Skip to main content

Full text of "USPTO Patents Application 09870801"

See other formats


IN THE UNITED STATES DISTRICT COURT 
FOR THE DISTRICT OF DELAWARE 


ARTHROCARE CORPORATION, 
Plaintiff, 


v. 


SMITH & NEPHEW, INC. 

Defendant. 


C.A.No. Ol-504-SLR 


SMITH & NEPHEW'S OPENING BRIEF IN SUPPORT OF ITS RULE 50(b) MOTION 
FOR JUDGMENT AS A MATTER OF LAW 

Dated: June 30, 2003 FISH & RICHARDSON P.C. 

William J. Marsden, Jr. (#2247) 
Keith A. Walter, Jr. (#4157) 
Eugene B. Joswick (#427 1) 
9 1 9 N. Market Street, Suite 1 1 00 
P.O. Box 1 1 14 

Wilmington, DE 19899-1114 
Telephone: (302) 652-5070 

MarkJ.Hebert 
225 Franklin Street 
Boston, MA 02110-2804 
Telephone: (617) 542-5070 

Kurtis D. MacFerrin . 
500 Arguello Street, Suite 500 
Redwood City, CA 94063 
Telephone: (650) 839-5070 

Attorneys for Defendant 
SMITH & NEPHEW, INC. 


TABLE OF CONTENTS 


Page 

I. NATURE AND STAGE OF THE PROCEEDINGS ? 

II. SUMMARY OF THE ARGUMENT ? 

III. CONCISE STATEMENT OF FACTS 4 

IV. ARGUMENT A 

: 4 

A. Applicable Legal Standards 4 

B. Smith & Nephew's Accused Probes And The Use Of These 
Probes Do Not Infringe The Patents In Suit Under The 

Doctrine Of Equivalents 5 

C. Smith & Nephew Does Not Directly Infringe The Method 

Claims Of The 4 592 And '882 Patents 6 

D. The '536 Patent 6 

1 . JMOL Of Non-Infringement Of The Claims Of The 
'536 Patent Is Appropriate Because ArthroCare 
Failed To Prove That These Probes Are Used As Part 

Of The "Electrosurgical System" 6 

D. The '592 Patent 10 

2. Smith & Nephew's Accused Probes Do Not Infringe 
The Claims Of The '592 Patent Because ArthroCare 
Has Failed To Prove That The Accused Probes 
Satisfy The Requirement That 'The Return Electrode 
Is Not In Contact With The Body Structure" Or The 
Requirement Of "Spacing A Return Electrode Away 

From The Body Structure" 10 

E. The '882 Patent 14 

1 . There Is No Infringement Of The '882 Patent 

Because The Certificate Of Correction Is Not Valid 14 

a. A Simultaneous Complementary Change 
to Claim 26 Shows That There Was No 

Manifest "Error" in Claim 1 15 

b. The Amendments To Claims 1 And 26 
Created Inconsistent Antecedent Basis 
Problems « Arid There Was No Way Of 

Knowing Which Was Correct , 16 

i 


TABLE OF CONTENTS f rnnt'H) 


Page 

c. ArthroCare's Failure To Object To The 
Examiner's Statement Of Reasons For 
Allowance Shows That There Was No 
"Manifest Error" In Claim 1 ..17 

d The Alleged Errors Were Not Even 

"Manifest" To Mr. Raffle 18 

2. Non-suction Models of Smith & Nephew's Saphyre 
Products do Not Intringe Claim 54 of the T 882 Patent 
Because ArthroCare Has Failed to Prove that these 
Products Satisfy the Requirement of "Evacuating 
Fluid Generated at the Target Site with a Suction 
Lumen Having a Distal End Adjacent the Electrode 
Terminal" jg 

E. Smith & Nephew is Not Liable for Contributing to the 

Infringement of Any Claim of the Patents-in-Suit 20 

F. Smith & Nephew is Not Liable for Inducement of 

Infringement of Any Claim of the Patents-in-Suit 22 

F. Because The Relevant Factual Evidence Is Undisputed, 
This Court Should Find The Asserted Claims Of The 
Patents-In-Suit Invalid As A Matter Of Law 23 

1 . There Are No Factual Disputes Relating To Validity 24 

2. The '536 Patent 25 

a. The Pao '499 Patent 25 

b. The Doss '007 Patent 26 

i. Return Electrode '. 26 

ii. Connector Near the Proximal End 

of the Shaft 29 

c. The Elsasser and Roos Article and the 

Roos '198 Patent 30 

i. 7Connector Near the Proximal 

End of the Shaft 30 

ii. Electrically Conducting Fluid 32 

3. The '882 Patent „ ; 35 


ii 


TABLE OF CONTENTS ( cnntM) 

Page 

a. The Slager Article ; 35 

i. UV Photons ; 35 

ii. Evacuating Fluid Generated at the 

Target Site : , 37 

iii. Applying Energy to a Patient 

Body Structure 37 

b. The Manwaring '138 Patent 38 

i. UV Photons 39 

ii. Evacuating Fluid Generated at the 

Target Site 39 

c. Enablement 41 

4. The '592 Patent 43 

a. Doss 4 007 44 

i. Return Electrode 44 

ii. Voltage in the Range From 500 to 

1400 Volts 44 

b. Slager Article 45 

i. Applying Energy to a Target Site 
on a Body Structure on or Within 

a Patient's Body 45 

ii. Spacing a Return Electrode Away 
from the Body Structure in the 
Presence of the Electrically 

Conductive Fluid... ....46 

V. CONCLUSION 47 

iii 


TABLE OF AUTHORITIF.S 


Paee(s) 

Allen Engineering Corp. v. Bartell Industrial, Inc., 

299 F.3d 1336 (Fed. Cir. 2002) 39 

Anderson v. Liberty Lobby, 

477 U.S. 242(1986) , 5 

Bristol-Myers Squibb Co. v. Ben Venue Laboratories Inc 

246 F.3d 1368 (Fed. Cir. 2001) ' [] 39 

Elkay Manufacturing Co. v. Ebco Manufacturing Co., 

192 F.3d 973 (Fed. Cir. 1999) 20 

Enzo Biochem.. Inc. v. Calgene, Inc., 

188 F.3d 1362 (Fed. Cir. 1999) 45 

Gomez v. Alleghany Health Services Inc., 

71 F.3d 1079 (3d Cir. 1995) 6 

Hewlett-Packard Co. v. Bausch & Lomb Inc., 

909 F.2d 1464 (Fed. Cir. 1990)... 24 

Hodosh v. Block Drug Co., 

833 F.2d 1575 (Fed. Cir. 1987) ... 22 

Hycor Corp. v. Schlueter Co., 

740 F.2d 1529 (Fed. Cir. 1984) 26, 28, 31, 37. 

40, 42, 47, 49 

IPPV Enterprises, LLC v. EchoStar Communs. Corp., 

191 F. Supp. 2d 530 (D. Del. 2002) 25, 31, 41 

Joy Technologies, Inc. v. Flakt, Inc., 

6 F.3d 770 (Fed. Cir. 1993) 8, 9, 10, 24 

KCJ Corp. v. Kinetic Concepts, Inc., 

223 F.3d 1351 (Fed. Cir. 2000) 1 1 

Lai tram Corp. v. Rexnord, Inc., 

939 F.2d 1533 (Fed. Cir. 1991) ;.. u 

Lifescan, Inc. v. Home Diagnostics, Inc., 

103 F. Supp. 2d 345 (D. Del. 2000) 6 

MEHL/Biophile, 

192F.2dat 1365 46 

MEHL/Biophile International Corp. v. Milgraum, 

192 F.3d 1362 (Fed. Cir. 1999) 28, 29, 33 

iv 


TABLE OF AUTHORITIES rcnntM) 


Page(s) 

Mahurkar v. C.R. Bard. Inc., 

79 F.3d 1572 (Fed. Cir. 1996) , , -, $ 

Malta v. Schulmerich Carillons. Inc., 

952 F.2d 1320 (Fed. Cir. 1991) 7 

Manville Sales Corp. v. Paramount System, Inc., 

917 F.2d 544 (Fed. Cir. 1990) 23. 24 

Marbnan v. Westview Instruments. Inc., 

52 F.3d 967 (Fed. Cir. 1995), affd, 517 U.S. 370 (1996) ..6 

Medtronic. Inc. v. Advanced Cardiovascular Systems, Inc., 

248 F.3d 1303 (Fed. Cir. 2001) 7 

National Presto Industries, Inc. v. West Bend Co , 

76 F.3d 1185 (Fed. Cir. 1996) 2 4 

Northvierw Motors, Inc. v. Chrysler Motors Corp., 

227 F.3d 78 (3rd Cir. 2000) ; 7 

Novartis Corp. v. Ben Venue Laboratoriess, Inc., 

271 F.3d 1043 (Fed. Cir. 2001) ; ; 7 

Pannu v. Iolab Corp., 

155 F.3d 1344 (Fed. Cir. 1998) 6, 27 

Perkin-Elmer, 

732 F.3d at 893 : 7 

Perkin-Elmer Corp. v. Computervision Corp., 

732 F.2d 888 (Fed. Cir. 1984) 6 

Proctor & Gamble Co. v. Nabisco Brands, Inc., 

604 F. Supp. 1485 (D. Del. 1985), overruled on other grounds 24 

Richardson-Vicks, Inc. v. Upjohn Co., 

Civ. Action No! 93-556-SLR, 1996 WL 31209 (D. Del.), affd 122 

F.3d 1476 (Fed. Cir. 1997) , 25 

Richardson-Vicks v. Upjohn Co., 

122 F.3d 1476 (Fed. Cir. 1997) 28, 32, 46, 47 

Superior Fireplace v. Majestic Products, 

270 F.3d 1358 (Fed. Cir. 2001)....,: 16 

Tyler Refrigeration v. Kvsa Ind. Corp. , 

777 F.2d 687 (Fed. Cir. 1985). ..........28, 33 


v 


TABLE OF AUTHORITIES (cont'd! 

Page(s) 

U.S. Environmental Products Inc. v. Westall, 

91 1 F:2d 713 (Fed. Cir. 1990) , • 2 6, 28, 31, 37. 

40, 42, 47, 49 

Ultradent Products. Inc. v. Life-Like Cosmetics Inc 

127 F.3d 1065 (Fed. Cir. 1997) '. Z 36 48 

Verdegaal Brothers, 

8l8F.2dat631 31 

Verdegaal Brothers. Inc.. v. Union Oil Company Of California, 

814 F.2d 628 (Fed. Cir. 1987) 2 5, 28, 29, 38, 

41 

In re Wands, 

858 F.2d 731 (Fed. Cir. 1988) . 43 

STATUTES 

35 U.S.C. § 1 12... 37 

35 U.S.C. §255 16 

35 U.S.C. § 271(c) 21,23 

Fed. R. Civ. P. 50 6, 7 


vi 


I. NATURE AND STAGE OF THE PROCEEDINGS 

For the Nature and Stage of the Proceedings, please see Smith & Nephew's Opening 
Brief in Support of Its Motion for a New Trial, filed concurrently. 

II. SUMMARY OF THE ARGUMENT 

ArthroCare failed to introduce evidence to show that Smith & Nephew itself directly 
infringes, contributes to the infringement by others, or actively induces infringement by others of 
any of the claims in suit. Since ArthroCare bears the burden of proving each of these allegations, 
its failure to carry these burdens requires judgment as a matter of law (JMOL) for Smith & 
Nephew on the following issues: 

(1) Neither Smith & Nephew's accused probes nor the use of these probes infringe . 
the patents-in-suit under the doctrine of equivalents. 

(2) Smith & Nephew does not directly infringe the method iims of the 4 592 and 
'882 Patents. 

(3) Smith & Nephew's accused probes do not infringe the claims of the '536 patent 
because ArthroCare failed to prove these probes include all of the elements required by the '536 
patent within an "electrosurgical system" as required by the claims. 

(4) Smith & Nephew's accused probes do not infringe the claims of the '592 patent 
because ArthroCare failed to prove that the accused probes satisfy the requirement that "the 
return electrode is not in contact with the body structure" or the requirement of "spacing a return 
electrode away from the body structure". Similarly, Smith & Nephew's accused probes do not 
infringe claim 47 of the '536 patent because ArthroCare failed to prove the return electrodes on 
the probes are "sufficiently spaced from the electrode terminal to minimize direct contact 
between the return electrode and the patient's tissue". 

(5) Smith & Nephew's accused probes do not infringe the claims of the '882 patent 
because ArthroCare failed to prove that the accused probes have "an electrode terminal," "a 
return electrode," "an active .electrode," and "an electrically conducting terminal," all of which 
are required because the Certificate of Correction is not valid. 

1 


(6) Non-suction models of Smith & Nephew's Saphyre product? * 0 not infringe 
claim 54 of the '882 patent because they do not "evacuatfe] fluid generated at the target site with 
a suction lumen having a distal end adjacent the electrode terminal". 

(7) Smith & Nephew is not liable for contributing to the infringement of any claim of 
the patents-in-suit. 

(8) Smith & Nephew is not liable for inducement of infringement of any claim of the 
patents-in-suit. 

Moreover, no reasonable jury could find that Smith & Nephew did not prove— with clear 
and convincing evidence— that each of the asserted claims is invalid as anticipated and/or non- 
enabled. Entry of JMOL is therefore appropriate. Specifically: 

(9) ArthroCare presented no expert testimony or any other evidence to rebut Smith 
& Nephew's evidence that six prior art references anticipate the asserted claims. Nor did 
ArthroCare dispute the prior art status of any of Smith & Nephew's invalidating art. 

( 1 0) Rather than present an answering case on validity, ArthroCare 's counsel relied 
exclusively on an incomplete and cursory cross-examination of Smith & Nephew's expert, Dr. 
Taylor. Because this cross-examination fell far short of establishing any basis on which a 
reasonable jury could have found for ArthroCare on validity, Smith & Nephew is entitled to 
judgment as a matter of law. ArthroCare merely threw up a smoke screen of alleged 
"concessions by Dr. Taylor," and succeeded in confusing the jury. This confusion is highlighted 
best by the Pao % 499 patent/which Smith & Nephew showed anticipated claims 46 and 56 of the 
'536 patent. ArthroCare's cross-examination on this point was limited to an element present only 
in claim ¥7,, against which Pao was not even asserted. Nonetheless, the jury — apparently 
confused by ArthroCare's misleading cross-examination and argument — found Pao did not 
anticipate claims 46 and 56. 

(11) Likewise, ArthroCare presented no evidence to rebut Smith & Nephew's clear 
and convincing evidence that the '882 patent is invalid for lack of enablement. ArthroCare 

3 


asserts that the 882 patent discloses a new phenomenon of physics called "coblanon" (as assert it 
ArthroCare must, because otherw.se the '882 patent merely descnbes well-known electrosur gl cal 
techniques from the prior art). But despite saying that this "coblation" phenomenon is highly 
dependent on very exact parameters, the specfication does not describe those parameters with 
specficty. Thus, to the extent that the '882 is not mva.id as being anticipated by the pnor an. it 
is invalid for lack of enablement. 1 

III. CONCISE STATEMENT OF FACTS 

The facts related to each of the grounds upon which Smith & Nephew moves for 
judgment as a matter of law are addressed in each of the corresponding sections of the argument. 

IV. ARGUMENT 

A. Applicable Legal Standards 

Entry of judgment as a matter of law (JMOL) is appropriate where "the jury's findings, 
presumed or express, are not supported by substantial evidence or, if they were, that the legal 
conclusion(s) implied [by] the jury's verdict cannot in law be supported by those findings." 
Pannu , lolab Corp., 155 F.3d 1344, 1348 (Fed. Cir. 1998). The question is not whether there is 
"literally no evidence" supporting the non-moving party, Lifescan. Inc. v. Home Diagnostics. 
Inc., 103 F. Supp. 2d 345, 350-51 (D. Del. 2000), but whether the evidence reasonably supports 
the jury's verdict. Gomez v. Alleghany Health Servs. Inc., 71 F.3d 1079, 1083 (3d Cir. 1995). 

District courts grant JMOL if, upon the record before the jury, reasonable jurors 
could not have reached that verdict. Fed. R. Civ. P. 50; Perkin-Elmer Corp. v. 
Computervision Corp., 732 F.2d 888, 893 (Fed. Cir. 1984). In deciding whether to grant 
JMOL on any issue after a jury has returned a verdict, the court determines whether 
substantial evidence exists in the record to support the jury's verdict when the correct 
legal standard is applied. Markman v. Westview Instruments, Inc., 52 F.3d 967, 975 (Fed. 

renews^" « ^ SP n ° f M ° L diSCUSSed in detai1 Smith & Nephew also 

renews and reserves all of ,ts arguments with respect to claim construction as set forth in its claim 


Cir. 1995), aff-4 517 U.S. 370 (1996). Substantial evidence is the quantum of evidence 
that reasonable jurors would accept as adequate to support the finding under review. 
Perkin-Elmer, 732 F.3d at 893. 

JMOL should be granted if "a party has been fully heard on an issue and there is no 
legally sufficient. evidentiary basis for a reasonable jury to find for that party on that issue." Fed. 
R. Civ. P. 50(a); see Northview Motors, Inc. v. Chrysler Motors Corp., 227 F.3d 78, 88 (3rd Cir. 
2000). In a patent infringement action, "JMOL of non-infringement is properly granted if no 
reasonable jury could have concluded that a limitation recited in the properly construed claims is 
found in the accused device, either literally or under the doctrine of equivalents." Medtronic. Inc. 
v. Advanced Cardiovascular Systems, Inc., 248 F.3d 1303, 1309 (Fed. Cir. 2001). 

To overcome a motion for JMOL, the non-moving party must point to "substantial 
evidence" to support a finding in its favor. See Malta v. Schulmerich Carillons. Inc., 952 F.2d 
1320, 1329 (Fed. Cir. 1991). Merely "offhand and conclusory statements" are not sufficient to 
overcome the motion. Id. at 1327. 

The patent owner bears the burden of proving infringement (by a preponderance of the 
evidence) that the accused device, or use of that device, has all the limitations of the asserted 
claims. Novartis Corp. v. Ben Venue Labs., Inc. 271 F.3d 1043, 1046 (Fed. Cir. 2001). 

B. Smith & Nephew's Accused Probes And The Use Of These Probes Do Not 
Infringe The Patents In Suit Under The Doctrine Of Equivalents 

ArthroCare introduced no evidence of infringement under the doctrine of equivalents, 

and JMOL on this issue should be granted. ArthroCare attempted to introduce evidence 

regarding equivalent infringement for the first time during redirect examination of its expert Dr. 

Goldberg. The Court properly excluded this belated "rebuttal" evidence. (D.I. 415 at 1 144). In 

making the ruling, the Court stated that ArthroCare should have brought the matter up during 

direct examination and that, even if it had, the testimony would not have been permitted because 

the equivalence analysis in Dr. Goldberg's report was insufficient. (Id.). Thus, judgment as a 

construction brief (D.I. 246 and 282), to the extent that the Court adopted a different claim 
construction from that set forth by Smith & Nephew. 


matter of law that Smith & Nephew does not infringe any claim of any patent-in-su,t under the 
doctrine of equivalents should be granted. 

C §92 aIStS? Paints' Infringe The Mcth ° d C,ahm ° f The 

ArthroCare failed to provide any evidence that Smith & Nephew itself uses or has used 
the Saphyre, ElectroBlade, or Control RF probes in surgery as required by the claims of the '592 
and '882 method patents. "A method claim is directly infringed only by one practicing the 
patented method." Joy Technologies. Inc. v. Flakt. Inc., 6 F.3d 770, 775 (Fed. Cir. 1993) 
(emphasis added). ArthroCare has offered no evidence from which a reasonable jury could 
conclude that Smith & Nephew uses its Saphyre, ElectroBlade, or Control RF probes to perform 
each step of the methods covered by ArthroCare's claims. Indeed, the only evidence at trial was 
that Smith & Nephew does not use the accused probes. (See, e.g., D.I. 414 at 961). Thus, the 
Court should enter judgment as a matter of law that Smith & Nephew does not directly infringe 
any claim of the '882 or '592 patent. 

D. The '536 Patent 

1 . JMOL Of Non-Infringement Of The Claims Of The '536 Patent Is 
Appropriate Because ArthroCare Failed To Prove That These 
Probes Are Used As Part Of The "Electrosurgical System" 

Claim 45 of the '536 patent, and the claims that depend from it (asserted claims 46, 47, 

and 56) claim an electrosurgical system, which includes its own fluid supply. Specifically, the 

'536 patent is directed to an electrosurgical system that can be used in open surgery - e.g, 

surgery in a dry environment - because "[ejlectrically conductive liquid, such as isotonic saline, 

is directed through a fluid path past a return electrode and to the target site to generate a current 

flow path." (JTX-1, col. 3, lines 26-30). As described in the Summary of the Invention: 2 

The above described method is particularly effective in a dry environment (i.e., 
the tissue is not submerged in fluid), such as open, laparoscopic or oral surgery, 
because the electrically conducting liquid provides a suitable current flow path 
from the target site to the return electrode. 


■ The Summary of the Invention is an optional part of the patent application. "Such summary 
should, when set forth, be comensurate with the invention as claimed.. ." 37 C.F.R. § 1 .73. 


(Id. at col. 3, lines 37-41). This is distinct from arthroscopic surgery, in which the joint is filled 
with saline (which is a biocompatible fluid) in order to move the soft tissue out of the way of the 
surgeon and wash out debris that is produced during the operation. Such a supply of saline in 
arthroscopic surgery is completely separate from any electrosurgical instrument, and the saline ts 
typically supplied by either an IV bag or a separate system such as the Intellijer. 

The Court construed the term "system" in claim 45 of the '536 patent to mean "an 
assemblage or combination of things or parts forming a unitary whole." (D.I. 354). The claims 
require that the system include several elements, including "an electrically conducting fluid 
supply for directing fluid to the target site, "which thus must all be part of the "unitary whole." 
However, ArthroCare's expert ignored the Court's construction and the requirement that an 
electrically conducting fluid supply for directing fluid to the target site be part of the claimed 
system - i.e., as part of a "unitary whole"— such that the system could be used in open surgery. 

Dr. Goldberg testified: 

Q. Now, is the Saphyre bipolar ablation probe used as part of an 
electrosurgical system? 

A. Yes, sir, it is. 


Q. Now, is the electrically conductive fluid supply physically connected to 
this probe that we've been looking at? 

A. Not this probe, sir. 

Q. So how is it then that this probe is part of a system that includes 
electrically conductive fluid? 

A. Again, my understanding of a system is that things don't have to be 
physically in contact. Another example that just came to mind is when we have a 
wireless computer system or an audio system, the mouse doesn't have to be connected by 
a wire to the computer to be part of the same system. They're all functioning to put in the 
data or to listen to the stereo. So it doesn *t have to be part of, physically connected. The 
electrical fluid in the joint will get there. The surgeon has to fill the entire joint to distend 
it and the fluid will get there. It's all part of the system, sir. 

(D.I. 41 1 at 398-399) (emphasis added). 


7 


In his testimony, Dr. Goldberg clearly foiled to apply the Court's constructs of the term 
"system." He never described how the Saphyre and a separate fluid supply form an "assemblage 
or combination of things or parts forming a unitary whole." Instead, he actually disavowed and 
disagreed with the Court's claim construction, and said that "it doesn't have to be part of, 
physically connected." (Id.). Since he did not agree with the Court's claim construction, he 
obviously did not provide any evidence that was in accordance with the Court's claim 
construction. Instead, all he said was that "the fluid will get there." (Id.). But he didn't say 
how. 1 

These omissions became even more apparent during Dr. Goldberg's testimony regarding 

the individual claim elements. For each of the accused products, Dr. Goldberg testified that the 

product comprises the first two elements of the system required by claim 45. However, Dr. 

Goldberg's analysis ignored the third element of the system, the electrically conducting fluid 

supply. For the Saphyre, Dr. Goldberg testified: 

And there is electrically conducting fluid supplied because this is arthroscopy 
and there is electrically conductive fluid delivered by the surgeon and the people 
in the operating room to the joint. 

(D.I. 41 1 at 447). This testimony is very misleading because Dr. Goldberg, and ArthroCare 

continually focused on arthroscopic surgery. But the claims are not so limited. In fact, if one 

were to use the Saphyre in, for example, an oral surgery such as described in the Summary of the 

Invention of the '536 patent 4 the device would not work because the Saphyre does not have a 

fluid supply as part of its system. Dr. Goldberg actually recognized this in his experimentation 

with the Saphyre product (Id. at 4 1 6): 

Q. You mentioned that you also tested the Saphyre when the return 
electrode was in air and the active electrode was in saline; is that right? 

A. Yes, sir. 

Q. Can you describe for the jury what happened when you used the 
Saphyre probe, in that mode? 


3 Likewise, for the Control RF and ElectroBlade products. Dr. Goldberg failed to provide any 
evidence that the products are a "system" as required by Claim 45. 


8 


includes the fluid supply simply because it is designed for arthroscopic 
surgery is misleading and incorrect. 

For the Control RF, Dr. Goldberg did not even mention a fluid supply and simply said 
(Id. at 448): 

There is electrically conductive fluid, as well as a current flow path when the 
generator is on. 

Similarly, for the ElectroBlade, instead of describing a fluid supply (Tr. at 449): 

Up the shaft is a return electrode. It's connected to the generator and it's in 
electrically conductive fluid and there is a current flow path through the 
electrically conductive fluid at the time the generator was activated. 

While the Smith & Nephew probes are used in the presence of saline or other electrically 
conducting fluids, that fluid is not supplied to the target site by the probes. (D.I. 415 at 976 and 
1013). Fluid, typically from an IV bag, is instead introduced by a separate and distinct piece of 
medical equipment such as the cannula that is also used for the videoarthroscope. (D.I. 414 at 
815-16; D.I. 268, Ex. 43). That separate piece of equipment is not part of the "electrosurgical 
system," The Smith & Nephew probes and fluid supply are not part of the same assemblage or 
combination of things or parts forming a "unitary whole." 5 

Moreover, ArthroCare introduced no evidence that the alleged system included a fluid 
supply "for directing fluid to the target site." Instead, the testimony was uncontroverted that the 
purpose of the fluid supply used with the Smith & Nephew probes was instead to flood the inside 
of the joint in order to move soft tissue back and also to wash out debris. (D.I. 414 at 780-81 and 
790) 


With respect to ArthroCare's attempt to argue that the separate Smith & Nephew Intellijet fluid 
supply system was part of an "electrosurgical system," that evidence was limited to the "System 
Configuration" contained in the ElectroBlade £FU. (D.I. 41 1 at 497; PX 189). However, Karen 
Drucker testified that this System Configuration is for compliance with European regulations. 
Thus, to the extent this evidence is taken to support the inference that the ElectroBlade and the 
Intelhjet, used in this configuration, are an "electrosurgical system," it is only evidence for their 
use in Europe. Moreover, Ms. Drucker explained that IFU showed that the Intellijet system was 
not completely separate from the ElectroBlade system. (D.I. 415 at 1018). 


9 


Since the probes each lack the fluid supply element as part of the electrosurgical system 
as required by the claims, they cannot directly infringe these claims. 6 See KCJ Corp. v. Kinetic 
Concepts, /nc, 223 FJd 1351, 1358-59 (Fed. Cir. 2000); Laitram Corp. v. Rexnord, Inc., 939 
F.2d 1533, 1535 (Fed. Cir. 1991) ("To establish infringement, every limitation set forth in a 
patent claim must be found in an accused product or process exactly or by substantial 
equivalent"). Because ArthroCare failed to present evidence by which a reasonable jury could 
find that any of the accused products satisfies the "system" requirement of claim 45 that is 
incorporated into asserted claims 46, 47, and 56, JMOL of non-infringement of these claims is 
proper. 

E. The '592 Patent 

1. Smith & Nephew's Accused Probes Do Not Infringe The Claims Of 
The '592 Patent Because ArthroCare Has Failed To Prove That The 
Accused Probes Satisfy The Requirement That "The Return 
Electrode Is Not In Contact With The Body Structure" Or The 
Requirement Of "Spacing A Return Electrode Away From The 
Body Structure" 

Claim 1 of the '592 patent requires "positioning a return electrode ... such that [it] is not 
in contact with the body structure" and claim 23 requires "spacing a return electrode away from 
the body structure." The Court construed these terms to mean that "the return electrode is not to 
contact the body structure at all during the performance of the claimed method." (D.L 353) 
(emphasis in original). 7 

ArthroCare's expert, Dr. Goldberg, again ignored the Court's claim construction when he 

rendered his opinion that the Smith & Nephew probes infringe: 

Q. Now, does that portion of the claim as construed by the Court 
require that the Saphyre bipolar ablation probe return electrode never contact the 
tissue during the course of an entire arthroscopic procedure? 

A. No, it doesn't. Mr. Bobrow, you raised a very important - 

6 And, as discussed above, ArthroCare has completely failed to provide any evidence that a 
separate fluid supply is in any way equivalent to a unitary whole. 

7 Claim 47 of the '536 patent includes a similar limitation which reads. "the return electrode being 
sufficiently spaced from the electrode terminal to minimize direct contact between the return 
electrode and the patient's tissue." Thus, Smith & Nephew submits that ArthroCare failed to 
prove infringement of that claim for the same reasons. 

10 


* * * 

A. I was about to try to explain to the members - the ladies and 
gentlemen of the jury as to why this is a very important point. The claim is 
talking about a method for applying electrical energy, so the issue is whether or 
not a device infringes when the electrical energy is not — when it is being 
applied. There are a lot of parts to a surgery, including putting in the camera, 
taking out the camera, taking care of the patient that don't involved applying 
electrical energy. So the key is, is this method being infringed when it's 
fulfilling the claim which is when the energy is being applied? So the only way 
not to infringe this claim with the device is to make sure that the return 
electrode — 

* * * 

is always in contact when the energy is on. And as the videotape and Mr. 
Marsden suggested, very clearly there is occasional contact frequently, but often 
there isn't. The probe is designed to enable they're not being contact. If it's not 
in contact, it's being infringed. 

(D.L 41 1 at 42 1-22) (emphasis added). 

Dr. Goldberg's testimony that the use of Smith & Nephew's products infringe the claims 
of the '592 patent is based on ArthroCare's previously-rejected interpretation of the claim term, 
rather than the Court's construction. Specifically, by stating that the "only way not to infringe 
this claim with the device is to make sure that the return electrode ... is always in contact when 
the energy is on," Dr. Goldberg is appling ArthroCare's temporal limitation that the Court 
specifically r^ected. (D.I. 352, p. 6) ("Both parties have proposed a claim construction that 
improperly imports a time limitation into the claim. The claim limitation in dispute has no 
relation to the time required to perform the method."). 

The following chart demonstrates how Dr. Goldberg has ignored the Court's construction 


and continued to apply ArthroCare's original and now rejected construction: 


ArthroCare's Rejected Argument 

Dr. Goldberg's Testimony 

"Smith & Nephew's proposed experts have not 
offered any evidence or opinion that the return 
electrode of the Saphyre is always contacting 
patient tissue during use." (D.I. 252 at 12) 
(emphasis added). 

"the only way not to infringe this claim with 
the device is to make sure that the return 
electrode . . . is always in contact when the 
energy is on." (Tr. at 421-22) (emphasis 
added). 


Further the Court's claim construction refers to the performance of all three steps of the 
method. Only one of those steps requires the application of RF energy. However, Dr. Goldberg 
•and ArthroCare completely ignored the first step of the method "positioning the electrode 


11 


terminal into at least close proximity with the target site." (JTX-3, claims 1 and 23). Both 
ArothroCare and Dr. Goldberg ignored return electrode contact with the tissue when the probe is 
being positioned before the RF energy is being applied. This misleading view is evident when 
Dr. Goldberg states "when we're talking about activation of energy, which is what the claims 
are referring to, they're limiting it to two very small periods of timer (D.I. 415 at 1 1 19) 
(emphasis added). But the Court's claim construction expressly rejected any time limit, and 
certainly is not limited to the time period of activation of energy. Thus, Dr. Goldberg's assertion 
of "what the claims are referring to" is simply incorrect. 

In fact, ArthroCare introduced absolutely no evidence that the method of using the 
accused products met these limitations of the '592 patent under the Court's claim construction. 
Indeed, even all of its cross-examination of Smith & Nephew's witnesses was based upon the 
erroneous claim construction which ArthroCare had proposed, and which the Court had rejected. 
(See, e.g., D.L 415 at 983 and 1035-36). 

Instead, under the Court's claim construction, all of the evidence at trial showed that the 
return electrode frequently contacted tissue at various times when one or more of the three steps 
of the method was being practiced. As can be seen in the various sales-training videos (DTX 
315, DTX 316, and DTX 897), the three steps of the method are continually being practiced if 
the power is not being applied, the active electrode is being positioned for the next time that the 
surgeon applies the power. 8 Thus, Dr. Goldberg's and ArthroCare 's evidence was not based on 
the Court's claim construction and cannot support a verdict of infringement. 

The confusion regarding the time period in which one analyzes the use of the accused 
devices was further compounded in ArthroCare' s closing argument, in which Mr. Bobrow 
misleadingly argued: 


8 ArthroCare attempted to mislead the jury when it twicestopped the Saphyre video at an instant 
in the middle of the performance of the claimed method when the return was not contacting tissue 
(D.I. 415 at 985), and suggested this was proof of infringement. The Court's claim construction 
was clear: the return electrode is not to contact the body "at all" during performance of the 
method and the method is not complete until all three steps are performed. 

12 


There is no minimum time period. If energy is applied for three seconds and the 
return electrode is not in contact for those three seconds, and the active electrode 
is close to the tissue, and RF energy is applied and all the other language is met, 
this is satisfied. This is satisfied. 

Now, if in the fourth second, it hits the tissue, well, then it's not practicing the 
method. But if in the fifth and sixth seconds, it's away from the tissue again, 
then it is. There is no time limitation. 

I can perform this method for two seconds. I could perform it for two minutes. 
There is no time limitation. 

(Tr. at 1580-81) (emphasis added). While this Court indeed held that there were no temporal 
limitations to the performance of the claimed method, it also held that that "the return electrode is 
not to contact the body at all during the performance of the claimed method' (4/9/03 
Memorandum Order at 2, D.I. 353) (emphasis in original). Thus, if the energy was still on when 
the return electrode "hits the tissue" in the fourth second of Mr. Bobrow's example, there would 
be no infringement no matter what happened over the first three seconds. 

Finally, ArthroCare presented no direct evidence that doctors do not touch the return 
electrode to tissue during use of the accused products. In fact, ArthroCare presented no evidence 
that the doctors who used the devices actually used them to perform the method of the asserted 
claims. Dr. Goldberg's only opinion, and all that the evidence showed, was that "doctors have 
used the Saphyre after the [patents' issue] date in the United States." (Tr. at 462; see also Tr. 
465-66 and 470). There is not one shred of evidence that the uses described by Dr. Goldberg 
were actually directly infringing the methods of the '592 patent. 

Dr. Goldberg ignored the Court's claim construction and presented its infringement case 
based on ArthroCare's long rejected argument of what the claim means. ArthroCare thus failed 
to present any relevant evidence by which a reasonable jury could find that the use of any of the 
three accused products satisfies the return electrode "not in contact" requirement. JMOL of non- 
infringement is proper. 


13 


F. The '882 Patent 

1. There Is No Infringement OfThe '882 Patent Because The 
Certificate Of Correction Is Not Valid 

The Certificate of Correction broadened the scope of claim 1 of the 882 patent by 
reducing the number of electrodes required by the claim. Prior to the Certificate of Correction, 
claim 1 of the '882 patent required four electrodes: an electrode terminal, an active electrode, a 
return electrode, and an electrically conducting terminal. (JTX-2 at col. 24 lines 8-12). After the 
Certificate of Correction, the claim required only two electrodes: an electrode terminal and a 
return electrode. (See Certificate of Correction attached to JTX-2). 

It was undisputed at trial that if the Certificate of Correction had not been obtained— or 
was invalid— Smith & Nephew would not infringe the '882 patent, because the accused Control 
RF and Saphyre products have only two electrodes. (See testimony of ArthroCare's expert, Dr. 
Goldberg, (Tr. 1110) (D.I. 415)). 9 

As set forth in Smith & Nephew's brief in support of its motion for a new trial (filed 
concurrently), Smith & Nephew contends that the issue of validity of the Certificate of Correction 
should never have been submitted to the jury. However, since it was submitted to the jury, and 
there was no evidence supporting the jury's finding that the Certificate of Correction was valid, 
JMOL should be entered for Smith & Nephew on this issue. 

The controlling case on the validity of the Certificate of Correction is Superior Fireplace 
v. Majestic Products, 270 F.3d 1358, 1368 (Fed. Cir. 2001). In that case, the Federal Circuit 
explained that corrections are permitted under 35 U.S.C. § 255 only in order to correct "a mistake 
of a clerical or typographical nature, or of minor character, which was not the fault" of the PTO. 
As explained in Superior Fireplace, a mistake "of a minor character" may not broaden the claim. 
270 F.3d at 1376. Since the Court has already determined here that the Certificate of Correction 
broadened the claim (D.I. 417 at 1550-51), and ArthroCare's expert Dr. Goldberg admitted as 


ArthroCare tried to create some confusion with the jury by having its expert, Dr. Goldberg, 
testify that the ElectroBlade product might be viewed as having more than two electrodes. (Tr. at 
1111-13). However, this testimony was irrelevant and confusing, since the '882 patent had never 


14 


much (D.I. 415 at 1 109-11), m order for the Certificate of Correction to be valid, the alleged 
"mistake" that was "corrected" must therefore qualify as one "of a clerical or typographical 
nature." 

A Certificate of Correction can validly correct a clerical or typographical mistake only if 
a review of the file history reveals (1) there was indeed a "clerical or typographical mistake" and 
(2) it is both "manifest" that there is an error to be corrected and it is also "manifest" how to 
correct the error. 270 F.3d at 1370. 

In Smith & Nephew's Opening Brief in Support of its Inequitable Conduct Case, Smith 
& Nephew showed how the Certificate of Correction at issue was actually obtained by 
ArthroCare's in-house attorney, John Raffle, in order to broaden the claim so that it could sue 
Ethicon — in other words, that there was no "mistake" involved at all. (D.I. 442 at 35). 
However, putting that issue aside, the prosecution history and the testimony from trial shows that 
no reasonable juror could have found that either the alleged mistake or the solution for correcting 
the alleged mistake was "manifest," for at least the following four reasons: 

a. A Simultaneous Complementary Change to Claim 26 Shows 
That There Was No Manifest "Error" in Claim 1 

Mr. Raffle filed the Request for Certificate of Correction on December 17, 1997. (DTX 

306 at 234-35).'° In the Request for Certificate of Correction, Mr. Raffle represented.that the 

alleged "errors" being corrected arose in connection with an amendment he filed during 

prosecution of the '882 patent application on March 25, 1997. (DTX 306 at 200-10). One of the 

alleged errors involved amending application claim 23 (which became patent claim 1) so that the 

claim required both an "active electrode" and an "electrode terminal." However, in that very 

same amendment, Mr. Raffle also amended application claim 52 (which became patent claim 26) 

so that it also required both an "active electrode" and an "electrode terminal." Thus, Mr. Raffle 


even been asserted against the ElectroBlade product. (See. e.g., ; Tr. at 1214; see also D.I. 405 at 

10 Although the Request refers to claim "23," it is clear that this was a mistaken reference to the 
application claim number, and that the request sought to change claim t. (DTX 306 at 239; D I. 
417 at 1510). 


15 


simultaneously amendedthe claims that would become claims 1 and 26 so that they both included 
an "active electrode," and an "electrode terminal," (as well as a "return electrode"). (See D.I. 417 
at 1511-13):" 

Q. So just to review, in Claim 1 , in the second — in the third line 
you changed active electrode to electrode terminal; right? 

A. Yes. 

Q. And in the third line of Claim 26, you left active electrode all 
alone. You didn't change it; right? 

A. That's correct. 

Q. O^ay- And then in the sixth line of Claim 1, you left active 
electrode again all alone, didn't change it; right? 

A. Correct. 

Q And in the corresponding sixth line of Claim 26, you changed 
active electrode to electrode terminal; right? 

A. Correct. 

Thus, anyone reviewing the file history of the '882 patent would see that one instance of 
"active electrode" was changed to "electrode terminal" in both claims 1 and 26, whereas the other 
instance of "active electrode" in both claims 1 and 26 was left unchanged. Accordingly, no 
reasonable juror could find that it was "manifest" that the term "active electrode" was in error in 
claim 1 , or that it was "manifest" that "active electrode" should be changed to "electrode 
terminal" in claim 1. 

b. The Amendments To Claims 1 And 26 Created Inconsistent 
Antecedent Basis Problems - And There Was No Way Of 
Knowing Which Was Correct 

ArthroCare has argued that an error in antecedent basis in claim 1 supports the notion that 
the so-called "mistake" was "manifest." 

Generally, the first time an element is referred to in a claim, an indefinite article ("a" or 
"an") is used, whereas thereafter, a definite article ("the or "said") is used to show that the same 


A side-by-side comparison of Mr. Raffle's amendments to application claims 23 and 52 
(which became patent claims 1 and 26 respectively) was used to cross-examine Mr. Raffle at trial. 
(Exhibit A to accompanying Declaration of William J. Marsden, Jr. 

16 


cla.m element is being described. To use a definite article for the first mention of a claim term is 
sometimes referred to as improper "antecedent basis." 

In this case, as a result of the amendment Mr. Raffle made to claim I. the term "active 
electrode" did not have a proper antecedent basis. (JTX-2, col. 24, lines 5-12). However, anyone 
renewing the file history would see that there were other instances in the claims of the 882 
patent in which there was an improper antecedent basis. For example, as a result of the 
amendment Mr. Raffle made to claim 26, at the very same time as his amendment to claim 1 , the 
term "electrode terminal" also did not have a proper antecedent basis. (JTX-2, col. 25, lines 24- 
30). Thus, anyone reviewing the file history for the '882 patent would see that (a) Mr. Raffle 
amended claim 1 to include both an "active electrode" and an "electrode terminal," but did not 
provide proper antecedent basis for the "active electrode," and (b) at the very same time, he 
amended claim 26 to include both an "active electrode" and an "electrode terminal," but did not 
provide proper antecedent basis for the "electrode terminal." 

Given this, it would not be possible for one reviewing the file history to determine (1) 
whether any error occurred at all, or if so (2) whether the error was in claim 1 or 26 or both, or (3) 
whether "electrode terminal" should be "active electrode" or "active electrode" should be 
"electrode terminal." Certainly, no reasonable juror could possibly find that any of this was 
"manifest." If anything, to the extent an antecedent basis error would be recognized at all, the 
most obvious way to correct the error would be to simply change "the" to "an" to correct the 
antecedent basis. 

c. ArthroCare's Failure To Object To The Examiner's 

Statement Of Reasons For Allowance Shows That There Was 
No "Manifest Error" In Claim 1 

Further, anyone reviewing the file history would see that the Examiner had relied on the 
alleged "mistake" in claim 1 when deciding to issue the '882 patent, and would thus not think that 
the alleged error was "manifest." 

As is not uncommon, the Examiner provided a statement of his reasons for allowing the 
'882 patent to issue, which relied on the scope of application claim 23 as of June 22, 1997 — i.e., 

17 


before it was broadened by Mr. Raffle's Certificate of Correction (DTX 306 at 222) (emphas.s 
added): 

The following is an examiner's statement of reasons for allowance: The prior art 
of record does not disclose or suggest a method for applying energy to a target 
site on a patient body structure comprising providing an electrode terminal and a 
return electrode electrically coupled to a high frequency voltage source- 
positioning the active electrode in close proximity to the target site in the 

SaTJi 3 " d T U ? Uy T dUCting termi " al; ^ 3 hl g h frequency 

voltage between the electrode terminal and the return electrode, the high 

frequency voltage being sufficient to vaporize the fluid in a thin layer over at 

least a portion of the electrode terminal and to induce the discharge of energy to 

the target site in contact with the vapor layer. 

As can be seen, the Examiner's Reasons for Allowance was clearly based on the 
"uncorrected" scope qf application claim 23 as it essentially quotes that claim (compare the 
Reasons for Allowance with application claim 23 as set forth in the Amendment of March 25, 
1997, DTX 306 at 201). 

Moreover, anyone reviewing the file history would know that such a statement of 
Reasons for Allowance is binding on the patentee, absent an objection by the patentee. See Elkay 
Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 979 (Fed. Cir. 1999) (holding that failure to respond to 
an examiner's reason for allowance functioned as a disavowal of a different interpretation of the 
claim). Thus, since ArthroCare never objected to the binding statement of Reasons for 
Allowance, there is simply no way that anyone reviewing the file history would think that it was 
"manifest" that there was an error in the statement, and thus in claim 1 . 

d. The Alleged Errors Were Not Even "Manifest" To Mr. 
Raffle 

As shown above, claims I and 26 both included an "active electrode" as well as an 
"electrode terminal," and they both had antecedent basis problems. Mr. Raffle carefully reviewed 
both claims when the '882 patent issued. (DTX 306 at 235). Yet he only sought a Certificate of 
Correction with respect to claim 1, and he was perfectly happy to leave claim 26 alone (Tr. 1541) 
(D.I. 417): 

Q. On the certificate of correction, you did not ask to change Claim 
26; right? 

A. I believe that's correct, yes. Claim 26. 

18 


Q. As issued. 

A. As issued. That's correct. 

Q. You did not ask to correct that? 

A. That's correct. 
Thus, to Mr. Raffle himself, the inclusion of both an "active electrode" and an "electrode 
terminal" in a claim was not a "manifest" error, and an antecedent basis problem with respect to 
one of those electrodes was also not a "manifest" error. Of course, as shown in Smith & 
Nephew's Opening Brief in Support of its Inequitable Conduct Case, Mr. Raffle's true motive in 
seeking the Certificate of Correction was to broaden claim 1 of the "882 patent for ArthroCare's 
lawsuit against Ethicon, and had nothing at all to do with correcting any actual "errors." 

In light of this clear evidence, no reasonable juror could have found either the alleged 
errors in claim 1 of the '882 patent to be "manifest," or the manner of correcting those alleged 
errors to be "manifest." Accordingly, JMOL should be entered that the Certificate of Correction 
is not valid, and therefore that there is no infringement of the '882 patent by the accused Smith & 
Nephew products. 

2. Non-suction Models of Smith & Nephew's Saphvre Products do Not 
Infringe Claim 54 of the '882 Patent Because ArthroCare Has Failed 
to Prove that these Products Satisfy the Requirement of "Evacuating 
Fluid Generated at the Target Site with a Suction Lumen Having a 
Distal End Adjacent the Electrode Terminal'' 

Claim 54 of the '882 patent requires evacuating fluid with a suction lumen having a distal 
end adjacent the electrode terminal. Several of the Saphyre models accused of infringing this 
claim do not come with suction. Thus, it is impossible for these models to evacuate fluid and 
infringe claim 54. ArthroCare has admitted that these products do not infringe this claim. D.I. 
41 7 at 1493-94, D.I. 405 at 3. Thus, JMOL of non-infringement of claim 54 is appropriate with 
respect to these products. 


19 


G. Smith & Nephew Is Not Liable For Contributing To The Infringement Of 
Any Claim Of The Patents-In-Suit «g«nenc ui 

Even if ArthroCare had offered evidence of direct infringement by Smith & Nephew 
customers, ArthroCare has not presented sufficient evidence from which a reasonable jury could 
find Smith & Nephew liable for contributory infringement under 35 U.S.C. § 271(c). As part of 
its case-in-chief on contributory infringement, ArthroCare had to prove that Smith & Nephew's 
probes are not staple articles of commerce suitable for substantial non-infringing uses. See 35 
U.S.C. § 271(c). The focus of the analysis of non-infringing uses is the thing actually sold by the 
accused infringer. Hodosh v. Block Drug Co., 833 F.2d 1575, 1578 (Fed. Cir. 1987). Yet 
ArthroCare never addressed the non-infringing uses, much less presented evidence that those uses 
are not substantial. 

Indeed, Dr. Goldberg's only testimony on the contributory infringement or the non- 
infringing uses for Smith & Nephew's probes is: 

Q. Now, Dr. Goldberg, the last subject I have for you today has to 
do with contributory infringement. Have you formed an opinion about whether 
Smith & Nephew is contributing to the infringement of ArthroCare 's asserted 
claims through its sale of the Saphyre, the Control RF and the ElectroBlade? 

A. Yes, I have. 

Q. Tell us your opinion, please? 

A. Smith & Nephew, by the fact that they are selling this device, 
teaching folks how to use it in an infringing way, are certainly contributing to the 
infringement of these patents. 

Q. And can you tell us of any documents or other information on 
which you base your opinion? 

A. Well, all the documents we have just gone through, the 
instructions for use and the sales guides, are clearly pointing, they are teaching 
to, and providing product to infringe these patents. And an important point to 
add, in terms of the contributing to infringement, is that, as I have shown, the 
documents themselves say that they are selling these devices to be used for 
arthroscopic surgery, not for other things, 

(Tr. at 499-500) (emphasis added). Not only is this testimony not supported, but it is also facially 

misleading and prejudicial. As discussed above, the patents-in-suit are not limited to arthroscopic 


20 


devices and methods, and in fact are directed to open surgeries. ArthroCare's continual emphasi; 
on arthroscopic products wrongly suggested to the jury that, since ArthroCare's commercial 
products are arthroscopic devices, Smith & Nephew's arthroscopic devices must infringe. This 
was unfair and misleading. 

As described above, Dr. Goldberg's opinions that the use of Smith & Nephew's probes 
infringe the patents-in-suit lack sufficient factual support, ignore the Court's claim construction, 
and was not disclosed in Dr. Goldberg's expert report. Even if one accepts Dr. Goldberg's 
findings of infringement, it is readily apparent and uncontested that there are substantial non- 
infringing uses for the accused products that do not infringe the asserted claims of the patents-in- 
suit. In fact, there are numerous non-infringing uses for each of the accused products. 

Examples of uses of the accused products that do not infringe the '592, '882, and '536 
patent claims are using the probes to apply energy while the return electrode is in contact with 
tissue, using the probes to apply energy without creating a vapqr layer, and using the probes as 
part of an electrosurgical system that does not have a fluid supply as part of a "unitary whole" 
electrosurgical system. 

Dr. Goldberg has testified that the accused products infringe the claims of the '592 patent 
because in use they are not always in contact with tissue while energy is being applied. (Tr. at 
421-22). In reaching this conclusion, Dr. Goldberg recognized that the return electrode of the 
accused devices does frequently touch tissue while power is being applied. (Tr. at 42 1-22) ("as 
the videotape and Mr. Marsden suggested, very clearly there is occasional contact frequently 
. ."). It is thus uncontested that using Smith & Nephew's probes to apply energy while the return 
electrode is in contact with tissue is a non-infringing use of these probes even under Dr. 
Goldberg's description of what constitutes infringement. 

Absent some evidence that these the non-infringing uses of Smith & Nephew's probes 
(z.e., use with the return electrode in contact with tissue) are not substantial non-infringing uses, 
no reasonable jury could conclude that Smith & Nephew is liable for contributory infringement. 

21 


H. Smith & Nephew is Not Liable for Inducement of Infringement of Anv 
Claim of the Patents-io-Suit. 6 • 

Nor has ArthroCare offered evidence sufficient to support a finding that Smith & 

Nephew has actively induced others to infringe any of the claims under 35 U.S.C. §27 1(b). To be 

liable for active inducement, the inducer must have "possessed the specific intent to encourage 

another's infringement and not merely that the defendant had knowledge of the acts alleged to 

constitute infringement." Manville Sales Corp. v. Paramount Sys.. Inc., 917 F.2d 544, 553 (Fed. 

Cir. 1990). To prove inducement, ArthroCare bears the burden of proving first that Smith & 

Nephew's customers directly infringe, for there is no liability for inducement without a 

corresponding act of direct infringement. Joy Technologies. Inc. v. Flakt. Inc., 6 F.3d 770, 774 

» 

(Fed. Cir. 1993); Proctor & Gamble Co. v. Nabisco Brands. Inc., 604 F. Supp. 1485, 1487 (D. 
Del. 1985), overruled on other grounds. National Presto Industries. Inc. v. West Bend Co., 76 
F.3d 1 185 (Fed. Cir. 1996) ("There can be no liability for inducement of infringement under 
section 271(b) unless an actual infringement in violation of section 27 1 (a) is induced."). 
ArthroCare must also prove that Smith & Nephew induced that direct infringement. Manville 
Sales, 917 F.2d at 553. Additionally, ArthroCare must show that Smith & Nephew had actual 
intent to cause the acts which constitute the infringement Hewlett-Packard Co. v. Bausch & 
Lomb Inc.. 909 F.2d 1464, 1468-69 (Fed. Cir. 1990). 

ArthroCare offered no evidence that any customer of Smith & Nephew has ever used any 
one of the accused probes in a way that meets all of the limitations of any of the claims in suit. 
Indeed, the only evidence ArthroCare introduced about how Smith & Nephew customers use the 
products came from Smith & Nephew clinical evaluation surveys, which do not address most, 
much less all of the elements required by the claims. (D.I. 410 at 466, 471, and 484). 

In addition, ArthroCare did not prove that Smith & Nephew intends to cause others to 
infringe any of the claims of the patents in suit. ArthroCare argued for the admissibility of 
otherwise inadmissible and highly prejudicial copying evidence, claiming that such evidence was 
relevant to show the intent to cause infringement element of its inducement charge. (Tr. at 24- 


22 


25). ArthroCare's "copying" story, which consisted only of an ad hominem attack and evidence 
that Smith & Nephew looked at certain AnhroCare products (with no evidence of actual 
copying), was wholly insufficient to show that Smith & Nephew actively induces any such 
infringement. Moreover, ArthroCare introduced no "evidence" of "copying ' related to the 
Saphyre product. 

ArthroCare also attempted to rely on evidence that Smith & Nephew instructs users to 
avoid contacting non-target tissue with the return electrode of the Saphyre product. (Tr. at 486). 
In arthroscopy, there is a well-recognized distinction between target and non-target tissue. Philip 
Eggers, one of the co-inventors of all three patents in suit, testified that tissue such as the 
meniscus is an example of target tissue and tissue such as cartilage is an example of non-target 
tissue. (Tr. at 35 1 -352). Smith & Nephew does not instruct users to avoid contact with any 
tissue, it only instructs users to avoid contact with non-targeted tissue. Thus, ArthroCare's 
supposed evidence that Smith & Nephew is inducing infringement of the '592 patent claims by 
instructing surgeons not to contact non-targeted tissue with the Saphyre probe does not support 
Dr. Goldberg's conclusion, and, in fact, contradicts it. 

ArthroCare's evidence is insufficient to support a finding that Smith & Nephew's 
customers or users actually use the accused probes in a way that directly infringes any of the 
claims, much less that Smith & Nephew actively induces them to do so. 

I* Because The Relevant Factual Evidence Is Undisputed, This Court Should 
Find The Asserted Claims Of The Patents-In-Suit Invalid As A Matter Of 
Law 

It is well recognized that a finding of invalidity requires proof by clear and convincing 
evidence. Mahurkarv. C.A Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996). Nonetheless, where 
the relevant facts are undisputed — whether the references are prior art and what those references 
disclose— a jury may not simply ignore those facts to find the patent valid. See Verdegaal 
Brothers, Inc.. v. Union Oil Company Of California, 814 F.2d 628, 632 (Fed. Cir. 1987) (granting 
JNOV based on the "uncontradicted disclosure" of a prior art reference); see also IPPV 
Enterprises. LLC v. EchoStar Communs. Corp., 191 F. Supp. 2d 530, 561-62 (D. Del. 2002) 

23 


(granting JMOL based on "undisputed evidence ' that the patent was invalid as anticipated and 
finding that no reasonable jury viewing the documentary evidence . . . could fairly conclude 
otherwise"). If the prior art references show that all of the limitations of a patent claim are 
present, the trial court is required to enter JMOL of anticipation. See id.; Anderson v. Liberty 
Lobby, 477 U.S. 242, 250-51 (1986) ("The tnal judge must direct a verdict ,f, under the 
governing law, there can be but one reasonable conclusion as to the verdict."); Richardson- Vicks. 
Inc. v. Upjohn Co., Civ. Action No. 93-556-SLR, 1996 WL 31209 (D. Del.), affd 122 F.3d 1476 
(Fed. Cir. 1997). (entering JMOL of invalidity where "the evidence, viewed in a light most 
favorable to plaintiff, nevertheless compels a verdict contrary to that of the jury"). 

1 • There Are No Factual Disputes Relating To. Validity 

In the present case, there are no factual disputes relating to validity. First, there is no 

dispute that the six references relied on by Smith & Nephew are prior art. Moreover, there is no 
real dispute about the relevant disclosures of these references, or of the patents-in-suit. 

Smith & Nephew proved by clear and convincing evidence that each of the asserted 
claims of the patents-in-suit is invalid. Its expert, Dr. Taylor, showed how— on a limitation-by- 
limitation basis— various prior art patents and articles anticipate the asserted claims of the '536 
(D.I. 416 at 1294-1313), '882 (D.I. 416 at 1313-25) and '592 (D.I. 416 at 1325-34) patents. 
Similarly, Dr. Manwaring, one of Smith & Nephew's other experts, also showed that the '882 
patent is invalid. (D.I. 414 at 883-96). ArthroCare, on the other hand, failed to put forth any 
evidence to rebut Smith & Nephew's prima facie showing of invalidity, and called no witnesses 
to testify on validity. Thus, ArthroCare failed to meet its burden to introduce rebuttal evidence 
showing that the claims are valid. U.S. Environmental Prods. Inc. v. Westall, 91 1 F.2d 713, 716 
(Fed. Cir. 1990) (holding that once a defendant, demonstrates a prima facie case of invalidity, the 
patent holder must come forward with convincing evidence to rebut the showing); see also Hycor 
Corp. v. Schlueter Co., 740 F.2d 1529, 1537 (Fed. Cir. 1984). 

Instead, all ArthroCare did was cross-examine Smith & Nephew's experts. But 
ArthroCare 's cross-examination fell far short of creating a record that can support the jury's 


24 


verdict that the asserted claims are valid. Nothing brought out in the cross-examinations of Dr S . 
Taylor and Manwaring undermined the limitation-by-limitation analysis presented by these 
experts. ArthroCare's counsel merely cited irrelevant concessions related to claim construction 
arguments that ArthroCare had proposed, and that this Court had already rejected. In light of the 
verdict of validity, ArthroCare's focus on irrelevant cross-examination topics clearly confused the 
jury, since none of these "concessions" rebutted Smith & Nephew's clear and convincing 
evidence of invalidity. Thus, no reasonable jury could have failed to have found the patents 
invalid, and the jury's verdict cannot stand. Pannu v. lolab Corp., 155 F.3d 1344, 1348 (Fed. Cir. 
1998). 

2. The '536 Patent 

Smith & Nephew proved by clear and convincing evidence that the asserted claims of the 
'536 patent are invalid. Specifically, Dr. Taylor provided a limitation-by-limitation analysis of 
how the Elsasser and Roos Article (DTX 59A and 59B; D.I. 416 at 1294-1300), the Roos '198 
patent (DTX 11; D.I. 416 at 1300-05), the Doss '007 patent (DTX 17; D.I. 416 at 1305-09), and 
the Pao '499 patent (DTX 21; D.I. 416 at 1309-13) each anticipate the asserted claims of the '536 
patent. ArthroCare provided no rebuttal evidence to contradict Dr. Taylor's testimony, and 
instead relied on its cross-examination of Dr. Taylor to do nothing more than confuse the jury. 
However, Dr. Taylor did not waver or contradict his testimony during cross-examination, and his 
testimony did not provide ArthroCare with the rebuttal evidence it needed to overcome Smith & 
Nephew's prima facie case of invalidity. 

a. The Pao '499 Patent 

Perhaps the most obvious example of how ArthroCare confused and misled the jury, and 
of the jury ignoring the evidence with respect to the issue of invalidity involves the Pao '499 
patent (DTX 21, Exhibit hereto). In his direct testimony, Dr. Taylor showed how the Pao '499 
patent disclosed every limitation— on a limitation-by-limitation basis— in claims 46 and 56 of the 
'536 patent, as well as the unasserted independent claim 45 (D.I. 416 at 1309-13; Exhibit B). 


25 


In its cross-examination of Dr. Taylor relating to the Pao '499 patent (D.I. 416 at 1405- 
12), ArthroCare only asked him about one claim limitation — "the return electrode being 
sufficiently spaced from the electrode terminal to minimize direct contact between the return 
electrode and the patient's tissue." But this is a limitation that is found only in claim 47 of the 
'536 patent {see JTX-1, claim 47 at col. 18, lines 32-36), which is the one claim against which 
Smith & Nephew did not assert the Pao '499 patent. (D.I. 416 at 1728). Thus, ArthroCare's 
cross-examination of Dr. Taylor on this issue was completely irrelevant and misleading. 

Since ArthroCare did not ofTer any rebuttal evidence and did not even cross-examine Dr. 
Taylor with respect to any other claim term, it was undisputed at trial that the Pao '499 patent 
anticipates claims 45, 46, and 56 of the '536 patent. Yet the jury found otherwise. Thus, JMOL 
of invalidity of these claims must be entered. Verdegaal Bros.,814 F.2d at 632; US. 
Environmental Prods., 91 1 F.2d at 716; Hycor, 740 F.2d at 1537. 

b. The Doss '007 Patent 

In his direct testimony, Dr. Taylor also showed how the Doss '007 patent (DTX 17, 
Exhibit 3) disclosed every limitation — on a limitation-by-limitation basis — of claims 45, 46, and 
47 of the '536 patent. (D.I. 416 at 1305-09; Exhibit C). In its cross-examination of Dr. Taylor, 
ArthroCare asked him about only two claim limitations: "return electrode" and "connector 
located at the proximal end of the shaft." See JTX-1, claim 45 at col. 18^ lines . 18-22. 12 But once 
again ArthroCare failed to elicit any testimony that Smith & Nephew's invalidity case. 

L Return Electrode 

Dr. Taylor explained that the Doss '007 patent discloses a return electrode under the 
Court's claim construction. (D.I. 416 1306-07, 1455-57). ArthroCare did not introduce any 
contrary testimony, and Dr. Taylor did not waver in his opinion on cross-examination. Instead of 
seeking any relevant testimony, ArthroCare asked a series of irrelevant and misleading questions 
regarding possible tissue effects by the return electrode. (D.L 416 at 1380-99). 

12 These limitations are found in independent claim 45. "Since the patentee [] does not argue the 
validity of the dependent claims separately, their validity will stand or fall with the independent 
claim [45]." Richardson- Vicks v. Upjohn Co., 122 F.3d 1476, 1480 (Fed. Cir. 1997). 

26 


First, ArthroCare asked Dr. Taylor whether the term "return electrode" was explicitly 
used in the Doss 007 patent. (D : 1. 416 at 1380). ArthroCare was apparently trying to mislead 
the jury by suggesting that the words "return electrode" must be explicitly disclosed or the 
reference does not anticipate. This is clearly wrong, as claim limitations can be inherently found 
in a reference. See MEHL/Biophile Int l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 
1999); see also Tyler Refrigeration v. Kysa Ind Corp., Ill F.2d 687, 689 (Fed. Cir. 1985). Thus, 
ArthroCare's attempt to show that an inherent limitation is not explicitly disclosed does not rebut 
Smith & Nephew's anticipation case. MEHL/Biophile Int 7 Corp., 192 F.3d at 1366; Verdegaal 
Bros.. Inc. v. Union Oil Co. of Cai, 814 F.2d 628, 630 (Fed. Cir. 1987). 

ArthroCare then set out on a path of questioning that not only ignored the Court's 
construction of the claim term "return electrode," but also reargued the claim construction that it 
had originally proposed and that the Court had rejected. ArthroCare had sought a claim 
construction that the return electrode would have minimal tissue effect. (Joint Claim 
Construction Statement) (D.I. 270 at 9). The Court squarely rejected ArthroCare's proposed 
claim construction, and instead held that "(a]s contrasted with an active electrode, the term 'return 
electrode' means 'an electrode having a larger area of contact than an active electrode, thus 
affording a lower current density.'" (4/19/03 Memorandum Order at 4) (D.I. 353). Yet 
ArthroCare ignored the Court's claim construction, and attempted to mislead the jury by asking 
questions related to tissue effect by the return electrode. At this point in the trial, the Court 
expressed some concern that the question may be misleading "because it is maybe inconsistent 
with what I've said." (D.I. 4 16 at 1 389). The Court went on: 

THE COURT: Well, if you are saying there is no difference between the two, I 
mean I do believe that under this definition there has to be a difference between 
the active and the return. If you are saying and your point is that in the [Doss] 
prior-art reference there is no difference between the two, then that is an 
appropriate line of cross. 

ArthroCare's counsel then assured the Court that that was his intention to show 
specifically that there was no difference between the two electrodes. (D.I. 416 at 1389-90). 
However, following this interchange, ArthroCare did not attempt to show that there is no 

27 


difference between the two, but instead went nght back to asking about tissue effects (D.L 416 at 
1396): 

Q. So again, my question, sir, simply is, is each electrode designed to 
cause a tissue effect? 

A. Yes. 

This line of questioning is clearly misleading as it fails to take into account the Court's 
claim construction, which permits the return electrode to have a tissue effect. Moreover, Dr. 
Taylor's answer in no way contradicts his prior testimony, nor his testimony on redirect (D.I. 416 
at 1455-57) (emphasis added): 

Q. Did you use the Court's definition of return electrode in determining 
whether or not the Doss reference had a return electrode? 

A. Yes. 

Q. And what is the critical element of the Court's definition of whether 
or not something constitutes a return electrode? 

A. The critical element is an electrode having a larger area of contact 
than an active electrode, thus affording a tower current density. 

Q. And when you reviewed the Doss patent, did you find such an 
electrode? 

A. Yes. The outer electrode is - just look at the geometry - 


* * * 


And just on the basis of plane geometry if you assume both electrodes 
have the same thickness, the outer electrode will have more surface area. 

Q. And does that outer electrode meet the Court's definition of a return 
electrode? 

A. I believe it does. 

Thus, ArthroCare failed to rebut Dr. Taylor's clear and convincing testimony that the 

Doss '007 patent discloses a return electrode. 


ii. Connector Near the Proximal End of the Shaft 

Dr. Taylor testified that that the Doss '007 patent discloses a connector near the proximal 
end of the shaft (D.I. 416 at 1307), pointing specifically to col. 3, lines 30-34, which provides as 
. follows: 

Reference is made to Fig. 9 which schematically shows a two-electrode 
embodiment of the invention. A source of alternating voltage 12 such as a radio- 
frequency generator producing a 0.1 to 20 megahertz electric current is operably 
connected to electrodes 14 and 16. 

This disclosure clearly meets this Court's interpretation of "connector" (4/9/03 
Memorandum Order at 2) (D.I. 353): 

The word connect means "to bind or fasten together; join or unite; link[.]" The 
word "connector," in terms of the "536 patent, shall be construed to mean a 
"structure that electrically links the electrode terminal to the high frequency 
power supply." 

In its definition, the Court did not require that the connector be removable. Thus, a wire 
that passes through the proximal end of the device as shown in Figs. 7 and 9 of the Doss '007 
patent would be a "connector" under the Court's construction. 

However, in its cross-examination, ArthroCare once again ignored the Court's claim 
construction, and asked only whether the location of the connector was explicitly disclosed (D.I. 
416 at 1400): 

Q. And here in the Doss '007 patent, would you agree with me that 
there is no disclosure of where the connector is located, in other words, there is 
nothing that tells you where the connector is located with respect to the shaft? 

A. Hold on a second. I believe that's correct. There is no specific 
mention of the location of that. 

As discussed above, this is both misleading and legally incorrect because elements that 
are inherently disclosed still anticipate. Therefore, ArthroCare did not rebut Dr. Taylor's 
testimony that the Doss '007 patent discloses a connector near the proximal end of the shaft. 
Verdegaal Bros. , 8 1 8 F.2d at 63 1 ; IPPV Enterprises, LLC, 191 F; Supp. 2d at 56 1 -62. 

Because the return electrode and connector elements were the only ones that ArthroCare 
even attempted to demonstrate were not in the Doss '007 patent, and because ArthroCare patently 


29 


failed in that attempt, ArthroCare did not rebut Smith & Nephew's prima facie case that the 
claims 45, 46, and 47 of the '536 patent are invalid as anticipated by the Doss '007 patent and 
JMOL of invalidity should be entered based on this reference. US Environmental Prods., 911 
F.2d at 716; Hycor, 740 F.2d at 1537. 

c. The Elsasser and Roos Article and the Roos '198 Patent 
In his direct testimony, Dr. Taylor showed how both the Elsasser and Roos Article (DTX 
59A and 59B) and the Roos ' 198 patent (DTX 1 1, Exhibit 5) disclosed every limitation-on a 
limitation-by-limitation basis^of claims 45, 46, 47, and 56 (Ross '198) and 45, 46, and 56 
(Elsasser and Roos Article) of the '536 patent (D.I. 416 at 1294-1305; Exhibits D and E). In its 
cross-examination of Dr. Taylor relating to these references, ArthroCare asked him only about 
two claim limitations— "electrically conducting fluid" and "connector near the proximal end of 
the shaft." See JTX-1, claim 45 at col. 18, lines 18-25. Again, the validity of the dependent 
claims, which ArthroCare did not separately challenge, stands or falls with the independent claim. 
Richardson-Vicks, 122 F.3d at 1480. And again, ArthroCare failed to rebut Smith & Nephew's 
clear and convincing invalidity proof. 

i. Connector Near the Proximal End of the Shaft 

ArthroCare cross-examined Dr. Taylor with respect to the "connector" limitation in the 

Roos ' 198 patent, but not with respect to the Elsasser and Roos Article. In any event, it was 

undisputed at trial that the Roos *198 patent and the Elsasser and Roos Article both disclose a 

connector at the proximal end of the shaft (DTX 1 1 at col. 7, lines 1-7) (emphasis added): 

In the present embodiment, two leads 16 pass outwards from the cylindrical 
neutral electrode 1 1, which at 20 are combined to form a single cable, leading to 
the rear end of the endoscope 13. The neutral electrode 1 1 is connected via a 
further insulated cable 14 to the high frequency generator. 

Figure 7 and claim 1 further disclose a connector (DTX 1 1 at col. 7, lines 51): 

Insulated cable means for connecting said treatment electrode to one pole of a 
high-frequency generator. . . 

Similarly, Figure 9 of the Elsasser and Roos Article clearly shows a removable connector near the 

proximal end of the endoscope. (DTX 59A at 133, Fig.^9) (Marsden Dec. Ex. 6) 

30 


It is clear that these disclosures in the Roos '198 patent and the Elsasser and Roos Article 
satisfy the limitation "connector near the proximal end of the shaft electrically coupling the 
electrode terminal to the electrosurgical power supply/' as construed by the Court. First the 
Court held that the term "connector" simply means "a structure that electrically links the 
electrode terminal to the high frequency power supply." (4/9/03 Memorandum Order at 2) (D.L 
353). In its definition, the Court did not require that the connector be removable. Thus, a wire 
that passes through the proximal end of the device would be a connector under the Court's 
construction. The Roos '198 patent at Figure 7 and col. 7, lines 1-7 and the Elsasser and Roos . 
Article at Figure 8 both show that all the wires lead to the rear (proximal end) of the endoscope. 
Thus, both references disclose a connector that is located at the proximal end of the shaft. 

Second, Dr. Taylor testified that the Roos ' 1 98 patent and the Elsasser and Roos Article 
each disclose a connector near the proximal end of the shaft. (D.I. 416 at 1298 and 1302-03, 
respectively; see also Exhibits D and E). For example, Dr. Taylor explained how the Roos '198 
patent discloses a connector at the proximal end of the shaft (D.L 416 1301-03) (emphasis 
added): 

Q. Have you done an element-by-element comparison of the teachings 
of the Roos 4 198 with the claims of the '536 patent? 

A. Yes, I have. 

* * * 

A. ... A connector, requires a connector, coupling the shaft to the 
electrosurgical power supply. And that element is satisfied by Figure 7 and the 
text in Column 7, Lines 1 through 5. And also in Claim I, as described here in 
this text. So that element is satisfied. 

Dr. Taylor also explained that the disclosure of the connector in the Roos ' 198 patent was 

inherent (D.L 416 at 1371-72): 

A. You do realize that all resectoscopes have connectors at the back 
end of the resectoscope. 

* * * 

A, There is nothing in the ' 198 patent that says it explicitly. But there 
are no resectoscopes on the market that don't have a connector at the end, on the 
back of the resectoscope. 


3i 


ArthroCare again did not introduce any contrary testimony and Dr. Taylor never wavered 
in his opinion. Instead, ArthroCare only asked whether the location of the connector was 
«/>/icir/, described in the Roos '198 patent (D.I. 416 1371). These questions were irrelevant 
since elements do not have to be explicitly recited to be found in a pnor art reference. See 
MEHUBiophile, 192 F.3d at 1365; Tyler Refrigeration, 111 F.2d at 687. 

Further, ArthroCare did not present any evidence, not even through cross-exammation, to 
contradict Dr. Taylor's testimony that the Elsasser and Roos Article discloses a connector at the 
proximal end of the shaft. And ArthroCare did not ask a single question about the connector's 
location in the Elsasser and Roos Article. 

ii- Electrically Conducting Fluid 

The other issue on which ArthroCare cross-examined Dr. Taylor related to the 
"electrically conducting fluid" limitation: Despite ArthroCare's lengthy cross-examination of Dr. 
Taylor, it was undisputed at trial that claim 1 of the Roos '198 patent and the Elsasser and Roos 
Article both explicitly disclose electrically conducting fluid. Claim 1 of the Roos '198 patent 
reads: 

[A] space being formed between said treatment electrode and said neutral 
electrode which is adapted to be filled with liquid to provide electrical 
conductance between said electrodes. 

(DTX 1 1 at col. 7, lines 59-62) (emphasis added). Similarly, the Elsasser and Roos Article also 
explicitly discloses electrically conducting fluid: 

[The device] offeifs] the high-frequency current a path to balance the potential 
difference that would be so short and offer such a low resistance that aberrant 
currents or leakage currents do not even occur. . . The current flows directly from 
the cutting loop to the neutral electrode through the adjacent tissue to be cut 
and the irrigation liquid. 

(DTX 59B at 4) (emphasis added). 

It is clear that the "liquid to provide electrical conductance" in claim 1 of the Roos '198 
patent and the "irrigation liquid" which "offerfs] such a low resistance" in the Elsasser and Roos 
Article are both the same as "electrically conductive fluid" as used in the '536 patent, for at least 
two reasons. 


32 


First, the words used in claim 1 of the Roos ' 198 patent and in the Elsasser and Roos 

Article both clearly meet this Court's interpretation of "electrically conductive fluid" (4/9/03 

Memorandum Order at 3) (D.L 353): 

"[Electrically conducting fluid" and "electrically conductive fluid" shall be 
construed to mean "any fluid that facilitates the passage of electrical current." 

In its definition, all the Court required was that the fluid "facilitatefl the passage of 
electrical current." Of course, a "liquid" is a type of "fluid," and since "facilitate" means simply 
"to make easier," a "liquid to provide electrical conductance" in claim 1 of the Roos '198 patent 
squarely meets this Court's definition of "any fluid that facilitates the passage of electrical 
current." Similarly, the "irrigation liquid" that "offerfs] such a low resistance" would clearly 
"facilitate the passage of electrical current." 

Second, the testimony at trial was undisputed that the Roos '198 patent and the Elsasser 
and Roos Article both disclose the use of electrically conducting fluid. Dr. Taylor testified that 
the Roos '198 patent and the Elsasser and Roos Article each disclose electrically conducting 
fluid. (D.I. 416 at 1299 and 1303, respectively). For example, Dr. Taylor explained that claim 1 
of the Roos '198 patent explicitly discloses electrically conducting fluid (D.L 416 at 1301-03) 
(emphasis added): 

A. ... The Roos * 198 patent basically follows up on the work that 
Doctors Elslsser and Roos did in their article and it's a bipolar electrosurg^cal 
device for the treatment of prostate and bladder tissue, commonly known as 
TURP. 

* * * 

It also requires an electrically conducting fluid supply, directed to the 
target site and generating current, flow path between the active and return 
electrode. That is diagrammaticaily shown here in Figures 7 and 8 and also 
specifically called out in Claim l f basically the last line in Claim L So that 
element is satisfied. 

Q. Just to pause on this one for a moment, that language that is 
quoted below the [demonstrative exhibit] drawing comes from Claim 1 of the 
Roos' 198 patent? 

A. That's correct. 

Q. That is where you found support for the electrically conducting] 
fluid limitation? 

33 ~ 


A. Yes. 

ArthroCare did not introduce any contrary testimony, and did not call its own expert Dr. 
Goldberg to testify in rebuttal to Smith & Nephew's invalidity case. Dr. Taylor never changed 
his opinion. Instead, ArthroCare's strategy was to once again mislead the jury by having Dr. 
Taylor "admit" irrelevant facts that in no way contradicted or overcame the fact that these 
references disclose electrically conducting fluid. 

For example. Dr. Taylor testified under cross-examination that the Roos '198 patent and 
the Elsasser and Roos Article do not use the words "saline" or "ringer's lactate." (D.I. 416 at 
1375). However, this line of questioning was misleading since the asserted claims of the '536 
patent do not require that the electrically conducting fluid be saline or ringer's lactate.' 3 Thus, 
ArthroCare failed to rebut Dr! Taylor's clear and convincing testimony that these references 
disclose an electrically conducting fluid under the Court's claim construction. 

ArthroCare also questioned Dr. Taylor about how some other prior art monopolar TURP 
devices used glycine or other non-conductive fluids (D.I. 416 at 1339), apparently trying to 
suggest some connection between TURP procedures and non-conductive fluids. 14 However, such 
a suggestion does not change the unchallenged fact that claim 1 of the Roos '198 patent explicitly 
discloses using electrically conducting fluid as Dr. Taylor testified. 

ArthroCare also attempted to confuse the jury by pointing to embodiments in the Roos 
'198 patent that used contact between the return electrode and the tissue to provide some of the 
electrical connection. (D.L 416 at 1345). However, Dr. Taylor pointed out that "this is not the 
embodiment that I talked about and it's not an embodiment that I described." (Id.). ArthroCare's 
focus on other embodiments is misleading. It is well-settled that all that is needed to anticipate is 
one anticipating embodiment or disclosure, even if other embodiments might not anticipate. See 


13 The saline limitation is found only in asserted claims 1 1 and 32 of the '592 patent. The 
references Smith & Nephew relied upon for anticipation of the '592 patent, the Doss '007 patent 
and the Slager article, explicitly disclose saline. 

u The Roos ' 198 patent and Elsasser and Roos Article both describe devices that can be used in 
procedures other than TURP (DTX- 1 1 at Col. 1, lines 1 8-22; DTX-59B at 5). 

34 


Ultradent Prods.. Inc. v. Life-Like Cosmetics, /nc, 127 F.3d 1065, 1068 (Fed. Cir. 1997) (holding 
that the district court erred in limiting the disclosure to the non-anticipating preferred 
embodiment when the other embodiments may anticipate). Therefore, this line of questions also 
did not rebut Dr. Taylor's direct testimony. 

Finally, ArthroCare pointed to a later-issued patent, the Roos '667 patent. (PX-605) (Tr. 
at 1359-70). However, Dr. Taylor testified that the Roos '667 patent was irrelevant to his opinion 
that electrically conductive fluid was used in the Roos '198 patent (D.I. 416 at 1365-66) and 
ArthroCare adduced no evidence to the contrary. 

None of Dr. Taylor's cross-examination testimony in any way contradicted his direct 
testimony, or the explicit disclosures of the references, that both the Roos 1 198 patent and the 
Elsasser and Roos Article clearly disclose an electrically conducting fluid. Thus, because 
ArthroCare put on no other evidence on this point, ArthroCare has not rebutted Smith & 
Nephew's prima facie case that the asserted claims of the '536 patent are invalid as anticipated by 
the Elsasser and Roos Article and the Roos ' 198 patent, and JMOL of invalidity of claims 46, 47, 
and 56 based on these references is clearly warranted. U.S. Environmental Prods., 911 F.2d at 
716; Hycor, 740 F.2d at 1537. 

3. The '882 Patent 

Smith & Nephew also proved by clear and convincing evidence that the asserted claims 

of the '882 patent are invalid. Specifically, Dr. Taylor provided a limitation-by-limitation 
analysis of how the Manwaring *138 patent (DTX 46; D.I. 416 at 1313-17) anticipates claims 1, 
13, and 54 and the Slager Article (DTX 65; D.I. 416 at 13 17-20) anticipates claims 1, 13, 17, and 
54 of the '882 patent. Dr. Manwaring, one of Smith & Nephew's other experts, also testified that 
the Manwaring M38 patent anticipated claims 1, 13, and 54 of the '882 patent. (D.I. 416 at 886- 
96). Dr. Taylor further testified that the asserted claims are invalid as not enabled under 35 
U.S.C. § 1 12, because the supposed new process of "coblation" is not adequately described to 
differentiate it from the prior art. (D.I. 416 at 1320-25). 


35 


ArthroCare once again provided no rebuttal evidence to contradict Dr. Taylor's and Dr. 
Manwanng's testimony, and instead relied on its cross-examination of these experts to confuse 
and mislead the jury. However, neither Dr. Taylor nor Dr. Manwaring wavered or contradicted 
their testimony during cross-examination, and their testimony went unrebutted. 

a. The Slager Article 

In its cross-examination of Dr. Taylor relating to the Slager Article (DTX 65). 
ArthroCare asked about two claim limitations— "at least a portion of the energy induced is in the 
form of photons having a wavelength in the ultraviolet spectrum" and "evacuating fluid generated 
at the target site"; as well as a portion of the preamble to claim 1 of the '882 patent— "applying 
energy to a target site on a patient body structure." However, ArthroCare failed to rebut Smith & 
Nephew's prima facie case of invalidity of the '882 patent. 

i. UV Photons 

Dr. Taylor testified that the Slager Article discloses energy in the form of photons having 
a wavelength in the ultraviolet spectrum (UV photons), which is a limitation in claim 13. (D.I. 
416 at 1319; Exhibit F). ArthroCare did not introduce any contrary testimony. Instead, 
ArthroCare attempted to mislead the jury by suggesting that, because UV photons were not 
explicitly disclosed, UV photons were not present at all. (D.I. 416 at 1419-21). 

However, Dr. Taylor explained, in detail, why the production of UV photons is inherently 
disclosed in the Slager Article based on principles of elementary chemistry: 

Q. So just from seeing a spark, just from seeing that flash of light with 
the naked eye, you can't tell whether or not there is ultraviolet light in there or 
whether there isn't True? 

A. That 's true, except you can 't have a spark in aqueous solution 
without the UV light 


Q. So you didn't do any tests and you didn't look at the literature; 

correct? 

A. Right. One has to realize, though, that if you have a spark in an 
aqueous solution, especially a sodium chloride aqueous solution, that you will 
generate UV photons because of the transition of the hydroxyl ion. You will 

36 


also generate what we would consider to be orange, yellowish-orange light, 580 
nanometers, because of the sodium ion transition. That is college chemistry. 
(D.I. 416 at 1419-20) (emphasis added)* 

Dr. Taylor's testimony that the Slager Article inherently discloses the production of UV 
photons was not rebutted by ArthroCare, and therefore, for purposes of anticipation analysis, it 
does contain that limitation. See generally Verdegaal Brothers, 814 F.2d at 63 1 (holding that a 
patent claim is anticipated by a reference that either explicitly or inherently discloses all of the 
claim limitations). 

ii. Evacuating Fluid Generated at the Target Site 
Dr. Taylor also testified that the Slager Article discloses evacuating fluid (bubbles) 

generated at the target site, which is a limitation in claim 54. (D.L 416 at 1320; Exhibit F). 
ArthroCare did not introduce any contrary testimony and Dr. Taylor never wavered on cross- 
examination. Instead, ArthroCare again attempted to mislead the jury by suggesting that, because 
the exact suction technique was not explicitly disclosed, that a suction lumen adjacent the 
electrode terminal is not disclosed. (D.L 416 at 1425-26). 

iii. Applying Energy to a Patient Body Structure 

Dr. Taylor testified that the Slager Article anticipates claim I of the '882 patent. (Tr. at 
1319; Exhibit F). Again, ArthroCare did not introduce any contrary testimony and instead 
attempted to mislead the jury by suggesting that, because the tissue used by Slager was a piece of 
aorta in a lab dish, the Slager Article did not disclose a "method for applying energy to a target 
site on a patient body structure" as set forth in the preamble of the '882 patent. (Tr. at 1426-28). 

The reference to "patient body structure" merely sets forth the intended environment of 
use in the preamble of the claim, and does not constitute a claim limitation. See Allen Engg 
Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346^7 (Fed. Cir. 2002); Bristol-Myers Squibb Co. 
v. Ben Venue Labs., Inc., 246 F.3d 1368, 1373-75 (Fed. Cir. 2001). 

Moreover, ArthroCare's suggestion is completely undercut by the position it took with 
respect to conception and reduction to practice of claim 1 of the '882 patent. In particular, in 

37 


order to avoid some of Smith & Nephew's prior art, ArthroCare asserted that claim 1 of the '882 

patent was reduced to practice by June 18, 1993. (DTX 406). However, Philip Eggers, one of the 

inventors of the patents-in-suit, testified that as of 1 993 his experiments had not progressed to 

being used in live patients, but only involved chicken parts in bowls of saline (D.I. 410 at 295): 

Q. My question to you, Mr. Eggers, is: As of January 25, 1993, or 
February 8, 1993, the development of your invention had not progressed to the 
point that it was being used on actual patients; right? 

A. That's correct. 

Q. It was only being used in experiments in bowls of saline on various 
chicken parts; right? 

A. Correct. 

Thus, the inventor himself believed that experiments in bowls of saline were covered by 
methods of applying energy to a target site on a body structure. 15 ArthroCare cannot have it both 
ways. If experiments on chicken parts in bowls of saline were sufficient to constitute reduction to 
practice of a "method for applying energy to a target site on a patient body structure," then a prior 
art method involving human aorta tissue in a lab dish certainly must also qualify as such a 
method. Accordingly, ArthroCare did not rebut Dr. Taylor's testimony, nor did it contradict his 
conclusion that the Slager Article anticipates the asserted claims of the '882 patent. 

Therefore, ArthroCare failed to rebut Smith & Nephew's prima facie case of invalidity 
based on the Slager Article, and JMOL of invalidity of claims 13, 17, and 54 based on this 
reference is warranted. U.S. Environmental Prods., 91 1 F.2d at 716; Hycor, 740 F.2d at 1537. 

b. The Manwaring '138 Patent 

In its cross-examination of Dr. Taylor relating to the Manwaring ' 1 38 patent (DTX 46), 
ArthroCare asked him about two claim limitations— "at least a portion of the energy induced is in 
the form of photons having a wavelength in the ultraviolet spectrum" and "evacuating fluid 
generated at the target site." ArthroCare also asked about these same two limitations in its cross- 

15 Claim 1 of the *882 patent was reduced to practice in June 1993, and there is no evidence that 
the invention progressed to use in live patients in that time. Further, the language in the 4 592 


38 


examination of Dr. Manwanng. However, ArthroCare failed to rebut Smith & Nephew s 
invalidity case in either cross-examination, and did not introduce any rebuttal evidence of its own 

i. UV Photons 

Dr. Taylor testified that the Manwaring * 138 patent discloses UV photons. (D.I. 416 at 
1316; Exhibits G and H). ArthroCare did not introduce any contrary testimony. Instead, 
ArthroCare attempted to mislead the jury by suggesting that, because Dr. Taylor did not test for 
UV photons, UV photons were not present at all. (D.I. 416 at 1429). However, as discussed 
above, Dr. Taylor explained why UV photons are inherently present when you have sparking in 
an aqueous solution, such as the sparking found in the Manwaring '138 patent, as a matter of 
elementary chemistry. (See D.I. 416 at 13 16 and DTX 46 at col. 6, lines 50-63). 

Dr. Taylor's opinion was corroborated by Dr. Manwaring. (D.I. 414 at 893-95 and 917- 
19). ArthroCare did not introduce any contrary testimony and Dr. Manwaring also never wavered 
on cross-examination. Instead, ArthroCare attempted to mislead the jury by suggesting that, 
because UV photons were not explicitly disclosed, UV photons were not present at all. (D.I. 414 
at 897-98). But making such a suggestion does not satisfy ArthroCare's obligation to introduce 
evidence relating to validity. Verdegaal Bros., 814 F.2d at 63 1; IPPV Enterprises, LLC, 191 F. 
Supp. 2d at 561-62. 

Thus, ArthroCare failed to rebut the testimony of either Dr. Taylor or Dr. Manwaring 
regarding the inherent presence of UV photons. 

ii. Evacuating Fluid Generated at the Target Site 

Dr. Taylor testified that the Manwaring *138 patent discloses evacuating fluid generated 
at the target site. (D.I. 416 at 1316-17; Exhibits G and H). ArthroCare did not introduce any 
contrary testimony. Instead, ArthroCare attempted to obfuscate the issues and mislead the jury by 
suggesting an improper limitations to this claim. 


patent, which was reduced to practice in February 1993, includes almost identical language: 
"method for applying energy to a target site on a body structure on or within a patient's body." 

39 


First, ArthroCare attempted to mislead the jury by suggesting that alt of the fluid at the 
target site must be evacuated (D.I. 416 at 1432-33) (emphasis added): 

Q. Right. But you are not going to take the fluid from this region at the 
tip and suck all of the fluid way over here, way up into the device and leave no 
fluid down at the tip, are you? You're going to suck fluid in, so that electrode tip 
has some fluid in contact with it; right? 

A. Oh, yes. 

ArthroCare asked similarly misleading questions of Dr. Manwaring during his cross-exami nation 
(D.I. 414 at 904-05): 

Q. So isn't it fair to say, then, that [sic] fluid remains at or on the target 
site, that you are trying to treat in the course of a surgery? 

A. That's correct. 

This was clearly misleading because there is no requirement that alt of the fluid be evacuated. 
(See JTX-2 at claim 54 and col. 23, lines 24-33). ArthroCare's misleading suggestion does not 
overcome Dr. Taylor's and Dr. Manwaring's testimony that the Manwaring '138 patent discloses 
evacuation. 

Second, ArthroCare tried to suggest that what is evacuated is not fluid generated at the 

target site, but rather the electrically conducing fluid (D.I. 414 at 903-04). This suggestion is 

irrelevant and misleading because, as Dr. Manwaring explained, the lumen would evacuate a 

mixture including saline as well as fluid that was generated at the target site (D.I. 414 at 921-21): 

Q. Would there be some fluid that was removed from the target site? 

A. Yes. Fluid would always be there, and the evacuation, whether it is 
sucking, essentially pulls fluid which is salt laden, electrically conductive, by the 
electrode. That's the principle. 

Q. Do you consider that evacuation? 

A. Yes. 

Q. Now, the fluid that is evacuated, would that include fluid that was 
generated at the target site? 

A. It can. 

Q. What kind of fluid would that include? 

" " 40 " " 


A. Well, heating in the presence of biologic tissue. Let's say one is 
ablating, which means removing, tumor tissue in the brain. That tissue is 
vaporized. And in that vaporization is fluid in the form of gas, which quickly 
mingles with the spinal fluid or the irrigated normal saline. So it's a mix again. 

this is consistent with the explicit disclosure of the '882 patent. (JTX-2 at col. 23, lines 
30-34). Thus, ArthroCare failed to rebut the testimony of either Dr. Taylor or Dr. Manwaring 
regarding the evacuation of fluid generated at the target site. 

Therefore, ArthroCare failed to rebut Smith & Nephew's prima facie case of invalidity of 
the asserted claims based on the Manwaring '138 patent and the Court should enter JMOL that 
claims 13 !7, and 54 are anticipated. U.S. Environmental Prods., 911 F.2d at 716; Hycor, 740 
F.2d at 1537. 

c. Enablement 

Dr. Taylor also testified that the '882 patent is invalid for lack of enablement. (D.I. 416 
at 1320-25). The test for whether patent claims are enabled is whether the specificajtion teaches 
those of ordinary skill in the art how to make and use the full scope of the invention without 
undue experimentation. In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988). 

The specification explains that the process of the '882 results in phenomenon the 
inventors called "cold ablation," which "can be precisely controlled to only affect a thin layer of 
cells without heating or otherwise damaging surrounding or underlying cells." '882 patent at 
11:38-41. 

The specification itself essentially establishes the enablement problem : 

The necessary conditions for forming a vapor layer near the active electrode 
tip(s), ionizing the atom or atoms within .the vapor layer and inducing the 
discharge of energy from plasma within the vapor layer will depend on a variety 
of factors, such as: the number of electrode terminals; electrode size and 
spacing; electrode surface area; asperities and sharp edges on the electrode 
surfaces; electrode materials; applied voltage and power; current limiting means, 
such as inductors; electrical conductivity of the fluid in contact with the 
electrodes; density of the fluid; and other factors. 

Id. at 1 1 :4-l 3. The specification further explains that the ionizaton induces the discharge of 
energetic electrons only "under optimal conditions." Id. at 10:65-66. 

41 


Despite this requirement of "optimal" conditions, the specification fails to specify what 
particular parameters should be used. Instead, the specification gives large ranges of parameters 
for nine different variables, with no guidance as to what particular combinations would result in. 
the "optimal conditions" required for cold ablation. 

Despite using this term in the patent, the evidence showed that ArthroCare itself 
recognized that the method of operation of its invention is not new at all, but identical to the prior 
art. ArthroCare has frequently backed off of this "cold ablation" assertion. Specifically, as Dr. 
Taylor explained, the principle of operation of the System 970, which ArthroCare asserts is 
covered by the patents-in-suit Tr. 1505 is the same as how prior art devices work (D.I. 416 at 
1323) (emphasis added): 

Q. Do you have any opinion as to whether ArthroCare's description of 
the mode of operation or the principle of operation of its System 970 is consistent 
with the opinion that you have offered here in court in this morning? 

A. Yes. Essentially, the opinion that I have, I think what is confirmed 
here in the text, is that the system operates in the same manner as a 
conventional electrosurgical system, use of arcing and such, that is described 
by what is known as prior art, stuff that has been known for a long time. 

With this understanding, and admission that the allegedly patented devices operate like 

prior art electrosurgical devices, Dr. Taylor, who was clearly qualified as one of skill in the art 

(cite|, testified that if ArthroCare tried to distinguish its patents over the prior art based on its 

alleged "Coblation" phenomenon, the claims would not be enabled (D.1. 416 at 1324-25): 

Q. Do you have an opinion as to whether the claims of the '882 patent 
are enabled to the extent it claims a new phenomenon? 

A. Yes, I have an opinion. 

Q. What is that opinion? 

A. That it is not. 

On cross-examination, Dr. Taylor did not contradict this testimony. ArthroCare's 
counsel merely cross-examined him on a laundry list of preferred embodiment parameters that 
were included in the '882 patent. (D.L 416 at 1436-38). However, this did not rebut Dr. Taylor's 
testimony in any way. None of these preferred embodiment parameters discloses how one skilled 

42 


in the art duplicating the device would get a device that produces "Coblation" instead of the prior 
art arcing described in ArthroCare's principle of operation. 

Further, if one were to build a device within the preferred embodiment parameters of the 
'882 patent, the result would simply be the device of the prior art Manwaring ' 138 patent. Here is 
a comparison of the most preferred embodiment of the '882 patent to the disclosure in the 
Manwaring '138 patent: 


Preferred element 

'882 Patent 

The Manwarinc '138 Patent 

Active electrode surface area 

1 to 20 mm' 
(15:37-39) 

1.4 mm* 

(5:20-27) 

Active electrode spaced from 
tissue 

0.05 to 0.5 mm 
(15:63-66) 

0 to 2 mm 

(5:55-61 and 6:53-57) 

Active electrode may be flush 
with Drobe surface 

(16:55-56) 

(5:55-61) 

Active electrode may be 
recessed from surface 

0.01 to 0.2 mm 
(16:57-60) 

0 to 2 mm 
(5:55-61) 

Active electrode may be 
several materials 

platinum, titanium 
tantalum or tungsten 
(16:64-66) 

stainless steel or tungsten 
(5:20-21) 

Fluid is preferably saline 

(1 2:38^0) 

(7:6-8) 


Thus, ArthroCare did not rebut Smith & Nephew's prima facie case of invalidity based 

on non-enablement, and the Court should enter JMOL. See generally, Enzo Biochem , Inc. v. 

Calgene. Inc., 188 F.3d 1362, 1374 (Fed. Cir. 1999) (finding that "[tjossing out the mere germ of 

an idea dos not constitute enabling disclosure" and that "reasonable detail must be provided in 

order to enable members of the public to understand and cany out the invention"). 

4. The '592 Patent 
Smith & Nephew also proved by clear and convincing evidence that the asserted claims 

of the 592 patent are invalid. Specifically, Dr. Taylor provided a limitation-by-limitation 

analysis of how the Doss '007 patent (DTX 17; D.I. 416 at 1325-30; Exhibit I) and Slager Article 

(DTX 65; D.I. 416 at 1330-34; Exhibit J) each anticipate the asserted claims of the '592 patent. 

ArthroCare again provided no rebuttal evidence to contradict Dr. Taylor's testimony, and instead 


43 


relied on its cross-examination of Dr. Taylor to confuse and mislead the jury. However, Dr. 
Taylor did not withdraw or contradict his testimony during cross-examination. 

a. Doss '007 

In its cross-examination of Dr. Taylor relating to the Doss '007 patent (DTX 17), 
ArthroCare asked about only two claim limitations— "return electrode" and "voltage [] in the 
range from 500 to 1400 volts peak to peak." See. e.g., JTX-3, claims 1 and 21. But once again 
ArthroCare failed to elicit any testimony to rebut Smith & Nephew's invalidity case. 

i. Return Electrode 

The '592 patent contains the same "return electrode" limitation as the '536 patent, 
discussed above at Section 2(b)(i). And as with the '536 patent, ArthroCare did not rebut Dr. 
Taylor's testimony that the Doss '007 patent discloses a return electrode. Further, this limitation 
is found in independent claim 1. Since ArthroCare did not argue the validity of claims 3, 4, or 1 1 
separately, their validity will stand or fall with independent claim 1. Richardson-Vicks, 122 F.3d 
at 1480. 

ii. Voltage in the Range From 500 to 1400 Volts 

Dr. Taylor testified that the Doss '007 patent inherently discloses a voltage in the range 
from 500 volts to 1400 volts peak to peak. (D.I. 416 at 1330). ArthroCare put on no evidence to 
rebut this testimony. Instead, ArthroCare once again limited its cross-examination to simply 
showing that the limitation was not expressly disclosed, ignoring the settled law that a limitation 
can be present in anticipating prior art inherently. MEHUBiophile, 192 F.2d at 1365: 

As explained by Dr. Taylor, instead of disclosing the peak to peak voltage, the Doss '007 
patent discloses a voltage of 20 to 200 volts RMS (root-mean-square). To convert from voltage 
expressed in RMS, one needs to multiply by 2.83 to get voltage expressed in peak-to-peak units. 
(D.I. 416 at 1330). This conversion results in a voltage of 560 volts peak-to-peak for the Doss 
'007 patent. (Id.). ArthroCare attempted to confuse the jury regarding this inherent disclosure by 


44 


asking Dr. Taylor whether the Doss '007 patent expressly disclosed a sine wave, which is the 

most common waveform used. (D.I. 416 at 1402). Dr. Taylor maintained his opinion (id): 

Q. And there is nothing in the Doss patent that says that a sine wave is 
used with this generator; correct? 

A. That's correct. 

Q. So we don't know whether there is a sine wave here or a square 
wave or some other waveform; right? 

A. You're correct. But, to my knowledge, there are no commercially- 
available square wave generators. 

Thus, ArthroCare failed to rebut Dr. Taylor's testimony that the Doss '007 patent inherently 
discloses a voltage of from 500 to 1400 volts peak-to-peak. 

Therefore, ArthroCare has not rebutted Smith & Nephew's prima facie case that the 
asserted claims of the '536 patent are invalid as. anticipated by the Doss '007 patent, and JMOL 
based on this reference is clearly warranted. U.S. Environmental Prods., 91 1 F.2d at 716; Hycor % 
740F.2dat 1537. 

b. Slager Article 

In its cross-examination of Dr. Taylor relating to the Slager Article (DTX 65), 
ArthroCare asked only about one claim limitation— "spacing a return electrode away from the 
body structure in the presence of the electrically conductive fluid"; and the preamble language— 
"applying electrical energy to a target site on a body structure on or within a patient's body." See 
JTX-3 at claim 23. ArthroCare again failed to elicit testimony sufficient to rebut Smith & 
Nephew's invalidity case. Further, this limitation is found in independent claim 23. Since 
ArthroCare did not argue the validity of claims 26, 27, 32, or 42 separately, their validity will 
stand or fall with independent claim 1. Richardson- Vicks, 122 F.3d at 1480 

i. Applying Energy to a Target Site on a Body Structure on or 
Within a Patient's Body 

The '592 patent contains the same "on or within a patient's body" limitation as the '882 

patent. And as discussed above with respect to the '882 patent in Section F(3)(a)(iii), ArthroCare 

45 


did not rebut Dr. Taylor's testimony that the Slager Article discloses a method for applying 
energy to a target site on a body structure on or within a patient's body. 

ii. Spacing a Return Electrode Away from the Body Structure 
in the Presence of the Electrically Conductive Fluid 

The Slager Article expressly discloses that a section of aortic tissue approximately 4 by 7 
centimeters in size was used in an in vitro experiment. (DTX 65 at 1382.) The article also 
discloses that the spacing between the active electrode and return electrode varied between 2 to 
10 centimeters. (Id. at 1383.) Thus, when the distance between the electrodes was 7 centimeters 
or more, the return electrode was necessarily not touching the aortic tissue sample. Dr. Taylor 
testified that the Slager Article discloses spacing a return electrode away from the body structure 
in the presence of the electrically conductive fluid. (D.I. 416 at 133 1). ArthroCare did not 
introduce any testimony to the contrary. Instead, ArthroCare asked Dr. Taylor a series of 
misleading cross-examination questions regarding an experiment described in the Slager Article 
on which Dr. Taylor was not basing his testimony. 

Specifically, the Slager Article describes both an in vitro and an in vivo experiment. (See 

DTX 65). These are two different experiments. Dr. Taylor based his opinion of invalidity on the 

in vitro experiment. His testimony on this point could not have been clearer. (D.I. 416 at 1414): 

Q. And the portions of this article that you were saying were relevant 
to the '882 and the '592 patent related to the in vitro test; correct? Not to the test 
on the pig? 

A. You said the in vitro test? 

Q. I did. 

A. Yes. 

Q. Okay. The in vitro means what in this article? 

A. In vitro means it's outside the body, generally in a dish preparation 
of some sort. I guess it's the opposite of in vivo, which is inside the body. 

ArthroCare 's counsel nevertheless went on to ask misleading questions about the 

irrelevant in vivo experiment, which did not form any part of the basis for Dr. Taylor's testimony 

(D.I. 416 at 1416-18). The jury may have been misled to believe that because the in vivo 

46 


experiment did not disclose all of the limitations, the same is true for the in vitro test. While the 
jury may have been misled, this cross examination did not rebut Dr. Taylor's clear testimony that 
the in vitro test in the Slager Article discloses a return electrode spaced away from the body 
structure in the presence of the electrically conductive fluid, nor does it rebut the explicit 
disclosure of the Slager Article. See Ultradent Prods., 127 F.3d at 1068 (a reference anticipates if 
any one embodiment anticipates, even if other embodiments do not). 

Thus, ArthroCare did not rebut Smith & Nephew's prima facie case that the asserted 
claims of the '592 patent are invalid as anticipated by the Slager Article, and JMOL is warranted 
based on this reference. U.S. Environmental Prods., 91 1 F.2d at 716; Hycor, 740 F.2d at 1537. 
V. CONCLUSION 

For the foregoing reasons, Smith & Nephew respectfully requests that the Court enter 
Judgment as a Matter of Law that the *882 certificate of correction is invalid, that the accused 
products do not infringe the asserted claims, that the asserted claims of the *536 and '592 patent 
are anticipated by the prior art, and that the asserted claims of the '882 patent are not enabled and 
are anticipated by the prior art. 


47 


Dated: June 30, 2003 


FISH & RICHARDSON P.C. 


William J. Madden, Jr. (#2247) 
Keith A. Walter Jr. (#4157) 
Eugene B. Joswifck>(g42J71) 
919 N. Market Street, Suite 1 100 
P.O. Box 1114 

Wilmington, DE 1 9899- 1114 
Telephone: (302)652-5070 
Facsimile: (302)652-0607 

MarkJ.Hebert 
225 Franklin Street 
Boston, MA 02110-2804 
Telephone: (617) 542-5070 
Facsimile: (617) 542-8906 

Kurtis D. MacFerrin 
500 Arguello Street, Suite 500 
Redwood City, California 94063 
Telephone: (650) 839-5070 
Facsimile: (650) 839-5071 


Attorneys for Defendant 
SMITH & NEPHEW, INC. 


48 


CERTIFICATE OF SERVirr 


I hereby certify that on this 30™ day of June, 2003, a tme and correct copy of SMITH & 
NEPHEW'S OPENING BRIEF IN SUPPORT OF ITS RULE 50(b) MOTION FOR 
JUDGMENT AS A MATTER OF LAW was caused to be served on the attorneys of record at the 
following addresses as indicated: 


BY HAND DELIVERY 

Jack B. Blumenfeld, Esq. 
Morris, Nichols, Arsht & Tunnell 
1201 North Market Street 
P.O.Box 1347 
Wilmington, DE 19899-1347 


Attorney for Plaintiff 
ArthroCare Corporation 


BY FEDERAL EXPRESS 

Matthew D. Powers, Esq. 
Jared Bobrow 
Perry Clark, Esquire 
Weil, Gotshal & Manges LLP 
201 Redwood Shores Parkway 
Redwood Shores, CA 94065 


Attorneys rbr Plaintiffs 
ArthroCare 


BY HAND DELIVERY 

Steven J. Balick, Esq. 

Ashby & Geddes 

222 Delaware Avenue, 1 7th Floor 

P.O. Box 1150 

Wilmington, DE 19899 


Attorney for Plaintiff7Counterclaim 

Defendant 

Ethicon, Inc. 



William J. M; 


1 


Page Blank (uspto)