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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 IPR2020-00128
`Case IPR2020-00129
`Case IPR2020-00130
`Patent RE 45,380
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`PATENT OWNER’S CONTINGENT MOTION TO AMEND
`U.S. PATENT RE 45,380 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
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`PAGE
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`INTRODUCTION ........................................................................................... 1
`I.
`LEGAL STANDARDS FOR AMENDING CLAIMS ................................... 1
`II.
`III. CLAIM LISTING ............................................................................................ 1
`IV. SCOPE OF THE SUBSTITUTE CLAIMS ..................................................... 2
`V. WRITTEN DESCRIPTION SUPPORT .......................................................... 2
`A.
`Substitute Claim 43 ............................................................................... 3
`B.
`Substitute Claim 44 ............................................................................... 5
`VI. THE LEVEL OF ORDINARY SKILL IN THE ART .................................... 8
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART .................................. 9
`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE ............... 9
`A.
`Substitute Claims 43 and 44: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a System
`With a Tubular Structure Having a Uniform, Fixed Outer Diameter
`and a Coaxial 0.056 Lumen Configured For Use With a 6 French
`Guide Catheter ..................................................................................... 10
`Substitute Claim 43: The Prior Art Does Not Disclose or Suggest the
`Claimed Combination of Elements, Including a Rapid Exchange
`Device That Provides Backup Support ............................................... 13
`Substitute Claim 44: None of the Prior Art Discloses or Suggests the
`Claimed Combination of Features Including the Recited Complex
`Side Opening ....................................................................................... 15
`IX. CONCLUSION .............................................................................................. 20
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`B.
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`C.
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`i
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .............................................................................. 3
`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) .............................................................................. 2
`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
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`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .............................................................................. 3
`Statutes
`35 U.S.C. § 102 ........................................................................................................ 10
`35 U.S.C. § 103 ........................................................................................................ 10
`35 U.S.C. § 316 ......................................................................................................1, 2
`Other Authorities
`37 C.F.R. § 42.121 ............................................................................................ 1, 2, 9
`37 C.F.R. § 42.22 ....................................................................................................... 1
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`ii
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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 45,380 (“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 either of issued claims 1 or 12 of the ’380 patent
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`invalid, Teleflex respectfully requests that the Board substitute the invalid claim(s)
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`with the respective proposed substitute claim of claims 43 and 44. See 37 C.F.R. §
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`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 ’380 patent that would be replaced under this Motion. This
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`claim listing includes one replacement claim for each of claims 1 and 12. The
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`number of proposed substitute claims is reasonable under 35 U.S.C. § 316(d)(1)(B)
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`and 37 C.F.R. § 42.121(a)(3).
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`IV. SCOPE OF THE SUBSTITUTE CLAIMS
`The proposed substitute claims comply with 35 U.S.C. § 316(d)(3) and 37
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`C.F.R. § 42.121(a)(2)(ii) because no substitute claim enlarges the scope of, or
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`eliminates any element from, the original claim it replaces. All amendments
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`reflected in substitute claims 43 and 44 are narrowing amendments, in that all
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`amendments only add limitations to the claims without removing language.
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`V. WRITTEN DESCRIPTION SUPPORT
`Substitute claims 43 and 44 are fully supported by the priority application1
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`because “the disclosure . . . reasonably conveys to those skilled in the art that the
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`inventor had possession of the claimed subject matter as of the filing date.”
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`Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1347 (Fed. Cir. 2019)
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`(citation to quoted case omitted); 37 C.F.R. § 42.121(b); see Ex-2124, ¶¶ 22-27.
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`“Drawings constitute an adequate description if they describe what is claimed and
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`1 The parties have stipulated that all patents at issue in these IPRs have
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`substantively identical disclosures, and have agreed to cite only the priority
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`application, IPR2020-00126, Ex. 1003, cited herein as “Ex. 1003 at XX.”
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`2
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`convey to those of skill in the art that the patentee actually invented what is
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`claimed.” Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc., 291 F.3d
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`1317, 1322 (Fed. Cir. 2002); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1566
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`(Fed. Cir. 1991).
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`A.
`Substitute Claim 43
`The priority application discloses a system for use with interventional
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`cardiology devices adapted to be insertable into a branch artery. Ex. 1003 at 6:15-
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`19; 7:5-7; 10:1-19; 11:13-18; 12:16-20; 17:17-18:14; 22:3-23:2; 38; 39. The
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`application discloses that the system includes a standard 6 French guide catheter
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`having a continuous lumen extending for a predefined length from a proximal end
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`at a hemostatic valve to a distal end adapted to be placed in the branch artery, id. at
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`7:12-13; 10:1-19; 11:15-16; 12:13-15; 17:3-16; 37, the continuous lumen of the
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`guide catheter having a circular cross-sectional inner diameter of at least 0.070
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`inches and sized such that interventional cardiology devices are insertable into and
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`through the continuous lumen of the guide catheter, id. at 6:15-17; 7:5-10, 12-13;
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`10:3-13; 11:16-18; 17:10-12; 18:5-14; 22:3-15.
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`The application discloses that the system includes a device adapted for use
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`with the guide catheter, the device having a flexible tip portion defining a tubular
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`structure, id. at 8:4-16; 12:1-2; 14:7-15:2; 32, and a circular cross-section and a
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`length that is shorter than the predefined length of the continuous lumen of the
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`3
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`guide catheter and a uniform, fixed cross-sectional outer diameter sized to be
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`insertable through the cross-sectional inner diameter of the continuous lumen of
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`the guide catheter, id. at 6:15-17; 8:12-16; 12:1-2, 5-6; 13:7-8; 14:7-9; 14:20-15:2;
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`32; 34; 41 at Figure 14, and defining a coaxial lumen having a cross-sectional inner
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`diameter of at least 0.056 inches through which interventional cardiology devices,
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`including stent catheters, are insertable while the tubular structure is located within
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`the guide catheter, id. at 6:15-17; 7:5-7, 17-18; 10:3-13; 11:16-18; 17:10-12; 18:5-
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`14; 22:3-15.
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`The application discloses that the device includes a substantially rigid
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`portion proximal of and operably connected to, and more rigid along a longitudinal
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`axis than the flexible tip portion, and defining a rail structure without a lumen, id.
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`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,
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`having a maximal cross-sectional dimension at a proximal portion that is smaller
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`than the cross-sectional outer diameter of the flexible tip portion, id. at 6:15-17;
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`12:1-2; 32, and having a length that, when combined with the length of the flexible
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`distal tip portion, defines a total length of the device along the longitudinal axis
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`that is longer than the length of the continuous lumen of the guide catheter, such
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`that when at least a distal portion of the flexible tip portion is extended distally of
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`the distal end of the guide catheter, at least a portion of the proximal portion of the
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`substantially rigid portion extends proximally through the hemostatic valve in
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`4
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`common with interventional cardiology devices that are insertable into the guide
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`catheter, id. at 7:3-7; 8:5-6; 10:3-9; 11:15-18; 22:3-23:2.
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`The application discloses that the tubular structure of the device includes a
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`flexible cylindrical distal tip portion and a flexible cylindrical reinforced portion
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`proximal to the flexible cylindrical distal tip portion, id. at 8:3-16; 12:1-2; 14:7-
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`15:2; 21:11-13; 32, where the flexible cylindrical distal tip portion is more flexible
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`than the flexible cylindrical reinforced portion, id. at 8:7-16; 14:10-15:2; 16:8-18;
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`21:11-17, and that the device is configured such that, when the flexible tip portion
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`extends into the branch artery, the flexible tip portion and substantially rigid
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`portion assist in resisting forces exerted by the interventional cardiology devices
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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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`B.
`Substitute Claim 44
`The application discloses a system for use with interventional cardiology
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`devices adapted to be insertable into a branch artery, Ex. 1003 at 6:15-19; 7:5-7;
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`10:1-19; 11:13-18; 12:16-20; 17:17-18:14; 22:3-23:2; 38; 39. The application
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`discloses that the system includes a standard 6 French guide catheter having a
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`continuous lumen with an internal diameter greater than or equal to 0.070 inches
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`extending for a predefined length from a proximal end at a hemostatic valve to a
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`5
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`distal end adapted to be placed in the branch artery, the continuous lumen of the
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`guide catheter having a circular cross-section and a cross-sectional inner diameter
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`sized such that the interventional cardiology devices are insertable into and through
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`the continuous lumen of the guide catheter, id. at 6:15-17; 7:3-10, 12-13; 10:1-19;
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`11:15-18; 12:13-15; 17:3-16; 18:5-14; 22:3-15; 37.
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`The application discloses that the system includes a device adapted for use
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`with the guide catheter, the device including an elongate structure having an
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`overall length that is longer than the predefined length of the continuous lumen of
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`the guide catheter, id. at 7:3-7; 8:5-6; 10:3-9; 11:15-16; 22:3-23:2, the elongate
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`structure including in a distal-to-proximal direction a cylindrical flexible tip
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`portion and a reinforced portion proximal to the flexible tip portion together
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`defining a tubular structure with a single lumen, id. at 8:3-16; 12:1-2; 13:7-8; 14:7-
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`15:2; 21:9-17; 32; 41 at Figure 14, having a circular cross-section that is smaller
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`than the circular cross-section of the continuous lumen of the guide catheter and a
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`length that is shorter than the predefined length of the continuous lumen of the
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`guide catheter, id. at 6:15-17; 8:12-16; 12:1-2, 5-6; 13:7-8; 14:7-9; 14:20-15:2; 32;
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`34; 41 at Figure 14. The application discloses that the flexible tip portion has a
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`cross-sectional outer diameter sized to be insertable through the cross-sectional
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`inner diameter of the continuous lumen of the guide catheter and defining a coaxial
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`lumen with the guide catheter and with the tubular structure having a cross-
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`6
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`sectional inner diameter of at least 0.056 inches through which the interventional
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`cardiology devices are insertable, id. at 6:15-17; 7:5-7, 17-18; 10:3-13; 11:16-18;
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`17:10-12; 18:5-14; 22:3-15.
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`The application discloses that the device includes a substantially rigid
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`portion proximal of, connected to, and more rigid along a longitudinal axis than,
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`the flexible tip portion and defining a rail structure without a lumen having a
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`maximal cross-sectional dimension at a proximal portion that is smaller than the
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`cross-sectional outer diameter of the flexible tip portion, id. at 6:15-17; 8:4-5;
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`8:17-9:5; 12:1-2; 14:7-9; 15:3-7; 16:18-17:2; 19:12-18; 32; 41, such that when at
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`least a distal portion of the flexible tip portion is extended distally of the distal end
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`of the guide catheter with at least proximal portion of the reinforced portion
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`remaining within the continuous lumen of the guide catheter, at least a portion of
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`the proximal portion of the substantially rigid portion extends proximally through
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`the hemostatic valve in common with the interventional cardiology devices that are
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`insertable into 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 device further includes a substantially
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`rigid partially cylindrical portion proximal to a distal end of the substantially rigid
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`portion, 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, ¶¶ 44, 51, the partially cylindrical portion defining an opening extending
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`for a distance along a side thereof defined transverse to the longitudinal axis of the
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`7
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`device that is adapted to receive the interventional cardiology devices passed
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`through the continuous lumen of the guide catheter and into the coaxial lumen
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`while the device is inserted into the continuous lumen, Ex. 1003 at 6:15-17; 7:5-7,
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`8:18-9:3; 10:7-19; 11:16-18; 12:7-8; 15:4-15; 16:19-17:2; 18:5-14; 19:12-18; 35,
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`where the opening in the partially cylindrical portion includes a first inclined
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`sidewall that is separated from a second inclined sidewall in the partially
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`cylindrical portion by a non-inclined concave track, id. at 8:18-9:3; 12:7-8, 11-12;
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`15:4-15; 35; 36 at Figure 6; 41; Ex-2124, ¶¶ 45-50, 52. Petitioner admits that
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`Figure 4 “discloses a non-inclined region.” IPR2020-00137 Petition at 15.
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`Petitioner also concedes that the application discloses two inclined slopes: “Figure
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`4 shows, at best, only two inclined slopes,” which is a “disclosure of only two
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`different inclined slopes.” IPR2020-01344 Petition at 69. The disclosure discloses
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`that the flexible tip portion is more flexible than the reinforced portion. Ex. 1003
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`at 8:7-16; 14:10-15:2; 16:8-18; 21:11-17.
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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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`IPR2020-00128 Petition at 15; IPR2020-00129 Petition at 13; IPR2020-00130
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`Petition at 12-13.
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`8
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`VII. THE SCOPE AND CONTENT OF THE PRIOR ART
`Before Teleflex’s effective filing date, the prior art described the use of a
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`standard full-length 5 French guide catheter being inserted through a 6 French
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`guide catheter to provide backup support for interventional cardiology devices
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`(Takahashi (Ex. 1010)). It also described embolic protection devices (Ressemann
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`(Ex. 1008); Adams ’280 (Ex. 1035)), suction catheters (Kataishi (Ex. 1025)),
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`balloon catheters (e.g., Enger (Ex. 1050)), and support catheters for fixed-wire
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`devices (Kontos (Ex. 1009); Adams ’292 (Ex. 1034)). No prior art2 known to
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`Teleflex or its expert, Mr. Keith, including that cited by Petitioner in these IPR
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`proceedings, described a rapid exchange guide extension catheter with the features
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`recited in the substitute claims. The closest art known to Teleflex and Mr. Keith is
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`listed in this paragraph. Ex-2124, ¶ 19.
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`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE
`As required by 37 C.F.R. § 42.121(a)(2)(i), the amendments reflected in the
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`proposed substitute claims are responsive to the grounds of unpatentability upon
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`which institution was granted. Each of substitute claims 43 and 44 is novel and
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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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`9
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`nonobvious under 35 U.S.C. §§ 102 and 103, as set forth below. Patentability
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`further is supported by the objective evidence.
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`A.
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`Substitute Claims 43 and 44: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a
`System With a Tubular Structure Having a Uniform, Fixed Outer
`Diameter and a Coaxial 0.056 Lumen Configured For Use With a
`6 French Guide Catheter
`Substitute claims 43 and 44 are directed to a system with “a standard 6
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`French guide catheter” with an inner diameter of at least “0.070 inches,” a
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`“substantially rigid portion,” and a tubular structure “having a cross-sectional inner
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`diameter of at least 0.056 inches” that defines a “coaxial lumen” with the guide
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`catheter. Substitute claim 43 adds that the tubular structure has a “uniform, fixed
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`cross-sectional outer diameter.” As discussed in the disclosure, an important
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`feature of the disclosed device is the ability to provide only a one French size
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`difference between the guide catheter and the guide extension catheter. Ex. 1003,
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`7:8-18. According to the specification, a one French size difference for a 6 French
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`guide catheter corresponds to an inner diameter of 0.056 inches for the guide
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`extension catheter. Id.
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`None of the prior art discloses or renders obvious the combination of
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`elements recited in substitute claims 43 and 44, including the coaxial and size
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`limitations in a rapid exchange device. The Itou reference is not prior art. In the
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`related Petitions, Petitioner has relied on a combination of Ressemann and
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`10
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`Takahashi or Kontos and Takahashi to argue for the obviousness of claims
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`containing “not more than one French size” difference limitations. As for the
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`alleged Ressemann/Takahashi combination, Ressemann is an “embolic protection
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`device” designed to stop blood flow within a cardiac artery. Ex. 1008 at 2:56-61,
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`6:10-15. To provide this function, Ressemann’s evacuation head includes both
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`balloons on the outer surface of the device, as well as a multi-lumen tube having at
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`least an evacuation lumen and an inflation lumen. Id., e.g., 6:35-65, Figs. 1A, 1B,
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`11A, 11B, 16D, 16E. As the Board already correctly found in denying institution
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`of a related IPR, the presence of multiple lumens means that the evacuation lumen
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`of Ressemann is not configured to be “coaxial” with the lumen of the guide
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`catheter. IPR2020-00133, Paper 20 at 14-15. Moreover, the presence of the
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`balloons and the inflation lumen preclude the ability to make a device that would
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`both fit in a 6 French guide catheter and have an 0.056 inch evacuation lumen.
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`And the Board correctly criticized any argument that it would have been obvious to
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`modify Ressemann to remove the balloons and the inflation lumen, noting that
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`“[t]hese modifications would extinguish the capability of the device to act as an
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`aspiration catheter.” IPR2020-00129, Paper 22 at 33. The presence of the
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`balloons also means that Ressemann’s device does not have a “tubular structure
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`having a uniform, fixed cross-sectional outer diameter . . . defining a coaxial
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`lumen,” as recited in substitute claim 43.
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`11
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`A similar analysis applies with respect to the alleged Kontos/Takahashi
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`combination. Kontos teaches a distal body structure 12 that has a narrow central
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`tube 16 designed to snugly receive the balloon of a balloon catheter, together with
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`projections at the distal and proximal ends that project outwardly to fill the gap
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`between the outer surface of the tube and the inner surface of the guide catheter:
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`Distal protrusion
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`Proximal protrusion
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`Ex. 1009 at Fig. 1 and 4:48-56. Petitioner has argued that it would have been
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`obvious to replace the funnel at the proximal end of Kontos’s device with an
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`angled opening. E.g., IPR2020-00136, Petition at 68-72. However, even assuming
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`such a modification would have been obvious (which it would not), it still would
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`not be possible in light of the other structures that project from the outer surface of
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`Kontos’s tube to size the device with an 0.056 inner diameter that still fits in a 6F
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`guide catheter. Moreover, if modified as proposed by Petitioner to remove the
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`funnel, it would render Kontos’s support catheter asymmetric at the proximal end,
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`12
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`with the axis of its lumen located substantially above the axis of the guide catheter
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`lumen:
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`Thus, Kontos’s device modified as proposed by Petitioner would not have a
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`“coaxial lumen,” as recited in substitute claims 43 and 44. It also does not (and
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`would not even if modified as proposed by Petitioner) have a “tubular structure
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`having a uniform, fixed cross-sectional outer diameter . . . defining a coaxial
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`lumen,” as recited in substitute claim 43.
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`B.
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`Substitute Claim 43: The Prior Art Does Not Disclose or Suggest
`the Claimed Combination of Elements, Including a Rapid
`Exchange Device That Provides Backup Support
`In addition to the size and outer-diameter uniformity limitations discussed in
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`the previous section, substitute claim 43 requires that the claimed device be
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`“configured such that, when the flexible tip portion extends into the branch artery,
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`the flexible tip portion and substantially rigid portion assist in resisting forces
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`exerted by the interventional cardiology devices passed through and beyond the
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`coaxial lumen that would otherwise tend to dislodge the guide catheter from the
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`artery.” Particularly in the context of a rapid exchange device such as that required
`13
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`by claim 43,3 this additional requirement for added backup support further
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`distinguishes claim 43 over the Kontos reference.
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`The device of Kontos is not designed to resist backout forces, nor would a
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`POSITA expect that Kontos’s device would do so. As discussed above, Kontos’s
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`device has a long, narrow tube 16 in its center portion, with larger-diameter
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`protrusions at its proximal and distal ends. Ex. 1009 at Fig. 1 and 4:48-56. As a
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`result of this design, when the distal end of Kontos’s device is extended out the end
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`of the guide catheter, there is a substantial gap between the tube and the inner walls
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`of the guide catheter, with the primary point of contact being limited to the
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`proximal “base portion” 18. Moreover, Kontos’s device is disclosed as being
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`made of a “pliable” material such as polyethylene, and it does not disclose any
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`reinforcement in the central, narrow portion of its tube 16. Id. at 4:1-4. As a
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`result, the device would be akin to a “wet noodle.” When subjected to backout
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`forces, a POSITA would expect it to twist, buckle and/or “crunch up,” rather than
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`resist forces.
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`3 The rapid exchange functionality is reflected, inter alia, in the claim requirements
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`for a tubular structure connected to a proximal substantially rigid portion that
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`defines a rail structure.
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`14
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`C.
`
`Substitute Claim 44: 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
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`are beyond a single-incline skived opening, and have a complex shape that further
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`improves the ability of interventional cardiology devices (particularly larger
`
`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:
`
`Complex Side Opening
`
`
`
`Id. at 35.
`
`Substitute claim 44 adds a complex side opening limitation: “the opening in
`
`the partially cylindrical portion includes a first inclined sidewall that is separated
`
`from a second inclined sidewall in the partially cylindrical portion by a non-
`
`inclined concave track.”
`
`
`
`15
`
`
`
`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
`
`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.
`
`
`
`16
`
`
`
`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 focusses 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:
`
`
`
`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.
`
`
`
`17
`
`
`
`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,
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`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
`
`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 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
`
`
`
`18
`
`
`
`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. Id. at e.g., 6:18-20, 35-65, Figs. 1A, 1B, 6C, 16D, 16E. Placing
`
`the tab portion of the collar outside these lumens (i.e., below the inflation lumen
`
`and core wire lumen of Ressemann’s shaft) provides a flexibility transition that
`
`helps maintain this patency. Yet Petitioner’s obviousness theory is premised on
`
`placing Ressemann’s collar on top of the shaft of the primary references, instead of
`
`at the bottom of the shaft as shown in and taught by Ressemann. This is further
`
`evidence that Petitioner’s obviousness theory is based on hindsight, not the
`
`teaching of the references.
`
`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
`
`facilitate delivery of the balloon catheter. Petitioner claims that the proximal
`
`opening Enger’s guidewire lumen has a complex shape including two inclined
`
`portions. IPR2020-00129, Petition at 54-55. But as Petitioner’s own expert
`
`
`
`19
`
`
`
`admitted, Enger does not disclose a side opening having two inclined regions. Ex.
`
`2137 at 236:2-21, 237:7-11. What Petitioner pointed to as the alleged second
`
`incline is not part of the guidewire opening, but is simply a cross-sectional view of
`
`a tubular “necked structure” where a separate part of the distal portion receives a
`
`metal tube of the push rod. Id. at 236:2-21, 237:7-11, see also id. at 228:10-229:3
`
`(admitting that immediately distal to the opening is a tube with a convex outer
`
`surface). And to make matters worse for Petitioner, the proximal opening of
`
`Enger’s guidewire lumen is not even an entrance opening; it is an exit opening.
`
`All the experts agree that this proximal opening could not and would not be used to
`
`receive even a guidewire while the device is positioned within the guide catheter
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`(as required by the claims). Ex. 2116 at 202:24-203:15; Ex. 2137 at 346:12-347:6,
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`see also id. at 90:15-23. Petitioner’s obviousness argument based on Enger
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`borders on specious.
`
`IX. CONCLUSION
`Teleflex respectfully requests that, if either of original claims 1 or 12 is
`
`found unpatentable, the Board enter the respective substitute claim(s) 43-44 in its
`
`
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