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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 IPR2020-00132
`Patent RE 45,760
`
`
`
`
`
`
`
`
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`
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`
`
`
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`PATENT OWNER RESPONSE
`
`
`

`

`TABLE OF CONTENTS
`
`
`INTRODUCTION ........................................................................................... 1
`I.
`II. BACKGROUND ............................................................................................. 2
`III. PERSON OF ORDINARY SKILL IN THE ART .......................................... 9
`IV. PETITIONER HAS NOT SHOWN THAT CLAIMS 32 AND 39 OF
`THE ’760 PATENT ARE INVALID .............................................................. 9
`A. GROUND 2: Petitioner Fails to Show that Claims 32 and 39 Are
`Obvious in View of Itou, Ressemann, and the Knowledge of a
`POSITA ................................................................................................. 9
`1.
`Itou (Ex-1007) ............................................................................. 9
`2. Ressemann (Ex-1008) ...............................................................11
`3. Claim 32 ....................................................................................17
`a. A POSITA Would Not Be Motivated to Add
`Ressemann’s Support Collar to Itou’s Proximal
`Opening to Create a Segment Defining the Side
`Opening Having “at least two inclined slopes” ..............17
`i.
`A POSITA Would Not Be Motivated to Modify
`Itou Based on Ressemann’s Fundamentally
`Different Embolic Protection Device ...................19
`ii. Ressemann Undisputedly Does Not Disclose a
`Device with a Segment Defining a Side Opening
`that Includes “at least two inclined slopes” .........22
`iii. The So-Called “Incline #1 in Ressemann’s
`Support Collar Serves No Purpose in
`Ressemann ............................................................29
`iv. The Purported “Motivations” Are Unsupported
`and Hindsight-Driven ...........................................31
`
`ii
`
`

`

`c.
`
`2.
`
`b.
`
`Even if a POSITA Was Motivated to Combine Itou
`and Ressemann, the Resulting Combination Would
`Not Work and/or Would Not Satisfy the Claim
`Language .........................................................................38
`Petitioner Fails to Show that the Itou/Ressemann
`Combination Would Result in the “not more than
`one French size smaller” Limitation ...............................43
`4. Claim 39 ....................................................................................45
`B. GROUND 3: The Petition Does Not Show that Challenged
`Claim 32 Is Obvious In View of Itou, Kataishi, and the
`Knowledge of a POSITA ....................................................................49
`1. Kataishi (Ex-1025) ....................................................................49
`2.
`Petitioner’s Arguments Based on Kataishi’s Distal
`Opening are Unsupported .........................................................51
`C. GROUND 4: The Petition Does Not Show that Claim 32 Is
`Obvious in View of Itou, Enger, and the Knowledge of a
`POSITA ...............................................................................................53
`1.
`Enger Does Not Show an Opening with Two Inclined
`Slopes ........................................................................................54
`Petitioner’s Proffered Motivation to Combine Is
`Fundamentally Flawed ..............................................................57
`D. The Repeated Copying of GuideLiner’s Complex Side Opening
`Supports the Conclusion that Challenged Claim 32 Was Not
`Obvious................................................................................................60
`1. Boston Scientific and QXMédical Copied Version 1 of
`GuideLiner ................................................................................61
`Petitioner Medtronic Copied Version 3 of GuideLiner ............64
`2.
`E. THE PETITION SHOULD BE DENIED BECAUSE INTER
`PARTES REVIEW IS UNCONSTITUTIONAL ...............................68
`V. CONCLUSION ...................................................................................................68
`
`iii
`
`

`

`CERTIFICATE OF WORD COUNT COMPLIANCE ...........................................70
`CERTIFICATION OF SERVICE............................................................................71
`
`
`
`
`
`
`
`iv
`
`

`

`TABLE OF AUTHORITIES
`
`
`Cases
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019) ............................................................................67
`In re Anova Hearing Labs, Inc.,
`809 F. App'x 840 (Fed. Cir. 2020) ........................................................................35
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2014) ...............................................61
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) ..........................................................................................67
`Personal Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ..............................................................................41
`Securus Techs., Inc. v. Glob. Tel*Link Corp.,
`701 F. App'x 971 (Fed. Cir. 2017) ........................................................................52
`Stryker Corp. v. Intermedics Orthopedics, Inc.,
`96 F.3d 1409 (Fed. Cir. 1996) ..............................................................................65
`Stryker Corp. v. Karl Storz Endoscopy America, Inc.,
`IPR2015-00764, Paper 13 (PTAB Sept. 2, 2015) .................................................35
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ............................................................................60
`
`
`
`v
`
`

`

`TABLE OF EXHIBITS
`
`Descri I tion
`
`2001
`
`Reserved
`
`2002 Gre 1 1 Sutton Lab Notebook
`
`2003 Memo Regarding Market Feasibility for the GuideLiner catheters
`— PROTECTIVE ORDER MATERIAL
`
`2004 Howard Root Notes
`
`2005
`
`Pro'ect S end Re n 01’:
`
`2006
`
`Invoice from MicroGrou n
`
`2007
`
`Invoice from MicroGrou n
`
`2008
`
`2009
`
`Invoices fi'om Medical Profiles & En1ineerin1
`
`Invoice from MicroGrou
`
`Invoice from Mountain Machine, Inc.
`2010
`
`2011
`Invoice from Medical Engineering & Design Inc.
`2012
`Reserved
`
`
`
`2013
`
`Sales Order from SPECTRA] tics
`
`2014
`
`Photos of Com . onent of GuideLiner Proto p e
`
`2015 Howard Root Deposition Transcript — PROTECTIVE ORDER
`MATERIAL
`
`2016
`
`Invoice from Medtronic
`
`2017 Memo Regarding Market Feasibility for the GuideLiner catheters
`— PROTECTIVE ORDER MATERIAL
`
`2018
`
`PowerPoint presentation titled “New Products on the Horizon”
`— PROTECTIVE ORDER MATERIAL
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`Redacted, Exce ted Fax to Patterson Law Firm
`
`Sales Order and Invoice from SPECTRA]
`
`ics
`
`Invoice from Medical En 1ineerin 1 & Desi 1
`
`Comuterized Desi Drawin1 of a GuideLiner
`
`Redacted Client/Matter Form from Patterson Law Firm
`
`2024
`
`Product Re . uirements: GuideLiner Catheter S stem
`
`2025
`
`Clinical Technical Re o ort
`
`2026
`
`Invoice from MicroGrou
`
`2027
`
`2028
`2029
`
`2030
`
`Invoice from Johnson Matthe Inc Sha e Memo A lications, Inc.
`
`Invoice from SPECTRAlytics
`Invoices from Medical Profiles & En1ineerin1
`
`Invoice from Automation & Metrolo 3 Inc.
`
`2031
`
`Invoice from Automation & Metrolo 3 Inc.
`
`vi
`
`

`

`Invoice from Farlow’s Scientific Glassblowing, Inc.
`2032
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`3033
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`2034
`Invoice from Farlow’s Scientific Glassblowing, Inc.
`2035
`2036 Research and Development Update July 2005 – PROTECTIVE ORDER
`MATERIAL
`2037 Exhibit BB to Declaration of Lora M. Friedemann in Opposition to
`Plaintiffs’ Motion for Preliminary Injunction – PROTECTIVE ORDER
`MATERIAL
`2038 Exhibit 36 to the Declaration of Kurt J. Niederlueke in Opposition to
`Plaintiffs’ Motion for Preliminary Injunction – PROTECTIVE ORDER
`MATERIAL
`2039 Declaration of Deborah Schmalz
`2040 Weekly Staff Meeting Memorandum
`2041 Business Update Section of Materials Presented to the Vascular
`Solutions Board of Directors October 2005 – PROTECTIVE ORDER
`MATERIAL
`2042 Declaration of Peter Keith
`2043 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Under Seal), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 78 –
`PROTECTIVE ORDER MATERIAL
`2044 Declaration of Amy Welch In Support of Plaintiffs’ Motion for
`Preliminary Injunction (Redacted), Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 79
`2045 Plaintiffs’ Second Supplemental Objections and Response to
`Defendants’ Interrogatory No. 7 Concerning Preliminary Injunction
`Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.) – PROTECTIVE ORDER MATERIAL
`2046 Declaration of Howard Root in Support of Plaintiff’s Motion for
`Preliminary Injunction, Vascular Solutions, Inc. v. Boston Scientific
`Corporation, 13-cv-01172 (JRT-SER) (D. Minn), Dkt. 12
`[Reserved]
`2047
`2048 Defendants’ Opposition to Plaintiffs’ Motion for Preliminary Injunction
`(Redacted), Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-
`PJS-TNL (D. Minn.), Dkt. 104
`2049 Amended Pretrial Scheduling Order, Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 229
`
`vii
`
`

`

`2050 Defendants’ Second Amended Notice of Deposition of Peter Keith,
`Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D.
`Minn.)
`2051 Defendants’ Amended Notice of Deposition of Amy Welch, Vascular
`Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2052 Drawings Submitted with Ressemann U.S. Patent App. 10/214,712
`2053 Defendants’ Interrogatories to Plaintiffs Concerning Preliminary
`Injunction Issues, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-
`01760-PJS-TNL (D. Minn.)
`2054 Defendants’ Requests for Production of Documents Concerning
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`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
`
`viii
`
`

`

`2075
`
`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 Declaration of Howard Root in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC v. Medtronic, Inc., 19-
`cv-01760-PJS-TNL (D. Minn.), Dkt. 189 – PROTECTIVE ORDER
`MATERIAL
`Joint Rule 26(f) Report (Patent), Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 17
`2076 Defendants’ Rule 30(b)(6) Notice of Deposition of Plaintffs on
`Preliminary Injunction Issues, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2077 Email withdrawing Defendants’ Rule 30(b)(6) Notice of Deposition
`2078 Defendants’ Answer and Defenses to Plaintiffs’ First Amended and
`Supplemental Complaint and Second Amended Counterclaims Against
`Plaintiffs, Vascular Solutions LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL (D. Minn.), Dkt. 233
`2079 Exhibit A to Defendants’ Answer and Defenses to Plaintiffs’ First
`Amended and Supplemental Complaint and Second Amended
`Counterclaims Against Plaintiffs, Vascular Solutions LLC v. Medtronic,
`Inc., 19-cv-01760-PJS-TNL (D. Minn.), Dkt. 233-1
`[Reserved]
`2080
`[Reserved]
`2081
`2082 Plaintiffs’ Notice of Deposition of Barry O’Connell, Vascular Solutions
`LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2083 Plaintiffs’ Notice of Deposition of Chris Eso, Vascular Solutions LLC v.
`Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2084 Plaintiffs’ Notice of Deposition of Mark Cardoso, Vascular Solutions
`LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.)
`2085 Exhibit introduced at depositions of Stephen J.D. Brecker and Richard
`A. Hillstead – Ressemann Figure 16D, Annotated
`2086 Exhibit introduced at depositions of Stephen J.D. Brecker and Richard
`A. Hillstead – Ressemann Cross-Section A-A Drawing, Annotated
`2087 Declaration of Joseph W. Winkels in Support of Patent Owner’s
`Unopposed Motion for Pro Hac Vice Admission
`
`ix
`
`

`

`2088 Declaration of Peter M. Kohlhepp in Support of Patent Owner’s
`Unopposed Motion for Pro Hac Vice Admission
`Invoice and Purchase Orders from Medical Engineering & Design, Inc.
`2089
`Invoices from Farlow’s Scientific Glassblowing, Inc.
`2090
`Invoices and Certificate of Compliance from MicroGroup, Inc.
`2091
`Invoice and Purchase Orders from Medical Engineering & Design, Inc.
`2092
`Invoices and Packing Slip from Automation & Metrology, Inc.
`2093
`Invoices and Certificate of Compliance from MicroGroup, Inc.
`2094
`2095 SPECTRAlytics Certificates of Completion
`2096
`Invoice from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2097
`Invoices from Farlow’s Scientific Glassblowing, Inc.
`2098 Patterson, Thuente, Skaar & Christensen, P.A.’s Privilege Log
`2099 VSI Planned Production Development Projects
`2100 Vascular Solutions, Inc. 2006 Strategic Objectives (Redacted)
`2101
`Invoice from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2102 Redacted, Excerpted Fax to Patterson Law Firm
`2103
`Invoice from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2104
`Invoices from Vita Needle Company
`2105 Vascular Solutions, Inc. Budget to Actual Variances (Redacted)
`2106
`Invoices and Packing Lists from LSA
`2107
`Invoices and Certificate of Completion from The MicroGroup, Inc.
`2108
`Invoices and Packing Lists from LSA
`2109 GuideLiner Team Meeting Agenda
`2110
`Invoices and Certificate of Completion from The MicroGroup, Inc.
`2111 SPECTRAlytics Certificates of Completion
`2112
`Invoices from Farlow’s Scientific Glassblowing, Inc.
`2113 Engineering Drawings
`2114 Engineering Drawing
`2115 Engineering Drawings
`2116 Deposition Transcripts of Stephen J.D. Brecker, M.D. dated August 11,
`2020 and September 14, 2020
`Invoices from Patterson, Thuente, Skaar & Christensen, P.A. (Redacted)
`2117
`2118 Declaration of Howard Root Submitted in Connection with Patent
`Owner’s Responses
`2119 Declaration of Gregg Sutton
`2120 Declaration of Mark Goemer
`2121 Declaration of Amanda O’Neil
`2122 Declaration of Steve Erb
`
`x
`
`

`

`2123 Declaration of Peter Keith Regarding Conception and Reduction to
`Practice Submitted in Connection with Patent Owner’s Responses
`2124 Declaration of Peter Keith in Support of Motions to Amend
`2125
`[Reserved]
`2126
`[Reserved]
`2127 Memo Regarding Market Feasibility for the GuideLiner catheters
`(Redacted)
`2128 Memo Regarding Market Feasibility for the GuideLiner catheters
`(Redacted)
`2129 PowerPoint presentation titled “New Products on the Horizon”
`(Redacted)
`2130 Research and Development Update July 2005 (Redacted)
`2131 Vascular Solutions, Inc. 2006 Strategic Objectives (Redacted)
`2132 Research & Development Update – July 2008 (Redacted)
`2133 Business Update Section of Materials Presented to the Vascular
`Solutions Board of Directors October 2005 (Redacted)
`2134 Vascular Solutions, Inc. Research & Development Update – January
`2006 (Redacted)
`2135 Mozid, et al., “The Utility of a Guideliner™ Catheter in Retrograde
`Percutaneous Coronary Intervention of a Chronic Total Occlusion With
`Reverse CARD – The “Capture” Technique,” Catheterization and
`Cardiovascular Interventions, pp. 929-932 (2004)
`2136 Candilio, et al., “Subadventitial Advancement of a Mother-and-Child
`Catheter to Allow Successful Recanalization of a Complex In-Stent
`Chronic Total Occlusion: Testing the Resistance of the Adventitia,” J.
`Invasive. Cardiol, E190-E194 (2017)
`2137 Deposition Transcripts of Richard A. Hillstead, Ph.D. dated September
`11, 2020 and September 15, 2020
`2138 Declaration of Peter T. Keith
`2139 Engineering Drawings – PROTECTIVE ORDER MATERIAL
`2140 Engineering Drawings – PROTECTIVE ORDER MATERIAL
`2141 Engineering Drawings – PROTECTIVE ORDER MATERIAL
`2142 GuideLiner® Catheter Instructions for Use
`2143 GuideLiner® V2 Catheter Instructions for Use
`2144 GuideLiner® V3 Catheter Instructions for Use
`2145 Declaration of Dr. John J. Graham, MB ChB, MRCP (UK)
`2146 Boyle, et al., “Catheter-induced coronary artery dissection: Risk factors,
`prevention and management,” J. Invasive. Cardiol., pp. 500-503 (2006)
`
`xi
`
`

`

`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
`[Reserved]
`2153
`[Reserved]
`2154
`[Reserved]
`2155 GuideLiner Brochure 2009
`2156 GuideLiner Brochure 2010
`2157 GuideLiner Brochure 2011
`2158 GuideLiner Brochure 2012
`2159 GuideLiner Brochure 2013
`2160 GuideLiner Brochure 2014
`2161 GuideLiner Brochure 2015
`2162 GuideLiner Brochure 2016
`2163 GuideLiner Brochure 2017
`2164 GuideLiner Brochure 2018
`2165 GuideLiner Brochure 2019
`2166 Eddin, et al., “Transradial interventions with the GuideLiner catheter:
`Role of proximal vessel angulation,” Cardiovascular Revascularization
`Medicine, 14 (2013) 275–279
`2167 Moscucci, Mauro, editor. Grossman & Baim’s Cardiac Cathererization,
`Angiography, and Intervention. 8th Ed., Lippincott Williams & Wilkins,
`2014
`2168 Kovacic, et al., “GuideLiner Mother-and-Child Guide Catheter
`Extension: A Simple Adjunctive Tool in PCI for Balloon Uncrossable
`Chronic Total Occlusions,” J. of Interventional Cardiol., Vol 26, No. 4,
`2013, 343-350
`de Man, et al., “Usefulness and safety of the Guideliner catheter to
`enhance intubation and support of guide catheters: insights from the
`Twente Guideliner registry,” EuroIntervention 8 (2012) 336-344
`
`2169
`
`xii
`
`

`

`2170 Unzué, et al., “The GuideLiner® Catheter in Complex Coronary
`Interventions,” Scientific letters / Rev Esp Cardiol. 2012;65(5):479–488
`2171 Park, et al., “Guideliner Microcatheter to Improve Back-Up Support
`During a Complex Coronary Stenting Procedure Through a Tortuous
`Left Internal Mammary Graft,” J. Invasive Cardiol. 2012;24(4):E77-E79
`2172 Roth et al., “Rapid-Exchange Guide Catheter Extension for Extending
`the Reach of an AL3 Guide in a Patient with a Long, Dilated Ascending
`Aorta,” Catheterization and Cardiovascular Interventions 80:1218–1220
`(2012)
`2173 Serajian, et al., “Novel Use of a GuideLiner Catheter to Visualize Distal
`LAD After LIMA Anastomosis in Selective Coronary Angiography,” J.
`Invasive Cardiol. 2012;24(2):E30-E31
`2174 Thomas, et al., “Successful Coronary Intervention of Circumflex Artery
`Originating From an Anomalous Left Main Coronary Artery Using a
`Novel Support Catheter: A Case Report and Review of Literature,” J.
`Invasive Cardiol. 2011;23(12):536-539
`2175 Pershad, et al., “GuideLiner Catheter Facilitated PCI – A Novel Device
`with Multiple Applications,” J. Invasive Cardiol. 2011;23(11): E254-
`E259
`2176 Cola, et al., “The GuidelinerTM Catheter for Stent Delivery in Difficult
`Cases: Tips and Tricks,” J. of Interventional Cardiol., Vol. 24, No. 5,
`2011, pp 450-461
`2177 Moynagh, et al., “Angiographic Success and Successful Stent Delivery
`for Complex Lesions Using the GuideLiner™ Five-in-six System- A
`Case Report,” Am Heart Hosp J. 2011;9(1):44–7
`2178 Hanna, et al., “Use of the GuideLiner Catheter for the Treatment of a
`Bifurcational Total Occlusion of the Native Left Anterior Descending
`Artery through a Tortuous Composite Venous Graft,” J. Invasive
`Cardiol. 2011; 23(3):E40-E42
`2179 Mamas, et al., “Distal Stent Delivery with Guideliner Catheter: First in
`Man Experience,” Catheterization and Cardiovascular Interventions,
`76:102–111 (2010)
`2180 Rao, et al., “The GuideLiner™ “child” catheter,” EuroIntervention,
`2010;6:277-279
`2181 GuideLiner Clinical Case information titled “Contemporary Chronic
`Total Occlusion Percutaneous Coronary Intervention: GuideLiner
`Catheter and R350 Guidewire Facilitated Reverse-Cart”
`2182 GuideLiner Clinical Case information titled “Use of GuideLiner Catheter
`to Reduce Contrast in Patients with Renal Insufficiency”
`
`xiii
`
`

`

`2183 GuideLiner Clinical Case information titled “GuideLiner Catheter is
`Useful Both for Support and to Minimize Contrast Load by Super-
`Selective Injections in a High-Risk Chronic Renal Failure Patient”
`2184 GuideLiner Clinical Case information titled “Successful Use of the
`GuideLiner”
`2185 GuideLiner Clinical Case information titled “Complex Primary PCI ST
`Elevation Myocardial Infarction Facilitated by the GuideLiner Catheter”
`2186 GuideLiner Clinical Case information titled “GuideLiner Catheter
`Facilitates Treatment of Calcific Ostial Circumflex Artery Despite
`Severe Retroflexion”
`2187 GuideLiner Clinical Case information titled “The “Child-in-Mother
`Technique: Successful Transradial Use of the GuideLiner Catheter in a
`Heavily Calcified Circumflex Artery:
`2188 GuideLiner Clinical Case information titled “GuideLiner Catheter Used
`for Proximal to Distal Stent Technique”
`2189 GuideLiner Clinical Case information titled “Successful Use of
`GuideLiner Catheter to Treat Sequential Distal Carotid Artery Stenoses”
`2190 GuideLiner Clinical Case information titled “Successful Treatment of
`Heavily Calcified Right Coronary Artery from the Right Radial Artery
`Approach Using the GuideLiner Catheter”
`2191 GuideLiner Clinical Case information titled “Successful Multi-Stent
`Delivery in a Heavily Calcified Right Coronary Artery Using the
`GuideLiner Catherter”
`2192 GuideLiner Clinical Case information titled “Successful Distal Stent
`Delivery Past Multiple Previous Stents Made Possible by the Guideliner
`Catheter”
`2193 GuideLiner Clinical Case information titled “Successful Transradial Use
`of the GuideLiner Catheter to Selectively Treat Severe Disease in the
`LAD”
`2194 Fabris, et al., “Guide extension, unmissable tool in the armamentarium
`of modern interventional cardiology. A comprehensive review,”
`International Journal of Cardiology 222 (2016) 141–147
`[Reserved]
`2195
`Information Disclosure Statement for U.S. Patent App. 14/210,572
`2196
`2197 PowerPoint Presentation titled “Proximal SA Tracker Week 28” –
`PROTECTIVE ORDER MATERIAL
`2198 PowerPoint Presentation titled “GLYDER RX Guide Extension
`Catheter” – PROTECTIVE ORDER MATERIAL
`[Reserved]
`
`2199
`
`xiv
`
`

`

`2200 Guidezilla Guide Extension Catheter 501(k) Summary
`2201 Glyder Team Meeting, June 9th, 2019 – PROTECTIVE ORDER
`MATERIAL
`2202 Email regarding competitive product spend freeze – PROTECTIVE
`ORDER MATERIAL
`2203 Med Device Online: Medtronic to acquire PercuSurge for $225 million
`2204 Medtronic Press Release: Medtronic Launches Telescope ™ Guide
`Extension Catheter to Support Complex Coronary Cases
`2205 Declaration of Heather S. Rosecrans
`2206 Declaration of James Phelan in Opposition to Motion for Preliminary
`Injunction
`[Reserved]
`2207
`2208 Medtronic 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 QXMédical Boosting Catheter website
`2215 Declaration of Dr. Craig Thompson
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`xv
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`I.
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`INTRODUCTION
`The ’760 patent that is the subject of the present IPR is one of the family of
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`patents covering an industry-changing product called GuideLiner. When Patent
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`Owner’s predecessor, Vascular Solutions, Inc. (“VSI”), introduced GuideLiner in
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`2009, it created a new product category called “guide extension catheters.”
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`GuideLiner was the first product that solved the long-felt need for better backup
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`support during the catheter-based treatment of diseased coronary arteries.
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`GuideLiner’s greatly increased backup support and other advantages enabled
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`physicians to treat coronary stenoses previously considered untreatable.
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`The patentability of the claims in the present IPR should be affirmed in their
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`entirety for the simple reason that Itou, the primary reference relied on for all
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`Grounds, is not prior art. As explained in Patent Owner’s Consolidated Response
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`Brief on Conception and Reduction to Practice (Paper No. 39), the inventors
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`conceived of the claimed invention in the late fall of 2004 and reduced it to
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`practice no later than August of 2005, which is prior to the filing date of Itou. This
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`conclusion is corroborated by extensive inventor and non-inventor testimony, as
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`well as dozens of contemporaneous documents.
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`Dependent claim 32, which recites that “the side opening includes at least
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`two inclined slopes,” claims a feature of GuideLiner that both Petitioner Medtronic
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`and infringer-turned-licensee Boston Scientific, among others, copied and
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`1
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`incorporated into their infringing products. Demonstrating the weakness of its
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`position, Medtronic asserts three separate grounds (Grounds 2-4) against claim 32
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`based on three secondary references (Kataishi, Ressemann, and Enger). But
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`contrary to what was asserted in the Petition, Petitioner’s experts now admit that
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`none of those secondary references teach a device with a proximal opening having
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`“at least two inclined regions.” Instead, Petitioner tries to rely on structure that
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`does not define the shape of a proximal opening and has nothing to do with
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`guiding interventional devices into a proximal opening. Petitioner’s arguments are
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`nothing more than a post-hoc hindsight analysis that uses the claim as a roadmap to
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`carefully pick and choose the right features to try to satisfy the claim language.
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`That is the antithesis of obviousness.
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`In view of these overarching issues, and a number of other deficiencies
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`described below, the Petition fails to show that any challenged claim is invalid.
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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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`angioplasty 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, ¶¶ 39-
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`66; Ex-2151, ¶¶ 4-8, 11; Ex-2215, ¶¶ 3-6, 9-19. This was because when an
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`interventional cardiology device encountered a complex lesion or tortuous
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`2
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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. Over the course of almost two decades, various products and
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`“tips and tricks” were developed to try to address this, but nothing solved the
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`problem. Id.
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`VSI was a small Minnesota medical device company working to develop
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`various vascular intervention technologies. In 2004, VSI’s founder, Howard Root,
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`recognized a need for a new type of product that would address the backup support
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`problem while overcoming the drawbacks of the existing options. Ex-2118, ¶¶ 5-
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`14. Beginning in the fall of 2004 and continuing into 2005, Mr. Root, along with
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`three coinventors, conceived of, built and successfully tested working prototypes
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`of the GuideLiner invention. Id., ¶¶ 5-58. In GuideLiner, Mr. Root and his team
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`invented a device that could be extended out the distal end of a traditional guide
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`catheter in order to guide an interventional cardiology device to a lesion deep in
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`the coronary vasculature and provide backup support.
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`GuideLiner succeeded beyond the inventors’ wildest expectations. For
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`physicians, GuideLiner solved the problem of insufficient backup support, and did
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`so in a way that was safer, more efficient and more predictable than existing
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`products and techniques. Ex-2145, ¶¶ 67-82, 239-256; Ex-2151, ¶¶ 9-17; Ex-2215,
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`¶¶ 7, 20-29. GuideLiner quickly became VSI’s flagship product and created a new
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`product category called “guide extension catheters.” GuideLiner has become one
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`of the most successful specialty catheters ever for cardiac intervention, having
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`been used in over a million procedures since its introduction in 2009. Ex-2060 at
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`1. Even today, many physicians refer to VSI as “the GuideLiner company.” Ex-
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`2044, ¶ 12.
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`The ’760 patent is one of a family of patents that issued covering the
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`GuideLiner technology. The ’760 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 and balloon
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`catheters. Ex-1001, Abstract.
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`One of the important benefits of the device disclosed in the ’760 patent is
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`increased “back-up support”—a feature important to countering the “guide catheter
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`backout” problem with complex coronary stenosis that Mr. Root and his team
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`recognized. As the patent teaches, when treating a stenosis, a guide catheter is
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`typically guided into the ostium (opening) of the branch artery to be treated, and a
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`guidewire is advanced into the artery beyond the stenosis. Id., 1:59-65. Below is
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`Figure 7 of the patent (color added), showing a typical guide catheter 56 (pink)
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`inserted into the ostium 60 of a coronary artery, with a guidewire 64 passing
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`through the guide catheter and attempting to cross a stenotic lesion 66:
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`4
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`Id., 7:56-8:3. When the wire or an interventional cardiology device such as a stent
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`or balloon catheter encounters a difficult or complex lesion, advancing it across the
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`lesion can create backward force strong enough to dislodge the guide catheter’s
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`distal end from the ostium. Id., 1:65-67; 5:4-13. The phantom guide catheter
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`(yellow) in Figure 7 shows how backward force generated by the advancing device
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`can cause the guide catheter to dislodge from the ostium.
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`The ’760 patent addresses this problem by providing a guide extension
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`catheter that provides increased backup support for guide catheters inserted into a
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`coronary artery. Id., 1:37-41. Figure 9 (color added), below, illustrates how the
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`guide extension catheter 12 (orange with blue tip) is inserted past the end of guide
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`catheter and deep into the coronary artery:
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`5
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`Not only does the guide extension catheter help guide interventional cardiology
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`devices closer to the desired location (e.g., a blockage or lesion); it also reduces the
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`tendency of the guide catheter (pink) to back out of the ostium when the operator
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`increases the pressure on the proximal end of a wire or a stent or balloon delivery
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`catheter to advance it across a lesion.
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`The guide extension catheter is designed to facilitate the insertion of
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`interventional cardiology devices,