NOTE: This disposition is nonprecedential.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, Cleveland, OH, argued for cross-appellants. Also represented by 

MATTHEW JOHN CAVANAGH; ERIN RACHAEL CONWAY,

NICHOLAS A. KURK, Chicago, IL.

______________________ 

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2 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

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 obvious. 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 Stephenson 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 proceedings consistent with this opinion.

1 Because the ’942 Decision and the ’277 Decision address overlapping issues, all citations are to the ’942 Decision unless otherwise noted.

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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 helical rim “to maintain a substantially correct anatomical 

shape of the helix and the helical rim,” ’942 patent at Abstract, 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 substantially similar specification, all citations are to the ’942 patent unless otherwise noted. See ’942 Decision, 2021 WL 

1433251, at *1. 

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4 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

12”). As shown in Figure 5, below, a molding device “is generally 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 molding 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 appeal, recites:

1. A molding device for a human ear, wherein the 

ear includes an antihelix, a superior limb of the triangular fossa, a helix, a helical rim, a base, a concha, and a scaphal area, the molding device 

comprising: 

one or more braces; and 

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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 constructed to retain the helix and helical rim 

within a space defined between the one or 

more braces and the scaphal mold, and further constructed to maintain a substantially correct anatomical shape of the helix 

and the helical rim, wherein 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.

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 includes a vertical support surface constructed to reversibly 

engage a second surface” and/or “a horizontal support surface 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 positioned 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 triangular fossa, a helix, a helical rim, a base, a 

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6 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

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 section, defines a compartment between 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 helix 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 patent further require that the “scaphal mold includes a generally 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.

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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 unpatentable. 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 opposed 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 discloses an ear splint with a wire core enclosed in a cover. 

See id. (citing J.A. 1978, 1980). Yotsuyanagi discloses thermoplastic splints that conform to the outside of an ear to 

3 Anne Dancey, et al., Acrylic Ear Splints for Treatment 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). 

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8 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

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 patent, the Board held that claims 1–2 and 9–10 would have 

been obvious over two combinations of prior art, both combinations 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, respectively. 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 surface.” ’942 Decision, 2021 WL 1433251, at *11. Additionally, 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 construction, the Board found that Dancey fails to disclose 

that limitation. Id.

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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 9

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 determined 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 interpretation of the meaning of the substitute claims, Talex 

proved that Becon’s substitute claims would have been obvious. Id. at *22.

Talex appealed, and Becon cross-appealed. We have jurisdiction 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 review the Board’s factual findings underlying those determinations for substantial evidence, In re Gartside, 203 F.3d 

1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence 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 invention, 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 

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10 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

person of ordinary skill in the art would have been motivated 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 extension.” 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 question 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” limitation. 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 

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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 annotations, 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 portion 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 consider 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 annotated 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 incorrectly 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 versions 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 version of figure 6 does not correct the inconsistencies in its 

argument concerning the “semi-cylindrical extension” limitation.

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.

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12 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

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 understand 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 considered 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 issue. See J.A. 3404–06 (Khosla’s expert declaration at 

¶¶ 200–03); see also J.A. 3611–13 (Daniali’s expert declaration at ¶¶ 201–04). Although the Board did not cite those

sections of Becon’s declarations with reference to its determination regarding the “broad flat surface” limitation, the 

Board cited Becon’s Patent Owner Response, which expressly relied on these declarations in opposition to Talex’s 

argument. See ’942 Decision, 2021 WL 1433251, at *11 (citing J.A. 734). Furthermore, “this court has said on multiple 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) (citations 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 

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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 13

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 patent 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: lexicography 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. (internal quotation marks omitted). Embodiments cannot limit 

the scope of the claims absent the patentee’s “words or expressions 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 extrinsic 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 “reversibly 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 inconsistent with the ’942 patent’s specification and adds unnecessary structural limitations concerning a surface’s 

orientation relative to a patient’s ear. Becon counters by 

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14 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

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 impermissibly 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 construction. The Board correctly determined that “[Talex’s] proposal 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 because “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. Although Talex now correctly asserts that “the specification 

considers ‘reversibly engage’ to be interchangeable ‘contact,’” Appellant’s Opening Br. 31, Talex failed to propose a 

sufficiently narrow construction to the Board. This strategic 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. Absent 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 

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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 15

confining the claims to those embodiments.”). The Board 

did not rely on any limiting language from the intrinsic evidence in restricting a claimed surface’s orientation relative 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 specification.

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 reversibly 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 supports 65 and 66 have an outer surface that is configured 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, adhesive strip 35 can be used to adhere the surfaces 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 

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16 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

describing reversible engagement, the specification describes supports that engage and disengage. The specification 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 engage” limitation is “interchangeably engage with and disengage 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 correct 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 finding that Dancey and Yotsuyanagi each disclose the “mold” 

limitation was unsupported by substantial evidence, 

(2) the Board erred in weighing Becon’s secondary considerations evidence, and (3) the Board abused its discretion 

in denying Becon’s motion to amend. We address each argument 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 limitations together as “the claimed ‘mold’ term.” See CrossAppellants’ Opening Br. 3. Becon first argues that the 

Board erred in construing the “mold” limitation. Becon argues 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. 

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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 functional 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 combination with another component or multiple components to alter 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 application of the “mold” limitation are thus limited to arguments 

based on Becon’s proposed construction. In view of our decision to affirm the Board’s construction of the “mold” limitation, 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 decisions 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 establish nonobviousness of the challenged claims of the ’942 

and ’277 patents. Becon argues that (1) the Board incorrectly concluded that Becon was not entitled to a presumption 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 

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18 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

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 considerations include commercial success enjoyed by embodiments 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. Frymaster 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 burden 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 correspondence 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 considerations 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 Factory 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 asserted objective evidence is tied to a specific product and 

that product ‘embodies the claimed features, and is coextensive with them.’” Polaris Indus., Inc. v. Arctic Cat, Inc., 

882 F.3d 1056, 1072 (Fed. Cir. 2018) (quoting Brown & 

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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 19

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 presumption 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 device, 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 considerations applied to a patented device. Overall, the Board concluded that Becon failed to establish a nexus and hence 

failed to show that the objective indicia supported nonobviousness.

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 embodies each of the challenged patent claims. See Cross-Appellants’ Opening Br. 70 (citing expert reports at J.A. 3323; 

J.A. 3338–44; J.A. 3529–30; J.A. 3546–51). Becon also argues that the Board ignored an annotated photo of the EarWell device. See id. at 72 (citing the Patent Owners’ 

Response at J.A. 1200). Becon finally argues that the 

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20 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

Board imposed a heightened burden on Becon by requiring 

a claim chart, a claim-by-claim analysis, or a limitation-bylimitation analysis. 

Talex counters that the Board was correct in determining that Becon’s threadbare evidence failed to meet its burden 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 patented 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 contends 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 challenged claims.” Id.

We conclude that the Board conducted a thorough review 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 labeled photo of the EarWell device lacks mention of several 

claim limitations that are at issue on appeal and also appears 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 improperly require that Becon’s evidence be presented in a particular format. See id. (stating that the “Patent Owner also 

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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 21

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 limitation-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 asserted 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 analysis,” 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 balancing 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 obvious. Similarly, weak, ambiguous, or debatable indicia may 

be found not to overcome strong prior art. Again, such determinations are for the Board to make, and we do not find 

their conclusions here to be reversible. Ultimately, the 

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22 TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED

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 asserted objective indicia do not support a conclusion of nonobviousness 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 objective 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 substitute claims would have added the following new limitation: 

“wherein 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.” The Board stated that this additional

limitation imposes a requirement that “specific structure” 

be “‘constructed to’ perform certain functions.” ’277 Decision, 2021 WL 1433255, at *19.

The Board found that Yotsuyanagi discloses the additional limitation recited in substitute claim 18 because 

“Yotsuyanagi seeks to mold the helix and helical rim during their growth by changing the shape of the ear” and “discloses 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 determined 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” distinguishes the substitute claims from the prior art, the 

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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 23

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 statements from Yotsuyanagi that describe correcting the shape 

of a helix. The Board also cited three clinical cases discussed 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 affirm 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 determination 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 patent 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.

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