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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 IPR2020-00127
`Patent 8,048,032
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`PATENT OWNER SUR-REPLY TO PETITIONER’S REPLY
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`TABLE OF CONTENTS
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`
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Claim Construction: The Structure “Through Which Interventional
`Cardiology Devices Are Insertable” Requires At Least the Defined Set of
`Guidewires, Balloon Catheters, Stents and Stent Catheters Be Insertable ..... 2
`
`III.
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`Petitioner Has Not Shown that the Challenged Claims Would Have
`Been Obvious ................................................................................................... 3
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`A. The Board Should Reject Petitioner’s New Theory Relying on
`Extensive Additional Modifications to Material Aspects of Kontos .... 3
`
`B. All Challenged Claims (Ground 1): Petitioner Has Not Shown
`That Kontos’s Support Catheter Has a “Cross-Sectional Inner
`Diameter Through Which Interventional Cardiology Devices are
`Insertable” As Required by Independent Claims 1 and 11 ................... 7
`
`C. Dependent Claims 2 and 12 (Ground 1): Petitioner Has Not
`Shown That Kontos Would Inherently Resist Axial and Shear
`Forces as Claimed ................................................................................. 9
`
`D. Dependent Claims 3, 4, 9, 13, and 18 (Ground 1): Petitioner Has
`Not Shown that a POSITA Would Be Motivated to Modify Kontos
`to Arrive at the Claimed Proximal Opening with a Reasonable
`Expectation of Success ........................................................................ 10
`
`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 ........................ 11
`
`a.
`
`b.
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`The evidence does not support a motivation to reduce
`the diameter of the guide catheter with a reasonable
`expectation of success .................................................... 11
`
`The purported motivation to “maximize the usable
`real estate” by “increasing the interior diameter” of
`Kontos is (i) new and (ii) unsupported ........................... 13
`
`
`
`i
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`
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`2.
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`3.
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`Petitioner’s other motivations are unsupported and driven
`by hindsight ............................................................................... 15
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`Petitioner’s modification would create a problematic
`gap/catch point where none existed before ............................... 17
`
`E. Dependent Claims 3 and 9 (Ground 1): Petitioner Has Not Shown
`its Proposed Kontos Modifications Would Meet the “Coaxial”
`Limitation ............................................................................................ 19
`
`F. Dependent Claim 6 (Ground 1): Petitioner has not shown that
`Kontos discloses the claimed “Flexible Cylindrical Reinforced
`Portion” ............................................................................................... 22
`
`G. Dependent Claims 8 and 17 (Ground 2): Petitioner Has Not Shown
`that it Would Have Been Obvious to Modify Kontos to Meet the
`“One French” Limitation ..................................................................... 23
`
`IV. Compelling Objective Evidence of Non-Obviousness Confirms that
`Claims 3, 9, 13, and 18 Were Not Obvious ................................................... 24
`
`A.
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`The Objective Evidence Is Undisputed ............................................... 24
`
`B.
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`C.
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`The Combination of Features That Resulted in GuideLiner’s
`Success and Praise Is Not in the Prior Art .......................................... 25
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`Copying by All GuideLiner’s Competitors Confirms
`Non-Obviousness ................................................................................ 26
`
`
`
`ii
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`
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`TABLE OF AUTHORITIES
`
`Cases
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................ 28
`
`Comcast Cable Communs., LLC v. Promptu Sys. Corp.,
`2021 U.S. App. LEXIS 42 (Fed. Cir. Jan. 4, 2021) .............................................. 23
`
`Howmedica Osteonics Corp. v. Zimmer, Inc.,
`640 F. App’x 951 (Fed. Cir. 2016) ......................................................................... 9
`
`In re Magnum Oil Tools Int'l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .............................................................................. 9
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ................................................................... 5, 8, 23
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ..................................................................... 27, 28
`
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................ 25
`
`Mytee Prods. v. Harris Rsch., Inc.,
`439 F. App'x 882 (Fed. Cir. 2011) .......................................................................... 9
`
`Real Time Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019) ............................................................................ 22
`
`Vitronics Corp. v. Conceptronic,
`90 F.3d 1576 (Fed. Cir. 1996) ................................................................................ 2
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ..................................................................... 25, 26
`
`Other Authorities
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`37 C.F.R. § 42.104(b)(3) .......................................................................................... 19
`
`37 C.F.R. § 42.23(b) ..............................................................................................5, 8
`
`PTAB Consolidated Trial Practice Guide (November 2019) ................... 5, 8, 13, 19
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`
`
`iii
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`
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`Introduction
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`I.
`
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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 delicate, fixed-wire balloon
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`catheters from kinking during use. Kontos’s device had a deliberately asymmetric
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`exterior, with a proximal protrusion to accommodate secure attachment of a
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`pushwire and to provide “leverage,” a distal marker band and soft tip covering, and
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`a proximal funnel structure.
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`The Petition posited one allegedly-obvious change to Kontos’s support
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`catheter: replacement of the proximal funnel with an angled side opening. But
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`after Patent Owner (“Teleflex”) pointed out numerous problems with this theory,
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`Petitioner changed course, and now proposes at least six significant additional
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`modifications to Kontos, along with new and different alleged motivations, to
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`reach at the claimed invention. These new and unsupported theories are improper
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`and fail on the merits.
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`The real-world facts confirm GuideLiner was not obvious. GuideLiner
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`solved an undisputed long-felt need, was met with immediate commercial success
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`and widespread industry acclaim, and was copied by competitors. Petitioner does
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`not dispute any of this. Instead, Petitioner merely tries to argue that guide
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`extension catheters (“GEC”) with the claimed features responsible for the success
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`1
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`had already been invented. But that is not true. The Board should confirm
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`patentability of the challenged claims.
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`II. Claim Construction: The Structure “Through Which Interventional
`Cardiology Devices Are Insertable” Requires At Least the Defined Set
`of Guidewires, Balloon Catheters, Stents and Stent Catheters Be
`Insertable
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`Petitioner’s Reply ignores that the specification expressly defines
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`“interventional cardiology devices” to include at least the set of guidewires,
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`balloon catheters, stents, and stent catheters. Paper 40 (“POR”), 9-10. If the
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`claims covered a device that could only receive one or two such devices, they
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`would use the conjunctive “or.” Id. A patentee can be his or her own
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`lexicographer when the definition of the term “is clearly stated in the patent
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`specification or file history.” Vitronics Corp. v. Conceptronic, 90 F.3d 1576, 1582
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`(Fed. Cir. 1996). Petitioner’s Reply ignores this.
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`Petitioner misapprehends Teleflex’s argument regarding the specification’s
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`discussion of “standard coronary devices.” Teleflex does not argue that “standard
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`coronary devices” and “interventional cardiology devices” are synonymous.
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`Teleflex’s point is that the specification’s express definition of “interventional
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`cardiology devices” as a minimum set of devices, including stents and balloon
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`catheters, is consistent with the clearly stated purpose of the invention as accepting
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`“standard coronary devices.” Ex-2242, 88:18-89:18. Indeed, the Summary of the
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`Invention describes a “coaxial guide catheter,” i.e., a structure that serves the same
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`2
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`basic function (delivering interventional cardiology devices) as the guide catheter
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`in which it is placed. Ex-1401, 2:53–64. Petitioner does not dispute that stents and
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`balloon catheters are among the most common “standard coronary devices.” POR,
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`10-11.
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`III. Petitioner Has Not Shown that the Challenged Claims Would Have
`Been Obvious
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`A. The Board Should Reject Petitioner’s New Theory Relying on
`Extensive Additional Modifications to Material Aspects of Kontos
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`For ’032 patent claims requiring a side opening (claims 3, 4, 9, 13, and 18)
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`or the “one French” differential (claims 8 and 17), the Petition was premised on a
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`single modification of Kontos: that a POSITA would have been motivated to
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`remove Kontos’s proximal funnel and replace it with an angled side opening. E.g.
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`Paper 3 (“Petition”), 41-47, 53-54, 65-66, 69-72. Petitioner now presents an
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`entirely new theory, premised on myriad additional, material modifications to
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`Kontos:
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`3
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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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`Ex-1409, Fig. 1; Petition, 43; Paper 71 (“Reply”), 18-19, 21-22. Petitioner’s Reply
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`contends, for the first time, that a POSITA would be motivated to completely
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`change Kontos, with at least six additional changes beyond those advocated in the
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`Petition: (1) “recess[ing]” Kontos’s marker bands; (2) attaching the distal soft tip
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`“align[ed] . . . with the tube” without overlapping structure; (3) removing Kontos’s
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`base portion 18; (4) “taper[ing] the pushrod” down to less than 0.005”; (5)
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`somehow “attach[ing]” the thin-tapered pushrod to Kontos’s tube wall without
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`4
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`base portion 18, and (6) “increas[ing]” the diameter of “tube 16.” E.g. Reply, 21-
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`22; Ex-2241, 124:13-126:20. Petitioner seeks to support this new theory with at
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`least twenty-eight new paragraphs of analysis in a new declaration from a new
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`expert.1 Reply, 14, 21-22 (citing Ex-1807, ¶¶168-182, 183-195).
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`
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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; 37 C.F.R. § 42.23(b);
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`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359, 1369-70
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`(Fed. Cir. 2016). Petitioner’s proposal of a complete redesign of Kontos is too late
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`and the Board must reject it.
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`1 Petitioner dropped its first engineering expert, Hillstead, who also did not meet
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`Petitioner’s own definition of a POSITA, after he was deposed. Ex-2239, 13:7-
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`10. Petitioner’s new expert, Jones, never reviewed the GuideLiner patent claims
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`(except claim 1 of the ’032) and has never designed a coronary catheter. Id.,
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`14:16-16:15, 26:11-17. Moreover, Jones admitted that his opinions were based at
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`least in part on inventor testimony regarding how the inventor came up with the
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`invention (id., 39:15-40:4), which should not be part of an obviousness
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`analysis. Jones’ role is an exercise in pure hindsight and his testimony (Ex-1807)
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`should be disregarded.
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`5
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`Even on the current record alone, there are numerous reasons to reject
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`Petitioner’s new invalidity theory. Six significant new modifications belies
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`obviousness and shows that Petitioner is using the invention as a roadmap.
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`Kontos’s device has a relatively narrow central tube 16 that fits snugly around a
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`“fragile” PTCA catheter, as well as outwardly-projecting structures at the distal
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`and proximal ends that serve various functions while not detracting from the ability
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`of the device to be used in a 6 French guide catheter. POR, 12-14. Redesigning
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`Kontos to remove all of those projecting structures is totally inconsistent with what
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`Kontos is 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 important “eccentric cross-section”: it “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 0.020”
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`pushwire down to fit into a 0.005” polymer wall by “pound[ing] wire 14 flat at its
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`junction with tube 16” (Ex-1807, ¶177) directly contradicts Petitioner’s argument
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`in a related IPR that a POSITA would be motivated to modify Itou’s pushwire
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`because where it has been “crushed” to create a “flat plate” creates a “potential
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`weakness point in the catheter.” IPR2020-00135, Paper 82, 17.
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`Petitioner does not adequately explain how a POSITA would expect to
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`successfully embed a “tapered” metal pushrod into an extremely thin polymer wall
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`6
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`of 0.005”. See Reply, 19. Petitioner’s expert admitted that one would probably
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`have to “bolster” the wall of the proximal portion of Kontos’s tube where the
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`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”). See also Ex-2241, 49:2-5
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`(Petitioner’s new expert admitting that he was not aware of any prior art showing a
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`wire tapered down to less than 0.005”); id. 158:1-14 (admitting that the polar
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`moment of inertia for a 0.005” pushwire would be 256 times smaller than Kontos’s
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`disclosed 0.020” pushwire).
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`Petitioner’s resort to a completely new invalidity theory for claims 3, 4, 8, 9,
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`13, 17, and 18 only confirms Petitioner’s improper use of hindsight. The Board
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`should reject Petitioner’s new theory and confirm patentability of these claims.
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`B. All Challenged Claims (Ground 1): Petitioner Has Not Shown
`That Kontos’s Support Catheter Has a “Cross-Sectional Inner
`Diameter Through Which Interventional Cardiology Devices Are
`Insertable” As Required by Independent Claims 1 and 11
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`
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`Teleflex disagrees with the Board’s preliminary claim construction of
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`“through which interventional cardiology devices are insertable” as only requiring
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`7
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`two of the four devices from the definition provided in the ’032 patent. Supra, § II.
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`Regardless of construction, Petitioner has failed to prove that Kontos discloses this
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`element.
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`Under the proper construction, Petitioner must show that Kontos’s device
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`had a coaxial lumen with a cross-sectional inner diameter through which
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`interventional devices, including stent catheters, were insertable. POR, 18-19. Id.
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`The Petition failed to do that. Id. Now for the first time in Reply, Petitioner tries
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`to introduce a new inherency argument and evidence, which it characterizes as
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`“unrebutted.” Reply, 5. This new inherency argument is untimely, improper, and
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`if accepted would prejudice Teleflex’s due process rights to fairly respond. TPG,
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`73-75 (citing 37 C.F.R. § 42.23(b)); Intelligent Bio-Sys., 821 F.3d at 1369-70.
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`Petitioner’s new inherency argument is not even supported by the new
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`evidence. Petitioner contends that Kontos’s tubular portion had an inner diameter
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`of 0.045” and that in the 2005-2006 timeframe there were stents sized to travel
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`through that lumen. Reply, 5. However, Petitioner and its expert rely only on the
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`bare crossing profile (outer diameter) of the identified stents. Id. (citing Ex-1806
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`¶¶155-58). Petitioner’s new evidence shows that these stents still require a
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`minimum guiding catheter inner diameter of 5 French (which is 0.056”)—far
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`larger than Kontos’s 0.045” inner diameter. E.g. Ex-1802, 25 (a “[n]on-expanded
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`profile” of 0.038”, but requires “[m]inimal internal diameter of guiding catheter”
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`
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`8
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`of 0.056”); id., 7-8 (“compatible with a 5 Fr guiding catheter”), 21-22 (deliverable
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`through “a Medtronic Zuma 5 Fr guiding catheter”); Ex-1804, 2 (“compatible with
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`the 5F guiding catheter”). Neither Petitioner nor its expert explain why a POSITA
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`would expect these stents to be insertable into Kontos, when the same exhibits
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`state that those same stents require guiding catheters with minimum inner
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`diameters of 0.056”/5 French.
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`Even under the Board’s preliminary construction, the “PTCA balloon
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`catheter 40 with balloon 48” is only one interventional cardiology device, not two.
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`POR, 20-21. Petitioner does not dispute this, but instead argues that Kontos is also
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`sized to accept a guidewire. Reply, 4. But this is a new and unresponsive
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`argument, and the Board should disregard it as untimely.
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`C. Dependent Claims 2 and 12 (Ground 1): Petitioner Has Not
`Shown That Kontos Would Inherently Resist Axial and Shear
`Forces as Claimed
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`Petitioner wrongly seeks to apply a burden-shifting paradigm used in patent
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`prosecution and reexamination. Reply, 5-6. The burden to prove invalidity
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`(including inherency) always stays on the Petitioner in IPRs. In re Magnum Oil
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`Tools Int'l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). Petitioner’s cases expressly
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`pertain to patent prosecution and reexamination, not inter partes review. Mytee
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`Prods. v. Harris Rsch., Inc., 439 F. App'x 882, 886 (Fed. Cir. 2011); Howmedica
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`Osteonics Corp. v. Zimmer, Inc., 640 F. App’x 951, 957 (Fed. Cir. 2016).
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`
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`9
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`
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`Even if the Board considers Petitioner’s untimely gap-filling evidence (Exs-
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`1806, 1807; Reply, 8-11), the 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. That is insufficient. While a guide-catheter-within-guide-catheter assembly
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`can improve backup support while still having a 0.015” annular gap, Kontos does
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`not disclose a guide-catheter-within-guide-catheter assembly. Kontos teaches a
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`“pliable,” close-fitting, narrow “support catheter” with asymmetric exterior
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`protrusions within a guide catheter. POR, 13-14, 22-25. The fact that a guide-
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`catheter-in-guide-catheter assembly provides increased backup support does not
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`mean that Kontos (which is not a standard guide catheter shape) necessarily does.
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`D. Dependent Claims 3, 4, 9, 13, and 18 (Ground 1): Petitioner Has
`Not Shown that a POSITA Would Be Motivated to Modify Kontos
`to Arrive at the Claimed Proximal Opening 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, 10. But Teleflex was correct. POR,
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`25-40. If Petitioner’s theory was that it would have been obvious to make seven
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`changes to Kontos, it was required to present and support that theory in its Petition.
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`Because Petitioner failed to do so, its new argument should be stricken. Moreover,
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`10
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`
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`as explained herein, Petitioner’s invalidity arguments remain flawed and should be
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`rejected regardless of its new theory and evidence.
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`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
`
`The Petition contended that a POSITA would be motivated to replace
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`Kontos’s funnel with a side opening to “permit a reduction of the outer diameter of
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`the catheter assembly” to allow use of a smaller guide catheter. Petition, 43-44.
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`Petitioner’s Reply adds a new motivation: “maximizing usable real estate” by
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`“increasing” the interior diameter of Kontos’s body 12. Reply, 11-13. Neither is
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`persuasive.
`
`a. The evidence does not support a motivation to reduce
`the diameter of the guide catheter with a reasonable
`expectation of success
`
`Kontos’s device as disclosed fits in a 6 French guide catheter and, even if the
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`funnel was removed, is still too large to fit into a 5 French guide catheter. POR,
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`34-36. Petitioner’s expert agrees. E.g. Ex-2241, 107:8-15. With this now
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`undisputed, Petitioner’s purported motivation to remove Kontos’s funnel to allow
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`downsizing of the guide catheter is entirely unsupported.
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`Petitioner argues that Kontos’s funnel may “rub” in a 6 French guide
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`catheter. Reply, 12. But as indicated above, Petitioner’s expert agrees Kontos
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`would work with a 6 French guide catheter. What’s more, Petitioner’s Ressemann
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`
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`11
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`
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`reference teaches that a funnel that touches the inner wall of the guide catheter is
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`actually beneficial because it can create a “sliding seal” that “prevents the passage
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`of fluid.” Ex-1408, 7:43-47. Petitioner’s contention that Kontos’s funnel is too
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`small to do much funneling (Reply, 12) is hindsight that ignores the teaching of
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`Kontos that the funnel was purposeful; its expert agreed that even when used in a 6
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`French guide catheter Kontos’s funnel would be useful. Ex-2241, 158:21-159:6.
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`Regarding a 5 French guide catheter, Petitioner does not dispute that
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`removing Kontos’s funnel would not enable it to fit in a 5 French guide catheter,
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`due to the presence of thickened base portion 18 and the distal marker band/soft tip
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`structure. Instead, Petitioner invokes its new overhaul of Kontos, which should be
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`rejected. Reply, 13 n.4; supra, § III.A. Moreover, the record is void of evidence
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`that a POSITA would have been motivated to make Kontos fit inside a 5 French
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`guide catheter at the time of the invention. In the 2005-2006 timeframe, 5 French
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`guide catheters “offer[ed] no major advantage and [were] not routinely used.” Ex-
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`2167, 33; see also Ex-2138, ¶178; Ex-2145, ¶220. The articles Petitioner’s expert
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`cites, Exs-1836-1838, were published in 2014, 2013, and 2008, well after the date
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`of invention. See Ex-1806, ¶171.
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`12
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`
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`b. The purported motivation to “maximize the usable real
`estate” by “increasing the interior diameter” of Kontos
`is (i) new and (ii) unsupported
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`The Petition argued only that one would be motivated to remove Kontos’s
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`funnel to decrease the size of the guide catheter. Petition, 43-44. Petitioner now
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`pivots to a new “maximize the usable real estate” motivation. Reply, 11, 13-14.
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`Petitioner improperly tries to latch on to testimony from Teleflex’s experts about
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`the benefits of the GuideLiner invention. Reply, 11 (citing “maximizing the usable
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`real estate”). But that shows hindsight, not obviousness. Moreover, “new
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`motivations” are new arguments that should not be permitted for the first time in
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`reply. TPG, 74.2
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`Petitioner’s new argument is also unpersuasive. First, a POSITA would not
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`expect merely removing Kontos’s funnel to allow one to increase the interior
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`2 Petitioner attempts to justify its new argument by asserting that “PO argue[d] that
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`it would not be possible to increase the diameter of body 12.” Reply, 14 (citing
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`POR, 27). Even if true, that would not open the door for an improper new
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`motivation. But it is not true—Teleflex actually argued that (i) “[t]he Petitioner
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`does not propose modifying Kontos in in any other way [other than removing the
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`funnel]” and (ii) “[n]or could it,” noting that Kontos’s other protruding structures
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`are necessary for Kontos’s function. POR, 27.
`
`
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`13
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`
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`diameter of Kontos due at least to Kontos’s raised marker band. POR, 27. And
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`Petitioner’s argument that a POSITA would modify Kontos to “recess” the marker
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`bands (Reply, 14) was absent from the Petition and should be disregarded. Supra,
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`§ III.A. Petitioner’s improper new evidence does not even adequately explain how
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`a POSITA would reasonably expect to successfully redesign Kontos’s tip structure.
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`See Ex-1807, ¶¶168-82. Petitioner does not explain, for example, how a POSITA
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`would expect to successfully recess marker band 36 in the thin (0.005”) wall of the
`
`tube 16, or having done that, how a POSITA would expect to securely attach/bind
`
`soft tip portion 28 without the overlapping material shown in Kontos. As
`
`Teleflex’s expert testified, there would not have been an obvious way to
`
`successfully do that in 2005. Ex-1800, 194:19-197:24.
`
`Second, redesigning Kontos’s device to increase its interior diameter without
`
`increasing the diameter of the guide catheter would have been contrary to Kontos’s
`
`teaching of a “support catheter” to (i) protect delicate fixed-wire balloon catheters
`
`and (ii) have a small enough profile to fit inside a lesion as a temporary stent. E.g.
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`POR, 13-14, 26-27; Ex-1409, 4:61-62 (“sizes [of 0.045” inner diameter tube]
`
`generally are suitable for existing PTCA catheters”), 5:20-22 (“relatively fragile
`
`PTCA catheter balloon 48 will be safely surrounded by the more durable body
`
`12”), 2:26-29 and 6:59-7:5 (serving as a stent itself), Figs. 5-9 (showing a very
`
`snug-fitting support catheter). Kontos’s statement that “other sizes may be used
`
`
`
`14
`
`
`
`for other applications” (see Reply, 3) does not show a desire for a loose versus
`
`snug fit—it simply recognizes that other-sized devices exist.
`
`Petitioner argues that Kontos prevents kinking through the use of a
`
`“lubricious inner coating.” Reply, 3. Kontos says nothing about its support
`
`catheter having a lubricious inner coating, much less that a lubricious coating is
`
`what prevents kinking. Second, Kontos is a “support” catheter, and the
`
`specification indicates that it prevents kinking by “supporting,” i.e., by the spatial
`
`relationship. Ex-1409, 6:50-58; 8:12-16, Figs. 5-9.
`
`2.
`
`Petitioner’s other motivations are unsupported and driven
`by hindsight
`
`The evidence shows that a side opening as compared to a funnel actually
`
`increased the likelihood that a device would become snagged or hung-up. POR,
`
`36-37. In Reply, Petitioner cites back to Ressemann’s teaching of a side opening
`
`providing “smoother” passage for a device. Reply, 15. But Ressemann is not
`
`comparing its angled opening to a funnel. Kontos already has funnel and therefore
`
`already provides “smoother” passage. Compared to a funnel (the relevant
`
`comparison), Ressemann taught that a side opening has increased risk of
`
`catching/hang-up. POR, 27-30; Compare Ex-1408, 7:40-44 (disclosing a
`
`“flare”/funnel with no hang-up concerns) with id. 25:20-29. Thus, there was no
`
`motivation to remove Kontos’s funnel to obtain that same benefit but with the
`
`added risk of catching/hang-up. Id.
`
`
`
`15
`
`
`
`As for purported “smoother passage of the catheter assembly as it navigates
`
`the vasculature,” Petitioner still fails to weigh any such negligible benefit against
`
`the importance of Kontos’s funnel to its disclosed functions. See Reply, 15-16.
`
`Kontos’s funnel is important to its device—it decreases the likelihood of devices
`
`getting caught/hung-up on the proximal opening (as compared to both a bare
`
`perpendicular opening and a side opening). POR, 36-37. It also prevents
`
`unwanted advancement beyond the end of the guide catheter. Ex-1409, 6:1-2.
`
`And Kontos does not have any issue with pushability—Petitioner takes Keith’s
`
`prior statements from another case entirely out of context. See Reply, 16. The
`
`“pushability” problem in Keith’s testimony is that due to materials and geometry
`
`Kontos’s tube is too flexible to provide backup support. See, e.g., Ex-1819, ¶¶89,
`
`112.
`
`Regarding a side opening permitting “smooth re-entry,” Petitioner’s Reply
`
`again shows impermissible hindsight, relying on testimony about use of the
`
`GuideLiner product as evidence of purported obviousness. See Reply, 16. And
`
`Petitioner fails to provide any rebuttal to Teleflex’s evidence that (i) all of the
`
`experts agree a POSITA would never actually push Kontos’s support catheter all
`
`the way out of the guide catheter, and (ii) the funnel prevents that from happening.
`
`POR, 37-38.
`
`
`
`16
`
`
`
`3.
`
`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
`
`create a problematic gap/catch point, further dissuading a POSITA from making
`
`this modification:
`
`
`
`POR, 26-30.
`
`
`
`Petitioner contends that when used in a 6 French guide catheter, the gap
`
`would be only 0.005”. Reply, 16-17. Petitioner’s new expert contends that
`
`guidewires are not blunt at their distal ends, but rather “ground to a progressive
`
`taper in [their] distal portion[s].” Ex-1807, ¶177 (quoting Ex-1015, 551). This
`
`“progressive taper” is not shown in Petitioner’s diagram and would only
`
`exacerbate the hang-up issue. Moreover, Petitioner’s expert admitted his analysis
`
`was limited to using Kontos in a 6 French guide catheter. Ex-2241, 120:1-7. While
`
`Kontos fits in a 6 French guide catheter, it could (and would) be used in larger
`
`
`
`17
`
`
`
`guide catheters. Ex-2238, 182:3-11; Ex-2241, 120:1-5. In larger guide catheters,
`
`the hang-up problem would only be increased.
`
`
`
`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, 17-18. But Ressemann itself teaches such
`
`gaps were problematic, and proposed either a funnel or a “reverse bevel” to try to
`
`mitigate that problem. POR, 28-29. The fact that another reference does not
`
`expressly mention the problem does not mean it does not exist and does not negate
`
`teaching away. The weight of the evidence is clear: a POSITA would not replace
`
`Kontos’s funnel with a side opening where doing so would create a gap. Ex-2138,
`
`¶¶156-161; Ex-1408, 25:23-29.
`
`
`
`Critically, Petitioner’s evidence and argument is directed to improving
`
`Kontos’s proximal opening as compared to just a perpendicular cut tube of uniform
`
`diameter. But Kontos discloses a funnel. Petitioner has not shown the funnel
`
`would have issues with accepting devices or that Kontos’s ability to accept devices
`
`would have been improved. There is no reason to replace the Kontos funnel with a
`
`side opening, particularly when doing so would create a problem where there was
`
`none before.
`
`
`
`18
`
`
`
`E. Dependent Claims 3 and 9 (Ground 1): Petitioner Has Not Shown
`its Proposed Kontos Modifications Would Meet the “Coaxial”
`Limitation
`
`Petitioner does not dispute that if Kontos’s funnel is replaced with an angled
`
`side opening and the guide catheter somehow “downsized” as Petitioner advocates,
`
`the proximal part of the Kontos section Petitioner calls the tip portion for claims 3
`
`and 9 (Petition, 29) would no longer be “coaxial” as required by those claims.
`
`Instead, Petitioner embarks in two new directions.
`
`First, Petitioner argues for a new and unsupported definition of coaxial.
`
`Reply, 18-19. The Petition did not propose applying anything other than plain and
`
`ordinary meaning. Petitioner’s Reply for the first time argues that “coaxial lumen”
`
`actually means something different: “aligned in the same direction as the axis of
`
`lumen of the guide catheter.” Reply, 18. This new construction is untimely and
`
`the Board should reject it. 37 C.F.R. § 42.104(b)(3); TPG, 45 (“The petitioner . . .
`
`cannot raise new claim construction issues that were not previously raised in its
`
`petition.”).
`
`Further, axes “aligned in the same direction” are “parallel,” not “coaxial.”
`
`The plain meaning of coaxial, as the Board recognized in a related decision
`
`denying institution, is not merely parallel axes. IPR2020-00133, Paper 20, 14-15.
`
`The ’032 patent and
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