`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00132
`Patent RE 45,760E
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
`
`
`[CONTAINS PROTECTIVE ORDER MATERIAL]
`
`

`

`TABLE OF CONTENTS
`
`INTRODUCTION COMMON TO ALL IPR PETITIONS .............................. 1
`I.
`INTRODUCTION TO THE PRESENT PATENT OWNER RESPONSE... 3
`II.
`III. BACKGROUND .......................................................................................................... 5
`A. The Revolutionary GuideLiner Product ........................................................... 5
`B. The ’760 Patent ....................................................................................................... 6
`C. The QXM and Medtronic Cases: Parallel Litigation Regarding the
`Validity of the ’760 Patent in the District of Minnesota ............................ 11
`
`IV. PRIORITY DATE – PRE-AIA LAW APPLIES ............................................... 14
`THE PERSON OF ORDINARY SKILL IN THE ART .................................. 16
`V.
`VI. CLAIM CONSTRUCTION .................................................................................... 16
`VII. MEDTRONIC’S REFERENCES .......................................................................... 16
`A. Itou (Ex. 1007) ..................................................................................................... 16
`B. Ressemann (Ex. 1008) ....................................................................................... 20
`VIII. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW ................. 24
`A. ALL GROUNDS: The Petition Should Be Denied Because the Itou
`Reference Is Not Prior Art ................................................................................. 24
`
`B. ALL GROUNDS: The Petition Should be Denied Under 35 U.S.C. §
`314(a) ..................................................................................................................... 27
`
`C. ALL GROUNDS: The Petition Should Be Denied Because Medtronic
`Failed to Justify Its Three-Petition Attack on the ’760 Patent .................. 32
`
`D. GROUND 1: Medtronic Has Not Shown that Itou’s Suction Catheter
`Anticipates Any Challenged Claim ................................................................. 35
`
`E. GROUND 2: Medtronic Has Not Shown that Any Challenged Claim Is
`Obvious in View of Itou and Ressemann and the Knowledge of a
`POSITA .................................................................................................................. 44
`
`
`
`ii
`
`
`
`
`
`
`
`

`

`
`1. The Petition Fails to Explain Motivation and Reasonable Expectation
`of Success to Combine Itou with Ressemann’s “Support Collar” .... 44
`
`a. The Petition Does Not Explain Why or How a POSITA Would Be
`Motivated to Select Ressemann’s Support Collar, Combine It with
`Itou, and Use It for a Purpose—Facilitating Insertion of Stents or
`Balloon Catheters—for Which It Is Not Disclosed ......................... 45
`
`b. The Petition Does Not Address Ressemann’s Teaching that
`Intravascular Devices Were Prone to “Hang-up” or “Catching” on
`the Angled Proximal Opening of Its Aspiration Lumen ................ 50
`
`c. The Petition Does Not Address How Structural, Non-Diametrical
`Aspects of Itou Would Be Expected to Successfully Receive
`Stents or Balloon Catheters ................................................................... 51
`
`2. The Petition Fails to Address Known Objective Evidence of Non-
`Obviousness ..................................................................................................... 53
`a. Commercial Success ................................................................................ 54
`b. Industry Praise .......................................................................................... 58
`c. Licensing and Licensing Attempts ...................................................... 59
`d. Copying....................................................................................................... 60
`e. Long-Felt Need ......................................................................................... 62
`F. GROUNDS 3 AND 4: Medtronic Has Failed to Show that There Is a
`Reasonable Likelihood of Prevailing as to Its Challenges to Dependent
`Claim 32 ................................................................................................................. 64
`
`G. The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ................................................................................................... 64
`
`IX. CONCLUSION........................................................................................................... 65
`
`iii
`
`
`
`
`
`
`
`
`
`
`
`

`

`TABLE OF AUTHORITIES
`
`
`Cases
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016)................................................................................57
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019).......................................................................... 64-65
`Bettcher Indus. v. Bunzl USA,
`661 F.3d 629 (Fed. Cir. 2011) ..................................................................................36
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc.,
`IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ..................................................54
`Comcast Cable Commc’ns LLC v. Rovi Guides, Inc.,
`IPR2019-00279, -00280, -00282, -00283, Paper 10 (PTAB July 1, 2019) .............33
`Comcast Cable Commc’ns, LLC v. Rovi Guides, Inc.,
`IPR2019-01354, -01355, Paper 10 (PTAB Jan. 27, 2020) ......................................33
`Dropbox, Inc. v. Whitserve LLC,
`IPR2019-01018, Paper 13 (P.T.A.B. Nov. 1, 2019) ................................................33
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000)................................................................................54
`E-One, Inc. v. Oshkosh Corp.,
`IPR2019-00161, Paper 16 (PTAB May 15, 2019) ...................................... 28-29, 31
`Gilead Scis. Inc. v. United States,
`IPR2019-01453, Paper 14 (PTAB Feb. 20, 2020) ............................................ 54, 63
`Gilead Scis., Inc. v. United States,
`IPR2019-01455, Paper 16 (PTAB Feb. 5, 2020) .....................................................54
`In re Chudik,
`674 F. App’x 1011 (Fed. Cir. 2017) ........................................................................37
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012)................................................................................53
`In re Fine,
`837 F.2d 1071 (Fed. Cir. 1988)................................................................................46
`In re Magnum Oil Tools Int'l, Ltd.,
`
`
`
`iv
`
`

`

`829 F.3d 1364 (Fed. Cir. 2016)................................................................................46
`In re Oelrich,
`666 F.2d 578 (C.C.P.A. 1981) .......................................................................... 36, 41
`Institut Pasteur et al., v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013)................................................................... 51, 58, 59
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016)................................................................................44
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................60
`Johns Manville Corp. et al. v. Knauf Insulation Inc. et al.,
`IPR2018-00827, Paper 9 (PTAB Oct. 16, 2018) .....................................................52
`LG Elecs., Inc. v. Wi-LAN Inc.,
`IPR2018-00704, Paper 14 (PTAB Sept. 5, 2018) ....................................................25
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) .............................................................................................65
`Merial Ltd. v. Virbac,
`IPR2014-01279, Paper 13 (PTAB Jan. 22, 2015) ...................................................54
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ..........................................................................37
`NHK Spring Co., Ltd., v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) ....................................... 27, 29, 30
`Par Pharm., Inc. v. Jazz Pharms. et al.,
`IPR2016-00002, Paper 12 (PTAB April 12, 2016) .................................................51
`PersonalWeb Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ........................................................................... 48, 52
`Pfenex, Inc. v. GlaxoSmithKline Biologicals SA,
`IPR2019-01027, Paper 12 (PTAB Nov. 13, 2019) ..................................................34
`Polaris Indus. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018)................................................................... 49, 54, 56
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01753, Paper 15 (PTAB Mar. 22, 2017) ..................................................57
`
`
`
`
`v
`
`

`

`Stryker Corp. et al.v. KFx Medical, LLC,
`IPR2019-00817, Paper 10 (PTAB Sept. 16, 2019) ........................................... 26, 54
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) ..................................................................................62
`Transclean Corp. v. Bridgewood Servs.,
`290 F.3d 1364 (Fed. Cir. 2002)......................................................................... 35, 36
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012)................................................................................53
`United States v. Booker,
`543 U.S. 220 (2005) .................................................................................................65
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016)................................................................................62
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010)................................................................................60
`
`Other Authorities
`35 U.S.C. § 100(i)(2) ...............................................................................................15
`35 U.S.C. § 311(b) ...................................................................................................15
`35 U.S.C. § 316(b) ............................................................................................ 27, 32
`35 U.S.C. §314(a) ....................................................................................................27
`37 C.F.R. § 42.108 ...................................................................................................27
`AIA § 3(n)(1) ...........................................................................................................14
`MPEP § 1440(II) ......................................................................................................15
`MPEP § 2159.02 ......................................................................................................14
`
`
`
`
`vi
`
`

`

`TABLE OF EXHIBITS
`
`
`2009
`2010
`
`2011
`
`Exhibit Description
`2001 Declaration of Howard Root Submitted in Connection with Patent
`Owner’s Preliminary Responses – PROTECTIVE ORDER MATERIAL
`2002 Gregg Sutton Lab Notebook – PROTECTIVE ORDER MATERIAL
`2003 Memo Regarding Market Feasibility for the GuideLiner catheters
` – PROTECTIVE ORDER MATERIAL
`2004 Howard Root Notes – PROTECTIVE ORDER MATERIAL
`2005 Project Spend Report – PROTECTIVE ORDER MATERIAL
`2006
`Invoice from MicroGroup – PROTECTIVE ORDER MATERIAL
`2007
`Invoice from MicroGroup – PROTECTIVE ORDER MATERIAL
`2008
`Invoices from Medical Profiles & Engineering – PROTECTIVE
`ORDER MATERIAL
`Invoice from MicroGroup – PROTECTIVE ORDER MATERIAL
`Invoice from Mountain Machine, Inc. – PROTECTIVE ORDER
`MATERIAL
`Invoice from Medical Engineering & Design Inc. – PROTECTIVE
`ORDER MATERIAL
`[Reserved]
`2012
`2013 Sales Order from SPECTRAlytics – PROTECTIVE ORDER
`MATERIAL
`2014 Photos of Component of GuideLiner Prototype – PROTECTIVE
`ORDER MATERIAL
`2015 Howard Root Deposition Transcript – PROTECTIVE ORDER
`MATERIAL
`Invoice from Medtronic – PROTECTIVE ORDER MATERIAL
`2016
`2017 Memo Regarding Market Feasibility for the GuideLiner catheters
` – PROTECTIVE ORDER MATERIAL
`2018 PowerPoint presentation titled “New Products on the Horizon”
` – PROTECTIVE ORDER MATERIAL
`2019 Redacted, Excerpted Fax to Patterson Law Firm – PROTECTIVE
`ORDER MATERIAL
`2020 Sales Order and Invoice from SPECTRAlytics – PROTECTIVE
`ORDER MATERIAL
`Invoice from Medical Engineering & Design – PROTECTIVE ORDER
`MATERIAL
`2022 Computerized Design Drawing of a GuideLiner – PROTECTIVE
`ORDER MATERIAL
`
`2021
`
`
`
`vii
`
`

`

`2028
`2029
`
`2030
`
`2031
`
`2032
`
`2023 Redacted Client/Matter Form from Patterson Law Firm – PROTECTIVE
`ORDER MATERIAL
`2024 Product Requirements: GuideLiner Catheter System – PROTECTIVE
`ORDER MATERIAL
`2025 Clinical Technical Report – PROTECTIVE ORDER MATERIAL
`2026
`Invoice from MicroGroup – PROTECTIVE ORDER MATERIAL
`2027
`Invoice from Johnson Matthey Inc (Shape Memory Applications, Inc.)
`– PROTECTIVE ORDER MATERIAL
`Invoice from SPECTRAlytics – PROTECTIVE ORDER MATERIAL
`Invoices from Medical Profiles & Engineering – PROTECTIVE
`ORDER MATERIAL
`Invoice from Automation & Metrology Inc. – PROTECTIVE ORDER
`MATERIAL
`Invoice from Automation & Metrology Inc. – PROTECTIVE ORDER
`MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`Invoice from Farlow’s Scientific Glassblowing, Inc. – PROTECTIVE
`ORDER MATERIAL
`2036 Research and Development Update July 2005 – PROTECTIVE ORDER
`MATERIAL
`2037 Exhibit BB to Declaration of Lora M. Friedemann in Opposition to
`Plaintiffs’ Motion for Preliminary Injunction – PROTECTIVE ORDER
`MATERIAL
`2038 Exhibit 36 to the Declaration of Kurt J. Niederlueke in Opposition to
`Plaintiffs’ Motion for Preliminary Injunction – PROTECTIVE ORDER
`MATERIAL
`2039 Declaration of Deborah Schmalz
`2040 Weekly Staff Meeting Memorandum – PROTECTIVE ORDER
`MATERIAL
`2041 Business Update Section of Materials Presented to the Vascular
`Solutions Board of Directors October 2005 – PROTECTIVE ORDER
`MATERIAL
`2042 Declaration of Peter Keith
`
`3033
`
`2034
`
`2035
`
`
`
`viii
`
`

`

`2043 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Under Seal), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 78 –
`PROTECTIVE ORDER MATERIAL
`2044 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Redacted), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 79
`2045 Plaintiffs’ Second Supplemental Objections and Response to
`Defendants’ Interrogatory No. 7 Concerning Preliminary Injunction
`Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.) – PROTECTIVE ORDER MATERIAL
`2046 Declaration of Howard Root in Support of Plaintiff’s Motion for
`Preliminary Injunction, Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn), Dkt. 12
`[Reserved]
`2047
`2048 Defendants’ Opposition to Plaintiffs’ Motion for Preliminary Injunction
`(Redacted), Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 104
`2049 Amended Pretrial Scheduling Order, Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 229
`2050 Defendants’ Second Amended Notice of Deposition of Peter Keith,
`Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D.
`Minn.)
`2051 Defendants’ Amended Notice of Deposition of Amy Welch, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2052 Drawings Submitted with Ressemann U.S. Patent App. 10/214,712
`2053 Defendants’ Interrogatories to Plaintiffs Concerning Preliminary
`Injunction Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-
`01760-PJS-TNL (D. Minn.)
`2054 Defendants’ Requests for Production of Documents Concerning
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`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.
`Vascular Solutions LLC, 17-cv-01969 (D. Minn.), Dkt. 125-22
`2057 Teleflex Product Patents Website
`2058 Confidential Presentation – PROTECTIVE ORDER MATERIAL
`
`
`
`ix
`
`

`

`2059 Plaintiffs’ First Supplemental Objections and Responses to Defendants’
`Interrogatories Concerning Preliminary Injunction Issues, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2060 Globe Newswire: Teleflex Announces Tenth Anniversary of GuideLiner
`Catheter Product Line
`2061 GuideLiner Marketing Material V1 Catheter
`2062 GuideLiner Marketing Material V2 Catheter
`2063 GuideLiner Marketing Material: That’s A Real Game Changer
`2064
`[Reserved]
`2065 GuideLiner Catheter Bibliography
`2066 Physician Testimonial Authorizations
`2067 Rao, U., et al., The GuideLiner “child” catheter, EuroIntervention 2010
`6:277-279
`2068 Defendants’ Answer, Defenses, and Counterclaims to Plaintiffs’
`Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 16
`2069 Exhibit E to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-5
`2070 Medtronic comparison of guide extension catheters
`2071 Exhibit A to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-1
`2072 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 77
`2073 Declaration of Alexander S. Rinn
`2074 Declaration of Howard Root in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 189 – PROTECTIVE ORDER
`MATERIAL
`
`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
`
`in interest to the patents, Vascular Solutions, Inc. (“VSI”), introduced GuideLiner
`
`in 2009, it enabled physicians to perform interventional cardiology procedures
`
`previously thought to be impossible.1 GuideLiner created the market for a new
`
`type of medical device—rapid exchange guide extension catheters capable of
`
`receiving and delivering stents and balloon catheters—that quickly became VSI’s
`
`flagship product. To this day, many still know and refer to Teleflex’s
`
`Interventional business as “the GuideLiner company.” GuideLiner and its
`
`associated patent coverage (“GuideLiner patents”) were an important factor in
`
`Teleflex’s decision to invest nearly $1 billion in the purchase of VSI in 2017. The
`
`success of GuideLiner also caught the eye of two of the largest medical product
`
`companies in the world, Boston Scientific (who 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 ’760 patent that is the subject of the present Petition.
`
`That litigation is ongoing.
`
`
`
`Having known for several years that it was going to infringe the GuideLiner
`
`patents, Medtronic should have filed its IPR petitions promptly after deciding it
`
`was going to infringe. Had Medtronic done so, those IPR proceedings would be
`
`completed by now.
`
`But for Medtronic, the largest medical products company in the world, being
`
`able to sell infringing products during the pendency of protracted litigation has
`
`great upside (and great downside for patent holders like Teleflex), even if
`
`
`
`2
`
`

`

`Medtronic ultimately loses and is forced to pay damages. Moreover, having
`
`closely copied GuideLiner, Medtronic’s validity challenge needs to prevail, not
`
`just on the broader claims, but on many of the narrower claims as well. So instead
`
`of filing its IPRs before infringing, Medtronic simply launched its infringing
`
`product and waited for the inevitable lawsuit. And even after the lawsuit was filed,
`
`Medtronic did not promptly file its IPRs. Instead, Medtronic waited until the last
`
`moment before its response to Teleflex’s preliminary injunction motion was due in
`
`the district court to file 13 IPR Petitions on five patents in suit. Medtronic then
`
`argued that the mere filing of the IPR petitions justified denial of Teleflex’s
`
`preliminary injunction motion. Medtronic has made no secret of the fact that, if
`
`any of its IPR petitions are granted, it will ask the district court to stay the litigation
`
`pending the outcome of those IPRs. If Medtronic is successful in this strategy, it
`
`will eat up most of the remaining life of the patents in suit (all but one of which
`
`expire in 2026), even if its validity challenge ultimately fails as to some or all of
`
`the claims. The Board should not help further such delay strategies, which
`
`weaken the value of patents for patent holders.
`
`II.
`
`INTRODUCTION TO THE PRESENT PATENT OWNER
`RESPONSE
`There are many reasons why the Board should not help further Medtronic’s
`
`delay strategies and should decline to institute this Petition. First, while Medtronic
`
`acknowledges that there is a dispute regarding whether its lead Itou reference
`
`
`
`3
`
`

`

`qualifies as prior art, Medtronic opted to stay silent on the contrary evidence in its
`
`possession relating to that issue, failing to even try to address it. And as the
`
`corroborated evidence submitted herewith shows, the inventors indisputably both
`
`conceived and reduced to practice the claimed invention prior to Itou’s effective
`
`date. Second, institution of the Petition would be a highly inefficient use of the
`
`Board’s resources. The same validity issues between the same parties are already
`
`being litigated in the district court and the district court has already invested the
`
`time to familiarize itself with the facts and law relating to the threshold invention
`
`date issue. Third, Medtronic failed to justify its three-petition attack on the ’760
`
`patent, an approach the Board’s guidelines recognize is almost never appropriate.
`
`These reasons alone show that the Board should deny the Petition.
`
`Moreover, Medtronic’s Ground 1 and Ground 2—the only grounds
`
`addressing the sole independent claim challenged—fail to address key claim
`
`elements and evidence necessary for institution. Medtronic’s anticipation
`
`argument (Ground 1) relies on the Itou reference, but Itou does not disclose a
`
`device having the claimed structure that is “configured to receive one or more
`
`stents or balloon catheters,” as claimed. Rather, the device Itou discloses is a
`
`suction catheter, designed solely for the purpose of suctioning thrombi and other
`
`loose materials out of vasculature in a distal-to-proximal direction. It does not
`
`disclose a structure that proximally receives stents or balloon catheters, either
`
`
`
`4
`
`

`

`expressly or under principles of inherency. Medtronic’s obviousness argument
`
`(Ground 2) fails to address known evidence teaching away from introducing stents
`
`or balloon catheters into a suction catheter like the device of Itou.
`
`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, regardless of whether Itou would be found to be prior art, 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, its founder Howard Root, along with a team of
`
`engineers and an individual specializing in medical device marketing, conceived of
`
`and began working on what would eventually become the revolutionary
`
`GuideLiner guide extension catheter. Ex. 2001 (Root Decl.), ¶¶ 5-14. By at least
`
`August 2005, VSI had reduced the GuideLiner invention to practice, as
`
`
`
`5
`
`

`

`corroborated by contemporaneous documents and witness declarations. Id., ¶¶ 15-
`
`46; Ex. 2039 (Schmalz Decl.), ¶¶ 4-12. Teleflex provided this timeline, and
`
`identified supporting documents, to Medtronic before the Petition was filed, in the
`
`form of a detailed interrogatory response served in the parallel District of
`
`Minnesota case. Ex. 2045 at 4-10. Yet Medtronic never acknowledged that
`
`information, much less sought to use or address it in this IPR.
`
`VSI launched the GuideLiner commercial product in 2009. The GuideLiner
`
`created a new market category—guide extension catheters. Ex. 2044, ¶ 9.
`
`GuideLiner “put VSI on the map.” Id., ¶ 4. Sales grew quickly, doubling from
`
`2010 to 2011, and doubling again from 2011 to 2013. Ex. 2043 (Welch Decl.), ¶
`
`13; see Ex. 2046 (Root 2013 Decl.), ¶ 39. By 2013 GuideLiner was VSI’s top-
`
`selling product, and by early 2014 it was used in all of the approximately 2,000
`
`cardiac catheterization laboratories across the United States. Ex. 2044, ¶¶ 4, 12.
`
`Total GuideLiner sales to date are more than
`
`. See Ex. 2043, ¶ 13.
`
`Until Medtronic entered the market with its infringing Telescope product,
`
`GuideLiner had over a
`
` market share in the U.S., with the remainder belonging
`
`to Teleflex’s licensee, Boston Scientific. See id., ¶¶ 34- 35.
`
`The ’760 Patent
`B.
`The ’760 patent is one of a family of patents that covers the GuideLiner
`
`products. The ’760 patent is directed to a coaxial guide catheter (also referred to as
`
`
`
`6
`
`

`

`a “guide extension catheter”) that is passed through the lumen of a guide catheter,
`
`advanced beyond the distal end of the guide catheter, and inserted into a branch
`
`artery of the aorta to facilitate delivery of stents, balloon angioplasty catheters and
`
`other interventional cardiology devices. Ex. 1001 at Abstract.
`
`
`
`One of the important benefits of the systems disclosed in the ’760 patent is
`
`increased “back-up support.” As the patent teaches, when treating a stenosis, a
`
`guide catheter is typically guided into the ostium (opening) of the branch artery to
`
`be treated, and a guidewire is passed through the lumen of the guide catheter and
`
`advanced into the artery beyond the stenosis. Id. at 1:61-65. Below is Figure 7 of
`
`the patent (color added), showing a typical guide catheter 56 (pink) inserted into
`
`the ostium 60 of a coronary artery, with a guidewire 64 passing through the guide
`
`catheter and attempting to cross a stenotic lesion 66:
`
`
`
`
`
`7
`
`

`

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

`

`Not only does the guide extension catheter help guide interventional cardiology
`
`devices closer to the desired location (e.g., a blockage or lesion); it also reduces the
`
`tendency of the guide catheter (pink) to back out of the ostium when the operator
`
`increases the pressure on the proximal end of a wire or a stent or balloon delivery
`
`catheter to advance it across a lesion.
`
`The guide extension catheter of the invention generally includes, from distal
`
`to proximal direction, a soft tip portion, a tubular portion, and a substantially rigid
`
`portion that has a rail segment to permit delivery without blocking use of the guide
`
`catheter. E.g., id. at 6:40-41, Figs. 1, 4, 20-22. An important advantage of the
`
`design is it reduces the available space to deliver interventional cardiology devices
`
`only slightly – by no more than “one French size” in the preferred embodiment.
`
`Id. at 3:36-51.
`
`The guide extension catheter preferably has a proximal side opening that
`
`includes, from distal to proximal direction, a first full circumference portion (34,
`
`blue), a hemicylindrical portion (36, green), and an arcuate portion (38, purple):
`
`
`Id. at 7:1-3; Fig. 4 (color added). The angled side opening is configured to receive
`
`
`
`stents and balloon catheters when the side opening is positioned within the lumen
`
`
`
`9
`
`

`

`of the guide catheter and the distal end of the guide extension catheter extends
`
`beyond the distal end of the guide catheter.
`
`The challenged claims of the ’760 patent cover this invention. Independent
`
`claim 25, for example, covers a system including a guide catheter and a guide
`
`extension catheter such as that shown in Figure 4. The full claim is provided
`
`below:
`
`25. A system, comprising:
`
`a guide catheter configured to be advanceable through a
`main blood vessel to a position adjacent an ostium of a
`coronary artery, the guide catheter having a lumen
`extending from a hemostatic valve at a proximal end of
`the guide catheter to a distal end of the guide catheter that
`is adapted to be positioned adjacent the ostium of the
`coronary artery; and
`
`a guide extension catheter configured to be partially
`advanceable through the guide catheter and into the
`coronary artery, the guide extension catheter having a
`length such that a distal end of the guide extension
`catheter is extendable through the lumen and beyond the
`distal end of the guide catheter, and a proximal end of the
`guide extension catheter is extendable through the
`hemostatic valve at the proximal end of the guide
`catheter,
`
`
`
`10
`
`

`

`the guide extension catheter including, in a proximal to
`distal direction, a substantially rigid segment, a segment
`defining a side opening, and a tubular structure defining a
`lumen coaxial and in fluid communication with the
`lumen of the guide catheter, the lumen of the tubular
`structure having a length that is shorter than the length of
`the lumen of the guide catheter and having a uniform
`cross-sectional inner diameter that is not more than one
`French size smaller than the cross-sectional inner
`diameter of the lumen of the guide catheter, the side
`opening ext