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 IPR2020-00131
`Patent RE 45,380E
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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 IPR2020-00131
`Patent RE 45,380E
`
`
`
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
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`
`
`TABLE OF CONTENTS
`
`
`I.
`
`II.
`
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS ......................... 1
`
`INTRODUCTION TO THE PRESENT PATENT OWNER
`RESPONSE ................................................................................................... 3
`
`III. BACKGROUND ........................................................................................... 5
`
`
`
`A.
`
`B.
`
`The Revolutionary GuideLiner Product ........................................... 5
`
`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
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ...........................14
`
`V.
`
`CLAIM CONSTRUCTION .....................................................................14
`
`A. Means-Plus-Function Limitations (Claim 25) ................................14
`
`
`
`B. Other Claim Terms ..........................................................................20
`
`VI. MEDTRONIC’S REFERENCES ..............................................................20
`
`A. Kontos (Ex. 1809) ..........................................................................20
`
`B. Adams (Ex. 1835)............................................................................22
`
`VII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ............24
`
`A. ALL GROUNDS: The Petition Should Be Denied
`Under 35 U.S.C. § 314(a) ................................................................24
`
`B. ALL GROUNDS: The Petition Should Be Denied
`Because Medtronic Failed to Justify Its Four-Petition
`Attack on the ’380 Patent ................................................................28
`
`
`
`
`i
`
`
`
`
`
`
`
`
`
`
`C. ALL GROUNDS: Medtronic Has Not Shown that
`Any Challenged Claim Is Rendered Obvious by Kontos
`in View of Adams and/or the Knowledge of a POSITA .................32
`
`1.
`
`
`2.
`
`
`
`“[M]eans for receiving the interventional device from an
`intermediate or distal portion of the means for guiding the
`interventional device to the location near the ostium of the
`branch vessel and guiding the interventional device deeper into
`the branch vessel” (Claim 25.b) ............................................33
`
`“. . . a side opening . . .” (Claim 25.c.i.) ...............................38
`
`D. ALL GROUNDS: The Petition Should Be Denied Because Medtronic
`Failed to Address Compelling Objective Evidence of Non-
`Obviousness that Medtronic Was Aware Of ...................................46
`
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Commercial Success .............................................................49
`
`Industry Praise .......................................................................53
`
`Licensing and Licensing Attempts .......................................55
`
`Copying .................................................................................55
`
`Long-Felt Need .....................................................................58
`
`E.
`
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ..............................................................................59
`
`
`VIII. CONCLUSION ..........................................................................................60
`
`
`
`
`
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Apple Inc. v. ContentGuard Holdings, Inc.,
` IPR2015-00353, Paper 9 (PTAB June 25, 2015) ................................................34
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................52
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019) ............................................................................59
`
`Askeladden L.L.C. v. Encoditech, LLC,
`IPR2017-00452, Paper 12 (PTAB July 31, 2017) ................................................41
`
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
`IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ...............................................49
`
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-01354, -01355, Paper 10 at 6 (PTAB Jan. 27, 2020) ............................31
`
`Dropbox, Inc. v. Whitserve LLC,
` IPR2019-01018, Paper 13 (PTAB Nov. 1, 2019) ...............................................31
`
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361(Fed. Cir. 2000) .............................................................................50
`
`E-One, Inc. v. Oshkosh Corp.,
`IPR2019-00161, Paper 16 (PTAB May 15, 2019) ........................................ 25, 27
`
`Freebit AS v. Bose Corp.,
`IPR2018-00142, Paper 7 (PTAB May 11, 2018) .................................................41
`
`Gilead Scis., Inc. v. United States,
`IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ...............................................49
`
`Gilead Scis., Inc. v. United States,
`IPR2019-01455, Paper 16 (PTAB Feb. 5, 2020) .................................................49
`
`In re Beigel,
`7 F. App'x 959 (Fed. Cir. 2001) ...........................................................................34
`
`iii
`
`
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
` 676 F.3d 1063 (Fed. Cir. 2012) ...........................................................................46
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 53, 55
`
`Intri-Plex Techs. Inc. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................56
`
`Kingston Tech. Co., Inc. v. SPEX Techs., Inc.,
`IPR2017-00824, Paper 8 (PTAB Aug. 17, 2017) ................................................34
`
`Lucia v. SEC,
`138 S. Ct. 2044 (2018)..........................................................................................59
`
`Marvell Semiconductor, Inc. v. Spectra Licensing Grp., LLC,
` IPR2017-01240, Paper 5 (PTAB Oct. 10, 2017) .................................................34
`
`Merial Ltd. v. Virbac,
`IPR2014-01279, Paper 13 (PTAB Jan. 22, 2015) ................................................49
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) ............................................................................15
`
`NHK Spring Co., Ltd., v. Intri-Plex Technologies, Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ......................................... 24, 26
`
`Pfenex, Inc. v. GlaxoSmithKline Biologicals SA,
`IPR2019-01027, Paper 12 at 13–14 (PTAB Nov. 13, 2019)................................32
`
`Polaris Indus. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) ............................................................................50
`
`QXMédical, LLC v. Vascular Sols. LLC,
`No. 17-cv-01969-PJS-TNL, (D. Minn. June 8, 2017) .........................................11
`
`R.J. Reynolds Vapor Co. v. Fontem Holdings 1 B.V.,
`IPR2018-00629, Paper 10 (PTAB Aug. 29, 2018) .............................................41
`
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) ........................................ 48, 53
`
`iv
`
`
`
`Square, Inc. v. 4361423 Canada Inc.
`IPR2019-01628, Paper 14 (PTAB Mar. 31, 2020) ........................................ 29, 30
`
`Stryker Corp. v. Karl Storz Endoscopy-America, Inc.,
` IPR2015-00764, Paper 13 (PTAB Sept. 2, 2015) ............................ 15, 44, 49, 58
`
`Toyota Motor Corp. v. Cellport Sys., Inc.,
`IPR2015-01422, Paper 8 (PTAB Dec. 16, 2015) .................................................34
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................46
`
`TriMed, Inc. v. Stryker Corp.,
`514 F.3d 1256 (Fed. Cir. 2008) ............................................................................15
`
`United States v. Booker,
`543 U.S. 220 (2005) .............................................................................................60
`
`Vascular Sols. LLC v. Medtronic, Inc.,
`No. 19-cv-01760-PJS-TNL (D. Minn) .................................................................11
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................58
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................55
`
`Other Authorities
`
`35 U.S.C. § 112 ....................................................................................................4, 15
`
`35 U.S.C. § 314(a) ...................................................................................................24
`
`35 U.S.C. § 316(b) ............................................................................................ 24, 28
`
`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
`2042 Declaration of Peter Keith
`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
`
`vii
`
`
`
`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
`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
`
`viii
`
`
`
`2079 Exhibit A to Defendants’ Answer and Defenses to Plaintiffs’ First
`Amended and Supplemental Complaint and Second Amended
`Counterclaims Against Plaintiffs, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`[Reserved]
`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)
`
`2080
`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
`
`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
`
`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.
`
`
`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
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`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, institution of the
`
`Petition would be a highly inefficient use of the Board’s resources. The same
`
`3
`
`
`
`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 those issues. Second, 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.
`
`What’s more, the Petition fails to make the threshold showings required for
`
`institution, for at least three reasons. First, Medtronic’s Kontos-based grounds are
`
`based on an unreasonable claim construction advanced by Medtronic. The sole
`
`independent claim Medtronic challenges has a means-plus-function limitation that
`
`Medtronic ignores, arguing instead that it is not governed by 35 U.S.C. § 112,
`
`paragraph 6, despite the fact that the “means” nomenclature was expressly
`
`employed in the claim (and not in the other two independent claims). Medtronic is
`
`wrong. The claim does not recite structure sufficient to overcome the presumption
`
`that Section 112(6) applies. That Medtronic has not even attempted to perform the
`
`appropriate claim construction analysis is basis alone to deny the Petition. And
`
`when the necessary Section 112(6) analysis is conducted, it is apparent that
`
`Medtronic’s lead Kontos reference does not meet the elements of the claims.
`
`Second, the Petition’s analysis is incomplete—it proposes replacing the
`
`proximal-side “funnel” of the Kontos device with a side opening, but it fails to
`
`address the substantial gap that this modification would expose between the
`
`4
`
`
`
`Kontos device and the inner wall of the guide catheter, increasing the likelihood
`
`that an interventional device would become caught or hung-up on the proximal
`
`opening. Kontos’s “funnel” structure was intended to mitigate this very issue by
`
`bridging that gap.
`
`Finally, Medtronic does not address the voluminous objective indicia of non-
`
`obviousness, even though Medtronic was fully aware of the striking commercial
`
`success, industry praise, licensing (including its own licensing request), copying,
`
`and long-felt 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 Board should decline to institute review
`
`based on this Petition.
`
`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
`
`5
`
`
`
`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. The GuideLiner
`
`created a new market category—guide extension catheters. Id., ¶ 9. 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 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.
`
`B.
`
`The ’380 Patent
`
`Medtronic’s Petition identifies five grounds that challenge independent
`
`claim 25 of the ’380 patent and/or claims depending from claim 25. Petition at 7.
`
`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 artery of the
`
`6
`
`
`
`aorta to facilitate delivery of stents, balloon angioplasty catheters and other
`
`interventional cardiology devices. Ex. 1801, 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
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`
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`Id. at 7:50–64. When the wire or an interventional cardiology device such as a
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`stent or balloon catheter encounters a difficult lesion, advancing it across the lesion
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`can create backward force strong enough to dislodge the guide catheter’s distal end
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`from the ostium. Id. at 1:59–61; 4:63–5:5. The phantom guide catheter (yellow) in
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`Figure 7 shows how backward force generated by the advancing device can cause
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`the guide catheter to dislodge from the ostium.
`
`
`
`The ’380 patent addresses this problem by providing a system with increased
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`backup support for guide catheters inserted into a coronary artery. Id. at 1:33–35.
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`Figure 9 (color added), below, illustrates how the guide extension catheter 12
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`(orange with blue tip) is inserted past the end of guide catheter and deep into the
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`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
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`tendency of the guide catheter (pink) to back out of the ostium when the operator
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`increases the pressure on the proximal end of a wire or a stent or balloon delivery
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`catheter to advance it across a lesion.
`
`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
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`single lumen that is preferably reinforced with coil or braid, and a substantially
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`rigid portion that has a rail segment to permit delivery without blocking use of the
`
`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,
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`blue), a hemicylindrical portion (36, green), and an arcuate portion (38, purple):
`
`Id. at 6:62–64, Fig. 4 (color added). The angled side opening is configured to
`
`receive stents and balloon catheters when the side opening is positioned within the
`
`
`
`9
`
`
`
`lumen of the guide catheter and the distal end of the guide extension catheter
`
`extends beyond the distal end of the guide catheter.
`
`Independent claim 25, the only independent claim challenged, is directed to
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`a system and is written in means-plus-function format. The full claim is provided
`
`below:
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`25. A system comprising:
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`means for guiding an interventional device from a
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`location outside of a subject, through a main vessel, to a
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`location near an ostium of a branch vessel; and
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`means for receiving the interventional device from an
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`intermediate or distal portion of the means for guiding
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`the interventional device to the location near the ostium
`
`of the branch vessel and guiding the interventional
`
`device deeper into the branch vessel,
`
`the means for receiving the interventional device and
`
`guiding the interventional device deeper into the branch
`
`vessel including, in a distal to proximal direction, a tip
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`portion, a reinforced portion, a side opening, and a
`
`substantially rigid portion, and having a length such
`
`that when the distal end of the tip portion is extended
`
`distally of the distal end of the means for guiding the
`
`interventional device to the location near the ostium of
`
`the branch vessel, a portion of the proximal end of the
`
`substantially rigid portion extends proximally of the
`
`proximal end of the means for guiding the
`
`10
`
`
`
`interventional device to the location near the ostium of
`
`the branch vessel,
`
`wherein the tip portion, the reinforced portion, the side
`
`opening, and the substantially rigid portion are
`
`configured to be passed, at least in part, into a lumen of
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`the means for guiding the interventional device to the
`
`location near the ostium of the branch vessel, and
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`the side opening and the substantially rigid portion are
`
`configured to be more rigid along a length thereof than
`
`the tip portion.
`
`Id. at 13:43–14:5.
`
`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, including certain of the claims challenged in
`
`this IPR, has been the subject of nearly three years of active litigation in the
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`District of Minnesota, in two separate cases. On June 8, 2017, QXMédical filed a
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`declaratory judgment action against VSI. QXMédical, LLC v. Vascular Sols. LLC,
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`No. 17-cv-01969-PJS-TNL, Dkt. 1 (D. Minn. June 8, 2017) (“QXM case”). On
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`July 2, 2019, while the QXM case was ongoing, Teleflex filed suit against
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`Medtronic, alleging that Medtronic’s copycat “Telescope” product infringes the
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`’380 patent, among others. Vascular Sols. LLC v. Medtronic, Inc., No. 19-cv-
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`01760-PJS-TNL (D. Minn) (“Teleflex v. Medtronic” or “district court case”); see
`
`also Ex. 1879. The QXM and Teleflex v. Medtronic cases have been designated
`
`11
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`
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`“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
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`asserted claims are not invalid as indefinite or invalid under the recapture rule, and
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`that QXM infringes certain claims. Ex. 1813; QXM, No. 17-cv-01969, Dkt 194 at
`
`1 (D. Minn.); id., Dkt. 156 at 41–42. The same Kontos reference (Ex. 1809) that is
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`Medtronic’s lead reference in this Petition was also one of the three “primary”
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`prior art references the alleged infringer in the QXM case relied on. E.g., QXM,
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`No. 17-cv-01969, Dkt. 110 at 6-8 (D. Minn.); id., Dkt. 111-1 at 12-13. Trial was
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`initially scheduled to begin on February 24, 2020, but QXM moved to stay,
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`agreeing to waive its remaining Section 102 and 103 defenses and to exit the U.S.
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`market for the duration of the stay. Id., Dkt. 194 at 2. In view of QXM’s
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`concessions, the Court agreed to stay the QXM case until the Board renders its
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`institution decisions on the IPRs Medtronic has filed against the GuideLiner
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`patents. Id.
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`The Teleflex v. Medtronic case concerns Medtronic’s infringement of several
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`patents, including the ’380 patent. Ex. 1879, ¶¶ 47–68. In that case, Medtronic
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`relies on invalidity grounds that, like the Petition, concern the Kontos and Adams
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`combination. Compare Ex. 2078 at 59 (¶ 19) and Ex. 2079 at 2 with Petition at 7.
`
`12
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`
`
`The parties have already conducted extensive fact discovery, including serving and
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`responding to interrogatories, serving and responding to document requests, and
`
`exchanging over 25,000 documents so far. Ex. 2073, ¶ 22. Further, Medtronic has
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`deposed Teleflex’s technical expert, Peter Keith, and Teleflex’s Regional Sales
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`Director Amy Welch. Ex. 2050; Ex. 2051. Fact discovery remains ongoing and is
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`set to close on September 1, 2020. Ex. 2049 at 2. The parties must submit their
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`joint claim construction statement by October 15, 2020. Id. at 4–5. The case must
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`be trial ready by August 1, 2021. Id. at 9.
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`Teleflex and Medtronic have also fully briefed and argued a motion for
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`preliminary injunction that concerns validity issues like those at issue in the
`
`Petition: whether Kontos in view of Adams renders certain claims of the ’380
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`patent invalid. Ex. 2048 at 38–39 and 42–44 (Medtronic opposition brief); Teleflex
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`v. Medtronic, No. 19-cv-01760-PJS-TNL, Dkt. 184 at 9–10 (Teleflex reply brief)
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`and Dkt. 191 at ¶¶ 30–43 (reply declaration of Teleflex technical expert Peter
`
`Keith discussing the Kontos and Adams references). In conjunction with this
`
`briefing, the parties submitted voluminous supporting evidence. E.g., id., Dkt. 191
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`at ¶¶ 30–43 (reply declaration of Teleflex technical expert Peter Keith addressing,
`
`inter alia¸ validity), Dkt. 79, 193 (declarations of Teleflex’s Regional Sales
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`Director Amy Welch addressing issues such as market success and licensing of the
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`GuideLiner product), Dkt. 112 (declaration of Medtronic’s expert Paul Zalesky
`
`13
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`
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`addressing validity and invention date), and Dkt. 110 (declaration of Medtronic
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`witness Heather S. Rosecrans addressing copying).
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART
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`For purposes of this Preliminary Response only, Teleflex does not currently
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`dispute Medtro
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