UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`
`
`Case IPR2020-00128
`Patent RE45,380
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`PATENT OWNER SUR-REPLY TO PETITIONER’S REPLY
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`TABLE OF CONTENTS
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`Page
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`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`The Proper Construction of “Through Which Interventional Cardiology
`Devices are Insertable” Is Dispositive Against the Petition (All Challenged
`Claims) ............................................................................................................ 2
`
`A.
`
`“Through Which Interventional Cardiology Devices are Insertable”
`Requires at Least the Defined Set of Guidewires, Balloon Catheters,
`Stents, and Stent Catheters are Insertable ............................................. 3
`
`B.
`
`“Interventional Cardiology Device” ..................................................... 5
`
`III. All Challenged Claims (Ground 1): Petitioner Has Not Shown that Itou’s
`Lumen Has the Claimed Structure with a “Cross-Sectional Inner Diameter
`Through Which Interventional Cardiology Devices are Insertable” Under
`Either Construction ......................................................................................... 7
`
`A.
`
`B.
`
`C.
`
`Itou’s Protective Catheter Is Not an “Interventional Cardiology
`Device” As That Term Is Defined and Used in the ’380 Patent ........... 7
`
`Petitioner’s New Inherency Argument Is Untimely and It Would Be
`Unfairly Prejudicial for the Board To Consider It ............................... 8
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`Petitioner’s New Inherency Argument Is Unpersuasive, Even If the
`Board Were to Consider It ................................................................. 10
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`IV.
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`Independent Claim 1 (Ground 1): Itou Does Not Anticipate Because Its
`Distal Tip Portion Is Not Cylindrical ............................................................ 11
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`V. Dependent Claims 3, 14, and 15 (Grounds 1 and 2) .................................... 12
`
`A.
`
`B.
`
`C.
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`Petitioner Failed to Show That Itou Anticipates Claims 3, 14, or 15
`(Ground 1) .......................................................................................... 12
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`Claim 3 Would Not Have Been Obvious in View of Itou and
`Ressemann (Ground 2) ....................................................................... 14
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`Claim 14 Would Not Have Been Obvious in View of Itou and
`Ressemann (Ground 2) ....................................................................... 16
`
`ii
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`

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`D. Claim 15 Is Not Obvious in View of Itou and Ressemann (Ground 2)
` ............................................................................................................. 18
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`VI. Petitioner Has Not Refuted the Striking Objective Evidence That Confirms
`Claims 3 and 14 Were Not Obvious .............................................................. 18
`
`A.
`
`B.
`
`C.
`
`The Objective Evidence, Including Nexus, Is Undisputed ................. 18
`
`The Combination of Features That Resulted in GuideLiner’s Success
`and Praise Is Not in the Prior Art ........................................................ 19
`
`The Fact That All of GuideLiner’s Competitors Copied its Design
`Confirms Non-Obviousness ................................................................ 20
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`VII. Non-AIA Patent ............................................................................................. 22
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`
`
`iii
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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) ............................................................................ 22
`
`In re Magnum Oil Tools Int'l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ............................................................................ 13
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .............................................................................. 9
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ..................................................................... 21, 22
`
`Jack Guttman, Inc. v. Kopykake Enters.,
`302 F.3d 1352 (Fed. Cir. 2002) .............................................................................. 3
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................................. 14
`
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................ 19
`
`Mytee Prods., Inc. v. Harris Rsch, Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ....................................................................... 13
`
`Tech. Patents LLC v. T-Mobile UK, Ltd.,
`700 F.3d 482 (Fed. Cir. 2012) ................................................................................ 6
`
`Vitronics Corp. v. Conceptronic,
`90 F.3d 1576 (Fed. Cir. 1996) ................................................................................ 3
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ..................................................................... 19, 20
`
`Other Authorities
`
`35 U.S.C. § 103 ........................................................................................................ 16
`
`35 U.S.C. § 312(a)(3) ................................................................................................. 9
`
`iv
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`

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`I.
`
`Introduction
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`The challenged claims are directed to a guide extension catheter (“GEC”)
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`with rapid exchange capability through which at least a defined set of
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`“interventional cardiology devices” are insertable. Petitioner’s reliance on Itou, a
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`suction catheter designed for an entirely different purpose, is unavailing. Petitioner
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`does not persuasively explain why the Board should ignore the patent’s express
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`definition of “interventional cardiology devices” as including at least guidewires,
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`balloon catheters, stents, and stent catheters. Even under the Board’s preliminary
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`construction, the Petition incorrectly relies on Itou’s protective catheter, which the
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`patent itself makes clear is not an interventional cardiology device. What’s more,
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`Itou’s protective catheter is inserted into Itou’s suction catheter only outside the
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`body. Unlike GuideLiner, Itou does not receive anything into its proximal opening
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`after it is loaded into a guide catheter.
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`Petitioner also raises an inherency argument for the first time in Reply. This
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`is a transparent and improper attempt to belatedly gap-fill. And Petitioner’s new
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`argument is not even supported by the new evidence.
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`Independent claim 1 of the ’380 patent requires that the tubular structure
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`(defined by the flexible tip portion) include “a flexible cylindrical distal tip
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`portion.” The distal tip portion of Itou’s suction catheter is not “cylindrical.” It is
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`1
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`

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`sharply angled to facilitate suction, and for this reason also Itou plainly does not
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`anticipate claim 1.
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`Ground 2’s obviousness arguments against claims 3, 14, and 15 likewise
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`fail. Petitioner does not show that a POSITA would be motivated to combine Itou
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`and Ressemann with a reasonable expectation of success. Moreover, there is
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`unusually compelling objective evidence of non-obviousness in this case. The
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`GuideLiner invention as embodied by claims 3 and 14 was a groundbreaking
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`product that solved a long-felt need in interventional cardiology and garnered
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`widespread industry praise and e copying by competitors. Petitioner fails to show
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`that the challenged claims are unpatentable.
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`II. The Proper Construction of “Through Which Interventional
`Cardiology Devices are Insertable” Is Dispositive Against the Petition
`(All Challenged Claims)
`
`
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`The Board must resolve two distinct claim construction issues for the ’380
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`patent: (i) whether the claim phrase “through which interventional cardiology
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`devices are insertable” requires structure through which at least the defined set of
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`guidewires, balloon catheters, stents, and stent catheters are insertable; and (ii)
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`whether “interventional cardiology devices” encompasses things like Itou’s
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`protective catheter that do not extend past the end of the guide catheter to provide
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`treatment.
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`2
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`

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`Petitioner incorrectly contends that resolution of these claim construction
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`issues “does not impact the outcome of this IPR.” Paper 83 (“Reply”), 2. The
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`Petition did not cite any evidence showing that Itou has the structure through
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`which balloon catheters, stents, and stent catheters are insertable as claimed,
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`relying instead on Itou’s pre-loaded protective catheter 5. Paper 43, Patent Owner
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`Response (“POR”), 9-11 and 19-21. If the Board rules in Teleflex’s favor on
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`either of these issues, the IPR fails on all grounds.
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`A.
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`“Through Which Interventional Cardiology Devices Are
`Insertable” Requires at Least the Defined Set of Guidewires,
`Balloon Catheters, Stents, and Stent Catheters Are Insertable
`
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`Petitioner’s Reply ignores that the specification expressly defines
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`“interventional cardiology devices” as including at least the set of guidewires,
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`balloon catheters, stents, and stent catheters. POR, 9-11. If the claims covered a
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`device that could only receive one or two such devices, they would use the
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`conjunctive “or.” Id. A patentee can be his/her own lexicographer if his/her
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`definition “is clearly stated in the patent specification or file history.” Vitronics
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`Corp. v. Conceptronic, 90 F.3d 1576, 1582 (Fed. Cir. 1996). When the patentee
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`has clearly defined the term, “that definition ‘usually . . . is dispositive; it is the
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`single best guide to the meaning of a disputed term.’” Jack Guttman, Inc. v.
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`Kopykake Enters., 302 F.3d 1352, 1360 (Fed. Cir. 2002) (quoting Vitronics, 90
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`F.3d at 1582). Petitioner’s Reply does not address this.
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`3
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`

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`Petitioner’s response to Teleflex’s argument regarding the specification’s
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`discussion of “standard coronary devices,” misapprehends Teleflex’s argument.
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`Reply, 2-3. Teleflex does not argue that “standard coronary devices” and
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`“interventional cardiology devices” are synonymous. Rather, Teleflex’s point is
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`that the specification’s express definition of “interventional cardiology devices” as
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`requiring a minimum set of devices including stents and balloon catheters, rather
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`than just any one or two of such devices, is consistent with the purpose of the
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`invention. POR, 9-11.
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`Construing the claim phrase “through which interventional cardiology
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`devices are insertable” to require only a guidewire and not a stent or balloon
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`catheter, for example, would be inconsistent with the clearly stated purpose of the
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`invention as accepting “standard coronary devices.” Petitioner does not dispute
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`that stents and balloon catheters are in fact some of the most common “standard
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`coronary devices.” POR, 9-11. And the Summary of the Invention describes the
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`invention as a “coaxial guide catheter,” i.e., a structure that serves the same basic
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`function (delivering interventional cardiology devices) as the guide catheter in
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`which it is placed. Ex-1001, 3:9–20. Petitioner’s expert, Dr. Zalesky, agrees that
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`in view of the way the term “interventional cardiology devices” is defined by the
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`GuideLiner patent specification, the invention must be able to deliver stents and
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`stent catheters. Ex-2242, 88:18-89:18.
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`4
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`

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`
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`Teleflex asks the Board to reconsider its preliminary claim construction and
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`properly interpret the phrase “through which interventional cardiology devices are
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`insertable” consistent with the definition in the specification to require structure
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`through which at least the defined set of guidewires, balloon catheters, stents, and
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`stent catheters are insertable.
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`B.
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`“Interventional Cardiology Device”
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`
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`Petitioner disputes that “interventional cardiology device” requires a device
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`that provides treatment to a location in the heart. Reply, 2-5. With this argument,
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`Petitioner asks the Board to ignore how the ’380 patent defines and uses that term
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`in favor of a broader general meaning based on extrinsic evidence. See Ex-1806
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`¶¶10-13 (relying only on extrinsic evidence); Ex-2238, 18:1-4 (Petitioner’s expert
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`construing the term as merely “those devices which would go into a [GEC]”). This
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`is improper.
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`Petitioner’s contention that the specification does not use the term
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`“interventional cardiology device” interchangeably with “cardiac treatment device”
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`and “interventional cardiology treatment device” is belied by the specification,
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`which expressly refers to the same set of devices, including guidewires, as both
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`“interventional cardiology devices” and “cardiac treatment device[s]”:
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`5
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`

`

`•
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`“[T]he term ‘interventional cardiology devices’ is to be understood to
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`include but not be limited to guidewires, balloon catheters, stents and
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`stent catheters.” Ex-1001, 1:41-44.
`
`•
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`“[A] cardiac treatment device, such as a guidewire, balloon or stent”.
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`Ex-1001, 4:53-54.
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`Petitioner cites no authority for the proposition that different words in the
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`specification are presumed to have different meanings. Indeed, patentees can and
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`often do use words interchangeably, which informs claim construction. E.g., Tech.
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`Patents LLC v. T-Mobile UK, Ltd., 700 F.3d 482, 492 (Fed. Cir. 2012) (“[T]he
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`patent uses the terms ‘receiving user’ and ‘subscriber’ interchangeably.”).
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`Petitioner also ignores that the patent expressly differentiates devices that might
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`broadly be considered interventional cardiology tools (like protective catheters),
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`from its use of “interventional cardiology device”. POR, 11-15.
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`Finally, Petitioner contends that Teleflex’s construction is incorrect because
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`it would read out guidewires, which Petitioner contends do not provide treatment.
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`Reply, 5. Petitioner is wrong, and its citation to Teleflex’s expert testimony is
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`highly misleading. Dr. Graham agreed that guidewires are not “routinely” used
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`alone to treat a lesion (Ex-1801, 89:2-4), but he testified unequivocally that
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`guidewires alone do provide treatment, by restoring some blood flow. Ex-1813,
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`108:25-109:3; see also id., 107:12-21 (same). Petitioner’s cardiologist expert
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`6
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`

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`agrees that passing a guidewire through a blocked blood vessel can itself restore
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`“some flow” and “it is not a bad thing.” Ex-2238, 20:21-21:8.
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`III. All Challenged Claims (Ground 1): Petitioner Has Not Shown that
`Itou’s Lumen Has the Claimed Structure with a “Cross-Sectional Inner
`Diameter Through Which Interventional Cardiology Devices Are
`Insertable” Under Either Construction
`
`The Petition relied only on Itou’s protective catheter for independent claim 1
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`and only on the protective catheter and a guidewire for independent claim 12. See
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`Petition, 27, 53. Teleflex’s Response explained that Itou’s protective catheter is
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`not an interventional cardiology device, and therefore the Petition’s challenge fails.
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`POR, 19-23. This is true under both the correct construction, which requires
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`structure defining a coaxial lumen through which at least guidewires, balloon
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`catheters, stents, and stent catheters are insertable, and under the Board’s
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`construction, which requires structure through which at least two of those are
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`insertable. Id.
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`A.
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`Itou’s Protective Catheter Is Not an “Interventional Cardiology
`Device” As That Term Is Defined and Used in the ’380 Patent
`
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`Petitioner argues that Itou’s protective catheter is an interventional
`
`cardiology device. Reply, 2-5. Yet Petitioner does not (and cannot) dispute that
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`the ’380 patent specification expressly differentiates between “interventional
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`cardiology devices,” and “tapered inner catheter”. POR, 12-15. Petitioner’s expert
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`agrees that the “tapered inner catheter” of the ’380 patent is like Itou’s protective
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`7
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`

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`catheter. Ex-2238, 26:2-10. And Petitioner does not dispute that Itou’s protective
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`catheter does not provide treatment. Reply, 4 (“even assuming a tapered inner
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`catheter does not provide treatment”). Nor could it—the express purpose of a
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`protective catheter is to protect heathy tissue. POR, 14-15. Petitioner fails to show
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`either independent claim 1 or 12, and therefore any challenged claim, is
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`anticipated.
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`B.
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`Petitioner’s New Inherency Argument Is Untimely and It Would
`Be Unfairly Prejudicial for the Board to Consider It
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`
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`Petitioner tries to argue, for the first time in Reply, that Itou inherently
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`discloses that all four types of enumerated interventional cardiology devices are
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`insertable through its suction catheter. Reply, 1, 6-9. Petitioner made no such
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`inherency arguments regarding the coaxial lumen “through which interventional
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`cardiology devices are insertable” limitation in its Petition. See Petition, 27-29,
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`53-55; see also POR, 19-24. Petitioner’s new inherency argument also relies
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`extensively on new evidence (Reply, 6 (citing new exhibits 1802, 1803, and 1804,
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`a new page of Ex-1015b (a 200+ page textbook), and new expert testimony)) to
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`gap-fill the Petition’s deficiencies.1
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`1 Petitioner dropped its 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, 13:7-10.
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`Petitioner’s new expert, Jones, never reviewed the GuideLiner patent claims
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`8
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`

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`Such new argument and evidence in Reply is contrary to IPR rules and, if
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`accepted, would prejudice Teleflex’s due process rights to fairly respond. PTAB
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`Consolidated Trial Practice Guide (November 2019) (“TPG”), 73-75 (citing 37
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`C.F.R. § 42.23(b)); Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd., 821 F.3d
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`1359, 1369-70 (Fed. Cir. 2016) (“It is of the utmost importance that petitioners in
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`the IPR proceedings adhere to the requirement that the initial petition identify
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`‘with particularity’ the ‘evidence that supports the grounds for the challenge to
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`each claim.’” (quoting 35 U.S.C. § 312(a)(3)). Teleflex was not allowed to submit
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`rebuttal evidence in response to Petitioner’s new argument. Petitioner’s new
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`argument and evidence are untimely and should be disregarded.
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`
`
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`
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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, he 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 analysis.
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`Jones’ entire role is an exercise in pure hindsight, and his testimony (Ex-1807)
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`should be disregarded.
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`9
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`

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`C.
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`Petitioner’s New Inherency Argument Is Unpersuasive, Even If
`the Board Were to Consider It
`
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`Petitioner’s new evidence purports to show stents that “were insertable
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`
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`through an opening of 0.046 inches” based on the “crossing profile” or “crimped
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`diameter” of the identified stents. Reply, 6 (citing Ex-1806 ¶¶47-51). Petitioner
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`ignores that its own evidence shows that the newly-disclosed 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 Itou’s effective 0.046” proximal opening. E.g., Ex-1802, 25
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`(specifying the “[m]inimal internal diameter of guiding catheter” for the 0.038”
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`Tsunami stent is “0.056 inch, 5 Fr”), 7-8 (Genic stent with a crimped profile of
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`0.9mm (0.035”) is “compatible with a 5 Fr guiding catheter”); Ex-1804, 2, Table 2
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`(BxSonic stent with a crossing profile of 0.042” is “compatible with the 5F guiding
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`catheter”).
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`Neither Petitioner nor its expert explain why a POSITA would expect these
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`stents to be insertable into Itou’s suction catheter, when the same exhibits state
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`that those same stents require guiding catheters with minimum inner diameters of
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`0.056”/5 French. Petitioner’s expert did not know whether stents could navigate
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`the transition into the lumen of Itou’s suction catheter, given its raised profile
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`pushwire design. Ex-2239, 66:1-12, 67:15-68:13 (“I would have to test to
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`determine what the maximum size that would pass through into the opening”).
`
`10
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`

`

`Petitioner’s new stent evidence, in addition to being untimely, is insufficient to
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`establish inherency.
`
`
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`Teleflex’s expert, Mr. Keith, explained that having a stent crossing profile
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`smaller than an opening does not mean that the stent is necessarily insertable. Ex-
`
`1805, 140:1-141:21. Petitioner characterizes this testimony as “questionable, as
`
`the 5 French version of GuideLiner v.3 also has an ID of 0.046 inches and is
`
`marketed for delivering stents.” Reply, 8. But GuideLiner V3 is not Itou and has
`
`different structure, and Petitioner does not even do that comparison. As
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`Petitioner’s own expert explained, Itou’s raised pushwire structure creates a
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`stepped or “offset” opening at the proximal opening of the suction catheter. Ex-
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`2239, 66:1-7.
`
`IV.
`
`Independent Claim 1 (Ground 1): Itou Does Not Anticipate Because Its
`Distal Tip Portion Is Not Cylindrical
`
`Claim 1 of the ’380 patent also requires that the tubular structure (which is
`
`defined by the flexible tip portion) include “a flexible cylindrical distal tip
`
`portion.” Ex-1001, 11:19-20. Petitioner does not address this aspect of claim 1;
`
`however, given that it includes a non-responsive argument regarding claim 6
`
`(Reply, 14-15), Teleflex presumes Petitioner intended that argument to apply to
`
`this element of claim 1. Petitioner’s repeated emphasis on “includes” is a red
`
`herring. Claim 1 requires that the tubular structure “includes a flexible cylindrical
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`distal tip portion.” The plain meaning of this language requires that the flexible
`
`11
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`

`

`distal tip portion is cylindrical, not merely that it include a cylindrical portion.
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`Itou’s distal tip portion is sharply angled, not “cylindrical.”
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`This makes sense, given the different purposes of Itou and the invention of
`
`claim 1. Itou is intended to suction thrombus, and the distal tip portion of its
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`tubular structure “has a shape inclined obliquely . . . to increase the area of the inlet
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`opening . . . to facilitate suction of a foreign matter . . . [and also] advance easily
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`between the foreign matter and the inner wall of the blood vessel.” Ex-1007, 4:4-
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`10. By contrast, the distal tip portion of the claimed tubular structure is intended to
`
`deliver interventional cardiology devices and therefore must be “cylindrical.” For
`
`this reason alone, Petitioner has not shown that Itou’s suction catheter with its
`
`obliquely angled distal tip portion anticipates independent claim 1 or any claims
`
`depending therefrom.
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`V. Dependent Claims 3, 14, and 15 (Grounds 1 and 2)
`
`A.
`
`Petitioner Failed to Show That Itou Anticipates Claims 3, 14,2 or
`15 (Ground 1)
`
`
`In Reply, Petitioner tries to save its deficient anticipation evidence with a
`
`legally erroneous “burden shifting” argument. Reply, 9-10. Such burden shifting
`
`has been rejected in IPRs. In re Magnum Oil Tools Int'l, Ltd., 829 F.3d 1364, 1375
`
`
`2 Petitioner does not make a separate anticipation (Ground 1) argument about claim
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`14. See Reply, 15.
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`12
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`

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`(Fed. Cir. 2016). Petitioner’s Mytee case states only that during examination of a
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`pending application, an examiner can shift the burden to the applicant to show
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`non-inherency of a functionally-defined limitation. Mytee Prods., Inc. v. Harris
`
`Rsch, Inc., 439 F. App’x 882, 886 (Fed. Cir. 2011). This burden-shifting
`
`presumption does not apply to issued patents. Id. Petitioner’s failure to argue or
`
`submit evidence to support inherency with its Petition is fatal to Ground 1 for all
`
`claims.
`
`Petitioner then cites back to its new inherency argument for claims 1 and 12,
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`contending Itou “necessarily accommodates the insertion of a guidewire, balloon,
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`stent and stent catheter.” Reply, 10. For the same reasons explained above, the
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`Board should not credit this argument.
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`Finally, Petitioner argues that after Itou’s protective catheter 5 is withdrawn
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`from the suction catheter, a physician “may wish to reinsert it.” Reply, 10. This
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`argument fails. First, it is undisputedly not disclosed by Itou and, therefore, cannot
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`support anticipation. Itou expressly states that suction catheter 2 may be pushed
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`further into the vasculature after protective catheter 5 is removed, which is counter
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`to Petitioner’s argument. Ex-1007, 7:19-23. Second, the protective catheter is not
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`an interventional cardiology device, as explained above. Third, Teleflex has not
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`had the opportunity to put in evidence showing why this new and untimely
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`argument does not make sense.
`
`13
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`

`

`Petitioner’s contention that the “order of insertion” was “not inventive”
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`(Reply, 11) misrepresents the testimony of inventor Mr. Root. Root testified it was
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`part of the invention. Ex-1115, 165:11-15 (“[T]hat’s part of the invention.”). Root
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`then simply stated that he did not consider it a separate invention. Id., 165:16-21
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`(“It’s certainly part of the way you deliver this new device, so it’s part of the
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`invention that way.”). Merely because one of the inventors stated that something is
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`not its own separate invention does not absolve Petitioner of its burden to show
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`that the prior art meets the limitations of the claims. Petitioner has not done so.
`
`B. Claim 3 Would Not Have Been Obvious in View of Itou and
`Ressemann (Ground 2)
`
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`The issue is not simply whether Itou and Ressemann are analogous art, as
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`Petitioner contends. See Reply, 11-12. There still must be sufficient motivation to
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`modify one in view of the other. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418-
`
`19 (2007). Itou and Ressemann are designed for different procedures and function
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`in different ways. POR, 28-33; Ex-2138, ¶¶140-147; Ex-2145, ¶¶183-87.
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`Concluding that both are in the same field of endeavor does not show sufficient
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`motivation to combine with a reasonable expectation of success.
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`Ressemann did disclose inserting interventional cardiology devices like
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`stents, but it was an embolic protection device, specifically designed to catch loose
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`emboli dislodged by the stent. Itou, on the other hand, is not an embolic protection
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`device. Teleflex showed that inserting an interventional cardiology device down
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`14
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`Itou’s suction catheter posed a “real risk” of pushing smaller, residual thrombotic
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`material out into the bloodstream. POR, 31. Petitioner’s own cardiologist expert
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`agreed this is “a potential risk”. Ex-2240, 14:24-15:13. Itou’s suction catheter,
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`unlike Ressemann’s embolic protection device, did not stop blood flow and had no
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`mechanism for mitigating these dislodged emboli. Petitioner has not shown that
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`just because Ressemann’s embolic protection device was designed to safely pass
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`stents, a POSITA would have been motivated to configure Itou’s suction catheter
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`to receive stents.
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`Petitioner contends that a POSITA would be motivated to modify Itou to
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`meet claim 3’s limitations because Itou’s suction catheter is “precisely the right
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`size for delivering angioplasty or stent catheters” and “[t]here is no meaningful
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`structural difference between the claims and Itou.” Reply, 12-13. As explained
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`above, this is wrong. Itou’s raised profile pushwire effectively blocks a substantial
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`portion of the proximal opening such that it is smaller than the minimum required
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`for stents. Supra, § II.C. Itou’s raised profile pushwire is not an issue for a suction
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`catheter like Itou that sucks soft thrombus distally-to-proximally. In fact, Itou’s
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`robust pushwire is important to its disclosed functions—it is intended that the
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`operator be able to rotate the pushwire, and thereby rotate the distal end suction
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`tube. Ex-1007, 2:19-21, 7:20-24 (“the suction catheter 2 is operated so as to be
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`rotated”). Petitioner’s experts agree that the ability to rotate Itou’s suction catheter
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`15
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`using its pushwire is important to its function. Ex-2239, 43:16-19 (“yes, I believe
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`it’s important that Itou be able to rotate”); Ex-2238, 151:5-14.
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`Petitioner also contends that the patented GuideLiner product “grew from”
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`VSI’s prior work on suction catheters. Reply, 13. Even if true, this would be
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`legally irrelevant. 35 U.S.C. § 103 (“Patentability shall not be negated by the
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`manner in which the invention was made.”). And it is not true. The cited
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`testimony merely states that VSI contemplated using reinforced polymer tubing
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`similar to that used in its Pronto aspiration catheter for the distal tubular section of
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`GuideLiner. Ex-1762, 44:22-47:1.
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`C. Claim 14 Would Not Have Been Obvious in View of Itou and
`Ressemann (Ground 2)
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`Petitioner attempts to fault Teleflex for purportedly requiring “bodily
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`incorporat[ion].” Reply, 15-16. But it was Petitioner who argued in the Petition
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`that “a POSITA would have been motivated to replace Itou’s proximal tip (23)
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`with the support collar disclosed in Ressemann.” Petition, 73 (emphasis added).
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`Teleflex responded, pointing out that Petitioner did not adequately explain how a
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`POSITA would expect to be able to do that. POR, 37-38. Petitioner now tries to
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`recast its argument as “modifying Itou with the shape of the Ressemann collar”
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`(Reply, 15), but even its new expert confirmed that the proposal was to “remove
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`Itou’s collar and replace it with Ressemann’s collar.” Ex-2239, 167:18-168:1.
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`16
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`Petitioner also incorrectly contends that its experts “are uniformly clear that
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`the particular construction of Ressemann embodiment 2100 is not what they rely
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`upon.” Reply, 16. Petitioner’s original engineering expert supported his opinion
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`by asserting that Ressemann teaches to “rest tab portion 2141b adjacent the
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`exterior of [Itou’s] wire-like portion 25.” Ex-1042, ¶108. Everyone now agrees
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`that Ressmann teaches to place tab portion inside a shaft 2120 and underneath the
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`core wire 2135. Ex-1008, 27:51-67.
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`Petitioner’s Reply also ignores the fundamental flaw in Petitioner’s proposed
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`combination: that a POSITA would not be motivated to myopically fixate on
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`Ressemann’s support collar in the first place, absent hindsight. POR, 34-37.
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`Petitioner went so far as to prevent its new engineering expert from even
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`considering how Ressemann’s support collar is used in Ressemann itself. Ex-
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`1807, ¶82. In Ressemann, the support collar is merely one structural component
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`buried within a complex embolic protection device. A POSITA would not be
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`motivated to extract this lone component from the complex evacuation sheath
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`assembly (in which it does not provide a concave track or perform any guiding
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`function) and use it to form the proximal opening in Itou’s structurally and
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`functionally different suction catheter unless he/she was using claim 14 as a
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`roadmap. Petitioner’s engineering expert admitted to using a hindsight-focused
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`approach when considering Ressemann. Ex-2137, 132:15-133:11 (“I'm not overly
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`17
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`concerned with what the collar was being done before I chose to use it. . . . I’m
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`more concerned about how I can use it in combination for what I want to do.”); see
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`also Ex-2116, 239:7-13.
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`D. Claim 15 Is Not Obvious in View of Itou and Ressemann
`(Ground 2)
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`Petitioner does not make any separate arguments about claim 15. Reply, 11-
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`13. Petitioner has failed to show that claim 15 is obvious for the same reasons it
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`failed to show claim 3 obvious. Surpa, § IV.A.-B.
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`VI. Petitioner Has Not Refuted the Striking Objective Evidence That
`Confirms Claims 3 and 14 Were Not Obvious
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`Petitioner does not dispute that GuideLiner was an incredibly successful
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`category-creating product, or that the nexus requirement is met. Reply, 17-22.
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`Instead, Petitioner argues that GuideLiner’s success should be disregarded because
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`the claimed elements individually were known in the art and it would have been
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`obvious to combine them. Id. at 17-19. But this ignores the very purpose of
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`objective evidence: to act as a real-world check against the tendency towards
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`hindsight. The Board should reject Petitioner’s flawed and unpersuasive attempt to
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`sidestep the compelling objective evidence.
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`A.
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`The Objective Evidence, Including Nexus, Is Undisputed
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`
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`Petitioner does not dispute any evidence showing that GuideLiner solved a
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`long-felt need, was the subject of extensive industry praise, and experienced
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`18
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