throbber
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. IPR2017-01205
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,561,314
`
`
`
`CLAIMS 27, 29-30
`
`
`
`
`
`
`
`

`

`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 Techniques for Placing Intravascular Pumps ..................... 4
`
`B. Placing Intravascular Blood Pumps .......................................................... 4
`
`1. Over-the-Wire .................................................................................... 5
`
`2. Rapid-Exchange ................................................................................ 5
`
`3. Guide Catheter ................................................................................... 7
`
`4. Interchangeability of Over-the-Wire and Rapid-Exchange .............. 7
`
`5. Known Benefits of Rapid Exchange ................................................. 8
`
`VI. Overview of the ’314 Patent ............................................................................ 9
`
`i
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`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 .............................................................................. 16
`
`A. Overview of Aboul-Hosn ........................................................................ 16
`
`B. Overview of Siess .................................................................................... 22
`
`C. Overview of Jegaden ............................................................................... 22
`
`D. Overview of Yock ................................................................................... 24
`
`E. Overview of Wampler ............................................................................. 24
`
`F. Overview of Crowley .............................................................................. 25
`
`VIII. Claim construction ......................................................................................... 26
`
`A. “distal” ..................................................................................................... 27
`
`B. “proximal” ............................................................................................... 28
`
`IX. Person having ordinary skill in the art ........................................................... 28
`
`X.
`
`Specific Grounds for Petition ........................................................................ 29
`
`A. Ground I: Claims 27 and 29-30 are rendered obvious by Aboul-Hosn in
`
`view Jegaden, and further in view of Siess and Wampler ..................... 29
`
`1. Claim 27 .......................................................................................... 29
`
`2. Claim 29 .......................................................................................... 81
`
`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
`
`Yock, and further in view of Siess and Wampler .................................. 84
`
`1. Claim 27 .......................................................................................... 84
`
`C. Ground III: Claims 29-30 are rendered obvious by Aboul-Hosn, in view
`
`of Yock, and further in view of Siess, Wampler, and Jegaden ...........100
`
`1. Claim 29 ........................................................................................100
`
`2. Claim 30 ........................................................................................102
`
`XI. Conclusion ...................................................................................................103
`
`
`
`
`
`iii
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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) .......................................................................... 18
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) .......................................................................... 32
`
`FEDERAL STATUTES
`
`35 U.S.C. § 102(a) ................................................................................................... 19
`
`35 U.S.C. § 102(b) ........................................................................................... 3, 4, 19
`
`35 U.S.C. § 103 .......................................................................................................... 1
`
`35 U.S.C. § 103(a) ..................................................................................................... 5
`
`35 U.S.C. § 112 ¶ 1 .................................................................................................. 18
`
`FEDERAL RULES
`
`Rule 42.104(a) ............................................................................................................ 2
`
`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) ............................................................................................... 24
`
`37 C.F.R § 42.104 ...................................................................................................... v
`
`iv
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`
`
`

`

`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 27 and 29-30 (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
`
`petition for IPR of claims 1-8, 10-23, and 25-27 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,
`
`3.
`
`Published 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.
`
`U.S. Patent No. 5,061,273 to Yock (EX1006,“Yock”), filed June 1, 1989 and
`
`issued October 29, 1991, is prior art under 35 U.S.C. § 102(b).
`
`5. 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
`
`6.
`
`U.S. Patent No. 5,421,338 to Crowley (EX1045, “Crowley”), filed June 3,
`
`1994 and issued June 6, 1995, 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 (EX1044).
`
`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 27 and 29-30 are rendered obvious by Aboul-Hosn in
`
`view of Jegaden, and further in view of Siess and Wampler under 35
`
`U.S.C. § 103(a).
`
`• Ground 2: Claim 27 is rendered obvious by Aboul-Hosn in view of Yock,
`
`and further in view of Siess and Wampler under 35 U.S.C. § 103(a).
`
`• Ground 3: Claims 29-30 are rendered obvious by Aboul-Hosn in view of
`
`Yock, and further in view of Siess, Wampler, and Jegaden under 35
`
`U.S.C. § 103(a).
`
`V. CONVENTIONAL TECHNOLOGY
`A. Conventional Techniques for Placing Intravascular Pumps
`The features of the Challenged Claims were well-known and included a
`
`
`
`cannula, connected to an axial flow pump (Collins ¶¶53, 57-65), pumping blood
`
`axially along the pump and through the cannula (Collins ¶¶66-70), a purge fluid
`
`system to prevent blood from entering the pump motor and to lubricate the pump
`
`motor (Collins ¶¶71-74), and techniques for monitoring blood pressure near the
`
`pump (Collins ¶¶75-81). The few other remaining details of the Challenged
`
`Claims were also well-known– i.e., purge fluid pump and fittings (in Wampler),
`
`pressure sensor configurations (in Aboul-Hosn or Siess)). (Collins ¶¶72-74.)
`
`Placing Intravascular Blood Pumps
`
`B.
`The guide wire mechanism of the Challenged Claims was also well-known
`
`4
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`in catheterization as the “rapid-exchange” technique. Along with “over the wire”
`
`and “guide catheters,” rapid exchange was used routinely to position blood pumps
`
`intravascularly. (Collins ¶¶82-102.)
`
`Over-the-Wire
`
`1.
`POSITAs used “over-the-wire” guide mechanisms to place intravascular
`
`blood pumps. (Collins ¶¶87-90.) For example, Voelker FIG. 3 applied the “over-
`
`the-wire” guide mechanism to an axial flow intravascular blood pump with the
`
`guide wire extending through the shaft 19 and other components so that the pump
`
`may be slipped over the guide wire. (Collins ¶89; EX1011[Voelker] 3:56-60.)
`
`(Collins ¶89; EX1011[Voelker] FIG. 3, annotated.)
`
`Rapid-Exchange
`
`2.
`“Rapid-exchange” was another well-known technique used to place
`
`intravascular assist devices at a desired location within a patient’s body. (Collins
`
`
`
`5
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`¶¶91-94.) Yock disclosed placing a conventional “rapid-exchange” catheter by
`
`sliding the catheter along a guide wire extending through a sleeve secured to the
`
`exterior of the tubular member or embedded within the cannula wall itself. (Id.
`
`¶¶91-92; EX1006[Yock] FIG. 10, 7:64-8:2.)
`
`(Collins ¶92; EX1006[Yock] FIG. 10, annotated.)
`
`
`
`Voelker, at Fig. 2 (below) also disclosed this rapid exchange approach as
`
`applied to an intravascular blood pump -- a guide wire 25 extending through a side
`
`sleeve for positioning a blood pump as illustrated below. (Collins ¶94;
`
`
`
`EX1011[Voelker] 3:34-43.)
`
`6
`
`
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`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`(Collins ¶94; EX1011[Voelker] FIG. 2, annotated.)
`
`As explained in further detail in Sections VII and X below, a POSITA could
`
`also readily adapt Aboul-Hosn’s blood pump to be delivered using the
`
`conventional “rapid-exchange” technique. (Id. ¶¶91-94.)
`
`Guide Catheter
`
`3.
`Yock also discloses using a guide catheter to position a guide wire. (Collins
`
`¶84; 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 ¶85.) In fact,
`
`the ’314 Patent acknowledges this conventional technique. (EX1001[’314 Patent]
`
`2:35-55.)
`
`Interchangeability of Over-the-Wire and Rapid-Exchange
`
`4.
`Over-the-wire and rapid-exchange techniques have long been used
`
`interchangeably to deliver cardiac assist devices, including blood pumps. (Collins
`
`¶¶97-100; 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 ¶98.) 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.)
`
`7
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
` The interchangeability of over-the-wire and rapid-exchange was also well
`
`understood for intravascular blood pump applications. (Collins ¶99.) 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
`
`course, adapting 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 ¶100; EX1001[Voelker] 3:34-55.)
`
`Known Benefits of Rapid Exchange
`
`5.
`The well-known rapid-exchange technique had many known advantages
`
`compared to an over-the-wire guide mechanism. (Collins ¶100.) For example,
`
`unlike over-the-wire, rapid-exchange does not require pre-loading the guide wire
`
`over a first portion, equal in length to the full length of guide wire entering the
`
`body. Accordingly, rapid exchange allowed one person instead of two to carry out
`
`the exchange procedure because the required length of guide wire is reduced,
`
`which also means that the required sterile zone can be shortened. (Collins ¶100;
`
`EX1006[Yock] 1:15-25.) Accordingly, the rapid-exchange guide mechanism
`
`simplified the exchange procedure and increased the speed at which devices could
`
`be inserted or withdrawn. (Collins ¶100; EX1023[Faxon] Fig. 5;
`
`EX1011[Voelker] 3:49-55). The rapid-exchange configuration also provides the
`
`8
`
`

`

`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
`
`through the rotor hub. (Collins ¶102.)
`
`VI. OVERVIEW OF THE ’314 PATENT
`A.
`Summary of the ’314 Patent
`The ’314 patent’s disclosure concerns placement of a conventional
`
`intravascular blood pump system using the same three conventional guide wire
`
`delivery techniques of the prior art discussed above. (EX1001[’314 patent] 9:13-
`
`32, 13:62-14:10, 15:5-21; Collins ¶¶103-11.) 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
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`(Collins ¶106; 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 ¶106.) 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. 5:47-52.) The guide mechanism 122 “includes a
`
`guide carriage 124 formed along at least a portion of the cannula 14, and a …
`
`guide wire 22 … dimensioned to pass slideably through a lumen (not shown)
`
`extending through the guide carriage 124.” (Id. 14:17-21; Collins ¶¶108-09.) As
`
`with the prior art (Collins ¶109), the guide carriage 124 is “an integral extension of
`
`the wall of the cannula 14.” (EX1001[’314 patent] 14:37-39.)
`
`11
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`(Collins ¶108; 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 ¶111.)
`
`12
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`
`
`(Collins ¶111; 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
`
`

`

`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 ¶182.) 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. ¶182.)
`
`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
`
`possible priority date (as defined above, the “EPD”) for the Challenged Claims.4
`
`The subject matter of the Challenged Claims is not supported by an earlier-filed
`
`provisional application. Provisional U.S. Application No. 60/152,249 (EX1012,
`
`the “’249 provisional application”).
`
`Numerous elements of the Challenged Claims lack support in the ’249
`
`provisional application. (Collins ¶127.) For example, independent claim 27
`
`requires “a purge lumen extending through the catheter and operatively arranged to
`
`deliver purge fluid,” “a pressure sensing element” and “the guide wire passes
`
`slidably and coaxially through the elongate lumen.” (EX1001 [’314 patent] 36:12;
`
`
`4 The ’314 Patent was filed August 17, 2016 and claims priority to PCT
`
`Application No. PCT/US00/24515, which was filed on September 1, 2000.
`
`14
`
`

`

`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
`
`provisional application.5 Collins ¶127; Dynamic Drinkware, LLC. v. Nat’l
`
`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (“the 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.”) (quoting New Railhead Mfg., LLC v.
`
`Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002) (emphasis in original).)
`
`
`5 During prosecution of the ’728 patent, which is related to the ’314 patent, the
`
`Examiner found that the claims directed to “the ‘side-rigger’ or ‘rapid-exchange’
`
`guide mechanism,” “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 which the Patent Owner never challenged in any subsequent
`
`response. (EX1043[’728 PH] 259-280.)
`
`15
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Accordingly, the EPD for the Challenged Claims is September 1, 2000.6
`
`(Collins ¶¶126-29.)
`
`VII. OVERVIEW OF THE PRIOR ART7
`A. Overview of Aboul-Hosn
`Aboul-Hosn discloses an axial flow intravascular blood pump for heart
`
`support that is delivered intravascularly to a desired location within the heart using
`
`the same well-known guide mechanisms as noted in the ’314 patent. (Collins
`
`¶131; EX1004[Aboul-Hosn] 11:9-14; 30:1-2.) Aboul-Hosn further discloses both
`
`percutaneous and surgical approaches for delivering the intravascular blood pump.
`
`(Collins ¶130; EX1004[Aboul-Hosn] FIG. 21, 21:19-22:30, 11:8-12.)
`
`
`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, Aboul-Hosn
`
`(EX1004) and Siess (EX1005) would still qualify as prior art under 35 U.S.C. §
`
`102(a), and Jegaden (EX1033), Yock (EX1006), and Wampler (EX1007) would
`
`remain prior art under 35 U.S.C. § 102(b).
`
`7 Aboul-Hosn and Siess were cited in an Information Disclosure Statement dated
`
`August 19, 2016, but there is no record that the Examiner relied upon them.
`
`(EX1003[’314 PH] 271, 280). There is no record of Jegaden, Yock, or Wampler
`
`being disclosed to the USPTO or considered by the Examiner during prosecution
`
`of the ’314 patent.
`
`16
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`Annotated FIGS. 21 and 23, below, show a percutaneous approach for
`
`delivering the pump using a guide wire to place a stabilization cannula 4118 (blue)
`
`and the blood pump 420 (green) in the left side of a patient’s heart. (Collins
`
`¶¶149-151; EX1004[Aboul-Hosn] 30:1-2, 20-27.) FIG. 21 shows how the blood
`
`pump passes along the guide wire up the femoral artery, so the cannula goes
`
`through the aorta and into the left ventricle. In FIG. 23, the cannula then also
`
`continues into the left atrium, where it is positioned to pump blood from the left
`
`atrium to the aorta. (Collins ¶¶150-51; EX1004[Aboul-Hosn] 29:17-28, 30:1-2,
`
`30:20-27.) In addition the cannula’s inflow tip may also be placed in “the left
`
`ventricle, … or any of the left heart vessels” to provide left heart support. (Id.
`
`26:10-13.)
`
`
`8 FIG. 20 is a zoomed-in view of the stabilization system 410 of FIG. 23; it
`
`identifies element 411 as the stabilization cannula that passes through the
`
`stabilization balloon 440 (red). (EX1004[Aboul-Hosn] 28:23-27.)
`
`17
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`
`
`(Collins ¶150; EX1004[Aboul-Hosn] FIGS. 21, 23, annotated.)
`
`FIGS. 1-13 show a surgical approach with details about the interior of the
`
`pump and cannula. Numerous conventional features of intravascular blood pumps
`
`are disclosed, including a “commercially available” cannula (EX1004 [Aboul-
`
`Hosn] 11:14), together with a “reverse flow” feature that reverses the direction of
`
`blood flow as it exits the pump. (Collins ¶¶152-53.)
`
`As shown below in FIGS. 1 and 2, and similar to the ’314 patent, the pump
`
`system has a conventional drive motor 80 (purple) connected to a rotor and
`
`associated blades 70 (red), within a housing body 52 (green) and a housing cap 62
`
`18
`
`

`

`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
`
`coupled to the housing cap 62 (green), and extends beyond the distal opening 32 of
`
`the outer conduit 30 (dark grey.) (Id.)
`
`
`
`(Collins ¶137; EX1004[Aboul-Hosn] FIGS. 1, 2, annotated.)
`
`As shown below, to apply the percutaneous approach in the reverse flow
`
`configuration, the pump (green) in the system of FIGS. 1-13 (i.e. an intravascular
`
`pump “provided for by the present invention”) would be readily connected to the
`
`
`9 The housing body 52 and the housing cap 60 may form “a unitary body.”
`
`(EX1004[Aboul-Hosn] 12:22-23.)
`
`19
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`multilumen catheter 428 (yellow). (Collins ¶¶146-47.) In this configuration, the
`
`catheter 428 would be used to advance the pump 420 and stabilization cannula 411
`
`over a guide wire to the desired location within the patient’s heart through the
`
`femoral artery. (Collins ¶¶146-47; EX1004[Aboul-Hosn] 29:18-25.)
`
`
`
`(Collins ¶140; EX1004[Aboul-Hosn] FIGS. 1, 23, annotated.)
`
`The pump 420 could also be configured without the reverse flow feature of
`
`the pump system of FIGS. 1-13. (Collins ¶139; see also EX1004[Aboul-Hosn]
`
`31:6-9.) In this configuration, the pump 420 would include the components of the
`
`pump system of FIGS. 1-13 that generate the axial flow of blood through the pump
`
`(i.e. rotor 70 and inlet tube 55, connected to drive unit 80), without the components
`
`20
`
`

`

`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,
`
`and outer cannula 30). (Collins ¶141.) Instead, the blood (represented by the red
`
`arrows) discharges axially over the drive unit and out the pump 420 (green). (Id.
`
`¶141.)
`
`
`
`(Collins ¶141; EX1004[Aboul-Hosn] FIGS. 1, 23, annotated.)
`
`Aboul-Hosn also suggests inserting a guide wire through cannula opening 27
`
`as seen in FIGS. 1 and 2 to place the pump, consistent with the rapid-exchange
`
`technique. (Id. ¶¶133-36; EX1004[Aboul-Hosn] 11:24-26: “a catheter guide wire
`
`may also be extended through the cannula openings 27 to dispose the inner cannula
`
`20 at desired locations.”)
`
`21
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`B. Overview of Siess
`Siess also discloses an intravascular blood pump configured to be delivered
`
`to a desired location within the patient’s vasculature using a guide wire. (Collins
`
`¶171-75; EX1005[Siess] 5:55-58.) The pump is connected to a catheter that
`
`includes a lumen to deliver a “biocompatible purge fluid[,] … that is pressurized so
`
`as to maintain a slow purge rate over the seals of about 1-5ml/hr[,]” to the
`
`microaxial pump 10. (Id. 8:31-44.) Additionally, it can have “electrical conduits
`
`extending therethrough to allow the operation of the drive unit to be monitored and
`
`controlled.” (Id. 8:31-38, 11:23-40.)
`
`
`
`(EX1005[Siess] FIG. 4, annotated.)
`
`C. Overview of Jegaden
`Jegaden discloses placing a conventional axial flow intravascular pump
`
`system (i.e. the Hemopump) to a desired location using the conventional rapid-
`
`exchange technique. (Collins ¶¶154-59; EX1033[Jegaden] 61-62.) As shown in
`
`FIG. 2, the five French (“5F”) catheter having a guide wire extending coaxially
`
`22
`
`

`

`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
`
`cannula and introduced into the femoral artery up to the aorta,” and “[t]hen the
`
`cannula is introduced into the femoral artery and is pushed into the aorta, guided
`
`by the vasculature catheter” (i.e. the 5F catheter). (Collins ¶155; EX1033[Jegaden]
`
`62.) The 5F catheter and cannula’s distal hole function as a rapid-exchange guide
`
`mechanism for the pump. (Collins ¶156.) Moreover, Fig. 2 shows a J-shaped
`
`distal tip at the end of the guide wire. (Collins ¶159; EX1033[Jegaden] Fig. 2.)
`
`Guide wire
`extending out in a
`distal direction
`
`Distal End of 5F
`Catheter
`
`Distal Hole of
`Canula
`
`5F Catheter
`
`Canula
`
`Guide wire
`
`
`
`(Collins ¶156; EX1033[Jegaden] FIG. 1, annotated.)
`
`23
`
`

`

`U.S. PATENT NO. 9,561,314
`Petition for Inter Partes Review
`
`D. Overview of Yock
`Yock discloses a conventional rapid-exchange catheter, shown in FIG. 10
`
`below, which includes an elongate tubular member, such as a cannula, and a sleeve
`
`(with an interior lumen for a guide wire) secured to the exterior of the tubular
`
`member or embedded within the cannula wall itself. (Id. ¶¶160-64; EX1006[Yock]
`
`FIG. 10, 7:64-8:2.) A guide wire is placed in a desired location in the body and
`
`inserted through the sleeve, and the catheter is advanced along the guide wire to
`
`the desired location. (Collins ¶160; EX1006[Yock] 7:64-8:25.) The orientation of
`
`the sleeve along the side of the cannula allows for the rapid exchange of catheters.
`
`(Collins ¶163; EX1006[Yock] 2:31-37.)
`
`
`
`(Collins ¶163; EX1006[Yock] FIG. 10, annotated.)
`
`E. Overview of Wampler
`Wampler discloses the Hemopump, introduced in Jegaden, which was the
`
`original catheter-based blood pump used for the treatment of cardiogenic shock.
`
`(Collins ¶165; EX1007[Wampler] 232-36.) Wampler provides a schematic of the
`
`Hemopump in FIG. 14-2, showing purge fluid inlet and outlet conduits connected
`
`24
`
`

`

`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
`
`Hemopump via lumens within the drive cable sheath. (Collins ¶¶167-68;
`
`EX1007[Wampler] 233-34.)
`
`(EX1007 [Wampler] FIG. 14-2.)
`
`
`
`F. Overview of Crowley
`The use of a distal tip member to improve the placement of intravascular
`
`devices in the heart was well-known before the EPD. (Collins ¶178) For example,
`
`Crowley describes the use of a guide wire 80 to “guid[e] the ultrasound device
`
`through a valve such as the heart.” (Id.; EX1045[Crowley] 16:41-43.) The guide
`
`wire “support[s] and stead[ies] the free end of the ultrasound device during axial
`
`movement of

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