding contact other than at these
nodes. (See A2061 60.) The nodal ribs are also placed at fixed locations along
the waveguides nodes of longitudinal vibration. (A2165 106; A2061 60.)
Because the nodal ribs are raised and placed at the fixed nodes, which experience
minimal longitudinal vibration (A2025/5:57-60; A3544 25-26; A2034; A204243; A2061 60), they represent ideal locations to physically support the sleeve
while avoiding damping of desired longitudinal vibration along the waveguide.
(A2028/11:8-26; A2165 106.)
- 15 -

The Sonicision is also designed to avoid unwanted transverse vibrations in


the first place. (A3552 51-52; A2173-74.) It is undisputed that transverse
vibrations result from asymmetry within the device. (A3552-53 53; A2053 43.)
Accordingly, the Sonicisions waveguide and blade are designed to be straight and
symmetrical, thereby avoiding these vibrations. (A2173-74; A2053 43.) The
Sonicision is further designed to resonate only at its longitudinal mode, which also
avoids unwanted transverse vibrations. (A2174.)
Because the Sonicisions waveguide does not experience unwanted
transverse vibrations, the Sonicision sleeve does not serve any dampening purpose.
In fact, Covidiens internal design documents identify dampening the waveguide as
a failure mode of the sleeve component. (A3553-54 54-56; A2177-78;
A2196.) Rather than perform any dampening function, Sonicisions sleeve is
designed to prevent a squealing sound that occurs when a waveguides nodal ribs
incidentally contact the surrounding metal inner tube during longitudinal
vibrations. (A2196; A2172.)
Finally, as shown below and in Section VI.D.2, the Sonicision device is
designed very differently from Ethicons claimed designs. (A136-143.) For
example, unlike the football-shaped rounded activation button claimed in Figure 2,
the Sonicision device has an activation button that is rectangular in shape and flat
across the front and sides. The 804 patents torque knob is flat across the front
- 16 -

with circular recesses, in contrast to the round, solid front of the Sonicision knob.
The proximal and distal portions of the Sonicisions trigger are parallel to each
other, as opposed to the 804 patents trigger, where the proximal portion curves
toward the device while the distal portion curves away from it. These and many
other dissimilarities are discussed in detail in Section VI.D.2.

IV.

SUMMARY OF THE ARGUMENT


The district court correctly granted summary judgment. The law and

undisputed material facts defeat Ethicons challenges to the judgment on appeal.


First, the district court correctly ruled that the asserted claims of the 501
patent are invalid as indefinite. The claims recite certain value ranges for
clamping force and clamping pressure, but the patent nowhere describes what
method is used to measure whether an accused device meets those limitations. Nor
was it publicly known in the art which method should be used. The undisputed
- 17 -

evidence showed that Ethicon used at least four different methods for measuring
clamping force and pressure, and each of these methods yielded significantly
different results. The patent does not disclose which, if any, of these measurement
methods should be employed.
The conclusory testimony of Ethicons expert, who plucked a method out of
thin air unanchored from the patents disclosure, cannot create a genuine issue of
disputed fact. And even his preferred method leaves unanswered critical questions
about the scope of the claims. As a result, the 501 patent fails to serve the most
basic notice function of patents. A skilled artisan has no way to discern the
boundaries of the claims, and a competitor has no way of evaluating whether a
product meets those claim limitations. Accordingly, the district court correctly
ruled the asserted claims invalid on summary judgment.
Second, the district court correctly granted summary judgment of
noninfringement on the 275 patent. On claim construction, the district court
correctly rejected Ethicons attempt to divorce the claim language from its context
and the specification. The district court then correctly ruled that no reasonable
fact-finder could find the accused Sonicision device practiced either of two
independent claim elements, much less both of them. Summary judgment was
therefore appropriate.

- 18 -

Third, the district court correctly granted summary judgment of invalidity of


the Design Patents. Ethicons own testimony and documents showed, as a matter
of law, that the claimed design is dictated by function, and thus is primarily
functional rather than primarily ornamental. Under this Courts precedent, the
Design Patents are therefore invalid.
Fourth, the district court correctly granted summary judgment of
noninfringement of the Design Patents. Whether the functional elements are
disregarded or considered the district court performed both analyses the
claimed and accused designs are so plainly dissimilar that summary judgment was
warranted under this Courts precedent. Moreover, the correct outcome is the
same regardless of whether the prior art is considered for context.
The judgment thus should be affirmed in its entirety.
V.

STANDARD OF REVIEW
This Court reviews the district courts grant of summary judgment de novo.

MRC Innovations, Inc. v. Hunter Mfg., LLP, 747 F.3d 1326, 1330-31 (Fed. Cir.
2014) (citing Braun v. Ann Arbor Charter Twp., 519 F.3d 564, 569 (6th Cir.
2008)). Summary judgment is appropriate when there is no genuine dispute as to
any material fact and the movant is entitled to judgment as a matter of law. Fed.
R. Civ. P. 56. Factual issues must be genuine to make summary judgment
inappropriate. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A
- 19 -

genuine issue exists only if the evidence is such that a reasonable jury could
return a verdict for the non-moving party. Wavetronix LLC v. EIS Elec.
Integrated Sys., 573 F.3d 1343, 1354 (Fed. Cir. 2009) (citing Anderson, 477 U.S.
at 248). Thus, the mere existence of some alleged factual dispute between the
parties will not defeat an otherwise properly supported motion for summary
judgment. Anderson, 477 U.S. at 247-48. Evidence that is merely colorable,
or is not significantly probative, will not prevent summary judgment. Invitrogen
Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1076 (Fed. Cir. 2005) (quoting
Anderson, 477 U.S. at 249-50).2
Claim construction is an issue of law reviewed de novo. See Lighting
Ballast Control LLC v. Phillips Elecs. N. Am. Corp., 744 F.3d 1272, 1276-77 (Fed.
Cir. 2014) (en banc).3

Ethicon criticizes the district court for incorporating portions of Covidiens


summary judgment briefs into its opinions. However, [t]his [C]ourt reviews
judgments, not opinions. Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549,
1556 (Fed. Cir. 1985). There is no indication that the court failed to consider
Ethicons evidence, and it ruled in Ethicons favor on several issues. (A110;
A120-26; A6068; A6081-94.)
3

On October 15, 2014, the U.S. Supreme Court heard argument in Teva
Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854, which addresses the
standard of review for claim construction and considers deference to the district
court. The district courts claim construction passes muster whether reviewed de
novo or deferentially.
- 20 -

VI.

ARGUMENT
A.

The District Court Correctly Granted Summary Judgment of


Invalidity Based on Indefiniteness of the 501 Patent

The district court correctly ruled that all asserted claims of the 501 patent
are invalid as indefinite as a matter of law. In its ruling, the court imposed on
Covidien the heavy burden of showing that the claims are insolubly ambiguous
and correctly determined that Covidien had met that burden on summary judgment.
(A108.) This conclusion is rooted in undisputed facts relating to the patents
disclosures (and lack thereof). Ethicons unsubstantiated expert testimony cannot
alter those facts. In short, the claims are indefinite because they require certain
ranges of clamping force or clamping pressure with no accompanying
disclosure of what measurement method is used to define the claim scope. (A99108.) And the undisputed facts show that the choice of a measurement method is
crucial because different methods none of which is even disclosed in the patent
yield different results.
Several months after the district courts ruling, the Supreme Court issued its
Nautilus decision rejecting the more stringent insolubly ambiguous standard and
entrenching the more challenger-friendly reasonable certainty standard. See
Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014) (holding
that claims are indefinite when the patent, and the prosecution history, fail to
inform, with reasonable certainty, those skilled in the art about the scope of the
- 21 -

invention). Accordingly, the district courts decision is even more clearly correct
today than it was at the time.
1.

The Patent Does Not Disclose the Use of Any Method of


Measuring Clamping Force and Pressure that Would
Inform a Skilled Artisan of the Boundaries of the Claims

It is undisputed that different methods of measuring clamping force and


pressure yield widely divergent results. Ethicons own witnesses and documents
showed that when different methods of measuring clamping force and pressure
were applied to the same device, they produced significantly different results. For
example, 501 patent co-inventor Noschang testified that Ethicon used four
different methods for measuring clamping force and pressure and that each of these
methods gave different results. (A4279-81 50-54; A2677; A2680; A2685-87;
A2689-91; A4291-92 80; A2710-13.) These methods differed in several respects.
They differed as to where along the length of the clamping jaw the measurements
were taken. (A4280-81 53; A2689-90; A4287-88 73; A2724; A2736.) They
would also differ dependent on the spacing of the clamp and blade (A4280-81
53; A2689-90; A2710-13; A4292-93 81-82; A2682-83) and the material that
was placed in the clamping jaw (A2701). It is also undisputed that none of these
four Ethicon-proprietary methods was disclosed in the patent or represented a
known industry standard. (A100-01; A4282 57; A2682-87; A2692; A4294-95
88; A2519-41; A2522.)
- 22 -

In fact, the patent did not specify any method for measuring clamping force
and clamping pressure to achieve the claimed ranges. Ethicons expert admitted
that the only way to generate force and pressure data that can be directly
compared with the limits proscribed [sic] in the 501 patent is to conduct the
measurements in the same manner as described in the patent. (A4281 55; A2706
158.) But the patent does not disclose, for example, where along the jaw the
clamping force and pressure should be measured. Nor does the patent state what
thickness and type of tissue should be used for the measurements. Ethicon
presented no evidence of an industry standard for measuring clamping force and
pressure, and its witnesses admitted that none existed. (See A2677; A2682-87;
A2522; A100-01.) Nor can Ethicons reference to a fully engaged clamping
surface (EB9) provide the necessary guidance. Ethicons expert testified that even
when the entire clamping surface is in contact with tissue, that tissue can be thick,
thin, stiff or compressible, and the clamping force and pressure measurements will
differ depending on these variables. (A2699-701; A4295-96 89-92; A2524-27.)
The 501 patent thus fails to give a skilled artisan the necessary guidance to
ascertain the scope of the claims and determine whether a surgical instrument falls
within them.
This case is very similar to Honeywell, where different testing conditions of
yarn did not produce identical or even essentially identical results and thus the
- 23 -

claimed melting point ranges were ruled indefinite. See Honeywell Intl. Inc. v.
Intl Trade Commn, 341 F.3d 1332, 1341 (Fed. Cir. 2003). As in Honeywell, the
results of any attempt to measure clamping pressure necessarily fall within or
outside the claim scope depending on the [measurement] method chosen, and the
patent does not teach the use of any particular method. Id. Hence, [c]ompetitors
trying to practice the invention or to design around it would be unable to discern
the bounds of the invention. Id. at 1341.
Like Honeywell, it is undisputed that different measurement methods yield
different results, and the choice of a particular method is crucial to deciding
infringement. At summary judgment, Ethicon asserted that infringement could be
determined for a device only when measured under the same conditions and in the
same way from test to test. (A4248; A4281 55; A2607.) Yet as explained
above, the 501 patent does not define these conditions.
The cases on which Ethicon relies are readily distinguished. The asserted
patent in Wellman relied on an industry standard to provide the method of
measurement. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1367 (Fed.
Cir. 2011). Here, by contrast, Ethicon admitted no such standard existed in the art
for the 501 patents measurements. (A2677; A2682-87; A2522; A100-01.) And
in Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., the Court relied on a welldefined standard as disclosed by the asserted patents that was tied to highly
- 24 -

specific measurements of four very specific chemical compounds in finding the


claims definite. 537 F.3d 1357, 1372 (Fed. Cir. 2008). Here, by contrast, the 501
patent does not provide a well-defined standard or highly specific
measurement. The 501 patent instead discloses nothing that would enable a
skilled artisan to discern the boundaries of the claims.
2.

Ethicons Conclusory and Unsubstantiated Expert


Testimony Does Not Create a Disputed Issue of Material
Fact

Ethicons reliance on unsupported expert opinions cannot create a genuine


issue of material fact to preclude summary judgment. See Invitrogen Corp. v.
Clontech Labs., Inc., 429 F.3d 1052, 1081, (Fed. Cir. 2005) (A party does not
manufacture more than a merely colorable dispute simply by submitting an expert
declaration asserting that something is black when the moving partys expert says
it is white; there must be some foundation or basis for the opinion.); Krippelz v.
Ford Motor Co., 667 F.3d 1261, 1269 (Fed. Cir. 2012) (conclusory testimony of
an expert witness, however, cannot create an issue of fact if none otherwise
exists). Specifically, Ethicon argues that the specifications general references to
average pressure and closed position provide enough guidance to answer the
questions surrounding the choice of a particular measurement method to define the
scope of the claims. But the patent simply provides no adequate disclosure to

- 25 -

inform a skilled artisan of the claim boundaries, and Ethicons conclusory expert
testimony cannot make something out of nothing.
a.

Ethicons Experts Assertions About Average


Pressure Do Not Give a Skilled Artisan Reasonable
Certainty About the Claim Scope

For the majority of the claims at issue, Ethicons arguments based on


average are irrelevant. Only 5 of the 17 asserted claims refer to an average
clamping force or clamping pressure (claims 1, 2, 13, 17, and 18); the other 12
asserted claims do not include this term. Ethicon provides no basis for injecting
the concept of average into the claims that do not recite this term. See
Interactive Gift Exp., Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir.
2001) (In construing claims, the analytical focus must begin and remain centered
on the language of the claims themselves, .). At claim construction, Ethicon
distinguished the claims that contained average clamping pressures and forces
from those that did not, and urged the inclusion of average only in the former set.
(A21.) The district court adopted Ethicons constructions (A24) and Ethicon
cannot challenge them now.
For claims that do recite average, Ethicon does not point to anything in the
patent that indicates how or where this average is to be measured to produce
reasonable certainty about the claim scope. Ethicon contends that measuring at the
midpoint of the clamp provides an average. But no evidence supports this
- 26 -

argument. Rather, Ethicon offers only the conclusory assertion of its expert, Dr.
Schafer. (EB24-26.) That is not enough to avoid summary judgment. See
Invitrogen, 429 F.3d at 1080-81 (no dispute of fact created where expert failed to
cite a factual basis for his opinion); Krippelz, 667 F.3d at 1269.
It is undisputed that the 501 patent does not even refer to the midpoint of
the clamp or state that measuring at the clamps midpoint provides an average
clamping force or pressure. (A2552; A2692.) It is also undisputed that no industry
standard existed for measuring at the midpoint. (A2677; A2682-87; A2522; A10001.) Dr. Schafers conclusory assertions equating measuring at the midpoint with
determining average clamping force cannot overcome these undisputed facts.
Worse than just conclusory, Dr. Schafer also admitted his assertion was
wrong. Dr. Schafer testified in his deposition that this paragraph of his report was
factually incorrect and the midpoint measurement was not equivalent to the
average clamping force. (A5973.)
Ethicons only other argument importing a midpoint measurement into the
patent relies on U.S. Patent No. 5,947,984 (the 984 patent). But the 984 patent
is not related to the 501 patent, nor is it cited anywhere in the 501 patent or its
prosecution history. Further, Ethicons expert admitted that the 984 patent never
defines measuring at the midpoint as providing the average clamping force or
pressure. (A5972.) Moreover, Ethicon identified no evidence that one of ordinary
- 27 -

skill in the art would rely on the 984 patent for a measuring method, rather than
any of the other methods available in the art. Interval Licensing LLC v. AOL, Inc.,
766 F.3d 1364, 1370 (Fed. Cir. 2014) (Although absolute or mathematical
precision is not required, it is not enough, as some of the language in our prior
cases may have suggested, to identify some standard for measuring the scope of
the phrase.).
In sum, Ethicons average/midpoint arguments were based solely on
unsupported expert opinion. This is insufficient to create a dispute of material fact
and avoid summary judgment. See McLean v. 988011 Ontario, Ltd., 224 F.3d 797,
800-01 (6th Cir. 2000) ([A]n experts opinion must be supported by more than
subjective belief and unsupported speculation and should be supported by good
grounds, based on what is known. (citations omitted)); see also Invitrogen, 429
F.3d at 1080-81; Krippelz, 667 F.3d at 1269.
b.

Ethicons Experts Assertions About Closed


Position Also Do Not Give a Skilled Artisan
Reasonable Certainty About the Claim Scope.

Ethicons reliance on closed position for providing the where and how
to measure clamping force and pressure is similarly flawed. The 501 patent does
not refer to clamping force or clamping pressure as being measured with the clamp
in a closed position against the blade. The only reference in the patent to closed
position refers to the clamping surface area, not to clamping force or pressure.
- 28 -

(A2515/4:27-29.) Moreover, even if the closed position was referenced in


relation to clamping force or pressure, this would still leave unanswered many
methodological questions that are critical to determining the claim scope and
whether an accused instrument falls within it. These questions include: (1) how
much tissue separates the clamp and blade; (2) what type of tissue separates the
clamp and blade; and (3) the compressibility of the tissue that separates the clamp
and blade. Ethicons fact witnesses and its expert admitted that the amount and
characteristics of the tissue placed in the jaw alter the clamping force and pressure
measurements. (A4289 77-78; A2699-701.) The patent does not provide any
guidance as to the thickness, type, and compressibility of the tissue to be used for
this measurement. Accordingly, as with Ethicons average/midpoint
arguments, the district court correctly ruled that Ethicons closed position
arguments do not overcome the indefiniteness of the claimed clamping force and
pressure ranges.
In sum, the undisputed factual record established the high level of
uncertainty surrounding the claimed clamping force and pressure ranges. In the
face of this record, Ethicons conclusory and unsupported expert testimony did not
create a material factual dispute. The district court therefore properly granted
summary judgment of indefiniteness.

- 29 -

B.

The District Court Correctly Granted Summary Judgment of


Noninfringement of the 275 Patent

The district court properly concluded that the undisputed material facts
warranted summary judgment of noninfringement of the 275 patent. Two
independent grounds support this conclusion.
First, undisputed facts warrant summary judgment for Covidien on the term
configured to loosely contact. The district court correctly construed this term to
mean: structured to have contact other than at fixed support points, but not tightly
fitted. (A14-15.) Under this construction, the uncontroverted documents and
witness testimony demonstrate that the sleeve component in the accused Sonision
device is not configured to loosely contact the transmission rod. Ethicons
conclusory expert testimony cannot overcome these undisputed facts.
Second, the undisputed facts warrant summary judgment for Covidien on the
term adapted to absorb undesired vibrations. There was no claim construction
dispute on this term, and there was no evidence that could support a finding that
the Sonicision meets this limitation.
1.

The Sonicision Sleeve Does Not Practice the Configured to


Loosely Contact Claim Limitation
a.

The District Court Correctly Construed the


Configured to Loosely Contact Claim Term

In correctly construing the configured to loosely contact claim term, the


district court complied with its obligation to read the claims in view of the
- 30 -

specification, of which they are a part. Am. Calcar, Inc. v. Am. Honda Motor
Co., Inc., 651 F.3d 1318, 1336 (Fed. Cir. 2011) (quoting Phillips v. AWH Corp.,
415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). [T]he specification is always
highly relevant to the claim construction analysis. Usually, it is dispositive; it is
the single best guide to the meaning of a disputed term. Phillips, 415 F.3d at
1315 (quotations omitted). While care should be taken not to read limitations
from the specification into the claims, Walker Digital, LLC v. Microsoft Corp.,
484 F. Appx 496, 497 (Fed. Cir. 2012), the claims cannot enlarge what is
patented beyond what the inventor has described as the invention. Abbott Labs.
v. Sandoz, Inc., 566 F.3d 1282, 1288 (Fed. Cir. 2009) (quoting Biogen, Inc. v.
Berlex Labs., Inc., 318 F.3d 1132, 1140 (Fed. Cir. 2003)). Accordingly, courts
may reach a narrower construction, limited to the embodiment(s) disclosed in the
specification, when the claims themselves, the specification, or the prosecution
history clearly indicate that the invention encompasses no more than that confined
structure or method. Id. at 1288.
Claim 1 recites an ultrasonic surgical device comprising, among other
things, a damping member configured to loosely contact the transmission rod over
a portion of the transmission rod. (A2030-31/Claim 1.) The district court
construed this term to mean structured to have contact other than at fixed support
points, but not tightly fitted. Reading the claim term in isolation, Ethicon
- 31 -

contends that the loose contact between the damping sheath and transmission rod
can occur anywhere along the transmission rod. This is the only aspect of the
district courts construction that Ethicon challenges on appeal. (EB30-32.)
The specification, however, does not support Ethicons expansive reading of
claim 1. Instead, the specification makes clear that the requisite loose contact
occurs along the transmission rod at locations other than where the damping sheath
is physically attached or supported on the transmission rod. (A2027/9:33-45,
10:50-55; A2028/11:8-26, 45-59.) The written description clarifies that the
damping member is physically attached to the transmission rod at fixed locations,
preferrably nodal points of longitudinal vibration (i.e., nodes). (A2027/9:33-42.)
The 275 patent defines a node as [a] minimum or zero crossing in the vibratory
motion standing wave, where axial motion is usually minimal and radial motion
is usually small. (A20025/5:57-60.) The 275 patent describes nodes as the
preferred location to physically support the damping sheath on the transmission
rod: The damping sheath 160 is only attached to the transmission rod at the nodal
points thereby preventing the sheath from otherwise adhering to the outer surface
of the transmission rod 86. (A2027/9:42-45.) The specification also describes the
claimed damping sheath as attached to the transmission rod at fixed locations, via
compliant members preferrably placed at or near longitudinal nodes.
(A2028/11:8-25; A2020/Fig. 6.)
- 32 -

(A2020/Fig. 6 (coloring and labeling added).)


The 275 patent specification makes clear that the physical attachment or
coupling of the damping sheath to the transmission rod (which occurs at fixed
locations along the transmission rod) is distinct from the loose contact recited in
claim 1 (which occurs over a portion of the transmission rod for the purpose of
dampening unwanted transverse vibrations):
damping sheath 160 of the surgical instrument 150 loosely
surrounds at least a portion of the transmission rod 86. The
damping sheath 160 may be positioned around the transmission
rod 86 to dampen or limit transverse side-to-side vibration of
the transmission rod 86 during operation. The damping sheath
160 preferably surrounds part of the third section 86c of the
transmission rod 86 and is coupled or attached to the
transmission rod 86 near one or more nodes.
(A2027/9:33-42 (emphasis added); see also A2028/11:45-59 (Referring now to
FIG. 7, . . . Each sleeve of the damping sheath 260 is captured longitudinally

- 33 -

between the compliant members 280 so that the damping sheath 260 is maintained
loosely in place around the transmission rod 286.).)
Thus, the 275 patents written description and disclosed embodiments
consistently teach that: (1) the claimed damping member must be physically
supported on the transmission rod at fixed locations; and (2) such physical
attachment of the damping member to the transmission rod is distinct from the
loose contact over a portion of the transmission rod that claim 1 requires. The
district court was obligated to construe the claim term in light of this disclosure.
See SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337,
1341 (Fed. Cir. 2001) (Where the specification makes clear that the invention
does not include a particular feature, that feature is deemed to be outside the reach
of the claims of the patent, even though the language of the claims, read without
reference to the specification, might be considered broad enough to encompass the
feature in question.). Accordingly, the district court correctly construed
configured to loosely contact to mean structured to have contact other than at
fixed support points, but not tightly fitted. (A14-15.)
In contrast, Ethicons proposed construction below contacting or capable
of contacting portions of the transmission rod, but not tightly fitted is
inconsistent with the intrinsic evidence discussed above. Ethicons construction
improperly fails to distinguish the loose contact of claim 1 from the physical
- 34 -

attachment of the damping sheath to the transmission rod at fixed locations. In


addition, Ethicons focus on the distinction between the claimed loose contact
and the prior arts use of silicon O-rings at nodes of the transmission rod is
misguided. (EB31.) This argument overlooks that the specification itself
distinguishes between the claimed loose contact and the damping sheaths
physical attachment at the nodes. (A2027/9:38-41.) Finally, even if Ethicon were
right in contending that the recited loose contact can be at the fixed support
points (EB32), it has provided no evidence that the Sonicision device loosely
contacts the waveguide at these fixed support points.
Although Ethicon does not challenge the structured to have contact aspect
of the district courts construction on appeal, Ethicons proposed construction
below also was overly broad because it would encompass structures where the
damping sheath need only be capable of loosely contacting the transmission rod.
The claim language itself defeats Ethicons construction: the damping sheath must
be configured to loosely contact the transmission rod, and not merely be capable
of loosely contacting it. In addition, the specification only discloses embodiments
of claim 1 that require actual loose contact. (See, e.g., A2027/9:34-36 (the
damping sheath 160 of the surgical instrument 150 loosely surrounds at least a
portion of the transmission rod 86), 10:50-55 (The slit 164 of the damping sheath
160 allows the damping sheath 160 to be assembled over the transmission rod 86
- 35 -

from either end. Without the slit 164, the sheath may not fit over the larger crosssectional diameters of the transmission rod 86 and the damping sheath 160 may not
be able to loosely contact the transmission rod 86.); A2028/11:53-55 (Each
sleeve of the damping sheath 260 is captured longitudinally between the compliant
members 280 so that the damping sheath 260 is maintained loosely in place around
the transmission rod 286.).) The district courts construction of configured to
loosely contact was therefore correct in its entirety.
b.

The Sonicision Sleeve is Not Configured to Loosely


Contact the Transmission Rod Other Than at Fixed
Support Points
(1)

There is No Evidence that the Sleeve is


Configured to Contact Portions of the
Waveguide Besides the Nodal Ribs

Applying the district courts correct claim construction, there is no


infringement as a matter of law because there is no evidence that the Sonicision
sleeve is structured to loosely contact the waveguide at points other than the
nodal ribs.4 Indeed, Ethicons expert opined that contact between the sleeve and
waveguides nodal ribs is irrelevant to the infringement analysis because the nodal
ribs serve as fixed support points for the sleeve. (A3546 30; A2045-46 ([I]t was
not my point to show contact at the rib. Thats not what the patent requires in
terms of lose [sic] contact. It has to have contact other than fixed locations.).) It

Nor has Ethicon provided any evidence of loose contact at the nodal ribs.
- 36 -

is undisputed that the Sonicision is structured to have a clearance between the


sleeve and waveguide. (A2061 60; A3676-82.) There is also no dispute that the
nodal ribs, which physically support the sleeve, have an increased diameter in
comparison to the rest of the waveguide. (A2061 60; A3676-78.) Accordingly,
the clearance between the sleeve and waveguide is greatest at portions of the
waveguide between the nodal ribs. (A2061 60.) Covidiens internal documents
and the testimony of its engineers show that, as a result of this design, the
Sonisicion sleeve is structured to avoid contacting portions of the waveguide other
than the nodal ribs. (A2177; A2196; A2070-72; A2172.) Ethicon failed to raise a
genuine dispute on this critical issue.
Covidiens research and development documents reveal that the sleeve and
waveguide are specifically designed to avoid contact other than at the nodal ribs
because such contact could result in the sleeve dampening desired, longitudinal
vibrations. (A3553-52 54-55; A2177; A2196.) If the sleeve were structured to
contact portions of the waveguide other than these points, the sleeve would
unnecessarily absorb longitudinal vibrations along the waveguide that are essential
to the effective operation of the device. (A2196; A2172; A2028/11:8-26.) Indeed,
dampening the waveguide is identified as a failure mode of the sleeve
component. (A2196.) Covidiens internal design documents and the testimony of

- 37 -

its engineer, Robert Stoddard, further confirm that the Sonicision is constructed so
that the sleeve contacts only the nodal ribs on the waveguide. (A2196; A2172.)
Ethicon misses the point in contending that design considerations with
respect to the sleeves contact points are irrelevant because intent is not an element
of direct infringement. The claim language itself requires the damping sheaths
design to have a particular purpose and function. See Typhoon Touch Techs., Inc.
v. Dell, Inc., 659 F.3d 1376, 1380-81 (Fed. Cir. 2011) (No error of law or fact has
been shown in the district courts construction of the memory for storing term as
requiring that the memory function is present in the device in that the device is
structured to store at least one data collection application.). The issue is thus
whether the accused devices were in fact configured to loosely contact the
transmission rods at points other than the nodal ribs. Even if some evidence were
to suggest that the Sonicision sleeve is capable of contacting or incidentally
contacts the waveguide other than at fixed support points, Ethicon failed to raise
any genuine issue of fact as to whether it is actually configured to do so.
(2)

The Record Shows No Contact Between the


Sonicision Sleeve and the Waveguide at Any
Location Between the Nodal Ribs

The undisputed evidence that the sleeve and waveguide are structured to
avoid contact between the nodal ribs is enough to support the summary judgment
of noninfringement. Ethicon failed to offer evidenceas opposed to attorney
- 38 -

argument and conclusory expert opinionthat could show the claimed loose
contact between the sleeve and portions of the waveguide between the nodal ribs.
(A3555-59 60-65.)
Ethicons expert, Dr. Schafer, asserted that CT scan images offered with his
expert report show contact between the sleeve and waveguide at locations other
than the nodal ribs. (A3617-18.) Dr. Schafers CT scans are the only purported
evidence of alleged contact between the sleeve and waveguide at these required
locations. But these images are insufficient to raise a genuine dispute that would
preclude summary judgment. Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d
1052, 1076 (Fed. Cir. 2005) (Evidence that is merely colorable, or is not
significantly probative, will not prevent summary judgment. (quoting Anderson,
477 U.S. at 249-50)). At best for Ethicon, these images confirm that there is
contact between the sleeve and waveguide at the raised nodal ribs (which is
undisputed). At locations other than the nodal ribs, however, these images show an
air gap between the sleeve and waveguide. (A3617-18; A2165-66 107.)
Covidiens expert, Dr. Durfee, performed similar CT scans of the device, which
confirm that the nodal ribs are the only portions of the Sonicision waveguide that
the sleeve contacts. (A2166-67.)
While Ethicon makes much of Covidiens experts recognition that one of
Dr. Schafers CT scans may reflect contact of the sleeve and waveguide between
- 39 -

the nodal ribs, any contact was due to a nonconforming wrinkle in the sleeve
component of that particular instrument. (A2165-66 107.) It is undisputed that
the Soncisions design specifications require a reduced diameter in the waveguide
and that this results in an increased clearance between the sleeve and waveguide
between the nodal ribs. (A2061 60; A3676-82.) This clearance avoids contact
between the sleeve and waveguide at locations between the nodal ribs, and any
instrument demonstrating otherwise does not conform to device requirements.
Considering Ethicons ultimate burden to prove infringement at trial, no reasonable
fact-finder could conclude from this single image of an apparently nonconforming
device that the sleeve is structured to loosely contact portions of the waveguide
between the nodal ribs. See Gart v. Logitech, Inc., 254 F.3d 1334, 1339 (Fed. Cir.
2001) (An infringement issue is properly decided upon summary judgment when
no reasonable jury could find that every limitation recited in the properly construed
claim either is or is not found in the accused device.).
2.

The Sonicision Sleeve Is Not Adapted to Absorb Undesired


Vibrations

Summary judgment was also appropriate for the additional and independent
reason that there is no evidence that the sleeve is adapted to absorb undesired
vibrations along the transmission rod. In fact, because there is no proof that the
undesired vibrations of claim 1 even exist in the Sonicision device, there can be no
finding that the sleeve is adapted to absorb them.
- 40 -

a.

There is No Evidence that the Sonicision Experiences


Undesired Transverse Vibration

Despite bearing the ultimate burden, Ethicon did not offer any evidence that
the Sonicision device experiences the type of undesired vibrations described in
the patent or identify where such vibrations might occur along its waveguide.
(A2023/2:30-35; A2027/9:34:38; A3551 49; A2044; A3555-59 60-65.) The
275 patent makes clear that the undesired vibrations of claim 1 are unwanted
transverse vibrations, rather than any form of desired longitudinal vibration.
(A2023/1:20-25; A2027/9:33-39, 60-62, 10:9-13; A3458 36.) Likewise,
Ethicons expert characterized transverse vibrations as non-longitudinal and
undesirable in ultrasonic cutting systems. (A3547 33-35; A2053 43.) Yet
Ethicon failed to offer any proof that transverse vibrations occur in the Sonicision
device. (A2044.) The record actually reveals that, by design, the Soncision device
avoids such transverse vibrations altogether. (A2173-74.)
It is not Covidiens burden to prove the absence of transverse vibrations.
Nevertheless, Covidien performed water and glycerin droplet tests in an effort to
detect the existence of transverse vibrations along the Sonicision waveguide
between the nodal ribs. (A3552 50; A2167-68.) These tests demonstrated the
lack of transverse vibrations, because the water and glycerin droplets did not
splatter when coming into contact with the vibrating waveguide. (A2167-68.)

- 41 -

In response to Covidiens testing evidence, Ethicon cites to one video that


purportedly shows test fluid splattering off of the transmission rod. (EB38.) But
this video does not depict a commercial Sonicision device. Instead, it shows
testing on an instrument that lacks a key internal support component, the distal Oring seal. (A2168 118; A2071-72.) This distal O-ring secures the waveguide in
place within the inner and outer tubes. (A2168 117-18; A2071-72.) All sold
instruments have this O-ring in place, with the waveguide housed within the inner
and outer tubes. (A2071-72.) Demonstration of undesired vibrations in an
instrument that lacks essential support mechanisms, rather than a fully-assembled
commercial device, cannot be considered evidence of transverse vibrations in
Sonicision devices that Covidien markets. Indeed, all other droplet tests Covidien
performed on a Sonicision device with the distal seal demonstrate a lack of
transverse vibration (A2167-68), and neither Ethicon nor Dr. Schafer pointed to a
single commercial Sonicision instrument that demonstrates transverse vibrations.
Moreover, Ethicon failed to provide any testing or experiments of its own to
show the existence of transverse vibrations in the Sonicision device, even though
Dr. Schafer admitted he had the experience, wherewithal, and means to do so.
(A3550-51 46-49; A2035-38; A2044.) Dr. Schafer testified that he had
experience with measuring transverse ultrasonic vibrations (A2035-36) and that he
was familiar with multiple methods of measuring them in ultrasonic surgical
- 42 -

instruments (A2036-37). He further admitted that he had access to the necessary


equipment in his laboratory. (A2038.) Yet, throughout discovery, Dr. Schafer
never tested a Sonicision device for the presence of transverse vibrations. (A2044.)
According to Dr. Schafer, he did not feel that [he] needed to test for the
appearance of any transverse vibrations, because claim 1 doesnt require that
there be transverse motion of the transmission rod. (A2044.) His assertion that
the Sonicision experiences undesired vibrations is thus unsupported by any
underlying testing or experimentation. (A2063-64 69-70.)
Further, Dr. Schafers mere statement, after his deposition, that alleged
droplet tests he conducted show transverse vibrations fails to raise a genuine issue
of material fact. See Dynacore Holdings Corp. v. U.S. Phillips Corp., 363 F.3d
1263, 1278 (Fed. Cir. 2004) (It is well settled that an experts unsupported
conclusion on the ultimate issue of infringement is insufficient to raise a genuine
issue of material fact, and that a party may not avoid that rule simply by framing
the experts conclusion as an assertion that a particular critical claim limitation is
found in the accused device.); see also Moore U.S.A., Inc. v. Standard Register
Co., 229 F.3d 1091, 1112 (Fed. Cir. 2000) (A party may not overcome a grant of
summary judgment by merely offering conclusory statements.). Not only were
these purported tests identified for the first time after the close of discovery, Dr.

- 43 -

Schafer also never provided any evidence or data to corroborate such testing.
(A3683; A3688-89 17.)
Additional undisputed facts reveal that the Sonicision is designed to avoid
generating any transverse vibrations. Ethicon concedes that asymmetry results in
the occurrence of transverse vibrations. (A2053 43). However, the Sonicision
waveguide and blade are designed to be symmetrical, thereby avoiding unwanted
transverse vibration. (A3552 51-52; A2173-74.) In addition, the Sonicision is
designed electrically to resonate only at its longitudinal mode, which also avoids
unwanted transverse vibrations. (A2173-74.) Covidiens engineer, Robert
Stoddard, testified that the Sonicision does not experience any problems with
transverse vibrations due to its design. (A2173-74.)
Ethicon also contends that because the Sonicision sleeve is positioned to
avoid metal-to-metal contact between the waveguide and surrounding inner tube,
the Sonicision sleeve is adapted to absorb undesired vibrations. (EB36-37.)
There is no dispute that the sleeve is supported by the waveguides nodal ribs to
prevent a squealing noise that results from metal-to-metal contact between the
waveguide and its surrounding inner tube. (A2196; A2172.) However, Ethicon
and its expert assume, without any factual support, that such contact is the result of
the undesired (i.e., transverse) vibrations disclosed in the patent (EB36-37), rather
than the desired longitudinal vibrations that indisputably cause axial (back-and- 44 -

forth) motion of the waveguide. This assumption is insufficient to overcome


summary judgment.
In fact, Covidiens engineer, Mr. Stoddard, testified that potential metal-tometal contact between the waveguides nodal ribs and the inner tube is caused by
desired longitudinal vibration (which the claimed damping member is not
supposed to absorb). (A2172; A2023/1:53-55, 2:1-7; A2027/10:7-13; A2309.)
Notwithstanding its ultimate burden, Ethicon offered no factual support to the
contrary. Dr. Schafers unsupported and conclusory assertion that potential metalto-metal contact is caused by the waveguide vibrating in an undesired way
(EB37) is insufficient to raise a genuine factual dispute. See Dynacore, 363 F.3d at
1278.
Finally, the portion of Mr. Stoddards testimony that Ethicon cites does not
support its contention that the sleeve is adapted to absorb undesired vibrations.
(EB38.) Mr. Stoddard testified that the purpose of the sleeve is to prevent contact
between the nodal ribs and the inner tube. (A2172.) The nodal ribs are raised in
order to maintain concentricity in the device and ensure that if contact occurs
between the waveguide and inner tube, that such contact occurs at nodal points
where longitudinal vibration in minimal. Mr. Stoddard explained that the sleeve
would prevent loss of energy if the nodal rib came in contact with the inner tube.
(A2172.) Mr. Stoddards testimony thus reveals that the sleeve avoids the loss of
- 45 -

desired longitudinal vibration, and has nothing to do with dampening of undesired


transverse vibrations.
Because the Sonicision does not experience problems with unwanted
transverse vibrations, contact between the sleeve and waveguide would not result
in the absorption of undesired vibrations, as required by claim 1. Rather, such
contact could have the adverse effect of absorbing desired, longitudinal vibrations
essential to the proper functioning of the device. That is why dampening the
waveguide is identified as a failure mode of the sleeve component. (A2196.)
b.

Even if Unwanted Transverse Vibrations May Occur,


the Sonicision Sleeve is Not Adapted to Absorb
Them

In any event, the Sonicisions sleeve is not adapted to absorb undesired


vibrations. This Court has construed adapted to to mean designed to or
configured to rather than merely capable of when, as here, the patent
claims and specification describe a particular objective to be accomplished. See
Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335, 1349 (Fed. Cir.
2012) (Amended claim 23 refers to the arms and magnetic members as adapted
to extend across respective side portions of a primary frame. In that context, the
phrase adapted to is most naturally understood to mean that the arms and
magnetic members are designed or configured to accomplish the specified
objective, not simply that they can be made to serve that purpose.).
- 46 -

Here, the 275 patents asserted claims and specification describe a


particular objective that the claimed damping sheath is designed to accomplish:
absorbing undesired vibrations. (A3548-50 40-45.) As such, the Sonicision
sleeve must be designed or configured to absorb undesired vibrations in order to
meet this claim element. See Aspex Eyewear, 672 F.3d at 1349. But there is no
evidence to suggest that the sleeve is designed or configured to absorb undesired
vibrations. The Sonicision sleeve is instead designed to avoid metal-to-metal
contact between the waveguide and inner tube and specifically dimensioned to
avoid contact other than at the nodal support points, where vibration is at a
minimum. (A2172; A3675-82; A2196.) The summary judgment was correct.
C.

The District Court Correctly Granted Summary Judgment of


Invalidity of the Design Patents Based on Functionality

The district court correctly ruled that, as a matter of law, the Design Patents
are invalid as functional. The district court properly began its invalidity analysis
by distinguishing the functional aspects of the claimed designs from their
ornamental aspects. See Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665, 680
(Fed. Cir. 2008) (Where a design contains both functional and non-functional
elements, the scope of the claim must be construed in order to identify the nonfunctional aspects of the design as shown in the patent.). The district court then
correctly ruled that the claimed design is primarily functional and thus ineligible
for patent protection. (A130-31.) See 35 U.S.C. 171; PHG Tech. v. St. John
- 47 -

Companies, 469 F.3d 1361, 1366 (Fed. Cir. 2006) (If [a] patented design is
primarily functional rather than ornamental, the patent is invalid.).
The court based its ruling on its analysis of the functionality factors set forth
by this Court in Berry Sterling: (1) whether the protected design represents the
best design; (2) whether alternative designs would adversely affect the utility of the
specified article; (3) whether there are any concomitant utility patents; (4) whether
the advertising touts particular features of the design as having specific utility; and
(5) whether there are any elements in the design or an overall appearance clearly
not dictated by function. (A126-31.) See Berry Sterling Corp. v. Pescor Plastics,
Inc., 122 F.3d 1452, 1455-56 (Fed. Cir. 1997); High Point Design LLC v. Buyers
Direct Inc., 730 F.3d 1301, 1315 (Fed. Cir. 2013). The district court correctly
concluded that the uncontroverted evidence on each factor established that the
claimed designs are dictated by function, and hence the Design Patents are
invalid. (A131.)
1.

The District Court Adequately Considered Alternative


Designs in Its Analysis

Ethicons principal argument on appeal is the incorrect assertion that the


district court failed to adequately consider alternative designs. (EB41-46.) For
example, Ethicon repeatedly contends that the district court only considered a
single alternative design (of a predecessor device), but there is no basis in the
record for Ethicons contention. The record contained at least nine of Ethicons
- 48 -

own designs as possible alternatives. (A5006; A5023-27.) The district court


accounted for these alternative designs in its analysis. For example, in its analysis
of the best design factor, the district court observed that Plaintiffs own
inventors agreed that of all the different alternative designs considered for
[Ethicons] Harmonic ACE, the claimed design was the best design ergonomically
that could have been chosen. (A127; A3051; A3053-54.) The court also
addressed the feedback that Ethicon had received from surgeons concerning
Ethicons alternative designs. (A127; A4536 14 and A3214-20.)
The district court further addressed alternative designs in its discussion of
the adverse utility of alternative designs factor. For example, the court noted
that [f]urther proof of functionality was provided by [Ethicons] own inventors,
who testified that alternative designs would not have worked as well as the design
embodied by the asserted Design Patents. (A127; A3051-87; A3053-54; A305861; A3086.) The court again considered the feedback Ethicon had received from
surgeons concerning the alternative designs. (A127-28.) The record therefore
contradicts Ethicons principal effort to undermine the district courts invalidity
ruling.

- 49 -

2.

The Undisputed Evidence Shows The Claimed Design Is the


Best Design and Alternative Designs Would Adversely
Affect Utility

In considering the alternative designs, the district court properly concluded


that no other design provided all the functional benefits of the claimed design. The
undisputed evidence showed both that the claimed design was the best design
(Berry Sterling factor #1) and that the alternative designs would adversely affect
utility (Berry Sterling factor #2).
In particular, Ethicons own inventors testified that of all the different
alternative designs considered for Ethicons own product, the claimed design was
the best design ergonomically that could have been chosen. (A3051; A3053-54.)
Surgeons also preferred [what Ethicon contends is the claimed design] the most
overall. (A3214-20; A3218; A4536 14.) Ethicons witnesses also testified that
the Design Patents open trigger design was surgeons preferred design and that
reverting to a closed trigger design would be a mistake, would not be as good.
(A3058-59.) Ethicons lead inventor further stated that the forward position is the
preferred placement of the Torque Knob used to control rotation. (A3060.) And
Ethicon confirmed through interviews with surgeons that rotation was of
significant importance to surgeons and a deciding factor for surgeons in
choosing among different configurations of the device. (A4538 18; A3246-47.)

- 50 -

The evidence further showed that surgeons prefer that ultrasonic hand-held
surgical devices have an open trigger for easy access and activation buttons and
knobs that are intuitive and easy to reach in a variety of positions. (A4536 14;
A3214-20.) All of the feedback that Ethicon solicited from surgeons during its
extensive testing of its Harmonic ACE products centered around the ergonomics of
the designs; Ethicon never asked the surgeons which designs they thought looked
nicer or were more pleasing aesthetically. (A5006; A5023-27.)
Ethicons attempt to run from the testimony of its own witnesses should be
rejected. For example, Ethicon incorrectly cites the testimony of Covidiens
industrial design expert when he is discussing the design of a different device a
needleless injection system in an attempt to argue there is no such thing as a
best design. (EB48; A5172-73.) But Ethicons own inventors repeatedly
testified that the claimed design was best or preferred most by surgeons.
(A3051; A3053-54; A3058-A3061; A3081; A3086; A5006-38.)
Ethicons attempt to analogize this case to prior decisions overturning
invalidity rulings also fails. For example, in Rosco (EB49), this Court reversed an
invalidity ruling where the evidence showed that alternative designs (for a school
bus mirror) performed the same functions as the claimed design. Rosco, Inc. v.
Mirror Lite Co., 304 F.3d 1373, 1379 (Fed. Cir. 2002). Conversely, the undisputed
evidence here shows that the alternative designs are not functionally equivalent to
- 51 -

the claimed design. And in High Point (EB45), this Court reversed a functionality
ruling because the district court had refused to consider evidence offered by the
plaintiff under three of the Berry Sterling factors. 730 F.3d at 1316-17.
Specifically, the district court had ignored evidence that alternative designs existed
in various catalogs, that no utility patents covered the claimed design, and that the
claimed design included certain ornamental aspects which did not perform any
function at all. Id. Here, by contrast, the district court considered the undisputed
evidence on all five Berry Sterling factors.
To the extent Ethicon suggests that the existence of alternative designs by
itself negates functionality, this suggestion contradicts precedent. This Court has
held that [t]he failure of [a district] court to give dispositive effect to the existence
of alternative designs in its validity analysis is not error. See Berry Sterling, 122
F.3d at 1456.
Ethicon also wrongly contends that the consideration of alternative designs
is paramount among the Berry Sterling factors. (EB41.) This Court instead has
observed that [t]he presence of alternative designs may or may not assist in
determining whether the challenged design can overcome a functionality
challenge. Berry Sterling, 122 F.3d at 1456. Here, the district court considered
all of the alternative designs proffered by Ethicon and properly concluded that the
undisputed evidence showed none of them worked equally as well as the claimed
- 52 -

design. See PHG, 469 F.3d at 1367 (Our case law makes clear that a full inquiry
with respect to alleged alternative designs includes a determination as to whether
the alleged alternative designs would adversely affect the utility of the specified
article, such that they are not truly alternatives within the meaning of our case
law.).
Finally, Ethicons contention that the district court confused the concept of
functionality with the question whether the object of the claimed design has a
function is wrong. The district court properly focused the inquiry on whether the
claimed designs are dictated by function. (A131.) See PHG, 469 F.3d at 1366
(The design of a useful article is deemed to be functional when the appearance of
the claimed design is dictated by the use or purpose of the article. (citations and
internal quotations omitted)). Ethicon has identified no error in the district courts
articulation or application of this Courts precedent.
3.

The Remaining Berry Sterling Factors Also Show


Functionality as a Matter of Law

Ethicon likewise has not identified any error in the district courts
application of the other three Berry Sterling factors.
On factor #3, the district court correctly ruled that [t]he existence of two
utility patents further demonstrates that . . . the Design Patents are all entirely
functional. (A128.) The evidence showed that surgeons want certain features in
ultrasonic hand-held surgical devices, such as an open trigger for easy access,
- 53 -

and activation buttons and knobs which are intuitive and easy to reach in a variety
of positions. (A4536 14; A3214-20.) The court observed that the claims of the
utility applications were directed to structures and features identical to the
structures and features claimed in the Design Patents. (A129; A2934-3037;
A3089-3190.) The court also noted that various unequivocal statements about
the ergonomic benefits of the designs by the Ethicon inventors in the utility patents
provide additional proof that the claimed design is primarily functional as a
whole. (A130; A3018-19; A3021.)
Ignoring the district courts actual analysis, Ethicon attributes to the court
the straw-man view that Ethicon could not seek utility and design patent protection
for the same device. The district court correctly followed this Courts instruction
to consider whether there are any concomitant utility patents. Berry Sterling,
122 F.3d at 1456. In doing so, the district court correctly observed that the utility
patents emphasized the purported functional advantages of the same features for
which Ethicon sought design patent protection. (A128-30.)
In the utility patent applications, Ethicon specifically called attention to the
functional benefits of the features claimed in the Design Patents and crafted claims
in an effort to cover the same features shown in the Design Patents. (A2934-3037
0008-18, 0111-0113, 0116, 0118, 0124-26, 0128, 0131-32, 135, 0138-39, Claims
1, 8, & 35; A3038-3049; A3088-3190 Claims 1, 2, 5, & 16.) Ethicon also
- 54 -

repeatedly used the term ergonomic a functional characteristic in the utility


patent applications to describe the same design it asserts to be aesthetic in the
Design Patents.
Ethicons citation to Avia and Crocs for the general proposition that there
are instances where the same article can enjoy utility and design patent protection
thus does not help its case. Neither case contains any substantive discussion of
when dual coverage is allowed and both are factually distinct. In Avia, unlike here,
there were not even any utility patents covering the sneakers in question. Avia
Grp. Intl, Inc. v. L.A. Gear Cal., Inc., 853 F.2d 1557, 1562-63 (Fed. Cir. 1988).
And in Crocs, also unlike here, the functionality of the design patent vis--vis the
utility patent was not an issue on appeal. Crocs, Inc. v. Intl Trade Commn, 598
F.3d 1294, 1302-1306 (Fed. Cir. 2010).
The utility patent applications are strong evidence of functionality because
Ethicon sought design patent protection for the same features for which Ethicon
sought utility patent protection. Ethicon highlighted the functionality of these very
features in the utility patent applications. Ethicons problem is that it tried to
secure design protection for the functional aspects of the device, not simply that it
tried to secure both design and utility patent protection for the same device. See,
e.g., In re Becton, Dickinson and Co., 675 F.3d 1368, 1375 (Fed. Cir. 2012) (utility
patent/trade dress; [T]he existence of a utility patent disclosing the utilitarian
- 55 -

advantages of the design showed it was functional.); TrafFix Devices, Inc. v.


Marketing Displays, Inc., 532 U.S. 23, 31 (2001) (utility patent/trade dress;
[D]isclosure of a feature in the claims of a utility patent constitutes strong
evidence of functionality.).
On factor #4, the district court correctly ruled that the undisputed evidence
shows Ethicons advertising touted the utility of the claimed design. The district
court observed that Ethicons Feeling is Believing advertisements were intended
to draw attention to the ergonomic benefits of the claimed designs, using phrases
like open design, easy access and optimum fit and comfort. (A130; A31923204.) Ethicon did not and could not meaningfully dispute this evidence.
On factor #5, the district court correctly ruled that the undisputed evidence
shows that the claimed designs have no elements that are entirely aesthetic. The
district court ruled that each and every aspect claimed in the Design Patents [was]
clearly dictated by function. (A131.) Ethicons witnesses established this point:
they could not identify any element in the Design Patents which was primarily
aesthetic, as opposed to being primarily functional. (A3051-52; A3063-64; A4536
14.)
Applying all the Berry Sterling factors to the claimed design as a whole, the
district courts summary judgment of invalidity based on functionality of the
claimed designs should be affirmed.
- 56 -

D.

The District Court Correctly Granted Summary Judgment of


Noninfringement on the Design Patents

The district court correctly ruled that, as a matter of law, the Sonicision
device does not infringe the Design Patents. This Court has made clear that
design patents have almost no scope beyond the drawings. Unidynamics Corp.
v. Automatic Prods Intl Ltd., 157 F.3d 1311, 1323 (Fed. Cir. 1998). For this
reason, and because the material facts are often undisputed, summary judgment of
noninfringement is commonplace in design patent cases. See, e.g., Egyptian
Goddess, 543 F.3d at 678; Oddzon Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396
(Fed. Cir. 1997). Here, the material facts are undisputed. These facts show that
the accused Sonicision device is plainly dissimilar to the claimed design.
Accordingly, the summary judgment should be affirmed.
1.

The District Court Correctly Factored Out the Functional


Aspects of the Claimed Design

Contrary to Ethicons argument, the district court properly factored out the
elements of the claimed designs dictated by function before comparing it to the
Sonicision device. (A131-33.) This Courts decision in Richardson requires the
decision-maker to factor out those elements of a design patent which are clearly
dictated by function before performing an ordinary observer analysis. Richardson
v. Stanley Works, Inc., 597 F.3d 1288, 1293-95 (Fed. Cir. 2010). That is exactly
what the district court did here. Specifically, it removed the U-Shaped Trigger,
- 57 -

Torque Knob and Rounded Button elements from the design before comparing the
design to the Sonicision device because it determined that every aspect claimed in
the Design Patents is clearly dictated by function. (A131-33.) Upon removing
these elements, the District Court correctly observed there was nothing left to
compare to the Sonicision, and hence there could be no infringement. (A133.)
Ethicon wrongly accuses the district court of applying a lower standard for
functionality because the court occasionally used the phrases informed by and
based on functional considerations. (EB50-51.) The district court
unambiguously ruled that all of the features claimed in the Design Patents were
dictated by functional considerations. (A130.) In fact, the district court used the
term dictated in connection with functionality at least 10 times in its opinion.
This is not a case like High Point, where the district court erroneously based its
decision on whether just the primary features of a claimed design performed
functions. High Point, 730 F.3d at 1316. The district court here properly focused
on all the features claimed in the Design Patents and correctly ruled that those
features, both individually and as a whole, were dictated by function. (A13133.)

- 58 -

2.

The District Courts Alternative Analysis, Which


Considered All Aspects of the Claimed Design, Also
Supports the Summary Judgment of Noninfringement

The district court also conducted an extensive, alternative analysis that


considered all aspects of claimed design (regardless of functionality) in comparing
it to the accused Sonicision device. (A135-143.) This alternative analysis which
Ethicon hardly challenges in its appeal brief is correct because the undisputed
evidence shows the plain dissimilarity between the claimed design and Sonicision
device. Accordingly, even if the district courts ruling on functionality were set
aside, the noninfringement judgment still should be affirmed.
As the district court correctly observed, the Sonicision does not practice
any of the alleged ornamental design features of the Design Patents as the designs
simply do not look alike except for the fact that both are hand-held surgical devices
with open trigger handles. (A135.) A comparison of the patent drawings with
pictures of the Sonicision device shows that these devices are plainly dissimilar.
(A136-42.) Most obviously, the claimed design has an overall contoured shape
and design scheme while the Sonicision device has an overall linear shape and
design scheme. (A135-36.)
This comparison alone establishes that the claimed design and Sonicision
device are sufficiently distinct to warrant summary judgment of
noninfringement. Egyptian Goddess, 543 F.3d at 678. No reasonable fact-finder
- 59 -

could find that an ordinary observer would be deceived by the similarity between
the claimed and accused designs, inducing him to purchase one supposing it to be
the other. Id. (quoting Gorham Co. v. White, 81 U.S. 511, 528 (1871).
The district court then correctly identified numerous dissimilarities between
the claimed design elements asserted by Ethicon and the features of the Sonicision
device. (A136-143.) The court used side-by-side comparisons of the claimed
design and accused device to illustrate these many differences. (A138-142;
A3229-43.) Below is a summary of the differences between Ethicons asserted
design elements and the Sonicision device considered by the court (the relevant
graphics follow each summary):
Ethicons Claimed Design

Covidiens Sonicision Device


U-Shaped Trigger

Contoured throughout

Linear throughout

Distal portion curves away from device


and proximal portion curves toward
device

Forward (distal) portion is parallel to


rear (proximal) portion

Continuously curved portion connects


distal and proximal portions

Linear and downwardly angled portion


connects distal and proximal portions

Width of distal portion is equal to or


greater than proximal portion

Width of distal portion is substantially


less than width of proximal portion

Proximal portion extends below bottom


of device handle

Proximal portion ends above bottom of


device handle

Proximal portion (front view) is curved

Proximal portion (front view) is straight

Proximal portion (front view) tapers


along its length, becoming narrower
with inward curve at bottom

Proximal portion (front view) remains


consistent in width throughout
- 60 -

Ethicons Claimed Design

Covidiens Sonicision Device

Continuously curved portion connecting


distal and proximal portions (bottom
view) is narrowed in center and widest
at ends

Linear and downwardly angled portion


connecting distal and proximal portions
(bottom view) is widest at end closest to
proximal portion and narrowest at end
closest to distal portion

- 61 -

Ethicons Claimed Design

Covidiens Sonicision Device


Rounded Activation Button

Football-shaped overall

Rectangular overall

Curved across its front

Flat front face and flat side faces

Placed directly above upper portion of


trigger

Placed behind upper portion of trigger

In contact with upper portion of trigger

Separated from upper portion of trigger

Appears to wrap around sides of device

Does not appear to wrap around the


device

- 62 -

Ethicons Claimed Design

Covidiens Sonicision Device


Torque Knob

Flat front face

Rounded across the front

Has curve from the front that peaks


before curving inward again

Curve tapers evenly from front

Widest portion is approximately onethird of overall distance from back of


knob to front

Widest portion is at its base

Front face has large circular recess at


center that reveals elements inside the
knob

Smooth across front face with no


circular recess

- 63 -

Finally, Ethicons lead designer, when asked where the elements shown in
the Design Patents existed in the Sonicision device, responded: Theyre not the
same. I mean, theyre different devices. (A3051; A3065; A3069; A3076-79;
A4537-38 17.)
Considering all these differences in light of the limited scope of design
patent protection, this is an easy case for summary judgment. These plainly
- 64 -

dissimilar designs are sufficiently distinct that no reasonable fact-finder could


find that an ordinary observer would be deceived into thinking one was the other.
Egyptian Goddess, 543 F.3d at 678; Gorham, 81 U.S. at 528. Accordingly, the
judgment of noninfringement should be affirmed.
3.

The District Court Did Not Need to Consider the Prior Art
in Ruling on the Infringement Claim Because the Claimed
Design and Accused Device Are Plainly Dissimilar

Ethicon also wrongly claims the district court erred by not considering the
frame of reference provided by the prior art. (EB53.) As shown above, the
designs are so plainly dissimilar that the district court did not need to consider the
prior art in recognizing those differences. The district courts approach is entirely
consistent with this Courts teachings in Egyptian Goddess: In some instances,
the claimed design and the accused design will be sufficiently distinct that it will
be clear without more that the patentee has not met its burden of proving the two
designs would appear substantially the same to the ordinary observer, as required
by Gorham. 543 F.3d at 678. The Court further explained, In other instances,
when the claimed and accused designs are not plainly dissimilar, resolution of the
question whether the ordinary observer would consider the two designs to be
substantially the same will benefit from a comparison of the claimed and accused
designs with the prior art. Id. Because the claimed and accused designs are

- 65 -

plainly dissimilar in this case, the district court properly granted summary
judgment without any need to compare those designs to the prior art.
Moreover, Ethicon had the burden to show that the Sonicision device was
not plainly dissimilar to the claimed design to potentially bring the prior art into
play. Egyptian Goddess, 543 F.3d at 678-79. As shown in subsection D.2 above,
Ethicon did not and could not carry that burden. Accordingly, an examination of
the prior art was unnecessary. See Egyptian Goddess, 543 F.3d at 678. In fact, this
Court recently affirmed the dismissal of a complaint for design patent infringement
at the pleading stage because a side-by-side comparison of the design patent
images and the images of the accused products showed that they were plainly
dissimilar. Anderson v. Kimberly-Clark Corp., 570 Fed. Appx. 927, 929 (Fed.
Cir. 2014).
Ethicon also incorrectly argues that the Revision Military case compels this
Court to consider the prior art before deciding the issue of infringement. (EB55.)
That case involved a reversal and remand for a district courts application of the
improper standard for determining injunctive relief. Revision Military, Inc. v.
Balboa Mfg. Co., 700 F.3d 524 (Fed. Cir. 2012). This Court suggested in dicta
that, based on the overall similarity between the design drawings and alleged
infringing product, the district court might want to consider the prior art on
remand. Id. at 527 (The district court did not consider the prior art . . . [b]ecause
- 66 -

[it felt that] this is not a particularly close case, [but] the record suggests
otherwise.). As shown above, however, this case is not a close one.
Finally, Ethicon has failed to show the outcome could be different even if
the district court were required to consider the prior art. For one thing, this Court
pointed out in Egyptian Goddess that [t]he accused infringer is the party with the
motivation to point out close prior art. Id. at 679 (emphasis added). In fact,
Covidien presented to the district court noninfringement evidence and arguments
based on the prior art. (A2830; A5625; A5628.) Moreover, the only relevance
Ethicon ascribes to the prior art is its contention that the clamping arm of almost
every ultrasonic surgical device was controlled by a thumb-ring or loop-shaped
trigger. (EB53-54; A5006; A5023-27.) Not only is Ethicons statement wrong
its own brief touts prior-art devices which feature a U-shaped trigger of the type
the district court found functional (EB43) but Ethicon essentially asserts that the
Sonicision devices mere use of an open trigger instead of a thumb-ring or loopshaped trigger can avoid summary judgment. Ethicons improper attempt to
monopolize any use of an open trigger flies in the face of the very limited scope of
design patent protection and should be rejected. See Unidynamics, 157 F.3d at
1323 ([D]esign patents have almost no scope beyond the drawings.).

- 67 -

4.

The District Court Correctly Noted the Sophistication of the


Ordinary Observer Who Purchases Surgical Instruments

Finally, Ethicon wrongly challenges the district courts ruling that the
ordinary observer here was the hospital or medical device supplier who
actually purchases the devices, and not the surgeon who uses them. (EB55.) The
court correctly recognized that, while a surgeon may have some input to a
hospital into which devices he or she prefers, the actual purchaser of the devices
was the relevant ordinary observer here. (A134; A3223.)
The case cited by Ethicon actually supports Covidiens position. In
Arminak, this Court affirmed a lower court finding that the industrial purchaser or
contract buyer was the ordinary observer for design patents covering components
used in making spray triggers, even though the spray bottles were eventually sold
to ordinary consumers at retail. Arminak & Assocs. v. Saint-Gobain Calmar, Inc.,
501 F.3d 1314, 1323 (Fed. Cir. 2007). This Court held that commercial or
industrial buyers can be ordinary observers. Id. at 1322. The district courts
ruling here that the ordinary observer for expensive surgical devices is the
hospital or medical device supplier is entirely consistent with Arminak. The
hospitals and medical device suppliers here are equivalent to the industrial
purchasers there, with surgeons being more akin to a retail consumer who might
offer opinions as to which device they prefer.

- 68 -

Finally, Ethicon fails to show how the correct outcome could differ even if
surgeons who themselves are more sophisticated with respect to these devices
than the general public were considered the ordinary observer. Ethicon has not
shown any legal error in the district courts analysis, much less one that could have
determined the outcome here.
VII. CONCLUSION
The district court correctly applied the law to the undisputed material facts.
The judgment should be affirmed in its entirety.
Dated: November 18, 2014

Respectfully submitted,

/s/ Drew M. Wintringham


Drew M. Wintringham
DLA Piper LLP (US)
1251 Avenue of the Americas
New York, NY 10020-1104
Telephone: (212) 335-4520
Facsimile: (917) 778-8520
Attorney for Defendants-Appellees
Covidien, Inc. and Covidien LP

- 69 -

CERTIFICATE OF SERVICE
I am employed in the County of San Diego, State of California. I am over
the age of 18 and not a party to the within cause. I am a legal secretary with DLA
Piper LLP (US), whose business address is 401 B Street, Suite 1700, San Diego,
CA 92101, and am filing and serving the following on behalf of Drew M.
Wintringham:
RESPONSE BRIEF FOR DEFENDANTS-APPELLEES
I hereby certify that I electronically filed the foregoing with the Clerk of the
Court for the United States Court of Appeals for the Federal Circuit by using the
appellate CM/ECF system on November 18, 2014 .
Participants in the case who are registered CM/ECF users will be served by
the appellate CM/ECF system.

Dated: November 18, 2014

- 70 -

CERTIFICATE OF COMPLIANCE
This brief complies with the type-volume limitation of Fed. R. App. P.
32(a)(7)(B). The brief contains 13,942 words, as calculated by the word count of
the word processing system used in preparing it, excluding the parts of the brief
exempted by Fed. R. App. P. 32(a)(7)(B)(iii) and Fed Cir. R. 32(b).
This brief complies with the typeface requirements of Fed. R. App. P.
32(a)(5) and the type style requirements of Fed. R. App. P. 32(a)(6). The brief has
been prepared in Microsoft Word 2010 in Times New Roman 14 point font.
Dated: November 18, 2014
/s/ Drew M. Wintringham
Drew M. Wintringham

- 71 -

2014 -1370

d
IN THE

United States Court of Appeals


FOR THE FEDERAL CIRCUIT

ETHICON ENDO-SURGERY, INC. and ETHICON ENDO-SURGERY, LLC,


Plaintiffs-Appellants,

v.
COVIDIEN, INC. and COVIDIEN LP,
Defendants-Appellees.
ON APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION IN CASE NO. 11- CV-871
JUDGE TIMOTHY S. BLACK

REPLY BRIEF FOR PLAINTIFFS-APPELLANTS

WILLIAM F. CAVANAUGH, JR.


CHAD J. PETERMAN
R. JAMES MADIGAN III
HELEN P. OREILLY
JEREMY A. WEINBERG
PATTERSON BELKNAP WEBB & TYLER LLP
1133 Avenue of the Americas
New York, New York 10036
( 212) 336-2000
Attorneys for Plaintiffs-Appellants

CERTIFICATE OF INTEREST
Counsel for Plaintiffs-Appellants Ethicon Endo-Surgery, Inc. and Ethicon
Endo-Surgery, LLC certify the following:
1. The full name of every party or amicus represented by me:
Ethicon Endo-Surgery, Inc. and Ethicon Endo-Surgery, LLC
2. The name of the real party in interest (if the party named in the caption is not
the real party in interest) represented by me is:
Not Applicable.
3. All parent corporations and any publicly held companies that own 10 percent
or more of the stock of the party or amicus curiae represented by me are:
Johnson and Johnson; Ethicon, Inc.; Ethicon, LLC; Ethicon PR
Holdings
4. The name of all law firms and the partners or associates that appeared for the
party or amicus now represented by me in the trial court or agency or are
expected to appear in this court are:
William F. Cavanaugh, Jr., Chad J. Peterman, R. James Madigan III,
Helen P. OReilly, Jeremy A. Weinberg
PATTERSON BELKNAP WEBB & TYLER LLP
Charles D. Hoffman
HOFFMANN MARSHALL STRONG LLP
David Edward Schmit
FROST BROWN & TODD, LLC

TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES ................................................................................... iii
STATEMENT OF RELATED CASES ....................................................................vi
STATEMENT OF JURISDICTION.........................................................................vi
INTRODUCTION .....................................................................................................1
I.

II.

III.

THE 501 PATENT: THE DISTRICT COURT ERRED IN GRANTING


SUMMARY JUDGMENT OF INDEFINITENESS.......................................1
A.

Closed Position......................................................................................2

B.

Average Force/Pressure.........................................................................4

THE 275 PATENT: THE DISTRICT COURT ERRED IN GRANTING


SUMMARY JUDGMENT OF NON-INFRINGEMENT...............................7
A.

The District Court Erred in Its Construction of Configured to


Loosely Contact...................................................................................7

B.

The District Court Erred in Finding that Sonicisions Sleeve Is Not


Configured to Loosely Contact the Transmission Rod ...................12

C.

The District Court Erred in Finding that Sonicisions Sleeve Is Not


Adapted To Absorb Undesired Vibrations ......................................14

THE DESIGN PATENTS: THE DISTRICT COURT ERRED IN


GRANTING SUMMARY JUDGMENT OF INVALIDITY AND NONINFRINGEMENT .........................................................................................17
A.

Validity................................................................................................17
1.

The District Court Erred in Ignoring Alternative Designs


That Would Work as Well as the Patented Designs .................18

2.

The District Court Erred in Addressing Other Concomitant


Utility Patent Applications........................................................21

3.
B.

The District Court Erroneously Ignored Aesthetic


Considerations...........................................................................22

Infringement ........................................................................................25
1.

The District Courts Errors in Assessing Functionality


Infected its Infringement Analysis............................................25

2.

The District Court Also Erred in Not Evaluating


Infringement in the Context of the Prior Art ............................25

CONCLUSION........................................................................................................32

ii

TABLE OF AUTHORITIES
Page(s)
Cases
Amini Innovation Corp. v. Anthony Cal., Inc.,
439 F.3d 1365 (Fed. Cir. 2006) ..........................................................................29
Anderson v. Kimberly-Clark Corp.,
570 F. Appx 927 (Fed. Cir. 2014) ...............................................................30, 31
Apple Inc. v. Motorola, Inc.,
757 F.3d 1286 (Fed. Cir. 2014) ..........................................................................13
Aventis Pharma SA v. Hospina, Inc.,
675 F.3d 1324 (Fed. Cir. 2012) ..........................................................................10
Avia Grp. Intl Inc. v. L.A. Gear Cal. Inc.,
853 F.2d 1557 (Fed. Cir. 1988) ..........................................................................22
Berry Sterling v. Pescro Plastics, Inc.,
122 F.3d 1452 (Fed. Cir. 1997) ..............................................................18, 19, 21
Best Lock Corp. v. Ilco Unican Corp.,
94 F.3d 1563 (Fed Cir. 1996) .......................................................................18, 19
Braintree Labs., Inc. v. Novel Labs., Inc.,
749 F.3d 1349 (Fed. Cir. 2014) ............................................................................8
Crocs, Inc. v. Intl Trade Commn,
598 F.3d 1294 (Fed. Cir. 2010) ....................................................................20, 29
Crown Packaging Tech., Inc. v. Ball Metal Beverage Container
Corp.,
635 F.3d 1373 (Fed. Cir. 2011) ........................................................................4, 6
Dealertrack, Inc. v. Huber,
674 F.3d 1315 (Fed. Cir. 2012) ............................................................................8
DSW, Inc. v. Shoe Pavilion, Inc.,
537 F.3d 1342 (Fed. Cir. 2008) ............................................................................9

iii

Egyptian Goddess, Inc. v. Swisa, Inc.,


543 F.3d 665 (Fed. Cir. 2008) (en banc) ..........................................26, 27, 31, 32
Enzo Biochem, Inc. v. Applera Corp.,
599 F.3d 1325 (Fed. Cir. 2010) ............................................................................8
EPOS Techs. Ltd. v. Pegasus Techs. Ltd.,
766 F.3d 1338 (Fed. Cir. 2014) ....................................................................12, 16
Freeny v. Apple, Inc.,
No. 2:13-CV-00361-WCB, 2014 U.S. Dist. Lexis 120446 (E.D.
Tex. Aug. 28, 2014) ..............................................................................................4
Goodyear Tire & Rubber Co. v. Hercules Tire & Rubber Co.,
162 F.3d 1113 (Fed. Cir. 1998) ..........................................................................29
Hill-Rom Servs. v. Stryker Corp.,
755 F.3d 1367 (Fed. Cir. 2014) ............................................................................9
Hupp v. Siroflex of Am., Inc.,
122 F.3d 1456 (Fed. Cir. 1997) ....................................................................20, 24
L.A. Gear v. Thom McAn Shoe Co.,
988 F.2d 1117 (Fed Cir. 1993) ...............................................................19, 20, 22
LG Elecs. v. Bizcom Elecs., Inc.,
453 F.3d 1364 (Fed. Cir. 2006) ..........................................................................10
Liebel-Flarsheim Co. v. Medrad, Inc.,
358 F.3d 898 (Fed. Cir. 2004) ..............................................................................8
Metro. Life Ins. Co. v. Bancorp Servs., L.L.C.,
527 F.3d 1330 (Fed. Cir. 2008) ........................................................................4, 6
Nautilus, Inc. v. Biosig Instruments, Inc.,
134 S. Ct. 2120 (2014)..................................................................................1, 4, 5
Orthokinetics, Inc. v. Safety Travel Chairs, Inc.,
806 F.2d 1565 (Fed. Cir. 1986) ............................................................................5
Pac. Coast Marine Windshields Ltd. v. Malibu Boats, LLC,
739 F.3d 694 (Fed. Cir. 2014) ............................................................................29

iv

PHG Techs., LLC v. St. John Cos., Inc.,


469 F.3d 1361 (Fed. Cir. 2006) ..............................................................17, 18, 21
Phillips v. AWH Corp.,
415 F.3d 1303 (Fed. Cir. 2005) ............................................................................9
Plantronics, Inc. v. Aliph, Inc.,
724 F.3d 1343 (Fed. Cir. 2013) ..........................................................................10
Revision Military, Inc. v. Balboa Mfr. Co.,
700 F.3d 524 (Fed. Cir. 2012) ..........................................................26, 30, 31, 32
Rosco, Inc. v. Mirror Lite Co.,
304 F.3d 1373 (Fed. Cir. 2002) ........................................................17, 19, 20, 21
Starhome GmbH v. AT&T Mobility LLC,
743 F.3d 849 (Fed. Cir. 2014) ............................................................................10
Teleflex, Inc. v. Ficosa N. Am. Corp.,
299 F.3d 1313 (Fed. Cir. 2002) ............................................................................8
Williamson v. Citrix Online, LLC,
770 F.3d 1371 (Fed. Cir. 2014) ..........................................................................11
Statutes
28 U.S.C. 1295(a)(1)..............................................................................................vi
28 U.S.C. 1331.......................................................................................................vi
28 U.S.C. 1338(a) ..................................................................................................vi
Other Authorities
FED. CIR. R. 47.5 .......................................................................................................vi
FED. R. APP. P. 4(a)(1)(A).........................................................................................vi

STATEMENT OF RELATED CASES


Pursuant to Federal Circuit Rule 47.5, counsel for Plaintiffs-Appellants
states there are no related cases to this case and there are no other cases that will be
directly affected by the Courts decision in this case.

STATEMENT OF JURISDICTION
The district court had jurisdiction in this action pursuant to 28 U.S.C.
1331 and 1338(a). The Notice of Appeal from the Final Judgment entered on
March 4, 2014 was timely filed on March 19, 2014 in accordance with FED. R.
APP. P. 4(a)(1)(A). This Court has appellate jurisdiction under 28 U.S.C.
1295(a)(1).

vi

INTRODUCTION
In its opening brief, Ethicon demonstrated that the district court erred in
granting summary judgment that: (1) the 501 patent is invalid as indefinite; (2) the
Sonicision device does not infringe the 275 patent; and (3) the Design Patents are
invalid and not infringed by Sonicision.
In its response, Covidien presents its own position on disputed fact issues
and credits its experts opinions over those of Ethicons experts. When both sides
evidence is consideredand not just Covidiensdisputed issues of material fact
made it improper to grant summary judgment.
I.

THE 501 PATENT: THE DISTRICT COURT ERRED IN


GRANTING SUMMARY JUDGMENT OF INDEFINITENESS
To warrant summary judgment of indefiniteness under Nautilus, Inc. v.

Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), Covidien needed to show that the
undisputed evidence, viewed with all reasonable inferences drawn in Ethicons
favor, clearly and convincingly establishes that [the] claims, read in light of the
specification delineating the [501] patent, and the prosecution history, fail to
inform, with reasonable certainty, those skilled in the art about the scope of the
invention. Id. at 2124. Covidien failed to meet that heavy burden. (Eth.Br. 2229)1

As used herein, Eth.Br. ___ refers to Ethicons Appeal Brief (Dkt. No. 24).
Cov.Br. ___ refers to Covidiens Response Brief (Dkt. No. 39).

In granting summary judgment of indefiniteness, the district court resolved


disputed fact issues in Covidiens favor, and largely ignored the opinions of
Ethicons expert, Dr. Schafer. Covidien continues this improper approach. It
argues that disputed facts were undisputed and discounts as conclusory all expert
evidence that is inconsistent with its position.
The district courts decision rests on an incorrect determination that
undisputed evidence establishes that, from the viewpoint of one skilled in the art,
there was no disclosed method of measurement [of clamping forces/pressures] in
the patent and no guidance as to whether the value determined was applicable to
the patent claims. (A0099) Covidien defends this determination by arguing that
the necessary guidance is lacking and that there are different methods for making
measurements available which lead to different results. (Cov.Br. 22-23) These
arguments ignore language in the specification and expert testimony demonstrating
that, based on the patents disclosure, a skilled artisan would perform the claimed
force/pressure measurements (1) with the clamp and blade in a closed position and
(2) in a manner that reflects the average pressure or force of the clamping surface
area, such as the midpoint of the clamping arm. (Eth.Br. 23-29)
A.

Closed Position

Based on the specifications teachings, a skilled artisan would know how to


measure the claimed force/pressure with the clamp arm and blade in a closed

position. (Eth.Br. 23-26) The specification of the 501 patent explains that [t]he
pressures discussed herein are pressures seen by tissue when the entire clamping
surface area is in contact with the tissue. (A0178/col.4:23-27) The specification
then states: a clamping surface area is the area where the blade and the tissue
pad are in close proximity when the clamping arm is in a closed position. (Id.)
These teachings could not be more pertinent or clearer.
Dr. Schafer testified that based on the foregoing disclosure a skilled artisan
would know to make the measurement with the clamp arm in a closed position,
i.e., with the clamp arm closed on the blade. (A4281-A4282) As he explained,
the 501 patent was directed to performing the measurement when the clamp jaw
is in the closed position and that a clamp jaw open at an angle ... does not lead
to the measurements required under the patent. (A4427/248)
Covidien distorts the specification and the expert evidence when it argues
that notwithstanding the explicit disclosure quoted above, the specification does
not refer to measuring clamping force/pressure in the closed position. (Cov.Br. 2829) As a fallback, Covidien argues that there are still unanswered ...
methodological questions regarding the measurement, including the amount and
compressibility of tissue in the clamping arm. (Cov.Br. 28-29) But with the clamp
arm and blade being in a closed position, the so-called unanswered ...
methodological questions are irrelevant because the measurement is not taken
3

until the clamp arm is actually closed on the blade. (Eth.Br. 23-26; A4281-A4282;
A4427/248; A4428/252)
In sum, Ethicon presented competent evidence that one of skill in the art
would understand from the patent that the closed position is the correct position in
which to take the required measurement. To be sure, Covidiens expert disagreed,
but this simply presented a conflict in [expert] declarations [which] created a
genuine issue of material fact that made summary judgment inappropriate. Metro.
Life Ins. Co. v. Bancorp Servs., L.L.C., 527 F.3d 1330, 1338-39 (Fed. Cir. 2008);
see also Crown Packaging Tech., Inc. v. Ball Metal Beverage Container Corp., 635
F.3d 1373, 1384 (Fed. Cir. 2011).2
B.

Average Force/Pressure

Ethicon also presented substantial evidence that a skilled artisan would


understand how to measure the force/pressure in order to calculate the average
pressure or force of the clamping surface area, by using the midpoint of the
clamping arm. (Eth.Br. 24-27) The patent directs those skilled in the art to use a
method that is reflective of the average pressure or force. For example, asserted
claims 1, 2, 13, 17, and 18 expressly recite calculating the average clamping
2

Although Nautilus modified the standard for indefiniteness, it did not overrule
decades of Federal Circuit precedent. As Judge Bryson noted, sitting by
designation in a recent district court case, Nautilus did not render all of the prior
Federal Circuit and district court cases [on indefiniteness] inapplicable. Freeny
v. Apple, Inc., No. 2:13-CV-00361-WCB, 2014 U.S. Dist. Lexis 120446, at *16
(E.D. Tex. Aug. 28, 2014).
4

force or pressure. (A4424-A4427/244-247; A0179/col.6:29, 6:33;


A0180/col.7:6, 7:25, 7:29; see also A0178/col.4:17-27; A0177/col.1:27-40, 1:622:54; A0179/col.5:41-64) For the claims that do not expressly recite average, the
patents written description makes clear to a skilled artisan that the average
pressure is the pressure of interest. (Id.) For example, the claim term pressure at
the clamping surface area is understood by a skilled artisan to refer to an average
pressure. (A4424/244)
Covidien argues that the specification lacks specific instructions on how to
measure the average or on the use of the midpoint. (Cov.Br. 26-28) But the
specification does not need to provide more detailed directions because
determining the average force/pressure was within the knowledge of a skilled
artisan. (A4427/247) See Nautilus, 134 S. Ct. at 2129 ([T]he certainty which
the law requires in patents is not greater than is reasonable, having regard to their
subject matter.); Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565,
1576 (Fed. Cir. 1986) ([W]hether a claim is invalid [for indefiniteness] requires a
determination whether those skilled in the art would understand what is claimed
.).
Measuring force/pressure at the middle of the clamp arm is a recognized
method for determining average force/pressure. (A4427/247) Based on basic
laws of physics and his knowledge as a skilled artisan, Dr. Schafer opined that
5

taking the force at the midpoint of the active portion of the clamping arm would
be representative of the average forces delivered by the clamping arm.
(A4356/102; A4366) Thus, he concluded that a skilled artisan would find it
common sense to take the force measurement and calculate pressure based on
measurements at the midpoint. (Id.) As an example, Dr. Schafer pointed to the
984 Whipple patent, which uses the midpoint for a force/pressure measurement.
(A4427/247) His opinions cannot be disregarded at the summary judgment stage.
See Metro. Life, 527 F.3d at 1338-39; Crown Packaging, 635 F.3d at 1384.
Covidiens assertion that Dr. Schafer admitted that the midpoint measurement was
not equivalent to the average clamping force is not supported by the cited record.
(Cov.Br. 27) Indeed, Dr. Schafer confirmed experimentally that the midpoint of
the active portion of the clamping arm is representative of the average clamping
force. (A4366; A4370)
*

Viewing disputed facts in Ethicons favor, a reasonable fact-finder could


conclude that Covidien has not established indefiniteness by clear and convincing
evidence. The district court therefore erred in granting summary judgment of
indefiniteness.

II.

THE 275 PATENT: THE DISTRICT COURT ERRED IN


GRANTING SUMMARY JUDGMENT OF NON-INFRINGEMENT
As Ethicon has demonstrated (Eth.Br. 29-39), the district court erred in its

construction of claim 1 of the 275 patent and in applying its (incorrect) claim
construction to Covidiens Sonicision device. Covidiens response does not justify
the district courts rulings.
A.

The District Court Erred in Its Construction of


Configured to Loosely Contact

In construing a damping member configured to loosely contact the


transmission rod over a portion of the transmission rod (A0169/16:64A0170/col.17:2 (emphasis added)), the district court committed a classic error of
claim construction. Instead of giving the italicized claim language its ordinary
meaning (A1625-A1627), the district court read limitations into the claim based on
features of a preferred embodiment. (A0014-A0015) The district courts
construction confuses the type of contact required by the claim (loose) with the
location of that contact (other than at fixed support points). Nothing in the intrinsic
evidence supports reading this latter feature into the claim. In fact, the term
fixed is not used anywhere in the 275 patent.
As a general rule, it is improper to read limitations from a preferred
embodiment described in the specification into the claims absent a clear
indication in the intrinsic record that the patentee intended the claims to be so

limited. Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1342 (Fed. Cir. 2012)
(quoting Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1342 (Fed. Cir.
2010)); see also Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1355
(Fed. Cir. 2014) (same). This is true even if the preferred embodiment is the only
embodiment. Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir.
2004); Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002).
The intrinsic evidence here does not indicatelet alone indicate with the
requisite claritythat fixed support points must be excluded from the points of
loose contact. Covidiens argument focuses on the following description of a
preferred embodiment:
Referring now to FIGS. 5 and 6, the damping sheath 160
of the surgical instrument 150 loosely surrounds at least a
portion of the transmission rod 86. The damping sheath
160 may be positioned around the transmission rod 86 to
dampen or limit transverse side-to-side vibration of the
transmission rod 86 during operation. The damping
sheath 160 preferably surrounds part of the third section
86c of the transmission rod 86 and is coupled or attached
to the transmission rod 86 near one or more nodes. The
damping sheath is only attached to the transmission rod
at the nodal points thereby preventing the sheath from
otherwise adhering to the outer surface of the
transmission rod 86.
(A0166/col.9:33-45 (emphasis added)) This passage is notable for its use of the
words may and preferably. There is nothing indicating that the sleeve must be
attached or coupled to the transmission rod or nodal points.

The language quoted above is a description of one of several possible


embodiments. But the district court relied on it in holding that the specification
distinguish[es] loose contact from attachment at fixed support members and
therefore requires that the loose contact cannot occur at fixed support points on
the transmission rod. (A0014-A0015) This holding is at odds with the intrinsic
record and settled law. See Phillips v. AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir.
2005) ([A]lthough the specification often describes very specific embodiments of
the invention, we have repeatedly warned against confining the claims to those
embodiments.); DSW, Inc. v. Shoe Pavilion, Inc., 537 F.3d 1342, 1347 (Fed. Cir.
2008) ([I]nterpreting what is meant by a word in a claim is not to be confused
with adding an extraneous limitation appearing in the specification, which is
improper. (internal quotation marks and citation omitted)).
The portions of the specification on which Covidien relies do not constitute
a definition, restriction, or disclaimer. There is no indication that the feature of
where loose contact cannot occur is essential for the invention. See Hill-Rom
Servs. v. Stryker Corp., 755 F.3d 1367, 1371-73 (Fed. Cir. 2014). Covidien admits
as much. (Cov.Br. 32-33) Covidien also acknowledges that the specification
describes nodes merely as a preferred location for support (id. at 32), and does
not even identify how many nodes should serve as support points (A0166/col.9:42
(near one or more nodes)), or precisely where the support points should be
9

located (Cov.Br. 32 (preferably placed at or near longitudinal nodes (emphasis


added))). Accordingly, there is no redefinition of the claim language or disclaimer
of its ordinary meaning in the intrinsic record. See Starhome GmbH v. AT&T
Mobility LLC, 743 F.3d 849, 854, 856 (Fed. Cir. 2014); Aventis Pharma SA v.
Hospina, Inc., 675 F.3d 1324, 1330 (Fed. Cir. 2012).
The specification also discloses several other embodiments, further
demonstrating that no single embodiment is exclusive or limiting. See Plantronics,
Inc. v. Aliph, Inc., 724 F.3d 1343, 1349-50 (Fed. Cir. 2013) (rejecting construction
that is improperly limited to one preferred embodiment and thereby excludes
others); LG Elecs. v. Bizcom Elecs., Inc., 453 F.3d 1364, 1377 (Fed. Cir. 2006)
(same), revd on other grounds, 553 U.S. 617 (2008). These alternative
embodiments include the sleeve being coupled to or maintained on the
transmission rod by compliant members (A0167/col.11:9-10); anchored by one
or more compliant members (A0167/col.11:67); or, according to Covidien,
supported on the transmission rod (Cov.Br. 32, 34). The specification
contemplates multiple ways in which the sleeve may interact with support
members, none of which are specifically required and none of which can be read to
limit the claimed invention. While the specification discloses examples and
embodiments ..., nowhere does the specification limit the [invention] to those

10

examples and embodiments. Williamson v. Citrix Online, LLC, 770 F.3d 1371,
1377 (Fed. Cir. 2014).
Nothing requires that the contact between the sleeve and the support
member(s) be anything other than loose. The district court recognized that the
sleeve may be attached to a support member and that the support member may be
positioned at fixed nodal points. (A0015) The district court concluded from this
that the loose contact cannot occur at fixed support points. (A0014) But that
conclusion does not follow either from the claim language or from the
specifications teachings. The contact between the sleeve and support members
can be loose even if they are attached or coupled. For example, as discussed
above, the specification discloses an embodiment in which the sleeve can be
maintained on the transmission rod by compliant members. (A0167/col.11:9-10)
The specification later uses the term loosely to modify the term maintained
(A0167/col.11:55), which establishes that the contact contemplated by the use of
the term maintained can be loose.
Finally, Covidien misreads the record when it argues that Ethicons expert,
Dr. Schafer, opined that contact between the sleeve and waveguides nodal ribs is
irrelevant to the infringement analysis because the nodal ribs serve as fixed support
points for the sleeve. (Cov.Br. 36 (citing A3546/30; A2045-46)) In the
testimony Covidien cites, Dr. Schafer was merely applying the district courts
11

(incorrect) claim constructionnot the correct construction. (See A2046/171:2171:5; see also A3595/56; A3602/59)
Under the correct construction, the loose contact that occurs over a
portion of the transmission rod can include nodal or other support locations. The
grant of summary judgment of non-infringement was based on an incorrect claim
construction and should be reversed. (Eth.Br. 32) See also EPOS Techs. Ltd. v.
Pegasus Techs. Ltd., 766 F.3d 1338, 1341 (Fed. Cir. 2014) (reversing grant of
summary judgment of non-infringement where district court erroneously relied on
features of preferred embodiments to limit the claim terms).
B.

The District Court Erred in Finding that Sonicisions Sleeve Is


Not Configured to Loosely Contact the Transmission Rod

Even under the district courts erroneous claim construction, there is at least
a material question of fact as to whether Sonicisions sleeve is structured to have
contact other than at fixed support points, but not tightly fitted.
The CT scan images submitted by both parties show the loose contact
required by claim 1 even under the adopted claim construction. The CT scans
performed by Dr. Schafer show Sonicisions sleeve is structured to loosely contact
the transmission rod at points other than the fixed support points. (A3562A3563; A3602/61-A3603/65; A3617-A3618; A3684/5-A3687/12) Covidiens
own expert, Dr. Durfee, admitted that one of the CT images, No. 9(e), showed that
the sheath touches in one location other than a fixed support point.
12

(A3671/107; see also A3618; A3526-A3527; A3562) Reviewing the same CT


images, Ethicons expert, Dr. Schafer, agreed. (A3602/61-A3603/65; A3617;
A3684/5; A3687/10) This contact was corroborated by the CT images proffered
by Covidien. (A3687/11) In its response, Covidien ignores its CT scan
evidence.3
In trying to discount this evidence, Covidien argues, unconvincingly, that the
contact shown by the CT images was due to a nonconforming wrinkle in the
sleeve of the Sonicision device tested, or that these images show air gaps
between the sleeve and transmission rod such that there is no contact. (Cov.Br. 3840) These arguments are based on the opinions of Covidiens expert, which are
hotly disputed by Ethicons expert and not supported by any underlying evidence.
For example, Dr. Durfee admits he had no evidence to support his theory that the
contact shown in CT image No. 9(e) resulted from a wrinkled, nonconforming
sleeve. (Eth.Br. 34) Nor is there any evidence to support his assertion that the
points of contact identified by Dr. Schafer are actually air gaps. (A3528; A3563;
A3634-A3636; A3686-A3687) Here, as elsewhere, the disagreements between the

Yet even if there was only a single image showing the requisite contact
(Cov.Br. 40), that would go to the weight of the evidence and not its admissibility.
See, e.g., Apple Inc. v. Motorola, Inc., 757 F.3d 1286, 1319 (Fed. Cir. 2014)
(disagreements about the factual underpinnings of an experts analysis go to the
weight of the evidence, not its admissibility).
13

experts raises disputed issues of material fact requiring denial of summary


judgment. (Eth.Br. 34)
Indeed, Soncisions structureincluding the flexible sleeve, vibrating
transmission rod, and minimal clearance (0.015 inches) between the twomakes
the requisite contact is inevitable. (Id. at 35-36) In response, Covidien argues that
its design goal was minimizing contact. (Cov.Br. 36-38) But Covidiens intent is
irrelevant and cannot rebut the showing that Sonicisions sleeve, as configured,
contacts the transmission rod. (Eth.Br. 35-36) Moreover, as the intrinsic record
makes clear, the purpose of the patented sleeve is to dampenthat is, minimize
undesired vibrations without dissipating desired longitudinal vibrations. (See, e.g.,
A0166/col.9:57-10:1; A0167/col.11:22-26; A0168/col.14:33-36; A0169/col.16:1521) It therefore should come as no surprise that dampening Sonicisions
longitudinal vibrations is identified as a failure mode (Cov.Br. 37), as it would
diminish desired vibrations and result in inadequate cutting and sealing, (A2196;
see also A0163/col.4:9-19).
C.

The District Court Erred in Finding that Sonicisions Sleeve Is


Not Adapted To Absorb Undesired Vibrations

As Ethicon demonstrated (Eth.Br. 36-39), the district court also ignored


record evidence showing that Sonicisions sleeve is adapted to absorb undesired

14

vibrations as claim 1 requires. Instead, in granting summary judgment, the court


adopted Covidiens position on this disputed issue.4
Sonicisions transmission rod produces undesired vibrations that are
absorbed by its sleeve. The evidence shows and Covidien concedes that:
(1) absent the sleeve, Sonicision would experience metal-to-metal contact between
the transmission rod and the inner tube; (2) metal-to-metal contact can result in
squealing and other problems; and (3) Sonicisions sleeve is specifically designed
to contact the transmission rod (or waveguide) in order to prevent this metal-tometal contact. (Cov.Br. 44-45; see also Eth.Br. 36-37) Based on these facts and
his expert experience, Dr. Schafer concluded that Sonicisions transmission rod
generates undesired vibrations which are absorbed by Sonicisions damping sleeve.
(A3606)
Droplet tests performed by both Drs. Durfee and Schafer demonstrate
undesired vibrations in Sonicision. (A3688/16-17) Although Covidien concedes
that a video of the tests performed by its expert, Dr. Durfee, shows test fluid flying
off the transmission rod (Cov.Br. 42), it argues that the Court should discount this
4

At Covidiens invitation, the district court also imposed multiple unwarranted


limitations on the claim language, equating undesired vibrations solely with
transverse vibrations and requiring Ethicon to show significant undesired
vibrations. (A0045-A0048; A0050) Neither of these limitations is required by
the patent or included in the district courts claim construction. In any event, the
evidence establishes that Sonicisions transmission rod experiences undesired
vibrations, transverse and other.
15

evidence on the theory that its experts test did not involve a commercial
Sonicision device (id.). But having offered tests of this device as evidence to show
how its device performs, Covidien cannot run away from what the tests show. The
record therefore contains admissible evidence establishing that Sonicisions
transmission rod generates unwanted vibrations.
Moreover, Covidiens current effort to differentiate a commercial Sonicision
device from the Sonicision device Dr. Durfee used in his tests only confirms the
existence of undesired vibrations and that the sleeve is adapted to absorb those
vibrations. Covidien argues that the device Dr. Durfee used in the droplet tests
differs from the Sonicision because it lacks support mechanisms, such as the distal
O-ring seal and sleeve, which are present in the Sonicision and help to secure the
transmission rod and limit undesired vibrations.5 (Id.) In other words, the
Sonicisions O-ring seal and sleevewhich were not part of the device Dr. Durfee
testedrespectively support the transmission rod and dampen and absorb its
undesired vibrations. (A3605/71)
The evidence only proves Ethicons point, that Sonicisions sleeve is
adapted to absorb undesired vibrations of the transmission rod. Covidiens
5

In the alternative, Covidien argues that the Sonicision device avoids all unwanted
vibrations because it is designed to be perfectly symmetrical. (Cov.Br. 41, 44)
This argument strains credulity as a perfectly symmetrical device cannot be
manufactured (A3604-A3605/69-70), and asymmetry results in transverse
vibrations (A1991).
16

witnesses testified that the sleeve is designed to prevent touching and act as a
buffer between the active transmission rod and the inner tube. (A5586;
A2172/42:6-11; A2006/57) Covidien also concedes that Sonicisions sleeve is
designed to avoidi.e., absorbthe above-discussed metal-to-metal contact
between the transmission rod and inner tube. (Cov.Br. 47) At a minimum, this
evidence, and Dr. Schafers expert opinion on the subject (A3605-A3606/73;
A3564/94), raise a disputed fact issue on whether Sonicisions sleeve is adapted
to absorb the undesired vibrations of the transmission rod.
III.

THE DESIGN PATENTS: THE DISTRICT COURT ERRED IN


GRANTING SUMMARY JUDGMENT OF INVALIDITY AND NONINFRINGEMENT
A.

Validity

Whether a patented design is dictated by function is a question of fact. PHG


Techs., LLC v. St. John Cos., Inc., 469 F.3d 1361, 1365 (Fed. Cir. 2006). The
district court ignored record evidence and erroneously decided that fact question in
Covidiens favor on summary judgment. Especially on summary judgment, the
evidence does not meet the stringent standard for invalidating a design patent on
grounds of functionality . Rosco, Inc. v. Mirror Lite Co., 304 F.3d 1373, 137778 (Fed. Cir. 2002).

17

1.

The District Court Erred in Ignoring Alternative Designs


That Would Work as Well as the Patented Designs

In determining whether a design as a whole is dictated by function, relevant


factors include whether the patented design represents the best design and
whether alternative designs would adversely affect the utility of the specified
article. PHG, 469 F.3d at 1366 (quoting Berry Sterling v. Pescro Plastics, Inc.,
122 F.3d 1452, 1456 (Fed. Cir. 1997)) (italics added in PHG). A design is not
dictated solely by its function when alternative designs for the article of
manufacture are available. Best Lock Corp. v. Ilco Unican Corp., 94 F.3d 1563,
1566 (Fed Cir. 1996). The district court erred in applying these factors.
Ethicon presented substantial evidence that alternative designs would work
as well as, or better than, the patented designs. (Eth.Br. 41-46) Covidien
acknowledges that the record contained evidence of alternative designs.
(Cov.Br. 48-49) The district court erred in failing to address alternative designs
that would work better than the patented trigger design. See, e.g. (A4808, A4811A4812, A5574/24):

18

For example, the district court ignored the testimony of Ethicons expert,
Mr. Ball, and the lead inventor, Dan Price, that triggers with longer distal portions
provide the user with a surer grip and more surface area against which to apply
force. (A4808, A4811-A4812, A5574/24) Mr. Price noted that a longer distal leg
would have made it easier for users to apply force in a distal direction, thus
making that motion easier to perform, and allowed users who wrap their fingers
around the distal end of the trigger to have greater purchase on the trigger and
apply more force on the device in a proximal direction. (A5574/24) Covidiens
own expert agreed that its possible to make to design another handle that
would function well yet look different (A5214/199:21-A5215/200:25), and that
there are a number of examples of different looking triggers that have the same
functional aspects as the patented designs (A5209/182:17-A5210/183:12).
Before and after Berry Sterling, this Court has treated the presence or
absence of alternative designs that work as well as the claimed design as a
dispositive factor in analyzing functionality. For example, in Rosco, this Court
rejected an argument that the claimed design of the 357 patent was dictated by
functional considerations because the defendant had not shown by clear and
convincing evidence that there are no designs, other than the one shown in Roscos
357 patent, that have the same functional capabilities as Roscos oval mirror.
304 F.3d at 1378-79; see also Best Lock, 94 F.3d at 1566; L.A. Gear v. Thom McAn
19

Shoe Co., 988 F.2d 1117, 1123 (Fed Cir. 1993); Hupp v. Siroflex of Am., Inc., 122
F.3d 1456, 1460-61 (Fed. Cir. 1997).
The fact that Ethicon decided to go to market with and patent a design that
tested better among focus groups than certain alternatives does not negate the
relevance of other (untested) alternatives. If other designs not considered by the
inventorslike the designs Ethicons expert proposedwould work as well or
better than the patented designs, then the patented designs as a whole are not
dictated by function. See Rosco, 304 F.3d at 1378-79.
Covidien sets up a straw man when it focuses on the functionality in general
of an open trigger design. (Cov.Br. at 50) The Design Patents do not cover the
general concept of an open trigger design. Rather, they cover a particular design
as shown in the patent drawings. The relevant issue for a functionality analysis is
the functionality of the particular patented designnot the abstract concept of
open trigger design in general. Cf. Crocs, Inc. v. Intl Trade Commn, 598 F.3d
1294, 1303 (Fed. Cir. 2010) (noting, in infringement context, the need to view the
patented design as a whole and the dangers of relying on an abstract description of
the patent rather than its drawings). Although an open trigger design might
generally have functional advantages over alternatives, this does not mean that the
particular open trigger design claimed in the Design Patents is dictated by
function. See L.A. Gear, 988 F.2d at 1123 (the fact that elements of the design
20

serve functional purposes does not mean that the specific design of each element,
and the combination of these elements into the patented design is dictated by
function) (emphasis added). Covidiens expert agreed that there are any number
of different looking triggers that would have the same functional aspects as the
Design Patents. (A5209/182:17-A5210/183:12)
Covidiens expert, Mr. Kemnitzer, conceded that there is no single best
design for this type of product. Covidien argues that his testimony concerned a
different device, but his testimony was that there is not one optimal design for
a handheld surgical device and that [he doesnt] think theres an ultimate design
for anything. (A5223/276:10-22; A5177/38:15-A5178/39:2 (emphasis added);
see also A5172/33:13-A5173/34:2; A5213/186:2-23; A4806-4807; A4999/273:18A5000/274:13)
When, as in this case, there are several ways to achieve the function of an
article of manufacture, the design of the article is more likely to serve a primarily
ornamental purpose. PHG, 469 F.3d at 1367 (quoting Rosco, 304 F.3d at 1378).
2.

The District Court Erred in Addressing Other Concomitant


Utility Patent Applications

Another relevant consideration in addressing functionality is whether there


are any concomitant utility patents. PHG, 469 F.3d at 1366 (quoting Berry
Sterling, 122 F.3d at 1456). The district court also erred in its treatment of this
factor. (A0128-A0129)
21

Covidien misses the mark when it argues that utility patent applications
emphasize the same features claimed in the design patents. (Cov.Br. 54-55
(emphasis added)) The utility patent applications are directed toward the
functional features of a general configuration for a surgical device (see, e.g.
A3036-A3037, A3189-A3190), whereas the Design Patents cover ornamental
aspects of a specific, aesthetically pleasing design for such a device. See L.A.
Gear, 988 F.2d at 1123 ([I]t is the ornamental aspect that is the basis of the design
patent.); Avia Grp. Intl Inc. v. L.A. Gear Cal. Inc., 853 F.2d 1557, 1563 (Fed.
Cir. 1988). As Ethicons expert explained, the utility patent application claims
cited by the district courtdistal rotation knob [with] a plurality of flutes and
a proximal trigger portion coupled to a shorter distal trigger hook (A0129)
could be practiced by myriad different looking designs and therefore do not
demonstrate, as a matter of law, that the designs are dictated by function. (A4808A4816; see also A5209/182:17-A5210/183:12)
3.

The District Court Erroneously Ignored Aesthetic


Considerations

As Ethicon has demonstrated (Eth.Br. 47), there is substantial evidence that


the patented designs were not dictated by function and that aesthetic considerations
heavily influenced the design. For example, the lead inventor sought to create a
signature look for Ethicon products, and design choices were substantially
motivated by a desire to achieve a more aesthetic, artistic gracefulness.
22

(A4603/271:22-23; A4612/280:16-17) The inventors married together


ergonomics and aesthetics in an effort to create the nicest looking design based on
[the functional choices the team had made for] the [trigger] handle.6
(A4611:279:17-19; A4612:2-4) For example, many of the designs undulating
curves were chosen not for any utilitarian purpose, but rather to establish a visual
unity of design. (A4611/279:20-A4612/280:18)
Covidiens brief draws attention to several elements of the patented designs
that are clearly not dictated by function (Cov.Br. 60-61):
Distal portion [of the trigger]
curves away the from device
(Cov.Br. 60)

The Ethicon inventors thus created a nice unified clean design thats pleasing
and in which the forms and the shapes and the curves relate to each other in a
way that is both well-functioning and welcoming, friendly, inviting,
clean, and good looking. (A4563/38:8-14, A4575/68:23-24, A4576/69:5-8,
A4576/69:14-23, A4577/70:15-18, A4579-A4580/90:25-91:3, A4585/113:5-8,
A4586/119:8-20, A4588/131:3-10, A4597/215:20-23, A4611/279:7-11,
A4612/280:2-7)
23

The part of the trigger connecting


the distal and proximal portions is
continuously curved and
narrowed in [the] center and
widest at [the] ends. (Cov.Br.
60-61)
Proximal portion tapers along its
length, becoming narrower with
[an] inward curve at [the]
bottom. (Cov.Br. 60)

Covidiens contention that no elements of the designs are entirely


aesthetic is a red herring. (Cov.Br. 56) There is no requirement that any aspect of
a design be entirely aestheticonly that the design not be dictated by function.
In fact, if the designs were entirely aesthetic, they would be governed by the law of
copyright not design patent. See Hupp, 122 F.3d at 1460 ([T]he fact that the
article of manufacture serves a function is a prerequisite of design patentability, not
a defeat thereof.).
24

The district court inverted the summary judgment standard, crediting


Covidiens evidence and ignoring countervailing evidence. At a minimum, there
were disputed issues of material fact as to whether the claimed designs are dictated
by function.
B.

Infringement

The district court also erred in granting summary judgment of noninfringement of the Design Patents. (See Eth.Br. 50-56)
1.

The District Courts Errors in Assessing Functionality


Infected its Infringement Analysis

As discussed in Ethicons opening brief, the district courts functionality


errors in its validity analysis carried over to its infringement analysis. (Eth.Br. 5052) For the reasons set forth above and in Ethicons opening brief, it was error for
the district court to factor out the entirety of the patented design as part of its
infringement analysis on the theory that the design supposedly was dictated by
function.
2.

The District Court Also Erred in Not Evaluating


Infringement in the Context of the Prior Art

The district court also erred by failing to consider the designs in light of the
prior art. (See Eth.Br. 52-56) Covidien argues that it was not necessary to
consider prior art designs because its accused design is plainly dissimilar to the
patented designs. (Cov.Br. 59) But a reasonable fact-finder, after considering all
25

the evidence at trial, could reach the opposite conclusion: that the Sonicision and
the Design Patents share important similarities, especially when viewed through
the eyes of an observer familiar with previous designs in this field.
Design patent infringement is measured exclusively under the ordinary
observer test through the eyes of an observer familiar with the prior art. Egyptian
Goddess, Inc. v. Swisa, Inc., 543 F.3d 665, 677 (Fed. Cir. 2008) (en banc); see
Revision Military, Inc. v. Balboa Mfr. Co., 700 F.3d 524, 527 (Fed. Cir. 2012)
(noting that the relevant prior art for purposes of design patent infringement is the
prior art with which the ordinary observer would reasonably be familiar). In
Egyptian Goddess, this Court made clear that it was not discarding the purpose of
the previously used point of novelty test, which sought to focus [the
infringement analysis] on those aspects of a design which render the design
different from prior art designs. 543 F.3d at 677. Rather, it held that this goal
was better achieved by the ordinary observer test, which the Court concluded has
always considered the prior art. Id. at 676-77.
Notwithstanding the clear teaching in Egyptian Goddess, the district court
refused to consider the prior art in its infringement analysis. (A0135 (relying on
comparison of the overall design[s] without more)) This was error.
Covidien tries to justify this result by citing Egyptian Goddesss statement
that, in some instances, the claimed and accused designs may be so plainly
26

dissimilar that it will be clear without more that there is no infringement.


(Cov.Br. 65 (quoting Egyptian Goddess, 543 F.3d at 678)) Drawing all reasonable
inferences in Ethicons favor, this is not such a case.
The accused Sonicision design and the patented designs are not plainly
dissimilar. In fact, their similarities are far greater than their differences. As
Ethicons expert notedand as a comparison of the designs confirmsthe
accused product and the asserted designs share an inverted U-shaped trigger whose
distal leg is approximately half as long as its proximal leg, with a length
approximately 2.5 times the size of the aperture (i.e., the width of the U), and a
width approximately equal to the size of the aperture. (A4689, A4702, A4714)
The rotation knobs of the two designs are both conical, share almost identical
proportions, and both have six equally spaced flutes created by six rounded
scallops. (A4717) The buttons of the two designs are both rounded, placed
directly above the trigger at the distal end of the device, approximately as wide as
the trigger, and also share similar proportions of height to width. (A4694, A4702,
A4720) These elements are aligned, one on top of another, at the distal end of the
device in both designs. These striking similarities (depicted below) far outweigh
any subtle design differences. Compare A4788 with A0211-A0214:

27

28

Resolving disputed fact issues in Covidiens favor, the district court ignored
overwhelming evidence of similarities, and instead focused on subtle design
differences. This was error. See Goodyear Tire & Rubber Co. v. Hercules Tire &
Rubber Co., 162 F.3d 1113, 1117 (Fed. Cir. 1998) (noting that similarities between
two designs, as well as differences, must be considered in infringement analysis);
Amini Innovation Corp. v. Anthony Cal., Inc., 439 F.3d 1365, 1371-72 (Fed. Cir.
2006) (reversing summary judgment of noninfringement). The test for design
patent infringement is not identity, but rather sufficient similarity. Pac. Coast
Marine Windshields Ltd. v. Malibu Boats, LLC, 739 F.3d 694, 701 (Fed. Cir.
2014); Crocs, 598 F.3d at 1303-04 (infringement analysis focuses on overall
impression of designs, not small differences in isolation).
In its only precedential decision addressing whether two designs are plainly
dissimilar, this Court found that the following designs were not so unalike as to
permit a court to ignore the prior art context in assessing infringement:

29

Revision Military, 700 F.3d at 527. There are several readily apparent differences
in the Revision Military designs the shape and sizes of the lenses, the concavity
of the nose bridge, and the venting along the top and bottomsbut this Court
disagreed with the lower courts conclusion that it could conduct the infringement
analysis without considering the prior art. Id.
As in Revision Military, this case should be remanded to the district court for
consideration of the similarities of the designs in light of prior designs in the field.
When the similarities in design are considered, and the summary judgment
standard is properly applied, a reasonable fact-finder could conclude that the
designs are not plainly dissimilar as a matter of law.7

Covidien cites the nonprecedential decision in Anderson v. Kimberly-Clark


Corp., 570 F. Appx 927 (Fed. Cir. 2014) (see Cov.Br. at 66), but that case
30

If anything, this is a case where consideration of prior art is especially


important. Record evidence shows that the Design Patents departed dramatically
from prior designs in the field, which predominantly featured thumb-ring or loopshaped controls. (A5573/20, A5575/28-30; A4656-A4657; A4662/61:8-24;
A5008-A5009; A5361-A5363)8 Because the Design Patents depart[ed]
conspicuously from previous devices in the field, it is naturally more likely [that
Covidiens Sonicision would] be regarded as deceptively similar to the claimed
design, and thus infringing. Egyptian Goddess, 543 F.3d at 677. The district
court, by ignoring the prior art, failed to credit Ethicon with this important
inference.
Contrary to Covidiens contention, Ethicon is not attempt[ing] to
monopolize any use of an open trigger design. (Cov.Br. 67 (emphasis in
original)) The point is not that all open trigger designs infringe the Design Patents,
but that without examining the prior art with which an ordinary observer would
reasonably be familiar, a fact-finder does not have the appropriate frame of
presented very different facts and has no bearing here. Anderson involved a
comparison between a patented design on a bloomers-style undergarment with
a prominent U-shaped design made of a different material than the rest of the
garment, and accused designs for briefs-style undergarments that completely
lacked the U-shaped design and were made of a single material. Id. at 933.
8

While there were patents on designs for surgical devices with U-shaped triggers,
there is no record evidence that these were ever commercialized, let alone
reasonably familiar to purchasers of ultrasonic surgical instruments.
Revision Military, 700 F.3d at 527.
31

reference to understand what similarities and differences would likely be noticed


by the ordinary observer. See Egyptian Goddess, 543 F.3d at 677; Revision
Military, 700 F.3d at 527.
*

For all of these reasons, it was error for the district court to grant summary
judgment of non-infringement, and to do so without considering the perspective of
an ordinary observer familiar with prior designs in the field. The grant of summary
judgment of non-infringement should be reversed.
CONCLUSION
For the reasons set forth above and in Ethicons opening brief, this Court
should reverse the orders granting summary judgment for the patents-in-suit.

December 19, 2014

Respectfully submitted,
/s/ William F. Cavanuagh, Jr.
William F. Cavanaugh, Jr.
Chad J. Peterman
R. James Madigan III
Jeremy A. Weinberg
Helen P. OReilly
PATTERSON BELKNAP WEBB & TYLER LLP
1133 Avenue of the Americas
New York, NY 10036
Tel. 212-336-2000
Fax 212-336-2222
wfcavanaugh@pbwt.com
Attorneys for Plaintiffs-Appellees
32

CERTIFICATE OF SERVICE
I hereby certify that on December 19, 2014, I caused the foregoing REPLY
BRIEF FOR PLAINTIFFS-APPELLANTS to be electronically filed with the
Clerk of the Court using the CM/ECF system, which will send notification of such
filing to the registered attorney(s) of record that the document has been filed and is
available for viewing and downloading.

/s/ William F. Cavanaugh, Jr.


William F. Cavanaugh, Jr.

CERTIFICATE OF COMPLIANCE
This brief complies with the type-volume limitation of FED. R. APP. P.
32(a)(7)(B). The brief contains 6,538 words, as calculated by the word count of
the word processing system used in preparing it, excluding the parts of the brief
exempted by FED. R. APP. P. 32(a)(7)(B)(iii) and FED. CIR. R. 32(b).
This brief complies with the typeface requirements of FED. R. APP. P.
32(a)(5) and the type style requirements of FED. R. APP. P. 32(a)(6). The brief has
been prepared in Microsoft Word 2010 in Times New Roman 14 point font.
December 19, 2014

/s/ William F. Cavanaugh, Jr.


William F. Cavanaugh, Jr.

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