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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 IPR2020-01341
`Case IPR2020-01342
`Patent 8,142,413
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`PATENT OWNER’S REQUEST FOR PRELIMINARY GUIDANCE
`ON CONTINGENT MOTION TO AMEND
`U.S. PATENT 8,142,413 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1
`I.
`REQUEST FOR PRELIMINARY GUIDANCE ........................................... 1
`II.
`III. LEGAL STANDARDS FOR AMENDING CLAIMS ................................... 1
`IV. CLAIM LISTING ............................................................................................ 2
`SCOPE OF THE SUBSTITUTE CLAIMS ..................................................... 2
`V.
`VI. WRITTEN DESCRIPTION SUPPORT .......................................................... 2
`Substitute Claim 15 ............................................................................... 3
`A.
`B.
`Substitute Claim 16 ............................................................................... 6
`C.
`Substitute Claim 17 ............................................................................... 6
`VII. THE LEVEL OF ORDINARY SKILL IN THE ART .................................... 7
`VIII. THE SCOPE AND CONTENT OF THE PRIOR ART .................................. 7
`IX. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE ............... 7
`Substitute Claims 15-17: The Prior Art Does Not Disclose or Suggest
`A.
`the Claimed Method of Providing Backup Support With a Coaxial
`Guide Catheter With a Lumen of 0.056 Inches Configured For Use
`With a 6 French Guide Catheter or About One French Smaller Than
`the Guide Catheter ................................................................................. 8
`Substitute Claim 17: None of the Prior Art Discloses or Suggest the
`Claimed Use of a Complex Side Opening .......................................... 10
`Substitute Claims15-17: Itou Fails to Disclose or Make Obvious
`Inserting a Treatment Catheter that Includes a Stent, Let Alone After
`Insertion of a Coaxial Guide Catheter ................................................. 15
`Substitute Claims 15-17: Objective, Real-World Evidence Supports
`Patentability ......................................................................................... 18
`Long-Felt Need ......................................................................... 19
`1.
`2.
`Commercial Success ................................................................. 19
`3.
`Industry Praise ........................................................................... 20
`4.
`Licensing ................................................................................... 21
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`B.
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`C.
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`D.
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`5.
`6.
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`Copying ..................................................................................... 22
`There is Nexus Between the Invention of Claims 15 and 17 and
`the Objective Evidence of Nonobviousness ............................. 23
`X. CONCLUSION .............................................................................................. 25
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`ii
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`TABLE OF AUTHORITIES
`
`
`Cases
`
`Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc.,
`291 F.3d 1317, 1322 (Fed. Cir. 2002) ....................................................................... 3
`Fox Factory, Inc. v. SRAM, LLC,
` 944 F.3d 1366 (Fed. Cir. 2019) ............................................................................... 23
`Graham v. John Deere Co.,
`383 U.S. 1, 36 (1966) ............................................................................................... 14
`Indivior Inc. v. Dr. Reddy’s Labs., S.A.,
`930 F.3d 1325, 1347 (Fed. Cir. 2019) ....................................................................... 3
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ......................................................................... 20, 21
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398, 421 (2007) ......................................................................................... 14
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 15 (PTAB Feb. 25, 2019) ..................................................... 2
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ................................................................................ 18
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555, 1566 (Fed. Cir. 1991) ....................................................................... 3
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ......................................................................... 19, 22
`Statutes
`35 U.S.C. § 102 .......................................................................................................... 8
`35 U.S.C. § 103 .......................................................................................................... 8
`35 U.S.C. § 316(d) ..................................................................................................... 1
`35 U.S.C. § 316(d)(1)(B) ........................................................................................... 2
`35 U.S.C. § 316(d)(3)................................................................................................. 2
`Other Authorities
`37 C.F.R. § 42.121 ..................................................................................................... 1
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`iii
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`37 C.F.R. § 42.121(a)(2)(i) ........................................................................................ 7
`37 CPR. § 42.121(a)(2)(i) ........................................................................................ 7
`37 C.F.R. § 42.121(a)(2)(ii) ....................................................................................... 2
`37 CPR. § 42.121(a)(2)(ii) ....................................................................................... 2
`37 C.F.R. § 42.121(a)(3) ............................................................................................ 2
`37 CPR. § 42.121(a)(3) ............................................................................................ 2
`37 C.F.R. § 42.121(b) ............................................................................................2, 3
`37 CPR. § 42.121(b) ............................................................................................ 2, 3
`37 C.F.R. § 42.22(a)(2) .............................................................................................. 1
`37 CPR. § 42.22(a)(2) .............................................................................................. 1
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`iv
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`iV
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`I.
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`INTRODUCTION
`Patent Owner Teleflex submits this Contingent Motion to Amend U.S.
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`Patent 8,142,413 (“Motion”), with the Declaration of Peter T. Keith in Support of
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`Motion to Amend (“Ex-2250”), under 37 C.F.R. § 42.121. If, after considering
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`Teleflex’s Patent Owner Responses, the Board finds any of issued claims 1, 7, or 8
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`of the ’413 patent invalid, Teleflex respectfully requests that the Board substitute
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`the invalid claim(s) with the respective proposed substitute claim of claims 15-17.
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`See 37 C.F.R. § 42.22(a)(2); 35 U.S.C. § 316(d).
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`II. REQUEST FOR PRELIMINARY GUIDANCE
`Pursuant to the Board’s Notice Regarding a New Pilot Program Concerning
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`Motion to Amend Practice and Procedures in Trial Proceedings Under the America
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`Invents Act Before the Patent Trial and Appeal Board, 84 Fed. Reg. 9,497 (March
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`15, 2019), Teleflex requests preliminary guidance from the Board on its Motion.
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`III. 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), 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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`1
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`proposed substitute claims are unpatentable. Lectrosonics, Inc. v. Zaxcom, Inc.,
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`IPR2018-01129, Paper 15, 4 (PTAB Feb. 25, 2019).
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`IV. 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 ’413 patent that would be replaced under this Motion. This
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`claim listing includes one replacement claim for each of claims 1, 7, and 8. 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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`V. 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 15-17 are narrowing amendments, in that all
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`amendments only add limitations to the claims, or merely clarifying amendments.
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`VI. WRITTEN DESCRIPTION SUPPORT
`Substitute claims 15-17 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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`1 All citations in this motion to the application for the ’413 patent are to IPR2020-
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`01341, Ex-1003. These citations are in the form, e.g., “Ex-1003, XX,” where XX
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`is the page of Exhibit 1003 rather than the page of the application.
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`2
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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-2250, ¶¶27-40.
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`“Drawings constitute an adequate description if they describe what is claimed and
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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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`Substitute Claim 15
`A.
`The priority application discloses a method of providing backup support for
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`a treatment catheter that includes a stent for use in the coronary vasculature and is
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`adapted to be passed through a standard guide catheter. Ex-1003, 25:5-7, 28:1-
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`29:12, 30:13-20, 34:20-36:10, 39:19-40:18, 55-57.
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`The standard guide catheter has a continuous lumen that extends for a
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`predefined length from a proximal end at a hemostatic valve to a distal end adapted
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`to be placed in an ostium of a branch artery that branches off from a first artery,
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`where the continuous lumen of the standard guide catheter has a circular cross-
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`sectional inner diameter sized such that the treatment catheter that includes a stent
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`is insertable into and through the continuous lumen. Id., 21:26-22:2, 25:3-18,
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`28:1-19, 29:15-16, 30:13-15, 34:20-35:12, 55.
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`3
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`The priority application discloses that the method includes a series of
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`sequential steps that includes inserting the standard guide catheter into the first
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`artery over a guidewire, positioning the distal end of the standard guide catheter in
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`the ostium of the branch artery, id., 21:25-22:2, 27:17-28:6, 28:14-19, 30:13-15,
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`34:20-35:8, 39:19-40:10, 55, and then inserting a coaxial guide catheter’s
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`cylindrical flexible tip portion into the continuous lumen of the standard guide
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`catheter, id., 24:14-16, 26:3-16, 27:17-28:6, 30:1-2, 5-6, 9-10, 16-18, 32:4-20,
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`35:13-20, 40:1-8, 50, 52, 54, 56, where the flexible tip portion defines a tubular
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`structure having a circular cross-section with a single lumen that is coaxial with the
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`lumen of the guide catheter and has an inner diameter not more than about one
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`French smaller than the inner diameter of the standard guide catheter, a cross-
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`sectional outer diameter, and a length that is shorter than the predefined length of
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`the continuous lumen of the standard guide catheter, id., 25:8-18, 26:5-16, 30:1-2,
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`5-6, 31:6, 32:2-20, 50, 52, 59 at Figure 14.
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`The priority application discloses then inserting a substantially rigid portion
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`of the coaxial guide catheter into the continuous lumen of the standard guide
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`catheter, id., 30:1-2, 33:1-3, 39:19-40:10, 50, where the substantially rigid portion
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`is proximal of, operably connected to, and more rigid along a longitudinal axis than
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`the flexible tip portion, defines a rail structure without a lumen, and has a maximal
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`cross-sectional dimension at a proximal portion that is smaller than the cross-
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`4
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`sectional outer diameter of the flexible tip portion and a length that, when
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`combined with the length of the flexible distal tip portion, defines a total length of
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`the coaxial guide catheter along the longitudinal axis that is longer than the length
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`of the continuous lumen of the standard guide catheter, where a distal portion of
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`the substantially rigid portion includes a side opening that is sized and configured
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`to receive the treatment catheter that includes a stent, id., 24:14-16, 25:3-7, 26:3-6,
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`26:17-27:5, 28:3-19, 29:15-18, 30:1-2, 7-8, 13-15, 31:4-8, 32:4-5, 34:4-19, 37:7-
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`13, 39:19-40:18, 50, 53, 55, 59.
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`The priority application discloses then advancing a distal portion of the
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`flexible tip portion distally beyond the distal end of the standard guide catheter and
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`into the branch artery such that the distal portion of the flexible tip portion extends
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`into the branch artery and such that at least a portion of the proximal portion of the
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`substantially rigid portion extends proximally through the hemostatic valve, and
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`inserting the treatment catheter that includes a stent into and through the
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`continuous lumen of the standard guide catheter alongside the rail structure of the
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`substantially rigid portion and advancing the treatment catheter that includes a
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`stent through the side opening and beyond the single lumen of the flexible tip
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`portion into contact with or past a lesion in the branch artery, id., 24:14-16, 25:3-7,
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`28:7-13, 29:16-18, 30:16-20, 36:1-10, 39:19-40:10, 56, 57. See also Ex-2250,
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`¶¶29-34.
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`5
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`Substitute Claim 16
`B.
`The priority application discloses that, when a distal portion of the tubular
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`structure is extended beyond the distal end of the standard guide catheter while a
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`proximal portion of the tubular structure remains within the lumen of the standard
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`guide catheter, the coaxial guide catheter assists in resisting axial and shear forces
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`exerted by the treatment catheter that includes a stent when passed through and
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`beyond the coaxial lumen that would otherwise tend to dislodge the standard guide
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`catheter from the branch artery. Ex-1003, 28:1-29:12, 30:13-20, 15:4-36:10,
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`40:11-18, 55-57.
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`The priority application further discloses that the guide catheter can be a
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`standard 6 French guide catheter and that the inner diameter of the tubular structure
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`is at least 0.056 inches. Id., 25:8-18; see also Ex-2250, ¶¶35-37.
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`Substitute Claim 17
`C.
`The priority application further discloses extending the treatment catheter
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`that includes a stent through a side opening that includes two inclined sidewalls
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`spaced apart by a non-inclined concave track, Ex-1003, 26:18-27:5, 30:7-8, 11-12,
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`31:4-8, 33:1-14, 34:15-19, 37:7-13, 53, 54, 59, and extending the treatment
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`catheter that includes a stent past a radiopaque marker proximate a distal tip of the
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`coaxial guide catheter, id., 25:19-26:2, 26:7-11, 32:7-13. See also Ex-2250, ¶¶38-
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`40.
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`VII. THE LEVEL OF ORDINARY SKILL IN THE ART
`In this Motion, Teleflex applies Petitioner’s definition of a POSITA.
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`IPR2020-01341 Petition at 11-12; IPR2020-01342 Petition at 11-12.
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`VIII. 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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`recited in the substitute claims. The closest art known to Teleflex and Mr. Keith is
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`listed in this paragraph. Ex-2250, ¶18.
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`IX. 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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`2 Itou (Ex-1007) also discloses a suction catheter. As explained in Section VI of
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`Patent Owner’s Response in IPR2020-01341 (filed concurrently herewith), Itou is
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`not prior art.
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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 15-17 is novel and
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`nonobvious under 35 U.S.C. §§ 102 and 103. Patentability further is supported by
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`objective evidence.
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`A.
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`Substitute Claims 15-17: The Prior Art Does Not Disclose or
`Suggest the Claimed Method of Providing Backup Support With
`a Coaxial Guide Catheter With a Lumen of 0.056 Inches
`Configured For Use With a 6 French Guide Catheter or About
`One French Smaller Than the Guide Catheter
`Substitute claim 15 is directed to a “method of providing backup support for
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`a treatment catheter that includes a stent” where the coaxial guide catheter’s
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`“cylindrical flexible tip portion [has] an inner diameter not more than about one
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`French smaller than the inner diameter of the standard guide catheter.” Substitute
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`claim 16 depends from claim 15, further reciting that “the standard guide catheter
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`is a standard 6 French guide catheter” and “the inner diameter of the tubular
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`structure is at least 0.056 inches.” Substitute claim 17 depends from claim 16.
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`As discussed in the disclosure, an important feature of the disclosed device
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`is the ability to provide an about one French difference between the guide catheter
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`and the guide extension catheter. Ex-1003, 25:8-18. Further, according to the
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`specification, an about one French difference for a 6 French guide catheter includes
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`an inner diameter of 0.056 inches for the guide extension catheter. Id.
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`8
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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 15-17, particularly the size limitations, in a
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`rapid exchange device. Itou is not prior art. In its various Petitions, Petitioner
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`relies on combinations of Ressemann and Takahashi or Kontos, Adams, and
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`Takahashi to argue for the obviousness of claims containing “not more than one
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`French” difference limitations. As for the alleged Ressemann/Takahashi
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`combination, Ressemann is an “embolic protection device” designed to stop blood
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`flow within a cardiac artery. Ex-1008, 2:56-61, 6:10-15. To provide this function,
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`Ressemann’s evacuation head includes both balloons on the outer surface of the
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`device, as well as a multi-lumen tube having at least an evacuation lumen and an
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`inflation lumen. Id., e.g., 6:35-65, Figs. 1A, 1B, 11A, 11B, 16D, 16E. The
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`presence of the balloons and the inflation lumen preclude the ability to make a
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`device that would both fit in a 6 French guide catheter and have an 0.056 inch
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`evacuation lumen, or one that is “about one French” smaller than the guide
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`catheter’s lumen. And the Board correctly criticized any argument that it would
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`have been obvious to modify Ressemann to remove the balloons and the inflation
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`lumen, noting that “[t]hese modifications would extinguish the capability of the
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`device to act as an aspiration catheter.” IPR2020-00129, Paper 22 at 33.
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`A similar analysis applies with respect to the alleged Kontos/Takahashi with
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`Adams combination. Kontos teaches a distal body structure 12 that has a narrow
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`central tube 16 designed to snugly receive the balloon of a balloon catheter,
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`together with projections at the distal and proximal ends that project outwardly to
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`fill the gap 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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`Ex-1009, Fig. 1, 4:48-56. Petitioner has argued that it would have been obvious to
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`replace the funnel at the proximal end of Kontos’s device with an angled opening.
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`E.g., IPR2020-00136, Petition, 68-72. Even assuming such a modification would
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`have been obvious (which it would not have been), it still would not be possible to
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`meet the limitation requiring an 0.056 inner diameter that fits in a 6F guide
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`catheter, or an “about one French” smaller tube, in light of the other structures that
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`project from Kontos’s tube’s outer surface.
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`B.
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`Substitute Claim 17: None of the Prior Art Discloses or Suggests
`the Claimed Use of a Complex Side Opening
`Claim 17 recites that “advancing the treatment catheter that includes a stent
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`through the side opening includes advancing the treatment catheter that includes a
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`stent past two inclined sidewalls spaced apart by a non-inclined concave track.”
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`10
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`The priority disclosure discloses forming 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 a treatment catheter that
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`includes a stent into the distal tubular portion while the tubular portion is located
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`deep within a surrounding guide catheter. The disclosure discloses side openings
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`that are beyond a single-incline skived opening, and have a complex shape that
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`further 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, 26:18-27:5, 30:7-8, 11-12, 33:1-44, 53, 54 at Figure 6, 59.
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`An example of this is shown in Figure 4:
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`Complex Side Opening
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`
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`Id. at 53.
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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 claim 17. In related
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`Petitions, in response to existing claims of the GuideLiner patents that recite a
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`complex side opening, Petitioner asserts obviousness arguments using Itou (Ex-
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`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 discloses a device with a
`11
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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 (Ex-1050) to argue
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`that it would have been obvious to modify the primary references to add a complex
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`side opening. Petitioner’s arguments are pure hindsight. Kataishi discloses a
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`suction catheter having a distal opening with a complex shape that, in combination
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`with its flexibility, facilitates the ability of the distal end to conform around a
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`thrombus attached to the side wall of a vessel to suction it out. Ex-1025, [0027]-
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`[0028]. As the Board preliminarily found in its Institution Decisions in related
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`IPRs, the Petitioner “does not explain sufficiently why the inclined shape of
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`Kataishi’s distal opening would have been applicable to” the proximal opening of
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`Itou or Kontos’s device. IPR2020-0135, Paper 22, 23; IPR2020-00136, Paper 20,
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`29. The Board’s 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 has 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 with two inclined slopes.
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`12
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`See, e.g., IPR2020-00135 Petition, 72-73. Petitioner argues that it would have
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`been obvious to incorporate Ressemann’s collar on top of the pushwire of the
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`primary references (Itou, Kontos, or Ressemann’s Figure 1 embodiment) to create
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`an “on ramp” into the opening of those references. Id., 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, 24:62-67. And the tiny asserted incline at
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`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 not even 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, 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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`13
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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, 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 for the device to function
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`properly. Id., 6:18-20, 35-65, Figs. 1A, 1B, 6C, 16D, 16E. Placing the tab portion
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`of the collar outside these lumens (i.e., below the inflation lumen and core wire
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`lumen of Ressemann’s shaft) provides a flexibility transition that helps maintain
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`this patency. Yet Petitioner’s obviousness theory is premised on placing
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`Ressemann’s collar on top of the shaft of the primary references, instead of at the
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`bottom of the shaft as shown in and taught by Ressemann. This is further evidence
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`that Petitioner’s obviousness theory is based on hindsight, not the teaching of the
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`references.
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`Finally, Enger shows a typical rapid exchange balloon catheter, with a distal
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`portion having a guidewire lumen that receives a guidewire to facilitate the balloon
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`catheter’s delivery. Petitioner claims that the proximal opening of Enger’s
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`guidewire lumen includes two inclined portions. IPR2020-00137, Petition, 84-86;
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`IPR2020-00138, Petition, 82-83. But Petitioner’s own expert admits that Enger
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`does not disclose a side opening having two inclined regions. Ex-2137, 236:2-21,
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`237:7-11. What Petitioner pointed to as the alleged second incline is not part of
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`the guidewire opening, but is simply a cross-sectional view of a tubular “necked
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`structure” where a separate part of the distal portion receives a metal tube of the
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`pushrod. Id., 236:2-21, 237:7-11, see also id., 228:10-229:3 (admitting that
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`immediately distal to the opening is a tube with a convex outer surface). To make
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`matters worse for Petitioner, the proximal opening of Enger’s guidewire lumen is
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`not even an entrance opening; it is an exit opening. All the experts agree that this
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`proximal opening would not and could not be used to receive even a guidewire
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`while the device is positioned within the guide catheter (as required by the claims).
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`Ex-2116, 202:24-203:15; Ex-2137, 346:12-347:6, see also id., 90:15-23.
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`C.
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`Substitute Claims 15-17: Itou Fails to Disclose or Make Obvious
`Inserting a Treatment Catheter that Includes a Stent, Let Alone
`After Insertion of a Coaxial Guide Catheter
`Substitute claim 15 claims a series of steps performed “in the order recited,”
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`including, after inserting a “coaxial guide catheter,” “inserting the treatment
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`catheter that includes a stent into and through the continuous lumen of the standard
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`guide catheter alongside the rail structure of the substantially rigid portion.” Even
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`
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`15
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`

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`assuming Itou is prior art, it does not meet these elements, nor does it make them
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`obvious. Petitioner’s experts agree that Itou is a suction catheter, and that it does
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`not disclose inserting a stent. Ex-2244, 68:21-69:14; Ex-2245, 98:8-99:13. Itou
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`does disclose using a protective catheter inside the suction catheter, but Petitioner
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`admits that Itou only teaches preassembling the suction catheter and protective
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`catheter outside the body, and afterwards inserting the combination into the guide
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`catheter. Petition, 72; see, e.g., Ex-1001, 7:13-15; Ex-2244, 74:18-22; Ex-2245,
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`100:23-25. In other words, Itou’s suction catheter is only “configured to receive”
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`the protective catheter, as Petitioner argues, outside the body.
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`Fundamentally, Petitioner does not establish why a POSITA would have
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`been motivated to insert a stent catheter into Itou’s suction catheter. All primary
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`cardiology experts in this case have each confirmed that they have never actually
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`used a suction catheter to deliver a device like a stent or balloon. Ex-2116, 94:16-
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`95:1, 98:12-14; Ex-2245, 57:8-15; Ex-1813, 125:25-126:1. This makes sense,
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`because using a suction catheter to deliver a stent could be dangerous. Ex-2138,
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`¶185; Ex-2145, ¶¶132-34; Ex-2240, 12:12-17; 16:8-17:22, 18:10-24. There is no
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`reason a POSITA would look to use Itou’s device, meant for an entirely different
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`purpose, and with a structure requiring insertion of its own protective catheter
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`outside the body, to deliver a stent catheter after the suction device is already
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`
`
`16
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`positioned inside the guide catheter in the body. Ex-2138, ¶¶170-72; Ex-2145,
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`¶¶115-29, 132-34.
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`Moreover, even if a POSITA were for some reason motivated to try inserting
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`Itou’s suction catheter and then a stent catheter into the guide catheter, this would
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`not be possible given the relative dimensions of Itou’s pushwire and tubular
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`portion. Ex-2138, ¶¶170-87; Ex-2145, ¶¶130-31. The diameter of Itou’s pushwire
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`is much greater than the wall thickness of the tubular portion. Ex-1007, 7:55-62;
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`Ex-2138, ¶173. As a result, the pushwire partially blocks Itou’s opening, reducing
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`its effective size to around 0.046 inches. Ex-2138, ¶174. When assembled outside
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`of the body, as actually taught by Itou, a POSITA can see and manipulate the
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`protective catheter into the coaxial guide catheter, but inside the guide catheter, a
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`stent catheter would have to attempt to enter the lumen of the coaxial guide
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`catheter axially, which would be restricted by the smaller effective opening due to
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`the pushwire. Ex-2138, ¶175; Ex-2145, ¶128. Petitioner does not advocate any
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`modification of Itou’s raised pushwire design, nor would there be any reason to do
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`so.
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`Even assuming Itou is prior art, it does not teach or make obvious an attempt
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`to advance a treatment catheter that includes a stent through Itou’s suction catheter.
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`
`
`17
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`D.
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`Substitute Claims 15-17: Objective, Real-World Evidence
`Supports Patentability
`Objective evidence of non-obviousness “may often be the most probative
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`and cogent evidence in the record.” Transocean Offshore Deepwater Drilling, Inc.
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`v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). That is
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`particularly true here, where GuideLiner guide