Filed: Mar. 13, 2020
Latest Update: Mar. 13, 2020
Summary: Case: 18-2232 Document: 87 Page: 1 Filed: 03/13/2020 United States Court of Appeals for the Federal Circuit _ KAKEN PHARMACEUTICAL CO., LTD., BAUSCH HEALTH COMPANIES INC., Appellants v. ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor _ 2018-2232 _ Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2017- 00190, IPR2017-01429. _ Decided: March 13, 2020 _ JO
Summary: Case: 18-2232 Document: 87 Page: 1 Filed: 03/13/2020 United States Court of Appeals for the Federal Circuit _ KAKEN PHARMACEUTICAL CO., LTD., BAUSCH HEALTH COMPANIES INC., Appellants v. ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor _ 2018-2232 _ Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2017- 00190, IPR2017-01429. _ Decided: March 13, 2020 _ JOH..
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Case: 18-2232 Document: 87 Page: 1 Filed: 03/13/2020
United States Court of Appeals
for the Federal Circuit
______________________
KAKEN PHARMACEUTICAL CO., LTD., BAUSCH
HEALTH COMPANIES INC.,
Appellants
v.
ANDREI IANCU, UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
AND DIRECTOR OF THE UNITED STATES
PATENT AND TRADEMARK OFFICE,
Intervenor
______________________
2018-2232
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2017-
00190, IPR2017-01429.
______________________
Decided: March 13, 2020
______________________
JOHN D. LIVINGSTONE, Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP, Atlanta, GA, argued for appel-
lants. Also represented by JEFFREY JACOBSTEIN, Boston,
MA; SAMHITHA MEDATIA, ANTHONY A. HARTMANN, CORA
RENAE HOLT, BARBARA RUDOLPH, Washington, DC.
NICHOLAS THEODORE MATICH, IV, Office of the Solicitor,
United States Patent and Trademark Office, Alexandria,
Case: 18-2232 Document: 87 Page: 2 Filed: 03/13/2020
2 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
VA, argued for intervenor. Also represented by THOMAS W.
KRAUSE, WILLIAM LAMARCA, ROBERT J. MCMANUS, BRIAN
RACILLA, FARHEENA YASMEEN RASHEED.
______________________
Before NEWMAN, O’MALLEY, and TARANTO, Circuit Judges.
TARANTO, Circuit Judge.
U.S. Patent No. 7,214,506 describes and claims meth-
ods for topically treating fungal infections in human nails.
The parties here treat Kaken Pharmaceutical Co. and
Bausch Health Companies Inc. (together, Kaken) as the pa-
tent owner. Acrux Limited and Acrux DDS Pty. Ltd. (to-
gether, Acrux), which no longer are parties to this
proceeding, successfully sought an inter partes review of
all claims of the ’506 patent under 35 U.S.C. § 311–319.
The Patent Trial and Appeal Board of the Patent and
Trademark Office ultimately determined that all claims of
the ’506 patent are unpatentable for obviousness. Acrux
DDS Pty. Ltd. v. Kaken Pharm. Co., Ltd., No. IPR2017-
00190,
2018 WL 2761408 (P.T.A.B. June 6, 2018).
Kaken appeals. The Director of the Patent and Trade-
mark Office, who intervened after Acrux withdrew, defends
the Board’s decision. We agree with Kaken on its principal
contention—that the Board erred in its claim construction
of one claim limitation. Because the Board’s obviousness
analysis materially relied on its erroneous claim construc-
tion, we cannot affirm the Board’s unpatentability deter-
mination. We reverse the claim construction, vacate the
Board’s decision, and remand the matter to the Board.
I
A
The ’506 patent, titled “Method For Treating Ony-
chomycosis,” provides a series of interlocking definitions.
The patent states that “[o]nychomycosis” is a class of “su-
perficial mycosis” that affects the “nail of [a] human or an
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KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 3
animal.” ’506 patent, col. 9, lines 32–35. The umbrella
term, “superficial mycosis,” encompasses infections that at-
tack tissues of the “skin or visible mucosa.”
Id., col. 5, lines
20–26. According to the patent, “skin” is “a tissue including
the three layers being epidermis, de[r]mis and subcutane-
ous tissue, accompanied by pilus (hair), nail, [and various
glandulae] as appendages.”
Id., col. 4, lines 54–57. In turn,
the “term ‘nail’ includes nail plate, nail bed, nail matrix,
further side nail wall, posterial nail wall, eponychium and
hyponychium which make up a tissue around thereof.”
Id.,
col. 4, lines 65–67.
Each of these structures is labeled in the following di-
agram:
J.A. 2435. Although the patent contains its own defini-
tions, including of “nail” and of “skin” (the latter including
“nail”), evidence before the Board explained that common
usage differs from the patent’s definitions. The “nail plate”
is the “horny appendage of the skin that is composed
mainly of keratin” and is “commonly called the nail.” J.A.
1236. By contrast, the “eponychium and hyponychium” are
the “skin structures surrounding the nail.” J.A. 1276.
One specific form of onychomycosis is “tinea unguium,”
which is caused by fungi of the Trichophyton species. ’506
patent, col. 9, lines 40–45. Two types of Trichophyton
fungi, Trichophyton rubrum and Trichophyton men-
tagrophytes, are the most common causes of onychomycosis
in humans. ’506 patent, col. 9, lines 35–38. Accordingly,
Case: 18-2232 Document: 87 Page: 4 Filed: 03/13/2020
4 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
the patent refers to “onychomycosis” and “tinea unguium”
interchangeably. E.g.,
id., col. 3, lines 41–45, col. 14, lines
60–63.
Traditionally, onychomycosis was treated with oral
medications.
Id., col. 2, lines 25–27. Because those oral
medications required long treatment periods and could
cause gastrointestinal disorders, it was “desired to develop
a topical preparation.”
Id., col. 2, lines 27–39. Topical
treatments, however, were largely ineffective—most treat-
ments “could not sufficiently permeate the thick keratin in
[the] nail plate.”
Id., col. 2, lines 40–45. It is a stated object
of the patent to provide a topical treatment that is effective
more quickly than oral medications “due to good permea-
bility, good retention capacity and conservation of high ac-
tivity in nail plate as well as . . . potent antifungal activity.”
Id., col. 3, lines 42–47.
The ’506 patent teaches a method of topically treating
onychomycosis with efinaconazole, also referred to as “KP-
103,” which is a specific kind of azole compound. See
id.,
col. 3, line 52 through col. 4, line 6;
id., col. 8, line 23
through col. 9, line 17. Claim 1, the only independent
claim, recites:
1. A method for treating a subject having onychomyco-
sis wherein the method comprises topically admin-
istering to a nail of said subject having
onychomycosis a therapeutically effective amount
of an antifungal compound represented by the fol-
lowing formula:
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KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 5
wherein, Ar is a non-substituted phenyl group or a phe-
nyl group substituted with 1 to 3 substituents
selected from a halogen atom and trifluorome-
thyl group,
R1 and R2 are the same or different and are hydrogen
atom, C1-6 alkyl group, a non-substituted aryl
group, an aryl group substituted with 1 to 3 sub-
stituents selected from a halogen atom, trifluo-
romethyl group, nitro group and C1-16 alkyl
group, C2-8 alkenyl group, C2-6 alkynyl group, or
C7-12 aralkyl group,
m is 2 or 3,
n is 1 or 2,
X is nitrogen atom or CH, and
*1 and *2 mean an asymmetric carbon atom.
Id., col. 17, line 33 through col. 18, line 28. The two possi-
bilities covered by the language “X is [a] nitrogen atom or
CH” are, respectively, a triazole or an imidazole. Claim 2,
which depends on claim 1, requires that the “compound
represented by the formula (II)” is KP-103, which is the tri-
azole version.
Id., col. 18, lines 29–32; see
id., col. 9, lines
15–17. The patent states that the “effectiveness of the KP-
103 used as an antifungal in the present invention for ony-
chomycosis has not been confirmed, but its antifungal ac-
tivity has been already known.”
Id., col. 9, lines 22–25.
B
In November 2016, Acrux petitioned for an inter partes
review of claims 1 and 2 of the ’506 patent, relying on two
sets of references. The first set consists of three references:
Japanese Patent Application No. 10-226639 (JP ’639); U.S.
Patent No. 5,391,367; and R.J. Hay et al., Tioconazole nail
solution—an open study of its efficacy in onychomycosis, 10
CLINICAL AND EXPERIMENTAL DERMATOLOGY 111 (1985)
Case: 18-2232 Document: 87 Page: 6 Filed: 03/13/2020
6 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
(Hay). Acrux argued that each of those references inde-
pendently teaches a method of topically treating ony-
chomycosis with various azole compounds. The second set
of references consists of two references: H. Ogura et al.,
Synthesis and Antifungal Activities of (2R,3R)-2-Aryl-1-az-
olyl-3-(substituted amino)-2-butanol Derivatives and Topi-
cal Antifungal Agents, 47 CHEM. PHARM. BULL. 1417 (1999)
(Ogura); and Abstracts F78, F79, and F80, 36
INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS
AND CHEMOTHERAPY 113 (1996) (Kaken Abstracts). Acrux
argued that both of those references disclose KP-103 as an
effective antifungal agent.
Acrux challenged both claims of the ’506 patent as un-
patentable for obviousness, stating six (related) grounds,
each one drawing a reference from the first set and a refer-
ence from the second set. Specifically, Acrux argued obvi-
ousness over JP ’639 in combination with Ogura or the
Kaken Abstracts, obviousness over the ’367 patent in com-
bination with Ogura or the Kaken Abstracts, and obvious-
ness over Hay in combination with Ogura or the Kaken
Abstracts. In its final written decision, the Board held
claims 1 and 2 unpatentable for obviousness over JP ’639,
the ’367 patent, and Hay, each in combination with the Ka-
ken Abstracts. Acrux,
2018 WL 2761408, at *12–26.
During the inter partes review, Kaken proposed that
the phrase “treating a subject having onychomycosis”
means “treating the infection at least where it primarily
resides in the keratinized nail plate and underlying nail
bed.”
Id. at *4. The Board rejected Kaken’s construction
as too narrow, concluding that “the express definition of on-
ychomycosis includes superficial mycosis, which in turn is
expressly defined as a disease that lies in the skin or visible
mucosa.”
Id. at *5. The Board also found significant that
the express definition of “nail includes the tissue or skin
around the nail plate, nail bed, and nail matrix.”
Id. Ac-
cordingly, the Board concluded, “treating onychomycosis”
Case: 18-2232 Document: 87 Page: 7 Filed: 03/13/2020
KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 7
includes treating “superficial mycosis that involves disease
of the skin or visible mucosa.”
Id. at *6. Applying that
construction, the Board determined that a skilled artisan
would have been motivated to combine the cited references
and that Kaken’s objective indicia of non-obviousness de-
served little weight.
Id. at *20–26.
Kaken timely appealed. We have jurisdiction under 28
U.S.C. § 1295(a)(4)(A).
II
Kaken challenges the Board’s construction of “treating
a subject having onychomycosis.” According to Kaken, the
Board’s construction ignores the ’506 patent’s core innova-
tion—a topical treatment that can easily penetrate the
tough keratin in the nail plate. Kaken asks us to reverse
the claim construction and either to reverse the obvious-
ness determination or to vacate it and remand for applica-
tion of the proper construction.
A
We review the Board’s claim construction de novo and
any underlying factual findings for substantial evidence.
Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.,
135 S. Ct.
831, 840–41 (2015); Wasica Finance GmbH v. Continental
Automotive Systems, Inc.,
853 F.3d 1272, 1278 (Fed. Cir.
2017). The parties accept that, in this matter, the claims
must be given their broadest reasonable interpretation.
We hold, in light of the specification and prosecution his-
tory, that the Board’s claim construction is unreasonable.
The broadest reasonable interpretation of “treating a sub-
ject having onychomycosis,” consistent with Kaken’s con-
struction, is penetrating the nail plate to treat a fungal
infection inside the nail plate or in the nail bed under it.
Case: 18-2232 Document: 87 Page: 8 Filed: 03/13/2020
8 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
1
The ’506 patent’s specification characterizes “ony-
chomycosis” in a way that links to three other crucial pas-
sages in the specification—two that provide express
definitions of other terms and one that characterizes an-
other term. Thus, after defining the terms “skin” and
“nail,” and characterizing “superficial mycosis,” the speci-
fication declares that “onychomycosis” is “a kind of the
above-mentioned superficial mycosis, in the other word a
disease which is caused by invading and proliferating in
the nail of human or an animal.” ’506 patent, col. 9, lines
32–35. This assertion about onychomycosis conveys that
the disease covered by the term has two basic features: (1)
it is a disease of the “nail” and (2) it is a kind of superficial
mycosis. Contrary to the Board’s conclusion, however, that
characterization, when coupled with the other three linked
specification passages, does not compel the conclusion that
“onychomycosis” reasonably is understood to involve inva-
sion of any part of what is defined as the “nail,” including
parts other than the nail plate or nail bed, such as skin in
its ordinary sense.
More specifically, the Board relied on the ’506 patent’s
definition of “nail”: the “term ‘nail’ includes nail plate, nail
bed, nail matrix, further side nail wall, posterial nail wall,
eponychium and hyponychium which make up a tissue
around thereof.”
Id., col. 4, lines 65–67; see Acrux,
2018
WL 2761408, at *5. That definition includes skin struc-
tures surrounding the nail plate. But the Board drew an
unwarranted inference from that broad definition. As a
matter of ordinary meaning, a statement that a particular
disease invades the body would not imply that it can invade
any part of the body. So too, when the specification says
that “onychomycosis” is a disease involving invasion of the
“nail,” it does not compel the conclusion that the disease
can invade any part of the defined “nail.” A disease that
invades the nail plate or bed only is still a disease that
Case: 18-2232 Document: 87 Page: 9 Filed: 03/13/2020
KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 9
invades the “nail” as defined. Thus, this language alone
does not support the Board’s conclusion that an infection of
any individual structure of the nail constitutes onychomy-
cosis.
The Board also relied on the specification’s characteri-
zation of “superficial mycosis.” The specification says that
superficial mycosis is a kind of mycosis in which “[a] seat
of the disease lie[s] in the skin or visible mucosa,”
id., col.
5, lines 23–24, in contrast to deep mycosis, which lies “in
viscus, central nervous system, subcutaneous tissue, mus-
cle, [h]orn or articulation,”
id., col. 5, lines 24–26. The
Board concluded that, because onychomycosis is stated to
be a type of superficial mycosis, “which in turn is expressly
defined as a disease that lies in the skin or
visible mucosa,” onychomycosis “includes infections of skin
contrary to [Kaken’s] interpretation of this term to require
infection of the nail plate and nail bed.” Acrux,
2018 WL
2761408, at *5. 1
The “superficial mycosis” characterization is no more
decisive in supporting the Board’s conclusion than is the
“nail” definition. Specifically, the Board’s inference runs
counter to the specification’s capacious definition of “skin”
as including “nail”: “a tissue including the three layers be-
ing epidermis, de[r]mis and subcutaneous tissue, accompa-
nied by pilus (hair), nail, [and certain glandulae] as
appendages.” ’506 patent, col. 4, lines 54–57 (emphasis
added). Because of that definition, the assertion that ony-
chomycosis is a type of disease that lies in the “skin” in no
way excludes onychomycosis from being limited to the
1 We understand the Board’s statement that “the ex-
press definition of onychomycosis includes superficial my-
cosis,” Acrux,
2018 WL 2761408, at *5, to mean simply that
the specification characterizes onychomycosis as a type of
superficial mycosis.
Case: 18-2232 Document: 87 Page: 10 Filed: 03/13/2020
10 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
“nail.” The characterization of “superficial mycosis” allows
that possibility and does not mean that every type of su-
perficial mycosis affects every type of “skin” structure.
The Board did not draw any inference specifically from
the contrast with “deep mycosis.” The specification de-
scribes deep mycosis as affecting “subcutaneous tissue,”
but the patent also defines “skin” as including “subcutane-
ous tissue.” Compare
id., col. 5, lines 23–26 with
id., col. 4,
lines 54–57. The overlap reinforces the general lesson that
the specification passages on which the Board relied do not
provide clarity about the reasonable bounds of the class of
structures that must be infected for a disease to constitute
“onychomycosis.”
Other parts of the specification, which explain that an
effective topical treatment would need to penetrate the nail
plate, support Kaken’s construction. A patent’s statement
of the described invention’s purpose informs the proper
construction of claim terms, including when the task is to
identify the broadest reasonable interpretation. See In re
Power Integrations, Inc.,
884 F.3d 1370, 1376–77 (Fed. Cir.
2018) (the patent at issue “strives to eliminate unnecessary
components,” so it would be unreasonable to construe a
claim term to include a “bulky [component]”). The ’506 pa-
tent briefly describes topical treatments known in the prior
art. It notes that those treatments were largely ineffective
because they “could not sufficiently permeate the thick ker-
atin in [the] nail plate.” ’506 patent, col. 2, lines 40–44.
Accordingly, the ’506 patent explains, an effective topical
treatment must have “good permeability, good retention
capacity and conservation of high activity in [the] nail
plate.”
Id., col. 3, lines 40–48. That discussion, in stating
the “object of [the] present invention” relevant to the claims
at issue,
id., col. 3, lines 40–41, supports Kaken’s construc-
tion. Treating an infection of the skin surrounding the nail
plate alone would not require all those properties,
Case: 18-2232 Document: 87 Page: 11 Filed: 03/13/2020
KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 11
including “high activity in [the] nail plate.”
Id., col. 3, lines
40–48 (emphasis added).
The Board discounted that evidence based on a flawed
understanding of the relationship between onychomycosis
and tinea unguium. The Board reasoned that the patent’s
description of an effective topical treatment is unhelpful
because it is preceded by the phrase “a therapeutic agent
for onychomycosis which exhibits the effect on tinea un-
guium by topical application” and tinea unguium “is in-
cluded in the definition of onychomycosis, but is not co-
extensive with it.” Acrux,
2018 WL 2761408, at *6 (citing
’506 patent, col. 3, lines 41–45). Although the Board is cor-
rect that onychomycosis is broader than tinea unguium, it
is not broader in a way that is significant for this analysis.
The patent explains that tinea unguium is onychomycosis
“caused by [the] Trichophyton species” of fungus and con-
trasts tinea unguium with “[o]nychocandidadis caused by
[the] Candida species or onychomychosis (sensu stricto)
caused by the other fungus.” ’506 patent, col. 9, lines 40–
44. That onychomycosis can be caused by fungi other than
the Trichophyton species does not decrease the probative
value, for determining the location of the infection, of the
patent’s description of an effective topical treatment for
tinea unguium.
2
The prosecution history—which includes, specifically,
statements made by Kaken to overcome a rejection and the
examiner’s statements explaining withdrawal of the rejec-
tion based on those statements—provides decisive support
for limiting the claim phrase at issue to a plate-penetrating
treatment of an infection inside or under the nail plate. A
patent’s prosecution history can “inform the meaning of the
claim language by demonstrating how the inventor under-
stood the invention and whether the inventor limited the
invention in the course of prosecution, making the claim
Case: 18-2232 Document: 87 Page: 12 Filed: 03/13/2020
12 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
scope narrower than it would otherwise be.” Phillips v.
AWH Corp.,
415 F.3d 1303, 1317 (Fed. Cir. 2005); see also
Hynix Semiconductor Inc. v. Rambus Inc.,
645 F.3d 1336,
1350 (Fed. Cir. 2011) (prosecution history is strong evi-
dence of what a skilled artisan “would have understood dis-
puted claim language to mean”). Particularly useful are
“express representations made by or on behalf of the appli-
cant to the examiner to induce a patent grant,” which in-
clude “arguments made to convince the examiner that the
claimed invention meets the statutory requirements of nov-
elty, utility, and nonobviousness.” Standard Oil Co. v.
American Cyanamid Co.,
774 F.2d 448, 452 (Fed. Cir.
1985). Prosecution history plays this role in applying the
broadest-reasonable-interpretation standard. See Mi-
crosoft Corp. v. Proxyconn, Inc.,
789 F.3d 1292, 1298
(Fed. Cir. 2015), overruled on other grounds by Aqua
Prods., Inc. v. Matal,
872 F.3d 1290 (Fed. Cir. 2017)
(en banc). In this case, Kaken’s statements during prose-
cution, followed by the examiner’s statements, make clear
the limits on a reasonable understanding of what Kaken
was claiming.
The ’506 patent issued from a divisional application of
U.S. Patent Application No. 10/031,929, which originally
had seventeen claims. Divisional dated Oct. 14, 2003, at
35–39, in Appl. No. 10/685,266. When Kaken submitted its
divisional application (the ’266 application), it included a
preliminary amendment that reduced the number of claims
to four: claims 2–17 were cancelled and claims 18–20 were
added. Preliminary Amendment dated Oct. 14, 2003, at 3–
4, in Appl. No. 10/685,266. Independent claim 18 described
a “method for treating [a] subject having onychomycosis”
using a compound having “formula (I).” Preliminary
Amendment dated Oct. 14, 2003, at 3; see ’506 patent, col.
3, lines 54–63. Claim 19, which depended on claim 18, re-
quired a compound having “formula (II).” Preliminary
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KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 13
Amendment dated Oct. 14, 2003, at 3; see ’506 patent, col.
8, lines 28–39.
The examiner, believing that claims 18–20 were di-
rected to a method of treating general mycosis, initially re-
jected Kaken’s application for obviousness-type double
patenting over claims 9–12 of U.S. Patent No. 5,620,994.
The ’994 patent describes a “fungicide” containing the same
compound described by formula (II) of the ’506 patent. ’994
patent, Abstract; see ’506 patent, col. 8, lines 28–39. While
independent claim 1 of the ’994 patent claims that com-
pound, ’994 patent, col. 17, line 51, through col. 18, line 19,
claim 9 of the ’994 patent claims a “process for treating my-
cosis” using the compound of claim 1,
id., col. 18, lines 46–
48. The examiner first explained that the “formula pre-
sented in instantly claimed Claim 19 [of the ’266 applica-
tion] is exactly the same as that in Claim [1] of [the ’994]
patent.” Non-Final Rejection dated June 14, 2006, at 4, in
Appl. No. 10/685,266; J.A. 1571. The examiner added that
claims 18–20 were not “patentably distinct” from claims 9–
12 of the ’994 patent because “[c]laims 9–12 . . . claim a pro-
cess to treat mycosis which again is a generic terminology
for ‘onychomycosis’ via administering the compound of for-
mula in Claim 1.” Non-Final Rejection dated June 14,
2006, at 4; J.A. 1571.
Kaken responded by submitting an amendment that
cancelled claim 1, clarified the wording of claim 18, and as-
serted the important difference between mycosis and ony-
chomycosis. Noting that the “[t]reatment of onychomycosis
significantly differs from the general treatment of mycoses
claimed in ’994,” Kaken explained that “[o]nychomycosis is
a condition that specifically affects the nail plate.” Amend-
ment filed Sept. 14, 2006, at 10, in Appl. No. 10/685,266
(emphasis added); J.A. 1589. Kaken further argued that
the “present invention shows the unexpected ability of an
azolylamine derivate to penetrate nail and be retained by
the nail.” Amendment filed Sept. 14, 2006, at 10 (emphasis
Case: 18-2232 Document: 87 Page: 14 Filed: 03/13/2020
14 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
added); J.A. 1589. Accordingly, Kaken concluded, the re-
jection should be withdrawn.
The examiner credited Kaken’s explanation and with-
drew the rejection. In allowing the claims, the examiner
stated, under the heading “Examiner’s Reasons for Allow-
ance,” that “unexpectedly and in contrast to previously
evaluated compositions/methods, the instantly claimed
method cures the onychomycosis because the medicament
upon direct administration to the nail, penetrates through
the nail plate and eradicates the infection at the site.” No-
tice of Allowability dated Dec. 26, 2006, at 5, in Appl. No.
10/685,266 (emphasis added); J.A. 1608. The examiner
also suggested that Kaken cancel claim 18 and make claim
19 independent, which Kaken did, and the resulting claims
19 and 20 became claims 1 and 2 of the issued ’506 patent.
Compare Notice of Allowability dated Dec. 26, 2006, at 3–4
with ’506 patent, col. 17, line 34 through col. 18, line 32.
This exchange would leave a skilled artisan with no
reasonable uncertainty about the scope of the claim lan-
guage in the respect at issue here. Kaken is bound by its
arguments made to convince the examiner that claims 1
and 2 are patentable. See Standard
Oil, 774 F.2d at 452.
Thus, Kaken’s unambiguous statement that onychomyco-
sis affects the nail plate, and the examiner’s concomitant
action based on this statement, make clear that “treating
onychomycosis” requires penetrating the nail plate to treat
an infection inside the nail plate or in the nail bed under
it. 2
2 The intrinsic evidence in this case is decisive, mak-
ing it unnecessary to review the expert evidence. See
SIPCO, LLC v. Emerson Electric Co.,
939 F.3d 1301, 1307
(Fed. Cir. 2019) (“To the extent the Board considered ex-
trinsic evidence when construing the claims, we need not
consider the Board’s findings on the evidence because the
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KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 15
Accordingly, we reverse the Board’s claim construction.
B
The Board relied on its erroneous claim construction
throughout its consideration of facts that were part of its
obviousness analysis. For example, in determining that a
skilled artisan would have been motivated to combine JP
’639, the ’367 patent, or Hay with the Kaken Abstracts, the
Board rejected Kaken’s primary argument as inconsistent
with the Board’s claim construction. Before the Board, Ka-
ken argued that because the Kaken Abstracts document
experiments testing KP-103 in vitro and in skin (in the or-
dinary, not patent-defined sense), a skilled artisan would
not have been motivated to use KP-103 to treat onychomy-
cosis. See Acrux,
2018 WL 2761408, at *20. The Board
concluded that this argument “relies upon an improperly
narrow interpretation of the claim terms ‘nail’ and ‘ony-
chomycosis’” and “hinge[s] on a requirement that is not in
the challenged claims, treatment of onychomycosis in the
nail plate or nail bed.”
Id. Accordingly, the Board dis-
missed Kaken’s arguments as “misdirected.”
Id.
Similarly, the Board rejected Kaken’s objective indicia
of non-obviousness because it concluded, relying on the
claim construction we have concluded is erroneous, that
there is no nexus between the objective indicia and the
challenged claims. In its Patent Owner’s response, Kaken
intrinsic record is clear.”); Eidos Display, LLC v. AU Op-
tronics Corp.,
779 F.3d 1360, 1365 (Fed. Cir. 2015). With
one possible exception, the evidence on both sides is uni-
form about the nail-penetrating character of onychomyco-
sis addressed by the patent. The one possible exception
involves an entirely superficial, on-the-nail fungus that
commonly can be just scraped off. See Acrux,
2018 WL
2761408, at *5. The intrinsic evidence is inconsistent with
including treatment of that fungus within the claim scope.
Case: 18-2232 Document: 87 Page: 16 Filed: 03/13/2020
16 KAKEN PHARMACEUTICAL CO., LTD. v. IANCU
identified KP-103 as the “active pharmaceutical ingredient
in Jublia®, the first FDA-approved monotherapy for the
topical treatment of onychomycosis.” J.A. 1121. Kaken
made several objective-indicia arguments based on
Jublia®: that Jublia® produced unexpected results; that
Jublia® has had significant commercial success; that
Jublia® received industry praise; and that Jublia® fulfilled
a long-felt, but unmet need. See Acrux,
2018 WL 2761408,
at *22–26. But before considering any of those arguments,
the Board pointed to evidence that the FDA approved
Jublia® as a “topical treatment of onychomycosis of the toe-
nails,” and Jublia®’s label directs the user to “apply Jublia®
to affected toenails once daily.” J.A. 1809; see Acrux,
2018
WL 2761408, at *23. Because “Jublia®[] is directed to
treatment of specific fungal infections in toenails, and not
to a ‘nail’ or to treat ‘onychomycosis,’” the Board explained,
the “method for Jublia®’s use is not reasonably commensu-
rate with the [scope] of the challenged claims.” Acrux,
2018
WL 2761408, at *23. Thus, the Board concluded, the objec-
tive indicia presented by Kaken “do not weigh in favor of a
finding that the subject matter of the claims would not
have been obvious.”
Id. at *24.
The foregoing determinations are infected by the erro-
neous claim construction. In this court, the Director has
sought to support the Board’s factual findings with little or
no reliance on the claim construction we have held to be
erroneous. But that effort is more a reconstruction of the
Board’s analysis than a description of the Board’s actual
reasoning. We conclude that the appropriate course in this
case, as in so many others involving a reversal of a Board
claim construction, is to vacate the Board’s decision and re-
mand the matter. See, e.g., Arista Networks, Inc. v. Cisco
Sys., Inc.,
908 F.3d 792, 798 (Fed. Cir. 2018); Dell Inc. v.
Acceleron, LLC,
818 F.3d 1293, 1300 (Fed. Cir. 2016). We
do not prejudge whether the correct claim construction per-
mits the same factual findings or obviousness conclusion,
Case: 18-2232 Document: 87 Page: 17 Filed: 03/13/2020
KAKEN PHARMACEUTICAL CO., LTD. v. IANCU 17
let alone what factual findings should be made on the evi-
dence when the correct claim construction is used. Nor do
we prejudge what effect the withdrawal of Acrux has on
how the Board should proceed on remand.
III
For the foregoing reasons, we reverse the Board’s claim
construction, vacate the Board’s final written decision, and
remand the matter to the Board.
Costs awarded to appellants.
REVERSED IN PART, VACATED, AND REMANDED