Talexmedical, LLC v. BECON MEDICAL LIMITED, HENRY STEPHENSON BYRD, M.D., Cross-Appellants 2021-2069,…

N OTE: This disposition is nonprecedential.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 R OBERT WEAVER , The Brickell IP Group,
PLLC, Miami, FL, argued for appellant. Also represented
by RICHARD G UERRA, J AVIER SOBRADO.
D AVID B OGDAN CUPAR , McDonald Hopkins LLC, Cleve-
land, OH, argued for cross-appellants. Also represented by
MATTHEW J OHN CAVANAGH ; ERIN RACHAEL CONWAY ,
N ICHOLAS A. K URK, Chicago, IL.
______________________
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 2
Before L OURIE, SCHALL , and REYNA, Circuit Judges.
L OURIE, 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.
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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 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.
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 4
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
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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 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
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 6
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.
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 7
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).
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 8
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.
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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 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).
D ISCUSSION
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
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 10
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
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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 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.
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 12
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
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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 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
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 14
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
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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 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
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 16
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.
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 17
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
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 18
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 &
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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 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
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 20
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
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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 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
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TALEXMEDICAL, LLC v. BECON MEDICAL LIMITED 22
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
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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 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.
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