Free Motion for Judgment - District Court of Arizona - Arizona


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O SBORN MALEDON 1
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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 UNDER 35 U.S.C. § 102(B) FOR LACK OF NOVELTY IN VIEW OF THE 1973 MATSUMOTO SURGERY ARTICLE

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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I. INTRODUCTION AND SUMMARY OF ARGUMENT Pursuant to Rules 50(b) 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 under 35 U.S.C. § 102(b) for lack of novelty in view of the 1973 Matsumoto Surgery article (Doc. No. 736). Dr. Goldfarb and the experts for both parties agreed that the Matsumoto prior art describes successful vascular grafts of porous, node and fibril ePTFE with internodal distance, tissue ingrowth, wall thickness and density within claims 20-27 of the Goldfarb patent. This unequivocal and unrebutted evidence is clear and convincing proof that Matsumoto disclosed all elements of the asserted claims. The Court's decision on JMOL did not dispute that Matsumoto disclosed all elements of the claims. (Doc. No. 833 at p. 8). Instead, the Court's decision relied solely on its conclusion that the Matsumoto article was non-enabling. As shown below, there was no proper evidence of non-enablement. Under the proper legal test, "[t]he specification need not explicitly teach those in the art to make and use the

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invention; the requirement is satisfied if, given what they already know, the specification teaches those in the art enough that they can make and use the invention without `undue experimentation.'" Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003) For completeness, Gore hereby incorporates by reference those arguments made in Gore's Motion For JMOL That Claims 20-27 Are Invalid Under 35 U.S.C. § 102(b) For Lack Of Novelty In View Of The 1973 Matsumoto Surgery Article (Doc. No. 736) and Gore's Opposition To Plaintiffs' Motion For Judgment As A Matter Of Law Regarding Gore's Claims Of Invalidity (Doc. No. 750). II. LEGAL STANDARD FOR JUDGMENT AS A MATTER OF LAW "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, -12224267

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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

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conclusions necessarily drawn by the jury in accord with its instructions enroute 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). III. ARGUMENT A. The Trial Record Establishes That the Matsumoto Surgery Article Teaches Every Element of Claims 20-27

A prior art reference does not have to expressly recite patent claim limitations to constitute anticipatory prior art and render patent claims invalid. See, e.g., Structural Rubber Products Co. v. Park Rubber Co., 749 F.2d 707, 716 (Fed. Cir. 1984) ("[T]he teaching in the prior reference need not be ipsissimis verbis..."); Phillips Petroleum Co. v. United States Steel Corp., 673 F. Supp. 1278, 1287 (D. Del. 1987) ("Of course, the prior art need not state the elements of the claim in identical language."). Such claim limitations can be inherent in the prior art disclosure. In re Omeprazole Patent Litig., 483 F.3d 1364, 1372 (Fed. Cir. 2007) ("[A] prior art reference without express reference to a claim limitation may nonetheless anticipate by inherency."). Also, the prior art disclosure of claim limitations can be based on a -22224267

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"drawing, or photograph" rather than text. Baron v. Bausch & Lomb Inc., 25 U.S.P.Q.2d 1641, 1662 (W.D.N.Y. 1992); see also Universal Athletic Sales Co. v. Am. Gym Recreational & Athletic Equip. Corp., 546 F.2d 530, 543 (3d Cir. 1976). What is relevant is only whether each and every claim limitation is disclosed in a single prior art reference. The trial evidence showed agreement between Plaintiffs and Gore that each and every claim limitation is actually disclosed in the Matsumoto Surgery article. Dr. Goldfarb, Gore's expert Dr. Wheeler, and Plaintiffs' expert Dr. Anderson, each agreed that the Matsumoto article discloses the successful use of ePTFE vascular grafts having a node and fibril microstructure. (Anderson 12/04/2007 Trial Tr. 3084:8-18; Goldfarb 11/28/2007 Trial Tr. 2101:15 ­ 2102:1, 2103:2-6; Wheeler 11/28/2007 Trial Tr. 2175:9-19). They also agreed that Matsumoto achieved tissue ingrowth ­ the same tissue ingrowth as in Dr. Goldfarb's work and as required by claims 20-27 of the '135 patent. (Goldfarb 11/28/2007 Trial Tr. 2103:7-24, 2108:14-

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16; Wheeler 11/28/2007 Trial Tr. 2179:1-11, 2175:20 ­ 2176:11; Anderson 12/04/2007 Trial Tr. 3088:21 ­ 3089:5). The evidence is also undisputed that the Matsumoto article depicts an average

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internodal distance of about 50 microns, a value within the ranges of claims 20-27 of the '135 patent. That 50 micron value is determined from Figure 4 of the article, a photomicrograph of a portion of a successful graft. During the interference, Dr. Goldfarb submitted an affidavit by an expert, Dr. Frederick Schoen stating his determination that the photomicrograph in Matsumoto showed that the average internodal distance, i.e., distance between nodes, in the Matsumoto graft was on the order of about 50 microns. (PX 116.3174-3175, ¶ 13) 1. Dr. Goldfarb stated in his trial testimony that "I don't have any reason to doubt" the correctness of Dr. Schoen's
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While Dr. Schoen's affidavit described his study of a photomicrograph from an earlier Japanese language Matsumoto publication, Dr. Goldfarb conceded that Figure 4 of the Matsumoto publication relied upon here is a reproduction of the same photomicrograph that appeared in the earlier Matsumoto publication discussed in the Schoen Declaration. (Goldfarb 11/28/2007 Trial Tr. 2105:19-2106:6). -32224267

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conclusion. (Goldfarb 11/28/2007 Trial Tr. 2106:7-15, 2107:12-14). Gore's expert Dr. Wheeler, a retired vascular surgeon, expressed his own independent determination that a person of ordinary skill in the art at the time would have understood that the vascular prosthesis depicted in Matsumoto's Figure 4, had an average internodal distance of about 50 microns. (Wheeler 11/28/2007 Trial Tr. 2176:17­2177:13). Neither Dr. Anderson nor any other witness for Plaintiffs challenged Dr. Wheeler's testimony and the Schoen affidavit that one skilled in the art could determine the internodal distance from the photomicrograph reproduced in Figure 4 in the Matsumoto article. (Wheeler 11/28/2007 Trial Tr. 2175:9-19; Wheeler 12/05/2007 Trial Tr. 3340:20 ­ 3341:1).

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Since Surgery is a refereed journal, the photomicrographs in the Matsumoto article which appeared in that journal would be understood by a person of ordinary skill in the art to be representative of the entire graft. (Wheeler 11/28/2007 Trial Tr. 2177:15­2178:8; Dolmatch 11/16/2007 Trial Tr. 1625:13-22). Thus, Matsumoto discloses an ePTFE vascular graft having average internodal distances of about 50 microns, which is within the numerical ranges of claims 21-27. 50 microns is also "not less than about 6 microns and small enough to prevent transmural blood flow" as required by claim 20. (Goldfarb 11/28/2007 Trial Tr. 2106:7 ­ 2107:3). Matsumoto also discloses a wall thickness of 0.5 mm, within the 0.2 to 0.8 range of claims 25 and 26. (PX116.2676; Goldfarb 11/28/2007 Trial Tr. 2102:2-23; Wheeler 11/28/2007 Trial Tr. 2174:8-18). Matsumoto further discloses a graft density of about 0.3 grams per milliliter, within the 0.2 to 0.5 range of claim 26. (Wheeler 11/28/2007 Trial Tr. 2174:19 ­ 2175:8). The following summary chart shows that the Matsumoto product as described in the article's text and in Figure 4 describes at least one product which meets each and every requirement of each of the Goldfarb patent claims 20-27. The "N/A" in the chart means the listed element is not in the particular claim.

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ELEMENTS OF '135 PATENT CLAIMS 20-27
ePTFE Graft/ Prosthesis Graft Permits Tissue Ingrowt h Yes Graft Wall Thickness (mm) Graft Density (g/ml) ePTFE Nodes and Fibrils Average Distance Between Nodes (microns)

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Claims

ePTFE Porous

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Claim 20

Yes

N/A

N/A

Yes

Yes

Not less than about 6, prevents transmural blood flow About 6- 200 prevents transmural blood flow About 6-150 prevents transmural blood flow About 6-150/200 prevents transmural blood flow About 6-80 prevents transmural blood flow About 6-80 About 6-80 About 6-80 About 50, which is within all numeric ranges and not less than 6 and prevents transmural blood flow

Claim 21

Yes

Yes

N/A

N/A

Yes

Yes

Claim 22

Yes

Yes

N/A

N/A

Yes

Yes

Claim 23

Yes

Yes

N/A

N/A

Yes

Yes

Claim 24

Yes

Yes

N/A

N/A

Yes

Yes

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Claim 25 Yes Yes Yes Yes N/A N/A Yes Yes 0.2-0.8 0.2-0.8 N/A 0.5 N/A 0.2-0.5 N/A 0.3 N/A N/A Yes Yes Yes Yes Yes Yes

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Claim 26 Claim 27
MATSUMOTO REFERENCE DISCLOSES

As a matter of law, the prior art disclosure of even a single product within the scope of a patent claim renders that claim invalid for anticipation under 35 U.S.C. § 102(b). Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985); Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1346 (Fed. Cir. 1999); Abbott

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Labs. v. Baxter Pharmaceutical Products, Inc., 471 F.3d 1363, 1367-1369 (Fed. Cir. 2006). 2 B. The Evidence of What Matsumoto Describes is Clear and Convincing

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As we have shown above, it was undisputed at trial that the Matsumoto article described a product that met each element of each of claims 20-27. Indeed, the testimony by Dr. Goldfarb and by Gore's expert, Dr. Wheeler, was fully in accord on this point. There can be no better example of evidence that is "clear and convincing." There was no evidence from which a reasonable jury could have determined that the Matsumoto article described a product that was not within the scope of each of the claims. C. Dr. Goldfarb's Effort to Distinguish the Matsumoto Article as not Characterizing Ranges is not Availing

When asked to describe his inventive contribution over the Matsumoto article, Dr. Goldfarb testified as follows: "Q. What contribution do you consider you made ... over what is described in the Matsumoto article? A. [By Dr. Goldfarb] The recognition of internodal distance as a primary determinant for patency of the grafts characterizing the specification. Q. A. You mean characterizing ranges? The ranges, yes."

(Goldfarb 11/28/2007 Trial Tr. 2107:4-11). As a matter of law, Dr. Goldfarb's attempt to salvage his invention from being deemed anticipated by the Matsumoto article is unavailing. See Titanium Metals, 778 F.2d at 782 ("It is also an elementary principle of patent law that when, as by a
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More detailed charts describing the comparison on a claim by claim, element by element basis are contained in Gore's earlier Rule 50(a) motion on anticipation (Doc. No. 736 at pp. 6-13), which are incorporated herein by reference. -62224267

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recitation of ranges or otherwise, a claim covers several compositions, the claim is `anticipated' if one of them is in the prior art."). In Abbott Labs., 471 F.3d at 1367, the Federal Circuit explained, reaffirming Titanium, that "[o]ur cases have consistently held that a reference may anticipate even when the relevant properties of the thing disclosed were not appreciated at the time." In the same case, the Federal Circuit discussed its holding in Atlas Powder, noting that the claims there covered air mixed into an explosive composition, and that those claims were anticipated by prior art that necessarily also contained air, "even though benefits of the air were not recognized" in the prior art. Id. at 1368. Here, the claims encompass the prior art Matsumoto article's product. Whether Matsumoto understood the specific range needed for useful products is wholly irrelevant to the law of anticipation. One prior art disclosed product falling within a claim renders that claim invalid for anticipation. Titanium Metals, supra. D. The Court's Initial Rule 50(a) Determination Re Non-Enablement is Unsupported by the Record 1. No Need for Contemporaneous Appreciation

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In its decision on Gore's Rule 50(b) motion on anticipation, the Court said "[t]he evidence establishes that the 1973 Matsumoto article was not enabling, as neither Gore nor any of the other doctors with whom Gore was working, could determine the structure disclosed in the Matsumoto article or replicate Matsumoto's results." (Doc. No. 833 at p. 8). As a matter of law, there is no requirement for contemporaneous recognition of the structure inherently disclosed in a prior art reference. See, e.g. Abbott Labs., 471 F.3d at 1368 (quoting with approval from an earlier decision "Inherent anticipation does not require that a person of ordinary skill in the art at the time would have recognized the inherent disclosure.").

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Here, the testimony is undisputed that the Matsumoto reference describes all of the elements of all of the asserted claims. Whether that was actually appreciated at the time by Gore or particular doctors is therefore legally irrelevant 2. The Issue of Alleged Failure to Replicate Matsumoto's Results

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The Court appears to have based its findings of inability to replicate Matsumoto's results upon the testimony of Mr. Detton. Mr. Detton was trained in psychology, and not qualified in medicine or surgery (Detton 11/27/2007 Trial Tr. 1926:11-12) and thus was not a person skilled in the art at the time. Dr. Wheeler and Dr. Anderson both agreed that a person of ordinary skill in the art at the time was a vascular surgeon, i.e. a surgeon with experience in vascular matters. (Anderson 12/04/2007 Trial Tr. 3078:7-18; Wheeler 11/29/2007 Trial Tr. 2138:14-16). In considering the enablement issue, the test is what would have been understood by the hypothetical person of ordinary skill in the art at the time. In re Omeprazole Patent Litig., 483 F.3d 1364, 1379 (Fed. Cir. 2007). In its Order, the Court also relied on Mr. Detton for his personal view of what

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he could figure out from Matsumoto (Doc. No. 833 at p. 8). This testimony is also legally irrelevant because Mr. Detton was not qualified as an expert to give an opinion as to how one of ordinary skill in the art would understand the Matsumoto reference. Moreover, there was confusion as to which Matsumoto article Mr. Detton was referring to. Mr. Detton explained that there were three different Matsumoto articles. The first one had no pictures, no scales, and was in Japanese (Detton 11/27/08 Trial Tr. 1959:20-24). It is clear in context that when Mr. Detton testified that "because the article itself did not define anything" (Detton 11/27/08 Trial Tr. 1960:15-16), he was referring to this first Japanese version. Mr. Detton then explains that while he personally had problems with the third Matsumoto article (i.e., the one at issue in this case), by the time it became available Gore was defining what it needed, which was more important than what Matsumoto had obtained. Mr. Detton said that if Gore had -82224267

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known earlier what Matsumoto had used, it would probably have shortened the development process. (Detton 11/27/08 Trial Tr. 1960:15 ­ 1961:3). There is no evidence that Mr. Detton had or could testify about the level of skill in the art or that he was capable of evaluating Figure 4 of the Matsumoto article at issue here. He was not qualified as an expert and offered no opinion as to how the Matsumoto Surgery article would be understood by one skilled in the art. The Detton testimony cannot support a finding that the 1973 Matsumoto Surgery article was not enabled. 3. No Evidence of Inability to Follow Matsumoto's Teachings

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There is no evidence in the record that anyone tried to replicate the express teachings of the Matsumoto article. Accordingly, it is respectfully noted that there is no support for that aspect of the non-enablement determination by the Court in Doc. 833, page 8. And as already discussed above, the contemporaneous failure to appreciate the Matsumoto structure, particularly the significance of the Figure 4 inherent disclosure of internodal distance, is irrelevant to the anticipation argument. Dr. Anderson's testimony on the non-enablement issue was based on his personal views at some unspecified time. But Dr. Anderson conceded that he was not a person skilled in the art (Anderson 12/04/2007 Trial Tr. 3078:7-14). And he was not asked for an opinion about the ability of persons skilled in the art as of 1973-74 to utilize the Matsumoto disclosure, just his own ability 3

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Dr. Anderson was asked "Does that teach you what you need to know in order to make a working vascular graft with ePTFE?" (Anderson 12/04/2007 Trial Tr. 3064:910). Neither that question nor the questions preceding it create a foundation for seeking the knowledge of a person of ordinary skill in the art as of the filing date of the Goldfarb application. To the contrary, the prior questions confirm that Dr. Anderson was testifying to his present views as a pathologist because he was focused on his "25 or 30 years of experience" (which started in 1978). He was asked to use "just the Matsumoto article" in his opinions, and was never asked to consider it in light of the knowledge a person of ordinary skill in the art would have had as of the 1973-74 period. (Anderson 12/04/2007 Trial Tr. 3063:15 ­ 3064:11) Dr. Anderson had not yet completed medical school at the time the Matsumoto article was published -92224267

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All that Plaintiffs offered was Dr. Anderson's testimony first that he personally did not know how to make a working graft from Matsumoto (Anderson 12/04/2007 Trial Tr. 3063:21 ­ 3064:3) and second, that he would personally need to do a lot of experimentation to reproduce a graft from Matsumoto. (Anderson 12/04/2007 Trial Tr. 3066:13-18). But Dr. Anderson testified he had no opinion about the structure shown in Matsumoto's Figure 4. (Anderson 12/04/2007 Trial Tr. 3086:10 ­ 3087:21). Of course, Figure 4 is the key to the Matsumoto structure relied on by Dr. Goldfarb's expert Dr. Schoen and by Gore's expert, Dr. Wheeler. Dr. Anderson's failure to take Figure 4 into account renders his testimony useless on the issue of enablement. Additionally, the need for experimentation by one skilled in the art does not disprove enablement. The test for enablement is whether one skilled in the art can make a graft as shown and described in these references without undue experimentation. Minn. Mining & Mfg. Co. v. Chemque Inc., 303 F.3d 1294, 1306 (Fed. Cir. 2002). "The test is not merely quantitative, since a considerable amount of

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experimentation is permissible . . . if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed." In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (citation omitted). There is no requirement that the reference itself detail how to make the grafts. See AK Steel Corp. v. Sollac, 344 F.3d 1234,1244 (Fed. Cir. 2003) (explaining that enablement does not require "describ[ing] how to make and use every possible variant of the claimed invention, for the artisan's knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability of the art.").4

and at the time Dr. Goldfarb filed his patent application. (Anderson 11/09/2007 Trial Tr. 1019:6-1020:25). 4 Within the purview of a person of ordinary skill in the art in 1973-74 are such prior art references as Gore's U.S. Patent 3,953,566 (DX3357) and Japanese Patent No. 13,560/67, (PX115.57, PX115.149-170) both describing the manufacture of porous ePTFE products. The Japanese Published application was actually cited in the `135 -102224267

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Moreover, Dr. Goldfarb told the PTO in 1984 that the reasons that Matsumoto's 100% success rate was not replicated by others were due to animal and surgeon factors ­ not an inability to reproduce grafts with the same ePTFE structure as disclosed: "As anyone skilled in the medical arts well knows, the physiological art is a highly unpredictable one involving many variables. One of these variables is the ability to accept any foreign object. Some animals reject such objects, regardless of whether there is tissue ingrowth and regardless of how compatible they are. This concept of rejection of organisms has been widely described in the literature and in the media recently with regard to heart and kidney transplants. The same concepts are involved in the rejection of vascular grafts. Some animals just will not accept a foreign object. In addition, there is always the possibility of surgeon error, or of the unsuitability of the animal to accept grafts because of other physical defects. Despite the claims by Matsumoto of 100% success, few researchers ever achieve that level because of the foregoing factors." (PX 116 at PX116.3969-3970). IV. CONCLUSION The evidence of record as to what the disclosure of the Matsumoto article described to a person of ordinary skill in this art in 1973-74 is undisputed. The

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Matsumoto reference disclosed a vascular graft meeting all of the elements contained in each of the asserted patent claims. There has been no probative evidence that a person of ordinary skill in the art could not make a product described in the Matsumoto article, particularly as aided by the photomicrograph in Figure 4 of that article.

patent. See `135 patent at Col. 4, lines 50-52 (PX 1). A person of ordinary skill in the art would be knowledgeable of these references in considering the Matsumoto article. (Wheeler 11/28/2007 Trial Tr. 2174:19-2175:5). -112224267

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O SBORN MALEDON 1
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Plaintiffs provided no evidence to establish what one skilled in the art would find missing from Matsumoto that renders it non-enabled. Instead they rely on conclusory opinions of witnesses not skilled in the art. Such testimony is legally insufficient to establish how the reference would be understood by a person skilled in the art at the appropriate time. Mr. Detton was not a physician or surgeon. Dr. Anderson testified both that he was not a person skilled in the art by his own definition and that he had no opinion as to what Figure 4 taught to a person of ordinary skill in this art. The evidence of record by both Dr. Wheeler and by Goldfarb's expert Dr. Schoen explained that Figure 4 taught an internodal distance of 50 microns. Dr. Schoen's evidence was conceded by Goldfarb to be a reasonable

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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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approach. There was no contradictory testimony. The use of Dr. Anderson's testimony or Mr. Detton's testimony as establishing alleged non-enablement of the Matsumoto reference is legally unjustified. Gore has established by clear and convincing, and indeed undisputed evidence,

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that the Matsumoto article describes a product which meets every element of clams 20-27. As a matter of law, that establishes that the patent claims 20-27 are invalid for anticipation. The jury verdict to the contrary is completely unsupported by any probative evidence. As a result, relief under Rule 50(b) is proper and is respectfully requested. For all the reasons stated herein and contained in the incorporated filings, Gore respectfully requests that the Court grant judgment as a matter of law that claims 2027 are invalid under 35 U.S.C. § 102(b) in view of the 1973 Matsumoto Surgery article.

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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 12th of August, 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

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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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