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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.: IPR2020-00127
`U.S. Patent No. 8,048,032
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,048,032
`
`

`

`IPR2020-00127
`Patent 8,048,032
`
`
`TABLE OF CONTENTS
`
`Page
`I. PRELIMINARY STATEMENT .................................................................... 1
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 .................................. 4
`A. Real Party-in-Interest ..................................................................................... 4
`B. Related Matters .............................................................................................. 4
`C. Lead and Backup Counsel ............................................................................. 5
`D. Service Information ....................................................................................... 6
`III. REQUIREMENTS FOR INTER PARTES REVIEW ................................. 6
`A. Grounds for Standing ..................................................................................... 6
`B. Precise Relief Requested and Asserted Grounds ........................................... 6
`IV. BACKGROUND .............................................................................................. 7
`A. Overview of the Technology ......................................................................... 7
`B. Overview of the ’032 Patent .......................................................................... 8
`C. Prosecution History of the ’032 Patent ........................................................11
`V. PERSON OF ORDINARY SKILL IN THE ART ......................................12
`VI. CLAIM CONSTRUCTION ..........................................................................13
`A. “standard guide catheter” (cl. 1, 11) ............................................................14
`B.
`“placed in a branch artery” (cl. 1, 11) ..........................................................15
`C.
`“flexural modulus” (cl. 19) ..........................................................................16
`VII. GROUND I: KONTOS RENDERS CLAIMS 1-7, 9, 11-16, AND 18-19
`OBVIOUS IN VIEW OF ADAMS AND/OR THE KNOWLEDGE OF A
`POSITA. ..................................................................................................................17
`A. Prior Art .......................................................................................................17
`1. Kontos ......................................................................................................17
`2. Adams ......................................................................................................20
`B. Claim 1 .........................................................................................................22
`1.
`[1.pre.I] .....................................................................................................22
`2.
`[1.pre.II] ...................................................................................................23
`
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`IPR2020-00127
`Patent 8,048,032
`
`3.
`[1.pre.III] ..................................................................................................27
`[1.a] ..........................................................................................................29
`4.
`[1.b] ..........................................................................................................31
`5.
`C. Claim 2 .........................................................................................................39
`D. Claim 3 .........................................................................................................41
`E. Claim 4 .........................................................................................................47
`F. Claim 5 .........................................................................................................48
`G. Claim 6 .........................................................................................................49
`H. Claim 7 .........................................................................................................52
`I.
`Claim 9 .........................................................................................................53
`J.
`Claim 11 .......................................................................................................54
`[11.pre.I]...................................................................................................54
`1.
`[11.pre.II] .................................................................................................55
`2.
`[11.pre.III] ................................................................................................55
`3.
`[11.a] ........................................................................................................55
`4.
`[11.b] ........................................................................................................56
`5.
`[11.c] ........................................................................................................57
`6.
`[11.d] ........................................................................................................59
`7.
`K. Claim 12 .......................................................................................................64
`L. Claim 13 .......................................................................................................65
`M. Claim 14 .......................................................................................................66
`N. Claim 15 .......................................................................................................67
`O. Claim 16 .......................................................................................................67
`P. Claim 18 .......................................................................................................67
`Q. Claim 19 .......................................................................................................68
`VIII. GROUND II: CLAIMS 8 AND 17 ARE RENDERED OBVIOUS BY
`KONTOS IN VIEW OF ADAMS, TAKAHASHI, AND/OR THE
`KNOWLEDGE OF A POSITA. ...........................................................................69
`A. Takahashi .....................................................................................................69
`B. Claim 8 .........................................................................................................70
`
`ii
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`IPR2020-00127
`Patent 8,048,032
`
`C. Claim 17 .......................................................................................................72
`IX. GROUND III: CLAIM 20 IS RENDERED OBVIOUS BY KONTOS IN
`VIEW OF ADAMS, BERG, AND/OR THE KNOWLEDGE OF A POSITA. 73
`A. Berg ..............................................................................................................73
`B. Claim 20 .......................................................................................................73
`X. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ............75
`XI. CONCLUSION...............................................................................................76
`XII. PAYMENT OF FEES (37 C.F.R. § 42.103)………………………………...76
`
`iii
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`

`IPR2020-00127
`Patent 8,048,032
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Boston Scientific Corp. v. Vascular Solutions, Inc.,
`IPR2014-00760, IPR2014-00761 (P.T.A.B., terminated Aug. 11,
`2014) ..................................................................................................................... 5
`Google LLC v. Pers. Audio, LLC,
`743 F. App’x 978 (Fed. Cir. 2018) ..................................................................... 50
`In re Harris,
`409 F.3d 1339 (Fed. Cir. 2005) .......................................................................... 75
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .................................................................... 39, 67
`KSR Int’l co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ....................................................................26, 29, 30, 35, 37
`Laryngeal Mask Co. v. Ambu, A/S,
`618 F.3d 1367 (Fed. Cir. 2010) .......................................................................... 16
`Microsoft Corp. v. Parallel Networks Licensing LLC,
`IPR2015-00483, Paper 10 (P.T.A.B. July 15, 2015) .......................................... 21
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 13
`Synaptic Medical Inc. v. Karl Storz-Endoscopy-America, Inc.,
`IPR2018-00462, Paper 6 (P.T.A.B. July 16, 2018) ............................................ 21
`Zip-Top LLC v. Stasher, Inc.,
`IPR2018-01216, Paper 14 (P.T.A.B. Jan. 17, 2019) .......................................... 20
`Statutes
`35 U.S.C. § 325(d) ....................................................................................... 20, 21, 70
`
`
`
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`IPR2020-00127
`Patent 8,048,032
`
`
`LIST OF EXHIBITS
`
`Exhibit Description
`1401 U.S. Patent No. 8,048,032 (“the ’032 patent”)
`1402
`File history for U.S. Patent No. 8,292,850
`1403
`File history for U.S. Patent No. 8,048,032
`1404 Assignment record of the ’032 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
`
`
`
`v
`
`

`

`IPR2020-00127
`Patent 8,048,032
`
`
`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 U.S. Patent No. RE45,776 (“Root”)
`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
`
`
`
`vi
`
`

`

`IPR2020-00127
`Patent 8,048,032
`
`
`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
`
`
`
`vii
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`

`IPR2020-00127
`Patent 8,048,032
`
`
`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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`

`IPR2020-00127
`Patent 8,048,032
`
`
`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
`
`
`
`ix
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`

`IPR2020-00127
`Patent 8,048,032
`
`
`Exhibit Description
`1484
`Plaintiffs’ Objections and Responses to Interrogatories [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`
`
`
`
`
`
`x
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`

`

`IPR2020-00127
`Patent 8,048,032
`
`I.
`
`PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) request inter
`
`partes review (“IPR”) of claims 1-9 and 11-20 (“Challenged Claims”) of U.S. Pat.
`
`No. 8,048,032 (“the ’032 patent,” Ex-1401). The ’032 patent is entitled Coaxial
`
`Guide Catheter for Interventional Cardiology Procedures and lists Howard Root et
`
`al. as inventors. Id., [54], [75].
`
`The ’032 patent describes a catheter assembly 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,” thereby preventing the GC from dislodging from the ostium. Id., 2:45-50.
`
`
`1 The ’032 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1405, ¶¶ 71 n.8, 118. A POSITA knew that the “coaxial guide
`
`catheter” of the ’032 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”).
`
`
`
`1
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`

`

`IPR2020-00127
`Patent 8,048,032
`
`
`The ’032 patent admits that the use of a guide extension catheter inside an
`
`outer guide catheter was known. Id., 2:17-33 (describing the use of a “smaller
`
`guide catheter within a larger guide catheter”). Indeed, such a catheter-in-a-catheter
`
`assembly was well-known in the art 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. Id., ¶ 70.
`
`
`
`Ex-1454, Fig. 2 (color and labels added).
`
`
`
`2
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`

`

`IPR2020-00127
`Patent 8,048,032
`
`
`
`The child catheter in the mother-and-child assembly had a continuous lumen
`
`that was longer than the lumen of the guide (“mother”) catheter. Id. The ’032
`
`patent alleges that such a design had certain drawbacks (Ex-1401, 2:34-44; 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., a
`
`tube) that is highly flexible so it can extend deep into the 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 ʼ032 patent.
`
`
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`3
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`IPR2020-00127
`Patent 8,048,032
`
`
`
`
`Ex-1409, 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 ’032 patent are unpatentable. Accordingly,
`
`Petitioner respectfully requests institution of a trial and cancellation/invalidation of
`
`the Challenged Claims.
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`A. Real Party-in-Interest
`Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner identifies Medtronic, Inc. and
`
`Medtronic Vascular, Inc. as real parties-in-interest. Medtronic plc is the ultimate
`
`parent of both entities.
`
`B. Related Matters
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner identifies that the ’032 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,
`
`
`
`4
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`

`IPR2020-00127
`Patent 8,048,032
`
`LLC v. Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017)
`
`(“QXMedical Litigation”).
`
`The ʼ032 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., IPR2014-00760,
`
`IPR2014-00761 (P.T.A.B., terminated Aug. 11, 2014).
`
`Petitioner is also concurrently filing another petition for IPR challenging the
`
`ʼ032 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
`Email: Cmorton@RobinsKaplan.com
`
`Additional Back-Up Counsel
`Christopher A. Pinahs (Reg. No.
`76,375)
`ROBINS KAPLAN LLP
`
`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
`
`
`
`5
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`

`

`IPR2020-00127
`Patent 8,048,032
`
`
`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 ’032 patent is
`
`available for IPR and that Petitioner is not barred or estopped from requesting such
`
`review on the identified grounds.
`
`B. Precise Relief Requested and Asserted Grounds
`Petitioner respectfully requests review of claims 1-9 and 11-20 of the ’032
`
`patent and cancellation of these claims as unpatentable in view of the following
`
`grounds:2
`
`
`2 This petition is also supported by the Declarations of Stephen JD Brecker, MD
`
`(Ex-1405) and Richard A. Hillstead, PhD (Ex-1442), as experts in the field of the
`
`
`
`6
`
`

`

`IPR2020-00127
`Patent 8,048,032
`
`
`No.
`1
`
`2
`
`3
`
`Grounds
`Claims 1-7, 9, 11-16, and 18-19 are rendered obvious by Kontos in
`view of Adams and/or the knowledge of a POSITA.
`Claims 8 and 17 are rendered obvious by Kontos in view of Adams,
`Takahashi, and/or the knowledge of a POSITA.
`Claim 20 is rendered obvious by Kontos in view of Adams, 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-1405, ¶¶ 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,
`
`and thus can treat CAD without the need for open-heart surgery. Ex-1405, ¶¶ 29,
`
`34-40.
`
`PCI was developed more than forty years ago, and although its catheter-
`
`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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`’032 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
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`herein.
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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
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`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.
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`B. Overview of the ’032 Patent
` The ’032 patent relates “generally to catheters used in interventional
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`cardiology procedures.” Ex-1401, 1:7-8. In particular, the ’032 patent discloses a
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`coaxial guide catheter (also known as an extension catheter) that extends “beyond
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`the distal end of the guide catheter, and … into [a] branch artery.” Id., Abstract.
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`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., 4:66-5:3;
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`Ex-1405, ¶¶ 118-19.
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`The ’032 patent explains that the guide extension catheter 12 has a tubular
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`portion that includes flexible distal tip 16 (pink) and reinforced portion 18 (blue),
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`as well as rigid portion 20 (yellow). Id., 3:28-30, 6:9-12, Fig. 1. Color has been
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`added to Figure 1, below, which has been annotated with the language of the
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`claims.3 Ex-1405, ¶ 120.
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`3 In claim 1, “a flexible tip portion” defines “a tubular structure.” Ex-1401, 10:29.
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`The “tubular structure” in claim 1 further “includes a flexible cylindrical distal tip
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`portion (pink) and a flexible cylindrical reinforced portion (blue) (claim 6).” Id.,
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`11:10-13. Claim 11 describes the guide extension catheter using different
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`language. Specifically, claim 11 recites “a flexible tip portion defining a tubular
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`structure,” and a “reinforced portion” that is proximal to the flexible tip portion.
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`Id., 11:39, 50 (corresponding, respectively, to the pink and blue portions of
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`annotated Fig. 1).
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`Id., Fig. 1 (annotations and color added).
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`The patent also addresses structural characteristics of the transition at or near
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`the extension catheter’s reinforced and rigid portions, sometimes referred to as a
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`“side opening” (red circle), which may have an “inclined slope.” Id., Figs. 4, 13-
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`16, 6:38-54, Ex-1405, ¶ 121.
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`Id., Fig. 4 (annotations and color added).
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`As shown below, the ’032 patent describes that extension catheter 12 is
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`deployed through guide catheter 56 (no color). A guidewire 64 and balloon (green)
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`extend from the distal tip (pink) of the extension catheter. Moving distally to
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`proximally, the extension catheter’s distal tip (pink) and a reinforced portion (blue)
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`extend out of the distal tip of guide catheter 56. Ex-1405, ¶ 122.
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`Ex-1401, Fig. 9 (color added).
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`Prosecution History of the ’032 Patent
`C.
`The Examiner found the claims of the ʼ032 patent allowable because
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`“[w]hile many of the structures were known, the arrangement of a claimed rail
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`structure4 with the claimed flexible tip that is insertable through a hemostatic valve
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`is not taught or suggested by the prior art.” Ex-1402 at 347 (Notice of Allowability
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`at 2). In other words, she believed that a mother-and-child assembly—where the
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`child catheter is characterized by a short distal lumen coupled to a proximally
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`located pushrod—was not described in the art. Ex-1405, ¶¶ 115-17. The Examiner,
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`however, was not aware of Kontos.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
`If a person of ordinary skill in the art (“POSITA”) was a medical doctor,
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`s/he would have had (a) a medical degree, (b) completed a coronary intervention
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`training program, and (c) experience working as an interventional cardiologist.
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`Alternatively, if a POSITA was an engineer s/he would have had (a) an
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`undergraduate degree in engineering, such as mechanical or biomedical
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`engineering; and (b) at least three years of experience designing medical devices,
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`including catheters or catheter-deployable devices. Extensive experience and
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`technical training might substitute for education, and advanced degrees might
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`substitute for experience. Additionally, a POSITA with a medical degree may have
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`access to a POSITA with an engineering degree, and a POSITA with an
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`engineering degree may have access to one with a medical degree. Ex-1405, ¶ 27;
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`4 See Section VI, infra (construing “rail structure”).
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`Ex-1442, ¶¶ 18-19.
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`VI. CLAIM CONSTRUCTION
`Claim terms are typically given their ordinary and customary meanings as
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`would have been understood by a POSITA at the time of the invention, having
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`taken into consideration the language of the claims, the specification, and the
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`prosecution history of record. Phillips v. AWH Corp., 415 F.3d 1303, 1312-16
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`(Fed. Cir. 2005) (en banc). When, as here, claim terms have been construed by a
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`district court, those constructions are properly considered during an IPR. 37 C.F.R.
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`§ 42.100(b). In the QXMedical Litigation, Patent Owner stipulated to the following
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`constructions:
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`• “reinforced portion”: “portion made stronger by additional material or
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`support” (Ex-1412 at 2)
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`• “interventional cardiology device(s)”: “devices including, but not limited
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`to, guidewires, balloon catheters, stents, and stent catheters” (Compare
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`Ex-1412 at 21 (Dkt. 36-1), with Ex-1464 at 1 n.1)
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`Further, Patent Owner advanced, 5 and the district court adopted, the following
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`constructions:
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`5 The full list of constructions advanced by Patent Owner in the QXMedical
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`Litigation is found at Ex-1412 (Dkt. 36-1).
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`• “substantially rigid”: “rigid enough to allow the device to be advanced
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`within the guide catheter” (Ex-1412 at 2 (Dkt. 36-1); Ex-1413 at 15)
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`• “rail structure”: “structure that facilitates monorail or sliding rail
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`delivery” (Ex-1413 at 20)
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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
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`ordinary meaning” (Id., 26)
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`• “lumen”: “the cavity of a tube” (Id., 25).
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`Petitioner agrees with the above construct