Talexmedical, LLC v. Becon Medical Limited

• Court: Court of Appeals for the Federal Circuit
• Decided: July 22, 2022
• Docket: 21-2069
• Status: Unpublished

Opinion

Case: 21-2069 Document: 37 Page: 1 Filed: 07/22/2022

NOTE: This disposition is nonprecedential.

United States Court of Appeals for the Federal Circuit ______________________

TALEXMEDICAL, LLC, Appellant

v.

BECON MEDICAL LIMITED, HENRY STEPHENSON BYRD, M.D., Cross-Appellants ______________________

2021-2069, 2021-2071, 2021-2109, 2021-2110 ______________________

Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2020- 00028, IPR2020-00030. ______________________

Decided: July 22, 2022 ______________________

ARTHUR ROBERT WEAVER, The Brickell IP Group, PLLC, Miami, FL, argued for appellant. Also represented by RICHARD GUERRA, JAVIER SOBRADO.

DAVID BOGDAN CUPAR, McDonald Hopkins LLC, Cleve- land, OH, argued for cross-appellants. Also represented by MATTHEW JOHN CAVANAGH; ERIN RACHAEL CONWAY, NICHOLAS A. KURK, Chicago, IL. ______________________ Case: 21-2069 Document: 37 Page: 2 Filed: 07/22/2022

Before LOURIE, SCHALL, and REYNA, Circuit Judges. LOURIE, Circuit Judge. TalexMedical, LLC appeals from two decisions of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) holding that claims 4–7 of U.S. Patent 8,167,942 (the “’942 patent”) and claim 16 of U.S. Patent 8,853,277 (the “’277 patent”) are not unpatentable as obvi- ous. See TalexMedical, LLC v. Becon Med. Ltd., IPR2020- 00028, 2021 WL 1433251 (P.T.A.B. Apr. 15, 2021) (“’942 Decision”) and TalexMedical, LLC v. Becon Med. Ltd., IPR2020-00030, 2021 WL 1433255 (P.T.A.B. Apr. 15, 2021) (“’277 Decision”). 1 Becon Medical Limited and Henry Ste- phenson Byrd (collectively, “Becon”) cross-appeal from the Board’s decisions holding that claims 1–3 and 9 of the ’942 patent and claims 1–2 and 9–10 of the ’277 patent would have been obvious over prior art. See id. For the reasons provided below, we affirm the judgment of invalidity for claims 1–3 and 9 of the ’942 patent and claims 1–2 and 9–10 of the ’277 patent. We also affirm the judgment of no invalidity for claim 4 of the ’942 patent and claim 16 of the ’277 patent. We finally hold that the Board erred in its construction of the “reversibly engage” claim limitation, vacate the judgment of no invalidity for claims 5–7 of the ’942 patent, and remand for further pro- ceedings consistent with this opinion.

1 Because the ’942 Decision and the ’277 Decision ad- dress overlapping issues, all citations are to the ’942 Deci- sion unless otherwise noted. Case: 21-2069 Document: 37 Page: 3 Filed: 07/22/2022

TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 3

BACKGROUND Becon owns the ’942 and ’277 patents, which describe “correcting misshaped ears using a molding device.” 2 ’942 patent at Abstract. A molding device includes one or more braces and a scaphal mold. Id. Talex’s annotated version of Figure 1 of the ’942 patent, below, depicts the relevant portions of an ear. See ’942 Decision, 2021 WL 1433251, at *1.

The molding device interacts with the helix and the hel- ical rim “to maintain a substantially correct anatomical shape of the helix and the helical rim,” ’942 patent at Ab- stract, or “the scaphal area of the ear,” id. at col. 2 l. 67– col. 3 l. 2; see also id. at col. 6 ll. 37–41 (“the scaphal area

2 Because the ’942 and ’277 patents share a substan- tially similar specification, all citations are to the ’942 pa- tent unless otherwise noted. See ’942 Decision, 2021 WL 1433251, at *1. Case: 21-2069 Document: 37 Page: 4 Filed: 07/22/2022

12”). As shown in Figure 5, below, a molding device “is gen- erally a semi-cylindrical extension from legs (or braces) 51 and 52 having rounded edges.” Id. at col. 6 ll. 37–41. “[T]he inner curvature of the scaphal mold 55 facing the legs 51 and 52 cooperates with inner surface of legs 51 and 52 to form a space therewith configured to mold the helix and helical rim during their growth while in the ear mold- ing device, such that the growth of the helix and helical rim conforms to a curvature defined by the space between the scaphal mold and the legs.” Id. at col. 6 ll. 41–47.

The ’942 patent claims a molding device for a human ear. Claim 1, the only independent claim at issue on ap- peal, recites: 1. A molding device for a human ear, wherein the ear includes an antihelix, a superior limb of the tri- angular fossa, a helix, a helical rim, a base, a con- cha, and a scaphal area, the molding device comprising: one or more braces; and Case: 21-2069 Document: 37 Page: 5 Filed: 07/22/2022

TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 5

a scaphal mold supported by the one or more braces, wherein the one or more braces and the scaphal mold are con- structed to retain the helix and helical rim within a space defined between the one or more braces and the scaphal mold, and fur- ther constructed to maintain a substan- tially correct anatomical shape of the helix and the helical rim, wherein the scaphal mold and one or more braces are con- structed to mold the helix and helical rim during their growth such that the growth of the helix and helical rim conforms to the space between the scaphal mold and the one or more braces. Id. at col. 10 ll. 19–34. Claim 4 further requires that “a foot member positioned at an end of the brace distal to the scaphal mold” “includes a broad flat surface adapted for securing the ear molding device to a first surface.” Id. at col. 10 ll. 35–39; col. 10 ll. 43–45. Claims 5–7 recite that the “one or more braces in- cludes a vertical support surface constructed to reversibly engage a second surface” and/or “a horizontal support sur- face constructed to reversibly engage a third surface.” Id. at col. 10 ll. 43–55. The ’277 patent claims a molding system for a human ear. The system includes a molding device and a cradle. The cradle includes a base section and a cover. ’277 patent, col. 2 ll. 21–22. The molding device is configured to be po- sitioned within the compartment defined by the cradle base and cover. See id. at col. 5 ll. 10–12; fig. 2. Claim 1, the only independent claim at issue on appeal, recites: 1. A molding system for a human ear, wherein the ear includes an antihelix, a superior limb of the tri- angular fossa, a helix, a helical rim, a base, a Case: 21-2069 Document: 37 Page: 6 Filed: 07/22/2022

concha, and a scaphal area, the molding system comprising: a cradle comprising: a base section defining an opening dimensioned to accommodate the passage of the ear through the opening, the base section including a posterior surface and an anterior surface; a cover releasably engageable with the base section, wherein the cover, when engaged with the base sec- tion, defines a compartment be- tween an inner surface of the cover and an inner surface of the base section; and an ear molding device comprising: one or more braces; and a scaphal mold supported by the one or more braces, wherein the one or more braces and the scaphal mold are adapted to retain the he- lix and helical rim within a space defined between the one or more braces and the scaphal mold, and to maintain a substantially correct anatomical shape of the helix and the helical rim. Id. at col. 10 ll. 28–49. Claim 9 of the ’942 patent and claim 16 of the ’277 pa- tent further require that the “scaphal mold includes a gen- erally arc-shaped semi-cylindrical extension from the one or more braces having rounded edges.” Id. at col. 12 ll. 12– 16; ’942 patent, col. 10 ll. 59–63. Case: 21-2069 Document: 37 Page: 7 Filed: 07/22/2022

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Talex petitioned for inter partes review of claims 1–7 and 9 of the ’942 patent and claims 1–2, 9–10, and 16 of the ’277 patent. J.A. 544; J.A. 1065. Talex asserted that each of the challenged claims would have been obvious over a combination of prior art references including Dancey,3 Gault, 4 and Yotsuyanagi. 5 J.A. 544; J.A. 1065. After the petition was instituted, Becon filed a contingent motion to amend the ’277 patent to add substitute claims 18–34 in the event the Board found original claims 1–17 unpatent- able. J.A. 1261. The proposed substitute claims modified the claims to further specify that “the scaphal mold and one or more braces are constructed to mold the helix and helical rim during their growth such that the growth of the helix and helical rim conforms to the space between the scaphal mold and the one or more braces.” J.A. 1285. Talex op- posed Becon’s motion to amend the claims and advanced similar obviousness arguments for the substitute claims. J.A. 1315. Dancey discloses an acrylic ear splint for non-surgical treatment of cryptotia, a congenital deformity of the ear. Dancey’s device is a two-part pressure splint that is custom made to fit an ear and move the upper portion of the ear into an anatomically correct position. See ’942 Decision, 2021 WL 1433251, at *6 (citing J.A. 1818–19). Gault dis- closes an ear splint with a wire core enclosed in a cover. See id. (citing J.A. 1978, 1980). Yotsuyanagi discloses ther- moplastic splints that conform to the outside of an ear to

3 Anne Dancey, et al., Acrylic Ear Splints for Treat- ment of Cryptotia, 115 Plastic and Reconstructive Surgery 2150–52 (2005). 4 David Thomas Gault, GB 2304579 A, published Mar. 26, 1997. 5 Takatoshi Yotsuyanagi, et al., Cryptotia Correction Using Thermoplastic Splint, 36 Plastic Surgery 1037–42 (1993). Case: 21-2069 Document: 37 Page: 8 Filed: 07/22/2022

treat cryptotia. See id. at *15–16 (citing J.A. 1953, 1958– 59). Regarding the ’942 patent, the Board held that claims 1–3 and 9 would have been obvious over Dancey and Gault and that claim 1 would have also been obvious over Yotsuyanagi and Gault. Id. at *20. Regarding the ’277 pa- tent, the Board held that claims 1–2 and 9–10 would have been obvious over two combinations of prior art, both com- binations including Yotsuyanagi and Gault, but not Dancey. ’277 Decision, 2021 WL 1433255, at *25–26. The Board also held that Talex failed to show that claims 4–7 of the ’942 patent and claim 16 of the ’277 patent would have been obvious. Several additional aspects of the Board’s decisions are particularly relevant to the parties’ arguments on appeal. First, the Board declined Becon’s request to construe “mold” and “molding device” to require reshaping an ear. The Board construed “scaphal mold” to mean “mold at the end of the one or more braces that is positionable in the scaphal area.” ’942 Decision, 2021 WL 1433251, at *3–5. The Board then found that Dancey and Yotsuyanagi each independently disclose an ear molding device as recited in the ’942 patent claims and the ’277 patent claims, respec- tively. Id. at *7; ’277 Decision, 2021 WL 1433255, at *8. Next, the Board found that Dancey, but not Yotsuyanagi, discloses the “semi-cylindrical extension” limitation. ’942 Decision, 2021 WL 1433251, at *11; ’277 Decision, 2021 WL 1433255, at *9. The Board then found that Talex failed to show that Dancey’s foot member includes a “broad flat sur- face.” ’942 Decision, 2021 WL 1433251, at *11. Addition- ally, the Board construed the “reversibly engage” limitation to mean “to engage a surface on a reverse side facing away from the ear.” Id. at *12. Applying its con- struction, the Board found that Dancey fails to disclose that limitation. Id. Case: 21-2069 Document: 37 Page: 9 Filed: 07/22/2022

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Furthermore, the Board concluded that Becon failed to establish that it was entitled to a nexus between secondary considerations and the asserted claims, or a presumption of a nexus, for any of the challenged claims. The Board explained that “[Becon’s] briefing and cited evidence lack sufficient specificity.” Id. at *14–15. The Board also deter- mined that, even if Becon had established a nexus, the Board would have found the strength of the obviousness allegations greater than the indicia of nonobviousness (e.g., copying and industry praise). Id. Finally, the Board denied Becon’s motion to amend the ’277 patent claims. ’277 Decision, 2021 WL 1433255, at *16. The Board determined that, even under Becon’s inter- pretation of the meaning of the substitute claims, Talex proved that Becon’s substitute claims would have been ob- vious. Id. at *22. Talex appealed, and Becon cross-appealed. We have ju- risdiction pursuant to 28 U.S.C. § 1295(a)(4)(A). DISCUSSION We review the Board’s legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we re- view the Board’s factual findings underlying those deter- minations for substantial evidence, In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by sub- stantial evidence if a reasonable mind might accept the ev- idence as adequate to support the finding. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). Obviousness is a question of law that “lends itself to several basic factual inquiries,” including the scope and content of the prior art, the level of ordinary skill in the art, differences between the prior art and the claimed inven- tion, and any relevant secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966) (citing Great Atl. & Pac. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 155 (1950)). “What the prior art teaches, whether a Case: 21-2069 Document: 37 Page: 10 Filed: 07/22/2022

person of ordinary skill in the art would have been moti- vated to combine references, and whether a reference teaches away from the claimed invention are questions of fact.” Meiresonne v. Google, Inc., 849 F.3d 1379, 1382 (Fed. Cir. 2017) (first citing Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1047–48 (Fed. Cir. 2016) (en banc), then citing In re Mouttet, 686 F.3d 1322, 1330 (Fed. Cir. 2012)). A. Talex’s Appeal Talex raises three arguments on appeal. Specifically, Talex argues that (1) the Board’s finding that Yotsuyanagi fails to disclose the “semi-cylindrical extension” limitation was unsupported by substantial evidence, (2) the Board’s finding that Dancey fails to disclose the “broad flat surface” limitation was unsupported by substantial evidence, and (3) the Board erred in construing the “reversibly engage” limitation. We address each argument in turn. I. Semi-Cylindrical Extension Claim 16 of the ’277 patent requires that the “scaphal mold includes a generally arc-shaped semi-cylindrical ex- tension.” The Board determined that Talex failed to show that the portion of Yotsuyanagi’s device characterized as the “scaphal mold” is the portion that includes the claimed extension. As noted above, what prior art teaches presents a ques- tion of fact that is reviewed for substantial evidence. See, e.g., In re Warsaw Orthopedic, Inc., 832 F.3d 1327, 1332 (Fed. Cir. 2016). Talex argues that it demonstrated that Yotsuyanagi discloses the “semi-cylindrical extension” lim- itation. Talex accuses the Board of failing to consider an annotated version of Yotsuyanagi’s figure 6, in which Talex allegedly identified a “semi-cylindrical extension” as part of Yotsuyanagi’s scaphal mold. Becon counters that the Board correctly found that what Talex identified as the “semi-circular extension” overlaps with portions of the same structure that Talex relied on as the brace. Becon Case: 21-2069 Document: 37 Page: 11 Filed: 07/22/2022

TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 11

also notes that Talex declined to clarify its argument in its reply before the Board. We agree with Becon that the Board’s determination was supported by substantial evidence. Some of Talex’s annotated figures indeed identified an extension as part of Yotsuyanagi’s brace. In view of Talex’s conflicting annota- tions, the Board could not discern whether any portion of Yotsuyanagi’s device identified as the claimed extension is part of the scaphal mold, and if so, whether any such por- tion can be considered semi-cylindrical. Talex did not use the opportunity to address its confusing annotations in its reply before the Board. We disagree with Talex that the Board failed to con- sider Talex’s annotated version of Yotsuyanagi’s figure 6. As Becon points out, the Board cited this figure and the portions of Talex’s expert’s declaration that discuss the an- notated version. See ’277 Decision, 2021 WL 1433255, at *9 (citing J.A. 1953–54 (Yotsuyanagi’s “Figs. 2–4, 6, 9”); J.A. 1908–09 (Talex’s expert’s declaration at ¶¶ 158–60)). In the declaration, an annotated version of “Figure 6” is in- correctly labeled as “Figure 3.” See J.A. 1088 (displaying a correctly labeled version of annotated figure 6 in Talex’s petition); see also J.A. 1953 (displaying the original ver- sions of figures 3 and 6 in Yotsuyanagi). The Board did not fail to consider Talex’s annotated version of figure 6 merely because this figure was mislabeled as figure 3 in Talex’s expert’s declaration. Furthermore, Talex’s annotated ver- sion of figure 6 does not correct the inconsistencies in its argument concerning the “semi-cylindrical extension” lim- itation. We therefore affirm the portion of the Board’s decision holding that Talex failed to prove by a preponderance of the evidence that all of the limitations of claim 16 of the ’277 patent are disclosed by the cited prior art. Case: 21-2069 Document: 37 Page: 12 Filed: 07/22/2022

II. Broad Flat Surface Talex next argues that it demonstrated that Dancey discloses a foot with a “broad flat surface,” as required by claim 4 of the ’942 patent. Talex explains that Dancey’s foot is designed to press against a patient’s skin for at least a year, so a person of ordinary skill in the art would under- stand that the bottom of Dancey’s foot would necessarily be broad and flat to avoid injury. Becon counters that the Board correctly found that Talex failed to show that the portion of Dancey’s foot adjacent to the patient’s head is broad or flat. Instead, as the Board found, Dancey’s foot appears thin rather than broad and curved rather than flat. We agree with Becon that the Board’s determination was supported by substantial evidence. The Board consid- ered Talex’s argument and expert testimony but found it unpersuasive. See ’942 Decision, 2021 WL 1433251, at *11 (citing J.A. 1876–77 (Talex’s expert’s declaration at ¶¶ 77– 79)). Becon provided opposing expert testimony on this is- sue. See J.A. 3404–06 (Khosla’s expert declaration at ¶¶ 200–03); see also J.A. 3611–13 (Daniali’s expert decla- ration at ¶¶ 201–04). Although the Board did not cite those sections of Becon’s declarations with reference to its deter- mination regarding the “broad flat surface” limitation, the Board cited Becon’s Patent Owner Response, which ex- pressly relied on these declarations in opposition to Talex’s argument. See ’942 Decision, 2021 WL 1433251, at *11 (cit- ing J.A. 734). Furthermore, “this court has said on multi- ple occasions that failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it.” Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017) (cita- tions omitted). We therefore affirm the portion of the Board’s decision holding that Talex failed to prove by a preponderance of the evidence that the structure it identifies as the foot member Case: 21-2069 Document: 37 Page: 13 Filed: 07/22/2022

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includes a “broad flat surface,” as required by claim 4 of the ’942 patent. III. Reversibly Engage Talex argues that the Board erred in construing the “reversibly engage” limitation in claims 5–7 of the ’942 pa- tent to mean “to engage a surface on a reverse side facing away from the ear.” See ’942 Decision, 2021 WL 1433251, at *6. A claim term is generally given its plain and ordinary meaning as understood by a skilled artisan. See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). “We depart from the plain and ordinary meaning of claim terms based on the specification in only two instances: lex- icography and disavowal.” Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014) (citing Thorner v. Sony Computer Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)). “To act as its own lexicographer, a patentee must clearly set forth a definition of the disputed claim term other than its plain and ordinary meaning and must clearly express an intent to redefine the term.” Id. (inter- nal quotation marks omitted). Embodiments cannot limit the scope of the claims absent the patentee’s “words or ex- pressions of manifest exclusion or restriction.” Id. at 1372 (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)). We review claim construction de novo except for subsidiary factual findings based on ex- trinsic evidence, which we review for substantial evidence. Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 331– 33 (2015). Talex asserts that the proper meaning of the “reversi- bly engage” limitation is “to simply engage, or contact, to stabilize the device.” Appellant’s Opening Br. 31. Talex contends that the Board’s adopted construction is incon- sistent with the ’942 patent’s specification and adds unnec- essary structural limitations concerning a surface’s orientation relative to a patient’s ear. Becon counters by Case: 21-2069 Document: 37 Page: 14 Filed: 07/22/2022

pointing to embodiments in the ’942 patent’s specification that are covered by claims 5–7 when using the construction of the “reversibly engage” limitation adopted by the Board. Becon also argues that Talex’s proposed construction im- permissibly reads the term “reversibly” out of the claims. We agree with Talex that the Board erred in adopting Becon’s proposal when construing the “reversibly engage” limitation, but we do not adopt Talex’s proposed construc- tion. The Board correctly determined that “[Talex’s] pro- posal fails to provide meaning to the term ‘reversibly’ by encompassing any engagement that stabilizes the device, which could include any engagement or contact with any other surface.” See ’942 Decision, 2021 WL 1433251, at *6. The Board agreed with Becon’s proposed construction be- cause “it more accurately tracks the claim language and specification.” See id. By focusing solely on which of the parties’ two proposed constructions “more clearly captures this form of engagement, and gives meaning to the term ‘reversibly,’” the Board failed to consider the possibility that both constructions are inconsistent with the intrinsic evidence. See id. Neither Talex nor Becon offered the Board a plausible construction of the “reversibly engage” limitation. Alt- hough Talex now correctly asserts that “the specification considers ‘reversibly engage’ to be interchangeable ‘con- tact,’” Appellant’s Opening Br. 31, Talex failed to propose a sufficiently narrow construction to the Board. This strate- gic choice led the Board down the wrong path. The Board’s construction improperly narrowed the scope of the claims by importing a directional limitation based on embodiments described in the specification. Ab- sent limiting language, we do not import aspects from the written description into the claims. See Hill-Rom, 755 F.3d at 1372–73; see also Phillips, 415 F.3d at 1323 (“[A]lthough the specification often describes very specific embodiments of the invention, we have repeatedly warned against Case: 21-2069 Document: 37 Page: 15 Filed: 07/22/2022

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confining the claims to those embodiments.”). The Board did not rely on any limiting language from the intrinsic ev- idence in restricting a claimed surface’s orientation rela- tive to an ear. Becon did not point to any evidence of disclaimer but instead merely argued that the claims, as construed, cover embodiments described in the specifica- tion. The Board considered the following portions of the ’942 patent’s specification while evaluating the meaning of the “reversibly engage” limitation. See ’942 Decision, 2021 WL 1433251, at *6. Horizontal support 63 and 64 have an outer surface that is configured to be contacted by the cradle cover 22 when the cover is engaged with the cradle base 21. The horizontal supports 63 and 64 can re- versibly engage or contact the cover when the cover is engaged with the cradle base, and when the cover is removed from the cradle base the horizontal support structures disengage from the cover. ’942 patent, col. 7 ll. 57–63 (emphases added). As discussed above, ear molding device 29 can also contact the cradle wall 34, if desired. Vertical sup- ports 65 and 66 have an outer surface that is con- figured to be contacted by the cradle wall 34. When the outer surfaces of vertical supports 65 and 66 are placed in contact with the cradle wall 34, ad- hesive strip 35 can be used to adhere the sur- faces 65 and 66 to the cradle wall 34, with or without the use of shims depending on the size of the ear being corrected. Id. at col. 8 ll. 6–13 (emphasis added). Consistent with the claim language, the ’942 patent’s specification describes the horizontal and vertical supports adapted to reversibly engage with respective surfaces. In Case: 21-2069 Document: 37 Page: 16 Filed: 07/22/2022

describing reversible engagement, the specification de- scribes supports that engage and disengage. The specifica- tion explains that this engagement may be facilitated by the use of adhesive, which further implies disengagement as well as engagement. See, e.g., id. at col. 3 ll. 24–37. And, finally, there is the plain meaning of the word “reversibly,” which clearly implies a two-way direction for engagement. We conclude that the meaning of the “reversibly en- gage” limitation is “interchangeably engage with and dis- engage from, to stabilize the device.” Accordingly, we vacate the Board’s construction of the “reversibly engage” limitation, vacate its judgment of no invalidity for claims 5–7 of the ’942 patent, and remand the ’942 Decision for the limited purpose of having the Board apply the cor- rect claim construction. B. Becon’s Cross-Appeal Becon raises three arguments on cross-appeal. Becon argues that (1) the Board erred in construing the “mold” limitation in all of the claims at issue and the Board’s find- ing that Dancey and Yotsuyanagi each disclose the “mold” limitation was unsupported by substantial evidence, (2) the Board erred in weighing Becon’s secondary consid- erations evidence, and (3) the Board abused its discretion in denying Becon’s motion to amend. We address each ar- gument in turn. I. Mold / Molding Device As indicated, all of the challenged claims include a “mold” and/or a “molding device.” Becon refers to these lim- itations together as “the claimed ‘mold’ term.” See Cross- Appellants’ Opening Br. 3. Becon first argues that the Board erred in construing the “mold” limitation. Becon ar- gues that the intrinsic evidence demonstrates that the claimed “mold” requires reshaping. Becon also argues that the Board incorrectly found that Dancey and Yotsuyanagi each disclose the “mold” limitation. Case: 21-2069 Document: 37 Page: 17 Filed: 07/22/2022

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Although the patent specifications describe reshaping by a molding device, the Board was correct in concluding that the “mold” limitation does not require reshaping. First, as the Board noted, the claims already include func- tional language. ’942 Decision, 2021 WL 1433251, at *4. Additionally, the specifications describe embodiments in which a mold alone is not necessarily sufficient to reshape an ear. Some examples describe a mold used in combina- tion with another component or multiple components to al- ter a portion of an ear. See id. Becon argues that the Board’s findings regarding Dancey and Yotsuyanagi were unsupported because the findings were based on an incorrect construction of the “mold” limitation. Becon’s arguments regarding applica- tion of the “mold” limitation are thus limited to arguments based on Becon’s proposed construction. In view of our de- cision to affirm the Board’s construction of the “mold” lim- itation, we do not need to address Becon’s challenge to the Board’s application of the construction. We therefore affirm the portions of the Board’s deci- sions declining to construe the “mold” limitation to require reshaping and finding that Dancey and Yotsuyanagi each teach the “mold” limitation. II. Secondary Considerations Becon argues that the Board erred in determining that Becon’s evidence of secondary considerations did not estab- lish nonobviousness of the challenged claims of the ’942 and ’277 patents. Becon argues that (1) the Board incor- rectly concluded that Becon was not entitled to a presump- tion of a nexus, (2) the Board incorrectly concluded that Becon did not demonstrate a long-felt but unresolved need, and (3) the Board failed to give proper weight to Becon’s evidence. Secondary considerations, also referred to as objective indicia of non-obviousness, may be used to establish that Case: 21-2069 Document: 37 Page: 18 Filed: 07/22/2022

an invention appearing to have been obvious in light of the prior art was not. See Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983). Secondary con- siderations include commercial success enjoyed by embod- iments of the patented invention, industry praise for the patented invention, copying by others, and the existence of a long-felt but unmet need for the invention. See Apple, 839 F.3d at 1052–53; see also Graham, 383 U.S. at 17–18. Evidence of objective indicia of nonobviousness must have a nexus to the claims, i.e., “there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention.” Henny Penny Corp. v. Fry- master LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)). “The patentee bears the bur- den of showing that a nexus exists . . . .” WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999) (citing Cable Elec. Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1027 (Fed. Cir. 1985)). “To determine whether the patentee has met that burden, we consider the correspond- ence between the objective evidence and the claim scope.” Henny Penny, 938 F.3d at 1332. The presence of a nexus is a factual question that we review for substantial evidence. See Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 837 (Fed. Cir. 2015). “[A] patentee is entitled to a rebuttable presumption of nexus between the asserted evidence of secondary consid- erations and a patent claim if the patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Fac- tory v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (emphasis added) (quoting Demaco, 851 F.2d at 1392). The presumption applies “when the patentee shows that the as- serted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coex- tensive with them.’” Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018) (quoting Brown & Case: 21-2069 Document: 37 Page: 19 Filed: 07/22/2022

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Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000)). “Conversely, ‘[w]hen the thing that is commercially successful is not coextensive with the patented invention—for example, if the patented invention is only a component of a commercially successful machine or process,’ the patentee is not entitled to a pre- sumption of nexus.” Fox Factory, 944 F.3d at 1373 (quoting Demaco, 851 F.2d at 1392). The Board determined that Becon failed to establish a nexus between purported objective indicia relating to its EarWell product and the challenged claims of the ’942 and ’277 patents. Specifically, it found that Becon failed to show that the EarWell product is the claimed invention. The Board explained that Becon relied on a presumption of nexus argument that assumed that the challenged claims cover the EarWell product. But the Board found that Becon provided no analysis of the claims with respect to the device. The Board also found that, in addition to failing to establish that the challenged claims cover the EarWell de- vice, Becon did not address whether any of the claims are coextensive with the EarWell device. The Board noted that Becon’s arguments relating to copying, long-felt need, and praise by others did not go to show that those considera- tions applied to a patented device. Overall, the Board con- cluded that Becon failed to establish a nexus and hence failed to show that the objective indicia supported nonobvi- ousness. Becon argues that the Board improperly concluded that Becon was not entitled to a presumption of a nexus. Becon accuses the Board of ignoring sections of Becon’s expert declarations contending that Becon’s EarWell product em- bodies each of the challenged patent claims. See Cross-Ap- pellants’ Opening Br. 70 (citing expert reports at J.A. 3323; J.A. 3338–44; J.A. 3529–30; J.A. 3546–51). Becon also ar- gues that the Board ignored an annotated photo of the Ear- Well device. See id. at 72 (citing the Patent Owners’ Response at J.A. 1200). Becon finally argues that the Case: 21-2069 Document: 37 Page: 20 Filed: 07/22/2022

Board imposed a heightened burden on Becon by requiring a claim chart, a claim-by-claim analysis, or a limitation-by- limitation analysis. Talex counters that the Board was correct in determin- ing that Becon’s threadbare evidence failed to meet its bur- den to demonstrate that it was entitled to a nexus. Talex argues that Becon relied on a sentence that “merely states that [Becon] believes [Talex’s] device ‘is a copy of the pa- tented EarWell ear molding device that is recited in [the challenged claims].’” ’942 Decision, 2021 WL 1433251, at *14. In response to Becon’s arguments that the Board overlooked evidence, Talex points out that the Board cited and discussed Becon’s expert declarations. Talex also con- tends that the Board did not ignore the annotated photo of the EarWell device. The Board instead stated that the photo “merely shows a labelled photo of the EarWell device in an effort to support [Talex]’s copying allegation, without any assertion that the device shown is covered by the chal- lenged claims.” Id. We conclude that the Board conducted a thorough re- view of Becon’s evidence in search of substantive analysis concerning a potential nexus or presumption of a nexus. Contrary to Becon’s allegations, the Board did consider Becon’s expert declarations and the annotated photo from Becon’s Patent Owners’ Response. See id. Notably, the la- beled photo of the EarWell device lacks mention of several claim limitations that are at issue on appeal and also ap- pears to be attorney argument. Becon essentially disagrees with the Board’s characterization of its evidence but fails to show that the Board committed reversible error. Furthermore, the Board did not impose an improperly heightened burden on Becon. The Board noted that Becon did not provide a claim-by-claim or limitation-by-limitation analysis, but this was not error. The Board did not improp- erly require that Becon’s evidence be presented in a partic- ular format. See id. (stating that the “Patent Owner also Case: 21-2069 Document: 37 Page: 21 Filed: 07/22/2022

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cites to its Patent Owner Response for support . . . without any assertion that the device shown is covered by the challenged claims, much less any claim-by-claim or limi- tation-by-limitation analysis.” (emphases added)). We have held that a nexus between asserted objective indicia relating to a product and the claims of a patent is needed to ensure that these indicia truly correspond to what is claimed rather than to something else. See, e.g., Henny Penny, 938 F.3d at 1332–33. Thus, objective indicia relating to a multi-component product are not necessarily attributed to a smaller portion of the product that is the subject of the claims. And objective indicia relating to a product consisting of components that are not part of as- serted claims do not necessarily show that what is patented is non-obvious. Arguments asserting nexus therefore must connect the indicia with the claims. It is that connection that the Board here found inadequate. Industry praise and copying may indicate non-obviousness when connected to the claims, but not when they do not. These are findings of fact that we are not free to ignore, unless they are clearly erroneous, and we do not consider that they are here. The Board used terms such as “no anal- ysis,” lack of “limitation-by-limitation analysis,” and lack of “sufficient specificity.” ’942 Decision, 2021 WL 1433251, at *14. Moreover, the Board found that, even if a nexus had been established, the strength of the prior art in light of the breadth of claim 1 overcame the objective indicia. Id. at *15. That is because one might envision a spectrum bal- ancing objective indicia and the prior art. If the indicia are especially strong, they might overwhelm close prior art, as what might have seemed to be obvious at the time of an invention may be shown by indicia not to have been obvi- ous. Similarly, weak, ambiguous, or debatable indicia may be found not to overcome strong prior art. Again, such de- terminations are for the Board to make, and we do not find their conclusions here to be reversible. Ultimately, the Case: 21-2069 Document: 37 Page: 22 Filed: 07/22/2022

question is whether what is claimed has been shown to be not obvious over the prior art. We therefore affirm the Board’s conclusion that the as- serted objective indicia do not support a conclusion of non- obviousness for lack of nexus. Given our affirmance of the Board’s finding that Becon failed to demonstrate a nexus, we need not review the Board’s evaluation of other objec- tive indicia of nonobviousness. III. Motion to Amend We finally consider whether the Board erred in denying Becon’s motion to amend. As discussed above, the substi- tute claims would have added the following new limitation: “wherein the scaphal mold and one or more braces are con- structed to mold the helix and helical rim during their growth such that the growth of the helix and helical rim conforms to the space between the scaphal mold and the one or more braces.” The Board stated that this additional limitation imposes a requirement that “specific structure” be “‘constructed to’ perform certain functions.” ’277 Deci- sion, 2021 WL 1433255, at *19. The Board found that Yotsuyanagi discloses the addi- tional limitation recited in substitute claim 18 because “Yotsuyanagi seeks to mold the helix and helical rim dur- ing their growth by changing the shape of the ear” and “dis- closes successfully treating patients by altering and improving the shape of the helix.” Id. at *22–23. The Board also found Talex’s arguments and evidence on this issue more credible than Becon’s. The Board thus deter- mined that granting the motion to amend would not have rendered the claims allowable. Becon argues for patentability of the substitute claims by referencing its arguments regarding its construction proposal for the “mold” term. Becon explains that if this court determines that “mold the helix and helical rim” dis- tinguishes the substitute claims from the prior art, the Case: 21-2069 Document: 37 Page: 23 Filed: 07/22/2022

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substitute claims should be found patentable and the Board’s denial of its motion should be reversed. Talex counters that the Board correctly determined that Yotsuyanagi discloses reshaping of the helix and helical rim. We agree with Talex that the Board fairly weighed the parties’ evidence regarding Yotsuyanagi’s teachings. Granting a motion to amend is a matter within the Board’s discretion, and substantial evidence supports the Board’s determination that Yotsuyanagi discloses the limitation added by the substitute claims. The Board cited state- ments from Yotsuyanagi that describe correcting the shape of a helix. The Board also cited three clinical cases dis- cussed in Yotsuyanagi that resulted in reshaped patient ears. Id. at *22–23. Since substantial evidence supported the Board’s finding, the Board did not abuse its discretion in denying Becon’s motion to amend. Accordingly, we af- firm the Board’s determinations regarding Becon’s motion to amend. CONCLUSION We have considered the parties’ remaining arguments, but we find them unpersuasive. We affirm the Board’s de- termination that claims 1–3 and 9 of the ’942 patent and claims 1–2 and 9–10 of the ’277 patent were shown to be unpatentable. We also affirm the Board’s determination that claim 4 of the ’942 patent and claim 16 of the ’277 pa- tent were not shown to be unpatentable. We vacate the Board’s determination that claims 5–7 of the ’942 patent were not shown to be unpatentable and remand for further proceedings consistent with this opinion. AFFIRMED-IN-PART, VACATED-IN-PART, AND REMANDED COSTS No costs.