Court Opinion

ID: 4146690
Source: CourtListenerOpinion
Date Created: 2017-02-21 17:00:57.372395+00
Date Added: 2024-06-11T09:21:27.344929
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

              IN RE: DEPOMED, INC.,
                       Appellant
                ______________________

                      2016-1378
                ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2014-
00652.
                 ______________________

              Decided: February 21, 2017
               ______________________

   ARLENE L. CHOW, Hogan Lovells US LLP, New York,
NY, argued for appellant. Also represented by ERIC J.
LOBENFELD, THOMAS SCHMIDT; JESSICA LYNN ELLSWORTH,
Washington, DC.

    KAKOLI CAPRIHAN, Office of the Solicitor, United
States Patent and Trademark Office, Alexandria, VA,
argued for intervenor Michelle K. Lee. Also represented
by NATHAN K. KELLEY, SARAH E. CRAVEN, LORA DRISCOLL,
SCOTT WEIDENFELLER.
                 ______________________

       Before DYK, REYNA, and STOLL, Circuit Judges.
     Opinion for the court filed by Circuit Judge STOLL.
2                             IN RE: DEPOMED, INC.

      Concurring opinion filed by Circuit Judge REYNA.
STOLL, Circuit Judge.
     Endo Pharmaceuticals, Inc. filed a petition for inter
partes review with the Patent Trial and Appeal Board to
review the patentability of Depomed, Inc.’s U.S. Patent
No. 6,723,340. The Board instituted an IPR proceeding
on a subset of the grounds in the petition and ultimately
determined that two instituted grounds collectively ren-
dered claims 1, 3–5, and 10–13 unpatentable as obvious.
Depomed appeals from the Board’s final written decision,
challenging the Board’s patentability determination. We
affirm.
                        BACKGROUND
                             I.
     Depomed is the assignee of the ’340 patent, which is
generally directed to vehicles for drug delivery. Specifi-
cally, the ’340 patent discloses “[u]nit dosage form tablets
for the delivery of pharmaceuticals [that] are formed of
the pharmaceutical dispersed in a solid unitary matrix
that is formed of a combination of poly(ethylene oxide)
and hydroxypropyl methylcellulose.” ’340 patent Ab-
stract. The patent explains that many drugs have their
greatest therapeutic effect when they are released in the
stomach in a prolonged, continuous manner because such
delivery presents fewer side effects and reduces the need
for repeated or frequent dosing.
    Gastric retention, where the particles in a drug are
retained in the stomach for a prolonged duration, can be
achieved by using drug formulation particles small
enough to be swallowed comfortably but that swell to a
larger size upon contact with gastric fluids. “One means
of achieving a swellable particle is to disperse the drug in
a solid matrix formed of a substance that absorbs the
gastric fluid and swells as a result of the absorbed fluid.”
Id. at col. 2 ll. 28–31. These polymer matrices also pro-
IN RE: DEPOMED, INC.                                      3

vide a controlled release of a drug over a prolonged period
of time.
     Poly(ethylene oxide) (“PEO”) is a matrix material that
possesses both swelling and controlled release properties
but raises toxicology concerns when used in the amounts
required for high drug dosages. Hydroxypropyl methyl-
cellulose (“HPMC”) is another matrix material that swells
to a lesser degree than PEO but offers “the benefit of a
more even and generally faster erosion in the gastric
environment so that the dosage forms can clear the GI
tract more predictably after a few hours of drug release.”
Id. at col. 3 ll. 20–23. The patent asserts that HPMC can
be disadvantageous, however, because it causes a high
initial burst of drug release and a lower degree of control
over the drug release rate during the initial course of the
drug release.
     The ’340 patent purports to improve on the prior art
by combining PEO and HPMC in a matrix “for a swella-
ble, sustained-release tablet [that] provides unexpectedly
beneficial performance, avoiding or substantially reducing
the problems enumerated above and offering improved
control and reliability while retaining both the ability to
swell for gastric retention and to control release.” Id. at
col. 3 ll. 35–40. Claim 1 is illustrative of the challenged
claims and is reproduced below:
    1. A controlled-release tablet for releasing a
    drug into at least a portion of a region defined by
    the stomach and the upper gastrointestinal tract,
    said tablet comprising a solid monolithic matrix
    with said drug dispersed therein, said matrix
    comprising a combination of poly(ethylene oxide)
    and hydroxypropyl methylcellulose at a weight
    ratio that causes said matrix to swell upon con-
    tact with gastric fluid to a size large enough to
    provide gastric retention, wherein;
4                                IN RE: DEPOMED, INC.

       said drug has a solubility in water that ex-
    ceeds one part of said drug per ten parts of water,
    by weight, and wherein;
       said poly(ethylene oxide) has a viscosity aver-
    age molecular weight from about 2,000,000 to
    about 10,000,000, and wherein
        said hydroxypropyl methylcellulose has a vis-
    cosity of from about 4,000 centipose to about
    200,000 centipose, measured as a 2% solution in
    water.
’340 patent col. 11 l. 60 – col. 12 l. 9.
                               II.
    Endo petitioned for IPR of the ’340 patent, alleging
that claims 1–5 and 10–13 were unpatentable as obvious
under 35 U.S.C. § 103 in view of five different prior art
grounds. 1 The Board instituted an IPR on claims 1, 3–5,
and 10–13 on the obviousness grounds of (1) PCT Applica-
tion No. WO 98/55107, titled “Gastric-Retentive Oral
Drug Dosage Forms for Controlled Release of Highly
Soluble Drugs” (“Shell 1998”); (2) Shell 1998 in combina-
tion with a 1993 article entitled “Swelling Studies on
Mixtures of Two Hydrophilic Excipients” (“Papadimitri-
ou”); and (3) Papadimitriou in combination with U.S.
Patent No. 4,871,548. The Board did not institute on two
other grounds in Endo’s petition, calling them redundant
of the instituted grounds. In addition, the Board did not
institute review of claim 2.

    1   Given the effective filing date of the claims of the
’340 patent, the version of 35 U.S.C. § 103 that applies
here is that in force preceding the changes made by the
America Invents Act. See Leahy–Smith America Invents
Act, Pub. L. No. 112-29, § 3(n), 125 Stat. 284, 293 (2011).
IN RE: DEPOMED, INC.                                      5

    The Board’s final written decision concluded that
claims 1, 3–5, and 11–13 are unpatentable as obvious in
view of Shell 1998. Endo Pharm., Inc. v. Depomed, Inc.,
IPR2014-00652, 2015 WL 5470293, at *6 (P.T.A.B. Sept.
16, 2015) (Final Written Decision). The Board additional-
ly found that claims 1, 3–5, and 10–13 are unpatentable
as obvious in view of Shell 1998 in combination with
Papadimitriou. Id. at *11.
    Depomed timely appealed to this court, and shortly
thereafter, Endo withdrew as a party to this appeal.
Following Endo’s withdrawal, the Director of the United
States Patent and Trademark Office intervened pursuant
to 35 U.S.C. § 143, filing a brief and participating in oral
argument.      We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A) and 35 U.S.C. § 141(c) to review the
Board’s final written decision.
                       DISCUSSION
     On appeal, Depomed argues that the Board erred in
failing to account for the unexpected results of combining
PEO and HPMC. Depomed also argues that the Board’s
obviousness conclusion improperly relied on hindsight
bias. Finally, Depomed argues that the Board applied an
incorrect legal standard to assess long-felt, but unmet,
need. We address each argument in turn.
                             I.
     We first consider Depomed’s argument that the Board
erred in its obviousness conclusion by failing to account
for the unexpected results of combining PEO and HPMC.
     A patent claim is unpatentable as obvious “if the
differences between the subject matter sought to be
patented and the prior art are such that the subject
matter as a whole would have been obvious at the time
the invention was made to a person having ordinary skill
in the art.” 35 U.S.C. § 103. Obviousness under § 103 is a
mixed question of law and fact. We review the Board’s
6                             IN RE: DEPOMED, INC.

ultimate obviousness determination de novo and underly-
ing factual findings for substantial evidence. Harmonic
Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir.
2016). Substantial evidence “means such relevant evi-
dence as a reasonable mind might accept as adequate to
support a conclusion.”          Consol. Edison Co. v.
NLRB, 305 U.S. 197, 217 (1938). Factual considerations
underlying the obviousness inquiry include the scope and
content of the prior art, the differences between the prior
art and the claimed invention, the level of ordinary skill
in the art, and relevant secondary considerations. KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (citing
Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966)).
Relevant secondary considerations include commercial
success, long-felt but unmet need, failure of others, and
unexpected results. Id.
    Citing column 3, lines 33–65 of the specification,
Depomed argues that the Board failed to account for the
alleged unexpected properties of the patented invention,
namely, that the combination of HPMC and PEO yielded
better controlled-release properties compared to using
HPMC or PEO alone. Column 3 of the specification states
that combining HPMC and PEO as a matrix for a swella-
ble, sustained-release tablet provides “unexpectedly
beneficial performance, avoiding or substantially reducing
the problems” with using either HPMC or PEO alone.
’340 patent col. 3 ll. 33–40.
    The Board considered Depomed’s argument and de-
termined that, to the contrary, Depomed’s evidence of
unexpected results was entitled to “little weight” and did
not overcome the petitioner’s showing of obviousness.
Final Written Decision, 2015 WL 5470293, at *23. The
Board separately explained that one of ordinary skill
would have expected that combining HPMC and PEO
would provide a solid matrix for controlled drug release
because Shell 1998 discloses a finite number of identified,
predictable polymers that could be used individually or in
IN RE: DEPOMED, INC.                                      7

combination, of which HPMC and PEO are “particularly
preferred” polymers. See J.A. 415. Though Shell 1998
does not explicitly disclose the combination of HPMC and
PEO, it suggests the desirability of such a combination by
stating that “[c]ertain combinations will often provide a
more controlled release of the drug than their components
when used individually.” Id. at 416. The Board held that
these facts support a conclusion “that the combination of
PEO and HPMC, identified by the Shell 1998 Publication
as particularly preferred polymers, would have been
obvious to one of ordinary skill in the art at the time of
the ’340 patent.” Final Written Decision, 2015 WL
5470293, at *9.
     On this record, we conclude that substantial evidence
supports the Board’s finding that Depomed’s evidence of
unexpected results is weak and entitled to little weight.
“To be particularly probative, evidence of unexpected
results must establish that there is a difference between
the results obtained and those of the closest prior art, and
that the difference would not have been expected by one of
ordinary skill in the art at the time of the invention.”
Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
752 F.3d 967, 977 (Fed. Cir. 2014). Here, Shell 1998
discloses (1) a finite number of matrix polymers, of which
HPMC and PEO are preferred; (2) that matrix polymers
“can be used individually or in combination”; and (3) that
“[c]ertain combinations will often provide a more con-
trolled release of the drug than their components when
used individually.” J.A. 416. The express disclosure that
combinations of polymers will often yield better results
than when used alone undermines Depomed’s suggestion
that the difference between using HPMC and PEO indi-
vidually and using them in combination would not have
been expected.
    At bottom, we discern no error in the Board’s ultimate
conclusion of obviousness. Even after giving Depomed’s
unexpected results evidence the weight afforded by the
8                             IN RE: DEPOMED, INC.

Board, we agree with the Board’s ultimate conclusion that
the claims are obvious in view of Shell 1998. 2
                            II.
    Depomed also argues that the Board’s analysis of the
prior art was erroneous “because it analyzed the prior art
through the distorted lens of hindsight bias.” Appellant
Br. 30. Specifically, Depomed argues that Shell 1998
discloses polymer combinations solely for the purpose of
overcoming deficiencies in the controlled release proper-
ties of certain polymers in their individual capacities.
Because HPMC and PEO did not exhibit these deficien-
cies in their individual capacities, Depomed argues that a
person of ordinary skill in the art would have had no
motivation to combine HPMC and PEO, and thus, the
Board’s obviousness conclusion was the result of hind-
sight bias. We disagree.
    As explained above, Shell 1998 does not explicitly
disclose the combination of HPMC and PEO. Shell 1998,
nevertheless, discloses combinations including, xanthan
gum combined with hydroxyethyl cellulose, hydroxypropyl
cellulose, or PEO. We agree, however, with the Board’s
finding that Shell 1998 “does not limit which polymers
could be combined or suggest that certain polymers would
not function properly in a combination matrix.” Final
Written Decision, 2015 WL 5470293, at *9. Accordingly,
we conclude that substantial evidence supports the

    2    The concurrence contends that we “appear to ac-
cept” an allegedly improper two-step framework in the
Board’s obviousness analysis. Concurrence 1. We do not
suggest a two-step framework. Rather, we simply find
substantial evidence supports the Board’s factual findings
underlying its conclusion of obviousness and agree with
its ultimate legal conclusion that the claims are invalid as
obvious.
IN RE: DEPOMED, INC.                                       9

Board’s interpretation of Shell 1998 and see no error in
the Board’s ultimate conclusion of obviousness.
                            III.
    Finally, Depomed argues that the Board incorrectly
required evidence demonstrating a failure of others to
establish a long-felt but unmet need. We agree.
     Though we have held that long-felt but unmet need is
closely related to the failure of others, they are distinct
considerations. See, e.g., Graham, 383 U.S. at 18 (listing
long-felt but unsolved need and failure by others as
separate secondary considerations); In re Cyclobenzaprine
Hydrochloride Extended-Release Capsule Patent Litiga-
tion, 676 F.3d 1063, 1081–83 (Fed. Cir. 2012) (noting that
“[l]ongfelt need is closely related to the failure of others”
but separately analyzing evidence of both in discrete
sections). While “[e]vidence is particularly probative of
obviousness when it demonstrates both that a demand
existed for the patented invention, and that others tried
but failed to satisfy that demand,” a patent owner may
establish a long-felt but unmet need without presenting
evidence of failure of others. In re Cyclobenzaprine, 676
F.3d at 1082.
     In its analysis of Depomed’s evidence of long-felt but
unmet need, the Board incorrectly stated that evidence
demonstrating a failure of others is necessary to show a
long-felt but unmet need. At oral argument, however,
counsel for the Director correctly acknowledged that
evidence of a failure of others is not required to demon-
strate long-felt but unmet need. See Oral Arg. at 14:40–
58, 15:14–24, http://oralarguments.cafc.uscourts.gov/defau
lt.aspx?fl=2016-1378.mp3.
    Even though the Board misstated the law, it accorded
some weight to Depomed’s long-felt but unmet need
evidence. Depomed’s evidence consisted of conclusory
inventor testimony that “there was a long-felt need in the
10                             IN RE: DEPOMED, INC.

field for a once-daily, gastric-retentive, controlled-release
dosage forms to deliver highly soluble drugs slowly,
evenly and reproducibly.” J.A. 758. Without citing any
evidentiary support, the inventor identified problems
associated with immediate release dosage forms of met-
formin and gabapentin and explained that these problems
were ameliorated by later dosage forms of these drugs
that practiced the ’340 patent.
     We conclude that, despite the Board’s misstatement of
the law, substantial evidence supports its assignment of
little weight to Depomed’s evidence of long-felt but unmet
need. We also agree with the Board’s ultimate conclusion
that the claims are obvious in view of Shell 1998.
                       CONCLUSION
    We have considered Depomed’s remaining arguments
regarding secondary considerations but discern no errors
in the Board’s analysis. 3 Because we find that the Board
did not err in holding claims 1, 3–5, and 10–13 of the ’340
patent unpatentable, we affirm.
                       AFFIRMED
                           COSTS
     No costs.

     3  Depomed additionally raises a separate issue
challenging the constitutionality of IPR proceedings. We
have previously held that such proceedings do not violate
Article III or the Seventh Amendment. MCM Portfolio
LLC v. Hewlett-Packard Co., 812 F.3d 1284, 1291–93
(Fed. Cir. 2015), cert. denied, 137 S. Ct. 292 (2016). “We
are bound by prior Federal Circuit precedent ‘unless
relieved of that obligation by an en banc order of the court
or a decision of the Supreme Court.’” Id. (quoting Deckers
Corp. v. United States, 752 F.3d 949, 959 (Fed. Cir.
2014)).
  United States Court of Appeals
      for the Federal Circuit
                 ______________________

               IN RE: DEPOMED, INC.,
                       Appellant
                ______________________

                       2016-1378
                 ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2014-
00652.
                 ______________________

REYNA, Circuit Judge, concurring.
    I agree that the asserted claims in this case would
have been obvious to a person of ordinary skill in the art
at the time of the invention. I write separately to express
two concerns.
                            I.
    I am troubled that the Board improperly employed a
two-step approach in its obviousness analysis. It first
made initial conclusions of obviousness and only later
considered Depomed’s objective indicia of non-
obviousness. By failing to correct the Board’s mistake
and instead discussing only its ultimate conclusion of
obviousness, the majority appears to accept such a two-
step framework.
   The Board’s approach is inconsistent with our prece-
dent. We repeatedly have stated that objective indicia of
non-obviousness are vital to an obviousness determina-
2                                       IN RE: DEPOMED, INC.

tion, not evidence to be ignored or mentioned as a mere
afterthought. 1 Such evidence is an important safeguard
against hindsight bias, 2 and “may often be the most
probative and cogent evidence in the record.” Stratoflex,
713 F.2d at 1538; see also MUELLER ON PATENT LAW

    1    See, e.g., Apple Inc. v. Samsung Elecs. Co., 839
F.3d 1034, 1052 (Fed. Cir. 2016) (en banc) (relying on
industry praise, copying, commercial success, and long-
felt need to determine that certain claims would not have
been obvious); Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d
1346, 1357 (Fed. Cir. 2013) (“Whether before the Board or
a court, this court has emphasized that consideration of
the objective indicia is part of the whole obviousness
analysis, not just an afterthought.”); In re Kao, 639 F.3d
1057, 1067 (Fed. Cir. 2011) (“[W]hen secondary considera-
tions are present, though they are not always dispositive,
it is error not to consider them.”); Stratoflex v. Aeroquip
Corp., 713 F.2d 1520, 1538 (Fed. Cir. 1983) (Markey, C.J.)
(“[E]vidence rising out of the so-called ‘secondary consid-
erations’ must always when present be considered en
route to a determination of obviousness.”).
     2   KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421
(2007) (“A factfinder should be aware, of course, of the
distortion caused by hindsight bias and must be cautious
of arguments reliant upon ex post reasoning.”); Graham
v. John Deere Co., 383 U.S. 1, 36 (1966) (objective indicia
“may also serve to ‘guard against slipping into use of
hindsight,’ and to resist the temptation to read into the
prior art the teachings of the invention in issue”) (citation
omitted); Apple, 839 F.3d at 1052 (recognizing that objec-
tive indicia guard against hindsight bias); In re Cycloben-
zaprine, 676 F.3d 1063, 1079 (Fed. Cir. 2012) (“The
objective considerations, when considered with the bal-
ance of the obviousness evidence in the record, guard as a
check against hindsight bias.”).
IN RE: DEPOMED, INC.                                      3

§ 9.02[C][2][b] (2012) (noting that the four Graham fac-
tors, including objective indicia, “have come to be essen-
tial to every nonobviousness analysis”).
     Of particular concern is the establishment of a prima
facie standard in the obviousness analysis, whether
actual or constructive. In an IPR, the law does not con-
template a burden-shifting test in the treatment of objec-
tive evidence of non-obviousness. But in this case, the
Board employed just such a test. First, it made prima
facie determinations of obviousness. See J.A. 17 (“[W]e
hold that Petitioner has shown by a preponderance of the
evidence that independent claim 1 is unpatentable under
35 U.S.C. § 103(a) for obviousness in view of the Shell
1998 Publication.”); J.A. 28 (“[W]e hold that Petitioner
has shown by a preponderance of the evidence that de-
pendent claims 3–5 and 10–13 are unpatentable under 35
U.S.C. § 103(a) for obviousness in view of the Shell 1998
Publication.”). Only later—in a different section under a
different heading—did it consider Depomed’s objective
indicia of non-obviousness. 3 See J.A. 34. Deferring con-
sideration of objective indicia until after deciding a claim
would have been obvious allows hindsight bias to creep
into step one (the prima facie showing) and limits the
meaningfulness of step two. The Board then compounded
its error by failing to address all of Depomed’s objective
indicia. For instance, it labeled one section, “Undue
Experimentation and Unexpected Results.” J.A. 39. But
under that heading, the Board wholly failed to discuss
unexpected results. See J.A. 39–40. This was error.

    3   Lest there be doubt, counsel for the PTO admitted
at oral argument that the Board employed a two-step
process. Oral Arg. at 18:40–19:16, http://oralarguments.
cafc.uscourts.gov/default.aspx?fl=2016-1378.mp3.
4                                       IN RE: DEPOMED, INC.

    We have held that district courts may not employ a
two-step burden-shifting scheme in an obviousness analy-
sis. Cyclobenzaprine, 676 F.3d at 1075. In Cycloben-
zaprine, the district court erred by making an obviousness
determination before considering the patentee’s objective
indicia of non-obviousness. We noted that a fact finder
must “consider all evidence relating to obviousness before
finding a patent invalid on those grounds.” Id. Failure to
do so results in an impermissible burden-shifting scheme
for which there is “no practical need.” Id. at 1080 n.7.
    As we explained in Cyclobenzaprine, the prohibition
against burden-shifting does not apply to ex parte patent
prosecution proceedings, and for good reason. “During
prosecution, a patent applicant, as a practical matter,
may not have the opportunity to present objective evi-
dence unless and until an examiner reviews the applica-
tion and issues an obviousness rejection.” Id. In other
words, objective indicia may not be available until well
after the examiner first considers the prior art, so it
makes sense for the examiner to make a prima facie
determination of obviousness and later consider any
objective indicia of non-obviousness. Id. An IPR, on the
other hand, is in many ways unlike ex parte prosecution.
    For purposes of evaluating whether claims would
have been obvious, particularly in light of the practical
considerations discussed in Cyclobenzaprine, an IPR
proceeding is more akin to litigation. As in litigation,
“validity, rather than patentability, is the issue.” Id. And
in both forums, “all evidence is presented to the fact
finder in a single proceeding.” Id. Just as a jury hears
evidence of both prior art and objective indicia before
making its obviousness finding, so too the Board should
hear all relevant evidence before determining whether
asserted claims would be been obvious. For these rea-
IN RE: DEPOMED, INC.                                      5

sons, I believe Cyclobenzaprine’s prohibition on a burden-
shifting scheme for obviousness should apply in the IPR
context. 4 And indeed it does.
    Recently, we held that burden-shifting “does not apply
in the adjudicatory context of an IPR.” In re Magnum Oil
Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). We
stated:
    Where, as here, the only question presented is
    whether due consideration of the four Graham
    factors renders a claim or claims obvious, no bur-
    den shifts from the patent challenger to the pa-
    tentee. This is especially true where the only
    issues to be considered are what the prior art dis-
    closes, whether there would have been a motiva-
    tion to combine the prior art, and whether that
    combination would render the patented claims
    obvious.
Id. at 1376. One of the four Graham factors is objective
indicia of non-obviousness. As such, in an IPR, the Board
should not first make an obviousness determination only
later to consider the patentee’s objective indicia of non-
obviousness. Doing so risks succumbing to the very
hindsight bias that objective indicia are intended to
ameliorate. See KSR, 550 U.S. at 421; Graham, 383 U.S.
at 36; Cyclobenzaprine, 676 F.3d at 1079. In light of
Magnum Oil, the Board erred by considering Depomed’s

    4    To be sure, IPR proceedings are not identical to
district court litigation. See Cuozzo Speed Techs., LLC
v. Lee, 136 S. Ct. 2131, 2143–44 (2016). But as we ex-
plained in Cyclobenzaprine and later in Magnum Oil, the
similarities most salient to an obviousness analysis
discourage burden-shifting.
6                                       IN RE: DEPOMED, INC.

objective indicia only after determining that certain
claims would have been obvious.
                            II.
    My second concern involves assigning “weight” to cer-
tain evidence. The majority accepts the Board’s finding
that it gave “little weight” to Depomed’s evidence of
unexpected results. See Maj. Op. 7.
    The Board’s assignment of “weight” to this evidence is
wrong for two reasons. First, results are either unex-
pected or they are not. Our case law does not ask whether
results are “really unexpected” or just a “little unex-
pected.” We ask only whether the results are unexpected.
As such, it is incorrect to assign a particular weight to
that evidence.
    Second, assigning weight to objective indicia of non-
obviousness imposes the very danger of burden-shifting
that Magnum Oil forecloses. The Board must decide a
binary issue: either the challenged claims would have
been obvious or they would not have been obvious. It
should make this determination only after considering all
evidence—both supporting and detracting from a finding
of obviousness. For us to assign “weight” to each piece of
evidence implies a new, incorrect standard of review. Our
review is not, for example, whether evidence of unex-
pected results “outweighs” the similarity between the
challenged claims and the prior art. Our review is wheth-
er the challenged claims would have been obvious. 5

    5   By analogy, a district court often considers mo-
tions to dismiss for failure to state a claim pursuant to
Fed. R. Civ. P. 12(b)(6). A court denies a 12(b)(6) motion
when the plaintiff alleges sufficient facts that, if true,
constitute a cause of action. Denial of a 12(b)(6) motion is
IN RE: DEPOMED, INC.                                      7

    Despite my reservations with both the Board’s and
majority’s analyses, I do not believe remand is necessary
here. Depomed’s objective indicia, even if analyzed under
the proper framework, do not compel a conclusion of non-
obviousness in view of Shell and Papadimitriou. I there-
fore concur in affirming the Board’s ultimate obviousness
determination.

not a conclusion that the plaintiff will prevail—rather, the
court then turns to the defendant’s evidence. Only after
considering the totality of the evidence from both sides
does the court ultimately decide the case.