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 IPR2020-00130
`Patent RE 45,380
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00130
`Patent RE 45,380
`
`
`
`
`
`
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
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`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS .............................1
`
`II.
`
`INTRODUCTION TO THE PRESENT PATENT OWNER RESPONSE .... 3
`
`III. BACKGROUND ............................................................................................. 4
`
`A. The Revolutionary GuideLiner Product ................................................ 4
`
`B. The ’380 Patent ..................................................................................... 5
`
`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’380 Patent in the District of Minnesota .....................10
`
`IV.
`
`THE PERSON OF ORDINARY SKILL IN THE ART ...............................13
`
`V.
`
`CLAIM CONSTRUCTION ..........................................................................13
`
`A. A flexible tip portion/tubular portion “defining a coaxial lumen
`having a cross-sectional inner diameter through which interventional
`cardiology devices are insertable” (Claims 1, 12) ..............................13
`
`B. Other Terms .........................................................................................18
`
`VI.
`
`THE KONTOS REFERENCE (Ex. 1409) ....................................................19
`
`VII. THE ADAMS REFERENCE (Ex. 1435) ......................................................21
`
`VIII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ................22
`
`A. ALL GROUNDS: The Petition Should Be Denied Under 35 U.S.C. §
`314(a) ...................................................................................................22
`
`B. ALL GROUNDS: The Petition Should Be Denied Because Medtronic
`Failed to Justify its Four-Petition Attack on the ’380 Patent ..............26
`
`C. ALL GROUNDS: Medtronic Has Not Identified Any Prior Art
`Showing the Claimed Structure “defining a coaxial lumen having a
`
`i
`
`
`
`cross-sectional inner diameter through which interventional
`cardiology devices are insertable” (Claim 1.b.i, Claim 12.b.ii) ..........30
`
`D. ALL GROUNDS: The Petition Should Be Denied Because It Failed
`to Address Known, Compelling Objective Evidence of Non-
`Obviousness .........................................................................................33
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Commercial Success .................................................................36
`
`Industry Praise ...........................................................................40
`
`Licensing and Licensing Attempts ...........................................41
`
`Copying .....................................................................................42
`
`Long-Felt Need .........................................................................44
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`E. The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ..................................................................................46
`
`
`IX. CONCLUSION ..............................................................................................47
`
`
`
`
`
`
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
`
`Cases
`
`Apple Inc. v. Samsung Elecs. Co.,
` 839 F.3d 1034 (Fed. Cir. 2016) ............................................................................39
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
` 941 F.3d 1320 (Fed. Cir. 2019) ............................................................................46
`
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
` IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ..............................................36
`
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
` IPR2019-00279, -00280, -00282, -00283, Paper 10 (PTAB July 1, 2019) .........28
`
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
` IPR2019-01354, -01355, Paper 10 (PTAB Jan. 27, 2020) ..................................28
`
`Dropbox, Inc. v. Whitserve LLC,
` IPR2019-01018, Paper 13 (PTAB Nov. 1, 2019) ................................................28
`
`E-One, Inc. v. Oshkosh Corp.,
` IPR2019-00161, Paper 16 (PTAB May 15, 2019) ........................................ 23, 25
`
`Gilead Scis., Inc. v. United States,
` IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ..............................................36
`
`Gilead Scis., Inc. v. United States,
` IPR2019-01455, Paper 16 (PTAB Feb. 5, 2020) .................................................36
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`
` 676 F.3d 1063 (Fed. Cir. 2012) ...........................................................................33
`
`Institut Pasteur v. Focarino,
` 738 F.3d 1337 (Fed. Cir. 2013) ............................................................................40
`
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
` IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................42
`
`
`iii
`
`
`
`Jack Guttman, Inc. v. Kopykake Enters.,
` 302 F.3d 1352 (Fed. Cir. 2002) ............................................................................14
`
`Lucia v. SEC,
` 138 S. Ct. 2044 (2018)..........................................................................................46
`
`Merial Ltd. v. Virbac,
` IPR2014-01279, Paper 13 (PTAB Jan. 22, 2015) ................................................36
`
`NHK Spring Co., Ltd., v. Intri-Plex Technologies, Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ................................................22
`
`
`Pfenex, Inc. v. GlaxoSmithKline Biologicals SA,
` IPR2019-01027, Paper 12 (PTAB Nov. 13, 2019) ..............................................29
`
`Polaris Indus. v. Arctic Cat,
` 882 F.3d 1056 (Fed. Cir. 2018) ............................................................................38
`
`Robert Bosch Tool Corp. v. SD3, LLC,
` IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) ........................................ 35, 39
`
`Square, Inc. v. 4361423 Canada Inc.
` IPR2019-01628, Paper 14 (PTAB Mar. 31, 2020) ........................................ 26, 28
`
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
` 96 F.3d 1409 (Fed. Cir. 1996) ..............................................................................44
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
` 699 F.3d 1340 (Fed. Cir. 2012) ...........................................................................33
`
`United States v. Booker,
` 543 U.S. 220 (2005) .............................................................................................46
`
`Vitronics Corp. v. Conceptronic,
` 90 F.3d 1576 (Fed. Cir. 1996) ..............................................................................13
`
`WBIP, LLC v. Kohler Co.,
` 829 F.3d 1317 (Fed. Cir. 2016) ............................................................................44
`
`
`
`iv
`
`
`
`Wyers v. Master Lock Co.,
` 616 F.3d 1231 (Fed. Cir. 2010) ............................................................................42
`
`
`Statutes
`
`35 U.S.C. § 311(b) ...................................................................................................31
`
`35 U.S.C. § 312(a)(3) ...............................................................................................31
`
`35 U.S.C. § 316(b) ............................................................................................ 22, 26
`
`
`
`
`
`
`v
`
`
`
`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]
`
`vi
`
`
`
`[Reserved]
`2037
`[Reserved]
`2038
`[Reserved]
`2039
`[Reserved]
`2040
`[Reserved]
`2041
`[Reserved]
`2042
`2043 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Under Seal), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 78 –
`PROTECTIVE ORDER MATERIAL
`2044 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Redacted), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 79
`[Reserved]
`2045
`2046 Declaration of Howard Root in Support of Plaintiff’s Motion for
`Preliminary Injunction, Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn), Dkt. 12
`[Reserved]
`2047
`2048 Defendants’ Opposition to Plaintiffs’ Motion for Preliminary Injunction
`(Redacted), Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 104
`2049 Amended Pretrial Scheduling Order, Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 229
`2050 Defendants’ Second Amended Notice of Deposition of Peter Keith,
`Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D.
`Minn.)
`2051 Defendants’ Amended Notice of Deposition of Amy Welch, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`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.
`
`vii
`
`
`
`Vascular Solutions LLC, 17-cv-01969 (D. Minn.), Dkt. 125-22
`2057 Teleflex Product Patents Website
`2058 Confidential Presentation – PROTECTIVE ORDER MATERIAL
`2059
`Plaintiffs’ First Supplemental Objections and Responses to Defendants’
`Interrogatories Concerning Preliminary Injunction Issues, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2060 Globe Newswire: Teleflex Announces Tenth Anniversary of GuideLiner
`Catheter Product Line
`2061 GuideLiner Marketing Material V1 Catheter
`2062 GuideLiner Marketing Material V2 Catheter
`2063 GuideLiner Marketing Material: That’s A Real Game Changer
`2064
`[Reserved]
`2065 GuideLiner Catheter Bibliography
`2066 Physician Testimonial Authorizations
`2067 Rao, U., et al., The GuideLiner “child” catheter, EuroIntervention 2010
`6:277-279
`2068 Defendants’ Answer, Defenses, and Counterclaims to Plaintiffs’
`Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 16
`2069 Exhibit E to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-5
`2070 Medtronic comparison of guide extension catheters
`2071 Exhibit A to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-1
`2072 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 77
`2073 Declaration of Alexander S. Rinn
`2074
`[Reserved]
`2075
`[Reserved]
`2076
`[Reserved]
`2077
`[Reserved]
`2078 Defendants’ Answer and Defenses to Plaintiffs’ First Amended and
`Supplemental Complaint and Second Amended Counterclaims Against
`Plaintiffs, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.), Dkt. 233
`2079 Exhibit A to Defendants’ Answer and Defenses to Plaintiffs’ First
`Amended and Supplemental Complaint and Second Amended
`Counterclaims Against Plaintiffs, Vascular Solutions LLC v. Medtronic,
`
`viii
`
`
`
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`2080 Excerpts from the March 11, 2019 Deposition of Peter Keith,
`QXMédical, LLC v. Vascular Solutions LLC, 17-cv-01969 (D. Minn.)
`Plaintiff’s Reply Memorandum in Support of Motion for Preliminary
`Injunction (Redacted), Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn)
`
`
`2081
`
`
`
`ix
`
`
`
`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
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`in 2009, it enabled physicians to perform interventional cardiology procedures
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`previously thought to be impossible.1 GuideLiner created the market for a new
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`type of medical device—rapid exchange guide extension catheters capable of
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`receiving and delivering stents and balloon catheters—that quickly became VSI’s
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`flagship product. To this day, many still know and refer to Teleflex’s
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`Interventional business as “the GuideLiner company.” GuideLiner and its
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`associated patent coverage (“GuideLiner patents”) were an important factor in
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`Teleflex’s decision to invest nearly $1 billion in the purchase of VSI in 2017. The
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`success of GuideLiner also caught the eye of two of the largest medical product
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`companies in the world, Boston Scientific (which licensed the GuideLiner patents
`
`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”).
`
`1
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`
`
`
`
`
`
`, and recognizing the importance of the GuideLiner
`
`invention, Medtronic set out to introduce a product to compete with GuideLiner.
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`While Medtronic appears to have started with the goal of avoiding infringement of
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`the GuideLiner patents, it ultimately abandoned those plans in favor of copying the
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`patented technology. In early 2019, Medtronic approached Teleflex on multiple
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`occasions seeking to license the GuideLiner patents. When Teleflex refused,
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`Medtronic launched its infringing Telescope product anyway. On July 2, 2019,
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`Teleflex filed suit for infringement of five of the GuideLiner patents in the District
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`of Minnesota, including the ’380 patent that is the subject of the present Petition.
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`That litigation is ongoing.
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`
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`Having known for several years that it was going to infringe the GuideLiner
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`patents, Medtronic should have filed its IPR petitions promptly after deciding it
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`was going to infringe. Had Medtronic done so, those IPR proceedings would be
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`completed by now.
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`But for Medtronic, the largest medical products company in the world, being
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`able to sell infringing products during the pendency of protracted litigation has
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`great upside (and great downside for patent holders like Teleflex), even if
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`Medtronic ultimately loses and is forced to pay damages. Moreover, having
`
`2
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`
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`closely copied GuideLiner, Medtronic’s validity challenge needs to prevail, not
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`just on the broader claims, but on many of the narrower claims as well. So instead
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`of filing its IPRs before infringing, Medtronic simply launched its infringing
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`product and waited for the inevitable lawsuit. And even after the lawsuit was filed,
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`Medtronic did not promptly file its IPRs. Instead, Medtronic waited until the last
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`moment before its response to Teleflex’s preliminary injunction motion was due in
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`the district court to file 13 IPR Petitions on five patents in suit. Medtronic then
`
`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
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`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
`
`expire in 2026), even if its validity challenge ultimately fails as to some or all of
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`the claims. The Board should not help further such delay strategies, which
`
`weaken the value of patents for patent holders.
`
`II.
`
`INTRODUCTION TO THE PRESENT PATENT OWNER
`RESPONSE
`
`The Board should not condone Medtronic’s delay strategies and should
`
`decline to institute this Petition. Institution would be a highly inefficient use of the
`
`Board’s resources. The same validity issues, between the same parties, and
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`regarding the same patent are already being litigated in the district court. The
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`3
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`
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`district court is already familiar with the ‘380 patent and Medtronic’s lead Kontos,
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`Adams, and Takahashi references. In addition, the Petition fails to identify any
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`prior art with the claimed structure required by each independent claim challenged:
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`a “coaxial lumen having a cross-sectional inner diameter through which
`
`interventional cardiology devices are insertable,” where the interventional
`
`cardiology devices include—as required by the claims—stents and stent catheters.
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`Finally, the Petition fails to address compelling objective evidence of
`
`nonobviousness that Medtronic knew about before filing. Medtronic was fully
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`aware of the commercial success, licensing and licensing requests, industry praise,
`
`and copying associated with the claimed invention before it filed the Petition, yet
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`there is nothing in the Petition to explain why Medtronic is likely to succeed in
`
`counteracting this known evidence. For at least these reasons, the Board should
`
`decline to institute.
`
`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
`
`4
`
`
`
`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.
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`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.,
`
`with the remainder belonging to Teleflex’s licensee, Boston Scientific. See id. at
`
`¶¶ 34–35.
`
`B.
`
`The ’380 Patent
`
`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
`
`5
`
`
`
`artery of the aorta to facilitate delivery of stents, balloon angioplasty catheters and
`
`other interventional cardiology devices. Ex. 1401 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
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`catheter and attempting to cross a stenotic lesion 66:
`
`Id. at Fig. 7, 7:50–64. When the wire or an interventional cardiology device such
`
`
`
`6
`
`
`
`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. Id. at 1:59–63; 4:63–5:5,
`
`7:65-8:3.
`
`
`
`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:
`
`Ex. 1401 at Fig. 9. Not only does the guide extension catheter help guide
`
`
`
`7
`
`
`
`interventional cardiology devices closer to the desired location (e.g., a blockage or
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`lesion); it also reduces the tendency of the guide catheter (pink) to back out of the
`
`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 tubular tip portion, a flexible tubular portion with a
`
`single lumen that is preferably reinforced with coil or braid, and a substantially
`
`rigid portion that has a rail segment to permit delivery without blocking use of the
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`guide catheter. E.g. id. at 6:34–35, Figs. 1, 4, 20–22. An 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
`
`3:28–43.
`
`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), 6:62–64. The angled side opening is configured to
`
`receive stents and balloon catheters when the side opening is positioned within the
`
`lumen of the guide catheter and the distal end of the guide extension catheter
`
`
`
`8
`
`
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`extends beyond the distal end of the guide catheter.
`
`An exemplary claim—independent claim 1—is reproduced below:
`
`1. A system for use with interventional cardiology
`
`devices adapted to be insertable into a branch artery, the
`
`system comprising:
`
` guide catheter having a continuous lumen extending for
`
` a
`
`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
`
` device adapted for use with the guide catheter,
`
` a
`
`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
`
`
`
`9
`
`
`
`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 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
`
`10
`
`
`
`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,
`
`Inc., No. 19-cv-01760-PJS-TNL, Dkt. 1 (D. Minn. July 2, 2019) (“Teleflex v.
`
`Medtronic” or “district court case”); see also Ex. 1479. The QXM and Teleflex v.
`
`Medtronic cases have been designated “related” and are assigned to the same
`
`judge, who is now exceedingly familiar with the subject matter and validity of the
`
`’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. 1413; QXM, No. 17-cv-01969, Dkt. 156 at
`
`41-42. The same Kontos reference (Ex. 1409) that is Medtronic’s lead reference in
`
`this Petition was also one of the three “primary” prior art references the defendant
`
`in the QXM case relied on. E.g. QXM, No. 17-cv-01969, Dkt. 110 at 6-8; id., Dkt.
`
`111-1 at 12-13. 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
`
`11
`
`
`
`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 ’380 patent. Ex. 1479, ¶¶ 47-68. In that case, Medtronic
`
`relies on the very same invalidity grounds it asserts in the Petition. Ex. 2078 at ¶
`
`19 of Medtronic counterclaims (incorporating the “grounds for invalidity
`
`articulated in the Petitions . . . in Case Nos. IPR2020-00128 and IPR2020-00130”).
`
`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. 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 Kontos in view of Adams renders certain claims of Teleflex’s patent ‘380
`
`12
`
`
`
`patent invalid. Ex. 2048 at 38–39 and 42–44 (Medtronic opposition brief); Teleflex
`
`v. Medtronic, No. 19-cv-01760-PJS-TNL, Dkt. 184 at 9-10 (Teleflex reply brief).
`
`In conjunction with this briefing, the parties submitted voluminous supporting
`
`evidence. E.g., id., Dkt. 191 at ¶¶ 26-43 (reply declaration of Teleflex technical
`
`expert Peter Keith discussing the Kontos and Adams references), 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 addressing, inter alia, validity),
`
`and Dkt. 110 (declaration of Medtronic witness Heather S. Rosecrans addressing
`
`copying).
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART
`
`For purposes of this Preliminary Response only, Teleflex does not currently
`
`dispute Medtronic’s proposed definition of a POSITA. Petition at 12-13. If a trial
`
`is instituted, Teleflex reserves the right to submit a different POSITA definition
`
`than proposed by Medtronic.
`
`V. CLAIM CONSTRUCTION
`
`A. A flexible tip portion/tubular portion “defining a coaxial lumen
`having a cross-sectional inner diameter through which
`interventional cardiology devices are insertable” (Claims 1, 12)
`
` patentee can be his or her own lexicographer when the definition of the
`
`
`
` A
`
`term “is clearly stated in the patent specification or file history.” Vitronics Corp. v.
`
`13
`
`
`
`Conceptronic, 90 F.3d 1576, 1582 (Fed. Cir. 1996). When the patentee has clearly
`
`defined the term, that definition “usually . . . is dispositive; it is the single best
`
`guide to the meaning of a disputed term.” Jack Guttman, Inc. v. Kopykake Enters.,
`
`302 F.3d 1352, 1360 (Fed. Cir. 2002). That is exactly the situation here. The ’380
`
`patent specification expressly defines the claim term “interventional cardiology
`
`devices”:
`
`For the purposes of this application, the term
`
`“interventional cardiology devices” is to be understood
`
`to include but not be limited to guidewires, balloon
`
`catheters, stents and stent catheters.
`
`Ex. 1401 at 1:41–44 (emphasis added). That means that “interventional cardiology
`
`devices,” as used in independent claims 1 and 12 of the ’380 patent, must include,
`
`at a minimum, guidewires, balloon catheters, stents and stent catheters. Medtronic
`
`accepts this construction. Petition at 13–14.2
`
`However, there is an important aspect of this construction that Medtronic
`
`ignores. The express language of the claims requires that the tubular structure of
`
`
`2 Medtronic notes that Teleflex “stipulated” to a definition of “interventional
`
`cardiology device(s)” in another litigation with a third party: “devices including,
`
`but not limited to, guidewires, balloon catheters, stents, and stent catheters.”
`
`Petition at 13. This definition is consistent with the specification’s definition.
`
`14
`
`
`
`claim 1 and the flexible tip portion of claim 12 define a coaxial lumen having a
`
`cross-sectional inner diameter “through which interventional cardiology devices
`
`are insertable.” Ex. 1401 at 10:58-67, 12:17-28. Properly construed, this language
`
`requires that at least all four enumerated devices (guidewires, balloon catheters,
`
`stents, and stent catheters) be insertable into the lumen. This construction is based
`
`on the
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