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 No.: IPR2020-00129
`U.S. Patent No. RE45,380
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE45,380
`
`

`

`IPR2020-00129
`Patent RE45,380
`
`TABLE OF CONTENTS
`
`Page
`
`I.PRELIMINARY STATEMENT ............................................................................. 1
`II.MANDATORY NOTICES (37 C.F.R. § 42.8) ...................................................... 4
`A.
`Real Party-in Interest ................................................................................ 4
`B.
`Related Matters ......................................................................................... 5
`C.
`Lead and Backup Counsel ........................................................................ 6
`D.
`Service Information .................................................................................. 6
`III.REQUIREMENTS FOR INTER PARTES REVIEW ......................................... 6
`A.
`Grounds for Standing Under 37 C.F.R. § 42.104(a) ................................ 6
`B.
`Precise Relief Requested and Asserted Grounds ..................................... 7
`IV.BACKGROUND .................................................................................................. 8
`A.
`Overview of the Technology .................................................................... 8
`B.
`The ’380 Patent ......................................................................................... 9
`C.
`Prosecution History of the ’380 Patent .................................................. 12
`D.
`Priority Date ........................................................................................... 12
`V.PERSON OF ORDINARY SKILL IN THE ART ............................................... 13
`VI.CLAIM CONSTRUCTION ................................................................................ 13
`A. Means-Plus-Function Limitations (cl. 25) ............................................. 15
`B.
`“concave track” (cl. 34) .......................................................................... 18
`C.
`“flexural modulus” (cl. 38) ..................................................................... 18
`VII.GROUND 1: RESSEMANN ANTICIPATES CLAIMS 25-31, 34-37
`AND 39. .......................................................................................................... 19
`A.
`Ressemann .............................................................................................. 19
`B.
`Claim 25 ................................................................................................. 22
`1.
`[25.p] ........................................................................................ 22
`2.
`[25.a] ........................................................................................ 22
`3.
`[25.b] ........................................................................................ 23
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`IPR2020-00129
`Patent RE45,380
`
`4.
`[25.c.i] ...................................................................................... 25
`[25.c.ii] ..................................................................................... 28
`5.
`[25.d] ........................................................................................ 29
`6.
`[25.e] ........................................................................................ 30
`7.
`Claim 26 ................................................................................................. 32
`C.
`Claim 27 ................................................................................................. 32
`D.
`Claims 28-30 .......................................................................................... 35
`E.
`Claim 31 ................................................................................................. 37
`F.
`Claim 34 ................................................................................................. 38
`G.
`Claim 35 ................................................................................................. 39
`H.
`Claim 36” ................................................................................................ 40
`I.
`Claim 37 ................................................................................................. 41
`J.
`Claim 39 ................................................................................................. 42
`K.
`VIII.GROUND 2: RESSEMANN IN VIEW OF THE KNOWLEDGE OF A
`POSITA RENDERS CLAIM 27 OBVIOUS. ................................................ 45
`IX.GROUND 3: RESSEMANN IN VIEW OF KATAISHI AND/OR THE
`KNOWLEDGE OF A POSITA RENDERS CLAIM 27 OBVIOUS. ........... 47
`A.
`Kataishi ................................................................................................... 47
`B.
`Claim 27 ................................................................................................. 49
`X.GROUND 4: RESSEMANN IN VIEW OF ENGER RENDERS CLAIM
`27 OBVIOUS. ................................................................................................ 53
`A.
`Enger ....................................................................................................... 53
`B.
`Claim 27 ................................................................................................. 53
`XI.GROUND 5: RESSEMANN IN VIEW OF TAKAHASHI RENDERS
`CLAIMS 32 AND 33 OBVIOUS. ................................................................. 56
`A.
`Takahashi ................................................................................................ 56
`B.
`Claim 32 ................................................................................................. 57
`C.
`Claim 33 ................................................................................................. 59
`XII.GROUND 6: RESSEMANN IN VIEW BERG AND/OR
`KNOWLEDGE OF POSITA RENDERS CLAIM 38 INVALID AS
`OBVIOUS. ..................................................................................................... 60
`
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`IPR2020-00129
`Patent RE45,380
`
`A.
`Berg ........................................................................................................ 60
`Claim 38 ................................................................................................. 60
`B.
`XIII. GROUND 7: ITOU ANTICIPATES CLAIMS 25-26, 28-30, 32-37,
`AND 39. .......................................................................................................... 63
`A.
`Itou .......................................................................................................... 63
`B.
`Claim 25 ................................................................................................. 65
`1.
`[25.pre] ..................................................................................... 65
`2.
`[25.a] ........................................................................................ 66
`3.
`[25.b] ........................................................................................ 66
`4.
`[25.c.i] ...................................................................................... 68
`5.
`[25.c.ii] ..................................................................................... 69
`6.
`[25.d] ........................................................................................ 70
`7.
`[25.e] ........................................................................................ 70
`Claim 26 ................................................................................................. 71
`C.
`Claims 28-30 .......................................................................................... 72
`D.
`Claim 32 ................................................................................................. 73
`E.
`Claim 33 ................................................................................................. 74
`F.
`Claim 34 ................................................................................................. 75
`G.
`Claim 35 ................................................................................................. 76
`H.
`Claim 36 ................................................................................................. 76
`I.
`Claim 37 ................................................................................................. 77
`J.
`Claim 39 ................................................................................................. 79
`K.
`XV.GROUND 8: ITOU IN VIEW OF THE KNOWLEDGE OF A POSITA
`RENDERS CLAIM 31 OBVIOUS. ............................................................... 81
`XVI.GROUND 9: ITOU IN VIEW OF KATAISHI RENDERS CLAIM 27
`OBVIOUS. ..................................................................................................... 83
`XVII. GROUND 10: ITOU IN VIEW OF BERG RENDER CLAIM 38
`OBVIOUS. ..................................................................................................... 86
`XVIII. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ............. 87
`XIX. CONCLUSION ............................................................................................... 88
`XX.PAYMENT OF FEES ....................................................................................... 88
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`IPR2020-00129
`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 prior to
`institution, Aug. 11, 2014) .................................................................................... 5
`In re Aoyama,
`656 F.3d 1293 (Fed. Cir. 2011) .......................................................................... 15
`In re Harris,
`409 F.3d 1339 (Fed. Cir. 2005) ........................................... 63, 64, 65, 66, 68, 87
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .......................................................................... 44
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) ........................................................ 34, 38, 39, 43
`TriMed, Inc. v. Styker Corp.,
`514 F.3d 1256 (Fed. Cir. 2008) .............................................................. 15, 16, 17
`Statutes
`35 U.S.C. § 112, ¶ 6 ................................................................................................. 15
`
`iv
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`

`

`IPR2020-00129
`Patent RE45,380
`
`LIST OF EXHIBITS
`
`Exhibit Description
`1201 U.S. Patent No. RE45,380 (“the ’380 patent”)
`1202
`File history for U.S. Patent No. 8,292,850
`1203
`File history for U.S. Patent No. RE45,380
`1204 Assignment record of the ’380 patent from the USPTO assignment
`database
`1205 Declaration of Doctor Stephen JD Brecker, M.D.
`1206
`Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1207 U.S. Patent No. 7,736,355 (“Itou”)
`1208 U.S. Patent No. 7,604,612 (“Ressemann”)
`1209 U.S. Patent No. 5,439,445 (“Kontos”)
`1210
`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.
`1213 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1214 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).
`1216 US Patent Publication 2003/0233117 (“Adams ’117”)
`1217 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1211
`
`1212
`
`1215
`
`v
`
`

`

`IPR2020-00129
`Patent RE45,380
`
`
`1221
`
`1224
`
`Exhibit Description
`1218 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1219 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1220 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)
`1222
`1223 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)
`1225 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1226 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1227 U.S. Patent No. RE45,776 (“Root”)
`1228
`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”)
`1230 U.S. Patent No. 5,413,560 (“Solar ’560”)
`1231
`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”)
`
`1229
`
`1232
`
`
`
`vi
`
`

`

`IPR2020-00129
`Patent RE45,380
`
`
`1240
`
`Exhibit Description
`1233 U.S. Publication Application No. 2004/0236215 (Mihara)
`1234 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1235 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1236 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1237 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1238 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1239 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)).
`1242 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1243
`Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1244 U.S. Patent No. 5,961,510 (“Fugoso”)
`1245 U.S. Patent No. 6,199,262 (“Martin”)
`1246 U.S. Patent No. 6,042,578 (“Dinh”)
`1247 WO 97/37713 (“Truckai”)
`1248
`Terumo Heartrail II product literature
`1249 Medtronic Launcher product literature
`1250 U.S. Patent No. 5,980,486 (“Enger”)
`1251 U.S. Patent No. 5,911,715 (“Berg”)
`1252 U.S. Patent No. 5,545,149 (“Brin”)
`
`1241
`
`
`
`vii
`
`

`

`IPR2020-00129
`Patent RE45,380
`
`
`Exhibit Description
`1253 U.S. Patent No. 5,720,300 (“Fagan”)
`1254 U.S. Patent No. 5,120,323 (“Shockey”)
`1255
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1256 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1257 U.S. Patent No. 5,445,625 (“Voda”)
`1258 U.S. Patent No. 6,595,952 (“Forsberg”)
`1259 U.S. Patent No. 6,860,876 (“Chen”)
`1260 U.S. Patent No. 6,638,268 (“Niazi”)
`1261 U.S. Patent No. 5,690,613 (“Verbeek”)
`1262
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1263 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1264 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
`1265 U.S. Patent No. 4,000,739 (“Stevens”)
`1266
`EP 0 881 921 B1 (“Lee”)
`1267 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1268 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)
`1270 Metz, Comparison of 6f with 7f and 8f guiding catheters for elective
`coronary angioplasty: Results of a prospective, multicenter,
`
`1269
`
`
`
`viii
`
`

`

`IPR2020-00129
`Patent RE45,380
`
`
`1271
`
`Exhibit Description
`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”)
`1272 U.S. Patent No. 5,704,926 (“Sutton”)
`1273
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`1274 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.
`1276 U.S. Patent No. 5,860,963 (“Azam”)
`1277
`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.
`1280 U.S. Patent No. 5,061,273 (“Yock”)
`1281
`Intentionally Left Blank
`1282 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
`
`1275
`
`1278
`1279
`
`1283
`
`
`
`ix
`
`

`

`IPR2020-00129
`Patent RE45,380
`
`
`Exhibit Description
`1284
`Plaintiffs’ Objections and Responses to Interrogatories [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`
`
`ii
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`

`IPR2020-00129
`Patent RE45,380
`
`I.
`
`PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioners”) request inter
`
`partes review (“IPR”) of claims 25-39 (“Challenged Claims”) of U.S. Pat. No.
`
`RE45,380 (“the ’380 patent” Ex-1201). The ʼ380 patent 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 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
`
`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,”
`
`
`
` 1
`
` The ’380 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1205, ¶ 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 GC further into the coronary artery. Id.; see also Ex-1209, 5:49-52.
`
`
`
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`1
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`

`IPR2020-00129
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`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
`
`outer GC was known. Ex-1201, 2:40-56 (describing use of a “smaller guide
`
`catheter within a larger guide catheter”). Indeed, such a catheter-in-a-catheter
`
`assembly—a “mother-and-child assembly”— was well-known. Ex-1205, ¶¶ 74-84.
`
`The child catheter (red below) (i.e., the extension catheter) is essentially a tube that
`
`is inserted into and extends beyond the GC (blue below) (i.e., the mother catheter)
`
`into the coronary artery. Id., ¶ 74.
`
`Ex-1254, Fig. 2 (annotation and color added).
`
`The child catheter in the mother-and-child assembly had a continuous lumen
`
`
`
`
`
`2
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`

`IPR2020-00129
`Patent RE45,380
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`that was longer than the lumen of the guide (“mother”) catheter. Id.; Ex-1205,
`
`¶¶ 74-84. The ’380 patent alleges that such a design had certain drawbacks (Ex-
`
`1201, 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) that is highly flexible so it can extend deep into the coronary artery.
`
`Ex-1201, Fig. 1 (annotations and color added).
`
`But such child catheters were already well-known, as evidenced by U.S.
`
`Patent No. 7,604,612 (“Ressemann”) and U.S. Patent No. 7,736,355 (“Itou”), both
`
`
`
`depicted below.
`
`
`
`
`
`3
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`

`

`IPR2020-00129
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`
`Ressemann
`
`Ex-1208, Fig. 6E (annotations and color added).
`
`Itou
`
`
`
`
`
`Ex-1207, Fig. 5 (annotations and color added).
`
`II. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real Party-in Interest
`Petitioners identify Medtronic, Inc. and Medtronic Vascular, Inc. as the real
`
`
`
`4
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`parties-in-interest. 37 C.F.R. § 42.8(b)(1). Medtronic plc is the ultimate parent of
`
`both entities.
`
`B. Related Matters
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioners identify 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, 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 prior to institution, Aug. 11, 2014).
`
`Petitioners are also concurrently filing other petitions 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.
`
`
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`IPR2020-00129
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`
`
`C. Lead and Backup Counsel
`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
`
`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. Petitioners consent 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, Petitioners certify that the ’380 patent is
`
`available for IPR and that Petitioners are not barred or estopped from requesting
`
`such review on the identified grounds.
`
`
`
`6
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`IPR2020-00129
`Patent RE45,380
`
`
`Precise Relief Requested and Asserted Grounds
`B.
`Petitioners respectfully request review and cancellation of claims 25-39 of
`
`
`
`the ʼ380 patent as unpatentable in view of the following grounds:2
`
`No.
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`Grounds
`Claims 25-31, 34-37 and 39 as anticipated by U.S. 7,604,612
`(“Ressemann”).
`Claim 27 as obvious over Ressemann in view of the knowledge of a
`POSITA.
`Claim 27 as obvious over Ressemann in view of US 2005/0015073
`(“Kataishi”) and the knowledge of a POSITA.
`Claim 27 as obvious over Ressemann in view of US 5,980,486
`(“Enger”) and the knowledge of a POSITA.
`Claims 32 and 33 as obvious over Ressemann in view of Takahashi
`and/or the knowledge of a POSITA.
`Claim 38 as obvious over Ressemann in view of Berg and/or the
`knowledge of a POSITA.
`Claims 25-26, 28-30, 32-37 and 39 as anticipated by U.S. 7,736,355
`(“Itou”).
`Claim 31 as obvious over Itou in view of the knowledge of a
`POSITA.
`Claim 27 as obvious over Itou in view of Kataishi and/or the
`knowledge of a POSITA.
`
`
` 2
`
` This petition is supported by the Declarations of Dr. Stephen JD Brecker, MD
`
`(Ex-1205), and Richard A. Hillstead, PhD (Ex-1242), as experts in the field of the
`
`’380 patent. Petitioners also submit the Declaration of Sylvia D. Hall-Ellis, PhD
`
`(Ex-1278) to support the authenticity and public availability of documents cited
`
`herein.
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`IPR2020-00129
`Patent RE45,380
`
`
`No.
`10
`
`Grounds
`Claim 38 as obvious over Itou in view of Berg and/or 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-1205, ¶¶ 32-36. This narrowing, sometimes called stenosis,
`
`restricts blood flow and increases the risk of heart attack or stroke. Id. Physicians
`
`developed percutaneous coronary interventional (“PCI”) procedures that use
`
`catheter-based technologies inserted through the femoral or radial artery to treat
`
`CAD without the need for open-heart surgery. Ex-1205, ¶¶ 33, 38-44.
`
`PCI was developed more than forty years ago. Although catheter-based
`
`technology has advanced, the basic components of PCI have remained largely
`
`unchanged. Ex-1205, ¶¶ 37, 45. During PCI, a physician uses a hollow needle to
`
`gain access to the patient’s vasculature. A GC is then introduced and advanced
`
`along the vasculature until its distal end is placed—by a few millimeters—in the
`
`ostium of a coronary artery. Ex-1205, ¶¶ 38, 46-62. A hemostatic valve is placed at
`
`the proximal end of the GC, remaining outside the patient’s body. Ex-1205, ¶¶ 39,
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`58. The hemostatic valve prevents blood from exiting the patient’s artery and keeps
`
`air from entering the bloodstream. Id.
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`IPR2020-00129
`Patent RE45,380
`
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`A smaller-diameter, more flexible guidewire can then be threaded through
`
`the lumen of the GC to the target site. Ex-1205, ¶¶ 60-62. This guidewire serves as
`
`a guiderail to advance a therapeutic catheter through the GC and to the occlusion.
`
`Id. The therapeutic catheter is typically passed through and beyond the occlusion in
`
`order to alleviate the stenosis. Ex-1205, ¶¶ 63-71. This last step—crossing the
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`therapeutic catheter past the occlusion—creates backward force that can dislodge
`
`the GC from the ostium. Id., ¶¶ 70-71. One way to ameliorate this backward force
`
`is to use a mother-and-child catheter assembly where the child catheter acts as an
`
`extension of the GC. Id., ¶¶ 72-84.
`
`The ’380 Patent
`B.
`The ’380 patent relates “generally to catheters used in interventional
`
`
`
`cardiology procedures.” Ex-1201, 1:31-32. In particular, the ʼ380 patent discloses a
`
`coaxial guide catheter (i.e. extension catheter) that extends through the lumen of a
`
`GC, “beyond the distal end of the guide catheter and insert[s] into [a] branch
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`artery.” Id., Abstract. The catheter assembly purports to have the benefit of a
`
`mother-and-child assembly—“assist[ing] 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., 5:23-27; Ex-1205, ¶¶ 129-30.
`
`
`
`The ’380 patent discloses extension catheter 12 with a tubular portion that
`
`includes a flexible distal tip 16 (pink) and a reinforced portion 18 (blue), as well as
`
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`

`IPR2020-00129
`Patent RE45,380
`
`rigid portion 20 (yellow). Ex-1201, 3:51-53, 6:34-35, Fig. 1.
`
`
`
`Ex-1201, Fig. 1 (annotations and color added).
`
`The patent also addresses structural characteristics of the transition at or near
`
`the extension catheter’s reinforced and rigid portions, sometimes referred to as a
`
`“side opening,” (red circle), which may have an “inclined slope.” Id., Figs. 4, 13-
`
`16, 6:62-7:11, 8:58-64, 11:33-40, 14:6-7; Ex-1205, ¶¶ 131-132.
`
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`IPR2020-00129
`Patent RE45,380
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`
`
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`Ex-1201, Fig 4 (annotations and color added) (bottom figure inverted).
`
`The ’380 patent describes that extension catheter 12 is deployed through
`
`guide catheter 56 (no color). A guidewire 64 and balloon (green) extend from the
`
`distal tip (pink) of the extension catheter. Moving distally to proximally, the
`
`extension catheter’s distal tip (pink) and a reinforced portion (blue) extend out of
`
`the distal tip of guide catheter 56. Ex-1205, ¶ 133.
`
`
`
`Ex-1201, Fig. 9 (color added).
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`IPR2020-00129
`Patent RE45,380
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`
`Prosecution History of the ’380 Patent
`C.
`The parent ʼ850 patent issued without an Office Action. Ex-1202. The
`
`
`
`Examiner, however, was not aware of Ressemann or Itou.
`
`
`
`Patent Owner sought reissuance in 2013. The claims of the ’380 patent also
`
`issued without an Office Action. Ex-1203.
`
`Priority Date
`D.
`The ’380 patent is subject to the AIA first-to-file provisions because it
`
`contains at least one claim that lacks written description, and therefore pre-AIA
`
`priority. AIA § 3(n)(1)(A); MPEP § 2159.02. Thus, Patent Owner cannot swear
`
`behind Itou.
`
`First, no pre-AIA application to which the ’380 patent claims priority
`
`contains disclosure of “a proximal side opening” outside of the substantially rigid
`
`segment, though the independent claims permit the side opening to be in the
`
`“flexible tip portion” or “reinforced portion.” Compare Ex-1201, claims 1, 11
`
`(independent claims not restricting location of side opening) with id., claim 3
`
`(dependent claim 3 requiring side opening to be in “tubular portion” of flexible tip
`
`portion).
`
`Second, claim 27 requires a side opening with two inclined slopes, while the
`
`only alleged support (see Ex-1203a at 19 (Preliminary Amendment (11/1/2013) at
`
`17), Fig. 4, discloses an arc and an inclined slope.
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`IPR2020-00129
`Patent RE45,380
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`Third, claim 27 requires a side opening portion with “at least two different
`
`inclined slopes,” but there is no support for more than two. At best, the ’380 patent
`
`supports only two inclined slopes. Ex-1201, Fig. 4.
`
`V.
`
`PERSON OF ORDINARY SKILL IN THE ART
`
`If a person of ordinary skill in the art (“POSITA”) was a medical doctor,
`
`s/he would have had (a) a medical degree; (b) completed a coronary intervention
`
`training program, and (c) experience working as an interventional cardiologist.
`
`Alternatively, if a POSITA was an engineer s/he would have had (a) an
`
`undergraduate degree in engineering, such as mechanical or biomedical
`
`engineering; and (b) at least three years of experience designing medical devices,
`
`including catheters or catheter-deployable devices. Extensive experience and
`
`technical training might substitute for education, and advanced degrees might
`
`substitute for experience. Additionally, a POSITA with a medical degree may have
`
`access to a POSITA with an engineering degree, and a POSITA with an
`
`engineering degree may have access to one with a medical degree. Ex-1205, ¶ 31;
`
`Ex-1242, ¶¶ 18-19.
`
`VI. CLAIM CONSTRUCTION
`
`A district court’s claim constructions are properly considered during an IPR.
`
`37 C.F.R. § 42.100(b). In the QXMedical Litigation, Patent Owner stipulated to
`
`these constructions:
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`IPR2020-00129
`Patent RE45,380
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`• “reinforced portion”: “portion made stronger by additional material or
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`support” (Ex-1212, 2)
`
`• “interventional cardiol