Court Opinion

ID: 4532063
Source: CourtListenerOpinion
Date Created: 2020-05-06 16:00:36.561141+00
Date Added: 2024-06-11T08:45:10.276906
License: Public Domain

Case: 18-2004   Document: 104-2     Page: 1    Filed: 04/27/2020

          NOTE: This disposition is nonprecedential.

     United States Court of Appeals
         for the Federal Circuit
                   ______________________

          BOSTON SCIENTIFIC SCIMED, INC.,
                     Appellant

                              v.

      ANDREI IANCU, UNDER SECRETARY OF
   COMMERCE FOR ITELLECTUAL PROPERTY AND
    DIRECTOR OF THE UNITED STATES PATENT
           AND TRADEMARK OFFICE,
                    Intervenor
              ______________________

                         2018-2004
                   ______________________

      Appeal from the United States Patent and Trademark
  Office, Patent Trial and Appeal Board in No. IPR2017-
  00060.
                   ______________________

           SEALED OPINION ISSUED: April 27, 2020
            PUBLIC OPINION ISSUED: May 6, 2020 *
                  ______________________

     MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
  Washington, DC, argued for appellant. Also represented

      *  This opinion was originally filed under seal and has
  been unsealed in full.
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  2                    BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

  by EDWARD HAN, JENNIFER SKLENAR, MARC A. COHN.

      KAKOLI CAPRIHAN, Office of the Solicitor, United States
  Patent and Trademark Office, Alexandria, VA, argued for
  intervenor. Also represented by SARAH E. CRAVEN, THOMAS
  W. KRAUSE, ROBERT J. MCMANUS.
                   ______________________

      Before WALLACH, TARANTO, and CHEN, Circuit Judges.
  WALLACH, Circuit Judge.
      Petitioners Edwards Lifesciences Corporation, Ed-
  wards Lifesciences LLC, and Edwards Lifesciences AG (col-
  lectively, “Edwards”) sought inter partes review (“IPR”) of
  claims 1–4 (“the Challenged Claims”) of Appellant Boston
  Scientific SciMed, Inc.’s (“Boston Scientific”) U.S. Patent
  No. 8,992,608 (“the ’608 patent”). The U.S. Patent and
  Trademark Office’s Patent Trial and Appeal Board
  (“PTAB”) instituted review and issued a final written deci-
  sion finding, inter alia, that the Challenged Claims are un-
  patentable as obvious. See Edwards Lifesciences Corp. v.
  Bos. Sci. SciMed, Inc., No. IPR2017-00060, 2018 WL
  1508704, at *1 (P.T.A.B. Mar. 23, 2018).
      Boston Scientific appeals. We have jurisdiction pursu-
  ant to 28 U.S.C. § 1295(a)(4)(A). We affirm.
                         BACKGROUND
                       I. The ’608 Patent
       Entitled “Everting Heart Valve,” the ’608 patent “pro-
  vides methods and [an] apparatus for endovascularly re-
  placing a patient’s heart valve.” ’608 patent, Abstract.
  Valve replacement is “used to repair or replace diseased
  heart valves.” Id. col. 1 ll. 23–24. It is a treatment option
  for “stenosis” (i.e., “a narrowing of the native heart valve”)
  and for “when the native valve leaks or regurgitates.” Id.
  col. 1 ll. 29–31. During endovascular aortic valve replace-
  ment, a transcatheter heart valve (“THV”) is inserted
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  BOSTON SCIENTIFIC SCIMED, INC. v. IANCU                       3

  endovascularly and then “deployed across the native dis-
  eased valve,” with “the replacement valve [positioned] in
  place of the native valve.” Id. col. 1 ll. 56–60. While endo-
  vascular “replacement of the aortic heart valve” is a less
  “invasive surgery,” id. col. 1 ll. 53–55; see J.A. 6759–61, it
  still presents the “risk of paravalvular leakage or regurgi-
  tation around” the deployed THV, id. col. 12 ll. 19–21. Be-
  cause the “surface of the native valve leaflets . . . is
  irregular,” the “interface . . . between leaflets . . . and [a
  THV’s] anchor . . . may comprise gaps where blood . . .may
  seep through,” resulting in “a risk of blood clot formation
  or insufficient blood flow.” Id. col. 12 ll. 23–27; see id.
  Fig. 13.
       The ’608 patent discloses a THV apparatus that in-
  cludes “a replacement valve and an expandable and re-
  trievable anchor.” Id. col. 1 ll. 17–19. The apparatus is
  “configured for endovascular delivery to the vicinity of the
  heart valve” with “at least a portion of the replacement
  valve . . . configured to evert about the anchor during endo-
  vascular deployment,” id. col. 2 ll. 46–49, the anchor having
  “a lip region and a skirt region,” id. col. 2 l. 59, “wherein
  the lip region and skirt region are configured for percuta-
  neous expansion to engage the patient’s heart valve,” id.
  col. 2 ll. 62–64. To address the risk of paravalvular leak-
  age, the ’608 patent discloses a “fabric seal,” that “[w]hen
  deployed,” “bunches up to create fabric flaps and pockets
  that extend into spaces formed by the native valve leaf-
  lets . . . , particularly when the pockets are filled with blood
  in response to backflow blood pressure.” Id. col. 14 ll. 24–
  28; see Figs. 33, 34. “This arrangement” is meant to “cre-
  ate[] a seal around the replacement valve.” Id. col. 14 ll.
  28–29.
      Independent claim 1 of the ’608 patent is representa-
  tive and recites:
      A system for replacing a heart valve, comprising:
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  4                    BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

          an expandable anchor having a collapsed
          delivery configuration and an expanded
          configuration, the expandable anchor com-
          prising a distal end;
          a replacement valve commissure support el-
          ement attached to the expandable anchor;
          a commissure portion of a replacement
          valve leaflet attached to the commissure
          support element; and
          a fabric seal at least partially disposed
          around an exterior portion of the expanda-
          ble anchor when the anchor is in the ex-
          panded configuration, the fabric seal
          having an undeployed state and a deployed
          state, wherein in the deployed state the fab-
          ric seal comprises flaps that extend into
          spaces formed by native valve leaflets;
          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, the fabric
          seal extends from the distal end of the re-
          placement valve and back proximally over
          the expandable anchor, the fabric seal be-
          ing adapted to prevent blood from flowing
          between the fabric seal and heart tissue.
  Id. col. 22 ll. 22–42 (emphases added).
                  II. The Relevant Prior Art
                          A. Spenser
      Entitled “Implantable Prosthetic Valve,” WIPO Inter-
  national Publication No. WO 03/047468 A1 (“Spenser”) re-
  lates to “a valve prosthesis for cardiac implantation or for
  implantation in other body ducts.” J.A. 1589. Spenser dis-
  closes “a valve prosthesis device suitable for [percutaneous]
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  BOSTON SCIENTIFIC SCIMED, INC. v. IANCU                      5

  implantation in body ducts,” that includes “a support stent,
  comprised of a deployable construction” with “a valve as-
  sembly comprising a flexible conduit having an inlet end
  and an outlet, made of pliant material,” such as polyure-
  thane (“PU”) and polyethylene terephthalate fabric
  (“PET”), “attached to the [stent’s] support beams providing
  collapsible slack portions of the conduit at the outlet.” J.A.
  1591–92; see J.A. 1590 (defining “percutaneously” as “in-
  serting the valve assembly on a delivery device similar to a
  catheter, then implanting the valve at the desired location
  via a large blood vessel such as the femoral artery”). Spen-
  ser teaches that “[t]o prevent leakage from the [valve] in-
  let[,] it is optionally possible to roll up some slack wall of
  the inlet over the edge of the frame so as to present [a]
  rolled-up sleeve-like portion,” that is, a fabric cuff, “at the
  inlet.” J.A. 1609; see J.A. 1613 (providing for use of “PU
  leaflets and PET tubular construction” for its valve).
                             B. Elliot
       Entitled “Implantable Prosthesis with Displaceab[l]e
  Skirt,” U.S. Application Publication No. 2003/0236567
  (“Elliot”) relates to “tubular prostheses, including, but not
  limited to, endovascular grafts and stent[ ]grafts, for main-
  taining patency of blood vessels and treating aneurysms
  (e.g., aortic aneurysms), and tubular conduits for maintain-
  ing patency in other bodily passageways.” J.A. 1710. Elliot
  discloses an “implantable prosthesis” with “a radially ex-
  pandable tubular body and at least one skirt extending
  therefrom.” J.A. 1702. The prosthesis “is positioned to by-
  pass the aneurysm . . . being in contiguous contact with the
  healthy portions of the aorta.” J.A. 1710. The prosthesis
  has “at least one skirt . . . (which may be formed in various
  geometric configurations)” such that its “peripheral
  edge . . . is free and displaceable to a greater diameter than
  the diameter of the tubular body[.]” J.A. 1712; see J.A. 1704
  (Figs. 2a, 2b), 1705 (Figs. 3b, 3c), 1707 (Figs. 5b, 5d), 1708
  (Fig. 7). The skirt may “be displaced to contact, and form
  a seal with a surrounding wall,” “respond[ing] to”
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  6                    BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

  “[i]rregularities and/or wall displacement . . . [to] mini-
  mize[e] endoleaks about the prosthesis.” J.A. 1712.
       Elliot teaches that, once the prosthesis is in position,
  the skirt or skirts on the prosthesis may inhibit certain
  “failures in the form of endoleaks,” in particular, “leaks be-
  tween the vascular prosthesis and the vessel wall.”
  J.A. 1710. Elliot explains that such endoleaks may be
  caused by the “continual expansion of [part of] the aneu-
  rysm” or by an imperfect fit between the “circular pros-
  the[sis]” and the “non-circular aortic lumens” due to
  “irregular vessel formation and/or [the] calcified topogra-
  phy of the [aortic] lumen[.]” J.A. 1710. Elliot teaches that
  its “skirt may be used to inhibit [such] endoleaks upon its
  selective displacement in response to irregular aortic shap-
  ing and/or aneurysm neck expansion.” J.A. 1710. “The
  skirt may actively inhibit [such] endoleaks by forming a
  physical barrier against flow between the tubular body and
  the aortic wall” and “may passively inhibit [such] endoleak
  formation by sufficiently restricting blood flow to allow co-
  agulation and clot formation” that may also “act as a bar-
  rier against endoleakage.” J.A. 1710.
                          DISCUSSION
          I. Standard of Review and Legal Standard
      “We review the PTAB’s factual findings for substantial
  evidence and its legal conclusions de novo.” Redline Detec-
  tion, LLC v. Star Envirotech, Inc., 811 F.3d 435, 449 (Fed.
  Cir. 2015) (citation omitted). “Substantial evidence is
  something less than the weight of the evidence but more
  than a mere scintilla of evidence.” In re NuVasive, Inc., 842
  F.3d 1376, 1379–80 (Fed. Cir. 2016) (internal quotation
  marks and citation omitted). “It is such relevant evidence
  as a reasonable mind might accept as adequate to support
  a conclusion.” Id. (internal quotation marks and citation
  omitted). “If two inconsistent conclusions may reasonably
  be drawn from the evidence in record, the PTAB’s decision
  to favor one conclusion over the other is the epitome of a
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  BOSTON SCIENTIFIC SCIMED, INC. v. IANCU                     7

  decision that must be sustained upon review for substan-
  tial evidence.” Elbit Sys. of Am., LLC v. Thales Visionix,
  Inc., 881 F.3d 1354, 1356 (Fed. Cir. 2018) (internal quota-
  tion marks, alterations, and citation omitted).
       A patent claim is invalid as obvious “if the differences
  between the subject matter sought to be patented 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 [(‘PHOSITA’)] to
  which said subject matter pertains.” 35 U.S.C. § 103(a)
  (2006). 1 Obviousness “is a question of law based on under-
  lying findings of fact.” In re Gartside, 203 F.3d 1305, 1316
  (Fed. Cir. 2000). Those underlying findings of fact include
  (1) “the scope and content of the prior art,” (2) “differences
  between the prior art and the claims at issue,” (3) “the level
  of ordinary skill in the pertinent art,” and (4) objective in-
  dicia of non-obviousness, such “as commercial success, long
  felt but unsolved needs, [and] failure of others.” Graham
  v. John Deere Co. of Kan. City, 383 U.S. 1, 17 (1966). “A
  determination of whether a patent claim is invalid as obvi-
  ous under § 103 requires consideration of all four Graham
  factors, and it is error to reach a conclusion of obviousness
  until all those factors are considered.” Apple Inc. v. Sam-
  sung Elecs. Co., 839 F.3d 1034, 1048 (Fed. Cir. 2016) (en
  banc) (citation omitted).

      1   Congress amended 35 U.S.C. § 103 when it enacted
  the Leahy-Smith America Invents Act (“AIA”). Pub. L.
  No. 112-29, § 3(c), 125 Stat. 284, 287 (2011). However, be-
  cause the application that led to the ’608 patent never con-
  tained (1) a claim having an effective filing date on or after
  March 16, 2013, or (2) a reference under 35 U.S.C. §§ 120,
  121, or 365(c) to any patent or application that ever con-
  tained such a claim, the pre-AIA § 103 applies. J.A. 79; see
  AIA, § 3(n)(1), 125 Stat. at 293.
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  8                    BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

      In assessing the prior art, the PTAB “consider[s]
  whether a PHOSITA would have been motivated to com-
  bine the prior art to achieve the claimed invention and
  whether there would have been a reasonable expectation of
  success in doing so.” In re Warsaw Orthopedic, Inc., 832
  F.3d 1327, 1333 (Fed. Cir. 2016) (internal quotation marks,
  alterations, and citation omitted). Motivation to combine
  “may be found explicitly or implicitly in market forces; de-
  sign incentives; the interrelated teachings of multiple pa-
  tents; any need or problem known in the field of endeavor
  at the time of invention and addressed by the patent; and
  the background knowledge, creativity, and common sense
  of the [PHOSITA].” Plantronics, Inc. v. Aliph, Inc., 724
  F.3d 1343, 1354 (Fed. Cir. 2013) (internal quotation marks
  and citations omitted). Expectation of success “need only
  be reasonable, not absolute.” Pfizer, Inc. v. Apotex, Inc.,
  480 F.3d 1348, 1364 (Fed. Cir. 2007) (citations omitted).
  The petitioner bears “the burden of proving a proposition
  of unpatentability by a preponderance of the evidence” in
  an IPR. 35 U.S.C. § 316(e).
      In assessing objective indicia of non-obviousness, the
  PTAB considers whether the evidence presented has “a
  ‘nexus’ to the [patent’s] claims.” Henny Penny Corp. v. Fry-
  master LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (citation
  omitted). “[T]here must be a legally and factually sufficient
  connection between the evidence and the patented inven-
  tion” for the evidence “to be accorded substantial weight in
  the obviousness analysis[.]” Id. (internal quotation marks
  and citation omitted). “[T]here is a presumption of nexus
  for objective considerations when the patentee shows that
  the asserted objective evidence is tied to a specific product
  and that product is the invention disclosed and claimed in
  the patent.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1329
  (Fed. Cir. 2016) (internal quotation marks and citations
  omitted). The patent owner “bears the burden of showing
  that a nexus exists.” WMS Gaming Inc. v. Int’l Game
  Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999). Further, the
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  patent owner “bears the burden of production with respect
  to evidence of secondary considerations of non[-]obvious-
  ness.” ZUP, LLC v. Nash Mfg., Inc., 896 F.3d 1365, 1373
  (Fed. Cir. 2018) (citation omitted).
    II. The PTAB Properly Concluded that the Challenged
       Claims Were Obvious over the Asserted Prior Art
       The PTAB, “[h]aving consider each of the Graham fac-
  tors individually,” weighed those factors “collectively,” and
  determined that “[t]he scope and content of the prior
  art . . . heavily favor[ed] [Edwards’] contention that [the
  Challenged Claims] would have been obvious over Spen-
  ser[] in combination with . . . Elliot,” and that, even if Bos-
  ton Scientific had “shown the requisite nexus between [its]
  alleged objective indicia of non[-]obviousness and the
  [C]hallenged [C]laims,” which it had not, its “objective evi-
  dence of non[-]obviousness . . . provide[d] only either very
  little or limited support for [the] non[-]obviousness of the
  [C]hallenged [C]laims.” Edwards Lifesciences, 2018 WL
  1508704, at *32. The PTAB, accordingly, concluded that
  Edwards “ha[d] demonstrated . . . that the subject matter
  of the [Challenged Claims] would have been obvious over
  the combination[] of . . . Spenser and Elliot[.]” Id. at *33.
  On appeal, Boston Scientific argues that: (1) the PTAB’s
  motivation to combine and reasonable expectation of suc-
  cess analysis was “contrary to law and unsupported by sub-
  stantial evidence,” Appellant’s Br. 46 (capitalization
  normalized and emphasis omitted); and, (2) the PTAB “in-
  explicably dismissed” Boston Scientific’s evidence of nexus,
  id. at 68, and its “consideration of [Boston Scientific’s] ob-
  jective indicia of non-obviousness was inadequate,” id. at
  62 (capitalization normalized and emphasis omitted). We
  disagree with Boston Scientific.
        A. Substantial Evidence Supports the PTAB’s
   Finding that a PHOSITA Would Have Been Motivated to
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   10                     BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

         Combine Spenser and Elliot with a Reasonable
                   Expectation of Success
        The PTAB found that, in combination, Spenser and El-
   liot “teach every limitation of [the Challenged Claims].”
   Edwards Lifesciences, 2018 WL 1508704, at *10. In partic-
   ular, the PTAB found that Spenser discloses a THV with a
   “fabric seal,” id. at *13; see id. at *10, Elliot discloses a stent
   graft with a “fabric seal with flaps,” id. at *13, and, to-
   gether, they teach a THV with “a fabric seal ‘adapted to
   prevent blood from flowing between the fabric seal and
   heart tissue,’ as recited by [independent] claim 1” of the
   ’608 patent, id. The PTAB found that a PHOSITA would
   have been motivated to combine Spenser’s THV and Elliot’s
   fabric seal to better address “the problem of paravalvular
   leakage” in THV, id. at *28, with a reasonable expectation
   of success, given “the proven capabilities of sealing” shown
   by such “fabric seals in the stent graft context.” Id. at *29.
   Boston Scientific argues that the PTAB’s motivation to
   combine and reasonable expectation of success analyses re-
   lied on “hindsight,” Appellant’s Br. 48, “failed to identify
   evidence that would have led a P[H]OSITA” to combine
   Spenser with Elliot, id. at 56 (capitalization normalized
   and emphasis omitted), and improperly “shifted the burden
   of proof to” Boston Scientific, id. at 54. We disagree with
   Boston Scientific.
        Substantial evidence supports the PTAB’s finding that
   a PHOSITA would have been motivated to combine Spen-
   ser’s THV with Elliot’s fabric seal with flaps. Paravalvular
   leakage was a well-known problem in prosthetic valves
   prior the 2004 priority date of the ’608 patent. J.A. 1905
   (U.S. Patent No. 3,365,728, issued in 1968, disclosing an
   aortic valve prosthesis with an “upholstered” seal to pre-
   vent “leakage between the valve and the tissue”); J.A. 3766
   (a medical textbook, published in 1994, explaining that
   “[t]he designer of any percutaneously placed [prosthetic]
   valve will need to consider” and “minimize,” inter alia,
   “perivalvular leak”); see also J.A. 3247–48 (Boston
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   Scientific’s Expert Deposition) (agreeing that the problem
   of “paravalvular leaks” was “known from the use of surgical
   valves” and the “percutaneous valve implants that had oc-
   curred by the date of [the ’608] patent”). 2 Similarly, endo-
   leaks were a well-known problem in stent grafts.
   J.A. 1953–54 (medical text, published in 1990, discussing a
   stent graft made of “woven [fabric]” with a “[frictional] seal-
   ing cuff,” noting that the “primary technical complications”
   were “[e]ndoleaks resulting from an incomplete seal”); see
   J.A. 1751–52 (Edwards’ Expert Declaration) (explaining
   that “stent designers and physicians . . . recognized the
   risk of . . . ‘endoleaks’” in stent grafts prior to the priority
   date of the ’608 patent). Both problems were addressed by
   the prior art with varying degrees of success. For example,
   for THVs, Spenser teaches use of a fabric cuff to prevent
   paravalvular leakage. J.A. 1609–10 (teaching use of a fab-
   ric cuff “[t]o prevent leakage” in a THV); see J.A. 1820

       2     Boston Scientific asserts that the PTAB “did not
   conduct its inquiry from the perspective of a P[H]OSITA”
   because the PTAB “credited [Edwards’ Expert] testimony
   above the testimony of [Boston Scientific’s Experts],” when
   Edwards’ Expert “ha[d] no relevant experience in
   [transcatheter or] surgical valve replacement, or [stent
   grafts]” and Boston Scientific’s Experts did. Appellant’s
   Br. 50. This argument is misplaced. Boston Scientific has
   not sought to exclude Edwards’ expert testimony. See id.
   at 50–54; J.A. 940 (PTAB Hearing Transcript) (Boston Sci-
   entific’s counsel stating that they “have not moved to ex-
   clude [Edwards’ Expert] on lack of qualification.”). Rather,
   Boston Scientific seeks for us to reassess expert credibility.
   See J.A. 940 (PTAB Hearing Transcript) (Boston Scien-
   tific’s counsel agreeing its argument “goes to the weight of
   the testimony”). We decline to do so. See Yorkey v. Diab,
   601 F.3d 1279, 1284 (Fed. Cir. 2010) (“We defer to the
   [PTAB’s] findings concerning the credibility of expert wit-
   nesses.”).
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   (Edwards’ Expert Declaration) (explaining that Spenser’s
   THV is “anchored into place upon expansion” with “the fab-
   ric seal . . . conform[ing] to the surrounding tissue”); J.A.
   3345 (Boston Scientific’s Expert Deposition) (agreeing that
   “Spenser’s cuff will prevent” paravalvular leakage “de-
   pend[ing] upon the degree of calcification” in the heart tis-
   sue). For stent grafts, Elliot teaches use of a “fabric skirt”
   that forms flaps to better conform to “irregular” or “calci-
   fied” vessel walls. J.A. 1710–11; see J.A. 1808 (Edwards’
   Expert Declaration) (explaining that Elliot’s “fabric
   skirt . . . forms flaps and pockets that prevent [paravalvu-
   lar leaks]”).
       “[F]rom the earliest disclosures of [THV] . . . it was well
   known to look to stent graft technology in forming external
   covers on THVs,” J.A. 1814, with various early THV pa-
   tents suggesting “the interchangeability of stent graft and
   prosthetic heart valve technology,” J.A. 1769; see, e.g., J.A.
   1984 (U.S. Patent No. 5,411,552, issued in 1995, disclosing
   a transcatheter “valve prosthesis, preferably a cardiac
   valve prosthesis”); J.A. 2187–89 (U.S. Patent No.
   5,957,949, issued in 1999, disclosing “a percutaneously
   placed artificial valve,” for “all valvular needs” made with
   “flexible and expandable . . . fabric” that can “conform[] to
   the surface of the living tissue”). Indeed, Elliot itself sug-
   gests that its fabric skirt seal has broader applicability,
   finding use in “implantable prosthes[es]” with “radially-ex-
   pandable tubular bod[ies]” generally. J.A. 1702. Where “a
   technique has been used to improve one device, and a
   [PHOSITA] would recognize that it would improve similar
   devices in the same way, using the technique is obvious.”
   KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Ac-
   cordingly, substantial evidence supports the conclusion
   that a PHOSITA would have been motivated to combine
   Spenser’s THV with Elliot’s fabric seal with flaps to better
   address paravalvular leakage in THVs, resulting in the
   claimed invention.
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       Further, substantial evidence supports the PTAB’s
   finding that a PHOSITA would have a reasonable expecta-
   tion of success in combining Spenser and Elliot. Specifi-
   cally, prior to the 2004 priority date of the ’608 patent,
   stent grafts using fabric skirt seals were commercially
   available and “successfully implanted in patients with a
   low rate of reported endoleaks.” J.A. 1755 (Edwards’ Ex-
   pert Declaration); see J.A. 2155 (medical study, published
   in 2002, discussing the effectiveness of a stent graft with a
   fabric skirt seal, reporting a 4 percent endoleak rate); J.A.
   2168 (commercial instructions for use of the same stent
   graft with fabric skirt seal, explaining that its “[e]ffective-
   ness was based on,” inter alia, the “absence of an endo-
   leak”). From this, a PHOSITA would have reasonably
   expected similar effectiveness and success using fabric
   skirt seals to prevent paravalvular leaks in THVs. See
   Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331
   (Fed. Cir. 2014) (“Conclusive proof of efficacy is not neces-
   sary to show obviousness. All that is required is a reason-
   able expectation of success.”). Accordingly, substantial
   evidence supports the PTAB’s finding that a PHOSITA
   would have had a reasonable expectation of success in com-
   bining Spenser and Elliot to achieve the claimed invention.
       Boston Scientific’s counterarguments are unpersua-
   sive. First, Boston Scientific argues that the PTAB “erred
   by shifting the burden of proof” to Boston Scientific “to
   show a lack of motivation to combine.” Appellant’s Br. 54
   (capitalization normalized and emphasis omitted). This ar-
   gument is misplaced. The PTAB first found that Edwards
   had persuasively met its burden of proof, showing that a
   PHOSITA would have been motivated to combine Spenser
   and Elliot with a reasonable expectation of success. See
   Edwards Lifesciences, 2018 WL 1508704, at *28–29. The
   PTAB then considered Boston Scientific’s “numerous argu-
   ments in opposition” and found them “insufficient . . . to re-
   but the strong rationale articulated by [Edwards].” Id. at
   *29; see id. at *29–32. The PTAB did not shift the burden
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   14                   BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

   of proof to Boston Scientific by considering Boston Scien-
   tific’s counterarguments. See Novo Nordisk A/S v. Caraco
   Pharm. Labs., Ltd., 719 F.3d 1346, 1353 (Fed. Cir. 2013)
   (explaining that while “the burden of persuasion remains
   with the challenger,” this does not “relieve the patentee of
   any responsibility to set forth evidence in opposition to a
   challenger’s prima facie case which, if left unrebutted,
   would be sufficient to establish obviousness”).
       Second, Boston Scientific lists “several pieces of evi-
   dence,” Appellant’s Br. 57; see id. at 57–62, that, according
   to Boston Scientific, the PTAB variously “ignored,” see id.
   at 58, 61–62, or misevaluated in its motivation to combine
   analysis, id. at 57, 58–60. This argument ignores our
   standard of review. Substantial evidence does not inquire
   whether Boston Scientific’s “preferred [evidence] could
   support a conclusion.” In re Inland Steel Co., 265 F.3d
   1354, 1366 (Fed. Cir. 2001). Rather, substantial evidence
   asks whether the there is “such relevant evidence as a rea-
   sonable mind might accept as adequate to support [the
   PTAB’s] conclusion.” Consol. Edison Co. of New York v.
   NLRB, 305 U.S. 197, 229 (1938). As discussed above, the
   record here does. See PAR Pharm., Inc. v. TWI Pharm.,
   Inc., 773 F.3d 1186, 1197 (Fed. Cir. 2014) (providing that
   “motivation to combine” may be found expressly in “the
   prior art” or implicitly, as “supported by testimony of an
   expert witness regarding [the] knowledge of a [PHOSITA]
   at the time of invention” (citation omitted)).
       Third, Boston Scientific argues that the PTAB “fail[ed]
   to address” evidence that a PHOSITA would not have a rea-
   sonable expectation of success in combining Spenser and
   Elliot. Appellant’s Br. 53–54; see id. at 51–54. Specifically,
   Boston Scientific argues the PTAB’s expectation of success
   analysis was flawed because it “ignored . . . undisputed” ev-
   idence that, while THVs are implanted in “the irregular,
   calcified environment of a diseased heart valve,” stent
   grafts are implanted in “healthy” or at least “different[ly]”
   irregular or calcified tissue. Id. at 52. This argument is
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   BOSTON SCIENTIFIC SCIMED, INC. v. IANCU                    15

   without merit. It is unrelated to “the objective reach of the
   [Challenged] [C]laim[s].” KSR, 550 U.S. at 419; see ’608
   patent col. 22 ll. 29–31; J.A. 3259–60 (Boston Scientific’s
   Expert Deposition) (agreeing that claim 1 of the ’608 patent
   “could cover a device for treatment of pure aortic regurgi-
   tation”). Further, it demands “absolute certainty” where
   only “a reasonable expectation of success” is required. PAR
   Pharm., 773 F.3d at 1198 (providing that “[t]he reasonable
   expectation of success requirement for obviousness does
   not necessitate an absolute certainty for success” (citation
   omitted)). The PTAB’s finding that a PHOSITA would
   have been motivated to combine Spenser and Elliot with a
   reasonable expectation of success is, therefore, supported
   by substantial evidence and otherwise in accordance with
   law.
     B. Substantial Evidence Supports the PTAB’s Finding
        that Boston Scientific Failed to Offer Meaningful
                 Evidence of Non-Obviousness
        The PTAB determined that, for its objective evidence
   on non-obviousness, Boston Scientific “ha[d] not shown the
   requisite nexus” between its proffered evidence and the
   claimed invention, and “even if nexus had been shown, the
   objective evidence [Boston Scientific] identifie[d] . . . pro-
   vide[d] only either very little or limited support for the
   non[-]obviousness of the [C]hallenged [C]laims.” Edwards
   Lifesciences, 2018 WL 1508704, at *32. Boston Scientific
   argues that it “established a nexus between [its] objective
   indicia of non-obviousness and the [claimed] invention” be-
   cause it offered objective evidence tied to Edwards’ THV
   (“the Sapien 3”) and established “how each element of the
   [C]hallenged [C]laims was practiced by [the] S[apien] 3.”
   Appellant’s Br. 66. Boston Scientific further argues that
   the PTAB “improperly analyzed [its] evidence of” objective
   indicia of non-obviousness—specifically its “evidence of the
   failure of others and the long-felt need to solve [paravalvu-
   lar leakage],” id. at 64 (capitalization normalized and em-
   phasis omitted), and its “evidence of copying, industry
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   16                   BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

   praise, and commercial success,” id. at 66. We disagree
   with Boston Scientific.
        Substantial evidence supports the PTAB’s determina-
   tion that Boston Scientific failed to establish a presumption
   of nexus. Independent claim 1 of the ’608 patent recites a
   THV with, inter alia, “a replacement valve commissure
   support element attached to an expandable anchor.” ’608
   patent col. 22 ll. 26–27. To establish that the Sapien 3 em-
   bodies this limitation, Boston Scientific provided a picture
   of the Sapien 3 with three portions circled in red, labeled
   “‘a replacement valve commissure support element at-
   tached to the expandable anchor’ and ‘a commissure por-
   tion of a replacement valve leaflet attached to the
   commissure support element.’” J.A. 526–27 (Boston Scien-
   tific’s Response). In support, Boston Scientific cited expert
   testimony that provided a similar picture, but no explana-
   tion. J.A. 527; see J.A. 6908–10 (Boston Scientific’s Expert
   Declaration) (citing J.A. 6712, a Sapien 3 presentation
   with an image of a Sapien 3 labeled “Commissure attach-
   ments”). Boston Scientific did not identify which aspect of
   the Sapien 3 meets the claim element “commissure support
   element” or which aspect of the Sapien 3 meets the claim
   element “the expandable anchor[.]” J.A. 526–27. Boston
   Scientific, therefore, failed to establish that the Sapien 3
   embodies “the invention disclosed and claimed in the pa-
   tent,” WBIP, 829 F.3d at 1329 (internal quotation marks
   and citations omitted), and, as such, that its objective evi-
   dence of non-obviousness has “a legally and factually suffi-
   cient connection” to the patented invention, Demaco Corp.
   v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392
   (Fed. Cir. 1988). Accordingly, substantial evidence sup-
   ports the PTAB’s determination that Boston Scientific
   failed to establish a presumption of nexus for its objective
   evidence of non-obviousness.
       Further, substantial evidence supports the PTAB’s de-
   termination that Boston Scientific’s proffered objective ev-
   idence lends minimal support to a conclusion of non-
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   BOSTON SCIENTIFIC SCIMED, INC. v. IANCU                    17

   obviousness. Boston Scientific offered evidence that “oth-
   ers, including [Edwards], tried and failed to solve the prob-
   lem of [paravalvular leakage]” and that “there was a long-
   felt need for a solution to the problem of paravalvular leak-
   age” from 2004 until the release of the Sapien 3 in 2014.
   J.A. 533, 538 (Boston Scientific’s Response) (capitalization
   normalized and emphasis omitted). However, as Boston
   Scientific acknowledged, there were other “strategies” used
   “to reduce [paravalvular leakage]” during that same time
   period. J.A. 535–36; see Monarch Knitting Mach. Corp. v.
   Sulzer Morat GmbH, 139 F.3d 877, 884 (Fed. Cir. 1998)
   (“The relevant secondary consideration is ‘long-felt but un-
   solved need,’ not long-felt need in isolation.” (emphasis
   omitted)).
        Next, Boston Scientific offered evidence that “[Ed-
   wards] copied the [claimed] invention” to design the Sapien
   3. J.A. 539 (capitalization normalized and emphasis omit-
   ted). However, Boston Scientific failed to establish that
   Edwards had access to an embodiment of the claimed in-
   vention prior to any alleged copying. J.A. 539–40 (arguing
   that Edwards had access to and copied Boston Scientific’s
   THV, but only providing attorney argument to support the
   conclusion that this THV was “an embodiment of the
   claimed invention”); see Institut Pasteur & Université
   Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1347–48
   (Fed. Cir. 2013) (“Copying requires duplication of features
   of the patentee’s work based on access to that work, lest all
   infringement be mistakenly treated as copying.”).
        Last, Boston Scientific offered evidence that “the indus-
   try has praised” the Sapien 3, J.A. 541 (capitalization nor-
   malized and emphasis omitted), and that the Sapien 3 “has
   enjoyed commercial success,” J.A. 545 (capitalization nor-
   malized and emphasis omitted). However, Boston Scien-
   tific’s evidence of industry praise was undermined by
   evidence that this praise was linked to design features
   other than its fabric seal and resulted, in part, from Ed-
   wards’ existing market share. J.A. 3414 (Edwards’ Expert
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   18                    BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

   Testimony) (explaining that the Sapien 3 and prior Sapien
   models have “received significant praise”), 3416 (discuss-
   ing the “many other differences” between the Sapien 3 and
   prior models, in addition to the fabric seal); see S. Ala. Med.
   Sci. Found. v. Gnosis S.P.A., 808 F.3d 823, 827 (Fed. Cir.
   2015) (providing that industry praise linked to “element[s]
   already known in the prior art” or “[un]connect[ed] . . . to
   the novel elements of the claims” carries little weight in an
   obviousness analysis). Further, Boston Scientific did not
   overcome evidence that Sapien 3’s commercial success was
   a result of Edwards’ pre-existing, dominant market share.
   J.A. 545 (Boston Scientific’s Response) (conceding that the
   Sapien 3 “supplanted sales of the previously market-lead-
   ing S[apien] XT”); see Geo. M. Martin Co. v. All. Mach. Sys.
   Int’l LLC, 618 F.3d 1294, 1304 (Fed. Cir. 2010) (providing
   that evidence of commercial success “carries little weight”
   where it may be ascribed to “pre-existing market share”).
   Accordingly, substantial evidence supports the PTAB’s de-
   termination that Boston Scientific’s proffered objective ev-
   idence lends minimal support to a conclusion of non-
   obviousness.
       Boston Scientific’s counterarguments are unavailing.
   First, Boston Scientific argues that the PTAB failed to find
   a presumption of nexus because it misconstrued the claim
   term “attached” to incorrectly “require[] the ‘commissure
   support element’ and the ‘expandable anchor’ to be two sep-
   arate elements.” Appellant’s Br. 68. Boston Scientific did
   not raise this claim construction argument in its briefing
   before the PTAB—rather, it only raised it during oral ar-
   gument before the PTAB. Compare J.A. 965–66 (Tran-
   script of Oral Argument) (arguing for the “broadest
   reasonable interpretation” of “the word ‘attached’”), with
   J.A. 495 (Boston Scientific’s Response) (proposing claim
   construction for only “‘flaps’ and ‘pockets’”). It is, accord-
   ingly, waived. See Redline Detection, 811 F.3d at 450
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   BOSTON SCIENTIFIC SCIMED, INC. v. IANCU                        19

   (providing that arguments made only as “unsupported oral
   argument” before the PTAB are waived on appeal). 3
        Second, Boston Scientific argues that the PTAB erred
   when it found “no nexus to any of the objective indicia be-
   cause” whether the “S[apien] 3 . . . practice[s] the ’608 pa-
   tent . . . is irrelevant to failure of others and long-felt need.”
   Appellant’s Br. 65 (emphasis omitted). However, Boston
   Scientific did not make this argument before the PTAB—
   rather, it argued the contrary. J.A. 538–39 (Boston Scien-
   tific’s Response) (arguing that there was long-felt but un-
   met need to solve the problem of paravalvular leakage
   “until 2014, when [Edwards] launched S[apien] 3 with a
   fabric seal” and that “the failure of [Edwards] and others
   to solve the problem of [paravalular leakage] until [then]
   proves that the [Challenged Claims of the] ’608 patent
   w[ere] not obvious”). This argument is also, therefore,
   waived. See In re Watts, 354 F.3d 1362, 1368 (Fed. Cir.
   2004) (explaining that arguments “not raised before the
   [PTAB]” are waived on appeal); Finnigan Corp. v. Int’l
   Trade Comm’n, 180 F.3d 1354, 1363 (Fed. Cir. 1999) (“A
   party’s argument should not be a moving target.”). The
   PTAB’s finding that Boston Scientific’s objective evidence
   lends minimal support to a conclusion of non-obviousness
   is, therefore, supported by substantial evidence and other-
   wise in accordance with law.

       3    Boston Scientific asserts that “there was no oppor-
   tunity for [it] to [raise this argument] in writing, as [Ed-
   wards] made its claim construction arguments for the first
   time in its Reply.” Appellant’s Br. 69 (citing J.A. 742–43
   (Edwards’ Reply)). This is inadequate. Boston Scientific
   could have requested leave to submit a surreply—it did not.
   See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081 (Fed.
   Cir. 2015) (explaining that it is within the PTABs discre-
   tion to allow surreplies during IPRs).
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   20                  BOSTON SCIENTIFIC SCIMED, INC. v. IANCU

                          CONCLUSION
       We have considered Boston Scientific’s remaining ar-
   guments and find them unpersuasive. 4 Accordingly, the
   Final Written Decision of the U.S. Patent and Trademark
   Office’s Patent Trial and Appeal Board is
                         AFFIRMED

        4  Because we affirm the PTAB’s conclusion that the
   Challenged Claims are obvious over a combination of Spen-
   ser and Elliot, we do not reach the unpatentability deter-
   minations based on other prior art combinations. See
   Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330,
   1332 n.1 (Fed. Cir. 2020) (declining to reach alternate un-
   patentability grounds upon affirmance of PTAB’s obvious-
   ness findings).