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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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`
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`Case IPR2020-01342
`U.S. Patent No. 8,142,413
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`PATENT OWNER SUR-REPLY
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`

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`I.
`II.
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
`PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS WOULD HAVE BEEN OBVIOUS ................................................ 2
`A. Claims 4, 9-14: The Board Should Reject Petitioner’s New Theory
`Relying on Extensive Additional Modifications to Material Aspects
`of Kontos ............................................................................................... 2
`B. All Claims: Inserting an ICD Must Take Place After the Coaxial
`Guide Catheter Is Inserted Into the Guide Catheter .............................. 9
`C. Claims 2 and 7 (Ground 1): Petitioner Has Not Shown That
`Kontos Would Inherently Resist Axial and Shear Forces as
`Claimed................................................................................................12
`D. Claims 4, 9-12, and 14 (Ground 1): Petitioner Has Not Shown
`that a POSITA Would Be Motivated to Modify Kontos to Arrive
`at the Claimed Proximal Side Opening Structure with a
`Reasonable Expectation of Success ....................................................13
`1.
`Petitioner has not shown that a POSITA would be
`motivated, with a reasonable expectation of success, to
`replace Kontos’s funnel with a side opening ............................14
`a.
`The evidence does not support a motivation to reduce
`the diameter of the guide catheter with a reasonable
`expectation of success ....................................................14
`The evidence does not support a motivation to
`“increas[e] the interior diameter” of Kontos’ device .....15
`Petitioner’s other motivations are unsupported and driven
`by hindsight ...............................................................................17
`Petitioner’s modification would create a problematic
`gap/catch point where none existed before ...............................18
`E. Claim 13 (Ground 2): Petitioner Has Not Shown That it Would
`Have Been Obvious to Modify Kontos to Meet the “One French”
`Limitation ............................................................................................20
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`b.
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`2.
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`3.
`
`i
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`

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`III. COMPELLING OBJECTIVE EVIDENCE CONFIRMS THAT
`CLAIMS 4, 9-12, AND 14 WOULD NOT HAVE BEEN OBVIOUS ........21
`A. The Objective Evidence Is Undisputed ...............................................21
`B. The Combination of Features That Resulted in GuideLiner’s
`Success and Praise Is Not in the Prior Art ..........................................22
`C. The Fact that GuideLiner’s Competitors Copied its Design
`Confirms Non-Obviousness ................................................................24
`IV. CONCLUSION ..................................................................................................26
`CERTIFICATE OF WORD COUNT COMPLIANCE ...........................................28
`CERTIFICATION OF SERVICE............................................................................29
`
`ii
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`

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`TABLE OF AUTHORITIES
`
`
`Cases
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .............................................................................. 5
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ..................................................................... 25, 26
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................24
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ..................................................................... 24, 25
`Statutes
`37 C.F.R. § 42.23(b) .................................................................................................. 5
`Other Authorities
`PTAB Consolidated Trial Practice Guide (November 2019) .................................... 5
`
`iii
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`

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`I.
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`INTRODUCTION
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`Kontos discloses a specific device designed for a specific purpose: a
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`“support catheter” having a narrow tube to protect a “relatively fragile PTCA
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`catheter balloon” from bending, buckling, or kinking during use. Kontos’s device
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`had a deliberately asymmetric exterior, with a proximal protrusion to accommodate
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`secure attachment of a pushwire and to provide “leverage,” a distal marker band
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`and soft tip covering, and a proximal funnel structure. The Petition posited that a
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`POSITA would be motivated replace Kontos’s proximal funnel with an angled side
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`opening. After Patent Owner (“Teleflex”) pointed out numerous problems with
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`this theory, Petitioner changed course in Reply and proposed numerous additional
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`modifications to Kontos.
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`Regardless of whether the Board considers Petitioner’s new hindsight-driven
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`redesign of Kontos, Petitioner has not carried its burden. As the Board found in a
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`related IPR proceeding, “the funnel portion of Kontos appears to be crucial to the
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`device’s ability to receive and facilitate exchange of balloon catheters.” IPR2020-
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`00136, Paper 104 at 24 (PTAB June 7, 2021). In this proceeding, Petitioner again
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`fails to establish why—absent hindsight—a POSITA would substantially redesign
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`Kontos to provide the claimed side opening configuration. Further, compelling
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`real-world objective evidence, including GuideLiner’s striking success and
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`1
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`

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`industry-wide acclaim, confirm that at least claims 4 and 9-12, and 14 were not
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`obvious. The Board should confirm patentability of the challenged claims.
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`II.
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`
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`PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS WOULD HAVE BEEN OBVIOUS
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`A. Claims 4, 9-14: The Board Should Reject Petitioner’s New Theory
`Relying on Extensive Additional Modifications to Material
`Aspects of Kontos
`For claims requiring a side opening (claims 4, 9-12, 14) or the “one French”
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`differential (claim 13), the Petition was premised on a single modification of
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`Kontos: that a POSITA would have been motivated to remove Kontos’s proximal
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`funnel and replace it with an angled side opening. Petition, 54-60, 64-74.
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`Petitioner now presents an entirely new theory, premised on myriad additional,
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`material modifications to Kontos:
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`2
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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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`
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`E.g., Ex-1409, Fig. 1; compare Petition, 55 with Reply, 20. The 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 numerous changes beyond those advocated in the Petition, for
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`example: (1) “recess[ing]” Kontos’s marker bands; (2) aligning distal soft tip 28
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`with tube 16; (3) removing Kontos’s base portion 18; (4) “taper[ing]” the wire; (5)
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`somehow “attach[ing]” the thin-tapered pushrod to Kontos’s tube wall without
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`base portion 18, and (6) “increas[ing]” the diameter of “tube 16.” E.g., Reply, 13,
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`3
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`15, 19-20; Ex-1807, ¶¶118-136; Ex-2241, 124:13-126:20; Ex-2260, 89:2-90:11.1
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`Petitioner seeks to support this new theory with numerous new paragraphs of
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`analysis in a new declaration from a new expert.2 Reply, 11-20 (citing Ex-1807,
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`¶¶120-121, 128-136).
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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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`both patents and “briefly read the first claim.” Ex-2259, 9:23-10:10. Many if not
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`all of the purported “benefits” of the modifications were provided to him “by
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`[Medtronic’s] attorneys.” See id., 54:12-17. And in previous, related IPRs, Jones
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`admitted that his opinions were based at least in part on inventor testimony
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`regarding how the inventor came up with the invention (Ex-2239, 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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`Petitioner cannot provide argument and evidence necessary to make out a
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`prima facie case of obviousness for the first time in Reply. PTAB Consolidated
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`Trial Practice Guide (November 2019) (“TPG”), 73-74 (citing 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)). Petitioner’s proposal of a complete redesign of Kontos
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`is untimely and the Board should reject it.
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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 very notion that it takes
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`more 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. Further, Kontos’s device has a
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`relatively narrow central tube 16 that fits snugly around a “fragile” PTCA catheter,
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`as well as outwardly-projecting structures at the distal and proximal ends that serve
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`various material functions. E.g., Patent Owner Response (“POR”), 6-9.
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`Redesigning Kontos to remove all of those projecting structures would have been
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`inconsistent with what Kontos was designed to do. Id.
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`For example, the protruding base section 18 of Kontos’s support catheter
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`creates an “eccentric cross-section” that “provides leverage for facilitating
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`manipulation of body 12.” Ex-1409, 4:34-38. Similarly, Petitioner’s new
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`argument that a POSITA would be motivated to “taper” the relatively thick
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`pushwire (Reply, 13 n.3, 19), contradicts Petitioner’s argument in a related IPR
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`5
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`that a POSITA would be motivated to modify Itou’s pushwire because where it has
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`been flattened created a “potential weakness point in the catheter.” IPR2020-
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`00135, Paper 82, 17.
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`Petitioner also does not adequately explain how a POSITA would expect to
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`successfully and securely embed a “tapered” metal pushrod into an extremely thin
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`polymer wall. See Reply, 19-20. Petitioner’s expert admitted that one would
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`probably have to “bolster” the wall of the proximal portion of Kontos’s tube where
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`the tapered pushwire was attached (which is exactly what Petitioner’s new Reply
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`modifications seek to avoid), and that this would be yet another new change to
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`Kontos. Ex-2241, 138:3-139:8. Kontos’s statement that tube 16 may be “molded
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`directly onto” the pushwire 14 (Ex-1409, 4:31-32) does not suggest that the robust
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`0.020” pushwire 14 would be tapered in any fashion, much less thinned out to less
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`than a quarter of its disclosed size (to less than 0.005”). Reply, 13, 19-20; see also
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`Ex-2241, 49:2-6 (Petitioner’s new expert admitting that he was not aware of any
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`prior art showing a wire tapered down to less than 0.005”); id., 158:1-14 (admitting
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`that the polar moment of inertia for a 0.005” pushwire would be 256 times smaller
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`than Kontos’s disclosed 0.020” pushwire).
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`Petitioner attempts to minimize the importance of the disclosed shape of
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`Kontos. E.g., Reply, 5-7. But the shape of Kontos was not chosen at random—as
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`the patent explains, its shape has particular features that were critical to the device.
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`6
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` Petitioner first takes issue with Patent Owner’s description of body 12,
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`arguing that Kontos “never states that it is ‘important’ for body 12 to be ‘narrow’
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`or have a ‘snug fit.’” Reply, 5. In fact, it argues that “Kontos teaches the
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`opposite.” Id. That is clearly not true—nowhere does Kontos say it is important
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`that body 12 not be narrow or not have a snug fit. The sections of the specification
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`that Petitioner cites simply explain that the particular sizes and shapes of the
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`disclosed support catheter may vary depending on the particular application. Id.
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`(citing Ex-1409, 4:46-48, 4:61-5:2). But nowhere is an embodiment disclosed
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`without a narrow tube distal of a wide, proximal funnel opening. In fact, a portion
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`of the specification that Petitioner relies on explains that the disclosed “sizes
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`generally are suitable for existing PTCA catheters . . . [but] other sizes may be used
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`for other applications.” Ex-1409, 4:61-67 (emphasis added). This makes sense: if
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`different sized catheters were inserted through Kontos, the size of Kontos may
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`need to change accordingly. But the portion of Kontos Petitioner cites does not
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`state that the geometry of the protective catheter should change depending on the
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`application.
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`Contrary to Petitioner’s argument, the shape of Kontos matters. In
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`particular, the shape of Kontos serves its primary purpose of facilitating the
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`delivery of “extremely soft and flexible” PTCA balloon catheters that are “readily
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`susceptible to kinking and bending.” E.g., Ex-1409, 1:9-16, 1:30-37; Ex-2244,
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`7
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`103:12-15; Ex-2245, 129:7-11. As the specification explains: “The balloon 48 of
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`PTCA catheter 40 [is] captured within the confines of body 12. In this
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`arrangement, the relatively fragile PTCA catheter balloon 48 will be safely
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`surrounded by the more durable body 12 . . .” Ex-1409, 5:17-22 (emphasis added).
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`The narrow tube of Kontos is not unplanned or insignificant.
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`Petitioner argues that body 12 need not be narrow or fit closely around a
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`PTCA balloon catheter, because “[i]t is Kontos’s ability to shorten the distance that
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`the IVCD traverses in the vasculature . . . not the spatial relationship with the
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`IVCD that reduces the likelihood of kinking.” Reply, 5-6. But even if reducing
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`the distance an ICD must traverse reduces the likelihood of kinking, that does not
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`mean it is the only feature of Kontos that does so. Indeed, contrary to Petitioner’s
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`argument, the specification explains how Kontos prevents kinking with body 12: it
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`“provides protection to the relatively fragile balloon 48 and helps prevent bending,
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`buckling, or kinking . . .” Ex-1409, 6:50-58; see also id., 8:12-16 (“body 12 act[s]
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`as a reinforcement to prevent buckling, kinking or bending of the distal end of the
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`catheter.”).
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`8
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`B. All Claims3: Inserting an ICD Must Take Place After the Coaxial
`Guide Catheter Is Inserted Into the Guide Catheter
`
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`Petitioner’s argument with respect to claim 1 is very brief, concluding: “PO
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`incorrectly alleges that the claims require a specific order of operations. They do
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`not and are invalid.” Reply, 7. For the reasons explained in Patent Owner’s
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`Response, it is Petitioner who is wrong—claim 1 requires inserting an ICD after
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`the coaxial guide catheter is inserted into the guide catheter. POR, 12-21.
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`Notably, Petitioner agrees that all the steps of claim 1 must take place in
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`order, except for step 1.f—a step Kontos performs (at best) in a sequence
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`inconsistent with the claim language. Reply, 2 (agreeing that claims terms 1.a
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`through 1.e only make sense if they take place in order); see POR, 18-21.
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`Petitioner’s argument that only this single claim element (which Kontos does not
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`disclose in the claimed order) need not take place in sequence, is yet a further
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`indication that its obviousness arguments are hindsight driven.
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`In Reply, Petitioner has no answer for numerous admissions from its own
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`experts that support Patent Owner’s position that claim 1 requires inserting an ICD
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`after the coaxial guide catheter is inserted into the guide catheter. POR, 15-16
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`3 Petitioner’s argument in Section IV.A allegedly applies to claims 1 and 11 of the
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`ʼ413 patent, but this claim numbering is incorrect and appears to be left over from
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`their briefing in related IPR2020-00127 regarding U.S. Patent No. 8,048,032.
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`9
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`(citing Ex-2244, 63:6-64:1 (Hillstead testifying that the substantially rigid portion
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`is already in the guide catheter when the ICD is inserted “alongside” it), Ex-2244,
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`62:18-24, (Hillstead agreeing step 1.f requires the insertion of an ICD “after the
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`prior steps that are recited in the claim”), Ex-2245, 94:8-12, 97:4-19 (Brecker
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`testifying it can be dangerous to advance an ICD at the same time as a guide
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`extension catheter), Ex-1405, ¶204 (Brecker testifying that inserting an ICD after
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`an extension catheter is inserted into a guide catheter is how physicians routinely
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`perform PCI procedures)); see also Ex-2260, 45:6-24 (same) and 48:24-49:9
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`(Brecker testifying that he cannot recall anyone inserting a guide extension catheter
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`with a preloaded stent or balloon into a guide catheter).
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`Further, Mr. Keith did not agree that “alongside” is simply an adjective that
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`reflects the relative positions of an ICD and the substantially rigid portion when
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`preassembled. Reply, 4. To the contrary, the cited testimony makes very clear that
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`Mr. Keith thought that while “alongside” might simply be an adjective in the
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`abstract, “you can’t pull that word out of the context of the claim that it’s in or the
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`step that it’s in,” and in the context of the claim, it describes motion, not just
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`relative position. Ex-1797, 16:6-21.
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`Mr. Keith’s opinions are consistent with the claim language. Independent
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`claim 1 recites a method with active steps: “inserting” an ICD “into and through
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`the continuous lumen of the standard guide catheter alongside of the substantially
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`10
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`rigid portion” and then “advancing” the ICD “through and beyond a lumen of the
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`flexible tip portion.” Ex-1001, 11:1-6 (emphasis added).
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`Regarding the “through and beyond” language of element 1.f, Petitioner
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`argues that an ICD can be inserted into a guide catheter and then advanced into the
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`coronary artery, in the event an ICD is preloaded into the coaxial guide catheter.
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`Reply, 4. But even if such a procedure was possible, it is not consistent with what
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`the claim language requires, it is not the routine procedure (as explained by
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`Petitioner’s own expert), and it could be dangerous (as explained by both
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`Petitioner’s and Patent Owner’s experts). POR, 13-16, n.4; Ex-1405, ¶204; Ex-
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`2245, 93:6-94:12, 97:4-17; Ex-2260, 45:6-24, 48:24-49:9; Ex-2138, ¶¶170-187.
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`Notably, Petitioner’s argument with respect to claim 1 appears to rest
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`entirely on claim construction—it does not respond at all to Patent Owner’s
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`evidence that prior art methods do not show performance of the required sequence.
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`Reply, 2-4, 7; POR, 18-21. Petitioner has failed to show that claim 1 is invalid.
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`11
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`C. Claims 2 and 74 (Ground 1): Petitioner Has Not Shown That
`Kontos Would Inherently Resist Axial and Shear Forces as
`Claimed
`
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`Petitioner’s Reply regarding the ability of Kontos to provide the claimed
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`backup support relies heavily on new, untimely evidence. See Reply, 7-11 (citing
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`Exs-1806, 1807 extensively). But even if the Board considers Petitioner’s
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`untimely gap-filling evidence, Petitioner fails to show that Kontos’s narrow,
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`“pliable” structure necessarily provides the claimed back-up support. At best,
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`Petitioner’s new evidence is directed to showing that Kontos could potentially do
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`that. E.g., Reply, 10 (“Polyethylene . . . can have rigid properties” (emphasis
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`added)). That is insufficient.
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`Petitioner quotes Patent Owner’s expert for the proposition that “a POSITA
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`‘would expect to pick the appropriate molded plastic material for the application.’”
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`Id., 9 (quoting Ex-1800, 69:20-70:13). But this does not help Petitioner, as “the
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`application” in Kontos is to provide a “support catheter” designed to “’protect[] the
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`fragile balloon’ of a PTCA balloon catheter.” POR, 6-9. And Kontos does not
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`4 Petitioner’s argument in Section IV.B allegedly applies to claims 2 and 12 of the
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`ʼ413 patent, but this claim numbering is incorrect, and appears to be left over from
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`Petitioner’s briefing in related IPR2020-00127 regarding U.S. Patent No.
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`8,048,032.
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`12
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`disclose a guide-catheter-within-guide-catheter assembly. Kontos teaches a
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`“pliable,” close-fitting “support catheter” with a narrowed waist and asymmetric
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`exterior protrusions within a guide catheter. Id., 6-9, 21-25. The fact that a
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`standard guide catheter in another standard guide catheter assembly provides
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`increased backup support does not mean that Kontos (which is not a standard guide
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`catheter shape) necessarily does.
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`D. Claims 4, 9-12, and 14 (Ground 1): Petitioner Has Not Shown that
`a POSITA Would Be Motivated to Modify Kontos to Arrive at the
`Claimed Proximal Side Opening Structure with a Reasonable
`Expectation of Success
`
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`Petitioner accuses Teleflex of erroneously “assum[ing] a POSITA would
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`make no further modifications to Kontos’s support assembly 10 after replacing the
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`proximal funnel with a side opening.” Reply, 11. Teleflex did not assume that—
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`the Petition plainly did not propose any modifications beyond replacing the
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`proximal funnel with a side opening. See generally Petition, 54-60, 64-72. If
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`Petitioner’s theory was that it would have been obvious to make numerous
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`additional material changes to Kontos—as is its position in Reply—it was required
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`to present and support that theory in its Petition. The Petitioner did not do that.
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`Moreover, as explained herein, Petitioner’s invalidity arguments remain
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`unpersuasive and fail to show that claims 4, 9-12, and 14 are invalid.
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`13
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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 a side opening
`
`a. The evidence does not support a motivation to reduce the
`diameter of the guide catheter with a reasonable
`expectation of success
`Petitioner argues that a POSITA would be motivated to “reduce the diameter
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`of the GC” that Kontos is used with. Reply, 12-13. But in the 2005 timeframe,
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`there was no reason to modify Kontos’s device to fit in a smaller GC, as it already
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`fit in a 6 French GC and 5 French GCs were rarely used. POR, 36-37. Petitioner’s
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`expert agrees. E.g., Ex-2241, 107:8-15. With this now undisputed, Petitioner’s
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`purported motivation to remove Kontos’s funnel to allow downsizing of the guide
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`catheter is entirely unsupported.
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`Petitioner’s argument that Kontos’s funnel may “rub” in a 6 French GC
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`(Reply, 13) is contradicted by its own expert, who testified that Kontos would
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`work fine with a 6 French GC. E.g., Ex-2241, 107:8-15. Petitioner’s contention
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`that Kontos’s funnel is too small to do much funneling (Reply, 13) is hindsight that
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`ignores Kontos’s teaching that the funnel was purposeful; Petitioner’s expert
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`agreed that even when used in a 6 French GC Kontos’s funnel would serve a useful
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`funneling function. Ex-2241, 158:21-159:6.
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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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`14
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`base portion 18 and the protruding distal marker band/overlapping soft tip
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`structure. Instead, Petitioner must invoke its new “at least six additional changes”
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`modification to Kontos. Reply, 13 n.3, 19-20. The Board should not credit this
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`new argument. Supra, §II.A. Moreover, there is still no record evidence that a
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`POSITA would have been motivated to make Kontos fit inside a 5 French guide
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`catheter at the time of the invention. The three articles Petitioner’s expert
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`references in a new declaration, Exs. 1836-1838, have not actually been made
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`record. See Ex-1806, ¶117. And based on what Patent Owner understands these
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`articles to be, they were published well after the date of invention. See IPR2020-
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`00130, Exs. 1836-1838.
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`b. The evidence does not support a motivation to “increas[e]
`the interior diameter” of Kontos’ device
`Petitioner’s second argument is a conflicting motivation to “increase[e] the
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`diameter of [Kontos’s ‘support’ catheter]” while keeping the size of the guide
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`catheter the same. Reply, 11-15. 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 a POSITA would redesign Kontos to “recess” the
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`marker bands. Id., 14-15. The Board should not credit this new argument. Supra,
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`§II.A. Further, Petitioner does not persuasively explain how a POSITA would
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`reasonably expect to successfully redesign Kontos’s tip structure. See Ex-1807,
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`¶¶128-136. Petitioner does not explain, for example, how a POSITA would expect
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`15
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`to successfully recess marker band 36 in the thin (0.005”) wall of the tube 16, or
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`how a POSITA would expect to securely attach/bind soft tip portion 28 without the
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`overlapping material shown in Kontos. And there would not have been an obvious
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`way to successfully do that in 2005. Ex-1800, 194:19-197:24.
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`Petitioner also improperly tries to latch on to testimony from Teleflex’s
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`experts about the benefits of the GuideLiner invention. Reply, 11-12 (citing
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`“‘maximizing the usable real estate’”). But that shows hindsight, not obviousness.
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`Further, redesigning Kontos’s device to increase its interior diameter would
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`have been contrary to Kontos’s teaching of a “support catheter” that is
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`narrow/snug-fitting. E.g., POR, 26-28; Ex-1409, 4:61-62 (“sizes [of 0.045” inner
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`diameter tube] generally are suitable for existing PTCA catheters”), 5:21-22
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`(“relatively fragile PTCA catheter balloon 48 will be safely surrounded by the
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`more durable body 12”), 2:26-29 and 6:59-7:5 (serving as a stent itself), Figs. 5-9
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`(showing a very snug-fitting support catheter). Kontos’s statement that “other
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`sizes may be used for other applications” (see Reply, 5) does not show a desire for
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`a loose versus snug fit—it simply recognizes that other-sized devices exist.
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`Petitioner’s Reply argument that Kontos prevents kinking through the use of
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`a “lubricious inner coating” is unsupported speculation. See Reply, 5-6. Kontos
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`says nothing about its support catheter having a lubricious inner coating, much less
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`that a lubricious coating prevents kinking. Additionally, Kontos is a “support”
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`16
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`catheter, and the specification indicates that it prevents kinking by “supporting,”
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`i.e., by the 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 driven
`by hindsight
`The evidence shows that a side opening as compared to a funnel actually
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`increased the likelihood that a device would become snagged or hung-up. POR,
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`28-31. In Reply, Petitioner cites back to Ressemann’s teaching of a side opening
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`providing “smoother” passage for a device. Reply, 16. But Ressemann is not
`
`comparing its angled opening to a funnel. Kontos already has funnel and therefore
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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 increased the risk of
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`catching/hang-up. POR, 29-31; compare Ex-1408, 7:40-44 (disclosing a
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`“flare”/funnel with no hang-up concerns) with id., 25:20-29. Thus, there would
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`have been no motivation to remove Kontos’s funnel to obtain the same benefit the
`
`funnel already provided but with the added risk of catching/hang-up. Id.
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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, 15-16.
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`Kontos’s funnel is important to its device—it decreases the likelihood of devices
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`getting caught/hung-up on the proximal opening (as compared to both a bare
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`perpendicular opening and a side opening). POR, 28-31. It also prevents
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`17
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`unwanted advancement beyond the end of the guide catheter. Ex-1409, 6:1-2.
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`And Kontos’s funnel did not create any ‘pushability’ issue. See Reply, 16. The
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`“pushability” problem Mr. Keith referenced in a separate case (Reply, 16) had
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`nothing to do with smooth passage or Kontos’ funnel; Mr. Keith was explaining
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`that Kontos’s tube is too flexible to provide backup support.
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`Regarding a side opening permitting “smooth re-entry,” Petitioner’s Reply
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`again shows impermissible hindsight, relying on testimony about use of the
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`GuideLiner product as evidence of purported obviousness. See Reply, 16-17. And
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`Petitioner provides no rebuttal to Teleflex’s evidence that (i) all of the experts
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`agree a POSITA would never actually push Kontos’s support catheter all the way
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`out of the guide catheter, and (ii) the funnel is there to prevent that. POR, 40-41.
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`3.
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`Petitioner’s modification would create a problematic
`gap/catch point where none existed before
`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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`the modification:
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`18
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`
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`POR, 26-31.
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`
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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, 17. Petitioner’s new expert contends that
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`guidewires are not blunt at their distal ends, but rather “ground to a progressive
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`taper in [their] distal portion[s].” Ex-1807, ¶131 (quoting Ex-1015, 551). This
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`“progressive taper” is not shown in Petitioner’s diagram and would only
`
`exacerbate the hang-up issue. Moreover, Petitioner’s expert admitted his analysis
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`was limited to using Kontos in a 6 French guide catheter. Ex-2241, 120:1-7. While
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`Kontos fits in a 6 French guide catheter, it could (and would) be used in larger
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`guide catheters. Ex-2238, 182:3-11; Ex-2241, 120:1-5. In larger guide catheters,
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`the hang-up problem would only be increased.
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`
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`Petitioner next contends that the gap/catch point would not be an issue
`
`because Ressemann (and a similar, related reference) shows devices with side
`
`openings that had larger gaps. Reply, 18. But Ressemann itself teaches such gaps
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`were problematic, and proposed either a funnel or a “reverse bevel” to try to
`
`mitigate that problem. POR, 29-30. The fact that another reference does not
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`expressly mention the problem does not mean it does not exist and does not negate
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`teaching away. The weight of the evidence is clear: a POSITA would not replace
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`Kontos’s funnel with a side opening where doing so would create a gap. Ex-2138,
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`¶¶223-236; Ex-1408, 25:23-29.
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`Critically, Petitioner’s evidence and argument is directed to improving
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`Kontos’s proximal opening as compared to just a perpendicular cut tube of uniform
`
`diameter. But Kontos discloses a funnel. Petitioner has not shown the funnel
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`would have issues with accepting devices or that Kontos’s ability to accept devices
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`would have been improved. There is no reason to replace the Kontos funnel with a
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`side opening, particularly when doing so would create a problem where there was
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`none. POR, 26-31.
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`E. Claim 13 (Ground 2): Petitioner Has Not Shown That it Would
`Have Been Obvious to Modify Kontos to Meet the “One French”
`Limitation
`
`
`Removing Kontos’s funnel would not permit the device to come close to
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`meeting the claimed “one French size” limitation. POR, 42-47. Petitioner’s Reply
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`effectively concedes this. Petitioner’s Reply instead introduces and attempts to
`
`rely on its new ‘at least six additional modifications’ to Kontos theory, contending
`
`that with those additional modifications to Kontos, a POSITA would arrive at the
`
`20
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`claimed “one French size” limitation. Reply, 19-20. The Board should reject this
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`untimely, hindsight-driven theory for all of the reasons explained above. Supra,
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`§II.A. Further, Kontos teaches away from increasing the interior diameter. POR,
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`43.
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`III. COMPELLING OBJECTIVE EVIDENCE CONFIRMS THAT
`CLAIMS 4, 9-12, AND 14 WOULD NOT HAVE BEEN OBVIOUS
`
`Petitioner does not dispute that GuideLiner was an incredibly successful
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`category-creating product. Reply, 20-24. Instead, Petitioner argues that
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`GuideLiner’s remarkable successes should be disregarded because, it contends,
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`certain claimed elements individually were known in the prior art. Id., 20-22. But
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`this ignores the purpose of objective evidence: to