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NOTE: This disposition is nonprecedential.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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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

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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

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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

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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

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“[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

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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).

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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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

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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 Case: 18-2004 Document: 104-2 Page: 10 Filed: 04/27/2020

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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

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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

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 Case: 18-2004 Document: 104-2 Page: 14 Filed: 04/27/2020

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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

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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

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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.

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

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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