Ex Parte Goff

Board of Patent Appeals and Interferences

Jan 19, 2010

11199303 (B.P.A.I. Jan. 19, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte DONALD C. GOFF
____________

Appeal 2009-006683
Application 11/199,303
Technology Center 1600
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Decided: January 19, 2010
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Before DONALD E. ADAMS, ERIC GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Patent Applicant from the
Patent Examiner’s rejection of claims 1-18 as anticipated and obvious over
prior art. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b)
and 134. We affirm the rejections.

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Application 11/199,303

STATEMENT OF THE CASE
The claims are to methods of treating schizophrenia with a
phosphodiesterase type 5 (PDE) inhibitor. Phosphodiesterases are enzymes
that degrade cyclic adenosine monophosphate and cyclic guanosine
monophosphate, ubiquitous second messengers for transducing the effects of
various extracellular signals (Spec. 18:22-23 & 19:17-18). According to the
Specification, PDE5 inhibitors had been known to treat male erectile
dysfunction and female sexual disorders, but had not been used to treat
schizophrenia (Spec. 15:7-20).
Claims 1-18 are pending and stand rejected by the Examiner as
follows:
1. Claims 1, 2, 6-9, and 13-181 under 35 U.S.C. § 102(a) as
anticipated by Aviv et al. (“An Open-Label Trial of Sildenafil Addition in
Risperidone-Treated Male Schizophrenia Patients with Erectile
Dysfunction,” 65 J. CLIN. PSYCHIATRY 97-103 (2004)), with DiPiro et al.
(PHARMACOTHERAPY: A PATHOPHYSIOLOGIC APPROACH 714-724 (1989)) as
evidence (Ans. 5-6);
2. Claims 4, 5, 10, and 11 under 35 U.S.C. § 102(a) as anticipated by
Aviv, with DiPiro as evidence (Ans. 6);
3. Claims 1-18 under 35 U.S.C. § 102(a) as anticipated by Aviv, with
DiPiro and PDR (PHYSICIAN’S DESK REFERENCE 2653-2656 (57th ed. 2003))
as evidence (Ans. 12);
4. Claims 1-3, 6-9, and 12 under 35 U.S.C. § 103(a) as obvious in
view of Aviv and Rosen et al. (“Overview of Phosphodiesterase 5 Inhibition

1 On page 4 of the Answer, it was started that claim 12 was rejected, but on
page 6, the Examiner indicated that claim 12 had been withdrawn from the
rejection for Aviv’s failure to teach the limitations of claim 12.
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in Erectile Dysfunction,” 92 AMERICAN J. OF CARDIOLOGY 9M-18M (2003))
(Ans. 10);
5. Claims 4, 5, 10, and 11 under 35 U.S.C. § 103(a) as obvious in
view of Aviv and Rosen (Ans. 11);
6. Claims 1-3, 6-9, and 12 under 35 U.S.C. § 103(a) as obvious in
view of Kelly et al. (“Sexuality and Schizophrenia: A Review,” 30
SCHIZOPHRENIA BULLETIN 767-779 (2004), Abstract only), Beers et al. (The
MERCK MANUAL OF DIAGNOSIS AND THERAPY 1836-1838 (17th ed. 1999)),
Rosen, and DiPiro (Ans. 7); and
7. Claims 4, 5, 10, and 11 under 35 U.S.C. § 103(a) as obvious in
view of Kelly, Beers, Rosen, and DiPiro (Ans. 8-9).
Claims 1, 2, 6, and 15 are representative and read as follows:
1. A method for treating schizophrenia in a patient which comprises
administration to the patient of an effective amount of a phosphodiesterase
type 5 (PDE5) inhibitor, or a pharmaceutically acceptable salt, solvate, or
composition thereof for treating schizophrenia.

2. The method of claim 1, wherein the PDE5 inhibitor comprises a
selected one of sildenafil, vardenafil, tadalafil, E-8010, zaprinast, and E-
4021.

6. A method of treating schizophrenia in a human being comprising
administering to said human a phosphodiesterase type 5 (PDE5) inhibiting
compound for treating schizophrenia.

15. The method of claim 1, wherein the PDE5 inhibitor provides
therapeutic effects in treatment of cognitive symptoms of schizophrenia.

CLAIM INTERPRETATION
The preamble of claim 1 states that the purpose of the claimed method
of administering a PDE5 inhibitor is for “treating schizophrenia.” We do not
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interpret the claim to require that the method be practiced with the intent to
treat schizophrenia because intent or recognition that a process achieves a
stated result does not change how the method is carried out. The steps are
the same, whether or not it is recognized that schizophrenia is treated.
Claim 1 also states that “an effective amount” of the PDE5 inhibitor is
“for treating schizophrenia.” Even though the claim does not require
recognition that schizophrenia treatment is accomplished by administering
the PDE5 inhibitor, because the claim is a treatment method and the PDE5
inhibitor is administered for that purpose, we interpret the claim to require
that the PDE5 inhibitor treat schizophrenia.

ANTICIPATION REJECTIONS OVER AVIV
1. Claims 1, 2, 6-9, and 12-18 stand rejected under 35 U.S.C. § 102(a)
as anticipated by Aviv, with DiPiro cited as evidence.
2. Claims 4, 5, 10, and 11 stand rejected under 35 U.S.C. § 102(a) as
anticipated by Aviv, with DiPiro cited as evidence.
3. Claims 1-18 stand rejected under 35 U.S.C. § 102(a) as anticipated
by Aviv, with DiPiro and PDR as evidence.
Appellant separately argued claims 1 and 15. Claims 2-14 and 16-18
stand or fall with claims 1 and 15 because separate reasons for their
patentability were not provided. 37 C.F.R. § 41.37(c)(1)(vii).

Statement of the issue
Claim 1 is drawn to a method treating schizophrenia comprising
administering an effective amount of a PDE5 inhibitor. The Examiner
found that Aviv taught administering sildenafil, a PDE5 inhibitor, to
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schizophrenic patients to treat erectile dysfunction. The Examiner found
that although Aviv did not teach that the sildenafil was for treating
schizophrenia, “administration of the identical compounds to those presently
claimed in the same host (or subject) must necessarily possess the
schizophrenia-controlling effect in the subject when administered, even if
intended for the treatment of erectile dysfunction, and further even though
such a property may not have been appreciated by the author” (Ans. 13).
Appellant contends that Aviv did not administer sildenafil, or other
PDE5 inhibiting compounds, to treat the psychiatric condition of
schizophrenia. Appellant argues that Aviv “teaches away” from the claimed
treatment method because Aviv concluded that sildenafil did not affect the
psychiatric status of the treated patient.
The issue to be addressed in this rejection is whether administering
sildenafil to schizophrenics, as taught by Aviv, anticipates the claimed
method of treating schizophrenia, when Aviv did not recognize this result
and expressly stated that the sildenafil did not affect the psychiatric status of
the treated patients.
Principles of Law
[A] prior art reference may anticipate when the claim limitation
or limitations not expressly found in that reference are
nonetheless inherent in it. . . . Inherency is not necessarily
coterminous with the knowledge of those of ordinary skill in
the art. Artisans of ordinary skill may not recognize the inherent
characteristics or functioning of the prior art.
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999)
It is well-established that an old process is not made patentable by
merely recognizing something that was not known before. In re Omeprazole
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Patent Litig., 483 F.3d 1364, 1373 (Fed. Cir. 2007); Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005); In re Cruciferous
Sprout Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002); In re Woodruff, 919
F.2d 1575, 1578 (Fed. Cir. 1990).
“Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially identical
processes, the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Thus,
once “the PTO shows sound basis for believing that the products of the
applicant and the prior art are the same, the applicant has the burden of
showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).

Findings of Fact (FF)
Aviv
1. Schizophrenia was known to be treated with antipsychotic medications,
such as risperidone (Aviv, 97-98).
2. The “pharmacologic[al] management” of schizophrenia “is complicated
by a high rate of adverse effects including sexual dysfunction.” (Aviv, at 97,
col. 2.)
3. Sildenafil is a PDE5 inhibitor utilized to treat erectile dysfunction (Aviv,
at 97-98).
4. Aviv described a clinical trial in which “sildenafil was coadministered to
12 risperidone-treated male schizophrenia outpatients who complained of
erectile dysfunction.” (Aviv, at 98, col. 1.)
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5. Sexual function was assessed by the International Index of Erectile
Function (IIEF) (Aviv, at 98, col. 2).
6. “The severity of symptoms of schizophrenia was assessed with both the
Positive and Negative Syndrome Scale (PANSS) and the Clinical Global
Impressions-Severity of Illness scale (CGI-S)” (Aviv, at 99, col. 1; footnotes
omitted).
7. Aviv reported a statistically significant improvement in sexual function
(Aviv, at 99, col. 2).
8. Aviv stated: “Sildenafil addition did not affect the psychiatric status of
our patients as measured by the PANSS and CGI-S.” (Aviv, at 102, col. 1.)

Specification
9. The Specification defines “cognitive impairment” in schizophrenia as “an
acquired deficit in one or more of memory function, attention, problem
solving, orientation and/or abstraction that impinges on an individual’s
ability to function independently.” (Spec. 11:8-10; 11:25-28.)

Analysis
There is no dispute that Aviv describes administering the PDE5
inhibitor sildenafil to schizophrenics (FF3, FF4; App. Br. 9), the same step
recited in claim 1. Because Aviv administered the same compound as
claimed, to the same patient population, and in the same way, the Examiner
had sound basis for believing that the prior art PDE5 inhibitor treated
schizophrenia, as required by claim 1, shifting the burden to Appellant to
prove that it did not. In re Spada, 911 F.2d at 708.
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Appellant contends that Aviv does not anticipate the claimed method
because Aviv did not use sildenafil “in the treatment of the psychiatric
condition of schizophrenia.” (App. Br. 9.) Rather, Appellant argues,
sildenafil was used instead for erectile dysfunction in patients treated with
risperidone (id.). As evidence that Aviv did not treat schizophrenia with
sildenafil, Appellant cites Aviv’s conclusion that “[s]ildenafil addition did
not affect the psychiatric status of our patients.” (FF8; App. Br. 9.)
Appellant’s evidence is not sufficient to establish that the Examiner
erred in concluding that Aviv anticipated claim 1. Aviv does indeed disclose
that sildenafil “did not affect the psychiatric status” of its treated patients,
but stated that the lack of an effect was “as measured by the PANSS and
CGI-S” scales (FF6, FF8). As the patients were already being treated with
risperidone, it is not evident that the sildenafil “did not affect the psychiatric
status” because it was without effect on schizophrenia or because the
patients’ schizophrenic symptoms had been alleviated by the risperidone
treatment. The fact remains that Aviv administered sildenafil to
schizophrenics, meeting all the positively recited steps of instant claim 1.
Appellant did not distinguish the claimed step from Aviv’s method, e.g., by
identifying differences in amounts or mode of sildenafil delivery.
Moreover, Appellant did not establish that all the symptoms
associated with schizophrenia were assessed by the PANSS and CGI-S
scales and thus would have been measured by Aviv. Claim 15, which
depends on claim 1, recites that the inhibitor “provides therapeutic effects in
treatment of cognitive symptoms of schizophrenia,” which includes effects
on “memory function, attention, problem solving, orientation and/or
abstraction” (FF9). Appellant has not established that the psychiatric
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assessment conducted in Aviv included all cognitive symptoms
encompassed by the claims.
Because the PTO does not have testing facilities, the Examiner is not
required to “prove” that Aviv accomplished the same method that is
claimed. See In re Best, 562 F.2d at 1255. It is enough that the Examiner
provided an adequate basis for believing that they are same, shifting the
burden to the patent applicant to prove that they are not. In re Spada, 911
F.2d at 708. Aviv describes administering sildenafil, a PDE5 inhibitor to
schizophrenics. While Aviv does not indicate that the sildenafil is effective
for treating schizophrenia, because of the identity between what is disclosed
in the prior art and what is claimed, the Examiner reasonably believed that
that the sildenafil would treat a symptom of schizophrenia, albeit inherently
and unrecognized by Aviv. It is not sufficient evidence that Aviv did not
recognize this effect, nor even think it likely, because merely recognizing
something that was not known before does not make an old process again
patentable.
Appellant also argues that “Aviv relies on the combination of
risperidone and sildenafil for whatever treatment is being provided to the
subject schizophrenia patients.” (Reply Br. 5.) However, claim 1 does not
exclude administering a known antipsychotic drug with the PDE5 inhibitor,
and dependent claims 10 and 11 specifically include “antipsychotic
medication” as part of the claimed method.
In sum, the Examiner did not err in finding that Aviv anticipates the
claimed method of treating schizophrenia. For the foregoing reasons and
those set forth by the Examiner, we affirm the rejection of claims 1 and 15.
Claims 2-14 and 16-18 fall with claims 1 and 15.
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OBVIOUSNESS REJECTIONS OVER AVIV AND ROSEN
4. Claims 1-3, 6-9, and 12 stand rejected under 35 U.S.C. § 103(a) as
obvious in view of Aviv and Rosen.
5. Claims 4, 5, 10, and 11 stand rejected under 35 U.S.C. § 103(a) as
obvious in view of Aviv and Rosen.

Analysis
The Examiner focused the analysis on claim 2, 7, and 9 which are
drawn to a method of treating schizophrenia with a PDE5 inhibitor that is
sildenafil, vardenafil, tadalafil, E8010, zaprinast, or E-4021. The Examiner
cited Aviv as in the anticipation rejections, adding Rosen for its teaching that
sildenafil, vardenafil, and tadalafil are known PDE5 inhibitors useful for
treating erectile dysfunction (Ans. 11). The Examiner determined that it
would have been obvious to have substituted sildenafil as taught by Aviv for
another PDE5 inhibitor known to be useful for treating erectile dysfunction
(id.). Appellant contends the Examiner erred in making this determination
for the same reasons as for Aviv, alone. As this argument was not supported
by sufficient evidence, we conclude that it is also lacking for the
combination of Aviv with Rosen.
We affirm the rejection of claims 2, 7, and 9. Claims 1, 3-6, 8, and
10-12 fall with claims 2, 7, and 9 because separate reasons for their
patentability were not provided. 37 C.F.R. § 41.37(c)(1)(vii).

REJECTIONS OVER KELLY AND OTHERS
6. Claims 1-3, 6-9, and 12 stand rejected under 35 U.S.C. § 103(a) as
obvious in view of Kelly, Beers, Rosen, and DiPiro (Ans. 7).
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7. Claims 4, 5, 10, and 11 stand rejected under 35 U.S.C. § 103(a) as
obvious in view of Kelly, Beers, Rosen, and DiPiro (Ans. 8-9).
We focus our analysis on representative claims 1 and 6. Claims 2-5
and 7-12 stand or fall with claims 1 and 6 because separate reasons for their
patentability were not provided. 37 C.F.R. § 41.37(c)(1)(vii).

Statement of the issue
The Examiner found that Kelly taught that schizophrenics have sexual
dysfunction and suggested that sildenafil be used to treat it. Appellant does
not dispute the Examiner’s factual findings, but contends that Kelly does not
teach sildenafil or other PDE5 inhibiting compounds for treatment of the
psychiatric condition of schizophrenia.
The issue to be addressed in this rejection is whether the Examiner
erred in determining that Kelly’s suggestion to administer sildenafil to
schizophrenics makes obvious the claimed method of treating schizophrenia
with the same medication.
Analysis
The facts in these rejections are not in dispute as to Kelly’s teaching
about sexual dysfunction and schizophrenia. Rather, Appellant contends
that the Examiner erred because administering sildenafil to treat erectile
dysfunction in schizophrenics, as suggested by Kelly, is not the same
method as administering the same drug to treat schizophrenia (App. Br. 15-
16).
The Examiner’s case is that administering sildenafil to schizophrenics
would inherently have treated schizophrenia because the same agent was
administered to the same population of subjects, creating a reasonable basis
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to believe that sildenafil’s anti-schizophrenic properties would have been
experienced by Kelly’s subjects. Appellant has not provided a reason to
doubt the Examiner’s conclusion. As argued for the rejections over Aviv,
Appellant attempts to distinguish Kelly’s disclosure for its lack of a teaching
that sildenafil treats schizophrenia. However, as explained for the Aviv
rejections, the recognition that sildenafil treated schizophrenia is
unnecessary to sustain the rejection because merely recognizing something
that was not known before does not make an old process patentable again.
The Examiner did not err in determining that Kelly’s suggestion to
administer sildenafil to schizophrenics makes obvious the claimed method of
treating schizophrenia with the same medication. We affirm the rejections
of claim 1 and 6. Claim 2-5 and 7-12 fall with claims 1 and 6.

SUMMARY
The rejections of claims 1-18 as anticipated and obvious over prior art
are affirmed.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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cdc

GEORGE MACK RIDDLE
30 GREENFIELD DRIVE
MORAGA CA 94556
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