Ex Parte Chada et al

Board of Patent Appeals and Interferences

May 12, 2010

10768566 (B.P.A.I. May. 12, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte KIRAN K. CHADA, ROLAND CHOUINARD, HENA ASHAR
and ABU SAYED
____________

Appeal 2009-013740
Application 10/768,566
Technology Center 1600
____________

Decided: May 12, 2010
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS and
FRANCISCO C. PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1, 8, 9, and 17-19,
the only claims pending in this application. We have jurisdiction under 35
U.S.C. § 6(b).

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STATEMENT OF THE CASE
The claims are directed to a method of reducing the amount of adipose
tissue in a subject (claims 1, 8, and 9) and a method of reducing the level of
adipose tissue formation in a subject (claims 17-19). Claims 1 and 17 are
illustrative:
1. A method of reducing the amount of adipose tissue in a subject
comprising administering to the subject an amount of an sFRP-5 peptide
effective to reduce the amount of adipose tissue, or an amount of a molecule
effective to stimulate expression of the sFRP-5 peptide in the subject,
wherein the sFRP-5 peptide compr[i]ses consecutive amino acids having the
sequence set forth in SE[Q] ID NO: 1.
17. A method of reducing the level of adipose tissue formation in a
subject comprising administering to the subject an amount of an sFRP-5
peptide effective to reduce the level of adipose tissue formation, or an
amount of a molecule effective to stimulate expression of the sFRP-5
peptide in the subject, wherein the sFRP-5 peptide comprises consecutive
amino acids having the sequence set forth in SE[Q] ID NO: 1.

The Examiner relies on the following evidence:
Xu US 2003/0143610 A1 Jul. 31, 2003

The rejection presented by the Examiner follows:
Claims 1, 8, 9, and 17-19 stand rejected under 35 U.S.C. § 102(e) as being
anticipated by Xu.
We affirm.

ISSUE
Does Xu’s method of administering Appellants’ active agent in the
Appellants’ effective amount to the same patient population as Appellants
inherently anticipate Appellants’ claimed method?
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FINDINGS OF FACT
FF 1. Xu teaches “a SARP3 polypeptide comprising the amino acid
sequence of SEQ ID NO:2” (Xu 2: ¶ [0018]; 29: 12- 30: 10; Ans. 4).
FF 2. Appellants concede that Xu’s SARP3 polypeptide having the amino
acid sequence of SEQ ID NO: 2 is identical to Appellants’ sFRP-5
polypeptide having the sequence of SEQ ID NO: 1 (App. Br. 13; see also
Ans. 4).
FF 3. Xu teaches that “a SARP3 polypeptide comprising the amino acid
sequence of SEQ ID NO:2 . . . or a fragment thereof” is a SARP3 modulator
(Xu 2: ¶ [0018]; Ans. 4).
FF 4. Xu teaches “a method for treating a subject having a metabolic
disorder characterized by aberrant SARP3 polypeptide activity or aberrant
SARP3 nucleic acid expression, e.g., obesity, diabetes, anorexia, or
cachexia”, wherein “[t]he method includes administering to the subject a
SARP3 modulator, e.g., in a pharmaceutically acceptable formulation” (id.).
FF 5. Appellants’ Specification discloses that the invention “provides for
an sFRP-5 polypeptide and methods of administration of such an sFRP-5
polypeptide to a subject for the treatment of obesity and other metabolic
disorders related to an overabundance of adipose tissue” (Spec. 1: 16-18).
FF 6. Xu teaches that “a therapeutically effective amount of polypeptide
(i.e., an effective dosage) ranges from about 0.001 to 30 mg/kg body
weight” (Xu 15: ¶ [0133]).
FF 7. Appellants’ therapeutically effective dosage is identical to Xu’s.
Specifically, Appellants’ Specification discloses that “[a] therapeutically
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effective amount of polypeptide (i.e., an effective dosage) ranges from about
0.001 to 30 mg/kg body weight” (Spec. 18: 27-28).
FF 8. Xu’s
[I]nvention is based, at least in part, on the discovery that the
SARP3 (secreted apoptosis-related protein 3), also referred to
herein as SFRP5 (secreted frizzled-related protein 5) nucleic
acid and polypeptide molecules . . . are expressed at high levels
in adipose tissue and hypothalamus, and are downregulated in
leptin pathway deficient genetic animal models of obesity, but
upregulated when fed a high fat diet. Without intending to be
limited to any particular theory or mechanism of action, it is
believed that SARP3 molecules can modulate lipid metabolism.

(Xu 2: ¶ [0020].)

FF 9. Xu teaches that in the ob/ob and db/bd “[g]enetic mouse models of
obesity . . . mice showed a lower level of SARP3 expression as compared to
their respective corresponding wild type strain, which is likely due to the
absence of the leptin signaling pathway in these mice” (Xu 27: ¶ [0227]).

PRINCIPLES OF LAW
The test which determines whether an invention has been anticipated
by a reference is whether the description of the invention in the reference is
“sufficient to put the public in possession of the invention.” In re LeGrice,
301 F.2d 929, 933 (1962); In re Elsner, 381 F.3d 1125, 1128 (Fed. Cir.
2004) (following LeGrice, and noting that “[i]n particular, one must be able
to make the claimed invention without undue experimentation.”).
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
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F.2d 628, 631 (Fed. Cir. 1987). Thus, “[n]ewly discovered results of known
processes directed to the same purpose are not patentable because such
results are inherent.” Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246
F.3d 1368, 1376 (Fed. Cir. 2001). “Inherency, however, may not be
established by probabilities or possibilities. The mere fact that a certain thing
may result from a given set of circumstances is not sufficient.” In re
Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal
quotation marks omitted).
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005)
emphasizes this point by illustrating the difference between claims that
recite a new use of an old composition and claims that recite a newly
recognized benefit of an old method. Perricone involved two sets of claims,
one directed to preventing sunburn damage and the other to treatment of skin
sunburn. In each case, the claims required topical application of a fatty acid
ester of ascorbic acid. The prior art described topical application of the same
compound (among thirteen others) to skin, in an amount that encompassed
the claimed effective amount. The Perricone court found that the claims
directed to preventing sunburn damage to exposed skin surfaces were
anticipated by the prior art, even though the prior art “[did] not disclose any
benefit directed to skin sunburn, or any of the other specific skin disorders,
as claimed” (id. at 1376). On the other hand, the court found that the claims
directed to treating skin sunburn were directed to a new use of the prior art
compounds, and therefore not anticipated, because the prior art “[did] not
disclose topical application to skin sunburn” (id. at 1379). That is, the prior
art did not disclose applying the compound to the same population (people
with sunburn) as required by the claims. As the court explained, “[t]he issue
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is not . . . whether [the prior art] lotion if applied to skin sunburn would
inherently treat that damage, but whether [the prior art] discloses the
application of its composition to skin sunburn” (id. at 1378).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

ANALYSIS
Appellants contend that “claims 1, 8, 9 and 17-19 do not stand
together but stand separately” (App. Br. 11). Appellants, however, provide
separate arguments for the following groups of claims: (I) claims 1, 8, and 9
and (II) claims 17-19 (see App. Br. 14 and 16). Accordingly, we have
reviewed the record as it relates to representative claims 1 and 17. 37 C.F.R.
§ 41.37(c)(1)(vii).

Claim 1:
Claim 1 is drawn to a method of reducing the amount of adipose
tissue in a subject. The claimed method comprises administering to a
subject an amount of a sFRP-5 peptide effective to reduce the amount of
adipose tissue, or an amount of a molecule effective to stimulate expression
of the sFRP-5 peptide in the subject. Claim 1 defines the sFRP-5 peptide as
a peptide comprising consecutive amino acids having the sequence set forth
in SEQ ID NO: 1.
Both Appellants and Xu teach the treatment of the same patient
population, e.g., an obese subject (FF 4 and 5), with an identical dosage (FF
6 and 7) of an identical active agent (FF 2 and 3). Accordingly, we find no
error in the Examiner’s finding that while Xu does not teach the reduction of
adipose tissue, since Xu administers the identical dosage of an identical
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active agent to the same patient population as Appellants, Xu’s method will
inherently reduce the amount of adipose tissue in a subject (see Ans. 4).
Since Xu teaches the same dosage as disclosed by Appellants (FF 6
and 7) we are not persuaded by Appellants’ contentions with regard to
dosage (Reply Br. 9-10).
Appellants contend that Xu fails to teach the administration of “(i) an
amount of an sFRP-5 peptide effective to reduce the amount of adipose
tissue, or (ii) an amount of a molecule effective to stimulate expression of
the sFRP-5 peptide in the subject” (App. Br. 13). We are not persuaded.
Claim 1 requires that the sFRP-5 peptide either reduce the amount of
adipose tissue or stimulate expression of the sFRP-5 peptide in the subject.
Since Xu administers the identical dosage of an identical active agent to the
same patient population as Appellants, Xu’s method will inherently reduce
the amount of adipose tissue in a subject. Thus, Xu anticipates claim 1.
Accordingly, we do not reach the merits of the alternative embodiment of
claim 1 regarding the amount of a molecule effective to stimulate expression
of the sFRP-5 peptide in the subject.
We are not persuaded by Appellants’ contention that Xu fails to teach
“what the ‘modulator should do[’]” or “what ‘modulating’ SARP3 means”
(App. Br. 14). The mechanism of action through which an active agent acts
is not at issue. To the contrary, the question is whether Xu’s method reduces
the amount of adipose tissue in a subject, by administering the same active
agent, in the same dosage, to the same patient population. We find no
persuasive argument or evidence on this record to support a conclusion that
Xu’s method would not inherently reduce the amount of adipose tissue in a
subject.
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Appellants contend that the Examiner mischaracterized Xu’s teaching
because a portion of Xu identifies “at least sixteen different possible types of
‘modulators,’ including ‘modulators’ that clearly achieve different ends”
(Reply Br. 7; see generally Reply Br. 6-9). We are not persuaded. Xu
teaches that SARP3 expression levels are down regulated in leptin pathway
deficient genetic animal models of obesity (FF 8 and 9) and teaches that
obesity can be treated by administering an effective amount of a SARP3
polypeptide comprising the amino acid sequence of SEQ ID NO: 2 (FF 3).
For the foregoing reasons we are not persuaded by Appellants’
contention that Xu “does not teach anything which could inherently result in
the claimed invention” (App. Br. 16). For the same reasons we are not
persuaded by Appellants’ contention that Perricone v. Medicis Pharm.
Corp., 432 F.3d 1368 (Fed. Cir. 2005) supports a different conclusion (App.
Br. 17). The Perricone court found that claims directed to preventing
sunburn damage to exposed skin surfaces were anticipated by the prior art,
even though the prior art “[did] not disclose any benefit directed to skin
sunburn, or any of the other specific skin disorders, as claimed” (id. at
1376). By analogy, Xu administers the identical dosage of an identical
active agent to the same patient population as Appellants, thus, Xu’s method
will inherently reduce the amount of adipose tissue in a subject.
Lastly, for the reasons set forth by the Examiner (Ans. 9), we are not
persuaded by Appellants’ contention that Xu fails to provide an enabling
disclosure of Appellants’ claimed invention because the Examiner of Xu
rejected Xu’s invention as lacking an enabling disclosure (App. Br. 19;
Reply Br. 10-12).

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Claims 17-19:
Claim 17 is drawn to a method of reducing the level of adipose tissue
formation in a subject. The claimed method comprising administering to the
subject an amount of a sFRP-5 peptide effective to reduce the level of
adipose tissue formation, or an amount of a molecule effective to stimulate
expression of the sFRP-5 peptide in the subject. Claim 17 defines the sFRP-
5 peptide as a peptide comprising consecutive amino acids having the
sequence set forth in SEQ ID NO: 1.
Appellants separate argument of claims 17-19 are a corollary to the
contentions made with regard to claim 1 (see App. Br. 14 and 16). We are
not persuaded for the reasons set forth above. In sum, since Xu administers
the identical dosage of an identical active agent to the same patient
population as Appellants, Xu’s method will inherently reduce the level of
adipose tissue formation in a subject.

CONCLUSION OF LAW
Xu’s method of administering Appellants’ active agent in Appellants’
effective amount to the same patient population as Appellants inherently
anticipates Appellants’ claimed method.
The rejection of claims 1 and 17 under 35 U.S.C. § 102(e) as being
anticipated by Xu is affirmed. Claims 8 and 9 fall together with claim 1.
Claims 18 and 19 fall together with claim 17.
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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

alw

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