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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`
`Case No.: IPR2020-01344
`U.S. Patent No. RE46,116
`______________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. RE46,116
`
`

`

`IPR2020-01344
`Patent RE46,116
`
`
`TABLE OF CONTENTS
`
`
`Page
`Preliminary Statement .................................................................................... 1 
`I.
`II. Mandatory Notices under 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. Overview of the Technology ................................................................ 8 
`B. Overview of the ’116 Patent ............................................................... 10 
`Person of ordinary skill in the art ................................................................. 11 
`V.
`VI. Claim Construction ....................................................................................... 12 
`A.
`“flexural modulus” ............................................................................. 13 
`VII. The Board should not decline to institute under 35 U.S.C. § 314(a) ........... 13 
`VIII. GROUND I: Kontos renders claims 52-53 obvious in view of
`Ressemann and/or the knowledge of a POSITA .......................................... 15 
`A.
`Claim 52 ............................................................................................. 15 
`1.
`[52.a] ........................................................................................ 15 
`2.
`[52.b] ........................................................................................ 16 
`3.
`[52.c] ........................................................................................ 17 
`4.
`[52.d] ........................................................................................ 25 
`5.
`[52.e] ........................................................................................ 26 
`6.
`[52.f] ......................................................................................... 26 
`Claim 53 ............................................................................................. 31 
`
`B.
`
`
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`IPR2020-01344
`Patent RE46,116
`
`
`TABLE OF CONTENTS
`(continued)
`
`Page
`
`IX. GROUND II: Kontos renders claims 25-40, 42, and 44-48 obvious in
`view of Ressemann, Takahashi and/or the knowledge of a POSITA .......... 32 
`A.
`Claim 25 ............................................................................................. 32 
`1.
`[25.a] ........................................................................................ 32 
`2.
`[25.b] ........................................................................................ 33 
`3.
`[25.c] ........................................................................................ 33 
`4.
`[25.d] ........................................................................................ 33 
`5.
`[25.e] ........................................................................................ 34 
`6.
`[25.f] ......................................................................................... 36 
`7.
`[25.g] ........................................................................................ 36 
`Claim 26 ............................................................................................. 37 
`B.
`Claim 27 ............................................................................................. 38 
`C.
`Claim 28. ............................................................................................ 39 
`D.
`Claim 29. ............................................................................................ 39 
`E.
`Claim 30 ............................................................................................. 40 
`F.
`Claim 31 ............................................................................................. 41 
`G.
`Claim 32 ............................................................................................. 41 
`H.
`Claim 33 ............................................................................................. 42 
`I.
`Claim 34. ............................................................................................ 43 
`J.
`Claim 35. ............................................................................................ 43 
`K.
`Claim 36. ............................................................................................ 45 
`L.
`M. Claim 37 ............................................................................................. 45 
`N.
`Claim 38. ............................................................................................ 47 
`O.
`Claim 39 ............................................................................................. 48 
`P.
`Claim 40. ............................................................................................ 48 
`Q.
`Claim 42. ............................................................................................ 49 
`
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`

`IPR2020-01344
`Patent RE46,116
`
`
`TABLE OF CONTENTS
`(continued)
`
`Page
`Claim 44 ............................................................................................. 50 
`R.
`Claim 45 ............................................................................................. 51 
`S.
`Claim 46 ............................................................................................. 53 
`T.
`Claim 47. ............................................................................................ 54 
`U.
`Claim 48. ............................................................................................ 56 
`V.
`II. GROUND III: Kontos renders claim 45 obvious in view of
`Ressemann, Takahashi, Kataishi, and/or the common knowledge of a
`POSITA ........................................................................................................ 58 
`The Challenged Claims are not entitled to claim priority to May 6,
`2006 .............................................................................................................. 62 
`A.
`The Effective Filing Date of the Challenged Claims is no
`Earlier than January 28, 2012 ............................................................. 62 
`1.
`The Challenged Claims Recite a Side Opening Outside of
`the Substantially Rigid Segment .............................................. 62 
`The Priority Applications Provide no Written Description
`Support for a Segment Defining a Side Opening Outside
`of the Substantially Rigid Segment ......................................... 65 
`The Effective Filing Date of Claims 45-46 are no Earlier than
`November 1, 2013 .............................................................................. 69 
`XI. GROUND IV: Root and the knowledge of a POSITA renders claims
`25-55 obvious ............................................................................................... 69 
`A.
`Root (Ex-1512) ................................................................................... 70 
`B.
`Root and the Knowledge of a POSITA Renders Claims 25-55
`Obvious .............................................................................................. 70 
`XII. GROUND V: Claims 45-46 are rendered obvious by Kontos in view
`of Ressemann, Takahashi, Root, and/or the knowledge of a POSITA ........ 76 
`XIII. Secondary Considerations ............................................................................ 76 
`XIV. Conclusion .................................................................................................... 78 
`
`X.
`
`2.
`
`B.
`
`
`
`
`
`-iii-
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`

`IPR2020-01344
`Patent RE46,116
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Arctic Cat, Inc. v. Polaris Industries Inc.,
`IPR2017-00433, Paper 17 (P.T.A.B. July 5, 2017) ............................................ 77
`D Three Enters., LLC v. SunModo Corp.,
`890 F.3d 1042 (Fed. Cir. 2018) .......................................................................... 62
`Helmsderfer v. Bobrick Washroom Equip., Inc.,
`527 F.3d 1379 (Fed. Cir. 2008) .......................................................................... 64
`In re Barker,
`559 F.2d 588 (C.C.P.A. 1977) ............................................................................ 69
`In re Wertheim,
`541 F.2d 257 (C.C.P.A. 1976) ............................................................................ 69
`KSR Int’l v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) .......................................................................... 65
`Lowe’s, Cos., Inc. v. Nichia Corp.,
`IPR2017-02011, Paper 13 (P.T.A.B. Mar. 12, 2018) ......................................... 77
`Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 63
`Revolution Eyewear, Inc. v. Aspex Eyewear, Inc.,
`563 F.3d 1358 (Fed. Cir. 2009) .......................................................................... 65
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 77
`Statutes
`35 U.S.C. § 112 ........................................................................................................ 65
`
`
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`i
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`

`

`IPR2020-01344
`Patent RE46,116
`
`35 U.S.C. § 120 ........................................................................................................ 65
`35 U.S.C. § 314(A) .................................................................................................. 13
`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) .............................................................................................. 12
`37 C.F.R. § 42.104 ..................................................................................................... 7
`37 C.F.R. § 42.104(a) ................................................................................................. 7
`
`
`
`
`
`ii
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`

`IPR2020-01344
`Patent RE46,116
`
`
`LIST OF EXHIBITS
`
`
`Exhibit Description
`1401 U.S. Patent No. RE 46,116 (“the ’116 patent”)
`1402
`File history for U.S. Patent No. 8,292,850
`1403
`File history for U.S. Patent No. RE 46,116
`1404 Assignment record of the ’116 patent from the USPTO assignment
`database
`1405 Declaration of Doctor Stephen JD Brecker, M.D.
`1406 Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1407 U.S. Patent No. 7,736,355 (“Itou”)
`1408 U.S. Patent No. 7,604,612 (“Ressemann”)
`1409 U.S. Patent No. 5,439,445 (“Kontos”)
`1410 New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions
`63: 452-456 (2004) (“Takahashi”)
`Excerpt of prosecution history of U.S. Patent No. 8,048,032
`(Application 11/416,629) (Amendment and Response, April 6, 2009)
`Joint Claim Construction Statement in QXMedical, LLC v. Vascular
`Solutions, Inc., D. Minn., No. 17-cv-01969 (January 10, 2018), D.I.
`36; D.I. 36-1.
`1413 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1414 Meads, C., et al., Coronary artery stents in the treatment of ischaemic
`heart disease: a rapid and systematic review, Health Technology
`Assessment 2000 4(23) (“Meads”)
`Excerpt from Grossman’s Cardiac Catheterization, Angiography, and
`Intervention (6th edition) (2000) (chapters 1, 4, 11, 23-25).
`1416 US Patent Publication 2003/0233117 (“Adams ’117”)
`1417 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1411
`
`1412
`
`1415
`
`
`
`iii
`
`

`

`1421
`
`IPR2020-01344
`Patent RE46,116
`
`Exhibit Description
`1418 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1419 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1420 Mehan, Coronary Angioplasty through 4 French Diagnostic
`Catheters, Catheterization and Cardiovascular Interventions 30:22-26
`(1993) (“Mehan”)
`Excerpt of prosecution history for application 11/232,876 (Office
`Action, 6/20/09)
`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)
`
`1429
`
`1432
`
`
`
`iv
`
`

`

`1440
`
`IPR2020-01344
`Patent RE46,116
`
`Exhibit Description
`1434 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1435 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1436 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1437 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1438 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1439 Urban et al., Coronary stenting through 6 French Guiding Catheters,
`Catheterization and Cardiovascular Diagnosis (1993) 28:263-266
`Excerpt of McGraw-Hill Dictionary of Scientific and Technical Terms
`(5th edition) (1994) (defining “flexural modulus”)
`Excerpt from Kern’s The Interventional Cardiac Catheterization
`Handbook (2nd edition) (2004) (chapter 1)).
`1442 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1443 Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1444 U.S. Patent No. 5,961,510 (“Fugoso”)
`1445 U.S. Patent No. 6,199,262 (“Martin”)
`1446 U.S. Patent No. 6,042,578 (“Dinh”)
`1447 WO 97/37713 (“Truckai”)
`1448
`Terumo Heartrail II product literature
`1449 Medtronic Launcher product literature
`1450 U.S. Patent No. 5,980,486 (“Enger”)
`1451 U.S. Patent No. 5,911,715 (“Berg”)
`1452 U.S. Patent No. 5,545,149 (“Brin”)
`1453 U.S. Patent No. 5,720,300 (“Fagan”)
`
`1441
`
`
`
`v
`
`

`

`IPR2020-01344
`Patent RE46,116
`
`Exhibit Description
`1454 U.S. Patent No. 5,120,323 (“Shockey”)
`1455
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1456 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1457 U.S. Patent No. 5,445,625 (“Voda”)
`1458 U.S. Patent No. 6,595,952 (“Forsberg”)
`1459 U.S. Patent No. 6,860,876 (“Chen”)
`1460 U.S. Patent No. 6,638,268 (“Niazi”)
`1461 U.S. Patent No. 5,690,613 (“Verbeek”)
`1462
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1463 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1464 QXMédical, LLC’s Opening Claim Construction
`Memorandum QXMedical, LLC v. Vascular Solutions, Inc., D. Minn.,
`No. 17-cv-01969 (March 14, 2018), D.I. 56
`1465 U.S. Patent No. 4,000,739 (“Stevens”)
`1466
`EP 0 881 921 B1 (“Lee”)
`1467 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1468 Defendants’ Memorandum in Opposition to Plaintiff’s Summary
`Judgment Motion and in Support of Defendants’ Summary Judgment
`Motion, QXMedical, LLC v. Vascular Solutions LLC et al., 17-cv-
`01969-PJS-TNL (D. Minn 2019)
`Excerpt of prosecution history for application 14/195,435 (Office
`Action, 10/06/15)
`
`1469
`
`
`
`vi
`
`

`

`1471
`
`IPR2020-01344
`Patent RE46,116
`
`Exhibit Description
`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
`1478
`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 U.S. RE45,380 (“the ’380 patent”)
`1482 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC et al. v. Medtronic,
`Inc., 19:cv-01760-PJS-TNL (July 12, 2019)
`Joint Fed. R. C. P. 26(f) Report [Excerpt], Vascular Solutions LLC et
`al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`Plaintiffs’ Objections and Responses to Interrogatories, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`
`1483
`
`1484
`
`
`
`vii
`
`

`

`1489
`1490
`1491
`1492
`1493
`
`1494
`1495
`
`IPR2020-01344
`Patent RE46,116
`
`Exhibit Description
`1485
`[RESERVED]
`1486
`[RESERVED]
`1487
`[RESERVED]
`1488 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)
`1496 U.S. Patent No. 4,886,507 (“Patton”)
`1497
`Excerpt of Patrick W. Serruys, Handbook of Coronary Stents (4th
`Edition) (2002)
`1498 U.S. Patent No. 5,167,636 (“Clement”)
`1499 U.S. Patent No. 5,897,497 (“Fernandez”)
`1500 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’032 File History
`1501 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’413 File History
`[RESERVED]
`1502
`1503 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’380 File History
`[RESERVED]
`
`1504
`
`
`
`viii
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`

`1508
`
`IPR2020-01344
`Patent RE46,116
`
`Exhibit Description
`1505 Originally filed Abstract, Specification, Drawings, and Claims from
`the ’379 File History
`1506 Non-Final Rejection from the ’379 File History filed on 2017-07-20
`1507 Applicant Initiated Interview Summary from the ’379 File History
`filed on 2018-01-24
`Ex. 7 of Teleflex Infringement Disclosures and Claim Chart, Vascular
`Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL (March
`1, 2020)
`1509 Mamas A. Mamas, Distal Stent Delivery with the Guideliner
`Catheter: First in Man Experience (2010)
`1510 Amendment to the claims from the ’379 File History filed on 2017-
`06-12
`1511 Applicant Arguments and Remarks Made in an Amendment from the
`’379 File History filed on 2018-01-19
`1512 U.S. Patent Application Publication US2017/0260219 (“Root”)
`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]
`1516
`[RESERVED]
`1517
`1518 Amended Pretrial Scheduling Order, Vascular Solutions LLC et al. v.
`Medtronic, Inc., 19:cv-01760-PJS-TNL (February 7, 2020)
`IPR2020-00136 Institution Decision (Paper 20)
`Plaintiffs’ Reply Brief in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`
`1515
`
`1519
`1520
`
`
`
`
`
`ix
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`

`

`IPR2020-01344
`Patent RE46,116
`
`I.
`
`PRELIMINARY STATEMENT
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) request inter
`
`partes review (“IPR”) of claims 25-55 (“Challenged Claims”) of U.S. Pat. No.
`
`RE46,116 (“the ’116 patent,” Ex-1401). The ’116 patent—which claims priority to
`
`a patent application filed on May 3, 2006 (Ex-1401, [60])—is entitled Coaxial
`
`Guide Catheter for Interventional Cardiology Procedures. Id., [54].
`
`The ’116 patent describes a catheter system that reduces the likelihood of a
`
`guide catheter dislodging from the ostium of a coronary artery during removal of a
`
`coronary stenosis. The purported invention requires a guide catheter (“GC”) and a
`
`guide extension catheter.1 The latter is inserted into and extended beyond the distal
`
`end of the GC (i.e., into a coronary branch artery). Id., Abstract, Figs. 8-9. In so
`
`doing, the guide extension catheter delivers “backup support by providing the
`
`ability to effectively create deep seating in the ostium of the coronary artery,”
`
`
`1 Despite claiming a method of using a guide extension catheter, the specification
`
`of the ʼ116 patent is silent regarding the use of a guide extension catheter and
`
`instead references a “coaxial guide catheter.” Ex-1405, ¶¶ 120-22. A POSITA
`
`would have recognized that a “coaxial guide catheter” was commonly understood
`
`to be a guide extension catheter. Id.; Ex-1409, 5:49-50 (referring to body 12 “as a
`
`guide catheter extension”).
`
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`IPR2020-01344
`Patent RE46,116
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`thereby preventing the GC from dislodging from the ostium. Id., 3:12-16, 8:33-46.
`
`The ’116 patent admits that the use of a guide extension catheter inside an
`
`outer guide catheter was known. Id., 2:50-67 (describing the use of a “smaller
`
`guide catheter within a larger guide catheter”); Ex-1405, ¶ 121. Indeed, such a
`
`catheter-in-catheter assembly was well-known in the art and described as a
`
`“mother-and-child assembly.” Ex-1405, ¶¶ 70-80. The child catheter (red in below
`
`figure) (i.e., the guide extension catheter) is essentially a tube that is inserted into
`
`and extends beyond the GC (blue in below figure) (i.e., the mother catheter) into
`
`the coronary artery. Ex-1405, ¶ 70.
`
`Ex-1454, Fig. 2 (annotations and color added).
`
`The child catheter in the original mother-and-child assembly had a
`
`
`
`
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`

`IPR2020-01344
`Patent RE46,116
`
`continuous lumen that was longer than the lumen of the guide (“mother”) catheter.
`
`Id.; Ex-1405, ¶ 70. The ’116 patent alleges that such a design had certain
`
`drawbacks (Ex-1401, 3:1-11; Ex-1405, ¶¶ 81-89) and modifies the child catheter of
`
`the mother-and-child assembly to have two parts: (i) a long thin pushrod (ii)
`
`coupled to a short distal lumen (i.e., tube) that can extend into the coronary artery.
`
`
`
`Ex-1401, Fig. 1 (annotations and color added).
`
`But such child catheters that served as guide extension catheters and had a
`
`short lumen connected to a long thin push rod 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 ʼ116 patent. Ex-1405,
`
`¶¶ 131-36.
`
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`IPR2020-01344
`Patent RE46,116
`
`
`Ex-1409, Fig. 6B (annotations and color added). It was also evidenced by U.S.
`
`Patent No. 7,604,612 (“Ressemann”). Ex-1405, ¶¶ 137-41.
`
`
`
`
`
`Ex-1408, Fig. 6B (annotations and color added).
`
`There is more than a reasonable likelihood that the Challenged Claims are
`
`unpatentable. Petitioner respectfully requests institution of trial and
`
`cancellation/invalidation of the Challenged Claims.
`
`
`
`4
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`

`

`IPR2020-01344
`Patent RE46,116
`
`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 Medtronic, Inc.
`
`B. Related Matters
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner identifies that the ’116 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)2; and (ii) QXMedical,
`
`LLC v. Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017)
`
`(“QXMedical Litigation”).
`
`Further, the ’116 patent is a reissue of U.S. Pat. No. 8,292,850 (“the ’850
`
`patent). The ’850 patent was previously the subject of litigation (i) in the U.S.
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`District Court for the District of Minnesota in Vascular Solutions, Inc. v. Boston
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`Scientific Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013), and (ii) at the
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`PTAB in Boston Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00762,
`
`
`2 The ʼ116 patent was not originally asserted and was added by Amended
`
`Complaint on February 14, 2020. Ex-1514.
`
`
`
`5
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`

`

`IPR2020-01344
`Patent RE46,116
`
`IPR2014-00763 (P.T.A.B., terminated Aug. 11, 2014).
`
`The ʼ116 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
`IPR2020-01343
`IPR2020-01344
`
`U.S. Patent No. Status
`8,048,032
`Trial Instituted
`8,048,032
`Trial Instituted
`RE45,380
`Trial Instituted
`RE45,380
`Trial Instituted
`RE45,380
`Trial Instituted
`RE45,760
`Trial Instituted
`RE45,760
`Trial Instituted
`RE45,776
`Trial Instituted
`RE45,776
`Trial Instituted
`RE47,379
`Trial Instituted
`RE47,379
`Trial Instituted
`8,142,413
`Pending
`8,142,413
`Pending
`RE46,116
`Pending3
`RE46,116
`Pending (Present Petition)
`
`C. Lead and Backup Counsel
`Pursuant to 37 C.F.R. § 42.8(b)(3), Petitioner identifies the following
`
`
`
`counsel of record:
`
`
`3 Petitioner concurrently filed a second IPR petition that applies Patent Owner’s
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`interpretation of the claims and specification of the ʼ116 patent. Ex-1520, at 11-12
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`(arguing that written description permits “side opening” to be outside substantially
`
`rigid segment).
`
`
`
`6
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`

`

`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
`
`IPR2020-01344
`Patent RE46,116
`
`
`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.
`
`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 ’116 patent is
`
`available for IPR and that Petitioner is not barred or estopped from requesting such
`
`review of the ’116 patent on the identified grounds.
`
`
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`7
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`IPR2020-01344
`Patent RE46,116
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`
`B.
`Precise Relief Requested and Asserted Grounds
`Petitioner respectfully request review of claims 25-55 of the ’116 patent and
`
`cancellation of these claims as unpatentable in view of the following grounds:4
`
`No.
`I
`
`II
`
`V
`
`Grounds
`Claims 52-53 are rendered obvious by Kontos in view of Ressemann,
`and the knowledge of a POSITA
`Claims 25-40, 42, and 44-48 are rendered obvious by Kontos in view of
`Ressemann, Takahashi, and the knowledge of a POSITA
`III Claim 45 is rendered obvious by Kontos in view of Ressemann,
`Takahashi, Kataishi, and the knowledge of a POSITA
`IV Claims 25-55 are rendered obvious by Root and the knowledge of a
`POSITA
`Claims 45-46 are rendered obvious by Kontos in view of Ressemann,
`Takahashi, Root, and the knowledge of a POSITA
`
`
`IV. BACKGROUND
`A. Overview of the Technology
`Coronary artery disease (“CAD”) occurs when plaque buildup narrows the
`
`arterial lumen. Ex-1405, ¶¶ 28, 30-32. This narrowing, sometimes called a stenosis,
`
`restricts blood flow and increases the risk of heart attack or stroke. Id. In response,
`
`
`4 This Petition is also supported by the Declarations of Dr. Stephen JD Brecker,
`
`MD (Ex-1405) and Richard A. Hillstead, PhD (Ex-1442), as experts in the field of
`
`the ’116 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.
`
`
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`8
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`IPR2020-01344
`Patent RE46,116
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`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.
`
`Although PCI was developed more than forty years ago, its basic
`
`components 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 into the needle, the needle is removed, and an
`
`introducer sheath is inserted over the guidewire and into the artery. Next, a guide
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`catheter can be introduced and advanced along the vasculature until its distal end is
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`placed—by a few millimeters—in the ostium of a coronary artery. Id., ¶¶ 42-55. At
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`the proximal end, a hemostatic valve is coupled to the guide catheter and remains
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`outside the patient’s body. Id., ¶¶ 35, 54. The hemostatic valve prevents blood
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`from exiting the patient’s artery and keeps air from entering the bloodstream. Id.
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`Another small diameter flexible guidewire can then be threaded through the
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`lumen of the guide catheter to the target site. Id., ¶¶ 56-58. This guidewire serves
`
`as a guiderail to advance a therapeutic catheter through the guide catheter and to
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`the occlusion. Id. The therapeutic cathe