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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`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 IPR2020-00136
`Patent RE 45,776
`
`
`
`
`
`
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`
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`
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`
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`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
`
`
`The Revolutionary GuideLiner Product ................................................ 5
`
`
`
`
`
`A.
`
`B.
`
`C.
`
`The ’776 Patent ..................................................................................... 6
`
`The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’776 Patent in the District of Minnesota .....................12
`
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ...............................16
`
`V.
`
`VI. MEDTRONIC’S REFERENCES ..................................................................16
`
`
`CLAIM CONSTRUCTION ..........................................................................16
`
`A. Kontos (Ex. 1409) ...............................................................................16
`
`
`
`
`
`
`
`
`
`
`
`
`VII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ................24
`
`
`B.
`
`C.
`
`Ressemann (Ex. 1408) .........................................................................18
`
`Takahashi (Ex. 1410) ..........................................................................21
`
`D. Kataishi (Ex. 1425)..............................................................................22
`
`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 Multiple-Petition Attack ......................................28
`
`C. ALL GROUNDS: Medtronic Has Not Shown That the Claimed Guide
`Extension Catheter, Including a “Partially Cylindrical Opening,”
`Would Have Been Obvious Based on Kontos and Ressemann ..........31
`
`ii
`
`

`

`1.
`
`2.
`
`3.
`
`The Petition Does Not Address Why One Skilled in the Art
`Would Focus on Ressemann’s Support Collar to Define a
`Partially Cylindrical Opening ...................................................33
`
`The Petition Does Not Address Reasons Why a POSITA Would
`Be Motivated Not to Make the Combination ............................36
`
`The Motivations Identified in the Petition Ignore Key
`Considerations That Are Necessary for the Board to Assess
`Likelihood of Success and Therefore Are Unsupported...........42
`
`D. GROUNDS 2 AND 4: Medtronic Has Not Shown That It Would
`Have Been Obvious to Make the Inner Diameter of Kontos’s Lumen
`“Not More Than One French Size Smaller” Than That of the Guide
`Catheter................................................................................................46
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`E.
`
`
`
`F.
`
`J.
`
`GROUNDS 3 and 4: Medtronic Has Not Shown That It Would Have
`Been Obvious to Modify the Proximal End of Kontos’s Guide
`Catheter Body Based on the Distal End of Kataishi’s
`Suction Catheter ..................................................................................49
`
`ALL GROUNDS: The Petition Failed to Address Known, Strong
`Objective Evidence of Non-Obviousness ...........................................54
`
`1. Commercial Success .................................................................58
`
`2.
`
`3.
`
`Industry Praise ...........................................................................61
`
`Licensing and Licensing Attempts ...........................................63
`
`4. Copying .....................................................................................63
`
`5.
`
`Long-Felt Need .........................................................................66
`
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ..................................................................................67
`
`
`VIII. CONCLUSION ..............................................................................................68
`
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................61
`
`
`Arctic Cat Inc. v. Bombardier Rec. Prods.,
` 876 F.3d 1350 (Fed. Cir. 2017) ............................................................................37
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
` 941 F.3d 1320 (Fed. Cir. 2019) ...........................................................................68
`
`
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
` IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ...............................................58
`
`Comcast Cable Commn’cs, LLC v. Rovi Guides, Inc.,
`IPR2019-00279, -00280, -00282, -00283, Paper 10 (PTAB July 1, 2019) .........31
`
`
`Comcast Cable Commn’cs., LLC v. Rovi Guides, Inc.,
`IPR2019-01354, -01355, Paper 10 (PTAB Jan. 27, 2020) ...................................31
`
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
` 567 F.3d 1314 (Fed. Cir. 2009) ............................................................................39
`
`Dropbox, Inc. v. Whitserve LLC,
` IPR2019-01018, Paper 13 (PTAB Nov. 1, 2019) ...............................................31
`
`
`E-One, Inc. v. Oshkosh Corp.,
` IPR2019-00161, Paper 16 (PTAB May 15, 2019) ........................................ 26, 28
`
`Gilead Scis., Inc. v. United States,
` IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ...............................................58
`
`Gilead Scis., Inc. v. United States,
` IPR2019-01455, Paper 16 (PTAB Feb. 5, 2020) .................................................58
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
` 676 F.3d 1063 (Fed. Cir. 2012) ............................................................................55
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 62, 63
`
`iv
`
`

`

`
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................64
`
`
`Kahn v. GMC,
` 135 F.3d 1472 (Fed. Cir. 1998) ............................................................................46
`
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) .........................................................................................68
`
`
`Merial Ltd. v. Virbac,
` IPR2014-01279, Paper 13 (PTAB Jan. 22, 2015) ................................................58
`
`NHK Spring Co., Ltd., v. Intri-Plex Technologies, Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ................................................25
`
`
`Pfenex, Inc. v. GlaxoSmithKline Biologicals SA,
`IPR2019-01027, Paper 12 (PTAB Nov. 13, 2019) ..............................................32
`
`
`Plas-Pak Indus. v. Sulzer Mixpac AG,
` 600 F. App’x 755 (Fed. Cir. 2015) .......................................................................40
`
`Polaris Indus. v. Arctic Cat, Inc.,
` 882 F.3d 1056 (Fed. Cir. 2018) ..................................................................... 38, 60
`
`Resmed Ltd. v. Fisher & Paykel Healthcare Ltd.,
` IPR2016-01724, Paper 50 (PTAB Mar. 7, 2018) .................................................38
`
`Robert Bosch Tool Corp. v. SD3, LLC,
` IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) ........................................ 57, 61
`
`Square, Inc. v. 4361423 Canada Inc.
` IPR2019-01628, Paper 14 (PTAB Mar. 31, 2020) ........................................ 30, 31
`
`Stryker Corp. et al.v. KFx Medical, LLC,
` IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ..............................................58
`
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
` 96 F.3d 1409 (Fed. Cir. 1996) ..............................................................................66
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
` 699 F.3d 1340 (Fed. Cir. 2012) ............................................................................55
`
`v
`
`

`

`
`United States v. Booker,
`543 U.S. 220 (2005) .............................................................................................68
`
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................................66
`
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................64
`
`
`Statutes
`
`35 U.S.C. § 314 ........................................................................................................25
`
`35 U.S.C. § 316 ................................................................................................. 25, 29
`
`vi
`
`

`

`TABLE OF EXHIBITS
`
`Exhibit Descri n tion
`
`2001
`
`2002
`
`2003
`
`Reserved
`
`Reserved
`
`Reserved
`
`2004
`
`Reserved
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`2010
`
`Reserved
`
`201 1
`
`2012
`
`2013
`
`2014
`
`2015
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`2016
`
`Reserved
`
`
`
`Reserved
`2017
`
`2018
`[Reserved]
`2019
`Reserved
`
`2020
`
`Reserved
`
`2021
`
`Reserved
`
`2022
`2023
`
`[Reserved]
`Reserved
`
`2024
`
`Reserved
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`203 1
`
`2032
`
`3033
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`2034
`
`Reserved
`
`2035
`
`Reserved
`
`2036
`
`Reserved
`
`vii
`
`

`

`[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
`
`viii
`
`

`

`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
`
`ix
`
`

`

`
`
`
`
`
`
`
`2079 Exhibit A to Defendants’ Answer and Defenses to Plaintiffs’ First
`Amended and Supplemental Complaint and Second Amended
`Counterclaims Against Plaintiffs, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`[Reserved]
`2080
`2081 Plaintiff’s Reply Memorandum in Support of Motion for Preliminary
`Injunction (Redacted), Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn)
`
`
`
`x
`
`

`

`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
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`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
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`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 ’776 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
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`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 the 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 the present Petition. The same
`
`validity issues between the same parties are already being litigated in the district
`
`3
`
`

`

`court and the district court has already invested the time to familiarize itself with
`
`the facts and law relating to the threshold invention date issue. Therefore,
`
`institution of the Petition would be a highly inefficient use of the Board’s
`
`resources. Moreover, Medtronic has failed to justify its multi-petition and multi-
`
`ground attack on the ’776 patent. These reasons alone show that the Board should
`
`deny the Petition.
`
`As to the merits of the Petition, the independent claims of the ’776 patent all
`
`require a “segment defining a partially cylindrical opening” positioned between a
`
`substantially rigid segment and a tubular structure. All of the Grounds in the
`
`Petition are premised on combining two prior art references (Kontos and
`
`Ressemann) in a very specific way – extracting a support collar from Ressemann
`
`and using it to form a partially cylindrical opening in Kontos’s device. However,
`
`the Petition fails to address several important considerations, including
`
`satisfactorily explaining why one skilled in the art would use Ressemann’s support
`
`collar for this purpose when it doesn’t even serve that purpose in Ressemann.
`
`Medtronic’s analysis is pure hindsight.
`
`Further, one of the things that makes the ’776 patent different from the other
`
`GuideLiner patents that Medtronic has attacked is that two of the three independent
`
`claims require that the partially cylindrical opening have “at least two inclined
`
`regions.” The use of such a complex side opening is an important feature of
`
`4
`
`

`

`GuideLiner because it provides many benefits, such as channeling interventional
`
`cardiology devices, preventing wire wrap, and helps orient the side opening within
`
`the guide catheter. Medtronic copied this patented feature into its infringing
`
`Telescope product. Medtronic’s arguments regarding this feature are nothing more
`
`than a post-hoc analysis that carefully picks and chooses just the right features to
`
`satisfy the claim language. That is the antithesis of obviousness.
`
`Finally, Medtronic does not address the voluminous objective indicia of non-
`
`obviousness, even though Medtronic was fully aware of the striking commercial
`
`success, industry praise, licensing and licensing requests, copying, and long-felt
`
`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.
`
`Thus, the Petition does not establish that Medtronic is likely to show that any of
`
`the challenged claims would have been obvious.
`
`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
`
`5
`
`

`

`rapid exchange guide extension catheter capable of receiving and delivering stents
`
`and balloon catheters. Over the next few years, VSI worked to obtain 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.
`
`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 nearly 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 ’776 Patent
`B.
`The ’776 patent is one of a family of patents that covers GuideLiner. The
`
`’776 patent is directed to a “guide extension catheter” that is passed through the
`
`lumen of a guide catheter, advanced beyond the distal end of the guide catheter,
`
`and inserted into a branch artery of the aorta to facilitate delivery of stents, balloon
`
`6
`
`

`

`angioplasty catheters and other interventional cardiology devices. Ex. 1401 at
`
`Abstract, 13:36–16:37.
`
`
`
`One of the important benefits of the guide extension catheter of the ’776
`
`patent is increased “back-up support.” Id. at 1:38-41. When treating a stenosis, a
`
`guide catheter is typically guided into the ostium (opening) of the branch artery to
`
`be treated, and a guidewire is passed through the lumen of the guide catheter and
`
`advanced into the artery beyond the stenosis. Id. at 1:61-65. Below is Figure 7 of
`
`the patent (color added), showing a typical guide catheter 56 (pink) inserted into
`
`the ostium 60 of a coronary artery, with a guidewire 64 passing through the guide
`
`catheter and attempting to cross a stenotic lesion 66:
`
`
`
`Id. at Fig. 7, 7:56-8:3. When the interventional cardiology device encounters a
`
`difficult lesion, advancing an interventional cardiology device across the lesion can
`
`create backward force strong enough to dislodge the guide catheter’s distal end
`
`7
`
`

`

`from the ostium. Id. at 1:65-67; 5:4-13. The phantom guide catheter (yellow) in
`
`Figure 7 shows how backward force generated by the advancing device can cause
`
`the guide catheter to dislodge from the ostium.
`
`
`
`The ’776 patent addresses this problem by providing a guide extension
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`catheter that provides increased backup support for guide catheters inserted into a
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`coronary artery. Id. at 1:38-41. Figure 9 (color added), below, illustrates how the
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`guide extension catheter 12 (orange with blue tip) is inserted past the end of guide
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`catheter and deep into the coronary artery:
`
`
`
`Not only does the guide extension catheter help guide interventional cardiology
`
`devices closer to the desired location (e.g., a blockage or lesion), but it also reduces
`
`the tendency of the guide catheter (pink) to back out of the ostium when the
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`8
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`

`

`operator increases the pressure on the proximal end of a wire or a stent or balloon
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`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 flexible tubular portion with a single
`
`lumen, and a substantially rigid portion that has a rail segment to permit delivery
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`without blocking use of the guide catheter. E.g., id. at 6:40-41 and Figs. 1, 4, 20-
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`22. An important advantage of this design is it reduces the available space to
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`deliver interventional cardiology devices only slightly — by no more than “one
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`French size” smaller than the guide catheter in the preferred embodiment. Id. at
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`3136—5 1 .
`
`The guide extension catheter preferably has a proximal partially cylindrical
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`opening that includes, from distal to proximal direction, a first full circumference
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`portion (34, blue), a hemicylindrical portion (36, green), and an arcuate portion
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`(38, purple), with inclined portions located at the junction between each portion:
`
`
`
`Id. at 7:1-3; Fig. 4 (color and annotations added). The partially cylindrical opening
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`is configured to receive interventional cardiology devices (including stent and
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`balloon catheters) when the opening is positioned within the guide catheter and the
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`distal end of the guide extension catheter extends beyond the distal end of the
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`guide catheter.
`
`The claims of the ’776 patent cover this invention. Independent claim 25
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`reads as follows:
`
`25. A guide extension catheter for use with a guide catheter,
`comprising:
`
`a substantially rigid segment;
`
`a tubular structure defining a lumen and positioned distal to the
`substantially rigid segment; and
`
`a segment defining a partially cylindrical opening positioned between
`a distal end of the substantially rigid segment and a proximal end of
`the tubular structure, the segment defining the partially cylindrical
`opening having an angled proximal end, formed from a material more
`rigid than a material or material combination forming the tubular
`structure, and configured to receive one or more interventional
`cardiology devices therethrough when positioned within the guide
`catheter,
`
`wherein a cross-section of the guide extension catheter at the proximal
`end of the tubular structure defines a single lumen.
`
`Id. at 13:36-52. Independent claims 52 and 53 contain nearly identical language
`
`and additionally require, inter alia, that “the segment defining the angled proximal
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`10
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`

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`end of the partially cylindrical opening includes at least two inclined regions.” Id.
`
`at 15:15-16:18.
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`Claims 52 and 53 cover an important feature of Teleflex’s current and most
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`successful version of GuideLiner, copied by Medtronic: the extended side opening.
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`Three different versions of GuideLiner have been introduced. Ex. 2044, 1] 11. The
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`current version of GuideLiner (“GuideLiner V3”) was introduced in 2013. Id.
`
`Like the previous versions of GuideLiner, GuideLiner V3 includes a flexible, coil-
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`reinforced tubular portion attached at its distal end to an atraumatic “bumper tip”
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`and attached at its proximal end to a substantially rigid push wire:
`
`Bumper
`Tip
`
`
`Tubular Portion
`
`Push
`
`w
`
`See Ex. 2070.
`
`GuideLiner V3 differed from the earlier versions of GuideLiner in that it
`
`added an extended side opening (referred to in Teleflex’s marketing material as a
`
`“half pipe”), shown in the ’776 patent at Fig. 4, above, at the transition between the
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`push wire and the tubular portion:
`
`Incli7ed
`
`I
`
`Hallfpipe
`
`Inclinedportion
`
`I
`
`'_-. _———fi5
`|
`I
`%Y—}
`
`Extended side opening (“half pipe”)
`
`11
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`

`

`
`
`See Ex. 2070; Ex. 2063 at 4. As can be seen, the side opening portion of
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`GuideLiner V3 has the two “inclined portions” as claimed in independent claims
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`52 and 53 of the ’776 patent: one where the hemispherical half pipe transitions into
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`the tubular portion and the other where the half pipe transitions into the push wire.
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`Among other things, this extended side opening helps to smoothly guide stents and
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`balloon catheters into the tubular portion. Ex. 2063 at 4.
`
`C.
`
`The QXM and Medtronic Cases: Parallel Litigation Regarding
`the Validity of the ’776 Patent in the District of Minnesota
`
`The validity of the ’776 patent claims has been the subject of nearly three
`
`
`
`years of active litigation in the District of Minnesota in two separate cases. On
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`June 8, 2017, QXMédical (“QXM”) filed a declaratory judgment action against
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`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
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`“Telescope” product infringes the ’776 patent, among others. Vascular Sols. LLC
`
`v. Medtronic, Inc., No. 19-cv-01760-PJS-TNL (D. Minn.) (“Teleflex v. Medtronic”
`
`or “district court case”); see also Ex. 1479. Both cases have been assigned to the
`
`same judge, who now is exceedingly familiar with the subject matter and validity
`
`of the ’776 patent.
`
`12
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`

`

`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 of this same ’776 patent, including claims that
`
`recite that the side opening has at least two inclined regions. Ex. 1413; QXM, No.
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`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 its remaining Section 102 and 103 defenses and to exit the U.S. market for
`
`the duration of the stay. Id., Dkt. 194 at 2. In view of QXM’s concessions, the
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`Court agreed to stay the QXM case until the Board renders its institution decisions
`
`on Medtronic’s IPR petitions. Id.
`
`Teleflex v. Medtronic concerns Medtronic’s infringement of several
`
`patents, including the ’776 patent. Ex. 1479, ¶¶ 69-86. In that case, Medtronic
`
`relies on the very same invalidity grounds it asserts in the Petition. Ex. 2078 at ¶
`
`23
`
`(incorporating the “grounds for invalidity articulated in the Petitions . . . in Case
`
`Nos. IPR2020-00135 and IPR2020-00136”). The parties have already conducted
`
`extensive fact discovery, including serving and responding to interrogatories and
`
`document requests, and exchanging over 25,000 documents. 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
`13
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`

`

`discovery remains ongoing and is set to close on September 1, 2020. Ex. 2049 at
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`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 fully briefed and argued a motion for
`
`preliminary injunction that, as does the Petition, includes Medtronic’s defenses that
`
`combinations of Kontos, Ressemann, and/or Kataishi render claims of the Teleflex
`
`patents invalid. Ex. 2048 at 39, 42-46 (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 ¶¶ 14-43 (reply declaration of Teleflex technical
`
`expert Peter Keith discussing Kontos, Ressemann and Kataishi), Dkt. 79, 193
`
`(declarations of Teleflex’s Regional Sales Director Amy Welch addressing issues
`
`such as market success and licensing of the GuideLiner product), Dkt. 112
`
`(declaration of Medtronic’s expert Paul Zalesky), and Dkt. 110 (declaration of
`
`Medtro