Court Opinion

ID: 3005406
Source: CourtListenerOpinion
Date Created: 2015-09-29 16:01:42.978469+00
Date Added: 2024-06-11T18:02:12.241148
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

                     SINAN TAS,
                      Appellant

                           v.

   PHILIP A. BEACHY, MICHAEL K. COOPER,
  JEFFREY A. PORTER, JAMES K. CHEN, ANSSI
          JUSSI NIKOLAI TAIPALE,
                    Appellees
             ______________________

                      2015-1175
                ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. 105,926,
105,949.
                 ______________________

              Decided: September 29, 2015
                ______________________

   SINAN TAS, Bor, Turkey, pro se.

    OLIVER ASHE, JR., Ashe, P.C., Reston, VA, for appel-
lees. Also represented by BRION P. HEANEY, Millen, White,
Zelano & Branigan PC, Arlington, VA.
                  ______________________
2                                             TAS   v. BEACHY

        Before PROST, Chief Judge, NEWMAN, and CHEN,
                      Circuit Judges.
PER CURIAM.
     This case involves Interference Nos. 105,926 and
105,949 (the ’926 and ’949 interferences, respectively). 1
The subject matter of the interferences relates to a meth-
od of treating humans that have a specific type of cancer,
a basal carcinoma cell (BCC) tumor, with a compound
called cyclopamine, as well as acceptable cyclopamine
alternatives. BCC tumors form when a signaling path-
way used by cells for initiating apoptosis (programmed
cell death) mutates, resulting in the uncontrolled prolifer-
ation of cells. The relevant signaling pathway here is the
Hedgehog/Smoothened (Hh/Smo) cell signaling pathway
and involves two proteins: Hedgehog (Hh) and Smooth-
ened (Smo). Cyclopamine takes advantage of the Hh/Smo
signaling pathway to initiate apoptosis, which inhibits the
BCCs from proliferating.
    This dispute arose when Dr. Sinan Taş and his co-
inventor added claims to the application that became U.S.
Patent No. 7,893,078 (the ’078 patent). These claims
recited “cyclopamine or another compound that selectively
inhibits Hedgehog/Smoothened signaling.”         See J.A.
4379–80 (emphasis added). Philip Beachy and four other
inventors (collectively, Beachy) then filed two patent
applications that claimed and purportedly also described
the subject matter claimed in the ’078 patent: U.S. Pa-
tent Application Nos. 13/363,934 and 13/364,121 (the ’934

    1   The America Invents Act (AIA), Pub. L. No. 112-
29, eliminated interference proceedings. Because the
applications and patents at issue in this case were filed
before March 16, 2013, we apply the pre-AIA 35 U.S.C.
§ 135.
TAS   v. BEACHY                                           3

and ’121 applications, respectively). 2 The United States
Patent and Trademark Office (USPTO) Patent Trial and
Appeal Board (PTAB) initiated two interferences to
determine whether Taş or Beachy first invented the
relevant subject matter, and consolidated the proceedings.
     The interferences contain one Count each, numbered
Count 2 in the ’949 interference and Count 3 in the ’926
interference. There is no Count 1. The PTAB designated
all claims of the ’078 patent (claims 1–23) and all pending
claims of the ’121 application (claims 201–213) as corre-
sponding to Count 2, and all claims of the ’078 patent and
all pending claims of the ’934 application (claims 101–112
and 114–127) as corresponding to Count 3.
    For both interferences, the PTAB declared Beachy the
Senior Party and Taş the Junior Party because it accord-
ed (1) the ’078 patent the benefit of International Applica-
tion No. PCT/TR01/00027, filed July 2, 2001, (2) the ’934
application the benefit of four prior applications, includ-
ing U.S. Patent Application No. 09/668,076 (the ’076
application), filed October 13, 2000, and (3) the ’121
application the benefit of four prior applications, includ-
ing U.S. Patent Application Nos. 09/708,964 (the ’964
application), filed November 8, 2000, and 09/685,244 (the
’244 application), filed October 10, 2000.
     Taş admitted that he cannot prove an actual date of
invention prior to the July 2, 2001, priority date. See J.A.
861 (Taş’s Preliminary Statement stating that “Taş
[relies] for its earliest constructive reduction to practice
on PCT/TR01/00027, filed on 02 July 2001.”); 37 C.F.R. §

      2  For the purposes of these interferences, Johns
Hopkins University School of Medicine and Genentech,
Inc. are the real parties in interest in the ’934 and ’121
applications. The PTAB below and the parties on appeal
refer to the appellee as Beachy, and we do the same.
4                                              TAS   v. BEACHY

1.629(a) (“A party shall be strictly held to any date alleged
in the preliminary statement.”). Taş instead argues, for
the ’949 interference, that no interference-in-fact exists
between the ’078 patent and the ’121 application. Taş
also attacks the written description and enablement
support of the priority applications to both Beachy appli-
cations, which, if successful, would give the Beachy appli-
cations a priority date later than the ’078 patent. See
Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993) (Not-
ing that the earlier-filed priority application must satisfy
section 112, paragraph 1.).
    We affirm the PTAB’s determination that an interfer-
ence-in-fact exists between Taş’s ’078 patent and Beachy’s
’121 application. We also affirm the PTAB’s determina-
tion that both the Counts and all the pending claims of
the ’121 and ’934 applications are sufficiently described
and enabled by the Beachy priority applications.
                             I
    “An interference exists if the subject matter of a claim
of one party would, if prior art, have anticipated or ren-
dered obvious the subject matter of a claim of the oppos-
ing party and vice versa.” 37 C.F.R. 41.203(a); see Eli
Lilly v. Bd. of Regents of Univ. of Washington, 334 F.3d
1264, 1267 (Fed. Cir. 2003). Once the PTAB declares an
interference, the party claiming that an interference-in-
fact does not exist bears the burden of persuasion. Case v.
CPC Int’l, Inc., 730 F.2d 745, 750 (Fed. Cir. 1984).
     Count 3 contains two alternatives. See J.A. 8–9. The
first alternative, based in large measure on claims 15 and
20 of Taş’s ’078 patent, recites a medicament comprising
cyclopamine that “causes decrease of size or disappear-
ance of the tumor.” The second alternative, based in large
measure on claims 115–116 of Beachy’s ’934 application,
recites a medicament comprising cyclopamine that “inhib-
its tumor cell proliferation.” In the ’949 interference, Taş
filed a preliminary motion in which he argued that the
TAS   v. BEACHY                                          5

two alternatives are not the same, and thus no interfer-
ence-in-fact exists, because inhibiting proliferation of a
tumor is not the same as causing the decrease of size or
disappearance of the tumor. The PTAB first correctly
noted that it must compare the claims of the patent and
application at issue, not the alternatives of a Count, to
determine whether an interference-in-fact exists. See 37
C.F.R. § 41.203(a). The PTAB nevertheless proceeded to
decide the merits of Taş’s argument because it determined
that Taş’s motion “essentially has compared” claims 15
and 20 of the ’078 patent to claim 201 of the ’121 applica-
tion.
    In response to Taş’s motion, the PTAB pointed out
that the claims also require the medicament comprising
cyclopamine to “induce apoptosis” in a BCC tumor. The
PTAB found that when apoptosis takes place in a BCC
tumor, the results recited in both Count 3 alternatives
occur: the tumor decreases in size and possibly disap-
pears, and the tumor cells stop proliferating. The PTAB
thus held that an interference-in-fact exists because the
claims recite consistent result limitations that are a
consequence of apoptosis having taken place.
     On appeal, Taş argues that the PTAB improperly con-
strued the “inhibits tumor cell proliferation” limitation
when the PTAB stated that “[i]f proliferation is inhibited,
then the tumor does not grow.” Taş Opening Br. at 41
(quoting J.A. 17). Taş contends that the “inhibits tumor
cell proliferation” limitation can also be met if the tumor
grows at a slower pace. But even under his proposed
construction, Taş does not dispute that inhibiting tumor
cell proliferation is a result of apoptosis in a BCC tumor.
Accordingly, the PTAB’s determination that the claims
recite consistent result limitations that are a consequence
of apoptosis having taken place remains unchallenged.
We therefore affirm the PTAB’s declaration that an
interference-in-fact exists between claims 15 and 20 of the
6                                             TAS   v. BEACHY

’078 patent and claim 201 of the ’121 application, as well
as the other claims unchallenged on appeal.
                            II
    Prior to the AIA, the person who first conceived and
reduced the invention to practice was generally consid-
ered to be the first inventor. See 35 U.S.C. § 102(g)
(2006). Under this regime, the filing of a patent applica-
tion serves as constructive reduction to practice of the
subject matter disclosed therein. Hyatt v. Boone, 146 F.
3d 1348, 1352 (Fed. Cir. 1998). When a party to an inter-
ference seeks the benefit of an earlier-filed U.S. patent
application, the earlier application must contain a written
description of the subject matter of the interference
Count, and must meet the enablement requirement. Id.
    In both interferences, Taş filed preliminary motions
challenging the written description and enablement
support for both Counts and the pending claims of the
Beachy applications. In one preliminary motion, Taş
argued that the ’076 priority application does not provide
written description or enablement support for five limita-
tions of Count 3. In another preliminary motion, Taş
argued that the ’244 and ’964 priority applications do not
provide written description or enablement for five limita-
tions of Count 2. And, in yet another preliminary motion,
Taş argued that the pending claims of the ’121 and ’934
applications are unpatentable because ten limitations
lack written description in the respective specifications of
those applications. 3
    To satisfy the written description requirement, the
specification must sufficiently describe the claimed inven-

    3  Taş also argued to the PTAB that the pending
claims of the ’121 and ’934 applications are unpatentable
as indefinite. The PTAB denied Taş’s indefiniteness
challenge. Taş does not appeal the PTAB’s denial.
TAS   v. BEACHY                                         7

tion to a person skilled in the art and show that the
inventor actually invented the claimed invention. Ariad
Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (en banc). Whether a specification provides
written support for a claim is a question of fact. Id. To
satisfy the enablement requirement, the specification
must describe the manner of making and using the inven-
tion “in such full, clear, concise, and exact terms as to
enable any person skilled in the art . . . to make and use
the same . . . .” 35 U.S.C. § 112 ¶ 1; see Rasmusson v.
SmithKline Beecham Corp., 413 F.3d 1318, 1322 (Fed.
Cir. 2005). Whether a specification enables a claim is a
question of law based on underlying factual findings. In
re Wands, 858 F.2d 731, 735 (Fed. Cir. 1988). We review
the PTAB’s enablement determination de novo, and its
factual findings for substantial evidence. In re Gartside,
203 F.3d 1305, 1313 (Fed. Cir. 2000); In re Vaeck, 947
F.2d 488, 495 (Fed. Cir. 1991).
    Substantial evidence “means such relevant evidence
as a reasonable mind might accept as adequate to support
a conclusion.” Consol. Edison Co. v. NLRB, 305 U.S. 197,
229 (1938). Our review of factual findings for substantial
evidence examines the record as a whole, taking into
account evidence that supports the PTAB’s position as
well as that evidence detracting from the PTAB’s conclu-
sion. Gartside, 203 F.3d at 1312. “[T]he possibility of
drawing two inconsistent conclusions from the evidence”
will not render the PTAB’s findings unsupported by
substantial evidence. See Consolo v. Fed. Mar. Comm’n,
383 U.S. 607, 620 (1966). If the evidence in record will
support several reasonable but contradictory conclusions,
we will not find the PTAB’s decision unsupported by
substantial evidence simply because the PTAB chose one
conclusion over another plausible alternative. In re
Jolley, 308 F.3d 1317, 1320 (Fed. Cir. 2002).
8                                             TAS   v. BEACHY

                             A
    As a preliminary matter, we note that the PTAB cred-
ited and relied on, to some extent, the testimony of
Beachy’s expert, Dr. Curran, for many of its findings. Taş
argues that the PTAB’s acceptance of Dr. Curran’s testi-
mony was in error because Dr. Curran is not a physician,
and the subject matter requires the expertise of a physi-
cian. Taş also argues that Dr. Curran’s testimony is not
reliable because certain publications contradict Dr. Cur-
ran’s testimony. Beachy responds by listing Dr. Curran’s
qualifications and pointing out that Taş failed to object to
Dr. Curran’s testimony in accordance with PTAB rules.
     The PTAB addressed Taş’s challenge to Dr. Curran in
its decision on rehearing. The PTAB noted that Taş failed
to challenge Dr. Curran’s qualifications in any of the
motions it decided, and the issue could not be raised for
the first time on rehearing. Because Taş’s challenge to
Dr. Curran was not properly raised below, we will not
consider it on appeal.
                             B
    On appeal, Taş first takes issue with the following
sentence from the ’076 and ’964 applications: “For in-
stance, the subject compounds can be utilized to cause
such transformed cells to become either post-mitotic or
apoptotic.” ’076 application, 38:9–12; ’964 application,
36:11–14. Taş argues that a person skilled in the art
would not believe this sentence is true, and the sentence
therefore does not provide written description or enable-
ment support.
   First, Taş argues that a person skilled in the art
would not believe this sentence because the “subject
compounds” in the applications (e.g., cyclopamine) are Hh
TAS   v. BEACHY                                          9

antagonists, but this sentence was “plagiarized” 4 from an
earlier patent that discussed the opposite, Hh agonists.
The PTAB dismissed this argument because Taş cited no
legal authority to suggest that the alleged act of plagia-
rism is at all relevant to the written description or ena-
blement analysis. On appeal, Taş argues that the alleged
act of plagiarism is relevant because a person skilled in
the art, knowing the content of the earlier patent and
presuming the earlier patent to be correct, would not
believe the sentence-at-issue in the applications. We
understand Taş’s argument to not be about the alleged act
of plagiarism itself, for which he still provides no legal
authority, but rather to be about what a person skilled in
the art would understand the applications to teach. On
this point, Taş contends that a person skilled in the art
would believe the earlier patent over the applications
because prior art references do not corroborate the state-
ment made in the applications. The PTAB heard argu-
ments from both sides about what the applications teach
a person skilled in the art, favored Beachy’s evidence over
Taş’s, and credited the plain disclosure of the applica-
tions. After reviewing the record, we find that the PTAB’s
findings are supported by substantial evidence.
    Taş next argues that a person skilled in the art would
not believe that cyclopamine can be used to cause the
relevant cells to become apoptotic because figure 4A in the
same applications contradicts this result. Taş describes

      4 On appeal, Taş elevates its “plagiarism” allega-
tions to also include accusations that the inventors inten-
tionally deceived the USPTO, engaged in fraud upon the
USPTO, and violated 37 C.F.R. § 1.56(a), which is the
duty of the inventor to disclose to the USPTO information
material to patentability. Taş waived these allegations by
failing to raise them below, and we find no merit to the
allegations.
10                                             TAS   v. BEACHY

figure 4A as showing tumor cells treated with cyclopa-
mine at various dose levels in which microscopically
visible cell death was not observed. Because apoptosis is
a form of cell death detectable by microscopic examina-
tion, Taş argues that figure 4A expressly teaches against
using a sufficient dose of cyclopamine to cause the rele-
vant cells to become apoptotic. Again, the PTAB heard
arguments from both sides and credited the testimony of
Beachy’s expert that the applications teach a person
skilled in the art that cyclopamine could be administered
in doses sufficient to induce apoptosis in BCCs. Applying
this Court’s guidance in Ariad Pharm., 598 F.3d at 1352,
the PTAB also determined that a working example of a
particular dose level resulting in measurable cell death
was not necessary to adequately describe or enable an
embodiment within the scope of Count 3. The PTAB
correctly applied the law, and its findings are supported
by substantial evidence.
                              C
     Taş also takes issue with the following sentence from
the ’076 and ’964 applications: “An ‘effective amount’ of a
subject compound, with respect to the subject method of
treatment, refers to an amount of the antagonist in a
preparation which, when applied as part of a desired
dosage regimen brings about, e.g., a change in the rate of
cell proliferation and/or the state of differentiation of a
cell and/or rate of survival of a cell according to clinically
acceptable standards for the disorder to be treated or the
cosmetic purpose.” ’076 application, 10:8–15 (emphasis
added); ’964 application, 12:22–29. According to Taş, the
inventors did not have possession of this subject matter
because the sentence does not specify which cells it is
referring to, or whether the change is an increase or a
decrease in the rate of proliferation, the state of differen-
tiation, or the rate of survival.
TAS   v. BEACHY                                         11

    The claims and Counts at issue here involve the ad-
ministration of cyclopamine to treat humans having BCC
tumors, which requires a sufficient dose of cyclopamine to
induce apoptosis and cause a decrease of size or disap-
pearance of the tumor. The PTAB found that the applica-
tions sufficiently described those claims and Counts, and
the PTAB’s findings are supported by substantial evi-
dence.
                            D
    Taş next argues that some teachings of the ’076 and
’964 applications are not enabling because they are “inop-
erative in entire categories,” such as treating injuries of
nervous system and immunology affected diseases, and
enhancing regeneration of tissue and organs. The claims
and Counts at issue here, however, only involve the
administration of cyclopamine to treat humans having a
BCC tumor. The teachings Taş complained of are for
embodiments not covered by the claims and Counts and
are therefore irrelevant to whether the applications
enable the claims and Counts.
                            E
    Taş also argues that the disclosure of human cancers
in the ’076 and ’964 applications does not provide written
description or enablement support for the Counts or
claims at issue. According to Taş, the applications must
describe the actual treatment of a human because (1)
Hh/Smo signaling was known to be necessary for non-
BCC cells required for human life, (2) effective doses of
cyclopamine was known to kill a high proportion of
adults, (3) the vast majority of cancer chemotherapy
tested in laboratory animals was known to fail in treating
cancer in humans, and (4) tumor cells were known to have
greater Hh/Smo signaling than normal cells, so inhibiting
the signaling would cause normal cells to succumb before
the tumor cells. In response, Beachy points to evidence in
front of the PTAB that teaches Hh signaling is inactive in
12                                            TAS   v. BEACHY

most adult tissues and cyclopamine was known to have no
adverse effects in humans.
     The PTAB correctly stated that the written descrip-
tion and enablement requirements do not demand as a
matter of law actual examples or an actual reduction to
practice. See Eli Lilly, 598 F.3d at 1352; Wands, 858 F.2d
at 735. The PTAB found that the description in the
priority applications of methods by which cyclopamine
may be administered, appropriate and effective dosages,
how the subject medicament works within the cancerous
cell, and a spectrum of conditions against which admin-
istration of the cyclopamine may be effective sufficiently
described the subject matter to a person skilled in the art,
and enabled such a person to make and use the invention
without undue experimentation. After considering all the
arguments and the record, we see no reason to disturb
that finding.
                             F
    In a final attack on the teachings of the ’076 and ’964
applications, Taş argues that the descriptions of mice
grafted with foreign tumor cells does not provide written
description or enablement support because (1) the amount
of cyclopamine applied to each mouse is not specified, (2)
the volume of the tumor grafts is not described, (3) the
described change in the size of the graft might be from a
spontaneous change instead of from a reaction to the
cyclopamine, and (4) the induction of apoptosis in the
tumor grafts is not described. These are the same argu-
ments Taş presented to the PTAB. See J.A. 36–37, 46.
The PTAB considered Taş’s arguments and evidence,
teachings from the applications, and the testimony from
Beachy’s expert, Dr. Curran, that a person skilled in the
art would have known that the administration of a suffi-
cient amount of cyclopamine to a human to inhibit Hh
signaling in the tumor would also result in a decrease in
tumor size. Substantial evidence therefore supports the
TAS   v. BEACHY                                        13

PTAB decision that Taş failed to meet it burden of show-
ing that the ’076 and ’964 applications do not provide
written description or enablement support.
                           III
    Beachy also filed preliminary motions in the interfer-
ence proceedings below, asking the PTAB to find the
claims of Taş’s ’078 patent invalid as lacking written
description, lacking enablement, and being indefinite.
The PTAB granted one of Beachy’s motions as to the lack
of written description for claims 2–20 and 23, and another
of Beachy’s motions as to the lack of written description
for claim 7. Taş appeals. Because claims 1–23 of the ’078
patent are unpatentable to Taş under 35 U.S.C. § 102(g)
based on Beachy’s prior invention of Counts 2 and 3, we
do not need to reach whether claims 2–20 and 23 are also
invalid under 35 U.S.C. § 112.
                          * * *
   We have considered all other arguments and find
them without merit.
    We therefore affirm the PTAB’s denial of Taş’s prelim-
inary motions regarding no interference-in-fact and lack
of written description and enablement for the Counts of
the ’926 and ’949 interferences and the claims of the ’121
and ’934 applications. With respect to these issues, the
PTAB correctly applied the law, and its findings are
supported by substantial evidence.
                      AFFIRMED
      No costs.