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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 IPR2020-00135
`Patent RE45,776
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`PATENT OWNER RESPONSE
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`

`

`TABLE OF CONTENTS
`
`
`
`Page
`
`
`I.
`II.
`
`V.
`
`INTRODUCTION ........................................................................................... 1
`BACKGROUND ............................................................................................. 3
`The GuideLiner Invention and the Resulting ‘776 Patent .................... 3
`A.
`III. THE PERSON OF ORDINARY SKILL IN THE ART ................................. 6
`IV. CLAIM CONSTRUCTION ............................................................................ 7
`“One or more interventional cardiology devices” (all challenged
`A.
`claims) ................................................................................................... 7
`“The segment defining the angled proximal end of the partially
`cylindrical opening includes at least one inclined region that tapers
`into a non-inclined region” (dependent claim 36) ............................. 10
`THE PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS ARE INVALID ............................................................................. 11
`A. Ground 1 (Claims 25-27, 29-33, 35-37, 41-45, and 47-49): Itou Does
`Not Anticipate the Challenged Claims ................................................ 11
`Itou (Ex-1007) .......................................................................... 11
`1.
`2.
`Independent Claim 25 ............................................................... 13
`3.
`Dependent Claim 32 ................................................................. 16
`4.
`Dependent Claim 36 ................................................................. 17
`B. GROUND 2 (Claims 39 and 46): The Petition Fails to Show That Itou
`in Combination With the knowledge of a POSITA Renders the
`Challenged Claims Obvious ................................................................ 19
`C. GROUND 3 (Claims 36-37, 52-56): Itou and Kataishi Do Not Render
`the Challenged Claims Obvious .......................................................... 19
`The Challenged Claims Are Patentable for the Same Reasons as
`1.
`Claim 25 .................................................................................... 19
`Claims 52 and 53: A POSITA Would Not Have Been Motivated
`to Modify Itou’s Proximal Opening Based on Kataishi’s Distal
`End to Create an “angled proximal end of the partially
`cylindrical opening [that] includes at least two inclined
`regions” .................................................................................... 20
`
`B.
`
`2.
`
`
`
`i
`
`

`

`i.
`ii.
`
`Kataishi (Ex-1025) ........................................................ 20
`Petitioner’s Arguments Based on Kataishi’s Distal
`Opening are Unsupported and Unpersuasive ................. 21
`Dependent Claims 36 and 37 .................................................... 25
`3.
`D. GROUND 4 (Claims 32, 36-37, 46, 52-56): The Petition Fails to
`Show that Itou in Combination with Ressemann Renders the
`Challenged Claims Obvious ................................................................ 25
`The Challenged Claims Are Patentable for the Same Reasons as
`1.
`Claim 25 .................................................................................... 25
`Claims 52 and 53: A POSITA Would Not Have Been
`Motivated to Combine Itou’s Proximal Opening with
`Ressemann’s Support Collar Such that “the segment defining
`the angled proximal end of the partially cylindrical opening
`includes at least two inclined regions”..................................... 26
`A POSITA Would Not Be Motivated to Modify Itou
`i.
`based on Ressemann’s Fundamentally Different Embolic
`Protection Device............................................................ 28
`Ressemaann Undisputedly Does Not Disclose a Device
`with a Segment Defining a Partially Cylindrical Opening
`that Includes “At Least Two Inclined Regions” ............ 30
`iii. The So-Called “Incline #1” in Ressemann’s Support
`Collar Serves No Purpose in Ressemann ....................... 37
`The Purported “Motivations” Are Unsupported and
`Hindsight-Driven ............................................................ 38
`Even if a POSITA Was Motivated to Combine Itou and
`Ressemann, the Resulting Combination Would Not Work
`and/or Would Not Satisfy the Claim Language ............. 44
`Claim 53: The Petition’s Proposed Combination of Itou with
`Ressemann’s Collar 2141 Would Not Result in a Lumen
`Having a “uniform cross-sectional inner diameter that is not
`more than one French size smaller” than the Inner Diameter of
`the Guide Catheter .................................................................... 49
`Dependent Claim 32 ................................................................. 51
`Dependent Claims 36 and 37 .................................................... 51
`
`2.
`
`3.
`
`4.
`5.
`
`ii.
`
`iv.
`
`v.
`
`ii
`
`

`

`2.
`
`E. GROUND 5 (Claims 52-56): The Petition Fails to Show That Itou in
`Combination with Enger Renders the Challenged Claims Obvious ... 52
`The Challenged Claims Are Patentable for the Same Reasons as
`1.
`Claim 25 .................................................................................... 52
`Claims 52 and 53: A POSITA Would Not Be Motivated to
`Modify Itou’s Proximal Opening in View of Enger Such that
`“the segment defining the angled proximal end of the partially
`cylindrical opening includes at least two inclined regions” ... 52
`Enger (Ex-1050) does not show an opening with two
`i.
`inclined regions ............................................................... 53
`Petitioner’s arguments for motivation to combine are
`fundamentally flawed ..................................................... 56
`GROUNDS 3,4, 5: THE REAL-WORLD EVIDENCE OF COPYING
`SHOWS THAT CHALLENGED CLAIMS 36 and 52-53 WERE
`NOT OBVIOUS .................................................................................. 59
`Boston Scientific and QX Medical Copied Version 1 of
`1.
`GuideLiner ................................................................................ 60
`Petitioner Copied Version 3 of GuideLiner .............................. 62
`2.
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional .................................................................................. 67
`
`G.
`
`ii.
`
`F.
`
`iii
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`
`Cases
`
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019)................................................................................67
`Aspex Eyewear, Inc. v. Marchon Eyewear, Inc.,
`672 F.3d 1335 (Fed. Cir. 2012)................................................................................13
`In re Anova Hearing Labs, Inc.,
`809 F. App'x 840 (Fed. Cir. 2020) ...........................................................................43
`In re Chudik,
`674 F. App’x 1011 (Fed. Cir. 2017) ........................................................................14
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997)................................................................... 13, 14, 16
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ..........................................................................14
`Panduit Corp. v. Dennison Mfg. Co.,
`774 F.2d 1082 (Fed. Cir. 1985)................................................................................60
`Securus Techs., Inc. v. Glob. Tel*Link Corp.,
`701 F. App'x 971 (Fed. Cir. 2017) ...........................................................................23
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) ..................................................................................66
`Stryker Corp. v. Karl Storz Endoscopy America, Inc.,
`IPR2015-00764, Paper 13 (PTAB Sept. 2, 2015) ....................................................44
`
`
`
`
`
`iv
`
`

`

`
`
`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.
`2032
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`v
`
`
`
`

`

`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
`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
`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
`
`vi
`
`

`

`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
`
`vii
`
`

`

`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
`
`viii
`
`

`

`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]
`
`ix
`
`

`

`[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)
`
`x
`
`

`

`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
`[Reserved]
`2153
`[Reserved]
`2154
`[Reserved]
`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
`2170 Unzué, et al., “The GuideLiner® Catheter in Complex Coronary
`Interventions,” Scientific letters / Rev Esp Cardiol. 2012;65(5):479–488
`
`2169
`
`xi
`
`

`

`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”
`
`xii
`
`

`

`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
`
`xiii
`
`

`

`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
`
`
`
`
`
`xiv
`
`

`

`
`
`I.
`
`INTRODUCTION
` The ’776 patent that is the subject of the present IPR 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 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 by
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`interventional (non-surgical) means.
`
`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 reduced the claimed invention to practice no later than August of
`
`2005, 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 to be prior art (which it is not), the
`
`patentability of all claims should be affirmed. Among other reasons, one of the
`
`1
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`

`

`things that makes the ’776 patent different from other GuideLiner patents is that
`
`two of the three independent claims require that the angled proximal end of the
`
`partially cylindrical opening, which leads into the guide extension catheter’s distal
`
`tubular portion, have “at least two inclined regions.” The use of such a complex
`
`side opening (also recited using slightly different terminology in dependent claim
`
`36) is an important feature of GuideLiner that both Petitioner Medtronic and
`
`infringer-turned-licensee Boston Scientific copied and incorporated into their
`
`infringing products. Demonstrating the weakness of its position, Petitioner has
`
`asserted three alternative grounds (Grounds 3, 4 and 5) against these claims. But
`
`contrary to what was asserted in the Petitions, Petitioner’s experts now admit that
`
`none of the references relied on in those grounds teach a device with a proximal
`
`opening having “at least two inclined regions.” Instead, Petitioner relies on
`
`structure that does not define the shape of a proximal opening and has nothing to
`
`do with guiding interventional devices into a proximal opening. Petitioner’s
`
`arguments are nothing more than a post-hoc hindsight analysis that uses the claim
`
`as a roadmap to carefully pick and choose features in an attempt to satisfy the
`
`claim language. That is the antithesis of obviousness.
`
`In view of these overarching flaws and other deficiencies described below,
`
`Petitioner has failed to show that any of the challenged claims are invalid.
`
`2
`
`

`

`II. BACKGROUND
`A. The GuideLiner Invention and the Resulting ’776 Patent
`Since at least the late 1980s, physicians have been treating diseased coronary
`
`arteries using catheter-based minimally invasive techniques to perform balloon
`
`angioplasty and place stents. However, catheter-based treatment was difficult, if
`
`not impossible, for many of the more complex coronary lesions. Ex-2145, ¶¶ 39-
`
`66; Ex-2151, ¶¶ 4-8; Ex-2215, ¶¶ 3-6, 9-19. This was because when interventional
`
`cardiology devices encountered a complex lesion or tortuous anatomy, it generated
`
`a back-force that tended to cause the guide catheter to “pop out” of a coronary
`
`artery. Id. Over the course of almost two decades, several products and techniques
`
`were developed to try to address the problem of insufficient backup support, but all
`
`of them had drawbacks. Ex-2145, ¶¶ 50-66; Ex-2151, ¶¶ 5-8.
`
`VSI was a small Minnesota medical device company working to develop
`
`various vascular intervention technologies. In 2004, VSI’s founder, Howard Root,
`
`recognized a need for a new type of product that would address the backup support
`
`problem while overcoming the drawbacks of the existing options. Ex-2074, ¶ 5,
`
`14. Beginning in the fall of 2004 and continuing into 2005, Mr. Root, along with
`
`three coinventors, conceived of, built and successfully tested working prototypes
`
`of the GuideLiner invention. Id. at ¶¶ 5-58. In GuideLiner, Mr. Root and his team
`
`invented a rapid-exchange device that could facilitate delivery of the full array of
`
`3
`
`

`

`interventional cardiology devices (including stents) deep into the vasculature by
`
`providing markedly improved backup support.
`
`GuideLiner succeeded beyond the inventors’ wildest expectations. For
`
`physicians, GuideLiner solved the problem of insufficient backup support, and did
`
`so in a way that was safer, more efficient and more predictable than existing
`
`products and techniques. Ex-2145, ¶¶ 67-82, 239-56; Ex-2151, ¶¶ 9-12; Ex-2215,
`
`¶¶ 7, 20-29. GuideLiner quickly became VSI’s flagship product and created a new
`
`product category called “guide extension catheters.” Ex-2043, ¶¶ 9-13.
`
`GuideLiner has become one of the most successful specialty cathet