`
`Trials@uspto.gov
`Tel: 571-272-7822
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`Paper 12
`Entered: July 31, 2013
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`HEART FAILURE TECHNOLOGIES, LLC
`Petitioner
`
`v.
`
`CARDIOKINETIX, INC.
`Patent Owner
`_______________
`
`Case IPR2013-00183
`Patent 7,582,051
`_______________
`
`
`Before THOMAS L. GIANNETTI, MICHAEL J. FITZPATRICK, and
`SCOTT E. KAMHOLZ, Administrative Patent Judges.
`
`
`KAMHOLZ, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
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`
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`Universal Electronics Exhibit 2009, Page 1
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`

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`Case IPR2013-00183
`Patent 7,582,051
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`Heart Failure Technologies, LLC (“Petitioner”) filed a petition to institute an
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`inter partes review of claims 1 and 10 of U.S. Patent 7,582,051 (the “ ’051
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`patent”). Paper 4 (“Pet.”). Patent Owner CardioKinetix, Inc. timely filed a
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`preliminary response. Paper 10 (“Prelim. Resp.”). The standard for instituting an
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`inter partes review is set forth in 35 U.S.C. § 314(a), which provides as follows:
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`THRESHOLD.—The Director may not authorize an inter
`partes review to be instituted unless the Director
`determines that the information presented in the petition
`filed under section 311 and any response filed under
`section 313 shows that there is a reasonable likelihood
`that the petitioner would prevail with respect to at least 1
`of the claims challenged in the petition.
`
`Petitioner presents the following grounds of unpatentability (Pet. 3):
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`References
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`Basis Claims challenged
`
`Murphy (Ex. 1002),1
`Khairkhahan (Ex. 1004),2 and
`Lane (Ex. 1006)3
`Murphy, Khairkhahan, and
`Salahieh (Ex. 1007)4
`Lesh (Ex. 1003),5 Khairkhahan,
`Nikolic (Ex. 1005),6 and Lane
`Lesh, Khairkhahan, Nikolic,
`and Salahieh
`
`§ 103 1, 10
`
`§ 103 1, 10
`
`§ 103 1, 10
`
`§ 103 1, 10
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`
`
`1 U.S. Patent 7,485,088 B2.
`2 U.S. Pre-Grant Publication US 2002/0111647 A1.
`3 U.S. Patent 7,717,955 B2.
`4 U.S. Pre-Grant Publication US 2005/0137688 A1.
`5 U.S. Patent 6,152,144.
`6 U.S. Pre-Grant Publication US 2003/0050685 A1.
`
` 2
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`Case IPR2013-00183
`Patent 7,582,051
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`We determine that the record before us does not demonstrate that there is a
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`reasonable likelihood that Petitioner would prevail with respect to at least one
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`challenged claim. We consequently deny the petition and decline to institute an
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`inter partes review of the ’051 patent.
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`B. The Invention
`
`The ’051 patent (Ex. 1001) is entitled “Peripheral Seal for a Ventricular
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`Partitioning Device,” and relates generally to a device used to divide a heart
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`chamber into a productive portion and a non-productive portion. Abstr. The
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`device finds particular application in patients having hearts with weakened walls or
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`enlarged chambers, due to various forms of congestive heart failure. Col. 2,
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`ll. 38-45. Partitioning relieves stress on the weakened wall tissue and reduces
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`chamber volume, thereby improving the heart function measurement known as
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`ejection fraction. Id.
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`Figure 1 of the ’051 patent is reproduced below:
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`Figure 1 illustrates partitioning device 10. The device includes an
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`expandable frame 13 formed from ribs 14 that extend from hub 12 to free proximal
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`ends 16. Col. 5, ll. 45-51. Partitioning membrane 11 is secured to the frame and is
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`unfurled when the free proximal ends expand radially. Id. at ll. 53-54. When
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` 3
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`Case IPR2013-00183
`Patent 7,582,051
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`unfurled, the membrane presents a pressure receiving surface 17 (the undersurface,
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`not indicated in Fig. 1). Id. at ll. 53-55. The membrane has a peripheral edge 18
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`(also not indicated in Fig. 1) that may have serrations. Id. at ll. 57-58. A
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`continuous expansive strand 19 extends around the periphery of the membrane on
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`the undersurface. Id. at 59-60. The strand applies pressure to the membrane to
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`seal the periphery to the wall of the ventricular chamber. Id. at 60-63. The strand
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`is biased outwardly and ensures that folds or wrinkles are not formed when the
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`device is expanded for deployment. Col. 3, l. 66 to col. 4, l. 2.
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`Claim 1 illustrates the claimed subject matter and is reproduced below:
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`1. A device for treating a patient by partitioning a
`chamber of the patient's heart into a primary productive
`portion and a secondary non-productive portion, the
`device comprising:
`
`an expandable frame formed of a plurality of ribs
`having distal ends secured to a central hub and
`free, outwardly flared, proximal ends,
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`a pressure receiving membrane formed at least in part
`of flexible material, the membrane forming a
`recess in an expanded, deployed configuration,
`wherein the membrane comprises a loose and
`flexible peripheral region configured to seal to a
`ventricular wall surface to partition the ventricle
`and create the secondary non-productive portion,
`wherein the flexible peripheral region of the
`membrane comprises notched serrations; and
`
`an outwardly biased member which is secured to the
`membrane at a position that is radially inward from
`the loose peripheral region of the membrane,
`wherein
`the outwardly biased member
`is
`configured to stiffen at least a portion of the
`membrane so as to reduce wrinkling of the
`membrane so that the peripheral region of the
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` 4
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`Case IPR2013-00183
`Patent 7,582,051
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`membrane may seal against a ventricular wall
`surface defining in part the heart chamber.
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`C. Claim Construction
`
`Consistent with the statute and the legislative history of the AIA, the Board
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`will interpret claims of an unexpired patent using the broadest reasonable
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`construction in light of the specification of the patent. See Office Patent Trial
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`Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012); 37 CFR
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`§ 42.100(b). Petitioner does not propose any constructions deviating from this
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`standard. Pet. 5. Patent Owner directs no comments to claim construction in the
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`Preliminary Response.
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`II. ANALYSIS
`
`A. Overview
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`Petitioner contends that claims 1 and 10 are (1) obvious over Murphy and
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`Khairkhahan in combination with either Lane or Salahieh, and (2) obvious over
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`Lesh, Khairkhahan, and Nikolic, also in combination with either Lane or Salahieh.
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`Pet. 3; see chart supra.
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`B. Obviousness of claims 1 and 10 over Murphy, Khairkhahan, and Lane
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`Petitioner’s presentation of this challenge appears at pages 5-17 of the
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`petition.
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`Murphy describes a device and method for reshaping a ventricle that has
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`non-viable tissue in its wall. Col. 6, l. 65–col. 7, l. 7. The ventricle is reshaped by
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`“imbricating” it, meaning that edges of the ventricle wall having non-viable tissue
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`between them are brought together so that the non-viable tissue is excluded. Id.
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`Figure 2b of Murphy is reproduced below:
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` 5
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`Case IPR2013-00183
`Patent 7,582,051
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`Figure 2b shows a shaping device 210, which has a main wire 212 running
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`through its center and a series of back ribs 214a-d coupled to the main wire at
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`collar 216. Col. 4, ll. 45-50. A patch (not shown) may be coupled to the shaping
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`device. Col. 6, ll. 31-33. The patch is sized to cover the non-viable tissue that is to
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`be excluded, col. 8, ll. 6-11, and is positioned to align with that tissue. Col. 10,
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`ll. 44-47. The ventricle wall is reshaped by pressing it against the shaping device
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`using a molding instrument. Col. 7, ll. 8-13. A clasping instrument applies
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`implements (such as sutures, staples, or clips) to the ventricle wall along the edges
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`of the portion to be excluded. Id. at ll. 13-21. When the implements are closed,
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`the ventricle wall will have been pulled over the shaping device and will maintain
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`its shape. Id. at ll. 25-28.
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`Khairkhahan describes devices and methods for occluding the left atrial
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`appendage, a portion of the heart in which blood may clot when it stagnates there
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`during atrial fibrillation. Khairkhahan ¶ [0003].
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`Figures 3 and 4 of Khairkhahan are reproduced below:
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` 6
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`Case IPR2013-00183
`Patent 7,582,051
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`Figures 3 and 4 show an occluding device 10, which has an occlusion
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`member 11 and stabilizing member 194. Id. at ¶ [0062]. The occlusion member
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`includes a mesh-like barrier 15 secured to a frame that is formed by an array of
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`radially outwardly-extending spokes 17. Id. at ¶¶ [0044], [0047], [0048]. The
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`spokes extend from hub 16. Id. at ¶ [0046]. Each spoke has a proximal zone 212
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`with an “enhanced degree of flexibility” to assist engagement of the occlusion
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`member with the wall of the left atrial appendage. Id. at ¶ [0064]. Each spoke
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`terminates with a proximal point 214, which may be either embedded in the barrier
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`or extend beyond it to assist further with engagement. Id. at ¶ [0065].
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`Lane describes replacement heart valve assemblies. Abstr. The assembly
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`includes a prosthesis, which serves as an interface between the surrounding tissue
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`and the replacement valve. Col. 1, ll. 60-67. The prosthesis includes an annular
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`ring that is implantable in the surrounding tissue and a sewing cuff to which the
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`replacement valve is stitched. Id.
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`Detail from Figure 17A is reproduced below:
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` 7
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`Case IPR2013-00183
`Patent 7,582,051
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`The detail from Figure 17A shows a heart valve assembly, which includes a
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`prosthesis (gasket member 312) and a valve (crown 314). Col. 24, ll. 19-21. The
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`gasket member includes annular ring 318, flexible baleen element 330, sewing cuff
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`320, and covering fabric 336. Id. at ll. 22-26. The baleen element has a base 380
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`from which fingers 382 extend. Col. 25, ll. 57-59. The fingers may be biased to
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`extend outwardly. Id. at 65-66. When they do so, they press the fabric covering
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`against the surrounding tissue to enhance the seal formed by the gasket member.
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`Col. 27, l. 64 to col. 28, l. 2. The fingers may have uniform or varying lengths,
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`may define undulations or lobes, or may vary in thickness. Col. 26, ll. 4-15;
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`Figs. 20A-D.
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`Petitioner argues that Murphy and Khairkhahan disclose all limitations of
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`each of claims 1 and 10 except the requirement that the peripheral region of the
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`membrane have “notched serrations.” Pet. 6-7. In particular, Petitioner contends
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` 8
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`Case IPR2013-00183
`Patent 7,582,051
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`that Khairkhahan discloses the claimed outwardly biased member. Pet. 9, 13.
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`Petitioner argues that Lane discloses the notched serrations. Id. at 7-8. Petitioner
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`asserts that a person having ordinary skill in the art would have had reason to
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`combine the relevant teachings of Murphy, Khairkhahan, and Lane to reach the
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`claimed subject matter because these references “are related to the repair of a
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`human heart.” Pet. 5; see also Pet. 9.
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`Patent Owner argues, among other things, that the petition fails to explain
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`how Khairkhahan discloses the outwardly biased member. Prelim. Resp. 10,
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`37-39. Patent Owner also argues that Petitioner has made no more than a bare
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`assertion of obviousness, without any explanation of how the teachings of the
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`references would be arranged or combined or why a person of ordinary skill would
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`have made the combination. Prelim. Resp. 8, 39-41.
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`We agree with Patent Owner on both points. The fact that Murphy,
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`Khairkhahan, and Lane all concern human heart repair is not in itself sufficient
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`rationale for making the combination. Many heart repair devices exist. That fact
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`alone would not make it obvious to combine their features. Petitioner must show
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`some reason why a person of ordinary skill in the art would have thought to
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`combine particular available elements of knowledge, as evidenced by the prior art,
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`to reach the claimed invention. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398,
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`418 (2007). This, the Petitioner has not done. That the references relied upon all
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`relate to human heart repair does not amount to “some articulated reasoning with
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`some rational underpinning to support the legal conclusion of obviousness.” See
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`id. (internal quotations omitted).
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`Moreover, we agree further with Patent Owner that Petitioner has not
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`explained satisfactorily how the references, when combined, meet the “outwardly
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`biased member” limitation. Petitioner relies on Khairkhahan alone for disclosure
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` 9
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`of this limitation, but simply reproduces Khairkhahan’s Figure 3 and paraphrases
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`two paragraphs of Khairkhahan’s specification. See, e.g., Pet. 13. Petitioner does
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`not identify what structure shown or described in these excerpts meets the
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`limitation. No structure shown in the Khairkhahan excerpts Petitioner relies on is
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`plainly an “outwardly biased member” as recited in claims 1 and 10. The petition
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`thus does not make clear the relevance of the cited disclosure to the claim
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`limitation at issue. It was Petitioner’s burden to demonstrate how the prior art
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`would have made obvious the claimed subject matter as a whole, and Petitioner has
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`not done this. Petitioner’s presentation is incomplete in this respect and, therefore,
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`insufficient to demonstrate a reasonable likelihood of prevailing on this
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`obviousness challenge.
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`For these reasons, we determine that Petitioner has not demonstrated a
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`reasonable likelihood that claims 1 and 10 are unpatentable over Murphy,
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`Khairkhahan, and Lane.
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`C. Obviousness of claims 1 and 10 over Murphy, Khairkhahan, and
`Salahieh
`
`Petitioner’s presentation of this challenge appears at pages 17-28 of the
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`petition. This challenge, however, suffers from the same deficiencies discussed
`
`above. Petitioner offers the same inadequate rationale for combining the
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`respective references: that they all relate to repair of the human heart. See Pet. 18.
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`As discussed, this assertion is insufficient to support an obviousness challenge.
`
`See supra. Moreover, this challenge also relies on Khairkhahan for disclosing the
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`“outwardly biased member” limitation, but Petitioner does not explain how the
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`cited passages of Khairkhahan meet that limitation. See, e.g., Pet. 25.
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`
`
`10
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`Case IPR2013-00183
`Patent 7,582,051
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`For these reasons, we determine that Petitioner has not demonstrated a
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`reasonable likelihood of prevailing on its assertion that claims 1 and 10 are
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`unpatentable over Murphy, Khairkhahan, and Salahieh.
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`D. Obviousness of claims 1 and 10 over Lesh, Khairkhahan, Nikolic, and
`Lane
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`Petitioner’s presentation of this challenge appears at pages 28-45 of the
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`petition.
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`Lesh, like Khairkhahan, describes devices and methods for occluding the left
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`atrial appendage. Abstr. Figure 1 is reproduced below:
`
`
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`Figure 1 of Lesh shows an occluding device 10 having occluding member 11
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`and retention member 12. Col. 7, ll. 31-33. The occluding member is disc-shaped
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`and is formed from a frame structure 14 of arms extending from hub 16 to outer
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`rim 13. Id. at ll. 35-41. The outer rim may contain a radial hoop 21 that maintains
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`the ring shape of the outer rim and facilitates its radial expansion. Id. at ll. 64-67.
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`The outer rim seals against the surface of the left atrial appendage. Col. 8,
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`ll. 60-62.
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`
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`11
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`Case IPR2013-00183
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`This challenge suffers from the same deficiencies as the challenges
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`discussed above. Petitioner offers the same inadequate rationale for combining the
`
`respective references: that they all relate to repair of the human heart. See Pet. 29.
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`As discussed, this assertion is insufficient to support an obviousness challenge.
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`See supra.
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`Petitioner also does not persuade us that the cited references disclose the
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`“outwardly biased member” limitation. Petitioner cites Khairkhahan and Lesh as
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`each disclosing this limitation. See, e.g., Pet. 38-39. Petitioner excerpts from
`
`Khairkhahan the same portions as in the challenges discussed supra, and similarly
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`gives no explanation as to how the cited passages meet the claim limitation.
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`Petitioner also cites Figures 1-3 of Lesh and portions of the specification that
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`describe the outer rim and the radial hoop. Id. Petitioner, however, does not
`
`explain how either of these structures satisfies the requirement that the outwardly
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`biased member be “at a position that is radially inward” from the peripheral region
`
`of the membrane. As can be seen in Lesh’s Figure 1, and as can be inferred from
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`its name, the outer rim is at the outermost edge of the occluding device. Petitioner
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`has not explained how Lesh’s radially outermost position meets the claimed
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`“position that is radially inward.”
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`Thus, Petitioner has neither provided an adequate rationale for the
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`combination of the cited references, nor shown that the references, when
`
`combined, disclose the claimed subject matter or otherwise would have made it
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`obvious. For these reasons, we determine that Petitioner has not demonstrated a
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`reasonable likelihood that claims 1 and 10 are unpatentable over Lesh,
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`Khairkhahan, Nikolic, and Lane.
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`Case IPR2013-00183
`Patent 7,582,051
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`E. Obviousness of claims 1 and 10 over Lesh, Khairkhahan, Nikolic, and
`Salahieh
`
`Petitioner’s presentation of this challenge appears at pages 45-59 of the
`
`petition. This challenge suffers from the same deficiencies discussed in section
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`II.D, supra, for the challenge based on Lesh, Khairkhahan, Nikolic, and Lane.
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`Petitioner offers the same inadequate rationale for combining the respective
`
`references as for the other challenges: that they all relate to repair of the human
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`heart. See Pet. 45. This assertion is insufficient to support an obviousness
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`challenge. Moreover, this challenge relies on Khairkhahan or Lesh for disclosing
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`the “outwardly biased member” limitation, but Petitioner does not explain how the
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`cited passages of Khairkhahan or Lesh meet that limitation. See, e.g., Pet. 54-55.
`
`For these reasons, we determine that Petitioner has not demonstrated a
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`reasonable likelihood that claims 1 and 10 are unpatentable over Lesh,
`
`Khairkhahan, Nikolic, and Salahieh.
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`III. SUMMARY
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`Petitioner has not shown that there is a reasonable likelihood that it would
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`prevail with respect to at least one of the claims challenged in the petition. The
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`petition is therefore denied.
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`IV. ORDER
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`For the reasons given, it is
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`
`
`ORDERED that the petition challenging the patentability of claims 1
`
`and 10 of Patent 7,582,051 is denied.
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`13
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`Case IPR2013-00183
`Patent 7,582,051
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`
`
`For PETITIONER:
`
`Sanford E. Warren, Jr.
`R. Scott Rhodes
`AKIN GUMP STRAUSS HAUER & FELD LLP
`swarren@akingump.com
`srhoades@akingump.com
`
`For PATENT OWNER:
`
`Richard Shoop
`James Shay
`SHAY GLENN LLP
`rick@shayglenn.com
`jim@shayglenn.com
`
`
`
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`14
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