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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-00135
`Case IPR2020-00136
`Patent RE 45,776
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`PATENT OWNER’S CONTINGENT MOTION TO AMEND
`U.S. PATENT RE 45,776 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
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`PAGE
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`INTRODUCTION ........................................................................................... 1
`I.
`LEGAL STANDARDS FOR AMENDING CLAIMS ................................... 1
`II.
`III. CLAIM LISTING ............................................................................................ 1
`IV. SCOPE OF THE SUBSTITUTE CLAIMS ..................................................... 2
`V. WRITTEN DESCRIPTION SUPPORT .......................................................... 4
`A.
`Substitute Claim 58 ............................................................................... 5
`B.
`Substitute Claim 59 ............................................................................... 6
`C.
`Substitute Claim 60 ............................................................................... 7
`D.
`Substitute Claim 61 ............................................................................... 7
`E.
`Substitute Claim 62 ............................................................................... 9
`F.
`Substitute Claim 63 ............................................................................... 9
`G.
`Substitute Claim 64 ............................................................................. 11
`H.
`Substitute Claim 65 ............................................................................. 11
`VI. THE LEVEL OF ORDINARY SKILL IN THE ART .................................. 13
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART ................................ 13
`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE ............. 14
`A.
`Substitute Claims 58-62, 64, and 65: None of the Prior Art Discloses
`or Suggests the Claimed Combination of Features Including the
`Recited Complex Side Opening .......................................................... 14
`Substitute Claims 61 and 62: The Prior Art Does Not Disclose the
`Claimed Combination of Elements, Including a Segment Defining a
`Partially Cylindrical Opening Comprising a Metal Rail Structure That
`Has Been Processed to Increase Its Flexibility ................................... 20
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`B.
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`i
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`C.
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`Substitute Claims 63-64: 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
`For Use With a 6 French Guide Catheter ............................................ 21
`Substitute Claim 65: The Prior Art Does Not Disclose or Suggest the
`Claimed Combination of Elements, Including a Tubular Structure
`With a Coaxial 0.056 Lumen For Use With a 6 French Guide Catheter
`and to Receive Stents and Balloon Catheters ...................................... 24
`IX. CONCLUSION .............................................................................................. 25
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`D.
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`ii
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .............................................................................. 5
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .................................................................................................. 18
`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) .............................................................................................. 18
`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) .............................................................................. 5
`Statutes
`35 U.S.C. § 102 ........................................................................................................ 14
`35 U.S.C. § 103 ........................................................................................................ 14
`35 U.S.C. § 316 .......................................................................................................... 2
`Other Authorities
`37 C.F.R. § 42.121 ...................................................................................... 1, 2, 5, 14
`37 C.F.R. § 42.22 ....................................................................................................... 1
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`iii
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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 RE 45,776 (“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 27, 33, 37, 42, 43, 45, 47, or 56 of
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`the ’776 patent invalid, Teleflex respectfully requests that the Board replace the
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`invalid claim(s) with the respective proposed substitute claim of claims 58-65. See
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`37 C.F.R. § 42.22(a)(2); 35 U.S.C. § 316(d).
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`II. LEGAL STANDARDS FOR AMENDING CLAIMS
`A motion to amend must (1) propose a reasonable number of substitute
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`claims, (2) that respond to a ground of unpatentability involved in the trial, (3) that
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`do not enlarge the scope of the claims or introduce new matter, and (4) are not
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`shown by a preponderance of the evidence to be unpatentable. See Memorandum
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`re: Guidance on Motions to Amend in view of Aqua Products (Nov. 21, 2017) at 2;
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`35 U.S.C. § 316(d); 37 C.F.R. § 42.121. It is Petitioner’s burden to show that the
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`proposed substitute claims are unpatentable. Lectrosonics, Inc. v. Zaxcom, Inc.,
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`IPR2018-01129, Paper 15 at 4 (PTAB Feb. 25, 2019).
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`III. CLAIM LISTING
`Pursuant to 37 C.F.R. § 42.121(b), Appendix A lists the changes made to the
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`issued claims of the ’776 patent that would be replaced under this Motion. This
`1
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`claim listing includes one replacement claim for each of claims 27, 33, 37, 42, 43,
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`45, 47, and 56. The number of proposed substitute claims is reasonable under 35
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`U.S.C. § 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 58-65 are narrowing amendments.
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`The language removed from issued claim 33 (substitute claim 59) is part of a
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`narrowing amendment because the claim now modifies “the non-inclined concave
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`track” specifically, and not just “the partially cylindrical opening” (which includes
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`the non-inclined concave track) generally. Accordingly, removing this language
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`does not eliminate any element of original claim 33.
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`Substitute claim 65 amends issued claim 56 in part by changing its
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`dependency from issued claim 53 to issued claim 52. That change in dependency
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`replaces issued claim 53’s limitation of “the lumen 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” with limitations
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`in substitute claim 65 that require that “the guide catheter is a standard 6 French
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`guide catheter that includes a lumen having a cross-sectional inner diameter greater
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`2
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`than or equal to 0.070 inches” and that “a uniform cross-sectional inner diameter of
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`the lumen of the tubular structure is greater than or equal to 0.056 inches.” The
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`amendment is narrowing because the original claim was directed to a one French
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`size difference for any size guide catheter, while the amendment is directed only to
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`a 6 French guide catheter with an inner diameter greater than or equal to 0.070
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`inches and a tubular structure that has an inner diameter greater than or equal to
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`0.056 inches. The dimensions recited in the claim are based on the description in
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`the priority application1 of what it means to have a one French size difference
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`when using a 6 French guide catheter. Ex. 1003 at 7:8-18. Teleflex expects that
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`Petitioner may advance a construction of the “one French size smaller” language
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`that was removed from issued claim 56 (substitute claim 65) to contend that the
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`amendment is a broadening one, arguing that the mathematical definition of a
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`French dimension as 0.0131 inches also applies to the removed “one French size”
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`claim language. To the extent the “one French size” difference phrase requires
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`construction, in the context of a 5 French coaxial guide catheter in a 6 French
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`guide catheter as recited in substitute claim 65 the priority application indicates
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`1 The parties have stipulated that all patents at issue in these IPRs have
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`substantively identical disclosures, and have agreed to cite only the priority
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`application, IPR2020-00126, Ex. 1003, cited herein as “Ex. 1003 at XX.”
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`3
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`that an 0.014 inch difference is one French size smaller, even though it is larger
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`than precisely 0.0131 inches: “A 6 French guide catheter has an internal diameter
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`greater than or equal to 0.070 inches. … For a 5 French in 6 French coaxial guide
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`catheter the internal diameter should be greater than or equal to 0.056 inches.” Id.
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`at 7:12-18. This is not surprising considering that, as Petitioner’s expert concedes,
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`a one French size difference, for example, a 5 French in 6 French, could be
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`“slightly larger or slightly smaller” than 0.0131 inches. Ex. 2137 at 372:6-9; see
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`id. at 367:5-9. Because French size values conventionally are applied to the outer
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`rather than inner diameter of a catheter, a POSITA would understand that a one
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`French size difference would not necessarily be exactly 0.0131 inches when
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`viewed from the perspective of the differential in inner catheter diameters. See Ex-
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`2124, ¶¶ 57, 58. The amendment thus is not a broadening one.
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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 58-65 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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`4
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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).
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`A.
`Substitute Claim 58
`Substitute claim 58 depends from issued independent claim 25, which the
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`priority application supports. It discloses a guide extension catheter for use with a
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`guide catheter, Ex. 1003 at 8:3-6; 12:1-2; 14:7-9; 32, that includes 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 tubular structure defining a lumen and positioned
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`distal to the substantially rigid segment, id. at 11:16-18; 12:1-2; 13:7-8; 14:7-15:2;
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`22:13-15; 32; 41 at Figure 14, and a segment defining a partially cylindrical
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`opening positioned between a distal end of the substantially rigid segment and a
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`proximal end of the tubular structure, id. at 8:18-9:3; 12:7-8; 13:4-12; 15:4-15;
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`16:19-17:2; 19:12-18; 35; 41. The claim need not expressly recite that the partially
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`cylindrical opening is in the substantially rigid segment. Ex-2124, ¶¶ 30-44, 51.
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`The segment defining the partially cylindrical opening has an angled proximal end,
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`is formed from a material more rigid than a material or material combination
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`5
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`forming the tubular structure, and is configured to receive one or more
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`interventional cardiology devices therethrough when positioned within the guide
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`catheter. Ex. 1003 at 7:5-7; 8:18-9:3; 10:3-13; 12:7-8; 13:4-12; 15:4-15; 16:8-
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`17:2; 17:10-12; 18:5-14; 19:12-18; 35; 41. The guide extension catheter’s cross-
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`section at the tubular structure’s proximal end defines a single lumen. Id. at 12:1-
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`2; 13:7-8; 32; 41 at Figure 14.
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`Regarding substitute claim 58, the application discloses that the segment
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`defining the partially cylindrical opening includes a portion having an arcuate
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`cross-sectional shape, id. at 8:18-9:3; 12:7-8; 12:11-12; 13:11-12; 15:5-7; 15:13-
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`15; 16:19-17:1; 19:12-18; 35; 36 at Figure 6; 41 at Figure 16, and a non-inclined
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`concave track, id. at 8:18-9:3; 12:7-8; 12:11-12; 15:4-15; 35; 36 at Figure 6; Ex-
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`2124, ¶ 52. Petitioner admits that Figure 4 “discloses a non-inclined region.”
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`IPR2020-00137 Petition at 15.
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`B.
`Substitute Claim 59
`The application discloses that the non-inclined concave track has a
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`hemicylindrical cross-sectional shape, Ex. 1003 at 8:18-9:3; 12:7-8; 12:11-12;
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`13:4-10; 15:5-7; 15:10-13; 35; 36 at Figure 6; 41, and that the segment defining the
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`partially cylindrical opening includes two inclined slopes separated by the non-
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`inclined concave track, id. at 8:18-9:3; 12:7-8; 12:11-12; 15:4-15; 35; 36 at Figure
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`6; 41, Ex-2124, ¶¶ 45-52. Petitioner concedes that the application discloses two
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`6
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`inclined slopes: “Figure 4 shows, at best, only two inclined slopes,” which is a
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`“disclosure of only two different inclined slopes.” IPR2020-01344 Petition at 69.
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`C.
`Substitute Claim 60
`Substitute claim 60 depends from issued claim 36, which specifies that the
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`segment defining the angled proximal end of the partially cylindrical opening
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`includes at least one inclined region that tapers into a non-inclined region. Ex.
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`1003 at 8:18-9:3; 12:7-8; 15:4-15; 35; Ex-2124, ¶ 53. Issued claim 36 depends
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`from issued claim 25, support for which is set forth above in the discussion of
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`substitute claim 58.
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`Regarding substitute claim 60, the application further discloses that the non-
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`inclined region of the segment defining the partially cylindrical opening defines a
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`concave track that is continuous with the tubular structure’s lumen. Ex. 1003 at
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`8:18-9:3; 12:7-8; 12:11-12; 13:4-12; 15:4-15; 35; 36 at Figure 6; 41; Ex-2124, ¶
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`52.
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`D.
`Substitute Claim 61
`The application discloses a guide extension catheter, Ex. 1003 at 8:3-6; 12:1-
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`2; 14:7-9; 32, for use with a guide catheter that has a substantially rigid segment,
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`id. at 6:15-17; 8:4-5; 8:17-9:5; 14:7-9; 15:3-5; 16:18-17:2; 19:12-18; 32; 41, a
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`tubular structure defining a lumen and positioned distal to the substantially rigid
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`segment, id. at 11:16-18; 12:1-2; 13:7-8; 14:7-15:2; 22:13-15; 32; 41 at Figure 14,
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`7
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`and a segment defining a partially cylindrical opening positioned between a distal
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`end of the substantially rigid segment and a proximal end of the tubular structure,
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`id. at 8:18-9:3; 12:7-8; 13:4-12; 15:4-15; 16:19-17:2; 19:12-18; 35; 41; see Ex-
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`2124, ¶¶ 30-44, 51. The application discloses that the partially cylindrical opening
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`is configured to receive one or more interventional cardiology devices
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`therethrough when positioned within the guide catheter, Ex. 1003 at 6:15-17; 7:5-
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`7; 10:3-13; 11:16-18; 17:10-12; 18:5-14; 22:3-15, and has an angled proximal end
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`with an inclined region that tapers into a non-inclined region, id. at 8:18-9:3; 12:7-
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`8; 15:4-15; 35; Ex-2124, ¶ 53. It also specifies that the partially cylindrical
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`opening is formed from a material that is more rigid than a material or material
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`combination forming the tubular structure, Ex. 1003 at 16:8-17:2, that a cross-
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`section of the guide extension catheter at the proximal end of the tubular structure
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`defines a single lumen, id. at 12:1-2; 13:7-8; 32; 41 at Figure 14, and that the
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`substantially rigid segment comprises a metal rail structure, id. 6:15-17; 8:17-18;
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`15:4-5; 16:18-19, where a cross-section of the substantially rigid segment is
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`sufficiently sized and configured to permit the tubular structure to be advanced
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`within and partially through the guide catheter while permitting at least partial
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`delivery of one or more received interventional cardiology devices alongside the
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`substantially rigid segment, through the angled proximal end of the partially
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`cylindrical opening, and through the lumen of the tubular structure, id. at 6:15-17;
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`8
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`7:5-7; 8:18-9:3; 11:16-18; 22:3-15. It also discloses that the segment defining the
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`partially cylindrical opening comprises a continuation of the metal rail structure,
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`id. at 8:17-9:5; 12:7-8; 13:1-12; 15:4-15; 19:12-18; 35; 40; 41, and that the
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`partially cylindrical opening has been processed to increase its flexibility, id. at
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`9:6-7; 13:1-3; 18:15-19:11; 40; Ex-2124, ¶¶ 36-37.
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`E.
`Substitute Claim 62
`The application discloses that the substantially rigid segment has an outer
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`size and the lumen of the tubular structure has an inner size, the lumen’s inner size
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`being greater than the substantially rigid segment’s outer size, Ex. 1003 at 6:15-17;
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`7:5-7; 8:18-9:3; 11:16-18; 22:3-15, and that the flexibility of the segment defining
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`the partially cylindrical opening is increased by forming transverse relief cuts in
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`the segment defining the partially cylindrical opening, id. at 13:1-3; 18:15-19:11;
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`40; Ex-2124, ¶¶ 36-37.
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`F.
`Substitute Claim 63
`The priority application discloses a guide extension catheter, Ex. 1003 at
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`8:3-6; 12:1-2; 14:7-9; 32, for use with a standard 6 French guide catheter, id. at
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`7:8-18, that includes a first substantially rigid segment that defines 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, and a tubular structure with a uniform,
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`fixed outer diameter that defines a lumen and is positioned distal to the first
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`9
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`substantially rigid segment, Ex. 1003 at 11:16-18; 12:1-2; 13:7-8; 14:7-15:2;
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`22:13-15; 32; 41 at Figure 14. It discloses that the lumen is configured to be
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`coaxial with the lumen of the guide catheter when positioned therein, id. at 6:15-
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`17; 12:5-6; 34, and that it has a uniform cross-sectional inner diameter of at least
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`0.056 inches, id. at 7:17-18; 12:7-8; 35. It discloses a tubular structure with a
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`cylindrical distal tip portion distal to a reinforced portion. Id. at 8:3-16; 12:1-2;
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`14:7-9; 14:17-15:2; 21:11-13; 32. It discloses a second substantially rigid segment
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`that defines a partially cylindrical opening positioned between a distal end of the
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`first substantially rigid segment and a proximal end of the tubular structure that has
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`an angled proximal end, id. at 8:18-9:3; 12:7-8; 13:1-12; 15:3-16; 19:12-18; 35;
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`40; 41; Ex-2124, ¶¶ 44, 51, 55, and is configured to receive stent catheters when
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`positioned within the guide catheter lumen, Ex. 1003 at 7:5-7; 10:3-13; 11:16-18;
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`17:10-12; 18:5-14; 22:13-15. It also discloses that a cross-section of the guide
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`extension catheter at the proximal end of the tubular structure defines a single
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`lumen, id. at 12:1-2; 13:7-8; 32; 41 at Figure 14, and that each of the first and
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`second substantially rigid segments is formed from a material more rigid along a
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`longitudinal axis of the guide extension catheter than a material or material
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`combination forming the tubular structure, id. at 16:8-17:2; 21:14-17. It discloses
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`that the tubular structure includes a reinforcing braid or coil extending along a
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`10
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`portion of the tubular structure surrounded by one or more polymer materials. Id.
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`at 8:12-16; 14:17-15:2; 16:8-17:2; 21:9-10.
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`G.
`Substitute Claim 64
`The priority application discloses that the substantially rigid segment and the
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`partially cylindrical opening can comprise a rigid portion of the guide extension
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`catheter, id. at 6:15-17; 8:18-9:3; 15:3-7, where the segment defining the angled
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`proximal end of the partially cylindrical opening includes two inclined sidewalls
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`separated by a concave track, id. at 8:18-9:3; 12:7-8; 12:11-12; 15:4-15; 35; 36 at
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`Figure 6; 41; Ex-2124, ¶¶ 45-50, 52.
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`H.
`Substitute Claim 65
`Substitute claim 65 depends from issued independent claim 52, which is
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`directed to a guide extension catheter for use with a guide catheter. Ex. 1003 at
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`8:3-6; 12:1-4; 14:7-9; 32; 33. The guide extension catheter includes 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 tubular structure defining a lumen positioned distal
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`to the substantially rigid segment, id. at 11:16-18; 12:1-2; 13:7-8; 14:7-15:2;
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`22:13-15; 32; 41 at Figure 14, and a segment defining a partially cylindrical
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`opening, id. at 8:18-9:3; 12:7-8; 13:4-12; 15:4-15; 16:19-17:2; 19:12-18; 35; 41;
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`Ex-2124, ¶¶ 30-44, 51. The application discloses that the segment defining a
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`partially cylindrical opening is positioned between a distal end of the substantially
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`11
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`rigid segment and a proximal end of the tubular structure, Ex. 1003 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, is formed from a material
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`having a greater flexural modulus than a flexural modulus of the tubular structure,
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`id. at 16:8-17:2, and that the segment defining the partially cylindrical opening,
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`which has an angled proximal end that includes at least two inclined regions, id. at
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`8:18-9:3; 12:7-8; 15:4-15; 35; Ex-2124, ¶¶ 45-50, and is configured to receive one
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`or more interventional cardiology devices when positioned within the lumen of the
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`guide catheter, Ex. 1003 at 6:15-17; 7:5-7; 10:3-13; 11:16-18; 17:10-12; 18:5-14;
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`22:3-15. It also discloses that the cross-section of the guide extension catheter at
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`the proximal end of the tubular structure defines a single lumen. Id. at 12:1-2;
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`13:7-8; 32; 41 at Figure 14.
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`Regarding substitute claim 65, the application discloses that a cross-section
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`of the substantially rigid segment is sized and configured to permit the guide
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`extension catheter’s tubular structure to be advanced partially through the guide
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`catheter and into a coronary artery while preserving space of the cross-sectional
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`inner diameter of the lumen of the guide catheter, id. at 6:15-17; 7:3-7; 10:7-9;
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`11:16-18; 17:17-18:14; 22:3-15, a standard 6 French guide catheter that has a
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`lumen with a cross-sectional inner diameter greater than or equal to 0.070 inches,
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`id. at 7:12-13, and that a uniform cross-sectional inner diameter of the lumen of the
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`tubular structure is greater than or equal to 0.056 inches and the lumen of the
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`12
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`tubular structure is configured to be coaxial with the lumen of the guide catheter
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`and to receive stents and balloon catheters when positioned therein, id. at 6:15-17;
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`7:17-18; 10:7-19; 12:5-6; 18:5-14; 22:3-23:2; 34.
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`VI. THE LEVEL OF ORDINARY SKILL IN THE ART
`In this Motion, Teleflex applies Petitioner’s definition of a POSITA.
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`IPR2020-00135 Petition at 13; IPR2020-00136 Petition at 13.
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`VII. THE SCOPE AND CONTENT OF THE PRIOR ART
`Before Teleflex’s effective filing date, the prior art described a full-length 5
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`French guide catheter used in a 6 French guide catheter for backup support during
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`interventional cardiology procedures (Takahashi (Ex. 1010)). It also described
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`embolic protection devices (Ressemann (Ex. 1008); Adams ’280 (Ex. 1035)),
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`suction catheters (Kataishi (Ex. 1025)), balloon catheters (Enger (Ex. 1050)), and
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`support catheters for fixed-wire devices (Kontos (Ex. 1009); Adams ’292 (Ex.
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`1034)). No prior art2 known to Teleflex or its expert, Mr. Keith, including that
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`cited by Petitioner in these IPR proceedings, described a rapid exchange guide
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`2 Itou (Ex. 1007) also discloses a suction catheter. As explained in Patent Owner’s
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`Consolidated Response Brief on Conception and Reduction to Practice, filed
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`herewith, Itou is not prior art.
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`13
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`
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`extension catheter with the features recited in the substitute claims. The closest art
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`known to Teleflex and Mr. Keith is listed in this paragraph. Ex-2124, ¶ 19.
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`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE
`As required by 37 C.F.R. § 42.121(a)(2)(i), the amendments reflected in the
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`proposed substitute claims are responsive to the grounds of unpatentability upon
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`which institution was granted. Each of substitute claims 58-65 is novel and
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`nonobvious under 35 U.S.C. §§ 102 and 103, as set forth below.
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`A.
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`Substitute Claims 58-62, 64, and 65: None of the Prior Art
`Discloses or Suggests the Claimed Combination of Features
`Including the Recited Complex Side Opening
`The priority disclosure discloses a guide extension catheter having a
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`substantially rigid proximal pushrod, a distal tubular portion, and a partially
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`cylindrical opening in between that facilitates entry of interventional cardiology
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`devices into the distal tubular portion. The disclosure discloses side openings that
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`are beyond a single-incline skived opening, and have a complex shape that further
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`improves the ability of interventional cardiology devices to smoothly enter into the
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`distal tubular portion without hanging up. An example of this is shown in Fig. 4:
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`Complex Side Opening
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`Ex. 1003 at 35.
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`14
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`
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`While the exact language varies by claim, substitute claims 58-62, 64 and 65
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`all add a complex side opening limitation:
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`Claim 58:
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`“the segment defining the partially cylindrical opening includes a
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`portion having an arcuate cross-sectional shape and a portion
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`having a non-inclined concave track”;
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`Claim 59:
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`“the segment defining the partially cylindrical opening includes two
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`inclined slopes separated by the non-inclined concave track”;
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`Claim 60:
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`“the non-inclined region of the segment defining the partially
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`cylindrical opening defines a concave track that is continuous with
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`the lumen of the tubular structure”;
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`Claims 61-62: “the partially cylindrical opening having an angled proximal end
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`with an . . . inclined region tapering into the non-inclined region”;
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`Claim 64:
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`“the segment defining the angled proximal end of the partially
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`cylindrical opening includes two inclined sidewalls separated by a
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`concave track”; and
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`Claim 65:
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`“the segment defining the angled proximal end of the partially
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`cylindrical opening includes at least two inclined regions” (recited
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`in claim 52, from which claim 65 depends).
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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 these substitute claims. In
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`15
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`
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`response to existing claims 36, 52 and 53 that recite a complex side opening,
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`Petitioner has asserted obviousness arguments using Itou (Ex. 1007), Ressemann
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`(Ex. 1008) or Kontos (Ex. 1009) as the primary reference. Petitioner does not
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`assert that any of these references discloses a device with a complex side opening
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`at the proximal end of a distal tubular section, and with good reason. Itou and
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`Ressemann both disclose devices having a single-incline proximal opening.
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`Kontos does not disclose a side opening at all. Instead, Petitioner relies on
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`Kataishi, Ressemann and Enger to argue that it would have been obvious to modify
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`the primary references to add a complex side opening. E.g., IPR2020-0135,
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`Petition, Grounds 3-5.
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`Petitioner’s arguments are pure hindsight. Kataishi discloses a suction
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`catheter having a distal opening with a complex shape that, in combination with its
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`flexibility, facilitates the ability of the distal end to conform around a thrombus
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`attached to the side wall of a vessel to suction it out. Ex. 1025 at [0027]-[0028].
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`As the Board preliminarily found in its Institution Decisions, Petitioner “does not
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`explain sufficiently why the inclined shape of Kataishi’s distal opening would have
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`been applicable to” the proximal opening of Itou or Kontos’s device. IPR2020-
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`0135, Paper 22 at 23; IPR2020-00136, Paper 20 at 29. The Board’s preliminary
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`conclusion was correct.
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`16
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`
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`As for Ressemann, it is undisputed that none of the embodiments of
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`Ressemann’s embolic protection device have a proximal opening with a complex
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`profile. Instead, Petitioner focusses on a component of Ressemann’s assembly—
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`the support collar 2141 shown in Figure 16J. Petitioner asserts that Ressemann’s
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`support collar has a complex side opening having inclined slopes 1 and 2:
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`
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`IPR2020-00135 Petition at 72-73. Petitioner argues that it would have been
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`obvious to incorporate Ressemann’s collar on top of the push wire of the primary
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`references (Itou, Kontos, or Ressemann’s Figure 1 embodiment) in order to create
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`an “on ramp” into the opening of those references. Id. at 74.
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`This analysis is overflowing with hindsight. In Ressemann’s device, what
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`Petitioner calls “incline #1” is not an “incline” or an “on-ramp” at all. The entire
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`tab portion 2141b of Ressemann’s collar (including the tip that supposedly defines
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`an on ramp) is buried deep inside Ressemann’s device, underneath at least three
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`17
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`
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`other components. Moreover, the purpose of the tab portion has nothing to do with
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`guiding components into an opening; rather, it provides a “flexibility transition”
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`between the proximal end of Ressemann’s evacuation head and the shaft. Ex. 1008
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`at 24:62-67. And the tiny asserted incline at the end of that tab portion (which
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`Petitioner relies on for “incline #1) serves no purpose whatsoever; it is merely the
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`incidental result of how the tip of the collar is machined. Petitioner’s expert
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`admitted that he did even not try to determine how the tab 2141b of Ressemann’s
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`collar was actually used in Ressemann’s device, explaining, “I’m not overly
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`concerned with what the collar was being done before I chose to use it.” Ex. 2137
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`at 131:21-133:6. Such testimony shows that Petitioner’s expert did exactly what
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`the law prohibits – he used the knowledge gained from reading Teleflex’s patent
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`disclosure to recreate the invention from pieces in various prior art references. See
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`KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“warning against a
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`temptation to read into the prior art the teachings of the invention in issue and
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`instructing courts to guard against slipping into use of hindsight”) (citing Graham
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`v. John Deere Co., 383 U.S. 1, 36 (1966)) (internal quotations omitted).
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`Moreover, Ressemann explicitly states that the function of providing a
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`flexibility transition is provided by placing the tab portion of the collar adjacent the
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`exterior walls of Ressemann’s multi-lumen tube. Ex. 1008 at 24:62-67. In
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`Ressemann’s device, both the evacuation head and the shaft have multiple lumens
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`
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`18
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`
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`that must connect together and maintain their patency in order for the device to
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`function properly. Id. at e.g., 6:18-20, 35-65, Figs. 1A, 1B, 6C, 16D, 16E. Placing
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`the tab portion of the collar outside these lumens (i.e., below the inflation lumen
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`and core wire lumen of Ressemann’s shaft) provides a flexibility transition that
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`helps maintain this patency. Yet Petitioner’s obviousness theory is premised on
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`placing Ressemann’s collar on top of the shaft of the primary references, instead of
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`at the bottom of the shaft as shown in and taught by Ressemann. This is further
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`evidence that Petitioner’s obviousness theory is based on hindsight, not the
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`teaching of the references.
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`Finally, Enger shows a typical example of a rapid exchange balloon catheter,
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`with a distal portion having a guidewire lumen that receives a guidewire to
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`facilitate delivery of the balloon catheter. Petitioner claims that the proximal
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`opening Enger’s guidew