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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-00135
`Case IPR2020-00136
`Patent RE 45,776
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`PATENT OWNER’S REPLY IN SUPPORT OF
`CORRECTED CONTINGENT MOTION TO AMEND
`U.S. PATENT RE 45,776 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 58-62 AND 65 ARE SUPPORTED
`UNDER § 112 .............................................................................................. 1
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`I.
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`II.
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`III. SUBSTITUTE CLAIM 65 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 58-60 and 63-65 Are Patentable Over Itou in View of
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`Ressemann and/or Kataishi ............................................................... 8
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`1.
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`Substitute Claims 58-60: Complex Side Opening ................. 8
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`a.
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`b.
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`Itou Plus Ressemann’s Collar ....................................... 9
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`Itou Plus Kataishi’s Distal Tip ................................... 12
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`2.
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`Substitute Claim 63 ............................................................... 15
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`3.
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`4.
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`a.
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`b.
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`“Configured to Receive Stent Catheters” ................... 15
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`Size and “Coaxial” Limitations .................................. 16
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`Substitute Claim 64: Complex Side Opening ...................... 17
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`Substitute Claim 65 ............................................................... 17
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`a.
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`b.
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`c.
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`“Configured … to Receive Stents” ............................. 17
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`Size and “Coaxial” Limitations .................................. 17
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`Complex Side Opening ............................................... 18
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`B. Claims 61 and 62 Are Patentable Over Itou in View of Ressemann
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`or Kataishi and Eidenschink ............................................................ 18
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`C. Claims 58-60 and 63-65 Are Patentable Over Kontos in View of
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`Ressemann ....................................................................................... 18
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`1.
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`2.
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`Substitute Claims 58-60: Complex Side Opening ............... 19
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`Substitute Claim 63 ............................................................... 21
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`a.
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`b.
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`“Configured to Receive Stent Catheters” ................... 21
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`Size, “Coaxial,” and “Uniform, Fixed Outer [Tubular
`Structure” Diameter” Limitations ............................... 21
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`3.
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`4.
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`Substitute Claim 64: Complex Side Opening ...................... 24
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`Substitute Claim 65 ............................................................... 24
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`a.
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`b.
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`c.
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`“Configured … to Receive Stents” ............................. 24
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`Size and “Coaxial” Limitations .................................. 24
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`Complex Side Opening ............................................... 24
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`D. Claims 61 and 62 Are Patentable Over Kontos in View of
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`Ressemann or Kataishi and Eidenschink ........................................ 24
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`E. Claims 63-65 Are Patentable Over Kontos in View of Ressemann
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`and Takahashi .................................................................................. 25
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`F. All Claims Are Patentable Over Kontos in View of Kataishi,
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`Kontos in View of Kataishi and Eidenschink, and Kontos in View
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`of Ressemann, Kataishi and Takahashi ........................................... 25
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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
`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) ................................................................ 22
`Bilstad v. Wakalopulos
`386 F.3d 1116 (Fed. Cir. 2004) ..........................................................................1, 3
`
`Campbell Soup Co. v. Gamon Plus, Inc.
`939 F.3d 1335 (Fed. Cir. 2019) ............................................................................ 22
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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) ........................................................................ 22
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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) ....................................................................... 20
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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) .............................................................................. 4
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`Tronzo v. Biomet, Inc.
`156 F.3d 1154 (Fed. Cir. 1998) .............................................................................. 3
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`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 Corrected
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`Contingent Motion to Amend U.S. Patent RE 45,776 with the Second Declaration
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`of Peter T. Keith in Support of Motions to Amend (“Ex-2243”), under 37 C.F.R. §
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`42.121. Teleflex submits that Petitioner has failed to show that any of the
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`substitute claims presented in this motion is unpatentable.
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`II.
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`SUBSTITUTE CLAIMS 58-62 AND 65 ARE SUPPORTED UNDER §
`112
`Petitioner does not challenge claims 63 or 64 as lacking written description.
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`However, it argues that claims 58-62 and 65 lack written description because they
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`recite “a segment defining a partially cylindrical opening” (referred to herein as a
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`“side opening”), arguing that the side opening can only be claimed as “part of the
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`substantially rigid segment.” Opp., 2 (emphasis by Petitioner). Petitioner’s
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`argument fails as a matter of both law and fact. As a legal matter, there is nothing
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`improper about presenting claims that are broader than the preferred embodiments.
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`See Bilstad v. Wakalopulos, 386 F.3d 1116, 1123-25 (Fed. Cir. 2004) (collecting
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`cases); Ethicon Endo-Surgery, Inc. v. United States Surgical Corp., 93 F.3d 1572,
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`1582 n.7 (Fed. Cir. 1996) (if the inventor “did not consider the precise location of
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`the lockout to be an element of his invention, he was free to draft claim 24 broadly
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`. . . to exclude the lockout’s exact location as a limitation of the claimed invention
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`. . . . Such a claim would not be unsupported by the specification even though it
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`1
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`would be literally infringed by undisclosed embodiments.”). This includes
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`reissues: “[T]hat a claim may be broader than the specific embodiment disclosed
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`in a specification is in itself of no moment. Indeed, the statutory provision for
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`broadened claims in reissue applications is intended to meet precisely the situation
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`in which a patentee has claimed ‘less’ than he had a right to claim.” In re
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`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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`2
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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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`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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`3
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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 and chemical arts, not generally considered
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`unpredictable. Ex-2242, 21:13-22:17; Ex-1904, ¶156; 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. The “Summary of the Invention” describes the invention broadly, stating
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`that the rigid portion only “preferably” has a cutout portion constituting a side
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`opening. Ex-1003, 8:17-9:5. Second, Petitioner’s expert agrees that the disclosure
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`shows a perpendicular end opening, and that at least Figures 20-21 show an end
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`opening on the tubular portion, made of polymer. Ex-1919, ¶25; Ex-2242, 41:15-
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`4
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`42:7, id., 29:8-20, 30:23-31:15, 40:7-16.1 Petitioner and its expert agree that
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`claims that do not require a side opening do not have a written description
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`problem. Ex-2242, 44:14-45:17. Petitioner did not dispute that claim 43 presented
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`in the ’380 patent’s motion to amend lacked written description, specifically
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`because it does not claim a side opening. Id., 45:18-46:7, 46:22-47:4; 47:21-48:10;
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`ʼ380 MTA Opp.; Ex-2243, ¶30. Third, while the disclosure shows both end
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`opening and side opening embodiments, nowhere does it state that either is critical
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`to the invention. Ex-2243, ¶30; Ex-2242, 65:19-25, 75:21-24; 79:19-82:1, 82:11-
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`83:11. Simply put, if having the opening be a side opening is not critical to the
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`invention, then the specific location or rigidity of the side opening cannot be
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`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, claims 58-62 and 65
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`already contain limitations relating to rigidity of the side opening segment,
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`specifically requiring it to be more rigid than the tubular structure. Further,
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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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`Petitioner’s argument ignores that the proximal portion of the tubular structure can
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`be more rigid than a side opening in the “substantially rigid” portion, for example
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`where the side opening is made of more flexible Nitinol and/or has relief cuts. Ex-
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`2243, ¶¶38-40. Where the side opening is less rigid than the tube that is just distal
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`to it, it makes little sense to require that the side opening be in “the substantially
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`rigid portion,” because the proximal portion of the tube would be at least as
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`substantially rigid. Clear rigidity-based demarcations would be inconsistent with
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`the understanding of a POSITA, Ex-2243, ¶¶37-38, particularly because the
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`specification expressly teaches that the portion of the substantially rigid portion
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`with a side opening can be 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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`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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`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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`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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`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 65 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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`7
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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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`“slightly larger or slightly smaller” than 0.0131 inches. Ex-2137, 371:25-372:9,
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`367:20-368:20l; Ex-2239, 156:10-24, 155:17-22.
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`IV. PETITIONER’S ARGUMENTS OF UNPATENTABILITY ARE NOT
`PERSUASIVE
`A. Claims 58-60 and 63-65 Are Patentable Over Itou3 in View of
`Ressemann and/or Kataishi
`1.
`Substitute Claims 58-60: Complex Side Opening
`Each of claims 58-60 recites a complex side opening. Claim 58 recites a
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`“partially cylindrical opening” with “a portion having a non-inclined concave
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`track.” Claim 59 recites “two inclined slopes separated by the non-inclined
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`concave track.” Claim 60 recites “the non-inclined region … defines a concave
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`track that is continuous with the lumen of the tubular structure.”
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`Teleflex’s claimed complex side opening is important to the operation of the
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`guide extension catheter for which Teleflex’s invention created a market; that is
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`why Petitioner and every other competitor copied it. IPR2020-00135, POR, 58-65.
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`Yet Petitioner does not point to a single reference that has a complex proximal side
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`opening, let alone such an opening that one uses to receive interventional
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`cardiology devices, let alone while inside a guide catheter deep in the vasculature,
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`3 Itou is not prior art, but Teleflex nevertheless addresses it substantively herein.
`8
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`let alone as part of a guide extension catheter sized to closely fit within the guide
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`catheter. Ressemann expressly taught the difficulty of delivering devices such as
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`stent catheters through a tube’s angled opening: Without a reverse bevel not used
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`in Medtronic’s combinations, “[s]tent delivery catheters … are particularly subject
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`to hanging up on the proximal end of the evacuation head[’s angled opening].”
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`Ex-1008, 25:27-29. Yet the Ressemann collar tab that Petitioner relies on so
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`dearly is buried deep inside Ressemann’s device, such that it has no role in shaping
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`Ressemann’s side opening. Ex-2243, ¶¶58-51. And the shape at the distal end of
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`Kataishi’s suction catheter has no concave track, has a significantly different
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`rigidity profile, and is for a completely different purpose—improving suction by
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`allowing that distal end to flex closer to and about a thrombus. Ex-2243, ¶¶67-81.
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`Petitioner transparently uses Teleflex’s claims as roadmaps to pick and choose
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`elements from disparate prior art, and then uses hindsight to string them together.
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`Itou Plus Ressemann’s Collar
`a.
`Petitioner admits that Itou does not disclose a complex side opening, relying
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`instead on Ressemann’s collar. But Ressemann’s own device does not have a
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`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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`9
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`(Ressemann’s collar’s tab 2141b’s tip) is buried inside shaft 2120 under many
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`layers of material. Id., ¶61. Unless using Teleflex’s claims as a roadmap, a
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`POSITA would not extract this lone component from the complex evacuation
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`sheath assembly (where it neither provides a first inclined slope or a non-inclined
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`concave track, nor performs any guiding function for a stent catheter) and use it as
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`a proximal opening in Itou’s structurally and functionally different suction
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`catheter. Petitioner’s original engineering expert admitted to using a hindsight-
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`focused approach when considering Ressemann, Ex-2137, 132:15-133:11 (“I’m
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`not overly concerned with what the collar was being done before I chose to use it
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`. . . I’m more concerned about how I can use it in combination for what I want to
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`do.”); see also Ex-2116, 239:7-13. While Petitioner actively prevented its new
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`engineering expert from considering how Ressemann actually uses collar 2141,
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`Ex-1807, ¶82 (“I have not been asked” to opine on “how collar 2141 is
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`incorporated into embodiment 2100.”), he nevertheless admits that his “opinions
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`are not based on how Ressemann is using the collar,” Ex-2239, 105:19-24, and that
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`his proposed use of the collar “is different than the way Ressemann, itself,
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`teaches,” id., 105:25-106:5. He also agreed that adding Ressemann’s collar to Itou
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`would require at least six different modifications, further showing the hindsight
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`nature of the combination. Ex-2241, 51:23-53:1, 43:21-52:1; Ex-2243, ¶62.
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`Because a POSITA would not be motivated to select the support collar in the first
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`10
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`place, the question of how the support collar would be incorporated into Itou is
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`moot.
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`Further, Petitioner’s supposed motivations for adding Ressemann’s collar to
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`Itou cannot withstand scrutiny. Petitioner asserts that adding Ressemann’s collar
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`to Itou would “increase[] the area for receiving a stent and/or balloon catheter,”
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`Opp., 16, but replacing Itou’s metal collar with Ressemann’s metal collar, or
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`merely grafting the collar on top, would decrease the cross-sectional area of Itou’s
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`tube opening. Ex-2243, ¶64. To the extent it was desired to increase the area of
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`Itou’s proximal opening, a POSITA simply could make Itou’s angle shallower, Ex-
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`2240, 157:4-5, 163:20-22, rather than extract a buried component from an
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`unrelated device and graft it onto Itou’s design. Ex-2243, ¶65. Petitioner also
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`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. But Petitioner fails to explain how
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`Ressemann’s metal collar would be better than Itou’s metal collar for reinforcing
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`the tube’s opening, or why it would provide a flexibility transition superior to that
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`of Itou’s design. Ex-2243, ¶66. The flexibility transition provided by the collar
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`tab is specifically tailored to Ressemann’s Figure 16 embodiment, which has
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`polymer lumens in the shaft that must maintain their patency. Id. Itou has no such
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`lumens in its shaft, instead having a rigid weld between the metal tubular portion
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`11
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`and metal pushwire. Id. Petitioner’s expert cannot say how the rigidity of Itou’s
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`metal pipe or pipe/wire weld compares to that of Ressemann’s collar. Ex-2240,
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`163:25-164:11. Its final justification—Ressemann’s collar should be used with
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`Itou because both devices relate to “removing coronary vessel occlusions,” Opp.,
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`17—proves too much. And it ignores that Itou and Ressemann are directed to
`
`fundamentally different purposes. Ex-2243, ¶60; see also Ex-2240, 169:21-170:9.
`
`Itou Plus Kataishi’s Distal Tip
`b.
`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
`
`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, ¶144; 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
`
`
`
`12
`
`
`
`and 12 show the guidewire lumen 15 running through the device’s distal tip.
`
`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
`
`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
`
`crossability,” Opp., 19-20, make no sense, because Kataishi’s distal tip crosses
`
`through the vasculature, while a guide extension catheter tube’s proximal end
`
`remains in the guide catheter. Ex-2243, ¶¶74-77. Its alleged motivation of
`
`“improved ability of an opening to accept material,” Opp., 20, ignores that
`
`“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
`
`
`
`13
`
`
`
`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., 20—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 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 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 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
`
`suction catheter to “be rotated, pushed or pulled,” id., 7:20-24. These conflicting
`
`motivations would prevent a POSITA from putting Kataishi’s distal tip on Itou’s
`
`proximal tube opening. Ex-2243, ¶¶76, 81-82.
`
`
`
`14
`
`
`
`2.
`
`Substitute Claim 63
`a.
`“Configured to Receive Stent Catheters”
`Claim 63 recites that the partially cylindrical opening is “configured to
`
`receive stent catheters when positioned within the lumen of the guide catheter.”
`
`Petitioner’s expert argues that “[t]he inner diameter of Itou’s tubular member of
`
`suction catheter (2) was large enough to accommodate inserting a balloon-
`
`expandable stent.” Ex-1904, ¶28. But its expert also admits that the “configured
`
`to” claim element requires more than just that the tubular member have a large
`
`enough lumen, because “‘configured to receive,’ it’s got to be big enough to allow
`
`the stent in, and there can’t be a blockage across the origin of the entrance.” Ex-
`
`2240, 176:25-178:6. Itou has such a blockage—its pushwire obstructs access to its
`
`tubular lumen. Ex-2243, ¶55. Petitioner’s expert also cites an argument from
`
`another of his declarations (Ex-1904, ¶28, citing Ex-1806, ¶¶49-52) that some
`
`stents had outer diameters (bare crossing profiles) less than Itou’s effective 0.046
`
`inch lumen diameter. A stent, however, is a long, bulky, stiff device that requires
`
`space beyond its bare crossing profile to move through a catheter, especially
`
`around bends in vessel anatomy. Ex-2243, ¶56. For that reason, manufacturers of
`
`the cited stents require in their instructions for use a minimum 5 French (0.056
`
`inches) catheter, e.g., Ex-1802, 25 (the “minimal internal diameter of guiding
`
`catheter” for the 0.038 inch profile Tsunami stent is “0.056 inch, 5 Fr”)—far larger
`
`
`
`15
`
`
`
`than Itou’s 0.046 inch proximal opening. Ex-2243, ¶56. Adding Ressemann’s
`
`collar to Itou’s device would only further restrict the size of the proximal opening,
`
`exacerbating Itou’s deficiency. Id. at 64. Indeed, Ressemann acknowledges the
`
`challenges of delivering stents, stating that, without a reverse bevel, “a stent
`
`delivery catheter is particularly subject to hanging up.” Ex-1008 at 25:27-29.
`
`Petitioner does not address this teaching of Ressemann, nor does it provide a
`
`reverse bevel. Its argument should be rejected because it has not established that
`
`its Itou device, whether or not modified by Ressemann, can deliver stent catheters.
`
`Size and “Coaxial” Limitations
`b.
`Claim 63 recites that (1) the tubular structure’s lumen is “configured to be
`
`coaxial with the lumen of the guide catheter,” and (2) “the lumen [of the tubular
`
`structure] ha[s] a uniform cross-sectional inner diameter of at least 0.056 inches”
`
`and is “for use with a standard 6 French guide catheter.” The drawing below, with
`
`dimensions provided by Petitioner’s expert, shows that the lumen of the tubular
`
`structure is fixedly offset from that of the guide catheter, so that it is not coaxial,
`
`and that the diameters do not meet claim 63’s size limitations:
`
`
`
`16
`
`
`
`2.2mm (.087”)
`
`1.5mm
`(.059”)
`
`1.72mm (.068”)
`
`0.45mm (.018”)
`
`
`
`Ex-2228 (dimensions from Ex-2239, 170:12-173:17).
`
`Substitute Claim 64: Complex Side Opening
`3.
`Claim 64 recites a complex side opening. For the reasons set forth above in
`
`Part IV.A.1, Itou in View of Ressemann and/or Kataishi does not render claims
`
`reciting a complex side opening unpatentable.
`
`4.
`
`Substitute Claim 65
`a.
`“Configured … to Receive Stents”
`Claim 65 recites that “the lumen of the tubular structure is configured to …
`
`receive stents.” Itou in View of Ressemann and/or Kataishi does not teach this
`
`limitation. See Part IV.A.2.a.
`
`Size and “Coaxial” Limitations
`b.
`Claim 65 recites that (1) the tubular structure has a lumen size of at least
`
`“0.056 inches” and that it is for use with “a standard 6 French guide catheter” with
`
`a lumen of
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