`Petition for Inter Partes Review
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
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`
`
`
`
`
`
`Abiomed, Inc. and Abiomed R&D, Inc.
`Petitioner
`
`v.
`
`Maquet Cardiovascular, LLC
`Patent Owner
`
`Case No. IPR2017-01205
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,561,314
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`
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`CLAIMS 27, 29-30
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`
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`I.
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`II. Mandatory Notices ........................................................................................... 1
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`A. Real Party-in-Interest ................................................................................ 1
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`B. Related Matters ......................................................................................... 1
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`C. Counsel ...................................................................................................... 1
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`D. Service Information ................................................................................... 1
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`III. Grounds for Standing ....................................................................................... 2
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`IV. Relief Requested .............................................................................................. 2
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`A. The Challenged Claims Are Invalid in View of the Following Prior Art:2
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`B. Grounds for Challenge .............................................................................. 3
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`V.
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`Conventional Technology ................................................................................ 4
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`A. Conventional Techniques for Placing Intravascular Pumps ..................... 4
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`B. Placing Intravascular Blood Pumps .......................................................... 4
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`1. Over-the-Wire .................................................................................... 5
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`2. Rapid-Exchange ................................................................................ 5
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`3. Guide Catheter ................................................................................... 7
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`4. Interchangeability of Over-the-Wire and Rapid-Exchange .............. 7
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`5. Known Benefits of Rapid Exchange ................................................. 8
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`VI. Overview of the ’314 Patent ............................................................................ 9
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`i
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`A. Summary of the ’314 Patent ...................................................................... 9
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`B. Prosecution History ................................................................................. 13
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`C. The Earliest Possible Priority Date for the ’314 Patent is September 1,
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`2000 ........................................................................................................ 14
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`VII. Overview of the Prior Art .............................................................................. 16
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`A. Overview of Aboul-Hosn ........................................................................ 16
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`B. Overview of Siess .................................................................................... 22
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`C. Overview of Jegaden ............................................................................... 22
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`D. Overview of Yock ................................................................................... 24
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`E. Overview of Wampler ............................................................................. 24
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`F. Overview of Crowley .............................................................................. 25
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`VIII. Claim construction ......................................................................................... 26
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`A. “distal” ..................................................................................................... 27
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`B. “proximal” ............................................................................................... 28
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`IX. Person having ordinary skill in the art ........................................................... 28
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`X.
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`Specific Grounds for Petition ........................................................................ 29
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`A. Ground I: Claims 27 and 29-30 are rendered obvious by Aboul-Hosn in
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`view Jegaden, and further in view of Siess and Wampler ..................... 29
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`1. Claim 27 .......................................................................................... 29
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`2. Claim 29 .......................................................................................... 81
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`3. Claim 30 .......................................................................................... 82
`ii
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`B. Ground II: Claim 27 is rendered obvious by Aboul-Hosn in view of
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`Yock, and further in view of Siess and Wampler .................................. 84
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`1. Claim 27 .......................................................................................... 84
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`C. Ground III: Claims 29-30 are rendered obvious by Aboul-Hosn, in view
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`of Yock, and further in view of Siess, Wampler, and Jegaden ...........100
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`1. Claim 29 ........................................................................................100
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`2. Claim 30 ........................................................................................102
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`XI. Conclusion ...................................................................................................103
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`iii
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`TABLE OF AUTHORITIES
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`Page(s)
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`FEDERAL CASES
`Dynamic Drinkware, LLC. V. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .......................................................................... 18
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) .......................................................................... 32
`
`FEDERAL STATUTES
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`35 U.S.C. § 102(a) ................................................................................................... 19
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`35 U.S.C. § 102(b) ........................................................................................... 3, 4, 19
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`35 U.S.C. § 103 .......................................................................................................... 1
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`35 U.S.C. § 103(a) ..................................................................................................... 5
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`35 U.S.C. § 112 ¶ 1 .................................................................................................. 18
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`FEDERAL RULES
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`Rule 42.104(a) ............................................................................................................ 2
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`Rule 42.104(b)(4)-(5) ............................................................................................... 31
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`Rules 42.22(a)(1) and 42.104(b)(1)-(2) ..................................................................... 3
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`FEDERAL REGULATIONS
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`37 C.F.R § 42.8(b)(4) ................................................................................................. 2
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`37 C.F.R § 42.100(b) ............................................................................................... 24
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`37 C.F.R § 42.104 ...................................................................................................... v
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`iv
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`I.
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`INTRODUCTION
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`Petitioners Abiomed, Inc. and Abiomed R&D, Inc. (collectively,
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`“Petitioner”) petition for inter partes review (“IPR”) of claims 27 and 29-30 (the
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`“Challenged Claims”) of U.S. Patent No. 9,561,314 (the “’314 patent”). The
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`Challenged Claims add nothing new to the art and should be found unpatentable
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`and canceled.
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`II. MANDATORY NOTICES
`A. Real Party-in-Interest
`The real parties in interest are Abiomed, Inc. and Abiomed R&D, Inc.
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`B. Related Matters
`Petitioner has filed, or will file, concurrently with the present Petition: (1) a
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`petition for IPR of claims 1-8, 10-23, and 25-27 of the ’314 patent; (2) petitions for
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`IPR of U.S. Patent Nos. 9,545,468 and 9,597,437; and (3) petitions for IPR of U.S.
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`Patent Nos. 7,022,100 (IPR2017-01025), 8,888,728 (IPR2017-01026 and
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`IPR2017-01027), and 9,327,068 (IPR2017-01028 and IPR2017-01029) (the
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`“related patents”) which are related to the ’314 patent.
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`C. Counsel
`Lead Counsel: David M. Tennant (Reg. No. 48,362)
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`Backup Counsel: Charles D. Larsen (Reg. No. 48,533); Christopher Carroll
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`(Reg. No. 55,776)
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`D.
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`Service Information
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`1
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`
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Pursuant to 37 C.F.R. § 42.8(b)(4), papers concerning this matter should be
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`served on the following. Petitioner consents to electronic service.
`
`David M. Tennant (Reg. No. 48,362)
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`E-mail: WCAbiomedIPR@whitecase.com
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`Post and hand delivery: White & Case LLP
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`701 Thirteenth Street, NW
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`Washington, DC 20005
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`Telephone: (202) 626-3684
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`
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`Fax: (202) 639-9355
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`III. GROUNDS FOR STANDING
`Petitioner certifies the ’314 patent is available for IPR and that Petitioner is
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`not barred or estopped from requesting IPR of the Challenged Claims.
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`IV. RELIEF REQUESTED
`Petitioner requests review of the Challenged Claims and a ruling that the
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`Challenged Claims are unpatentable.
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`A. The Challenged Claims Are Invalid in View of the Following
`Prior Art1:
`1. WO 99/02204 to Aboul-Hosn (EX1004,“Aboul-Hosn”), published January
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`21, 1999, is prior art under 35 U.S.C. § 102(b).
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`2.
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`U.S. Patent No. 5,921,913 to Siess (EX1005,“Siess”), filed June 24, 1997
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`and issued July 13, 1999, is prior art under 35 U.S.C. § 102(b).
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`1 The pre-AIA statutory framework applies to the ’314 Patent.
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`2
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`
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Jegaden, Clinical Results of Hemopump Support in Surgical Cases,
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`3.
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`Published in Temporary Cardiac Assist with an Axial Pump System, p.61-65
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`(Springer 1991) (EX1033,“Jegaden”), is prior art under 35 U.S.C. § 102(b).2
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`4.
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`U.S. Patent No. 5,061,273 to Yock (EX1006,“Yock”), filed June 1, 1989 and
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`issued October 29, 1991, is prior art under 35 U.S.C. § 102(b).
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`5. Wampler et al., Clinical Experience with the Hemopump Left Ventricular
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`Support Device, published in Supported Complex and High Risk Coronary
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`Angioplasty, ch. 14, 231-49 (Springer 1st ed. 1991) (EX1007,“Wampler”),
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`published in 1991, is prior art under 35 U.S.C. § 102(b).3
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`6.
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`U.S. Patent No. 5,421,338 to Crowley (EX1045, “Crowley”), filed June 3,
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`1994 and issued June 6, 1995, is prior art under 35 U.S.C. § 102(b).
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`B. Grounds for Challenge
`Petitioner respectfully requests review of the Challenged Claims and
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`
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`cancellation of those claims under the following statutory grounds:
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`2 Jegaden bears a copyright date of 1991 and was publicly available from 1992.
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`EX1033. Declaration of Leupold (EX1044).
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`3 Wampler bears a copyright date of 1991 and was publicly available from 1991.
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`See EX1007; Declaration of Kiersten Batzli (EX1035); Library of Congress Card
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`Catalog (EX1036).
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`3
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`• Ground 1: Claims 27 and 29-30 are rendered obvious by Aboul-Hosn in
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`view of Jegaden, and further in view of Siess and Wampler under 35
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`U.S.C. § 103(a).
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`• Ground 2: Claim 27 is rendered obvious by Aboul-Hosn in view of Yock,
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`and further in view of Siess and Wampler under 35 U.S.C. § 103(a).
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`• Ground 3: Claims 29-30 are rendered obvious by Aboul-Hosn in view of
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`Yock, and further in view of Siess, Wampler, and Jegaden under 35
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`U.S.C. § 103(a).
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`V. CONVENTIONAL TECHNOLOGY
`A. Conventional Techniques for Placing Intravascular Pumps
`The features of the Challenged Claims were well-known and included a
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`
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`cannula, connected to an axial flow pump (Collins ¶¶53, 57-65), pumping blood
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`axially along the pump and through the cannula (Collins ¶¶66-70), a purge fluid
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`system to prevent blood from entering the pump motor and to lubricate the pump
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`motor (Collins ¶¶71-74), and techniques for monitoring blood pressure near the
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`pump (Collins ¶¶75-81). The few other remaining details of the Challenged
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`Claims were also well-known– i.e., purge fluid pump and fittings (in Wampler),
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`pressure sensor configurations (in Aboul-Hosn or Siess)). (Collins ¶¶72-74.)
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`Placing Intravascular Blood Pumps
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`B.
`The guide wire mechanism of the Challenged Claims was also well-known
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`4
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`in catheterization as the “rapid-exchange” technique. Along with “over the wire”
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`and “guide catheters,” rapid exchange was used routinely to position blood pumps
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`intravascularly. (Collins ¶¶82-102.)
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`Over-the-Wire
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`1.
`POSITAs used “over-the-wire” guide mechanisms to place intravascular
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`blood pumps. (Collins ¶¶87-90.) For example, Voelker FIG. 3 applied the “over-
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`the-wire” guide mechanism to an axial flow intravascular blood pump with the
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`guide wire extending through the shaft 19 and other components so that the pump
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`may be slipped over the guide wire. (Collins ¶89; EX1011[Voelker] 3:56-60.)
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`(Collins ¶89; EX1011[Voelker] FIG. 3, annotated.)
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`Rapid-Exchange
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`2.
`“Rapid-exchange” was another well-known technique used to place
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`intravascular assist devices at a desired location within a patient’s body. (Collins
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`5
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`¶¶91-94.) Yock disclosed placing a conventional “rapid-exchange” catheter by
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`sliding the catheter along a guide wire extending through a sleeve secured to the
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`exterior of the tubular member or embedded within the cannula wall itself. (Id.
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`¶¶91-92; EX1006[Yock] FIG. 10, 7:64-8:2.)
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`(Collins ¶92; EX1006[Yock] FIG. 10, annotated.)
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`
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`Voelker, at Fig. 2 (below) also disclosed this rapid exchange approach as
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`applied to an intravascular blood pump -- a guide wire 25 extending through a side
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`sleeve for positioning a blood pump as illustrated below. (Collins ¶94;
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`
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`EX1011[Voelker] 3:34-43.)
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`6
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`(Collins ¶94; EX1011[Voelker] FIG. 2, annotated.)
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`As explained in further detail in Sections VII and X below, a POSITA could
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`also readily adapt Aboul-Hosn’s blood pump to be delivered using the
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`conventional “rapid-exchange” technique. (Id. ¶¶91-94.)
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`Guide Catheter
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`3.
`Yock also discloses using a guide catheter to position a guide wire. (Collins
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`¶84; EX1006[Yock] 3:56-4:50.) The same technique as disclosed by Yock has had
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`been adapted to place axial flow intravascular blood pumps. (Collins ¶85.) In fact,
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`the ’314 Patent acknowledges this conventional technique. (EX1001[’314 Patent]
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`2:35-55.)
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`Interchangeability of Over-the-Wire and Rapid-Exchange
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`4.
`Over-the-wire and rapid-exchange techniques have long been used
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`interchangeably to deliver cardiac assist devices, including blood pumps. (Collins
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`¶¶97-100; EX1023[Faxon] 58-59; EX1006[Yock]8:16-25; EX1011[Voelker]
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`FIGS. 2 and 3.) Over-the-wire and rapid-exchange were part of a limited set of
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`delivery techniques. (Collins ¶98.) For example, U.S. Patent No. 5,928,181 to
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`Coleman et al. (EX1042,“Coleman”) discloses that catheters coupled to a
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`cardiopulmonary bypass pump may be suitably guided into position using either
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`technique. (EX1042[Coleman] 34:14-39.)
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`7
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
` The interchangeability of over-the-wire and rapid-exchange was also well
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`understood for intravascular blood pump applications. (Collins ¶99.) For
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`example, Voelker’s blood pump could be configured to use either technique. (Id.;
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`EX1011[Voelker] FIG. 2 (over-the-wire), and FIG. 3 (rapid-exchange).) Of
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`course, adapting an intravascular blood pump to use over-the-wire or rapid-
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`exchange involves certain design choices, but such design choices were also well-
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`known within the prior art. (Collins ¶100; EX1001[Voelker] 3:34-55.)
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`Known Benefits of Rapid Exchange
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`5.
`The well-known rapid-exchange technique had many known advantages
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`compared to an over-the-wire guide mechanism. (Collins ¶100.) For example,
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`unlike over-the-wire, rapid-exchange does not require pre-loading the guide wire
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`over a first portion, equal in length to the full length of guide wire entering the
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`body. Accordingly, rapid exchange allowed one person instead of two to carry out
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`the exchange procedure because the required length of guide wire is reduced,
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`which also means that the required sterile zone can be shortened. (Collins ¶100;
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`EX1006[Yock] 1:15-25.) Accordingly, the rapid-exchange guide mechanism
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`simplified the exchange procedure and increased the speed at which devices could
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`be inserted or withdrawn. (Collins ¶100; EX1023[Faxon] Fig. 5;
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`EX1011[Voelker] 3:49-55). The rapid-exchange configuration also provides the
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`8
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`benefits of additional design flexibility by not requiring the guide wire to travel
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`through the rotor hub. (Collins ¶102.)
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`VI. OVERVIEW OF THE ’314 PATENT
`A.
`Summary of the ’314 Patent
`The ’314 patent’s disclosure concerns placement of a conventional
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`intravascular blood pump system using the same three conventional guide wire
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`delivery techniques of the prior art discussed above. (EX1001[’314 patent] 9:13-
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`32, 13:62-14:10, 15:5-21; Collins ¶¶103-11.) The background of the ’314 patent
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`openly admits that it is not the first to use “guide mechanism[s]” to place an
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`intravascular pump. (EX1001[’314 patent] 2:35-45.)
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`Fig. 1 of the ’314 patent illustrates a conventional over-the-wire placement
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`technique. (Id. 5:25-30.)
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`9
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
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`(Collins ¶106; EX1001[’314 patent] FIG. 1, annotated.)
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`
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`The conventional intravascular blood pump system includes an intravascular
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`blood pump 12 rotor hub, cannula 14, and over-the-wire guide mechanism 16 with
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`a guide wire lumen that passes through the center of the rotor hub and the cannula
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`14. (Id. 9:13-24; Collins ¶106.) The blood pump 12 provides heart support in the
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`same manner as conventional axial-flow intravascular blood pumps – by
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`“deliberately re-rout[ing] through and past the right and/or left ventricle in an
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`10
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`effort to reduce the volume of blood to be pumped by the particular ventricle.”
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`(Compare EX1001[’314 patent] 20:43-48 with id. 2:16-19; Collins ¶103.)
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`FIG. 6 shows the conventional “rapid-exchange” or “side-rigger” guide
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`mechanism of the prior art. (Id. 5:47-52.) The guide mechanism 122 “includes a
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`guide carriage 124 formed along at least a portion of the cannula 14, and a …
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`guide wire 22 … dimensioned to pass slideably through a lumen (not shown)
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`extending through the guide carriage 124.” (Id. 14:17-21; Collins ¶¶108-09.) As
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`with the prior art (Collins ¶109), the guide carriage 124 is “an integral extension of
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`the wall of the cannula 14.” (EX1001[’314 patent] 14:37-39.)
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`11
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
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`(Collins ¶108; EX1001[’314 patent] FIG. 6, annotated.)
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`Finally, the ’314 patent at FIG. 10 shows a “guide catheter” mechanism 132
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`as in the prior art where the rotor and shroud are placed in two different steps.
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`(EX1001[’314 patent] 5:65-6:3; Collins ¶111.)
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`12
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
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`(Collins ¶111; EX1001[’314 patent] FIG. 10, annotated.)
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`Prosecution History
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`B.
`During prosecution of the ’314 patent, in the sole office action the Examiner
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`indicated that eight co-pending and patented applications were relevant to the
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`Challenged Claims, but found the Challenged Claims to be patentably distinct –
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`not because of a specific combination of elements, but because “a guide wire not
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`passing through the rotor hub and a housing and catheter with a purge lumen” were
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`not disclosed in those applications. (EX1003[’314 PH] 238.) There is no
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`13
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`patentable synergy between the recited guide wire configuration and the purge
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`system feature that the Examiner found missing. (Collins ¶182.) As with the other
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`conventional features of the Challenged Claims, a “guide wire not passing through
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`the rotor hub” and a “housing and catheter with a purge lumen” were conventional
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`elements that were well-known and disclosed by prior art references not relied on
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`by the Examiner. (Id. ¶182.)
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`C. The Earliest Possible Priority Date for the ’314 Patent is
`September 1, 2000
`
`The September 1, 2000 priority date of the ’314 patent is the earliest
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`possible priority date (as defined above, the “EPD”) for the Challenged Claims.4
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`The subject matter of the Challenged Claims is not supported by an earlier-filed
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`provisional application. Provisional U.S. Application No. 60/152,249 (EX1012,
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`the “’249 provisional application”).
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`Numerous elements of the Challenged Claims lack support in the ’249
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`provisional application. (Collins ¶127.) For example, independent claim 27
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`requires “a purge lumen extending through the catheter and operatively arranged to
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`deliver purge fluid,” “a pressure sensing element” and “the guide wire passes
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`slidably and coaxially through the elongate lumen.” (EX1001 [’314 patent] 36:12;
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`4 The ’314 Patent was filed August 17, 2016 and claims priority to PCT
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`Application No. PCT/US00/24515, which was filed on September 1, 2000.
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`14
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`36:67-37:1; 37:27-28.) None of these limitations are supported in the ’249
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`provisional application.5 Collins ¶127; Dynamic Drinkware, LLC. v. Nat’l
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`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (“the specification of the
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`provisional must ‘contain a written description of the invention and the manner
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`and process of making and using it, in such full, clear, concise, and exact terms,’
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`35 U.S.C. § 112 ¶1, to enable an ordinarily skilled artisan to practice the invention
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`claimed in the non-provisional application.”) (quoting New Railhead Mfg., LLC v.
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`Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002) (emphasis in original).)
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`5 During prosecution of the ’728 patent, which is related to the ’314 patent, the
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`Examiner found that the claims directed to “the ‘side-rigger’ or ‘rapid-exchange’
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`guide mechanism,” “a blood pressure detection mechanism,” and “a guide wire and
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`an elongate lumen” were not entitled to the priority date of the ’249 provisional
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`application, and which the Patent Owner never challenged in any subsequent
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`response. (EX1043[’728 PH] 259-280.)
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`15
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Accordingly, the EPD for the Challenged Claims is September 1, 2000.6
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`(Collins ¶¶126-29.)
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`VII. OVERVIEW OF THE PRIOR ART7
`A. Overview of Aboul-Hosn
`Aboul-Hosn discloses an axial flow intravascular blood pump for heart
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`support that is delivered intravascularly to a desired location within the heart using
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`the same well-known guide mechanisms as noted in the ’314 patent. (Collins
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`¶131; EX1004[Aboul-Hosn] 11:9-14; 30:1-2.) Aboul-Hosn further discloses both
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`percutaneous and surgical approaches for delivering the intravascular blood pump.
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`(Collins ¶130; EX1004[Aboul-Hosn] FIG. 21, 21:19-22:30, 11:8-12.)
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`6 If the Board finds that one or more Challenged Claims is entitled to the
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`September 3, 1999 filing date of the ’249 provisional application, Aboul-Hosn
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`(EX1004) and Siess (EX1005) would still qualify as prior art under 35 U.S.C. §
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`102(a), and Jegaden (EX1033), Yock (EX1006), and Wampler (EX1007) would
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`remain prior art under 35 U.S.C. § 102(b).
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`7 Aboul-Hosn and Siess were cited in an Information Disclosure Statement dated
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`August 19, 2016, but there is no record that the Examiner relied upon them.
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`(EX1003[’314 PH] 271, 280). There is no record of Jegaden, Yock, or Wampler
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`being disclosed to the USPTO or considered by the Examiner during prosecution
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`of the ’314 patent.
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`16
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Annotated FIGS. 21 and 23, below, show a percutaneous approach for
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`delivering the pump using a guide wire to place a stabilization cannula 4118 (blue)
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`and the blood pump 420 (green) in the left side of a patient’s heart. (Collins
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`¶¶149-151; EX1004[Aboul-Hosn] 30:1-2, 20-27.) FIG. 21 shows how the blood
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`pump passes along the guide wire up the femoral artery, so the cannula goes
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`through the aorta and into the left ventricle. In FIG. 23, the cannula then also
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`continues into the left atrium, where it is positioned to pump blood from the left
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`atrium to the aorta. (Collins ¶¶150-51; EX1004[Aboul-Hosn] 29:17-28, 30:1-2,
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`30:20-27.) In addition the cannula’s inflow tip may also be placed in “the left
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`ventricle, … or any of the left heart vessels” to provide left heart support. (Id.
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`26:10-13.)
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`8 FIG. 20 is a zoomed-in view of the stabilization system 410 of FIG. 23; it
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`identifies element 411 as the stabilization cannula that passes through the
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`stabilization balloon 440 (red). (EX1004[Aboul-Hosn] 28:23-27.)
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`17
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
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`(Collins ¶150; EX1004[Aboul-Hosn] FIGS. 21, 23, annotated.)
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`FIGS. 1-13 show a surgical approach with details about the interior of the
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`pump and cannula. Numerous conventional features of intravascular blood pumps
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`are disclosed, including a “commercially available” cannula (EX1004 [Aboul-
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`Hosn] 11:14), together with a “reverse flow” feature that reverses the direction of
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`blood flow as it exits the pump. (Collins ¶¶152-53.)
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`As shown below in FIGS. 1 and 2, and similar to the ’314 patent, the pump
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`system has a conventional drive motor 80 (purple) connected to a rotor and
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`associated blades 70 (red), within a housing body 52 (green) and a housing cap 62
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`(green).9 (EX1004[Aboul-Hosn] 12:12-13:13.) The inner cannula 20 (blue) is
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`coupled to the housing cap 62 (green), and extends beyond the distal opening 32 of
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`the outer conduit 30 (dark grey.) (Id.)
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`
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`(Collins ¶137; EX1004[Aboul-Hosn] FIGS. 1, 2, annotated.)
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`As shown below, to apply the percutaneous approach in the reverse flow
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`configuration, the pump (green) in the system of FIGS. 1-13 (i.e. an intravascular
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`pump “provided for by the present invention”) would be readily connected to the
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`9 The housing body 52 and the housing cap 60 may form “a unitary body.”
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`(EX1004[Aboul-Hosn] 12:22-23.)
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`19
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`multilumen catheter 428 (yellow). (Collins ¶¶146-47.) In this configuration, the
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`catheter 428 would be used to advance the pump 420 and stabilization cannula 411
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`over a guide wire to the desired location within the patient’s heart through the
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`femoral artery. (Collins ¶¶146-47; EX1004[Aboul-Hosn] 29:18-25.)
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`
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`(Collins ¶140; EX1004[Aboul-Hosn] FIGS. 1, 23, annotated.)
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`The pump 420 could also be configured without the reverse flow feature of
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`the pump system of FIGS. 1-13. (Collins ¶139; see also EX1004[Aboul-Hosn]
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`31:6-9.) In this configuration, the pump 420 would include the components of the
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`pump system of FIGS. 1-13 that generate the axial flow of blood through the pump
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`(i.e. rotor 70 and inlet tube 55, connected to drive unit 80), without the components
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`20
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`that cause the blood flow to reverse course (i.e. housing body 52, housing cap 60,
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`and outer cannula 30). (Collins ¶141.) Instead, the blood (represented by the red
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`arrows) discharges axially over the drive unit and out the pump 420 (green). (Id.
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`¶141.)
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`
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`(Collins ¶141; EX1004[Aboul-Hosn] FIGS. 1, 23, annotated.)
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`Aboul-Hosn also suggests inserting a guide wire through cannula opening 27
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`as seen in FIGS. 1 and 2 to place the pump, consistent with the rapid-exchange
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`technique. (Id. ¶¶133-36; EX1004[Aboul-Hosn] 11:24-26: “a catheter guide wire
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`may also be extended through the cannula openings 27 to dispose the inner cannula
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`20 at desired locations.”)
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`21
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
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`B. Overview of Siess
`Siess also discloses an intravascular blood pump configured to be delivered
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`to a desired location within the patient’s vasculature using a guide wire. (Collins
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`¶171-75; EX1005[Siess] 5:55-58.) The pump is connected to a catheter that
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`includes a lumen to deliver a “biocompatible purge fluid[,] … that is pressurized so
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`as to maintain a slow purge rate over the seals of about 1-5ml/hr[,]” to the
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`microaxial pump 10. (Id. 8:31-44.) Additionally, it can have “electrical conduits
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`extending therethrough to allow the operation of the drive unit to be monitored and
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`controlled.” (Id. 8:31-38, 11:23-40.)
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`(EX1005[Siess] FIG. 4, annotated.)
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`C. Overview of Jegaden
`Jegaden discloses placing a conventional axial flow intravascular pump
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`system (i.e. the Hemopump) to a desired location using the conventional rapid-
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`exchange technique. (Collins ¶¶154-59; EX1033[Jegaden] 61-62.) As shown in
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`FIG. 2, the five French (“5F”) catheter having a guide wire extending coaxially
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`22
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`through its lumen and exiting its distal end is “passed through the distal hole of the
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`cannula and introduced into the femoral artery up to the aorta,” and “[t]hen the
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`cannula is introduced into the femoral artery and is pushed into the aorta, guided
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`by the vasculature catheter” (i.e. the 5F catheter). (Collins ¶155; EX1033[Jegaden]
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`62.) The 5F catheter and cannula’s distal hole function as a rapid-exchange guide
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`mechanism for the pump. (Collins ¶156.) Moreover, Fig. 2 shows a J-shaped
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`distal tip at the end of the guide wire. (Collins ¶159; EX1033[Jegaden] Fig. 2.)
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`Guide wire
`extending out in a
`distal direction
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`Distal End of 5F
`Catheter
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`Distal Hole of
`Canula
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`5F Catheter
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`Canula
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`Guide wire
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`
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`(Collins ¶156; EX1033[Jegaden] FIG. 1, annotated.)
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`23
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
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`D. Overview of Yock
`Yock discloses a conventional rapid-exchange catheter, shown in FIG. 10
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`below, which includes an elongate tubular member, such as a cannula, and a sleeve
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`(with an interior lumen for a guide wire) secured to the exterior of the tubular
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`member or embedded within the cannula wall itself. (Id. ¶¶160-64; EX1006[Yock]
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`FIG. 10, 7:64-8:2.) A guide wire is placed in a desired location in the body and
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`inserted through the sleeve, and the catheter is advanced along the guide wire to
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`the desired location. (Collins ¶160; EX1006[Yock] 7:64-8:25.) The orientation of
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`the sleeve along the side of the cannula allows for the rapid exchange of catheters.
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`(Collins ¶163; EX1006[Yock] 2:31-37.)
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`
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`(Collins ¶163; EX1006[Yock] FIG. 10, annotated.)
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`E. Overview of Wampler
`Wampler discloses the Hemopump, introduced in Jegaden, which was the
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`original catheter-based blood pump used for the treatment of cardiogenic shock.
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`(Collins ¶165; EX1007[Wampler] 232-36.) Wampler provides a schematic of the
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`Hemopump in FIG. 14-2, showing purge fluid inlet and outlet conduits connected
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`24
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`to a purge fluid pump that delivers a continuous infusion of purge fluid to the
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`Hemopump via lumens within the drive cable sheath. (Collins ¶¶167-68;
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`EX1007[Wampler] 233-34.)
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`(EX1007 [Wampler] FIG. 14-2.)
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`
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`F. Overview of Crowley
`The use of a distal tip member to improve the placement of intravascular
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`devices in the heart was well-known before the EPD. (Collins ¶178) For example,
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`Crowley describes the use of a guide wire 80 to “guid[e] the ultrasound device
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`through a valve such as the heart.” (Id.; EX1045[Crowley] 16:41-43.) The guide
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`wire “support[s] and stead[ies] the free end of the ultrasound device during axial
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`movement of