Trials@uspto.gov
`571.272.7822
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`
`
`
`
` Paper No. 64
`March 23, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00060
`Patent 8,992,608 B2
`____________
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 64
`March 23, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00060
`Patent 8,992,608 B2
`____________
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`
`IPR2017-00060
`Patent 8,992,608 B2
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`INTRODUCTION
`I.
`We have jurisdiction to hear this inter partes review under 35 U.S.C.
`§ 6(c). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. For the reasons discussed below, claims 1–4 of
`U.S. Patent No. 8,992,608 B2 (Ex. 1001, “the ’608 patent”) were shown to
`be unpatentable by a preponderance of the evidence.
`PROCEDURAL HISTORY
`A.
`Edwards Lifesciences Corporation, Edwards Lifesciences LLC, and
`Edwards Lifesciences AG (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`requesting institution of inter partes review of claims 1–4 of the ’608 patent.
`Boston Scientific Scimed, Inc. (“Patent Owner”) filed a Preliminary
`Response (Paper 6, “Prelim. Resp.”).
`Pursuant to 35 U.S.C. § 314(a), we determined the Petition showed a
`reasonable likelihood that Petitioner would prevail in establishing the
`unpatentability of claims 1–4 and instituted inter partes review of the ’608
`patent. Paper 7 (“Inst. Dec.”). After institution, Patent Owner filed a Patent
`Owner Response. Paper 21; Paper 22 (publicly available redacted version of
`the Patent Owner Response) (“PO Resp.”). Petitioner filed a Reply to Patent
`Owner’s Response. Paper 33; Paper 34 (publicly available redacted version
`of Petitioner’s Reply to Patent Owner’s Response) (“Pet. Reply”).
`Patent Owner also filed a Motion to Exclude expert testimony
`(Paper 41, “PO Mot.”), to which Petitioner provided a Response in
`opposition (Paper 45, “Pet. Resp.”), further to which Patent Owner provided
`a reply in support (Paper 49 (publicly available redacted version of Patent
`Owner’s Reply to Petitioner’s Response); Paper 50 (“PO Reply”); and
`further to which Petitioner provided a Surreply (Paper 51, “Pet. Surreply”).
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`Oral argument was held before the Board on December 19, 2017.
`Paper 55 (“Tr.”).1 We issue this Final Written Decision pursuant to
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Having considered the record
`before us, we determine Petitioner has shown by a preponderance of the
`evidence that claims 1–4 of the ’608 patent are unpatentable. See 35 U.S.C.
`§ 316(e). We also deny Patent Owner’s Motion to Exclude.
`RELATED MATTERS
`B.
`According to the parties the ’608 patent is a subject of a case
`captioned Boston Scientific Corp. et al. v. Edwards Lifesciences Corp., Case
`No. 1:16-cv-00275 (D. Del.). Pet. 25; Paper 4, 2. Petitioner also states that
`“there is at least one pending U.S. patent application, serial number
`14/873,462, that claims priority to the ’608 patent.” Id. at 26.
`REAL PARTIES IN INTEREST
`C.
`Petitioner identifies Edwards Lifesciences Corporation, Edwards
`Lifesciences LLC, and Edwards Lifesciences AG as real parties in interest.
`Pet. 25. Patent Owner identifies Boston Scientific Scimed, Inc. and Boston
`Scientific Corp. as real parties in interest. Paper 4, 2.
`
`
`1 Prior to the oral argument, Patent Owner filed Objections (Paper 53) to the
`demonstratives filed by Petitioner and Petitioner filed Objections (Paper 52;
`see also Paper 58 (corrected objections)) to the demonstratives filed by
`Patent Owner. The objections of the Parties generally relate to allegations
`that a demonstrative slide misstates the record or is improper new evidence
`or argument. See id. Demonstrative exhibits are not evidence. In this Final
`Written Decision, we rely directly on the arguments presented properly in
`the briefs of the Parties and the evidence of record, not on demonstrative
`slides; therefore, the objections of the Parties are overruled.
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`BACKGROUND
`II.
`The ’608 patent, titled “Everting Heart Valve,” issued March 31,
`2015, from U.S. Application No. 12/492,512, filed June 26, 2009. Ex. 1001,
`(21), (22), (45), (54). As background information, below we provide a
`summary of the ’608 patent, along with an illustrative claim from the ’608
`patent, and we identify the instituted grounds of unpatentability and the
`proffered expert testimony. We also address our reasons for denying the
`Motion to Exclude.
`SUMMARY OF THE ’608 PATENT
`A.
`The ’608 patent generally relates to “methods and apparatus for
`endovascularly replacing a patient’s heart valve.” Ex. 1001, Abstract.
`“Valve replacement may be indicated when there is a narrowing of the
`native heart valve, commonly referred to as stenosis, or when the native
`valve leaks or regurgitates.” Id. at 1:29–31. Petitioner further explains that
`the ’608 patent “is directed to a collapsible and expandable prosthetic heart
`valve delivered via a catheter (‘transcatheter heart valve’ or ‘THV’).” Pet. 1.
`Figures 3A and 3B of the ’608 patent are reproduced below.
`
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`Illustrated in Figure 3A is the delivery and in Figure 3B the deployment of a
`replacement heart valve and anchor. Ex. 1001, 3:36–38. Apparatus 10 may
`be deployed from lumen 112 by retracting sheath 110, which causes anchor
`30 to dynamically self-expand to a partially deployed configuration. Id. at
`7:30–39. “Control wires 50 then are retracted relative to apparatus 10 and
`tubes 60 to impose foreshortening upon anchor 30.” Id. at 7:39–41.
`The ’608 patent also states that “[a]nnular base 22 of replacement
`valve 20 preferably is coupled to skirt region 34 of anchor 30, while
`commissures 24 of replacement valve leaflets 26 are coupled to and
`supported by posts 38.” Id. at 5:60–63. “Replacement valve 20 is
`preferably made from biologic tissues, e.g. porcine valve leaflets or bovine
`or equine pericardium tissues or human cadaver tissue.” Id. at 5:51–53.
`According to the ’608 patent, one of the obstacles to replacing a
`patient’s heart valve is the risk of paravalvular leakage (“PVL”) around the
`replacement valve, as illustrated in Figure 13, reproduced below.2
`
`
`
`
`2 Paravalvular leakage is also referred to as paravalvular aortic regurgitation
`(“PAR”). PO Resp. 7 (further describing PVL / PAR as “the tendency for
`blood to leak around the outside of the prosthetic frame during diastole, the
`phase of the cardiac cycle when the aortic valve must prevent blood from
`reentering the heart through the aorta”) (citing Ex. 2004, 307). Additionally,
`the Parties do not distinguish “perivalvular” leakage from “paravalvular”
`leakage, therefore, our understanding is that the two terms are used in the art
`interchangeably. See, e.g., Ex. 1059, 12 (describing the use of a cuff to
`prevent “perivalvular leak around the valve”).
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`Figure 13 illustrates paravalvular leaking around a replacement heart valve
`and anchor. Id. at 3:60–61. Diseased aortic valve AV includes native valve
`leaflets L with an irregular surface. Id. at 12:19–23. “[I]nterface I between
`leaflets L and anchor 30 may comprise gaps where blood B may seep
`through,” posing “a risk of blood clot formation or insufficient blood flow.”
`Id. at 12:23–27.
`The ’608 patent describes “optional elements for reducing
`regurgitation or leakage” including sacs arranged in a variety of ways, as
`well as seals that “expand over time to seal the interface between the anchor
`and valve and the patient’s tissue.” Id. at 12:28–42, 14:11–19; Figs. 14,
`15A, 15B, 15C, 15D, 15E, 27, 28, 29, 30, 31. Further, the ’608 patent states
`that “[a]nother way to seal the replacement valve against leakage” is
`illustrated in Figures 32, 33, and 34 as utilizing a fabric seal. Id. at 14:21–
`23.
`
`Figures 32, 33, and 34 are reproduced below.
`
`
`
`
`An embodiment of the replacement heart valve and anchor is illustrated in
`Figure 32 in an undeployed configuration and in Figure 33 in a deployed
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`configuration. Ex. 1001, 4:38–42. Figure 34 illustrates the replacement
`heart valve deployed in a patient’s heart valve. Id. at 4:43–44. The ’608
`patent explains:
`A fabric seal 380 extends from the distal end of valve 20 and
`back proximally over anchor 30 during delivery. When
`deployed, as shown in FIGS. 33 and 34, fabric seal 380 bunches
`up to create fabric flaps and pockets that extend into spaces
`formed by the native valve leaflets 382, particularly when the
`pockets are filled with blood in response to backflow blood
`pressure. This arrangement creates a seal around the replacement
`valve.
`Id. at 14:21–29. The ’608 patent contains no additional description of fabric
`seal 380 or of the “flaps and pockets” it creates. As explained by Petitioner,
`the disclosure of the ’608 patent focuses “primarily on self-expanding THV
`technology,” not on the various sealing features briefly mentioned in the
`’608 patent. Pet. 27–28; see also Ex. 1001, 2:40–3:12 (in the ’608 patent the
`“Summary of the Invention” does not expressly address “fabric seal,”
`“flaps,” or “pockets”); 1:63–64, 2:10–11 (addressing deficiencies in the prior
`art and stating that the “[s]tandard self-expanding systems have very poor
`accuracy in deployment” and that “[a]nother drawback of prior art self-
`expanding replacement heart valve systems is their lack of radial strength”).
`With regard to the prosecution history of the ’608 patent, Petitioner
`identifies June 16, 2004, as the priority date. Pet. 1; see also PO Resp. 6 n.2
`(Patent Owner does not dispute the priority date identified by Petitioner).
`Petitioner explains that during prosecution the Examiner found that “[a]n
`implantable fabric having pleats and pockets is well known in the art” and
`that it “would have been obvious to one of ordinary skill in the art to modify
`the seal [of a reference disclosing an artificial valve] to include pleats as an
`obvious alternative design choice.” Pet. 37 (quoting Ex. 1002, 353)
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`(emphasis omitted). The application claims were then amended by the
`applicant to require a fabric seal such that “when the expandable anchor is in
`the collapsed delivery configuration, the fabric seal extends from the distal
`end of the replacement valve and back proximally over the expandable
`anchor, the fabric seal being adapted to prevent blood from flowing between
`the fabric seal and heart tissue.” Id. at 38 (quoting Ex. 1002, 358) (emphasis
`omitted). The Examiner allowed the amended claims without explanation.
`Id. at 39 (citing Ex. 1002, 373).
`B.
`ILLUSTRATIVE CLAIM
`Claim 1 is the sole independent claim challenged, from which
`challenged claims 2–4 depend. Claim 1 is illustrative of the claimed subject
`matter and is reproduced below:
`1. A system for replacing a heart valve, comprising:
`[1.1] an expandable anchor having a collapsed delivery
`configuration and an expanded configuration, the expandable
`anchor comprising a distal end;
`[1.2] a replacement valve commissure support element attached
`to the expandable anchor;
`[1.3] a commissure portion of a replacement valve leaflet
`attached to the commissure support element; and
`[1.4] a fabric seal at least partially disposed around an exterior
`portion of the expandable anchor when the anchor is in the
`expanded configuration, [1.5] the fabric seal having an
`undeployed state and a deployed state, [1.6] wherein in the
`deployed state the fabric seal comprises flaps that extend into
`spaces formed by native valve leaflets;
`[1.7] wherein a distal end of the replacement valve leaflet is
`attached to the fabric seal and when the expandable anchor is
`in the collapsed delivery configuration, [1.8] the fabric seal
`extends from the distal end of the replacement valve and back
`proximally over the expandable anchor, [1.9] the fabric seal
`being adapted to prevent blood from flowing between the
`fabric seal and heart tissue.
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`Ex. 1001, 22:22–42 (additional numbering of claim elements corresponding
`to Pet. 77 (Appendix of “Element-By-Element” breakdown of claim 1)).
`INSTITUTED GROUNDS OF UNPATENTABILITY
`C.
`We instituted inter partes review of claims 1–4 of the ’608 patent
`on the following grounds of unpatentability asserted in the Petition:
`Reference(s)
`Basis
`Claims challenged
`Spenser3 and Elliot4
`§ 103 1–4
`Spenser and Thornton5
`§ 103 1–4
`Spenser and Cook6
`§ 103 1–4
`Inst. Dec. 24.
`
`PROFFERED EXPERT DECLARATIONS
`D.
`Petitioner supports its challenge with the Declaration of Nigel P.
`Buller, M.D., dated October 10, 2016 (Ex. 1007); the Supplemental
`Declaration of Nigel P. Buller, M.D., dated April 25, 2017 (Ex. 1035); and
`the Reply Declaration of Nigel P. Buller, M.D., dated September 22, 2017
`(Ex. 1045). Dr. Buller is a retired Consultant Cardiologist and formerly, the
`“Head of Interventional Cardiology at the Queen Elizabeth Hospital,
`Birmingham and the Lead Clinician for the Cardiac Catheterization
`Laboratories.” Ex. 1007 ¶ 6. Petitioner also supports its challenge with the
`Declaration of Larry Wood, dated September 21, 2017 (Ex. 1046).
`
`3 WO 03/047468 A1, published June 12, 2003 (Ex. 1004, “Spenser”)
`(citations to Spenser are to the original pagination).
`4 U.S. Patent App. Pub. No. 2003/0236567 A1, published
`December 25, 2003 (Ex. 1005, “Elliot”).
`5 U.S. Patent No. 6,015,431, issued January 18, 2000
`(Ex. 1019, “Thornton”).
`6 U.S. Patent App. Pub. No. 2004/0082989 A1, published April 29, 2004
`(Ex. 1006, “Cook”).
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`Mr. Wood is currently “the Corporate Vice President, Transcatheter Heart
`Valves, at Edwards Lifesciences.” Ex. 1046 ¶ 5.
`Patent Owner’s opposition relies on the Declaration of Dr. Andrew J.
`Manganaro, (Ex. 2079) and the Declaration of Stephen J. D. Brecker
`(Ex. 2080), both of which are dated June 23, 2017. Dr. Manganaro is a
`“board-certified cardiac, thoracic, and vascular surgeon with more than 25
`years of experience.” Ex. 2079 ¶ 5. Dr. Brecker is an interventional
`cardiologist with over twenty-five years of medical experience. Ex. 2080
`¶ 2.
`
`In our consideration of the expert testimony, Patent Owner argues that
`Dr. Buller’s declaration is “entitled to little or no weight because he lacks
`experience in the relevant technologies.” PO Resp. 15–19. Patent Owner
`states that Dr. Buller has never performed a valve replacement procedure
`and has never implanted stent grafts. Id. at 16. In comparison, Patent
`Owner asserts that its experts are surgeons and that “to the extent that there
`is any disagreement between Dr. Buller and Patent Owner’s experts, the
`Board should give less or no weight to Dr. Buller’s opinions.” Id. at 17.
`Indeed, Dr. Buller is a cardiologist, not a surgeon. Ex. 2028, 37:17–
`19. Patent Owner, however, fails to provide a persuasive justification for
`why the fact that Dr. Buller has never performed a valve replacement
`procedure and has never implanted stent grafts matters, such that Dr.
`Buller’s testimony should be given “little or no weight.” Patent Owner also
`has not persuasively explained why we should find the opinion of surgeons
`more credible than Dr. Buller’s opinion as a cardiologist. Further. Patent
`Owner has not shown that Dr. Buller lacks credibility because he is not a
`surgeon or that Dr. Buller’s opinions are not based on relevant evidence.
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`We, therefore, determine that Patent Owner has not shown that Dr. Buller’s
`opinions are entitled to little or no weight.
`Next, Patent Owner argues that Dr. Buller is not a person of ordinary
`skill in the art because there is “no indication that Dr. Buller had a working
`knowledge of heart valve designs in 2004.” PO Resp. 16. During oral
`argument, Patent Owner suggested Dr. Buller was “barely” a person of
`ordinary skill in the art. Tr. 31:3–10. Patent Owner has not moved to
`exclude Dr. Buller’s testimony on the grounds that he is unqualified.
`Regardless, to testify as an expert under Federal Rule of Evidence 702, a
`person need only be “qualified in the pertinent art by knowledge, skill,
`experience, training, or education.” Sundance, Inc. v. DeMonte Fabricating
`Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). Thus, the issue is not
`whether Dr. Buller had a “working knowledge of heart valve designs in
`2004,” as Patent Owner argues. See PO Resp. 16. We have considered
`Dr. Buller’s qualifications and are persuaded that he is so qualified at the
`time he offered his opinions in this matter. See Ex. 1007 ¶¶ 6–26.
`Patent Owner also argues that Dr. Buller’s declaration is entitled to
`little or no weight because he “repeatedly relies on unsupported, conclusory
`assertions, rather than credible evidence.” PO Resp. 18. We have
`considered the opinions expressed by each of the experts in this case and
`accord the appropriate weight to each of their opinions based on whether the
`opinion is credible and whether it is supported by credible evidence.
`E. MOTION TO EXCLUDE
`Patent Owner filed a Motion to Exclude the Declaration of Nigel P.
`Buller, M.D. (Ex. 1007) and the Reply Declaration of Nigel P. Buller, M.D.
`(Ex. 1045) on the basis that Dr. Buller failed to consider “evidence of
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`objective indicia or secondary considerations of nonobviousness.” PO
`Mot. 1. A motion to exclude deals with the admissibility of evidence under
`the Federal Rules of Evidence. See 37 C.F.R. §§ 42.62 (applying the
`Federal Rules of Evidence to inter partes reviews), 42.64; Office Patent
`Trial Practice Guide, 77 Fed. Reg. 48,756, 48,758 (August 14, 2012)
`(“Admissibility of evidence is generally governed by the Federal Rules of
`Evidence.”). As stated in the Office Patent Trial Practice Guide, the parties
`may submit motions to exclude regarding evidence “believed to be
`inadmissible.” Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,758.
`Further, a motion to exclude “must explain why the evidence is not
`admissible (e.g., relevance or hearsay).” Id. at 48,767.
`Patent Owner reasons that:
`Dr. Buller’s opinions should be excluded under Rule 702
`because—absent consideration of objective indicia—they will
`not “help the trier of fact to understand the evidence or to
`determine a fact in issue,” are not “based on sufficient facts,” and
`are not “the product of reliable principles and methods . . .
`reliably applied . . . to the facts of the case.”
`PO Mot. 4 (quoting Fed. R. Evid. 702). According to Patent Owner, the
`“Federal Circuit has criticized obviousness experts for failing to consider the
`objective indicia.” Id. at 3 (citing Kinetic Concepts, Inc. v. Smith & Nephew,
`Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012); InTouch Techs., Inc. v. VGO
`Commc’ns., Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014)). Patent Owner
`proceeds to argue at length that Petitioner “fails to show lack of nexus,” an
`issue outside the scope of a proper motion to exclude. PO Mot. 5–7
`(emphasis omitted).
`
`In response, Petitioner asserts that Dr. Buller was not required to
`anticipate and address in his initial declaration objective evidence of
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`nonobviousness that had not yet been raised by Patent Owner in this case.
`Pet. Resp. 3–4 (citations omitted). Petitioner further contends that, in his
`Reply Declaration, Dr. Buller addressed Patent Owner’s objective evidence
`of nonobviousness, including allegations of copying, and reached the
`opinion that Patent Owner failed to establish the required nexus between the
`asserted evidence and the product (“Petitioner’s S3 THV”) relied on by
`Patent Owner. Id. at 2 (citing Ex. 1045 ¶¶ 9–27), 7. Petitioner also contends
`that “[o]nce Dr. Buller determined that there was no nexus between
`Petitioners’ S3 THV and the Challenged Claims, there was no need for him
`to further address specific evidence of secondary considerations.” Id. at 6;
`see also id. at 2 (noting that “other than the nexus issue, neither of [Patent
`Owner]’s experts addressed any of the secondary considerations”).
`Petitioner also notes that it provided a declaration from Mr. Wood further
`addressing objective evidence of nonobviousness. Id. at 2–3. Petitioner
`further argues that the issues raised by Patent Owner go to the weight
`accorded Dr. Buller’s testimony, not to its admissibility. Id. at 8–9.
`
`In reply, Patent Owner asserts that it is seeking to exclude Dr. Buller’s
`declarations, not a ruling on the weight that should be afforded his
`testimony. PO Reply 5 (emphasis omitted). Patent Owner further argues
`that “[b]ecause Dr. Buller’s analysis of nexus is incorrect, he is not relieved
`of the need to consider the objective evidence of nonobviousness,” after
`which Patent Owner improperly argues at length that it has “demonstrated
`nexus.” Id. at 2–5. As with its Motion, Patent Owner’s substantive nexus
`arguments in its Reply disputing Dr. Buller’s opinions are misplaced. The
`issue properly raised by the Motion to Exclude is the admissibility, not the
`correctness, of Dr. Buller’s opinions. In its Surreply, Petitioner argues that
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`the new arguments and evidence relied on by Patent Owner in its Reply to
`purportedly show nexus are improper and should be disregarded. Pet.
`Surreply 1–2.
`Rule 702 precludes expert testimony when it is not “based on
`sufficient facts or data” or is not “the product of reliable principles and
`methods.” Fed. R. Evid. 702(b)–(c). Expert opinion that is not “sufficiently
`tied to the facts of the case” is “not relevant and, ergo, non-helpful.”
`Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 591 (1993). Rule
`702(d) further limits expert testimony to situations where “the expert has
`reliably applied the principles and methods to the facts of the case.”
`Rule 702 thus serves “a ‘gatekeeping role,’ the objective of which is to
`ensure that expert testimony admitted into evidence is both reliable and
`relevant.” Sundance, 550 F.3d at 1360. The policy considerations for
`excluding expert testimony, such as those implemented by the gatekeeping
`framework established by the Supreme Court in Daubert, are less
`compelling in bench proceedings, such as inter partes reviews, than in jury
`trials. See, e.g., Volk v. United States, 57 F. Supp. 2d 888, 896 n.5 (N.D.
`Cal. 1999).
`We agree with prior panels of the Board, which have determined
`under similar circumstances that an expert’s declaration in support of a
`Petition is not properly the subject of a motion to exclude on the basis that
`the expert did not consider objective evidence of nonobviousness that is not
`yet in evidence in the proceeding. See Activision Blizzard, Inc. v.
`Acceleration Bay, LLC, IPR2016-00724, slip op. at 30 n.13, 57 (PTAB
`Sept. 15, 2017) (Paper 53); Activision Blizzard, Inc. v. Acceleration Bay,
`LLC, IPR2015-01953, slip op. at 36 n.15, 57 (PTAB Apr. 19, 2017) (Paper
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`107). Patent Owner does not contend, and has not shown, that there was
`objective evidence of nonobviousness in this proceeding that Dr. Buller
`failed to address when he provided a declaration in support of the Petition.
`We also agree with Petitioner that Dr. Buller addressed objective evidence
`of nonobviousness in his Reply Declaration. Ex. 1045 ¶¶ 9–27. That
`Dr. Buller purportedly did not address objective evidence of nonobviousness
`in his reply to the satisfaction of Patent Owner does not support exclusion of
`Dr. Buller’s declaration.
`Nor does Patent Owner direct us to any authority to support the
`contention that an expert’s declaration should be excluded for failure to
`address objective evidence of nonobviousness. Patent Owner’s effort to
`exclude Dr. Buller’s declarations are not persuasively supported by the cases
`upon which Patent Owner relies. See Kinetic Concepts, 688 F.3d at 1342
`(does not exclude an expert’s testimony based on an alleged failure to
`address objective evidence of nonobviousness); InTouch Techs., 751 F.3d at
`1327 (same). Intri-Plex Tech., also relied on by Patent Owner, merely states
`the unremarkable proposition that “[e]vidence of secondary considerations
`of non-obviousness, when present, must always be considered en route to a
`determination of obviousness.” Intri-Plex Tech., Inc. v. Saint-Gobain
`Performance Plastics Rencol Ltd., IPR2014-00309, slip op. at 35–36 (PTAB
`Mar. 23, 2014) (Paper 83) (further explaining that “fact finders must
`withhold judgment on an obviousness challenge until it considers all
`relevant evidence, including that relating to the objective considerations”)
`(citations omitted).
`The Board, not Dr. Buller, is the “fact finder” in this proceeding, and
`we are obligated to consider all relevant evidence, including the declarations
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`of Dr. Buller, as well as objective evidence of nonobviousness provided by
`Patent Owner. For the foregoing reasons, Patent Owner’s Motion to
`Exclude Dr. Buller’s declarations is denied. Moreover, to the extent Patent
`Owner has improperly disputed the merits of Dr. Buller’s opinions under the
`pretext of the Motion to Exclude, those arguments will not be given
`consideration beyond the extent to which they were properly raised in Patent
`Owner’s Response to the Petition.
`III. ANALYSIS
`In our analysis of whether Petitioner has sufficiently shown that the
`challenged claims of the ’608 patent would have been obvious over the
`asserted prior art, we next address the applicable principals of law; the
`construction of the claim terms “flaps” and “pockets;” the scope and content
`of the asserted prior art of Spenser, Elliot, Thornton, and Cook; the
`differences between the claimed subject matter and the asserted prior art; the
`level of ordinary skill in the art; the objective evidence of nonobviousness;
`and, finally, the reasons supporting obviousness.
`PRINCIPLES OF LAW
`A.
`To prevail in its challenge to the patentability of claims 1–4 of the
`’608 patent, Petitioner must prove unpatentability by a preponderance of the
`evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). In an inter partes
`review, “[a] claim in an unexpired patent . . . shall be given its broadest
`reasonable construction in light of the specification of the patent in which it
`appears.” 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2142 (2016) (upholding the use of the broadest reasonable
`interpretation standard). In determining the broadest reasonable
`construction, we presume that claim terms carry their ordinary and
`
`16
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`IPR2017-00060
`Patent 8,992,608 B2
`
`customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). A patentee may define a claim term in a manner that
`differs from its ordinary meaning; however, any special definitions must be
`set forth in the specification with reasonable clarity, deliberateness, and
`precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`A patent claim is unpatentable as obvious under 35 U.S.C. § 103(a) if
`“the differences between” the claimed subject matter “and the prior art are
`such that the subject matter as a whole would have been obvious at the time
`the invention was made to a person having ordinary skill in the art to which
`said subject matter pertains.” 35 U.S.C. § 103(a). An invention “composed
`of several elements is not proved obvious merely by demonstrating that each
`of its elements was, independently, known in the prior art.” KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398, 418 (2007). Rather, “it can be important to
`identify a reason that would have prompted a person of ordinary skill in the
`relevant field to combine the elements in the way the claimed new invention
`does.” Id.
`An obviousness determination “cannot be sustained by mere
`conclusory statements; instead, there must be some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness.” Id. (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006));
`see In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir.
`2016). The question of obviousness is resolved on the basis of underlying
`factual determinations, including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of skill in the art; and (4) objective evidence of nonobviousness.
`Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966).
`
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`
`CLAIM CONSTRUCTION
`B.
`Claim 1 recites “the fabric seal comprises flaps.” Ex. 1001, 22:34.
`Claim 2 depends from claim 1 and further recites “the fabric seal defines a
`plurality of pockets.” Id. at 22:43–44. Petitioner contends that “flaps”
`should be construed to mean “circumferentially oriented folds or unattached
`ends.” Pet. 43. Petitioner further contends that “pockets” should be
`construed to mean “open spaces or cavities formed by flaps of the fabric
`seal.” Id. at 45.
`Patent Owner argues that Petitioner’s proposed constructions are not
`the broadest reasonable interpretation, but proposes no alternative. PO Resp.
`20 (noting that the district court, with respect to the ’608 patent, construed
`“flaps” to mean “fabric projecting from the anchor” and “pockets” to mean
`“cavities formed by the fabric seal”) (citing Ex. 2032, 3). Patent Owner
`further asserts that “Petitioner cannot meet its burden of proving that claims
`1–4 are unpatentable even under its own proposed constructions.” Id. Patent
`Owner, therefore, does not dispute that the meaning of “flaps” and “pockets”
`is at least as broad as Petitioner’s proposed construction.
`In the absence of any dispute between the parties, we determine no
`express construction of “flaps” or “pockets” is necessary. Vivid Techs., Inc.
`v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those
`terms need be construed that are in controversy, and only to the extent
`necessary to resolve the controversy”).
`SCOPE AND CONTENT OF THE PRIOR ART
`C.
`Petitioner relies on Spenser, Elliot, Thornton, and Cook with respect
`to its contentions that claims 1–4 of the ’608 patent would have been
`
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`IPR2017-00060
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`obvious under the instituted grounds. Pet. 66–73. Patent Owner does not
`dispute the prior art status of any of the asserted references.
`1.
`Spenser (Ex. 1004)
`Spenser, titled “Implantable Prosthetic Valve,” describes a prosthetic
`valve comprised of a support stent and valve assembly. Ex. 1004, Abstract.
`Figure 1 of Spenser is reproduced below.
`
`
`Figure 1 illustrates an implantable prosthetic tricuspid valve suitable for
`deployment by a stent. Ex. 1004, 14. Tricuspid implantable prosthetic valve
`20 includes valve assembly 28, with inlet 24, outlet 26, and outer walls
`consisting of collapsible pliant material 29. Id. at 22. Valve assembly 28 is
`attached to annular support stent 22 at bores 25 on support beams 23. Id.
`“[C]uff portion 21 of the valve assembly 28 is wrapped around support stent
`22 at inlet 24 to enhance the stability.” Id. “Preferably cuff portion 21 of
`valve material 28 is attached to support beams 23.” Id. Spenser describes as
`an “important feature” the constant length of the support beams 23 such that
`“there is no need for slack material as the attachment points (25) remain at
`constant distances regardless of the position of the valve device (crimped or
`deployed).” Id. at 23. Spenser explains that with support beams of constant
`
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`IPR2017-00060
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`length, “there is no relative movement between the valve assembly and the
`support beams,” resulting in “greater stability, enhanced safety, better
`sealing and consequently longer lifespan.” Id. While the support beams
`remain a constant length, “the entire support stent may
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