`
`
`
`
`
`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.: IPR2020-01342
`U.S. Patent No. 8,142,413
`______________________________
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,142,413
`
`
`
`
`
`
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`
`TABLE OF CONTENTS
`
`
`Page
`PRELIMINARY STATEMENT .................................................................... 1
`I.
`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 .................................................................... 6
`D.
`Service Information .............................................................................. 6
`III. REQUIREMENTS FOR INTER PARTES REVIEW ................................... 7
`A. Grounds for Standing ........................................................................... 7
`B.
`Precise Relief Requested and Asserted Grounds ................................. 7
`IV. BACKGROUND ............................................................................................ 8
`A. Overview of the Technology ................................................................ 8
`B. Overview of the ’413 Patent ................................................................. 9
`PERSON OF ORDINARY SKILL IN THE ART ....................................... 11
`V.
`VI. CLAIM CONSTRUCTION ......................................................................... 12
`A.
`“interventional cardiology device(s)” ................................................ 13
`B.
`“standard guide catheter” ................................................................... 14
`C.
`“placed in a branch artery” ................................................................. 15
`VII. THE BOARD SHOULD NOT DECLINE TO INSTITUTE UNDER
`35 U.S.C. § 314(A). ...................................................................................... 16
`VIII. GROUND 1: KONTOS RENDERS CLAIMS 1-2, 4-5, 7-12, 14
`OBVIOUS IN VIEW OF ADAMS AND/OR THE KNOWLEDGE
`OF A POSITA. ............................................................................................. 18
`A.
`Prior Art .............................................................................................. 18
`1.
`Kontos ...................................................................................... 18
`2.
`Adams ...................................................................................... 20
`Claim 1 ............................................................................................... 21
`1.
`[1.pre.I] ..................................................................................... 21
`-i-
`
`
`B.
`
`
`
`
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`
`TABLE OF CONTENTS
`
`C.
`D.
`E.
`F.
`G.
`H.
`I.
`
`Page
`[1.pre.II] ................................................................................... 25
`2.
`[1.pre.III] .................................................................................. 28
`3.
`[1.pre.IV] .................................................................................. 31
`4.
`[1.a] .......................................................................................... 34
`5.
`[1.b] .......................................................................................... 36
`6.
`[1.c] .......................................................................................... 36
`7.
`[1.d] .......................................................................................... 38
`8.
`[1.e] .......................................................................................... 45
`9.
`[1.f] ........................................................................................... 48
`10.
`Claim 2 ............................................................................................... 52
`Claim 4 ............................................................................................... 54
`Claim 5 ............................................................................................... 60
`Claim 7 ............................................................................................... 62
`Claim 8. .............................................................................................. 63
`Claim 9. .............................................................................................. 64
`Claim 10: ............................................................................................ 66
`1.
`[10.a] ........................................................................................ 66
`2.
`[10.b] ........................................................................................ 66
`Claim 11 ............................................................................................. 67
`J.
`Claim 12 ............................................................................................. 70
`K.
`Claim 14 ............................................................................................. 71
`L.
`IX. GROUND 2: KONTOS RENDERS CLAIM 13 OBVIOUS IN VIEW
`OF ADAMS AND TAKAHASHI. ............................................................... 72
`A.
`Takahashi ............................................................................................ 72
`B.
`Claim 13. ............................................................................................ 73
`SECONDARY CONSIDERATIONS .......................................................... 75
`X.
`XI. CONCLUSION ............................................................................................. 76
`
`-ii-
`
`
`
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Aerospace, Inc.,
`IPR2017-01275, Paper 12 (P.T.A.B. Oct. 31, 2017) .......................................... 75
`Arctic Cat, Inc. v. Polaris Industries Inc.,
`IPR2017-00433, Paper 17 (P.T.A.B. July 5, 2017) ...................................... 75, 76
`Boston Scientific Corp. v. Vascular Solutions, Inc.,
`IPR2014-00759 (P.T.A.B., terminated Aug. 13, 2014) ........................................ 6
`Fed. Land Bank of St. Paul v. Bismarck Lumber Co.,
`314 U.S. 95 (1941) .............................................................................................. 26
`Google LLC v. Pers. Audio, LLC,
`743 F. App’x 978 (Fed. Cir. 2018) ..................................................................... 68
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`Laryngeal Mask Co. v. Ambu, A/S,
`618 F.3d 1367 (Fed. Cir. 2010) .......................................................................... 17
`Lowe’s, Cos., Inc. v. Nichia Corp.,
`IPR2017-02011, Paper 13 (P.T.A.B. Mar. 12, 2018) ......................................... 75
`Microsoft Corp. v. Parallel Networks Licensing LLC,
`IPR2015-00483, Paper 10 (P.T.A.B. July 15, 2015) .......................................... 21
`QXMedical, LLC v. Vascular Solutions, LLC,
`No. 17-cv-01969 (D. Minn., filed June 8, 2017) .........................................passim
`Rowe v. Dror,
`112 F.3d 473 (Fed. Cir. 1997) ............................................................................ 22
`Synaptic Medical Inc. v. Karl Storz-Endoscopy-America, Inc.,
`IPR2018-00462, Paper 6 (P.T.A.B. July 16, 2018) ............................................ 21
`
`
`
`iii
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`Vascular Solutions, Inc. v. Boston Scientific Corp.,
`No. 13-cv-01172 (D. Minn., filed May 16, 2013) ................................................ 5
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al.,
`No. 19-cv-01760 (D. Minn., filed July 2, 2019) ................................................... 5
`Zip-Top LLC v. Stasher, Inc.,
`IPR2018-01216, Paper 14 (P.T.A.B. Jan. 17, 2019) .......................................... 20
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 76
`Statutes
`35 U.S.C. § 314(A) .................................................................................................. 17
`35 U.S.C. § 325(d) ....................................................................................... 20, 21, 72
`Other Authorities
`37 C.F.R. § 42.8 ......................................................................................................... 5
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 5
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 5
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 6
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 7
`37 C.F.R. § 42.100(b) .............................................................................................. 13
`37 C.F.R. § 42.104 ....................................................................................... 7, 8, 9, 10
`
`
`
`
`iv
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`LIST OF EXHIBITS
`
`
`Exhibit Description
`1401 U.S. Patent No. 8,142,413 (“the ’413 patent”)
`1402
`[RESERVED]
`1403
`File history for U.S. Patent No. 8,142,413
`1404 Assignment record of the ’413 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”)
`1418 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1419 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`
`1411
`
`1412
`
`1415
`
`
`
`v
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`1421
`
`Exhibit Description
`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)
`1422 Cordis, Instructions for Use, CYPHER™ (April 2003)
`1423 Medtronic, Summary of Safety and Effectiveness Data, Driver™
`Coronary Stent System (October 1, 2003)
`1424 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”)
`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)
`
`1429
`
`1432
`
`
`
`vi
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`1440
`
`1441
`
`Exhibit Description
`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”)
`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”)
`
`
`
`vii
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`Exhibit Description
`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,
`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”)
`[RESERVED]
`1475
`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
`
`1469
`
`1471
`
`1478
`
`
`
`viii
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`1483
`
`1484
`
`1485
`1486
`1487
`1488
`
`Exhibit Description
`1479 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
`[RESERVED]
`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
`Plaintiffs’ Objections and Responses to Interrogatories, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`[RESERVED]
`[RESERVED]
`[RESERVED]
`Preliminary Injunction Order, Vascular Solutions LLC et al. v.
`Medtronic, Inc., 19:cv-01760-PJS-TNL (April 9, 2020)
`[RESERVED]
`[RESERVED]
`[RESERVED]
`[RESERVED]
`Screenshot from Docket Navigator regarding Judge Schiltz's Motions
`to Stay Pending Inter Partes Review
` [RESERVED]
`Plaintiffs’ Infringement Disclosures in Vascular Solutions LLC et al.
`v. Medtronic, Inc., 19:cv-01760-PJS-TNL (March 1, 2020)
`[RESERVED]
`Excerpt of Patrick W. Serruys, Handbook of Coronary Stents (4th
`Edition) (2002)
`[RESERVED]
`[RESERVED]
`[RESERVED]
`[RESERVED]
`[RESERVED]
`
`1498
`1499
`1500
`1501
`1502
`
`1489
`1490
`1491
`1492
`1493
`
`1494
`1495
`
`1496
`1497
`
`ix
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`1515
`
`Exhibit Description
`1503
`[RESERVED]
`1504
`[RESERVED]
`1505
`[RESERVED]
`1506
`[RESERVED]
`1507
`[RESERVED]
`1508
`[RESERVED]
`1509
`[RESERVED]
`1510
`[RESERVED]
`1511
`[RESERVED]
`1512
`[RESERVED]
`1513
`IPR2020-00127 Institution Decision (Paper 20)
`1514
`First Amended and Supplemental Complaint, Vascular Solutions LLC
`et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL (February 14, 2020)
`Screenshot showing docket of Motion to Stay Order, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`(February 7, 2020)
`[RESERVED]
`Ex. 6 of Teleflex Infringement Disclosures and Claim Chart, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL (March
`1, 2020)
`[RESERVED]
`[RESERVED]
`[RESERVED]
`
`1516
`1517
`
`1518
`1519
`1520
`
`
`
`
`
`x
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`I.
`PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) request inter
`
`partes review (“IPR”) of claims 1-2, 4-5, and 7-14 (“Challenged Claims”) of U.S.
`
`Pat. No. 8,142,413 (“the ’413 patent,” Ex-1401). The ’413 patent is entitled
`
`Coaxial Guide Catheter for Interventional Cardiology Procedures. Id., [54].
`
`The ’413 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. Id., Abstract. The purported invention requires a
`
`guide catheter (“GC”) and a coaxial guide 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 Unlike the other patents in this family—that explicitly claim a “guide extension
`
`catheter” or, more vaguely, claim a device/system “for use” with a guide
`
`catheter—the ʼ413 patent claims a “coaxial guide catheter.” Ex-1405, ¶ 116. A
`
`POSITA knew, however, that the “coaxial guide catheter” of the ’413 patent was
`
`commonly understood as a guide extension catheter because it extends the guide
`
`catheter further into the coronary artery. Id., ¶ 71; see also Ex-1409, 5:49-52
`
`(referring to body 12 “as a guide catheter extension”). For ease of discussion, and
`
`to match the terminology of the ʼ413 patent, Petitioner uses “coaxial guide
`
`catheter” when referring to the extension catheter of the ʼ413 patent.
`
`
`
`1
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`Abstract, Figs. 8-9. In so doing, the coaxial guide 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., 2:51-55, 7:66-8:12.
`
`The ’413 patent admits that the use of a coaxial guide catheter inside an
`
`outer guide catheter was known. Id., 2:23-39 (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
`
`coaxial guide 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.
`
`
`
`
`
`2
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`Ex-1454, Fig. 2 (annotations and color added).
`
`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.; Ex-1405, ¶ 70.
`
`The ’413 patent alleges that such a design had certain drawbacks (Ex-1401, 2:40-
`
`50; 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.
`
`
`
`Id., Fig. 1 (annotation and color added).
`
`But such child catheters that served as coaxial guide 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 ʼ413 patent. Ex-1409, [45].
`
`
`
`3
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`
`
`Id., 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 ’413 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 ’413 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,
`
`
`
`4
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`Inc., et al., No. 19-cv-01760 (D. Minn., filed July 2, 2019)2; and (ii) QXMedical,
`
`LLC v. Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017)
`
`(“QXMedical Litigation”).
`
`The ’413 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., IPR2014-00759
`
`(P.T.A.B., terminated Aug. 13, 2014).
`
`The ʼ413 patent shares a common specification with and is related to several
`
`patents that, as shown in the below table, are currently subject to IPR:
`
`IPR No.
`IPR2020-00126
`IPR2020-00127
`IPR2020-00128
`IPR2020-00129
`IPR2020-00130
`IPR2020-00132
`IPR2020-00134
`IPR2020-00135
`IPR2020-00136
`IPR2020-00137
`IPR2020-00138
`IPR2020-01341
`IPR2020-01342
`
`2 The ʼ413 patent was not originally asserted. The ʼ413 patent was added by
`
`Status
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Trial Instituted
`Pending
`Pending (Present Petition)
`
`U.S. Patent No.
`8,048,032
`8,048,032
`RE45,380
`RE45,380
`RE45,380
`RE45,760
`RE45,760
`RE45,776
`RE45,776
`RE47,379
`RE47,379
`8,142,413
`8,142,413
`
`Amended Complaint on February 14, 2020. Ex-1514.
`
`
`
`5
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`RE46,116
`RE46,116
`
`IPR2020-01343
`IPR2020-01344
`
`C. Lead and Backup Counsel
`Pursuant to 37 C.F.R. § 42.8(b)(3), Petitioner identifies the following
`
`Pending
`Pending
`
`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
`
`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
`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.
`
`
`
`6
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`III. REQUIREMENTS FOR INTER PARTES REVIEW
`A. Grounds for Standing
`Pursuant to 37 C.F.R. § 42.104, Petitioner certifies that the ’413 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 1-2, 4-5, and 7-14 of the
`
`’413 patent and cancellation of these claims as unpatentable in view of the
`
`following grounds:3
`
`No. Grounds
`1
`Claims 1-2, 4-5, 7-12, 14 are rendered obvious by Kontos in view of
`Adams and/or the common knowledge of a POSITA.
`Claim 13 is rendered obvious by Kontos in view of Adams, Takahashi,
`and/or the common knowledge of a POSITA.
`
`2
`
`
`
`
`3 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
`
`’413 patent. Petitioner also submits the declaration of Sylvia D. Hall-Ellis, PhD
`
`(Ex-1478) to support the authenticity and public availability of the documents cited
`
`herein.
`
`
`
`7
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`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. Id., ¶¶ 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
`
`largely unchanged. Id., ¶¶ 33, 41. During PCI, a physician uses a hollow needle to
`
`gain access to the patient’s vasculature. Id., ¶ 34. A guidewire is then introduced
`
`through the needle and into the vasculature. Id. After removal of the needle, an
`
`introducer sheath is placed and then the guidewire and guide catheter can be
`
`advanced along the vasculature until its distal end is placed—by a few
`
`millimeters—in the ostium of a coronary artery. Id., ¶¶ 42-55. A hemostatic valve
`
`is placed at the proximal end of the guide catheter and remains outside the patient’s
`
`body. Id., ¶¶ 35, 54. 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
`
`
`
`8
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`lumen of the guide catheter to the target site. Id., ¶¶ 56-58. 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., ¶¶ 59-67. This last
`
`step—crossing the therapeutic catheter past the occlusion—creates backward force
`
`that can dislodge the guide catheter from the ostium. Id., ¶¶ 66-67. 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., ¶¶ 68-80.
`
`B. Overview of the ’413 Patent
`The ’413 patent relates “generally to catheters used in interventional
`
`cardiology procedures.” Ex-1401, 1:13-17. In particular, the ’413 patent discloses a
`
`coaxial guide 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., 5:4-8; Ex-1405, ¶¶ 115-17.
`
`The ’413 patent claims a coaxial guide catheter 12 that includes a
`
`substantially rigid segment (yellow) and a tubular structure (blue). Ex-1405, ¶ 118.
`
`
`
`9
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`
`
`
`Ex-1401, 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
`
`“partially cylindrical portion” or a “side opening,” (red circle), which may have an
`
`“inclined slope.” Id., Figs. 4, 13-16; see also id., 6:44-60, 8:40-46; 12:7-13; Ex-
`
`1405, ¶ 119.
`
`
`
`
`
`Ex-1401, Fig. 4 (annotations and color added) (bottom figure inverted by
`
`
`
`10
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`Petitioner).
`
`As shown below, the ’413 patent describes that coaxial guide 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-1405, ¶ 120.
`
`Ex-1401, Fig. 9 (color added).
`
`
`
`PERSON OF ORDINARY SKILL IN THE ART
`If a person of ordinary skill in the art (“POSITA”) was a medical doctor,
`
`11
`
`V.
`
`
`
`

`

`IPR2020-01342
`Patent No. 8,142,413
`s/he would have had (a) a medical degree, (b) completed a coronary intervention
`
`training program, and (c) experience working as an interventional cardiologist.
`
`Alternatively, if a POSITA was an engineer s/he would have had (a) an
`
`undergraduate degree in engineering, such as mechanical or biomedical
`
`engineering; and (b) at least three years of experience designing medical devices,
`
`including catheters or catheter-deployable devices. Extensive experience and
`
`technical training might substitute for education, and advanced degrees might
`
`substitute for experience. Additionally, a POSITA with a medical degree may have
`
`access to a POSITA with an engineering degree, and a POSITA with an
`
`engineering degree may have access to one with a medical degree. Ex-1405, ¶ 27;
`
`Ex-1442, ¶¶ 18-19.
`
`VI. CLAIM CONSTRUCTION
`When, as here, claim terms have been construed by a district court, those
`
`constructions are properly considered during an IPR. 37 C.F.R. § 42.100(b). In the
`
`QXMedical Litigation, Patent Owner advanced, and the district court adopted, the
`
`following constructions:
`
` “substantially rigid”: “rigid enough to allow the device to be advanced
`
`within the guide catheter” (Ex-1412, at 6-8; Ex-1413, at 15)
`
` “rail structure”: “structure that facilitates monorail or sliding rail
`
`delivery” (Ex-1413, at 20).
`
`12
`
`
`
`

`

`IPR2020-01