`Patent 8,142,413
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`
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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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`
`
`
`Case IPR2020-01341
`U.S. Patent No. 8,142,413
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`PETITIONER’S REPLY
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`IPR2020-01341
`Patent 8,142,413
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`TABLE OF CONTENTS
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`III.
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`
`INTRODUCTION ............................................................................................ 1
`I.
`II. CLAIM CONSTRUCTION ............................................................................. 2
`A.
`“Interventional Cardiology Device(s)” ................................................. 2
`B.
`Claim-Step Order .................................................................................. 4
`ITOU IS PRIOR ART. ..................................................................................... 7
`A.
`Teleflex must prove prior invention. ..................................................... 7
`B.
`Teleflex failed to prove reduction to practice before Itou. ................... 8
`1.
`Teleflex failed to show that VSI assembled prototypes. ........... 9
`2.
`Teleflex failed to show that VSI performed the claimed
`methods. ................................................................................... 12
`Teleflex failed to show that VSI determined that its
`inventions would work for their intended purpose. ................. 16
`Teleflex has not shown diligence. ....................................................... 21
`Evidence shows that VSI did not actually or constructively
`reduce to practice before Itou. ............................................................. 24
`IV. GROUND 1: ITOU ANTICIPATES. ............................................................ 26
`A.
`Catheter 5 is an interventional cardiology device. .............................. 26
`B.
`Catheter 5 is inserted through the guide catheter “alongside of
`the substantially rigid portion” of the coaxial guide catheter. ............ 27
`Itou discloses challenged claims depending from claim 1. ................. 28
`C.
`V. GROUNDS 2, 3: ITOU RENDERS OBVIOUS. ........................................... 30
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`3.
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`C.
`D.
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`IPR2020-01341
`Patent 8,142,413
`A. A POSITA had the motivation to advance interventional
`cardiology devices other than catheter 5 through Itou’s catheter
`2 after catheter 2 was positioned in the coronary artery. .................... 31
`B. A POSITA had a reasonable expectation of success because
`catheter 2 is inherently capable of receiving interventional
`cardiology devices other than catheter 5 when it is positioned
`within a guide catheter. ....................................................................... 33
`VI. SECONDARY CONSIDERATIONS DO NOT OVERCOME
`OBVIOUSNESS. ............................................................................................ 36
`A.
`There is no nexus where Itou and Ressemann disclose every
`element of claims 4, 9, and 14. ............................................................ 36
`Teleflex’s secondary considerations evidence does not establish
`copying. ............................................................................................... 38
`1.
`Teleflex’s alleged evidence of copying is actually
`copying of the prior art. ........................................................... 38
`2. Medtronic did not copy GuideLiner. ....................................... 39
`VII. CONCLUSION .............................................................................................. 40
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`
`B.
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`ii
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`IPR2020-01341
`Patent 8,142,413
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Accent Packaging, Inc. v. Leggett & Platt, Inc.,
`707 F.3d 1318 (Fed. Cir. 2013) ............................................................................. 4
`Altiris, Inc. v. Symantec Corp.,
`318 F.3d 1363 (Fed. Cir. 2003) ............................................................................. 5
`Arctic Cat v. GEP Power Prods.,
`919 F.3d 1320 (Fed. Cir. 2019) ...........................................................................24
`ATI Techs. ULC v. Iancu,
`920 F.3d 1362 (Fed. Cir. 2019) .......................................................................7, 21
`Bos. Sci. Corp. v. Johnson & Johnson,
`481 F. Supp. 2d 1018 (N.D. Cal. 2007) ...............................................................17
`Curtiss-Wright Flow Corp. v. Velan, Inc.,
`438 F.3d 1374 (Fed. Cir. 2006) ............................................................................. 3
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ............................................................................. 8
`Gen. Access Sols., Ltd. v. Sprint Spectrum L.P.,
`811 F. App’x 654 (Fed. Cir. 2020) ........................................................................ 8
`Hill-Rom Servs. v. Stryker Corp.,
`755 F.3d 1367 (Fed. Cir. 2014) ............................................................................. 3
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .................................................................... 36, 38
`In re Meyer Mfg. Corp.,
`411 F. App’x 316 (Fed. Cir. 2010) ......................................................................23
`In re Steed,
`802 F.3d 1311 (Fed. Cir. 2015) ............................................................ 7, 8, 12, 14
`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) .............................................................................16
`
`
`
`iii
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`Patent 8,142,413
`Interactive Gift Express, Inc. v. Compuserve, Inc.,
`256 F.3d 1323 (Fed. Cir. 2001) ............................................................................. 5
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .................................................................... 38, 39
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................................31
`Lacks Indus., Inc. v. McKechnie Vehicle Components USA, Inc.,
`322 F.3d 1335 (Fed. Cir. 2003) ...........................................................................15
`Lucent Techs., Inc. v. Gateway, Inc.,
`No. 02-cv-2060-B(CAB), 2007 WL 2070346 (S.D. Cal. July 12, 2007) ............12
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996)....................................................................... 15, 17
`Mantech Environmental Corp. v. Hudson Environmental Servs., Inc.,
`152 F.3d 1368 (Fed. Cir. 1998) ............................................................................. 5
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) .......................................................................8, 15
`Mformation Tech. v. Research in Motion Ltd.,
`764 F.3d 1392 (Fed. Cir. 2014) ............................................................................. 5
`Ormco Corp. v. Align Tech.,
`463 F.3d 1299 (Fed. Cir. 2006) ...........................................................................36
`Perfect Surgical Techniques, Inc. v. Olympus Am., Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) ...........................................................................21
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994)....................................................................... 13, 20
`Slip Track Sys., Inc. v. Metal-Lite, Inc.,
`304 F.3d 1256 (Fed. Cir. 2002) ...........................................................................20
`Synqor, Inc. v. Artesyn Techs., Inc.,
`No. 2:07-CV-497-TJW-CE, 2010 WL 2991037 (E.D. Tex. July 26, 2010) ......... 3
`
`
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`iv
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`Patent 8,142,413
`Taskett v. Dentlinger,
`344 F.3d 1337 (Fed. Cir. 2003) ...........................................................................13
`TC Tech. LLC v. Sprint Corp.,
`379 F. Supp. 3d 305 (D. Del. 2019) .....................................................................13
`Toshiba Memory Corp. v. Anza Tech., Inc.,
`IPR2018-01597, 2020 WL 1229855 (PTAB Mar. 12, 2020) ..............................24
`Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc.,
`774 F.3d 968 (Fed. Cir. 2014)..............................................................................32
`Valencell, Inc. v. Fitbit, Inc.,
`784 F. App’x 1005 (Fed. Cir. 2019) ...................................................................... 9
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) ...........................................................................37
`Statutes
`37 C.F.R. § 42.6(a)(3) ..............................................................................................21
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`v
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`IPR2020-01341
`Patent 8,142,413
`INTRODUCTION
`I.
`To try to avoid Itou, Teleflex asks the Board to rewrite its claims. It asks the
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`Board to limit “interventional cardiology device(s)” (“IVCD”) to treatment
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`devices. The Board need not change the construction adopted at institution.
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`Teleflex also asks the Board to mandate that the claims recite sequentially
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`performed steps, even though the plain claim language does not require it. The
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`dispute relates to whether an IVCD and an extension catheter may be
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`preassembled, before the two are advanced—together—into a guide catheter. They
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`may, and under the correct constructions, Itou anticipates the claims challenged in
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`Ground 1.
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`All challenged claims are obvious in view of Ressemann, which explicitly
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`teaches sequentially performed steps, plus delivery of a balloon-expandable stent
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`(which Teleflex agrees is an IVCD). To attempt to refute obviousness, Teleflex
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`argues that a POSITA would never look to the teachings of one coronary catheter
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`designed to remove unwanted material from the coronary vasculature to inform use
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`of a second catheter having the same purpose. Thus, Teleflex overlooks that Itou
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`and Ressemann are analogous and applies an inappropriately rigid obviousness
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`framework.
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`1
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`IPR2020-01341
`Patent 8,142,413
`II. CLAIM CONSTRUCTION
`“Interventional Cardiology Device(s)”
`A.
`At institution, the Board construed “interventional cardiology devices” to
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`refer “to at least two types of the devices selected from the group that includes, but
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`is not limited to, guidewires, balloon catheters, stents, and stent catheters.”
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`Institution Decision (I.D.), Paper 11, 16. The Board need not change its
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`construction. Teleflex’s proposal—reading more than 30 additional words into the
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`claim term—should be rejected.1 Teleflex asks that IVCDs be limited to the
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`enumerated devices and “any other device delivered beyond the end of the device
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`for use with a standard guide catheter to a location in the vasculature requiring
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`treatment, to provide treatment to that location.” Patent Owner Response (POR),
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`Paper 23, 14. Teleflex’s narrowing is unwarranted.
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`1 To the extent that Teleflex argues that the claimed coaxial guide catheter must be
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`large enough to receive stents (POR, 45, 49), Medtronic’s arguments still apply.
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`Had Teleflex intended to claim a stent, it knew how to do so. Ex-1845, 14:18
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`(reciting “balloon catheter or stent”); Patent Owner’s Contingent Motion to Amend
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`(MTA), Paper 26, App’x A (substitute claim 15 reciting “a treatment catheter that
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`includes a stent”).
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`2
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`Patent 8,142,413
`When Teleflex wanted to claim a “treatment” device instead of an IVCD, it
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`did. Ex-1845, 16:3 (reciting “treatment catheter”); MTA, App’x A (substitute
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`claim 15 reciting “a treatment catheter that includes a stent”); Curtiss-Wright Flow
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`Corp. v. Velan, Inc., 438 F.3d 1374, 1381 (Fed. Cir. 2006) (“[C]laim
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`differentiation takes on relevance in the context of a claim construction that would
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`render additional, or different, language in another independent claim
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`superfluous.”). Thus, “interventional cardiology device” is presumed to have a
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`different meaning than “treatment catheter.”
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`Similarly, the specification does not use “treatment device” synonymously
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`with “interventional cardiology device.” Using different terms in the specification
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`presumptively conveys different meanings. Synqor, Inc. v. Artesyn Techs., Inc.,
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`No. 2:07-CV-497-TJW-CE, 2010 WL 2991037, at *15 (E.D. Tex. July 26, 2010).
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`Here, the specification never equates these terms. Ex-1806 ¶10. The logical
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`reading is that “interventional cardiology device(s)” refers to a genus, of which
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`“interventional cardiology treatment device” is a species. That the two are not
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`synonymous is consistent with a POSITA’s understanding. Id. ¶¶11-13. The
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`specification’s teaching regarding sequential use of an inner catheter and “a cardiac
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`treatment device” does not lead to a different result. It is black letter law that
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`specification embodiments are not read into patent claims. Hill-Rom Servs. v.
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`Stryker Corp., 755 F.3d 1367, 1371-72 (Fed. Cir. 2014).
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`3
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`Patent 8,142,413
`Teleflex’s proposed construction cannot be correct because requiring an
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`“interventional cardiology device” to “provide treatment to that location” would
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`read out a guidewire, which the specification explicitly defines as an IVCD. See
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`Accent Packaging, Inc. v. Leggett & Platt, Inc., 707 F.3d 1318, 1326 (Fed. Cir.
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`2013). A guidewire does not “provide treatment to that location.” Instead, it is “a
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`rail over which a series of therapeutic devices can be advanced.” Ex-1015, 95;
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`Ex-1806 ¶14. Teleflex’s expert, Graham, agrees, testifying that a guidewire is used
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`with a stent or balloon. Ex-1801, 89:2-23. Indeed, he admits that “treatment”
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`means effectively opening up blocked arteries. Ex-1846, 13:6-15. This is why a
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`guidewire is never sufficient. Id., 22:11-12, 23:24-24:9 (describing guidewires
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`used with subsequent stenting, angioplasty, or bypass); Ex-1852, 142, Fig. 22
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`(explaining guidewire techniques followed by treatment catheters). Brecker
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`concurs. Ex-1806 ¶15; Ex-2238, 19:6-16, 20:7-8; 21:17-22:20.
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`B. Claim-Step Order
`The parties dispute whether claim 1’s steps must be performed in the
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`sequence recited. Compare Petition (Pet.), Paper 1, 12-13 with POR, 9-14. As to
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`limitation 1.f.i, the issue is whether the coaxial guide catheter must already have
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`been inserted into the standard guide catheter (“GC”) before an IVCD is inserted
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`thereto. The answer is no. Claim 1 allows for either preassembly of a coaxial guide
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`catheter and IVCD, or sequential insertion.
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`4
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`Patent 8,142,413
`“Unless the steps of a method actually recite an order, the steps are not
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`ordinarily construed to require one.” Interactive Gift Express, Inc. v. Compuserve,
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`Inc., 256 F.3d 1323, 1342 (Fed. Cir. 2001). Teleflex argues that claim 1 “only
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`makes sense if the steps take place in order,” POR, 10, but that is only the case for
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`some steps. The parties agree that a GC must be inserted into a first artery (1.a)
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`before its distal end can be positioned in a branch artery (1.b). Similarly, a GC
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`must already be positioned before the coaxial guide catheter can be inserted thereto
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`(1.c-1.e). But the plain claim language permits an IVCD to be advanced either
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`simultaneously with the coaxial guide catheter or sequentially. Ex-1005 ¶¶221-25,
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`250-59, 320-24; Ex-1806 ¶¶17-23; Pet., 49-51.
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`The specification’s disclosure of an embodiment in which insertion is
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`sequential does not limit the claims. Altiris, Inc. v. Symantec Corp., 318 F.3d 1363,
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`1369-1371 (Fed. Cir. 2003) (finding error where method steps were construed to
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`require the order used by the sole embodiment). This is not a case in which
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`sequential insertion is required to perform the claimed method. Cf. Mformation
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`Tech. v. Research in Motion Ltd., 764 F.3d 1392, 1398-1400 (Fed. Cir. 2014)
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`(agreeing that claims to remotely deploying software required connection before
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`transmission); Mantech Environmental Corp. v. Hudson Environmental Servs.,
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`Inc., 152 F.3d 1368, 1375-1376 (Fed. Cir. 1998) (determining that claims for
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`5
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`IPR2020-01341
`Patent 8,142,413
`remediating groundwater contamination required the provision of wells, before
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`acid is introduced thereto).
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`First, Teleflex argues there can be no “backup support” for an IVCD if there
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`is preassembly. POR, 12. Even assuming the preamble is limiting, that is
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`nonsensical. Regardless of whether the IVCD is inserted simultaneously with—or
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`after—the coaxial guide catheter, the result is the same. Before the IVCD is ever
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`advanced into the coronary artery the coaxial guide catheter is already in position
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`within the GC. And the patent teaches that it is the relative orientation of the
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`GC/coaxial guide catheter—at the time the IVCD is advanced into the coronary
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`artery—that provides backup support. Ex-1001, Fig. 9, 8:4-9.
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`Second, step 1.f.i requires that two things be positioned “alongside” each
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`other: (a) the IVCD; and (b) the coaxial guide catheter’s substantially rigid portion.
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`“Alongside” is an adjective that accurately reflects the relative positions of (a) and
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`(b), even where the two are preassembled. Teleflex’s experts do not disagree.
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`Ex-1797, 16:6-17:10, 31:9-23; Ex-1846, 49:23-50:25.
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`Finally, step 1.f.ii requires that the IVCD be advanced “through and beyond”
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`the lumen of the coaxial guide catheter. Teleflex’s experts confirm that—following
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`preassembly—an IVCD can be inserted into a guide catheter and then advanced
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`into the coronary artery. Id. Brecker concurs, Ex-1005 ¶¶221-25; Ex-1806 ¶¶17-23,
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`and real-world evidence bears this out. Ex-1848, Abstract, [0204]-[0207], Figs.
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`6
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`IPR2020-01341
`Patent 8,142,413
`23a-23c (disclosing preassembly and advancement of balloon); Ex-1849, Figs. 2C,
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`4 (same).
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`Accordingly, the default rule that method steps need not be performed in the
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`order recited applies to claim 1.2
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`III.
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`ITOU IS PRIOR ART.
`Teleflex failed to prove prior invention. Itou remains prior art.
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`A. Teleflex must prove prior invention.
`To prove prior invention, Teleflex “bears the burden of proof to establish
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`either: (1) prior reduction to practice; or (2) prior conception coupled with due
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`diligence.” ATI Techs. ULC v. Iancu, 920 F.3d 1362, 1369 (Fed. Cir. 2019).
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`Antedating a reference “requires documentary support.” In re Steed, 802 F.3d
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`1311, 1316 (Fed. Cir. 2015).
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`2 Claims depending from claim 1 confirm that the ’413 patent does not require
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`every step to be performed in the order recited. As written, claims 10 and 11 would
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`require an IVCD to move backwards, in a distal to proximal direction (advancing
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`first through the side opening’s full circumference portion and then through its
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`partially cylindrical portion, or advancing through a flexible tip before advancing
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`through a reinforced portion). Ex-1001, 12:14-25. Neither scenario makes sense. In
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`use, an IVCD is advanced proximal to distal. Pet., 7-8, 11.
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`7
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`Patent 8,142,413
`Teleflex misstates its burden—if the Board doubts the evidence, then
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`Teleflex did not satisfy its burden. “The burden of showing actual reduction of
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`practice is on the party seeking its benefit.” Id. at 1317. Teleflex bears “the burden
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`of going forward with evidence…and presenting persuasive argument based on”
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`that evidence. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
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`1379-80 (Fed. Cir. 2015). Teleflex bears that burden for “every claim limitation.”
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`Gen. Access Sols., Ltd. v. Sprint Spectrum L.P., 811 F. App’x 654, 658 (Fed. Cir.
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`2020).
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`Teleflex failed to prove reduction to practice before Itou.
`B.
`To prove reduction to practice, Teleflex must show “(1)…performance of a
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`process that met all the limitations of the [claimed method]; (2) determination that
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`the invention would work for its intended purpose; and (3) the existence of
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`sufficient evidence to corroborate inventor testimony regarding these events.”
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`Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). “Even the
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`most credible inventor testimony is a fortiori required to be corroborated by
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`independent evidence….” Id. at 1171-72.
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`IPR2020-01341
`Patent 8,142,413
`Teleflex tries to prove reduction to practice using VSI’s so-called “April”
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`and “July” GuideLiner RX prototypes. POR, 24-33.3 But Teleflex failed to show
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`that VSI assembled those prototypes, performed the claimed methods using those
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`prototypes, and tested those prototypes to determine that the inventions would
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`work for their intended purpose, all before Itou.
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`Teleflex failed to show that VSI assembled prototypes.
`1.
`To perform the claimed methods, VSI first needed to build prototypes
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`embodying the claimed coaxial guide catheters. Teleflex failed to adduce evidence
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`sufficient to show that VSI assembled its April and July components before Itou.
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`Component parts, alone, cannot prove assembled prototypes. Valencell, Inc. v.
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`Fitbit, Inc., 784 F. App’x 1005, 1009 (Fed. Cir. 2019).
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`3 Some arguments and evidence refer to separate “early GuideLiner prototypes.”
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`See, e.g., POR, 15-16; Ex-2122 ¶¶5-12. Those “early” prototypes cannot show
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`whether and/or when VSI reduced to practice. Teleflex does not contend—and did
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`not adduce evidence showing—that those prototypes embodied the claims or that
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`VSI performed the claimed methods using those prototypes. Ex-2118, App’x A-B
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`(charting only April and July prototypes); Ex-1798, 46:1-19.
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`9
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`No document shows that VSI assembled its April and July components—
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`i.e., had a complete RX prototype—before Itou.4 Documents suggest the opposite:
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` and
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`VSI likely did not figure it out in the tight window between receiving components
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`and Itou. Ex-1770, 15; §III.D., infra (discussing documents suggesting that VSI
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`did not have a working prototype before Itou). Joining dissimilar materials—e.g.,
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`steel and polymer—would have been difficult and required documentation.
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`Ex-1755 ¶¶72-74. VSI laboratory notebooks log zero RX work during the critical
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`timeframe. Ex-1796 (Sutton); Ex-1758 (Welch); Ex-1760, 86-93 (Kauphusman,
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`OTW work only); Ex-1761, 107-13 (Mytty, OTW work only).
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`Only less-than-precise inventor testimony suggests that VSI assembled its
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`April and July components before Itou. See, e.g., Ex-1798, 47:21-48:16 (Root did
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`not assemble, “can’t say” who did, does not “have a specific date”). More
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`important, no non-inventor corroborates the inventors or confirms assembly before
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`Itou. New for these proceedings, Erb’s declaration now mentions the April and
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`4 Teleflex’s “complete” RX drawing, Ex-2022, is just that—a drawing. It does not
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`suggest that VSI assembled prototypes. Root does not contend that VSI built
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`prototypes according to Ex-2022. Ex-1798, 55:16-56:14. No evidence suggests that
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`VSI ordered the proximal part. Ex-1755 ¶256.
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`10
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`IPR2020-01341
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`July component drawings, Ex-2122 ¶¶14-18, but he does not remember reviewing
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`those drawings separate from these proceedings. Ex-1799, 22:5-31:12. Even when
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`coached, Erb could barely remember relevant components. Ex-2248, 93:14-95:12.
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`Erb, a machinist, worked on early GuideLiner prototype components, before VSI
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`outsourced the April/July components work. Ex-2122 ¶¶5-13, 19. Erb “help[ed]
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`assemble some of the subsequent prototypes.” Id. ¶19. But he does not identify the
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`specific prototypes or, critical to the reduction-to-practice inquiry, when he
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`assembled them.5
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`Teleflex asks the Board to believe that VSI assembled prototypes at an
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`undisclosed time between receiving components in summer 2005 and September
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`23, 2005, without assembly documents and with only vague, uncorroborated
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`inventor testimony. See Ex-1755 ¶¶66-74, 143-45. Teleflex has not done enough.
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`5 During his deposition, after conferring with his counsel for 30 minutes, Erb
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`added to his declaration testimony, testifying for the first time that VSI assembled
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`the April and July components. Ex-1799, 36:7-19. Erb’s gap-filling after
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`conferring with counsel cannot qualify as sufficient corroborating evidence.
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`Regardless, even when counsel pressed, Erb did not provide assembly dates. Id.,
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`37:2-38:15.
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`11
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`IPR2020-01341
`Patent 8,142,413
`Even if the Board assumes assembly based on parts orders and inventor say-
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`so, the April and July prototypes did not embody all challenged claims. They did
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`not feature a “proximal side opening defined by the proximal portion of the tubular
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`structure.” Ex-1001, claims 9-12. The distal portion of the proximal hypotube
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`defined a side opening. Ex-2118, 71-72.
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`2.
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`Teleflex failed to show that VSI performed the claimed
`methods.
`Teleflex must prove that VSI “performed a process that met all the
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`limitations of the claim.” Steed, 802 F.3d at 1318. The patent does not claim only
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`GECs; it claims methods using GECs. Thus, here, evidence that VSI built
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`prototypes that it could have used to perform the claimed methods falls short—the
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`Board needs evidence that VSI did perform those methods. Lucent Techs., Inc. v.
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`Gateway, Inc., No. 02-cv-2060-B(CAB), 2007 WL 2070346, at *2 (S.D. Cal. July
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`12, 2007) (Though “a computer executing the algorithm…would perform all the
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`method steps of claim 13, the thesis alone cannot show that the method was ever
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`performed.”).
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`VSI did not perform the claimed methods because it did not use prototypes
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`in vivo. All challenged claims require inserting a guide catheter into a “first artery,”
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`positioning it “in a branch artery,” advancing a coaxial guide catheter “into the
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`second artery,” and inserting an interventional cardiology device “into contact with
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`or past a lesion in the second artery.” Ex-1001, claim 1. VSI’s testing—using at
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`12
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`
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`IPR2020-01341
`Patent 8,142,413
`most a model simulating anatomy—cannot satisfy the “artery” and “lesion”
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`limitations. See, e.g., TC Tech. LLC v. Sprint Corp., 379 F. Supp. 3d 305, 319 (D.
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`Del. 2019) (finding “computer simulations could not meet all the limitations of the
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`asserted claims, [thus] they are insufficient to show actual reduction to practice”).
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`The Board must consider the claim language and determine whether VSI
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`performed every limitation. See Taskett v. Dentlinger, 344 F.3d 1337, 1340-41
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`(Fed. Cir. 2003). Teleflex would not contend that model testing infringes the
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`challenged claims, so it cannot contend that its testing satisfied them.6
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`Moreover, Teleflex failed to prove that VSI performed the claimed methods
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`before Itou, even in a model. First, no evidence establishes a credible testing
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`timeline. Teleflex argues that VSI tested prototypes in April and July 2005 (POR,
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`27-28), but no evidence supports those dates. No documents show RX testing,
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`much less date it. Teleflex and the inventors resort to citing photographs of an
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`6 Some cases note that human testing is not necessary to determine that a medical
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`device would work for its intended purpose. See, e.g., Scott v. Finney, 34 F.3d
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`1058, 1063 (Fed. Cir. 1994). But separate from and in addition to determining that
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`the inventions would work for their intended purpose, VSI needed to perform the
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`claimed methods. Those methods, according to plain claim language, require in
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`vivo use.
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`
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`13
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`
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`IPR2020-01341
`Patent 8,142,413
`OTW (prior art) prototype. Ex-2129. No one—no inventor, no non-inventor—
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`speaks to particular testing as of a particular date. Ex-2118 ¶¶17-19 (describing
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`general testing practices rather than specific prototypes/specific testing); Ex-1798,
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`22:1-23:25 (“I can’t tell you exactly who,” and “I can’t give you the specific date
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`that that testing occurred.”), 39:22-40:5; Ex-2122 (no dates). The best the
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`witnesses can do is swear that VSI accomplished what it needed to accomplish
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`before Itou. That is not credible. That is not enough. See Steed, 802 F.3d at 1318
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`(affirming no reduction to practice when applicant “did not provide facts showing
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`any specific dates or events of actual reduction of practice but only presented
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`statements of generalized activity”).
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`Second, even if inventors did date particular testing before Itou, no evidence
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`corroborates that testimony. Erb does not detail steps performed during prototype
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`testing, testifying only that “[a]dditional testing…was performed on [those]
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`prototypes.” Ex-2122 ¶19. Erb “was not personally involved in, tests of the
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`GuideLiner prototypes involving the delivery of stents and balloons in a benchtop
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`heart model,” a critical step in all claimed methods. Id. ¶12.7 Schmalz, Teleflex’s
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`7 During his deposition, after conferring with his counsel for 30 minutes, Erb
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`changed his sworn declaration and added brand-new testing testimony. Ex-1799,
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`35:1-40:21. Erb’s 180-degree pivot undoing his declaration testimony after
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`
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`14
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`
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`IPR2020-01341
`Patent 8,142,413
`other primary non-inventor witness, provides no testing testimony. Ex-2039. She
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`has no personal knowledge of relevant prototypes. Ex-1766, 34:11-35:1, 49:22-
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`50:1, 71:16-80:19. She only assumes that engineers outside her department tested
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`conferring with counsel cannot qualify as sufficient corroborating evidence. Erb is
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`an unreliable, interested (current Teleflex employee) witness willing to change his
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`testimony as needed. No case, to Medtronic’s knowledge, has held that an
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`interested, non-inventor witness’s testimony, alone, is sufficient to corroborate
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`inventor testimony. Lacks Indus., Inc. v. McKechnie Vehicle Components USA,
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`Inc., 322 F.3d 1335, 1350 (Fed. Cir. 2003) (noting “courts have consistently
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`required documentary corroboration of oral testimony by interested parties”). An
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`interested witness—even a non-inventor—is not sufficient to corroborate
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`presumed-biased inventor testimony. Interested witnesses—like inventors—are
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`inherently unreliable, and well-established corroboration requirements are
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`designed to guard against self-serving testimony. See Medichem, 437 F.3d at 1170
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`(noting that the corroboration requirement guards against fraud and “provides an
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`additional safeguard against courts being deceived by inventors who may be
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`tempted to mischaracterize the events of the past through their testimony”);
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`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996).
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`15
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`IPR2020-01341
`Patent 8,142,413
`prototypes based on an unreliable document that she did not prepare. Ex-2039;
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`Ex-1766, 44:20-45:18; Ex-2024; §III.D., infra.
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`Telling, Teleflex does not appear to contend that VSI performed the claimed
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`methods, arguing only that testing “met all of the limitations of the contested
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`claims relative to the structure of the claimed guide extension catheter.” POR, 31
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`(emphasis added).8 Teleflex overlooks its burden to prove that VSI performed the
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`claimed methods to reduce these inventions to practice.9
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`3.
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`Teleflex failed to show that VSI determined that its
`inventions would work for their intended purpose.
`Separate from performing the claimed methods, VSI needed to determine
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`that the inventions would work for their intended purpose. The Board already
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`determined that the intended purpose of VSI’s GuideLiner inventions is “to
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`8 Teleflex tries to skirt its obligation to prove that VSI performed the methods,
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`arguing that Itou teaches only claimed structures, not methods. POR, 32-33 (citing
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`Stempel). Stempel addressed antedating a species reference. 241 F.2d 755, 759
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`(C.C.P.A. 1957). Stempel does not change reduction-to-practice requirements for
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`method claims. Regardless, Medtronic contends that Itou teaches the claimed
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`methods.
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`9 At minimum, Teleflex does not contend that VSI performed the process recited in
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`claim 5, requiring “injecting a fluid.” Ex-2118, 69.
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`16
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`IPR2020-01341
`Patent 8,142,413
`increase backup support for delivery of interventional cardiology devices,” with
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`“crossing tough or total occlusions [being] one noted benefit of the invention.”
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`IPR2020-00128 Final Written Decision (Paper 127), 55-56; Ex-1798, 4:6-7:23
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`(Root: GuideLiner is intended “to get better back-up support” for “complex
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`procedures,” including a “tight lesion” or “chronic total occlusion”).
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`The intended purpose required particular testing. Teleflex failed to show that
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`VSI p