Ex Parte Marcel et al

Board of Patent Appeals and Interferences

May 24, 2010

10315445 (B.P.A.I. May. 24, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TONY MARCEL,
FRANCOIS ROUGEON, and CATHERINE ROUGEOT
__________

Appeal 2009-0106321
Application 10/315,445
Technology Center 1600
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Decided:2 May 24, 2010
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to peptide-
containing pharmaceutical compositions. The Examiner rejected the claims
for lack of enablement and lack of written description.

1 Institute Pasteur is the real party in interest (App. Br. 1).
2 Oral argument was presented in this case on May 13, 2010.

Appeal 2009-010632
Application 10/315,445

We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 45-55 are pending (App. Br. 1). Claims 52-55 have been
withdrawn from consideration by the Examiner (id.). Claims 45-51 stand
rejected and are on appeal (id.).
Claim 45, the sole independent claim on appeal, reads as follows:
45. A composition, comprising:

a peptide comprising at least one amino acid sequence
selected from the group consisting of SEQ ID NO: 1, SEQ ID
NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, and

a pharmaceutical agent capable of treating impaired
sexual behavior in a mammal having impaired sexual behavior,

wherein the amount of the pharmaceutical agent in the
composition alone is not sufficient to treat impaired sexual
behavior in a mammal having impaired sexual behavior and
wherein the amount of the peptide and the pharmaceutical agent
together is sufficient to treat impaired sexual behavior in a
mammal having impaired sexual behavior.

The Examiner cites the following documents as evidence of
unpatentability:

Vishnu M. Dhople and Ramakrishnan Nagaraj, Conformation and
activity of δ-Lysin and its analogs, 26 PEPTIDES 217-225 (2005).

Thomas Frei et al., Different Extracellular Domains of the Neural Cell
Adhesion Molecule (N-CAM) Are Involved in Different Functions, 118 J.
CELL BIOL. 177-194 (1992).

GOODMAN AND GILMAN’S, THE PHARMACOLOGICAL BASIS OF
THERAPEUTICS, 8th ed., pages 33-48 (1993).
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Johanne Louise Neiiendam et al., An NCAM-derived FGF-receptor
agonist, the FGL-peptide, induces neurite outgrowth and neuronal survival
in primary rat neurons, 91 J. NEUROCHEM. 920-935 (2004).

The following rejections are before us for review:
(1) Claims 45-51, rejected under 35 U.S.C. § 112, first paragraph, as
lacking enablement for the full scope of the claimed subject matter (Ans.
3-8); and
(2) Claims 45-51, rejected under 35 U.S.C. § 112, first paragraph, as
lacking written description (id. at 8-10).
During prosecution, the Examiner made a species election
requirement between the sequences recited in claim 45, and in response to
Appellants’ election, examination of the claims was limited to SEQ ID NO:
2 (see Final Rejection 3 (entered January 24, 2008)).
We limit our consideration of the merits of the appealed rejections to
the elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI
1987).
ENABLEMENT
ISSUE
The Examiner concedes that the Specification enables (a) a
composition “comprising a peptide consisting of the amino acid sequence of
SEQ ID NO: 2,” and (b) a composition comprising a peptide “consisting of
the amino acid sequence of SEQ ID NO: 2 in an amount sufficient to
increase the number and duration of sexually-related behaviors in male rats
(increased non-sexual contact, increased latency of the first mount; increased
number of ejaculations per sexual episode, and increased number of mounts
with intromissions)” (Ans. 3-4).
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The Examiner contends, however, that the Specification does not
reasonably provide enablement for a composition comprising a peptide
comprising SEQ ID NO: 2, and a pharmaceutical agent capable of treating
impaired sexual behavior in a mammal, “wherein the amount of the
pharmaceutical agent in the composition alone is not sufficient to treat
impaired sexual behavior and wherein the amount of the peptide and the
pharmaceutical agent together is sufficient to treat impaired sexual behavior
in a mammal having impaired sexual behavior” (id. at 4).
The Examiner reasons that Appellants’ Specification shows only that
the pentapeptide consisting of SEQ ID NO: 2 changes the sexual behavior in
normal male rats, whereas the claims encompass treating impaired sexual
behavior in any mammal (id. at 5). Given the complexities of modeling
human behavioral disorders in rats, the Examiner contends, a skilled artisan
would expect that undue experimentation would be required to apply the
claimed peptide to all disorders encompassed by the claims (id.).
The Examiner also urges that claim 45 encompasses polypeptides that
include a peptide having SEQ ID NO: 2, but having flanking peptides of up
to 500 amino acids (id.). Given this breadth, and the fact that even nominal
changes in amino acid composition can affect a particular peptide’s
biological activity, the Examiner reasons that a skilled artisan would have
had to perform an undue amount of experimentation to determine which
polypeptides encompassed by the claims would or would not have the
required biological activity (id. at 6 (citing Frei, Dhople, and Neiiendam)).
Moreover, the Examiner urges, the Specification fails to teach
co-administration of any pharmaceutical encompassed by the claims, much
less any synergistic activity that the claims require (id. at 6-7). Given the
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unlikely prospect of generating true synergistic activity, and the absence of
any demonstrated effect in female rats, the Examiner reasons that undue
experimentation would be required to practice the full scope of the claimed
invention (id. at 7 (citing Goodman and Gilman’s)).
Appellants contend that the Examiner has not established that
practicing the claimed invention would have required undue experimentation
(App. Br. 3-4).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner’s conclusion
of non-enablement is supported by the evidence of record.
FINDINGS OF FACT (“FF”)
1. The Specification discloses that tests were conducted to determine the
effect of the pentapeptide encoded by SEQ ID NO: 2 on the sexual behavior
of male Wistar rats who, after treatment with the peptide, were exposed to
sexually receptive female rats (Spec. 17-18 (Example 3)).
2. The tests showed that the male rats exhibited “a significantly
increased latency of first mounts” (Spec. 18 (Example 4)), that the “number
of episodes of intercourse . . . are significantly increased” (id. (Example 5)),
and that the peptide-induced improvement in the rats’ sexual behavior was
dose-responsive (id. at 20 (Example 7)).
PRINCIPLES OF LAW
The Examiner bears the burden of establishing that practicing the full
scope of the claimed subject matter would have required undue
experimentation. In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993)
(“[T]he PTO bears an initial burden of setting forth a reasonable explanation
as to why it believes that the scope of protection provided by that claim is
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not adequately enabled by the description of the invention provided in the
specification of the application.”).
“The enablement requirement is met if the description enables any
mode of making and using the invention.” Johns Hopkins Univ. v. Cellpro,
Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) (quoting Engel Indus., Inc. v.
Lockformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)).
ANALYSIS
We agree with Appellants that the Examiner has not made a prima
facie case of non-enablement.
As the Examiner concedes, the Specification enables “a composition
comprising a peptide consisting of the amino acid sequence of SEQ ID NO:
2” (Ans. 3-4). Thus, the composition conceded by the Examiner as being
enabled may contain not only the pentapeptide of SEQ ID NO: 2, but also
any other pharmaceutical agent, in any amount, including the agent recited
in claim 45, in the amount recited in the claim.
The Examiner’s enablement conclusion regarding the conceded
enabled subject matter is supported by the Specification’s undisputed
disclosure that the pentapeptide of SEQ ID NO: 2 can be used to increase the
libido of male rats (FF 1-2). Thus, as the method of making the claimed
composition is not in dispute, and as the Examiner concedes (Ans. 4) the
Specification enables the use of a composition containing the pentapeptide
having the claimed sequence in methods of increasing the libido of male
rats, we conclude that Appellants’ Specification provides an adequate
disclosure of how to both make and use the claimed composition.
We note, as the Examiner argues, that the claims encompass any
number of flanking peptides that might affect the demonstrated biological
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activity of the pentapeptide of SEQ ID NO: 2. We also note that the claims
encompass virtually any additional pharmaceutical agent capable of treating
impaired sexual behavior.
However, as Appellants point out (App. Br. 4), an ordinary artisan
need only test a peptide encompassed by claim 45 in accordance with the
procedures outlined in the Specification to determine whether it functions
adequately in the enabled method of use. Given Appellants’ disclosure of
specific procedures for testing the peptides, and combinations of the peptides
with other agents, to determine whether they retain the function of the
pentapeptide of SEQ ID NO: 2 (see FF 1-2), we are not persuaded that
practicing the full scope of the claimed invention would have required undue
experimentation.
We further note, as the Examiner argues, that the claims do not limit
the composition to any particular method of use. However, as noted above,
“[t]he enablement requirement is met if the description enables any mode of
making and using the invention.” Johns Hopkins Univ. v. Cellpro, Inc., 152
F.3d at 1361 (emphasis added).
In the instant case, claim 45 recites a composition, not a process, and
the Examiner does not dispute that the Specification enables the use of a
composition containing a pentapeptide having the claimed sequence in
methods of increasing the libido of male rats (see Ans. 3-4). As the
evidence of record supports Appellants’ position that an ordinary artisan
would have required only routine experimentation guided by the
Specification to determine whether a particular flanking sequence, or
impaired sexual behavior treating agent, encompassed by the claims would
be applicable to the use enabled by the Specification, we agree with
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Appellants that the Examiner’s conclusion of non-enablement is not
supported by the evidence of record.
Accordingly, we reverse the Examiner’s enablement rejection of
claim 45 and its dependents.
WRITTEN DESCRIPTION
ISSUE
In rejecting claims 45-51 for lack of written descriptive support, the
Examiner again notes that, in view of the Specification, the claims broadly
encompass peptides as large as 500 amino acids (Ans. 9).
However, the Examiner reasons, “the description of four short peptide
sequences (SEQ ID NOs: 1-4) is not adequate written description of an
entire genus of functionally equivalent polypeptides which incorporate any
larger amino acid sequence that contains the amino acid sequence of SEQ ID
NO: 2 and all possible peptide variants thereof” (id.).
Moreover, the Examiner finds, “[t]here is also not adequate written
description of an entire genus of pharmaceutical agents capable of treating
impaired sexual behavior in a mammal” (id.) .
Appellants contend that the complete sequence set forth in SEQ ID
NO: 2 is a structural feature common to all members of the claimed genus,
and is therefore adequately representative of the genus’ members (App. Br.
5, citing Example 4 and Example 9, claim 1, of the Written Description
Training Materials, rev. 1, March 25, 2008 (included in Evidence
Appendix)).
Appellants further contend that the genus of pharmaceutical agents
that treat impaired sexual behavior “were well-known at the time the present
application was filed. A patent need not teach, and preferably omits, what is
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well-known in the art” (App. Br. 5 (citing In re Buchner, 929 F.2d 660, 661
(Fed. Cir. 1991))).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the evidence of record
supports that Examiner’s finding that the claims lack adequate descriptive
support in the Specification.
FINDINGS OF FACT
3. The Specification discloses that “the invention relates to the treatment
of DSM-III disorders [Diagnostic and Statistical Manual of Mental
Disorders], such as impaired interpersonal and behavioral disorders” (Spec.
1).
4. The Specification discloses that “included in these disorders are
sexual defects, including arousal disorders, impaired sexual behavior in the
form of a lack of affective attention, and impaired social activity linked to
sexuality. These latter disorders can manifest in part as a condition known
as male erectile dysfunction (M.E.D.)” (id.).
5. The Specification discloses that “PDE5 inhibitors, such as sildenafil,
alpha blocking agents, such as moxysylate or phentolamine, and
prostaglandins have been used” to treat M.E.D. (Id. at 2.)
6. The Diagnostic and Statistical Manual of Mental Disorders (Third
Edition) (hereinafter “DSM-III”), provides an extensive list of
“[p]sychosexual disorders,” which include M.E.D. at page 279 (see App.
Br., Evidence Appendix).
PRINCIPLES OF LAW
To meet the initial burden of establishing a prima facie case of
unpatentability based on a lack of written description, the Examiner must “
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“‘present[] evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.’” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
Recently addressing the description requirement, the Federal Circuit
noted that, “[f]or generic claims, we have set forth a number of factors for
evaluating the adequacy of the disclosure, including ‘the existing knowledge
in the particular field, the extent and content of the prior art, the maturity of
the science or technology, [and] the predictability of the aspect at issue.’”
Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (en banc) (quoting Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed.
Cir. 2005).
The court also advised that the “doctrine never created a heightened
requirement to provide a nucleotide-by-nucleotide recitation of the entire
genus of claimed genetic material; it has always expressly permitted the
disclosure of structural features common to the members of the genus.” Id.
at 1352.
In accordance with these concepts, Example 4 of the Written
Description Training Materials3 (http://www.uspto.gov/web/menu/
written.pdf) (pages 13-16) explains that, in the context of expressed
sequence tags, open “comprising” language that includes unnamed
nucleotides flanking a sequence recited a claim does not lack descriptive
support because each member of the genus necessarily contains the named
sequence, and because adding any desired sequence would be within the
knowledge and skill in the art.

3 Revision 1, March 25, 2008.
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Example 9 of the Training Materials advances a similar result with
respect to a claim reciting an isolated protein “comprising” a specific
sequence, since the all members of the genus share the structural feature of
the claim-recited sequence, and since additions to the named sequence
would have been within the knowledge of skilled artisans (id. at 31).
ANALYSIS
We agree with Appellants that the Examiner’s finding of lack of
written description is not supported by the evidence of record.
We acknowledge that claim 45 encompasses peptides that, in addition
to the pentapeptide recited in SEQ ID NO: 2, also have flanking
polypeptides of considerable size. However, every member of that genus
includes the common structural feature of the sequence recited in SEQ ID
NO: 2, and, as discussed above regarding enablement, determining which
members of the genus possess the required functional properties involves
only routine experimentation.
In view of the disclosure of a structural feature common to all
members of the genus, and methods allowing an ordinary artisan to routinely
determine peptides that fall within the language of the claims, we agree with
Appellants that the Specification provides adequate descriptive support for
the peptide recited in claim 45.
Regarding the “pharmaceutical agent capable of treating impaired
sexual behavior in a mammal having impaired sexual behavior” recited in
claim 45, we note, as the Examiner points out (Ans. 23), that the patents
cited by Appellants to support the well known nature of such agents appear
to have been first submitted at the Appeal Brief stage. We do not agree with
the Examiner, however, that “even if the evidence supplied by the Appellant
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had been filed prior to the Brief, the references still would not have been
persuasive” (id.).
Specifically, the Specification discloses that disorders involving
impaired sexual behavior were well known in the art, as evidenced by their
inclusion and characterization in the DSM-III manual (FF 3, 6). In
particular, the Specification lists male erectile dysfunction (M.E.D) as an
example of such disorders (FF 4). Moreover, the Specification provides
examples of prior art agents useful for treating M.E.D. (FF 5).
Given the Specification’s disclosure, and the Examiner’s failure to
present any specific evidence supporting the assertion that a skilled artisan
would fail to recognize a disorder involving impaired sexual behavior, or an
agent useful for treating it, we find that a preponderance of the evidence
supports Appellants’ position. Accordingly, we reverse the Examiner’s
rejection of claim 45, and its dependents, for failure to meet the written
description requirement.
SUMMARY
We reverse the Examiner’s rejection of claims 45-51 under 35 U.S.C.
§ 112, first paragraph, as lacking enablement for the full scope of the
claimed subject matter.
We also reverse the Examiner’s rejection of claims 45-51 under 35
U.S.C. § 112, first paragraph, as lacking written description.

REVERSED

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cdc

OBLON, SPIVAK, MCCLELLAND MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA VA 22314
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