Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 6
`Entered: May 24, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEOCHORD, INC.,
`Petitioner,
`
`v.
`
`UNIVERSITY OF MARYLAND, BALTIMORE and
`HARPOON MEDICAL, INC.,
`Patent Owner.
`
`Case IPR2016-00208
`Patent 7,635,386 B1
`
`Before SALLY C. MEDLEY, ERICA A. FRANKLIN, and
`JAMES A. WORTH, Administrative Patent Judges.
`
`WORTH, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`DECISION
`Decision on Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`

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`IPR2016-00208
`Patent 7,635,386 B1
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`
`I.
`
`INTRODUCTION
`
`On November 18, 2015, Petitioner NeoChord, Inc. filed a Petition
`
`(Paper 2, “Pet.”) requesting inter partes review of claims 1–23 of U.S.
`
`Patent No. 7,635,386 B1 (the ’386 patent, Ex. 1001). No Preliminary
`
`Response was filed.
`
`The University of Maryland, Baltimore, filed a mandatory notice
`
`pursuant to 37 C.F.R. § 42.8, representing that it is the Patent Owner and a
`
`real party-in-interest. Paper 5, 2. The University of Maryland, Baltimore,
`
`further states that Harpoon Medical, Inc. is the exclusive licensee and is also
`
`a real party-in-interest. Id.
`
`Institution of an inter partes review is authorized by statute when “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.” 35 U.S.C. § 314(a); see also 37 C.F.R. § 42.108.
`
`For the reasons set forth below, we conclude that the information presented
`
`in the Petition establishes a reasonable likelihood that Petitioner would
`
`prevail in showing that claims 1–23 of the ’386 patent are unpatentable.
`
`Accordingly, we institute an inter partes review for the challenged
`
`claims.
`
`A. Related Matters
`
`The parties state that they are unaware of any related judicial or
`
`administrative proceedings. Pet. 2; Paper 5, 2.
`
`B. The ’386 Patent (Ex. 1001)
`
`The ’386 patent is titled “Methods and Devices for Performing
`
`Cardiac Valve Repair,” and relates to methods for performing repairs to
`
`2
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`Patent 7,635,386 B1
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`cardiac valves, and in particular, the mitral and tricuspid valves. Ex. 1001,
`
`at [57], 1:14–16. Such repairs may include implantation of artificial chordae
`
`tendinae,1 valve resection, implantation of an annuloplasty ring, and bow-tie
`
`repair. Id. at [57], 4:59–5:11.
`
`The ’386 patent states that the conventional approach for valve repair
`
`is problematic because it requires stopping the heart, which makes it difficult
`
`to accurately determine, assess, and secure the appropriate length for
`
`artificial chordae to ensure proper functioning of the valve. Id. at 4:36–47.
`
`Further, the ’386 states that as a general matter, cardiopulmonary bypass
`
`required by the conventional approach may adversely affect almost all of the
`
`organ systems of the body, and lead to strokes, myocardial damage,
`
`respiratory failure, kidney failure, bleeding, or death. Id. at 4:10–35.
`
`The ’386 patent is directed to a minimally invasive surgical approach
`
`in which valve repair may be performed while the heart is still beating with
`
`small incisions using specialized instruments under audio or visual guidance.
`
`Id. at 4:59–64, 6:13–14, 6:22–27. The ’386 patent describes accessing the
`
`heart through a small incision between the ribs or through the abdomen,
`
`followed by a small incision in the heart wall at or near the apex of the heart.
`
`Id. at 6:54–67, 9:43–10:2. An access port, including a manifold, may be
`
`inserted into the site of entry. Id. at 10:13–14. The ’386 patent describes, as
`
`an alternative approach to the heart, a percutaneous, endovascular approach
`
`through the femoral or internal jugular veins, or through the femoral artery,
`
`using needle puncture to access the apical region of the heart. Id. at 6:27–
`
`31, 10:2–7.
`
`
`1 The ’386 patent refers to these structures with alternate spellings, i.e., both
`as “chordae tendinae” and as “chordae tendineae.”
`
`3
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`
`The surgical approach described in the ’386 patent is depicted below
`
`in Figure 6:
`
`
`
`Figure 6 depicts an instrument inserted through an incision in the apex of the
`
`heart. For a repair that inserts artificial chordae tendinae, the instrument
`
`may attach a suture to a leaflet of the mitral valve, and attach the other end
`
`of the suture near the apex of the heart. Id. at 13:60–14:5. See Figure 9
`
`below:
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`4
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`Figure 9 shows suture placement in one embodiment to form an artificial
`
`
`
`chorda.
`
`C. Illustrative Claims
`
`The Petition challenges claims 1–23 of the ’386 patent. Of these,
`
`claims 1 and 19 are recited as independent claims directed to methods.
`
`Independent claim 1, reproduced below, is representative of the
`
`subject matter on appeal:
`
`1. A method for repairing a defective mitral or
`tricuspid valve, comprising:
`creating an access in an apical region of a heart
`through which a defective cardiac valve is accessed;
`introducing a device through said access; and
`repairing said cardiac valve by use of said device,
`wherein the repairing comprises replacing one or
`more chordae tendineae, and using said device to
`implant one or more artificial chordae tendineae,
`and
`
`5
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`
`the one or more artificial chordae
`wherein
`comprises a suture with one or more leaflets of the
`heart.
`
`
`Ex. 1001, 20:41–52.
`
`D. The Alleged Grounds of Unpatentability
`
`In the Petition, Petitioner set forth its contentions that claims 1–23 are
`
`unpatentable on the following grounds (Pet. 20–60):
`
`References
`
`Speziali2
`
`Basis
`
`Claims challenged
`
`§ 102 1, 3, 7–17, 19, 22, 23
`
`Speziali
`
`§ 103
`
`2, 4
`
`Speziali and Bachman3
`
`§ 103
`
`5, 6, 18, 20, 21
`
`Lattouf I4 and Carpentier5
`
`§ 103
`
`1–9, 11–15, 17–19,
`
`Lattouf I, Carpentier, and Downing6
`
`§ 103
`
`10, 16, 20, 21
`
`22, 23
`
`
`2 Speziali, U.S. Patent No. 8,465,500 B2, iss. June 18, 2013 (Ex. 1006).
`
`3 Bachman, U.S. Patent Application Pub. No. 2004/0044365 A1, pub. Mar.
`4, 2004 (Ex. 1008).
`
`4 Lattouf, U.S. Patent No. 6,978,176 B2, iss. Dec. 20, 2005 (Ex. 1004)
`(“Lattouf I”).
`
`5 Alain Carpentier, Cardiac valve surgery—the “French correction,” 86
`THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 323–337
`(Sept. 1983) (Ex. 1009) (“Carpentier”).
`
`6 Downing, U.S. Patent No. 6,840,246 B2, iss. Jan. 11, 2005 (Ex. 1005).
`
`6
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`Patent 7,635,386 B1
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`
`References
`
`Basis
`
`Claims challenged
`
`Lattouf I and Bachman
`
`§ 103
`
`1–9, 11, 14, 15, 17–
`
`Lattouf I and Downing
`
`§ 103
`
`237
`
`1–23
`
`Lattouf II8
`
`§ 102 1, 3, 6–9, 11–15, 17–
`
`19, 22, 23
`
`Lattouf II and Downing
`
`§ 103
`
`2, 4, 10, 16, 20, 21
`
`Downing and Oz9
`
`§ 103
`
`1–13, 19–23
`
`Downing, Oz, and Lattouf I
`
`§ 103
`
`14–18
`
`
`
`
`
`II. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, the Board interprets claim terms in an
`
`unexpired patent according to the broadest reasonable construction in light
`
`of the specification of the patent in which they appear. 37 C.F.R.
`
`§ 42.100(b); see In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79
`
`(Fed. Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee,
`
`136 S. Ct. 890 (mem.) (2016). Under that standard, and absent any special
`
`definitions, we give claim terms their ordinary and customary meaning, as
`
`
`7 This chart reflects the listing of claims on page 8 of the Petition. We note
`that, for this ground and for certain other grounds, the Petition does not
`analyze in its discussion each of the claims listed on page 8.
`
`8 Lattouf, U.S. Patent No. 7,871,433 B2, iss. Jan. 18, 2011 (Ex. 1007)
`(“Lattouf II”).
`
`9 Oz, U.S. Patent No. 6,269,819 B1, iss. Aug. 7, 2001 (Ex. 1010).
`
`7
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`would be understood by one of ordinary skill in the art at the time of the
`
`invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007). Any special definitions for claim terms must be set forth with
`
`reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d
`
`1475, 1480 (Fed. Cir. 1994).
`
`Petitioner proposes constructions of “creating an access in an apical
`
`region of a heart” in claim 1; “percutaneously accessing an apical region of a
`
`heart” in claim 19; “replacing . . . chordae tendin[e]ae” in claims 1 and 19;
`
`“a suture with one or more leaflets of the heart,” in claims 1 and 19; and
`
`“endovascularly via [an antegrade/a retrograde] approach” in claims 20 and
`
`21. Pet. 9–17.
`
`We construe only claim terms relevant to issues in dispute and only to
`
`the extent necessary to resolve the issues presented by the Petition. See
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`
`1999). For purposes of this Decision, we provide an express construction
`
`for the limitations “creating an access in an apical region of a heart” and “a
`
`suture with one or more leaflets of the heart,” requested by Petitioner. In
`
`addition, we construe an additional limitation relevant to one of the asserted
`
`grounds, “an optimal configuration of the one or more artificial chordae,” as
`
`set forth below.
`
`1. “creating an access in an apical region of a heart”
`
`Petitioner asserts that the broadest reasonable construction of the
`
`limitation “creating an access in an apical region of a heart” (claim 1) is
`
`“creating an incision or puncture in a wall of the heart in the region near the
`
`apex of the heart.” Pet. 10–11 (citing Ex. 1011 ¶ 44). Petitioner observes
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`that there are no natural openings in the apex of the heart, and identifies the
`
`recited “access” with entry 504 of Figure 5 of the ’386 patent. Pet. 9–10.
`
`The Specification discloses that “[t]ypically, access into the left
`
`ventrical (420), for instance, so as to perform a mitral valve repair, is gained
`
`through making a small incision into the apical region . . . .” Ex. 1001,
`
`9:47–49; see also 9:51–55 (similarly describing incision into the right
`
`ventrical for tricuspid valve repair). The Specification also discloses needle
`
`puncture as an alternative to an incision, in the context of a percutaneous
`
`approach. Id. at 10:2–7. On this record, we agree that an “access” may be
`
`an incision or a puncture in the heart.
`
`With respect to Figure 5, to which Petitioner refers, we note that the
`
`Specification describes that an “access port (550)” may be inserted into entry
`
`(504) to prevent blood loss. Id. at 10:13–17. However, the Specification
`
`refers to the incision as creating the “access” before noting that “if
`
`necessary,” a retraction device may create “greater access,” and describing
`
`the insertion of an access port. Id. at 9:47–49; 9:51–55; 10:8–15. As such,
`
`on this record, the “access” of claim 1 is not limited to the use of any
`
`additional structure, such as a port. We therefore determine, on this record,
`
`that the broadest reasonable construction of the limitation “creating an
`
`access in an apical region of a heart” is “creating an incision or puncture in a
`
`wall of the heart at or near the apex of the heart.”
`
`2. “a suture with one or more leaflets of the heart”
`
`Petitioner asserts that the broadest reasonable construction of “a
`
`suture with one or more leaflets of the heart” (claims 1 and 19) is “a suture
`
`inserted directly through the tissue of a native leaflet of a heart and not
`
`indirectly through a clip or other device that is in turn attached to the native
`
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`leaflet.” Pet. 15 (citing Ex. 1011 ¶ 50). Petitioner states that its proposed
`
`construction is consistent with the Specification of the ’386 patent. Pet. 15
`
`(citing Ex. 1001, 12:2–13:46; Fig. 9).
`
`On this record, we agree with Petitioner that, in claims 1 and 19, the
`
`limitation “a suture with one or more leaflets of the heart,” refers to a suture
`
`which is connected directly to the valve leaflet. This understanding is
`
`consistent with the prosecution history. During prosecution, the patentee
`
`traversed a rejection by the Examiner based on Lattouf I by arguing that
`
`Lattouf I lacked a suture connected to the valve leaflet. Ex. 1003, 9–10.10
`
`We, therefore, construe “a suture with one or more leaflets of the heart” to
`
`be “a suture which is directly connected to the valve leaflet.”
`
`3. “an optimal configuration of the one or more artificial chordae”
`
`Claim 15 ultimately depends from claim 1, and recites “determining
`
`an optimal configuration of the one or more artificial chordae before
`
`anchoring the artificial chordae.” Petitioner does not propose a construction
`
`for “optimal configuration,” but states in a footnote as follows:
`
`Petitioner notes that the phrase “optimal configuration” appears
`ambiguous in view of the recitation of “optimal arrangement,
`length, placement and configuration” in the specification.
`Ex.1001, 14:6–9. Although not at issue in this proceeding, the
`use of the term “optimal configuration” presents 35 U.S.C. § 112
`issues for these reasons. For purposes of this Petition and this
`limitation in this ground, the term “optimal configuration” does
`
`
`10 The patentee was essentially arguing that Lattouf I used a suture
`connected to a clip that was connected to the valve leaflet. See id. In its
`Petition, Petitioner asserts that Lattouf I discloses an additional embodiment
`using a suture as an artificial chorda without a clip, and that this embodiment
`was not the focus of prosecution before the Examiner. Pet. 30, 33 (citing
`Ex.1004, 3:58-62; Ex. 1011 ¶¶ 64, 79). See discussion infra.
`
`10
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`not need to be defined as the exact same term is used in Spezialli
`[sic].
`
`Pet. 26 n.7. We do not agree with Petitioner that the term “optimal
`
`configuration” is rendered ambiguous by the Specification’s listing of a
`
`series of related surgical considerations, i.e., optimal arrangement, length,
`
`placement and configuration. Although the Specification does not describe
`
`the limitation in the form of a definition, the Specification states as follows:
`
`It is to be noted that a fundamental challenge in successfully
`replacing one or more chordae tendineae and restoring proper
`functioning of a cardiac valve, is determining the appropriate
`artificial cord length and securing the artificial cord at a location
`so as to ensure the optimal replacement chordae length. The
`valve will not function properly if the length of the artificial cord
`is too long or too short. Because the heart is stopped using
`conventional techniques, it is virtually impossible to ensure that
`the cords are of the correct length and are appropriately spaced
`inside the ventricle to produce a competent valve. Accordingly,
`methods of the invention include the measuring and determining
`of the optimal arrangement, length, placement, and configuration
`of an implanted suture, for instance, a replacement cord length,
`while the heart is still beating and, typically, before the access
`site of the heart is closed. An optimal arrangement of a suture,
`for instance, an optimal cord length, is that arrangement that
`effectuates said repair, for instance, by minimizing reperfusion
`as determined by means well known in the art, for instance, by
`direct echo guidance.
`
`
`Ex. 1001, 14:63–15:15. Based on the ordinary and customary meaning of
`
`the terms in the context of the Specification, we ascertain that the broadest
`
`reasonable interpretation of “determining an optimal configuration of the
`
`one or more artificial chordae before anchoring the artificial chordae” is
`
`“determining the location of the attachment points for each end of the suture
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`11
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`and the length of the suture to restore proper valve functioning prior to
`
`attaching the suture as an artificial chorda.”
`
`B.
`
`Anticipation by Speziali (Ex. 1006)
`
`Relying on the Declaration of Dr. Lishan Aklog (Ex. 1011), Petitioner
`
`contends that Speziali anticipates claims 1, 3, 7–17, 19, 22, and 23. Pet. 20–
`
`26. We determine, on the current record, that Petitioner has established a
`
`reasonable likelihood of prevailing on its assertion as to claims 1, 3, 7–14,
`
`19, 22, and 23, but not as to claims 15–17.
`
` Overview of Speziali
`
`Petitioner asserts Speziali is prior art under pre-AIA 35 U.S.C.
`
`§102(e). Pet. 20. The Speziali reference is an issued patent, U.S. Patent No.
`
`8,465,500 B2, filed July 11, 2007 as a national stage of the PCT Application
`
`No. PCT/US06/[0]01699, filed January 19, 2006. Id. Petitioner further
`
`asserts that Speziali claims priority to U.S. Provisional Application No.
`
`60/645,677, filed January 21, 2005. Id.11
`
`Speziali relates to a “thorascopic heart valve repair method and
`
`apparatus.” Ex. 1006, at [54]. Speziali discloses the steps of inserting an
`
`instrument through the patient’s chest wall and heart wall, capturing a valve
`
`leaflet with a movable tip on an instrument, operating a needle to penetrate
`
`the captured leaflet and draw a suture through the leaflet, withdrawing the
`
`instrument from the heart chamber, and anchoring the suture to the heart
`
`wall, e.g., tying the suture off at the apex of the heart after adjusting its
`
`tension for optimal valve operation as observed with ultrasonic imaging. Id.,
`
`at [57], 3:1–10.
`
`
`11 We do not determine the priority date of Speziali at this time.
`
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` Analysis
`
`Petitioner sets forth in the Petition how each limitation of claims 1, 3,
`
`7–17, 19, 22, and 23 would be understood to be disclosed by Speziali. Pet.
`
`20–26. We determine, on the current record, that Petitioner has established a
`
`reasonable likelihood of prevailing on its assertion as to claims 1, 3, 7–14,
`
`19, 22, and 23, but not as to claims 15–17.
`
`i. Claim 1
`
`Petitioner maps Speziali to the limitations of claim 1. Pet. 20–26. In
`
`particular, Petitioner relies on Speziali’s disclosure of repair of mitral valve
`
`16 using instrument 10 through a stab incision for the preamble and the
`
`method steps of “creating an access in an apical region of a heart through
`
`which a defective cardiac valve is accessed” and “introducing a device
`
`through said access,” as recited by claim 1. Pet. 20–23 (citing Ex. 1006,
`
`5:14–21). Petitioner relies on Speziali’s disclosure of grasping a prolapsing
`
`edge of mitral valve 16 with instrument 10 to secure an artificial chorda and
`
`pulling suture 18 through a leaflet for the steps of “repairing said cardiac
`
`valve by use of said device, wherein the repairing comprises replacing one
`
`or more chordae tendineae, and using said device to implant one or more
`
`artificial chordae tendineae,” and “wherein the one or more artificial chordae
`
`comprises a suture with one or more leaflets of the heart,” as recited by
`
`claim 1. Id. at 21–23 (citing Ex. 1006, 5:19–21, 6:10–12, 6:61–62).
`
`Based on the supporting declaration of Dr. Aklog, and on our
`
`independent review of the evidence, we determine that Petitioner has
`
`established a sufficient showing, at this stage of the proceeding, that Speziali
`
`discloses the recited steps of claim 1. On this record, we therefore determine
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`that Petitioner has established a reasonable likelihood of prevailing on its
`
`assertion that Speziali anticipates claim 1.
`
`ii. Claims 3, 7–17, 19, 22, and 23
`
`Petitioner also maps Speziali to the limitations of claims 3, 7–17, 19,
`
`22, and 23. Pet. 20–26. We have similarly reviewed the evidence relating to
`
`these claims. Based on our independent review of the evidence at this stage
`
`of the proceeding, we determine that Petitioner has established a sufficient
`
`showing that Speziali discloses the limitations of claims 3, 7–14, 19, 22, and
`
`23, but not claims 15–17.
`
`Claim 15 ultimately depends from claim 1 and further recites the step
`
`of “determining an optimal configuration of the one or more artificial
`
`chordae before anchoring the artificial chordae.” Petitioner relies for this
`
`limitation on the disclosure in Speziali of adjusting the tension of the suture
`
`for optimal valve operation before tying off the suture. Pet. 26 (citing Ex.
`
`1006, 3:8–10). There are at least two deficiencies in the Petition’s
`
`explanation of how this disclosure in Speziali meets the limitation. First,
`
`Petitioner does not explain the temporal relationship between anchoring and
`
`tying off. Second, Speziali discloses an optimization of valve configuration
`
`or operation rather than an optimization of artificial chordae configuration,
`
`as recited by claim 15. To the extent that Speziali’s optimization of the
`
`valve is based on adjusting the suture tension, a change in suture (artificial
`
`chorda) tension does not necessarily result in a change in the configuration
`
`thereof. Indeed, applying the construction of the limitation set forth in the
`
`claim construction section above, the configuration of the artificial chorda
`
`relates to suture placement and length. The statute and rules place the
`
`burden on the Petitioner to provide a sufficient explanation for its case-in-
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`chief in the Petition. 35 U.S.C. §§ 312(a)(3), 316(e); 37 C.F.R. §
`
`42.104(b)(4),(5). For these reasons, we determine that Petitioner has not
`
`established a reasonable likelihood of prevailing on its assertion as to claim
`
`15 and claims 16 and 17, which depend therefrom.
`
`Thus, we determine, on this record, that Petitioner has established a
`
`reasonable likelihood of prevailing on its assertion that Speziali anticipates
`
`claims 3, 7–14, 19, 22, and 23, but not claims 15–17.
`
`C. Obviousness Over Speziali
`
`In its Petition, Petitioner alleges how each limitation of claims 2 and 4
`
`would be understood to be disclosed by Speziali, and why the claims would
`
`have been obvious in view of the entirety of Speziali’s disclosure. Pet. 26–
`
`27. We determine, on the current record, that Petitioner has established a
`
`reasonable likelihood of prevailing on its assertion as to claims 2 and 4.
`
`Claims 2 and 4 depend from claim 1, and recite further limitations relating to
`
`the resection of leaflets and performing annuloplasty.
`
`Petitioner contends that it would have been obvious to modify the
`
`method of Speziali to perform additionally leaflet resection and annuloplasty
`
`on the same valves based on the discussion in the background section of
`
`Speziali. Pet. 26–27. In the background section of the reference, Speziali
`
`explains that valve resection and annuloplasty were other repairs performed
`
`as part of the state of the art. Pet. 26–27 (citing Ex. 1006, 1:58–61).
`
`Petitioner argues that it would have been obvious for a person of ordinary
`
`skill in the art to perform additional procedures together based on the
`
`professional judgment of the surgeon with a reasonable expectation of
`
`success, as the combination of a finite number of mitral valve repair
`
`techniques. Pet. 27 (citing Ex. 1011 ¶ 57).
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`Based on our review of the evidence, including the Declaration, we
`
`determine that Petitioner has established a reasonable likelihood of
`
`prevailing on its assertion as to claims 2 and 4.
`
`D. Obviousness over Speziali and Bachman (Ex. 1008)
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`Petitioner contends the combination of Speziali and Bachman renders
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`obvious claims 5, 6, 18, 20, and 21. Pet. 27–29. We determine, on the
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`current record, that Petitioner has established a reasonable likelihood of
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`prevailing on its assertion as to claims 5, 6, 18, 20, and 21.
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`1. Overview of Bachman
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`Bachman relates to “a single catheter mitral valve repair device for
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`stabilizing a tissue portion and selectively applying a tissue fastener thereto.”
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`Ex. 1008, at [57]. Bachman discloses the steps of inserting a guidewire
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`endovascularly to the left atrium, advancing elongated body 14 of the
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`instrument towards the mitral valve, using a vacuum force to capture a tissue
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`portion of the mitral valve, stabilizing tissue portion 72, using a deployable
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`needle 64 to attach fastener material 62, and then attaching the fastener
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`material to tissue portion 74 on the mitral valve which is nearby tissue
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`portion 72 on the mitral valve. Id. ¶¶ 42–43. Bachman discloses that the
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`repair device may approach the mitral valve from an antegrade position or
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`from a retrograde position. Id.
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`2. Analysis
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`Claims 5, 6, and 18 depend from claim 1, and further recite stapling or
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`suturing an annulus for the valve repair, performance of a bow-tie procedure,
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`and the application of a vacuum. Claims 20 and 21 depend from claim 19,
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`and further specify that accessing an apical region of the heart is performed
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`endovascularly via an antegrade approach or a retrograde approach.
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`In its Petition, Petitioner alleges how each limitation of claims 5, 6,
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`18, 20, and 21 would be understood to be disclosed by the combination of
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`Speziali and Bachman, and why such a combination would have been
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`obvious. Pet. 27–30 (citing Ex. 1008 ¶¶ 6–9, 42). For example, with
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`respect to dependent claim 5, Petitioner relies on the disclosure in Bachman
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`of implantation of a prosthetic ring for valvular remodeling. Pet. 29 (citing
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`Ex. 1008 ¶ 6). Based on the supporting declaration of Dr. Aklog, and on our
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`independent review of the evidence, we determine that Petitioner has
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`established a sufficient showing, at this stage of the proceeding, that
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`Bachman discloses the additional recitations of claims 5, 6, 18, 20, and 21.
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`Petitioner argues that a person of ordinary skill would have used
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`professional judgment to combine the teachings of Bachman relating to
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`“well known” additional repair techniques with the teachings of Speziali in
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`order to effectuate a repair that mimics the techniques employed in open
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`procedures, and as selected from a finite number of options. Pet. 28–29
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`(citing Ex. 1011 ¶¶ 60–61). On this record, we determine that Petitioner has
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`established a reasonable likelihood of prevailing on its assertion that the
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`combination of Speziali and Bachman renders obvious claims 5, 6, 18, 20,
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`and 21.
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`E. Obviousness over Lattouf I (Ex. 1004) and Carpentier (Ex.
`1009)
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`Petitioner contends the combination of Lattouf I and Carpentier
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`renders obvious claims 1–9, 11–15, 17–19, 22, 23. Pet. 31–38. We
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`determine, on the current record, that Petitioner has established a reasonable
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`likelihood of prevailing on its assertion.
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` Overview of Lattouf I
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`Lattouf I is directed to the treatment of patients with congestive heart
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`failure and discloses two minimally invasive procedures, a procedure for
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`connecting the leaflets of the patient’s heart valve and a procedure for
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`implanting a pacemaker. Ex. 1004, at [54], [57]. As to the first procedure,
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`Lattouf I discloses a method of gaining access to a patient’s heart chamber
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`through the wall of the heart, such as at the apex, by piercing the heart wall
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`and placing a valved passageway within the heart wall. Id. at [57], 2:10–14,
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`2:44–61. Lattouf I describes the use of an elongated grasping device that
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`may be inserted into the heart to engage and grip the valve leaflets, e.g., to
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`place the valve in position for a bow-tie technique. Id. at 3:24–35. Lattouf I
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`describes joining together the valve leaflets using clips or staples. Id. at
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`3:35–45. In the alternative, Lattouf I discloses that, when a bow-tie will not
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`prevent reshaping of the ventricular architecture, the surgeon “provid[es] an
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`artificial chordae tendinae such as a strand extending between the valve
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`leaflets and the heart wall . . . .” Id. at 3:46–58. In one embodiment, a
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`strand has one end secured to the closed end of the leaflet clip, and another
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`end secured to the ventricular wall. Id. at 8:36–53, Fig. 27.
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` Overview of Carpentier
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`Carpentier is a copy of an address by Dr. Carpentier read at an annual
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`meeting of the American Association for Thoracic Surgery in 1983, and
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`published in The Journal of Thoracic and Cardiovascular Surgery in that
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`year. Ex. 1009, 323. Carpentier lists three types of valve disease and their
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`etiologies. Id. at 326 and Table II. Carpentier describes several types of
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`valve repair, including prosthetic ring annuloplasty, leaflet fixation on
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`secondary chordae, transposition of chordae, commisurotomy, and
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`reconstruction. Id. at 327–337. Carpentier is primarily directed to
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`traditional surgical methods involving cooling the patient, stopping the heart,
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`and making an incision in the heart with adequate exposure. See id. at 326;
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`Ex. 1011 ¶ 65. Carpentier discloses a surgical treatment of chordal rupture
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`in which a suture is passed through secondary chordae and then through the
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`valve leaflet. Id. at 328.
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` Analysis
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`In its Petition, Petitioner alleges how each limitation of claims 1–9,
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`11–15, 17–19, 22, and 23 would be understood to be disclosed by the
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`combination of Lattouf I and Carpentier, and why such a combination would
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`have been obvious. Pet. 31–38.
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`Petitioner asserts that Lattouf I discloses the entirety of the valve
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`repair through an apical access, as recited by independent claim 1. Pet. 33
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`(citing Ex. 1004, 2:10–14, 2:46–48, 3:24–35, 3:46–58, 7:63–8:5). As set
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`forth above, during prosecution, the patentee traversed a rejection based on
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`Lattouf I by arguing that Lattouf I does not disclose suturing the leaflet of
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`the valve. Ex. 1003, 4, 9–10, 23. Nevertheless, Petitioner asserts that
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`Lattouf I discloses two embodiments, the main embodiment in which a clip
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`attaches to the valve leaflet, and an alternative embodiment in which a suture
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`attaches directly to the leaftlet. Pet. 30, 33 (citing Ex. 1004, 3:58–62; Ex.
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`1011 ¶¶ 64, 79).
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`Petitioner does not rely on Lattouf I for suturing, but rather argues that
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`even under the understanding of Lattouf I argued by the patentee during
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`prosecution, it would have been obvious to substitute the clip attached to the
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`valve leaflet in Lattouf I with Carpentier’s technique of directly suturing the
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`valve leaflet. Pet. 30 n.8, 32–33 (citing Ex. 1009, 328). Based on the
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`current record, we determine that Petitioner has established a sufficient
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`showing that Lattouf I and Carpentier disclose the limitations of independent
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`claim 1.12
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`Petitioner argues that it would have been obvious to mimic an open
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`surgical approach (and retain Carpentier’s use of a suture) while using the
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`minimally invasive beating heart approach of Lattouf I in order to mimic the
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`preferred repair. Pet. 32–33 (citing Ex. 1011, ¶¶ 66–67). Based on the
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`declaration of Dr. Aklog, we determine that Petitioner has established a
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`reasonable likelihood that the combination of Lattouf I and Carpentier
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`renders obvious independent claim 1.
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`We have similarly reviewed the evidence relating to claims 2–9, 11–
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`15, 17–19, 22, and 23. Based on our independent review of the evidence at
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`this stage of the proceeding, we determine that Petitioner has established a
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`sufficient showing that Lattouf I and Carpentier disclose the limitations of
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`claims 2–9, 11–15, 17–19, 22, and 23. For similar reasons as for claim 1, we
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`determine that Petitioner has established a reasonable likelihood that the
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`combination of Lattouf I and Carpentier renders obvious claims 2–9, 11–15,
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`17–19, 22, and 23.
`
`
`12 On this record, we agree with Petitioner that, apart from Carpentier,
`Lattouf I also discloses an embodiment that directly attaches a suture to the
`valve leaflet. Ex. 1004, 3:58–63 (“One end of the strand is secured to the
`connecting element securing the free edges of the valve leaflets or the free
`edges themselves and the other end . . . is secured to a location on the heart
`wall, preferably on the exterior of the heart wall.”) (emphasis added); see
`Pet. 30, 33.
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`F. Obviousn