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`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 IPR2020-00128
`Patent RE 45,380
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`PATENT OWNER RESPONSE
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`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 3
`
`I.
`
`II.
`
`III. THE ’380 PATENT ......................................................................................... 4
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ................................. 9
`
`V.
`
`
`CLAIM CONSTRUCTION ............................................................................ 9
`
`A. A flexible tip portion/tubular portion “defining a coaxial lumen
`having a cross-sectional inner diameter through which interventional
`cardiology devices are insertable” (Independent claims 1 and 12) ....... 9
`
`B.
`
`“Interventional cardiology device” (all challenged claims) ..............111
`
`A.
`
`Itou (Ex-1007) ...................................................................................155
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`
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`
`
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`VI. MEDTRONIC’S REFERENCES ................................................................155
`
`
`B. Ressemann (Ex-1008) ........................................................................ 17
`
`
`VII. THE PETITION FAILS TO SHOW THAT THE CHALLENGED CLAIMS
`ARE INVALID .............................................................................................. 19
`
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`A.
`
`Independent Claims 1 and 12: The Petition Does Not Show that Itou
`Anticipates (GROUND 1) ................................................................... 19
`
`1.
`
`2.
`
`Itou Does Not Disclose A Flexible Tip Portion With a Tubular
`Structure Defining a Coaxial Lumen “through which
`interventional devices are insertable” ...................................... 20
`
`Itou Does Not Disclose that “At Least Two Types” of
`Interventional Cardiology Devices are Insertable .................... 22
`
`B.
`
`Independent Claims 1: The Petition Does Not Show that Itou
`Discloses “a flexible cylindrical distal tip portion” (GROUND 1) ..233
`
`C. Dependent Claim 3: The Petition Does Not Demonstrate that a tubular
`structure “defining a proximal side opening . . . to receive an
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`interventional cardiology device into the coaxial lumen while the
`proximal portion remains within the lumen of the guide catheter” Is
`Anticipated or Obvious .....................................................................244
`
`1.
`
`2.
`
`The Petition Does Not Show that Itou Anticipates Claim 3
`(GROUND 1) ..........................................................................244
`
`The Petition Does Not Show that Claim 3 Is Obvious in View
`of Itou, Ressemann, and the Knowledge of a POSITA
`(GROUND 2) ............................................................................ 28
`
`i.
`
`ii.
`
`Petitioner provides no legitimate motivation to combine
`Itou and Ressemann ........................................................ 29
`
`A POSITA would not reasonably expect the combination
`of Itou and Ressemann to be successful .......................322
`
`D. Dependent Claim 14: The Petition Does Not Show that a Device with
`“a partially cylindrical portion defining an opening extending for a
`distance along a side thereof defined transverse to a longitudinal axis
`that is adapted to receive an interventional cardiology device passed
`through continuous lumen of the guide catheter and into the coaxial
`lumen while the device is inserted into the continuous lumen” Is
`Anticipated or Obvious .....................................................................333
`
`1.
`
`2.
`
`The Petition Fails to Show that Itou Anticipates Claim 14
`(GROUND 1) ............................................................................ 33
`
`The Petition Fails to Show that Claim 14 Is Obvious in View of
`Itou, Ressemann, and the Knowledge of a POSITA (GROUND
`2) .............................................................................................344
`
`E. Dependent Claim 15: The Petition Does Not Show that Claim 15 Is
`Anticipated or Obvious ....................................................................... 38
`
`1.
`
`2.
`
`The Petition Does Not Show that Claim 15 Is Anticipated By
`Itou (GROUND 1) .................................................................... 38
`
`The Petition Does Not Show that Claim 15 Is Obvious Over
`Itou in View of Ressemann and the Knowledge of a POSITA
`(GROUND 2) ............................................................................ 39
`
`ii
`
`
`
`
`VIII. Claims 3 and 14: Strong Objective, Real-World Evidence Shows Non-
`Obviousness ................................................................................................... 39
`
`A. Long-Felt Need ..................................................................................411
`
`B. Commercial Success..........................................................................444
`
`C.
`
`Industry Praise ...................................................................................488
`
`D. Licensing ...........................................................................................500
`
`E. Copying .............................................................................................500
`
`1. Boston Scientific’s Guidezilla ................................................511
`
`2. QXM’s Boosting Catheter ......................................................533
`
`3.
`
`Petitioner’s Telescope .............................................................533
`
`F.
`
`There Is Nexus Between the Invention of Claims 3 and 14 and the
`Objective Evidence of Nonobviousness ............................................577
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`IX. The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ...........................................................................................633
`
`
`X.
`
`
`
`
`
`CONCLUSION ............................................................................................644
`
`
`
`iii
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
` 941 F.3d 1320 (Fed. Cir. 2019) ............................................................................ 66
`
`Aspex Eyewear, Inc. v. Marchon Eyewear, Inc.,
` 672 F.3d 1335 (Fed. Cir. 2012) ............................................................................ 26
`
`Fox Factory, Inc. v. SRAM, LLC,
` 944 F.3d 1366 (Fed. Cir. 2019) ..................................................................... 59, 65
`
`Gambro Lundia AB v. Baxter Healthcare Corp.,
` 110 F.3d 1573 (Fed. Cir. 1997) ............................................................................ 62
`
`In re Schreiber,
` 128 F.3d 1473 (Fed. Cir. 1997) ............................................................................ 26
`
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 49, 51
`
`
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ............................................... 52
`
`
`Jack Guttman, Inc. v. Kopykake Enters.,
` 302 F.3d 1352 (Fed. Cir. 2002) ............................................................................ 11
`
`Lectrosonics, Inc. v. Zaxcom, Inc.,
` IPR2018-01129, Paper 333 (PTAB Jan. 24, 2020) .............................................. 59
`
`Lucia v. SEC,
` 138 S. Ct. 2044 (2018) ......................................................................................... 66
`
`Mytee Prods., Inc. v. Harris Research, Inc.,
` 439 F. App’x 882 (Fed. Cir. 2011) ....................................................................... 27
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................ 41
`
`
`
`iv
`
`
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ..................................................................... 43, 45
`
`
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................ 52
`
`
`
`
`
`
`v
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`
`
`TABLE OF EXHIBITS
`
`Exhibit Description
`2001
`[Reserved]
`2002 Gregg Sutton Lab Notebook
`2003 Memo Regarding Market Feasibility for the GuideLiner catheters
` – PROTECTIVE ORDER MATERIAL
`2004 Howard Root Notes
`2005 Project Spend Report
`2006
`Invoice from MicroGroup
`2007
`Invoice from MicroGroup
`2008
`Invoices from Medical Profiles & Engineering
`2009
`Invoice from MicroGroup
`2010
`Invoice from Mountain Machine, Inc.
`2011
`Invoice from Medical Engineering & Design Inc.
`2012
`[Reserved]
`2013 Sales Order from SPECTRAlytics
`2014 Photos of Component of GuideLiner Prototype
`2015 Howard Root Deposition Transcript – PROTECTIVE ORDER
`MATERIAL
`Invoice from Medtronic
`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
`2020 Sales Order and Invoice from SPECTRAlytics
`2021
`Invoice from Medical Engineering & Design
`2022 Computerized Design Drawing of a GuideLiner
`2023 Redacted Client/Matter Form from Patterson Law Firm
`2024 Product Requirements: GuideLiner Catheter System
`2025 Clinical Technical Report
`2026
`Invoice from MicroGroup
`2027
`Invoice from Johnson Matthey Inc (Shape Memory Applications, Inc.)
`2028
`Invoice from SPECTRAlytics
`2029
`Invoices from Medical Profiles & Engineering
`2030
`Invoice from Automation & Metrology Inc.
`2031
`Invoice from Automation & Metrology Inc.
`
`vi
`
`
`
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`2032
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`3033
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`2034
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`2035
`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
`2041 Business Update Section of Materials Presented to the Vascular
`Solutions Board of Directors October 2005 – PROTECTIVE ORDER
`MATERIAL
`[Reserved]
`2042
`2043 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Under Seal), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 78 –
`PROTECTIVE ORDER MATERIAL
`2044 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Redacted), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 79
`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
`
`vii
`
`
`
`2050 Defendants’ Second Amended Notice of Deposition of Peter Keith,
`Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D.
`Minn.)
`2051 Defendants’ Amended Notice of Deposition of Amy Welch, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2052 Drawings Submitted with Ressemann U.S. Patent App. 10/214,712
`2053 Defendants’ Interrogatories to Plaintiffs Concerning Preliminary
`Injunction Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-
`01760-PJS-TNL (D. Minn.)
`2054 Defendants’ Requests for Production of Documents Concerning
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`[Reserved]
`2055
`2056 Expert Report of Peter T. Keith on Infringement, Claim Coverage, and
`Lack of Acceptable Noninfringing Alternatives, QXMédical, LLC v.
`Vascular Solutions LLC, 17-cv-01969 (D. Minn.), Dkt. 125-22
`2057 Teleflex Product Patents Website
`2058 Confidential Presentation – PROTECTIVE ORDER MATERIAL
`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
`
`viii
`
`
`
`2075
`
`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
`Joint Rule 26(f) Report (Patent), Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 17
`2076 Defendants’ Rule 30(b)(6) Notice of Deposition of Plaintffs on
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2077 Email withdrawing Defendants’ Rule 30(b)(6) Notice of Deposition
`2078 Defendants’ Answer and Defenses to Plaintiffs’ First Amended and
`Supplemental Complaint and Second Amended Counterclaims Against
`Plaintiffs, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.), Dkt. 233
`2079 Exhibit A to Defendants’ Answer and Defenses to Plaintiffs’ First
`Amended and Supplemental Complaint and Second Amended
`Counterclaims Against Plaintiffs, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`[Reserved]
`2080
`[Reserved]
`2081
`2082 Plaintiffs’ Notice of Deposition of Barry O’Connell, Vascular Solutions
`LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2083 Plaintiffs’ Notice of Deposition of Chris Eso, Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2084 Plaintiffs’ Notice of Deposition of Mark Cardoso, Vascular Solutions
`LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2085 Exhibit introduced at depositions of Stephen J.D. Brecker and Richard
`A. Hillstead – Ressemann Figure 16D, Annotated
`2086 Exhibit introduced at depositions of Stephen J.D. Brecker and Richard
`A. Hillstead – Ressemann Cross-Section A-A Drawing, Annotated
`2087 Declaration of Joseph W. Winkels in Support of Patent Owner’s
`Unopposed Motion for Pro Hac Vice Admission
`2088 Declaration of Peter M. Kohlhepp in Support of Patent Owner’s
`Unopposed Motion for Pro Hac Vice Admission
`Invoice and Purchase Orders from Medical Engineering & Design, Inc.
`
`2089
`
`ix
`
`
`
`Invoices from Farlow’s Scientific Glassblowing, Inc.
`2090
`Invoices and Certificate of Compliance from MicroGroup, Inc.
`2091
`Invoice and Purchase Orders from Medical Engineering & Design, Inc.
`2092
`Invoices and Packing Slip from Automation & Metrology, Inc.
`2093
`Invoices and Certificate of Compliance from MicroGroup, Inc.
`2094
`2095 SPECTRAlytics Certificates of Completion
`2096
`Invoice from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2097
`Invoices from Farlow’s Scientific Glassblowing, Inc.
`2098 Patterson, Thuente, Skaar & Christensen, P.A.’s Privilege Log
`2099 VSI Planned Production Development Projects
`2100 Vascular Solutions, Inc. 2006 Strategic Objectives (Redacted)
`2101
`Invoice from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2102 Redacted, Excerpted Fax to Patterson Law Firm
`2103
`Invoice from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2104
`Invoices from Vita Needle Company
`2105 Vascular Solutions, Inc. Budget to Actual Variances (Redacted)
`2106
`Invoices and Packing Lists from LSA
`2107
`Invoices and Certificate of Completion from The MicroGroup, Inc.
`2108
`Invoices and Packing Lists from LSA
`2109 GuideLiner Team Meeting Agenda
`2110
`Invoices and Certificate of Completion from The MicroGroup, Inc.
`2111 SPECTRAlytics Certificates of Completion
`2112
`Invoices from Farlow’s Scientific Glassblowing, Inc.
`2113 Engineering Drawings
`2114 Engineering Drawing
`2115 Engineering Drawings
`2116 Deposition Transcripts of Stephen J.D. Brecker, M.D. dated August 11,
`2020 and September 14, 2020
`Invoices from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2117
`2118 Declaration of Howard Root Submitted in Connection with Patent
`Owner’s Responses
`2119 Declaration of Gregg Sutton
`2120 Declaration of Mark Goemer
`2121 Declaration of Amanda O’Neil
`2122 Declaration of Steve Erb
`2123 Declaration of Peter Keith Regarding Conception and Reduction to
`Practice Submitted in Connection with Patent Owner’s Responses
`2124 Declaration of Peter Keith in Support of Motions to Amend
`2125
`[Reserved]
`
`x
`
`
`
`[Reserved]
`2126
`2127 Memo Regarding Market Feasibility for the GuideLiner catheters
`(Redacted)
`2128 Memo Regarding Market Feasibility for the GuideLiner catheters
`(Redacted)
`2129 PowerPoint presentation titled “New Products on the Horizon”
`(Redacted)
`2130 Research and Development Update July 2005 (Redacted)
`2131 Vascular Solutions, Inc. 2006 Strategic Objectives (Redacted)
`2132 Research & Development Update – July 2008 (Redacted)
`2133 Business Update Section of Materials Presented to the Vascular
`Solutions Board of Directors October 2005 (Redacted)
`2134 Vascular Solutions, Inc. Research & Development Update – January
`2006 (Redacted)
`2135 Mozid, et al., “The Utility of a Guideliner™ Catheter in Retrograde
`Percutaneous Coronary Intervention of a Chronic Total Occlusion With
`Reverse CARD – The “Capture” Technique,” Catheterization and
`Cardiovascular Interventions, pp. 929-932 (2004)
`2136 Candilio, et al., “Subadventitial Advancement of a Mother-and-Child
`Catheter to Allow Successful Recanalization of a Complex In-Stent
`Chronic Total Occlusion: Testing the Resistance of the Adventitia,” J.
`Invasive. Cardiol, E190-E194 (2017)
`2137 Deposition Transcripts of Richard A. Hillstead, Ph.D. dated September
`11, 2020 and September 15, 2020
`2138 Declaration of Peter T. Keith
`2139 Engineering Drawings -PROTECTIVE ORDER MATERIAL
`2140 Engineering Drawings -PROTECTIVE ORDER MATERIAL
`2141 Engineering Drawings -PROTECTIVE ORDER MATERIAL
`2142 GuideLiner® Catheter Instructions for Use
`2143 GuideLiner® V2 Catheter Instructions for Use
`2144 GuideLiner® V3 Catheter Instructions for Use
`2145 Declaration of Dr. John J. Graham, MB ChB, MRCP (UK)
`2146 Boyle, et al., “Catheter-induced coronary artery dissection: Risk factors,
`prevention and management,” J. Invasive. Cardiol., pp. 500-503 (2006)
`2147 Dunning, et al., “Iatrogenic Coronary Artery Dissections Extending Into
`and Involving the Aortic Root,” Cathet. Cardiovasc. Intervent., pp. 387-
`393 (2000)
`
`xi
`
`
`
`2148 Hatem, et al., “Zero contrast retrograde chronic total occlusions
`percutaneous coronary intervention: a case series,” Eur. Heart J. – Case
`Reports (2017)
`2149 Meerkin, David, “Optimization of Guide Catheter Support: What are my
`Options?” (2010)
`2150 Ryan, et al., “Guidelines for Percutaneous Transluminal Coronary
`Angioplasty,” AHIA/ACC Task Force Circulation, Vol 88, No 6,
`(December 1993) 2987-3007
`2151 Declaration of Dr. Lorenzo Azzalini
`2152 Declaration of Steve Jagodzinkski (Redacted)
`2153 Declaration of Steve Jagodzinkski -PROTECTIVE ORDER
`MATERIAL
`2154 GuideLiner 2009 Sales Spreadsheet -PROTECTIVE ORDER
`MATERIAL
`2155 GuideLiner Brochure 2009
`2156 GuideLiner Brochure 2010
`2157 GuideLiner Brochure 2011
`2158 GuideLiner Brochure 2012
`2159 GuideLiner Brochure 2013
`2160 GuideLiner Brochure 2014
`2161 GuideLiner Brochure 2015
`2162 GuideLiner Brochure 2016
`2163 GuideLiner Brochure 2017
`2164 GuideLiner Brochure 2018
`2165 GuideLiner Brochure 2019
`2166 Eddin, et al., “Transradial interventions with the GuideLiner catheter:
`Role of proximal vessel angulation,” Cardiovascular Revascularization
`Medicine, 14 (2013) 275–279
`2167 Moscucci, Mauro, editor. Grossman & Baim’s Cardiac Cathererization,
`Angiography, and Intervention. 8th Ed., Lippincott Williams & Wilkins,
`2014
`2168 Kovacic, et al., “GuideLiner Mother-and-Child Guide Catheter
`Extension: A Simple Adjunctive Tool in PCI for Balloon Uncrossable
`Chronic Total Occlusions,” J. of Interventional Cardiol., Vol 26, No. 4,
`2013, 343-350
`de Man, et al., “Usefulness and safety of the Guideliner catheter to
`enhance intubation and support of guide catheters: insights from the
`Twente Guideliner registry,” EuroIntervention 8 (2012) 336-344
`
`2169
`
`xii
`
`
`
`2170 Unzué, et al., “The GuideLiner® Catheter in Complex Coronary
`Interventions,” Scientific letters / Rev Esp Cardiol. 2012;65(5):479–488
`2171 Park, et al., “Guideliner Microcatheter to Improve Back-Up Support
`During a Complex Coronary Stenting Procedure Through a Tortuous
`Left Internal Mammary Graft,” J. Invasive Cardiol. 2012;24(4):E77-E79
`2172 Roth et al., “Rapid-Exchange Guide Catheter Extension for Extending
`the Reach of an AL3 Guide in a Patient with a Long, Dilated Ascending
`Aorta,” Catheterization and Cardiovascular Interventions 80:1218–1220
`(2012)
`2173 Serajian, et al., “Novel Use of a GuideLiner Catheter to Visualize Distal
`LAD After LIMA Anastomosis in Selective Coronary Angiography,” J.
`Invasive Cardiol. 2012;24(2):E30-E31
`2174 Thomas, et al., “Successful Coronary Intervention of Circumflex Artery
`Originating From an Anomalous Left Main Coronary Artery Using a
`Novel Support Catheter: A Case Report and Review of Literature,” J.
`Invasive Cardiol. 2011;23(12):536-539
`2175 Pershad, et al., “GuideLiner Catheter Facilitated PCI – A Novel Device
`with Multiple Applications,” J. Invasive Cardiol. 2011;23(11):E254-
`E259
`2176 Cola, et al., “The GuidelinerTM Catheter for Stent Delivery in Difficult
`Cases: Tips and Tricks,” J. of Interventional Cardiol., Vol. 24, No. 5,
`2011, pp 450-461
`2177 Moynagh, et al., “Angiographic Success and Successful Stent Delivery
`for Complex Lesions Using the GuideLiner™ Five-in-six System- A
`Case Report,” Am Heart Hosp J. 2011;9(1):44–7
`2178 Hanna, et al., “Use of the GuideLiner Catheter for the Treatment of a
`Bifurcational Total Occlusion of the Native Left Anterior Descending
`Artery through a Tortuous Composite Venous Graft,” J. Invasive
`Cardiol. 2011; 23(3):E40-E42
`2179 Mamas, et al., “Distal Stent Delivery with Guideliner Catheter: First in
`Man Experience,” Catheterization and Cardiovascular Interventions,
`76:102–111 (2010)
`2180 Rao, et al., “The GuideLiner™ “child” catheter,” EuroIntervention,
`2010;6:277-279
`2181 GuideLiner Clinical Case information titled “Contemporary Chronic
`Total Occlusion Percutaneous Coronary Intervention: GuideLiner
`Catheter and R350 Guidewire Facilitated Reverse-Cart”
`2182 GuideLiner Clinical Case information titled “Use of GuideLiner Catheter
`to Reduce Contrast in Patients with Renal Insufficiency”
`
`xiii
`
`
`
`2183 GuideLiner Clinical Case information titled “GuideLiner Catheter is
`Useful Both for Support and to Minimize Contrast Load by Super-
`Selective Injections in a High-Risk Chronic Renal Failure Patient”
`2184 GuideLiner Clinical Case information titled “Successful Use of the
`GuideLiner”
`2185 GuideLiner Clinical Case information titled “Complex Primary PCI ST
`Elevation Myocardial Infarction Facilitated by the GuideLiner Catheter”
`2186 GuideLiner Clinical Case information titled “GuideLiner Catheter
`Facilitates Treatment of Calcific Ostial Circumflex Artery Despite
`Severe Retroflexion”
`2187 GuideLiner Clinical Case information titled “The “Child-in-Mother
`Technique: Successful Transradial Use of the GuideLiner Catheter in a
`Heavily Calcified Circumflex Artery:
`2188 GuideLiner Clinical Case information titled “GuideLiner Catheter Used
`for Proximal to Distal Stent Technique”
`2189 GuideLiner Clinical Case information titled “Successful Use of
`GuideLiner Catheter to Treat Sequential Distal Carotid Artery Stenoses”
`2190 GuideLiner Clinical Case information titled “Successful Treatment of
`Heavily Calcified Right Coronary Artery from the Right Radial Artery
`Approach Using the GuideLiner Catheter”
`2191 GuideLiner Clinical Case information titled “Successful Multi-Stent
`Delivery in a Heavily Calcified Right Coronary Artery Using the
`GuideLiner Catherter”
`2192 GuideLiner Clinical Case information titled “Successful Distal Stent
`Delivery Past Multiple Previous Stents Made Possible by the Guideliner
`Catheter”
`2193 GuideLiner Clinical Case information titled “Successful Transradial Use
`of the GuideLiner Catheter to Selectively Treat Severe Disease in the
`LAD”
`2194 Fabris, et al., “Guide extension, unmissable tool in the armamentarium
`of modern interventional cardiology. A comprehensive review,”
`International Journal of Cardiology 222 (2016) 141–147
`[Reserved]
`2195
`Information Disclosure Statement for U.S. Patent App. 14/210,572
`2196
`2197 PowerPoint Presentation titled “Proximal SA Tracker Week 28” -
`PROTECTIVE ORDER MATERIAL
`2198 PowerPoint Presentation titled “GLYDER RX Guide Extension
`Catheter” -PROTECTIVE ORDER MATERIAL
`[Reserved]
`
`2199
`
`xiv
`
`
`
`2200 Guidezilla Guide Extension Catheter 501(k) Summary
`2201 Glyder Team Meeting, June 9th, 2019 -PROTECTIVE ORDER
`MATERIAL
`2202 Email regarding competitive product spend freeze -PROTECTIVE
`ORDER MATERIAL
`2203 Med Device Online: Medtronic to acquire PercuSurge for $225 million
`2204 Medtronic Press Release: Medtronic Launches Telescope ™ Guide
`Extension Catheter to Support Complex Coronary Cases
`2205 Declaration of Heather S. Rosecrans
`2206 Declaration of James Phelan in Opposition to Motion for Preliminary
`Injunction
`[Reserved]
`2207
`2208 Medtronics GuardWire Information Website
`2209 GuideLiner Catheter Instructions For Use
`2210 Guidezilla Guide Extension Catheter (5-in-6) Instruction For Use
`2211 Guidant Product Catalog
`2212 U.S. Patent No. 5,290,247 (Crittenden)
`2213 Lee, et al., “Saphenous Vein Graft Intervention,” JACC: Cardiovascular
`Interventions, Vol. 4, No. 8, 2011:831-43
`2214 QX Médical Boosting Catheter website
`2215 Declaration of Dr. Craig Thompson
`
`
`
`
`xv
`
`
`
`I.
`
`INTRODUCTION
`
`The ’380 patent is one of the family of patents covering an industry-
`
`changing product called GuideLiner. When Patent Owner’s predecessor, Vascular
`
`Solutions, Inc. (“VSI”), introduced GuideLiner in 2009, it created a new product
`
`category called “guide extension catheters.” GuideLiner was the first product that
`
`solved the long-felt need for better guide catheter backup support during the
`
`catheter-based treatment of diseased coronary arteries. GuideLiner’s greatly
`
`increased backup support and other advantages enabled physicians to treat
`
`coronary stenoses that previously had been untreatable with interventional
`
`techniques.
`
`The patentability of the claims in the present IPR should be affirmed in their
`
`entirety for the simple reason that Itou, the primary reference relied on for all
`
`Grounds, does not qualify as prior art. As explained in Patent Owner’s
`
`Consolidated Response Brief on Conception and Reduction to Practice (Paper No.
`
`39), the inventors conceived of the claimed invention in the late fall of 2004 and
`
`reduced it to practice no later than August of 2005, which is prior to the filing date
`
`of Itou. This conclusion is corroborated by extensive inventor and non-inventor
`
`testimony, as well as dozens of contemporaneous documents.
`
`Even if Itou was considered prior art (which it is not), the patentability of all
`
`challenged claims should be affirmed for the reasons set forth below. In particular,
`
`1
`
`
`
`the Petition fails to show that Itou discloses a device through which the minimum
`
`set of common interventional cardiology devices defined in the patent—including
`
`stents and stent catheters—are insertable. And even under the Board’s preliminary
`
`construction requiring only two interventional cardiology devices, the Petition still
`
`fails: Itou’s protective catheter plainly is not an “interventional cardiology device.”
`
`The Petition also does not show that the specific configuration required by
`
`dependent claims 3 and 14—a side opening structure to receive an interventional
`
`cardiology device while the proximal portion remains within the lumen of the
`
`guide catheter—is anticipated or obvious.
`
`Finally, there is remarkably strong objective evidence of nonobviousness in
`
`this case for at least claims 3 and 14. These claims closely cover the features that
`
`have led to the GuideLiner’s extraordinary success and allowed it to finally (and
`
`elegantly) solve the problem of insufficient backup support that had plagued the
`
`interventional cardiology field since at least the late 1980s. When the GuideLiner
`
`launched in 2009, it was met with acclaim and quickly created an entirely new
`
`category of device—the guide extension catheter. It also spawned copycat
`
`products—Boston Scientific’s Guidezilla, Petitioner’s Telescope, and the QXM
`
`Boosting Catheter. The striking objective evidence that the GuideLiner invention
`
`of claims 3 and 14 was not, in the real world, obvious to those working in the field
`
`2
`
`
`
`both demonstrates and confirms that the claims are (and should be) patentable over
`
`the prior art. The Board should confirm the patentability of the challenged claims.
`
`II. BACKGROUND
`Since at least the late 1980s, physicians have been treating diseased coronary
`
`arteries using catheter-based minimally invasive techniques to perform balloon
`
`angioplasties and place stents. However, catheter-based treatment was difficult, if
`
`not impossible, for many of the more complex coronary lesions. Ex-2145, ¶¶ 39-
`
`40; Ex-2138, ¶¶ 57-58. This was because when interventional cardiology devices
`
`encountered a complex lesion or a tortuous anatomy, it generated a back-force that
`
`tended to cause the guide catheter to “pop out” of the coronary artery. Ex-2145, ¶¶
`
`39-49; Ex-2138, ¶¶ 57-59. Over the course of more than a decade, various
`
`products and “tips and tricks” were developed to try to address this, but nothing
`
`really solved the problem. Ex-2145, ¶¶ 50-66; Ex-2138, ¶¶ 60-68.
`
`It wasn’t until 2004 when VSI’s founder Howard Root, and three other VSI
`
`employees invented GuideLiner that someone finally came up with a simple,
`
`elegant solution that, for the first time, really solved the backup support issue. Ex-
`
`2138, ¶ 69, 167; Ex-2145, ¶¶ 67-70; Ex-2151 ¶ 9. In GuideLiner, Mr. Root and his
`
`team invented a device with “rapid exchange” functionality that could still deliver
`
`the full array of interventional cardiology devices (including stents) through a
`
`3
`
`
`
`distal tubular portion located deep with a guide catheter, all while providing
`
`increased backup support. Ex-2138, ¶ 69, 167; Ex-2145, ¶¶ 67-82.
`
`GuideLiner succeeded beyond the inventors’ wildest expectations. For
`
`physicians, GuideLiner enabled routine catheter-based treatment of coronary
`
`stenoses that previously had been untreatable, and did