`
`
`
`
`
`
`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.: IPR2020-00134
`U.S. Patent No. RE 45,760E
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE 45,760
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`
`TABLE OF CONTENTS
`
`Page
`PRELIMINARY STATEMENT .................................................................... 1
`I.
`II. MANDATORY NOTICES (37 C.F.R. § 42.8) .............................................. 5
`A.
`Real Party-in Interest ............................................................................. 5
`B.
`Related Matters ...................................................................................... 5
`C.
`Lead and Backup Counsel ..................................................................... 6
`D.
`Service Information ............................................................................... 7
`III. REQUIREMENTS FOR INTER PARTES REVIEW ................................ 7
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a) ............................. 7
`B.
`Precise Relief Requested and Asserted Grounds .................................. 8
`IV. BACKGROUND ............................................................................................. 8
`A.
`Technology Overview .......................................................................... 8
`B.
`The ’760 Patent ................................................................................... 10
`C.
`Prosecution History of the ’760 Patent ............................................... 13
`D.
`Priority Date ........................................................................................ 14
`V. THE PERSON OF ORDINARY SKILL IN THE ART ............................ 15
`VI. CLAIM CONSTRUCTION ......................................................................... 16
`VII. GROUND 1: ITOU ANTICIPATES CLAIMS 48, 51 AND 53. ............... 18
`A.
`Itou ....................................................................................................... 18
`B.
`Claim 48: ............................................................................................. 21
`1.
`[48.pre.] .................................................................................... 21
`2.
`[48.a] ........................................................................................ 21
`3.
`[48.b] ........................................................................................ 24
`4.
`[48.c.i] ...................................................................................... 26
`5.
`[48.c.ii] ..................................................................................... 30
`6.
`[48.c.iii] .................................................................................... 31
`7.
`[48.d] ........................................................................................ 35
`Claim 51 .............................................................................................. 36
`
`C.
`
`
`
`i
`
`

`

`D.
`
`IPR2020-00134
`Patent RE 45,760E
`1.
`[51.pre] ..................................................................................... 36
`2.
`[51.a] ........................................................................................ 36
`3.
` [51.b] ....................................................................................... 37
`4.
` [51.c.i] ..................................................................................... 37
`5.
`[51.c.ii] ..................................................................................... 37
`6.
`[51.c.iii] .................................................................................... 38
`7.
`[51.d] ........................................................................................ 38
`8.
`[51.e] ........................................................................................ 39
`Claim 53 .............................................................................................. 40
`1.
`[53.pre] ..................................................................................... 40
`2.
`[53.a] ........................................................................................ 41
`3.
` [53.b] ....................................................................................... 41
`4.
` [53.c.i] ..................................................................................... 41
`5.
`[53.c.ii] ..................................................................................... 42
`6.
`[53.c.iii] .................................................................................... 42
`7.
`[53.d] ........................................................................................ 42
`8.
`[53.e] ....................................................................................... 44
`VIII. GROUND 2: ITOU RENDERS CLAIMS 48, 51 AND 53
`OBVIOUS IN VIEW OF RESSEMANN AND THE COMMON
`KNOWLEDGE OF A POSITA. .................................................................. 45
`Ressemann ........................................................................................... 45
`A.
`B.
`Claims 48, 51, 53 ................................................................................. 48
`1.
`48.c.iii, 51.c.iii, 53.c.iii ............................................................ 48
`IX. GROUND 3: ITOU RENDERS CLAIM 52 OBVIOUS IN VIEW
`THE COMMON KNOWLEDGE OF A POSITA. ................................... 54
`A.
`Claim 52. The system of claim 51, wherein a longitudinal
`length of the reinforcing braid or coil is between 20 to 30 cm. .......... 54
`X. GROUND 4: RESSEMANN RENDERS CLAIMS 48 AND 51-53
`OBVIOUS IN VIEW OF TAKAHASHI AND THE COMMON
`KNOWLEDGE OF A POSITA. .................................................................. 56
`
`
`
`ii
`
`

`

`C.
`
`IPR2020-00134
`Patent RE 45,760E
`A.
`Takahashi ............................................................................................. 56
`B.
`Claim 48 .............................................................................................. 57
`1.
`48.pre ........................................................................................ 57
`2.
`48.a ........................................................................................... 57
`3.
`48.b ........................................................................................... 59
`4.
`48.c.i ......................................................................................... 60
`5.
`48.c.ii ........................................................................................ 63
`6.
`48.c.iii ....................................................................................... 67
`7.
`48.d ........................................................................................... 71
`Claim 51 .............................................................................................. 73
`1.
`51.pre ........................................................................................ 74
`2.
`51.a ........................................................................................... 74
`3.
` 51.b .......................................................................................... 74
`4.
` 51.c.i ........................................................................................ 74
`5.
`51.c.ii ........................................................................................ 74
`6.
`51.c.iii ....................................................................................... 74
`7.
`51.d ........................................................................................... 74
`8.
`51.e ........................................................................................... 77
`Claim 52 .............................................................................................. 79
`53.pre ........................................................................................ 80
`1.
`2.
`53.a ........................................................................................... 80
`3.
` 53.b .......................................................................................... 81
`4.
` 53.c.i ........................................................................................ 81
`5.
`53.c.ii ........................................................................................ 81
`6.
`53.c.iii ....................................................................................... 81
`7.
`53.d ........................................................................................... 81
`8.
`53.e ........................................................................................... 85
`
`D.
`
`
`
`
`
`
`iii
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`IX. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ........... 86
`XI. CONCLUSION ............................................................................................. 87
`XII. PAYMENT OF FEES ..................................................................................... 87
`
`
`
`
`
`iv
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`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 at 1477 ................................................................................................. 34
`Legget & Platt, Inc. v. VUTEK, Inc.,
`537 F.3d 1349 (Fed. Cir. 2008) .......................................................................... 20
`Perfect Web Techs., Inc. v. Info USA, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) .......................................................................... 64
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 16
`Statutes
`35 U.S.C. § 325(d) ................................................................................................... 56
`Other Authorities
`83 Fed. Reg. 51,340-51,359 (Oct. 11, 2018) ........................................................... 16
`
`
`
`
`
`v
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`LIST OF EXHIBITS
`
`Exhibit Description
`1601 U.S. Patent No. RE45,760 (“the ’760 patent”)
`1602
`File history for U.S. Patent No. 8,292,850
`1603
`File history for U.S. Patent No. RE45,760
`1604 Assignment record of the ’760 patent from the USPTO assignment
`database
`1605 Declaration of Doctor Stephen JD Brecker, M.D.
`1606
`Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1607 U.S. Patent No. 7,736,355 (“Itou”)
`1608 U.S. Patent No. 7,604,612 (“Ressemann”)
`1609 U.S. Patent No. 5,439,445 (“Kontos”)
`1610
`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.
`1613 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1614 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).
`1616 US Patent Publication 2003/0233117 (“Adams ’117”)
`1617 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1611
`
`1612
`
`1615
`
`
`
`vi
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`1621
`
`1624
`
`Exhibit Description
`1618 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1619 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1620 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)
`1622
`1623 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)
`1625 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1626 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1627 U.S. Patent No. RE45,776 (“Root”)
`1628
`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”)
`1630 U.S. Patent No. 5,413,560 (“Solar ’560”)
`1631
`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”)
`1633 U.S. Publication Application No. 2004/0236215 (Mihara)
`
`1629
`
`1632
`
`
`
`vii
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`1641
`
`1640
`
`Exhibit Description
`1634 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1635 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1636 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1637 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1638 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1639 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)).
`1642 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1643
`Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1644 U.S. Patent No. 5,961,510 (“Fugoso”)
`1645 U.S. Patent No. 6,199,262 (“Martin”)
`1646 U.S. Patent No. 6,042,578 (“Dinh”)
`1647 WO 97/37713 (“Truckai”)
`1648
`Terumo Heartrail II product literature
`1649 Medtronic Launcher product literature
`1650 U.S. Patent No. 5,980,486 (“Enger”)
`1651 U.S. Patent No. 5,911,715 (“Berg”)
`1652 U.S. Patent No. 5,545,149 (“Brin”)
`1653 U.S. Patent No. 5,720,300 (“Fagan”)
`
`
`
`viii
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`Exhibit Description
`1654 U.S. Patent No. 5,120,323 (“Shockey”)
`1655
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1656 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1657 U.S. Patent No. 5,445,625 (“Voda”)
`1658 U.S. Patent No. 6,595,952 (“Forsberg”)
`1659 U.S. Patent No. 6,860,876 (“Chen”)
`1660 U.S. Patent No. 6,638,268 (“Niazi”)
`1661 U.S. Patent No. 5,690,613 (“Verbeek”)
`1662
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1663 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1664 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
`1665 U.S. Patent No. 4,000,739 (“Stevens”)
`1666
`EP 0 881 921 B1 (“Lee”)
`1667 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1668 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)
`1670 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”)
`
`1669
`
`
`
`ix
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`Exhibit Description
`1671
`Feldman, Coronary Angioplasty Using New 6 French Guiding
`Catheters, Catheterization and Cardiovascular Diagnosis 23:93-99
`(1991) (“Feldman”)
`1672 U.S. Patent No. 5,704,926 (“Sutton”)
`1673
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`1674 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.
`1676 U.S. Patent No. 5,860,963 (“Azam”)
`1677
`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.
`1680 U.S. Patent No. 5,061,273 (“Yock”)
`1681 U.S. RE45,380 (“the ’380 patent”)
`1682 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
`
`1675
`
`1678
`1679
`
`1683
`
`1684
`
`
`
`x
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`I. PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) requests inter
`
`partes review (“IPR”) of claims 48 and 51-53 (“Challenged Claims”) of U.S. Pat.
`
`No. RE 45,760 (“the ’760 patent,” Ex-1601). The ʼ760 patent—which claims
`
`priority to a patent application filed on May 3, 2006 (Ex-1601, [60])—is entitled
`
`Coaxial Guide Catheter for Interventional Cardiology Procedures and lists
`
`Howard Root et al. as inventors. Id., [54], [72]. The Challenged Claims were
`
`issued on a first Office Action, meaning there is no substantive file history for the
`
`ʼ760 patent.
`
`The ’760 patent describes a catheter assembly system that reduces the
`
`likelihood of a guide catheter dislodging from the coronary artery ostium 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.,
`
`
`1 The ’760 patent refers to the guide extension catheter as a “coaxial guide
`
`catheter.” Ex-1605, ¶¶ 75 n.8, 129. A POSITA knew that the ’760 patent’s “coaxial
`
`guide catheter” was commonly understood as a guide extension catheter because it
`
`extends the guide catheter further into the coronary artery. Id.; see also Ex-1609,
`
`5:49-50 (referring to body 12 “as a guide catheter extension”).
`
`
`
`1
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`Abstract; Figs. 8, 9. In so doing, the guide extension catheter delivers “backup
`
`support by providing the ability to effectively create deep seating in the ostium of
`
`the coronary artery,” thereby preventing the GC from dislodging from the ostium.
`
`Id., 3:7-11; see also id., 8:23-35.
`
`The ’760 patent admits that using a guide extension catheter inside an outer
`
`guide catheter was known. Ex-1601, 2:46-61 (describing the use of a “smaller
`
`guide catheter within a larger guide catheter”). Ex-1605. Indeed, such a catheter-in-
`
`a-catheter assembly was well-known in the art as a “mother-and-child assembly,”
`
`where the child catheter (red in below figure) (i.e., the guide extension catheter) is
`
`essentially a tube that is inserted into and extends beyond the GC (blue in below
`
`figure) (i.e., the mother catheter) into the coronary artery. Ex-1605, ¶¶ 74-84,
`
`103-104.
`
`
`
`2
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`
`
`Ex-1654, Fig. 2 (annotation and color added).
`
`The child catheter in the original mother-and-child assembly had a continuous
`
`lumen that was longer than the lumen of the guide (“mother”) catheter. Id. The
`
`’760 patent alleges that such a design had certain drawbacks (Ex-1601, 2:63-3:6)
`
`and modifies the child catheter of the mother-and-child assembly to have two parts:
`
`(i) a long thin pushrod (ii) coupled to a short distal lumen (i.e., a tube) that is
`
`highly flexible so it can extend deep into the coronary artery.
`
`
`
`3
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`Ex-1601, Fig. 1 (annotation and color added).
`
`But child catheters with short lumen connected to a long thin pushrod were
`
`already well-known in the art, evidenced by U.S. Patent No. 7,736,355 (“Itou”)
`
`
`
`(Ex-1607).
`
`
`
`
`
`Ex-1608, Fig. 6B (annotations and color added); infra, §VII.A.
`
`It was also evidenced by U.S. Patent No. 7,604,612 (“Ressemann”).
`
`
`
`4
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`
`
`Ex-1608, Fig, 6E (annotations and color added); infra, §VII.A.
`
`For the reasons set forth herein, there is more than a reasonable likelihood
`
`that the Challenged Claims of the ’760 patent are unpatentable based on the
`
`Grounds discussed below. Accordingly, Petitioner respectfully requests institution
`
`of a trial under 37 C.F.R. Part 42 and cancellation/invalidation of the Challenged
`
`Claims.
`
`II. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real Party-in Interest
`Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner identifies Medtronic, Inc. and
`
`Medtronic Vascular, Inc. as the real parties-in-interest. Medtronic plc is the
`
`ultimate parent of both entities.
`
`B. Related Matters
`
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner identifies that the ’760 patent is
`
`currently the subject of litigation in two separate actions in the U.S. District Court
`
`
`
`5
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`for the District of Minnesota: (i) Vascular Solutions LLC, et al. v. Medtronic, Inc.,
`
`et al., No. 19-cv-01760 (D. Minn., filed July 2, 2019); and (ii) QXMedical, LLC v.
`
`Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017)
`
`(“QXMedical Litigation”).
`
`Further, the ’760 patent is a reissue of U.S. Pat. No. 8,292,850 (“the ʼ850
`
`patent). The ʼ850 patent was previously the subject of litigation (i) in the U.S.
`
`District Court for the District of Minnesota in Vascular Solutions, Inc. v. Boston
`
`Scientific Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013), and (ii) at the
`
`PTAB in Boston Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00762,
`
`IPR2014-00763 (P.T.A.B., terminated Aug. 11, 2014).
`
`Petitioner is also concurrently filing other petitions for IPR challenging
`
`different ’760 patent claims.
`
`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
`
`
`
`
`6
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`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 Under 37 C.F.R. § 42.104(a)
`Pursuant to 37 C.F.R. §42.104, Petitioner certifies that the ’760 patent is
`
`available for IPR and that Petitioner is not barred or estopped from requesting such
`
`review of the ʼ760 patent on the identified grounds.
`
`
`
`7
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`B. Precise Relief Requested and Asserted Grounds
`Petitioner respectfully requests review of claims 48 and 51-53 of the ʼ760
`
`
`
`patent and cancellation of these claims as unpatentable in view of the following
`
`grounds:2
`
`
`
`No.
`1
`2
`
`3
`4
`
`Grounds
`Itou anticipates claims 48, 51 and 53.
`Itou renders claims 48, 51 and 53 obvious in view of Ressemann and
`the knowledge of a POSITA.
`Itou renders claim 52 obvious in view of the knowledge of a POSITA.
`Ressemann renders claims 48 and 51-53 obvious in view of the
`knowledge of a POSITA.
`
`
`
`IV. BACKGROUND
`A. Technology Overview
`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
`
`arterial lumen. Ex-1605, ¶¶ 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 Stephen JD Brecker, MD
`
`(Ex-1605), and Richard A. Hillstead, Ph.D., (Ex-1642), as experts in the ’760
`
`patent field. Petitioner also submits Sylvia D. Hall-Ellis, PhD’s declaration
`
`(Ex-1678) to support authenticity and public availability of the documents cited
`
`herein.
`
`
`
`8
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`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-1605, ¶¶ 33,
`
`38-44.
`
`PCI was developed over 40 years ago, and although its catheter-based
`
`technology has advanced, the basic PCI components remain largely unchanged.
`
`Ex-1605, ¶¶ 37, 45. During PCI, a physician uses a hollow needle to access the
`
`patient’s vasculature. Ex-1605, ¶¶ 38, 46-59. A guidewire is introduced into the
`
`needle, the needle is removed, and an introducer sheath is inserted over the
`
`guidewire and into the artery. Next, a guide catheter is introduced and advanced
`
`along the vasculature until its distal end is placed—by a few millimeters—in the
`
`coronary artery ostium. Id., ¶¶ 38, 46-59. At the proximal end, a hemostatic valve
`
`is coupled to the guide catheter and remains outside the patient’s body. Id., ¶¶ 39,
`
`58. The valve prevents blood from exiting the patient’s artery and keeps air from
`
`entering the bloodstream. Id.
`
`A smaller-diameter, more flexible guidewire is then threaded through 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 guidewire and therapeutic catheter typically must then be passed through
`
`and beyond the occlusion in order to alleviate the stenosis. Id., ¶¶ 63-71. This last
`
`
`
`9
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`step—crossing the guidewire and therapeutic catheter past the occlusion—creates
`
`backward force that can dislodge the guide catheter from the ostium. Id., ¶¶ 70-71.
`
`As discussed 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. ¶¶ 72-84.
`
`B. The ’760 Patent
`The ’760 patent relates “generally to catheters used in interventional
`
`cardiology procedures.” Ex-1601, 1:37-38. In particular, the ʼ760 patent discloses a
`
`coaxial guide catheter (also known as an extension catheter) that extends through
`
`the lumen of a GC, “beyond the distal end of the guide catheter and insert[s] 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., 5:30-34; Ex-1605, ¶¶ 129-130.
`
`
`
`The ’760 patent claims a guide extension catheter 12 that includes a
`
`substantially rigid segment (yellow) and a tubular structure (blue) and a tip portion
`
`(pink). Ex-1601, 3:58-61, 6:40-41, Fig. 1. Color has been added to Figure 1, below,
`
`which has been annotated with the language of claim 51.
`
`
`
`10
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`
`
`Ex-1601, Fig. 1 (annotations and color added).
`
`The ʼ760 patent also recites that the extension catheter include “in a proximal
`
`to distal direction, a substantially rigid segment, a segment defining a side opening,
`
`and a tubular structure.” Id., 15:14-53, 15:60-16:36, 16:39-17:13. The
`
`specification, however, provides no written description support for a “side
`
`opening” located anywhere other than in the substantially rigid segment 20, circled
`
`in red below.” Ex-1601, Figs. 4, 13-16; see also id., 7:1-17, 8:63-9:5.
`
`
`
`11
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`
`
`
`Ex-1601, Fig 4 (annotations and color added) (bottom figure inverted by
`
`Petitioner).
`
`
`
`Regardless, the ’760 patent describes that extension catheter 12 is deployed
`
`through guide catheter 56 (no color). A guidewire 64 and balloon (green) extend
`
`from the extension catheter’s distal tip (pink). Moving distally to proximally, the
`
`extension catheter’s distal tip (pink) and a reinforced portion (blue) extend out of
`
`the guide catheter’s distal tip 56. Ex-1605, ¶ 131.
`
`
`
`Ex-1601, Fig. 9 (color added).
`
`
`
`12
`
`
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`C. Prosecution History of the ’760 Patent
`The predecessor, ʼ850 patent issued without an Office Action. See generally
`
`Ex-1602. According to the Examiner, the claims were allowable because “adding a
`
`guide catheter to the claimed rail structure3 with the claimed flexible tip that is
`
`insertable through a hemostatic valve is not taught or suggested by the prior art.”
`
`Ex-1602 at 83 (Notice of Allowance at 3).
`
`Patent Owner sought reissuance in 2014. The Examiner found the claims were
`
`patentable because he found no prior art disclosing “a guide extension catheter
`
`which is long enough to extend from both ends of the guide catheter and includes a
`
`rigid segment, a segment defining a side opening and a tubular structure, where the
`
`lumen of the tubular structure is shorter than the guide catheter.” Ex-1603 at 708
`
`(Non-Final Rejection, December 10, 2014 at 10). In other words, in both the
`
`original and reissue prosecutions, the Examiner believed 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 the art, but he was
`
`not aware of Itou or Ressemann.
`
`
`3 Infra, § VI. (construing “rail structure”).
`
`
`
`13
`
`

`

`IPR2020-00134
`Patent RE 45,760E
`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 or claims priority to any
`
`patent or application that is subject to the AIA first-to-file provisions.
`
`AIA § 3(n)(1)(A); MPEP § 2159.02. This would prevent, for instance, any attempt
`
`by Patent Owner to swear behind the Itou patent. The ’760 patent is subject to the
`
`AIA first-to-file provisions because (1) it contains claims that lack written
`
`description, and therefore pre-AIA priority,4 and (2) it claims priority to RE 45,380
`
`(“the ’380 patent”), which is subject to the AIA first-to-file provisions. Thus,
`
`Patent Owner cannot swear behind Itou in this proceeding. First, no pre-AIA
`
`application to which the ’760 patent claims priority contains disclosure of “a side
`
`opening portion” that is not part of the substantially rigid segment, but the
`
`independent claims allow the side opening to, in the alternative, be in the
`
`reinforced s