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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`
`
`Case IPR2020-00135
`Patent RE45,776
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`PATENT OWNER SUR-REPLY
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION .......................................................................................... 1
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`I.
`
`II.
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`CLAIM CONSTRUCTION ............................................................................ 2
`
`A.
`
`B.
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`“One or more interventional cardiology devices”
`(all challenged claims) .......................................................................... 2
`
`The segment defining the angled proximal end of the partially
`cylindrical opening includes at least one inclined region that tapers
`into a non-inclined region” (dependent claim 36) ................................ 3
`
`III. PETITIONER HAS NOT SHOWN THAT THE
`CHALLENGED CLAIMS ARE INVALID ................................................... 4
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`A. Ground 1—Alleged Anticipation by Itou
`(Claims 25-27, 29-33, 35-37, 41-45, and 47-49) ................................. 4
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`1.
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`2.
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`3.
`
`Independent Claim 25 ................................................................. 4
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`Dependent Claim 32 ................................................................... 6
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`Dependent Claim 36 ................................................................... 8
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`B. GROUND 2—Alleged Obviousness in View of Itou
`(Claims 39 and 46) ............................................................................... 8
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`C. GROUND 3—Alleged Obviousness of Itou in View
`of Kataishi (Claims 36-37, 52-56) ........................................................ 8
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`D. GROUND 4—Alleged Obviousness of Itou in View
`of Ressemann (Claims 32, 36-37, 46, 52-56) .................................... 11
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`1.
`
`2.
`
`The Challenged Claims Are Patentable for
`the Same Reasons as Claim 25 ................................................. 11
`
`It Would Not Have Been Obvious to Modify Itou’s Proximal
`Opening to Have “Two Inclined Regions” (Claims 52-56)
`or an “Inclined Region That Tapers into a Non-Inclined
`Region” (Claim 36) ................................................................... 13
`
`
`
`ii
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`
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`a.
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`b.
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`c.
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`Petitioner’s New “Three Incline” Theory
`is Improper and Wrong ................................................... 14
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`Petitioner’s Alleged Motivations Are Based on
`Hindsight, Not the Teachings of the Prior Art ............... 17
`
`Petitioner Has Not Shown That the Resulting
`Structure Would Meet All Claim Limitations ................ 19
`
`3.
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`Petitioner Has Effectively Conceded the Patentability
`of Claims 53-56 ........................................................................ 21
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`4.
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`Dependent Claim 32 ................................................................. 22
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`
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`
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`E. GROUNDS 3, 4, 5—The Real-World Evidence of Copying
`By All GuideLiner Competitors Shows That Claims 36
`and 52-53 Were Not Obvious .............................................................. 22
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`IV. Non-AIA Patent ............................................................................................ 25
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`
`
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`
`
`iii
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`TABLE OF AUTHORITIES
`
`
`
`Cases
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`Page(s)
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ..................................................................... 25
`
`
`In re Magnum Oil Tools Int'l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ....................................................................... 5
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ................................................................. 5, 16
`
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)....................................................................................... 12
`
`Liqwd, Inc. v. L’Oreal USA, Inc.,
`941 F.3d 1133 (Fed. Cir. 2019) .................................................................... 24
`
`
`Mytee Prods., Inc. v. Harris Rsch., Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ................................................................. 5
`
`
`Tech. Patents LLC v. T-Mobile UK, Ltd.,
`700 F.3d 482 (Fed. Cir. 2012) ........................................................................ 2
`
`
`
`
`
`iv
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`
`
`I.
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`INTRODUCTION
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`Using improper hindsight, the Petition sought to use advantages of the ‘776
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`patent’s claimed two-incline side opening as motivations to argue that it would
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`have been obvious to add such an opening to Itou’s suction catheter. Patent
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`Owner’s (“Teleflex”) Response proved that none of the cited secondary references
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`actually show such a two-incline proximal side opening, much less provide a
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`motivation to add one to Itou. So in Reply, Petitioner totally changed positions,
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`now arguing that these claims are unpatentable because the two-incline side
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`opening “provide[s] no benefit” over a single incline. Paper 82 (“Reply”), 12-13.
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`Petitioner’s new position is contradicted by its own experts. Moreover, all of
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`Teleflex’s competitors (including Petitioner) copied Teleflex’s multiple-incline
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`side opening design, and none used a single-incline design. Petitioner touts the
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`advantage of its two-incline “on-ramp” in advertising, and its own documents
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`show that it
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` but ultimately ended up “
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` Ex-2071, 15, 18, 20; Ex-2197, 1; Ex-2138, ¶218.
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`This is but one example of the improper, illogical, and unpersuasive
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`positions taken by Petitioner. The Petition should be rejected in its entirety.
`
`1
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`
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`II. CLAIM CONSTRUCTION
`
`A.
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`“One or more interventional cardiology devices” (all challenged
`claims)
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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 cardiac vasculature. In doing so,
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`Petitioner improperly asks the Board to ignore how the ’776 patent defines and
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`uses that term in favor of a broader general meaning based on extrinsic evidence.
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`See Reply, 1-2; Ex-1806 ¶¶10-13 (relying only on extrinsic evidence). Petitioner’s
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`contention that the specification does not use “interventional cardiology device”
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`interchangeably with “cardiac treatment device” and “interventional cardiology
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`treatment device” is wrong. The specification expressly refers to the same set of
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`devices as both “interventional cardiology devices” and “cardiac treatment
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`devices.” Compare Ex-1001, 1:47-50 with 4:61-64.
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`Petitioner wrongly argues, without authority, that different words in the
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`specification are presumed to have different meanings. Patentees can and often do
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`use words interchangeably, informing resulting claim construction. E.g. Tech.
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`Patents LLC v. T-Mobile UK, Ltd., 700 F.3d 482, 492 (Fed. Cir. 2012). Petitioner
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`also ignores the inconvenient fact that the patent differentiates devices that might
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`broadly be considered interventional cardiology tools—such as protective
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`catheters—from how it uses the term “interventional cardiology device.” See
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`Paper 43, Patent Owner Response (“POR”), 8-9.
`
`2
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`
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`Finally, Petitioner challenges Teleflex’s construction because it would
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`exclude guidewires, which Petitioner contends do not provide treatment. Reply, 2.
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`Petitioner is wrong, and its citation to Teleflex’s expert testimony is highly
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`misleading. Graham agreed that guidewires are not routinely used alone to treat
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`lesions (Ex-1801, 89:2-4), but he also testified unequivocally that guidewires alone
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`do provide treatment, by restoring some blood flow. Ex-1813, 108:25-109:3;
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`107:12-21. And Petitioner’s cardiologist expert agrees that in passing a guidewire
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`through a total occlusion, “you can see some flow, whereas prior to passing the
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`guidewire there is no flow” and that is “not a bad thing.” Ex-2238, 19:19-20:2,
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`20:21-21:10.
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`B.
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`“The segment defining the angled proximal end of the partially
`cylindrical opening includes at least one inclined region that
`tapers into a non-inclined region” (claim 36)
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`Petitioner’s argument is based on the premise that the word “includes” in
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`claim 36 encompasses only “at least one inclined region.” Reply, 2. It is much
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`more reasonable and logical to read “includes” as encompassing the language that
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`follows, i.e., an “inclined region that tapers into a non-inclined region.” Indeed,
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`Petitioner does not acknowledge, much less dispute, that Petitioner’s reading of the
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`claim language gives no meaning to the “non-inclined” aspect of the claim. Ex-
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`2138, ¶111.
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`3
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`
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`Petitioner’s reliance on claim 44 of the ’379 patent (Reply, 2) is unavailing.
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`Claim 44 of ’379 is a different claim, from a different patent, with different claim
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`language. And the two claims do not have the same scope. For example, the
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`following structure is covered by claim 36 of ’776 but not claim 44 of ’379:
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`
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`Tubular Structure
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`Opening with
`inclined region
`tapering into non-
`inclined region
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`
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`
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`Substantially
`rigid segment
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`
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`Claim 36 should be interpreted in accordance with its plain meaning to require that
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`the segment defining the angled proximal end of the partially cylindrical opening
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`includes both an inclined region and the non-inclined region that it tapers into.
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`III. PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS ARE INVALID
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`A. Ground 1—Alleged Anticipation by Itou (Claims 25-27, 29-33, 35-
`37, 41-45, and 47-49)
`
`1.
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`Independent Claim 25
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`
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`Claim 25 recites a partially cylindrical opening with an angled proximal end
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`that is “configured to receive one or more interventional cardiology devices
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`therethrough when positioned within the guide catheter.” Petitioner now tries to
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`frame the issue as whether it “has . . . proven inherency” of this limitation in Itou.
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`Reply, 5. But the Petition did not assert inherency. The Petition’s sole bases for
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`4
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`
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`asserting that this limitation was met by Itou were: (1) the limitation is a statement
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`of intended use entitled to no patentable weight; and (2) the limitation is met by
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`Itou’s protective catheter 5. See Petition, 24-25. Petitioner now abandons both
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`arguments, as neither are mentioned in its Reply.
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`
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`Petitioner’s inherency argument is also based on improper new evidence.
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`Virtually all of the citations on pages 3-5 of Petitioner’s Reply are to two new
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`expert declarations (Ex-1806 and Ex-1807) and two new exhibits regarding stents
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`(Ex-1802 and Ex-1804). Id. Petitioner’s debut of this evidence in its Reply only
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`confirms that the argument is new and should be rejected. See Intelligent Bio-Sys.,
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`Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359, 1369-70 (Fed. Cir. 2016).
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`
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`Petitioner also wrongly attempts to shift the burden to Teleflex on inherency.
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`Reply, 5. Mytee states that during examination of a pending application, an
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`examiner can shift the burden to the applicant to show non-inherency of a
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`functionally-defined limitation. Mytee Prods., Inc. v. Harris Rsch., Inc., 439 F.
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`App’x 882, 885-86 (Fed. Cir. 2011). But this burden-shifting presumption does
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`not apply to issued patents in IPR. Id. at 886; see also In re Magnum Oil Tools
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`Int'l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). The Petition’s failure to argue or
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`submit evidence to support inherency is fatal to Ground 1 for all claims.
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`5
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`2.
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`Dependent Claim 32
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`Petitioner’s argument for dependent claim 32 is also based on improper new
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`evidence. In an effort to prove that Itou’s device is “configured to receive a stent
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`and a balloon catheter,” the Petition relied on evidence showing (1) that the tubular
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`portion of Itou’s suction catheter has an ID (inner diameter) of 0.059”; and (2) that
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`pre-2006 commercially-available stents could be delivered through a catheter
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`having an ID of 0.056”. Petition, 30-31. But Itou’s pushwire partially blocks the
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`opening into the tubular portion, leaving it with an effective opening size of only
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`0.046”. POR, 16-17. This is not surprising, as Itou is a suction catheter designed
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`to suction thrombus in a distal-to-proximal direction, and is not concerned with
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`receiving interventional cardiology devices in a proximal-to-distal direction. Id.
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`Moreover, Itou’s robust pushwire is important to its disclosed functions—Itou
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`explains that it is intended that the operator be able to rotate the suction
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`catheter. Ex-1007, 2:19-21, 7:20-24. Petitioner’s experts agree. Ex-2239, 43:16-
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`19 (“yes, I believe it’s important for Itou to be able to rotate”); Ex-2238, 151:5-14.
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`In Reply, Petitioner submits new evidence purporting to show stents with a
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`“crossing profile” or “crimped diameter” less than 0.046”. Reply, 3; Ex-1802, Ex-
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`1804. This is another instance of new evidence that should not be submitted for
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`the first time in reply. And even if considered, Petitioner’s improper new evidence
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`would not change the result. Petitioner’s new evidence still shows that the
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`6
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`
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`identified stents required a minimum guide catheter ID of at least 5 French (which
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`is 0.056”). E.g. Ex-1802, 25 (a “[n]on-expanded profile” of 0.038”, but requires
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`“[m]inimal internal diameter of guiding catheter” of 0.056”); id., 7-8 (“compatible
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`with a 5 Fr guiding catheter”), 21-22 (deliverable through “all commercially
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`available 6 Fr guiding catheters and through a Medtronic Zuma 5 Fr guiding
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`catheter”); Ex-1804, 2, Table 2 (“compatible with the 5F guiding catheter”). This
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`new evidence does not prove that stents could be delivered through the 0.046”
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`effective opening size at the proximal end of Itou’s tubular portion.
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`Petitioner also argues that Itou is capable of receiving stents because Itou’s
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`pushwire is flexible and can bend out of the way. Reply, 3. But claim 25 requires
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`that the side opening be capable of receiving interventional cardiology devices
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`“when positioned within the guide catheter.” When Itou’s suction catheter is
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`inserted into the guide catheter, the pushwire is constrained by the walls of the
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`guide catheter and has no ability to “bend” out of the way. Ex-2238, 110:20-
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`111:24; see also Ex-2138, ¶137.
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`Finally. Petitioner argues that the combination of the side opening and the
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`flattened weld point immediately proximal to the opening in Itou’s suction catheter
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`provide space for a stent to enter the tubular portion. Reply, 3. But this argument
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`ignores how much longer stents are than the opening/weld point. Petitioner’s new
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`evidence indicates that stents range in length from 8-30mm. Ex-1802. Using the
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`7
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`
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`dimensions provided by Petitioner’s new technical expert, the combined length of
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`Itou’s side opening and flattened weld point is slightly over 3mm. See Ex-1807,
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`¶125.1 Thus, even the shortest stent is more than double the length of Itou’s weld
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`point/angled region. Petitioner has failed to prove that Itou’s suction catheter is
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`configured to receive balloon catheters and stents.
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`3.
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`Dependent Claim 36
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`Petitioner does not dispute that what it points to as the “non-inclined region”
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`is flat and does not form part of the opening. Therefore, under the proper
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`construction (supra, §II(B)), claim 36 is not anticipated by Itou. Ex-2138, ¶143.
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`B. GROUND 2—Alleged Obviousness in View of Itou (Claims 39
`and 46)
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`The parties agree that the patentability of claims 39 and 46 turns on whether
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`claim 25 is anticipated under Ground 1.
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`C. GROUND 3—Alleged Obviousness of Itou in View of Kataishi
`(Claims 36-37, 52-56)
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`Petitioner does not dispute that if its anticipation argument for claim 25 fails,
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`then Ground 3 also fails.
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`1 Using the dimensions provided by Petitioner’s new expert, Jones (Ex-1807,
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`¶125), and the Pythagorean theorem, the length of Itou’s side opening is 2.45mm.
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`Jones estimated the length of the weld to be ~0.0295” (0.75mm), yielding a total
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`length of 3.2mm. Ex-2239, 35:16-36:14.
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`8
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`In addition, the Board’s Institution Decision preliminarily found that
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`Petitioner had not “explain[ed] sufficiently why the inclined shape of Kataishi’s
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`distal opening would have been applicable to the [proximal] opening” of Itou’s
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`suction catheter. Paper 22, 22-23. This remains the case. The purpose of
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`Kataishi’s distal opening shape is to increase suction by allowing the distal end to
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`flex and conform about a thrombus formed on a vessel wall—a purpose that is
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`inapplicable to Itou’s rigid metal proximal collar. Ex-2138, ¶144; Ex-2145, ¶152.
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`Petitioner now argues that a POSITA would nonetheless have been
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`motivated to apply Kataishi’s distal opening shape to Itou’s proximal end because
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`the Ressemann reference allegedly teaches that the proximal and distal ends of
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`Ressemann’s evacuation head both contribute to smooth passage of therapeutic
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`devices. Reply, 8-10. This argument fails for at least three reasons. First, it is
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`untimely. Petitioner’s Ground 3 was not “Itou in view of Kataishi and
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`Ressemann”; it did not even mention Ressemann.2 Second, the cited passage of
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`Ressemann is ambiguous, at best, and Petitioner’s interpretation of it is hindsight-
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`2 Petitioner misleadingly asserts that Teleflex responded to such an argument in its
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`POR. See Reply, 10 (citing “POR, 22”). That is wrong—neither page 22 nor any
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`other page of the POR addressed any alleged relevance of Ressemann to the
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`Itou/Kataishi combination.
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`9
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`
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`driven. The passage states that the ends of Ressemann’s evacuation head are
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`angled to do two things, but that does not mean that both angles serve both
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`functions. See Ex-1008, 6:52-57. Indeed, contrary to Petitioner’s hindsight-driven
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`reading, Ressemann later assigns only one of these functions to each angled
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`portion. Id., 7:48-53; 23:17-20. Third, the shape of the proximal and distal
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`openings in the cited Ressemann embodiment are different from one another, and
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`the proximal opening is a simple angled skive (just like in Itou). Id., Fig. 1A.
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`Thus, assuming hypothetically that a POSITA were to consider the relevance of
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`this aspect of Ressemann’s device (highly unlikely absent hindsight), he/she would
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`conclude that the shape of the proximal opening should not be the same as the
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`distal opening, and that a simple skive is preferred for the proximal opening.
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`With more hindsight, Petitioner next argues that a POSITA would be
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`motivated to apply Kataishi’s distal opening shape to Itou’s proximal opening
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`because it would provide a larger size to facilitate introduction of stents and
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`balloon catheters into Itou’s device. Reply, 9. Neither Kataishi nor Itou mention
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`delivering stents or balloons. Petitioner also ignores Teleflex’s evidence (and the
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`admission of Petitioner’s original technical expert) that the increased size does not
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`depend on having a complex, multi-angle shape, but rather is a function of how
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`“sharp” one chooses to angle the opening. See POR, 24, 38-39.
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`10
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`
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`Finally, Petitioner’s renewed assertions regarding “crossability” rely on
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`illogical and unsupported inferences. Petitioner points to the Sakurada reference,
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`which it claims describes testing showing that the shape of Kataishi’s distal end
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`improves crossability. Reply, 10. But the two cited pages of Sakurada do not say
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`that. Ex-1055, 6, 8. Sakurada attributes the improved crossability of Kataishi to
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`only one thing: the support wire that runs the length of the device. Id., 10.
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`Moreover, Sakurada describes only one benefit of the complex shape of Kataishi’s
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`distal end: increased suction due to its ability to flex and conform to the side wall
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`of the vessel. Id., 8, 10.
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`D. GROUND 4—Alleged Obviousness of Itou in View of Ressemann
`(Claims 32, 36-37, 46, 52-56)
`
`1. The Challenged Claims Are Patentable for the Same Reasons
`as Claim 25
`
`Petitioner incorrectly asserts that Teleflex did not challenge any limitations
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`for claims 52 and 53 other than the “two inclines” limitation. Reply, 11. The POR
`
`pointed out that the Petition relied solely on Itou as satisfying the claimed
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`requirement for a segment “configured to receive one or more interventional
`
`cardiology devices therethrough when positioned within the guide catheter,” and
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`all challenged claims were therefore patentable for the same reason as claim 25.
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`POR, 25.
`
`11
`
`
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`Petitioner’s Reply argues for the first time that it would have been obvious
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`in view of Ressemann to modify Itou to meet this claim limitation. Reply, 11.
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`This argument should be rejected as untimely, as it was absent from the Petition.
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`See Petition, 64-71, 72, 75. It would be unfair and prejudicial to Teleflex to permit
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`an argument that Teleflex had no reason to address in its Response.
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`The issue also is not simply whether Itou and Ressemann are analogous art,
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`as Petitioner contends. See Reply, 11-12. There still must be sufficient motivation
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`to modify one in view of the other. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,
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`418-19 (2007). Itou and Ressemann are designed for different procedures and
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`function in different ways. POR, 27-30; Ex-2138, ¶¶154-59; Ex-2145, ¶¶183-87.
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`Simply concluding that both are in the same field does not show sufficient
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`motivation to combine with a reasonable expectation of success.3 Ground 4 fails
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`for the same reason as Ground 1.
`
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`3 Petitioner also contends that GuideLiner “grew from” VSI’s prior work on
`
`suction catheters. Reply, 12. Even if true, this would be legally irrelevant. 35
`
`U.S.C. § 103 (“Patentability shall not be negated by the manner in which the
`
`invention was made.”). And it is not true. The cited testimony merely states that
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`VSI contemplated using reinforced polymer tubing similar to that used in its
`
`12
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`
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`2.
`
`It Would Not Have Been Obvious to Modify Itou’s Proximal
`Opening to Have “Two Inclined Regions” (Claims 52-56) or
`an “Inclined Region That Tapers into a Non-Inclined
`Region” (Claim 36)
`
`It is undisputed that Ressemann does not teach a proximal opening with two
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`inclined regions, as required by claims 52-56, or an inclined region that tapers into
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`a non-inclined region, as required by claim 36:
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`Single incline
`opening
`
`Single incline
`opening
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`During the first round of depositions, Petitioner’s original two experts were forced
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`to admit that Ressemann’s collar tab is buried inside Ressemann’s device and
`
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`Pronto aspiration catheter for the distal tubular section of GuideLiner. Ex-1762,
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`
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`44:22-47:1.
`
`13
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`
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`serves no guiding or receiving purpose. POR, 30-36. As the POR explained,
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`Petitioner failed to show that a POSITA would be motivated to look to the shape of
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`Ressemann’s buried collar in the first place. Id.
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`Petitioner does not really even dispute this in reply. Instead, it offers new
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`arguments that rely on yet more improper hindsight and should be rejected.
`
`a. Petitioner’s New “Three Incline” Theory is Improper
`and Wrong
`
`
`
`The Petition was based on the argument that Ressemann’s support collar
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`2141 has two inclined slopes, illustrated as follows:
`
`
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`Petition, 73. But after its original two experts admitted that the proximal incline
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`(“1” in Petitioner’s illustration) is buried inside Ressemann’s device and serves no
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`purpose, Petitioner pivoted to an entirely new argument: that Ressemann’s collar
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`2141 actually has three inclines, illustrated with a new diagram purporting to show
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`inclines A, B, and C:
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`14
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`
`
`
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`Reply, 13-20; Ex-1806 ¶¶81-90. Petitioner supports this new argument with a
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`declaration from a new expert, who acknowledges that he simply “came to [a]
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`different conclusion[]” as Petitioner’s original expert. Ex-2239, 83:15-84:10.4
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`Petitioner uses this new position to argue that middle incline B, together with
`
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`4 After the first round of depositions, Petitioner dropped its engineering expert
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`Hillstead and retained another, Jones. Ex-2239, 13:7-10. But Jones never
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`reviewed the GuideLiner patent claims, save claim 1 of ’032. Id., 14:16-16:15.
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`And he was prevented from considering how the collar component was used in
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`Ressemann. Ex-1807, ¶82. And he admitted that his opinions were based at least
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`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 has been an exercise in hindsight, and his improper rebuttal
`
`declaration (Ex-1807) should be given no weight.
`
`15
`
`
`
`incline C, forms a side opening that meets the language of claims 52-56 and 36.
`
`Reply, 19; Ex-1807, ¶¶130-32.
`
`
`
`All of this should be disregarded. New obviousness theories are not
`
`permitted for the first time in reply, nor is evidence that could have been submitted
`
`with the Petition. Consolidated Trial Practice Guide (November 2019), 73-74; 37
`
`C.F.R. § 42.23(b); Intelligent Bio-Sys., 821 F.3d at 1369-70. It would be patently
`
`unfair for the Board to consider this new argument, offered for the first time late in
`
`the proceeding when Teleflex is unable to respond with evidence.
`
`
`
`Petitioner seeks to disguise how jarringly new this evidence and argument is
`
`by pointing to testimony it elicited from Teleflex witnesses about inclines in other
`
`products. Reply, 13-14. But that testimony is not even about the Ressemann
`
`reference. See id. (citing images and testimony about GuideLiner V1 and
`
`prototype drawings of Guideliner). Petitioner has not shown that these products,
`
`with different shapes than Ressemann, prove Ressemann’s collar has three
`
`inclines.
`
`Petitioner’s new assertion about three inclined regions is also wrong.
`
`Petitioner’s new expert relies on a perspective view that makes it appear as if there
`
`might be a change of angle along the inclined portion:
`
`16
`
`
`
`Reply, 15. But such a perspective view is misleading. Indeed, Petitioner’s first
`
`technical expert presented what he believed a side view of Ressemann’s collar
`
`
`
`would look like, plainly showing only a single incline:
`
`
`
`Single
`incline
`
`
`
`Ex-1042, ¶103 (red annotations in original; blue annotations added). Petitioner’s
`
`effort to contradict the testimony of its first technical expert with that of a second
`
`(new) technical expert is improper and incorrect.
`
`b.
`
`Petitioner’s Alleged Motivations Are Based on
`Hindsight, Not the Teachings of the Prior Art
`
`
`
`The Petition asserted four alleged motivations for incorporating
`
`Ressemann’s collar into Itou’s suction catheter in a different way and for a different
`
`purpose than the collar serves in Ressemann: (1) increasing the area for receiving an
`
`17
`
`
`
`interventional device; (2) providing an “on-ramp” for interventional devices; (3)
`
`providing a flexibility transition; and (4) reinforcing the lumen opening. Petition,
`
`73. Teleflex addressed each in its Response. POR, 37-43.
`
`Petitioner’s Reply ignores (2). This is not surprising given the undisputed
`
`evidence that the so-called “first incline” of Ressemann’s collar is not part of the
`
`shape of Ressemann’s proximal opening and does not provide an “on-ramp” for any
`
`interventional device in Ressemann. Id.
`
`As for (1), Petitioner ignores the admission of its original technical expert,
`
`who agreed that a larger opening is solely a result of having a less-steep inclined
`
`region, and unrelated to two inclines. Ex-2137, 194:21-195:21; see also POR, 38-
`
`39. Petitioner’s cardiologist expert, Brecker, also admitted that multiple inclines
`
`are not needed to obtain the benefit of a larger opening. Ex-2238, 144:22-145:3.
`
`As for (3), the POR pointed out that the flexibility transition provided by the
`
`collar tab makes sense in Ressemann, where multiple polymer lumens in the shaft
`
`must maintain their patency for the device to operate properly. POR, 41-42. Itou’s
`
`device has no such lumens in the shaft, and has a rigid weld connecting the metal
`
`tubular portion to the metal pushwire. Id. Petitioner’s assertion that a POSITA
`
`would nonetheless be motivated to extract Ressemann’s entire collar and engineer it
`
`into Itou’s device because of a “potential weakness” at the weld point (Reply, 17-
`
`18) belies credibility. Petitioner’s new expert points to several references
`
`18
`
`
`
`disclosing various different transition structures in various interventional devices.
`
`Ex. 1807, ¶¶52-56. None of the references involve a simple metal-pushrod-to-
`
`metal-collar connection like that in Itou, where there is no change in material or
`
`stiffness at the “transition” point. See id; Ex-2239, 100:20-101:3 (Petitioner’s new
`
`expert admitting “I don't think I’m aware of a catheter where there are two metal
`
`portions joined by a transitional member”).
`
`As for (4), the POR pointed out that Itou’s proximal opening needed no
`
`reinforcement, since it is already formed from a “metal pipe.” POR, 42. In Reply,
`
`Petitioner now flips positions, arguing that Itou’s proximal opening has too much
`
`reinforcement and that a POSITA would be motivated to incorporate Ressemann’s
`
`thinner collar into Itou’s opening because it would provide less reinforcement.
`
`Reply 16-17. Such ever-shifting positions only further demonstrate the hindsight
`
`nature of Petitioner’s arguments.
`
`c.
`
`Petitioner Has Not Shown That the Resulting
`Structure Would Meet All Claim Limitations
`
`
`
`Mounting Ressemann’s collar on Itou’s pushwire would be a challenging
`
`engineering proposition and create a ledge that would serve as a catchpoint. POR,
`
`45-47. Petitioner’s new engineering expert purports to address these problems by
`
`asserting that the entire structure could be encased in enough polymer and
`
`“adhesive filler” to securely hold the tab portion of Ressemann’s collar on Itou’s
`
`19
`
`
`
`pushwire and minimize any ledge. Reply, 18 (citing Ex-1807, ¶¶ 90-96, 129-132).
`
`A cross-section of the resulting structure is illustrated by the new expert as follows:
`
`
`
`Ex-1807, ¶130. Even if this was correct (which it is not, see Ex-2138, ¶174), this
`
`proposed solution still has the problem of the extremely small size of “incline 1,”
`
`which would disappear inside that added material. Ex-2138, ¶173. Petitioner’s
`
`new expert provides a single conclusory assertion that the tiny incline would still
`
`be “intact” (Ex-1807, ¶131), but when asked at deposition whether he knew the
`
`dimensions of the tiny angle compared to the polymer coating he was proposing,
`
`he conceded that he had “not worked that out or provided an opinion on that.” Ex-
`
`2239, 116:19-24. Further, there is no evidence a POSITA would be motivated to
`
`preserve the tiny incline, particularly given the undisputed evidence that it serves
`
`no purpose in Ressemann.
`
`
`
`Petitioner’s new expert alternatively argues that the tab portion of
`
`Ressemann’s collar could be located under the pushwire and that the resulting
`
`structure would still have two inclines due to the alleged new “third incline.” Ex-
`
`20
`
`
`
`1807, ¶132. As discussed above, this untimely and unsupported argument should
`
`be rejected. Moreover, neither Petitioner nor its expert show what this structure
`
`would look like from an axial view. It would look like this, with the pushwire
`
`blocking a substantial portion of the tubular portion’s lumen:
`
`
`
`Since Petitioner’s purported motivation for this modification is to make Itou’s
`
`suction catheter capable of delivering interventional cardiology devices, the
`
`modification makes no sense at all.
`
`3.
`
`Petitioner Has Effectively Conceded the Patentability of
`Claims 53-56
`
`
`
`Even if Itou and Ressemann were combined as asserted in the Petition, the
`
`resulting structure would not meet independent claim 53’s requirement that the
`
`lumen be “not more than one French size smaller” than the lumen of the guide
`
`catheter. POR, 48-50. Petitioner’s Reply is silent on this point. This is not
`
`surprising considering that the allegedly-obvious combination of Itou and
`
`21
`
`
`
`Ressemann (with the pushwire located below the tubular portion) could not
`
`possibly meet this limitation:
`
`Guide catheter
`lumen
`
`Suction
`catheter lumen
`
`Ex-1807, ¶130 (dotted lines and annotations added). Petitioner’s new expert
`
`
`
`admitted this. Ex-2239, 174:3-9.
`
`4.
`
`Dependent Claim 32
`
`
`
`As explained supra, adding Ressemann’s collar on top of Itou’s pushwire
`
`would make the opening even smaller. Thus, even assuming it were obvious to
`
`combine Itou with Ressemann, the resulting structure would not meet the
`
`limitations of claim 32.
`
`E. GROUNDS 3, 4, 5—The Real-World Evidence of Copying By All
`GuideLiner C
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