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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,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00133
`Patent RE 45,760E
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
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`

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`TABLE OF CONTENTS
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS .............................. 1
`
`INTRODUCTION TO THE PRESENT PATENT OWNER RESPONSE... 3
`
`I.
`
`II.
`
`III. BACKGROUND .......................................................................................................... 5
`
`A. The Revolutionary GuideLiner Product ........................................................... 5
`
`B. The ’760 Patent ....................................................................................................... 6
`
`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’760 Patent in the District of Minnesota ............................ 11
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART .................................. 13
`
`V. CLAIM CONSTRUCTION .................................................................................... 14
`
`VI. MEDTRONIC’S REFERENCES .......................................................................... 14
`
`A. Ressemann (Ex. 1208) ....................................................................................... 14
`
`B. Takahasi (Ex. 1210) ............................................................................................ 16
`
`VII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ................. 18
`
`A. ALL GROUNDS: The Petition Should Be Denied Under 35 U.S.C. §
`314(a) ..................................................................................................................... 18
`
`B. ALL GROUNDS: The Petition Should Be Denied Because Medtronic
`Failed to Justify Its Three-Petition Attack on the ‘760 Patent .................. 21
`
`C. ALL GROUNDS: Medtronic Has Not Shown that Any Challenged
`Claim Is Obvious in View of Ressemann, Takahashi, and the
`Knowledge of a POSITA ................................................................................... 25
`
`1. Ressemann Fails to Disclose a “Tubular Structure Defining a Lumen
`Coaxial … With the Lumen of the Guide Catheter” (Claim 25.c.i) . 26
`
`2. The Petition Fails to Show that a POSITA Would Have Been
`Motivated to Completely Eliminate Ressemann’s Emboli Protection
`Purpose to Achieve the “One-French” Limitation (Claim 25.c.ii) ... 28
`
`a. The Petition’s Modifications Would Render Ressemann’s Device
`Inoperable for Its Intended Purpose..................................................... 29
`
`
`
`ii
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`

`

`b. The Petition Fails to Establish a Motivation to Combine
`Ressemann and Takahashi ..................................................................... 32
`
`c. Takahash and Ressemann Teach Away from Their Combination
` ....................................................................................................................... 35
`
`D. ALL GROUNDS: The Petition Fails to Address Known Objective
`Evidence of Non-Obviousness .......................................................................... 36
`
`1. Commercial Success ...................................................................................... 39
`
`2. Industry Praise ................................................................................................ 43
`
`3. Licensing and Licensing Attempts ............................................................ 44
`
`4. Copying............................................................................................................. 45
`
`5. Long-Felt Need ............................................................................................... 47
`
`E. The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ................................................................................................... 48
`
`VIII. CONCLUSION........................................................................................................... 49
`
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`
`iii
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`

`

`TABLE OF AUTHORITIES
`
`
`Cases
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d (Fed. Cir. 2016) .........................................................................................42
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d (Fed. Cir. 2019) .................................................................................. 48, 49
`
`Askeladden L.L.C. v. Encoditech, LLC,
`IPR2017-00452, Paper 12 (PTAB July 31, 2017) ...................................................30
`
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
`IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ..................................................39
`
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-00279, -00280, -00282, -00283, Paper 10 (PTAB July 1, 2019) .............23
`
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-01354, -01355, Paper 10 (PTAB Jan. 27, 2020) ......................................23
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009)................................................................................29
`
`Dropbox, Inc. v. Whitserve LLC,
`IPR2019-01018, Paper 13 (PTAB Nov. 1, 2019) ....................................................23
`
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 dropbF.3d 1361 (Fed. Cir. 2000) ......................................................................39
`
`E-One, Inc. v. Oshkosh Corp.,
`IPR2019-00161, Paper 16 (PTAB May 15, 2019) ........................................... 19, 21
`
`Freebit AS v. Bose Corp.,
`IPR2018-00142, Paper 7 (PTAB May 11, 2018) ....................................................30
`
`Gilead Scis., Inc. v. United States,
`IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ...................................................39
`
`
`
`iv
`
`

`

`
`Gilead Scis., Inc. v. United States,
`IPR2019-01455, Paper 16 (PTAB Feb. 5, 2020) .....................................................39
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012)................................................................................36
`
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016)................................................................................31
`
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ..................................................46
`
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) .............................................................................................49
`
`Merial Ltd. v. Virbac,
`IPR2014-01279, Paper 13 (PTAB Jan. 22, 2015) ...................................................39
`
`NHK Spring Co., Ltd., v. Intri-Plex Technologies, Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ....................................... 18, 19, 20
`
`Pfenex, Inc. v. GlaxoSmithKline Biologicals SA,
`IPR2019-01027, Paper 12 (PTAB Nov. 13, 2019) ..................................................24
`
`Plas-Pak Indus. v. Sulzer Mixpac AG,
`600 Fed. Appx. 755 (Fed. Cir. 2015) .......................................................................30
`
`Polaris Indus. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018)................................................................... 29, 39, 41
`
`R.J. Reynolds Vapor Co. v. Fontem Holdings 1 B.V.,
`IPR2018-00629, Paper 10 (PTAB Aug. 29, 2018) ..................................................30
`
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) ........................................... 38, 42
`
`Square, Inc. v. 4361423 Canada Inc.,
`IPR2019-01628, Paper 14 (PTAB Mar. 31, 2020) ..................................................22
`
`
`
`
`v
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`

`

`Stryker Corp. et al.v. KFx Medical, LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ..................................................38
`
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) ..................................................................................47
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012)................................................................................36
`
`United States v. Booker,
`543 U.S. 220 (2005) .................................................................................................49
`
`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)................................................................................45
`
`
`Other Authorities
`
`35 U.S.C. § 314(a) ...................................................................................................18
`
`35 U.S.C. § 316(b) ............................................................................................ 18, 22
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`vi
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`

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`TABLE OF EXHIBITS
`
`Exhibit Description
`2001
`[Reserved]
`2002
`[Reserved]
`2003
`[Reserved]
`2004
`[Reserved]
`2005
`[Reserved]
`2006
`[Reserved]
`2007
`[Reserved]
`2008
`[Reserved]
`2009
`[Reserved]
`2010
`[Reserved]
`2011
`[Reserved]
`2012
`[Reserved]
`2013
`[Reserved]
`2014
`[Reserved]
`2015
`[Reserved]
`2016
`[Reserved]
`2017
`[Reserved]
`2018
`[Reserved]
`2019
`[Reserved]
`2020
`[Reserved]
`2021
`[Reserved]
`2022
`[Reserved]
`2023
`[Reserved]
`2024
`[Reserved]
`2025
`[Reserved]
`2026
`[Reserved]
`2027
`[Reserved]
`2028
`[Reserved]
`2029
`[Reserved]
`2030
`[Reserved]
`2031
`[Reserved]
`2032
`[Reserved]
`3033
`[Reserved]
`2034
`[Reserved]
`2035
`[Reserved]
`2036
`[Reserved]
`
`
`
`vii
`
`

`

`[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.)
`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.
`
`
`
`viii
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`

`

`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,
`
`
`
`ix
`
`

`

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

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`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®
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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
`
`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 (who licensed the GuideLiner patents
`
`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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`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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`

`

`
`
`
`
`, 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
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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 ’760 patent that is the subject of the present Petition.
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`That litigation is ongoing.
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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
`
`Medtronic ultimately loses and is forced to pay damages. Moreover, having
`
`
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`2
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`

`

`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
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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
`
`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
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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
`
`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, institution of the
`
`Petition would be a highly inefficient use of the Board’s resources. The same
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`validity issues between the same parties are already being litigated in the district
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`3
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`court and the district court has already invested the time to familiarize itself with
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`the facts and law. Further, Medtronic failed to justify its three-petition attack on
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`the ’760 patent, an approach the Board’s guidelines recognize is almost never
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`appropriate. These reasons alone show that the Board should deny the Petition.
`
`Moreover, Medtronic’s Petition fails to identify any prior art providing the
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`important “coaxial” limitation of independent claim 25, the only independent claim
`
`challenged. In addition, Medtronic’s obviousness argument is premised on
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`modifying the primary reference, Ressemann, to eliminate the very functionality
`
`(emboli protection) that is the subject of the Ressemann patent. Indeed, the
`
`Ressemann patent is titled “Emboli protection devices and related methods of use.”
`
`Medtronic fails to provide sufficient motivation or provide any logical explanation
`
`for why a POSITA, absent hindsight, would be motivated to modify Ressemann’s
`
`device in a way that renders it inoperable for Ressemann’s intended purpose.
`
`Finally, Medtronic does not address the voluminous objective indicia of non-
`
`obviousness, even though Medtronic was fully aware of the striking commercial
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`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
`
`explain why Medtronic is likely to succeed in counteracting this known evidence.
`
`For at least these reasons, the Petition does not establish that Medtronic is likely to
`
`show that any of the challenged claims would have been obvious.
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`
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`4
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`

`III. BACKGROUND
`
`A. The Revolutionary GuideLiner Product
`
`In the early 2000s, VSI was a small Minnesota medical device company
`
`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
`
`team, conceived of what would eventually become the revolutionary GuideLiner
`
`guide extension catheter. The invention was a new type of medical device—a
`
`rapid exchange guide extension catheter capable of receiving and delivering stents
`
`and balloon catheters. Over the next few years, VSI worked to obtain the
`
`necessary regulatory approvals and commercialize the invention.
`
`VSI launched the GuideLiner commercial product in 2009. Ex. 2044, ¶ 9.
`
`The GuideLiner created a new market category—guide extension catheters. Id.
`
`The GuideLiner product “put VSI on the map.” Id. ¶ 4. Sales grew quickly,
`
`doubling 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 VSI’s top-selling product, and by early 2014 it was used in nearly 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.,
`
`
`
`5
`
`

`

`with the remainder belonging to Teleflex’s licensee, Boston Scientific. See id. at
`
`¶¶ 34–35.
`
`B.
`
`The ’760 Patent
`
`The ’760 patent is one of a family of patents that covers the GuideLiner
`
`products. The ’760 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,
`
`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
`
`other interventional cardiology devices. Ex. 1201 at Abstract.
`
`
`
`One of the important benefits of the systems disclosed in the ’760 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
`
`advanced into the artery beyond the stenosis. Id. at 1:61-65. 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
`
`catheter and attempting to cross a stenotic lesion 66:
`
`
`
`6
`
`

`

`
`Id. at Fig. 7, 7:56-8:3. When the wire or an interventional cardiology device such
`
`as a 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 from the ostium. Id. at 1:65-67, 5:4-13. The phantom guide catheter
`
`(yellow) in Figure 7 shows how backward force generated by the advancing device
`
`can cause the guide catheter to dislodge from the ostium. Id. at 1:65-67; 5:4-13,
`
`8:4-9.
`
`
`
`The ’760 patent addresses this problem by providing a system with increased
`
`backup support for guide catheters inserted into a coronary artery. Id. at 1:38-41.
`
`Figure 9 (color added), below, illustrates how the guide extension catheter 12
`
`(orange with blue tip) is inserted past the end of guide catheter and deep into the
`
`coronary artery:
`
`
`
`7
`
`

`

`
`Not only does the guide extension catheter help guide interventional cardiology
`
`devices closer to the desired location (e.g., a blockage or lesion); it also reduces the
`
`tendency of the guide catheter (pink) to back out of the ostium when the operator
`
`increases the pressure on the proximal end of a wire or a stent or balloon delivery
`
`catheter to advance it across a lesion.
`
`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
`
`portion that has a rail segment to permit delivery without blocking use of the guide
`
`catheter. E.g., id. at 6:40-41, Figs. 1, 4, 20-22. An important advantage of the
`
`design is it reduces the available space to deliver interventional cardiology devices
`
`only slightly – by no more than “one French size” in the preferred embodiment.
`
`Id. at 3:36-51.
`
`The guide extension catheter preferably has a proximal side opening that
`
`
`
`8
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`

`

`includes, from distal to proximal direction, a first full circumference portion (34,
`
`blue), a hemicylindrical portion (36, green), and an arcuate portion (38, purple):
`
`
`Id. at 7:1-3, Fig. 4 (color added). The angled side opening is configured to receive
`
`
`
`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
`
`beyond the distal end of the guide catheter.
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`The challenged claims of the ’760 patent cover this invention. Independent
`
`claim 25, 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. The full claim is provided
`
`below:
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`25. A system, comprising:
`
`a guide catheter configured to be advanceable through a
`
`main blood vessel to a position adjacent an ostium of a
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`coronary artery, the guide catheter having a lumen
`
`extending from a hemostatic valve at a proximal end of
`
`the guide catheter to a distal end of the guide catheter that
`
`is adapted to be positioned adjacent the ostium of the
`
`coronary artery; and
`
`a guide extension catheter configured to be partially
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`advanceable through the guide catheter and into the
`
`coronary artery, the guide extension catheter having a
`
`length such that a distal end of the guide extension
`
`catheter is extendable through the lumen and beyond the
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`distal end of the guide catheter, and a proximal end of the
`
`guide extension catheter is extendable through the
`
`hemostatic valve at the proximal end of the guide
`
`catheter,
`
`the guide extension catheter including, in a proximal to
`
`distal direction, a substantially rigid segment, a segment
`
`defining a side opening, and a tubular structure defining a
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`lumen coaxial and in fluid communication with the
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`lumen of the guide catheter, the lumen of the tubular
`
`structure having a length that is shorter than the length of
`
`the lumen of the guide catheter and having a uniform
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`cross-sectional inner diameter that is not more than one
`
`French size smaller than the cross-sectional inner
`
`diameter of the lumen of the guide catheter, the side
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`opening extending for a distance along a longitudinal
`
`axis of the segment defining the side opening and
`
`accessible from a longitudinal side defined transverse to
`
`the longitudinal axis, and the side opening and the lumen
`
`of the tubular structure configured to receive one or more
`
`stents or balloon catheters when the segment defining the
`
`side opening and a proximal end portion of the tubular
`
`structure are positioned within the lumen of the guide
`
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`10
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`catheter and the distal end of the guide extension catheter
`
`extends beyond the distal end of the guide catheter;
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`wherein a material forming the segment defining the side
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`opening is more rigid than the tubular structure.
`
`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’760 Patent in the District of Minnesota
`
`The validity of the ’760 patent 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 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 July 2, 2019, while the QXM case was ongoing, Teleflex
`
`filed suit against Medtronic, alleging that Medtronic’s copycat “Telescope”
`
`product infringes the ’760 patent, among others. Vascular Sols. LLC v. Medtronic,
`
`Inc., No. 19-cv-01760-PJS-TNL, Dkt. 1 (D. Minn. July 2, 2019) (“Teleflex v.
`
`Medtronic” or “district court case”); see also Ex. 1279. 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
`
`’760 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
`
`
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`that QXM infringes certain claims. Ex. 1213; QXM, No. 17-cv-01969, Dkt. 156 at
`
`41-42. Trial was initially scheduled to begin on February 24, 2020, but QXM
`
`moved to stay, agreeing to waive certain Section 102 and 103 defenses and to exit
`
`the U.S. market for the duration of the stay. In view of QXM’s concessions, the
`
`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., Dkt. 194 at 1-
`
`2.
`
`The Teleflex v. Medtronic case concerns Medtronic’s infringement of several
`
`patents, including the ’760 patent. Ex. 1279, ¶¶ 115-143. In the district court case,
`
`Medtronic relies on the same combinations of prior art that it is asserting in this
`
`IPR—Ressemann plus Takahashi, Ressemann plus Takahashi plus Kataishi, and
`
`Ressemann plus Takahashi plus Enger. Compare Ex. 2078 at Counterclaim ¶ 31
`
`and Ex. 2079 at 2 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.
`
`E.g. 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 discovery remains ongoing and is set to close on September 1, 2020.
`
`Ex. 2049 at 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.
`
`
`
`12
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`at 9.
`
`Teleflex and Medtronic have also briefed and argued a motion for
`
`preliminary injunction that concerns the same validity issues as the Petition:
`
`whether Ressemann in view of Takahashi renders claims of the ’760 patent invalid.
`
`Ex. 2048 at 44-46; Teleflex v. Medtronic, No. 19-cv-01760-PJS-TNL, Dkt. 184 at
`
`9–10 (D. Minn.). In conjunction with this briefing, the parties submitted
`
`voluminous supporting evidence. E.g., id, Dkt. 191 (reply declaration of Teleflex
`
`technical expert Peter Keith addressing, inter alia, validity), Dkt. 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), 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 13. If a trial is
`
`instituted, Teleflex reserves the right to submit a different POSITA definition than
`
`that proposed by Medtronic.
`
`
`
`
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`
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`V. CLAIM CONSTRUCTION
`
`At this stage, no specific construction of claim terms is necessary for the
`
`Board to deny the Petition in view of the deficiencies Teleflex identifies. Teleflex
`
`reserves the right to propose claim constructions if trial is instituted.
`
`VI. MEDTRONIC’S REFERENCES
`
`A. Ressemann (Ex. 1208)
`
`Ressemann is titled “Emboli protection devices and related methods of use.”
`
`Ex. 1208. As the title indicates, Ressemann discloses various embodiments of an
`
`“evacuation sheath assembly” designed to block blood flow and prevent emboli
`
`during removal of blockages from a vessel. Ex. 1208 at 2:56-61, 6:18-19.
`
`Ressemann’s evacuation sheath assembly includes an evacuation head with a
`
`“multi-lumen tube” consisting of offset lumens. E.g., id