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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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`
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00134
`Patent RE 45,760E
`
`
`
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`
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
`
`
`

`

`
`
`TABLE OF CONTENTS
`
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS ............................ 1
`I.
`INTRODUCTION TO THE PRESENT PATENT OWNER RESPONSE .... 3
`II.
`III. BACKGROUND ............................................................................................. 5
`A. The Revolutionary GuideLiner Product ................................................ 5
`B. The ’760 Patent ..................................................................................... 7
`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’760 Patent in the District of Minnesota ....................... 9
`IV. PRIORITY DATE – PRE-AIA LAW APPLIES ..........................................11
`V. THE PERSON OF ORDINARY SKILL IN THE ART ...............................13
`VI. CLAIM CONSTRUCTION ..........................................................................13
`VII. MEDTRONIC’S REFERENCES ..................................................................13
`A.
`Itou (Ex. 1607) ....................................................................................13
`B. Ressemann (Ex. 1608) .........................................................................17
`C. Takahashi (Ex. 1610) ..........................................................................20
`VIII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ................22
`A. The Petition Should Be Denied Because the Itou Reference Is
`Not Prior Art ........................................................................................22
`B. ALL GROUNDS: The Petition Should Be Denied Under
`35 U.S.C. § 314(a) ...............................................................................26
`C. ALL GROUNDS: The Petition Should Be Denied Because
`Medtronic Failed to Justify Its Three-Petition Attack on the ’760
`Patent ...................................................................................................31
`D. GROUND 1: Medtronic Has Not Shown that Itou’s Suction
`Catheter Anticipates Any Challenged Claim ......................................33
`
`
`
`i
`
`

`

`2.
`
`E. GROUND 2: Medtronic Has Not Shown that Any Challenged
`Claim Is Obvious in View of Itou and Ressemann and the
`Knowledge of a POSITA ....................................................................40
`1.
`The Petition Incompletely Addresses Only Interior Lumen
`Diameter with Respect to the “configured to receive one or
`more stents or balloon catheters” Limitation (Claim 48.c.iii,
`51.c.iiii, 53.c.iii) ........................................................................40
`The Petition Fails to Explain Both Motivation to Combine Itou
`with Ressemann’s “Support Collar” and Reasonable
`Expectation of Success in Doing So (Claim 48.c.iii, 51.c.iiii,
`53.c.iii) ......................................................................................42
`F. GROUND 3: Medtronic Has Failed to Show that There Is a
`Reasonable Likelihood of Prevailing as to Its Challenge to
`Dependent Claim 52 ............................................................................45
`G. GROUND 4: Medtronic Has Not Shown that Any Challenged Claim
`Is Obvious in View of Ressemann, Takahashi, and the Knowledge of
`a POSITA ............................................................................................46
`1. Ressemann Fails to Disclose a “Tubular Structure Defining a
`Lumen Coaxial . . . with the Lumen of the Guide Catheter”
`(Claims 48.c.i, 51.c.i, 53.c.1) ....................................................46
`The Petition Fails to Show that a POSITA Would Have Been
`Motivated to Completely Eliminate Ressemann’s Emboli
`Protection to Achieve the “One-French” Limitation (Claims
`48.c.ii, 51.c.ii, 53.c.ii) ...............................................................49
`a.
`The Petition’s Modifications Would Render Ressemann’s
`Device Inoperable for Its Intended Purpose ...................50
`The Petition Fails to Establish a Motivation to
`Combine Ressemann and Takahashi ..............................52
`Takahashi and Ressemann Teach Away from Their
`Combination ...................................................................54
`H. GROUNDS 2-4: The Petition Fails to Address Known Objective
`Evidence of Non-Obviousness ............................................................55
`
`2.
`
`b.
`
`c.
`
`ii
`
`

`

`1. Commercial Success .................................................................58
`2.
`Industry Praise ...........................................................................61
`3.
`Licensing and Licensing Attempts ...........................................63
`4. Copying .....................................................................................63
`5. Long-Felt Need……….………………………………………66
`
`
`
`I.
`
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ..................................................................................67
`IX. CONCLUSION ..............................................................................................68
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`
`Cases
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................61
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019) ............................................................................67
`Askeladden L.L.C. v. Encoditech, LLC,
`IPR2017-00452, Paper 12 (PTAB July 31, 2017) ................................................51
`Bettcher Indus. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) ..............................................................................35
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
`IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ...............................................58
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-00279, -00280, -00282, -00283, Paper 10 (PTAB July 1, 2019) ..........32
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-01354, -01355, Paper 10 (PTAB Jan. 27, 2020) ...................................32
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ............................................................................50
`Dropbox, Inc. v. Whitserve LLC,
`IPR2019-01018, Paper 13 (PTAB Nov. 1, 2019) .................................................32
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) ............................................................................58
`E-One, Inc. v. Oshkosh Corp.,
`IPR2019-00161, Paper 16 (PTAB May 15, 2019) ........................................ 28, 30
`Freebit AS v. Bose Corp.,
`IPR2018-00142, Paper 7 (PTAB May 11, 2018) .................................................51
`Gilead Scis., Inc. v. United States,
`IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ................................................58
`
`iv
`
`

`

`Health Care Logistics, Inc. v. Kit Check, Inc.,
`IPR2019-00385, Paper 7 (PTAB June 3, 2019) ...................................................41
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) ............................................................................55
`In re Oelrich,
`666 F.2d 578 (C.C.P.A. 1981) ..............................................................................35
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) ..................................................................... 35, 36
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 61, 63
`LG Elecs., Inc. v. Wi-LAN Inc.,
`IPR2018-00704, Paper 14 (PTAB Sept. 5, 2018) .......................................... 23, 24
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) ..........................................................................................67
`Microboards Tech., LLC v. Stratasys Inc.,
`IPR2015-00287, Paper 13 (PTAB May 28, 2015) ...............................................41
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) .......................................................................36
`NHK Spring Co., Ltd., v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) .................................... 26, 29, 30
`PersonalWeb Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ..............................................................................41
`Polaris Indus. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) ..................................................................... 58, 60
`R.J. Reynolds Vapor Co. v. Fontem Holdings 1 B.V.,
`IPR2018-00629, Paper 10 (PTAB Aug. 29, 2018) ...............................................50
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) ........................................ 57, 58
`
`v
`
`

`

`Square, Inc. v. 4361423 Canada Inc.,
`IPR2019-01628, Paper 14 (PTAB Mar. 31, 2020) ...............................................32
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) ..............................................................................66
`Stryker Corp. v. KFx Med., LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ........................................ 25, 58
`Transclean Corp. v. Bridgewood Servs.,
`290 F.3d 1364 (Fed. Cir. 2002) ............................................................................34
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................55
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................66
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................63
`Statutes
`35 U.S.C. § 100(i)(2) ...............................................................................................12
`35 U.S.C. § 311(b) ...................................................................................................13
`35 U.S.C. § 314(a) ............................................................................................ 25, 26
`35 U.S.C. § 316(b) ............................................................................................ 26, 31
`37 C.F.R. § 42.108 ...................................................................................................25
`AIA § 3(n)(1) ...........................................................................................................12
`Other Authorities
`MPEP § 1440(II) ......................................................................................................12
`MPEP § 2159.02 ......................................................................................................12
`November 2019 Consolidated Trial Practice Guide ................................... 31, 32, 33
`
`
`vi
`
`

`

`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
`
`vii
`
`

`

`2030
`
`2031
`
`2032
`
`2028
`2029
`
`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
`2042 Declaration of Peter Keith
`
`3033
`
`2034
`
`2035
`
`viii
`
`

`

`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.)
`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.
`Vascular Solutions LLC, 17-cv-01969 (D. Minn.), Dkt. 125-22
`2057 Teleflex Product Patents Website
`2058 Confidential Presentation – PROTECTIVE ORDER MATERIAL
`
`ix
`
`

`

`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
`Joint Rule 26(f) Report (Patent), Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 17
`2076 Defendants’ Rule 30(b)(6) Notice of Deposition of Plaintffs on
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2077 Email withdrawing Defendants’ Rule 30(b)(6) Notice of Deposition
`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
`
`2075
`
`x
`
`

`

`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,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`[Reserved]
`2080
`2081 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)
`
`
`
`xi
`
`

`

`I.
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS
`Petitioner Medtronic has filed 13 IPR petitions against a family of five
`
`related patents protecting Patent Owner Teleflex’s revolutionary GuideLiner®
`
`guide extension catheter (hereinafter “GuideLiner”). When Teleflex’s predecessor
`
`in interest to the patents, Vascular Solutions, Inc. (“VSI”), introduced GuideLiner
`
`in 2009, it enabled physicians to perform interventional cardiology procedures
`
`previously thought to be impossible.1 GuideLiner created the market for a new
`
`type of medical device—rapid exchange guide extension catheters capable of
`
`receiving and delivering stents and balloon catheters—that quickly became VSI’s
`
`flagship product. To this day, many still know and refer to Teleflex’s
`
`Interventional business as “the GuideLiner company.” GuideLiner and its
`
`associated patent coverage (“GuideLiner patents”) were an important factor in
`
`Teleflex’s decision to invest nearly $1 billion in the purchase of VSI in 2017. The
`
`success of GuideLiner also caught the eye of two of the largest medical product
`
`companies in the world, Boston Scientific (which licensed the GuideLiner patents
`
`and has paid royalties since 2013) and more recently, Petitioner Medtronic.
`
`
`1 VSI converted to Vascular Solutions LLC on August 8, 2017. The business now
`
`operates as the Interventional Business Unit of Teleflex Incorporated (“Teleflex”).
`
`1
`
`

`

`Medtronic has known this dispute was coming for years. Medtronic
`
`
`
`
`
`
`
`, and recognizing the importance of the GuideLiner
`
`invention, Medtronic set out to introduce a product to compete with GuideLiner.
`
`While Medtronic appears to have started with the goal of avoiding infringement of
`
`the GuideLiner patents, it ultimately abandoned those plans in favor of copying the
`
`patented technology. In early 2019, Medtronic approached Teleflex on multiple
`
`occasions seeking to license the GuideLiner patents. When Teleflex refused,
`
`Medtronic launched its infringing Telescope product anyway. On July 2, 2019,
`
`Teleflex filed suit for infringement of five of the GuideLiner patents in the District
`
`of Minnesota, including the ’760 patent that is the subject of the present Petition.
`
`That litigation is ongoing.
`
`
`
`Having known for several years that it was going to infringe the GuideLiner
`
`patents, Medtronic should have filed its IPR petitions promptly after deciding it
`
`was going to infringe. Had Medtronic done so, those IPR proceedings would be
`
`completed by now.
`
`But for Medtronic, the largest medical products company in the world, being
`
`able to sell infringing products during the pendency of protracted litigation has
`
`great upside (and great downside for patent holders like Teleflex), even if
`
`2
`
`

`

`Medtronic ultimately loses and is forced to pay damages. Moreover, having
`
`closely copied GuideLiner, Medtronic’s validity challenge needs to prevail, not
`
`just on the broader claims, but on many of the narrower claims as well. So instead
`
`of filing its IPRs before infringing, Medtronic simply launched its infringing
`
`product and waited for the inevitable lawsuit. And even after the lawsuit was filed,
`
`Medtronic did not promptly file its IPRs. Instead, Medtronic waited until the last
`
`moment before its response to Teleflex’s preliminary injunction motion was due in
`
`the district court to file 13 IPR Petitions on five patents in suit. Medtronic then
`
`argued that the mere filing of the IPR petitions justified denial of Teleflex’s
`
`preliminary injunction motion. Medtronic has made no secret of the fact that, if
`
`any of its IPR petitions are granted, it will ask the district court to stay the litigation
`
`pending the outcome of those IPRs. If Medtronic is successful in this strategy, it
`
`will eat up most of the remaining life of the patents in suit (all but one of which
`
`expire in 2026), even if its validity challenge ultimately fails as to some or all of
`
`the claims. The Board should not help further such delay strategies, which weaken
`
`the value of patents for patent holders.
`
`II.
`
`INTRODUCTION TO THE PRESENT PATENT OWNER
`RESPONSE
`There are many reasons why the Board should not help further Medtronic’s
`
`delay strategies and should decline to institute this Petition. First, while Medtronic
`
`acknowledges that there is a dispute regarding whether its lead Itou reference
`
`3
`
`

`

`qualifies as prior art, Medtronic opted to stay silent on the contrary evidence in its
`
`possession relating to that issue, failing to even try to address it. And as the
`
`corroborated evidence submitted herewith shows, the inventors indisputably both
`
`conceived and reduced to practice the claimed invention prior to Itou’s effective
`
`date. Second, institution of the Petition would be a highly inefficient use of the
`
`Board’s resources. The same validity issues between the same parties are already
`
`being litigated in the district court. Third, Medtronic failed to justify its three-
`
`petition attack on the ’760 patent, an approach the Board’s guidelines recognize is
`
`almost never appropriate. These reasons alone show that the Board should deny
`
`the Petition.
`
`Moreover, the Petition’s four grounds fail to make the threshold showings
`
`required for institution. Grounds 1 and 3 rely solely on the Itou reference, but Itou
`
`does not disclose a device having the claimed structure that is “configured to
`
`receive one or more stents or balloon catheters,” as claimed. Rather, the device
`
`Itou discloses is a suction catheter.
`
`Ground 2 alternatively advocates combining Itou with the Ressemann
`
`reference, but the Petition does not explain the proposed combination or address
`
`known evidence teaching away from introducing stents or balloon catheters into a
`
`suction catheter like the device of Itou.
`
`4
`
`

`

`Ground 4, a third alternative ground, advocates combining Ressemann with
`
`the Takahashi reference. However, the Petition fails identify any prior art
`
`providing the important “coaxial” limitation. In addition, the Ground 4
`
`combination is nonsensically premised on modifying Ressemann to eliminate the
`
`very emboli protection functionality that is the subject of the Ressemann patent.
`
`Indeed, Ressemann is titled “Emboli protection devices and related methods of
`
`use.”
`
`Finally, Medtronic does not address the voluminous objective indicia of non-
`
`obviousness, even though Medtronic was fully aware of the striking commercial
`
`success, industry praise, licensing and licensing requests, copying, and long-felt
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`need associated with the claimed invention. There is nothing in the Petition to
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`explain why Medtronic is likely to succeed in counteracting this known evidence.
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`For at least these reasons, the Board should decline to institute review.
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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 catheter-based technologies. Ex. 2044 (Welch Decl.), ¶¶ 8,
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`10. In the fall of 2004, its founder Howard Root, with a team of engineers and an
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`individual specializing in medical device marketing, conceived of and began
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`working on what would eventually become the revolutionary GuideLiner guide
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`5
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`

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`extension catheter. Ex. 2001 (Root Decl.), ¶¶ 5–14. By at least August 2005, VSI
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`had reduced the GuideLiner invention to practice, as corroborated by
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`contemporaneous documents and witness declarations. Id., ¶¶ 15–46; Ex. 2039
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`(Schmalz Decl.), ¶¶ 4–12. Teleflex provided this timeline, and identified
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`supporting documents, to Medtronic before the Petition was filed. Ex. 2045 at 4–
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`10. Yet Medtronic never acknowledged that information, much less sought to use
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`or address it in its Petition.
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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. 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.), ¶
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`13; see Ex. 2046 (Root 2013 Decl.), ¶ 39. By 2013 GuideLiner was VSI’s top-
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`selling product, and by early 2014 it was used in all of the approximately 2,000
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`cardiac catheterization laboratories (hospitals) across the United States. Ex. 2044,
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`¶¶ 4, 12. Total GuideLiner sales to date are more than
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`. See Ex. 2043,
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`¶ 13. Until Medtronic entered the market with its infringing Telescope product,
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`GuideLiner had over a
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` market share in the U.S., with the remainder belonging
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`to Teleflex’s licensee, Boston Scientific. See id., ¶¶ 34–35.
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`6
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`

`

`The ’760 Patent
`B.
`The ’760 patent is one of a family of patents that covers the GuideLiner
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`products. The ’760 patent is directed to a system including a coaxial guide catheter
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`(also called a “guide extension catheter”) that is passed through the lumen and
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`advanced beyond the distal end of a 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. 1601 at Abstract.
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`
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`One of the important benefits of the systems disclosed in the ’760 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 1:61–65. When the wire or an
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`interventional cardiology device such as a stent or balloon catheter encounters a
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`difficult lesion, advancing it across the lesion can create backward force strong
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`enough to dislodge the guide catheter’s distal end from the ostium. Id. at 1:65–67;
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`5:4–13.
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`
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`The ’760 patent addresses this problem by providing a system with increased
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`backup support for guide catheters inserted into a coronary artery. Id. at 1:38–41.
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`The guide extension catheter of the invention generally includes, distally to
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`proximally, a soft tip portion, a tubular portion, and a substantially rigid portion
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`7
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`

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`that has a rail segment to permit delivery without blocking use of the guide
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`catheter. E.g., id. at 6:40–41, Figs. 1, 4, 20-22. An important advantage: it reduces
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`the available space to deliver interventional cardiology devices only slightly, by no
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`more than “one French size” in the preferred embodiment. Id. at 3:36–51.
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`The guide extension catheter preferably has a proximal side opening that
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`includes a first full circumference portion (34, blue), a hemicylindrical portion (36,
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`green), and an arcuate portion (38, purple):
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`Id. at 7:1–3; Fig. 4 (color added). The angled side opening is configured to receive
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`
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`stents and balloon catheters when the side opening is positioned within the lumen
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`of the guide catheter and the distal end of the guide extension catheter extends
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`beyond the distal end of the guide catheter.
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`The challenged claims of the ’760 patent cover this invention. Independent
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`claim 48, for example, covers a system including a guide catheter and a guide
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`extension catheter such as that shown in Figure 4. Independent claims 51 and 53
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`are similar but have unique “wherein” limitations at the end of the respective
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`claims.
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`8
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`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’760 Patent in the District of Minnesota
`The ’760 patent has been the subject of nearly three years of active litigation
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`in the District of Minnesota in two separate cases. On June 8, 2017, QXMédical
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`filed a declaratory judgment action against VSI. QXMédical, LLC v. Vascular
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`Sols. LLC, No. 17:cv-01969-PJS-TNL, Dkt. 1 at ¶¶ 13–15 (D. Minn. June 8, 2017)
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`(“QXM case”). On July 2, 2019, while the QXM case was ongoing, Teleflex filed
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`suit against Medtronic, alleging that Medtronic’s copycat “Telescope” product
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`infringes the ’760 patent, among others. Vascular Sols. LLC v. Medtronic, Inc.,
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`No. 19-cv-01760-PJS-TNL (D. Minn.) (“Teleflex v. Medtronic” or “district court
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`case”); see also Ex. 1679 at ¶¶ 115–143. The QXM and Teleflex v. Medtronic
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`cases have been designated “related” and are assigned to the same judge, who is
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`now exceedingly familiar with the subject matter and validity of the ’760 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. 1613; 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 certain Section 102
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`and 103 defenses and to exit the U.S. market for the dur