Free Motion for Judgment - District Court of Arizona - Arizona

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William J. Maledon, No. 003670 Brett L. Dunkelman, No. 006740 Osborn Maledon, P.A. 2929 North Central Avenue Suite 2100 Phoenix, Arizona 85012-2794 (602) 640-9000 [email protected] [email protected] David H. Pfeffer Arnold I. Rady James W. Gould Morgan & Finnegan, LLP 3 World Financial Center New York, NY 10281-2101 (212) 415-8700 (212) 415-8701 John S. Campbell W. L. Gore & Associates, Inc. 551 Paper Mill Road Newark, Delaware 19714 Attorneys for W. L. Gore & Associates, Inc. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA Bard Peripheral Vascular, Inc., and David Goldfarb, M.D., Plaintiffs, v. W. L. Gore & Associates, Inc., Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) No.: CV-03-0597-PHX-MHM GORE'S RULE 50(B) MOTION FOR JUDGMENT AS A MATTER OF LAW THAT CLAIMS 20-27 ARE INVALID FOR FAILURE TO SATISFY THE WRITTEN DESCRIPTION REQUIREMENT OF 35 U.S.C. § 112, ¶1

W. L. Gore & Associates, Inc., Counterclaimant, v. Bard Peripheral Vascular, Inc., David Goldfarb, M.D., and C. R. Bard, Inc., Counterdefendants.

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Pursuant to Rules 50(b) and 59(a) of the Federal Rules of Civil Procedure, W.L. Gore & Associates, Inc. ("Gore") renews its motion for judgment as a matter of law ("JMOL") that claims 20-27 are invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112 (Doc. No. 732, incorporated herein by reference), and, in the alternative, moves for a new trial on the issue of written description. During the 30 year prosecution, the scope of the claims of the `135 patent was changed and broadened. By omitting wall thickness and transmural tissue ingrowth in claims first added years later, Dr. Goldfarb claimed an invention that he not only did not possess as of the October 1974 filing date but that he continued to assert was not his invention during prosecution. This is the epitome of a written description violation. The Court premised its denial of Gore's 50(a) motion on the erroneous grounds that (a) wall thickness being critical or essential is a necessary part of the written description test and (b) validity for written description regarding transmural tissue ingrowth was asserted by Gore and decided during claim construction. (Doc. 833, p. 6). As shown below, the first is legally incorrect and the second is contrary to the law of this case. When these incorrect grounds are removed, the clear conclusion is that Gore should be granted JMOL because the evidence presented at trial does not provide a legally sufficient basis for a reasonable jury to have ruled for Plaintiffs on the issue of written description. I. LEGAL STANDARD A. Judgment As A Matter Of Law

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"Judgment as a matter of law is appropriate when the evidence, construed in the light most favorable to the nonmoving party, permits only one reasonable conclusion, which is contrary to the jury's verdict." Omega Envtl., Inc. v. Gilbarco, -12224158

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Inc., 127 F.3d 1157, 1161 (9th Cir. 1997). Judgment as a matter of law may be granted "[i]f a party has been fully heard on an issue during a jury trial and the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue . . ." FED.R.CIV.P. 50(a). Motions made pursuant to Rules 50(a) and 50(b) are evaluated under the same standard. Juhnke v. EIG Corp., 444 F.2d 1323, 1325 (9th Cir. 1971) (noting that directed verdict and motion for judgment notwithstanding the verdict "are measured by the same standards as the latter is merely a renewal of the former."). In evaluating a Rule 50(b) motion, the trial court must determine whether the evidence "constitutes `substantial evidence' in support of the jury's findings and, if so, whether those findings can support the legal conclusions necessarily drawn by the jury in accord with its instructions en route to its verdict." Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir. 1984). The Court may rely on a party's Rule 50(a) motion in determining whether to award judgment notwithstanding the verdict under Rule 50(b). Andreas v. Volkswagen of America, Inc., 336 F.3d 789, 794 (8th Cir. 2003); Cambridge Plating Co. v. Napco, Inc., 85 F.3d 752, 761 (1st Cir. 1996). B. New Trial

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FED. R. CIV. P. 59(a) authorizes granting a new trial and provides in pertinent part: A new trial may be granted to all or any of the parties and on all or part of the issues (1) in an action in which there has been a trial by jury, for any of the reasons for which new trials have heretofore been granted in actions at law in the courts of the United States . . . The grant of a new trial is "confided almost entirely to the exercise of discretion on the part of the trial court." Allied Chem. Corp. v. Daiflon, Inc., 449 U.S. 33, 36 (1980). An appellate court will uphold a district court's granting a new trial if any of the district court's grounds are "reasonable." Silver Sage Partners v. City of -22224158

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Desert Hot Springs, 251 F.3d 814, 819 (9th Cir. 2001). "On a new trial motion, a district court has the right and duty `to weigh the evidence as he saw it . . .'" Clanahan v. McFarland Unified School District, 2007 U.S. Dist. LEXIS 58710, 12-15 (E. D. Cal. Aug. 3, 2007) (quoting Murphy v. City of Long Beach, 914 F.2d 183, 187 (9th Cir. 1990)). "The judge can weigh the evidence and assess the credibility of witnesses, and need not view the evidence from the perspective most favorable to the prevailing party." Landes Const. Co., Inc. v. Royal Bank of Canada, 833 F.2d 1365, 1371 (9th Cir. 1987). "Even if substantial evidence supports the jury's verdict, a district court may grant a new trial if `the verdict is contrary to the clear weight of the evidence, or is based upon evidence which is false, or to prevent, in the sound discretion of the trial court, a miscarriage of justice.'" Clanahan at *12-13 (quoting United States v. 4.0 Acres of Land, 175 F.3d 1133, 1139 (9th Cir. 1999)). C. Written Description

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As discussed in Gore's Motion For JMOL That Claims 20-27 Are Invalid For Failure To Satisfy The Written Description Requirement of 35 U.S.C. § 112, ¶1 (Doc. No. 732), 35 U.S.C. § 112, ¶1 requires, inter alia, that patent specifications contain a "written description of the invention." The written description requirement is particularly important where the originally filed claims are amended or new claims are added during prosecution. To avoid a situation where these new or amended claims differ significantly from what the inventor originally described as his invention, the written description requirement functions to "ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him...." In re Wertheim, 541 F.2d 257, 262 (C.C.P.A. 1976). To satisfy this requirement, the patent application as originally filed "must . . .

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convey with reasonable clarity to those skilled in the art that . . . [the inventor] was in
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possession of the invention. The invention is, for purposes of the `written description' inquiry, whatever is now claimed." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 156364 (Fed. Cir. 1991)(emphasis in original). This applies to both claims that are narrowed by adding limitations and (as here) claims that are broadened by deleting limitations. II. ARGUMENT A. The Written Description Issue Was Not Decided During The Claim Construction Process

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Plaintiffs have mischaracterized Gore's written description arguments as a rehashing of claim construction issues. (Doc. No. 758 at pp. 2, 5). Misled by Plaintiffs, the Court erroneously stated that it has "previously considered and rejected [invalidity] argument[s] after Gore asserted [them] during claim construction." (Doc. No. 833 at p. 6). This is contrary to the law of this case. The Special Master's Report as adopted by the Court specifically noted that "[t]he invalidity issue, however, is distinct from that of claim construction, and the Special Master was not charged with consideration of claim validity." See Special Master's Report (Doc. No. 314 at p. 18 fn. 3). This repeats what the Special Master Mr. Amend said during the Markman hearing: MR. AMEND: If I give a construction that lines up with the claims being invalid, that's not something that I need to concern myself with. MR. GOULD: I understand. MR. AMEND: You agree with that? MR. GOULD: That's right. (Doc. No. 301, 8/05/05 Markman Hearing Tr. 39:2-7). Therefore validity is a separate issue from claim construction, and whether adequate support for the claims exists in the specification was NOT an issue decided -42224158

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during the claim construction process. Certainly, if all the claims had been interpreted to include a wall thickness between 0.2-0.8 mm and complete transmural cellular ingrowth, there would be no written description issue. But this Court's claim construction did not do that. That means that now the validity of those claims must be judged by this Court's broader construction to determine if the "construction lines up with the claims being invalid", as the Special Master said. See e.g., Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1373-80 (Fed. Cir. 2007) (after patent owner successfully argued for broad claim construction, the courts ruled that the patent was invalid because, under that broad claim construction, the specification did not meet written description and enablement requirements of Section 112). Under the Court's construction here, a failure to comply with the written description requirement does exist for claims 20-24 and 27, because the invention of these claims fail to specify both wall thickness and transmural tissue ingrowth limitations, which is a different invention from that described in the Goldfarb application. Claims 25 and 26 fail to comply with the written description requirement because they fail to recite transmural tissue ingrowth. Plaintiffs' arguments, especially for wall thickness, are estopped by Dr. Goldfarb's successful argument to the Patent Office that wall thickness was a required part of his invention. See Conoco, Inc. v. Energy & Environmental Int'l, L.C., 460 F.3d 1349, 1363 (Fed. Cir. 2006) ("We have recognized that prosecution history estoppel can occur during prosecution ... by surrendering claim scope through argument to the patent examiner."); Abbott Labs. v. Dey, L.P., 287 F.3d 1097, 1103 (Fed. Cir. 2002), cert. denied 537 U.S. 1039 (2002) ("[E]ven if the claim limitation has not been amended, an argument-based estoppel may nevertheless arise based on statements made by the applicant during prosecution.")

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B.

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There Is No Evidence To Contradict Gore's Evidence That Valid Claims Require An Average Wall Thickness Of 0.2 to 0.8 mm

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Rather than provide any evidence refuting Gore's clear evidence that valid claims require wall thickness between 0.2 to 0.8 mm, Plaintiffs posit a straw man by stating "Gore cannot point to anywhere in the specification where a wall thickness of 0.2-0.8 mm is identified as the `critical' or `essential' parameter." (Doc. No. 758 at p. 7) The Court's Order (Doc. 833 at p. 6) fell into the same error. First, the law of written description looks to the elements of the claims as issued. Whether those elements are critical or essential is simply not legally relevant. The Federal Circuit's decision in PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235 (Fed. Cir. 2002), held that even if the originally filed application does not describe a given element as "critical" to the invention, later-added claims violate the written description requirement if they extend beyond the invention originally described. See 304 F.3d at 1248. Second, Gore's evidence about wall thickness in the specification and prosecution history are directed to what Dr. Goldfarb believed and argued was required as a part of his invention. Having so argued and prevailed he is now estopped from taking the position that wall thickness is not a part of his invention. Dr. Goldfarb was clear in his application that he believed maintaining a graft's wall thickness within the range of 0.2 to 0.8 mm was a requirement for his invention to achieve adequate transmural cellular ingrowth and the development of a neointima. (Doc. No. 732 at pp. 3-8). Dr. Goldfarb also stated in his application that wall thickness is one of the "two major factors which combine to control the extent and uniformity of transmural ingrowth" (PX 1 at col. 7 lns. 5-8) and that grafts with wall thicknesses outside the range of 0.2 to 0.8 mm will not work for their intended purpose. (PX 1 at col. 6 lns. 65-67, col. 7 lns. 9-17, col. 7 lns. 1-4). These statements estop Dr. Goldfarb from saying now that wall thickness was not a required part of his -62224158

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invention. Dr. Goldfarb is similarly estopped from denying wall thickness is a required element of his invention by the arguments he made to the Patent Office. Specifically, the wall thickness in the range of 0.2-0.8 mm was repeatedly relied on to overcome prior art. (PX 115 at PX 115.217 lns. 24-30, PX 115.220 lns. 4-7, PX 115.610; PX 116 at PX 116.2674-2678, PX 116.2681-2682, PX 116.3965-3966, PX 116.3971). Dr. Goldfarb submitted and relied upon affidavits to the PTO stating that grafts with wall thicknesses outside his preferred range would result in "clinically unacceptable results" (PX 115 at PX 115.281 lns. 11-13, 15-18, PX 115.282 lns. 5-8) and subject the patient to "an unreasonably high risk of clinical failure." (PX 115 at PX 115.285 ln. 22 - PX 115.286 ln. 2). Having been successful in these arguments, Plaintiffs are now estopped from arguing to the contrary that wall thickness is not a required part of Dr. Goldfarb's invention. See Conoco, Inc., 460 F.3d at 1363; Abbott Labs., 287 F.3d at 1103. In the face of Dr. Goldfarb's arguments regarding his invention requiring wall thickness, Plaintiffs cannot now argue that the Court should put on blinders and not look beyond the face of the patent in determining whether the a wall thickness of 0.2 to 0.8 mm is a required part of Dr. Goldfarb's invention. (Doc. No. 758 at pp. 5, 6). 1 Plaintiffs do not, and indeed cannot, point to a single instance in the specification which supports an invention of a graft of any wall thickness as claimed in claims 20While Plaintiffs rely on New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1295 (Fed. Cir. 2002), for the proposition that the adequacy of the written description is measured from the face of the application (Doc. No. 758 at pp. 5, 6), they ignore the case's admonition that "the disclosure must show [the inventor] had invented each feature that is included as a claim limitation . . . the [written description] requirement is not satisfied if one of ordinary skill in the art must first make the patented invention before he can ascertain the claimed features of that invention." 298 F.3d at 1295. Here, the specification simply does not disclose making a graft of any wall thickness, but rather a graft with a wall thickness within a specified range. This means that one of ordinary skill in the art would actually have to make the patented invention before ascertaining which wall thickness would result in a functioning graft. -72224158
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24 and 27 (rather than a specific range as set forth in claims 1-19 and 25-26). As discussed above, Gore has provided numerous references to the contrary in both the specification and the prosecution history that Dr. Goldfarb repeatedly argued that the defined range was required by his invention. Despite the many instances of estoppel against Dr. Goldfarb in both the specification and the prosecution history, Plaintiffs maintain "[t]he only evidence that Gore submits is the conclusory testimony of its expert, Dr. Wheeler..." and further maintain that Dr. Wheeler's opinions are inconsistent with those of its own expert, Dr. Anderson. (Doc. No. 758 at p. 7). Plaintiffs are incorrect. Not only did Dr. Wheeler, a retired vascular surgeon, testify at trial that a person of ordinary skill in the art as of the filing date of the `135 patent application would understand wall thickness to be a required part of Goldfarb's invention (Wheeler 11/28/2007 Trial Tr. 2197:12-2198:2, 2198:13-2203:12, 2204:6-2205:16), but, as shown at trial, his opinion is wholly consistent with the opinion given under oath by Dr. Anderson on the same subject during the interference. (Wheeler 11/28/2007 Trial Tr. 2204:62205:16). Further, Dr. Goldfarb's litigation-induced testimony that "wall thickness is not part of the invention" (Goldfarb 11/8/07 Trial Tr. 705:10) carries no weight, because it directly contradicts what he told the Patent Office. Specifically, Dr. Goldfarb's testimony in the interference in 1988 contradicts his current litigation-induced position that wall thickness is not and never was part of his invention: "My preferred wall thickness was 0.5 millimeters but certainly not to exceed 0.8. And although I hadn't tried it, something thinner than 0.3 or so 0.2 would have been too flimsy to sew mechanically to the artery" (PX 116 at PX 116.9747). Thus while the claims here were not legally construed to all require a wall thickness limitation, such a claim is not what Dr. Goldfarb testified -82224158

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was his invention at least as of 1988. It is not therefore surprising that his specification filed in 1974 does not contain a written description of a claim without a wall thickness as understood by a person of ordinary skill in the art. The only evidence at trial on whether one skilled in the art as of the October 24, 1974 filing date would understand from the Goldfarb specification that Dr. Goldfarb's invention require a wall thickness limitation came from Dr. Wheeler. Dr. Wheeler agreed with Dr. Goldfarb's and Dr. Anderson's testimony during the interference that one skilled in the art would read the Goldfarb application to require a wall thickness range. (Wheeler 11/28/07 Trial Tr. 2197-98). Claims 20-24 and 27 are thus invalid because they are not supported by the written description of the patent application as filed. See Gentry Gallery v. Berkline Corp., 134 F.3d 1473, 1478-80 (Fed. Cir. 1998); PIN/NIP, 304 F.3d at 1247-48. These claims encompass grafts having any wall thickness, including thicknesses far beyond the 0.2 to 0.8 mm range. These claims also do not require transmural tissue ingrowth, an element of his invention as described in the Goldfarb application. Thus, these claims are invalid for going beyond what Dr. Goldfarb actually described as his invention. C. There Is No Evidence To Contradict Gore's Evidence That Valid Claims Require Controlled Cellular Transmural Ingrowth Through The Wall Of The Graft

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Initially, as explained above, the Court is simply wrong in stating that the issue of written description invalidity for transmural tissue ingrowth was "considered and rejected" by the Court after "Gore asserted it during claim construction." (Doc. 833, p. 6). The issue of patent invalidity was not part of the claim construction proceeding, as acknowledged by the Master during the Markman hearing and in the Master's Report. Gore also clearly stated it was not asserting invalidity in that proceeding. Further, Gore's Motion for Summary Judgment of Patent Invalidity (Doc. No. 68) -92224158

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which included written description as one basis, was decided by the Court (Doc. No. 163) prior to the Court's claim construction. Therefore, the Court never decided written description validity based on the expansive claim construction. On the merits with the benefit of the Court's claim construction, Plaintiffs attempt to relegate the importance of transmural tissue ingrowth to but one of "numerous other objectives described in the specification." (Doc. No. 758 at p. 9). However, the portion of the specification Plaintiffs rely on for this proposition, namely col. 3, lines 27-35, simply doesn't support their position. Id. Rather than suggest that transmural ingrowth is merely one of many objectives of the invention, the portion of the specification Plaintiffs cite actually states that a structure which allows "uniform, controlled transmural cellular ingrowth" and thereby assures establishment of a neointima is "a major objective" of the invention. (PX 1 at col. 3 lns. 27-31). Moreover, while Plaintiffs argue that transmural cellular ingrowth is "only one" objective of the invention, they cannot and have not disputed that the patent specification unambiguously identifies controlled transmural ingrowth as a required element of a successful graft. (PX 1 at col. 2 lns. 42-45, col. 2 lns. 56-59, Abstract, col. 3 lns. 27-33). Rather, Plaintiffs rely on the conclusory statement of its expert Dr. Dolmatch that complete transmural ingrowth is not "essential" today. (Doc. No. 758 at p. 9). First, as shown above, "essential" is not the test for written descriptions. Second, such litigation-induced conclusory comments by a witness without reference to how one skilled in the art saw the specification and prosecution history at the time the application for the `135 patent was filed, cannot overcome the estoppel from the clear statements by Dr. Goldfarb in the specification. Equally unpersuasive is Plaintiffs' reliance on Dr. Goldfarb's ambiguous trial testimony that "you can have good results sometimes with [complete transmural cellular ingrowth] ­ with or without it." Id. citing (Goldfarb 11/8/07 Trial Tr. 668:13-102224158

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20). Dr. Goldfarb's testimony is in direct contrast with his argument to the PTO that "[i]t is, of course, one of the principal objectives of the present invention to control uniform cellular ingrowth through the walls of the artificial vascular structure... ." (PX 115.216, Lns. 6-9) (emphasis added). Moreover, the issue is not whether or not Dr. Goldfarb now believes that transmural tissue or cellular ingrowth is required to achieve specific results. Rather, the issue is the Goldfarb application, as understood by a person of ordinary skill in the art as of its October 1974 filing date, described Dr. Goldfarb's invention to be a product devoid of the requirement that the structure allow controlled transmural cellular ingrowth. Clearly, Dr. Goldfarb did not. Despite the repeated statements of Dr. Goldfarb that his invention required controlled transmural cellular growth, many years after the application was filed Dr. Goldfarb added what are now claims 20-27, which omit any reference to transmural or through the wall cellular or tissue ingrowth. By omitting the requirement that the prosthesis be capable of controlling cellular ingrowth through the wall as Dr. Goldfarb repeatedly stated, these later claims are not supported by the written description of the invention as set forth in Dr. Goldfarb's 1974 application. This Court's claim construction did not decide this issue. Under Gore's clear and convincing evidence based on Dr. Goldfarb's own admissions, claims 20-27 are invalid under 35 U.S.C. § 112. D. Dr. Goldfarb's Trial Testimony Contradicting Statements He Made To The PTO Misled The Jury

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If the Court does not grant judgment as a matter of law, a new trial should be granted pursuant to FED. R. CIV. P. 59. Dr. Goldfarb's trial testimony regarding wall thickness and transmural tissue ingrowth contradicted arguments he made to the PTO and misled the jury. As discussed above, Dr. Goldfarb's trial testimony that "wall thickness is not part of the invention" (Goldfarb 11/8/07 Trial Tr. 705:10) directly contradicts what his patent application as filed told a person of ordinary skill in the art -112224158

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and what Dr. Goldfarb asserted to the PTO. (PX 115 at PX 115.217 lns. 24-30, PX 115.220 lns. 4-7, PX 115.610; PX 116 at PX 116.2674-2678, PX 116.2681-2682, PX 116.3965-3966, PX 116.3971). Similarly, Dr. Goldfarb's trial testimony that "you can have good results sometimes with [complete transmural cellular ingrowth] ­ with or without it" (Goldfarb 11/8/07 Trial Tr. 668:13-20) is in direct contrast with his assertions to the PTO that "[i]t is, of course, one of the principal objectives of the present invention to control uniform cellular ingrowth through the walls of the artificial vascular structure...." (PX 115 at PX 115.216 lns. 6-9) (emphasis added). Plaintiffs have not and cannot offer an explanation for Dr. Goldfarb's change of position. Through his trial testimony, Dr. Goldfarb misled the jury into thinking that his invention was something that it is not. Regardless of what Plaintiffs now contend, when Dr. Goldfarb filed his application he believed that a wall thickness in the range of 0.2-0.8 mm and complete transmural cellular or tissue ingrowth were a required part of his invention and that is what a person of ordinary skill in the art would understand from reading his 1974 patent application. His arguments to the PTO are unambiguous. His recent attempts to mislead the jury have prejudiced Gore and warrant a new trial pursuant to FED. R. CIV. P. 59(a). See Clanahan v. McFarland Unified School District, 2007 U.S. Dist. LEXIS 58710, at *12-13. III. CONCLUSION For the reasons stated herein and contained in the incorporated filings, Gore respectfully requests that the Court grant judgment of a matter of law that the '135 Patent is invalid for failure to meet the written description requirement of 35 U.S.C. § 112, or, in the alternative, grant a new trial on the written description issue.

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The Phoenix Plaza 21st Floor 2929 North Central Avenue Phoenix, Arizona 85012-2794 P.O. Box 36379 Phoenix, Arizona 85067-6379 Telephone Facsimile 602.640.9000 602.640.9050

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-122224158

Case 2:03-cv-00597-MHM

Document 844

Filed 08/12/2008

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O SBORN MALEDON 1
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DATED this 12th day of August, 2008 OSBORN MALEDON, P.A. s/William J. Maledon Brett L. Dunkelman William J. Maledon 2929 North Central Avenue Phoenix, Arizona 85012-2794 David H. Pfeffer Arnold I. Rady James W. Gould Morgan & Finnegan, L.L.P. 3 World Financial Center New York, New York 10281-2101 John S. Campbell W. L. Gore & Associates, Inc. 551 Paper Mill Road Newark, Delaware 19714 Attorneys for W. L. Gore & Associates, Inc.

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The Phoenix Plaza 21st Floor 2929 North Central Avenue Phoenix, Arizona 85012-2794 P.O. Box 36379 Phoenix, Arizona 85067-6379 Telephone Facsimile 602.640.9000 602.640.9050

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CERTIFICATE OF SERVICE I hereby certify that on August 12th, 2008, I electronically transmitted the attached document to the Clerk' s Office using the CM/ECF System for filing and transmittal of a Notice of Electronic Filing to the CM/ECF registrants. s/Susanne Wedemeyer

-132224158

Case 2:03-cv-00597-MHM

Document 844

Filed 08/12/2008

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