Boston Scientific Scimed, Inc. v. Iancu ( 2020 )

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NOTE: This disposition is nonprecedential.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.
Case: 18-2004 Document: 104-2 Page: 2 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 3 Filed: 04/27/2020
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:
Case: 18-2004 Document: 104-2 Page: 4 Filed: 04/27/2020
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]
Case: 18-2004 Document: 104-2 Page: 5 Filed: 04/27/2020
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”
Case: 18-2004 Document: 104-2 Page: 6 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 7 Filed: 04/27/2020
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.
Case: 18-2004 Document: 104-2 Page: 8 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 9 Filed: 04/27/2020
BOSTON SCIENTIFIC SCIMED, INC. v. IANCU 9
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
Case: 18-2004 Document: 104-2 Page: 10 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 11 Filed: 04/27/2020
BOSTON SCIENTIFIC SCIMED, INC. v. IANCU 11
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.”).
Case: 18-2004 Document: 104-2 Page: 12 Filed: 04/27/2020
12 BOSTON SCIENTIFIC SCIMED, INC. v. IANCU
(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.
Case: 18-2004 Document: 104-2 Page: 13 Filed: 04/27/2020
BOSTON SCIENTIFIC SCIMED, INC. v. IANCU 13
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
Case: 18-2004 Document: 104-2 Page: 14 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 15 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 16 Filed: 04/27/2020
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-
Case: 18-2004 Document: 104-2 Page: 17 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 18 Filed: 04/27/2020
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
Case: 18-2004 Document: 104-2 Page: 19 Filed: 04/27/2020
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).
Case: 18-2004 Document: 104-2 Page: 20 Filed: 04/27/2020
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).