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 IPR2020-00130
`Patent RE45,380
`
`PATENT OWNER RESPONSE
`
`

`

`
`
`PAGE
`
`TABLE OF CONTENTS
`
`2. 
`
` 
`INTRODUCTION ........................................................................................... 1 
`I. 
`BACKGROUND ............................................................................................. 2 
`II. 
`III.  THE ’380 PATENT ......................................................................................... 4 
`IV.  THE PERSON OF ORDINARY SKILL IN THE ART ................................. 9 
`V. 
`CLAIM CONSTRUCTION ............................................................................ 9 
`A. 
`“A system for use with interventional cardiology devices adapted to
`be insertable” and 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 
`VI.   THE REFERENCES THE PETITION RELIES ON .................................... 11 
`A.  Kontos (Ex-1409) ................................................................................ 11 
`B. 
`Adams (Ex-1435) ............................................................................... 15 
`VII.  GROUND 1: THE PETITION FAILS TO SHOW THAT THE
`CHALLENGED CLAIMS ARE INVALID IN VIEW OF KONTOS,
`ADAMS, AND THE KNOWLEDGE OF A POSITA ................................... 19 
`A. 
`Independent Claims 1, 12: The Petition Fails to Show that Kontos
`Teaches a “system for use with interventional cardiology devices”
`Having the Claimed Device with a Flexible Tip Portion “defining a
`coaxial lumen having a cross-sectional inner diameter through which
`interventional cardiology devices are insertable” .............................. 19 
`1. 
`Under the Correct Construction, the Petitioner Fails to Show
`that Any Challenged Claim Is Invalid ...................................... 20 
`Even Under the Board’s Preliminary Construction, Petitioner
`Still Fails to Show that Any Challenged Claim Is Invalid ....... 21 
`Independent Claim 1: The Petitioner Does Not Show that Kontos
`Discloses a “Cylindrical” Reinforced Portion ..................................... 22 
`i
`
`B. 
`
` 
`
`

`

`C. 
`
`2. 
`
`3. 
`
`4. 
`
`E. 
`
`Dependent Claims 2 and 13: Petitioner Has Not Shown that Kontos
`Discloses a Structure Configured as Claimed Such that it “assists in
`resisting axial and shear forces exerted by the interventional
`cardiology device passed through and beyond the coaxial lumen that
`would otherwise tend to dislodge the guide catheter from the branch
`artery” .................................................................................................. 24 
`D.  Dependent Claim 3: The Petition Does Not Show that a System “. . .
`wherein the proximal portion of the tubular structure further
`comprises structure defining a proximal side opening extending for a
`distance along the longitudinal axis . . . to receive the interventional
`cardiology devices into the coaxial lumen while the proximal portion
`remains within the lumen of the guide catheter” Would Have Been
`Obvious Based on Kontos in view of Adams ..................................... 28 
`1. 
`No Motivation or Reasonable Expectation of Success—
`Removing Kontos’ Funnel Portion would Create Problems .... 29 
`Petitioner’s Modification Requires Ignoring What Adams
`Actually Teaches ....................................................................... 33 
`Petitioner’s Alleged Motivations Are Based on Hindsight
`And/or Unsupported by the Evidence ....................................... 36 
`If Modified as Proposed in the Petition, the Resulting Structure
`Would No Longer Meet the Requirement for a “Coaxial
`Lumen” ...................................................................................... 42 
`Dependent Claims 4, 9, 14, and 19: Petitioner’s Arguments Fail For
`The Same Reasons as For Claim 3 ...................................................... 43 
`VIII.  GROUND II: THE PETITION FAILS TO SHOW THAT CLAIMS 8 AND
`18 ARE INVALID IN VIEW OF KONTOS, ADAMS, TAKAHASHI, AND
`THE KNOWLEDGE OF A POSITA ............................................................ 44 
`IX.  GROUND III: THE PETITION FAILS TO SHOW THAT CLAIM 21 IS
`INVALID IN VIEW OF KONTOS, ADAMS, BERG, AND THE
`KNOWLEDGE OF A POSITA ..................................................................... 49 
`Claims 3, 9, 14, and 19: Strong Objective, Real-World Evidence Shows
`Non-Obviousness ........................................................................................... 50 
`
`X. 
`
` 
`
`ii 
`
`

`

`A. 
`B. 
`C. 
`D. 
`E. 
`
`Long-Felt Need .................................................................................... 52
`Commercial Success............................................................................ 55
`Industry Praise ..................................................................................... 59
`Licensing ............................................................................................. 62
`Copying ............................................................................................... 62
`Boston Scientific’s Guidezilla .................................................. 63
`1.
`QXM’s Boosting Catheter ........................................................ 65
`2.
`Petitioner’s Telescope ............................................................... 65
`3.
`There Is Nexus Between the Invention of Claims 3, 9, 14, and 19 and
`the Objective Evidence of Nonobviousness ........................................ 69
`THE PETITION SHOULD BE DENIED BECAUSE INTER PARTES
`REVIEW IS UNCONSTITUTIONAL .......................................................... 76
`XII. CONCLUSION .............................................................................................. 77
`
`F. 
`
`XI.
`
`iii
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`Arctic Cat Inc. v. Bombardier Rec. Prods.,
`876 F.3d 1350 (Fed. Cir. 2017) ............................................................................ 32
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320, 1325 (Fed. Cir. 2019) .................................................................. 76
`Aspex Eyewear, Inc. v. Marchon Eyewear, Inc.,
`672 F.3d 1335 (Fed. Cir. 2012) ............................................................................ 24
`Fox Factory,
`944 F.3d at 1373 ............................................................................................ 69, 75
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573 (Fed. Cir. 1997) ............................................................................ 72
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) ............................................................................ 25
`Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ............................................................... 33, 59, 62
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ............................................... 63
`Jack Guttman, Inc. v. Kopykake Enters.,
`302 F.3d 1352 (Fed. Cir. 2002) ............................................................................ 10
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 at 33 (PTAB Jan. 24, 2020) ....................................... 70
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) .......................................................................................... 76
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ....................................................................... 25
`Panduit Corp. v. Dennison Mfg. Co.,
`774 F.2d 1082 (Fed. Cir. 1985) ............................................................................ 62
`
`iv
`
`

`

`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) .............................................................................. 69
`Transclean Corp. v. Bridgewood Servs.,
`290 F.3d 1363 (Fed. Cir. 2002) ............................................................................ 25
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................ 50
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................... 52, 55, 62
`Winner Int’l Royalty Corp. v. Wang,
`202 F.3d 1340 (Fed. Cir. 2000) ............................................................................ 42
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................ 62
`
`v
`
`

`

`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]
`2035
`[Reserved]
`2036
`[Reserved]
`
`

`

`[Reserved]
`2037
`[Reserved]
`2038
`[Reserved]
`2039
`[Reserved]
`2040
`[Reserved]
`2041
`[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
`[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
`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
`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
`2080 Excerpts from the March 11, 2019 Deposition of Peter Keith,
`QXMédical, LLC v. Vascular Solutions LLC, 17-cv-01969 (D. Minn.)
`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]
`[Reserved]
`[Reserved]
`
`2089
`2090
`2091
`2092
`2093
`2094
`2095
`2096
`2097
`2098
`2099
`2100
`2101
`2102
`2103
`2104
`2105
`2106
`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)
`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
`2165 GuideLiner Brochure 2019
`
`

`

`2169
`
`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
`
`

`

`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”
`
`

`

`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
`
`

`

`I.
`
`INTRODUCTION
`This Petition challenges the ’380 GuideLiner patent based on prior art that is
`
`very different from the claimed invention: Kontos, a narrow-lumen “support
`
`catheter” with raised-profile proximal and distal ends and a proximal funnel that is
`
`intended to protect delicate PTCA balloon catheters during delivery or exchanges
`
`from “bending or kinking,” and Adams, an expandable mesh “guide seal”.
`
`At the outset, the Petition fails to show that the narrow-lumen Kontos
`
`device, designed to protect similarly narrow balloon catheters, has the claimed
`
`structure through which the minimum set of common interventional cardiology
`
`devices defined in the patent—including stents and stent catheters—are insertable.
`
`This deficiency is fatal to all challenged claims. What’s more, the Petition fails to
`
`demonstrate that Kontos’ narrow-waist, irregularly shaped device that was loose-fit
`
`into a guide catheter provides the claimed backup support. It also fails to show
`
`that a POSITA would have been motivated to make the substantial modifications
`
`to Kontos’ device required to arrive at the proximal side opening and maximum
`
`one French inner diameter differential required by dependent claims, or that those
`
`substantial modifications would have been expected to work. In fact, the
`
`Petitioner’s proposal to remove Kontos’ funnel, exposing a gap at the device’s
`
`proximal end, would have been expected to cause problems, not improve the
`
`device.
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`1
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`

`

`Finally, there is remarkably strong objective evidence of nonobviousness in
`
`this case for at least claims 3, 9, 14, and 19. 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 guide catheter backup
`
`support that had plagued the interventional cardiology field since at least the late
`
`1980s to early 1990s. 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, Medtronic’s Telescope, and QXMédical’s Boosting Catheter. The
`
`striking objective evidence that the GuideLiner invention of claims 3, 9, 14, and 19
`
`was not, in the real world, obvious to those working in the field both demonstrates
`
`and confirms that the claims are 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. E.g.,
`
`Ex-2145, ¶¶ 40-49; Ex-2151, ¶4; Ex-2215, ¶¶ 3-6. This was because when
`
`interventional cardiology devices encountered a complex lesion or a tortuous
`
` 
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`2 
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`

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`anatomy, it generated a back-force that tended to cause the guide catheter to
`
`back out” of the coronary artery. Ex-2145, ¶¶ 41-42; Ex-2215, ¶¶ 3-6; Ex-2138,
`
`¶¶57-59, 91-92. Over the course of almost 15 years, various products and “tips and
`
`tricks” were developed to try to address this, but nothing really solved the
`
`problem. E.g., Ex-2145, ¶¶ 50-66; Ex-2215, ¶¶ 9-19; Ex-2151, ¶¶ 5-8; Ex-2138,
`
`¶¶60-68.
`
`It wasn’t until late 2004 and into 2005 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, truly solved the backup
`
`support issue. Ex-2145, ¶¶ 67-71, 76-82; Ex-2215, ¶¶ 2, 7-9, 20-; Ex-2151, ¶¶ 9-
`
`17; Ex-2138, ¶¶ 69-82, 214-219. 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 distal tubular portion
`
`located deep within a guide catheter, all while providing increased backup support.
`
`Id.
`
`GuideLiner succeeded beyond the inventors’ wildest expectations. For
`
`physicians, GuideLiner enabled catheter-based treatment of coronary stenoses that
`
`previously had been untreatable, and did so in a way that was safer, more efficient
`
`and more predictable than existing products and techniques. E.g., Ex-2145, ¶¶ 67-
`
`71, 76-82 (Decl. of Dr. Graham); Ex-2215, ¶¶ 2, 7-9, 20-29 (Decl. of Dr.
`
` 
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`3 
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`

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`Thompson); Ex-2151, ¶¶ 9-17 (Decl. of Dr. Azzalini). GuideLiner quickly became
`
`VSI’s flagship product and created a new product category called “guide extension
`
`catheters.” GuideLiner has become one of the most successful specialty catheters
`
`ever for cardiac intervention, having been used in more than one million
`
`procedures across at least 62 countries since its introduction in 2009. Even today,
`
`many physicians refer to VSI as “the GuideLiner company.”
`
`III. THE ’380 PATENT
`Mr. Root and his team sought patent protection for their inventions. The
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`’380 patent is one of a family of patents that eventually issued covering the
`
`GuideLiner technology. The ’380 patent is directed to a coaxial guide catheter
`
`(also referred to as a “guide extension catheter”) that is passed through the lumen
`
`of a guide catheter, advanced beyond the distal end of the guide catheter, and
`
`inserted into a branch artery of the aorta to facilitate delivery of stents, balloon
`
`angioplasty catheters and other interventional cardiology devices. Ex-1401,
`
`Abstract.
`
`The guide extension catheter generally includes, from distal to proximal
`
`direction, a soft tip portion, a tubular portion, and a substantially rigid portion that
`
`has a rail segment to permit delivery without blocking use of the guide catheter.
`
`E.g. id. at 6:34-35, Figs. 1, 4, 20-22.; Ex-2138, ¶¶ 93-94. Figure 1 shows an
`
`embodiment of the invention; Figure 9 (color added) illustrates how the guide
`
` 
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`4 
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`

`extension catheter 12 (orange with blue tip) is inserted past the end of the guide
`
`catheter and deep into the coronary artery:
`
`
`
`Ex-1401, Figs. 1, 9; Ex-2138, ¶¶ 96-98. An important advantage of the design is it
`
`only slightly reduces the available space to deliver interventional cardiology
`
`devices—by no more than “one French size” smaller than the guide catheter in the
`
`preferred embodiment. Id. at 3:28-43; Ex-2138, ¶ 94.
`
`The guide extension catheter is designed to facilitate the insertion of
`
`interventional cardiology devices, including stent and balloon catheters, into a
`
` 
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`5 
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`

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`proximal opening in a distal tubular portion while the guide extension catheter is
`
`located inside a guide catheter. E.g. Ex-1401, Abstract, 8:18-32; Ex-2138, ¶¶ 96-
`
`98. To that end, a proximal portion of the device includes, from distal to proximal
`
`direction, a first full circumference portion, a hemicylindrical portion, and an
`
`arcuate portion. Exemplary embodiments are shown below in Figures 4 and 12-13:
`
`Ex-1401; see also id. at 6:62-64 (red arrows added). This structure forms an
`
`opening that directs the interventional device—in a proximal to distal direction as
`
`indicated by the red arrow annotation— into the tubular portion. Ex-2138, ¶ 95.
`
`6
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`

`

` An exemplary claim—is provided below:
`
`1. A system for use with interventional cardiology
`devices adapted to be insertable into a branch artery, the
`system comprising:
`
`a guide catheter having a continuous lumen extending for
`a predefined length from a proximal end at a hemostatic
`valve to a distal end adapted to be placed in the branch
`artery, the continuous lumen of the guide catheter having
`a circular cross-sectional inner diameter sized such that
`interventional cardiology devices are insertable into and
`through the continuous lumen of the guide catheter; and
`
`a device adapted for use with the guide catheter,
`including:
`
`a flexible tip portion defining a tubular structure and
`having a circular cross-section and a length that is shorter
`than the predefined length of the continuous lumen of the
`guide catheter, the tubular structure having a cross-
`sectional outer diameter size