UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00128
`Patent RE 45,380
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
`
`
`
`
`
`
`
`
`

`

`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
`
`
`
`
`
`
`IV. PRIORITY DATE – PRE-AIA LAW APPLIES ..........................................14
`
`V.
`
`VI. CLAIM CONSTRUCTION ..........................................................................15
`
`
`B. The ’380 Patent ..................................................................................... 6
`
`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity
`of the ’380 Patent in the District of Minnesota ...................................11
`
`
`
`THE PERSON OF ORDINARY SKILL IN THE ART ...............................15
`
`A. A flexible tip portion/tubular portion “defining a coaxial lumen
`having a
`cross-sectional inner diameter through which interventional
`cardiology
`devices are insertable” (Claims 1, 12) .................................................15
`
`
`
`
`
`
`
`
`
`
`VII. THE ITOU REFERENCE (Ex. 1007) ...........................................................19
`
`VIII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ................21
`
`
`B. Other Terms .........................................................................................19
`
`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) ...................................................................................................24
`
`i
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`C. ALL GROUNDS: The Petition Should Be Denied Because Medtronic
`Failed
`to Justify its Multiple-Petition Attack on the ’379 Patent ...................30
`
`
`
`D. ALL GROUNDS: Medtronic Has Not Shown that Itou’s Suction
`Catheter Anticipates Any Challenged Claim ......................................33
`
`E. GROUNDS 2 AND 3: Medtronic Has Failed to Demonstrate a
`Reasonable Likelihood of Prevailing as to Its Challenges to
`Dependent Claims ...............................................................................39
`
`1.
`
`2.
`
`
`Grounds 2 and 3 Are Substantively Deficient Because Ground 1
`Fails ...........................................................................................39
`
`Grounds 2 and 3 Fail to Address Known Objective Evidence of
`Non-Obviousness ......................................................................40
`
`(a) Commercial Success .......................................................41
`
`(b)
`
`Industry Praise ................................................................44
`
`(c) Licensing and Licensing Attempts .................................46
`
`(d) Copying ...........................................................................47
`
`(e) Long-Felt Need ...............................................................49
`
`F.
`
`
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ..................................................................................51
`
`
`IX. CONCLUSION ..............................................................................................52
`
`
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`
`Cases
`
`Apple Inc. v. Samsung Elecs. Co.,
` 839 F.3d 1034 (Fed. Cir. 2016) ............................................................................44
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
` 941 F.3d 1320 (Fed. Cir. 2019) ............................................................................51
`
`Bettcher Indus. v. Bunzl USA,
` 661 F.3d 629 (Fed. Cir. 2011) ..............................................................................35
`
`Comcast Cable Commc’ns., LLC v. Rovi Guides, Inc.,
` IPR2019-01354, -01355, Paper 10 (PTAB Jan. 27, 2020) ...................................31
`
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
` 868 F.2d 1251 (Fed. Cir. 1989) ............................................................................38
`
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.,
` IPR2017-01298, Paper 8 (PTAB Oct. 25, 2017) ..................................................38
`
`E-One, Inc. v. Oshkosh Corp.,
` IPR2019-00161, Paper 16 (PTAB May 15, 2019) ........................................ 26, 29
`
`Gilead Scis., Inc. v. United States,
` IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ........................................ 41, 51
`
`Guangdong Alison Hi-Tech Co., Ltd. v. Aspen Aerogels, Inc.,
` IPR2017-00413, Paper 10 (PTAB June 8, 2017) ................................................38
`
`In re Oelrich,
` 666 F.2d 578 (C.C.P.A. 1981) ..............................................................................35
`
`Institut Pasteur v. Focarino,
` 738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 44, 46
`
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
` IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................47
`
`iii
`
`

`

`
`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) ................................................22
`
`Lucia v. SEC,
` 138 S. Ct. 2044 (2018) .........................................................................................51
`
`Newzoom, LLC v. Crane Merchandizing Systems, Inc.
` IPR2018-01441, Paper 11 (PTAB Jan. 9, 2019) ..................................................37
`
`NHK Spring Co., Ltd., v. Intri-Plex Technologies, Inc.,
` IPR2018-00752, Paper 8 (P.T.A.B. Sept. 12, 2018) (Precedential) ........ 25, 27, 28
`
`Pfenex, Inc. v. GlaxoSmithKline Biologicals SA,
` IPR2019-01027, Paper 12 (PTAB Nov. 13, 2019) ..............................................32
`
`Polaris Indus. v. Arctic Cat,
` 882 F.3d 1056 (Fed. Cir. 2018) ............................................................................43
`
`Robert Bosch Tool Corp. v. SD3, LLC,
` IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) ........................................ 40, 44
`
`Stryker Corp. et al. v. KFx Medical, LLC,
` IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ....................................... 24, 41
`
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
` 96 F.3d 1409 (Fed. Cir. 1996) ..............................................................................49
`
`Transclean Corp. v. Bridgewood Servs.,
` 290 F.3d 1364 (Fed. Cir. 2002) ............................................................... 33, 36, 38
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
` 699 F.3d 1340 (Fed. Cir. 2012) ............................................................................40
`
`United States v. Booker,
` 543 U.S. 220 (2005) .............................................................................................52
`
`
`iv
`
`

`

`Vitronics Corp. v. Conceptronic,
` 90 F.3d 1576 (Fed. Cir. 1996) ..............................................................................16
`
`Wyers v. Master Lock Co.,
` 616 F.3d 1231 (Fed. Cir. 2010) ..................................................................... 47, 49
`
`Statutes
`
`35 U.S.C. § 100(i)(2) ...............................................................................................14
`
`35 U.S.C. § 311(b) ...................................................................................................15
`
`35 U.S.C. § 314(a) ............................................................................................ 24, 25
`
`37 C.F.R. § 42.108 ...................................................................................................24
`
`
`
`v
`
`

`

`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
`
`

`

`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
`[Reserved]
`
`3033
`
`2034
`
`2035
`
`2042
`
`vii
`
`

`

`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
`
`

`

`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 ’380 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, and the district court has already invested
`
`significant time to familiarize itself with the facts and law relating to the threshold
`
`invention date issue. Third, Medtronic failed to justify its four-petition attack on
`
`the ’380 patent, an approach the Board’s guidelines recognize is almost never
`
`appropriate. These reasons alone show that the Board should deny the Petition.
`
`The Petition also fails to make the threshold showing required for
`
`anticipation. Medtronic’s Ground 1 relies on the Itou reference as allegedly
`
`anticipating the challenged claims, but Itou does not disclose a device “through
`
`which interventional cardiology devices are insertable,” as recited in both
`
`independent claims of the ’380 patent. The specification defines “interventional
`
`cardiology devices” to include at least guidewires, balloon catheters, stents and
`
`stent catheters. But the Petition only purports to show that Itou has structure
`
`through which a protective catheter is insertable. That is not enough. For at least
`
`this reason, Ground 1 is clearly deficient.
`
`4
`
`

`

`The remaining Grounds 2 and 3 challenge only claims that depend from the
`
`independent claims challenged by the deficient Ground 1, therefore Grounds 2 and
`
`3 are deficient as well. Grounds 2 and 3—which raise obviousness arguments—
`
`are also deficient for at least the reason that they fail to address compelling
`
`objective evidence of nonobviousness that Medtronic knew about. Medtronic was
`
`fully aware of the commercial success, licensing and licensing requests, industry
`
`praise, and copying associated with the claimed invention before it filed the
`
`Petition, yet there is nothing in the Petition to explain why Medtronic is likely to
`
`succeed in counteracting this known evidence.
`
`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, its founder Howard Root, along with a team of
`
`engineers and an individual specializing in medical device marketing, conceived of
`
`and began working on what would eventually become the revolutionary
`
`GuideLiner guide extension catheter. Ex. 2001 (Root Decl.) ¶¶ 5–14. By at least
`
`August 2005, VSI had reduced the GuideLiner invention to practice, as
`
`corroborated by contemporaneous documents and witness declarations. Id. ¶¶ 15–
`
`47; Ex. 2039 (Schmalz Decl.) ¶¶ 4–12. Teleflex provided this timeline, and
`
`5
`
`

`

`identified supporting documents, to Medtronic before the Petition was filed in the
`
`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, much less sought to use or address it in this IPR.
`
`VSI launched the GuideLiner commercial product in 2009. The GuideLiner
`
`created a new market category—guide extension catheters. Ex. 2044, ¶ 9.
`
`GuideLiner “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 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. ¶¶ 34–35.
`
`The ’380 Patent
`B.
`The ’380 patent is one of a family of patents that covers the GuideLiner
`
`products. The ’380 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
`
`6
`
`

`

`artery of the aorta to facilitate delivery of stents, balloon angioplasty catheters and
`
`other interventional cardiology devices. Ex. 1001 at Abstract.
`
`
`
`One of the important benefits of the systems disclosed in the ’380 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 1:53–59. 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:
`
`
`
`7
`
`

`

`Id. at 7:50–64. 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 1:59–63; 4:63–5:5. 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.
`
`
`
`The ’380 patent addresses this problem by providing a system with increased
`
`backup support for guide catheters inserted into a coronary artery. Id. at 1:31–35.
`
`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:
`
`
`
`8
`
`

`

`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 6:34–35 and Figs. 1, 4, 20–22. An important advantage of the
`
`design is that 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 3:28–43.
`
`The guide extension catheter preferably has a proximal side opening that
`
`includes, from distal to proximal direction, a first full circumference portion (34,
`
`blue), a hemicylindrical portion (36, green), and an arcuate portion (38, purple):
`
`
`
`E.g., id. at Fig. 4 (color added) and 6:65–7:8.
`
`An exemplary claim—independent claim 1—is reproduced below:
`
`
`
`9
`
`

`

`1. A system for use with interventional cardiology devices
`adapted to be insertable into a branch artery, the system
`comprising:
`
` a
`
` 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 the 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
`continuous lumen of the guide catheter; and
`
` a
`
` device adapted for use with the guide catheter, including: a
`flexible tip portion defining a tubular structure and 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 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
`
` a
`
` 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
`having a maximal cross-sectional dimension at a proximal
`portion that is smaller than the cross-sectional outer diameter of
`
`10
`
`

`

`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,
`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.
`
`wherein the tubular structure includes a flexible cylindrical
`distal tip portion and a flexible cylindrical reinforced portion
`proximal to the flexible cylindrical distal tip portion and
`wherein the flexible cylindrical distal tip portion is more
`flexible than the flexible cylindrical reinforced portion.
`
`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’380 Patent in the District of Minnesota
`The validity of the ’380 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 ’380 patent, among others. Vascular Sols. LLC v. Medtronic,
`
`11
`
`

`

`Inc., No. 19-cv-01760-PJS-TNL (D. Minn.) (“Teleflex v. Medtronic” or “district
`
`court case”); see also Ex. 1079. 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 ’380 patent.
`
`The QXM case is trial-ready. The Court has construed a number of claim
`
`terms and has issued a summary judgment order holding, inter alia, that the
`
`asserted claims are not invalid as indefinite or invalid under the recapture rule, and
`
`that QXM infringes certain claims. Ex. 1013; QXM, No. 17-cv-01969, Dkt 194 at
`
`1 (D. Minn.); id., 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 2.
`
`The Teleflex v. Medtronic case concerns Medtronic’s infringement of several
`
`patents, including the ’380 patent. Ex. 1079, ¶¶ 47-68. In that case, Medtronic
`
`relies on the same Itou and Ressemann-based invalidity grounds it asserts in the
`
`Petition. Compare Ex. 2048 at 39 (identifying “invalidity basis” for claims 12, 13,
`
`and 15 of the ’380 patent) with Petition at 8. The parties have already conducted
`
`extensive fact discovery, including serving and responding to interrogatories,
`
`12
`
`

`

`serving and responding to document requests, and exchanging over 25,000
`
`documents so far. Ex. 2073, ¶ 22. Further, Medtronic has deposed Teleflex’s
`
`technical expert, Peter Keith, and Teleflex’s Regional Sales Director Amy Welch.
`
`Ex. 2050; Ex. 2051. Fact 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,