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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.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00126
`Patent 8,048,032
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
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`TABLE OF CONTENTS
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`PAGE
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS ........................ 1
`
`INTRODUCTION TO THE PRESENT PATENT OWNER
`RESPONSE ................................................................................................. 3
`
`A.
`
`The Revolutionary GuideLiner Product ............................................ 6
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`B.
`
`C.
`
`
`The ’032 Patent ................................................................................. 7
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`The QXM and Medtronic Cases: Parallel Litigation Regarding
`the Validity of the ’032 Patent in the District of Minnesota ...........12
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`THE PERSON OF ORDINARY SKILL IN THE ART ...........................16
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`
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`I.
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`II.
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`III. BACKGROUND ......................................................................................... 6
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`IV. PRIORITY DATE – PRE-AIA LAW APPLIES ......................................14
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`V.
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`VI. CLAIM CONSTRUCTION ......................................................................16
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`VII. THE ITOU REFERENCE (Ex. 1007) .......................................................20
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`VIII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ............21
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`A. A flexible tip portion/tubular portion “defining a coaxial lumen
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`having a cross-sectional inner diameter through which interventional
`
`cardiology devices are insertable” (Claims 1, 11) ..........................16
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`B. Other Terms .....................................................................................20
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`A. ALL GROUNDS: The Petition Should Be Denied Because
`
`the Itou Reference Is Not Prior Art .................................................21
`
`B. ALL GROUNDS: The Petition Should Be Denied Under
`
`35 U.S.C. § 314(a) ...........................................................................25
`
`
`
`i
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`C. ALL GROUNDS: Medtronic Has Not Shown that Itou’s
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`Suction Catheter Anticipates Any Challenged Claim .....................36
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`D. GROUNDS 2 AND 3: Medtronic Has Failed to Demonstrate
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`a Reasonable Likelihood of Prevailing as to Its Challenges to
`
`Dependent Claims ...........................................................................37
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`1.
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`2.
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`Grounds 2 and 3 Are Substantively Deficient Because
`Ground 1 Fails .......................................................................37
`
`Grounds 2 and 3 Fail to Address Known Objective
`Evidence of Non-Obviousness ..............................................37
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`(a) Commercial Success ...................................................38
`
`(b)
`
`Industry Praise ............................................................42
`
`(c) Licensing and Licensing Attempts .............................44
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`(d) Copying .......................................................................44
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`(e) Long-Felt Need ...........................................................47
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`IX. CONCLUSION ..........................................................................................50
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`E.
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`The Petition Should Be Denied Because Inter Partes Review
`Is Unconstitutional ..........................................................................49
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`
`
`ii
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`
`
`TABLE OF AUTHORITIES
`
`
`Cases
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................41
`
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
` 941 F.3d 1320 (Fed. Cir. 2019) ...........................................................................49
`
`
`Bettcher Indus. v. Bunzl USA,
`661 F.3d 629 (Fed. Cir. 2011) ..............................................................................33
`
`
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
`868 F.2d 1251 (Fed. Cir. 1989) ............................................................................35
`
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.,
`IPR2017-01298, Paper 8 (PTAB Oct. 25, 2017) ..................................................35
`
`
`Guangdong Alison Hi-Tech Co., Ltd. v. Aspen Aerogels, Inc.,
`IPR2017-00413, Paper 10 (PTAB June 8, 2017) .................................................35
`
`
`In re Oelrich,
`666 F.2d 578 (C.C.P.A. 1981) ..............................................................................33
`
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 42, 44
`
`
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................44
`
`
`Jack Guttman, Inc. v. Kopykake Enters., 302 F.3d 1352 (Fed. Cir. 2002) ..............16
`
`LG Elecs., Inc. v. Wi-LAN Inc., IPR2018-00704, Paper 14 (PTAB Sept. 5, 2018).23
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) ..........................................................................................49
`
`
`NHK Spring Co., Ltd., v. Intri-Plex Technologies, Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) .................................................26
`
`
`
`
`
`iii
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`

`

`Polaris Indus. v. Arctic Cat,
`882 F.3d 1056 (Fed. Cir. 2018) ............................................................................40
`
`
`Transclean Corp. v. Bridgewood Servs.,
` 290 F.3d 1364 (Fed. Cir. 2002) .............................................................. 31, 33, 35
`
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................37
`
`
`United States v. Booker,
`543 U.S. 220 (2005) ..............................................................................................49
`
`
`Vitronics Corp. v. Conceptronic,
`90 F.3d 1576 (Fed. Cir. 1996) ..............................................................................16
`
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................47
`
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................44
`
`
`Other Authorities
`35 U.S.C. § 100(i)(1)(A) ..........................................................................................15
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`35 U.S.C. § 311(b) ...................................................................................................14
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`35 U.S.C. § 314(a) ............................................................................................... i, 25
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`35 U.S.C. § 316(b) ...................................................................................................25
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`37 C.F.R. § 42.108 ...................................................................................................25
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`AIA § 3(n)(1) ...........................................................................................................15
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`MPEP § 2159.02 ......................................................................................................15
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`MPEP § 2163(II)(A)(3)(b) .......................................................................................15
`
`U.S.C. §314(a) .........................................................................................................25
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`
`
`iv
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`v
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`TABLE OF EXHIBITS
`
`Exhibit
`
`Descri n tion
`
`200 1
`
`Declaration of Howard Root Submitted in Connection with Patent
`
`Owner’s Prelimina Res onses — PROTECTIVE ORDER MATERIAL
`
`
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`Gre ; ; Sutton Lab Notebook — PROTECTIVE ORDER MATERIAL
`
`Memo Regarding Market Feasibility for the GuideLiner catheters
`— PROTECTIVE ORDER MATERIAL
`
`Howard Root Notes — PROTECTIVE ORDER MATERIAL
`
`Pro'ect S 0 end Re I ort — PROTECTIVE ORDER MATERIAL
`
`Invoice from MicroGrou u — PROTECTIVE ORDER MATERIAL
`
`Invoice from MicroGrou n — PROTECTIVE ORDER MATERIAL
`
`Invoices fi'om Medical Profiles & Engineering — PROTECTIVE
`ORDER MATERIAL
`
`Invoice from MicroGrou u — PROTECTIVE ORDER MATERIAL
`
`Invoice from Mountain Machine, Inc. — PROTECTIVE ORDER
`MATERIAL
`
`Invoice from Medical Engineering & Design Inc. — PROTECTIVE
`ORDER MATERIAL
`
`Reserved
`
`Sales Order from SPECTRAlytics — PROTECTIVE ORDER
`MATERIAL
`
`Photos of Component of GuideLiner Prototype — PROTECTIVE
`ORDER MATERIAL
`
`Howard Root Deposition Transcript — PROTECTIVE ORDER
`MATERIAL
`
`Invoice from Medtronic — PROTECTIVE ORDER MATERIAL
`
`Memo Regarding Market Feasibility for the GuideLiner catheters
`— PROTECTIVE ORDER MATERIAL
`
`PowerPoint presentation titled “New Products on the Horizon”
`— PROTECTIVE ORDER MATERIAL
`
`Redacted, Excerpted Fax to Patterson Law Firm — PROTECTIVE
`ORDER MATERIAL
`
`Sales Order and Invoice from SPECTRAlytics — PROTECTIVE
`ORDER MATERIAL
`
`Invoice from Medical Engineering & Design — PROTECTIVE ORDER
`MATERIAL
`
`Computerized Design Drawing of a GuideLiner — PROTECTIVE
`ORDER MATERIAL
`
`vi
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`

`

`2028
`2029
`
`2030
`
`2031
`
`2032
`
`2023 Redacted Client/Matter Form from Patterson Law Firm – PROTECTIVE
`ORDER MATERIAL
`2024 Product Requirements: GuideLiner Catheter System – PROTECTIVE
`ORDER MATERIAL
`2025 Clinical Technical Report – PROTECTIVE ORDER MATERIAL
`2026
`Invoice from MicroGroup – PROTECTIVE ORDER MATERIAL
`2027
`Invoice from Johnson Matthey Inc (Shape Memory Applications, Inc.)
`– PROTECTIVE ORDER MATERIAL
`Invoice from SPECTRAlytics – PROTECTIVE ORDER MATERIAL
`Invoices from Medical Profiles & Engineering – PROTECTIVE
`ORDER MATERIAL
`Invoice from Automation & Metrology Inc. – PROTECTIVE ORDER
`MATERIAL
`Invoice from Automation & Metrology Inc. – PROTECTIVE ORDER
`MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`2036 Research and Development Update July 2005 – PROTECTIVE ORDER
`MATERIAL
`2037 Exhibit BB to Declaration of Lora M. Friedemann in Opposition to
`Plaintiffs’ Motion for Preliminary Injunction – PROTECTIVE ORDER
`MATERIAL
`2038 Exhibit 36 to the Declaration of Kurt J. Niederlueke in Opposition to
`Plaintiffs’ Motion for Preliminary Injunction – PROTECTIVE ORDER
`MATERIAL
`2039 Declaration of Deborah Schmalz
`2040 Weekly Staff Meeting Memorandum – PROTECTIVE ORDER
`MATERIAL
`2041 Business Update Section of Materials Presented to the Vascular
`Solutions Board of Directors October 2005 – PROTECTIVE ORDER
`MATERIAL
`[Reserved]
`
`3033
`
`2034
`
`2035
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`2042
`
`
`
`vii
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`

`

`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
`2045 Plaintiffs’ Second Supplemental Objections and Response to
`Defendants’ Interrogatory No. 7 Concerning Preliminary Injunction
`Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.) – PROTECTIVE ORDER MATERIAL
`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.)
`2052 Drawings Submitted with Ressemann U.S. Patent App. 10/214,712
`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.)
`[Reserved]
`2055
`2056 Expert Report of Peter T. Keith on Infringement, Claim Coverage, and
`Lack of Acceptable Noninfringing Alternatives, QXMédical, LLC v.
`Vascular Solutions LLC, 17-cv-01969 (D. Minn.), Dkt. 125-22
`2057 Teleflex Product Patents Website
`2058 Confidential Presentation – PROTECTIVE ORDER MATERIAL
`
`
`
`viii
`
`

`

`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 Declaration of Howard Root in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 189 – PROTECTIVE ORDER
`MATERIAL
`
`ix
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`
`
`I.
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`INTRODUCTION COMMON TO ALL IPR PETITIONS
`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.
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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”).
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`1
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`

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`Medtronic has known this dispute was coming for years. Medtronic
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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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`2
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`

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`Medtronic ultimately loses and is forced to pay damages. Moreover, having
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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.
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`II.
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`INTRODUCTION TO THE PRESENT PATENT OWNER
`RESPONSE
`There are many reasons why the Board should not condone Medtronic’s
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`delay strategies, and why it instead should decline to institute this Petition. First,
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`while Medtronic acknowledges that there is a dispute regarding whether its lead
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`3
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`

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`reference, Itou, qualifies as prior art, Medtronic opted to stay silent on the contrary
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`evidence in its possession relating to that issue, failing even to try to address it. As
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`the corroborated evidence submitted herewith shows, the inventors indisputably
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`both conceived and reduced to practice the claimed invention prior to Itou’s
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`effective date; the Petition makes no attempt to explain how Medtronic is likely to
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`succeed in counteracting this showing. Because Itou, the basis for each Ground of
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`Medtronic’s Petition, is not prior art, this Petition should not be instituted. Indeed,
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`failures such as Medtronic’s to address known evidence has been held sufficient to
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`justify denial of an IPR petition; the PTAB should follow that precedent here.
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`Second, institution of the present Petition would be a highly inefficient use of the
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`Board’s resources. The same validity issues between the same parties are already
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`being litigated in the district court and the district court has already invested
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`significant time to familiarize itself with the facts and law relating to the threshold
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`invention date issue. Third, Medtronic failed to justify its dual-petition attack on
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`the ’032 patent. These reasons alone show that the Board should deny the Petition.
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`The Petition also fails to make the threshold showing required for
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`anticipation. Medtronic’s Ground 1 relies on the Itou reference as allegedly
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`anticipating the challenged claims, but Itou does not disclose a device “through
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`which interventional cardiology devices are insertable,” as recited in both
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`independent claims of the ’032 patent. The specification defines “interventional
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`
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`4
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`

`

`cardiology devices” to include at least guidewires, balloon catheters, stents and
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`stent catheters. The device of the Itou reference is not designed to receive
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`interventional cardiology devices, including stents and stent catheters, at all.
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`Rather, it is a suction catheter, designed solely for the purpose of suctioning
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`thrombi and other loose materials out of vasculature in a distal-to-proximal
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`direction. The Petition does not show (or even argue) that Itou discloses a
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`structure through which interventional cardiology devices including at least
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`balloon catheters, stents and stent catheters are insertable. Thus, even if Itou is
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`found to be prior art, the Petition does not establish that Medtronic is likely to
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`establish anticipation. For at least this reason, Ground 1 is clearly deficient.
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`The remaining Grounds 2 and 3 challenge only claims that depend from the
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`independent claims challenged by the deficient Ground 1, therefore Grounds 2 and
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`3 are deficient as well. Grounds 2 and 3—which raise obviousness arguments—
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`are also deficient for at least the reason that they fail to address compelling
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`objective evidence of nonobviousness that Medtronic knew about. Medtronic was
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`fully aware of the commercial success, licensing and licensing requests, industry
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`praise, and copying associated with the claimed invention before it filed the
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`Petition, yet there is nothing in the Petition to explain why Medtronic is likely to
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`succeed in counteracting this known evidence.
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`
`
`5
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`

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`III. BACKGROUND
`A.
`The Revolutionary GuideLiner Product
`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 a team
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`of engineers and an individual specializing in medical device marketing, conceived
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`of and began working on what would eventually become the revolutionary
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`GuideLiner guide extension catheter. Ex. 2001 (Root Decl.) ¶¶ 5–14. By at least
`
`August 2005, VSI had reduced the GuideLiner invention to practice, as
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`corroborated by contemporaneous documents and witness declarations. Id. ¶¶ 15–
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`47; Ex. 2039 (Schmalz Decl.) ¶¶ 4–12. Teleflex provided this timeline, and
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`identified supporting documents, to Medtronic before the Petition was filed in the
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`form of a detailed interrogatory response served in the parallel District of
`
`Minnesota case. Ex. 2045 at 4–10. Yet Medtronic never acknowledged that
`
`information, nor did it address it in this IPR.
`
`VSI launched the GuideLiner commercial product in 2009. The GuideLiner
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`created a new market category—guide extension catheters. Ex. 2044, ¶ 9.
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`GuideLiner “put VSI on the map.” Id. ¶ 4. Sales grew quickly, doubling from
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`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 VSI’s top-
`
`
`
`6
`
`

`

`selling product, and by early 2014 it was used in all of the approximately 2,000
`
`cardiac catheterization laboratories 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. at ¶¶ 34–35.
`
`The ’032 Patent
`B.
`The ’032 patent is one of a family of patents that covers the GuideLiner
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`products. The ’032 patent is directed to a coaxial guide catheter (also referred to as
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`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
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`artery of the aorta to facilitate delivery of stents, balloon angioplasty catheters and
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`other interventional cardiology devices. Ex. 1001 at Abstract.
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`One of the important benefits of the device disclosed in the ’032 patent is
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`increased “back-up support.” As the patent teaches, when treating a stenosis, a
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`guide catheter is typically guided into the ostium (opening) of the branch artery to
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`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
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`the patent (color added), showing a typical guide catheter 56 (pink) inserted into
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`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:
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`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
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`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; 4:40–49. The phantom guide catheter (yellow) in
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`Figure 7 shows how backward force generated by the advancing device can cause
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`the guide catheter to dislodge from the ostium.
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`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
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`coronary artery. Id. at 1:8–12. Figure 9 (color added), below, illustrates how the
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`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:
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`Not only does the guide extension catheter help guide interventional cardiology
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`devices closer to the desired location (e.g., a blockage or lesion); it also reduces the
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`tendency of the guide catheter (pink) to back out of the ostium when the operator
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`increases the pressure on the proximal end of a wire or a stent or balloon delivery
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`catheter to advance it across a lesion.
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`The guide extension catheter of the invention generally includes, from distal
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`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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`catheter. E.g., id. at 6:9–10 and Figs. 1, 4, 20–22. An important advantage of the
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`design is it reduces the available space to deliver interventional cardiology devices
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`only slightly – by no more than “one French size” smaller than the guide catheter
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`in the 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).
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`An exemplary claim—claim 1—is provided below:
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`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
`a branch artery, the continuous lumen of the guide
`catheter having a circular cross-sectional inner diameter
`sized such that interventional cardiology devices are
`insertable into and through the lumen to the branch
`artery, the device comprising:
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` a
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` flexible tip portion defining a tubular structure having a
`circular cross-section and a length that is shorter than the
`predefined length of the continuous lumen of the guide
`catheter, the tubular structure having a cross-sectional
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`outer diameter sized to be insertable through the cross-
`sectional inner diameter of the continuous lumen of the
`guide catheter and defining a coaxial lumen having a
`cross-sectional inner diameter through which
`interventional cardiology devices are insertable; and
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` a
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` substantially rigid portion proximal of and operably
`connected to, and more rigid along a longitudinal axis
`than, the flexible tip portion and defining a rail structure
`without a lumen and having a maximal cross-sectional
`dimension at a proximal portion that is smaller than the
`cross-sectional outer diameter of the flexible tip portion
`and having a length that, when combined with the length
`of the flexible distal tip portion, defines a total length of
`the device along the longitudinal axis that is longer than
`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
`portion is extended distally of the distal end of the guide
`catheter, at least a portion of the proximal portion of the
`substantially rigid portion extends proximally through the
`hemostatic valve in common with interventional
`cardiology devices that are insertable into the guide
`catheter.
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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
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`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
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`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,
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`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-
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`01760-PJS-TNL (D. Minn) (“Teleflex v. Medtronic” or “district court case”); see
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`also Ex. 1079. The QXM and Teleflex v. Medtronic cases have been designated
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`“related” and are assigned to the same judge, who is now exceedingly familiar with
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`the subject matter and validity of the ’032 patent.
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`The QXM case is trial-ready. The Court has construed a number of claim
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`terms and has issued a summary judgment order holding, inter alia, that the
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`asserted claims are not invalid as indefinite or invalid under the recapture rule, and
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`that QXM infringes certain claims. Ex. 1013; QXM, No. 17-cv-01969, Dkt 194 at
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`1 (D. Minn.); id., Dkt. 156 at 41–42. Trial was initially scheduled to begin on
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`February 24, 2020, but QXM moved to stay, agreeing to waive its remaining
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`Section 102 and 103 defenses and to exit the U.S. market for the duration of the
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`stay. In view of QXM’s concessions, the Court agreed to stay the QXM case until
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`the Board renders its institution decisions on the IPRs Medtronic has filed against
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`the GuideLiner patents. Id., Dkt. 194 at 2.
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`The Teleflex v. Medtronic case concerns Medtronic’s infringement of several
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`patents, including the ’032 patent. Ex. 1079, ¶¶ 28–46. In that case, Medtronic
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`relies on many of the same combinations of prior art that it is asserting in this
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`IPR—including Itou and Itou plus Ressemann. Compare Ex. 2048 at 39 with
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`Petition at 7. The parties have already conducted extensive fact discovery,
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`including serving and responding to interrogatories, serving and responding to
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`document requests, and exchanging over 25,000 documents so far. Ex. 2073, ¶ 22.
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`Further, Medtronic has deposed Teleflex’s technical expert, Peter Keith, and
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`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,
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`2020. Id. at 4–5. The case must be trial ready by August 1, 2021. Id. at 9.
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`Teleflex and Medtronic have also fully briefed and argued a motion for
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`preliminary injunction that concerns the same validity issues as th