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`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.: IPR2020-00136
`U.S. Patent No. RE 45,776
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE 45,776
`
`

`

`IPR2020-00136
`Patent RE 45,776
`
`
`TABLE OF CONTENTS
`
`Page
`I. PRELIMINARY STATEMENT .................................................................... 1
`II. MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................... 5
`A. Real Party-in-Interest ................................................................................. 5
`B. Related Matters ........................................................................................... 5
`C. Lead and Backup Counsel .......................................................................... 6
`D. Service Information ..................................................................................... 7
`III. REQUIREMENTS FOR INTER PARTES REVIEW ............................... 7
`A. Grounds for Standing ................................................................................. 7
`B. Precise Relief Requested and Asserted Grounds ..................................... 7
`IV. BACKGROUND ............................................................................................. 8
`A. Overview of the Technology ....................................................................... 8
`B. Overview of the ’776 Patent .....................................................................10
`C. Prosecution History of the ’776 Patent ....................................................12
`V. THE PERSON OF ORDINARY SKILL IN THE ART ............................13
`VI. CLAIM CONSTRUCTION .........................................................................13
`A. “concave track” (cl. 37) .............................................................................15
`B.
`“flexural modulus” (cls. 52, 54) ................................................................16
`VII. GROUND 1: KONTOS RENDERS CLAIMS 25-27, 29, 33, 35-37, 39,
`41-49, AND 52 OBVIOUS IN VIEW OF RESSEMANN AND/OR THE
`KNOWLEDGE OF A POSITA. ...........................................................................17
`A. Kontos .........................................................................................................17
`B. Ressemann ..................................................................................................20
`C. Claim 25 ......................................................................................................21
`D. Claim 26 ......................................................................................................38
`E. Claim 27 ......................................................................................................39
`F. Claim 29 ......................................................................................................40
`G. Claim 33 ......................................................................................................40
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`H. Claim 35 ......................................................................................................41
`I. Claim 36 ......................................................................................................42
`J. Claim 37 ......................................................................................................43
`K. Claim 39 ......................................................................................................44
`L. Claim 41 ......................................................................................................44
`M. Claim 42 ......................................................................................................45
`N. Claim 43 ......................................................................................................46
`O. Claim 44 ......................................................................................................46
`P. Claim 45 ......................................................................................................47
`Q. Claim 46 ......................................................................................................48
`R. Claim 47 ......................................................................................................49
`S. Claim 48 ......................................................................................................50
`T. Claim 49 ......................................................................................................51
`U. Claim 52: ....................................................................................................53
`1.
`[52.pre].....................................................................................................53
`2.
`[52.a] ........................................................................................................53
`3.
`[52.b] ........................................................................................................53
`4.
`[52.c.i] ......................................................................................................53
`5.
`[52.c.ii] .....................................................................................................53
`6.
`[52.c.iii] ....................................................................................................54
`7.
`[52.c.iv] ....................................................................................................54
`8.
`[52.d] ........................................................................................................55
`9.
`[52.e] .........................................................................................................55
`VIII. GROUND 2: KONTOS RENDERS CLAIMS 53-56 AND 30-32
`OBVIOUS IN VIEW OF RESSEMANN, TAKAHASHI, AND/OR THE
`COMMON KNOWLEDGE OF A POSITA. ......................................................56
`A. Takahashi ...................................................................................................56
`B. Claim 53 ......................................................................................................57
`1.
`[53.pre].....................................................................................................57
`2.
`[53.a] ........................................................................................................58
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`
`[53.b.i] ......................................................................................................58
`3.
`[53.b.ii] .....................................................................................................59
`4.
`[53.c.i] ......................................................................................................61
`5.
`[53.c.ii] .....................................................................................................61
`6.
`[53.c.iii] ....................................................................................................61
`7.
`[53.c.iv] ....................................................................................................61
`8.
`[53.d] ........................................................................................................62
`9.
`C. Claim 54 ......................................................................................................62
`D. Claim 55 ......................................................................................................62
`E. Claim 56 ......................................................................................................63
`F. Claim 30 ......................................................................................................64
`G. Claim 31 ......................................................................................................65
`H. Claim 32 ......................................................................................................66
`IX. GROUND 3: KONTOS RENDERS CLAIM 52 OBVIOUS IN VIEW OF
`RESSEMANN, KATAISHI, AND/OR THE COMMON KNOWLEDGE OF A
`POSITA. ..................................................................................................................66
`A. Kataishi .......................................................................................................66
`B. Claim 52 ......................................................................................................68
`X. GROUND 4: KONTOS RENDERS CLAIMS 53-56 OBVIOUS IN VIEW
`OF RESSEMANN, TAKAHASHI, KATAISHI, AND/OR THE COMMON
`KNOWLEDGE OF A POSITA. ...........................................................................72
`A. Claim 53 ......................................................................................................72
`B. Claims 54-56 ...............................................................................................73
`XI. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ...........73
`XII. CONCLUSION ..........................................................................................74
`XIII. PAYMENT OF FEES ..................................................................................74
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`IPR2020-00136
`Patent RE 45,776
`
`
`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) ..................................................................................................................... 6
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .................................................................... 36, 50
`KSR Int’l co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 33
`Novartis Pharm. Corp. v. W.-Ward Pharm. Int’l Ltd.,
`923 F.3d 1051 (Fed. Cir. 2019) .......................................................................... 28
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 13
`Shenzhen Zhiyi Tech Co. v. iRobot Corp.,
`IPR2017-02137, Paper 9 (P.T.A.B. Apr. 2, 2018) ............................................. 56
`Zip-Top LLC v. Stasher, Inc.,
`IPR2018-01216, Paper 14 (P.T.A.B. Jan. 17, 2019) .......................................... 55
`Statutes
`35 U.S.C. § 103 .......................................................................................................... 5
`35 U.S.C. § 325(d) ............................................................................................. 55, 56
`
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`IPR2020-00136
`Patent RE 45,776
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`
`LIST OF EXHIBITS
`
`Exhibit Description
`1401 U.S. Patent No. RE45,776 (“the ’776 patent”)
`1402
`File history for U.S. Patent No. 8,292,850
`1403
`File history for U.S. Patent No. RE45,776
`1404 Assignment record of the ’776 patent from the USPTO assignment
`database
`1405 Declaration of Doctor Stephen JD Brecker, M.D.
`1406
`Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1407 U.S. Patent No. 7,736,355 (“Itou”)
`1408 U.S. Patent No. 7,604,612 (“Ressemann”)
`1409 U.S. Patent No. 5,439,445 (“Kontos”)
`1410
`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.
`1413 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1414 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).
`1416 US Patent Publication 2003/0233117 (“Adams ’117”)
`1417 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1411
`
`1412
`
`1415
`
`
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`IPR2020-00136
`Patent RE 45,776
`
`
`1421
`
`1424
`
`Exhibit Description
`1418 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1419 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1420 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)
`1422
`1423 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)
`1425 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1426 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1427
`Intentionally Left Blank
`1428
`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”)
`1430 U.S. Patent No. 5,413,560 (“Solar ’560”)
`1431
`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”)
`
`1429
`
`1432
`
`
`
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`Patent RE 45,776
`
`
`1440
`
`Exhibit Description
`1433 U.S. Publication Application No. 2004/0236215 (Mihara)
`1434 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1435 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1436 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1437 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1438 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1439 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)).
`1442 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1443
`Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1444 U.S. Patent No. 5,961,510 (“Fugoso”)
`1445 U.S. Patent No. 6,199,262 (“Martin”)
`1446 U.S. Patent No. 6,042,578 (“Dinh”)
`1447 WO 97/37713 (“Truckai”)
`1448
`Terumo Heartrail II product literature
`1449 Medtronic Launcher product literature
`1450 U.S. Patent No. 5,980,486 (“Enger”)
`1451 U.S. Patent No. 5,911,715 (“Berg”)
`1452 U.S. Patent No. 5,545,149 (“Brin”)
`
`1441
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`Patent RE 45,776
`
`
`Exhibit Description
`1453 U.S. Patent No. 5,720,300 (“Fagan”)
`1454 U.S. Patent No. 5,120,323 (“Shockey”)
`1455
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1456 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1457 U.S. Patent No. 5,445,625 (“Voda”)
`1458 U.S. Patent No. 6,595,952 (“Forsberg”)
`1459 U.S. Patent No. 6,860,876 (“Chen”)
`1460 U.S. Patent No. 6,638,268 (“Niazi”)
`1461 U.S. Patent No. 5,690,613 (“Verbeek”)
`1462
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1463 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1464 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
`1465 U.S. Patent No. 4,000,739 (“Stevens”)
`1466
`EP 0 881 921 B1 (“Lee”)
`1467 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1468 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)
`1470 Metz, Comparison of 6f with 7f and 8f guiding catheters for elective
`coronary angioplasty: Results of a prospective, multicenter,
`
`1469
`
`
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`IPR2020-00136
`Patent RE 45,776
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`
`1471
`
`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”)
`1472 U.S. Patent No. 5,704,926 (“Sutton”)
`1473
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`1474 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.
`1476 U.S. Patent No. 5,860,963 (“Azam”)
`1477
`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.
`1480 U.S. Patent No. 5,061,273 (“Yock”)
`1481 U.S. RE45,380 (“the ’380 patent”)
`1482 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
`
`1475
`
`1478
`1479
`
`1483
`
`
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`IPR2020-00136
`Patent RE 45,776
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`
`Exhibit Description
`1484
`Plaintiffs’ Objections and Responses to Interrogatories [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`
`
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`IPR2020-00136
`Patent RE 45,776
`
`I.
`
`PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) request inter
`
`partes review (“IPR”) of claims 25-27, 29-33, 35-37, 39, 41-49, and 52-56
`
`(“Challenged Claims”) of U.S. Patent No. RE 45,776 (“the ’776 patent,” Ex-1401).
`
`The ’776 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 the subject of 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 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
`
`
`1 The ’776 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1405, ¶¶ 71 n.6, 118. A POSITA knew that the “coaxial guide
`
`catheter” of the ’776 patent was commonly understood as a guide extension
`
`catheter because it extends the guide catheter further into the coronary artery. Id.;
`
`see also Ex-1409, 5:49-52 (referring to body 12 “as a guide catheter extension”).
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`IPR2020-00136
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`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., 8:24-35.
`
`The ’776 patent admits that the use of a guide extension catheter inside an
`
`outer guide catheter 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-catheter
`
`assembly was well known in the art and described as a “mother-and-child
`
`assembly.” Ex-1405, ¶¶ 70-80. 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. 1405, ¶ 70.
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`
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`Ex. 1454, 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 ’776 patent alleges that such a design had certain drawbacks (Ex. 1401,
`
`2:63-3:6; Ex-1405, ¶¶ 81-89) 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
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`IPR2020-00136
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`coronary artery.
`
`
`
`Ex. 1401, 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 pushrod were already well-known in the art,
`
`as evidenced by U.S. Patent No. 5,439,445 (“Kontos”), which issued more than ten
`
`years before the earliest purported priority date of the ʼ776 patent.
`
`Ex. 1409, Fig. 6B (annotations and color added).
`
`It was also evidenced by U.S. Patent No. 7,604,612 (“Ressemann”).
`
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`
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`Ex. 1408, Fig. 6B (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. Accordingly,
`
`Petitioner respectfully requests institution of a trial and cancellation/invalidation of
`
`the Challenged Claims of the ’776 patent as unpatentable under 35 U.S.C. § 103.
`
`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 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
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`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
`
`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 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
`
`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
`
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`Email: Cmorton@RobinsKaplan.com
`
`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
`
`D. Service Information
`Pursuant to 37 C.F.R. § 42.8(b)(4), please direct all correspondence to lead
`
`and back-up counsel at the above addresses. Petitioner consents to electronic
`
`service at the above-identified email addresses.
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW
`
`A. Grounds for Standing
`
`Pursuant to 37 C.F.R. § 42.104, Petitioner certifies that the ’776 patent is
`
`available for IPR and that 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, 35-37, 39,
`
`41-49, and 52-56 of the ’776 patent and cancellation of these claims as
`
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`unpatentable in view of the following grounds:2
`
`No.
`1
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`2
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`3
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`4
`
`Grounds
`Claims 25-27, 29, 33, 35-37, 39, 41-49, and 52 are rendered obvious by
`Kontos in view of Ressemann and/or the knowledge of a POSITA
`Claims 30-32 and 53-56 are rendered obvious by Kontos in view of
`Ressemann, Takahashi, and/or the knowledge of a POSITA
`Claim 52 is rendered obvious by Kontos in view of Ressemann, Kataishi,
`and/or the knowledge of a POSITA
`Claims 53-56 are rendered obvious by Kontos in view of Ressemann,
`Takahashi, Kataishi, and/or the knowledge of a POSITA
`
`
`IV. BACKGROUND
`A. Overview of the Technology
`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
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`arterial lumen. Ex-1405, ¶¶ 28, 30-32. This narrowing, sometimes called a stenosis,
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`restricts blood flow and increases the risk of heart attack or stroke. Id. In response,
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`physicians developed percutaneous coronary interventional (“PCI”) procedures
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`that use catheter-based technologies inserted through the femoral or radial artery,
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`2 This Petition is also supported by the Declarations of Stephen JD Brecker, MD
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`(Ex-1405), and Dr. Richard A. Hillstead (Ex-1442), as experts in the field of the
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`’776 patent. Petitioner also submits the declaration of Sylvia S. Hall-Ellis, PhD
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`(Ex-1478) to support the authenticity and public availability of the documents cited
`
`herein.
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`and thus can treat CAD without the need for open-heart surgery. Ex. 1405, ¶¶ 29,
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`34-40.
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`PCI was developed more than forty years ago, and although its catheter-
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`based technology has advanced, the basic components of PCI have remained
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`largely unchanged. Id., ¶¶ 33, 41. During PCI, after a physician uses a hollow
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`needle to gain access to the patient’s vasculature, a guide catheter is introduced and
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`advanced along the vasculature until its distal end is placed—by a few
`
`millimeters—in the ostium of a coronary artery. Id., ¶¶ 34, 42-55. A hemostatic
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`valve is placed at the proximal end of 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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`Another small diameter flexible guidewire can then be threaded through the
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`lumen of the guide catheter to the target site. Id., ¶¶ 56-58. This guidewire serves
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`as a guiderail to advance a therapeutic catheter through the guide catheter and to
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`the occlusion. Id. The therapeutic catheter typically must then be passed through
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`and beyond the occlusion in order to alleviate the stenosis. Id., ¶¶ 59-67. This last
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`step—crossing the therapeutic catheter past the occlusion—creates backward force
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`that can dislodge the guide catheter from the ostium. Id., ¶¶ 66-67. As discussed
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`above, one way to ameliorate this backward force is to use a mother-and-child
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`catheter assembly where the child catheter acts as an extension of the guide
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`catheter into the coronary artery. Id., ¶¶ 68-80.
`
`B. Overview of the ’776 Patent
`The ’776 patent relates “generally to catheters used in interventional
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`cardiology procedures.” Ex. 1401, 1:37-38. In particular, the ’776 patent discloses
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`a coaxial guide catheter (also known as an extension catheter) that extends
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`“beyond the distal end of the guide catheter and . . . into [a] branch artery.” Id.,
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`Abstract. The catheter assembly purports to have the benefit of a mother-and-child
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`assembly—it “assists in resisting both the axial forces and the shearing forces that
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`tend to dislodge a guide catheter from the ostium of a branch artery.” Id., 5:30-34;
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`Ex-1405, ¶¶ 118-19.
`
`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). Ex-1405, ¶ 120.
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`Id., 13:36-52, Fig. 1 (color added).
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`The ʼ776 patent also recites “a partially cylindrical opening positioned
`
`between a distal end of the substantially rigid segment and a proximal end of the
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`tubular structure.” Id., 13:36-49. The specification, however, provides no written
`
`description support for the placement of this feature and, as shown below, only
`
`describes the partially cylindrical opening (red circle) positioned in the
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`substantially rigid segment 20. Ex-1405, ¶ 121.
`
`
`
`
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`Ex. 1401, Fig. 4 (annotations and color added).
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`Regardless, as shown below, the ’776 patent describes that extension
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`catheter 12 is deployed through guide catheter 56 (no color). A guidewire 64 and
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`balloon (green) extend from the distal tip (pink) of the extension catheter. Moving
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`distally to proximally, the extension catheter’s tip (pink) and tubular portion (blue)
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`extend out of the distal tip of guide catheter 56. Ex-1405, ¶ 122.
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`
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`Ex. 1401, Fig. 9 (color added).
`
`C. Prosecution History of the ’776 Patent
`The parent ʼ850 patent issued without an Office Action. See generally Ex.
`
`1402. According to the Examiner, the claims of the ʼ850 patent were allowable
`
`because “adding a guide catheter to the claimed rail structure with the claimed
`
`flexible tip that is insertable through a hemostatic valve is not taught or suggested
`
`by the prior art.” Id. at 83 (Notice of Allowance at 3). In other words, he believed
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`that a mother-and-child assembly—where the child catheter is characterized by a
`
`short distal lumen coupled to a proximally located pushrod—was not described in
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`the art. The Examiner, however, was not aware of Kontos or Ressemann. Patent
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`Owner sought reissuance in 2014. As with the original prosecution, the claims of
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`the ’776 patent issued without any substantive Office Action rejecting the claims
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`as unpatentable. See generally Ex. 1403.
`
`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 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