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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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`
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`Case IPR2020-00132
`Case IPR2020-00134
`Patent RE 45,760
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`PATENT OWNER’S CONTINGENT MOTION TO AMEND
`U.S. PATENT RE 45,760 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
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`PAGE
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`B. 
`
`C. 
`
`
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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 .......................................................... 4 
`A. 
`Substitute Claim 54 ............................................................................... 4 
`B. 
`Substitute Claim 55 ............................................................................... 7 
`C. 
`Substitute Claim 56 ............................................................................... 7 
`D. 
`Substitute Claim 57 ............................................................................... 8 
`E. 
`Substitute Claim 58 ............................................................................. 11 
`VI.  THE LEVEL OF ORDINARY SKILL IN THE ART .................................. 14 
`VII.  THE SCOPE AND CONTENT OF THE PRIOR ART ................................ 14 
`VIII.  THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE ............. 15 
`A. 
`Substitute Claims 56, 57, and 58: None of the Prior Art Discloses or
`Suggests the Claimed Combination of Features Including the Recited
`Complex Side Opening ....................................................................... 15 
`Substitute Claim 58: The Prior Art Does Not Disclose or Suggest the
`Claimed Combination of Elements, Including a Tubular Structure
`Having a Uniform, Fixed Outer Diameter and a Coaxial 0.056 Lumen
`Configured For Use With a 6 French Guide Catheter ........................ 21 
`Substitute Claim 54, 55, 56, and 58: Itou Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a Coaxial
`Tube Configured For Use With Stent Catheters ................................. 24 
`IX.  CONCLUSION .............................................................................................. 25
`i
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`
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`TABLE OF AUTHORITIES
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`Page(s)
`
`Cases
`Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .............................................................................. 4
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .................................................................................................. 19
`Indivior Inc. v. Dr. Reddy’s Labs., S.A.,
`930 F.3d 1325 (Fed. Cir. 2019) .............................................................................. 4
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................................. 19
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 15 (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 (Fed. Cir. 1991) .............................................................................. 4
`Statutes
`35 U.S.C. § 102 ........................................................................................................ 15
`35 U.S.C. § 103 ........................................................................................................ 15
`35 U.S.C. § 316 ......................................................................................................1, 2
`Other Authorities
`37 C.F.R. § 42.121 ...................................................................................... 1, 2, 4, 15
`37 C.F.R. § 42.22 ....................................................................................................... 1
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`ii
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`
`
`I.
`
`INTRODUCTION
`Patent Owner Teleflex submits this Contingent Motion to Amend U.S.
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`Patent RE 45,760 (“Motion”), with the Declaration of Peter T. Keith in Support of
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`Motions to Amend (“Ex-2124”), under 37 C.F.R. § 42.121. This motion does not
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`seek preliminary guidance. If, after considering Teleflex’s Patent Owner
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`Responses, the Board finds any of issued claims 37, 38, 39, 48, or 51 of the ’760
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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 54-58. See 37
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`C.F.R. § 42.22(a)(2); 35 U.S.C. § 316(d).
`
`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).
`
`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 ’760 patent that would be replaced under this Motion. This
`1
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`claim listing includes one replacement claim for each of claims 37, 38, 39, 48, and
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`51. The number of proposed substitute claims is reasonable under 35 U.S.C. §
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`316(d)(1)(B) 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 54-58 are narrowing amendments.
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`The amendment to substitute claim 58 that recites that “the tubular structure
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`. . . [has] a[n] inner diameter that is greater than or equal to 0.056 inches so as to
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`be not more than one French size smaller than the . . . inner diameter of the . . .
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`standard 6 French guide catheter” is narrowing because the original claim recited a
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`“one French size” difference, while the amendment recites only a 6 French guide
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`catheter with at least an 0.070 inch inner diameter used with a tubular structure
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`having an inner diameter “greater than or equal to 0.056 inches.” This 0.014 inch
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`one French size difference is supported by the disclosure in the priority application
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`2 
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`of “a 5 French in 6 French coaxial guide catheter” system. Ex. 1003 at 7:8-18.1
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`Teleflex expects that Petitioner may advance a construction of the “one French size
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`smaller” language in substitute claim 58 to contend that the amendment is
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`broadening or otherwise improper, arguing that the mathematical definition of a
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`one French dimension as 0.0131 inches applies to the “one French size” element.
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`To the extent “one French size” requires construction, in the context of a 5 French
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`coaxial guide catheter in a 6 French guide catheter as recited in the claim the
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`application indicates that an 0.014 inch difference is one French size smaller, even
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`though it is larger than precisely 0.0131 inches: “A 6 French guide catheter has an
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`internal diameter greater than or equal to 0.070 inches. . . . For a 5 French in 6
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`French coaxial guide catheter the internal diameter should be greater than or equal
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`to 0.056 inches.” Id. at 7:12-18. This is not surprising considering that, as
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`Petitioner’s expert concedes, a one French size difference, e.g., a 5 in 6 French,
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`could be “slightly larger or slightly smaller” than 0.0131 inches. Ex. 2137 at
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`372:6-9; see id. at 367:5-9. Because French size values conventionally are applied
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`to outer rather than inner diameters, a POSITA would understand that a one French
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` 
`1 The parties have stipulated that all patents at issue in these IPRs have
`
`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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`3 
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`size difference would not necessarily be exactly 0.0131 inches when viewed from
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`the perspective of the differential in inner catheter diameters. See Ex-2124, ¶¶ 57,
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`58. The amendment thus is not broadening.
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`All other amendments either add limitations to the claims without removing
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`language, or update the dependencies of certain dependent claims to depend from
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`an intervening dependent claim instead of the independent claim.
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`V. WRITTEN DESCRIPTION SUPPORT
`Substitute claims 54-58 are fully supported by the priority application
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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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`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).
`
`A.
`Substitute Claim 54
`Substitute claim 54 depends from issued independent claim 25, which the
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`priority application discloses is directed to a system comprising a guide catheter
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`4 
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`and a guide extension catheter. Ex. 1003 at 8:3-6; 12:1-2, 5-6, 16-20; 14:7-9; 32;
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`34; 38; 39, where the guide catheter is configured to be advanceable through a
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`main blood vessel to a position adjacent an ostium of a coronary artery, id. at 10:1-
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`11:4; 12:13-20; 17:3-12; 22:3-23:2; 37-39, and has a lumen extending from a
`
`hemostatic valve at a proximal end of the guide catheter to a distal end of the guide
`
`catheter that is adapted to be positioned adjacent the ostium of the coronary artery,
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`id. at 7:3-5; 10:1-19; 11:15-16; 12:13-15; 17:3-16; 37. The application discloses
`
`that the guide extension catheter is configured to be partially advanceable through
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`the guide catheter and into the coronary artery, id. at 6:15-17; 7:5-7; 10:1-13;
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`12:16-20; 17:17-18:14; 22:6-9; 38; 39, and has a length such that a distal end of the
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`guide extension catheter is extendable through the lumen and beyond the distal end
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`of the guide catheter while and a proximal end of the guide extension catheter is
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`extendable through the hemostatic valve at the proximal end of the guide catheter,
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`id. at 7:3-7; 8:5-6; 10:3-9; 11:15-16; 22:3-23:2. The application discloses that the
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`guide extension catheter includes, in a proximal to distal direction, a substantially
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`rigid segment, id. at 6:15-17; 8:4-5; 8:17-9:5; 12:1-2; 13:7-8; 14:7-9; 15:3-5;
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`16:18-17:2; 19:12-18; 32; 41, a segment defining a side opening, id. at 8:18-9:3;
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`12:7-8; 13:4-12; 15:4-15; 16:19-17:2; 19:12-18; 35; 41, and a tubular structure
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`defining a lumen coaxial and in fluid communication with the lumen of the guide
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`catheter, the lumen of the tubular structure having a length that is shorter than the
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`5 
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`length of the lumen of the guide catheter, id. at 6:15-17; 8:12-16; 12:1-2, 5-6; 13:7-
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`8; 14:7-9; 14:20-15:2; 15:8-9; 32; 34; 41 at Figure 14, and having a uniform cross-
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`sectional inner diameter that is not more than one French size smaller than the
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`cross-sectional inner diameter of the lumen of the guide catheter, id. at 7:8-18, the
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`side opening extending for a distance along a longitudinal axis of the segment
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`defining the side opening and accessible from a longitudinal side defined
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`transverse to the longitudinal axis, id. at 8:18-9:3; 12:7-8; 13:4-12; 15:4-15; 16:19-
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`17:2; 19:12-18; 35; 41. The claim need not expressly recite that the side opening
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`segment is in the substantially rigid segment. Ex-2124, ¶¶ 30-44, 51. The
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`application discloses that the side opening and the lumen of the tubular structure
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`are configured to receive one or more stents or balloon catheters when the segment
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`defining the side opening and a proximal end portion of the tubular structure are
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`positioned within the lumen of the guide catheter and the distal end of the guide
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`extension catheter extends beyond the distal end of the guide catheter, Ex. 1003 at
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`6:15-17; 7:5-7; 10:7-19; 11:16-18; 12:7-8; 18:5-14; 22:3-23:2; 35, and that a
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`material forming the segment defining the side opening is more rigid than the
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`tubular structure, id. at 16:8-17:2.
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`With respect to substitute claim 54 specifically, the application discloses that
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`the uniform cross-sectional inner diameter of the lumen of the tubular structure is
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`greater than a largest outer dimension of the substantially rigid segment, id. at
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`6 
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`6:15-17; 8:4-5; 12:1-2; 32, and that the tubular structure has a uniform, fixed outer
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`diameter and is configured to allow entry and passage therethrough of stent
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`catheters that are advanced alongside the substantially rigid portion, id. at 6:15-17;
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`7:5-7; 10:3-13; 11:16-18; 12:1-2; 14:20-21; 17:10-12; 18:5-14; 22:3-15; 32.
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`B.
`Substitute Claim 55
`The application discloses the substantially rigid segment is eccentrically
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`positioned relative to a cross-section of the tubular structure, id. at 12:1-2, 7-8;
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`15:3-4; 32; 35, and the guide extension catheter is configured so that, when the
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`tubular structure extends into the coronary artery, the tubular portion and the
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`substantially rigid segment assist in resisting forces exerted by stent catheters
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`passed through and beyond the coaxial lumen that would otherwise tend to
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`dislodge the guide catheter from the artery, id. at 10:7-11:12; 12:16-20; 18:5-14;
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`22:16-23:2; 38, 39; Ex-2124, ¶¶ 25-27.
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`C.
`Substitute Claim 56
`Substitute claim 56 depends from issued claim 32, which states that the
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`segment defining the side opening introduced in issued claim 25 includes at least
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`two inclined slopes, which are disclosed in the priority application. Ex. 1003 at
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`8:19-9:3; 12:7-8; 15:4-15; 35; Ex-2124, ¶¶ 30-51. Petitioner concedes that the
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`application discloses two inclined slopes: “Figure 4 shows, at best, only two
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`7 
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`inclined slopes,” which is a “disclosure of only two different inclined slopes.”
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`IPR2020-01344 Petition at 69.
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`Regarding substitute claim 56 specifically, the priority application discloses
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`a stent releasably joined to a distal end of an elongate balloon catheter, Ex. 1003 at
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`3:16-18; 10:7-9, 18-19; 17:10-12; 22:13-15; 39, and that the two inclined slopes
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`are separated by a non-inclined concave track, id. at 8:18-9:3; 12:7-8, 11-12; 15:4-
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`15; 35; 36 at Figure 6; Ex-2124, ¶ 52. Petitioner admits that Figure 4 “discloses a
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`non-inclined region.” IPR2020-00137 Petition at 15.
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`D.
`Substitute Claim 57
`The priority application discloses a system comprising a guide catheter and a
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`guide extension catheter. Ex. 1003 at 8:3-6; 12:1-2, 5-6, 16-20; 14:7-9; 32; 34; 38;
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`39. It discloses a guide catheter configured to be advanceable through a main
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`blood vessel to a position adjacent an ostium of a coronary artery, id. at 6:15-17;
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`7:5-7; 10:1-13; 12:16-20; 17:17-18:14; 22:6-9; 38; 39, that has a lumen extending
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`from a hemostatic valve at a proximal end of the guide catheter to a distal end of
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`the guide catheter that is adapted to be positioned adjacent the ostium of the
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`coronary artery, id. at 7:3-5; 10:1-19; 11:15-16; 12:13-15; 17:3-16; 37. The
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`application discloses a guide extension catheter configured to be partially
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`advanceable through the guide catheter and into the coronary artery, id. at 6:15-17;
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`7:5-7; 10:1-13; 12:16-20; 17:17-18:14; 22:6-9; 38; 39, that has a length such that a
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`8 
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`distal end is extendable through the lumen and beyond the distal end of the guide
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`catheter while a proximal end is extendable through the hemostatic valve at the
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`proximal end of the guide catheter, id. at 7:3-7; 8:5-6; 10:3-9; 11:15-16; 22:3-23:2.
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`The application discloses that the guide extension catheter includes, in a proximal
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`to distal direction, a first substantially rigid segment defining a rail structure
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`without 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-
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`17:2; 19:12-18; 32; 41; Ex-2124, ¶¶ 54, a second substantially rigid segment
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`defining a side opening, Ex. 1003 at 8:18-9:3; 12:7-8; 13:1-12; 15:3-16; 16:19-
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`17:2; 19:12-18; 35; 40; 41; Ex-2124, ¶¶ 44, 51, 55, and a tubular structure with a
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`uniform, fixed outer diameter and a lumen coaxial and in fluid communication
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`with the lumen of the guide catheter and having a length that is shorter than the
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`length of the lumen of the guide catheter, Ex. 1003 at 6:15-17; 8:12-16; 12:1-2, 5-
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`6; 13:7-8; 14:7-9; 14:20-15:2; 15:8-9; 32; 34; 41 at Figure 14, and has a uniform
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`cross-sectional inner diameter that is not more than one French size smaller than a
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`cross-sectional inner diameter of the lumen of the guide catheter, id. at 7:8-18. It
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`discloses that the side opening extends for a distance along a longitudinal axis of
`
`the second substantially rigid and is accessible from a longitudinal side defined
`
`transverse to the longitudinal axis, id. at 8:18-9:3; 12:7-8; 13:4-12; 15:4-15; 16:19-
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`17:2; 19:12-18; 35; 41, and that the side opening and the lumen of the tubular
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`structure are configured to receive one or more stents or balloon catheters when the
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`9 
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`second substantially rigid segment and a proximal end portion of the tubular
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`structure are positioned within the lumen of the guide catheter and the distal end of
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`the guide extension catheter extends beyond the distal end of the guide catheter, id.
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`at 6:15-17; 7:5-7; 10:7-19; 11:16-18; 18:5-14; 22:3-23:2. It discloses that the
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`tubular structure comprises a flexible cylindrical distal tip portion, id. at 8:4, 7-11;
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`14:7-8, 10-12; 21:11-13, and a flexible reinforced portion that is reinforced with
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`one or more metallic elements in a braided or coiled pattern, id. at 8:12-16; 14:17-
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`15:2; 16:8-17:2; 21:9-10, proximal of and operably connected to the flexible
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`cylindrical distal tip portion id. at 8:3-16; 12:1-2; 14:7-9; 14:20-21; 32, where the
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`flexible cylindrical distal tip portion is more flexible than the flexible reinforced
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`portion and first and second substantially rigid segments, id. at 8:7-18; 14:17-15:5;
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`16:8-17:2; 21:14-17. The application discloses that the second substantially rigid
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`segment is more rigid than a distal end portion of the tubular structure including
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`both the flexible cylindrical distal tip portion and the flexible reinforced portion,
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`id. at 16:8-17:2. It discloses that the side opening comprises first and second
`
`inclined regions, with a non-inclined concave track positioned between the regions,
`
`id. at 8:18-9:3; 12:7-8, 11-12; 15:4-15; 35; 36 at Figure 6; Ex-2124, ¶¶ 45-50, 52,
`
`and that the device is configured so that, when at least a distal portion of the
`
`tubular structure is extended distally of the distal end of the guide catheter with at
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`least a proximal portion of the flexible reinforced portion remaining within the
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`10 
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`guide catheter, at least a portion of the proximal portion of the first substantially
`
`rigid portion extends proximally through a single hemostatic valve in common
`
`with any of the stent or balloon catheters that are insertable into the guide catheter,
`
`Ex. 1003 at 6:15-17; 7:3-7, 8:5-6; 10:7-19; 11:15-18; 12:5-6; 17:17-18:14; 34; 38;
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`39, whereby a distal portion of the tubular structure is configured to extend past the
`
`ostium of a vessel and anchor within the vessel so that the reinforced portion and
`
`the substantially rigid rail structure segment are configured resist forces exerted by
`
`the stents or balloon catheters passed through and beyond the device that would
`
`otherwise tend to dislodge the guide catheter from an artery, id. at 10:7-11:12;
`
`12:16-20; 18:5-14; 22:16-23:2; 38; 39; Ex-2124, ¶¶ 25-27.
`
`E.
`Substitute Claim 58
`The application discloses a system with a standard 6 French guide catheter
`
`with an internal diameter greater than or equal to 0.070 inches advanceable through
`
`a main blood vessel to a position adjacent an ostium of a coronary artery, Ex. 1003
`
`at 6:15-17; 7:5-7; 7:12-13; 10:1-13; 12:16-20; 17:17-18:14; 22:6-9; 38; 39, having
`
`a lumen extending from a hemostatic valve at a proximal end of the guide catheter
`
`to a distal end of the guide catheter that is adapted to be positioned adjacent the
`
`ostium of the coronary artery, id. at 7:3-5; 10:1-19; 11:15-16; 12:13-15; 17:3-16;
`
`37. The application discloses that the system also comprises a guide extension
`
`catheter partially advanceable through the guide catheter and into the coronary
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`11 
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`artery, id. at 6:15-17; 7:5-7; 10:1-13; 12:16-20; 17:17-18:14; 22:6-9; 38; 39, with a
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`length such that a distal end of the guide extension catheter is extendable through
`
`the lumen and beyond the distal end of the guide catheter, and a proximal end of
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`the guide extension catheter is extendable through the hemostatic valve at the
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`proximal end of the guide catheter, id. at 7:3-7; 8:5-6; 10:3-9; 11:15-16; 22:3-23:2.
`
`It discloses that the guide extension catheter includes, in a proximal to distal
`
`direction, a substantially rigid rail structure segment, 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; 19:12-18; 32; 41, a segment defining a
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`side opening, id. at 8:18-9:3; 12:7-8; 13:4-12; 15:4-15; 16:19-17:2; 19:12-18; 35;
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`41; Ex-2124, ¶¶ 30-44, 51, and a tubular structure comprising a reinforced portion
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`and a cylindrical distal tip portion distal to the reinforced portion, the tubular
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`structure defining a single lumen that is coaxial and in fluid communication with
`
`the lumen of the guide catheter when positioned therein and having a length that is
`
`shorter than the length of the lumen of the guide catheter, Ex. 1003 at 6:15-17; 8:3-
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`16; 12:1-2, 5-6; 13:7-8; 14:7-15:2; 15:8-9; 21:9-13; 32; 34; 41 at Figure 14, and
`
`having a uniform cross-sectional inner diameter that is greater than or equal to
`
`0.056 inches so as to be not more than one French size smaller than the cross-
`
`sectional inner diameter of the lumen of the standard 6 French guide catheter, id. at
`
`7:17-18. It discloses a side opening extending along a longitudinal axis of the
`
`segment defining the side opening, accessible from a longitudinal side defined
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`12 
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`transverse to the longitudinal axis, id. at 8:18-9:3; 12:7-8; 13:4-12; 15:4-15; 16:19-
`
`17:2; 19:12-18; 35; 41, and the side opening and the lumen of the tubular structure
`
`configured to receive one or more stents or balloon catheters when the segment
`
`defining the side opening and a proximal end portion of the tubular structure are
`
`positioned within the lumen of the guide catheter and the distal end of the guide
`
`extension catheter extends beyond the distal end of the guide catheter, id. at 6:15-
`
`17; 7:5-7; 10:7-19; 11:16-18; 18:5-14; 22:3-23:2. It discloses that the segment
`
`defining the side opening includes a first inclined region proximate to a non-
`
`inclined region that is proximate to a second inclined region, id. at 8:18-9:3; 12:7-
`
`8, 11-12; 15:4-15; 35; 36 at Figure 6; Ex-2124, ¶¶ 45-50, 52, and that the segment
`
`defining the side opening and the rail structure segment are more rigid than the
`
`tubular structure and the reinforced portion is more rigid than the tip portion, Ex.
`
`1003 at 8:7-18; 14:17-15:5; 16:8-17:2; 21:14-17, where a distal portion of the
`
`tubular structure is configured to extend past the ostium of a vessel and anchor
`
`within the vessel so as to resist forces exerted by received stent and balloon
`
`catheters that would otherwise tend to dislodge the guide catheter from the ostium,
`
`id. at 10:7-11:12; 12:16-20; 18:5-14; 22:16-23:2; 38; 39, the tip portion includes an
`
`atraumatic bumper formed from a flexible material and having a lumen continuous
`
`with the lumen of the tubular structure, id. at 14:10-12; 16:12-13, the reinforced
`
`portion includes a reinforcing braid or coil, id. at 8:12-14; 14:17-15:2; 16:8-19;
`
` 
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`13 
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`21:9-10, and the tip portion includes a marker band positioned distal to the distal
`
`end of the reinforcing braid or coil, id. at 7:20-8:2, 7-11; 14:10, 13-16.
`
`VI. THE LEVEL OF ORDINARY SKILL IN THE ART
`In this Motion, Teleflex applies Petitioner’s definition of a POSITA.
`
`IPR2020-00132 Petition at 15; IPR2020-00134 Petition at 15.
`
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART
`Before Teleflex’s effective filing date, the prior art described a standard full-
`
`length 5 French guide catheter being inserted through a 6 French guide catheter to
`
`provide backup support for interventional cardiology devices (Takahashi (Ex.
`
`1010)). It also described embolic protection devices (Ressemann (Ex. 1008);
`
`Adams ’280 (Ex. 1035)), suction catheters (Kataishi (Ex. 1025)), balloon catheters
`
`(e.g., Enger (Ex. 1050)), and support catheters (Kontos (Ex. 1009); Adams ’292
`
`(Ex. 1034)). No prior art2 known to Teleflex or its expert, Mr. Keith, including
`
`that cited by Petitioner in these IPR proceedings, described a rapid exchange guide
`
`extension catheter with the features recited in the substitute claims. The closest art
`
`known to Teleflex and Mr. Keith is listed in this paragraph. Ex-2124, ¶ 19.
`
` 
`2 Itou (Ex. 1007) also discloses a suction catheter. As explained in Patent Owner’s
`
`Consolidated Response Brief on Conception and Reduction to Practice, filed
`
`herewith, Itou is not prior art.
`
` 
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`14 
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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
`
`proposed substitute claims are responsive to the grounds of unpatentability upon
`
`which institution was granted. Each of substitute claims 54-58 is novel and
`
`nonobvious under 35 U.S.C. §§ 102 and 103, as set forth below. Patentability
`
`further is supported by the objective evidence.
`
`A.
`
`Substitute Claims 56, 57, and 58: 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
`
`substantially rigid proximal pushrod, a distal tubular portion, and a partially
`
`cylindrical opening in between that facilitates entry of interventional cardiology
`
`devices into the distal tubular portion while the tubular portion is located deep
`
`within a surrounding guide catheter. The disclosure discloses side openings that
`
`are beyond a single-incline skived opening, and have a complex shape that further
`
`improves the ability of interventional cardiology devices (particularly larger
`
`devices such as stents) to smoothly enter into the distal tubular portion without
`
`hanging up. Ex. 1003 at 8:18-9:3; 12:7-8; 12:11-12; 15:4-15; 35; 36 at Figure 6;
`
`41. An example of this is shown in Figure 4:
`
` 
`
`15 
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`

`

`Complex Side Opening
`
`
`
`Id. at 35.
`
`Substitute claims 56, 57, and 58 all add a complex side opening limitation:
`
`Claim 56:
`
`“two inclined slopes are separated by a non-inclined concave
`
`track”;
`
`Claim 57:
`
`“the side opening comprises a first inclined region, a second
`
`inclined region, and a non-inclined concave track positioned
`
`between the first and second inclined regions”; and
`
`Claim 58:
`
`“the segment defining the side opening includes a first inclined
`
`sidewall proximate to a non-inclined region that is proximate to a
`
`second inclined sidewall.”
`
`None of the prior art discloses or suggests the claimed combination of
`
`features including the complex side opening recited in each of these substitute
`
`claims. In response to existing claims of the GuideLiner patents that recite a
`
`complex side opening, Petitioner has asserted obviousness arguments using Itou
`
`(Ex. 1007), Ressemann (Ex. 1008) or Kontos (Ex. 1009) as the primary reference.
`
`Petitioner does not assert that any of these references disclose a device with a
`
`complex side opening at the proximal end of a distal tubular section, and with good
`16 
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`

`

`reason. Itou and Ressemann both disclose devices having a single-incline
`
`proximal opening. Kontos does not disclose a side opening at all, much less a
`
`“complex” one.
`
`Petitioner has relied on Kataishi, Ressemann and Enger to argue that it
`
`would have been obvious to modify the primary references to add a complex side
`
`opening. Petitioner’s arguments are pure hindsight. Kataishi discloses a suction
`
`catheter having a distal opening with a complex shape that, in combination with its
`
`flexibility, facilitates the ability of the distal end to conform around a thrombus
`
`attached to the side wall of a vessel to suction it out. Ex. 1025 at [0027]-[0028].
`
`As the Board preliminarily found in its Institution Decisions, the Petitioner “does
`
`not explain sufficiently why the inclined shape of Kataishi’s distal opening would
`
`have been applicable to” the proximal opening of Itou or Kontos’s device.
`
`IPR2020-0135, Paper 22 at 23; IPR2020-00136, Paper 20 at 29. The Board’s
`
`preliminary conclusion was correct.
`
`As for Ressemann, it is undisputed that none of the embodiments of
`
`Ressemann’s embolic protection device have a proximal opening with a complex
`
`profile. Instead, Petitioner focuses on a single component of Ressemann’s
`
`assembly—the support collar 2141 shown in Figure 16J. Petitioner asserts that
`
`Ressemann’s support collar has a complex side opening having inclined slopes 1
`
`and 2:
`
` 
`
`17 
`
`

`

` 
`
`IPR2020-00135, Petition at 72-73. Petitioner argues that it would have been
`
`obvious to incorporate Ressemann’s collar on top of the push wire of the primary
`
`references (Itou, Kontos, or Ressemann’s Figure 1 embodiment) in order to create
`
`an “on ramp” into the opening of those references. Id. at 74.
`
`This analysis is overflowing with hindsight. In Ressemann’s device, what
`
`Petitioner calls “incline #1” of the support collar is not an “incline” or an “on-
`
`ramp” at all. The entire tab portion 2141b of Ressemann’s collar (including the tip
`
`that supposedly defines an on ramp) is buried deep inside Ressemann’s device,
`
`underneath at least three other components. Moreover, the purpose of the tab
`
`portion has nothing to do with guiding components into an opening; rather, it
`
`provides a “flexibility transition” between the proximal end of Ressemann’s
`
`evacuation head and the shaft. Ex. 1008 at 24:62-67. And the tiny asserted incline
`
`at the end of that tab portion (which Petitioner relies on for “incline #1) serves no
`
`purpose whatsoever; it is merely the incidental result of how the tip of the collar is
`18 
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`

`

`machined. Petitioner’s expert admitted that he did even not try to determine how
`
`the tab 2141b of Ressemann’s collar was actually used in Ressemann’s device,
`
`explaining that “I’m not overly concerned with what the collar was being done
`
`before I chose to use it.” Ex. 2137 at 131:21-133:6. Such testimony shows that
`
`Petitioner’s expert did exactly what the law prohibits – he used the knowledge
`
`gained from reading Teleflex’s patent disclosure to recreate the invention from
`
`pieces in various prior art references. See KSR Int'l Co. v. Teleflex Inc., 550 U.S.
`
`398, 421 (2007) (“warning against a temptation to read into the prior art the
`
`teachings of the invention in issue and instructing courts to guard against slipping
`
`into use of hindsight”) (citing Graham v. John Deere Co., 383 U.S. 1, 36 (1966))
`
`(internal quotations omitted).  
`
`Moreover, Ressemann explicitly states that the function of providing a
`
`flexibility transition is provided by placing the tab portion of the collar adjacent the
`
`exterior walls of Ressemann’s multi-lumen tube. Ex. 1008 at 24:62-67. In
`
`Ressemann’s device, both the evacuation head and the shaft have multiple lumens
`
`that must connect together and maintain their patency in order for the device to
`
`function properly. Ex. 1008 at e.g., 6:18-20, 35-65,