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`
`
`
`
`
`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 IPR2020-00136
`Patent RE45,776
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER RESPONSE
`
`
`

`

`TABLE OF CONTENTS
`
`
`2.
`
`3.
`
`I.
`II.
`
`Page
`INTRODUCTION ........................................................................................... 1
`BACKGROUND ............................................................................................. 3
`The GuideLiner Invention ..................................................................... 3
`A.
`B.
`The ‘776 Patent ..................................................................................... 4
`III. THE PERSON OF ORDINARY SKILL IN THE ART ................................. 8
`IV. ALL GROUNDS AND ALL CHALLENGED CLAIMS: PETITIONER
`HAS NOT SHOWN THAT KONTOS AND RESSEMANN RENDER
`OBVIOUS THE CLAIMED GUIDE EXTENSION CATHETER HAVING
`A “PARTIALLY CYLINDRICAL OPENING” ............................................. 9
`A. Kontos (Ex-1409) .................................................................................. 9
`Ressemann (Ex-1408) ......................................................................... 12
`B.
`C. A POSITA Would Not Combine Kontos with Ressemann to Create a
`“partially cylindrical opening having an angled proximal end” ......... 16
`1. Removing Konto’s Funnel Would Create Problems, Not Solve
`Them .......................................................................................... 17
`2. Petitioner’s Alleged Motivations Are Based on Hindsight
`and/or Unsupported by the Evidence ........................................ 22
`V. GROUND 1: THE PETITION FAILS TO SHOW THAT CLAIMS 52, 36-
`37, AND 49 WOULD HAVE BEEN OBVIOUS BASED ON KONTOS IN
`VIEW OF RESSEMANN FOR ADDITIONAL REASONS ....................... 29
`A. Claim 52 .............................................................................................. 30
`1.
`Ressemann Undisputedly Does Not Disclose a Device with a
`Segment Defining a Partially Cylindrical Opening that Includes
`At Least Two Inclined Regions ................................................. 32
`The Tip of the Tab Portion in Ressemann’s Support Collar
`Serves No Purpose in Ressemann ............................................. 37
`Even if a POSITA Was Motivated to Combine Kontos and
`Ressemann, the Petitioner Has Not Shown that the Resulting
`Combination Would Satisfy the Claim Language and Would Be
`Reasonably Expected to Work .................................................. 38
`Claims 36 and 37 ................................................................................. 42
`
`B.
`
`ii
`
`

`

`Claim 49 .............................................................................................. 43
`C.
`VI. GROUND 2: THE PETITION FAILS TO SHOW THAT KONTOS IN
`VIEW OF RESSEMANN AND TAKAHASHI RENDERS CLAIMS 53-56
`AND 30-32 OBVIOUS ................................................................................. 43
`VII. GROUND 3: THE PETITION FAILS TO SHOW THAT KONTOS IN
`VIEW OF RESSEMANN AND KATAHASHI RENDERS CLAIM 52
`OBVIOUS ...................................................................................................... 47
`A. Kataishi (Ex-1425) ............................................................................. 48
`Petitioner’s Obviousness Arguments Based on Kataishi Are Without
`B.
`Merit .................................................................................................... 49
`VIII. GROUND 4: THE PETITION FAILS TO SHOW THAT CLAIMS 53-56
`ARE OBVIOUS OVER KONTOS IN VIEW OF RESSEMANN,
`TAKAHASHI, AND KATAISHI ................................................................. 53
`IX. ALL GROUNDS: OBJECTIVE, REAL-WORLD EVIDENCE ALSO
`SHOWS THAT THE CHALLENGED CLAIMS WERE NOT OBVIOUS 53
`Long-Felt Need .................................................................................... 55
`A.
`B.
`Commercial Success............................................................................ 58
`C.
`Industry Praise ..................................................................................... 62
`D.
`Licensing ............................................................................................. 65
`E.
`Copying ............................................................................................... 66
`Boston Scientific Guidezilla ...................................................... 66
`1.
`2.
`QXM’s Boosting Catheter ......................................................... 69
`3.
`Petitioner’s Telescope ............................................................... 69
`There Is Nexus Between the Invention of Claims 25, 52 and 53 and
`the Objective Evidence of Nonobviousness ........................................ 73
`THE PETITION SHOULD BE DENIED BECAUSE INTER PARTES
`REVIEW IS UNCONSTITUTIONAL .................................................... 80
`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 82
`CERTIFICATION OF SERVICE............................................................................ 83
`
`
`X.
`
`F.
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`
`Arctic Cat Inc. v. Bombardier Rec. Prods.,
`876 F.3d 1350 (Fed. Cir. 2017)................................................................................21
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019)................................................................................80
`Fox Factory, v. SRAM, LLC,
`944 F.3d at 1373 (2019 ..................................................................................... 73, 79
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573 (Fed. Cir. 1997)................................................................................75
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997)................................................................................43
`Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013)................................................................... 22, 62, 65
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016)................................................................................29
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ...................................................73
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) .............................................................................................80
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882, (Fed. Cir. 2011) .........................................................................43
`Panduit Corp. v. Dennison Mfg. Co.,
`774 F.2d 1082 (Fed. Cir. 1985)................................................................................66
`Securus Techs., Inc. v. Glob. Tel*Link Corp.,
`701 F. App'x 971 (Fed. Cir. 2017) ...........................................................................51
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) ..................................................................................72
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012)................................................................................54
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016)......................................................................... 56, 66
`
`iv
`
`

`

`TABLE OF EXHIBITS
`
`
`
`Exhibit Description
`2001
`[Reserved]
`2002
`[Reserved]
`2003
`[Reserved]
`2004
`[Reserved]
`2005
`[Reserved]
`2006
`[Reserved]
`2007
`[Reserved]
`2008
`[Reserved]
`2009
`[Reserved]
`2010
`[Reserved]
`2011
`[Reserved]
`2012
`[Reserved]
`2013
`[Reserved]
`2014
`[Reserved]
`2015
`[Reserved]
`2016
`[Reserved]
`2017
`[Reserved]
`2018
`[Reserved]
`2019
`[Reserved]
`2020
`[Reserved]
`2021
`[Reserved]
`2022
`[Reserved]
`2023
`[Reserved]
`2024
`[Reserved]
`2025
`[Reserved]
`2026
`[Reserved]
`2027
`[Reserved]
`2028
`[Reserved]
`2029
`[Reserved]
`2030
`[Reserved]
`2031
`[Reserved]
`2032
`[Reserved]
`3033
`[Reserved]
`2034
`[Reserved]
`
`v
`
`

`

`[Reserved]
`2035
`[Reserved]
`2036
`[Reserved]
`2037
`[Reserved]
`2038
`[Reserved]
`2039
`[Reserved]
`2040
`[Reserved]
`2041
`2042 Declaration of Peter Keith
`2043 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Under Seal), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 78 –
`PROTECTIVE ORDER MATERIAL
`2044 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Redacted), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 79
`[Reserved]
`2045
`2046 Declaration of Howard Root in Support of Plaintiff’s Motion for
`Preliminary Injunction, Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn), Dkt. 12
`[Reserved]
`2047
`2048 Defendants’ Opposition to Plaintiffs’ Motion for Preliminary Injunction
`(Redacted), Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 104
`2049 Amended Pretrial Scheduling Order, Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 229
`2050 Defendants’ Second Amended Notice of Deposition of Peter Keith,
`Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D.
`Minn.)
`2051 Defendants’ Amended Notice of Deposition of Amy Welch, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2052 Drawings Submitted with Ressemann U.S. Patent App. 10/214,712
`2053 Defendants’ Interrogatories to Plaintiffs Concerning Preliminary
`Injunction Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-
`01760-PJS-TNL (D. Minn.)
`2054 Defendants’ Requests for Production of Documents Concerning
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2055 Article Titled: Understanding Low-Friction Coatings for Medical
`Devices
`
`vi
`
`

`

`2056 Expert Report of Peter T. Keith on Infringement, Claim Coverage, and
`Lack of Acceptable Noninfringing Alternatives, QXMédical, LLC v.
`Vascular Solutions LLC, 17-cv-01969 (D. Minn.), Dkt. 125-22
`2057 Teleflex Product Patents Website
`2058 Confidential Presentation – PROTECTIVE ORDER MATERIAL
`2059 Plaintiffs’ First Supplemental Objections and Responses to Defendants’
`Interrogatories Concerning Preliminary Injunction Issues, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2060 Globe Newswire: Teleflex Announces Tenth Anniversary of GuideLiner
`Catheter Product Line
`2061 GuideLiner Marketing Material V1 Catheter
`2062 GuideLiner Marketing Material V2 Catheter
`2063 GuideLiner Marketing Material: That’s A Real Game Changer
`2064
`[Reserved]
`2065 GuideLiner Catheter Bibliography
`2066 Physician Testimonial Authorizations
`2067 Rao, U., et al., The GuideLiner “child” catheter, EuroIntervention 2010
`6:277-279
`2068 Defendants’ Answer, Defenses, and Counterclaims to Plaintiffs’
`Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 16
`2069 Exhibit E to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-5
`2070 Medtronic comparison of guide extension catheters
`2071 Exhibit A to Complaint, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 1-1
`2072 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 77
`2073 Declaration of Alexander S. Rinn
`2074
`[Reserved]
`2075
`[Reserved]
`2076
`[Reserved]
`2077
`[Reserved]
`2078 Defendants’ Answer and Defenses to Plaintiffs’ First Amended and
`Supplemental Complaint and Second Amended Counterclaims Against
`Plaintiffs, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.), Dkt. 233
`
`vii
`
`

`

`2079 Exhibit A to Defendants’ Answer and Defenses to Plaintiffs’ First
`Amended and Supplemental Complaint and Second Amended
`Counterclaims Against Plaintiffs, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`[Reserved]
`2080
`2081 Plaintiff’s Reply Memorandum in Support of Motion for Preliminary
`Injunction (Redacted), Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn)
`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
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`
`2089
`2090
`2091
`2092
`2093
`2094
`2095
`2096
`2097
`2098
`2099
`2100
`2101
`2102
`2103
`2104
`2105
`
`viii
`
`

`

`[Reserved]
`2106
`[Reserved]
`2107
`[Reserved]
`2108
`[Reserved]
`2109
`[Reserved]
`2110
`[Reserved]
`2111
`[Reserved]
`2112
`[Reserved]
`2113
`[Reserved]
`2114
`[Reserved]
`2115
`2116 Deposition Transcripts of Stephen J.D. Brecker, M.D. dated August 11,
`2020 and September 14, 2020
`[Reserved]
`2117
`[Reserved]
`2118
`[Reserved]
`2119
`[Reserved]
`2120
`[Reserved]
`2121
`[Reserved]
`2122
`[Reserved]
`2123
`2124 Declaration of Peter Keith in Support of Motions to Amend
`2125
`[Reserved]
`2126
`[Reserved]
`2127
`[Reserved]
`2128
`[Reserved]
`2129
`[Reserved]
`2130
`[Reserved]
`2131
`[Reserved]
`2132
`[Reserved]
`2133
`[Reserved]
`2134
`[Reserved]
`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)
`
`ix
`
`

`

`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)
`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
`
`x
`
`

`

`2169
`
`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
`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
`
`xi
`
`

`

`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”
`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”
`
`xii
`
`

`

`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
`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
`
`xiii
`
`

`

`I.
`
`INTRODUCTION
`The ’776 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 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 via interventional (non-surgical) means.
`
`GuideLiner is one of the most successful specialty catheters ever for cardiac
`
`intervention, having been used in more than one million procedures since its
`
`introduction in 2009. Even today, many physicians refer to VSI as “the
`
`GuideLiner company.”
`
`The features that made GuideLiner successful are recited in the claims of the
`
`‘776 patent and distinguish the claims over the art relied on in this IPR. All of the
`
`claims are directed to a guide extension catheter having, inter alia, a “partially
`
`cylindrical opening having an angled proximal end . . . configured to receive one or
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`more interventional cardiology devices therethrough when positioned within the
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`guide catheter.” Kontos, the primary reference relied on for all grounds of the
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`present petition, undisputedly does not disclose such a side opening, and the
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`modifications proposed by Petitioner are both hindsight-based and contrary to the
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`purpose and teaching of Kontos.
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`Moreover, one of the things that makes the ’776 patent different from other
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`GuideLiner patents is that two of the three independent claims require that the
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`angled proximal end of the partially cylindrical opening have “at least two inclined
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`regions.” Neither of the secondary references that Petitioner relies on for this
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`limitation (Ressemann and Kataishi) disclose a proximal opening with “at least two
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`inclined regions,” much less provide a motivation to modify Kontos to include
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`such a proximal opening. Petitioner’s arguments are nothing more than a post-hoc
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`hindsight analysis that uses the Patent Owner’s claims as a roadmap to carefully
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`pick and choose features in an attempt to satisfy the claim language.
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`In addition, several of the claims, including independent claim 53, add a
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`further requirement that the lumen of the guide extension catheter be “not more
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`than one French size smaller” than the guide catheter with which the extension
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`catheter is used. Petitioner’s obviousness arguments with respect to this limitation
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`are contrary to the fundamental purpose of Kontos and fail to address how the
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`allegedly-obvious modifications would actually result in a device meeting the “one
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`French size” limitation.
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`Finally, there is unusually strong objective evidence of nonobviousness for
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`all of the claims of this patent, including long-felt need, commercial success, praise
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`in the industry, licensing and copying. This overwhelming objective evidence
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`resolves any doubt as to the non-obviousness of the claim invention. The Board
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`should confirm the patentability of the challenged claims in their entirety.
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`II. BACKGROUND
` The GuideLiner Invention
`Since at least the late 1980s, physicians have been treating diseased coronary
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`arteries using catheter-based minimally invasive techniques to perform balloon
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`angioplasties and place stents. However, catheter-based treatment was difficult, if
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`not impossible, for many of the more complex coronary lesions. Ex-2145, ¶¶ 36-
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`66; Ex-2151, ¶ 4-8, 11; Ex-2215, ¶¶ 3-6, 9-19. This was because when
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`interventional cardiology devices encountered a complex lesion or a tortuous
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`anatomy, it generated a back-force that caused the guide catheter to “pop out” of
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`the coronary artery. Id. Over the course of almost two decades, various products
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`and “tips and tricks” were developed to try to address the problem of insufficient
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`backup support, but nothing fully solved the problem. Ex-2145, ¶¶ 50-66; Ex-
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`2151, ¶¶ 5-8.
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`It wasn’t until the 2005 invention of GuideLiner that someone finally came
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`up with a simple, elegant solution that, for the first time, fully solved the backup
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`support issue. In GuideLiner, the inventors created a device with “rapid exchange”
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`functionality that could receive and deliver the full array of interventional
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`cardiology devices (including stents) deep into the vasculature by providing
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`markedly increased backup support. Ex-2138, ¶ 68.
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`GuideLiner succeeded beyond the inventors’ wildest expectations. For
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`physicians, GuideLiner enabled routine catheter-based treatment of coronary
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`stenoses that previously had been untreatable, and did so in a way that was safer,
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`more efficient and more predictable than existing products and techniques. Ex-
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`2145, ¶¶ 67-82, 239-256; Ex-2151, ¶¶ 9-17; Ex-2215, ¶¶ 7, 20-29. GuideLiner
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`quickly became VSI’s flagship product and created a new product category called
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`“guide extension catheters.” Ex-2043, ¶¶ 9-13. GuideLiner has become one of the
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`most successful specialty catheters ever for cardiac intervention, having been used
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`in more than one million procedures across at least 62 countries since its
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`introduction in 2009. Ex-2060 at 1. Even today, many physicians refer to VSI as
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`“the GuideLiner company.” Ex-2044, ¶ 12.
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`The ʼ776 Patent
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`The ’776 patent is one of a family of patents claiming priority to the original
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`patent application filed on the GuideLiner technology. The ’776 patent is directed
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`to a guide extension catheter that is passed through the lumen of a guide catheter,
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`advanced beyond the distal end of the guide catheter, and inserted into a branch
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`artery to facilitate delivery of stents, balloon angioplasty catheters and other
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`interventional cardiology devices. Ex-1401 at Abstract.
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`The guide extension catheter generally includes, from distal to proximal
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`direction, a soft tip portion, a tubular portion, and a substantially rigid portion that
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`has a rail segment to permit delivery without blocking use of the guide catheter.
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`E.g., id. at 6:40-7:3 and Figs. 1, 4, 20–22. Figure 1 shows an embodiment of the
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`invention; Figure 9 (color added) illustrates how the guide extension catheter 12
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`(orange with blue tip) is inserted past the end of guide catheter and deep into the
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`coronary artery:
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`Ex-1401 at Figs. 1, 9; Ex-2138, ¶ 95. One important advantage of the design is
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`that it only slightly reduces the available space to deliver interventional cardiology
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`devices – by no more than “one French size” smaller than the guide catheter in the
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`preferred embodiment. Id. at 3:36-51; Ex-2138, ¶ 92.
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`The guide extension catheter is designed to facilitate the insertion of
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`interventional cardiology devices, including stent and balloon catheters, into its
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`proximal end while the guide extension catheter is located inside a guide catheter.
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`To that end, the guide extension catheter includes, from distal to proximal
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`direction, a first full circumference portion, a hemicylindrical portion, and an
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`arcuate portion. Exemplary embodiments are shown below in Figures 4 and 12-13:
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`Ex-1401, Figs. 4, 12-13 (arrows added); see also id. at 7:1-3. This structure forms
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`a side opening that directs the interventional device—in a proximal to distal
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`direction as indicated by the red arrow annotation—into the tubular portion. Id. at
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`8:23-37; see also Ex-2138, ¶ 92.
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`
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`The ‘776 patent has three independent claims. Claim 25 reads as follows:
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`25. A guide extension catheter for use with a guide catheter,
`comprising:
`a substantially rigid segment;
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`a tubular structure defining a lumen and positioned distal to the
`substantially rigid segment; and
`a segment defining a partially cylindrical opening positioned between
`a distal end of the substantially rigid segment and a proximal end of
`the tubular structure, the segment defining the partially cylindrical
`opening having an angled proximal end, formed from a material more
`rigid than a material or material combination forming the tubular
`structure, and configured to receive one or more interventional
`cardiology devices therethrough when positioned within the guide
`catheter,
`wherein a cross-section of the guide extension catheter at the proximal
`end of the tubular structure defines a single lumen.
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`Independent claims 52 and 53 contain nearly identical language and additionally
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`require, inter alia, that the segment defining the angled proximal end of the
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`partially cylindrical opening “includes at least two inclined regions.”
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`III. THE PERSON OF ORDINARY SKILL IN THE ART
`For the purposes of this Response only, Patent Owner does not dispute
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`Petitioner’s proposed definition of a POSITA. Petition at 13.1
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`1 Petitioner’s engineering expert, Dr. Richard Hillstead, does not appear to meet
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`the Petitioner’s definition of a POSITA. He does not have an undergraduate
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`degree in engineering (Ex-2137, 462:8-13); his Ph.D. is in business administration.
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`IV. ALL GROUNDS AND ALL CHALLENGED CLAIMS: PETITIONER
`HAS NOT SHOWN THAT KONTOS AND RESSEMANN RENDER
`OBVIOUS THE CLAIMED GUIDE EXTENSION CATHETER
`HAVING A “PARTIALLY CYLINDRICAL OPENING”
`All independent claims of the ’776 patent (25, 52 and 53) require a “segment
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`defining a partially cylindrical opening… having an angled proximal end.”
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`Recognizing that Kon