Ex parte Chuang

OCR transcription for search; preserved printed pages are authoritative

Board of Patent Appeals
and Interferences

Informative

Opinion

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES

Ex parte LEE-MING CHUANG and WEN-LING CHOU

Appeal 2008-5143
Application 11/147,849
Technology Center 1600

Decided: November 13, 2008

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
isolated polypeptide encoding a prostaglandin reductase which the Examiner
has rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

Appeal 2008-5143
Application 11/147,849

Background

“Peroxisome proliferator-activated receptors (PPARs) belong to a
family of nuclear receptors that regulate lipid and glucose metabolism”
(Spec. 1:10-11). The Specification notes that after “activation by either
dietary fatty acids or their metabolic derivatives, PPARs trigger a cascade of
transcriptional events leading to altered lipid and glucose metabolism”
(Spec. 1:12-14). According to the Specification “PPARs are promising
therapeutic targets of diseases, e.g., type II diabetes, obesity, dyslipidemia,
coronary heart disease, inflammatory disease, and cancer” (Spec. 1:17-19).
Statement of the Case
The Claims

Claims 4 and 20-22 are on appeal.’ We will focus on claims 4 and 20,
which are representative and read as follows:

4. An isolated polypeptide, comprising the amino acid sequence of

SEQ ID NO: 1.

20. An isolated polypeptide, comprising a sequence that has at least

95% sequence identity to SEQ ID NO: 1, wherein the polypeptide

reduces 15-keto prostaglandin but does not reduce leukotriene B4.
The prior art

The Examiner relies on the following prior art references to show
unpatentability:

Kawai et al., Functional annotation of a full-length mouse cDNA
collection, 409 NATURE 685-690 (2001).

' Claims 13-19 were withdrawn from consideration (see App. Br. 1).

2

Appeal 2008-5 143
Application 111147,849
Okazaki et al., Analysis of the mouse transcriptome based on
functional annotation of 60,770full-length cDNAs, 420 NATURE563-573
(2002).
The issues
The rejections as presented by the Examiner are as follows:
A. 	Claims 4 and 20-22 stand rejected under 35 U.S.C. 5 102(b), as being
anticipated by Kawai (Ans. 4).
B. 	Claims 4 and 20-22 stand rejected under 35 U.S.C. 5 102(b), as being
anticipated by Okazaki (Ans. 5).
A. 	35 U.S.C. $102(b) rejection over Kawai
The Examiner contends that "Kawai . . . disclose the isolation of a
polynucleotide and encoded polypeptide annotated as a zinc-containing
alcohol dehydrogenase superfamily homolog having 100% homology to
SEQ ID NO: 1" (Ans. 4). The Examiner argues that "the polypeptide
sequence of the three [two?] cited references were used in the rejection and
not the cDNA sequence. Thus, the examiner is not saying that a cDNA
anticipates a protein but that a conception of a11 amino acid sealleiice in [the1
prior art anticipates the claimed protein" (id. at 7).
Appellants begin by citing "Wen-Hwa Lee v. Thaddeus P. Dryja, 79
U.S.P.Q.2d 1614; 2005 WL 3 121465, a decision made by the Board of
Patent Appeals and Interferences" (App. Br. 2). Appellants rely upon Wen-
Hwa Lee to argue that a "cDNA is at most an equivalent of its encoded
protein but does not contain every element of the isolated protein encoded
thereby" (id. at 3). Appellants quote from Wen-Hwa Lee:
"assuming arguendo that it was well within ordinary skill in the
art to prepare, isolate and purify the protein product of a given

Appeal 2008-5 143
Application 111147,849
cDNA clone at the time the ' 163 application [the patent
application at issue] was filed, the 4.7 kb cDNA described in
the '163 specification would have made its encoded protein
obvious at best"
(App. Br. 3).
Appellants also contend that "disclosure of the cDNA at best renders
its encoded protein obvious. In other words, the fact that a novel product can
be readily made does not render the product not novel" (id. at 3).
In view of these conflicting positions, we frame the anticipation issue
before us as follows:
Does the teaching of the amino acid sequence of SEQ ID NO: 1 by
Kawai without a teaching of the expressed protein product anticipate an
isolated protein comprising SEQ ID NO: l ?
Findings of Fact (FF)
1. 	The Examiner states that both Kawai and Okazaki teach "the
isolation of a polynucleotide and encoded polypeptide annotated as a zinc-
containing alcohol dehydrogenase superfamily homolog having 100%
homology to SEQ ID NO: 1" (Ans. 4, 5). This fact is not disputed by
Appellants.
2. 	The Examiner states that the RIKENIFANTOM database
disclosed "the polypeptide sequence having 100% sequence homology to
SEQ ID NO: 1 . . . Accession # IPR002085, Hit number 18 ID=B83006H24
and the polypeptide sequence with date stamp May 18,2001" (Ans. 4, 5).
This fact is not disputed by Appellants

Appeal 2008-5 143
Application 111147,849
A. Discussion of 35 U.S.C. $102(b) over Kawai
We agree with the Examiner that the prior art teaches polypeptide
sequences which are 100% identical to those claimed by Appellants (FF 1-
2). Appellants have provided no evidence to rebut the teachings identified
by the Examiner. Appellants also acknowledge that, in the prior art, "[olne
of the myriad cDNAs encodes an amino acid sequence identical to SEQ ID
NO: 1" (App. Br. 2). While we recognize that the prior art did not
physically create the claimed proteins, the Federal Circuit in Donohue
addressed this issue, noting "[ilt is not, however, necessary that an invention
disclosed in a publication shall have actually been made in order to satisfy
the enablement requirement." In re Donohue, 766 F.2d 53 1, 533 (Fed. Cir.
1985). See Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246
F.3d 1368, 1379 (Fed. Cir. 2001) ("[Alnticipation does not require actual
performance of suggestions in a disclosure. Rather, anticipation only
requires that those suggestions be enabling to one of skill in the art").
Appellants did not dispute that the prior art of Kawai, in concert with
the knowledge of the skilled artisan, was enabling for expression of the
isolated polypeptide of claim 4 (see App. Br. 3). A reference is presumed to
be enabled for the purpose of an anticipation rejection. The burden rests with
the Appellants to establish that the prior art is not enabling.
[Plroof of efficacy is not required for a prior art reference to be
enabling for purposes of anticipation. . . . [Tlhe proper issue is
whether the [prior art] is enabling in the sense that it describes
the claimed invention sufficiently to enable a person of ordinary
skill in the art to carry out the invention.

Appeal 2008-5 143
Application 111147,849
Impax Labs. v. Aventis Pharms., 468 F.3d 1366, 1383 (Fed. Cir. 2006).
"Anticipation does not require the actual creation or reduction to practice of
the prior art subject matter; anticipation requires only an enabling
disclosure." Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380
(Fed. Cir. 2003) (citing In re Donohue, 766 F.2d 53 1, 533 (Fed. Cir. 1985)).
Consequently, we find that the Kawai reference was enabled for the
expression of SEQ ID NO: 1 and under Donohue, properly anticipates claim
4.
In our opinion, Wen-Hwa Lee, cited by Appellants, differs from the
facts in this case in several ways. First, Wen-Hwa Lee was an interference
proceeding in which the issue was whether Dryja had sufficient evidence to
establish that it had possession of a single enabled embodiment within the
scope of the count. Thus, the standard was not the same anticipation
standard as in this case. Secondly, there was no evidence in the record that
Dryja had disclosed a complete coding sequence for a protein. Instead, there
was evidence that the plasmids containing a mutation where "in vivo
analysis confirmed that the Dryja plasmids were unable to express the
retinoblastoma protein." 	Wen-Hwa Lee v. Thaddeus P. Dvyja, 79 USPQ2d
1614, 1627-28 (BPAI 2005). Thus, the reason that the cDNA did not
anticipate was because the disclosed cDNAs had a stop codon and were not
enabled to express the protein. Id. The reason was not because the Board
applied a generic rule that cDNAs cannot anticipate proteins.
We affirm the rejection of claim 4 as anticipated by Kawai. Pursuant
to 37 C.F.R. 5 41.37(c)(l)(vii)(2006), we also affirm the rejections of claims
20-22, as these claims were not argued separately.

Appeal 2008-5 143
Application 111147,849
B. 35 U.S.C. $102(b) rejection over Okuzuki
Appellants rely upon the arguments discussed above regarding the
Kawai reference in order to overcome the Okazaki reference. We have
already addressed these arguments in our discussion of claim 4 above, and
we found them to be unavailing. It therefore follows that Appellants have
not shown that the Examiner erred in concluding that the Okazaki reference
anticipates claim 4.
We affirm the rejection of claim 4 as anticipated by Okazaki. Pursuant
to 37 C.F.R. 5 41.37(c)(l)(vii)(2006), we also affirm the rejections of claims
20-22, as these claims were not argued separately.
CONCLUSION
In summary, we affirm the rejection of claim 4 as anticipated by
Kawai. Pursuant to 37 C.F.R. 5 41.37(c)(l)(vii)(2006), we also affirm the
rejections of claims 20-22, as these claims were not argued separately. We
affirm the rejection of claim 4 as anticipated by Okazaki. Pursuant to 37
C.F.R. 5 41.37(c)(l)(vii)(2006), we also affirm the rejections of claims 20-
22, as these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. 5 l.l36(a)(l)(iv)(2006).
AFFIRMED
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