U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`
`
`
`
`
`
`
`Abiomed, Inc. and Abiomed R&D, Inc.
`Petitioner
`
`v.
`
`Maquet Cardiovascular, LLC
`Patent Owner
`
`Case No. IPR2017-01204
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,561,314
`
`
`
`
`CLAIMS 1-8, 10-23, and 25-26
`
`
`
`
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`
`
`
`I.
`
`II. Mandatory Notices ........................................................................................... 1
`
`A. Real Party-in-Interest ................................................................................ 1
`
`B. Related Matters ......................................................................................... 1
`
`C. Counsel ...................................................................................................... 1
`
`D. Service Information ................................................................................... 1
`
`III. Grounds for Standing ....................................................................................... 2
`
`IV. Relief Requested .............................................................................................. 2
`
`A. The Challenged Claims Are Invalid in View of the Following Prior
`
`Art: ........................................................................................................... 2
`
`B. Grounds for Challenge .............................................................................. 3
`
`V.
`
`Conventional Technology ................................................................................ 4
`
`A. Conventional Intravascular Blood Pumps ................................................. 4
`
`B. Placing Intravascular Blood Pumps .......................................................... 5
`
`1. Over-the-Wire .................................................................................... 5
`
`2. Rapid-Exchange ................................................................................ 6
`
`3. Guide Catheter ................................................................................... 8
`
`i
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`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`4. Interchangeability of Over-the-Wire and Rapid Exchange ............... 8
`
`VI. Overview of the ’314 Patent ............................................................................ 9
`
`A. Summary of the ’314 Patent ...................................................................... 9
`
`B. Prosecution History ................................................................................. 13
`
`C. The Earliest Possible Priority Date for the ’314 Patent is September
`
`1, 2000 .................................................................................................... 14
`
`VII. Overview of the Prior Art .............................................................................. 15
`
`A. Overview of Aboul-Hosn ........................................................................ 16
`
`B. Overview of Siess .................................................................................... 21
`
`C. Overview of Jegaden ............................................................................... 21
`
`D. Overview of Wampler ............................................................................. 23
`
`E. Overview of Wampler_712 ................................................................... 24
`
`F. Overview of Crowley ............................................................................. 26
`
`VIII. Claim construction ......................................................................................... 27
`
`A. “distal” ..................................................................................................... 27
`
`B. “proximal” ............................................................................................... 28
`
`IX. Person having ordinary skill in the art ........................................................... 29
`
`X.
`
`Specific Grounds for Petition ........................................................................ 29
`
`ii
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`A. Ground I: Claims 1-8, 14-20, and 25-26 are obvious over Aboul-
`
`Hosn in view of Siess and Wampler ...................................................... 30
`
`1. Claim 1 ............................................................................................ 30
`
`2. Claim 2 ............................................................................................ 61
`
`3. Claim 3 ............................................................................................ 62
`
`4. Claim 4 ............................................................................................ 62
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`5. Claim 5 ............................................................................................ 64
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`6. Claim 6 ............................................................................................ 67
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`7. Claim 7 ............................................................................................ 70
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`8. Claim 8 ............................................................................................ 70
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`9. Claim 14 .......................................................................................... 73
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`10. Claim 16 .......................................................................................... 73
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`11. Claim 17 .......................................................................................... 75
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`12. Claim 18 .......................................................................................... 75
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`13. Claim 19 .......................................................................................... 76
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`14. Claim 20 .......................................................................................... 78
`
`15. Claim 25 .......................................................................................... 86
`
`16. Claim 26 .......................................................................................... 86
`
`iii
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`B. Ground II: Claims 10-11, 13, 21, and 23 are obvious over Aboul-
`
`Hosn in view of Siess and Wampler, and further in view of Jegaden. .. 86
`
`1. Claim 10 .......................................................................................... 86
`
`2. Claim 11 .......................................................................................... 88
`
`3. Claim 13 .......................................................................................... 89
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`4. Claim 21 .......................................................................................... 91
`
`5. Claim 23 .......................................................................................... 91
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`C. Ground III: Claim 12 and 22 are obvious over Aboul-Hosn in view
`
`Siess and Wampler, and further in view of Crowley. ............................ 91
`
`1. Claim 12 .......................................................................................... 91
`
`2. Claim 22 .......................................................................................... 92
`
`D. Ground IV: Claim 15 is obvious over Aboul-Hosn in view of Siess
`
`and Wampler, and further in view of Wampler_712. ............................ 92
`
`1. Claim 15 .......................................................................................... 93
`
`XI. Conclusion ..................................................................................................... 94
`
`
`
`iv
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`
`FEDERAL CASES
`Dynamic Drinkware, LLC. V. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) .......................................................................... 14
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) .......................................................................... 28
`
`FEDERAL STATUTES
`
`35 U.S.C. § 102(a) ................................................................................................... 15
`
`35 U.S.C. § 102(b) ............................................................................................... 4, 15
`
`35 U.S.C. § 103 .......................................................................................................... 1
`
`35 U.S.C. § 103(a) ................................................................................................. 4, 5
`
`35 U.S.C. § 112 ¶ 1 .................................................................................................. 14
`
`35 U.S.C. § 312 ......................................................................................................... iv
`
`35 U.S.C. § 314(a) ..................................................................................................... 4
`
`FEDERAL RULES
`
`Rule 42.104(a) ............................................................................................................ 3
`
`Rule 42.104(b)(4)-(5) ............................................................................................... 31
`
`Rules 42.22(a)(1) and 42.104(b)(1)-(2) ..................................................................... 3
`
`FEDERAL REGULATIONS
`
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 2
`
`37 C.F.R. § 42.100(b). ............................................................................................. 28
`
`37 C.F.R. § 42.104 .................................................................................................... iv
`
`v
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`I.
`
`INTRODUCTION
`
`Petitioners Abiomed, Inc. and Abiomed R&D, Inc. (collectively,
`
`“Petitioner”) petition for inter partes review (“IPR”) of claims 1-8, 10-23, and 25-
`
`26 (the “Challenged Claims”) of U.S. Patent No. 9,561,314 (the “’314 patent”).
`
`The Challenged Claims add nothing new to the art and should be found
`
`unpatentable and canceled.
`
`II. MANDATORY NOTICES
`A. Real Party-in-Interest
`The real parties in interest are Abiomed, Inc. and Abiomed R&D, Inc.
`
`B. Related Matters
`Petitioner has filed, or will file, concurrently with the present Petition: (1) a
`
`second petition for inter partes review of claims 27 and 29-30 of the ’314 patent;
`
`(2) petitions for IPR of U.S. Patent Nos. 9,545,468 and 9,597,437; and (3) petitions
`
`for IPR of U.S. Patent Nos. 7,022,100 (IPR2017-01025), 8,888,728 (IPR2017-
`
`01026 and IPR2017-01027), and 9,327,068 (IPR2017-01028 and IPR2017-01029)
`
`(the “related patents”) which are related to the ’314 patent.
`
`C. Counsel
`Lead Counsel: David M. Tennant (Reg. No. 48,362)
`
`Backup Counsel: Charles D. Larsen (Reg. No. 48,533); Christopher Carroll
`
`(Reg. No. 55,776)
`
`D. Service Information
`
`1
`
`

`

`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
`
`served on the following. Petitioner consents to electronic service.
`
`David M. Tennant (Reg. No. 48,362)
`
`E-mail: WCAbiomedIPR@whitecase.com
`
`Post and hand delivery: White & Case LLP
`
`701 Thirteenth Street, NW
`
`Washington, DC 20005
`
`Telephone: (202) 626-3684
`
`
`
`Fax: (202) 639-9355
`
`III. GROUNDS FOR STANDING
`Petitioner certifies the ’314 patent is available for IPR and that Petitioner is
`
`not barred or estopped from requesting IPR of the Challenged Claims.
`
`IV. RELIEF REQUESTED
`Petitioner requests review of the Challenged Claims and a ruling that the
`
`Challenged Claims are unpatentable.
`
`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
`
`21, 1999, is prior art under 35 U.S.C. § 102(b).
`
`2.
`
`U.S. Patent No. 5,921,913 to Siess (EX1005,“Siess”), filed June 24, 1997
`
`and issued July 13, 1999, is prior art under 35 U.S.C. § 102(b).
`
`1 The pre-AIA statutory framework applies to the ’314 Patent.
`
`2
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Jegaden, Clinical results of Hemopump support in surgical cases, Published
`
`3.
`
`in Temporary Cardiac Assist with an Axial Pump System, p.61-65 (Springer 1991)
`
`(EX1033,“Jegaden”), is prior art under 35 U.S.C. § 102(b).2
`
`4. Wampler et al., Clinical Experience with the Hemopump Left Ventricular
`
`Support Device, published in Supported Complex and High Risk Coronary
`
`Angioplasty, ch. 14, 231-49 (Springer 1st ed. 1991) (EX1007,“Wampler”),
`
`published in 1991, is prior art under 35 U.S.C. § 102(b).3
`
`5.
`
`U.S. Patent No. 5,421,338 to Crowley (EX1047,“Crowley”), filed June 3,
`
`1994 and issued June 6, 1995, is prior art under 35 U.S.C. § 102(b).
`
`6.
`
`U.S. Patent No. 4,625,712 to Wampler (EX1008, “Wampler_712”). Filed
`
`September 28, 1983 and issued December 2, 1986, is prior art under 35 U.S.C. §
`
`102(b).
`
`B. Grounds for Challenge
`Petitioner respectfully requests review of the Challenged Claims and
`
`cancellation of those claims under the following statutory grounds:
`
`2 Jegaden bears a copyright date of 1991 and was publicly available from 1992.
`
`EX1033; Declaration of Leupold (EX1046).
`
`3 Wampler bears a copyright date of 1991 and was publicly available from 1991.
`
`See EX1007; Declaration of Kiersten Batzli (EX1035); Library of Congress Card
`
`Catalog (EX1036).
`
`3
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`• Ground 1: Claims 1-8, 14, 16-20, and 25-26 are rendered obvious by
`
`Aboul-Hosn in view of Siess and Wampler, under 35 U.S.C. § 103(a).
`
`• Ground 2: Claims 10-11, 13, 21, and 23 are rendered obvious by Aboul-
`
`Hosn in view of Siess and Wampler, and further in view of Jegaden
`
`under 35 U.S.C. § 103(a).
`
`• Ground 3: Claims 12 and 22 are rendered obvious by Aboul-Hosn in
`
`view of Siess and Wampler, and further in view of Crowley under 35
`
`U.S.C. § 103(a).
`
`• Ground 4: Claims 15 is rendered obvious by Aboul-Hosn in view of Siess
`
`and Wampler, and further in view of Wampler_712 under 35 U.S.C. §
`
`103(a).
`
`V. CONVENTIONAL TECHNOLOGY
`A. Conventional Intravascular Blood Pumps
`The blood pump features of the Challenged Claims were well known: (1) a
`
`cannula formed as a tube, connected at its proximal end to an axial flow pump and
`
`with a distal end to be disposed in a heart chamber (Collins ¶¶52, 55-59;
`
`EX1004[Aboul-Hosn] 30:20-28; U.S. Patent No. 4,625,712 to Wampler
`
`(EX1008[Wampler_712] 3:40-51); EX1013[Siess] 5:28-61); (2) a pump having a
`
`tapered rotor with a distally extending tip and multiple blades disposed within a
`
`shroud, to pump blood axially along the pump and through the cannula (Collins
`
`4
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`¶¶61-65; EX1004[Aboul-Hosn] 12:28-13:31, 16:30-17:26;
`
`EX1008[Wampler_712] 3:26-39; U.S. Patent No. 4,846,152 to Wampler et al.
`
`(EX1009,[Wampler_152] 2:63-3:23); EX1005[Siess] 6:26-7:21); (3) a purge fluid
`
`system to prevent blood from entering the pump motor and to lubricate the pump
`
`motor (Collins ¶¶66-72; EX1004[Aboul-Hosn] 20:16-21:3;
`
`EX1008[Wampler_712] 3:40-51; EX1005[Seiss913] 8:31-44); and (4) techniques
`
`for monitoring blood pressure near the pump (Collins ¶¶73-79; EX1004[Aboul-
`
`Hosn] 29:16-25; EX1005[Siess] 11:25-56). The few other minor details of the
`
`Challenged Claims were also well-known in intravascular blood pumps in the prior
`
`art—I.e., purge fluid pump and fittings (in Wampler), or pressure sensor
`
`configurations (in Aboul-Hosn or Siess). (Collins ¶¶70-72, 76-78.)
`
`Placing Intravascular Blood Pumps
`
`B.
`The guide wire mechanism of the Challenged Claims was well-known in
`
`catheterization as the “over-the-wire” technique. Along with “rapid-exchange” and
`
`“guide catheters,” over-the-wire was used routinely to position blood pumps
`
`intravascularly. (Collins ¶¶81-82.)
`
`Over-the-Wire
`
`1.
`POSITAs used “over-the-wire” guide mechanism to place intravascular
`
`blood pumps. (Collins ¶¶86-88.) For example, as shown below in FIG. 3, U.S.
`
`5
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Patent No. 6,248,091 to Voelker4 (EX1011,“Voelker”) applied the “over-the-wire”
`
`guide mechanism to an axial flow intravascular blood pump with the guide wire
`
`extending coaxially through the flexible shaft 23, the shaft 19, and the impeller
`
`wheel 20 so that the pump may be slipped over the guide wire. (Collins ¶88;
`
`EX1011[Voelker] 3:56-60; EX1004[Aboul-Hosn] 22:10-16, FIG. 3.)
`
`
`
`(Collins ¶88; EX1011[Voelker] FIG. 3, annotated.)
`
`As explained in further detail in Sections VII.A and X below, Aboul-Hosn
`
`disclosed that same well-known “over-the-wire” catheterization technique and
`
`used it in delivering intravascular blood pumps into the heart.
`
`Rapid-Exchange
`
`2.
`“Rapid-exchange” was a well-known catheterization technique. (Collins
`
`¶90.) Yock disclosed placing a conventional “rapid-exchange” catheter by sliding
`
`4 Voelker is also published as PCT Publication WO97/46270 on Dec. 11, 1997.
`
`6
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`it along a guide wire extending through a sleeve secured to the exterior of the
`
`cannula or embedded within the cannula wall itself. (Id. ¶91; EX1006[Yock] FIG.
`
`10;7:64-8:2.)
`
`(Collins ¶91; EX1006[Yock] FIG. 10, annotated.)
`
`
`
`Voelker, at Fig. 2 (below) applied this rapid exchange approach to an
`
`intravascular blood pump—a guide wire 25 extended through a side channel for
`
`positioning a blood pump as illustrated below. (Collins ¶93; EX1011[Voelker]
`
`
`
`3:34-43.)
`
`(Collins ¶93; EX1011[Voelker] FIG. 2, annotated.)
`
`
`
`7
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`Guide Catheter
`
`3.
`Yock also discloses using a guide catheter to position a guide wire. (Collins
`
`¶83; EX1006[Yock] 3:56-4:50.) The same technique as disclosed by Yock has had
`
`been adapted to place axial flow intravascular blood pumps. (Collins ¶84.) In fact,
`
`the ’314 Patent acknowledges this conventional technique. (EX1001[’314 Patent]
`
`2:34-55.)
`
`Interchangeability of Over-the-Wire and Rapid Exchange
`
`4.
`Over-the-wire and rapid-exchange techniques have long been used
`
`interchangeably, with minimal differences in design, to deliver cardiac assist
`
`devices, including blood pumps. (Collins ¶96; EX1023[Faxon] 58-59;
`
`EX1006[Yock] 8:16-25; EX1011[Voelker] FIGS. 2 and 3.) Over-the-wire and
`
`rapid-exchange were part of a limited set of delivery techniques. (Collins ¶97.)
`
`For example, U.S. Patent No. 5,928,181 to Coleman et al. (EX1042, “Coleman”)
`
`discloses that catheters coupled to a cardiopulmonary bypass pump may be
`
`suitably guided into position using either technique. (EX1042[Coleman] 34:14-
`
`39.)
`
` The interchangeability of over-the-wire and rapid-exchange was also well
`
`understood for intravascular blood pump applications. (Collins ¶98.) For
`
`example, Voelker’s blood pump could be configured to use either technique. (Id.;
`
`EX1011[Voelker] FIG. 2 (over-the-wire), and FIG. 3 (rapid-exchange).) Of
`
`8
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`course, deploying an intravascular blood pump to use over-the-wire or rapid-
`
`exchange involves certain design choices, but such design choices were also well-
`
`known within the prior art. (Collins ¶99; EX1001[Voelker] 3:34-55.)
`
`VI. OVERVIEW OF THE ’314 PATENT
`A. Summary of the ’314 Patent
`The ’314 patent describes placement of a conventional intravascular blood
`
`pump system using the same three conventional guide wire delivery techniques
`
`discussed above. (EX1001[’314 patent] 9:13-32, 13:62-14:10, 15:5-21; Collins
`
`¶102-104.) The background of the ’314 patent openly admits that it is not the first
`
`to use “guide mechanism[s]” to place an intravascular pump. (EX1001[’314
`
`patent] 2:35-45.)
`
`FIG. 1 of the ’314 patent illustrates a conventional over-the-wire placement
`
`technique. (Id. 5:25-30.)
`
`9
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`Pump
`
`Cannula
`
`“Over-the-wire”
`guide mechanism
`
`Guide wire
`
`(Collins ¶105; EX1001[’314 patent] FIG. 1, annotated.)
`
`
`
`The conventional intravascular blood pump system includes an intravascular
`
`blood pump 12 rotor hub, cannula 14, and over-the-wire guide mechanism 16 with
`
`a guide wire lumen that passes through the center of the rotor hub and the cannula
`
`14. (Id. 9:13-24; Collins ¶105.) The blood pump 12 provides heart support in the
`
`same manner as conventional axial-flow intravascular blood pumps – by
`
`“deliberately re-rout[ing] through and past the right and/or left ventricle in an
`
`10
`
`

`

`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.”
`
`(Compare EX1001[’314 patent] 20:43-48 with id. 2:16-19; Collins ¶103.)
`
`FIG. 6 shows the conventional “rapid-exchange” or “side-rigger” guide
`
`mechanism of the prior art. (Id. 5:25-30.) The guide mechanism 122 “includes a
`
`guide carriage 124 formed along at least a portion of the cannula 14, and a suitable
`
`… guide wire 22 … dimensioned to pass slideably through a lumen (not shown)
`
`extending through the guide carriage 124.” (Id. 14:15-21; Collins ¶107-108.) As
`
`with the prior art (Collins ¶108), the guide carriage 124 may be formed as “an
`
`integral extension of the wall of the cannula 14.” (EX1001[’437 patent] 14:37-39.)
`
`11
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`(Collins ¶107; EX1001[’314 patent] FIG. 6, annotated.)
`
`
`
`Finally, the ’314 patent at FIG. 10 shows a “guide catheter” mechanism 132
`
`as in the prior art where the rotor and shroud are placed in two different steps.
`
`(EX1001[’314 patent] 5:65-6:3; Collins ¶110)
`
`12
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`
`
`(Collins ¶110; EX1001[’314 patent] FIG. 10, annotated.)
`
`Prosecution History
`
`B.
`During prosecution of the ’314 patent, in the sole office action the Examiner
`
`indicated that eight co-pending and patented applications were relevant to the
`
`Challenged Claims, but found the Challenged Claims to be patentably distinct—
`
`not because of a specific combination of elements, but because “a guide wire not
`
`passing through the rotor hub and a housing and catheter with a purge lumen” were
`
`not disclosed in those applications. (EX1003[’314 PH] 238.) There is no
`
`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
`
`system feature that the Examiner found missing. (Collins ¶112.) As with the other
`
`conventional features of the Challenged Claims, a “guide wire not passing through
`
`the rotor hub” and a “housing and catheter with a purge lumen” were conventional
`
`elements that were well-known and disclosed by prior art references not relied on
`
`by the Examiner. (Id. ¶113.)
`
`C. The Earliest Possible Priority Date for the ’314 Patent is
`September 1, 2000
`
`The earliest possible priority date (as defined above, the “EPD”) for the
`
`Challenged Claims is September 1, 2000, which is the date of PCT Application
`
`No. PCT/US00/24515, to which the ’314 patent claims priority. The subject matter
`
`of the Challenged Claims is not supported by its claimed earlier-filed provisional
`
`application. (EX1012, the “’249 provisional application”).
`
`Independent claims 1 and 20 require, for example, “a purge lumen extending
`
`through the catheter and operatively arranged to deliver purge fluid,” “a pressure
`
`sensing element”, “an elongate lumen arranged coaxially with at least a portion of
`
`the cannula,” “an end of the elongate lumen is adjacent an end of the cannula,” and
`
`“the elongate lumen sized to slidably receive the guide wire.” (EX1001[’314
`
`patent] 34:11-14; 34:22; 34:17-18; 34:15-21; 34:18-21; 36:2-3; 36:12, 36:5-9.)
`
`14
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`None of these limitations are supported in the ’249 provisional application.5
`
`(Collins ¶124-125; Dynamic Drinkware, LLC. v. Nat’l Graphics, Inc., 800 F.3d
`
`1375, 1378 (Fed. Cir. 2015) (“[T]he specification of the provisional must contain a
`
`written description of the invention and the manner and process of making and
`
`using it, in such full, clear, concise, and exact terms, 35 U.S.C. § 112 ¶1, to enable
`
`an ordinarily skilled artisan to practice the invention claimed in the non-
`
`provisional application.”) (emphasis in original).)
`
`Accordingly, the EPD for the Challenged Claims is September 1, 2000.6
`
`(Collins ¶127.)
`
`VII. OVERVIEW OF THE PRIOR ART
`
`
`5 During prosecution of the related ’728 Patent, the Examiner found that the claims
`
`directed to “a blood pressure detection mechanism,” and “a guide wire and an
`
`elongate lumen” were not entitled to the priority date of the ’249 provisional
`
`application, and the Patent Owner never challenged in any subsequent response.
`
`(EX1043[’728 PH] 259-280.)
`
`6 If the Board finds that one or more Challenged Claims is entitled to the
`
`September 3, 1999 filing date of the ’249 provisional application, the cited prior art
`
`would still qualify as prior art under 35 U.S.C. § 102(a) or 102(b).
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`15
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`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`A. Overview of Aboul-Hosn7
`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
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`using the same well-known guide mechanisms as noted in the ’314 patent.
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`(Collins ¶128; EX1004[Aboul-Hosn] 11:9-14; 30:1-2.) Aboul-Hosn further
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`discloses both percutaneous and surgical approaches for delivering the blood
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`pump. (Collins ¶147-151; EX1004[Aboul-Hosn] FIG. 21; 21:19-22:30; 11:8-12.)
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`Annotated FIGS. 21 and 23, below, show a percutaneous approach for
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`delivering the pump using a guide wire. (Collins ¶148; EX1004[Aboul-Hosn]
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`30:1-2, 20-27.) FIG. 21 shows how the blood pump (green) passes along the guide
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`wire up the femoral artery, so the cannula 4118 (blue) goes through the aorta and
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`into the left ventricle. In FIG. 23, the cannula then also continues into the left
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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 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 during prosecution of the ’314 patent. (EX1003[’314 PH] 552-
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`558.)
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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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`16
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`atrium, where it is positioned to pump blood from the left atrium to the aorta.
`
`(Collins ¶¶148-149; EX1004[Aboul-Hosn] 29:17-28, 30:1-2, 30:20-27.) In
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`addition, the cannula’s inflow tip may also be placed in “the left ventricle, … or
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`any of the left heart vessels” to provide left heart support. (Id. 26:10-13.)
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`
`
`(Collins ¶148; 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 ¶¶135-137.)
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`17
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`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 60
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`(green)9. (EX1004[Aboul-Hosn] 12:12-13:13.) The inner cannula 20 (blue) is
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`coupled to the housing cap 60 (green), and extends beyond the distal opening 32 of
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`the outer conduit 30 (dark grey). (Id.)
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`(Collins ¶135; EX1004[Aboul-Hosn] FIGS. 1, 2, annotated.)
`
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`9 The housing body 52 and the housing cap 60 may form “a unitary body.”
`
`(EX1004[Aboul-Hosn] 12:22-23.)
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`
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`18
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`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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`multilumen catheter 428 (yellow). (Collins ¶¶144-145.) 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 ¶145; EX1004[Aboul-Hosn] 29:18-25.)
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`(Collins ¶138; 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 ¶139-141; see also EX1004[Aboul-
`
`
`
`19
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Hosn] 31:6-9.) In this configuration, the pump 420 would include the components
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`of the pump system of FIGS. 1-13 that generate the axial flow of blood through the
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`pump (i.e. rotor 70 and inlet tube 55, connected to drive unit 80), without the
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`components that cause the blood flow to reverse course (i.e. housing body 52,
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`housing cap 60, and outer cannula 30). (Collins ¶139.) Instead, the blood
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`(represented by the red arrows) discharges axially over the drive unit and out the
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`pump 420 (green). (Id.)
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`(Collins ¶139; EX1004[Aboul-Hosn] FIGS. 1, 23, annotated.)
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`As explained in greater detail in Section X.A.1(i) below, Aboul-Hosn uses a
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`guide wire to deploy the pumps intravascularly using the over-the-wire technique.
`
`
`
`20
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`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`(Collins ¶129; EX1004[Aboul-Hosn] 11:26-28, 14:13-16, 14:20-24, 21:22-24,
`
`22:10-16.) FIG. 3 shows the conventional over-the-wire technique. (Collins ¶129;
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`EX1004[Aboul-Hosn] 14:17-15:18, 17:19-22, FIG. 12.)
`
`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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`¶¶168-172; 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. 3:15-18, 11:23-40.)
`
`(EX1005[Siess] FIG. 4, annotated.)
`
`C. Overview of Jegaden
`
`
`
`21
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`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 ¶¶152-157; EX1033[Jegaden] 61-62.) As shown in
`
`FIG. 2, the five French (“5F”) catheter having a guide wire extending coaxially
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`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 ¶153; 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 ¶154-156.)
`
`22
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`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`Guide wire
`extending out in a
`distal direction
`
`Distal End of 5F
`Catheter
`
`Distal Hole of
`Canula
`
`5F Catheter
`
`Cannula
`
`Guide wire
`
`
`
`(Collins ¶154; EX1033[Jegaden] FIG. 1, annotated.)
`D. Overview of Wampler
`Wampler discloses the Hemo