`
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`MEDTRONIC, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`
`Case No.: IPR2020-01343
`U.S. Patent No. RE 46,116
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE 46,116
`
`
`
`90839775.1
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`IPR2020-01343
`Patent RE 46,116
`
`
`TABLE OF CONTENTS
`
`Page
`PRELIMINARY STATEMENT .................................................................... 1
`I.
`II. MANDATORY NOTICES (37 C.F.R. § 42.8) .............................................. 5
`A.
`Real Party-in Interest ............................................................................ 5
`B.
`Related Matters ..................................................................................... 5
`C.
`Lead and Backup Counsel .................................................................... 7
`D.
`Service Information .............................................................................. 8
`III. REQUIREMENTS FOR INTER PARTES REVIEW ................................... 8
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a) ............................ 8
`B.
`Precise Relief Requested and Asserted Grounds ................................. 8
`IV. BACKGROUND ............................................................................................ 9
`A. Overview of the Technology ................................................................ 9
`B.
`The ’116 Patent .................................................................................. 10
`C.
`Priority Date ....................................................................................... 12
`THE PERSON OF ORDINARY SKILL IN THE ART .............................. 13
`V.
`VI. CLAIM CONSTRUCTION ......................................................................... 14
`A.
`“flexural modulus” (cl. 48) ................................................................. 15
`VII. THE BOARD SHOULD NOT DECLINE TO INSTITUTE UNDER
`35 U.S.C. §314(A). ....................................................................................... 15
`VIII. PRIOR ART .................................................................................................. 16
`A.
`Ressemann .......................................................................................... 16
`B.
`Itou ...................................................................................................... 19
`C. Kataishi ............................................................................................... 21
`IX. GROUND 1: RESSEMANN ANTICIPATES CLAIMS 52 AND 53. ........ 23
`A.
`Claim 52 ............................................................................................. 23
`[52.A] ....................................................................................... 23
`1.
`[52.B] ....................................................................................... 24
`2.
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`[52.C] ....................................................................................... 27
`3.
`[52.D] ....................................................................................... 28
`4.
`Claim 53: ............................................................................................ 31
`B.
`X. GROUND 2: ITOU RENDERS CLAIMS 25-40, 42, 44-48, 52 AND
`53 OBVIOUS IN VIEW OF RESSEMANN AND THE COMMON
`KNOWLEDGE OF A POSITA. ................................................................... 32
`A.
`Claim 25 ............................................................................................. 32
`[25.A] ....................................................................................... 32
`1.
`[25.B] ....................................................................................... 33
`2.
`[25.C] ....................................................................................... 38
`3.
` [25.D] ...................................................................................... 39
`4.
`Claim 26. ............................................................................................ 47
`B.
`Claim 27 ............................................................................................. 49
`C.
`Claim 28. ............................................................................................ 51
`D.
`Claim 29 ............................................................................................. 52
`E.
`Claim 30 ............................................................................................. 53
`F.
`Claim 31 ............................................................................................. 53
`G.
`Claim 32 ............................................................................................. 54
`H.
`Claim 33. ............................................................................................ 55
`I.
`Claim 34 ............................................................................................. 55
`J.
`Claim 35. ............................................................................................ 56
`K.
`Claim 36. ............................................................................................ 56
`L.
`M. Claim 37. ............................................................................................ 59
`N.
`Claim 38. ............................................................................................ 60
`O.
`Claim 39 ............................................................................................. 60
`P.
`Claim 40 ............................................................................................. 62
`Q.
`Claim 42 ............................................................................................. 62
`R.
`Claim 44. ............................................................................................ 63
`S.
`Claim 45 ............................................................................................. 64
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`Claim 46. ............................................................................................ 67
`T.
`Claim 47 ............................................................................................. 69
`U.
`Claim 48 ............................................................................................. 72
`V.
`W. Claim 52 ............................................................................................. 73
`[52.A] ....................................................................................... 73
`1.
`[52.B] ....................................................................................... 73
`2.
`[52.C] ....................................................................................... 73
`3.
`[52.D] ....................................................................................... 73
`4.
`Claim 53. ............................................................................................ 74
`X.
`XI. GROUND 3: ITOU RENDERS CLAIM 45 OBVIOUS IN VIEW OF
`RESSEMANN, KATAISHI AND THE COMMON KNOWLEDGE
`OF A POSITA. ............................................................................................. 74
`XII. ANY ARGUMENT BY PATENT OWNER OF AN EARLY
`CONCEPTION AND REDUCTION TO PRACTICE DATE
`SHOULD NOT PRECLUDE INSTITUTION ............................................. 77
`XIII. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ............. 78
`XIV. CONCLUSION ............................................................................................. 80
`XV. PAYMENT OF FEES (37 C.F.R. § 42.103) ................................................. 80
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`Patent RE 46,116
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Aerospace, Inc.,
`IPR2017-01275, Paper 12 (P.T.A.B. Oct. 31, 2017) .......................................... 79
`Arctic Cat, Inc. v. Polaris Industries Inc.,
`IPR2017-00433, Paper 17 (P.T.A.B. July 5, 2017) ............................................ 79
`Boston Scientific Corp. v. Vascular Solutions, Inc.,
`IPR2014-00762, IPR2014-00763 (P.T.A.B., terminated Aug. 11,
`2014) ..................................................................................................................... 6
`Lowe’s, Cos., Inc. v. Nichia Corp.,
`IPR2017-02011, Paper 13 (P.T.A.B. Mar. 12, 2018) ......................................... 79
`Mylan Pharms. Inc. v. Boehringer Ingelheim Pharms. Inc.,
`IPR2016-01563, Paper 14, 4 (PTAB Dec. 7, 2016) ........................................... 77
`Petroleum Geo-Services Inc. v. W. Geco LLC,
`IPR2014-01477, Paper 18 (P.T.A.B. Mar. 17, 2015) ......................................... 79
`QXMedical, LLC v. Vascular Solutions, LLC,
`No. 17-cv-01969 (D. Minn., filed June 8, 2017) .........................................passim
`Vascular Solutions, Inc. v. Boston Scientific Corp.,
`No. 13-cv-01172 (D. Minn., filed May 16, 2013) ................................................ 6
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al.,
`No. 19-cv-01760 (D. Minn., filed July 2, 2019) ................................................... 6
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 80
`Statutes
`35 U.S.C. § 102 .................................................................................................... 5, 80
`35 U.S.C. § 103 .................................................................................................... 5, 80
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`
`35 U.S.C. § 314(A) .................................................................................................. 15
`Other Authorities
`37 C.F.R. pt. 42 ........................................................................................................ 80
`37 C.F.R. § 42.8 ......................................................................................................... 5
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 5
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 5
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 7
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 8
`37 C.F.R. § 42.15(a) ................................................................................................. 80
`37 C.F.R. § 42.100(b) .............................................................................................. 14
` 37 C.F.R. § 42.103 .................................................................................................. 80
`37 C.F.R. § 42.104 ..................................................................................................... 8
`37 C.F.R. § 42.104(a) ................................................................................................. 8
`McGraw-Hill Dictionary of Scientific and Technical Terms .................................. 15
`MPEP § 2159.02 ...................................................................................................... 12
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`
`EXHIBIT LIST
`
`
`Exhibit Description
`1001 U.S. Patent No. RE 46,116 (“the ’116 patent”)
`1002
`File history for U.S. Patent No. 8,292,850
`1003
`File history for U.S. Patent No. RE 46,116
`1004 Assignment record of the ’116 patent from the USPTO assignment
`database
`1005 Declaration of Doctor Stephen JD Brecker, M.D.
`1006 Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1007 U.S. Patent No. 7,736,355 (“Itou”)
`1008 U.S. Patent No. 7,604,612 (“Ressemann”)
`1009 U.S. Patent No. 5,439,445 (“Kontos”)
`1010 New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions
`63: 452-456 (2004) (“Takahashi”)
`Excerpt of prosecution history of U.S. Patent No. 8,048,032
`(Application 11/416,629) (Amendment and Response, April 6, 2009)
`Joint Claim Construction Statement in QXMedical, LLC v. Vascular
`Solutions, Inc., D. Minn., No. 17-cv-01969 (January 10, 2018), D.I.
`36; D.I. 36-1.
`1013 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1014 Meads, C., et al., Coronary artery stents in the treatment of ischaemic
`heart disease: a rapid and systematic review, Health Technology
`Assessment 2000 4(23) (“Meads”)
`Excerpt from Grossman’s Cardiac Catheterization, Angiography, and
`Intervention (6th edition) (2000) (chapters 1, 4, 11, 23-25).
`1016 US Patent Publication 2003/0233117 (“Adams ’117”)
`1017 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1011
`
`1012
`
`1015
`
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`

`1021
`
`IPR2020-01343
`Patent RE 46,116
`
`Exhibit Description
`1018 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1019 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1020 Mehan, Coronary Angioplasty through 4 French Diagnostic
`Catheters, Catheterization and Cardiovascular Interventions 30:22-26
`(1993) (“Mehan”)
`Excerpt of prosecution history for application 11/232,876 (Office
`Action, 6/20/09)
`1022 Cordis, Instructions for Use, CYPHER™ (April 2003)
`1023 Medtronic, Summary of Safety and Effectiveness Data, Driver™
`Coronary Stent System (October 1, 2003)
`1024 Boston Scientific, Summary of Safety and Effectiveness Data,
`TAXUS™ Express2™ Drug-Eluting Coronary Stent System (March 4,
`2004)
`1025 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1026 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1027 U.S. Patent No. RE45,776 (“Root”)
`1028 Baim, Randomized Trial of a Distal Embolic Protection Device
`During Percutaneous Intervention of Saphenous Vein Aorto-Coronary
`Bypass Grafts, Circulation 105:1285-1290 (2002) (“Baim”)
`Limbruno, Mechanical Prevention of Distal Embolization During
`Primary Angioplasty, Circulation 108:171-176 (2003) (“Limbruno”)
`1030 U.S. Patent No. 5,413,560 (“Solar ’560”)
`1031
`Schöbel, Percutaneous Coronary Interventions Using a New 5 French
`Guiding Catheter: Results of a Prospective Study, Catheterization &
`Cardiovascular Interventions 53:308-312 (2001) (“Schöbel”)
`The sliding rail system (monorail): description of a new technique for
`intravascular instrumentation and its application to coronary
`angioplasty, Z. Kardio. 76:Supp. 6, 119-122 (1987) (“Bonzel”)
`1033 U.S. Publication Application No. 2004/0236215 (Mihara)
`
`1029
`
`1032
`
`
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`

`1040
`
`IPR2020-01343
`Patent RE 46,116
`
`Exhibit Description
`1034 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1035 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1036 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1037 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1038 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1039 Urban et al., Coronary stenting through 6 French Guiding Catheters,
`Catheterization and Cardiovascular Diagnosis (1993) 28:263-266
`Excerpt of McGraw-Hill Dictionary of Scientific and Technical Terms
`(5th edition) (1994) (defining “flexural modulus”)
`Excerpt from Kern’s The Interventional Cardiac Catheterization
`Handbook (2nd edition) (2004) (chapter 1)).
`1042 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1043 Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1044 U.S. Patent No. 5,961,510 (“Fugoso”)
`1045 U.S. Patent No. 6,199,262 (“Martin”)
`1046 U.S. Patent No. 6,042,578 (“Dinh”)
`1047 WO 97/37713 (“Truckai”)
`1048
`Terumo Heartrail II product literature
`1049 Medtronic Launcher product literature
`1050 U.S. Patent No. 5,980,486 (“Enger”)
`1051 U.S. Patent No. 5,911,715 (“Berg”)
`1052 U.S. Patent No. 5,545,149 (“Brin”)
`1053 U.S. Patent No. 5,720,300 (“Fagan”)
`
`1041
`
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`IPR2020-01343
`Patent RE 46,116
`
`Exhibit Description
`1054 U.S. Patent No. 5,120,323 (“Shockey”)
`1055
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1056 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1057 U.S. Patent No. 5,445,625 (“Voda”)
`1058 U.S. Patent No. 6,595,952 (“Forsberg”)
`1059 U.S. Patent No. 6,860,876 (“Chen”)
`1060 U.S. Patent No. 6,638,268 (“Niazi”)
`1061 U.S. Patent No. 5,690,613 (“Verbeek”)
`1062
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1063 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1064 QXMédical, LLC’s Opening Claim Construction
`Memorandum QXMedical, LLC v. Vascular Solutions, Inc., D. Minn.,
`No. 17-cv-01969 (March 14, 2018), D.I. 56
`1065 U.S. Patent No. 4,000,739 (“Stevens”)
`1066
`EP 0 881 921 B1 (“Lee”)
`1067 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1068 Defendants’ Memorandum in Opposition to Plaintiff’s Summary
`Judgment Motion and in Support of Defendants’ Summary Judgment
`Motion, QXMedical, LLC v. Vascular Solutions LLC et al., 17-cv-
`01969-PJS-TNL (D. Minn 2019)
`Excerpt of prosecution history for application 14/195,435 (Office
`Action, 10/06/15)
`
`1069
`
`
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`1071
`
`IPR2020-01343
`Patent RE 46,116
`
`Exhibit Description
`1070 Metz, Comparison of 6f with 7f and 8f guiding catheters for elective
`coronary angioplasty: Results of a prospective, multicenter,
`randomized trial, American Heart Journal. Vol. 134, Number 1, pp
`132-137 (“Metz”)
`Feldman, Coronary Angioplasty Using New 6 French Guiding
`Catheters, Catheterization and Cardiovascular Diagnosis 23:93-99
`(1991) (“Feldman”)
`1072 U.S. Patent No. 5,704,926 (“Sutton”)
`1073
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`1074 Yokoyama, Feasibility and safety of thrombectomy with TVAC
`aspiration catheter system for patients with acute myocardial
`infarction, Heart Vessels (2006) 21:1–7 (“Yokoyama”)
`[RESERVED]
`1075
`1076 U.S. Patent No. 5,860,963 (“Azam”)
`1077
`10/16/2019 Deposition of Peter Keith in Vascular Solutions, LLC. v.
`Medtronic, Inc., D. Minn., No. 19-cv-01760
`Sylvia Hall-Ellis’s Librarian Declaration
`1078
`1079 Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`1080 U.S. Patent No. 5,061,273 (“Yock”)
`1081 U.S. RE45,380 (“the ’380 patent”)
`1082 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC et al. v. Medtronic,
`Inc., 19:cv-01760-PJS-TNL (July 12, 2019)
`Joint Fed. R. C. P. 26(f) Report [Excerpt], Vascular Solutions LLC et
`al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`Plaintiffs’ Objections and Responses to Interrogatories, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`
`1083
`
`1084
`
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`1089
`1090
`1091
`1092
`1093
`
`IPR2020-01343
`Patent RE 46,116
`
`Exhibit Description
`1085
`[RESERVED]
`1086
`[RESERVED]
`1087
`[RESERVED]
`1088 Preliminary Injunction Order, Vascular Solutions LLC et al. v.
`Medtronic, Inc., 19:cv-01760-PJS-TNL (April 9, 2020)
`[RESERVED]
`[RESERVED]
`[RESERVED]
`[RESERVED]
`Screenshot from Docket Navigator regarding Judge Schiltz's Motions
`to Stay Pending Inter Partes Review
`[RESERVED]
`Plaintiffs’ Infringement Disclosures in Vascular Solutions LLC et al. v.
`Medtronic, Inc., 19:cv-01760-PJS-TNL (March 1, 2020)
`1096 U.S. Patent No. 4,886,507 (“Patton”)
`1097
`Excerpt of Patrick W. Serruys, Handbook of Coronary Stents (4th
`Edition) (2002)
`1098 U.S. Patent No. 5,167,636 (“Clement”)
`1099 U.S. Patent No. 5,897,497 (“Fernandez”)
`1100
`[RESERVED]
`1101
`[RESERVED]
`1102
`[RESERVED]
`1103
`[RESERVED]
`1104
`[RESERVED]
`1105
`[RESERVED]
`1106
`[RESERVED]
`1107
`[RESERVED]
`
`1094
`1095
`
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`1109
`1110
`1111
`1112
`1113
`1114
`
`1115
`
`IPR2020-01343
`Patent RE 46,116
`
`Exhibit Description
`1108
`Ex. 7 of Teleflex Infringement Disclosures and Claim Chart, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL (March
`1, 2020)
`[RESERVED]
`[RESERVED]
`[RESERVED]
`[RESERVED]
`IPR2020-00127 Institution Decision (Paper 20)
`First Amended and Supplemental Complaint, Vascular Solutions LLC
`et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL (February 14, 2020)
`Screenshot showing docket of Motion to Stay Order, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`(February 7, 2020)
`IPR2020-00128 Institution Decision (Paper 22)
`1116
`[RESERVED]
`1117
`1118 Amended Pretrial Scheduling Order, Vascular Solutions LLC et al. v.
`Medtronic, Inc., 19:cv-01760-PJS-TNL (February 7, 2020)
`[RESERVED]
`Plaintiffs’ Reply Brief in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`
`1119
`1120
`
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`IPR2020-01343
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`I. PRELIMINARY STATEMENT
`Medtronic, Inc. (“Petitioner”) requests inter partes review (“IPR”) of claims
`
`25-40, 42, 44-48, 52 and 53 (“Challenged Claims”) of U.S. Pat. No. RE 46,116
`
`(“the ’116 patent,” Ex-1001). The ʼ116 patent—which claims priority to a patent
`
`application filed on May 3, 2006 (Ex-1001, [60])—is entitled Coaxial Guide
`
`Catheter for Interventional Cardiology Procedures and lists Howard Root et al. as
`
`inventors. Id., [54], [72].
`
`The ’116 patent describes a catheter system that reduces the likelihood of a
`
`guide catheter dislodging from the ostium of a coronary artery during the removal
`
`of a coronary stenosis. The purported invention requires a guide catheter (“GC”)
`
`and a guide extension catheter.1 The latter is inserted into and extended beyond the
`
`distal end of the GC (i.e., into a coronary branch artery). Id., Abstract; Figs. 8, 9. In
`
`
`1 Despite claiming a method of using a guide extension catheter, the specification
`
`of the ʼ116 patent is silent regarding the use of a guide extension catheter and
`
`instead references a “coaxial guide catheter.” Ex-1005, ¶ 130. A POSITA would
`
`have recognized that the “coaxial guide catheter” of the ’116 patent is what was
`
`commonly understood as a guide extension catheter because it extends the guide
`
`catheter further into the coronary artery. Id.; see also Ex-1009, 5:49-52 (referring
`
`to body 12 “as a guide catheter extension”).
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`so doing, the guide extension catheter delivers “backup support by providing the
`
`ability to effectively create deep seating in the ostium of the coronary artery,”
`
`thereby preventing the GC from dislodging from the ostium. Ex-1001, 3:12-16;
`
`see also id., 8:33-46; Ex-1005, ¶¶ 72-73.
`
`The ’116 patent admits that the use of a guide extension catheter inside an
`
`outer guide catheter was known. Id., 2:50-62 (describing the use of a “smaller
`
`guide catheter within a larger guide catheter”); Ex-1005, ¶¶ 74-84, 103-04. Indeed,
`
`such a catheter-in-a-catheter assembly was well-known in the art as a “mother-and-
`
`child assembly,” where the child catheter (red in below figure) (i.e., the guide
`
`extension catheter) is essentially a tube that is inserted into and extends beyond the
`
`GC (blue in below figure) (i.e., the mother catheter) into the coronary artery. Id.,
`
`¶ 74.
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`Ex-1054, Fig. 2 (annotation and color added).
`
`The child catheter in the original mother-and-child assembly had a continuous
`
`lumen that was longer than the lumen of the guide (“mother”) catheter. Id. The
`
`’116 patent alleges that such a design had certain drawbacks (Ex-1001, 3:1-11) and
`
`modifies the child catheter of the mother-and-child assembly to have two parts: (i)
`
`a long thin pushrod (ii) coupled to a short distal lumen (i.e., a tube) that is highly
`
`flexible so it can extend deep into the coronary artery..
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`Ex-1001, Fig. 1 (annotations and color added).
`
`But child catheters that served as guide extension catheters and had a short
`
`lumen connected to a long thin pushrod were already well-known in the art, as
`
`evidenced by U.S. Patent No. 7,604,612 (“Ressemann”).
`
`Ex-1008, Fig. 6B (annotations and color added); see, § VIII(A), infra.
`
`It was also evidenced by U.S. Patent No. 7,736,355 (“Itou”) (Ex-Itou).
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`
`Ex-Itou, Fig, 5 (annotations and color added); see, § VIII(B), infra.
`
`For the reasons herein, there is more than a reasonable likelihood that the
`
`Challenged Claims of the ’116 patent are unpatentable. Accordingly, Petitioner
`
`respectfully requests institution of trial and cancellation/invalidation of the
`
`Challenged Claims as unpatentable under 35 U.S.C. §§ 102 and/or 103.
`
`II. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real Party-in Interest
`The real parties-in-interest are Medtronic, Inc. and Medtronic Vascular, Inc.
`
`37 C.F.R. § 42.8(b)(1). Medtronic plc is the ultimate parent of Medtronic, Inc.
`
`B. Related Matters
`
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner identifies that the ’116 patent is
`
`currently the subject of litigation in two separate actions in the U.S. District Court
`
`for the District of Minnesota: (i) Vascular Solutions LLC, et al. v. Medtronic, Inc.,
`
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`90839775.1
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`Patent RE 46,116
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`et al., No. 19-cv-01760 (D. Minn., filed July 2, 2019);2 and (ii) QXMedical, LLC v.
`
`Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017)
`
`(“QXMedical Litigation”).
`
`Further, the ’116 patent is a reissue of U.S. Pat. No. 8,292,850 (“the ʼ850
`
`patent). The ʼ850 patent was previously the subject of litigation (i) in the U.S.
`
`District Court for the District of Minnesota in Vascular Solutions, Inc. v. Boston
`
`Scientific Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013), and (ii) at the
`
`PTAB in Boston Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00762,
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`IPR2014-00763 (P.T.A.B., terminated Aug. 11, 2014).
`
`Petitioner concurrently files another petition for IPR of the ʼ116 patent based
`
`on prior art references having different priority dates and different disclosures than
`
`the references discussed herein.
`
`The ’116 patent shares a common specification and is related to several
`
`patents that, as shown in the table below, Petitioner is currently challenging in IPR:
`
`U.S. Patent No. Status
`IPR No.
`8,048,032
`Trial Instituted
`IPR2020-00126
`8,048,032
`Trial Instituted
`IPR2020-00127
`RE45,380
`Trial Instituted
`IPR2020-00128
`RE45,380
`Trial Instituted
`IPR2020-00129
`RE45,380
`Trial Instituted
`IPR2020-00130
`
`2 The ’116 patent was not originally asserted, but added by Amended Complaint on
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`February 14, 2020. See Ex-1114, 35.
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`
`IPR2020-00132
`IPR2020-00134
`IPR2020-00135
`IPR2020-00136
`IPR2020-00137
`IPR2020-00138
`IPR2020-01341
`IPR2020-01342
`IPR2020-01343
`IPR2020-01344
`
`
`
`RE45,760
`RE45,760
`RE45,776
`RE45,776
`RE47,379
`RE47,379
`8,142,413
`8,142,413
`Re46,116
`Re46,116
`
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Pending
`Pending
`Pending (Present Petition)
`Pending
`
`C. Lead and Backup Counsel
`
`Pursuant to 37 C.F.R. § 42.8(b)(3), Petitioner identifies the following counsel
`
`Back-Up Counsel
`Sharon Roberg-Perez (Reg. No. 69,600)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email: Sroberg-perez@robinskaplan.com
`
`of record:
`
`Lead Counsel
`Cyrus A. Morton (Reg. No. 44,954)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email: Cmorton@RobinsKaplan.com
`Additional Back-Up Counsel
`Christopher A. Pinahs (Reg. No.
`76,375)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email:
`Cpinahs@RobinsKaplan.com
`
`
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`D. Service Information
`Pursuant to 37 C.F.R. § 42.8(b)(4), please direct all correspondence to lead
`
`and back-up counsel at the above addresses. Petitioner consents to electronic
`
`service at the above-identified email addresses.
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Pursuant to 37 C.F.R. §42.104, Petitioner certifies that the ’116 patent is
`
`available for IPR and that Petitioner is not barred or estopped from requesting such
`
`review of the ʼ116 patent on the identified grounds.
`
`B. Precise Relief Requested and Asserted Grounds
`Petitioner respectfully requests review of the ʼ116 patent claims identified
`
`
`
`below and their cancellation as unpatentable in view of the following grounds:3
`
`No.
`
`1
`
`Grounds
`
`Ressemann anticipates claims 52 and 53
`
`
`3 This petition is supported by the Declarations of Dr. Stephen JD Brecker, MD
`
`(Ex-1005), and Dr. Richard A. Hillstead, Ph.D., (Ex-1042), as experts in the field
`
`of the ’116 patent. Petitioner also submits the declaration of Sylvia D. Hall-Ellis,
`
`PhD (Ex-1078) to support the authenticity and public availability of documents
`
`cited herein.
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`No.
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`2
`
`3
`
`Grounds
`
`Itou renders claims 25-40, 42, 44-48, 52 and 53 obvious in view of
`Ressemann and the common knowledge of a POSITA.
`
`Itou renders claim 45 obvious in view of Ressemann, Kataishi and the
`common knowledge of a POSITA
`
`
`IV. BACKGROUND
`A. Overview of the Technology
`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
`
`arterial lumen. Ex-1005, ¶¶ 32-36. This narrowing, sometimes called a stenosis,
`
`restricts blood flow and increases the risk of heart attack or stroke. Id. In response,
`
`physicians developed percutaneous coronary interventional (“PCI”) procedures
`
`that use catheter-based technologies inserted through the femoral or radial artery,
`
`and can treat CAD without the need for open-heart surgery. Id., ¶¶ 33, 38-44.
`
`PCI was developed more than forty years ago, and although its catheter-
`
`based technology has advanced, the basic components of PCI have remained
`
`largely unchanged. Id., ¶¶ 37, 45. During PCI, a physician uses a hollow needle to
`
`gain access to the patient’s vasculature. Id., ¶¶ 38, 46-59. A guidewire is then
`
`introduced into the needle, the needle is removed, and an introducer sheath is
`
`inserted over the guidewire and into the artery. Next, a guide catheter can be
`
`introduced and advanced along the vasculature until its distal end is placed—by a
`
`few millimeters—in the ostium of a coronary artery. Id., ¶¶ 38, 46-59, 64. At the
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`proximal end, a hemostatic valve is coupled to the guide catheter and remains
`
`outside the patient’s body. Id., ¶¶ 39, 58. The hemostatic valve prevents blood from
`
`exiting the patient’s artery and keeps air from entering the bloodstream. Id.
`
`A smaller-diameter, more flexible guidewire can then be threaded through
`
`the lumen of the guide catheter to the target site. Id., ¶¶ 60-62. This guidewire
`
`serves as a guiderail to advance a therapeutic catheter through the guide catheter
`
`and to the occlusion. Id. The guidewire and therapeutic catheter typically must then
`
`be passed through and beyond the occlusion in order to alleviate the stenosis. Id.,
`
`¶¶ 63-69. This last step—crossing the guidewire and therapeutic catheter past the
`
`occlusion—creates the backward force that can dislodge the guide catheter from
`
`the ostium. Id., ¶¶ 70-71. As discussed above, one way to ameliorate this backward
`
`force is to use a mother-and-child catheter assembly where the child catheter acts
`
`as an extension of the guide catheter into the coronary artery.
`
`B. The ’116 Patent
`On its face, the ’116 patent claims priority to May 3, 2006. Ex-1001. The ’116
`
`patent relates “generally to catheters used in interventional cardiology procedures.”
`
`Ex-10