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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 IPR2020-00132
`Case IPR2020-00134
`Patent RE 45,760
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`PATENT OWNER’S REPLY IN SUPPORT OF CONTINGENT MOTION
`TO AMEND U.S. PATENT RE 45,760 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
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`INTRODUCTION ....................................................................................... 1
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` SUBSTITUTE CLAIMS 54-56, 58 ARE SUPPORTED UNDER
`§ 112 ............................................................................................................ 1
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`I.
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`II.
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`III. SUBSTITUTE CLAIM 58 IS NOT A BROADENING
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`AMENDMENT ........................................................................................... 7
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`IV. PETITIONER’S ARGUMENTS OF UNPATENTABILITY ARE NOT
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`PERSUASIVE ............................................................................................. 8
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`A. Claims 54 and 55 Are Patentable Over Itou Because Itou Does Not
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`Disclose “Passage Therethrough of Stent Catheters” ....................... 8
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`B. Claims 56-58 Are Patentable Over Itou in View of Ressemann or
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`Ressemann and Kataishi .................................................................... 9
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`1.
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`Substitute Claim 56 ................................................................. 9
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`2.
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`3.
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`a. A “Stent” Is Insertable .................................................. 9
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`b. Complex Side Opening ............................................... 10
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`i.
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`ii.
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`Itou Plus Ressemann’s Collar .......................... 11
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`Itou Plus Kataishi’s Distal Tip ......................... 13
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`c.
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`Size and “Coaxial” Limitations .................................. 16
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`Substitute Claim 57 ............................................................... 17
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`Substitute Claim 58 ............................................................... 17
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`C. Claims 54-58 Are Patentable Over Kontos in View of Ressemann
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`and Takahashi .................................................................................. 18
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`1.
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`Substitute Claims 54 and 55 ................................................. 18
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`a.
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`b.
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`“Configured” for “Stent Catheters” ............................ 18
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`“Not More Than One French Size Smaller” and
`“Uniform, Fixed Outer [Tubular Structure]
`Diameter” .................................................................... 18
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`2.
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`Substitute Claim 56 ............................................................... 21
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`a.
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`“Stent” Delivery .......................................................... 21
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`b. Complex Side Opening ............................................... 21
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`V. CONCLUSION .......................................................................................... 25
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`CERTIFICATION OF SERVICE........................................................................ 27
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`CERTIFICATE OF WORD COUNT COMPLIANCE ....................................... 28
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`3.
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`Substitute Claim 57 ............................................................... 24
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`a.
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`“Coaxial,” “Reinforced Portion,” and Size
`Limitations .................................................................. 24
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`b. Complex Side Opening ............................................... 24
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`4.
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`Substitute Claim 58 ............................................................... 24
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`D. All Claims Are Patentable Over Kontos in View of
`Ressemann, Takahashi, and Kataishi .............................................. 25
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`ii
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`CASES
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`TABLE OF AUTHORITIES
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` PAGE
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`Amgen Inc. v. Hoechst Marion Roussel
`314 F.3d 1313 (Fed. Cir. 2003) .................................................................................. 3
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`Ashley Furniture Indus. v. Lifestyle Enter.
`574 F. Supp. 2d 920 (W.D. Wis. 2008) ................................................................ 19
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`Bilstad v. Wakalopulos
`386 F.3d 1116 (Fed. Cir. 2004) ..................................................................... 1, 2, 3
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`Campbell Soup Co. v. Gamon Plus, Inc.
`939 F.3d 1335 (Fed. Cir. 2019) ............................................................................ 19
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`Cooper Cameron Corp. v. Kvaerner Oil-Field Prods., Inc.
`291 F.3d 1317 (Fed. Cir. 2002) .............................................................................. 3
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`Cordis Corp. v. Medtronic AVE
`339 F.3d 1352 (Fed. Cir. 2003) ..........................................................................2, 3
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`Datascope Corp. v. Kontron, Inc.
`611 F. Supp. 889 (D. Mass. 1985) ........................................................................ 19
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`Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.
`93 F.3d 1572 (Fed. Cir. 1996) ............................................................................1, 2
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`Gentry Gallery, Inc. v. Berkline Corp.
`134 F.3d 1473 (Fed. Cir. 1998) .............................................................................. 3
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`ICU Med., Inc. v. Alaris Med. Sys.
`558 F.3d 1368 (Fed. Cir. 2009) .............................................................................. 3
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`In re Global IP Holdings
`927 F.3d 1373 (Fed. Cir. 2019) .............................................................................. 4
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`In re Peters
`723 F.2d 891 (Fed. Cir. 1983) ................................................................................ 2
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`In re Rasmussen
`650 F.2d 1212 (C.C.P.A. 1981) .............................................................................. 2
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`
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`iii
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`In re Schweickert
`676 F. App’x 988 (Fed. Cir. 2017) ....................................................................... 23
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`Lampi Corp. v. Am. Power Prods., Inc.
`228 F.3d 1365 (Fed. Cir. 2000) .............................................................................. 2
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`PowerOasis Inc. v. T-Mobile USA, Inc.
`522 F.3d 1299 (Fed. Cir. 2008) .............................................................................. 3
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`Tronzo v. Biomet, Inc.
`156 F.3d 1154 (Fed. Cir. 1998) .............................................................................. 3
`Other Authorities
`37 C.F.R. § 42.121 ..................................................................................................... 1
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`iv
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`I.
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`INTRODUCTION
`Patent Owner Teleflex submits this Reply in Support of Contingent Motion
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`to Amend U.S. Patent RE 45,760, with the Second Declaration of Peter T. Keith in
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`Support of Motions to Amend (“Ex-2243”), under 37 C.F.R. § 42.121. Teleflex
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`submits that Petitioner has failed to show that any of the substitute claims
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`presented in this motion is unpatentable.
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`II.
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`SUBSTITUTE CLAIMS 54-56, 58 ARE SUPPORTED UNDER § 112
`Petitioner argues that claims 54-56 and 58 lack written description because
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`they recite “a segment defining a side opening,” arguing that the side opening can
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`only be claimed as “part of the substantially rigid segment.” Opp., 1-2 (emphasis
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`by Petitioner). Petitioner’s argument fails as a matter of both law and fact. As a
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`legal matter, there is nothing improper about presenting claims that are broader
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`than the preferred embodiments. See Bilstad v. Wakalopulos, 386 F.3d 1116,
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`1123-25 (Fed. Cir. 2004) (collecting cases); Ethicon Endo-Surgery, Inc. v. United
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`States Surgical Corp., 93 F.3d 1572, 1582 n.7 (Fed. Cir. 1996) (if the inventor “did
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`not consider the precise location of the lockout to be an element of his invention,
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`he was free to draft claim 24 broadly … to exclude the lockout’s exact location as
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`a limitation of the claimed invention…. Such a claim would not be unsupported by
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`the specification even though it would be literally infringed by undisclosed
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`embodiments.”). This includes reissues: “[T]hat a claim may be broader than the
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`1
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`specific embodiment disclosed in a specification is in itself of no moment. Indeed,
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`the statutory provision for broadened claims in reissue applications is intended to
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`meet precisely the situation in which a patentee has claimed ‘less’ than he had a
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`right to claim.” In re Rasmussen, 650 F.2d 1212, 1215 (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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`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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`2
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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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`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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`3
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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 and chemical arts, not generally considered
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`unpredictable. Ex-2242, 21:13-22:17; Ex-1903, ¶219; 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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`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, 30:23-31:15, 40:7-16.1 Petitioner
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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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`4
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`and its expert agree that claims that do not require a side opening do not have a
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`written description problem. Ex-2242, 44:14-45:17. Petitioner and its expert did
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`not dispute that proposed claim 43 presented in the ’380 patent’s motion to amend
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`lacked written description, specifically because it does not claim a side opening.
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`Id., 45:18-46:7, 46:22-47:4; 47:21-48:10; ʼ380 MTA Opp.; Ex-2243, ¶30. Third,
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`while the disclosure shows both end opening and side opening embodiments,
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`nowhere does it state that either is critical to the invention. Ex-2243, ¶30; Ex-
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`2242, 65:19-25, 75:21-24; 79:19-82:1, 82:11-83:11. Simply put, if having the
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`opening be a side opening is not critical to the invention, then the specific location
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`or rigidity of the 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. Indeed, substitute claims 54-
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`56 and 58 already contain a limitation relating to rigidity of the side opening
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`segment, specifically reciting that the side opening is “more rigid” than the tubular
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`structure. Further, Petitioner’s argument ignores that the proximal portion of the
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`tubular structure can be more rigid than a side opening in the “substantially rigid”
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`portion, for example where the side opening is made of more flexible Nitinol
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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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`and/or has relief cuts. Ex-2243, ¶¶38-40. Where the side opening is less rigid than
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`the tube that is just distal to it, it makes little sense to require that the side opening
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`be in “the substantially rigid portion,” because the proximal portion of the tube
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`would be at least as substantially rigid. Clear rigidity-based demarcations would
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`be inconsistent with the understanding of a POSITA. Ex-2243, ¶¶37-38. This is
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`particularly true because the specification expressly teaches that the portion of the
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`substantially rigid portion that has the side opening can be made flexible. Id., ¶36;
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`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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`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 identifies no instances where Teleflex
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`distinguished any prior art or traversed any office action rejection based on the side
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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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`6
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`opening being in the substantially rigid portion. Id., 117:4-118:12. Indeed, the file
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`history of Teleflex’s related ’379 patent confirms that the specification provides
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`written description support for claims that do not specifically require the side
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`opening to be in the substantially rigid portion. In an office action response,
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`Teleflex changed “providing a segment defining a side opening” to “defining a
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`side opening portion,” Ex-1003, 229, 232, and the claims were allowed, id., 680-
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`88, without specifically stating which portion of the device the side opening is
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`defined into. A POSITA reading this file history would understand that the basis
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`of the rejection was that the claims originally required providing a discrete portion
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`of a device during fabrication that was a separate side opening segment. Ex-2124,
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`¶43. The amended claim language, which recites “defining a side opening portion”
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`without specifying whether the side opening is formed into the reinforced portion
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`or the substantially rigid portion, overcame the written description rejection. See
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`id.
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`III. SUBSTITUTE CLAIM 58 IS NOT A BROADENING AMENDMENT
`Substitute claim 58 does not contain a broadening amendment, for the
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`reasons set forth in Teleflex’s opening motion at 2-4, in Ex-2124, ¶57, and in Ex-
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`2243, ¶¶47-51. Petitioner’s expert confirms that a POSITA would not have
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`understood a “one French size” difference for catheter inner diameters to mean
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`exactly 0.0131 inches, testifying that a one French size difference could be
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`7
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`“slightly larger or slightly smaller” than 0.0131 inches. Ex-2137, 371:25-372:9,
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`367:20-368:20; Ex-2239, 156:10-24, 155:17-22.
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`IV. PETITIONER’S ARGUMENTS OF UNPATENTABILITY ARE NOT
`PERSUASIVE
`A. Claims 54 and 55 Are Patentable Over Itou3 Because Itou Does
`Not Disclose “Passage Therethrough of Stent Catheters”
`Petitioner’s sole Itou-based attack on claims 54 and 55 is one of anticipation.
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`Claim 54 recites that “the tubular structure … is configured to allow entry and
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`passage therethrough of stent catheters.” Claim 55 depends from claim 54.
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`Petitioner argues that “[a] lumen of this [Itou’s] size is necessarily configured ‘to
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`allow entry and passage therethrough of stent catheters.’ (Ex. 1903, ¶33; see also
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`id., ¶¶13-32.).” Opp., 12. Petitioner appears to be relying on Ex-1903, ¶¶21-30, to
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`argue that a stent can pass through Itou’s 0.059 inch inner diameter tube. Even
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`Petitioner’s expert agrees that size alone may not meet the “configured to”
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`element: “‘[C]onfigured to receive,’ it’s got to be big enough to allow the stent in,
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`and there can’t be a blockage across the origin of the entrance.” Ex-2240, 176:25-
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`178:6. Itou has such a blockage—its pushwire obstructs access to its tubular
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`lumen, resulting in an effective inner diameter of 0.046 inches. Ex-2243, ¶55.
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`That diameter is too small to allow any of the stents cited by Petitioner to pass. Id.
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`3 Itou is not prior art, but Teleflex nevertheless addresses it substantively herein.
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`Petitioner’s expert declaration contains a naked citation to an argument from
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`another of his declarations (Ex-1903, ¶29, citing Ex-1806, ¶¶49-52) that there were
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`stents with outer diameters (bare crossing profiles) less than Itou’s effective 0.046
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`inch lumen diameter. A stent, however, is a long, bulky, stiff device that requires
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`space beyond its bare crossing profile to move through a catheter, especially
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`around bends in vessel anatomy. Ex-2243, ¶56. For that reason, manufacturers of
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`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. Petitioner’s argument
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`should be rejected because it has not established that its Itou device can deliver
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`stent catheters.
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`B. Claims 56-58 Are Patentable Over Itou in View of Ressemann or
`Ressemann and Kataishi
`1.
`Substitute Claim 56
`a.
`A “Stent” Is Insertable
`Claim 56 recites that the claimed device can deliver “a stent releasably
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`joined to the distal end of the elongate balloon catheter.” For the reasons set forth
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`above in Part IV.A, Itou cannot deliver a stent. Adding Ressemann’s collar to
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`Itou’s device would only further restrict the size of the proximal opening, thus
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`exacerbating Itou’s deficiency. Ex-2243, ¶64. Indeed, Ressemann expressly
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`9
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`teaches the challenges of delivering stents, stating that, without a reverse bevel, “a
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`stent delivery catheter is particularly subject to hanging up.” Ex-1008 at 25:27-29.
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`Petitioner does not address this teaching of Ressemann, nor does it provide a
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`reverse bevel. Petitioner’s failure to show that Itou, either in original or modified
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`form, can pass stents is fatal to its attack.
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`Complex Side Opening
`b.
`Claim 56 recites “two inclined slopes … separated by a non-inclined
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`concave track.” Teleflex’s claimed complex side opening is important to the
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`operation of the guide extension catheter for which Teleflex’s invention created a
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`market; that is why Petitioner and every other competitor copied it. IPR2020-
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`00132, POR, 60-67. Yet Petitioner does not point to a single reference that has a
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`complex proximal side opening, let alone such an opening that one uses to receive
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`interventional cardiology devices, let alone while inside a guide catheter deep in
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`the vasculature, let alone as part of a guide extension catheter sized to closely fit
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`within the guide catheter. The Ressemann collar tab that Petitioner so dearly relies
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`on is buried deep inside Ressemann’s device, such that it has no role in shaping
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`Ressemann’s side opening. And the shape at the distal end of Kataishi’s suction
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`catheter has no concave track, has a significantly different rigidity profile, and,
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`further, is for a completely different purpose—improving suction by allowing that
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`distal end to flex closer to and about a thrombus. Petitioner transparently uses
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`10
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`Teleflex’s claims as roadmaps to pick and choose elements from disparate prior
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`art, and then uses hindsight to string them together.
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`Itou Plus Ressemann’s Collar
`i.
`Petitioner admits that Itou does not disclose claim 56’s complex side
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`opening, relying instead on Ressemann’s collar. But Ressemann’s own device
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`does not have a complex side opening. Ex-1008, Figs. 1A, 16A.
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`Petitioner’s proposed combination also fails because a POSITA would not
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`be motivated to myopically fixate on Ressemann’s support collar in the first place,
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`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 56 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 inclined slope or a non-inclined concave track, nor
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`performs any guiding function for a stent) and use it as a proximal opening in
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`Itou’s structurally and functionally different suction catheter. Petitioner’s original
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`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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`11
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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
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`2100.”), he nevertheless admits that his “opinions are not based on how
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`Ressemann is using the collar,” Ex-2239, 105:19-24, and that his proposed use of
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`the collar “is different than the way Ressemann, itself, teaches,” id., 105:25-106:5.
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`He agreed that adding Ressemann’s collar to Itou would requires at least six
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`different modifications, further showing the hindsight nature of the combination.
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`Ex-2241, 51:23-53:1, 43:21-52:1; Ex-2243, ¶62. Because a POSITA would not be
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`motivated to select the support collar in the first place, the question of how the
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`support collar would be incorporated into Itou is moot.
`
`Petitioner’s supposed motivations for adding Ressemann’s collar to Itou do
`
`not withstand scrutiny. Petitioner asserts that adding Ressemann’s collar to Itou
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`would “increase[] the area for receiving a stent and/or balloon catheter,” Opp., 19,
`
`but replacing Itou’s metal collar with Ressemann’s metal collar, or merely grafting
`
`the collar on top, 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 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 catheter lumen, as well as
`
`
`
`12
`
`
`
`provide a flexibility transition between the distal tubular structure and the proximal
`
`shaft.” Opp., 19. But Petitioner fails to explain how Ressemann’s metal collar
`
`would be better than Itou’s metal collar for reinforcing the tube’s opening, or why
`
`it would provide a flexibility transition superior to that of 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 its shaft, instead
`
`having a rigid weld between the metal tubular portion and metal pushwire. Id.
`
`Further, Petitioner’s expert cannot say how the rigidity of Itou’s metal pipe or its
`
`pipe/wire weld compares to that of Ressemann’s collar. Ex-2240, 163:25-164:11.
`
`Its final justification—Ressemann’s collar should be used with Itou because both
`
`devices relate to “removing coronary vessel occlusions,” Opp., 19—proves too
`
`much, and also ignores that Itou and Ressemann are directed to fundamentally
`
`different purposes, Ex-2243, ¶60, ¶xx; see also Ex-2240, 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
`
`
`
`13
`
`
`
`case. The primary purpose of Kataishi’s distal opening shape is to increase suction
`
`by allowing the distal tip to flex and conform over a thrombus on a vessel wall
`
`(“the concave portion helps to increase the flexibility of the distal tip of the
`
`catheter,” Ex-2240, 104:2-5)—a purpose that is irrelevant to Itou’s rigid metal
`
`proximal collar. IPR2020-00132, Ex-2138, ¶174; Ex-2145, ¶152.
`
`Petitioner’s argument also fails because Kataishi does not disclose a non-
`
`inclined concave track: Guidewire lumen 15 creates a ridge along the bottom of
`
`the tube’s distal end. Ex-2243, ¶¶68-70; Ex-2240, 109:11-13. Kataishi Figures 2
`
`and 12 show the guidewire lumen 15 running through the device’s distal tip, and
`
`Figure 4 shows that guidewire lumen 15 creates a ridge along the bottom of the
`
`tube. Ex-2240, 107:16-108:1. Sakurada appears to show this ridge. Ex-1055, Fig.
`
`1A. Any argument by Petitioner that there is a concave track despite the guidewire
`
`lumen’s longitudinal ridge would be nonsensical, and its expert’s speculation that
`
`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
`
`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
`
`
`
`14
`
`
`
`the plain meaning of the term, much less a benefit or reason to provide a concave
`
`track, it cannot be relied on to provide such a shape to Itou’s proximal end.
`
`Petitioner’s first and third alleged motivations to combine, “improved
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`crossability,” Opp., 21-22, make no sense, because Kataishi’s distal tip crosses
`
`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., 22, 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 also
`
`Ex-1025, ¶27, which has no bearing on how the distal tip would perform if
`
`positioned on a guide extension catheter within a guide catheter. Ex-2243, ¶78.
`
`Petitioner’s last justification—Itou’s collar should be given the shape of Kataishi’s
`
`distal tip because both references are directed to “removing occlusions from
`
`coronary arteries using, inter alia, a catheter,” Opp., 22—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.”
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`Ex-2240, 105:24-106:7. But a POSITA would recognize that using Kataishi’s
`
`deliberately-flexible distal tip structure on the proximal opening of a guide
`
`extension catheter would present a kink point. Ex-2243, ¶81. Indeed, Petitioner
`
`does not explain just how Kataishi is being combined with Itou—for example, is
`
`
`
`15
`
`
`
`the shape of Kataishi being cut into Itou’s pipe, is Kataishi’s distal end being
`
`grafted onto Itou’s tube and how, etc. Petitioner also does not attempt to reconcile
`
`Kataishi’s teaching that the distal tip’s shape is for “improving flexibility of the
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`catheter distal end,” Ex-1025, ¶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-1007, 4:33-34, to provide enough strength for the
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`suction catheter to “be rotated, pushed or pulled,” id., 7:20-24. These conflicting
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`motivations would prevent a POSITA from putting Kataishi’s distal tip on Itou’s
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`proximal tube opening. Ex-2243, ¶¶76, 81-82.
`
`Size and “Coaxial” Limitations
`c.
`Claim 56 depends from original claim 25, which recites (1) a “coaxial”
`
`lumen and (2) that the tubular structure’s lumen be “not more than one French size
`
`smaller” than that of the guide catheter. The drawing below, with dimensions from
`
`Petitioner’s expert, shows that the lumen of the tubular structure is fixedly offset
`
`from that of the guide catheter, and that its inner diameter is 0.028 inches smaller:
`
`2.2mm (.087”)
`
`1.5mm
`(.059”)
`
`
`
`16
`
`1.72mm (.068”)
`
`0.45mm (.018”)
`
`
`
`
`
`Ex-2228 (dimensions from Ex-2239, 170:12-173:17).
`
`Substitute Claim 57
`2.
`Petitioner has failed to show that Itou plus Ressemann or Kataishi discloses
`
`(1) a tubular structure “coaxial” with the guide catheter; (2) that the inner diameter
`
`of the tubular structure is “not more than one French size smaller” than that of the
`
`guide catheter; or (3) a complex side opening, specifically, one with “a non-
`
`inclined concave track positioned between … first and second inclined regions,” as
`
`recited in claim 57. See Parts IV.B.1.c, IV.B.1.b.
`
`Substitute Claim 58
`3.
`Petitioner has failed to show that Itou plus Ressemann or Kataishi discloses
`
`(1) a tubular structure “coaxial” with the guide catheter; (2) a system that includes
`
`a tubular structure with an inner diameter “greater than or equal to 0.056 inches”
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`and a standard 6 French guide catheter with an internal diameter of at least “0.070
`
`inches”; or (3) a complex side opening, specifically, one with “a first inclined
`
`sidewall proximate to a non-inclined region that is proximate to a second inclined
`
`sidewall,” as recited in claim 58. See Parts IV.B.1.c, IV.B.1.b.
`
`
`
`17
`
`
`
`C. Claims 54-58 Are Patentable Over Kontos in View of Ressemann
`and Takahashi
`1.
`Substitute Claims
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