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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`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
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`Patent Owner.
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`IPR2020-00126
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`PATENT OWNER’S SUR-REPLY
`ADDRESSING CONCEPTION AND REDUCTION TO PRACTICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`
`Patent Owner.
`
`
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`IPR2020-00126
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`PATENT OWNER’S SUR-REPLY
`ADDRESSING CONCEPTION AND REDUCTION TO PRACTICE
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`I.
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`Petitioner Bears the Burden of Persuasion ...................................................... 2
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`TABLE OF CONTENTS
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`II. GuideLiner’s Priority is Amply Corroborated ................................................ 3
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`A. Conception ............................................................................................. 3
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`B. Reduction to Practice............................................................................. 5
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`1.
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`2.
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`VSI Built the April and July GuideLiner Prototypes .................. 5
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`The April and July 2005 GuideLiner Prototypes Were
`Tested and Shown to Work for Their Intended Purpose ............ 9
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`III. Diligence ........................................................................................................ 12
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`IV. Petitioner’s Reply Confirms There is No Substantial Dispute That the
`ʼ032 Patent Claims Cover the Prototypes ...................................................... 12
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`A. Attachment of Proximal and Distal Sections
`(Claims 1, 10-11, 22) ........................................................................... 15
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`B.
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`“Flexible Distal Tip Portion” / “Flexible Tip Portion”
`(Claims 6, 11) ...................................................................................... 15
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`C.
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`“Resisting Axial and Shear Forces” (Claims 2, 12) ............................ 16
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`D.
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`“Proximal Side Opening” in the Tubular Portion (Claims 3, 4) ......... 17
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`E.
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`“One French Smaller” (Claims 8, 17) ................................................. 17
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`F.
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`Standard Guide Catheter Length and Single Hemostatic Valve
`(Claims 10, 14, 22) .............................................................................. 18
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`V. Petitioner’s Procedural Challenge Fails ........................................................ 18
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`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 21
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`CERTIFICATION OF SERVICE............................................................................ 22
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`i
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`TABLE OF AUTHORITIES
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`
`Cases
`
`Compass Bank v. Intellectual Ventures II, LLC,
`IPR2014-00786, Paper 46 (PTAB Sept. 23, 2015) ............................................... 10
`
`Cooper v. Goldfarb,
`154 F.3d 1321 (Fed. Cir. 1998) .............................................................................. 8
`
`DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
`928 F.2d 1122 (Fed. Cir. 1991) ............................................................................ 11
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .............................................................................. 2
`
`E.I. du Pont de Nemours & Co. v. Unifrax I LLC,
`921 F.3d 1060 (Fed. Cir. 2019) ..........................................................................6, 8
`
`Fleming v. Escort Inc.,
`774 F.3d 1371 (Fed. Cir. 2014) .............................................................................. 8
`
`Fox Grp., Inc. v. Cree, Inc.,
`700 F.3d 1300 (Fed. Cir. 2012) .............................................................................. 3
`
`Green Cross Corp. v. Shire Human Genetic Therapies, Inc.,
`IPR2016-00258, Paper 89 (PTAB Mar. 22, 2017) ................................................. 2
`
`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) ......................................................................... 9, 17
`
`Intellectual Ventures II LLC v. Motorola Mobility LLC,
`692 F. App’x 626 (Fed. Cir. 2017) ......................................................................... 8
`
`Loral Fairchild Corp. v. Matsushita Elec. Indus.,
`266 F.3d 1358 (Fed. Cir. 2001) ................................................................. 6, 10, 11
`
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) ............................................................................2, 3
`
`Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) .............................................................................. 3
`
`
`
`ii
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`
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`Motorola Mobility LLC v. Intellectual Ventures II LLC,
`IPR2014-00504, Paper 84 (PTAB Mar. 13, 2020) ................................................. 2
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`NFC Tech, LLC v. Matal,
`871 F.3d 1367 (Fed. Cir. 2017) ..........................................................................6, 8
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`Pfizer, Inc. v. Genentech, Inc.,
`IPR2017-01488, Paper 87 (PTAB, Nov. 29, 2018) ......................................... 9, 16
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`Research in Motion Corp. v. Multimedia Ideas LLC,
`IPR2013-00036, Paper 15 (PTAB Mar. 18, 2013) ............................................... 18
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`Other Authorities
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`37 CFR §42.6(a)(3) ........................................................................................... 18, 19
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`iii
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`The GuideLiner was the first rapid exchange (“RX”) guide extension
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`catheter (“GEC”) to improve backup support for delivery of stents and other
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`interventional cardiology devices, including difficult cases. It was known that two
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`full-length over-the-wire (“OTW”) catheters, i.e., the “mother-and-child”
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`approach, would provide backup support allowing interventional devices to
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`navigate tortuous arteries and tough occlusions. The GuideLiner inventors built on
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`that concept to create an innovative RX GEC. Although it took time to
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`commercialize the device, it was apparent from early GuideLiner prototypes,
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`including those built and tested in April and July 2005, that the invention worked
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`for its intended purpose.
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`Petitioner makes two primary arguments in response. First, Petitioner
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`attempts a “gotcha”, asking the Board to ignore Patent Owner’s (“Teleflex”)
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`evidence and argument based solely on procedure. This argument cannot prevail
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`in the context of this unique case. Second, Petitioner argues that Teleflex’s
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`evidence is not sufficiently corroborated. This argument fails the rule of reason
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`test. Because Petitioner cannot meet its burden to show that Itou antedates the
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`GuideLiner patents, its challenge on conception and reduction to practice
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`(“CRTP”) fails.
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`1
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`I.
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`Petitioner Bears the Burden of Persuasion
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`In IPRs, the burden of persuasion on invalidity rests on the petitioner and
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`never shifts to the patent owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
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`800 F.3d 1375, 1378 (Fed. Cir. 2015). That rule applies to CRTP. Id.; Motorola
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`Mobility LLC v. Intellectual Ventures II LLC, IPR2014-00504, Paper 84 at 14-15
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`(PTAB Mar. 13, 2020). Indeed, Petitioner leveraged its burden to obtain more
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`words—and the last word—on CRTP. Ex-1099, 5:14-7:10, 11:22-14:1.
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`When Petitioner came forward with Itou, the burden of production shifted to
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`Teleflex to present evidence and argument sufficient to support a date of invention
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`prior to Itou. Dynamic Drinkware, 800 F.3d at 1378-80; Green Cross Corp. v.
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`Shire Human Genetic Therapies, Inc., IPR2016-00258, Paper 89 at 13 (PTAB Mar.
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`22, 2017). Teleflex responded with a detailed brief, supported by extensive
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`documentary and testimonial evidence. Paper 39 (“POR”). In the face of
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`Teleflex’s robust evidence of the GuideLiner’s priority, Petitioner cannot meet its
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`ultimate burden of persuasion on invalidity by its alleged antedating reference.
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`Even if the Board were uncertain about the evidence, Petitioner, the party with the
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`ultimate burden, loses. Dynamic Drinkware, 800 F.3d at 1378-79; see also
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`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996).
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`2
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`II. GuideLiner’s Priority is Amply Corroborated
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`A. Conception
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`Separate proof of conception is only necessary if the Board finds no actual
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`reduction to practice before Itou. See Fox Grp., Inc. v. Cree, Inc., 700 F.3d 1300,
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`1304-05 (Fed. Cir. 2012). Corroboration is not required for signed and dated
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`physical exhibits created by the inventors because the “trier of fact can conclude
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`for itself what documents show, aided by testimony as to what the exhibit would
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`mean to one skilled in the art.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157,
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`1169-70 (Fed. Cir. 2006) (quoting Mahurkar, 79 F.3d at 1577-78).
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`Even if the earliest conception documents were disregarded, others prior to
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`the critical date undisputedly show conception of the entire invention, including
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`the side opening:
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`3
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`POR, 14-15; Ex-2114. Petitioner’s expert, Zalesky, agrees. E.g. Ex-2237, 211:11-
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`16, App’x A cl. 13.
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`4
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`Additional evidence also reflects the side opening:
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`Ex-2022; Ex-2237, 250:9-13; see also POR, 11, 16; Ex-2113; Ex-2019; Ex-2122,
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`
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`¶8.
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`B. Reduction to Practice
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`1.
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`VSI Built the April and July GuideLiner Prototypes
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`In the face of specific and corroborated evidence that VSI1 designed and
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`built the April and July 2005 GuideLiner prototypes, Petitioner tries to change the
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`subject, first by arguing that more documents should exist. Paper 79 (“Reply”) 8-
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`11. Zalesky admits that the rigid set of documents and activities he would expect
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`to see relate to regulatory clearance, not CRTP, and that his own record-keeping
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`practices were “overkill.” Ex-2237, 77:19-78:2, 63:23-64:9, 115:18-117:10.
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`Indeed, Zalesky and the regulations he cites recognize and accept variability in this
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`1 VSI is the predecessor-in-interest to the GuideLiner patents.
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`5
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`regard. Id., 98:20-99:8, 100:3-18, 101:10-19, 109:15-22; Ex-1771, 9, 22; Ex-1772,
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`7, 52.
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`Petitioner also sidesteps that many documents from 2005 no longer exist and
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`that VSI simply did not and was not required to generate Zelesky’s prescribed
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`documentation. Ex-2118, ¶20; Ex-1762, 24:25-26:24, 85:11-16; Ex-2237, 98:20-
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`100:18, 109:15-22; Ex-1771, 9, 22; Ex-1772, 7, 52; Ex-1766, 21:20-22:5. The
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`Federal Circuit rejects arguments about numerosity of corroborating documents for
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`CRTP particularly when, as here, many years have passed since the facts in
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`question. NFC Tech, LLC v. Matal, 871 F.3d 1367, 1373-74 (Fed. Cir. 2017);
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`Loral Fairchild Corp. v. Matsushita Elec. Indus., 266 F.3d 1358, 1363-64 (Fed.
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`Cir. 2001). The rule of reason does not require the type or volume of documents
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`that Petitioner demands. E.I. du Pont de Nemours & Co. v. Unifrax I LLC, 921
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`F.3d 1060, 1077-78 (Fed. Cir. 2019). The fact that Teleflex no longer has some of
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`the documents that once existed does not make the substantial RTP evidence any
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`less persuasive.
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`Petitioner next speculates that evidence about the GuideLiner prototypes
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`might relate to an OTW device. Reply 11-16. Petitioner’s speculation fails on
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`chronology. The sole document Petitioner cites to posit that a hypotube was used
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`in an OTW device bears November 2005 and January 2006 dates, far later than the
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`cut-down hypotubes used for the April and July 2005 prototypes. Compare Ex-
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`6
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`1763, 6 with Exs-2113, -2114. Petitioner’s speculation also fails on materials and
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`dimensions. The hypotube in the OTW drawing is nitinol and roughly 19cm, quite
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`different than the 100cm stainless steel hypotubes used for the GuideLiner
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`prototypes. Id. The 43in distal section in the OTW drawing also differs
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`dramatically from the 11.8in prototype distal section. Ex-2237, 164:24-167:19;
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`compare Ex-1763, 6 with Exs-2089, Ex-2092.
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`Petitioner also dredges up a handful of notebook pages dated after the April
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`and July prototypes were assembled and tested. Reply 9-10. Nothing about these
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`pages disproves CRTP of GuideLiner RX before Itou. These pages only further
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`corroborate that VSI did not generate detailed testing records until the design
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`verification stage, when formal documentation is required for FDA approval. Ex-
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`2118, ¶¶54-57; Ex-1762, 84:19-85:16; Ex-1766, 21:20-22:5, 48:18-49:17; see Ex-
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`2099 (expected completion of OTW design verification testing in January 2006).
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`Petitioner’s third argument, that the GuideLiner prototype parts could have
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`been used for other VSI products (Reply 11-16), is, as Zalesky admits, pure
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`conjecture and contradicted by the evidence. Ex-2237, 151:8-152:10, 156:3-
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`160:17, 172:11-174:25. Moreover, the corroborating invoices and related
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`documents are specifically tied to an accounting report for the GuideLiner project,
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`not a general ledger that would suggest the parts could be used for other products,
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`as Zalesky speculates. Ex-2005; Ex-2237, 145:1-19, 207:14-208:9.
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`7
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`Petitioner next hypothesizes that the GuideLiner prototypes were not
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`assembled. Reply 16-17. Zalesky admits this does not make sense. Ex-2237,
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`208:14-209:4. The proximal and distal sections of the prototypes were specifically
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`counterbored for the two pieces to be joined. POR, 9-11, 14; Ex-2089, 8; Ex-2092,
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`8; Ex-2113; Ex-2114. Root and Sutton detail how the prototypes were assembled.
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`Ex-2118, ¶¶25, 34-35, 41, 44, 46; Ex-2119, ¶¶32, 34-36. Erb, who participated
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`first-hand in the process, corroborates that testimony. Ex-2122, ¶¶10, 12; see also
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`Ex-2039, ¶¶5-7, 9, 11.
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`Rule of reason evidence must be considered as a whole, even where no one
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`piece of evidence in and of itself establishes a fact, and even where the evidence is
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`circumstantial. NFC Tech., 871 F.3d at 1371-72. The law does not require
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`corroboration of every point of a reduction to practice. Cooper v. Goldfarb, 154
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`F.3d 1321, 1330 (Fed. Cir. 1998); Intellectual Ventures II LLC v. Motorola
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`Mobility LLC, 692 F. App’x 626, 627 (Fed. Cir. 2017). The goal of the rule of
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`reason is to determine “whether the inventor’s story is credible.” Fleming v.
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`Escort Inc., 774 F.3d 1371, 1377 (Fed. Cir. 2014); see also E.I. duPont, 921 F.3d
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`at 1077-78. Zalesky does not assert that any of Teleflex’s evidence is false. Ex-
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`2237, 138:5-139:25, 154:4-155:13, 188:3-18, 227:14-17, 250:19-22. With its
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`arguments, Medtronic only implicates its own credibility with overkill, conjecture,
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`and rejection of controlling law.
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`8
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`2.
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`The April and July 2005 GuideLiner Prototypes Were
`Tested and Shown to Work for Their Intended Purpose
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`The intended purpose of the GuideLiner was to increase backup support for
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`delivery of interventional cardiology devices, including procedures involving
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`tough or chronic total occlusions. Exs-2002, -2003, -2024.
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`Petitioner’s expert agrees that no testing would have been required to know
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`that an RX catheter design would work for that purpose. Brecker testified that a
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`POSITA in 2005 would understand, without any physical testing, that Itou would
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`provide this increased backup support. Ex-2116, 110:20-113:24; Ex-2238, 87:18-
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`89:5. Brecker explained it was an inherent, known principle that a catheter-within-
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`a-catheter would increase backup support for this purpose. Ex-2116, 110:20-
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`111:24. Zalesky and Jones are in accord, as is Teleflex’s expert, Keith. Ex-2237,
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`182:19-184:22, 36:13-37:10, 57:19-60:8; Ex-2241, 85:20-25, 86:21-89:2; Ex-
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`2123, ¶20; Ex-1764, 49:15-50:25; see also Ex-1010 (successful testing of mother-
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`and-child in chronic total occlusion cases). Zalesky further testified that the
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`GuideLiner patents use the same principle as the mother-and-child approach as it
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`relates to axial and shear forces. Ex-2237, 95:20-23. Such admissions about
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`inherency show that no testing was required to reduce GuideLiner to practice.
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`Pfizer, Inc. v. Genentech, Inc., IPR2017-01488, Paper 87 at 24 (PTAB, Nov. 29,
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`2018); see In re Stempel, 241 F.2d 755, 759 (C.C.P.A. 1957).
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`
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`9
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`
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`The inventors did not merely know the GuideLiner would work, they proved
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`it. Root testified about the specific GuideLiner benchtop tests, including delivering
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`and retrieving interventional devices in the same coronary anatomies Zalesky said
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`he would test for more difficult lesions and anatomies. Ex-1762, 105:18-24,
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`106:9-13, 100:18-102:13; Ex-2237, 59:4-13, 152:11-153:21; see also Ex-2118,
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`¶¶17-18, 35, 38; Ex-2119, ¶¶37-38, 41. Root’s testimony is corroborated by Erb,
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`who not only witnessed the testing, but explained that the testing proved the
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`prototypes worked. Ex-2122, ¶¶11-12. Invoices for prototype parts and the fact
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`that Erb had just joined VSI in early 2005 corroborate his memory about the
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`timeframe. Ex-1756, 33:16-24; Ex-2122, ¶¶1, 5-12; Ex-2110. Additional
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`corroboration comes from Schmalz, who testified that the GuideLiner RX would
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`not be included in the August 24, 2005 Product Requirements document (Ex-2024)
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`unless it had been tested and shown to work for its intended purposes, and that she
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`had an independent recollection of a working GuideLiner RX prototype before that
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`document. Ex-2039, ¶¶4-7; Ex-1766, 21:20-22:5, 46:17-47:2, 48:18-49:3, 49:18-
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`21; Ex-2118, ¶54; Ex-2119, ¶44. If testing were required, Teleflex’s evidence is
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`more than enough under the rule of reason. Loral Fairchild, 266 F.3d at 1364-65;
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`Compass Bank v. Intellectual Ventures II, LLC, IPR2014-00786, Paper 46 at 22-24
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`(PTAB Sept. 23, 2015).
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`
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`10
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`
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`The inventors were not required to show that the GuideLiner worked
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`perfectly or for every difficult case. DSL Dynamic Scis., Ltd. v. Union Switch &
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`Signal, Inc., 928 F.2d 1122, 1126 (Fed. Cir. 1991). Zalesky agrees. Ex-2237,
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`33:24-34:3, 37:14-18, 112:19-113:5. And whereas repeatability is key in
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`regulatory clearance and commercialization, “[o]nce the invention has been shown
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`to work for its intended purpose, [RTP] is complete.” Loral Fairchild, 266 F.3d at
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`1362-63; Ex-2237, 36:1-5. Indeed, when asked whether testing for regulatory
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`purposes was the same as that for RTP, Zalesky responded with an emphatic “No,
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`no, no, no, no.” Ex-2237, 63:23-64:9. Zalesky also admitted that, like VSI, he
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`never began the formal regulatory process until he knew the product would work
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`for its intended purpose. Id., 64:17-20.
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`The additional engineering VSI conducted after RTP was undisputedly to
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`refine the product for regulatory purposes and commercialization. Ex-2118, ¶¶59-
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`75, 88-91; Ex-2119, ¶¶6, 23, 41, 44, 48-49, 52; Ex-2122, ¶¶13-14. This is
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`something that “absolutely” happens, even in Zalesky’s experience. Ex-2237,
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`113:20-114:11; see also id., 43:22-44:10, 44:21-45:5, 117:3-118:1. Changes for
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`commercialization—even substantial ones—do not disprove an earlier RTP. DSL
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`Dynamic, 928 F.2d at 1126. Again, Zalesky agrees. Ex-2237, 193:19-194:3,
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`194:22-195:11.
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`
`
`11
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`
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`III. Diligence
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`The extensive record about VSI’s continual work to optimize GuideLiner,
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`along with its work to patent the invention, shows diligence from conception to
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`constructive reduction to practice. POR, 28-29, 3-19.
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`IV. Petitioner’s Reply Confirms There is No Substantial Dispute That the
`ʼ032 Patent Claims Cover the Prototypes
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`Petitioner relies on Zalesky’s claim chart to argue that the GuideLiner April
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`and July 2005 prototypes did not reduce to practice each claim element of the ʼ032
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`patent. Reply, 3, n.2. But Zalesky testified—vehemently—that his opinions are
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`not based on any understanding of what the claim terms mean. Ex-2237, 216:8-12;
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`218:7-12. Zalesky’s charts “largely depend” on his belief that there is insufficient
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`corroboration that the prototypes were built and tested, not that they lacked any
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`claim limitations. Id., 217:24-218:6; see also 216:13-24; Ex-1755, App’x A. But
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`the question of whether the prototypes were built and tested is a separate question.
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`Ample evidence shows they were. Supra, Part II(B).
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`Nevertheless, the annotated drawings from Teleflex’s Response are updated
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`below with some of the particular language of the ʼ032 patent claims that Zalesky
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`purports to address:
`
`
`
`12
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`
`
`April Prototypes
`April Prototypes
`
`Flexible tip portion
`(claims 11—22)
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`Reinforced portion
`
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`
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`
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`
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`
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`
`(claims 1-10) Distal End
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`
`See Exs-2089, -2113.
`See Exs-2089, -2113.
`
`
`
`
`
`
`
`13
`13
`
`
`
`
`
`Flexible tip portion
`(claims 11—22)
`§ E
`
`July Prototypes
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`
`Reinforced portion
`
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`Flexible tip portion (claims 1—10)
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`
`Substantially rigid portion defining rail structure
`
`a -
`
`--
`
`A
`
`II
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`4”“ Machined end for connecting
`to MED component
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`“en MW.I'.;|.
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`0
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`See Exs-2092, -2114.
`See Exs-2092, -2114.
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`14
`14
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`A. Attachment of Proximal and Distal Sections (Claims 1, 10-11, 22)
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`Zalesky’s chart disingenuously alleges there is no evidence showing how the
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`distal and proximal components of the April and July 2005 prototypes were
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`assembled. E.g. Ex-1755, App’x A cls. 1, 10-11, 22. As detailed above, the
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`corroborated evidence shows these parts had bored/machined ends specifically to
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`facilitate their connection. See supra, 8. According to Zalesky, it “doesn’t make a
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`lot of sense” for VSI to have commissioned these prototype components only to
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`leave them unassembled. Ex-2237, 208:14-19.
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`B.
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`“Flexible Distal Tip Portion” / “Flexible Tip Portion” (Claims 6,
`11)
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`Zalesky’s chart argues that there is no evidence that the July 2005 prototype
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`had a flexible distal tip. Ex-1755, App’x A cls. 6, 11. Even if true, it would not
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`negate RTP by the April prototype. See Ex-2237, 34:17-36:5. And it is not true.
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`Zalesky admitted that the unreinforced distal tip of the July prototype’s distal
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`section had merely been shortened from the April distal tip. Id., 178:21-180:4.
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`This is consistent with Root’s explanation. Ex-2118, ¶44. This July distal design
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`is almost identical to that of the full GuideLiner drawing at Exhibit 2022:
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`15
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`Ex-2022.
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`C.
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`“Resisting Axial and Shear Forces” (Claims 2, 12)
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`Zalesky’s chart states that he is unaware of evidence that the prototypes
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`would assist in resisting axial and shear forces, i.e., backup support. Ex-1755
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`¶¶233-237, App’x A cls. 2, 12. But he admitted that the GuideLiner patents “use[]
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`the same principle as the mother and child as it relates to axial and shear forces,”
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`and explained how those forces support delivery of a device through a lesion. Ex-
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`2237, 95:20-23, 183:9-184:6. Moreover, because Petitioner and its experts
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`contend that this principle is inherently disclosed in Itou, they cannot deny it for
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`purposes of CRTP. Petition -00126 at 38; Ex-2116, 110:20-113:24; Ex-2241,
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`86:21-89:5; Pfizer, IPR2017-01488, Paper 87 at 24.
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`16
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`D.
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`“Proximal Side Opening” in the Tubular Portion (Claims 3, 4)
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`Zalesky’s chart does not dispute that the cut-down hypotubes had a side
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`opening, but alleges that the prototypes made with those hypotubes did not meet
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`claims 3 and 4 because, according to Zalesky, the side opening in the cut-down
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`hypotubes can only be part of the “substantially rigid portion.” Ex-1755 App’x A
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`cls. 3, 4; see Ex-2237, 211:11-16, 222:18-22. Zalesky’s argument lacks foundation
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`because his rebuttal is not based on any understanding of the claim terms. Ex-
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`2237, 216:8-12, 214:5-8, 218:7-12, 203:17-20, 216:13-24. Further, Petitioner
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`contends that Itou’s suction catheter, which has a proximal side opening formed
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`from a cut metal pipe, meets the side opening limitation of claims 3-4 (Petition
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`00126 at 39, 43). Petitioner cannot have it both ways. In re Stempel, 241 F.2d at
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`759 (all the patentee need show is “so much of the claimed invention as the
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`reference happens to show”).
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`E.
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`“One French Smaller” (Claims 8, 17)
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`Zalesky’s chart argues that the July prototype did not meet the “one French
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`smaller” claim limitation and that there is not corroboration for the April prototype.
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`Ex-1755 App’x A cls. 8, 17. But VSI purchased 6-French guide catheters in April
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`2005 for GuideLiner testing and Root detailed how the April distal section was
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`suitable for a 6-French guide catheter. Ex-2016; Ex-2118, ¶36, App’x A cls. 8, 17.
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`17
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`F.
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`Standard Guide Catheter Length and Single Hemostatic Valve
`(Claims 10, 14, 22)
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`Zalesky’s chart argues that there is no corroborated evidence that the
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`prototypes used a standard guide catheter or a single hemostatic valve. Ex-1755
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`App’x A cls. 10, 14, 22. But he does not dispute that the prototypes were “for use”
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`with a standard guide catheter and single hemostatic valve (as recited in the
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`claims), as those advantages of the GuideLiner design were identified at the outset.
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`Ex-2002, 8; Ex-2004, 1-2; Ex-2237, 49:8-12, 61:24-62:2, 45:24-46:1, 202:17-
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`203:5; Ex-2022. And again, that standard 6-French guide catheters were delivered
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`on April 6, 2005, corroborates that the prototypes were tested in a standard guide
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`catheter. Ex-2016.
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`V.
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`Petitioner’s Procedural Challenge Fails
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`Petitioner attempts to sandbag Teleflex with belated deployment of a
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`procedural rule, 37 CFR §42.6(a)(3), to cancel the evidence altogether.
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`Petitioner’s argument ignores the unique procedural course the Board has charted
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`for this five-patent, eleven-IPR dispute and would nullify thousands of pages of
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`briefing and exhibits, at least six depositions, and an extraordinary investment by
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`both parties to have this issue resolved on the merits by the Board. Petitioner
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`should have raised the issue three months ago. Research in Motion Corp. v.
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`Multimedia Ideas LLC, IPR2013-00036, Paper 15 at 7-8 (PTAB Mar. 18, 2013).
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`Instead, it relied on the Root declaration to argue for—and obtain—more words to
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`18
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`
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`address CRTP. Ex-1099, 5:14-7:10, 11:22-14:1. Having done so, it cannot now
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`have the content of that declaration ignored by the Board.
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`The Board advised that the primary purpose of §42.6(a)(3) is to avoid the
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`need to scour the evidentiary record to determine what issues are disputed by the
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`parties. Ex-2233, 18:13-15. Petitioner’s Itou-based CRTP challenge spans seven
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`IPRs and has led to a departure from the standard briefing rules. First, the Board
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`indicated its preference that Teleflex submit a unified, 5000-word consolidated
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`Response on CRTP. Teleflex did so to meet the Board’s preference, not to evade
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`word limits. Second, the Board allowed two sets of post-institution briefs on this
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`issue, with Petitioner having the final word in a sur-surreply. Ex-1099, 13:17-14:1.
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`Given the unique circumstances of this dispute, Teleflex’s single Response
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`not only argued the primary dispute, which was whether the prototypes were
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`actually reduced to practice, it additionally briefed where the key claim elements of
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`the GuideLiner patents, going so far as to annotate drawings to show where those
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`key elements were found. POR, e.g. 9-11, 14-16. In addition, Teleflex submitted a
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`detailed declaration with claim charts explaining where each element of the
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`challenged claims was found in the prototypes. POR, 22; Ex-2118, App’x A-E.
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`Petitioner did not move to strike. Rather, it replied with responsive evidence,
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`including rebuttal claim charts appended to its expert’s declaration. Reply, p. 3, n.
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`2 (incorporating by reference Ex-1755, App’x A-E).
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`
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`19
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`
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`As discussed supra, Petitioner’s Reply confirms that there is little dispute
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`that the April and July 2005 prototypes embodied each element of the GuideLiner
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`patent claims. The focus of the dispute is whether Teleflex has come forward with
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`sufficient and corroborated evidence that the prototypes were actually made and
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`shown to work for their intended purpose. E.g. Ex-2237, 252:24-253:24, 214:5-8,
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`216:8-12. The briefs have crystalized the issues, and Petitioner’s sur-surreply
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`affords it the final word. Having instituted a trial on CRTP, each party having
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`invested substantial resources in gathering and presenting documentary and
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`testimonial evidence and having used the fair opportunity to challenge the other’s
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`evidence, the Board should decide the issue on the merits.
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`Dated: January 26, 2021
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`Respectfully submitted,
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`/ J. Derek Vandenburgh /
`
`
`J. Derek Vandenburgh (Lead Counsel)
`Registration No. 32,179
`Carlson, Caspers, Vandenburgh
` & Lindquist, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Telephone: (612) 436-9600
`Facsimile: (612) 436-9650
`Email:
`DVandenburgh@carlsoncaspers.com
`
`Lead Counsel for Patent Owner
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`20
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`CERTIFICATE OF WORD COUNT COMPLIANCE
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`Pursuant to 37 C.F.R. §42.24(d), the undersigned certifies that this Patent
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`Owner’s Sur-Reply Addressing Conception and Reduction to Practice complies
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`with (i) the 2,800 word limitation set forth in the Board’s Order Adjusting Word
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`Counts for Briefing on Conception and Reduction to Practice, and (ii) the 500
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`word limitation to address Petitioner’s “incorporation by reference argument” set
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`forth by the Board in its oral order of January 5, 2021 as set forth in Exhibit 2233.
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`The word count application of the word processing program used to prepare this
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`Sur-Reply indicates that it contains 3,260 words, excluding the parts exempted by
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`37 C.F.R. §42.24, with 467 of them being to address Petitioner’s “incorporation by
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`reference argument.”
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`Dated: January 26, 2021
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`Respectfully submitted,
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`/J. Derek Vandenburgh/
`J. Derek Vandenburgh
`(Lead Counsel for Patent Owner)
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`21
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`CERTIFICATION OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e) and the agreement of the parties, the
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`undersigned certifies that on January 26, 2021, a true and correct copy of the
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`foregoing Patent Owner’s Sur-Reply Addressing Conception and Reduction to
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`Practice, exhibits filed contemporaneously with the foregoing brief, and the Patent
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`Owner’s Updated Exhibit List were served via electronic mail upon the following:
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`Cyrus A. Morton (Reg. No. 44,954)
`Sharon Roberg-Perez (Reg. No. 69,600)
`Christopher A. Pinahs (Reg. No. 76,375)
`William E. Manske
`Emily J. Tremblay
`Robins Kaplan LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 349-8500
`Fax: 612-339-4181
`Email: Cmorton@robinskaplan.com
`Email: Sroberg-perez@robinskaplan.com
`Email: Cpinahs@robinskaplan.com
`Email: Wmanske@robinskaplan.com
`Email: Etremblay@robinskaplan.com
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`/J. Derek Vandenburgh/
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`J. Derek Vandenburgh (Lead Counsel)
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`22
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`
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