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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 IPR2020-00127
`Patent 8,048,032
`
`
`
`
`
`
`
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`
`
`PATENT OWNER RESPONSE
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`
`
`TABLE OF CONTENTS
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`
`
`PAGE
`
`INTRODUCTION ........................................................................................... 1
`I.
`BACKGROUND ............................................................................................. 2
`II.
`III. THE ’032 PATENT ......................................................................................... 4
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ................................. 8
`V.
`CLAIM CONSTRUCTION ............................................................................ 9
`A. A flexible tip portion/tubular portion “defining a coaxial lumen
`having a cross-sectional inner diameter through which interventional
`cardiology devices are insertable” (Independent claims 1 and 11) ....... 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 ................................... 18
`A.
`Independent Claims 1, 11: The Petition Fails to Show that Kontos
`Teaches Structure “defining a coaxial lumen having a cross-sectional
`inner diameter through which interventional cardiology devices are
`insertable” ........................................................................................... 18
`1.
`Under the Correct Construction, the Petitioner Fails to Show
`that Any Challenged Claim Is Invalid ...................................... 19
`Even Under the Board’s Preliminary Construction, Petitioner
`Still Fails to Show that Any Challenged Claim Is Invalid ....... 20
`Dependent Claims 2 and 12: Petitioner Has Not Shown that Kontos
`Discloses 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
`
`2.
`
`B.
`
`
`
`i
`
`
`
`C.
`
`E.
`
`2.
`
`3.
`
`4.
`
`would otherwise tend to dislodge the guide catheter from the branch
`artery”.................................................................................................. 21
`Dependent Claim 3: The Petition Does Not Show that a Device “. . .
`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 an interventional
`cardiology device 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 ..................................... 25
`1.
`No Motivation or Reasonable Expectation of Success—
`Removing Kontos’ Funnel Portion would Create Problems .... 26
`Petitioner’s Modification Requires Ignoring What Adams
`Actually Teaches ....................................................................... 30
`Petitioner’s Alleged Motivations Are Based on Hindsight
`And/or Unsupported by the Evidence ....................................... 32
`If Modified as Proposed in the Petition, the Resulting Structure
`Would No Longer Meet the Requirement for a “Coaxial
`Lumen” ...................................................................................... 39
`D. Dependent Claims 4, 9, 13, and 18: Petitioner’s Arguments Fail For
`The Same Reasons as For Claim 3 ...................................................... 40
`Dependent Claim 6: The Petitioner Does Not Show that Kontos
`Discloses a “Cylindrical” Reinforced Portion ..................................... 41
`VIII. GROUND II: THE PETITION FAILS TO SHOW THAT CLAIMS 8 AND
`17 ARE INVALID IN VIEW OF KONTOS, ADAMS, TAKAHASHI, AND
`THE KNOWLEDGE OF A POSITA ............................................................ 43
`IX. GROUND III: THE PETITION FAILS TO SHOW THAT CLAIM 20 IS
`INVALID IN VIEW OF KONTOS, ADAMS, BERG, AND THE
`KNOWLEDGE OF A POSITA ..................................................................... 47
`Claims 3, 9, 13, and 18: Strong Objective, Real-World Evidence Shows
`Non-Obviousness ........................................................................................... 49
`A.
`Long-Felt Need .................................................................................... 51
`
`X.
`
`
`
`ii
`
`
`
`B.
`C.
`D.
`E.
`
`Commercial Success............................................................................ 53
`Industry Praise ..................................................................................... 57
`Licensing ............................................................................................. 60
`Copying ............................................................................................... 60
`1.
`Boston Scientific’s Guidezilla .................................................. 61
`2.
`QXM’s Boosting Catheter ........................................................ 63
`3.
`Petitioner’s Telescope ............................................................... 64
`There Is Nexus Between the Invention of Claims 3, 9, 13, and 18 and
`the Objective Evidence of Nonobviousness ........................................ 68
`XI. The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional ............................................................................................. 75
`XII. CONCLUSION .............................................................................................. 76
`
`F.
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`iii
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`
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Arctic Cat Inc. v. Bombardier Rec. Prods.,
`876 F.3d 1350 (Fed. Cir. 2017) ............................................................................ 29
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320, 1325 (Fed. Cir. 2019) .................................................................. 75
`Aspex Eyewear, Inc. v. Marchon Eyewear, Inc.,
`672 F.3d 1335 (Fed. Cir. 2012) ............................................................................ 21
`Fox Factory,
`994 F.3d at 1375 ............................................................................................ 68, 74
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573 (Fed. Cir. 1997) ............................................................................ 71
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) ............................................................................ 22
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 30, 57
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 at 41 (PTAB Mar. 23, 2014) ...................................... 61
`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) ....................................... 68
`Lucia v. SEC,
`138 S. Ct. 204 (2018) ............................................................................................ 75
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ....................................................................... 22
`Panduit Corp. v. Dennison Mfg. Co.,
`774 F.2d 1082 (Fed. Cir. 1985) ............................................................................ 60
`
`
`
`iv
`
`
`
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) .............................................................................. 67
`Transclean Corp. v. Bridgewood Servs.,
`290 F.3d 1364 (Fed. Cir. 2002) ............................................................................ 22
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................ 49
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ............................................................... 51, 53, 60
`Winner Int’l Royalty Corp. v. Wang,
`202 F.3d 1340 (Fed. Cir. 2000) ............................................................................ 38
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................ 61
`
`
`
`v
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`
`
`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
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`I.
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`INTRODUCTION
`This Petition challenges the ’032 GuideLiner patent based on prior art that is
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`very different from the claimed invention: Kontos, a narrow-tube “support
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`catheter” with raised-profile proximal and distal ends and a proximal funnel that is
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`intended to protect delicate PTCA balloon catheters during delivery or exchanges
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`from “bending or kinking,” and Adams, an expandable mesh “guide seal.”
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`At the outset, the Petition fails to show that the narrow-tube Kontos device,
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`designed to protect similarly narrow balloon catheters, has the claimed structure
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`through which the minimum set of common interventional cardiology devices
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`defined in the patent—including stents and stent catheters—are insertable. This
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`deficiency is fatal to all challenged claims. What’s more, the Petition fails to
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`demonstrate that Kontos’ narrow-waist, irregularly shaped device that was loose-fit
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`into a guide catheter provides the claimed backup support. It also fails to show
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`that a POSITA would have been motivated to make the substantial modifications
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`to Kontos’ device required to arrive at the proximal side opening and maximum
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`one French inner diameter differential required by dependent claims, or that those
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`substantial modifications would have been expected to work. In fact, the
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`Petitioner’s proposal to remove Kontos’ funnel, exposing a gap at the device’s
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`proximal end, would have been expected to cause problems, not improve the
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`device.
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`Finally, there is remarkably strong objective evidence of nonobviousness in
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`this case for at least claims 3, 9, 13, and 18. These claims closely cover the
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`features that have led to the GuideLiner’s extraordinary success and allowed it to
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`finally (and elegantly) solve the problem of insufficient guide catheter backup
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`support that had plagued the interventional cardiology field since at least the late
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`1980s to early 1990s. When the GuideLiner launched in 2009, it was met with
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`acclaim and quickly created an entirely new category of device—the guide
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`extension catheter. It also spawned copycat products—Boston Scientific’s
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`Guidezilla, Petitioner’s Telescope, and the QXMédical’s Boosting Catheter. The
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`striking objective evidence that the GuideLiner invention of claims 3, 9, 13, and 18
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`was not, in the real world, obvious to those working in the field both demonstrates
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`and confirms that the claims are patentable over the prior art. The Board should
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`confirm the patentability of the challenged claims.
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`II. BACKGROUND
`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. E.g., Ex-2145, ¶¶
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`40-49; Ex-2151, ¶4; Ex-2215, ¶¶ 3-6. This was because when interventional
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`cardiology devices encountered a complex lesion or a tortuous anatomy, it
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`generated a back-force that tended to cause the guide catheter to “back out” of the
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`coronary artery. Ex-2145, ¶¶ 41-42; ; Ex-2215, ¶¶ 3-6; Ex-2138, ¶¶ 57-59. Over
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`the course of almost 15 years, various products and “tips and tricks” were
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`developed to try to address this, but nothing really solved the problem. E.g., Ex-
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`2145, ¶¶ 50-66; Ex-2215, ¶¶ 9-19; Ex-2151, ¶¶ 5-8; Ex-2138, ¶¶60-68.
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`It wasn’t until late 2004 and into 2005 when VSI’s founder Howard Root,
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`and three other VSI employees invented GuideLiner that someone finally came up
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`with a simple, elegant solution that, for the first time, really solved the backup
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`support issue. Ex-2145, ¶¶ 67-71, 76-82; Ex-2215, ¶¶ 2, 7-9, 20-; Ex-2151, ¶¶ 9-
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`17; Ex-2138, ¶¶ 69, 73-82, 214-216. In GuideLiner, Mr. Root and his team
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`invented a device with “rapid exchange” functionality that could still deliver the
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`full array of interventional cardiology devices (including stents) through a distal
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`tubular portion located deep within a guide catheter, all while providing increased
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`backup support. Id.
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`GuideLiner succeeded beyond the inventors’ wildest expectations. For
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`physicians, GuideLiner enabled catheter-based treatment of coronary stenoses that
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`previously had been untreatable, and did so in a way that was safer, more efficient
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`and more predictable than existing products and techniques. E.g., Ex-2145, ¶¶ 67-
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`71, 76-82 (Decl. of Dr. Graham); Ex-2215, ¶¶ 2, 7-9, 20-29 (Decl. of Dr.
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`Thompson); Ex-2151, ¶¶ 9-17 (Decl. of Dr. Azzalini). GuideLiner quickly became
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`VSI’s flagship product and created a new product category called “guide extension
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`catheters.” GuideLiner has become one of the most successful specialty catheters
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`ever for cardiac intervention, having been used in more than one million
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`procedures across at least 62 countries since its introduction in 2009. Even today,
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`many physicians refer to VSI as “the GuideLiner company.”
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`III. THE ’032 PATENT
`Mr. Root and his team sought patent protection for their inventions. The
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`’032 patent is one of a family of patents that eventually issued covering the
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`GuideLiner technology. The ’032 patent is directed to a coaxial guide catheter
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`(also referred to as a “guide extension catheter”) that is passed through the lumen
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`of a guide catheter, advanced beyond the distal end of the guide catheter, and
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`inserted into a branch artery of the aorta to facilitate delivery of stents, balloon
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`angioplasty catheters and other interventional cardiology devices. Ex-1401 at
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`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 6:9-10 and Figs. 1, 4, 20-22. Ex-2138, ¶¶ 93-94. Figure 1 shows an
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`embodiment of the invention; Figure 9 (color added) illustrates how the guide
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`extension catheter 12 (orange with blue tip) is inserted past the end of the guide
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`catheter and deep into the coronary artery:
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`Ex-1401, Figs. 1, 9; Ex-2138, ¶¶ 96-98. An important advantage of the design is it
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`reduces the available space to deliver interventional cardiology devices only
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`slightly—by no more than one French size smaller than the guide catheter in the
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`preferred embodiment. Id. at 3:1-20.
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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 a
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`proximal opening in a distal tubular portion while the guide extension catheter is
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`located inside a guide catheter. E.g. Ex-1401, Abstract, 8:18-32; Ex-2138, ¶¶ 96-
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`98. To that end, a proximal portion of the device 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; see also id. at 6:41–51 (red arrows added). This structure forms an
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`opening that directs the interventional device—in a proximal to distal direction as
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`indicated by the red arrow annotation—into the tubular portion. Ex-2138, ¶ 95.
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`An exemplary claim—claim 1—is provided below:
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`1. A device for use with a standard guide catheter, the
`standard 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
`a 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 lumen to the branch
`artery, the device comprising:
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` a
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` flexible tip portion defining a tubular structure 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 sized to be insertable through the cross-
`sectional inner diameter of the continuous lumen of the
`guide catheter and defining a coaxial lumen having a
`cross-sectional inner diameter throu