`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`
`Case IPR2020-01341
`U.S. Patent No. 8,142,413
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,142,413
`
`
`
`
`
`
`
`

`

`IPR2020-01341
`Patent 8,142,413
`
`
`TABLE OF CONTENTS
`
`
`Page
`Preliminary Statement .................................................................................... 1 
`I.
`II. Mandatory Notices Under 37 C.F.R. § 42.8 ................................................... 4 
`A.
`Real Party-in-Interest ........................................................................... 4 
`B.
`Related Matters ..................................................................................... 4 
`C.
`Lead and Backup Counsel .................................................................... 6 
`D.
`Service Information .............................................................................. 6 
`III. Requirements for Inter Partes Review ............................................................ 7 
`A. Grounds for Standing ........................................................................... 7 
`B.
`Precise Relief Requested and Asserted Grounds ................................. 7 
`IV. Background ..................................................................................................... 7 
`A. Overview of the Technology ................................................................ 7 
`B. Overview of the ’413 Patent ................................................................. 9 
`Person of Ordinary Skill In The Art ............................................................. 11 
`V.
`VI. Claim Construction ....................................................................................... 12 
`A.
`“interventional cardiology device(s)” (all challenged claims) ........... 13 
`B.
`“standard guide catheter” (all challenged claims) .............................. 14 
`C.
`“placed in a branch artery” (all challenged claims) ........................... 15 
`VII. The Board Should Not Decline To Institute Under 35 U.S.C. § 314(a). ..... 16 
`VIII. Prior Art ........................................................................................................ 17 
`A.
`Itou ...................................................................................................... 17 
`B.
`Ressemann .......................................................................................... 19 
`IX. Ground 1: ITOU ANTICIPATES CLAIMS 1-2, 4, and 7-14. ..................... 21 
`A.
`Claim 1 ............................................................................................... 21 
`1.
`[1.pre.i] ..................................................................................... 21 
`2.
`[1.pre.ii] .................................................................................... 24 
`
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`IPR2020-01341
`Patent 8,142,413
`
`
`TABLE OF CONTENTS
`(continued)
`
`B.
`C.
`D.
`E.
`F.
`G.
`
`Page
`[1.pre.iii] ................................................................................... 26 
`3.
`[1.pre.iv] ................................................................................... 29 
`4.
`[1.a] .......................................................................................... 31 
`5.
`[1.b] .......................................................................................... 33 
`6.
`[1.c] .......................................................................................... 34 
`7.
`[1.d.i] ........................................................................................ 38 
`8.
`[1.d.ii] ....................................................................................... 42 
`9.
`[1.e] .......................................................................................... 45 
`10.
`[1.f] ........................................................................................... 49 
`11.
`Claim 2. .............................................................................................. 52 
`Claim 4. .............................................................................................. 52 
`Claim 7 ............................................................................................... 55 
`Claim 8. .............................................................................................. 58 
`Claim 9. .............................................................................................. 59 
`Claim 10 ............................................................................................. 60 
`[10.pre] ............................................................................................... 60 
`[10.a] .................................................................................................. 60 
`[10.b] ................................................................................................. 60 
`Claim 11 ............................................................................................. 62 
`H.
`Claim 12. ............................................................................................ 65 
`I.
`Claim 13. ............................................................................................ 66 
`J.
`Claim 14 ............................................................................................. 67 
`K.
`X. Ground 2: ITOU RENDERS CLAIMS 1-2, 4-5, and 7-14 OBVIOUS
`IN VIEW OF THE COMMON KNOWLEDGE OF A POSITA. ............... 70 
`A.
`Claim 1 ............................................................................................... 70 
`B.
`Claims 2, 4-5, 7-14 ............................................................................. 75 
`-ii-
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`IPR2020-01341
`Patent 8,142,413
`
`
`TABLE OF CONTENTS
`(continued)
`
`Page
`
`XI. Ground 3: ITOU RENDERS CLAIMS 1-2, 4-5, and 7-14 OBVIOUS
`IN VIEW OF RESSEMANN AND THE COMMON KNOWLEDGE
`OF A POSITA. ............................................................................................. 77 
`A.
`Claim 1 ............................................................................................... 77 
`B.
`Claim 2 ............................................................................................... 83 
`C.
`Claim 4 ............................................................................................... 83 
`D.
`Claim 5 ............................................................................................... 83 
`E.
`Claim 7 ............................................................................................... 85 
`F.
`Claim 8 ............................................................................................... 86 
`G.
`Claim 9 ............................................................................................... 88 
`H.
`Claim 10 ............................................................................................. 90 
`I.
`Claims 11-12 ...................................................................................... 91 
`J.
`Claim 13 ............................................................................................. 93 
`K.
`Claim 14 ............................................................................................. 93 
`XII. Any Argument by Patent Owner of an Early Conception and
`Reduction to Practice Date Should Not Preclude Institution. ...................... 95 
`XIII. Secondary Considerations ............................................................................ 96 
`XIV. Conclusion .................................................................................................... 98 
`
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`-iii-
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`IPR2020-01341
`Patent 8,142,413
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Aerospace, Inc.,
`IPR2017-01275, Paper 12 (P.T.A.B. Oct. 31, 2017) .......................................... 95
`Altiris Inc. v. Symantec Corp.,
`318 F.3d 1363 (Fed. Cir. 2003) .......................................................................... 49
`Arctic Cat, Inc. v. Polaris Industries Inc.,
`IPR2017-00433, Paper 17 (P.T.A.B. July 5, 2017) ............................................ 95
`Boston Scientific Corp. v. Vascular Solutions, Inc.,
`IPR2014-00759 (P.T.A.B., terminated Aug. 11, 2014) ........................................ 6
`Fed. Land Bank of St. Paul v. Bismarck Lumber Co.,
`314 U.S. 95 (1941) .............................................................................................. 31
`Interactive Gift Express, Inc. v. Compuserve Inc.,
`256 F.3d 1323 (Fed. Cir. 2001) .......................................................................... 49
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 73
`Laryngeal Mask Co. v. Ambu, A/S,
`618 F.3d 1367 (Fed. Cir. 2010) .......................................................................... 17
`Legget & Platt, Inc. v. VUTEK, Inc.,
`537 F.3d 1349 (Fed. Cir. 2008) .......................................................................... 20
`Lowe’s, Cos., Inc. v. Nichia Corp.,
`IPR2017-02011, Paper 13 (P.T.A.B. Mar. 12, 2018) ......................................... 95
`Mylan Pharms. Inc. v. Boehringer Ingelheim Pharms. Inc.,
`IPR2016-01563, Paper 14 (PTAB Dec. 7, 2016) ......................................... 93, 94
`Petroleum Geo-Services Inc. v. W. Geco LLC,
`IPR2014-01477, Paper 18 (P.T.A.B. Mar. 17, 2015) ......................................... 95
`
`
`
`iv
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`

`

`IPR2020-01341
`Patent 8,142,413
`
`QXMedical, LLC v. Vascular Solutions, LLC,
`No. 17-cv-01969 (D. Minn., filed June 8, 2017) .........................................passim
`Rowe v. Dror,
`112 F.3d 473 (Fed. Cir. 1997) ............................................................................ 22
`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) ................................................... 5
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 96
`Statutes
`35 U.S.C. § 314(A) .................................................................................................. 17
`Other Authorities
`37 C.F.R. § 42.8 ................................................................................................... 5, 98
`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) ...................................................................................... 7, 9, 10
`37 C.F.R. § 42.24(a)(i) ............................................................................................. 98
`37 C.F.R. § 42.100(b) .............................................................................................. 13
`U.S. Patent No. 7,604,612 .......................................................................................... 4
`U.S. Patent No. 7,736,355 .......................................................................................... 4
`
`
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`

`IPR2020-01341
`Patent 8,142,413
`
`
`LIST OF EXHIBITS
`
`
`Exhibit Description
`1001 U.S. Patent No. 8,142,413 (“the ’413 patent”)
`1002
`[RESERVED]
`1003
`File history for U.S. Patent No. 8,142,413
`1004 Assignment record of the ’413 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”)
`1018 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1019 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`
`1011
`
`1012
`
`1015
`
`
`
`vi
`
`

`

`1021
`
`IPR2020-01341
`Patent 8,142,413
`
`Exhibit Description
`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)
`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.
`
`1029
`
`1032
`
`
`
`vii
`
`

`

`1040
`
`1041
`
`IPR2020-01341
`Patent 8,142,413
`
`Exhibit Description
`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”)
`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”)
`
`
`
`viii
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`

`IPR2020-01341
`Patent 8,142,413
`
`Exhibit Description
`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)
`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”)
`
`1069
`
`1071
`
`
`
`ix
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`

`

`IPR2020-01341
`Patent 8,142,413
`
`1083
`
`1084
`
`1085
`1086
`1087
`1088
`
`Exhibit Description
`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
`[RESERVED]
`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
`[RESERVED]
`[RESERVED]
`[RESERVED]
`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)
`[RESERVED]
`Excerpt of Patrick W. Serruys, Handbook of Coronary Stents (4th
`Edition) (2002)
`[RESERVED]
`[RESERVED]
`
`1089
`1090
`1091
`1092
`1093
`
`1094
`1095
`
`1096
`1097
`
`1098
`1099
`
`x
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`

`

`IPR2020-01341
`Patent 8,142,413
`
`Exhibit Description
`1100
`[RESERVED]
`1101
`[RESERVED]
`1102
`[RESERVED]
`1103
`[RESERVED]
`1104
`[RESERVED]
`1105
`[RESERVED]
`1106
`[RESERVED]
`1107
`[RESERVED]
`1108
`[RESERVED]
`1109
`[RESERVED]
`1110
`[RESERVED]
`1111
`[RESERVED]
`1112
`[RESERVED]
`1113
`IPR2020-00127 Institution Decision (Paper 20)
`1114
`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)
`Ex. 6 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]
`
`1115
`
`1116
`1117
`
`1118
`1119
`1120
`
`
`
`
`
`
`xi
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`

`IPR2020-01341
`Patent 8,142,413
`
`I.
`
`PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) request inter
`
`partes review (“IPR”) of claims 1-2, 4-5, and 7-14 (“Challenged Claims”) of U.S.
`
`Pat. No. 8,142,413 (“the ’413 patent,” Ex-1001). The ’413 patent is entitled
`
`Coaxial Guide Catheter for Interventional Cardiology Procedures. Ex-1001, [54].
`
`The ’413 patent describes a catheter assembly 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 coaxial guide 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,
`
`
`1 Unlike the other patents in this family—that explicitly claim a “guide extension
`
`catheter” or, more vaguely, a device/system “for use” with a guide catheter—the
`
`ʼ413 patent claims a “coaxial guide catheter.” A POSITA knew, however, that the
`
`“coaxial guide catheter” of the ’413 patent was commonly understood as a guide
`
`extension catheter because it extends the guide catheter further into the coronary
`
`artery. Ex-1005, ¶¶ 128-29; Ex-1009, 5:49-50 (referring to body 12 “as a guide
`
`catheter extension”). For ease of discussion, and to match the terminology of the
`
`ʼ413 patent, Petitioner uses the phrase “coaxial guide catheter” when referring to
`
`the extension catheter of the ʼ413 patent.
`
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`IPR2020-01341
`Patent 8,142,413
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`Figs. 8-9. In so doing, the coaxial guide 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. Id., 2:51-55,
`
`7:66-8:12.
`
`The ’413 patent admits that use of a coaxial guide catheter inside an outer
`
`guide catheter was known. Ex-1001, 2:23-39 (describing use of a “smaller guide
`
`catheter within a larger guide catheter”). Such a catheter-in-a-catheter assembly
`
`was well-known in the art and described as a “mother-and-child assembly.”
`
`Ex-1005, ¶¶ 74-84. The child catheter (red in below figure) (i.e., the coaxial guide
`
`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.
`
`Ex-1054, Fig. 2 (color and labels added).
`2
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`IPR2020-01341
`Patent 8,142,413
`
`
`The child catheter in the mother-and-child assembly has a continuous lumen
`
`that is longer than the lumen of the guide (“mother”) catheter. Id.; Ex-1005, ¶ 74.
`
`The ’413 patent alleges that this design had certain drawbacks (Ex-1001, 2:40-50;
`
`Ex-1005, ¶¶ 85-93) and modifies the child catheter to have: (i) a long thin pushrod
`
`(ii) coupled to a short distal lumen (i.e., a tube) that is highly flexible.
`
`Id., 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. 7,736,355 (“Itou”) (Ex-1007).
`
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`IPR2020-01341
`Patent 8,142,413
`
`Ex-1007, Fig, 5 (annotations and color added).
`
`It was also evidenced by U.S. Patent No. 7,604,612 (“Ressemann”).
`
`
`
`Ex-1008, Fig. 6E (annotations and color added).
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`A. Real Party-in-Interest
`Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner identifies Medtronic, Inc. and
`
`Medtronic Vascular, Inc. as real parties-in-interest. Medtronic plc is the ultimate
`
`parent of both entities.
`
`B. Related Matters
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner identifies that the ’413 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,
`
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`IPR2020-01341
`Patent 8,142,413
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`Inc., 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)
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`(“QXMedical Litigation”).
`
`The ’413 patent was previously the subject of litigation (i) in the U.S.
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`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
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`PTAB in Boston Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00759
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`(P.T.A.B., terminated Aug. 11, 2014).
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`The ʼ413 patent shares a common specification and is related to several
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`patents that, as shown in the below table, Petitioner is currently challenging in IPR:
`
`IPR No.
`
`Status
`
`U.S. Patent
`No.
`8,048,032
`8,048,032
`RE45,380
`RE45,380
`RE45,380
`RE45,760
`RE45,760
`RE45,776
`RE45,776
`RE47,379
`RE47,379
`8,142,413
`
`IPR2020-00126
`IPR2020-00127
`IPR2020-00128
`IPR2020-00129
`IPR2020-00130
`IPR2020-00132
`IPR2020-00134
`IPR2020-00135
`IPR2020-00136
`IPR2020-00137
`IPR2020-00138
`IPR2020-01341
`
`2 The ʼ413 patent was not originally asserted. The ʼ413 patent was added by
`
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Pending (Present Petition)
`
`Amended Complaint on February 14, 2020. Ex-1114.
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`IPR2020-01341
`Patent 8,142,413
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`
`8,142,413
`RE46,116
`RE46,116
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`Pending
`Pending
`Pending
`
`IPR2020-01342
`IPR2020-01343
`IPR2020-01344
`
`C. Lead and Backup Counsel
`Pursuant to 37 C.F.R. § 42.8(b)(3), Petitioner identifies the following
`
`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
`
`counsel 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
`
`
`
`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.
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`III. REQUIREMENTS FOR INTER PARTES REVIEW
`A. Grounds for Standing
`Petitioner certifies that the ’413 patent is available for IPR and that
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`Petitioner is not barred or estopped from requesting such review on the identified
`
`grounds.
`
`B.
`Precise Relief Requested and Asserted Grounds
`Petitioner respectfully requests review of claims 1-2, 4-5, and 7-14 of the
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`’413 patent and cancellation of these claims as unpatentable in view of the
`
`following grounds:3
`
`No.
`1
`2
`
`3
`
`Grounds
`Claims 1-2, 4, and 7-14 are anticipated by Itou
`Claims 1-2, 4-5, and 7-14 are rendered obvious by Itou in view of the
`knowledge of a POSITA
`Claims 1-2, 4-5, and 7-14 are rendered obvious by Itou in view of
`Ressemann and the knowledge of a POSITA
`
`
`IV. BACKGROUND
`A. Overview of the Technology
`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
`
`
`3 This petition is supported by the Declarations of Stephen JD Brecker, MD
`
`(Ex-1005) and Richard A. Hillstead, PhD (Ex-1042), as experts in the field of the
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`’413 patent. Petitioner also submits the declaration of Sylvia D. Hall-Ellis, PhD
`
`(Ex-1078) to support authenticity and public availability of exhibits cited herein.
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`arterial lumen. Ex-1005, ¶¶ 32, 34-36. This narrowing, sometimes called a stenosis,
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`restricts blood flow and increases the risk of heart attack or stroke. Id. In response,
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`physicians developed percutaneous coronary interventional (“PCI”) procedures
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`that use catheter-based technologies inserted through the femoral or radial artery.
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`Id., ¶ 33. These procedures treat CAD without the need for open-heart surgery. Id.,
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`¶¶ 38-44.
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`PCI was developed more than forty years ago, and although catheter-based
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`technology has advanced, the basic components of PCI remain largely unchanged.
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`Id., ¶¶ 37, 45. During PCI, a physician uses a hollow needle to gain access to the
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`patient’s vasculature. Id., ¶ 38. A guidewire is then introduced through the needle
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`and into the vasculature. Id. After removal of the needle, an introducer sheath is
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`placed and then the guidewire and guide catheter are advanced along the
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`vasculature until the guide catheter’s distal end is placed—by a few millimeters—
`
`in the ostium of a coronary artery. Id., ¶¶ 46-59. A hemostatic valve is placed at the
`
`proximal end of the guide catheter and remains outside the patient’s body. Id.,
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`¶¶ 39, 58. The hemostatic valve prevents blood from exiting the patient’s artery
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`and keeps air from entering the bloodstream. Id.
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`Another small diameter 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
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`the occlusion. Id. The therapeutic catheter typically must then be passed through
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`and beyond the occlusion in order to alleviate the stenosis. Id., ¶ 63-71. This last
`
`step—crossing the therapeutic catheter past the occlusion—creates 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
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`catheter assembly where the child catheter acts as an extension of the guide
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`catheter into the coronary artery. Id., ¶¶ 72-84.
`
`B. Overview of the ’413 Patent
`The ’413 patent relates “generally to catheters used in interventional
`
`cardiology procedures.” Ex-1001, 1:13-17. In particular, the ’413 patent discloses a
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`coaxial guide catheter (also known as an extension catheter) that extends “beyond
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`the distal end of the guide catheter, and … into [a] branch artery.” Id., Abstract.
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`The catheter assembly purports to have the benefit of a mother-and-child
`
`assembly—it “assists in resisting both the axial forces and the shearing forces that
`
`tend to dislodge a guide catheter from the ostium of a branch artery.” Id., 5:4-8.
`
`The ’413 patent claims a coaxial guide catheter (12) that includes a
`
`substantially rigid segment (yellow) and a tubular structure (blue). Ex-1005, ¶ 130.
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`Ex-1001, Fig. 1 (annotations and color added).
`
`The ’413 patent also addresses structural characteristics of the transition at
`
`or near the extension catheter’s reinforced and rigid portions, sometimes referred
`
`to as a “partially cylindrical portion” or a “side opening,” (red circle). Id., Figs. 4,
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`13-16, 6:44-60, 8:40-46, claim 9; Ex-1005, ¶¶ 103-120, 131.
`
`
`
`
`
`Ex-1001, Fig. 4 (annotations and color added) (bottom figure inverted by
`
`Petitioner).
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`
`As shown below, the ’413 patent describes that coaxial guide catheter (12) is
`
`deployed through guide catheter (56) (no color). A guidewire (64) and balloon
`
`(green) extend from the distal tip (pink) of the coaxial guide catheter. Moving
`
`distally to proximally, the coaxial guide