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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00127
`Patent 8,048,032
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
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`
`I.
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS ............................ 1
`
`TABLE OF CONTENTS
`
`II.
`
`INTRODUCTION TO THE PRESENT PATENT OWNER RESPONSE .... 3
`
`III. BACKGROUND ............................................................................................. 4
`
`A.
`
`B.
`
`C.
`
`The Revolutionary GuideLiner Product ................................................ 4
`
`The ’032 Patent ..................................................................................... 5
`
`The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’032 Patent in the District of Minnesota .....................10
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ...............................12
`
`V.
`
`CLAIM CONSTRUCTION ..........................................................................13
`
`A. A flexible tip portion/tubular portion “defining a coaxial lumen
`having a cross-sectional inner diameter through which
`interventional cardiology devices are insertable” (Claims 1, 11) .......13
`
`B.
`
`Other Terms .........................................................................................18
`
`VI. THE KONTOS REFERENCE (Ex. 1409) ....................................................18
`
`VII. THE ADAMS REFERENCE (Ex. 1435) ......................................................20
`
`VIII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ................21
`
`A. ALL GROUNDS: The Petition Should Be Denied Under
`35 U.S.C. § 314(a) ...............................................................................21
`
`B.
`
`ALL GROUNDS: The Petition Should Be Denied Because
`Medtronic Failed to Justify Its Filing of Multiple Petitions ...............25
`
`C. ALL GROUNDS: Medtronic Has Not Identified Any Prior Art
`Showing the Claimed Structure “defining a coaxial lumen having
`a cross-sectional inner diameter through which interventional
`cardiology devices are insertable” (Claim 1.a, Claim 11.b) ...............27
`
`D. ALL GROUNDS: The Petition Should Be Denied Because It
`Failed to Address Known, Compelling Objective Evidence of
`
`i
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`
`
`Non-Obviousness ................................................................................30
`
`1.
`
`2.
`
`3.
`
`Commercial Success .................................................................33
`
`Industry Praise ...........................................................................37
`
`Licensing and Licensing Attempts ...........................................38
`
`4. Copying .....................................................................................39
`
`5.
`
`Long-Felt Need .........................................................................41
`
`E.
`
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ..................................................................................43
`
`IX. CONCLUSION ..............................................................................................44
`
`CERTIFICATE OF WORD COUNT COMPLIANCE ...........................................45
`
`CERTIFICATION OF SERVICE............................................................................46
`
`
`
`
`
`
`ii
`
`
`
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................36
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019) ............................................................................43
`
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
`IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ...............................................33
`
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-00279, -00280, -00282, -00283, Paper 10 (PTAB July 1, 2019) ..........27
`
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-01354, -01355, Paper 10 (PTAB Jan. 27, 2020) ...................................26
`
`Dropbox, Inc. v. Whitserve LLC,
`IPR2019-01018, Paper 13 (PTAB Nov. 1, 2019) .................................................27
`
`E-One, Inc. v. Oshkosh Corp.,
`IPR2019-00161, Paper 16 (PTAB May 15, 2019) ........................................ 23, 24
`
`Gilead Scis., Inc. v. United States,
`IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ................................................33
`
`Gilead Scis., Inc. v. United States,
`IPR2019-01455, Paper 16 (PTAB Feb. 5, 2020) ..................................................33
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) ............................................................................30
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 37, 38
`
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................39
`
`Jack Guttman, Inc. v. Kopykake Enters.,
`302 F.3d 1352 (Fed. Cir. 2002) ............................................................................13
`
`iii
`
`
`
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) ..........................................................................................43
`
`Merial Ltd. v. Virbac,
`IPR2014-01279, Paper 13 (PTAB Jan. 22, 2015) ................................................33
`
`NHK Spring Co., Ltd., v. Intri-Plex Technologies, Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) .................................... 21, 23, 24
`
`Polaris Indus. v. Arctic Cat,
`882 F.3d 1056 (Fed. Cir. 2018) ............................................................................35
`
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) .................................. 32, 33, 36
`
`Square, Inc. v. 4361423 Canada Inc.,
`IPR2019-01628, Paper 14 (PTAB Mar. 31, 2020) ........................................ 25, 26
`
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) ..............................................................................41
`
`Stryker Corp. v. KFx Medical, LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ...............................................33
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................30
`
`United States v. Booker,
`543 U.S. 220 (2005) ..............................................................................................43
`
`Vitronics Corp. v. Conceptronic,
`90 F.3d 1576 (Fed. Cir. 1996) ..............................................................................13
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................41
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................39
`
`Statutes
`
`35 U.S.C. § 102(b) ...................................................................................................18
`
`35 U.S.C. § 311(b) ...................................................................................................28
`
`
`
`iv
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`
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`35 U.S.C. § 312(a)(3) ...............................................................................................28
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`35 U.S.C. § 314(a) ...................................................................................................21
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`35 U.S.C. § 316(b) ............................................................................................ 21, 25
`
`Other Authorities
`
`November 2019 Consolidated Trial Practice Guide ................................... 25, 26, 28
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`
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`
`
`
`
`v
`
`
`
`TABLE OF EXHIBITS
`
`Exhibit Descri n tion
`
`2001
`
`2002
`
`2003
`
`Reserved
`
`Reserved
`
`Reserved
`
`2004
`
`Reserved
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`2010
`
`Reserved
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`2016
`
`Reserved
`
`
`
`Reserved
`2017
`
`2018
`[Reserved]
`2019
`Reserved
`
`2020
`
`Reserved
`
`2021
`
`Reserved
`
`2022
`2023
`
`[Reserved]
`Reserved
`
`2024
`
`Reserved
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`3033
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`2034
`
`Reserved
`
`2035
`
`Reserved
`
`2036
`
`Reserved
`
`vi
`
`
`
`[Reserved]
`2037
`[Reserved]
`2038
`[Reserved]
`2039
`[Reserved]
`2040
`[Reserved]
`2041
`[Reserved]
`2042
`2043 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Under Seal), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 78 –
`PROTECTIVE ORDER MATERIAL
`2044 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Redacted), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 79
`[Reserved]
`2045
`2046 Declaration of Howard Root in Support of Plaintiff’s Motion for
`Preliminary Injunction, Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn), Dkt. 12
`[Reserved]
`2047
`2048 Defendants’ Opposition to Plaintiffs’ Motion for Preliminary Injunction
`(Redacted), Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 104
`2049 Amended Pretrial Scheduling Order, Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 229
`2050 Defendants’ Second Amended Notice of Deposition of Peter Keith,
`Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D.
`Minn.)
`2051 Defendants’ Amended Notice of Deposition of Amy Welch, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`[Reserved]
`2052
`2053 Defendants’ Interrogatories to Plaintiffs Concerning Preliminary
`Injunction Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-
`01760-PJS-TNL (D. Minn.)
`2054 Defendants’ Requests for Production of Documents Concerning
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2055 Article Titled: Understanding Low-Friction Coatings for Medical
`Devices
`2056 Expert Report of Peter T. Keith on Infringement, Claim Coverage, and
`Lack of Acceptable Noninfringing Alternatives, QXMédical, LLC v.
`
`
`
`vii
`
`
`
`Vascular Solutions LLC, 17-cv-01969 (D. Minn.), Dkt. 125-22
`2057 Teleflex Product Patents Website
`2058 Confidential Presentation – PROTECTIVE ORDER MATERIAL
`2059
`Plaintiffs’ First Supplemental Objections and Responses to Defendants’
`Interrogatories Concerning Preliminary Injunction Issues, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2060 Globe Newswire: Teleflex Announces Tenth Anniversary of GuideLiner
`Catheter Product Line
`2061 GuideLiner Marketing Material V1 Catheter
`2062 GuideLiner Marketing Material V2 Catheter
`2063 GuideLiner Marketing Material: That’s A Real Game Changer
`2064
`[Reserved]
`2065 GuideLiner Catheter Bibliography
`2066 Physician Testimonial Authorizations
`2067 Rao, U., et al., The GuideLiner “child” catheter, EuroIntervention 2010
`6:277-279
`2068 Defendants’ Answer, Defenses, and Counterclaims to Plaintiffs’
`Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 16
`2069 Exhibit E to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-5
`2070 Medtronic comparison of guide extension catheters
`2071 Exhibit A to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-1
`2072 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 77
`2073 Declaration of Alexander S. Rinn
`2074
`[Reserved]
`2075
`[Reserved]
`2076
`[Reserved]
`2077
`[Reserved]
`2078 Defendants’ Answer and Defenses to Plaintiffs’ First Amended and
`Supplemental Complaint and Second Amended Counterclaims Against
`Plaintiffs, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.), Dkt. 233
`2079 Exhibit A to Defendants’ Answer and Defenses to Plaintiffs’ First
`Amended and Supplemental Complaint and Second Amended
`Counterclaims Against Plaintiffs, Vascular Solutions LLC v. Medtronic,
`
`
`
`viii
`
`
`
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`2080 Excerpts from the March 11, 2019 Deposition of Peter Keith,
`QXMédical, LLC v. Vascular Solutions LLC, 17-cv-01969 (D. Minn.)
`Plaintiff’s Reply Memorandum in Support of Motion for Preliminary
`Injunction (Redacted), Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn)
`
`2081
`
`
`
`
`
`
`ix
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`
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`I.
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`INTRODUCTION COMMON TO ALL IPR PETITIONS
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`Petitioner Medtronic has filed 13 IPR petitions against a family of five
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`related patents protecting Patent Owner Teleflex’s revolutionary GuideLiner®
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`guide extension catheter (hereinafter “GuideLiner”). When Teleflex’s predecessor
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`in interest to the patents, Vascular Solutions, Inc. (“VSI”), introduced GuideLiner
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`in 2009, it enabled physicians to perform interventional cardiology procedures
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`previously thought to be impossible.1 GuideLiner created the market for a new
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`type of medical device—rapid exchange guide extension catheters capable of
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`receiving and delivering stents and balloon catheters—that quickly became VSI’s
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`flagship product. To this day, many still know and refer to Teleflex’s
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`Interventional business as “the GuideLiner company.” GuideLiner and its
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`associated patent coverage (“GuideLiner patents”) were an important factor in
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`Teleflex’s decision to invest nearly $1 billion in the purchase of VSI in 2017. The
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`success of GuideLiner also caught the eye of two of the largest medical product
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`companies in the world, Boston Scientific (which licensed the GuideLiner patents
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`and has paid royalties since 2013) and, more recently, Petitioner Medtronic.
`
`Medtronic has known this dispute was coming for years. Medtronic
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`
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`1 VSI converted to Vascular Solutions LLC on August 8, 2017. The business now
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`operates as the Interventional Business Unit of Teleflex Incorporated (“Teleflex”).
`
`1
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`
`
`
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`, and recognizing the importance of the GuideLiner
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`invention, Medtronic set out to introduce a product to compete with GuideLiner.
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`While Medtronic appears to have started with the goal of avoiding infringement of
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`the GuideLiner patents, it ultimately abandoned those plans in favor of copying the
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`patented technology. In early 2019, Medtronic approached Teleflex on multiple
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`occasions seeking to license the GuideLiner patents. When Teleflex refused,
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`Medtronic launched its infringing Telescope product anyway. On July 2, 2019,
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`Teleflex filed suit for infringement of five of the GuideLiner patents in the District
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`of Minnesota, including the ’032 patent, which is the subject of the present
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`petition. That litigation is ongoing.
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`
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`Having known for several years that it was going to infringe the GuideLiner
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`patents, Medtronic should have filed its IPR petitions promptly after deciding it
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`was going to infringe. Had Medtronic done so, those IPR proceedings would be
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`completed by now.
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`But for Medtronic, the largest medical products company in the world, being
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`able to sell infringing products during the pendency of protracted litigation has
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`great upside (and great downside for patent holders like Teleflex), even if
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`Medtronic ultimately loses and is forced to pay damages. Moreover, having
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`
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`2
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`
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`closely copied GuideLiner, Medtronic’s validity challenge needs to prevail, not
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`just on the broader claims, but on many of the narrower claims as well. So instead
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`of filing its IPRs before infringing, Medtronic simply launched its infringing
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`product and waited for the inevitable lawsuit. And even after the lawsuit was filed,
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`Medtronic did not promptly file its IPRs. Instead, Medtronic waited until the last
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`moment before its response to Teleflex’s preliminary injunction motion was due in
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`the district court to file 13 IPR Petitions on five patents in suit. Medtronic then
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`argued that the mere filing of the IPR petitions justified denial of Teleflex’s
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`preliminary injunction motion. Medtronic has made no secret of the fact that, if
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`any of its IPR petitions are granted, it will ask the district court to stay the litigation
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`pending the outcome of those IPRs. If Medtronic is successful in this strategy, it
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`will eat up most of the remaining life of the patents in suit (all but one of which
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`expire in 2026), even if its validity challenge ultimately fails as to some or all of
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`the claims. The Board should not help further such delay strategies, which weaken
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`the value of patents for patent holders.
`
`II.
`
`INTRODUCTION TO THE PRESENT PATENT OWNER
`RESPONSE
`
`The Board should not condone Medtronic’s delay strategies and should
`
`decline to institute this Petition. Institution would be a highly inefficient use of the
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`Board’s resources. The same validity issues, between the same parties, and
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`regarding the same patent are already being litigated in the district court. The
`
`
`
`3
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`
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`district court is already familiar with the ’032 patent and Medtronic’s lead Kontos,
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`Adams, and Takahashi references. In addition, the Petition fails to identify any
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`prior art with the claimed structure required by each independent claim challenged:
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`a “coaxial lumen having a cross-sectional inner diameter through which
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`interventional cardiology devices are insertable,” where the interventional
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`cardiology devices include—as required by the claims—stents and stent catheters.
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`Finally, the Petition fails to address compelling objective evidence of
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`nonobviousness that Medtronic knew about before filing. Medtronic was fully
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`aware of the commercial success, licensing and licensing requests, industry praise,
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`and copying associated with the claimed invention before it filed the Petition, yet
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`there is nothing in the Petition to explain why Medtronic is likely to succeed in
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`counteracting this known evidence. For at least these reasons, the Board should
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`decline to institute.
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`III. BACKGROUND
`
`A.
`
`The Revolutionary GuideLiner Product
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`In the early 2000s, VSI was a small Minnesota medical device company
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`working on developing various catheter-based technologies. Ex. 2044 (Welch
`
`Decl.), ¶¶ 8, 10. In the fall of 2004, VSI’s founder Howard Root, along with his
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`team, conceived of what would eventually become the revolutionary GuideLiner
`
`guide extension catheter. The invention was a new type of medical device—a
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`
`
`4
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`
`
`rapid exchange guide extension catheter capable of receiving and delivering stents
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`and balloon catheters. Over the next few years, VSI worked to obtain the
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`necessary regulatory approvals and commercialize the invention.
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`VSI launched the GuideLiner commercial product in 2009. The GuideLiner
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`created a new market category—guide extension catheters. Id. ¶ 9. The
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`GuideLiner product “put VSI on the map.” Id. ¶ 4. Sales grew quickly, doubling
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`from 2010 to 2011, and doubling again from 2011 to 2013. Ex. 2043 (Welch
`
`Decl.), ¶ 13; see Ex. 2046 (Root 2013 Decl.), ¶ 39. By 2013 GuideLiner was
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`VSI’s top-selling product, and by early 2014 it was used in all of the approximately
`
`2,000 cardiac catheterization laboratories (hospitals) across the United States. Ex.
`
`2044, ¶¶ 4, 12. Total GuideLiner sales to date are more than
`
`. See Ex.
`
`2043, ¶ 13. Until Medtronic entered the market with its infringing Telescope
`
`product, GuideLiner had over a
`
` market share in the U.S., with the remainder
`
`belonging to Teleflex’s licensee, Boston Scientific. See id. ¶¶ 34–35.
`
`B.
`
`The ’032 Patent
`
`The ’032 patent is one of a family of patents that covers the GuideLiner
`
`products. The ’032 patent is directed to a coaxial guide catheter (also referred to as
`
`a “guide extension catheter”) that is passed through the lumen of a guide catheter,
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`advanced beyond the distal end of the guide catheter, and inserted into a branch
`
`artery of the aorta to facilitate delivery of stents, balloon angioplasty catheters and
`
`
`
`5
`
`
`
`other interventional cardiology devices. Ex. 1401 at Abstract.
`
`
`
`One of the important benefits of the device disclosed in the ’032 patent is
`
`increased “back-up support.” As the patent teaches, when treating a stenosis, a
`
`guide catheter is typically guided into the ostium (opening) of the branch artery to
`
`be treated, and a guidewire is passed through the lumen of the guide catheter and
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`advanced into the artery beyond the stenosis. Id. at 1:30–36. Below is Figure 7 of
`
`the patent (color added), showing a typical guide catheter 56 (pink) inserted into
`
`the ostium 60 of a coronary artery, with a guidewire 64 passing through the guide
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`catheter and attempting to cross a stenotic lesion 66:
`
`
`Id. at 7:26–40. When the wire or an interventional cardiology device such as a
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`stent or balloon catheter encounters a difficult lesion, advancing it across the lesion
`
`can create backward force strong enough to dislodge the guide catheter’s distal end
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`from the ostium. Id. at 1:36–38; 4:40–46. The phantom guide catheter (yellow) in
`
`Figure 7 shows how backward force generated by the advancing device can cause
`
`
`
`6
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`
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`the guide catheter to dislodge from the ostium. Id. at 7:41-43.
`
`
`
`The ’032 patent addresses this problem by providing a guide extension
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`catheter that provides increased backup support for guide catheters inserted into a
`
`coronary artery. Id. at 1:8–11. Figure 9 (color added), below, illustrates how the
`
`guide extension catheter 12 (orange with blue tip) is inserted past the end of guide
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`catheter and deep into the coronary artery:
`
`
`Id. at 5:41-43. Not only does the guide extension catheter help guide
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`interventional cardiology devices closer to the desired location (e.g., a blockage or
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`lesion); it also reduces the tendency of the guide catheter (pink) to back out of the
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`ostium when the operator increases the pressure on the proximal end of a wire or a
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`stent or balloon delivery catheter to advance it across a lesion.
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`The guide extension catheter of the invention generally includes, from distal
`
`to proximal direction, a soft tip portion, a tubular portion, and a substantially rigid
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`portion that has a rail segment to permit delivery without blocking use of the guide
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`
`
`7
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`
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`catheter. E.g., id. at 6:9–10 and Figs. 1, 4, 20–22. An advantage of the design is it
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`reduces the available space to deliver interventional cardiology devices only
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`slightly – by no more than “one French size” smaller than the guide catheter in the
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`preferred embodiment. Id. at 3:5–20.
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`The guide extension catheter preferably has a proximal side opening that
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`includes, from distal to proximal direction, a first full circumference portion (34,
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`blue), a hemicylindrical portion (36, green), and an arcuate portion (38, purple):
`
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`Id. at 6:41–51; Fig. 4 (color added).
`
`An exemplary claim—claim 1—is provided below:
`
`
`
`1. A device for use with a standard guide catheter, the
`
`standard guide catheter having a continuous lumen
`
`extending for a predefined length from a proximal end at
`
`a hemostatic valve to a distal end adapted to be placed in
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`a branch artery, the continuous lumen of the guide
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`catheter having a circular cross-sectional inner diameter
`
`sized such that interventional cardiology devices are
`
`insertable into and through the lumen to the branch
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`artery, the device comprising:
`
` flexible tip portion defining a tubular structure having a
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` a
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`
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`8
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`
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`circular cross-section and a length that is shorter than the
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`predefined length of the continuous lumen of the guide
`
`catheter, the tubular structure having a cross-sectional
`
`outer diameter sized to be insertable through the cross-
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`sectional inner diameter of the continuous lumen of the
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`guide catheter and defining a coaxial lumen having a
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`cross-sectional inner diameter through which
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`interventional cardiology devices are insertable; and
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` substantially rigid portion proximal of and operably
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` a
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`connected to, and more rigid along a longitudinal axis
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`than, the flexible tip portion and defining a rail structure
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`without a lumen and having a maximal cross-sectional
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`dimension at a proximal portion that is smaller than the
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`cross-sectional outer diameter of the flexible tip portion
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`and having a length that, when combined with the length
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`of the flexible distal tip portion, defines a total length of
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`the device along the longitudinal axis that is longer than
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`the length of the continuous lumen of the guide catheter,
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`
`
`such that when at least a distal portion of the flexible tip
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`portion is extended distally of the distal end of the guide
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`catheter, at least a portion of the proximal portion of the
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`substantially rigid portion extends proximally through the
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`hemostatic valve in common with interventional
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`cardiology devices that are insertable into the guide
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`catheter.
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`
`
`9
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`
`
`C.
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`The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’032 Patent in the District of Minnesota
`
`The validity of the ’032 patent, including certain of the claims challenged in
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`
`
`this IPR, has been the subject of nearly three years of active litigation in the
`
`District of Minnesota, in two separate cases. On June 8, 2017, QXMédical filed a
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`declaratory judgment action against VSI. QXMédical, LLC v. Vascular Sols. LLC,
`
`No. 17-cv-01969-PJS-TNL, Dkt. 1 (D. Minn. June 8, 2017) (“QXM case”). On
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`July 2, 2019, while the QXM case was ongoing, Teleflex filed suit against
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`Medtronic, alleging that Medtronic’s copycat “Telescope” product infringes the
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`’032 patent, among others. Vascular Sols. LLC v. Medtronic, Inc., No. 19-cv-
`
`01760-PJS-TNL, Dkt. 1 (D. Minn) (“Teleflex v. Medtronic” or “district court
`
`case”); see also Ex. 1479. The QXM and Teleflex v. Medtronic cases have been
`
`designated “related” and are assigned to the same judge, who is now exceedingly
`
`familiar with the subject matter and validity of the ’032 patent.
`
`The QXM case is trial-ready. The Court has construed a number of claim
`
`terms and has issued a summary judgment order holding, inter alia, that the
`
`asserted claims are not invalid as indefinite or invalid under the recapture rule, and
`
`that QXM infringes certain claims. Ex. 1413; QXM, No. 17-cv-01969, Dkt 194 at
`
`1; id. at Dkt. 156 at 41–42. The same Kontos reference (Ex. 1409) that is
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`Medtronic’s lead reference in this Petition was also one of the three “primary”
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`prior art references the defendant in the QXM case relied on. E.g. QXM, No. 17-
`
`
`
`10
`
`
`
`cv-01969, Dkt. 110 at 6-8; id. at Dkt. 111-1 at 12-13. Trial was initially scheduled
`
`to begin on February 24, 2020, but QXM moved to stay, agreeing to waive its
`
`remaining Section 102 and 103 defenses and to exit the U.S. market for the
`
`duration of the stay. Id. at Dkt. 194 at 2. In view of QXM’s concessions, the
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`Court agreed to stay the QXM case until the Board renders its institution decisions
`
`on the IPRs Medtronic has filed against the GuideLiner patents. Id.
`
`The Medtronic case concerns Medtronic’s infringement of several patents,
`
`including the ’032 patent. Ex. 1479, ¶¶ 28–46. In that case, Medtronic relies on
`
`the same invalidity grounds as this Petition. Compare Ex. 2078 at ¶ 15 with
`
`Petition at 7. The parties have already conducted extensive fact discovery,
`
`including serving and responding to interrogatories, serving and responding to
`
`document requests, and exchanging over 25,000 documents so far. Ex. 2073, ¶ 22.
`
`Further, Medtronic has deposed Teleflex’s technical expert, Peter Keith, and
`
`Teleflex’s Regional Sales Director Amy Welch. Ex. 2050; Ex. 2051. Fact
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`discovery remains ongoing and is set to close on September 1, 2020. Ex. 2049 at
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`2. The parties must submit their joint claim construction statement by October 15,
`
`2020. Id. at 4–5. The case must be trial ready by August 1, 2021. Id. at 9.
`
`Teleflex and Medtronic have also fully briefed and argued a motion for
`
`preliminary injunction that concerns validity issues like those at issue in the
`
`Petition: whether Kontos in view of Adams renders certain claims of Teleflex’s
`
`
`
`11
`
`
`
`patents invalid. Ex. 2048 at 38–39 and 42–44 (Medtronic opposition brief);
`
`Teleflex v. Medtronic, No. 19-cv-01760-PJS-TNL, Dkt. 184 at 9-10 (Teleflex
`
`Reply brief).2 In conjunction with this briefing, the parties submitted voluminous
`
`supporting evidence. E.g., id. Dkt. 191 at ¶¶ 30-43 (reply declaration of Teleflex
`
`technical expert Peter Keith discussing the Kontos and Adams references), Dkts.
`
`79, 193 (declarations of Teleflex’s Regional Sales Director Amy Welch addressing
`
`issues such as market success and licensing of the GuideLiner product), Dkt. 112
`
`(declaration of Medtronic’s expert Paul Zalesky addressing, inter alia, validity),
`
`and Dkt. 110 (declaration of Medtronic witness Heather S. Rosecrans addressing
`
`copying).
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART
`
`For purposes of this Preliminary Response only, Teleflex does not currently
`
`dispute Medtronic’s proposed definition of a POSITA. Petition at 12. If a trial is
`
`instituted, Teleflex reserves the right to submit a different POSITA definition than
`
`that proposed by Medtronic.
`
`
`
`
`2 Claims of the ’032 patent, while asserted in the parallel District of Minnesota
`
`litigation between Teleflex and Medtronic, were not specifically asserted as part of
`
`the preliminary injunction briefing.
`
`
`
`12
`
`
`
`V. CLAIM CONSTRUCTION
`
`A. A flexible tip portion/tubular portion “defining a coaxial lumen
`having a cross-sectional inner diameter through which
`interventional cardiology devices are insertable” (Claims 1, 11)
`
`A patentee can be his or her own lexicographer when the definition of the
`
`term “is clearly stated in the patent specification or file history.” Vitronics Corp. v.
`
`Conceptronic, 90 F.3d 1576, 1582 (Fed. Cir. 1996). When the patentee has clearly
`
`defined the term, that definition “usually . . . is dispositive; it is the single best
`
`guide to the meaning of a disputed term.” Jack Guttman, Inc. v. Kopykake Enters.,
`
`302 F.3d 1352, 1360 (Fed. Cir. 2002). That is exactly the situation here. The ’032
`
`patent specification expressly defines the claim term “interventional cardiology
`
`devices”:
`
`For the purposes of this application, the term
`
`“interventional cardiology devices” is to be understood
`
`to include but not be limited to guidewires, balloon
`
`catheters, stents and stent catheters.
`
`Ex. 1401 at 1:17–21 (emphasis added). That means that “interventional cardiology
`
`devices,” as used in independent claims 1 and 11 of the ’032 patent, must include,
`
`at a minimum, guidewires, balloon catheters, stents and stent catheters. Medtronic
`
`
`
`13
`
`
`
`accepts this construction, Petition at 14.3
`
`However, there is an important aspect of this construction that Medtronic
`
`ignores. The express language of the claims requires that the tubular structure of
`
`claim 1 and the flexible tip portion of claim 11 define a coaxial lumen having a
`
`cross-sectional inner diameter “through which interventional cardiology devices
`
`are insertable.” Ex. 1401 at 10:29–37 and 11:39–49. Properly construed, this
`
`language requires that at least all four enumerated devices (guidewires, balloon
`
`catheters, stents, and stent catheters) be insertable into the lumen. This construction
`
`is based on the plain language of the claims (“interventional cardiology devices”),
`
`as well as the definition’s use of the inclusive conjunction “and.”
`
`In this regard, it is important to compare the language of claims 1 and 11
`
`with that of claims of other patents in the same family as the ’032 patent.
`
`Independent claim 25 of related U.S. Patent No. RE45,380 uses different language
`
`and recites only “an interventional device.” IPR2020-00128, Ex. 1001 at 13:44
`
`(emphasis added). Similarly, another patent in the same family, U.S. Patent No.
`
`
`3 Medtronic notes that Teleflex “stipulated” to a definition of “interventional
`
`cardiology device(s)” in another litigation wi