`
`
`
`
`
`
`
`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.: IPR2020-00126
`U.S. Patent No. 8,048,032
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,048,032
`
`

`

`IPR2020-00126
`Patent 8,048,032
`
`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 ....................................................................................... 6
`III. REQUIREMENTS FOR INTER PARTES REVIEW ............................. 6
`A. Grounds for Standing ..................................................................................... 6
`B. Precise Relief Requested and Asserted Grounds ........................................... 7
`IV.
`BACKGROUND .......................................................................................... 7
`A. Overview of the Technology ......................................................................... 7
`B. Overview of the ’032 Patent .......................................................................... 9
`C. Prosecution History of the ’032 Patent ........................................................12
`D. Priority Date ...............................................................................................14
`V. THE PERSON OF ORDINARY SKILL IN THE ART ............................14
`VI.
`CLAIM CONSTRUCTION ......................................................................15
`A. “standard guide catheter” (cl. 1, 11) ............................................................17
`B.
`“placed in a branch artery” (cl. 1, 11) ..........................................................17
`C.
`“flexural modulus” (cl. 19, 20) ....................................................................18
`VII. GROUND 1: ITOU ANTICIPATES CLAIMS 1-19 AND 22. ..............19
`A. Overview of Itou ..........................................................................................19
`B. Claim 1 .........................................................................................................22
`1.
`[1.pre.I] .....................................................................................................22
`2.
`[1.pre.II] ...................................................................................................22
`3.
`[1.pre.III] ..................................................................................................25
`4.
`[1.a] ..........................................................................................................26
`5.
`[1.b] ..........................................................................................................28
`C. Claim 2 .........................................................................................................35
`
`
`
`i
`
`

`

`IPR2020-00126
`Patent 8,048,032
`D. Claim 3. ........................................................................................................39
`E. Claim 4 .........................................................................................................43
`F. Claim 5. ........................................................................................................43
`G. Claim 6 .........................................................................................................44
`H. Claim 7. ........................................................................................................46
`I. Claim 8. ........................................................................................................47
`J. Claim 9. ........................................................................................................48
`K. Claim 10 .......................................................................................................51
`L. Claim 11 .......................................................................................................51
`1.
`[11.pre.I]...................................................................................................51
`2.
`[11.pre.II] .................................................................................................52
`3.
`[11.pre.III] ................................................................................................52
`4.
`[11.a] ........................................................................................................52
`5.
`[11.b] ........................................................................................................53
`6.
`[11.c] ........................................................................................................55
`7.
`[11.d] ........................................................................................................56
`M. Claim 12. ......................................................................................................58
`N. Claim 13. ......................................................................................................59
`O. Claim 14. ......................................................................................................60
`P. Claims 15-18 ................................................................................................62
`Q. Claim 19. ......................................................................................................63
`R. Claim 22 .......................................................................................................65
`VIII. GROUND II: CLAIMS 3, 13, AND 14 ARE RENDERED OBVIOUS
`BY ITOU IN VIEW OF RESSEMANN AND/OR THE COMMON
`KNOWLEDGE OF A POSITA. ...........................................................................65
`A. Overview of Ressemann ..............................................................................65
`B. Claim 3 .........................................................................................................67
`C. Claim 13 .......................................................................................................72
`D. Claim 14 .......................................................................................................75
`IX. GROUND III: ITOU RENDERS CLAIM 20 OBVIOUS IN VIEW OF
`BERG AND THE COMMON KNOWLEDGE OF A POSITA. .......................76
`
`
`
`ii
`
`

`

`IPR2020-00126
`Patent 8,048,032
`A. Overview of Berg .........................................................................................76
`B. Claim 20 .......................................................................................................77
`X. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ............79
`XI.
`CONCLUSION ..........................................................................................80
`XII. PAYMENT OF FEES (37 C.F.R. § 42.103) .............................................80
`
`
`
`
`
`
`
`
`
`iii
`
`

`

`IPR2020-00126
`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
`In re Harris,
`409 F.3d 1339 (Fed. Cir. 2005) .......................................................................... 80
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .............................................................. 37, 42, 62
`Laryngeal Mask Co. v. Ambu, A/S,
`618 F.3d 1367 (Fed. Cir. 2010) .......................................................................... 18
`Legget & Platt, Inc. v. VUTEK, Inc.,
`537 F.3d 1349 (Fed. Cir. 2008) .................................................................... 22, 46
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 15
`
`
`
`
`
`
`iv
`
`

`

`IPR2020-00126
`Patent 8,048,032
`
`LIST OF EXHIBITS
`
`Exhibit Description
`1001 U.S. Patent No. 8,048,032 (“the ’032 patent”)
`1002
`File history for U.S. Patent No. 8,292,850
`1003
`File history for U.S. Patent No. 8,048,032
`1004 Assignment record of the ’032 patent from the USPTO assignment
`database
`1005 Declaration of Doctor Stephen JD Brecker, M.D.
`1006
`Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1007 U.S. Patent No. 7,736,355 (“Itou”)
`1008 U.S. Patent No. 7,604,612 (“Ressemann”)
`1009 U.S. Patent No. 5,439,445 (“Kontos”)
`1010
`New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions
`63: 452-456 (2004) (“Takahashi”)
`Excerpt of prosecution history of U.S. Patent No. 8,048,032
`(Application 11/416,629) (Amendment and Response, April 6, 2009)
`Joint Claim Construction Statement in QXMedical, LLC v. Vascular
`Solutions, Inc., D. Minn., No. 17-cv-01969 (January 10, 2018), D.I.
`36; D.I. 36-1.
`1013 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1014 Meads, C., et al., Coronary artery stents in the treatment of ischaemic
`heart disease: a rapid and systematic review, Health Technology
`Assessment 2000 4(23) (“Meads”)
`Excerpt from Grossman’s Cardiac Catheterization, Angiography, and
`Intervention (6th edition) (2000) (chapters 1, 4, 11, 23-25).
`1016 US Patent Publication 2003/0233117 (“Adams ’117”)
`1017 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1011
`
`1012
`
`1015
`
`
`
`v
`
`

`

`1021
`
`1024
`
`IPR2020-00126
`Patent 8,048,032
`Exhibit Description
`1018 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1019 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1020 Mehan, Coronary Angioplasty through 4 French Diagnostic
`Catheters, Catheterization and Cardiovascular Interventions 30:22-26
`(1993) (“Mehan”)
`Excerpt of prosecution history for application 11/232,876 (Office
`Action, 6/20/09)
`Cordis, Instructions for Use, CYPHER™ (April 2003)
`1022
`1023 Medtronic, Summary of Safety and Effectiveness Data, Driver™
`Coronary Stent System (October 1, 2003)
`Boston Scientific, Summary of Safety and Effectiveness Data,
`TAXUS™ Express2™ Drug-Eluting Coronary Stent System (March
`4, 2004)
`1025 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1026 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1027 U.S. Patent No. RE45,776 (“Root”)
`1028
`Baim, Randomized Trial of a Distal Embolic Protection Device
`During Percutaneous Intervention of Saphenous Vein Aorto-
`Coronary Bypass Grafts, Circulation 105:1285-1290 (2002) (“Baim”)
`Limbruno, Mechanical Prevention of Distal Embolization During
`Primary Angioplasty, Circulation 108:171-176 (2003) (“Limbruno”)
`1030 U.S. Patent No. 5,413,560 (“Solar ’560”)
`1031
`Schöbel, Percutaneous Coronary Interventions Using a New 5
`French Guiding Catheter: Results of a Prospective Study,
`Catheterization & Cardiovascular Interventions 53:308-312 (2001)
`(“Schöbel”)
`The sliding rail system (monorail): description of a new technique for
`intravascular instrumentation and its application to coronary
`angioplasty, Z. Kardio. 76:Supp. 6, 119-122 (1987) (“Bonzel”)
`1033 U.S. Publication Application No. 2004/0236215 (Mihara)
`
`1029
`
`1032
`
`
`
`vi
`
`

`

`1040
`
`IPR2020-00126
`Patent 8,048,032
`Exhibit Description
`1034 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1035 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1036 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1037 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1038 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1039 Urban et al., Coronary stenting through 6 French Guiding Catheters,
`Catheterization and Cardiovascular Diagnosis (1993) 28:263-266
`Excerpt of McGraw-Hill Dictionary of Scientific and Technical
`Terms (5th edition) (1994) (defining “flexural modulus”)
`Excerpt from Kern’s The Interventional Cardiac Catheterization
`Handbook (2nd edition) (2004) (chapter 1)).
`1042 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1043
`Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1044 U.S. Patent No. 5,961,510 (“Fugoso”)
`1045 U.S. Patent No. 6,199,262 (“Martin”)
`1046 U.S. Patent No. 6,042,578 (“Dinh”)
`1047 WO 97/37713 (“Truckai”)
`1048
`Terumo Heartrail II product literature
`1049 Medtronic Launcher product literature
`1050 U.S. Patent No. 5,980,486 (“Enger”)
`1051 U.S. Patent No. 5,911,715 (“Berg”)
`1052 U.S. Patent No. 5,545,149 (“Brin”)
`1053 U.S. Patent No. 5,720,300 (“Fagan”)
`
`1041
`
`
`
`vii
`
`

`

`IPR2020-00126
`Patent 8,048,032
`Exhibit Description
`1054 U.S. Patent No. 5,120,323 (“Shockey”)
`1055
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1056 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1057 U.S. Patent No. 5,445,625 (“Voda”)
`1058 U.S. Patent No. 6,595,952 (“Forsberg”)
`1059 U.S. Patent No. 6,860,876 (“Chen”)
`1060 U.S. Patent No. 6,638,268 (“Niazi”)
`1061 U.S. Patent No. 5,690,613 (“Verbeek”)
`1062
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1063 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1064 QXMédical, LLC’s Opening Claim Construction
`Memorandum QXMedical, LLC v. Vascular Solutions, Inc., D. Minn.,
`No. 17-cv-01969 (March 14, 2018), D.I. 56
`1065 U.S. Patent No. 4,000,739 (“Stevens”)
`1066
`EP 0 881 921 B1 (“Lee”)
`1067 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1068 Defendants’ Memorandum in Opposition to Plaintiff’s Summary
`Judgment Motion and in Support of Defendants’ Summary Judgment
`Motion, QXMedical, LLC v. Vascular Solutions LLC et al., 17-cv-
`01969-PJS-TNL (D. Minn 2019)
`Excerpt of prosecution history for application 14/195,435 (Office
`Action, 10/06/15)
`1070 Metz, Comparison of 6f with 7f and 8f guiding catheters for elective
`coronary angioplasty: Results of a prospective, multicenter,
`randomized trial, American Heart Journal. Vol. 134, Number 1, pp
`132-137 (“Metz”)
`
`1069
`
`
`
`viii
`
`

`

`IPR2020-00126
`Patent 8,048,032
`Exhibit Description
`1071
`Feldman, Coronary Angioplasty Using New 6 French Guiding
`Catheters, Catheterization and Cardiovascular Diagnosis 23:93-99
`(1991) (“Feldman”)
`1072 U.S. Patent No. 5,704,926 (“Sutton”)
`1073
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`1074 Yokoyama, Feasibility and safety of thrombectomy with TVAC
`aspiration catheter system for patients with acute myocardial
`infarction, Heart Vessels (2006) 21:1–7 (“Yokoyama”)
`Excerpt from Plaintiff’s infringement allegations in Vascular
`Solutions, LLC. v. Medtronic, Inc., D. Minn., No. 19-cv-01760
`(October 11, 2019), D.I. 1-14.
`1076 U.S. Patent No. 5,860,963 (“Azam”)
`1077
`10/16/2019 Deposition of Peter Keith in Vascular Solutions, LLC. v.
`Medtronic, Inc., D. Minn., No. 19-cv-01760
`Sylvia Hall-Ellis’s Librarian Declaration
`Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`1080 U.S. Patent No. 5,061,273 (“Yock”)
`1081 U.S. RE45,380 (“the ’380 patent”)
`1082 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC et al. v. Medtronic,
`Inc., 19:cv-01760-PJS-TNL (July 12, 2019)
`Joint Fed. R. C. P. 26(f) Report [Excerpt], Vascular Solutions LLC et
`al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`Plaintiffs’ Objections and Responses to Interrogatories [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`1075
`
`1078
`1079
`
`1083
`
`1084
`
`
`
`
`
`
`ix
`
`

`

`IPR2020-00126
`Patent 8,048,032
`PRELIMINARY STATEMENT
`I.
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) requests inter
`
`partes review (“IPR”) of claims 1-20, and 22 (“Challenged Claims”) of U.S. Pat.
`
`No. 8,048,032 (“the ’032 patent,” Ex-1001). The ’032 patent is entitled Coaxial
`
`Guide Catheter for Interventional Cardiology Procedures and lists Howard Root et
`
`al. as inventors. Id., [54], [75]. The ʼ032 patent was filed on May 3, 2006. Id., [22].
`
`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
`
`
`1 The ’032 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1005, ¶¶ 76 n.7, 131. 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-1009, 5:49-52 (referring to body 12 “as a guide catheter extension”).
`
`
`
`1
`
`

`

`IPR2020-00126
`Patent 8,048,032
`artery,” thereby preventing the GC from dislodging from the ostium. Id., 2:45-50;
`
`see also id., 7:60-8:5.
`
`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 as a “mother-and-child assembly” (Ex-1005,
`
`¶¶ 74-85, 104-09), 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. Id.,
`
`¶ 74.
`
`
`
`2
`
`
`
`

`

`IPR2020-00126
`Patent 8,048,032
`Ex-1054, 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 ’032 patent alleges that such a design had certain drawbacks (Ex-1001,
`
`2:34-44; Ex-1005, ¶¶ 86-94) 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-1001, Fig. 1 (annotations and color added).
`
`But child catheters with a short lumen connected to a long thin pushrod were
`
`already well-known in the art, as evidenced by U.S. Patent No. 7,736,355 (“Itou”)
`
`
`
`(Ex-1007).
`
`
`
`3
`
`

`

`IPR2020-00126
`Patent 8,048,032
`
`Ex-1007, Fig. 5 (annotations and color added); see, infra, § VII.A.
`
`It was also evidenced by U.S. Patent No. 7,604,612 (“Ressemann”).
`
`
`
`
`
`Ex-1008, Fig. 6E (annotations and color added), see, infra, § VIII.A.
`
`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 under 37 C.F.R. Part 42 and
`
`cancellation/invalidation of the Challenged Claims.
`
`
`
`4
`
`

`

`IPR2020-00126
`Patent 8,048,032
`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 ’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,
`
`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.
`
`
`
`5
`
`

`

`IPR2020-00126
`Patent 8,048,032
`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
`
`Back-Up Counsel
`Sharon Roberg-Perez (Reg. No. 69,600)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email: Sroberg-
`perez@robinskaplan.com
`
`Additional Back-Up Counsel
`Christopher A. Pinahs (Reg. No.
`76,375)
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 612.349.8500
`Fax: 612.339.4181
`Email:
`Cpinahs@RobinsKaplan.com
`
`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
`
`
`
`6
`
`

`

`IPR2020-00126
`Patent 8,048,032
`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 1-20 and 22 of the ’032
`
`patent and cancellation of these claims as unpatentable in view of the following
`
`grounds2:
`
`No.
`1
`2
`
`3
`
`
`IV. BACKGROUND
`
`Grounds
`Claims 1-19 and 22 are anticipated by U.S. 7,736,355 (“Itou”).
`Claims 3, 13, and 14 are rendered obvious by Itou in view of U.S.
`7,604,612 (“Ressemann”) and the knowledge of a POSITA.
`Claim 20 is rendered obvious by Itou in view of U.S. 5,911,715
`(“Berg”) and the knowledge of a POSITA.
`
`A. Overview of the Technology
`
`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
`
`arterial lumen. Ex-1005, ¶¶ 32-36. This narrowing, sometimes called a stenosis,
`
`restricts blood flow and increases the risk of heart attack or stroke. Id. In response,
`
`
`2 This petition is also supported by the Declarations of Dr. Stephen JD Brecker,
`
`MD (Ex-1005), and Dr. Richard A. Hillstead (Ex-1042), as experts in the field of
`
`the ’032 patent. Petitioner also submits the declaration of Sylvia D. Hall-Ellis, PhD
`
`(Ex-1078) to support the authenticity and public availability of the documents cited
`
`herein.
`
`
`
`7
`
`

`

`IPR2020-00126
`Patent 8,048,032
`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-1005, ¶¶ 33,
`
`38-44.
`
`PCI was developed more than forty years ago, and although its
`
`catheter-based technology has advanced, the basic components of PCI have
`
`remained largely unchanged. Ex-1005, ¶¶ 37, 45. During PCI, after a physician
`
`uses a hollow needle to gain access to the patient’s vasculature, a guide catheter is
`
`introduced and advanced along the vasculature until its distal end is placed—by a
`
`few millimeters—in the ostium of the coronary artery. Id., ¶¶ 38, 46-59. A
`
`hemostatic valve is placed at the proximal end of the guide catheter and remains
`
`outside the patient’s body. Id., ¶¶ 39, 58. The hemostatic valve prevents blood
`
`from exiting the patient’s artery and keeps air from entering the bloodstream. Id.
`
`Another small diameter flexible guidewire can then be threaded through the
`
`lumen of the guide catheter to the target site. Id., ¶¶ 60-62. This guidewire serves
`
`as a guiderail to advance a therapeutic catheter through the guide catheter and to
`
`the occlusion. Id. The therapeutic catheter typically must then be passed through
`
`and beyond the occlusion in order to alleviate the stenosis. Id., ¶¶ 63-69. This last
`
`step—crossing the therapeutic catheter past the occlusion—creates backward force
`
`that can dislodge the guide catheter from the ostium. Id., ¶¶ 70-71. As discussed
`
`
`
`8
`
`

`

`IPR2020-00126
`Patent 8,048,032
`above, one way to ameliorate this backward force is to use a mother-and-child
`
`catheter assembly where the child catheter acts as an extension of the guide
`
`catheter into the coronary artery. Id., ¶¶ 72-85.
`
`B. Overview of the ’032 Patent
`The ’032 patent relates “generally to catheters used in interventional
`
`cardiology procedures.” Ex-1001, 1:7-8. In particular, the ’032 patent discloses a
`
`coaxial guide catheter (also known as an extension catheter) that extends “beyond
`
`the distal end of the guide catheter and . . . into [a] branch artery.” Id., Abstract.
`
`The catheter assembly purports to have the benefit of a mother-and-child
`
`assembly—it “assists in resisting both the axial forces and the shearing forces that
`
`tend to dislodge a guide catheter from the ostium of a branch artery.” Id., 4:66-5:3;
`
`Ex-1005, ¶¶ 131-32.
`
`The ’032 patent explains that the guide extension catheter 12 has a tubular
`
`portion that includes a flexible distal tip 16 (pink) and a reinforced portion 18
`
`(blue), as well as rigid portion 20 (yellow). Id., 3:28-30, 6:9-12, Fig. 1. Color has
`
`been added to Figure 1, below, which has been annotated with the language of the
`
`claims.3 Ex-1005, ¶ 133.
`
`
`3 In claim 1, “a flexible tip portion” defines “a tubular structure.” Ex-1001, 10:29.
`
`The “tubular structure” in claim 1 further “includes a flexible cylindrical distal tip
`
`
`
`9
`
`

`

`IPR2020-00126
`Patent 8,048,032
`
`
`
`Ex-1001, Fig. 1 (annotations and color added).
`
`The patent also addresses structural characteristics of the transition at or near
`
`the extension catheter’s reinforced and rigid portions, sometimes referred to as a
`
`“side opening,” (red circle), which may have an “inclined slope.” Id., Figs. 4,
`
`13-16, 6:38-54, 8:34-40, 10:63-11:3; Ex-1005, ¶ 134.
`
`
`portion (pink) and a flexible cylindrical reinforced portion (blue) (claim 6).” Id.,
`
`11:10-13. Claim 11 describes the guide extension catheter using different
`
`language. Specifically, claim 11 recites “a flexible tip portion defining a tubular
`
`structure,” and a “reinforced portion” that is proximal to the flexible tip portion.
`
`Id., 11:39, 50 (corresponding, respectively, to the pink and blue portions of
`
`annotated Fig. 1).
`
`
`
`10
`
`

`

`IPR2020-00126
`Patent 8,048,032
`
`
`
`
`
`Ex-1001, Fig. 4 (annotations and color added) (bottom figure inverted by
`
`Petitioner).
`
`As shown below, the ’032 patent describes that extension catheter 12 is
`
`deployed through guide catheter 56 (no color). A guidewire 64 and balloon (green)
`
`extend from the distal tip (pink) of the extension catheter. Moving distally to
`
`proximally, the extension catheter’s distal tip (pink) and a reinforced portion (blue)
`
`extend out of the distal tip of guide catheter 56. Ex-1005, ¶ 135.
`
`
`
`11
`
`

`

`IPR2020-00126
`Patent 8,048,032
`
`
`
`Ex-1001, Fig. 9 (color added).
`
`Prosecution History of the ’032 Patent
`C.
`During prosecution of the ’032 patent, the Examiner rejected pending
`
`claims, finding (in part), that they were obvious over Niazi (6,638,268) (Ex-1060,
`
`below, right) in view of Solar (2003/0195546) (Ex-1063, below, left).
`
`
`
`Ex-1063, Fig. 1; Ex-1060, Fig. 3 (respectively).
`
`The Examiner explained that Niazi discloses “a coaxial guide catheter 52
`
`comprising a tubular structure . . . sized to be insertable through the lumen of the
`
`guide catheter 51 and defines a coaxial lumen through which cardiology devices
`
`
`
`12
`
`

`

`IPR2020-00126
`Patent 8,048,032
`are insertable.” Ex-1003. Moreover, the distal flexible tip of the guide catheter “is
`
`flexible and is suitable for extending beyond the distal end of the guide catheter,”
`
`where “a rigid portion is proximal of and connected to the flexible tip portion that
`
`when combined with the tip is longer than the lumen of the catheter.” Id. Niazi can
`
`be combined with Solar to disclose “an elongate device comprising a pushing
`
`member 5 and tracking member 7 that is rigid and becomes more flexible as it
`
`moves distally.” Id., 5.
`
`Patent Owner overcame the obviousness rejections by amending the
`
`independent claims to recite (among other limitations) a “standard guide catheter,”
`
`with a “continuous lumen extending for a predefined length,” and a “circular cross-
`
`sectional inner diameter.” The claims were also amended to clarify that the
`
`“substantially rigid portion” was “more rigid along a longitudinal axis” than the
`
`flexible tip portion, and that the length of the two portions together “defines a total
`
`length of the device along the longitudinal axis that is longer than the length of the
`
`continuous lumen of the guide catheter.” Ex-1001, 11:52-53, 10:45-47; Ex-1069.
`
`According to the Examiner, the claims were allowable because “[w]hile
`
`many of the structures are known, the arrangement of a claimed rail structure with
`
`the claimed flexible tip that is insertable through a hemostatic valve is not taught or
`
`suggested by the prior art.” Ex-1003 (8/3/11 Notice of Allowance at 2). In other
`
`words, she believed that a mother-and-child assembly—where the child catheter is
`
`
`
`13
`
`

`

`IPR2020-00126
`Patent 8,048,032
`characterized by a short distal lumen coupled to a proximally-located pushrod—
`
`was not described in the art. The Examiner, however, was not aware of Itou.
`
`D.
`
`Priority Date
`
`The AIA first-to-file provisions apply to a patent that contains even one
`
`claim that is not supported by a pre-March 16, 2013 application. AIA § 3(n)(1)(A);
`
`MPEP § 2159.02. The ’032 patent is subject to the AIA’s first-to-file provisions
`
`because it contains at least one claim that lacks a written description, and therefore,
`
`pre-AIA priority. Thus, Patent Owner cannot swear behind Itou in this proceeding.
`
`No pre-AIA application to which the ’032 patent claims priority contains
`
`disclosure of “a proximal side opening” outside of the substantially rigid segment,
`
`but the independent claims permit the side opening to be in the “flexible tip
`
`portion” or “reinforced portion.” Compare Ex-1001, 10:21-53, 11:28-12:4
`
`(independent claims not restricting location of side opening), with id., 10:63-11:3
`
`(dependent claim 3 requiring side opening to be in “tubular portion” of flexible tip
`
`portion).
`
`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
`
`
`
`14
`
`

`

`IPR2020-00126
`Patent 8,048,032
`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 e