IPR2020-01343
`Patent RE 46,116
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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 IPR2020-01343
`U.S. Patent No. RE 46,116
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`PETITIONER’S REPLY
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`Patent RE 46,116
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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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.
`
`
`
`
`Case IPR2020-01343
`U.S. Patent No. RE 46,116
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`PETITIONER’S REPLY
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`IPR2020-01343
`Patent RE 46,116
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`TABLE OF CONTENTS
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`INTRODUCTION ............................................................................................ 1
`I.
`II. GROUND 1: TELEFLEX DOES NOT DISPUTE THAT
`RESSEMANN ANTICIPATES CHALLENGED CLAIMS 52 AND
`53. ..................................................................................................................... 2
`ITOU IS PRIOR ART. ...................................................................................... 2
`A.
`Teleflex must prove prior invention. ..................................................... 3
`B.
`Teleflex failed to prove reduction to practice before Itou. .................... 3
`1.
`Teleflex failed to show that VSI assembled prototypes. ............. 4
`2.
`Teleflex failed to show that VSI performed the claimed
`methods. ...................................................................................... 7
`Teleflex failed to show that VSI determined that its
`inventions would work for their intended purpose. .................. 11
`Teleflex has not shown diligence. ....................................................... 16
`Evidence shows that VSI did not actually or constructively
`reduce to practice before Itou. ............................................................. 19
`IV. GROUND 2: THE CHALLENGED CLAIMS ARE OBVIOUS IN
`VIEW OF ITOU AND RESSEMANN AND THE KNOWLEDGE OF
`A POSITA. ...................................................................................................... 21
`A.
`Independent claim 25 is obvious in view of Itou and Ressemann
`and the knowledge of a POSITA. ........................................................ 21
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`III.
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`3.
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`C.
`D.
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`IPR2020-01343
`Patent RE 46,116
`1.
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`2.
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`B.
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`A POSITA had the motivation to advance a balloon
`catheter or stent through Itou’s catheter 2. ............................... 22
`A POSITA had a reasonable expectation of success
`because catheter 2 is inherently capable of receiving a
`“balloon catheter or stent [that is advanced]…through the
`side opening and through the tubular structure” when the
`suction catheter is in the guide catheter. ................................... 25
`The shape of the opening claimed in claim 45 was not
`inventive. ............................................................................................. 27
`1.
`Ressemann’s collar 2141 has at least two inclined slopes. ....... 28
`2.
`Itou in view of Ressemann renders claim 45 obvious. ............. 31
`V. GROUND 4: ITOU IN VIEW OF KATAISHI RENDERS CLAIM 45
`OBVIOUS. ..................................................................................................... 34
`VI. SECONDARY CONSIDERATIONS DO NOT OVERCOME
`OBVIOUSNESS. ............................................................................................ 37
`A.
`Teleflex is not entitled to a presumption of nexus. ............................. 37
`B.
`Teleflex’s secondary consideration evidence all relates to prior
`art features and functionality. .............................................................. 39
`1.
`Teleflex’s alleged evidence of copying is actually
`copying of the prior art. ............................................................ 41
`2. Medtronic did not copy GuideLiner. ......................................... 42
`VII. CONCLUSION .............................................................................................. 43
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`IPR2020-01343
`Patent RE 46,116
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC,
`825 F.3d 1373 (Fed. Cir. 2016) ............................................................................31
`Arctic Cat v. GEP Power Prods.,
`919 F.3d 1320 (Fed. Cir. 2019) ............................................................................19
`ATI Techs. ULC v. Iancu,
`920 F.3d 1362 (Fed. Cir. 2019) ........................................................................3, 16
`Bos. Sci. Corp. v. Johnson & Johnson,
`481 F. Supp. 2d 1018 (N.D. Cal. 2007) ...............................................................12
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .............................................................................. 3
`Fox Factory, Inc. v. SRAM, LLC,
`944 F.3d 1366 (Fed. Cir. 2019) ............................................................................38
`Gen. Access Sols., Ltd. v. Sprint Spectrum L.P.,
`811 F. App’x 654 (Fed. Cir. 2020) ......................................................................... 3
`Google LLC v. Lee,
`759 F. App’x 992 (Fed. Cir. 2019) .......................................................................31
`In re Applied Materials, Inc.,
`692 F.3d 1289 (Fed. Cir. 2012) ............................................................................32
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ............................................................................41
`In re Magna Elecs., Inc.,
`611 F. App’x 969 (Fed. Cir. 2015) .......................................................................28
`In re Meyer Mfg. Corp.,
`411 F. App’x 316 (Fed. Cir. 2010) .......................................................................18
`In re Steed,
`802 F.3d 1311 (Fed. Cir. 2015) ..................................................................... 3, 7, 9
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`IPR2020-01343
`Patent RE 46,116
`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) .............................................................................. 11
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ..................................................................... 41, 42
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) .................................................................................. 1, 22, 27
`Lacks Indus., Inc. v. McKechnie Vehicle Components USA, Inc.,
`322 F.3d 1335 (Fed. Cir. 2003) ............................................................................10
`Lucent Techs., Inc. v. Gateway, Inc.,
`No. 02-cv-2060-B(CAB), 2007 WL 2070346 (S.D. Cal. July 12, 2007) .............. 7
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) ....................................................................... 10, 12
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) ........................................................................3, 10
`Perfect Surgical Techniques, Inc. v. Olympus Am., Inc.,
`841 F.3d 1004 (Fed. Cir. 2016) ............................................................................16
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ..........................................................................8, 15
`Slip Track Sys., Inc. v. Metal-Lite, Inc.,
`304 F.3d 1256 (Fed. Cir. 2002) ............................................................................15
`Taskett v. Dentlinger,
`344 F.3d 1337 (Fed. Cir. 2003) .............................................................................. 8
`TC Tech. LLC v. Sprint Corp.,
`379 F. Supp. 3d 305 (D. Del. 2019) ....................................................................... 8
`Toshiba Memory Corp. v. Anza Tech., Inc.,
`IPR2018-01597, 2020 WL 1229855 (PTAB Mar. 12, 2020) ...............................18
`Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc.,
`774 F.3d 968 (Fed. Cir. 2014) ..............................................................................23
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`Patent RE 46,116
`Valencell, Inc. v. Fitbit, Inc.,
`784 F. App’x 1005 (Fed. Cir. 2019) ....................................................................... 4
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................37
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) ............................................................................40
`Statutes
`37 C.F.R. § 42.6(a)(3) ..............................................................................................16
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`IPR2020-01343
`Patent RE 46,116
`INTRODUCTION
`I.
`Teleflex concedes that Ressemann anticipates claims 52 and 53 (Ground 1).
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`Teleflex attempts to refute only evidence that independent claim 25 and dependent
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`claim 45 are obvious based on Itou in view of Ressemann. Itou discloses the
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`structure claim 25 requires, even if it does not explicitly say, as Ressemann does, to
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`pass a balloon catheter or a stent through the disclosed catheter. To convince the
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`Board to ignore Ressemann’s teaching, Teleflex argues that a POSITA would never
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`look to the teachings of one coronary catheter designed to remove unwanted
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`material from the coronary vasculature (Ressemann) to inform the use of a second
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`catheter, Itou, having the same purpose. Thus, it overlooks both that Itou and
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`Ressemann are analogous art and that an obviousness inquiry properly takes into
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`account the “inferences and creative steps that a person of ordinary skill in the art
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`would employ.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007).
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`Claim 45 also recites that a balloon catheter and stent are at least partially
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`advanced “through a side opening structure having at least two inclined slopes.”
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`Based on Teleflex’s own witnesses’ testimony, however, the specific shape of this
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`opening is inconsequential. And two-incline shapes, with larger total areas of entry,
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`were known in the art. It is obvious to use a known prior art shape that provides the
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`same or greater benefits.
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`1
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`Patent RE 46,116
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`H.
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`GROUND 1: TELEFLEX DOES NOT DISPUTE THAT RESSEMANN
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`ANTICIPATES CHALLENGED CLAINIS 52 AND 53.
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`Teleflex argues that its purported invention is a method of using a guide
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`extension catheter to deliver a stent or balloon catheter into a coronary artery.
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`Patent Owner Response (POR), Paper 21, 1. That is exactly what is taught in
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`Ressemann, which explicitly discloses extending a guide extension catheter
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`(assembly 100) through a guide catheter (160) and into a coronary artery. Below,
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`left. It teaches that a balloon—expandable stent (193) should then be advanced
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`through the guide catheter and the guide extension catheter into the vasculature.
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`Below, right.
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`stent delivery system 193
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`proximal
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`Ex-1008, Figs. 6B, 6B (annotation added).
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`The purported invention was not novel in View of Ressemann. Petition
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`(Pet), Paper 1, 23—31.
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`Ill.
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`ITOU IS PRIOR ART.
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`Teleflex failed to prove prior invention. Itou remains prior art-
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`IPR2020-01343
`Patent RE 46,116
`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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`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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`Patent RE 46,116
`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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`Teleflex tries to prove reduction to practice using VSI’s so-called “April”
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`and “July” GuideLiner RX prototypes. POR, 16-25.1 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 guide extension catheters. Teleflex failed to adduce
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`evidence sufficient to show that VSI assembled its April and July components
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`before Itou. Component parts, alone, cannot prove assembled prototypes.
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`Valencell, Inc. v. Fitbit, Inc., 784 F. App’x 1005, 1009 (Fed. Cir. 2019).
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`1 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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`No document shows that VSI assembled its April and July components—
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`i.e., had a complete RX prototype—before Itou.2 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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`2 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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`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.3
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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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`3 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 conferring
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`with counsel cannot qualify as sufficient corroborating evidence. Regardless, even
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`when counsel pressed, Erb did not provide assembly dates. Id., 37:2-38:15.
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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.”).4
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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 advancing a guide catheter “through a main
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`blood vessel to an ostium of a coronary artery” and advancing a balloon catheter or
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`stent “into the coronary artery.” Ex-1001, claims 25, 52. VSI’s testing—using at
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`most a model simulating anatomy—cannot satisfy the “blood vessel” and
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`“coronary artery” limitations. See, e.g., TC Tech. LLC v. Sprint Corp., 379 F. Supp.
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`4 Teleflex’s expert, Keith, did not apply the law correctly, opining that VSI “could
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`reduce to practice and show that the method works for its intended purpose without
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`ever performing the method.” Ex-1797, 84:14-85:16. Keith is unreliable.
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`Patent RE 46,116
`3d 305, 319 (D. Del. 2019) (finding “computer simulations could not meet all the
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`limitations of the asserted claims, [thus] they are insufficient to show actual
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`reduction to practice”). The Board must consider the claim language and determine
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`whether VSI performed every limitation. See Taskett v. Dentlinger, 344 F.3d 1337,
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`1340-41 (Fed. Cir. 2003). Teleflex would not contend that model testing infringes
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`the challenged claims, so it cannot contend that its testing satisfied them.5
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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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`19-20), 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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`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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`5 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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`Patent RE 46,116
`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. ¶12.6 Schmalz, Teleflex’s
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`6 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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`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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`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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`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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`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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`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, 23
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`(emphasis added).7 Teleflex overlooks its burden to prove that VSI performed the
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`claimed methods to reduce these inventions to practice.8
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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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`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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`7 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, 24-25 (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 at least portions
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`of the claimed methods.
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`8 At minimum, Teleflex does not contend that VSI performed the process recited in
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`claim 26, requiring “injecting one or more fluids.” Ex-2118, 80.
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`11
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`IPR2020-01343
`Patent RE 46,116
`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 performed any testing before Itou, §III.B.2., supra, much less the required
`
`testing.
`
`Here, reduction to practice requires testing.
`a.
`In passing, Teleflex suggests that VSI did not need to test prototypes at all.
`
`Setting aside VSI’s separate obligation to perform the claimed methods, the law is
`
`clear that no testing is not an option here. Without exception, reduction to practice
`
`requires demonstrating that the invention would work. Demonstrating requires
`
`testing in all but simple cases. Catheters, in particular, require testing. Mahurkar,
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`79 F.3d at 1578; Bos. Sci. Corp. v. Johnson & Johnson, 481 F. Supp. 2d 1018,
`
`1024 (N.D. Cal. 2007).
`
`Teleflex cites neither law nor evidence to support its “no testing” argument.
`
`It conflates invalidity/inherency/obviousness with reduction to practice. Arguments
`
`regarding what would have been inherent/obvious to a POSITA do not relieve VSI
`
`of its obligation to demonstrate that the inventions would work for their intended
`
`purpose. Inferring cannot replace demonstrating.
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`VSI needed to conduct particular testing.
`b.
`To determine whether the claimed methods would increase backup support,
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`including to cross tough/total occlusions, VSI needed to set up a model simulating
`
`an occlusion, run the prototype through to test whether it could access and cross
`
`the simulated occlusion, and compare the prototype’s backup support to a standard
`
`GC. Ex-1764, 64:2-67:12; Ex-1797, 76:8-20, 82:11-25 (Keith confirming that
`
`simulation can test lesions and comparative testing can measure relative backup
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`support); Ex-1755 ¶¶233-37, 257-58. Increased backup support, by definition,
`
`requires a comparison.
`
`No evidence suggests that VSI compared RX prototypes to standard GC
`
`arrangements to confirm increased backup support. VSI performed that work for
`
`OTW prototypes, not RX. Ex-1760, 86-93 (benchtop testing comparing OTW to
`
`standard GC); Ex-1761, 107-13 (same); Ex-1798, 57:25-61:9. Kauphusman and
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`Mytty performed the only basic, comparative backup support testing in the record,
`
`for OTW, not RX. Ex-1755 ¶258. Further, no evidence suggests that VSI simulated
`
`occlusions. VSI’s benchtop model was “very simple.” Ex-2237, 135:5-23.
`
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`Ex-2129 (showing OTW prototype)
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`
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`Compare VSI’s model with those designed to simulate challenging anatomy and
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`tough occlusions:
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`
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`Ex-1010, Fig. 1B
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`
`
`
`
`The Board cannot determine that VSI demonstrated that its inventions would
`
`Ex-1055, Fig. 2
`
`
`
`work for their intended purpose based on Teleflex’s conclusory, uncorroborated
`
`evidence. The Board judges “[t]he adequacy of a reduction to practice…by what
`
`one of ordinary skill in the art would conclude from the results of the tests.” Slip
`
`Track Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1265 (Fed. Cir. 2002). But
`
`Teleflex offers no testing evidence that the Board can evaluate. The inventors offer
`
`conclusory say-so that the inventions worked. No non-inventor discusses testing
`
`the April or July prototypes with any specificity. §III.B.2., supra; cf. Scott, 34 F.3d
`
`at 1063 (wherein the court had the opportunity to evaluate a video showing testing
`
`of prosthetic implant). The Board needs something to judge.
`
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`C. Teleflex has not shown diligence.
`Teleflex can prove neither actual nor constructive reduction to practice.
`
`“[T]o antedate a reference, the applicant must not only have conceived the
`
`invention before the reference date, but must have reasonably continued activity to
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`reduce the invention to practice.” ATI, 920 F.3d at 1369. Inventors still require
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`corroboration, and Teleflex still bears the burden of proof. Id. at 1370.
`
`“Reasonable diligence must be shown throughout the entire critical period, which
`
`begins just prior to the competing reference’s effective date and ends on the date of
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`the invention’s reduction to practice.” Perfect Surgical Techniques, Inc. v.
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`Olympus Am., Inc., 841 F.3d 1004, 1007 (Fed. Cir. 2016).
`
`Teleflex’s POR contains no facts showing diligence—it cites exhibits
`
`without identifying the relevant facts or applying the diligence standard to those
`
`facts. POR, §V.A.3. Teleflex incorporated by reference. 37 C.F.R. § 42.6(a)(3).
`
`Still, the exhibits show only scattered activities, virtually none related to actual
`
`work on an RX device:
`
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`• October 2005: prosecution counsel opens file (Ex-2023); VSI
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`mentions concept reviews predating October (and Itou) (Ex-2133)9
`
`• November 2005: VSI creates component drawing (Ex-2115)
`
`• December 2005: prosecution counsel works ~22 hours (Ex-2117)
`
`• January 2006: prosecution counsel works ~27 hours (Ex-2101,
`
`Ex-2102)
`
`• March 2006: prosecution counsel works ~9 hours (Ex-2103); VSI
`
`orders hypotubes (Ex-2104)
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`• April 2006: VSI orders hypotubes (Ex-2106, Ex-2107, Ex-2108)
`
`
`9 Root testified that the concept reviews could have occurred anytime between
`
`January and October 2005 and, if before Itou, are irrelevant to establishing
`
`
`
`diligence. Ex-1798, 77:21-79:5.
`
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`VSI did not touch the project for entire months. Over a six-month period,
`
`Teleflex identifies one engineering activity and a week-and-a-half’s worth of
`
`prosecution work. Root can say only “that work occurred during that period of
`
`time, but [he] can’t specify what event happened at what date on that timeframe.”
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`Ex-1798, 74:19-24. VSI planned for regulatory submissions (Ex-2099, Ex-2100,
`
`Ex-2133) but did not work to hit those goals, forcing it to delay through 2008.
`
`Ex-2132, 7. In Root’s words, “the work wasn’t done, so therefore the deadline, or I
`
`would call it the goal, wasn’t met.” Ex-1798, 87:3-8.
`
`VSI needed to work on the project at regular intervals over the eight-month
`
`period. “Merely asserting diligence is not enough; a party must account for the
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`entire period during which diligence is required.” In re Meyer Mfg. Corp., 411 F.
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`App’x 316, 319-20 (Fed. Cir. 2010) (unexplained two-month gap meant no
`
`diligence); Toshiba Memory Corp. v. Anza Tech., Inc., IPR2018-01597, 2020 WL
`
`1229855, at *15-17 (PTAB Mar. 12, 2020) (no diligence when PO could not
`
`account for several-week period). The fact that witnesses state, without supporting
`
`facts, that VSI “continuously worked” on the project and never “abandoned or
`
`paused” cannot be enough. Ex-2118 ¶62; Ex-2039 ¶12.
`
`Teleflex prepared a sparse record of sporadic prosecution work, scattered
`
`parts purchases, and a company with shifting priorities. Courts have excused
`
`periods of inventor inactivity if evidence shows that the inventor “put[] the
`
`
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`invention into someone else’s hands for needed testing.” Arctic Cat v. GEP Power
`
`Prods., 919 F.3d 1320, 1332 (Fed. Cir. 2019). That is not VSI’s story.
`
`D. Evidence shows that VSI did not actually or constructively reduce
`to practice before Itou.
`VSI could not have reduced to practice before Itou. VSI delayed RX work,
`
`pushing out anticipated milestones due to lagging engineering work.
`
`GuideLiner did not advance past early-stage concept development in 2005.
`
`Ex-2128 (June 2005 memo part of “Phase I” under VSI standard operating
`
`procedures); Ex-1755 ¶¶172, 222. By July 2005, VSI had only an OTW design;
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`RX development was “to follow.” Ex-2130, 3.
`
`VSI’s August 2005 Product Requirements document indicates that VSI had
`
`not yet reduced to practice. Ex-2024. The document is an early, incomplete draft,
`
`missing entire sections. Compare Ex-2024 with Ex-1767
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`
`
`; Ex-1755 ¶¶196-200.
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` Ex-1
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