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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.: IPR2020-00133
`U.S. Patent No: RE45,760
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE 45,760
`
`

`

`IPR2020-00133
`Patent RE45,760
`
`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 ............................................................................... 6
`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 .................................. 7
`IV. BACKGROUND ............................................................................................. 8
`A. Overview of the Technology ................................................................. 8
`B.
`The ’760 Patent ..................................................................................... 9
`C.
`Prosecution History of the ’760 Patent ............................................... 12
`V. THE PERSON OF ORDINARY SKILL IN THE ART ............................ 13
`VI. CLAIM CONSTRUCTION ......................................................................... 14
`B.
`“flexural modulus” (cl. 36, 44) ............................................................ 16
`VII. GROUND 1: RESSEMANN RENDERS CLAIMS 25-42, 44, AND
`47 OBVIOUS IN VIEW OF TAKAHASHI AND THE COMMON
`KNOWLEDGE OF A POSITA ................................................................... 17
`A.
`Ressemann ........................................................................................... 17
`B.
`Takahashi ............................................................................................. 19
`C.
`Claim 25 .............................................................................................. 20
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`IPR2020-00133
`Patent RE45,760
`[25.pre] ..................................................................................... 20
`1.
`[25.a] ........................................................................................ 21
`2.
`[25.b] ........................................................................................ 23
`3.
`[25.c.i] ...................................................................................... 24
`4.
` [25.c.ii] .................................................................................... 28
`5.
`[25.c.iii] .................................................................................... 32
`6.
`[25.d] ........................................................................................ 36
`7.
`Claim 26 .............................................................................................. 40
`D.
`Claim 27 .............................................................................................. 42
`E.
`Claim 28 .............................................................................................. 43
`F.
`Claim 29 .............................................................................................. 43
`G.
`Claim 30 .............................................................................................. 45
`H.
`Claim 31 .............................................................................................. 46
`I.
`Claim 32 .............................................................................................. 47
`J.
`Claim 33 .............................................................................................. 49
`K.
`Claim 34 .............................................................................................. 49
`L.
`M. Claim 35 .............................................................................................. 50
`N.
`Claim 36 .............................................................................................. 50
`O.
`Claim 37 .............................................................................................. 52
`Claim 38 .............................................................................................. 53
`P.
`Q.
`Claim 39 .............................................................................................. 54
`R.
`Claim 40 .............................................................................................. 55
`T.
`Claim 42 .............................................................................................. 58
`U.
`Claim 44 .............................................................................................. 59
`V.
`Claim 47 .............................................................................................. 61
`VIII. GROUND 2: RESSEMANN RENDERS CLAIM 32 OBVIOUS IN
`VIEW OF TAKAHASHI, KATAISHI AND THE COMMON
`KNOWLEDGE OF A POSITA. .................................................................. 65
`A. Kataishi ................................................................................................ 65
`
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`IPR2020-00133
`Patent RE45,760
`B.
`Claim 32: The system of claim 25, wherein the segment
`defining the side opening includes at least two inclined slopes. ......... 67
`IX. GROUND 3: RESSEMANN RENDERS CLAIM 32 OBVIOUS IN
`VIEW OF TAKAHASHI, ENGER AND THE COMMON
`KNOWLEDGE OF A POSITA. .................................................................. 70
`A.
` Enger................................................................................................... 70
`B.
`Claim 32: The system of claim 25, wherein the segment
`defining the side opening includes at least two inclined slopes. ......... 71
`SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ........... 75
`X.
`XI. CONCLUSION ............................................................................................. 75
`XIII. PAYMENT OF FEES ................................................................................... 76
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`IPR2020-00133
`Patent RE45,760
`
`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 Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .......................................................................... 62
`Perfect Web Techs., Inc. v. Info USA, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) .......................................................................... 28
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 14
`Shenzhen Zhiyi Tech Co. v. iRobot Corp.,
`IPR2017-02137, Paper 9 (P.T.A.B. Apr. 2, 2018) ............................................. 71
`Zip-Top LLC v. Stasher, Inc.,
`IPR2018-01216, Paper 14 (P.T.A.B. Jan. 17, 2019) .......................................... 71
`Statutes
`35 U.S.C. § 325(d) ............................................................................................. 20, 71
`Other Authorities
`83 Fed. Reg. 51,340-51,359 (Oct. 11, 2018) ........................................................... 14
`
`
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`IPR2020-00133
`Patent RE45,760
`
`LIST OF EXHIBITS
`
`Exhibit Description
`1201 U.S. Patent No. RE45,760 (“the ’760 patent”)
`1202
`File history for U.S. Patent No. 8,292,850
`1203
`File history for U.S. Patent No. RE45,760
`1204 Assignment record of the ’760 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).
`
`1211
`
`1212
`
`1215
`
`
`
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`

`IPR2020-00133
`Patent RE45,760
`
`1221
`
`1224
`
`Exhibit Description
`1216 US Patent Publication 2003/0233117 (“Adams ’117”)
`1217 U.S. Patent No. 5,902,290 (“Peacock”)
`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”)
`Baim, Randomized Trial of a Distal Embolic Protection Device
`1228
`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”)
`Schöbel, Percutaneous Coronary Interventions Using a New 5
`1231
`French Guiding Catheter: Results of a Prospective Study,
`Catheterization & Cardiovascular Interventions 53:308-312 (2001)
`
`1229
`
`
`
`vi
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`

`IPR2020-00133
`Patent RE45,760
`
`1232
`
`Exhibit Description
`(“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”)
`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”)
`
`1240
`
`1241
`
`
`
`vii
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`IPR2020-00133
`Patent RE45,760
`
`Exhibit Description
`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”)
`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”)
`
`
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`Patent RE45,760
`
`1269
`
`1271
`
`Exhibit Description
`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,
`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”)
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`1273
`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”)
`10/16/2019 Deposition of Peter Keith in Vascular Solutions, LLC. v.
`1277
`Medtronic, Inc., D. Minn., No. 19-cv-01760
`Sylvia Hall-Ellis’s Librarian Declaration
`
`1275
`
`1278
`
`
`
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`IPR2020-00133
`Patent RE45,760
`
`Exhibit Description
`Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`1279
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`1280 U.S. Patent No. 5,061,273 (“Yock”)
`1281 U.S. RE45,380 (“the ’380 patent”)
`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
`Plaintiffs’ Objections and Responses to Interrogatories [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`1283
`
`1284
`
`
`
`x
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`IPR2020-00133
`Patent RE45,760
`I. PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) requests inter
`
`partes review (“IPR”) of claims 25-42, 44, and 47 (“Challenged Claims”) of U.S.
`
`Pat. No. RE 45,760 (“the ’760 patent,” Ex-1201). The ʼ760 patent—which claims
`
`priority to a patent application filed on May 3, 2006 (Ex-1201, [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
`
`issued on a first Office Action, meaning there is no substantive file history for the
`
`ʼ760 patent.
`
`The ’760 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
`
`
`1 The ’760 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1205, ¶¶ 71 n.8, 125-129. A POSITA knew that the ’760 patent’s
`
`“coaxial guide catheter” of the ’760 patent was commonly understood as a guide
`
`extension catheter because it extends the guide catheter further into the coronary
`
`artery. Id.; see also Ex-1209, 5:49-52 (referring to body 12 “as a guide catheter
`
`extension”).
`
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`IPR2020-00133
`Patent RE45,760
`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,”
`
`thereby preventing the GC from dislodging from the ostium. Id., 3:7-11; see also
`
`id., 8:23-35.
`
`The ’760 patent admits that the use of a guide extension catheter inside an
`
`outer guide catheter was known. Ex-1201, 2:46-61 (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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`where the child catheter (red in below figure) (i.e., the guide extension catheter) is
`
`essentially a tube that is inserted into and extends beyond the GC (blue in below
`
`figure) (i.e., the mother catheter) into the coronary artery. Ex-1205, ¶¶ 70-80.
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`IPR2020-00133
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`
`
`Ex-1254, Fig. 2 (annotations 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
`
`’760 patent alleges that such a design had certain drawbacks (Ex-1201, 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., a tube) that is
`
`highly flexible so it can extend deep into the coronary artery.
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`IPR2020-00133
`Patent RE45,760
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`Ex-1201, Fig. 1 (annotations and color added).
`
`But child catheters with a short lumen connected to a long thin push rod were
`
`already well-known in the art, as evidenced by U.S. Patent No. 7,604,612
`
`(“Ressemann”) (Ex-1208).
`
`
`
`
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`Ex-1208, Fig, 6E (annotations and color added); and see infra, §VII.A.
`
`For the reasons set forth herein, there is more than a reasonable likelihood
`
`that the Challenged Claims of the ’760 patent are unpatentable based on the
`
`Grounds discussed below. Accordingly, Petitioner respectfully requests institution
`
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`IPR2020-00133
`Patent RE45,760
`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 ’760 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 ’760 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).
`
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`Patent RE45,760
`Petitioner is also concurrently filing other petitions for IPR challenging
`
`different claims of the ʼ760 patent, or based on prior art references having different
`
`priority dates and different 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 counsel
`
`Back-Up Counsel
`Sharon Roberg-Perez (Reg. No. 69,600)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email: Sroberg-perez@robinskaplan.com
`
`of record:
`
`Lead Counsel
`Cyrus A. Morton (Reg. No. 44,954)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email: Cmorton@RobinsKaplan.com
`Additional Back-Up Counsel
`Christopher A. Pinahs (Reg. No.
`76,375)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email:
`Cpinahs@RobinsKaplan.com
`
`D. Service Information
`
`Pursuant to 37 C.F.R. § 42.8(b)(4), please direct all correspondence to lead
`
`and back-up counsel at the above addresses. Petitioner consents to electronic
`
`service at the above-identified email addresses.
`
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`IPR2020-00133
`Patent RE45,760
`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 ’760 patent is
`
`available for IPR and that Petitioner is not barred or estopped from requesting such
`
`review of the ʼ760 patent on the identified grounds.
`
`B. Precise Relief Requested and Asserted Grounds
`Petitioner respectfully requests review of claims 25-42, 44, and 47 of the ʼ760
`
`
`
`patent and cancellation of these claims as unpatentable in view of the following
`
`grounds:2
`
`
`
`No.
`1
`
`2
`
`3
`
`Grounds
`Ressemann renders claims 25-42, 44 and 47 obvious in view of
`Takahashi and the knowledge of a POSITA.
`Ressemann renders claim 32 obvious in view of Takahashi, Kataishi
`and the knowledge of a POSITA
`Ressemann renders claim 32 obvious in view of Takahashi, Enger and
`the knowledge of a POSITA
`
`
`2 This petition is also supported by the Declarations of Stephen JD Brecker, MD
`
`(Ex-1205), and Richard A. Hillstead, Ph.D., (Ex-1242), as experts in the field of
`
`the ’760 patent. Petitioner also submits 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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`IPR2020-00133
`Patent RE45,760
`IV. BACKGROUND
`
`A. Overview of the Technology
`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
`
`arterial lumen. Ex-1205, ¶¶ 28, 30-32. This narrowing, sometimes called a stenosis,
`
`restricts blood flow and increases the risk of heart attack or stroke. Id. In response,
`
`physicians developed percutaneous coronary interventional (“PCI”) procedures
`
`that use catheter-based technologies inserted through the femoral or radial artery,
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`and thus can treat CAD without the need for open-heart surgery. Ex-1205, ¶¶ 29,
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`34-40.
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`PCI was developed over forty years ago, and although its catheter-based
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`technology has advanced, the basic components of PCI have remained largely
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`unchanged. Ex-1205, ¶¶ 33, 41. During PCI, a physician uses a hollow needle to
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`gain access to the patient’s vasculature. A guidewire is then introduced into the
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`needle, the needle is removed, and an introducer sheath is inserted over the
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`guidewire and into the artery. Next, a guide catheter can be introduced and
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`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. Id., ¶¶ 34, 42-55. At the proximal
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`end, a hemostatic valve is coupled to the guide catheter and remains outside the
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`patient’s body. Id., ¶¶ 35, 54. The hemostatic valve prevents blood from exiting the
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`patient’s artery and keeps air from entering the 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. Id., ¶¶ 56-58. This guidewire
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`serves as a guiderail to advance a therapeutic catheter through the guide catheter
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`and to the occlusion. Id. The guidewire and therapeutic catheter typically must then
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`be passed through and beyond the occlusion in order to alleviate the stenosis. Id.,
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`¶¶ 59-65. This last step—crossing the guidewire and therapeutic catheter past the
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`occlusion—creates backward force that can dislodge the guide catheter from the
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`ostium. Id., ¶¶ 66-67. As discussed above, one way to ameliorate this backward
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`force is to use a mother-and-child catheter assembly where the child catheter acts
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`as an extension of the guide catheter into the coronary artery. Id., ¶¶ 68-80.
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`B. The ’760 Patent
`The ’760 patent relates “generally to catheters used in interventional
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`cardiology procedures.” Ex-1201, 1:37-38. In particular, the ʼ760 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., 5:30-34; Ex-1205, ¶ 126.
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`The ’760 patent claims a guide extension catheter 12 that includes a
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`substantially rigid segment (yellow) and a tubular structure (blue) and a tip portion
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`(pink). Color has been added to Figure 1, below, which has been annotated with the
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`language of claims 25 and 35.
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`
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`Ex-1201, Fig. 1 (annotations and color added).
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`The ʼ760 patent also recites that the extension catheter includes, “in a
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`proximal to distal direction, a substantially rigid segment, a segment defining a
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`side opening, and a tubular structure.” Id., 15:14-53, 15:60-16:36, 16:39-17:13.
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`The specification, however, provides no written description support for the
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`placement of a “side opening” anywhere other than in the substantially rigid
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`segment 20, circled in red below. Ex-1201, Figs. 4, 13-16; see also id., 7:1-17,
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`8:63-9:5.
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`
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`Ex-1201, Fig 4 (annotations and color added) (bottom figure inverted by
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`Petitioner).
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`
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`Regardless, the ’760 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 distal tip (pink) and a reinforced portion (blue) extend out
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`of the distal tip of guide catheter 56.
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`Ex-1201, Fig. 9 (color added).
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`C. Prosecution History of the ’760 Patent
`The predecessor ʼ850 patent issued without an Office Action. See generally
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`Ex-1202. According to the Examiner, the claims of the ʼ850 patent were allowable
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`because “adding a guide catheter to the claimed rail structure3 with the claimed
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`flexible tip that is insertable through a hemostatic valve is not taught or suggested
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`by the prior art.” Ex-1202 at 83 (Notice of Allowance at 3).
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`Patent Owner sought reissuance in 2014. The Examiner found the claims were
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`patentable because he found no prior art disclosing “a guide extension catheter
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`which is long enough to extend from both ends of the guide catheter and includes a
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`rigid segment, a segment defining a side opening and a tubular structure, where the
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`3 Infra, § VI. (construing “rail structure”).
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`lumen of the tubular structure is shorter than the guide catheter.” Ex-1203 at 708
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`(Non-Final Rejection, December 10, 2014 at 10). In other words, in both the
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`original prosecution of the ’850 patent, and the prosecution of the ’760 reissuance,
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`the Examiner believed that a mother-and-child assembly—where the child catheter
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`is characterized by a short distal lumen coupled to a proximally located pushrod—
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`was not described in the art, but he was not aware of Ressemann.
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`V. THE PERSON OF ORDINARY SKILL IN THE ART
` If a person of ordinary skill in the art (“POSITA”) was a medical doctor, s/he
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`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 one with an engineering
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`degree might have access to one with a medical degree. Ex-1205, ¶ 27; Ex-1242,
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`¶¶ 18-19.
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`VI. CLAIM CONSTRUCTION
`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 have been understood by a POSITA at
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`the time of the invention, having taken into consideration the language of the
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`claims, the specification, and the prosecution history of record. Phillips, 415 F.3d
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`at 1312-16.
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`When, as here, claim terms have been construed by a district court, those
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`constructions are properly considered during an IPR. 37 C.F.R. § 42.100(b). In the
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`QXMedical Litigation,4 Patent Owner stipulated to the following constructions:
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`• “reinforced portion”: “portion made stronger by additional material or
`support” (Ex-1212 at 2)
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`Further, Patent Owner advanced, and the district court adopted, the following
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`constructions:
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`• “substantially rigid”: “rigid enough to allow the device to be advanced
`within the guide catheter” (Id. (Dkt. 36-1) at 2; Ex-1213 at 15)
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`• “rail structure”: “structure that facilitates monorail or sliding rail
`delivery” (Ex-1213 at 20)
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`4 The full list of constructions advanced by Patent Owner in the QXMedical
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`Litigation is found at Ex-1212 (Dkt. 36-1).
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`Additionally, the district court provided the following construction:
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`• “side opening”: “need no construction and will be given [its] plain and
`ordinary meaning” (Id. at 26)
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`• “lumen”: “the cavity of a tube” (Id. at 25)
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` •
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` “wherein a material forming the segment defining the side opening is
`more rigid than the tubular structure”: “wherein the matter forming the
`segment defining the side opening is more rigid than the tubular
`structure” (Id. at 31).
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`Petitioner agrees with the above constructions for purposes of this IPR5 (Ex-1205,
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`¶¶ 130-136) and proposes the following additional construction:
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`A. “concave track” (cl. 30)
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`The ʼ760 patent does not define the claim term “concave track.” It mentions
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`that a cutout portion, which supports a track, “may” have certain amounts removed
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`and “may” extend for certain lengths, and later refers to cutout portion 44, which is
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`not labeled in a Figure. Ex-1201, 4:11-23, 4:37-39, 7:25-26; Ex-1205, ¶¶ 137-138.
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`Figure 6,