Court Opinion

ID: 4299897
Source: CourtListenerOpinion
Date Created: 2018-08-01 15:00:31.136424+00
Date Added: 2024-06-11T13:26:12.842832
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

                  OTONOMY, INC.,
                     Appellant

                           v.

               AURIS MEDICAL, AG,
                   Cross-Appellant
               ______________________

                 2017-1850, 2017-1880
                ______________________

   Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board in No.
106,030.
               ______________________

               Decided: August 1, 2018
               ______________________

    RICHARD TORCZON, Wilson, Sonsini, Goodrich &
Rosati, PC, Washington, DC, argued for appellant. Also
represented by ADAM WILLIAM BURROWBRIDGE; MICHAEL
T. ROSATO, Seattle, WA.

    JONATHAN GARWOOD GRAVES, Cooley LLP, Reston,
VA, argued for cross-appellant. Also represented by
JOSEPH VAN TASSEL; BONNIE WEISS MCLEOD, Washington,
DC.
               ______________________
2                        OTONOMY, INC.   v. AURIS MEDICAL, AG

Before MOORE, O’MALLEY, and WALLACH, Circuit Judges.
O’MALLEY, Circuit Judge.
     Otonomy, Inc. (“Otonomy”) appeals the decision of the
Patent Trial and Appeal Board (“the Board”), which
entered judgment against it on the sole count of an inter-
ference between Auris Medical, AG’s U.S. Patent No.
9,066,865 (“the ’865 patent”) and Otonomy’s U.S. Patent
Application No. 13/848,636 (“the ’636 application”).
Otonomy, Inc. v. Auris Medical, AG, Interference No.
106,030, 2017 WL 394237, at *28 (P.T.A.B. Jan. 26, 2017).
In reaching this decision, the Board: (1) found that Oton-
omy failed to show that the ’865 patent was unpatentable
for lack of written description under 35 U.S.C. § 112;
(2) accorded Auris the benefit of a filing date before Oton-
omy’s earliest alleged priority date; and (3) denied Auris’s
motion for judgment that Otonomy’s involved claims are
unpatentable as anticipated under 35 U.S.C. § 102(b) by
Auris’s PCT Publication No. WO 2007/038949 (“the WO
’949”).
    On appeal, Otonomy challenges the Board’s decision
denying its motion for unpatentability with respect to
claim 9 of the ’865 patent (the sole remaining claim) and
its decision according Auris the benefit of its earlier-filed
application for purposes of priority. Auris conditionally
cross-appeals, arguing that, if we disagree with the
Board’s priority determination, we should reverse the
Board’s anticipation decision and find that the WO ’949
anticipates Otonomy’s involved claims.
    We reverse the Board’s accorded benefit decision and
find that Auris is not entitled to an effective filing date
before June 2014. Given that the ’865 patent would have,
at best, a June 27, 2014 filing date, which post-dates
Otonomy’s publication, we find that the Board erred in
entering judgment on priority against Otonomy. With
respect to the cross-appeal, because substantial evidence
OTONOMY, INC.   v. AURIS MEDICAL, AG                      3

supports the Board’s determination that Otonomy’s
involved claims are not anticipated by the WO ’949, we
affirm.
                       I. BACKGROUND
                   A. Factual Background
    The commonly claimed invention is a method of using
a suspended-fluoroquinolone composition to treat middle
and inner ear disorders. Otonomy filed its ’636 applica-
tion on March 21, 2013. That application discloses “com-
positions and methods for the treatment of otic diseases
or conditions with antimicrobial agent compositions and
formulations administered locally . . . through direct
application of these compositions and formulations onto or
via perfusion into” targeted portions of the ear. ’636
application, Abstract. Otonomy’s involved claims are
claims 38, 43, and 46–50 of the ’636 application (“Otono-
my’s involved claims”).
     The ’865 patent, which issued to Auris on June 30,
2015, “relates to compositions of one or more pharmaceu-
tical compounds for the prevention and/or treatment of
tinnitus and other disorders of the inner ear.” ’865 pa-
tent, col. 1, ll. 17–19. Specifically, the claimed invention
“provides compositions containing (i) a pharmaceutically
active agent selected from a group consisting of an arylcy-
cloalkylamine or a derivative, analogue or pharmaceuti-
cally active salt thereof, and (ii) a biocompatible polymer
or a combination of biocompatible polymers.” Id. at col. 3,
ll. 28–32. The ’865 patent has one independent claim—
claim 1, set forth below—and eight dependent claims.
   The ’865 patent issued from U.S. Patent Application
No. 14/317,319 (“the ’319 application”), filed on June 27,
4                        OTONOMY, INC.   v. AURIS MEDICAL, AG

2014. 1 That same day, Auris submitted a preliminary
amendment that added several claims directed to thera-
peutic compositions containing various claimed active
ingredients, including fluoroquinolones, for use in the
claimed methods. The ’319 application is a continuation
of U.S. Patent No. 11/992,632, which is the national stage
application       of       international       application
PCT/EP2005/010478 (“the ’478 PCT”). It is undisputed
that the specifications of the ’319 application, the ’632
application, and the ’478 PCT are substantially identical.
Otonomy, 2017 WL 394237, at *20. The ’478 PCT was
filed on September 28, 2005, and was published as the
WO ’949 on April 12, 2007.
                  B. Procedural History
    On July 20, 2015, the Board declared an interference
between the parties. The Board initially identified Oton-
omy as the senior party, based on the March 2013 filing
date of the ’636 application, and Auris as the junior party,
based on the June 2014 filing date of the Auris ’319
application. Otonomy, 2017 WL 394237, at *2.
    The Board designated claim 1 of the ’865 patent as the
sole count of the interference and indicated that all of
Auris’s ’865 patent claims (claims 1–9) and all of Otono-
my’s involved claims (claims 38, 43, 46–50) corresponded
to the count.
    Auris claim 1 provides as follows:
    1. A method of treating a middle or inner ear dis-
    ease comprising intratympanically administering
    to a patient in need thereof a controlled release

    1   Because Auris certified that its 2014 application
was not subject to the provisions of the America Invents
Act (“AIA”), the Patent and Trademark Office examined it
under pre-AIA rules. Joint Appendix (J.A.) 693-94.
OTONOMY, INC.   v. AURIS MEDICAL, AG                      5

    composition comprising a pharmaceutically active
    agent and a thermosetting polymer; wherein the
    pharmaceutically active agent is selected from an-
    tibiotics and is suspended in the composition, and
    the thermosetting polymer has a gelation temper-
    ature of at least about 15° C.,
    wherein the thermosetting polymer is poloxamer
    407 and is present at a concentration of about 20%
    (w/w), and
    wherein the antibiotic is fluoroquinolone.
’865 patent, col. 17, ll. 13–23.
    Both parties sought approval to file several motions
with the Board. The Board authorized four motions, two
for each party:
   •    Auris Motion 1: requesting that the Board accord
        benefit to the ’632 application and the ’478 PCT;
   •    Auris Motion 2: seeking judgment that Otonomy’s
        involved claims are anticipated under 35 U.S.C.
        § 102(b);
   •    Otonomy Motions 1 and 2: seeking judgment that
        the claims of the ’865 patent are unpatentable
        based on the written description and enablement
        requirements of 35 U.S.C. § 112; 2 and
   •    Otonomy Motion 6: requesting that the Board ac-
        cord benefit to a chain of previously filed applica-
        tions and provisional applications.
Otonomy, 2017 WL 394237, at *2–3. 3

    2   The Board authorized Otonomy to file Motions 1
and 2 jointly in a single motion.
   3    The Board did not authorize Otonomy Motion 3,
which sought judgment against Auris based on unpatent-
6                        OTONOMY, INC.   v. AURIS MEDICAL, AG

    On January 26, 2017, the Board issued the decision
now on appeal. At the outset, the Board denied Auris
Motion 2, finding that, although the WO ’949 disclosed
each of the elements found within Otonomy involved
claim 38, there “is no discernable single embodiment
which teaches all of the claim elements as arranged.” Id.
at *5. The Board concluded that there was “too much
picking and choosing among embodiments for one of
ordinary skill in the art to envision the claimed inven-
tion.” Id. at *7.
    Next, the Board granted in part and denied in part
Otonomy’s Motions 1 and 2. As to Motion 1, the Board
denied Otonomy’s written description challenge to all nine
claims of the ’865 patent, relying exclusively on Auris’s
June 27, 2014 preliminary amendment to provide the
necessary disclosure. Id. at *13. As to Motion 2, the
Board found that Auris claim 9, which is directed to the
treatment of a viral or bacterial infection, was enabled,
but that Auris claims 1–8 were not. Id. at *17–19. Ac-
cordingly, the Board granted Otonomy Motion 2 in part,
concluding that claims 1–8 were unpatentable. Id. at
*19. 4 This left claim 9 as Auris’s sole remaining claim
and grounds for asserting priority.
    The Board then granted Auris Motion 1, for benefit of
the ’632 application and the ’478 PCT, finding that the
’478 PCT “describe[s] the addition of fluoroquinolone for
use as an antibiotic in the delivery composition for treat-
ing inner ear diseases” and that “at least one specific
example (Example 2) includes 20% poloxamer 407 and
ketamine.” Id. at *20. The Board concluded that the
combination of these two elements met the limitations of

ability under 35 U.S.C. § 103 over certain prior art refer-
ences.
    4    The Board’s decision with respect to enablement
is not at issue on appeal.
OTONOMY, INC.   v. AURIS MEDICAL, AG                      7

the count, and accorded benefit of the ’478 PCT’s Septem-
ber 28, 2005 filing date to Auris. Id. at *21, *28.
    Finally, the Board granted in part Otonomy Motion 6,
finding that the ’636 application is entitled to the benefit
of its parent nonprovisional applications, the earliest of
which had a filing date of May 14, 2009. Id. at *28.
Neither party disputes that priority date on appeal.
    Given the Board’s determinations regarding accorded
benefit, the Board issued a redeclaration identifying Auris
as the senior party. Id. Because the Board accorded
Auris the benefit of a filing date before Otonomy’s earliest
alleged priority date, the Board entered judgment against
Otonomy on count 1.
    Otonomy timely appealed and Auris timely cross-
appealed. We have jurisdiction pursuant to 28 U.S.C.
§ 1295(a)(4)(A).
                   II. OTONOMY’S APPEAL
    On appeal, Otonomy argues that the Board erred in
denying Otonomy Motion 1 with respect to Auris’s sole
remaining claim—claim 9 of the ’865 patent. Specifically,
Otonomy argues that the Board erred in relying on a
theory that neither party advanced: “that the Auris 2014
application supported the present claims on the basis of
the preliminary amendment (rather than the body of the
specification itself).” Appellant Br. 12. Otonomy submits
that, had the Board found Auris claim 9 unpatentable for
lack of written description, there would not have been a
priority contest. Accordingly, Otonomy requests that we
reverse the Board’s decision on claim 9 of the ’865 patent,
and remand for entry of judgment in favor of Otonomy. In
the alternative, Otonomy maintains that the Board “mis-
apprehended the Auris PCT ’478 disclosure and the
controlling law in granting Auris Motion 1 and thus
according benefit to Auris.” Id. at 14.
8                        OTONOMY, INC.   v. AURIS MEDICAL, AG

    As explained below, we agree with Otonomy’s alterna-
tive argument and conclude that Auris is not entitled to
the benefit of the ’478 PCT’s 2005 filing date. We there-
fore reverse the Board’s decision on Auris Motion 1.
Consistent with the Board’s analysis with respect to
Otonomy Motion 1, wherein the Board found that the only
written description support for the commonly claimed
invention is set forth in the claims added by the 2014
preliminary amendment, we further find that Auris is not
entitled to an effective filing date prior to 2014. Accord-
ingly, the Board erred in awarding priority to Auris.
       A. Auris is Not Entitled to the Benefit of the
               ’478 PCT’s 2005 Filing Date
    Accorded benefit is defined as “Board recognition that
a patent application provides a proper constructive reduc-
tion to practice under 35 U.S.C. § 102(g)(1).” 37 C.F.R.
§ 41.201. Constructive reduction to practice “means a
described and enabled anticipation under 35 U.S.C.
§ 102(g)(1), in a patent application of the subject matter of
a count.” Id. To establish a constructive reduction to
practice and thereby the right to benefit of an earlier-filed
application for priority purposes, the movant need only
show that the earlier-filed application discloses a single
embodiment within the scope of the interference count
that complies with 35 U.S.C. § 112. Hunt v. Treppschuh,
523 F.2d 1386, 1389 (CCPA 1975) (holding that, where a
“parent application is relied upon as a prior constructive
reduction to practice[,] . . . the § 112, first paragraph
requirements need only be met for an embodiment within
the count”).
    Priority and reduction to practice are questions of law
based on subsidiary fact findings. Cooper v. Goldfarb, 154
F.3d 1321, 1327 (Fed. Cir. 1998). We review the Board’s
legal conclusions de novo, and its factual findings for
substantial evidence. Singh v. Brake, 317 F.3d 1334,
1340 (Fed. Cir. 2003) (citations omitted).
OTONOMY, INC.   v. AURIS MEDICAL, AG                      9

    In Auris Motion 1, Auris argued that it was entitled to
priority benefit of the ’478 PCT, filed on September 28,
2005. 5 According to Auris, the ’478 PCT demonstrates
that it possessed at least a single embodiment within the
scope of the interference count. The Board agreed, finding
that Example 2 of the ’478 PCT, which includes 20%
poloxamer 407 and ketamine, together with a separate
teaching that an antibiotic such as fluoroquinolone could
be used as an additional ingredient, “me[t] the limitations
of the count.” Otonomy, 2017 WL 394237, at *20–21.
    Otonomy argued to the Board that the ’478 PCT does
not teach the requisite suspension of fluoroquinolone. Id.
at *21. Although the Board recognized that this argu-
ment was “literally correct” based on the passages Oton-
omy cited, it found that, because the “dissolved ketamine
was stirred overnight,” it was “at least suspended in the
stirred mixture.” Id. Given the “description of fluoro-
quinolone as an antibiotic ingredient,” the Board found
that, absent “persuasive evidence to the contrary we are
of the view that if both were included they would be
‘suspended’ in that embodiment if mixed in the described
manner of Example 2.” Id. at *22. The Board concluded
that, because “there is an example of ketamine suspended
in poloxamer” together with a “clear teaching of an addi-
tional embodiment with an additional ingredient, includ-
ing fluoroquinolones,” the ’478 PCT described an
embodiment that satisfied the count. Id.
   On appeal, Otonomy argues that the Board erred in
permitting Auris to piece together disparate bits of disclo-

   5     Auris also argued that it was entitled to the bene-
fit of the ’632 application, but conceded that the ’478 PCT
and the ’632 application have the same specification as
the ’319 application, and proffered no separate grounds
for entitlement to the 2008 filing date of the ’632 applica-
tion. See Otonomy, 2017 WL 394237, at *20.
10                       OTONOMY, INC.   v. AURIS MEDICAL, AG

sure and that, regardless of “[w]hether accorded benefit is
viewed as an anticipation or written description analysis,
the result is the same: unguided post hoc selection is not
the proper standard.” Appellant Br. 26. We agree.
    It is undisputed that the ’478 PCT lacks any explicit
disclosure of a single embodiment of a suspended-
fluoroquinolone composition or its use. Counsel for Auris
conceded as much at oral argument. Oral Arg. at 20:03-
17,                      available                      at
http://oralarguments.cafc.uscourts.gov/default
.aspx?fl=2017-1850.mp3 (“There is no single express
embodiment” including suspension and fluoroquinolone.”).
The relevant question on appeal is whether the disclosure
in the ’478 PCT nevertheless shows that Auris possessed
at least a single embodiment within the scope of the
interference count. See Falkner v. Inglis, 448 F.3d 1357,
1363 (Fed. Cir. 2006) (stating that constructive reduction
to practice of a single embodiment requires compliance
with both the enablement and written description re-
quirements 35 U.S.C. § 112, first paragraph).
    The interference count requires, in relevant part, “in-
tratympanically administering to a patient in need there-
of a controlled release composition comprising a
pharmaceutically active agent and a thermosetting poly-
mer; wherein the pharmaceutically active agent . . . is
suspended in the composition.”        Otonomy, 2017 WL
394237, at *8 (emphasis added). Auris and the Board
relied on Example 2 of the ’478 PCT as providing support
for an active agent that is suspended. Id. at *21–22. But
Example 2 discloses that “[k]etamine was dissolved in the
poloxamer solution at a concentration of 1 mM with a
magnetic stirrer over night.” Id. at *21 (emphasis added).
Indeed, Otonomy’s expert, Dr. Salt, testified that Example
2 teaches dissolved ketamine, rather than a suspended
active agent. J.A. 3423.
OTONOMY, INC.   v. AURIS MEDICAL, AG                     11

    The Board did not address Dr. Salt’s testimony, and
instead stated that, because the “dissolved ketamine was
stirred overnight,” it was “at least suspended in the
stirred mixture.” Otonomy, 2017 WL 394237, at *21.
Given that the ’478 PCT describes the addition of fluoro-
quinolone for use as an antibiotic, the Board found that, if
both ketamine and fluoroquinolone were included they
would be “suspended” if mixed. Id. at *21–22. Neither
party advanced that theory, and the Board cited no evi-
dence to support it. Indeed, counsel for Auris conceded at
oral argument that Example 2 does not teach suspension
and that the Board erred in concluding otherwise. Oral
Arg. at 17:24–37 (“The Board seemed to find, and we are
not sure what they were doing here, but they seemed to
find teaching of suspension in Example 2 . . . which is not
correct.”).   The Board’s own unsupported conjecture
cannot supply the requisite substantial evidence to accord
benefit to Auris. See In re Kao, 639 F.3d 1057, 1067 (Fed.
Cir. 2011) (finding that Board “conjecture does not supply
the requisite substantial evidence”). As Otonomy points
out, moreover, to the extent the Board assumed that
ketamine would have been suspended at some point
during the overnight stirring step, that assumption is
irrelevant because the count requires that the fluoroquin-
olone be suspended at the time of treatment. See Otonomy,
2017 WL 394237, at *8.
    Auris maintains that, even if the Board erred in its
analysis of what Example 2 teaches regarding how the
ingredient is mixed within the polymer material, “any
such error was harmless.” Cross-Appellant Br. 11. Ac-
cording to Auris, Example 2 “meets the limitations of the
count, except for the limitation that provides that the
pharmaceutically active agent [fluoroquinolone] is sus-
pended in the composition.” Id. at 43. Because the ’478
PCT provides an “express teaching of a limited number of
ways (specifically, three ways) of mixing an active agent
within a polymer,” Auris argues that a person of ordinary
12                       OTONOMY, INC.   v. AURIS MEDICAL, AG

skill would “immediately envisage” using a suspended-
fluoroquinolone composition. Id. at 45.
    Although the Board did not consider this argument in
its analysis of Auris Motion 1, it expressly rejected it in
the context of Auris Motion 2. 6 Specifically, in connection
with Auris Motion 2, the Board found that “too much
picking and choosing among the embodiments” is required
to anticipate the claimed suspended-fluoroquinolone
composition. Otonomy, 2017 WL 394237, at *7. As dis-
cussed below in conjunction with Auris’s cross-appeal,
substantial evidence supports the Board’s finding that the
’478 PCT (and its corresponding publication, the WO ’949)
does not describe a suspended-fluoroquinolone composi-
tion.
    We conclude that the Board erred in finding that the
’478 PCT discloses an embodiment that meets all of the
limitations of the count. Accordingly, Auris is not entitled
to the benefit of the ’478 PCT’s September 2005 filing
date. We therefore reverse the Board’s decision on Auris
Motion 1.
         B. Auris is Not Entitled to an Effective
             Filing Date Before June 2014
    In ruling on Otonomy Motion 1, the Board found that
the original specification of the ’319 application, which is
substantially identical to that of the ’478 PCT, does not

     6  Auris Motion 1 and Auris Motion 2 were decided
in view of the same substantive disclosure: the ’478 PCT
and its corresponding publication WO ’949. And the
standard by which the Board reviewed each motion was
the same: whether the ’478 PCT or WO ’949 sufficiently
discloses a suspended-fluoroquinolone composition.
Despite the common question, the Board reached oppo-
site—and in these circumstances, irreconcilable—
conclusions.
OTONOMY, INC.   v. AURIS MEDICAL, AG                      13

provide full scope written description support for the
commonly-claimed invention. Otonomy, 2017 WL 394237,
at *11. The test for sufficiency of written description “is
whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as
of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Sufficien-
cy of written description is a question of fact, which we
review for substantial evidence. Gen. Hosp. Corp. v.
Sienna Biopharm., Inc., 888 F.3d 1368, 1371 (Fed. Cir.
2018).
     In Otonomy Motion 1, Otonomy argued to the Board
that “ketamine treatment of the inner ear is the invention
of the ’865 patent, and prior to the filing of a preliminary
amendment no Auris application disclosed or claimed a
method of administering a composition without an arylcy-
cloalkylamine such as ketamine.” Otonomy, 2017 WL
394237, at *8. The Board agreed that the “specification
consistently describes the use of ketamine” and includes
“fluoroquinolone only as a potential adjunct pharmaceuti-
cal, in a variety of formulations.” Id. at *13.
    The Board found that the “only description of the in-
vention as presently claimed is in the claims filed by
amendment, and it is in fact somewhat divorced from the
entirety of the rest of the description in making the inven-
tion, and the only description of this embodiment without
inclusion of arylcycloalkylamine.” Id. at *11. In reaching
this conclusion, the Board emphasized that the “only
objective factual support for the claim requiring only
fluoroquinolone” was provided in the 2014 preliminary
amendment, and that the amendment was necessary to
“overcom[e]” the “specification’s clear focus on inclusion of
another medicament.” Id. at *13.
    Substantial evidence supports the Board’s decision
that the original specification of the ’319 application does
14                       OTONOMY, INC.   v. AURIS MEDICAL, AG

not provide sufficient written description support for the
claimed suspended-fluoroquinolone composition. As the
Board explained, it took the June 2014 preliminary
amendment introducing a claim with no express arylcy-
cloalkylamine limitation to suggest the commonly-claimed
invention. Setting aside the question of whether the
Board was entitled to rely exclusively on a preliminary
amendment in its written description analysis—
particularly where neither party requested it do so 7—the
record shows that Auris is not entitled to an effective
filing date prior to June 27, 2014, the date on which it
filed the preliminary amendment. See Reiffin v. Microsoft
Corp., 214 F.3d 1342, 1346 (Fed. Cir. 2000) (“[C]laims to
subject matter in a later-filed application not supported
by an ancestor application in terms of § 112 ¶ 1 . . .do not

     7  On appeal, the parties seem to agree that the
Board’s decision to rely solely on the preliminary amend-
ment for written description support was in error. Oton-
omy explains that Auris never argued that the 2014
preliminary amendment provided written description
support because it was faced with a strategic decision—
Auris could either: (1) rely on the 2005 priority date of its
’478 PCT and shield itself from nine years of intervening
prior art; or (2) broaden the scope of its invention beyond
what was claimed in the ’478 PCT, but only claim a 2014
priority date. Auris selected the former option, and
claimed priority to the ’478 PCT. On appeal, Auris sub-
mits that, “although it reached the correct result in find-
ing that the Auris claims met the written description
requirement, the Board erred in relying solely on the
Preliminary Amendment in reaching this conclusion.”
Cross-Appellant Br. 31. Auris maintains that the error
was harmless, however, because the original specification
provides sufficient written description support. We accept
the parties’ agreement that the Board erred, but disagree
with Auris that any such error would have been harmless.
OTONOMY, INC.   v. AURIS MEDICAL, AG                    15

receive the benefit of the earlier application’s filing
date.”).
    C. The Board Erred in Awarding Priority to Auris
    In sum, as described in connection with our review of
Auris Motion 1, Auris is not entitled to the benefit of the
’478 PCT’s 2005 filing date. And, as described in connec-
tion with our review of Otonomy Motion 1, the ’865 patent
cannot claim priority any earlier than June 2014, when
Auris filed its preliminary amendment to the ’319 applica-
tion.
    Given that the effective filing date of the ’865 patent
is, at best, the 2014 filing date of the ’319 application,
which post-dates Otonomy’s published application, we
find that the Board erred in awarding priority to Auris.
We therefore reverse the judgment of priority against
Otonomy and remand for entry of judgment on priority
against Auris.
                 III. AURIS’S CROSS-APPEAL
    Auris conditionally cross-appeals, arguing that the
Board erred when it concluded that the WO ’949 (the
published version of the ’478 PCT) did not anticipate
Otonomy’s involved claims. “A patent claim is invalid for
anticipation under 35 U.S.C. § 102 when a prior art
reference describes ‘each and every claim limitation and
enable[s] one of skill in the art to practice an embodiment
of the claimed invention without undue experimentation.’”
In re Chudik, 851 F.3d 1365, 1372 (Fed. Cir. 2017) (quot-
ing ClearValue, Inc. v. Pearl River Polymers, Inc., 668
F.3d 1340, 1344 (Fed. Cir. 2012)). Anticipation is a ques-
tion of fact, which we review for substantial evi-
dence. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d
1331, 1341 (Fed. Cir. 2016). “Substantial evidence is
more than a mere scintilla,” it is evidence that a “reason-
able mind might accept as adequate to support a conclu-
sion.” Id. at 1337.
16                       OTONOMY, INC.   v. AURIS MEDICAL, AG

     In Auris Motion 2, Auris contended that WO ’949 an-
ticipated Otonomy claim 38 (Otonomy’s sole independent
claim) by disclosing each and every element of the claim
as arranged. Specifically, Auris argued that the WO ’949
contains: (1) Example 2, which discloses most of the
limitations of claim 38, except for a suspension of fluoro-
quinolone; and (2) “specific teachings that compositions in
accordance with the present invention can comprise other
biologically active agents including antibiotics, such as
fluoroquinolone.” Cross-Appellant Br. 33. Given these
disclosures, Auris argued that a person of ordinary skill in
the art would have been able to practice an embodiment
within the scope of claim 38 without undue experimenta-
tion.
    Looking at the WO ’949, the Board found that it “does
in fact individually teach [the claimed] elements, and in
the structure of a composition for treatment of inner ear
diseases,” but that there “is no discernable single embod-
iment which teaches all of the claim elements as ar-
ranged.” Otonomy, 2017 WL 394237, at *5. Specifically,
the Board found that the WO ’949 “describes pharmaceu-
tical compositions for the treatment of inner ear disor-
ders,” and that, in terms of selecting a pharmaceutical,
“there are potentially infinite” options available. Id. at
*6. In terms of delivery vehicles, the Board found that the
WO ’949 describes that the “composition can be solid,
liquid, semi-solid, or gel-like” and that the delivery vehi-
cle can be “a solution, suspension, or thermosetting gel.”
Id. Given these different options, the Board found that
there was “too much picking and choosing among embod-
iments for one of ordinary skill in the art to envision the
claimed invention.” Id. at *7.
    On appeal, Auris argues that the Board’s anticipation
analysis “improperly focused on the relatively large
number of theoretical combinations disclosed” in the WO
’949 and failed to consider key teachings that would allow
a person of skill in the art “to immediately narrow down
OTONOMY, INC.   v. AURIS MEDICAL, AG                      17

or look past these theoretical combinations and recognize
a single disclosed embodiment that anticipates Otonomy’s
broad claims.” Cross-Appellant Reply 1. Auris maintains
that, when the teachings of the WO ’949 are considered in
context, there are relatively few potential combinations.
    Where a combination of disclosed elements is con-
cerned, “a reference can anticipate a claim even if it
‘d[oes] not expressly spell out’ all the limitations arranged
or combined as in the claim.” Blue Calypso, 815 F.3d at
1343 (quoting Kennametal, Inc. v. Ingersoll Cutting Tool
Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015)). We have
recognized that “a reference may still anticipate if that
reference teaches that the disclosed components or func-
tionalities may be combined and one of skill in the art
would be able to implement the combination.” Id. at
1344.
    While Auris points to multiple, distinct teachings
within the WO ’949, it does not identify guidance in the
disclosure to link them together. And, although Auris
contends that the Board erred by ignoring key embodi-
ments and teachings from WO ’949, including Example 2
and a separate teaching that a fluoroquinolone could be
an additional ingredient, anticipation requires that the
reference provide specific guidance that would lead a
person of ordinary skill to an embodiment within the
claim. See In re Arkley, 455 F.2d 586, 587 (CCPA 1972)
(noting that an anticipating reference “must clearly and
unequivocally disclose the claimed compound or direct
those skilled in the art to the compound without any need
for picking, choosing, and combining various disclosures
not directly related to each other by the teachings of the
cited reference”).
    Looking at the number of possible formulations and
combinations disclosed in the WO ’949, the Board found
that nothing therein would lead a person of ordinary skill
in the art to pick and choose among the elements of the
18                       OTONOMY, INC.   v. AURIS MEDICAL, AG

disclosure to arrive at a suspended-fluoroquinolone com-
position as claimed. Otonomy, 2017 WL 394237, at *5–7.
We conclude that substantial evidence supports the
Board’s findings. Accordingly, we affirm the Board’s
determination that the WO ’949 does not anticipate
Otonomy claim 38.
                     IV. CONCLUSION
     We have reviewed the parties’ remaining arguments
and find them unpersuasive. For the foregoing reasons,
we reverse the Board’s decision according Auris the bene-
fit of priority to its ’478 PCT. Because we conclude that
the ’865 patent is not entitled to an effective filing date
prior to June 2014—which is after Otonomy’s 2009 ac-
corded benefit date—we reverse the Board’s priority
determination and remand for entry of judgment on
priority in favor of Otonomy. With respect to the cross-
appeal, we affirm the Board’s decision that Otonomy’s
involved claims are not anticipated by the WO ’949.
     REVERSED AND REMANDED IN NO. 17-1850;
            AFFIRMED IN NO. 17-1880
                          COSTS
     No costs.