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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
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`Petitioner,
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`v.
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`TELEFLEX LIFE SCIENCES LIMITED,
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`Patent Owner.
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`PETITIONER’S OPENING BRIEF ON COLLATERAL ESTOPPEL
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`Case IPR2020-01341
`U.S. Patent No. 8,142,413
`
`Case IPR2020-01342
`U.S. Patent No. 8,142,413
`
`Case IPR2020-01343
`U.S. Patent No. RE 46,116
`
`Case IPR2020-01344
`U.S. Patent No. RE 46,116
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`TABLE OF CONTENTS
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`I.
`II.
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`Page
`INTRODUCTION ........................................................................................... 1
`COLLATERAL ESTOPPEL DOES NOT APPLY. ....................................... 2
`A. None of the issues that Medtronic appealed in the first set of
`IPRs are final for purposes of collateral estoppel. ................................ 3
`These proceedings address new, different issues that the Board
`has not yet considered. .......................................................................... 4
`1.
`The Board has not considered whether Patent Owner can
`show that VSI performed the methods as claimed or
`tested their intended purpose. ..................................................... 5
`The Board’s prior decisions did not answer
`unpatentability questions that are unique to these IPRs. ............ 7
`III. CONCLUSION ................................................................................................ 8
`
`
`
`B.
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`2.
`
`i
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`
`
`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Bettcher Indus., Inc. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) .............................................................................. 3
`Canfield Sci., Inc. v. Drugge,
`No. 16-cv-04636, 2020 WL 6375654 (D.N.J. Oct. 30, 2020) .............................. 3
`Comair Rotron, Inc. v. Nippon Densan Corp.,
`49 F.3d 1535 (Fed. Cir. 1995) .............................................................................. 4
`Hologic, Inc. v. Minerva Surgical, Inc.,
`325 F. Supp. 3d 507, 519 (D. Del. 2018), vacated on other grounds
`sub nom. Minerva Surgical, Inc. v. Hologic, Inc., 141 S. Ct. 2298
`(2021) .................................................................................................................... 3
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) ............................................................................ 5
`SynQor, Inc. v. Vicor Corp.,
`988 F.3d 1341 (Fed. Cir. 2021) ............................................................................ 2
`Trustid, Inc. v. Next Caller Inc.,
`C.A. No. 18-172 (MN), 2021 WL 3015280 (D. Del. July 6, 2021) ..................... 3
`Statutes
`35 U.S.C. § 318 .......................................................................................................... 3
`
`
`ii
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`
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`I.
`
`INTRODUCTION
`In June 2021, the Board issued eleven final written decisions examining five
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`challenged patents directed to guide extension catheters and methods for
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`manufacturing the same. IPR2020-00126 to -00130, IPR2020-00132, IPR2020-
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`00134 to -00138 (the “previously decided IPRs” or “first set of IPRs”). In
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`September 2021, Medtronic appealed those decisions. Because collateral estoppel
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`does not apply to non-final decisions, there is no collateral estoppel.
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`Even if the decisions were final, collateral estoppel would not apply. The
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`issues in the present IPRs are not identical and were not actually litigated in the
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`earlier IPRs. The present claims are method-of-use claims with different claim
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`elements. The ’413 patent also presents a new claim construction dispute regarding
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`the order of steps and the meaning of “alongside.” The Board also based its
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`decision, in part, on the notion that certain reply arguments were not included in
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`the earlier petitions. That is not the case in the present petitions.
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`Focusing specifically on the Board’s question regarding conception and
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`reduction practice and whether Itou is prior art, collateral estoppel does not apply.
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`Obviously Patent Owner has the burden of showing reduction to practice of all of
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`the elements of the method claims at issue. This includes a different legal test,
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`namely, whether the inventors actually performed the methods as claimed. Under
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`this test, Patent Owner cannot demonstrate all of the claim elements, which require
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`1
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`
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`in vivo testing. Separately, Patent Owner cannot show that the method worked for
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`its intended purpose of providing increased back up support because there is no
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`comparative testing. These are new issues that the Board did not address last time.
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`The Board cannot—and should not—apply collateral estoppel.
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`II. COLLATERAL ESTOPPEL DOES NOT APPLY.
`For two independent reasons, collateral estoppel does not apply. In
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`particular, collateral estoppel is inapplicable because (i) the first set of IPRs are not
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`final, and (ii) the issues to be decided in these IPRs are different than the issues
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`previously addressed in the first set of IPRs.
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`IPR decisions can, when final, give rise to collateral estoppel (i.e., issue
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`preclusion). IPR determinations have a preclusive effect when “(1) the issue is
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`identical to one decided in the first action; (2) the issue was actually litigated in the
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`first action; (3) resolution of the issue was essential to a final judgment in the first
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`action; and (4) [the party] had a full and fair opportunity to litigate the issue in the
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`first action.” SynQor, Inc. v. Vicor Corp., 988 F.3d 1341, 1353 (Fed. Cir. 2021).
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`Here, collateral estoppel does not apply because Medtronic appealed the
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`final written decisions, including the Board’s determinations regarding conception
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`and reduction to practice and whether another prior art reference, Kontos, rendered
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`certain claims invalid as obvious. In other words, the previous IPRs are not final
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`decisions for purposes of collateral estoppel. Separately, the issues here, including
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`2
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`
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`conception and reduction to practice of the challenged method-of-use claims and
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`whether those claims are unpatentable under Itou and Kontos, are not identical to
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`the issues decided in the first set of IPRs. Thus, collateral estoppel does not attach.
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`A. None of the issues that Medtronic appealed in the first set of IPRs
`are final for purposes of collateral estoppel.
`The Board’s final written decisions in the first set of IPRs are not final, and
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`therefore collateral estoppel does not apply or preclude the Board’s consideration
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`of any issues in these proceedings. An IPR determination is not final until “the
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`time for appeal has expired or any appeal has terminated.” 35 U.S.C. § 318. Thus,
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`the Board’s final written decisions “do[] not have preclusive effect until that
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`decision is either affirmed or the parties waive their appeal rights.” Trustid, Inc. v.
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`Next Caller Inc., C.A. No. 18-172 (MN), 2021 WL 3015280, at *3 (D. Del. July 6,
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`2021) (collecting cases); see Canfield Sci., Inc. v. Drugge, No. 16-cv-04636, 2020
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`WL 6375654, at *2 (D.N.J. Oct. 30, 2020) (citing XY, LLC v. Trans Ova Genetics,
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`890 F.3d 1282, 1294 (Fed. Cir. 2018) (“[A]ffirmance of an invalidity finding . . .
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`has a collateral estoppel effect . . . .”)); Hologic, Inc. v. Minerva Surgical, Inc., 325
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`F. Supp. 3d 507, 519 (D. Del. 2018), vacated on other grounds sub nom. Minerva
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`Surgical, Inc. v. Hologic, Inc., 141 S. Ct. 2298 (2021) (“The PTAB finding is on
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`appeal and does not have preclusive effect as to this action unless and until the
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`appeal is resolved.”); cf. Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629,
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`644 (Fed. Cir. 2011) (in analogous IPR estoppel context, “estoppel requires
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`3
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`
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`exhaustion of all appeal rights”).
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`
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`Medtronic appealed each of the previously decided IPRs. Unless and until
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`the Federal Circuit affirms those appeals, the Board’s final written decisions are
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`not operative, final judgments for purposes of collateral estoppel. For this reason,
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`no preclusive effect attaches—the resolution of the present IPR proceedings is not
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`bound by the former.
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`B.
`
`These proceedings address new, different issues that the Board
`has not yet considered.
`For a separate and independent reason, the Board’s final written decisions in
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`the first set of IPRs do not have preclusive effect. In particular, collateral estoppel
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`does not attach because these proceedings challenge new patents reciting unique
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`claims. It is axiomatic that “separate patents describe ‘separate and distinct
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`inventions,’ and it can not be presumed that related patents rise and fall together.”
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`Comair Rotron, Inc. v. Nippon Densan Corp., 49 F.3d 1535, 1539 (Fed. Cir. 1995)
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`(quoting 35 U.S.C. § 121). For that reason alone, the issues are not identical.
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`Collateral estoppel does not attach.
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`More to the point, at issue for the first time are method-of-use claims (e.g.,
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`methods of using the claimed guide extension catheter). Patent Owner claims
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`performance of particular steps in the anatomy, rather than only a guide extension
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`catheter (or methods of making the same). The challenged method-of-use claims
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`create unique issues for the Board’s resolution: (i) the reduction to practice inquiry
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`4
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`
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`and required showing is different for the challenged method-of-use claims, and (ii)
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`whether the prior art, including Itou and/or Kontos, teaches claim limitations—
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`including “alongside,” “coaxial,” and “stent”—that were not addressed in the prior
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`final written decisions.
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`1.
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`The Board has not considered whether Patent Owner can
`show that VSI performed the methods as claimed or tested
`their intended purpose.
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`The Board’s resolution of conception and reduction to practice issues in the
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`first set of IPRs does not resolve those issues here, when unique method-of-use
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`claims require more from Patent Owner, legally and factually. In the first set of
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`IPRs, the Board considered whether Patent Owner adduced evidence sufficient to
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`show that VSI assembled prototypes embodying the challenged apparatus claims
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`and tested those devices to confirm that they would work. But here, though Patent
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`Owner created essentially the same factual record, reduction to practice requires
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`more this time. To reduce the challenged method-of-use claims to practice, Patent
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`Owner must prove that VSI performed the methods as claimed and, separately,
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`determined that the methods would work for their intended purpose.
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`First, new this time, reduction to practice requires “performance of a process
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`that met all the limitations of the [claimed method].” Medichem, S.A. v. Rolabo,
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`S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). Unlike last time, the first prong of the
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`reduction-to-practice test requires more than prototype assembly—it requires
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`5
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`
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`prototype assembly and the limitation-by-limitation performance of the claimed
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`method of using that prototype.
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`Second, also new this time, the claims require using the claimed guide
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`extension catheter in vivo. The ’413 patent requires insertion into a “first artery,”
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`positioning “in a branch artery,” advancement “into the second artery,” and further
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`insertion “into contact with or past a lesion in the second artery.” ’413 patent claim
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`1. The ’116 patent requires advancing a guide catheter “through a main blood
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`vessel to an ostium of a coronary artery” and advancing a balloon catheter or stent
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`“into the coronary artery.” ’116 patent claims 25, 52. Because the Board’s prior
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`decisions do not address actual, in vivo testing, they do not address the same issue
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`as these proceedings.
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`Third, the challenged methods-of-use claims are intended to provide
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`increased backup support (a familiar concept), but that intended purpose required
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`using the claimed guide extension catheter and confirming increased backup
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`support using comparative testing with a standard guide catheter. The inventions
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`are methods of using a guide extension catheter that increases backup support, thus
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`there must be a comparison supporting such an increase. The Board’s prior
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`decisions provide no basis for such a comparison. Further, Patent Owner provides
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`no evidence of any testing or use of the rapid exchange catheter prototypes,
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`according to the claims of the ’413 and ’116 patents, in support of that intended
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`6
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`purpose. Because the Board did not decide, and the Patent Owner did not provide
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`evidence of, testing and use of rapid exchange prototypes to demonstrate increased
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`backup support, collateral estoppel does not preclude the Board’s consideration of
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`those issues here.
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`The issue is whether Patent Owner provided sufficient evidence of reduction
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`to practice of each claimed method-of-use. They did not, and the Board’s previous
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`decisions cannot provide an estoppel basis to provide otherwise.
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`2.
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`The Board’s prior decisions did not answer unpatentability
`questions that are unique to these IPRs.
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`Because the method claims of the ’413 and ʼ116 patents present different
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`questions of patentability than those decided in the previous IPRs, the Board’s
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`prior decisions are not issue preclusive. Obviously the Board did not reach the
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`merits of the application of Itou as prior art, and Medtronic seeks that application
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`here. For Kontos grounds, these IPRs present unique issues substantively and
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`procedurally which preclude collateral estoppel.
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`For example, according to Patent Owner, the IPRs challenging the ʼ413
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`patent present a new question of claim construction concerning the claim limitation
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`“alongside.” Additionally, in the IPRs challenging the ʼ116 patent, the Board must
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`address the claim construction of “coaxial” and whether Itou/Kontos alone (or in
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`combination with other prior art) are sized to receive a stent.
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`7
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`The Kontos grounds at issue here were also not fully and fairly litigated in
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`the prior IPRs. The Board based its decisions, in part, on Patent Owner’s
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`arguments that Medtronic raised new arguments on reply. See, e.g. IPR2020-
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`00127, Final Written Decision (Paper 105) at 46 (noting that the Petitions did not
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`discuss recessing marker bands). This issue, and the others raised again by Patent
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`Owner, were explicitly in the present Petitions. Thus, again, collateral estoppel
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`does not apply. The Board should reweigh the evidence on the full record present
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`in these IPRs.
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`III. CONCLUSION
`Collateral estoppel only attaches to previously rendered, final judgments that
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`determined issues identical to those raised in ongoing proceedings. The Board’s
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`prior written decisions in IPR2020-00126 to -00130, IPR2020-00132, and
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`IPR2020-00134 to -00138 are not final because Medtronic appealed them. And
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`they are not preclusive because they do not address issues of method patent claim
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`invention dates, applicable prior art, and validity. Collateral estoppel simply does
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`not apply.
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`
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`Dated: November 12, 2021
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`
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`Respectfully submitted,
`
`/Cyrus A. Morton/
`Cyrus A. Morton
`Reg. No. 44,954
`
`
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`
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`8
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`
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`Robins Kaplan LLP
`2800 LaSalle Plaza
`800 LaSalle Avenue
`Minneapolis, MN 55402
`Attorney for Petitioner
`
`
`
`
`
`9
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`
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e)(4), the undersigned certifies that on November
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`12, 2021, a copy of PETITIONER’S OPENING BRIEF ON COLLATERAL
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`ESTOPPEL was served by electronic mail on Patent Owner’s counsel at the
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`following addresses indicated in Patent Owner’s Mandatory Notices:
`
`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
`
`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
`
`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
`
`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
`
`Alexander S. Rinn
`arinn@carlsoncaspers.com
`
`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
`
`Shelleaha L. Jonas
`sjonas@carlsoncaspers.com
`
`Tara C. Norgard
`tnorgard@carlsoncaspers.com
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`
`
`
`/Cyrus A. Morton/
`Cyrus A. Morton
`Registration No. 44,954
`Attorney for Petitioner
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`
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`10
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`Dated: November 12, 2021
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`Respectfully submitted,
`
`
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