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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.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-00136
`U.S. Patent No. RE45,776
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`PATENT OWNER SUR-REPLY
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
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`INTRODUCTION ........................................................................................... 1
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`CLAIM CONSTRUCTION—CLAIM 36 ..................................................... 2
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`III. PETITIONER HAS NOT SHOWN THAT THE CHALLENGED CLAIMS
`WOULD HAVE BEEN OBVIOUS ................................................................ 3
`
`A.
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`The Board Should Not Credit Petitioner’s New Theory Relying on
`Substantial New Modifications to Material Aspects of Kontos ............ 3
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`B.
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` Grounds 1 and 2—Kontos Plus Ressemann’s Collar Member ............ 7
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`1.
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`Petitioner has not shown that a POSITA would be motivated,
`with a reasonable expectation of success, to replace Kontos’s
`funnel with Ressemann’s isolated collar component .................. 8
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`a.
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`b.
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`The evidence does not support the Petition’s motivation
`to reduce the diameter of the GC with a reasonable
`expectation of success ...................................................... 8
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`The purported motivation to “maximize the usable real
`estate” by “increasing the interior diameter” of Kontos is
`both new and unsupported .............................................. 10
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`Petitioner’s other motivations are unsupported and hindsight-
`driven......................................................................................... 12
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`Petitioner’s modification would create a problematic gap/catch
`point where none existed before ............................................... 14
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`Petitioner failed to show a reasonable expectation of success
`with the precise tab-on-top combination .................................. 16
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`Petitioner’s new “three inclines” theory is both improper and
`wrong......................................................................................... 18
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`2.
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`3.
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`4.
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`5.
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`
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`i
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`C.
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`D.
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`Claim 49 (Ground 1): Petitioner Has Not Shown that Kontos Provides
`the Claimed Backup Support to Assist in Resisting Axial and Shear
`Forces .................................................................................................. 21
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`“One French Size”—Petitioner Failed to Show that a POSITA Would
`Be Motivated to Modify the References with a Reasonable
`Expectation of Success (Grounds 2 and 4, Claims 30-31, 53-56) ..... 22
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`E. Kataishi Does Not Render a Double-Inclined Side Opening Obvious
`(Ground 3, Claim 52) .......................................................................... 23
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`IV. ALL GROUNDS, ALL CHALLENGED CLAIMS: COMPELLING
`OBJECTIVE EVIDENCE CONFIMS THAT INDEPENDENT CLAIMS
`25, 52, AND 53 WOULD NOT HAVE BEEN OBVIOUS .......................... 25
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`A.
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`B.
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`C.
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`The Objective Evidence Is Undisputed ............................................... 25
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`The Combination of Features That Resulted in GuideLiner’s Success
`and Praise Is Not in the Prior Art ........................................................ 26
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`The Fact that All of GuideLiner’s Competitors Copied its Design
`Confirms Non-Obviousness ................................................................ 27
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`
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`ii
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`TABLE OF AUTHORITIES
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`Cases
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`In re Magnum Oil Tools Int'l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ............................................................................ 21
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ....................................................................... 5, 19
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ..................................................................... 27, 28
`
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................ 26
`
`Mytee Prods. v. Harris Rsch., Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ....................................................................... 21
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................ 26
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`Other Authorities
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`37 C.F.R. § 42.23(b) ........................................................................................... 5, 19
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`iii
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`
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`INTRODUCTION
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`I.
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`As Patent Owner (“Teleflex”) noted in its Response, one of the things that
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`makes the ’776 patent different from the other GuideLiner patents is that two of the
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`three independent claims require a “segment defining a partially cylindrical
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`opening” proximal of the tubular structure that has “at least two inclined regions.”
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`Using improper hindsight, the Petition sought to use advantages of the
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`claimed two-incline side opening as motivations to argue that it would have been
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`obvious to modify Kontos’s narrow support catheter and add such a specifically-
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`shaped opening. But Teleflex’s Response showed that neither of the cited
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`secondary references (Ressemann and Kataishi) actually shows such a two-incline
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`proximal side opening, much less provides a motivation to add one to Kontos.
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`Teleflex also proved that Petitioner ignored critical aspects of Kontos’s structure,
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`such that its proposed modifications did not actually result in the claimed
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`invention.
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`So in Reply, Petitioner totally changed positions. Petitioner now proposes at
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`least six significant additional modifications to Kontos in an effort to arrive at the
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`claimed invention. It also provides new and different alleged motivations for
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`making these changes, and argues that Ressemann’s isolated collar component
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`actually has at least three inclined regions, rather than the two its Petition pointed
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`1
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`to. The moving target of ever-changing theories only confirms the hindsight
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`Petitioner is using.
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`The real-world facts confirm the invention was not obvious. GuideLiner
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`solved an undisputed long-felt need, was met with immediate commercial success
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`and widespread industry acclaim, and was copied by competitors, and Petitioner
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`does not dispute any of this. Instead, Petitioner tries to argue that guide extension
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`catheters with the claimed features responsible for GuideLiner’s success had
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`already been invented. But that is indisputably not true. The Board should
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`confirm patentability of the challenged claims.
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`II. CLAIM CONSTRUCTION—CLAIM 36
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`Petitioner’s assertions regarding claim 36 (Paper 69 (“Reply”), 1), are wrong
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`but also immaterial. In the other ’776 patent IPR, Petitioner seeks to read claim 36
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`on the single angle opening of Itou, giving rise to a claim construction dispute
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`there. See IPR2020-00135, Paper 43, 10-11. But here, construing claim 36 is
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`unnecessary because the primary reference Kontos does not have a side opening of
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`any sort and Petitioner relies only on the flawed combination of Kontos plus
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`Ressemann for claim 36. To the extent the Board concludes otherwise, it should
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`adopt the construction proposed by Teleflex in IPR2020-00135. Id.
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`2
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`III. PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS WOULD HAVE BEEN OBVIOUS
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`A. The Board Should Not Credit Petitioner’s New Theory Relying on
`Substantial New Modifications to Material Aspects of Kontos
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`Teleflex’s Response pointed out that Petitioner’s obviousness arguments did
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`not make sense because it ignored aspects of Kontos’s device other than the funnel,
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`such as the protruding base portion 18 and the distal tip configuration. E.g. POR,
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`23-24, 45-47. Now in Reply, Petitioner relies on an entirely new argument,
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`premised on myriad additional, material modifications to Kontos:
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`Kontos:
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`Kontos, as modified in Petition:
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`Kontos, as completely redesigned in Reply:
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`3
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`Ex-1409, Fig. 1; Petition, 34; Reply, 7-8, 13-15, 20-21. Petitioner’s Reply
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`contends, for the first time, that a POSITA would be motivated to completely
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`change Kontos, with at least six additional changes beyond those advocated in the
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`Petition: (1) “recess[ing]” Kontos’s marker bands; (2) attaching the distal soft tip
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`in-line rather than with overlapping structure; (3) removing Kontos’s base portion
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`18; (4) “taper[ing] the pushrod” down to less than 0.005 inches; (5) somehow
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`“attach[ing]” the thin-tapered pushrod to Kontos’s tube wall without base portion
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`18, and (6) “increase[ing]” the diameter of “tube 16.” E.g. Reply, 20-21; Ex-2241,
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`124:13-126:20. Petitioner seeks to support this new invalidity theory with at least
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`twenty-eight new paragraphs of analysis in a new declaration from a new expert.
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`Reply, 8, 20-21 (citing Ex-1807, ¶¶168-182, 183-195).1
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`1 After the first round of depositions, Petitioner dropped its engineering expert
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`Hillstead and retained another, Jones. Ex-2239, 13:7-10. But Jones never
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`reviewed the GuideLiner patent claims (save claim 1 of the ’032). Id., 14:16-
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`16:15. And he admitted that his opinions were based at least in part on inventor
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`testimony regarding how the inventor came up with the invention (id., 39:15-40:4),
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`which should not be part of an obviousness analysis. Jones’ entire role has been an
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`exercise in pure hindsight, and his testimony (Ex-1807) should be given no weight.
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`4
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`IPR rules prohibit this type of belatedly-raised “new issue.” PTAB
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`Consolidated Trial Practice Guide (November 2019) (“TPG”), 73-74; 37 C.F.R.
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`§ 42.23(b); Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359,
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`1369-70 (Fed. Cir. 2016). It would be facially unfair to allow Petitioner to present
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`this new theory, with new, detailed evidence, at a stage where Teleflex has not
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`been permitted to present evidence in response. Petitioner’s proposal of a
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`complete redesign of Kontos is too late and the Board must reject it.
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`Even with just the evidence of record, there are numerous substantive
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`reasons to reject Petitioner’s new invalidity theory. The very notion that it takes
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`more than six significant modifications to get from Kontos to the claimed structure
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`belies obviousness and shows that Petitioners are using the invention as a roadmap.
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`Kontos’s device has a relatively narrow central tube 16 that fits snugly around a
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`“fragile” PTCA catheter, as well as outwardly-projecting structures at the distal
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`and proximal ends that serve various functions while not detracting from the ability
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`of the device to be used in a 6 French guide catheter. POR, 9-12, 25. Redesigning
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`Kontos to remove those projecting structures is inconsistent with what Kontos is
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`designed to do. Id.
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`For example, Kontos teaches that the protruding base section 18 of his
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`support catheter creates an “eccentric cross-section” that is important to the
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`invention—it “provides leverage for facilitating manipulation of body 12.” Ex-
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`5
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`1409, 4:34-38. Similarly, Petitioner’s new argument that a POSITA would be
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`motivated to “taper” the relatively-thick 0.020” pushwire down to less than 0.005”
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`(e.g. Ex-1807, ¶¶190, 194-195 (showing “tapered” pushrod)) directly contradicts
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`Petitioner’s argument in a related IPR that a POSITA would be motivated to
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`modify Itou’s pushwire because where it has been “crushed” to create a “flat plate”
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`creates a “potential weakness point in the catheter.” IPR2020-00135, Paper 82, 17.
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`Moreover, Petitioner does not adequately explain how a POSITA would
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`expect to successfully attach a metal pushrod that had been “tapered” to less than
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`0.005” to the purported Kontos/Ressemann combination. See Reply, 21. Kontos’s
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`statement that tube 16 may be “molded directly onto” the pushwire 14 (Ex-1409,
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`4:31-32) does not suggest that the robust, relatively large-diameter 0.020”
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`pushwire would be tapered in any fashion, much less thinned out to a small
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`fraction of its disclosed size. See also Ex-2241, 49:2-5 (Petitioner’s new expert
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`admitting that he was not aware of any prior art showing a wire tapered down to
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`less than 0.005 inches); id. 158:1-14 (admitting that the polar moment of inertia for
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`a 0.005” pushwire would be 256 times smaller than Kontos’ disclosed 0.020”
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`pushwire).
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`Petitioner relies on this new theory for all of the challenged claims. Reply,
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`8, 13-15, 20-21. Petitioner’s resort to a completely new invalidity theory only
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`6
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`confirms Petitioner’s improper use of hindsight. The Board should reject
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`Petitioner’s new theory and confirm that the challenged claims are patentable.
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`B. Grounds 1 and 2—Kontos Plus Ressemann’s Collar Member
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`Petitioner contends that “PO’s entire opposition is based on the mistaken
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`belief that after adding Ressemann’s collar, a POSITA would make no further
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`modification to Kontos’s support assembly 10.” Reply, 5. But Teleflex was not
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`mistaken. Petitioner is the master of its Petition. If Petitioner’s invalidity theory
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`was that it would have been obvious to make a myriad of additional material,
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`undisclosed changes to Kontos rather than the one the Petition identified, then
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`Petitioner was required to present and support that theory in its Petition, not for the
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`first time in Reply.
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`Petitioner also ignores the predicate question of why a POSITA would be
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`motivated to look to Ressemann’s collar 2141 in the first place. Petitioner’s first
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`engineering expert admitted at deposition that the tab portion 2141b of that collar
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`does not define the shape of Ressemann’s proximal opening and instead is buried
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`deep inside a shaft 2120. E.g. POR, 37; Ex-2116, 141:5-19. Apparently
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`recognizing this inconvenient fact, Petitioner directed its new Reply expert to
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`deliberately ignore how Ressemann actually used collar 2141b and instead to just
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`consider the collar component in isolation. Ex-1807, ¶82. Petitioner now does not
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`dispute that the collar tab 2141b its Petition relied heavily on actually forms no
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`7
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`part of Ressemann’s proximal opening. POR, 22-38. For this reason alone, the
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`Board should reject the proposed combination as premised on improper hindsight.
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`Moreover, even assuming that a POSITA were motivated to look to the
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`shape of Ressemann’s collar in isolation, Petitioner has not carried its burden.
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`1.
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`Petitioner has not shown that a POSITA would be
`motivated, with a reasonable expectation of success, to
`replace Kontos’s funnel with Ressemann’s isolated collar
`component
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`The Petition contended that a POSITA would be motivated to replace
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`Kontos’s funnel with a side opening to “permit a reduction of the outer diameter of
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`the catheter assembly” to allow use of a smaller guide catheter. Petition, 29-31. In
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`Reply, Petitioner repeats that motivation and also adds a new one: “maximizing
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`usable real estate” by “increasing” the interior diameter of Kontos’s body 12.
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`Reply, 5, 7-8. Neither is persuasive.
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`a. The evidence does not support the Petition’s motivation
`to reduce the diameter of the GC with a reasonable
`expectation of success
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`There is no reason to modify Kontos’s device to fit in a 6 French guide
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`catheter (“GC”), since the device as disclosed fits in a 6 French GC. POR, 25-26.
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`Petitioner’s argument that Kontos’s funnel may “rub” in a 6 French GC (Reply, 6)
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`is contradicted by its own expert, who testified that Kontos would work fine with a
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`6 French GC. E.g. Ex-2241, 107:8-15. It is also contradicted by Ressemann,
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`which teaches that a funnel that touches the inner wall of the guide catheter is
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`8
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`beneficial because it can create a “sliding seal” that “prevents the passage of fluid.”
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`Ex-1408, 7:43-47. Petitioner’s contention that Kontos’s funnel is too small to do
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`much funneling (Reply, 6) is hindsight that ignores Kontos’s teaching that the
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`funnel was purposeful; its expert agreed that even when used in a 6 French GC
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`Kontos’s funnel would be useful. Ex-2241, 158:21-159:6.
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`Petitioner does not dispute that removing Kontos’s funnel would not enable
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`it to fit in a 5 French GC, due to the presence of thickened base portion 18 and the
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`distal marker band/overlapping soft tip structure. Instead, Petitioner invokes its
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`new “at least six additional changes” modification to Kontos. Reply, 7 n.2, 20-21.
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`The Board should disregard these improper, new proposed modifications, for the
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`reasons explained above. Supra, §III(A). Moreover, there is still no record
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`evidence that a POSITA would have been motivated to make Kontos fit inside a 5
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`French GC at the time of the invention. In the 2005/2006 timeframe, 5 French
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`GCs “offer[ed] no major advantage and [were] not routinely used.” Ex-2167, 33;
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`see also Ex-2138, ¶170; Ex-2145, ¶220. The three articles Petitioner’s expert cites,
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`Exs. 1836-1838, were published in 2014, 2013, and 2008, well after the date of
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`invention. See Ex-1806, ¶171.
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`9
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`b. The purported motivation to “maximize the usable real
`estate” by “increasing the interior diameter” of Kontos
`is both new and unsupported
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`The Petition argued only that one would be motivated to remove Kontos’s
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`funnel to decrease the size of the guide catheter. Petition, 30-31 (“the diameter of
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`the GC could be reduced”). After seeing Teleflex’s Response, Petitioner now tries
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`to pivot to a new “maximize the usable real estate” motivation. Reply, 5-8. But
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`the TPG specifically identifies “new motivations” as arguments that should not be
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`permitted for the first time in reply. TPG, 74.2
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`Petitioner’s new argument is also unpersuasive. Petitioner based its
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`argument on testimony that maximizing usable real estate is one the benefits of the
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`GuideLiner invention. Reply, 5. That shows hindsight, not obviousness.
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`Moreover, the only way that Petitioner can maximize real estate inside Kontos’
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`support catheter is by invoking the improper additional modifications, such as
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`recessing the marker band. Id., 8. As discussed above, those additional
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`modifications are untimely and unsupported. Supra, §III(A). And Petitioner does
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`2 Petitioner attempts to justify its new argument by asserting that “PO argue[d] that
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`it would not be possible to increase the diameter of body 12.” Reply, 8 (citing
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`POR, 23-24). Even if true, that would not open the door. And it is not true—
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`Teleflex said no such thing at pages 23-24 or anywhere else in its POR.
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`10
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`not explain how a POSITA would expect to successfully recess marker band 36 in
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`the thin (0.005”) polymer wall, or having done that, how a POSITA would expect
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`to securely attach soft tip 28 without the disclosed overlapping material. As
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`Teleflex’s expert testified when asked about recessing Kontos’s marker band, there
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`would not have been an obvious way to successfully do that in 2005. Ex-1800,
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`194:19-197:24.
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`Redesigning Kontos in order to increase interior diameter also would have
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`been contrary to Kontos’s teaching of a “support catheter” to (i) protect delicate
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`fixed-wire balloon catheters and (ii) have a small enough profile to fit inside a
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`lesion as a temporary stent. E.g. POR, 10-12; Ex-1409, 4:61-62 (0.045” inner
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`diameter “generally are suitable for existing PTCA catheters”), 5:20-22 (“relatively
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`fragile PTCA catheter balloon 48 will be safely surrounded”), 2:26-29 and 6:59-
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`7:5 (support catheter serves as a stent itself), Figs. 5-9 (snug-fitting support
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`catheter). Kontos’s statement that “other sizes may be used for other applications”
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`(see Reply, 3) does not show a desire for a loose, rather than snug fit—it simply
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`recognizes that other-sized devices exist.
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`Petitioner argues that Kontos’s device does not actually prevent kinking via
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`the support catheter’s “spatial relationship” with the PTCA catheter, but rather
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`through the use of a “lubricious inner coating.” Reply, 3. This is untethered from
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`the teaching of Kontos. First, Kontos says nothing about its support catheter
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`11
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`having a lubricious inner coating, much less that a lubricious coating is what
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`prevents the kinking. Second, Kontos’s device is called a “support” catheter, and
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`the specification indicates that it prevents kinking by “supporting,” i.e., by the
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`spatial relationship. Ex-1409, 6:50-58; 8:12-16, Figs. 5-9.
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`2.
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`Petitioner’s other motivations are unsupported and
`hindsight-driven
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`Petitioner’s Reply focuses first on a new purported motivation for the
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`Kontos-plus-Ressemann’s collar combination: “increase the area of entry . . . into
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`the side opening.” Reply, 9. The Petition did not rely on this motivation for this
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`combination. See Petition, 29-34, 55-56 (identifying four motivations). And with
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`good reason—it is transparent hindsight. Petitioner points to testimony from Dr.
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`Graham regarding the size of the opening of Ressemann’s collar when considering
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`the “tab” portion of that collar. Reply, 9. But it is now undisputed that the tab
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`portion 2141b of Ressemann’s collar is not part of Ressemann’s proximal opening
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`and does not contribute to its shape. POR, 32-38. Petitioner’s late pivot to focus
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`on the purported increased “area of entry” provided by the Ressemann collar tab is
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`just more hindsight driven by benefits of the GuideLiner invention.
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`Petitioner next cites “reinforc[ing] the proximal opening.” Reply, 9. The
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`point is not, as Petitioner argues, whether the combination is the “most desirable.”
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`Id. Rather, a POSITA would not be motivated to look to Ressemann’s specific,
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`customized collar component shape in the first place, absent hindsight. This is
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`12
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`particularly true given that Kontos relies on an entirely different proximal shape
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`for its tubular portion and an entirely different pushwire connection than
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`Ressemann. Moreover, even if a POSITA did, for some reason, look to
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`Ressemann’s collar component, a POSITA would not, without hindsight,
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`incorporate it in the complex, tab-on-top way Petitioner advocates. Indeed,
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`Ressemann’s collar tab 2141b is shaped concave up to mate under Ressemann’s
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`multi-lumen tube and inside the bottom of shaft 2120, and Ressemann teaches to
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`use the tab portion in that way. Ex-2138, ¶186. Ressemann itself teaches away
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`from Petitioner’s complex tab-on-top combination.
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`As for purported “smooth passage of other therapeutic devices” into the
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`proximal opening, Teleflex provided evidence that, compared to a funnel, a side
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`opening actually increased the likelihood of device hang-up. POR, 20, 26; Ex-
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`1408, 25:20-29. Petitioner cites back to Ressemann’s teaching of a side opening
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`providing “smoother” passage. Reply, 10. But Ressemann is not comparing its
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`angled opening to a funnel. Kontos already has funnel and therefore already
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`provides “smoother” passage. Compared to a funnel (the relevant comparison),
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`Ressemann taught that a side opening has increased risk of catching/hang-up.
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`Compare Ex-1408, 7:40-44 (disclosing a “flare”/funnel with no hang-up concerns)
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`with id. 25:20-29. Thus, there was no motivation to remove Kontos’s funnel to
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`obtain that same benefit but with the added risk of catching/hang-up. Id.
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`13
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`
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`As for purported “smoother passage of the catheter assembly as it navigates
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`the vasculature,” Petitioner still fails to weigh any such negligible benefit against
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`the importance of Kontos’s funnel to its disclosed functions. See Reply, 10.
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`Kontos’s funnel decreases the likelihood of device hang-up (as compared to both a
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`bare perpendicular opening and a side opening). POR, 26-27. And Kontos does
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`not have any issue with pushability—Petitioner takes Keith’s statements from
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`another case entirely out of context. See Reply, 16. The “pushability” problem is
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`that due to materials and geometry, the tube is too flexible to provide backup
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`support. See, e.g., Ex-1819, ¶¶89, 112.
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`Regarding permitting “smooth re-entry,” Petitioner again relies on
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`impermissible hindsight by citing testimony about use of the GuideLiner product
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`as purported evidence of obviousness. See Reply, 10. And Petitioner fails to
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`provide any rebuttal to Teleflex’s evidence that (i) the experts agree a POSITA
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`would never actually push Kontos’s support catheter all the way out of the GC, and
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`(ii) Kontos provides the funnel to deter that from happening. POR, 27-28.
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`3.
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`Petitioner’s modification would create a problematic
`gap/catch point where none existed before
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`Replacing Kontos’s funnel with a side opening would have been expected to
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`create a problematic gap/catch point, further dissuading a POSITA from making
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`this modification:
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`14
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`POR, 19. Nothing in Petitioner’s Reply changes this.
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`Petitioner first contends that when used in a 6 French GC, the gap would be
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`“only” 0.005 inches. Reply, 11-12. But Petitioner’s own new expert contends that
`
`guidewires are “ground to a progressive taper in its distal portion.” Ex-1807, ¶177
`
`(quoting Ex-1015, 551). Moreover, Petitioner’s expert admitted his analysis was
`
`strictly limited to using Kontos in a 6 French GC. Ex-2241, 120:1-7. While
`
`Kontos fits in a 6 French GC, it could (and would in 2005) be used in larger GCs.
`
`Ex-2238, 182:3-11; Ex-2241, 120:1-5. In larger GCs, the hang-up problem would
`
`only be increased.
`
`
`
`Petitioner next contends that Ressemann (and a similar, related reference)
`
`shows devices with side openings that had larger gaps. Reply, 12-13. But
`
`Ressemann itself teaches that such a gap was problematic and proposed either a
`
`funnel or a “reverse bevel” to try to mitigate that problem. POR, 20. The fact that
`
`another reference does not expressly mention the problem does not mean it doesn’t
`
`
`
`15
`
`
`
`exist and does not negate teaching away. The weight of the evidence is clear: a
`
`POSITA would be dissuaded from replacing Kontos’s funnel with a side opening
`
`where doing so would create a gap. Ex-2138, ¶¶142-149; Ex-1408, 25:23-29.
`
`
`
`Critically, Petitioner’s evidence and argument is directed to improving
`
`Kontos’s proximal opening as compared to just a perpendicular cut tube of uniform
`
`diameter. But that is not what Kontos discloses—Kontos discloses a funnel.
`
`Petitioner has not shown that Kontos’s funnel would have been expected to have
`
`issues with accepting devices or that Kontos’s ability to accept devices would have
`
`been improved—so there is no reason to replace it with a side opening, particularly
`
`when doing so would create a problem where there was none before.
`
`4.
`
`Petitioner failed to show a reasonable expectation of success
`with the precise tab-on-top combination
`
`A POSITA would have expected combining Ressemann’s collar in the
`
`unusual, tab-on-top manner necessary to arrive at the claimed invention to be
`
`difficult with no clear expectation of success. POR, 41-42. In Reply, Petitioner
`
`provides a new engineering expert who purports to address these problems. Reply,
`
`13-14 (citing Ex-1807, ¶¶188-92). A cross-section of the purported result is below,
`
`without (left) and with (right) Petitioner’s newly tapered pushwire:
`
`
`
`16
`
`
`
`
`
`Ex-1807, ¶189.
`
`Even if this was correct (it is not, and would not be expected to eliminate the
`
`issues, see Ex-2138, ¶195-196), this proposed solution ignores the extremely small
`
`size of alleged “incline 1,” which would simply disappear inside the added
`
`material. Ex-2138, ¶194. Petitioner’s new expert asserts that the angle at the tip of
`
`Ressemann’s tab could be “preserved. Ex-1807, ¶190. But when asked at
`
`deposition whether he knew the dimensions of the tiny angle compared to the
`
`polymer coating he was proposing, he conceded that he had “not worked that out
`
`or provided an opinion on that.” Ex-2239, 116:19-24. What’s more, there is no
`
`evidence of why a POSITA would be motivated to try to preserve the tiny incline,
`
`given the undisputed evidence that it serves no purpose in Ressemann. POR, 33-
`
`37.
`
`
`
`17
`
`
`
`Petitioner’s purported expectation of success also relies on its new
`
`wholescale redesign of Kontos:
`
`Reply, 14-15. For the reasons explained above, the Board should reject this
`
`
`
`argument. Supra, §III(A).
`
`5.
`
`Petitioner’s new “three inclines” theory is both improper
`and wrong.
`
`Perhaps recognizing the hindsight of its Ressemann tab-on-top argument,
`
`Petitioner alternatively argues that Ressemann’s tab could be put underneath the
`
`pushwire while still maintaining two inclines due to an alleged “third incline”:
`
`
`
`18
`
`
`
`Reply, 15-18 (citing Ex-1806, ¶¶197-200, Ex-1807, ¶192). This is yet another new
`
`theory. The Petition argued that Ressemann’s “support collar 2141” had “two
`
`inclines” as follows:
`
`
`
`
`
`Petition, 55. Petitioner’s new “three inclines” theory comes from Petitioner’s new
`
`expert, who acknowledged that he simply “came to [a] different conclusion[]” than
`
`Petitioner’s original expert. Ex-2239, 83:15-84:10. Such new obviousness
`
`theories are not permitted for the first time in reply, nor is such evidence that could
`
`
`
`19
`
`
`
`have been submitted with the Petition. TPG, 73-74; 37 C.F.R. § 42.23(b);
`
`Intelligent Bio-Sys., 821 F.3d at 1369-70. It would be patently unfair for the Board
`
`to consider this new argument when Teleflex has not been allowed to respond with
`
`evidence.
`
`Petitioner seeks to disguise how jarringly new this evidence and argument is
`
`by pointing to testimony it elicited from Teleflex’s witnesses regarding inclines
`
`present in other products. Reply, 15-17. But that testimony is not even about the
`
`Ressemann reference. See id. (citing images and testimony about GuideLiner V1
`
`and prototype drawings of Guideliner). Petitioner has not shown that these
`
`products, with different shapes than Ressemann, prove that Ressemann’s collar has
`
`three inclines.
`
`Petitioner’s new assertion about three inclined regions is also wrong.
`
`Petitioner’s new expert relies solely on a perspective view that makes it appear as
`
`if there might be a change of angle along the inclined portion:
`
`
`
`20
`
`
`
`
`
`Reply, 17-18. But such a perspective view is misleading. Indeed, Petitioner’s first
`
`engineering expert presented what he believed a side view of Ressemann’s collar
`
`would look like, plainly showing only a single incline:
`
`
`
`Single
`incline
`
` Ex-1442, ¶83 (red annotations original; blue annotations added). The Board
`
`should reject Petitioner’s effort to contradict the testimony of its original expert
`
`
`
`with a new expert.
`
`C. Claim 49 (Ground 1): Petitioner Has Not Shown that Kontos
`Provides the Claimed Backup Support to Assist in Resisting Axial
`and Shear Forces
`
`
`Petitioner wrongly seeks to apply a burden-shifting paradigm used in patent
`
`prosecution to this IPR. Reply, 18 n.4. The Federal Circuit has expressly rejected
`
`such burden shifting in IPRs—the burden to prove invalidity (including inherency)
`
`always stays on the Petitioner. In re Magnum Oil Tools Int'l, Ltd., 829 F.3d 1364,
`
`1375 (Fed. Cir. 2016). Petitioner’s case expressly pertains to patent prosecution,
`
`not inter partes review. Mytee Prods. v. Harris Rsch., Inc., 439 F. App’x 882, 886
`
`(Fed. Cir. 2011).
`
`
`
`21
`
`
`
`Demonstrating the insufficiency of the evidence cited with its Petition, the
`
`Reply relies exclusively on two new expert declarations (Ex-1806 and Ex-1807).
`
`Reply, 18-20. Even if the Board was to consider Petitioner’s untimely gap-filling
`
`evidence, Petitioner still fails to show that Kontos’s narrow, “pliable” structure
`
`necessarily provides the claimed back-up support. At best, Petitioner’s new
`
`evidence is directed to showing that Kontos could potentially do that. That is not
`
`enough. While a guide-catheter-within-guide-catheter assembly can provide
`
`improved backup support while still having a 0.015 annular gap, Kontos does not
`
`disclose a guide-catheter-within-guide-catheter assembly. Kontos instead teaches a
`
`“pliable,” close-fitting, narrow “support catheter” with asymmetric exterior
`
`protrusions. POR, 9-12. That a guide-catheter-in-guide-catheter assembly
`
`provides increased backup support does not mean that Kontos necessarily does.
`
`D.
`
`“One French Size”—Petitioner Failed to Show that a POSITA
`Would Be Motivated to Modify the References with a Reasonable
`Expectation of Success (Grounds 2 and 4, Claims 30-31, 53-56)
`
`Simply removing Kontos’s funnel would not permit the device to come close
`
`to meeting the one French limitation. POR, 45-47. Recognizing this, Petitioner
`
`again resorts to its new ‘at least six additional modifications’ th
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