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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.
`Petitioner,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-01344
`U.S. Patent No. RE46,116
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`PATENT OWNER SUR-REPLY
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`I.
`II.
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`TABLE OF CONTENTS
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`Page
`Introduction ...................................................................................................... 1
`Petitioner Has Not Shown that the Challenged Claims Would Have Been
`Obvious ............................................................................................................ 1
`A. Grounds 1-3 (Claims 25-40, 42, 44-48, 52, 53): The Board Should
`Reject Petitioner’s New Theory Relying on Extensive Additional
`Modifications to Material Aspects of Kontos ....................................... 1
`B. Grounds 1-2 (Claims 25-40, 42, 44-48, 52, 53): Petitioner Has Not
`Shown that a POSITA Would Have Been Motivated with a
`Reasonable Expectation of Success to Redesign Kontos to Have the
`Claimed “Side Opening” ....................................................................... 6
`1. The evidence does not support a motivation to “maximiz[e] the
`usable area in the catheter assembly” of Kontos ........................ 6
`2. Petitioner’s other motivations are unsupported and driven by
`hindsight ...................................................................................... 6
`3. Petitioner’s modification would create a problematic gap/catch
`point where none existed before ............................................... 11
`4. Petitioner fails to show that a POSITA would replace Kontos’s
`funnel with Ressemann’s collar 2141 (Ground 2, claim 45) ... 12
`C. Ground 2 and Ground 3 (Claims 25-40, 42, 44-48): Petitioner Failed
`to Show that a POSITA Would Modify the References to Arrive at the
`Claimed “One French Size” Requirement ......................................... 17
`D. Ground 2 (Dependent Claim 32): Petitioner Failed to Show a POSITA
`Would Modify Kontos’s Support Catheter to “coaxially align[] the
`tubular structure” of the Guide Extension Catheter with the Guide
`Catheter.................................................................................................. 7
`E. Ground 2 (Dependent Claim 37): Petitioner Failed to Show that it
`Would Have Been Obvious to “advance[] a delivery system including
`the stent” Through Kontos’s Support Catheter ................................... 20
`Ground 3 (Dependent Claim 45): Petitioner Failed to Show that a Side
`Opening “Having At Least Two Inclined Slopes” Would Have Been
`Obvious ............................................................................................... 21
`G. Grounds 4 and 5 (Claims 25-55): The Root Publication Is Not Prior
`Art ........................................................................................................ 23
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`F.
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`ii
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`III. COMPELLING OBJECTIVE EVIDENCE CONFIRMS THAT
`INDEPENDENT CLAIM 25 AND THE CLAIMS DEPENDING FROM IT
`WOULD NOT HAVE BEEN OBVIOUS ..................................................... 25
`The Objective Evidence Is Undisputed ............................................... 25
`A.
`B.
`The Combination of Features That Resulted in GuideLiner’s Success
`and Praise Is Not in the Prior Art ........................................................ 26
`C. GuideLiner and Telescope Practice Claim 25 ..................................... 27
`That GuideLiner’s Competitors Copied its Design Confirms Non-
`D.
`Obviousness ......................................................................................... 29
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`iii
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`TABLE OF AUTHORITIES
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`
`Cases
`Bilstad v. Wakalopulos,
`386 F.3d 1116 (Fed. Cir. 2004) ................................................................................ 24
`Cordis Corp. v. Medtronic AVE,
`339 F.3d 1352 (Fed. Cir. 2003) ................................................................................ 24
`Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,
`93 F.3d 1572 (Fed. Cir. 1996) .................................................................................. 24
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ........................................................................... 4, 15
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ......................................................................... 30, 31
`Lampi Corp. v. Am. Power Prods., Inc.,
`228 F.3d 1365 (Fed. Cir. 2000) ................................................................................ 24
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................... 27
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ......................................................................... 27, 30
`Other Authorities
`37 C.F.R. § 42.23(b) ........................................................................................... 4, 15
`37 C.F.R. § 42.104(b)(3) .......................................................................................... 18
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`iv
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`I.
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`Introduction
`The challenged claims require advancing a guide extension catheter beyond
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`the distal end of a guide catheter while a segment defining a side opening of the
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`guide extension catheter remains within the guide catheter. As the Board found in
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`its Final Written Decision in a related IPR proceeding, “the funnel portion of
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`Kontos appears to be crucial to the device’s ability to receive and facilitate
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`exchange of balloon catheters.” IPR2020-00136, Paper 104 at 24 (PTAB June 7,
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`2021). In this proceeding, Petitioner again fails to establish why—absent
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`hindsight—a POSITA would substantially redesign Kontos (including removing
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`the funnel portion) to provide the side opening configuration of independent claims
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`25 and 52 and the “one French size” differential of independent claim
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`25. Petitioner also ignores the problems such modifications would have been
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`expected to create. Compelling objective evidence, which the Petitioner fails to
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`persuasively address, further confirms that independent claim 25 and its dependent
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`claims are not obvious.
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` Petitioner Has Not Shown that the Challenged Claims Would Have
`Been Obvious
`A. Grounds 1-3 (Claims 25-40, 42, 44-48, 52, 53): The Board Should
`Reject Petitioner’s New Theory Relying on Extensive Additional
`Modifications to Material Aspects of Kontos
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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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`1
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`modification to Kontos’s support assembly 10.” Reply, 4. Teleflex was not
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`mistaken. The Petition did not propose modifications beyond substituting
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`Ressemann’s proximal opening or support collar for Kontos’s funnel. Petition, 15-
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`58. When Teleflex’s Response pointed out that Petitioner’s obviousness
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`arguments did not make sense and/or would not meet the claim limitations (for
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`example, the “one French size” element of independent claim 25) (POR, 19-20, 26-
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`28)—Petitioner realized that Patent Owner was right. Therefore, in Reply,
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`Petitioner proposes an entirely new argument, premised on myriad additional,
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`material modifications to Kontos to arrive at Patent Owner’s claimed invention.
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`The moving target created by Petitioner’s Reply is demonstrated below:
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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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`2
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`Ex-1409, Fig. 1; compare Petition, 20 with Reply, 13, 18. Petitioner’s Reply
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`contends, for the first time, that a POSITA would have been motivated to
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`completely redesign Kontos, with at least six additional changes beyond those
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`advocated in the Petition: (1) “recess[ing]” Kontos’s marker bands; (2) attaching
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`the distal soft tip in-line rather than with overlapping structure; (3) removing
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`Kontos’s base portion 18; (4) “taper[ing] the pushrod” down to less than 0.005
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`inches; (5) “attach[ing]” the thin-tapered pushrod to Kontos’s tube wall without
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`base portion 18, and (6) “increase[ing]” the diameter of “tube 16.” E.g., Reply, 7,
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`9-10, 12-13, 18; Ex-2241, 124:13-126:20.1 Petitioner seeks to support this new
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`theory with at least six paragraphs of new analysis in a new declaration from a new
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`expert (Reply, 7, 9-10, 12-13, 18 (citing Ex-1807, ¶¶119, 126-131))2 and fifteen
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`1 Much of the expert declaration testimony that Petitioner submitted in support of
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`its replies is identical to the testimony the same experts provided in the earlier IPR
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`proceedings. Therefore, Patent Owner submits and cites to cross-examination
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`testimony regarding those re-offered opinions from the previous set of IPRs.
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`Petitioner has agreed that Patent Owner may use the previous deposition testimony
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`in these proceedings.
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`2 After the first round of depositions, Petitioner dismissed its engineering expert
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`Hillstead and retained another, Jones. But Jones just “cursorily” looked through
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`3
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`paragraphs of new analysis from Petitioner’s other expert, who similarly changed
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`course from his previous declaration (Compare Ex-1405 (Brecker Decl. ISO
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`Petition), ¶¶154, 160, 189 with Ex-1806 (Brecker Decl. ISO Reply), ¶¶128-136,
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`143-149, 159).
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`IPR rules prohibit this type of belatedly-raised “new issue” at the Reply
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`stage. PTAB Consolidated Trial Practice Guide (November 2019) (“TPG”), 73-
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`74; 37 C.F.R. § 42.23(b); Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
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`821 F.3d 1359, 1369-70 (Fed. Cir. 2016). It would be unfair to allow Petitioner to
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`present this new theory at a stage where Teleflex is not permitted to present
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`evidence in response. Petitioner’s proposal of a complete redesign of Kontos is
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`untimely and the Board must reject it.
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`both patents and “briefly read the first claim”. Ex-2259, 9:23-10:10. The
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`purported “benefits” of the modifications were provided to him “by [Medtronic’s]
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`attorneys.” Id., 54:12-17. Jones admitted that his opinions were based at least in
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`part on inventor testimony regarding how the inventor came up with the invention
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`(Ex-2239, 39:14-40:4), which should not be part of an obviousness
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`analysis. Jones’ entire role has been an exercise in hindsight, and his testimony
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`(Ex-1807) should be given no weight.
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`4
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`Even without Patent Owner having an opportunity to respond with evidence,
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`the record does not support Petitioner’s new theory. The notion that it takes more
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`than six significant modifications to create the claimed structure from Kontos
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`shows Petitioner’s use of the claims as a roadmap. Kontos’s device has a relatively
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`narrow central tube 16 that fits snugly around a “fragile” PTCA catheter balloon,
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`as well as outwardly-projecting structures at the distal and proximal ends that serve
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`various important functions. POR, 9-10, 13, 19-20, 22, 26. Completely
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`redesigning Kontos to remove those material structures is inconsistent with what
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`Kontos was designed to do. Id.
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`For example, Kontos teaches that the protruding base section 18 creates an
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`“eccentric cross-section” that is important to the invention—it “provides leverage
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`for facilitating manipulation of body 12.” Ex-1409, 4:34-38. Petitioner’s new
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`argument that a POSITA would be motivated to “taper” the relatively-thick 0.020”
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`pushwire down to less than 0.005” (e.g. Ex-1807, ¶¶131-133, 144, 148-149) is
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`directly contradicted by its argument in a related IPR that a POSITA would be
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`motivated to modify Itou’s pushwire because where it has been “crushed” to create
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`a “flat plate” creates a “potential weakness point in the catheter.” IPR2020-00135,
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`Paper 82, 17 (PTAB Dec. 21, 2021).
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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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`5
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`0.005” to the purported Kontos/Ressemann combination. See Reply, 17-18.
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`Kontos’s statement that tube 16 may be “molded directly onto” pushwire 14 (Ex-
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`1409, 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 to a small fraction of
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`its disclosed size. See also Ex-2241, 49:2-6 (Petitioner’s new expert admitting that
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`he was not aware of any prior art showing a wire tapered down to less than
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`0.005”); id., 158:1-14 (admitting that the polar moment of inertia for a 0.005”
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`pushwire would be 256 times smaller than Kontos’s disclosed 0.020” pushwire).
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`Petitioner relies on this new theory for all of the challenged claims. Reply,
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`7, 12-13, 17, 18. The Board should reject Petitioner’s new theory and confirm that
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`the challenged claims are patentable.
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`B. Grounds 1-2 (Claims 25-40, 42, 44-48, 52, 53): Petitioner Has Not
`Shown that a POSITA Would Have Been Motivated with a
`Reasonable Expectation of Success to Redesign Kontos to Have
`the Claimed “Side Opening”
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`The evidence does not support a motivation to “maximiz[e]
`the usable area in the catheter assembly” of Kontos
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`Petitioner’s first argument is that a POSITA would be motivated to reduce
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`the diameter of the GC that Kontos is used with. Reply, 5. But in the 2005
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`timeframe, there was no reason to modify Kontos’s device to fit in a smaller GC,
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`as it already fit in a 6 French GC and 5 French GCs were rarely used. POR, 21.
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`Petitioner’s argument that Kontos’s funnel may “rub” in a 6 French GC (Reply, 5)
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`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. Petitioner’s contention that Kontos’s
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`funnel is too small to do much funneling (Reply, 5) is hindsight that ignores
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`Kontos’s teaching that the funnel was purposeful; its expert agreed that even when
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`used in a 6 French GC Kontos’s funnel would serve a useful funneling function.
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`Ex-2241, 158:21-159:5.
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`Petitioner also does not dispute that even after removing Kontos’s funnel,
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`Kontos would still not fit within a 5 French GC due to the presence of thickened
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`base portion 18 and the protruding distal marker band/overlapping soft tip
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`structure. Instead, Petitioner invokes its new “at least six additional changes” to
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`Kontos. Reply, 6 n.1, 18. The Board should not credit this new argument. Supra,
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`§II.A. Moreover, there is still no record evidence that a POSITA would have been
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`motivated to make Kontos fit inside a 5 French GC at the time of the invention—
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`the three articles Petitioner’s new expert cites, (Exs. 1836-1838)3, were published
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`well after the date of invention. See Ex-1806, ¶117.
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`Petitioner’s second argument is a conflicting motivation to “increas[e] the
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`diameter of [Kontos’s ‘support’ catheter]” while keeping the size of the guide
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`3 These three articles have not been made record and should be disregarded on this
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`basis alone. See Ex-1806, ¶117.
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`7
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`catheter the same. Reply, 6-7. Recognizing that the modifications to Kontos
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`advocated by the Petition do not actually achieve that purported benefit, Petitioner
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`changes course, arguing in Reply that a POSITA would redesign Kontos to
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`“recess” the marker bands. Reply, 7. The Board should not credit this new
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`argument. Supra, §II.A. Further, Petitioner does not persuasively explain how a
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`POSITA would have reasonably expected to successfully redesign Kontos’s tip
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`structure. See Ex-1807, ¶¶128-133. Petitioner does not explain, for example, how
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`a POSITA would have successfully recessed marker band 36 in the thin (0.005”)
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`wall of the tube 16, or how a POSITA would have securely attached soft tip
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`portion 28 without the overlapping material shown in Kontos. Indeed, there would
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`not have been an obvious way to successfully do that in 2005. Ex-1800, 194:19-
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`197:24.
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`Redesigning Kontos’s device to increase its interior diameter would also
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`have been contrary to Kontos’s teaching of a “support catheter” that is
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`narrow/snug-fitting. POR, 9-10, 22. Kontos’s statement that “other sizes may be
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`used for other applications” (see Reply, 2) does not show a desire for a loose
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`versus snug fit—it simply recognizes that other-sized devices exist. Petitioner’s
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`Reply argument that Kontos prevents kinking through the use of a “lubricious
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`inner coating” is unsupported speculation. See Reply, 2. Kontos says nothing
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`about its support catheter having a lubricious inner coating, much less that a
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`8
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`lubricious coating prevents kinking. Additionally, Kontos is a “support” catheter,
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`and 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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`Petitioner’s other motivations are unsupported and driven
`by hindsight
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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 the
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`side opening.” Reply, 7-8. The Petition did not suggest this motivation. Petition,
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`17-25, 36. Such a “newly raised rationale to combine the prior art” is improper in
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`a Reply. E.g., TPG, 74. It is also hindsight. Petitioner points to testimony from
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`Dr. Graham regarding the size of the opening of Ressemann’s collar when
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`considering the “tab” portion of that collar. Reply, 8. But it is undisputed that the
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`tab portion 2141b of Ressemann’s collar is not part of Ressemann’s proximal
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`opening and does not contribute to its shape or define the “area” of its opening.
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`POR, 33-38.
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`Petitioner next cites “smooth passage of other therapeutic devices” into the
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`proximal opening. Reply, 8. But Teleflex provided evidence that, compared to a
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`funnel, a side opening was actually thought to increase the likelihood of device
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`hang-up. POR, 22-23, 40-41; Ex-1408, 25:20-29. Petitioner cites back to
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`Ressemann’s teaching of a side opening providing “smoother” passage. Reply, 8.
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`But Ressemann is not comparing its angled opening to a funnel. Kontos’s funnel
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`already provides “smoother” passage. Compared to a funnel (the relevant
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`comparison), Ressemann taught that a side opening actually had increased risk of
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`catching/hang-up. Compare Ex-1408, 7:40-43 (disclosing a “flare”/funnel with no
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`hang-up concerns) with id., 25:20-29.
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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, 8-9.
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`Kontos’s funnel decreases the likelihood of device hang-up, (POR, 22-23), and
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`Kontos has no pushability issue. The “pushability” problem Mr. Keith referenced
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`in a separate case, (Reply, 9), had nothing to do with smooth passage or Kontos’s
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`funnel; Mr. Keith was explaining that Kontos’s tube is too flexible to provide
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`backup support. Ex-1819, ¶¶89, 112.
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`Regarding “smooth re-entry,” Petitioner again relies on impermissible
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`hindsight, citing testimony about use of the GuideLiner product as purported
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`evidence of obviousness. See Reply, 9. Petitioner provides no rebuttal to
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`Teleflex’s evidence that (i) the experts agree a POSITA would never actually push
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`Kontos’s support catheter all the way out of the GC, and (ii) Kontos’s funnel is
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`there to prevent that. POR, 24.
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`10
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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 proximal funnel with a side opening would have been
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`expected to create a problematic gap/catch point, dissuading a POSITA from the
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`modification:
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`POR, 14-16.
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`Petitioner contends that when used in a 6 French guide catheter, the gap
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`would be only 0.005”. Reply, 10. However, Petitioner’s new expert admits that
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`guidewires are not blunt at their distal ends, but rather are “ground to a progressive
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`taper.” Ex-1807, ¶131 (quoting Ex-1015, 551). This “taper,” not shown in
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`Petitioner’s diagram, would exacerbate the hang-up issue. Moreover, Petitioner’s
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`expert admitted his analysis was limited to using Kontos in a 6 French guide
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`catheter. Ex-2241, 120:1-7. While Kontos fits in a 6 French guide catheter, a
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`POSITA would have expected it to also be used in larger guide catheters, (Ex-
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`11
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`2238, 182:3-11; Ex-2241, 120:1-5), where the expected hang-up problem would be
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`exacerbated.
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`Petitioner next contends that the gap/catch point would not have been an
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`issue because Ressemann (and a similar, related reference) shows devices with side
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`openings that had larger gaps. Reply, 10-11. But Ressemann itself teaches such
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`gaps were problematic, proposing either a funnel or a “reverse bevel” to try to
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`mitigate that problem. POR, 15-16; Ex-1408, 7:40-47 and Fig. 11A.
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`Petitioner’s evidence and argument is directed to improving Kontos’s
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`proximal opening as compared to a perpendicular-cut tube of uniform diameter.
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`But Kontos discloses a funnel. Petitioner has not shown the funnel would have
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`issues with accepting devices or that Kontos’s ability to accept devices would have
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`been improved. There is no persuasive evidence that a POSITA would have
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`replaced Kontos’s funnel with a side opening, particularly when doing so would
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`create a problem where there was none before.
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`Petitioner fails to show that a POSITA would replace
`Kontos’s funnel with Ressemann’s collar 2141 (Ground 2,
`claim 45)
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`Petitioner’s Reply still ignores the predicate question of why a POSITA
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`would be motivated to look to Ressemann’s collar 2141 in the first place. See
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`POR, 32-38. In fact, Petitioner doubled down and directed its new Reply expert to
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`ignore how Ressemann actually used collar 2141b. Ex-1807, ¶67. Petitioner now
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`12
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`does not dispute that collar tab 2141b relied on in the Petition forms no part of
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`Ressemann’s opening. The Board should reject the proposed combination as
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`premised on improper hindsight.
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` Moreover, even if looking to the shape of Ressemann’s collar in isolation
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`were not hindsight, Petitioner has not proven that a POSITA would have
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`reasonably expected its unusual tab-on-top combination to be successful. In Reply,
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`Petitioner provides a new engineering expert who purports to address the problems
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`Patent Owner identified. Reply, 12-13 (citing Ex-1807, ¶¶142-45, 159). A cross-
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`section of the purported result is below, without (left) and with (right) Petitioner’s
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`newly tapered pushwire:
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`Ex-1807, ¶143. Petitioner’s new expert asserts that this construction would
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`somehow “preserve[]” the tiny angle at the tip of Ressemann’s tab. Ex-1807,
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`¶144. But when asked about the dimensions of the tiny angle compared to his
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`13
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`proposed polymer coating, he conceded he had “not worked that out or provided an
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`opinion on that.” Ex-2239, 116:19-24.
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`Once again, Petitioner’s purported expectation of success also relies on its
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`new wholesale Kontos redesign:
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`Reply, 13. The Board should reject this new argument. Supra, §II.A.
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`Petitioner’s Reply also posits a new argument: Ressemann’s tab could be put
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`underneath the pushwire while still maintaining two inclines due to an alleged
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`“third incline”:
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`14
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`Reply, 13-16 (citing Ex-1806, ¶¶136-39, Ex-1807, ¶158); see also Ex-1806, ¶¶86-
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`91. The Petition argued that Ressemann’s “support collar 2141” had “two
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`inclines,” not three:
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`Petition, 52. Petitioner’s new “three inclines” theory is presented through its new
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`expert, who “came to [a] different conclusion[]” than Petitioner’s original expert.
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`Ex-2239, 83:15-84:10; Ex-2259, 56:18-57:3. New invalidity theories in Reply are
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`not permitted. TPG, 73-74; 37 C.F.R. § 42.23(b); Intelligent Bio-Sys., 821 F.3d at
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`1369-70.
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`Petitioner seeks to disguise how jarringly new this evidence and argument is
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`by pointing to testimony from Teleflex’s witnesses. Reply, 14-16. But that
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`testimony is not even about the Ressemann reference. It was about GuideLiner,
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`which cannot prove that Ressemann’s collar has three inclines. See id.
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`
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`15
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`
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`Petitioner’s new assertion about three inclined regions is also wrong. Its
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`new expert relies solely on a perspective view that makes it appear as if there
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`might be a change of angle along the inclined portion:
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`Reply, 15. But such a perspective view is misleading. Indeed, Petitioner’s first
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`engineering expert presented what he believed a side view of Ressemann’s collar
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`
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`would look like, showing one incline:
`
`
`
`Single
`incline
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`Ex-1442, ¶163 (red annotations original; blue annotations added). Petitioner’s
`
`effort to contradict its first expert with a second is not credible and the Board
`
`should disregard it.
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`16
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`
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`C. Ground 2 and Ground 3 (Claims 25-40, 42, 44-48): Petitioner
`Failed to Show that a POSITA Would Modify the References to
`Arrive at the Claimed “One French Size” Requirement
`
`Removing Kontos’s funnel would not permit the device to even come close
`
`to meeting the claimed “one French size” limitation. POR, 26-29. Petitioner does
`
`not dispute this in Reply. Instead, Petitioner tries to use its new, untimely, and
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`unsupported “at least six additional modifications” theory to reach the claimed
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`“one French size” limitation. Reply, 18. The Board should reject this hindsight-
`
`driven theory for at least the reasons explained above. Supra, §II.A. Further,
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`Kontos teaches away from increasing the interior diameter. See POR, 25-26.
`
`D. Ground 2 (Dependent Claim 32): Petitioner Failed to Show a
`POSITA Would Modify Kontos’s Support Catheter to “coaxially
`align[] the tubular structure” of the Guide Extension Catheter with
`the Guide Catheter
`
`Petitioner does not dispute that if Kontos’s funnel is replaced with an angled
`
`
`
`side opening and the guide catheter is somehow “downsized” as Petitioner
`
`advocates, the lumen of tube 16 and the lumen of body 12 would no longer be
`
`“coaxially align[ed],” as required by claim 32. Reply, 16-17. Instead, Petitioner
`
`argues for a new, unsupported definition of “coaxially aligning.” Reply, 16-17.
`
`Petitioner’s Reply for the first time argues that “coaxially align[ed]” actually
`
`means something different—“aligned in the same direction” as the axis of lumen
`
`of the guide catheter.” Compare Reply, 16 with Petition, 12-13, 41 (proposing
`
`
`
`17
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`

`

`
`plain meaning). This new construction is untimely and the Board should reject it.
`
`
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`37 C.F.R. § 42.104(b)(3); TPG, 45.
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`Further, axes “aligned in the same direction” are “parallel,” not “coaxial.”
`
`The plain meaning of coaxial, as the Board recognized previously, is not merely
`
`parallel axes. IPR2020-00133, Paper 20, 14-15 (June 26, 2020). The ’116 patent
`
`and Kontos are consistent with the plain meaning of “coaxial.” All examples of
`
`the “coaxial guide catheter” show a distal tubular portion having a generally
`
`symmetric structure with a lumen disposed coincident with the axis of the lumen of
`
`the guide catheter.4 E.g., Ex-1401, Figs. 3, 4, 8, 9:
`
`
`4 Petitioner wrongly accuses Teleflex of taking the position that, to be coaxial, the
`
`lumens must be “perfectly concentric.” See Reply, 16. Lumens in a tube-in-tube
`
`arrangement cannot be “perfectly concentric” because, among other things,
`
`clearance is required.
`
`
`
`18
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`

`

`
`
`
`
`“Coaxial”:
`
`Common axis of GEC
`within guide catheter 56
`
`From Fig. 9, annotation
`added to highlight
`coaxial arrangement of
`GEC within guide
`catheter
`
`Kontos uses “coaxial” to refer to the tubular structure of its full-length
`
`embodiment, contrasting that with the substantially offset, “eccentric” proximal
`
`structure of Figure 3:
`
`
`
`
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`19
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`

`

`
`
`
`
`“Coaxial”:
`
`“Eccentric”:
`
`“[T]ube 116 and lumen 122 are
`generally cylindrical and coaxial
`along the length of body 112 ... [B]
`ase portion 118 is symmetrical
`about its axis, not eccentric.” Ex-
`1409, 8:31-37
`
`“[T]ube 16 has an eccentric
`cross-section at base potion
`18....” Ex-1409, 4:35-36.
`
`Ex-1409, 4:35-38; 8:31-42. Petitioner’s last-minute, hindsight-driven effort to
`
`rewrite the plain meaning of coaxial is unsupported.
`
`Further, Petitioner again invokes the six additional changes to Kontos
`
`theory, which is new in Reply and is not the theory identified in the Petition.
`
`Reply, 17. The Board should reject this argument. Supra, §II.A.
`
`E. Ground 2 (Dependent Claim 37): Petitioner Failed to Show that it
`Would Have Been Obvious to “advance[] a delivery system
`including the stent” Through Kontos’s Support Catheter
`
`Patent Owner showed that Kontos’s tube 16 is far too small to accept stents.
`
`
`
`POR, 31-32. Petitioner offers no counter-arguments in reply. For the reasons set
`
`
`
`20
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`

`

`
`forth above with respect to independent claim 25 (supra, §II.A-C) and at POR, 31-
`
`
`
`32, Petitioner failed to show that claim 37 is obvious.
`
`F. Ground 3 (Dependent Claim 45): Petitioner Failed to Show that a
`Side Opening “Having At Least Two Inclined Slopes” Would Have
`Been Obvious
`
`As set forth above with respect to independent claim 25, Ground 3—a four
`
`
`
`reference combination—also fails. The Board already found Petitioner’s position
`
`that a POSITA would have been motivated, in view of Kataishi’s distal opening, to
`
`modify the proximal opening of the Kontos-Ressemann combination to be
`
`unpersuasive, and it should do so again here. IPR2020-00136, Paper 104, 47; see
`
`also IPR2020-00129, Paper 127 at 39 n.10 (PTAB June 17, 2021).
`
`Petitioner argues that a POSITA would apply Kataishi’s distal opening
`
`shape to Kontos’s proximal end because Ressemann allegedly teaches that both
`
`the proximal and distal ends of Ressemann’s evacuation head contribute to smooth
`
`passage of therapeutic devices. Reply, 19. This argument fails. First, the cited
`
`Ressemann passage is ambiguous at best and Petitioner’s interpretation is
`
`hindsight-driven. The passage states that the ends of Ressemann’s evacuation head
`
`are angled to do two things, but that does not mean both ends serve both functions.
`
`See Ex-1408, 6:52-57. In fact, Ressemann later assigns only one of those functions
`
`to each end. Id., 7:48-53 (angled distal end facilitates atraumatic passage of the
`
`evacuation head into the vessel); 23:17-20 (angled proximal end facilitates passage
`
`
`
`21
`
`

`

`
`of therapeutic devices through the evacuation head). Second, the shape of the
`
`
`
`proximal and distal openings in the cited Ressemann embodiment are different
`
`from one another, and the proximal opening is a single angled skive. Id., Fig. 1A.
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`Thus, assuming hypothetically that a POSITA were to consider the relevance of
`
`this aspect of Ressemann’s device (which he/she would not absent hindsight),
`
`he/she would conclude that the shape of the proximal opening should not be the
`
`same as the distal opening.
`
`Petitioner next argues that a POSITA would apply Kataishi’s distal opening
`
`shape to Kontos’s proximal opening to provide a larger size to facilitate
`
`introduction of stents and balloon catheters. Reply, 20-21. This, too, is hindsight.
`
`That is indisputably not the purpose of the distal opening of Kataishi’s suction
`
`catheter. POR, 48. Moreover, Ressemann discloses no problems receiving
`
`interventional cardiology devices into its proximal opening having only one
`
`inclined slope.
`
`Petitioner’s renewed assertions regarding “crossability” are unsupported.
`
`Petitioner points to Sakurada, which it claims describes testing confirming that the
`
`shape of Kataishi’s distal end improves crossability. Reply, 21-22. But Sakurada
`
`does not say that. Ex-1455, 300-02. To the contrary, Sakurada attributes the
`
`improved crossability of Kataishi’s device to one thing only: the support wire that
`
`runs the length of the device. Id., 304. Moreover, Sakurada describes only one
`
`
`
`22
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`

`

`
`benefit of the complex shape of Kataishi’s distal end, entirely unrelated to Kontos:
`
`
`
`increased suction due to its ability to flex and conform to the side wall of the
`
`vessel. Id., 302, 304.
`
`G. Grounds 4 and 5 (Claims 25-55): The Root Publication Is Not
`Prior Art
`
`Grounds 4 and 5 are no more than a backdoor attempt by Petitioner to
`
`
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`improperly challenge written description in an IPR. POR, 50-51. The Board
`
`should reject Petitioner’s arguments on this basis alone