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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-00126
`Case IPR2020-00127
`Patent 8,048,032
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`PATENT OWNER’S CORRECTED CONTINGENT MOTION TO AMEND
`U.S. PATENT 8,048,032 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
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`PAGE
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`INTRODUCTION ........................................................................................... 1
`I.
`LEGAL STANDARDS FOR AMENDING CLAIMS ................................... 1
`II.
`III. CLAIM LISTING ............................................................................................ 1
`IV. SCOPE OF THE SUBSTITUTE CLAIMS ..................................................... 2
`V. WRITTEN DESCRIPTION SUPPORT .......................................................... 2
`A.
`Substitute Claim 23 ............................................................................... 3
`B.
`Substitute Claim 24 ............................................................................... 5
`C.
`Substitute Claim 25 ............................................................................... 7
`VI. THE LEVEL OF ORDINARY SKILL IN THE ART .................................... 8
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART .................................. 8
`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE ............... 9
`A.
`Substitute Claims 23-25: None of the Prior Art Discloses or Suggests
`the Claimed Combination of Features Including the Recited Complex
`Side Opening ......................................................................................... 9
`Substitute Claims 23 and 25: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a Tubular
`Structure Having a Coaxial 0.056 Lumen Configured For Use With a
`6 French Guide Catheter ..................................................................... 15
`Substitute Claims 24-25: The Prior Art Does Not Disclose or Suggest
`the Claimed Combination of Elements, Including a Coaxial Lumen
`With a Reinforced Portion Having a Uniform, Fixed Outer Diameter
`Where the Reinforced and Substantially Rigid Portions Provide
`Backup Support ................................................................................... 18
`IX. CONCLUSION .............................................................................................. 20
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`B.
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`C.
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`i
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc.,
`291 F.3d 1317, 1322 (Fed. Cir. 2002) .................................................................... 3
`Graham v. John Deere Co.,
`383 U.S. 1, 36 (1966) ............................................................................................ 13
`Indivior Inc. v. Dr. Reddy’s Labs., S.A.,
`930 F.3d 1325, 1347 (Fed. Cir. 2019) .................................................................... 2
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398, 421 (2007) ...................................................................................... 13
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129 (PTAB Feb. 25, 2019) .................................................................. 1
`Memorandum re: Guidance on Motions to Amend in view of Aqua
`Products (Nov. 21, 2017) ....................................................................................... 1
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555, 1566 (Fed. Cir. 1991) .................................................................... 3
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`Statutes
`35 U.S.C. § 102 .......................................................................................................... 9
`35 U.S.C. § 103 .......................................................................................................... 9
`35 U.S.C. § 316(d) ..................................................................................................... 1
`35 U.S.C. § 316(d)(1)(B) ........................................................................................... 2
`35 U.S.C. § 316(d)(3)................................................................................................. 2
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`Other Authorities
`37 C.F.R. § 42.121 ..................................................................................................... 1
`37 C.F.R. § 42.121(a)(2)(i) ........................................................................................ 9
`37 C.F.R. § 42.121(a)(2)(ii) ....................................................................................... 2
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`ii
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`37 C.F.R. § 42.121(a)(3) ............................................................................................ 2
`37 CPR. § 42.121(a)(3) ............................................................................................ 2
`37 C.F.R. § 42.121(b) ............................................................................................1, 2
`37 CPR. § 42.121(b) ............................................................................................ 1, 2
`37 C.F.R. § 42.22(a)(2) .............................................................................................. 1
`37 CPR. § 42.22(a)(2) .............................................................................................. 1
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`iii
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`iii
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`I.
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`INTRODUCTION
`Patent Owner Teleflex submits this Corrected Contingent Motion to Amend
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`U.S. Patent 8,048,032 (“Motion”), with the Declaration of Peter T. Keith in
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`Support of Motions to Amend (“Ex-2124”), under 37 C.F.R. § 42.121. This
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`motion does not seek preliminary guidance. If, after considering Teleflex’s Patent
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`Owner Responses, the Board finds any of issued claims 1, 11, or 16 of the ’032
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`patent invalid, Teleflex respectfully requests that the Board substitute the invalid
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`claim(s) with the respective proposed substitute claim of claims 23-25. See 37
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`C.F.R. § 42.22(a)(2); 35 U.S.C. § 316(d).
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`II. LEGAL STANDARDS FOR AMENDING CLAIMS
`A motion to amend must (1) propose a reasonable number of substitute
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`claims, (2) that respond to a ground of unpatentability involved in the trial, (3) that
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`do not enlarge the scope of the claims or introduce new matter, and (4) are not
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`shown by a preponderance of the evidence to be unpatentable. See Memorandum
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`re: Guidance on Motions to Amend in view of Aqua Products (Nov. 21, 2017) at 2;
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`35 U.S.C. § 316(d); 37 C.F.R. § 42.121. It is Petitioner’s burden to show that the
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`proposed substitute claims are unpatentable. Lectrosonics, Inc. v. Zaxcom, Inc.,
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`IPR2018-01129, Paper 15 at 4 (PTAB Feb. 25, 2019).
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`III. CLAIM LISTING
`Pursuant to 37 C.F.R. § 42.121(b), Appendix A lists the changes made to the
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`issued claims of the ’032 patent that would be replaced under this Motion. This
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`claim listing includes one replacement claim for each of claims 1, 11, and 16. The
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`number of proposed substitute claims is reasonable under 35 U.S.C. § 316(d)(1)(B)
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`and 37 C.F.R. § 42.121(a)(3).
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`IV. SCOPE OF THE SUBSTITUTE CLAIMS
`The proposed substitute claims comply with 35 U.S.C. § 316(d)(3) and 37
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`C.F.R. § 42.121(a)(2)(ii) because no substitute claim enlarges the scope of, or
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`eliminates any element from, the original claim it replaces. All amendments
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`reflected in substitute claims 23-25 are narrowing amendments, in that all
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`amendments only add limitations to the claims without removing language.
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`V. WRITTEN DESCRIPTION SUPPORT
`Substitute claims 23-25 are fully supported by the priority application1
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`because “the disclosure . . . reasonably conveys to those skilled in the art that the
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`inventor had possession of the claimed subject matter as of the filing date.”
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`Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1347 (Fed. Cir. 2019)
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`(citation to quoted case omitted); 37 C.F.R. § 42.121(b); see Ex-2124, ¶¶ 22-27.
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`“Drawings constitute an adequate description if they describe what is claimed and
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`1 The parties have stipulated that all patents at issue in these IPRs have
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`substantively identical disclosures, and have agreed to cite only the priority
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`application, IPR2020-00126, Ex. 1003, cited herein as “Ex. 1003 at XX.”
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`2
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`convey to those of skill in the art that the patentee actually invented what is
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`claimed.” Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc., 291 F.3d
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`1317, 1322 (Fed. Cir. 2002); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1566
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`(Fed. Cir. 1991).
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`A.
`Substitute Claim 23
`The priority application discloses a device for use with a standard 6 French
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`guide catheter that has a continuous lumen extending for a predefined length from
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`a proximal end at a hemostatic valve to a distal end adapted to be placed in a
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`branch artery, Ex. 1003 at 6:15-17; 7:3-10, 12-13; 10:1-19; 11:15-16; 12:13-15;
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`17:3-16; 37, where the continuous lumen of the guide catheter has a circular cross-
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`sectional inner diameter sized such that interventional cardiology devices are
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`insertable into and through the lumen to the branch artery, id. at 6:15-17; 10:3-13;
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`11:15-18; 17:10-12; 18:5-14; 22:3-15.
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`The application discloses that the device comprises, in a distal-to-proximal
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`direction, a flexible tip portion defining a tubular structure, id. at 8:4-16; 12:1-2;
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`14:7-15:2; 32, having a circular cross-section and a length that is shorter than the
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`predefined length of the continuous lumen of the standard 6 French guide catheter
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`and a cross-sectional outer diameter sized to be insertable through the cross-
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`sectional inner diameter of the continuous lumen of the guide catheter, id. at 6:15-
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`17; 7:8-10, 17-18; 8:12-16; 12:1-2, 5-6; 13:7-8; 14:7-9; 14:20-15:2; 32; 34; 41 at
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`3
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`Figure 14, and defining a coaxial lumen having a cross-sectional inner diameter of
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`at least 0.056 inches through which interventional cardiology devices are
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`insertable, id. at 6:15-17; 7:17-18; 10:3-13; 11:16-18; 17:10-12; 18:5-14; 22:3-15.
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`The application discloses that the device includes a substantially rigid side
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`opening that includes a first inclined region, a second inclined region, and a non-
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`inclined concave track between the first and second inclined regions, id. at 8:18-
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`9:3; 12:7-8, 11-12; 15:4-15; 35; 36 at Figure 6; Ex-2124, ¶¶ 45-50, 52. The claim
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`need not expressly recite that the side opening is in the substantially rigid portion.
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`Id. ¶¶ 30-44, 51. Petitioner admits that Figure 4 “discloses a non-inclined region,”
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`IPR2020-00137 Petition at 15, and that the application discloses two inclined
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`slopes: “Figure 4 shows, at best, only two inclined slopes,” which is a “disclosure
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`of only two different inclined slopes,” IPR2020-01344 Petition at 69. The
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`application discloses that the device includes a substantially rigid portion proximal
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`of and operably connected to, and more rigid along a longitudinal axis than, the
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`flexible tip portion, that defines a rail structure without a lumen, Ex. 1003 at 6:15-
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`17; 8:4-5; 8:17-9:5; 12:1-2; 14:7-9; 15:3-7; 16:18-17:2; 19:12-18; 32; 41, with a
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`maximal cross-sectional dimension at a proximal portion that is smaller than the
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`cross-sectional outer diameter of the flexible tip portion, id. at 6:15-17; 12:1-2; 32,
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`and a length that, when combined with the length of the flexible distal tip portion,
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`defines a total length of the device along the longitudinal axis that is longer than
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`4
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`the length of the continuous lumen of the guide catheter, such that when at least a
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`distal portion of the flexible tip portion is extended distally of the distal end of the
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`guide catheter, at least a portion of the proximal portion of the substantially rigid
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`portion extends proximally through the hemostatic valve in common with
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`interventional cardiology devices that are insertable into the guide catheter, id. at
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`7:3-7; 8:5-6; 10:3-9; 11:15-18; 22:3-23:2.
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`B.
`Substitute Claim 24
`The application discloses a device for use with a standard guide catheter that
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`has a continuous lumen extending for a predefined length from a proximal end at a
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`hemostatic valve to a distal end adapted to be placed in a branch artery, id. at 6:15-
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`17; 7:3-10, 12-13; 10:1-19; 11:15-16; 12:13-15; 17:3-16; 37, where the continuous
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`lumen of the guide catheter having a circular cross-section and a cross-sectional
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`inner diameter sized such that interventional cardiology devices are insertable into
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`and through the lumen to the branch artery, id. at 6:15-17; 10:3-13; 11:15-18;
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`17:10-12; 18:5-14; 22:3-15.
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`The application discloses that the device has an elongate structure with an
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`overall length longer than the predefined length of the continuous lumen of the
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`guide catheter, id. at 7:3-7; 8:5-6; 10:3-9; 11:15-16; 22:3-23:2, including a flexible
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`tip portion defining a tubular structure, id. at 8:4-16; 12:1-2; 14:7-15:2; 32, having
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`a circular cross-section that is smaller than the circular cross-section of the
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`5
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`continuous lumen of the guide catheter and a length that is shorter than the
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`predefined length of the continuous lumen of the guide catheter, id. at 6:15-17;
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`8:12-16; 12:1-2, 5-6; 13:7-8; 14:7-9; 14:20-15:2; 32; 34; 41 at Figure 14, the
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`flexible tip portion being sized having a cross-sectional outer diameter sized to be
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`insertable through the cross-sectional inner diameter of the continuous lumen of
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`the guide catheter and defining a coaxial lumen having a cross-sectional inner
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`diameter through which interventional cardiology devices are insertable, id. at
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`6:15-17; 7:5-7, 17-18; 10:3-13; 11:16-18; 12:1-2; 14:20-21; 17:10-12; 18:5-14;
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`22:3-15; 32.
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`The application discloses that the elongate structure comprises a reinforced
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`portion having a uniform, fixed cross-sectional outer diameter proximal to the
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`flexible tip portion, id. at 8:3-16; 12:1-2; 14:7-15:2; 21:11-13; 32, and a
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`substantially rigid portion proximal of and connected to, and more rigid along a
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`longitudinal axis than, the flexible tip portion and defining a rail structure without
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`a lumen, id. at 6:15-17; 8:4-5; 8:17-9:5; 12:1-2; 14:7-9; 15:3-7; 16:18-17:2; 19:12-
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`18; 32; 41, and having a maximal cross-sectional dimension at a proximal portion
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`that is smaller than the cross-sectional outer diameter of the flexible tip portion, id.
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`at 6:15-17; 12:1-2; 32. The application discloses that when at least a distal portion
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`of the flexible tip portion is extended distally of the distal end of the guide catheter
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`with at least proximal portion of the reinforced portion remaining within the
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`6
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`continuous lumen of the guide catheter, at least a portion of the proximal portion of
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`the substantially rigid portion extends proximally through the hemostatic valve in
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`common with interventional cardiology devices that are insertable into the guide
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`catheter. Id. at 7:3-7; 8:5-6; 10:3-9; 11:15-18; 22:3-23:2.
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`The application discloses a side opening positioned between a proximal end
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`of the reinforced portion and a distal end of the substantially rigid portion, id. at
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`8:18-9:3; 12:7-8; 15:4-15; 16:19-17:2; 19:12-18; 35, the side opening having a first
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`inclined sidewall that tapers into a non-inclined concave track that is proximate a
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`second inclined sidewall, id. at 8:18-9:3; 12:7-8, 11-12; 15:4-15; 35; 36 at Figure
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`6; Ex-2124, ¶¶ 30-53. The application discloses that the device is configured so
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`that, when the reinforced portion extends into the branch artery, the reinforced
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`portion and the substantially rigid portion assist in resisting forces exerted by the
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`interventional cardiology devices passed through and beyond the coaxial lumen
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`that would otherwise tend to dislodge the guide catheter from the artery, Ex. 1003
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`at 10:7-11:12; 12:16-20; 18:5-14; 22:16-23:2; 38, 39; Ex-2124, ¶¶ 25-27.
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`C.
`Substitute Claim 25
`The application discloses that the reinforced portion is reinforced with
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`metallic elements in a braided or coiled pattern, Ex., 1003 at 8:12-16; 14:17-15:2;
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`16:8-17:2; 21:9-10, the standard guide catheter is a standard 6 French guide
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`catheter, id. at 7:8-10, 12-13; and each of the flexible tip portion and reinforced
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`7
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`portion has a cross-sectional inner diameter greater than or equal to 0.056 inches
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`through which the interventional cardiology devices are insertable, id. at 6:15-17;
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`7:5-7; 7:17-18; 10:3-13; 11:16-18; 17:10-12; 18:5-14; 22:3-15.
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`VI. THE LEVEL OF ORDINARY SKILL IN THE ART
`In this Motion, Teleflex applies Petitioner’s definition of a POSITA.
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`IPR2020-00126 Petition at 14-15; IPR2020-00127 Petition at 12-13.
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`VII. THE SCOPE AND CONTENT OF THE PRIOR ART
`Before Teleflex’s effective filing date, the prior art described the use of a
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`standard full-length 5 French guide catheter being inserted through a 6 French
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`guide catheter to provide backup support for interventional cardiology devices
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`(Takahashi (Ex. 1010)). It also described embolic protection devices (Ressemann
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`(Ex. 1008); Adams ’280 (Ex. 1035)), suction catheters (Kataishi (Ex. 1025)),
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`balloon catheters (e.g., Enger (Ex. 1050)), and support catheters for fixed-wire
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`devices (Kontos (Ex. 1009); Adams ’292 (Ex. 1034)). No prior art2 known to
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`Teleflex or its expert, Mr. Keith, including that cited by Petitioner in these IPR
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`proceedings, described a rapid exchange guide extension catheter with the features
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`2 Itou (Ex. 1007) also discloses a suction catheter. As explained in Patent Owner’s
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`Consolidated Response Brief on Conception and Reduction to Practice, filed
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`herewith, Itou is not prior art.
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`8
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`recited in the substitute claims. The closest art known to Teleflex and Mr. Keith is
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`listed in this paragraph. Ex-2124, ¶ 19.
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`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE
`As required by 37 C.F.R. § 42.121(a)(2)(i), the amendments reflected in the
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`proposed substitute claims are responsive to the grounds of unpatentability upon
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`which institution was granted. Each of substitute claims 23-25 is novel and
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`nonobvious under 35 U.S.C. §§ 102 and 103, as set forth below. Patentability
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`further is supported by the objective evidence.
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`A.
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`Substitute Claims 23-25: None of the Prior Art Discloses or
`Suggests the Claimed Combination of Features Including the
`Recited Complex Side Opening
`The priority disclosure discloses a guide extension catheter having a
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`substantially rigid proximal pushrod, a distal tubular portion, and a partially
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`cylindrical opening in between that facilitates entry of interventional cardiology
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`devices into the distal tubular portion while the tubular portion is located deep
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`within a surrounding guide catheter. The disclosure discloses side openings that
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`are beyond a single-incline skived opening, and have a complex shape that further
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`improves the ability of interventional cardiology devices (particularly larger
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`devices such as stents) to smoothly enter into the distal tubular portion without
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`hanging up. Ex. 1003 at 8:18-9:3; 12:7-8; 12:11-12; 15:4-15; 35; 36 at Figure 6;
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`41. An example of this is shown in Figure 4:
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`9
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`Complex Side Opening
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`Id. at 35.
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`While the exact language varies by claim, substitute claims 23 and 24-25 all
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`add complex side opening limitations:
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`Claims 23:
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`“a substantially rigid side opening that includes a first inclined
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`region, a second inclined region, and a non-inclined concave track
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`between the first and second inclined regions”; and
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`Claims 24-25: “the side opening having a first inclined sidewall that tapers into a
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`non-inclined concave track that is proximate a second inclined
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`sidewall.”
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`None of the prior art discloses or suggests the claimed combination of
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`features including the complex side opening recited in each of these substitute
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`claims. In response to existing claims of the GuideLiner patents that recite a
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`complex side opening, Petitioner has asserted obviousness arguments using Itou
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`(Ex. 1007), Ressemann (Ex. 1008) or Kontos (Ex. 1009) as the primary reference.
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`Petitioner does not assert that any of these references disclose a device with a
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`complex side opening at the proximal end of a distal tubular section, and with good
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`reason. Itou and Ressemann both disclose devices having a single-incline
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`proximal opening. Kontos does not disclose a side opening at all, much less a
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`“complex” one.
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`Petitioner has relied on Kataishi, Ressemann and Enger to argue that it
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`would have been obvious to modify the primary references to add a complex side
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`opening. Petitioner’s arguments are pure hindsight. Kataishi discloses a suction
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`catheter having a distal opening with a complex shape that, in combination with its
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`flexibility, facilitates the ability of the distal end to conform around a thrombus
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`attached to the side wall of a vessel to suction it out. Ex. 1025 at [0027]-[0028].
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`As the Board preliminarily found in its Institution Decisions, the Petitioner “does
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`not explain sufficiently why the inclined shape of Kataishi’s distal opening would
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`have been applicable to” the proximal opening of Itou or Kontos’s device.
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`IPR2020-0135, Paper 22 at 23; IPR2020-00136, Paper 20 at 29. The Board’s
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`preliminary conclusion was correct.
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`As for Ressemann, it is undisputed that none of the embodiments of
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`Ressemann’s embolic protection device have a proximal opening with a complex
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`profile. Instead, Petitioner focuses on a single component of Ressemann’s
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`assembly—the support collar 2141 shown in Figure 16J. Petitioner asserts that
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`Ressemann’s support collar has a complex side opening having inclined slopes 1
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`and 2:
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`11
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`IPR2020-00135 Petition at 72-73. Petitioner argues that it would have been
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`obvious to incorporate Ressemann’s collar on top of the push wire of the primary
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`references (Itou, Kontos, or Ressemann’s Figure 1 embodiment) in order to create
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`an “on ramp” into the opening of those references. Id. at 74.
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`This analysis is overflowing with hindsight. In Ressemann’s device, what
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`Petitioner calls “incline #1” of the support collar is not an “incline” or an “on-
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`ramp” at all. The entire tab portion 2141b of Ressemann’s collar (including the tip
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`that supposedly defines an on ramp) is buried deep inside Ressemann’s device,
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`underneath at least three other components. Moreover, the purpose of the tab
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`portion has nothing to do with guiding components into an opening; rather, it
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`provides a “flexibility transition” between the proximal end of Ressemann’s
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`evacuation head and the shaft. Ex. 1008 at 24:62-67. And the tiny asserted incline
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`at the end of that tab portion (which Petitioner relies on for “incline #1) serves no
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`purpose whatsoever; it is merely the incidental result of how the tip of the collar is
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`machined. Petitioner’s expert admitted that he did even not try to determine how
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`the tab 2141b of Ressemann’s collar was actually used in Ressemann’s device,
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`explaining that “I’m not overly concerned with what the collar was being done
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`before I chose to use it.” Ex. 2137 at 131:21-133:6. Such testimony shows that
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`Petitioner’s expert did exactly what the law prohibits – he used the knowledge
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`gained from reading Teleflex’s patent disclosure to recreate the invention from
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`pieces in various prior art references. See KSR Int'l Co. v. Teleflex Inc., 550 U.S.
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`398, 421 (2007) (“warning against a temptation to read into the prior art the
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`teachings of the invention in issue and instructing courts to guard against slipping
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`into use of hindsight”) (citing Graham v. John Deere Co., 383 U.S. 1, 36 (1966))
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`(internal quotations omitted).
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`Moreover, Ressemann explicitly states that the function of providing a
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`flexibility transition is provided by placing the tab portion of the collar adjacent the
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`exterior walls of Ressemann’s multi-lumen tube. Ex. 1008 at 24:62-67. In
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`Ressemann’s device, both the evacuation head and the shaft have multiple lumens
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`that must connect together and maintain their patency in order for the device to
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`function properly. Id. at e.g., 6:18-20, 35-65, Figs. 1A, 1B, 6C, 16D, 16E. Placing
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`the tab portion of the collar outside these lumens (i.e., below the inflation lumen
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`and core wire lumen of Ressemann’s shaft) provides a flexibility transition that
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`helps maintain this patency. Yet Petitioner’s obviousness theory is premised on
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`13
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`placing Ressemann’s collar on top of the shaft of the primary references, instead of
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`at the bottom of the shaft as shown in and taught by Ressemann. This is further
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`evidence that Petitioner’s obviousness theory is based on hindsight, not the
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`teaching of the references.
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`Finally, Enger shows a typical example of a rapid exchange balloon catheter,
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`with a distal portion having a guidewire lumen that receives a guidewire to
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`facilitate delivery of the balloon catheter. Petitioner claims that the proximal
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`opening of Enger’s guidewire lumen has a complex shape including two inclined
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`portions. But as Petitioner’s own expert admitted, Enger does not disclose a side
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`opening having two inclined regions. Ex. 2137 at 236:2-21, 237:7-11. What
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`Petitioner pointed to as the alleged second incline is not part of the guidewire
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`opening, but is simply a cross-sectional view of a tubular “necked structure” where
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`a separate part of the distal portion receives a metal tube of the push rod. Id. at
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`236:2-21, 237:7-11, see also id. at 228:10-229:3 (admitting that immediately distal
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`to the opening is a tube with a convex outer surface). And to make matters worse
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`for Petitioner, the proximal opening of Enger’s guidewire lumen is not even an
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`entrance opening; it is an exit opening. All the experts agree that this proximal
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`opening could not and would not be used to receive even a guidewire while the
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`device is positioned within the guide catheter (as required by the claims). Ex. 2116
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`14
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`at 202:24-203:15; Ex. 2137 at 346:12-347:6, see also id. at 90:15-23. Petitioner’s
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`obviousness argument based on Enger borders on specious.
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`B.
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`Substitute Claims 23 and 25: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a
`Tubular Structure Having a Coaxial 0.056 Lumen Configured
`For Use With a 6 French Guide Catheter
`Substitute claims 23 and 25 are directed to a guide extension catheter for use
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`with “a standard 6 French guide catheter” that has a “tubular structure . . . defining
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`a coaxial lumen having a cross-sectional inner diameter of at least 0.056 inches
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`through which interventional cardiology devices are insertable,” as recited in
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`substitute claim 23, or where “each of the flexible tip portion and reinforced
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`portion has a cross-sectional inner diameter greater than or equal to 0.056 inches
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`through which the interventional cardiology devices are insertable” with a “coaxial
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`lumen,” as recited in substitute claim 24, from which substitute claim 25 depends.
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`As discussed in the disclosure, an important feature of the disclosed device is the
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`ability to provide only a one French size difference between the guide catheter and
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`the guide extension catheter. Ex. 1003 at 7:8-18. According to the specification, a
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`one French size difference for a 6 French guide catheter corresponds to an inner
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`diameter of 0.056 inches for the guide extension catheter. Id.
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`None of the prior art discloses or renders obvious the combination of
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`elements recited in substitute claims 23 and 25, including the coaxial and size
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`limitations, in a rapid exchange device. The Itou reference is not prior art. In the
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`15
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`related Petitions, Petitioner has relied on a combination of Ressemann and
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`Takahashi or Kontos and Takahashi to argue for the obviousness of claims
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`containing “not more than one French size” limitations. As for the alleged
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`Ressemann/Takahashi combination, Ressemann is an “embolic protection device”
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`designed to stop blood flow within a cardiac artery. Ex. 1008 at 2:56-61, 6:10-15.
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`To provide this function, Ressemann’s evacuation head includes both balloons on
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`the outer surface of the device, as well as a multi-lumen tube having at least an
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`evacuation lumen and an inflation lumen. Id., e.g., 6:35-65, Figs. 1A, 1B, 11A,
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`11B, 16D, 16E. As the Board already correctly found in denying institution of a
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`related IPR, the presence of multiple lumens means that the evacuation lumen of
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`Ressemann is not configured to be “coaxial” with the lumen of the guide catheter.
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`IPR2020-00133, Paper 20 at 14-15. Moreover, the presence of the balloons and
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`the inflation lumen preclude the ability to make a device that would both fit in a 6
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`French guide catheter and has an 0.056 inch evacuation lumen. And the Board
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`correctly criticized any argument that it would have been obvious to modify
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`Ressemann to remove the balloons and the inflation lumen, noting that “[t]hese
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`modifications would extinguish the capability of the device to act as an aspiration
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`catheter.” IPR2020-00129, Paper 22 at 33. The presence of the balloons also
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`means that Ressemann’s device does not have “a reinforced portion having a
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`
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`16
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`
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`uniform, fixed cross-sectional outer diameter,” as recited in substitute claim 25 (via
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`substitute claim 24, from which substitute claim 25 depends).
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`A similar analysis applies with respect to the alleged Kontos/Takahashi
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`combination. Kontos teaches a distal body structure 12 that has a narrow central
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`tube 16 designed to snugly receive the balloon of a balloon catheter, together with
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`projections at the distal and proximal ends that project outwardly to fill the gap
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`between the outer surface of the tube and the guide catheter:
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`Distal protrusion
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`Proximal protrusion
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`
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`Ex. 1009 at Fig. 1 and 4:48-56. Petitioner has argued that it would have been
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`obvious to replace the funnel at the proximal end of Kontos’s device with an
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`angled opening. E.g., IPR2020-00136, Petition at 68-72. However, even assuming
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`such a modification would have been obvious (which it would not), it still would
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`not be possible to meet for an 0.056 inner diameter that still fits in a 6F guide
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`catheter in light of the other structures that project from the outer surface of
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`Kontos’s tube. Moreover, if modified as proposed by Petitioner to remove the
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`17
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`
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`funnel, it would render Kontos’s support catheter asymmetric at the proximal end,
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`with the axis of its lumen located substantially above the axis of the guide catheter
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`lumen:
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`Thus, Kontos’s device modified as proposed by Petitioner would not have a tubular
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`structure or a flexible tip portion “defining a coaxial lumen,” as recited in
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`substitute claims 23 and 24. It also does not (and would not even if modified as
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`proposed by Petitioner) have “a reinforced portion having a uniform, fixed cross-
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`sectional outer diameter,” as recited in substitute claim 25.
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`C.
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`Substitute Claims 24-25: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a
`Coaxial Lumen With a Reinforced Portion Having a Uniform,
`Fixed Outer Diameter Where the Reinforced and Substantially
`Rigid Portions Provide Backup Support
`Substitute claims 24-25 are directed to a guide extension catheter that has a
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`“coaxial lumen” and “a reinforced portion having a uniform, fixed cross-sectional
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`outer diameter proximal to the flexible tip portion” where “the device is configured
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`so that, when the reinforced portion extends into the branch artery, the reinforced
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`portion and the substantially rigid portion assist in resisting forces exerted by the
`18
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`
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`interventional cardiology devices passed through and beyond the coaxial lumen
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`that would otherwise tend to dislodge the guide catheter from the artery.”
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`Particularly in the context of a rapid exchange device such as that required by
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`claims 24-25,3 this additional requirement for added backup support further
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`distinguishes claims 24-25 over the Kontos reference.
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`The device of Kontos is not designed to resist backout forces, nor would a
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`POSITA expect that Kontos’s device would do so. As discussed above, Kontos’s
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`device has a long, narrow tube 16 in its center portion, with larger-diameter
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`protrusions at its proximal and distal ends. Ex. 1009 at Fig. 1 and 4:48-56. As a
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`result of this design, when the distal end of Kontos’s device is extended out the end
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`of the guide c