Trials@uspto.gov
`571-272-7822
`
`
`Paper No. 8
`Filed: October 23, 2017
`
`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.
`_______________
`
`Cases IPR2017-01204
`IPR2017-01205
`Patent 9,561,314 B2
`_______________
`
`
`Before BART A. GERSTENBLITH, JEREMY M. PLENZLER, and
`KEVIN W. CHERRY, Administrative Patent Judges.
`
`
`CHERRY, Administrative Patent Judge.
`
`
`
`
`
`
`
`DECISION
`Denying Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`571-272-7822
`
`
`Paper No. 8
`Filed: October 23, 2017
`
`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.
`_______________
`
`Cases IPR2017-01204
`IPR2017-01205
`Patent 9,561,314 B2
`_______________
`
`
`Before BART A. GERSTENBLITH, JEREMY M. PLENZLER, and
`KEVIN W. CHERRY, Administrative Patent Judges.
`
`
`CHERRY, Administrative Patent Judge.
`
`
`
`
`
`
`
`DECISION
`Denying Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`
`I. INTRODUCTION
`
`A. Background
`Abiomed, Inc. and Abiomed R&D, Inc. (collectively, “Petitioner”)
`filed Petitions to institute an inter partes review of claims 1–8, 10–23, 25–
`27, 29, and 30 (“the challenged claims”) of U.S. Patent No. 9,561,314 B2
`(Ex. 10011, “the ’314 patent”). IPR2017-01204, Paper 2 (“’1204 Pet.”)2;
`IPR2017-01205, Paper 2 (“’1205 Pet.”)3. Maquet Cardiovascular, LLC
`(“Patent Owner”) filed a Preliminary Response in each proceeding.
`IPR2017-01204, Paper 7 (“’1204 Prelim. Resp.”); IPR2017-01205, Paper 6
`(“’1205 Prelim. Resp.”). We review the Petitions according to 35 U.S.C.
`§ 314(a), which provides that an inter partes review may not be instituted
`“unless . . . there is a reasonable likelihood that the petitioner would prevail
`with respect to at least 1 of the claims challenged in the petition.” Upon
`consideration of the Petitions and Patent Owner’s Preliminary Responses,
`we do not institute an inter partes review for any of the challenged claims.
`B. Related Matters
`Petitioner and Patent Owner identify a number of proceedings related
`to the ’314 patent. ’1204 Pet. 1; ’1205 Pet. 1; ’1204 Paper 8, 1–2; ’1205
`Paper 7, 1–2.
`
`
`1 The Exhibit number is the same in both of IPR2017-01204 and IPR2017-
`01205. References to exhibits and papers include the appropriate ’1204 or
`’1205 prefix to indicate the relevant proceeding. When no prefix is included
`for an exhibit, the exhibit number (and exhibit) is the same in both
`proceedings.
`2 The ’1204 Petition challenges claims 1–8, 10–23, 25, and 26 of the
`’314 patent.
`3 The ’1205 Petition challenges claims 27, 29, and 30 of the ’314 patent.
`
`2
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
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`C. Asserted Grounds of Unpatentability and Evidence of Record
`Petitioner contends that the challenged claims are unpatentable under
`35 U.S.C. § 103(a) as set forth below (’1204 Pet. 4, 30–93; ’1205 Pet. 4, 29–
`102).
`
`References
`Aboul-Hosn4, Siess5, and Wampler6
`
`Claim(s) Challenged
`1–8, 14, 16–20, 25, and
`26
`10, 11, 13, 21, 23, 27,
`29, and 30
`12 and 22
`
`Aboul-Hosn, Siess, Wampler, and
`Jegaden7
`Aboul-Hosn, Siess, Wampler, and
`Crowley8
`Aboul-Hosn, Siess, Wampler, and
`Wampler ’7129
`Aboul-Hosn, Yock10, Siess, and
`Wampler
`Aboul-Hosn, Yock, Siess, Wampler,
`and Jegaden
`Petitioner provides testimony from John M. Collins, Ph.D. ’1204
`Ex. 1002; ’1205 Ex. 1002 (collectively, “the Collins Declaration”).
`
`15
`
`27
`
`29 and 30
`
`
`4 WO 99/02204 A1, pub. Jan. 21, 1999 (Ex. 1004, “Aboul-Hosn”).
`5 U.S. Pat. No. 5,921,913, iss. July 13, 1999 (Ex. 1005, “Siess”).
`6 Richard K. Wampler & Raymond A. Riehtl, Clinical Experience with the
`Hemopump Left Ventricular Assist Device, published in Supported Complex
`and High Risk Coronary Angioplasty, Ch. 14, 231–49 (Springer 1st ed.
`1991) (Ex. 1007, “Wampler”).
`7 O. Jegaden, Clinical Results of Hemopump Support in Surgical Cases,
`published in Temporary Cardiac Assist with an Axial Pump System, p. 61–
`65 (Springer 1991) (Ex. 1033, “Jegaden”).
`8 U.S. Pat. No. 5,421,338, iss. June 6, 1995 (’1204 Ex. 1047,
`’1205 Ex. 1045, “Crowley”).
`9 U.S. Pat. No. 4,625,712, iss. Dec. 2, 1986 (Ex. 1008, “Wampler ’712”).
`10 U.S. Pat. No. 5,061,273, iss. Oct. 29, 1991 (Ex. 1006, “Yock”).
`
`3
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`
`D. The ’314 Patent
`The ’314 patent “relates generally to blood pumps and, more
`particularly, to an improved intra-vascular blood pump having a guide
`mechanism which provides the ability to selectively guide the intravascular
`pump to a desired location within a patient’s circulatory system.” Ex. 1001,
`1:27–31. Figures 1 and 3 of the ’314 patent are exemplary, and are
`reproduced below.
`
`
`Figure 1, reproduced above, is a fragmentary section view of a human heart
`including an intravascular blood pump system. Id. at 5:25–30.
`
`4
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`
`
`
`Figure 3, reproduced above, is a section view of the intravascular blood
`pump system shown in Figure 1. Id. at 5:35–38.
`The ’314 patent explains that its “intravascular blood pump system
`. . . overcomes the drawbacks of the prior art by providing a guide
`mechanism as part of the intravascular blood pump.” Id. at 8:54–56.
`Intravascular blood pump system 10 includes intravascular blood pump 12,
`cannula 14, and guide mechanism 16. Id. at 9:16–19. Intravascular blood
`pump 12 is driven by drive cable assembly 18 and motor assembly 20. Id. at
`9:19–20. Guide mechanism 16 is described as an “over-the-wire”
`mechanism having “a suitable guide element dimensioned to pass slideably
`through a central lumen extending through the drive cable 18, blood
`pump 12, and cannula 14.” Id. at 9:20–24. An example guide element may
`include guide wire 22. Id. at 9:26–27.
`The ’314 patent explains that “‘over-the-wire’ guide mechanism 16
`provides the ability to selectively guide the blood pump 12 and cannula 14 to
`a predetermined position in the circulatory system of a patient. . . .” Id. at
`9:28–32. First, guide wire 22 is introduced into the patient’s vascular
`
`5
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`system and advanced to a desired location in the circulatory system. Id. at
`9:33–38. Intravascular blood pump 12 and cannula 14 are then advanced
`along guide wire 22 to the location in the circulatory system. Id. at 9:45–49.
`E. Illustrative Claim
`As noted above, Petitioner challenges claims 1–8, 10–23, 25–27, 29,
`and 30 of the ’314 patent. Claims 1, 20, and 27 are independent, with
`claims 2–8, 10–19, 21–23, 25, 26, 29, and 30 depending, directly or
`indirectly, therefrom. Claim 1 is illustrative, and is reproduced below:
`1. An intravascular blood pump system, comprising:
`an intravascular blood pump adapted to be guided to a
`predetermined location within the circulatory system of a
`patient by a guide wire and the intravascular blood pump
`configured to provide left-heart support, the intravascular
`blood pump comprising a rotor having a rotor hub tapering in
`the distal direction, at least one blade extending radially
`outward from the rotor hub;
`a cannula coupled to a distal end of the intravascular blood pump,
`one or more first ports and one or more second ports
`establishing fluid communication between a lumen of the
`cannula and an exterior region of the cannula, wherein at least
`one first port is located in proximity to the rotor and at least
`one second port is spaced apart from and located distal to the
`at least one first port, and wherein the intravascular blood
`pump is configured to draw blood from the patient's heart into
`the at least one second port through the cannula lumen and
`out the at least one first port to provide left-heart support
`while the cannula is positioned across an aortic valve of the
`patient, the cannula is configured such that when the
`intravascular blood pump is positioned in the patient to
`provide left-heart support the distal end of the cannula and the
`at least one second port are positioned inside the patient's
`heart and the proximal end of the cannula and the at least one
`first port are positioned in the patient's aorta;
`
`6
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`
`a catheter connected to a proximal end of the intravascular blood
`pump, a purge lumen extending through the catheter and
`operatively arranged to deliver purge fluid towards the
`intravascular blood pump;
`an elongate lumen arranged coaxially with at least a portion of
`the cannula and in series longitudinally with the cannula, and
`an end of the elongate lumen is adjacent an end of the cannula,
`the elongate lumen sized to slidably receive the guide wire
`and having a diameter sized smaller than a diameter of the
`cannula lumen;
`a pressure sensing element configured to sense pressure
`proximate the intravascular blood pump;
`a housing connected to a proximal end of the catheter; and
`first and second conduits each connected to the housing, at least
`one of the first conduit and second conduit in fluid
`communication with the purge lumen.
`Ex. 1001, 33:51–34:27.
`
`
`II. ANALYSIS
`
`A. Claim Construction
`Only those terms that are in controversy need to be construed, and
`only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v.
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). We construe the
`claims using the broadest reasonable construction in light of the ’314 patent
`Specification. See 37 C.F.R. § 42.100(b). Applying that standard, we
`generally interpret the claim terms of the ’314 patent according to their
`ordinary and customary meaning in the context of the patent’s written
`description. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). An inventor is entitled to be his or her own lexicographer of patent
`claim terms by providing a definition of the term in the specification with
`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
`
`7
`
`
`
`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`1475, 1480 (Fed. Cir. 1994). In the absence of such a definition, however,
`limitations are not to be read from the specification into the claims. In re
`Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
`Petitioner and Patent Owner each propose constructions for multiple
`terms. ’1204 Pet. 27–28; ’1205 Pet. 26–28; ’1204 Prelim. Resp. 13–14;
`’1205 Prelim. Resp. 13–14. For the purposes of this Decision, we determine
`that no term requires express construction.
`B. Challenges
`1. Aboul-Hosn/Siess/Wampler Grounds
`Petitioner challenges claims 1–8, 14, 16–20, 25, and 26 as
`unpatentable over Aboul-Hosn, Siess, and Wampler under 35 U.S.C.
`§ 103(a). ’1204 Pet. 30–86. Petitioner additionally challenges claims 10,
`11, 13, 21, 23, 27, 29, and 30 as unpatentable over Aboul-Hosn, Siess,
`Wampler, and Jegaden. ’1204 Pet. 86–91; ’1205 Pet. 29–84. Petitioner
`challenges claims 12 and 22 as unpatentable over Aboul-Hosn, Siess,
`Wampler, and Crowley. ’1204 Pet. 91–92. Petitioner challenges claim 15
`as unpatentable over Aboul-Hosn, Siess, Wampler, and Wampler ’712.
`’1204 Pet. 93. We have reviewed Petitioner’s challenges, as well as Patent
`Owner’s Preliminary Responses to those challenges and the evidence relied
`on in those papers. Based on our review of the record before us, we
`determine that Petitioner has failed to establish a reasonable likelihood of
`prevailing at trial on any of the challenges noted above.
`The deficiency is similar for each of the challenges noted above. For
`simplicity, we address specifically only the challenge to claim 1 with the
`understanding that the discussion applies equally to Petitioner’s other
`challenges.
`
`8
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`
`In its challenge, Petitioner cites a combination of Aboul-Hosn’s
`embodiments as teaching various claim features. ’1204 Pet. 31–54 (citing,
`for example, the embodiments of Figures 1–13 and 23 in Aboul-Hosn).
`Patent Owner contends that Petitioner has failed to establish sufficiently that
`the features of those different embodiments are interchangeable or provide
`sufficient rationale to combine the teachings of those different embodiments.
`See, e.g., ’1204 Prelim. Resp. 26–31. We agree.
`Aboul-Hosn “relates to the transport of fluids between various body
`regions and the increased stabilization of [a] body organ.” Ex. 1004, 1:12–
`14. Aboul-Hosn’s Figure 1, reproduced below, illustrates a reverse flow
`pump located external to the vasculature, while Figure 23, also reproduced
`below, illustrates an intravascular axial flow pump.
`
`Figure 1, reproduced above, is an exploded perspective section view of a
`reverse flow pump system with a conduit extending into a blood vessel and
`the pump located external to the blood vessel; Figure 23, also reproduced
`
`
`
`9
`
`
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`above, is a partial section view of the heart and a stabilization system used in
`cooperation with an intravascular pump. Id. at 8:20–23, 10:10–11.
`Petitioner’s challenge treats the various features of Aboul-Hosn’s
`different embodiments as if they are interchangeable with one another. See
`’1204 Pet. 30–60. For example, Petitioner contends that “Aboul-Hosn
`discloses that the axial flow pump system of FIGS. 1–13 with or without the
`reverse flow feature can be delivered to the heart percutaneously by
`connecting the pump components illustrated in FIGS. 1–13 with the
`multilumen catheter 428 and adapting the inner cannula 20 and the outer
`conduit 30 as the stabilization cannula 411 in FIG. 23.” ’1204 Pet. 31 (citing
`’1204 Ex. 1002 ¶¶ 205–206; Ex. 1004, 8:20–9:13, 14:13–16, 29:18–30:28).
`The citations to Aboul-Hosn, however, do not support Petitioner’s
`contentions. Page 8, line 20 through page 9, line 13 of Aboul-Hosn are
`simply a brief description of Figures 1–12. Page 14, lines 13 through 16 of
`Aboul-Hosn provide a general explanation that “[t]he lengths of the inner
`cannula 20 and outer conduit 30 may further be varied in accordance with
`particular applications such as open heart surgery, or during closed heart or
`other laproscopic procedures which involve forming other openings to
`provide percutaneous access to inner body regions.” Finally, page 29, line
`17 through page 30, line 28 of Aboul-Hosn describes Figures 21 and 23,
`noting that “stabilization apparatus 410 and a pump 420 may be introduced
`into the body as shown in Fig. 21 through the femoral artery 430 with a
`catheter 428 linking the device to the exterior of the body” (Ex. 1004,
`29:17–19), and, importantly, that “Figure[] 23 . . . illustrate[s a] different
`embodiment[] of the present invention” (id. at 30:20–21).
`
`10
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`
`The cited portion of the Collins Declaration also fails to support
`sufficiently Petitioner’s contentions. In paragraph 205, Dr. Collins refers,
`generally, to 13 pages of prior testimony and concludes that “pump 420
`could include a variety of known blood pumps, including the pump system
`of FIGS. 1–13.” ’1204 Ex. 1002 ¶ 205. Dr. Collins’s opinion as to what
`pump 420 could include or would accommodate, however, is not the same as
`what Aboul-Hosn teaches.
`Petitioner also fails to provide a sufficient rationale to combine the
`teachings of Aboul-Hosn’s different embodiments. Petitioner simply fails to
`explain sufficiently why one skilled in the art would have found it obvious to
`combine those teachings.
`
`Ultimately, the ’1204 and ’1205 Petitions are deficient because of the
`failure to explain sufficiently and support the challenges therein. Based on
`the record before us, we are left unpersuaded that the features of Aboul-
`Hosn’s various embodiments are interchangeable or that one skilled in the
`art would have combined those features in the manner proposed by
`Petitioner. Accordingly, we determine that Petitioner has failed to establish
`a reasonable likelihood of prevailing in showing that claims 1–8, 14, 16–20,
`25, and 26 are unpatentable over Aboul-Hosn, Siess, and Wampler; that
`claims 10, 11, 13, 21, 23, 27, 29, and 30 are unpatentable over Aboul-Hosn,
`Siess, Wampler, and Jegaden; that claims 12 and 22 are unpatentable over
`Aboul-Hosn, Siess, Wampler, and Crowley; or that claim 15 is unpatentable
`over Aboul-Hosn, Siess, Wampler, and Wampler ’712.
`2. Aboul-Hosn/Yock/Siess/Wampler Grounds
`Petitioner additionally challenges claim 27 as unpatentable over
`Aboul-Hosn, Yock, Siess, and Wampler, and challenges claims 29 and 30 as
`
`11
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`unpatentable over Aboul-Hosn, Yock, Siess, Wampler, and Jegaden. Those
`challenges also fail for the reasons set forth above. See, e.g., ’1205 Pet. 84–
`85 (relying on sections X.A.1(a)–(i) (the discussion of the Aboul-Hosn/
`Siess/Wampler grounds) for the analysis of claim elements 27(a) – 27(i),
`respectively).
`
`
`III. SUMMARY
`Petitioner has failed to establish a reasonable likelihood of prevailing
`on any of its challenges. Accordingly, we do not institute inter partes
`review with respect to any of the challenged claims.
`
`
`IV. ORDER
`For the reasons given, the ’1204 Petition and the ’1205 Petition are
`each denied and no inter partes review is instituted.
`
`
`
`
`
`
`12
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`IPR2017-01204 and IPR2017-01205
`Patent 9,561,314 B2
`
`PETITIONER:
`David M. Tennant
`Charles D. Larsen
`Christopher Carroll
`WHITE & CASE LLP
`dtennant@whitecase.com
`charles.larsen@whitecase.com
`christopher.carroll@whitecase.com
`
`
`PATENT OWNER:
`Michael S. Connor
`Christopher TL Douglas
`S. Benjamin Pleune
`Travis Iams
`Lauren E. Burrow
`Christopher B. Kelly
`mike.connor@alston.com
`christopher.douglas@alston.com
`ben.pleune@alston.com
`travis.iams@alston.com
`lauren.burrow@alston.com
`chris.kelly@alston.com
`
`
`
`
`13
`
`
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