`
`
`
`
`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.: IPR2020-00135
`U.S. Patent No. RE45,776
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE45,776
`
`

`

`IPR2020-00135
`Patent RE45,776
`
`
`TABLE OF CONTENTS
`
`Page
`PRELIMINARY STATEMENT ....................................................................... 1
`I.
`II. MANDATORY NOTICES UNDER 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 ....................................................................................... 6
`REQUIREMENTS FOR IPR ..................................................................... 7
`III.
`A. Grounds for Standing ..................................................................................... 7
`B. Precise Relief Requested and Asserted Grounds ........................................... 7
`Claims 39 and 46 are rendered obvious by Itou in view of the knowledge of a
`POSITA. ..................................................................................................................... 7
`BACKGROUND .......................................................................................... 8
`IV.
`A. Overview of the Technology ......................................................................... 8
`B. The ’776 Patent .............................................................................................. 9
`C. Prosecution History of the ’776 Patent ........................................................11
`D. Priority Date .................................................................................................12
`V. PERSON OF ORDINARY SKILL IN THE ART ......................................13
`CLAIM CONSTRUCTION ......................................................................13
`VI.
`A. “concave track” (claim 37) ..........................................................................15
`B.
`“flexural modulus” (claims 52, 54) ..............................................................16
`VII. GROUND 1: ITOU ANTICIPATES CLAIMS 25-27, 29-33, 35-37, 39,
`41-43, 45, AND 47-49. ............................................................................................16
`A.
`Itou ...............................................................................................................16
`B. Claim 25 .......................................................................................................18
`1.
`[25.pre] .....................................................................................................18
`2.
`[25.a] ........................................................................................................19
`3.
`[25.b] ........................................................................................................20
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`IPR2020-00135
`Patent RE45,776
`4.
`[25.c.i] ......................................................................................................21
`5.
`[25.c.ii] .....................................................................................................22
`6.
`[25.c.iii] ....................................................................................................22
`7.
`[25.c.iv] ....................................................................................................24
`8.
`[25.d] ........................................................................................................25
`C. Claim 26 .......................................................................................................26
`D. Claim 27 .......................................................................................................26
`E. Claim 29 .......................................................................................................27
`F. Claim 30 .......................................................................................................28
`G. Claim 31 .......................................................................................................29
`H. Claim 32 .......................................................................................................30
`I. Claim 33 .......................................................................................................31
`J. Claim 35 .......................................................................................................32
`K. Claim 36 .......................................................................................................32
`L. Claim 37 .......................................................................................................33
`M. Claim 41 .......................................................................................................34
`N. Claim 42 .......................................................................................................34
`O. Claim 43 .......................................................................................................36
`P. Claim 44 .......................................................................................................36
`Q. Claim 45 .......................................................................................................37
`R. Claim 47 .......................................................................................................38
`S. Claim 48 .......................................................................................................39
`T. Claim 49: ......................................................................................................39
`VIII. GROUND 2: ITOU RENDERS CLAIMS 39 AND 46 OBVIOUS IN
`VIEW OF THE COMMON KNOWLEDGE OF A POSITA. ..........................43
`A. Claim 39 .......................................................................................................43
`B. Claim 46 .......................................................................................................44
`IX. GROUND 3: ITOU RENDERS CLAIMS 36-37 AND 52-56 OBVIOUS
`IN VIEW OF KATAISHI AND THE COMMON KNOWLEDGE OF A
`POSITA. ..................................................................................................................46
`A. Overview of Kataishi ...................................................................................46
`
`
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`ii
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`IPR2020-00135
`Patent RE45,776
`B. Claim 36 .......................................................................................................47
`C. Claim 37 .......................................................................................................51
`D. Claim 52 .......................................................................................................53
`1.
`[52.c.iii] ....................................................................................................54
`2.
`[52.e] ........................................................................................................54
`E. Claim 53 .......................................................................................................57
`1.
`[53.pre] .....................................................................................................57
`2.
`[53.d] ........................................................................................................58
`F. Claim 54 .......................................................................................................58
`G. Claim 55 .......................................................................................................59
`H. Claim 56 .......................................................................................................60
`X. GROUND 4: ITOU RENDERS CLAIMS 32, 36-38 AND 52-56
`OBVIOUS IN VIEW OF RESSEMANN AND THE COMMON
`KNOWLEDGE OF A POSITA. ...........................................................................61
`A. Overview of Ressemann ..............................................................................61
`B. Claim 32 .......................................................................................................64
`C. Claim 36 .......................................................................................................68
`D. Claim 37 .......................................................................................................69
`E. Claim 46 .......................................................................................................70
`F. Claim 52 .......................................................................................................72
`1.
`[52.e] ........................................................................................................72
`G. Claim 53 .......................................................................................................75
`1.
`[53.d] ........................................................................................................75
`H. Claim 54 .......................................................................................................75
`I. Claim 55 .......................................................................................................76
`J. Claim 56 .......................................................................................................76
`XI. GROUND 5: ITOU RENDERS CLAIMS 52-56 OBVIOUS IN VIEW
`OF ENGER AND THE COMMON KNOWLEDGE OF A POSITA. .............76
`A. Enger ...........................................................................................................76
`B. Claim 52 .......................................................................................................77
`1.
`[52.e] ........................................................................................................77
`
`
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`IPR2020-00135
`Patent RE45,776
`C. Claim 53 .......................................................................................................81
`1.
`[53.d] ........................................................................................................81
`D. Claim 54 .......................................................................................................81
`E. Claim 55 .......................................................................................................82
`F. Claim 56 .......................................................................................................82
`SECONDARY CONSIDERATIONS .......................................................82
`XII.
`XIII. CONCLUSION ............................................................................................83
`
`
`
`
`
`
`
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`IPR2020-00135
`Patent RE45,776
`
`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) ................................................................................................................... 11
`In re Schreiber,
`128 F.3d at 1477 ..................................................................................... 30, 36, 47
`Legget & Platt, Inc. v. VUTEK, Inc.,
`537 F.3d 1349 (Fed. Cir. 2008) .......................................................................... 24
`Shenzhen Zhiyi Tech Co. v. iRobot Corp.,
`IPR2017-02137, Paper 9 (P.T.A.B. Apr. 2, 2018) ............................................. 82
`Zip-Top LLC v. Stasher, Inc.,
`IPR2018-01216, Paper 14 (P.T.A.B. Jan. 17, 2019) .......................................... 82
`Statutes
`35 U.S.C. § 325(d) ............................................................................................. 82, 83
`
`
`
`
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`

`

`IPR2020-00135
`Patent RE45,776
`
`LIST OF EXHIBITS
`
`Exhibit Description
`1001 U.S. Patent No. RE45,776 (“the ’776 patent”)
`1002
`File history for U.S. Patent No. 8,292,850
`1003
`File history for U.S. Patent No. RE45,776
`1004 Assignment record of the ’776 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
`
`
`
`vi
`
`

`

`1021
`
`1024
`
`IPR2020-00135
`Patent RE45,776
`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
`Intentionally Left Blank
`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
`
`
`
`vii
`
`

`

`1040
`
`IPR2020-00135
`Patent RE45,776
`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
`
`
`
`viii
`
`

`

`IPR2020-00135
`Patent RE45,776
`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
`
`
`
`ix
`
`

`

`IPR2020-00135
`Patent RE45,776
`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 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 [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`1075
`
`1078
`1079
`
`1083
`
`1084
`
`
`
`
`
`x
`
`

`

`IPR2020-00135
`Patent RE45,776
`PRELIMINARY STATEMENT
`I.
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) request inter
`
`partes review (“IPR”) of claims 25-27, 29-33, 35-39, 41-49, and 52-56
`
`(“Challenged Claims”) of U.S. Patent No. RE45,776 (“’776 patent,” Ex-1001). The
`
`’776 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
`
`Challenged Claims were never subject to a prior art based Office Action, meaning
`
`there is no substantive file history for the ʼ776 patent.
`
`The ’776 patent describes a catheter system that reduces the likelihood of a
`
`guide catheter (“GC”) dislodging from the ostium of a coronary artery during the
`
`removal of a coronary stenosis. The purported invention requires a 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 so doing,
`
`
`1 The ’776 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1005, ¶ 131. A POSITA knew that the “coaxial guide catheter” of the
`
`’776 patent was commonly understood to be 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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`1
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`IPR2020-00135
`Patent RE45,776
`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., 3:7-11, 8:24-35.
`
`The ’776 patent admits the use of a guide extension catheter inside an outer
`
`GC was known. Id., 2:46-62 (describing as the use of a “smaller guide catheter
`
`within a larger guide catheter”). Indeed, such a catheter-in-a-catheter assembly was
`
`well-known in the art as a “mother-and-child assembly.” Ex-1005, ¶¶ 74-85. The
`
`child catheter (red in below figure) (i.e., guide extension catheter) is essentially a
`
`tube that is inserted into and extends beyond the GC (blue in below figure) (i.e.,
`
`mother catheter) into the coronary artery. Ex-1005, ¶ 74.
`
`Ex-1054, Fig. 2 (annotations and color added).
`2
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`

`IPR2020-00135
`Patent RE45,776
`The child catheter in the mother-and-child assembly had a continuous lumen
`
`that was longer than the lumen of the guide (“mother”) catheter. Id.; Ex-1005,
`
`¶¶ 74-85. The ’776 patent alleges such a design had certain drawbacks (Ex-1001,
`
`2:63-3:6) 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.,
`
`tube) that is highly flexible so it can extend deep into the coronary artery.
`
`Ex-1001, Fig. 1 (annotations and color added).
`
`But such child catheters that served as guide extension catheters, and had a
`
`short lumen connected to a long thin push rod, were already well-known in the art,
`
`as evidenced by U.S. Patent No. 7,736,355 (“Itou”) (Ex-1007).
`
`
`
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`IPR2020-00135
`Patent RE45,776
`
`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).
`
`For the reasons set forth herein, there is more than a reasonable likelihood
`
`that the Challenged Claims of the ’776 patent are unpatentable. Petitioner
`
`respectfully requests institution of a trial under 37 C.F.R. Part 42 and
`
`cancellation/invalidation of the Challenged Claims.
`
`
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`

`IPR2020-00135
`Patent RE45,776
`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 ’776 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., 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 ’776 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
`
`ʼ776 patent based on prior art references having different priority dates and
`
`
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`IPR2020-00135
`Patent RE45,776
`disclosures than the references discussed herein.
`
`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
`
`
`
`Service Information
`D.
`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.
`
`
`
`6
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`IPR2020-00135
`Patent RE45,776
`III. REQUIREMENTS FOR IPR
`
`A. Grounds for Standing
`
`Pursuant to 37 C.F.R. § 42.104, Petitioner certifies that the ’776 patent is
`
`available for IPR and Petitioner is not barred or estopped from requesting such
`
`review.
`
`B.
`
`Precise Relief Requested and Asserted Grounds
`
`Petitioner respectfully requests review of claims 25-27, 29-33, 35-39, 41-49,
`
`and 52-56 of the ’776 patent and cancellation of those claims as unpatentable based
`
`on the following grounds:2
`
`No.
`1
`
`2
`
`3
`
`4
`
`5
`
`Grounds
`Claims 25-27, 29-33, 35-37, 41-45, and 47-49 are anticipated by
`Itou.
`Claims 39 and 46 are rendered obvious by Itou in view of the
`knowledge of a POSITA.
`Claims 36-37 and 52-56 are rendered obvious by Itou in view of
`Kataishi and/or the knowledge of a POSITA.
`Claims 32, 36-38, 46, 52-56 are rendered obvious by Itou in view of
`Ressemann and/or the knowledge of a POSITA.
`Claims 52-56 are rendered obvious by Itou in view of Enger and/or
`the knowledge of a POSITA.
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`
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`2 This Petition is supported by Declarations of Stephen JD Brecker, MD (Ex-1005),
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`and Dr. Richard A. Hillstead (Ex-1042), as experts in the field of the ’776 patent.
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`Petitioner also submits the declaration of Sylvia D. Hall-Ellis, PhD (Ex-1078) to
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`support the authenticity and public availability of the documents cited herein.
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`IPR2020-00135
`Patent RE45,776
`IV. BACKGROUND
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`A. Overview of the Technology
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`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
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`arterial lumen. Ex-1005, ¶¶ 32-36. This narrowing, sometimes called a stenosis,
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`restricts blood flow and increases the risk of heart attack or stroke. Id., ¶ 35.
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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 to
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`treat CAD without the need for open-heart surgery. Ex-1005, ¶¶ 33, 38-44.
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`PCI was developed over forty years ago. Although its catheter-based
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`technology has advanced, basic PCI components have remained largely
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`unchanged. Ex-1005, ¶ 37, 45. During PCI, a physician uses a hollow needle to
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`gain access to the patient’s vasculature, and a guide catheter (“GC”) is introduced
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`and advanced along the vasculature until its distal end is placed—by a few
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`millimeters—in the ostium of a coronary artery. Ex-1005, ¶¶ 38, 46-62.
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`A small diameter flexible guidewire can then be threaded through the lumen
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`of the GC to the target site. Ex-1005, ¶¶ 60-62. This guidewire serves as a guiderail
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`to advance a therapeutic catheter through the GC and to the occlusion. Id. The
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`therapeutic catheter typically must then be passed through and beyond the
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`occlusion in order to alleviate the stenosis. Ex-1005, ¶¶ 63-71. This last step—
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`crossing the therapeutic catheter past the occlusion—creates backward force that
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`IPR2020-00135
`Patent RE45,776
`can dislodge the GC from the ostium. Ex-1005, ¶¶ 70-71. As discussed above, one
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`way to ameliorate this backward force is to use a mother-and-child assembly where
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`the child catheter acts as an extension of the GC into the coronary artery. Ex-1005,
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`¶¶ 72-85.
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`The ’776 Patent
`B.
`The ’776 patent relates “generally to catheters used in interventional
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`cardiology procedures.” Ex-1001, 1:37-38. In particular, the ’776 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. The
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`catheter assembly purports to have the benefit of a mother-and-child assembly—it
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`“assists in resisting both the axial forces and the shearing forces that tend to
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`dislodge a guide catheter from the ostium of a branch artery.” Id., 5:30-34,
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`Abstract; Ex-1205, ¶¶ 131-132
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`The ’776 patent claims a guide extension catheter 12 that includes a
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`substantially rigid segment (yellow) and a tubular portion (blue).
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`IPR2020-00135
`Patent RE45,776
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`
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`Ex-1001, 13:36-49, Fig. 1 (annotations and color added). Ex-1005, ¶ 133.
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`The ʼ776 patent also recites “a partially cylindrical opening positioned
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`between a distal end of the substantially rigid segment and a proximal end of the
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`tubular structure.” Ex-1001, 13:36-44 The specification, however, provides no
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`written description support for the placement of this feature, and, as shown below,
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`only describes the partially cylindrical opening (red circle) positioned in the
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`substantially rigid segment 20.
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`IPR2020-00135
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`
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`Id., Fig. 4 (annotations and color added); see Ex-1005, ¶ 134.
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`Regardless, the ’776 patent describes that extension catheter 12 is deployed
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`through guide catheter 56 (no color). A guidewire 64 and balloon (green) extend
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`from the distal tip (pink) of the extension catheter. Moving distally to proximally,
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`the extension catheter’s tip (pink) and tubular portion (blue) extend out the distal
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`tip of guide catheter 56. Ex-1005, ¶ 135.
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`Ex-1001, Fig. 9 (color added).
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`
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`Prosecution History of the ’776 Patent
`C.
`The parent ʼ850 patent issued without Office Action. See generally Ex-1002.
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`Patent Owner sought reissuance in 2014. The claims of the ’776 patent also issued
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`without any substantive 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 not supported by a pre-March 16, 2013 application or claims priority to any
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`patent or application that is subject to the AIA first-to-file provisions. AIA
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`§ 3(n)(1)(A); MPEP § 2159.02. The ’776 patent is subject to the AIA first-to-file
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`provisions because (1) it contains claims that lack written description, and
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`therefore pre-AIA priority,3 and (2) it claims priority to RE45,380 (“the ’380
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`patent”), which is subject to the AIA first-to-file provisions. Thus, Patent Owner
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`cannot swear behind Itou in this proceeding.
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`The ’776 patent lacks written description support for at least the following
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`reasons. First, there is no disclosure of “a partially cylindrical opening” that is not
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`part of the substantially rigid segment, but each of independent claim places it
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`between a distal end of the substantially rigid segment and a proximal end