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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`
`Case No.: IPR2020-00128
`U.S. Patent No. RE45,380
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE 45,380
`
`

`

`IPR2020-00128
`Patent RE45,380
`
`
`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 ..................................................................... 6
`D.
`Service Information ............................................................................... 7
`III. REQUIREMENTS FOR INTER PARTES REVIEW ............................... 7
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a) ............................. 7
`B.
`Precise Relief Requested and Asserted Grounds .................................. 8
`IV. BACKGROUND ............................................................................................. 8
`A. Overview of the Technology ................................................................. 8
`B.
`The ’380 Patent ................................................................................... 10
`C.
`Prosecution History of the ’380 Patent ............................................... 13
`D.
`Priority Date ........................................................................................ 14
`V. THE PERSON OF ORDINARY SKILL IN THE ART ........................... 15
`VI. CLAIM CONSTRUCTION ......................................................................... 15
`A.
`“placed in the branch artery” (cl. 1, 12) .............................................. 17
`B.
`“flexural modulus” (cl. 20, 21) ............................................................ 18
`VII. GROUND 1: ITOU ANTICIPATES CLAIMS 1-4, 6-10, 12-20
`AND 23. ......................................................................................................... 19
`A.
`Itou ....................................................................................................... 19
`B.
`Claim 1 ................................................................................................ 22
`
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`i
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`C.
`D.
`E.
`F.
`G.
`H.
`I.
`J.
`K.
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`IPR2020-00128
`Patent RE45,380
`1.
`[1.pre] ....................................................................................... 22
`[1.a.i] ........................................................................................ 22
`2.
`[1.a.ii] ....................................................................................... 25
`3.
`[1.b] .......................................................................................... 27
`4.
`[1.b.i] ........................................................................................ 27
`5.
`[1.b.ii] ....................................................................................... 29
`6.
`[1.b.iii] ...................................................................................... 36
`7.
`Claim 2 ................................................................................................ 38
`Claim 3 ................................................................................................ 42
`Claim 4 ................................................................................................ 46
`Claim 6. ............................................................................................... 46
`Claim 7 ................................................................................................ 47
`Claim 8 ................................................................................................ 48
`Claim 9 ................................................................................................ 48
`Claim 10 .............................................................................................. 51
`Claim 12 .............................................................................................. 52
`1.
`[12.pre] ..................................................................................... 52
`2.
`[12.a] ........................................................................................ 52
`3.
`[12.b] ........................................................................................ 52
`4.
`[12.b.i] ...................................................................................... 52
`5.
`[12.b.ii] ..................................................................................... 53
`6.
`[12.b.iii] .................................................................................... 55
`7.
`[12.b.iv] .................................................................................... 56
`8.
`[12.b.v] ..................................................................................... 59
`Claim 13. ............................................................................................. 59
`L.
`M. Claim 14 .............................................................................................. 60
`N.
`Claim 15 .............................................................................................. 61
`O.
`Claims 16-19 ....................................................................................... 63
`P.
`Claim 20. ............................................................................................. 63
`
`
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`ii
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`

`

`IPR2020-00128
`Patent RE45,380
`Q.
`Claim 23 .............................................................................................. 65
`VIII. GROUND 2: ITOU RENDERS CLAIMS 3, 14, AND 15
`OBVIOUS IN VIEW OF RESSEMANN AND THE COMMON
`KNOWLEDGE OF A POSITA. ................................................................. 65
`A.
`Ressemann ........................................................................................... 66
`B.
`Claim 3 ................................................................................................ 67
`C.
`Claim 14 .............................................................................................. 72
`D.
`Claim 15 .............................................................................................. 75
`IX. GROUND 3: ITOU RENDERS CLAIM 21 OBVIOUS IN VIEW
`OF BERG AND THE COMMON KNOWLEDGE OF A POSITA. ...... 76
`A.
`Berg ..................................................................................................... 76
`B.
`Claim 21 .............................................................................................. 77
`SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ........... 80
`X.
`XI. CONCLUSION ............................................................................................. 80
`XIII. PAYMENT OF FEES (37 C.F.R. § 42.103) .............................................. 81
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`IPR2020-00128
`Patent RE45,380
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Boston Scientific Corp. v. Vascular Solutions, Inc.,
`IPR2014-00762, IPR2014-00763 (P.T.A.B., terminated Aug. 11,
`2014) ..................................................................................................................... 5
`In re Harris,
`409 F.3d 1339 (Fed. Cir. 2005) .......................................................................... 78
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .............................................................. 38, 44, 61
`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, 36
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 14
`Statutes
`35 U.S.C. §§ 102 ...................................................................................................... 79
`
`
`
`
`
`iv
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`IPR2020-00128
`Patent RE45,380
`
`LIST OF EXHIBITS
`
`Exhibit Description
`1001 U.S. Patent No. RE45,380 (“the ’380 patent”)
`1002
`File history for U.S. Patent No. 8,292,850
`1003
`File history for U.S. Patent No. RE45,380
`1004 Assignment record of the ’380 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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`

`IPR2020-00128
`Patent RE45,380
`
`1021
`
`1024
`
`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)
`Cordis, Instructions for Use, CYPHER™ (April 2003)
`1022
`1023 Medtronic, Summary of Safety and Effectiveness Data, Driver™
`Coronary Stent System (October 1, 2003)
`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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`vi
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`IPR2020-00128
`Patent RE45,380
`
`1041
`
`1040
`
`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”)
`
`
`
`vii
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`

`IPR2020-00128
`Patent RE45,380
`
`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)
`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”)
`
`1069
`
`
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`IPR2020-00128
`Patent RE45,380
`
`Exhibit Description
`1071
`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”)
`Excerpt from Plaintiff’s infringement allegations in Vascular
`Solutions, LLC. v. Medtronic, Inc., D. Minn., No. 19-cv-01760
`(October 11, 2019), D.I. 1-14.
`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
`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
`Intentionally Left Blank
`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 [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`1075
`
`1078
`1079
`
`1083
`
`1084
`
`
`
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`

`IPR2020-00128
`Patent RE45,380
`
`
`
`I.
`
`PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) requests inter
`
`partes review (“IPR”) of claims 1-4, 6-10, 12-21, and 23 (“Challenged Claims”) of
`
`U.S. Pat. No. RE 45,380 (“the ’380 patent,” Ex-1001). The ʼ380 patent—which
`
`claims priority to a patent application filed on May 3, 2006 (Ex-1001, [62])—is
`
`entitled Coaxial Guide Catheter for Interventional Cardiology Procedures and lists
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`Howard Root et al. as inventors. Id., [54], [72]. The Challenged Claims were never
`
`subject to an Office Action, meaning there is no substantive file history for the
`
`ʼ380 patent.
`
`The ’380 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 The ’380 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1005, ¶¶ 75 n.8, 129. A POSITA knew that the “coaxial guide
`
`catheter” of the ’380 patent was commonly understood as a guide extension
`
`catheter because it extends the guide catheter further into the coronary artery. Id.;
`
`see also Ex-1009, 5:49-50 (referring to body 12 “as a guide catheter extension”).
`
`
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`1
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`

`IPR2020-00128
`Patent RE45,380
`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. Id., 3:1-5; see also id.
`
`8:19-30.
`
`The ’380 patent admits that the use of a guide extension catheter inside an
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`outer guide catheter was known. Ex-1001, 2:40-56 (describing the use of a
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`“smaller guide catheter within a larger guide catheter”). Indeed, such a catheter-in-
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`a-catheter assembly was well-known in the art as a “mother-and-child assembly,”
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`(Ex-1005, ¶¶ 74-84, 103-104) where the child catheter (red in below figure) (i.e.,
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`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. Ex-1005, ¶ 74.
`
`
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`2
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`IPR2020-00128
`Patent RE45,380
`
`
`
`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 ’380 patent alleges that such a design had certain drawbacks (Ex-1001,
`
`2:57-67) 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)
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`that is highly flexible so it can extend deep into the coronary artery.
`
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`IPR2020-00128
`Patent RE45,380
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`Ex-1001, Fig. 1 (annotations and color added).
`
`But child catheters with 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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`Ex-1007, Fig. 5 (annotations and color added); see also § VII.A, infra.
`
`It was also evidenced by U.S. Patent No. 7,604,612 (“Ressemann”).
`
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`4
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`

`IPR2020-00128
`Patent RE45,380
`
`
`
`Ex-1008, Fig, 6E (annotations and color added); see also § VIII.A, infra.
`
`For the reasons set forth herein, there is more than a reasonable likelihood
`
`that the Challenged Claims of the ’380 patent are unpatentable. Accordingly,
`
`Petitioner respectfully requests institution of a trial under 37 C.F.R. Part 42 and
`
`cancellation/invalidation of the Challenged Claims.
`
`II. MANDATORY NOTICES (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 the 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 ’380 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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`IPR2020-00128
`Patent RE45,380
`Inc., et al., No. 19-cv-01760 (D. Minn., filed July 2, 2019); and (ii) QXMedical,
`
`LLC v. Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017)
`
`(“QXMedical Litigation”).
`
`Further, the ’380 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,
`
`IPR2014-00763 (P.T.A.B., terminated Aug. 11, 2014).
`
`Petitioner is also concurrently filing another petition for IPR challenging the
`
`ʼ380 patent based on prior art references having different priority dates and
`
`disclosures than the references discussed herein, or challenging different claims.
`
`C. Lead and Backup Counsel
`
`Pursuant to 37 C.F.R. § 42.8(b)(3), Petitioner identifies the following
`
`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
`
`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
`
`
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`

`IPR2020-00128
`Patent RE45,380
`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.
`
`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 ’380 patent is
`
`available for IPR and that Petitioner is not barred or estopped from requesting such
`
`review of the ʼ380 patent on the identified grounds.
`
`
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`IPR2020-00128
`Patent RE45,380
`Precise Relief Requested and Asserted Grounds
`B.
`Petitioner respectfully requests review of claims 1-4, 6-10, 12-21 and 23 of
`
`the ʼ380 patent and cancellation of these claims as unpatentable in view of the
`
`following grounds:2
`
`No.
`1
`
`2
`
`3
`
`Grounds
`Claims 1-4, 6-10, 12-20, and 23 are anticipated by U.S. 7,736,355
`(“Itou”).
`Claims 3, 14, and 15 are rendered obvious by Itou in view of U.S.
`7,604,612 (“Ressemann”) and the knowledge of a POSITA.
`Claim 21 is rendered obvious by Itou in view of U.S. 5,911,715
`(“Berg”) and the 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
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`
`2 This petition is also supported by the Declarations of Stephen JD Brecker, MD
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`(Ex-1005), and Richard A. Hillstead, PhD (Ex-1042), as experts in the field of the
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`’380 patent. Petitioner also submits the declaration of Sylvia D. Hall-Ellis, PhD
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`(Ex-1078) to support authenticity and public availability of the documents cited
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`herein.
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`IPR2020-00128
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`that use catheter-based technologies inserted through the femoral or radial artery,
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`and thus can treat CAD without the need for open-heart surgery. Ex-1005, ¶¶ 33,
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`38-44.
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`PCI was developed more than forty years ago, and although its catheter-
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`based technology has advanced, the basic components of PCI have remained
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`largely unchanged. Ex-1005, ¶¶ 37, 45. During PCI, a physician uses a hollow
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`needle to gain access to the patient’s vasculature. Ex-1005, ¶¶ 38, 46-59. A
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`guidewire is then introduced into the needle, the needle is removed, and an
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`introducer sheath is inserted over the guidewire and into the artery. Next, a guide
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`catheter can be introduced and advanced along the vasculature until its distal end is
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`placed—by a few millimeters—in the ostium of a coronary artery. Ex-1005, ¶¶ 38,
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`46-59, 64. At the proximal end, a hemostatic valve is coupled to the guide catheter
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`and remains outside the patient’s body. Ex-1005, ¶¶ 39, 58. The hemostatic valve
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`prevents blood from exiting the patient’s artery and keeps air from entering the
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`bloodstream. Id.
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`A smaller-diameter, more flexible guidewire can then be threaded through
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`the lumen of the guide catheter to the target site. Ex-1005, ¶¶ 60-62. This
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`guidewire serves as a guiderail to advance a therapeutic catheter through the guide
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`catheter and to the occlusion. Id. The guidewire and therapeutic catheter typically
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`must then be passed through and beyond the occlusion in order to alleviate the
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`stenosis. Ex-1005, ¶¶ 63-69. This last step—crossing the guidewire and therapeutic
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`catheter past the occlusion—creates backward force that can dislodge the guide
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`catheter from the ostium. Ex-1005, ¶¶ 70-71. As discussed above, one way to
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`ameliorate this backward force is to use a mother-and-child catheter assembly
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`where the child catheter acts as an extension of the guide catheter into the coronary
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`artery. Id., ¶¶ 72-84.
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`The ’380 Patent
`B.
`The ’380 patent relates “generally to catheters used in interventional
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`cardiology procedures.” Ex-1001, 1:32-33. In particular, the ʼ380 patent discloses a
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`coaxial guide catheter (also known as an extension catheter) that extends through
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`the lumen of a GC, “beyond the distal end of the guide catheter and insert[s] into
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`[a] branch artery.” Id., Abstract. The catheter assembly purports to have the benefit
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`of a mother-and-child assembly—it “assists in resisting both the axial forces and
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`the shearing forces that tend to dislodge a guide catheter from the ostium of a
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`branch artery.” Id., 5:23-26; Ex-1005, ¶¶ 129-30.
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`The ’380 patent explains that the guide extension catheter 12 has a tubular
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`portion that includes a flexible distal tip 16 (pink) and a reinforced portion 18
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`(blue), as well as rigid portion 20 (yellow). Ex-1001, 3:51-53; 6:34-35; Fig. 1.
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`Color has been added to Figure 1, below, which has been annotated with the
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`language of claim 1.3 Ex-1005, ¶ 131.
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`Ex-1001, Fig. 1 (annotations and color added).
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`The patent also addresses structural characteristics of the transition at or near
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`the extension catheter’s reinforced and rigid portions, sometimes referred to as a
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`“side opening,” (red circle), which may have an “inclined slope.” Id., Figs. 4, 13-
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`16; see also id. 6:62-7:11, 8:58-64; claims 3, 26; Ex-1005, ¶ 132.
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`3 In claim 1 “a flexible tip portion” defines “a tubular structure.” Ex-1001, 10:58.
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`The “tubular structure” in claim 1 further “includes a flexible cylindrical distal tip
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`portion (pink) and a flexible cylindrical reinforced portion (blue).” Id., 11:19-21.
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`Claim 12 describes the guide extension catheter using different language.
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`Specifically, claim 12 recites “a flexible tip portion defining a tubular structure,”
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`and a “reinforced portion” that is proximal to the flexible tip portion. Id., 12:17, 29
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`(corresponding, respectively, to the pink and blue portions of annotated Fig. 1).
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`Ex-1001, Fig 4 (annotations and color added).
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`The ’380 patent describes that extension catheter 12 is deployed through
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`guide catheter 56 (no color). A guidewire 64 and balloon (green) extend from the
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`distal tip (pink) of the extension catheter. Moving distally to proximally, the
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`extension catheter’s distal tip (pink) and a reinforced portion (blue) extend out of
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`the distal tip of guide catheter 56. Ex-1005, ¶ 133.
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`Ex-1001, Fig. 9 (color added).
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`Prosecution History of the ’380 Patent
`C.
`The parent ʼ850 patent issued without an Office Action. Ex-1002. According
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`to the Examiner, the claims of the ʼ850 patent were allowable because “adding a
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`guide catheter to the claimed rail structure4 with the claimed flexible tip that is
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`insertable through a hemostatic valve is not taught or suggested by the prior art.”
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`Ex-1002 at 83 (Notice of Allowance at 3). In other words, he believed that a
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`mother-and-child assembly—where the child catheter is characterized by a short
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`distal lumen coupled to a proximally located pushrod—was not described in the
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`art. The Examiner, however, was not aware of Itou or Ressemann. Patent Owner
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`4 See § VI, infra (construing “rail structure”).
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`sought reissuance in 2013, and as with the original prosecution, the claims of the
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`’380 patent issued without an Office Action. Ex-1003.
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`Priority Date
`D.
`The AIA first-to-file provisions apply to a patent that contains even one
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`claim that is not supported by a pre-March 16, 2013 application. AIA § 3(n)(1)(A);
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`MPEP § 2159.02. The ’380 patent is subject to the AIA first-to-file provisions
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`because it contains at least one claim that lacks written description, and therefore
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`pre-AIA priority. Thus, Patent Owner cannot swear behind Itou in this proceeding.
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`First, no pre-AIA application to which the ’380 patent claims priority contains
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`disclosure of “a proximal side opening” outside of the substantially rigid segment,
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`but the independent claims permit the side opening to be in the “flexible tip
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`portion” or “reinforced portion.” Compare Ex-1001, claims 1, 11 (independent
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`claims not restricting location of side opening) with id., claim 3 (dependent claim 3
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`requiring side opening to be in “tubular portion” of flexible tip portion”). Second,
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`claim 27 requires a side opening with two inclined slopes, while the only alleged
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`support (See Ex-1003 at 19 (Preliminary Amendment, November 1, 2013)), Fig 4,
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`discloses an arc and an inclined slope. Third, claim 27 requires a side opening
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`portion with “at least two different inclined slopes,” but there is no support for
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`more than two. At best, the ’380 patent supports only two inclined slopes. Ex-
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`1001, Fig. 4.
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`V.
`THE PERSON OF ORDINARY SKILL IN THE ART
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`If a person of ordinary skill in the art (“POSITA”) was a medical doctor,
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`s/he would have had (a) a medical degree; (b) completed a coronary intervention
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`training program, and (c) experience working as an interventional cardiologist.
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`Alternatively, if a POSITA was an engineer s/he would have had (a) an
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`undergraduate degree in engineering, such as mechanical or biomedical
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`engineering; and (b) at least three years of experience designing medical devices,
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`including catheters or catheter-deployable devices. Extensive experience and
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`technical training might substitute for education, and advanced degrees might
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`substitute for experience. Additionally, a POSITA with a medical degree may have
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`access to a POSITA with an engineering degree, and a POSITA with an
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`engineering degree may have access to one with a medical degree. Ex-1005, ¶ 31;
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`Ex-1042, ¶¶ 18-19.
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`VI. CLAIM CONSTRUCTION
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`For IPR proceedings, the Board applies the claim construction standard set
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`forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 83
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`Fed. Reg. 51,340-51,359 (Oct. 11, 2018). Claim terms are typically given their
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`ordinary and customary meanings, as would