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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 IPR2020-00126
`Case IPR2020-00127
`Patent 8,048,032
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`PATENT OWNER’S REPLY IN SUPPORT OF
`CORRECTED CONTINGENT MOTION TO AMEND
`U.S. PATENT 8,048,032 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`I.
`SUBSTITUTE CLAIMS 23-25 ARE SUPPORTED UNDER § 112 ............. 1
`II.
`SUBSTITUTE CLAIMS 23-25 ARE NOT INDEFINITE ............................. 8
`III.
`IV. PETITIONER’S ARGUMENTS OF UNPATENTABILITY ARE NOT
`PERSUASIVE ................................................................................................. 9
`A.
`Claims 23-25 Are Patentable Over Itou in View of Either
`Ressemann or Kataishi .......................................................................... 9
`1.
`Substitute Claim 23 ..................................................................... 9
`a.
`“Interventional Cardiology Devices Are Insertable” ....... 9
`b.
`Complex Side Opening ................................................... 11
`i. Itou Plus Ressemann’s Collar ................................... 12
`ii. Itou Plus Kataishi’s Distal Tip ................................. 15
`Size and “Coaxial” Limitations ...................................... 17
`c.
`Substitute Claim 24 ................................................................... 18
`2.
`Substitute Claim 25 ................................................................... 18
`3.
`Substitute Claims 23-25 Are Patentable Over Kontos in View of
`Ressemann and Takahashi .................................................................. 19
`1.
`Substitute Claim 23 ................................................................... 19
`a.
`“Interventional Cardiology Devices Are Insertable” ..... 19
`b.
`Complex Side Opening ................................................... 19
`c.
`0.056 Inch Inner Diameter Tube In 6 French Guide
`Catheter and “Coaxial” Limitations ............................... 21
`Substitute Claim 24 ................................................................... 24
`Substitute Claim 25 ................................................................... 25
`i
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`2.
`3.
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`B.
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`Substitute Claims 23-25 Are Patentable Over Kontos and Kataishi ... 25
`C.
`CONCLUSION .............................................................................................. 25
`V.
`CERTIFICATION OF SERVICE............................................................................ 27
`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 28
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`ii
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`TABLE OF AUTHORITIES
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`Cases
`Amgen Inc. v. Hoechst Marion Roussel,
`314 F.3d 1313 (Fed. Cir. 2003) .............................................................................. 3
`Ashley Furniture Indus. v. Lifestyle Enter.,
`574 F. Supp. 2d 920 (W.D. Wis. 2008) ................................................................ 22
`Bilstad v. Wakalopulos,
`386 F.3d 1116 (Fed. Cir. 2004) ..................................................................... 2, 3, 4
`Campbell Soup Co. v. Gamon Plus, Inc.,
`939 F.3d 1335 (Fed. Cir. 2019) ............................................................................ 22
`Cooper Cameron Corp. v. Kvaerner Oil-Field Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .............................................................................. 3
`Cordis Corp. v. Medtronic AVE,
`339 F.3d 1352 (Fed. Cir. 2003) ..........................................................................2, 4
`Datascope Corp. v. Kontron, Inc.,
`611 F. Supp. 889 (D. Mass. 1985) ........................................................................ 22
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`717 F.3d 1336 (Fed. Cir. 2013) .............................................................................. 8
`Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,
`93 F.3d 1572 n.7 (Fed. Cir. 1996) .......................................................................... 2
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1998) ..........................................................................3, 4
`ICU Med., Inc. v. Alaris Med. Sys.,
`558 F.3d 1368 (Fed. Cir. 2009) .............................................................................. 4
`In re Global IP Holdings,
`927 F.3d 1373 (Fed. Cir. 2019) .............................................................................. 5
`In re Peters,
`723 F.2d 891 (Fed. Cir. 1983) ................................................................................ 3
`
`
`
`iii
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`
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`In re Rasmussen,
`650 F.2d 1212 (C.C.P.A. 1981) .............................................................................. 2
`In re Schweickert,
`676 F. App’x 988 (Fed. Cir. 2017) ....................................................................... 21
`Lampi Corp. v. Am. Power Prods., Inc.,
`228 F.3d 1365 (Fed. Cir. 2000) .............................................................................. 3
`PowerOasis Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) .............................................................................. 4
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) .............................................................................. 4
`Statutes
`35 U.S.C. § 112 ................................................................................................. 1, 2, 8
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`iv
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`I.
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`INTRODUCTION
`Teleflex submits this Reply in Support of Corrected Contingent Motion to
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`Amend U.S. Patent 8,048,032, with the Second Declaration of Peter T. Keith in
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`Support of Motions to Amend (“Ex-2243”). Teleflex submits that Petitioner has
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`failed to show that any of the substitute claims presented in this motion is
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`unpatentable.
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`II.
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`SUBSTITUTE CLAIMS 23-25 ARE SUPPORTED UNDER § 112
`Petitioner’s § 112 attack on claim 23 is unfounded, because the claim recites
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`a “substantially rigid” side opening. Petitioner’s quote of the claim language omits
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`this language; its argument ignores it. Petitioner’s intent not to challenge this
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`limitation under § 112 is supported by its appropriate decision not to challenge
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`under § 112 claim 44 of the ’380 patent, which recites “a substantially rigid
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`partially cylindrical portion proximal to a distal end of the substantially rigid
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`portion.” Petitioner also misreads claim 23 to “require a side opening that is
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`separate from (distal to) the ‘substantially rigid portion.’” Opp., 1. Petitioner’s
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`expert confirms that “there are just two separate portions [of the device] in this
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`claim,” Ex-2242, 132:18-20, the flexible tip portion and the substantially rigid
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`portion, and that, as a POSITA would understand, “the portion of the device that
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`includes the side opening must be part of the substantially rigid portion,” id.,
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`132:21-25. Ex-2243, ¶16. Dependent claim 9 supports Teleflex’s construction.
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`1
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`Petitioner argues that claims 23-25 lack written description because they do
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`not expressly claim the side opening as “part of the substantially rigid segment.”
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`Opp., 1-2 (emphasis by Petitioner). Petitioner’s argument fails as a matter of both
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`law and fact. As a legal matter, there is nothing improper with presenting claims
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`that are broader than the preferred embodiments. See Bilstad v. Wakalopulos, 386
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`F.3d 1116, 1123-25 (Fed. Cir. 2004) (collecting cases); Ethicon Endo-Surgery, Inc.
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`v. United States Surgical Corp., 93 F.3d 1572, 1582 n.7 (Fed. Cir. 1996) (if the
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`inventor “did not consider the precise location of the lockout to be an element of
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`his invention, he was free to draft claim 24 broadly … to exclude the lockout’s
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`exact location as a limitation of the claimed invention…. Such a claim would not
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`be unsupported by the specification even though it would be literally infringed by
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`undisclosed embodiments.”). This includes reissues: “[T]hat a claim may be
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`broader than the specific embodiment disclosed in a specification is in itself of no
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`moment. Indeed, the statutory provision for broadened claims in reissue
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`applications is intended to meet precisely the situation in which a patentee has
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`claimed ‘less’ than he had a right to claim.” In re Rasmussen, 650 F.2d 1212, 1215
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`(C.C.P.A. 1981).
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`Many cases have found claims to comply with § 112 even when the claims
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`are broader than the disclosure. See, e.g., Ethicon, 93 F.3d at 1582; Cordis Corp.
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`v. Medtronic AVE, 339 F.3d 1352, 1364-65 (Fed. Cir. 2003) (claim broadly
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`2
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`covering tubular members having only complete slots, only half-slots, or any
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`combination of the two supported by specification disclosed only alternating
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`complete slots and half-slots); Lampi Corp. v. Am. Power Prods., Inc., 228 F.3d
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`1365, 1377-78 (Fed. Cir. 2000) (claims covering non-identical half-shells
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`adequately supported even though the figures showed only identical half shells); In
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`re Peters, 723 F.2d 891, 893 (Fed. Cir. 1983) (reissue claims covering both tapered
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`and non-tapered tips supported by disclosure of only tapered tips; “[t]he broadened
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`claims merely omit an unnecessary limitation that had restricted one element of the
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`invention to the exact and non-critical shape disclosed in the original patent”).
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`There are two exceptions to the general principle that claims can be broader
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`than the preferred embodiments: the technology is unpredictable, or the
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`specification makes clear that the unclaimed aspect is critical to the invention.
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`Bilstad, 385 F.3d at 1125; see also Cooper Cameron Corp. v. Kvaerner Oil-Field
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`Prods., Inc., 291 F.3d 1317, 1323 (Fed. Cir. 2002). Petitioner’s cited cases fall
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`within those exceptions and are readily distinguishable. Indeed, the Federal Circuit
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`has expressly narrowed two of the four to their facts. In Amgen Inc. v. Hoechst
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`Marion Roussel, 314 F.3d 1313, 1333 (Fed. Cir. 2003), the Federal Circuit
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`clarified the limited reach of Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473
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`(Fed. Cir. 1998), noting that “[t]he court in Gentry concluded that the inventor had
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`clearly expressed in the written description that he considered his invention to be
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`3
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`limited to the specific location of the controls on the console on the sofa (‘the only
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`possible location’) and that any variation was ‘outside the stated purpose of the
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`invention.’” See also Cordis, 339 F.3d at 1365 (distinguishing Gentry Gallery).
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`The Federal Circuit similarly construed Tronzo v. Biomet, Inc., 156 F.3d 1154
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`(Fed. Cir. 1998), narrowly, stating the patent at issue had distinguished the prior art
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`as inferior and touted the advantages of its embodiment. Bilstad, 386 F.3d at 1125.
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`Medtronic’s other two cases are similarly inapt. In ICU Med., Inc. v. Alaris
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`Med. Sys., 558 F.3d 1368, 1378 (Fed. Cir. 2009), the specification disclosed only
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`medical valves that required spikes, while the claims did not recite spikes at all.
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`The Federal Circuit concluded that a POSITA reading the specification would not
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`understand that the inventor had invented a spikeless medical valve. Id. In
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`PowerOasis Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1301, 1310 (Fed. Cir.
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`2008), the Federal Circuit ruled that the claims, which were part of a CIP, were not
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`entitled to a parent application’s priority date because the CIP “added considerable
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`new language to the specification, which the district court characterized as
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`‘substantial new matter.’”
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`Petitioner takes the position that by 2005 the technology at issue in this case
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`was mature and, unlike some biotech or chemical arts, not generally considered
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`unpredictable. Ex-2242, 21:13-22:17; Ex-1900, ¶178; Ex-1807, ¶¶207-16. The
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`maturity of the catheter field at the time of the invention supports a finding that
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`4
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`there is sufficient written description support. In re Global IP Holdings, 927 F.3d
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`1373, 1377 (Fed. Cir. 2019).
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`The disclosure does not indicate that putting the side opening specifically in
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`the substantially rigid portion is critical to the invention. Ex-2124, ¶33; Ex-2243,
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`¶¶27-43. First, the “Summary of the Invention” describes the invention broadly,
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`indicating that the rigid portion only “preferably” has a cutout portion constituting
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`a side opening. Ex-1003, 8:17-9:5. Second, Petitioner’s expert agrees that the
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`disclosure shows a perpendicular end opening, and that at least Figures 20-21 show
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`that the end opening is part of the tubular portion that is made of polymer. Ex-
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`1919, ¶25; Ex-2242, 41:15-42:7, id., 29:8-20, 30:23-31:17, 40:7-16.1 Petitioner
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`and its expert agree that claims that do not require a side opening at all do not have
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`a written description problem. Ex-2242, 44:14-45:17. Petitioner did not dispute
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`that proposed claim 43 presented in the ’380 patent’s motion to amend lacked
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`written description, specifically because it does not claim a side opening. Id.,
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`45:18-46:7, 46:22-47:4; 47:21-48:10; ʼ380 MTA Opp.; Ex-2243, ¶30. Third, while
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`1 One of Petitioner’s experts acknowledged that Figure 1 of the patent may show a
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`side opening. Ex-2241, 56:24-57:13. The opening in Figure 1 is shown to be in
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`the reinforced portion 18, which is not part of the rigid portion. Ex-1003, 14:7-8,
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`18:18-19; Ex-2243, ¶33.
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`5
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`the disclosure shows both end opening and side opening embodiments, nowhere
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`does it state that either is critical to the invention. Ex-2243, ¶30; Ex-2242, 65:19-
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`25, 75:21-24; 79:19-82:1; 82:11-83:11. Simply put, if having the opening be a side
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`opening is not critical to the invention, then the specific location or rigidity of the
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`side opening cannot be critical, either.
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`Petitioner’s argument that, if a side opening is recited, it must be in a
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`“substantially rigid portion,” borders on implausible. It ignores that the proximal
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`portion of the tubular structure can be more rigid than a side opening in the
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`“substantially rigid” portion, for example, where the side opening is made of more
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`flexible Nitinol and/or has relief cuts. Ex-2243, ¶¶38-40. Where the side opening
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`is less rigid than the tube that is just distal to it, it makes little sense to require that
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`the side opening be in “the substantially rigid portion,” because the proximal
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`portion of the tube would be at least as substantially rigid. Clear rigidity-based
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`demarcations would be inconsistent with the understanding of a POSITA. Ex-
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`2243, ¶¶37-38. This is particularly true because the specification expressly teaches
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`that the portion of the substantially rigid portion that has the side opening can be
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`made flexible. Id., ¶36; Ex-2242, 54:7-14, 57:1-58:7.
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`Finally, Petitioner’s argument ignores that a POSITA at the time of the
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`invention would have known that the side opening could be made out of metal or
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`6
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`polymer,2 with relief cuts to increase flexibility, or varying material thicknesses.
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`Ex-2243, ¶37; Ex-2242, 62:6-63:16, 89:23-90:3; Ex-2241, 150:3-155:1. It is
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`undisputed that the written description analysis must be conducted through the lens
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`of a POSITA. Ex-2242, 90:4-16. Petitioner has also not identified any instances
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`where Teleflex distinguished any prior art or traversed any office action rejection
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`based on the side opening being in the substantially rigid portion. Id., 117:4-
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`118:12; 99:11-100:14. Indeed, the file history of Teleflex’s related ’379 patent
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`confirms that the specification provides written description support for claims that
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`do not specifically require the side opening to be in the substantially rigid portion.
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`In an office action response, Teleflex changed “providing a segment defining a
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`side opening” to “defining a side opening portion,” Ex-1003, 229, 232, and the
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`claims were allowed, id., 680-88, without specifically stating which portion of the
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`device the side opening is defined into. A POSITA reading this file history would
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`understand that the basis of the rejection was that the claims originally required
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`providing a discrete side opening segment portion during fabrication. Ex-2124,
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`2 Petitioner was unable to argue that the side opening must be made out of metal,
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`because the application discloses that “[o]ther substantially rigid materials may be
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`used as well,” Ex-1003, 15:5; id., 16:18-19, which Petitioner’s expert agreed
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`includes polymers, Ex-2242, 59:10-60:17, 61:5-12.
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`7
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`¶43. The amended claim language, reciting “defining a side opening portion”
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`without specifying whether the side opening is formed into the reinforced or the
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`substantially rigid portion, overcame the written description rejection. See id.
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`III. SUBSTITUTE CLAIMS 23-25 ARE NOT INDEFINITE
`“[A] claim … is unpatentable for indefiniteness if the claim, read in light of
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`the specification delineating the patent, and the prosecution history, fails to inform,
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`with reasonable certainty, those skilled in the art about the scope of the invention.”
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`Memorandum re: Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-
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`Grant Proceedings (January 6, 2021), 3. Petitioner misreads claim 23, claiming it
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`“recites a ‘substantially rigid side opening’ that is outside of both the ‘flexible tip
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`portion’ and the ‘substantially rigid portion.’” Opp., 11. But the claim does not
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`recite a separate side opening “segment,” and there is no basis for requiring the
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`side opening to be positioned outside of the substantially rigid segment. Ex-2243,
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`¶45. Petitioner’s expert testimony refutes Petitioner’s argument. See Part II above.
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`Petitioner challenges substitute claim 24 as indefinite because it recites that
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`the substantially rigid portion is “connected to” the flexible tip portion. Opp., 11.
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`Petitioner’s argument incorrectly assumes that “connected to” requires a direct
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`connection. Ex-2243, ¶46. “Connected to” includes direct and indirect
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`connections. E.g., Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336,
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`1342 (Fed. Cir. 2013). Its expert confirms “the specification teaches an indirect
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`8
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`connection, such that the flexible tip portion is connected to the reinforced portion,
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`which is connected to the substantially rigid portion.” Ex-1902 at 36 n.5, 93 n.10.
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`Petitioner’s argument ignores that claim 24 recites that the flexible tip extends out
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`the guide catheter while a portion of the reinforced portion extends within the
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`guide catheter and a proximal portion of the substantially rigid portion extends
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`through the hemostatic valve. This necessarily means that the flexible tip portion
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`is distal of the reinforced portion, which is distal of the substantially rigid portion,
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`as is disclosed in the application. Ex-1003, 14:7-9, 16:12-19; Ex-2243, ¶46.
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`IV. PETITIONER’S ARGUMENTS OF UNPATENTABILITY ARE NOT
`PERSUASIVE
`A. Claims 23-25 Are Patentable Over Itou3 in View of Either
`Ressemann or Kataishi
`1.
`Substitute Claim 23
`a.
`“Interventional Cardiology Devices Are Insertable”
`Substitute claim 23 recites a tubular structure “through which interventional
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`cardiology devices are insertable.” Properly construed, this term requires that at
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`least “guidewires, balloon catheters, stents, and stent catheters” be insertable into
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`and through the device. Ex-1003 at 3:16-18 (emphasis added); IPR2020-00126,
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`Ex-2138, ¶¶102-13. Petitioner’s expert agrees that the specification’s language
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`means that “the invention [must] be able to deliver stents [and] stent catheters.”
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`3 Itou is not prior art, but Teleflex nevertheless addresses it substantively herein.
`9
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`Ex-2242, 85:21-86:21. Petitioner argues that “interventional cardiology devices
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`(e.g., PTCA balloons and stents) were insertable through the lumen of Itou’s
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`‘flexible tip portion,’” Opp., 13 (citing “Ex. 2127, 2; Ex. 1900, ¶18”). But the
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`cited evidence does not support that statement. Ex-2127 is a GuideLiner
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`development document that addresses only the size of the distal tube, not
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`obstructions caused by a pushwire. Unlike GuideLiner, Itou’s pushwire obstructs
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`access to its tubular lumen. Ex-2243, ¶55. Ex-1900, ¶18 merely states that a
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`“[p]rotective catheter (5) is insertable,” but that is not an interventional cardiology
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`device. The application differentiates between its “tapered inner catheter” and
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`“interventional cardiology devices” designed to provide treatment, IPR2020-
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`00126, Ex-2138, ¶111, and Petitioner’s expert agrees such a “tapered inner
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`catheter” is equivalent to a protective catheter as termed in Itou. Ex-2238, 26:2-10.
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`Itou’s protective catheter does not provide treatment, nor could it, because a
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`protective catheter protects healthy tissue. IPR2020-00126, Reply, 5; Ex-2243,
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`¶54. And even if Itou’s protective catheter was somehow considered to be an
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`interventional cardiology device, it would be just one device, which would not
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`meet the “interventional cardiology devices” element.
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`In his declaration’s background section, Petitioner’s expert cites an
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`argument from another of his declarations (Ex-1900, ¶54, citing Ex-1806, §III(A))
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`that there were stents with outer diameters (bare crossing profiles) less than Itou’s
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`10
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`
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`effective 0.046 inch lumen diameter. A stent, however, is a long, bulky, stiff
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`device that requires space beyond its bare crossing profile to move through a
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`catheter, especially around bends. Ex-2243, ¶56. For that reason, manufacturers
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`of the cited stents require in their instructions for use a minimum 5 French (0.056
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`inches) catheter, e.g., Ex-1802, 25 (the “minimal internal diameter of guiding
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`catheter” for the 0.038 inch profile Tsunami stent is “0.056 inch, 5 Fr”)—far larger
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`than Itou’s 0.046 inch proximal opening. Ex-2243, ¶56.
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`Complex Side Opening
`b.
`Petitioner admits that Itou does not disclose claim 23’s complex side
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`opening: “a first inclined region, a second inclined region, and a non-inclined
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`concave track between the first and second inclined regions.” Teleflex’s claimed
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`complex side opening is important to the operation of the guide extension catheter
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`for which Teleflex’s invention created a market; that is why Petitioner and every
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`other competitor copied it. IPR2020-00126, POR, 50-57. Yet Petitioner does not
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`point to a single reference with a complex proximal side opening, let alone such an
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`opening that is used to receive interventional cardiology devices, let alone while
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`inside a guide catheter deep in the vasculature, let alone as part of a guide
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`extension catheter sized to closely fit within the guide catheter. Ressemann
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`expressly taught the difficulty of delivering devices such as stent catheters through
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`a tube’s angled opening: Without a reverse bevel Petitioner’s combinations do not
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`11
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`use, “[s]tent delivery catheters … are particularly subject to hanging up on the
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`proximal end of the evacuation head[’s angled opening].” Ex-1008, 25:27-29. Yet
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`Ressemann buries the collar tab that Petitioner so dearly relies on deep inside his
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`device, such that it has no role in shaping Ressemann’s side opening. Ex-2243,
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`¶¶58-51. And the shape at the distal end of Kataishi’s suction catheter has no
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`concave track, has a significantly different rigidity profile, and is for a completely
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`different purpose—improving suction by allowing that distal end to flex over a
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`thrombus. Ex-2243, ¶¶67-81. Petitioner transparently uses Teleflex’s claims as
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`roadmaps to pick and choose elements from disparate prior art, using hindsight to
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`string them together.
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`Itou Plus Ressemann’s Collar
`i.
`Petitioner relies on Ressemann’s collar for a complex side opening. But
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`
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`Ressemann’s own device does not have a complex side opening. Ex-1008, Figs.
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`1A, 16A. Petitioner’s proposed combination also fails because a POSITA would
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`not be motivated to myopically fixate on Ressemann’s support collar in the first
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`place, absent hindsight. Ex-2243, ¶¶58-66. The alleged first “inclined region”
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`(Ressemann’s collar tab 2141b’s tip) is buried inside shaft 2120 under many layers
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`of material. Id., ¶61. Unless using claim 23 as a roadmap, a POSITA would not
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`extract this lone component from the complex evacuation sheath assembly (where
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`it neither provides a first incline or concave track, nor performs any guiding
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`12
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`
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`function for an interventional cardiology device) and use it as a proximal opening
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`in Itou’s structurally and functionally different suction catheter. Petitioner’s
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`original engineering expert admitted to using a hindsight-focused approach when
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`considering Ressemann, Ex-2137, 132:15-133:11 (“I’m not overly concerned with
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`what the collar was being done before I chose to use it . . . . I’m more concerned
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`about how I can use it in combination for what I want to do.”); see also Ex-2116,
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`239:7-13. While Petitioner actively prevented its new engineering expert from
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`considering how Ressemann actually uses collar 2141, Ex-1807, ¶82 (“I have not
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`been asked” to opine on “how collar 2141 is incorporated into embodiment 2100”),
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`he nevertheless admits that his “opinions are not based on how Ressemann is using
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`the collar,” Ex-2239, 105:19-24, and that his proposed use of the collar “is
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`different than the way Ressemann, itself, teaches,” id., 105:25-106:5. He also
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`agreed that adding Ressemann’s collar to Itou would require at least six different
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`modifications, further showing the hindsight nature of the combination. Ex-2241,
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`51:23-53:1, 43:21-52:1; Ex-2243, ¶62. Because a POSITA would not be
`
`motivated to select the support collar in the first place, the question of how the
`
`support collar would be incorporated into Itou is moot.
`
`Finally, Petitioner’s supposed motivations for adding Ressemann’s collar to
`
`Itou cannot withstand scrutiny. It asserts that adding Ressemann’s collar to Itou
`
`would “increase[] the area for receiving a stent and/or balloon catheter.” Opp., 17.
`
`
`
`13
`
`
`
`Either replacing Itou’s metal collar with Ressemann’s metal collar, or merely
`
`grafting the collar on top, however, would decrease the cross-sectional area of
`
`Itou’s tube opening. Ex-2243, ¶64. To the extent it was desired to increase the
`
`area of Itou’s proximal opening, a POSITA simply could make Itou’s angle
`
`shallower, Ex-2240, 157:4-5, 163:20-22, rather than extract a buried component
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`from an unrelated device and graft it onto Itou’s design. Ex-2243, ¶65. Petitioner
`
`also asserts that Ressemann’s collar would “reinforce the proximal opening of the
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`catheter lumen, as well as provide a flexibility transition between the distal tubular
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`structure and the proximal shaft.” Opp., 17-18. But Petitioner fails to explain how
`
`Ressemann’s metal collar would be better than Itou’s metal pipe for reinforcing the
`
`tube’s opening, or why it would provide a flexibility transition superior to that of
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`Itou’s design. Ex-2243, ¶66. The flexibility transition provided by the collar tab is
`
`specifically tailored to Ressemann’s Figure 16 embodiment, which has polymer
`
`lumens in the shaft that must maintain their patency. Id. Itou has no such lumens
`
`in the shaft, instead having a rigid weld between the metal tubular portion and
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`metal pushwire. Id. Further, Petitioner’s expert cannot say how the rigidity of
`
`Itou’s metal pipe, or Itou’s pipe/wire weld, compares to that of Ressemann’s collar.
`
`Ex-2240, 163:25-164:11. Petitioner’s final justification—Ressemann’s collar
`
`should be used with Itou because both devices relate to “removing coronary vessel
`
`occlusions,” Opp., 18—proves too much. It also ignores that Itou and Ressemann
`
`
`
`14
`
`
`
`are directed to fundamentally different purposes. Ex-2243, ¶60; see also Ex-2240,
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`169:21-170:9.
`
`Itou Plus Kataishi’s Distal Tip
`ii.
`Kataishi does not disclose a tube’s proximal side opening, let alone a
`
`complex side opening. The Board preliminarily concluded Petitioner failed to
`
`“explain sufficiently why the inclined shape of Kataishi’s distal opening would
`
`have been applicable to the angled partially cylindrical opening at the proximal end
`
`of Itou’s suction catheter.” IPR2020-00135, Paper 22 at 23. That remains the
`
`case. The primary purpose of the shape of Kataishi’s distal opening is to increase
`
`suction by allowing the distal tip to flex and conform over a thrombus on a vessel
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`wall (“the concave portion helps to increase the flexibility of the distal tip of the
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`catheter,” Ex-2240, 104:2-5)—a purpose that is irrelevant to Itou’s rigid metal
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`proximal collar. IPR2020-00126, Ex-2138, ¶144; Ex-2145, ¶152.
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`Petitioner’s argument also fails because Kataishi does not disclose a non-
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`inclined concave track: Guidewire lumen 15 creates a ridge along the bottom of
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`the tube’s distal end. Ex-2243, ¶¶68-70; Ex-2240, 109:11-13. Kataishi Figures 2
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`and 12 show the guidewire lumen 15 running through the device’s distal tip, and
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`Figure 4 shows that guidewire lumen 15 creates a ridge along the bottom of the
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`tube. Ex-2240, 107:16-108:1. Sakurada appears to show this ridge. Ex-1055, Fig.
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`1A. Any argument by Petitioner that there is a concave track despite the guidewire
`
`
`
`15
`
`
`
`lumen’s longitudinal ridge would be nonsensical, and its expert’s speculation that
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`the guidewire lumen might be buried in the distal tip’s floor so there is no ridge
`
`finds no support in Kataishi. Kataishi undisputedly does not state that its distal tip
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`has a concave track, and creation of such a design, for example by adding material
`
`to bury the guidewire lumen’s ridge, would be contrary to Kataishi’s multiple
`
`statements that its distal tip is designed to be “flexible.” Ex-1025, ¶¶10, 26, 27, 28,
`
`claim 22; Ex-2243, ¶70. Because Kataishi does not teach a concave track within
`
`the plain meaning of the term, much less a benefit or reason to provide one, it
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`cannot be relied on to provide such a shape to Itou’s proximal end.
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`Petitioner’s first and third alleged motivations to combine, “improved
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`crossability,” Opp., 20-21, make no sense, because Kataishi’s distal tip crosses
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`through the vasculature, while a guide extension catheter tube’s proximal end
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`remains in the guide catheter. Ex-2243, ¶¶74-77. Its alleged motivation of
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`“improved ability of an opening to accept material,” Opp., 20, ignores that
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`“Kataishi teaches enhancing suction by reducing the gap to better cover the
`
`atheroma with the distal end of the suction catheter,” Ex-2240, 103:2-10; see Ex-
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`1025, ¶27, which has no bearing on how the distal tip would perform if on a guide
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`extension catheter within a guide catheter. Ex-2243, ¶78. Petitioner’s last
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`justification—Itou’s collar should be given the shape of Kataishi’s distal tip
`
`because both references are directed to “removing occlusions from coronary
`
`
`
`16
`
`
`
`arteries using, inter alia, a catheter,” Opp., 21—again proves too much. Instead,
`
`Kataishi teaches away from Teleflex’s claims: Its “[i]mproved flexibility means
`
`the catheter can get [to] and cover the lesion,” which “enhances suction.” Ex-
`
`2240, 105:24-106:7. But a POSITA would recognize that using Kataishi’s
`
`deliberately-flexible distal tip on the proximal opening of a guide extension
`
`catheter’s tube would present a kink point. Ex-2243, ¶81. Indeed, Petitioner does
`
`not explain just how Kataishi is being combined with Itou—for example, is the
`
`shape of Kataishi cut into Itou’s pipe, is Kataishi’s distal end grafted onto Itou’s
`
`tube and how, etc. It does not attempt to reconcile Kataishi’s teaching that the
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`distal tip’s shape is for “improving flexibility of the catheter distal end,” Ex-1025,
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`¶27, with Itou’s opposite teaching that the pipe’s “proximal end portion 231 is
`
`secured firmly by being welded to the distal end of the wire-like portion,” Ex-
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`1007, 4:33-34, to provide enough strength for the suction catheter to “be rotated,
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`pushed or pulled,” id., 7:20-24. These conflicting motivations would prevent a
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`POSITA from putting Kataishi’s distal tip on Itou’s proximal tube opening. Ex-
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`2243, ¶¶76, 81-82.
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`Size and “Coaxial” Limitations
`c.
`The asserted combination of Itou and Ressemann’s collar also fail to meet
`
`claim 23’s requirements that (1) the device be “for use with a standard 6 French
`
`
`
`17
`
`
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`guide catheter” and have a tubular structure with an “inner diameter of at least
`
`0.056 inches,” a
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