Appeal No. 2001-0545 Page 6
Application No. 08/442,423
in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of
the claims. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1403
(Fed. Cir. 1988). In setting forth an enablement rejection under 35 U.S.C. § 112,
first paragraph, the examiner should set forth his or her analysis for each of the
relevant Wands factors in order to expedite review on appeal.
In this case, the examiner is relying on the state of the art in gene therapy
and anti-sense therapy to demonstrate the unpredictability of the instant claims,
and thus for the conclusion that the specification does not teach the skilled
artisan how to deliver the claimed nucleic acid ligands for bFGF. The examiner
acknowledges that gene expression is not a requirement for the claimed method,
but does not appear to give that difference much weight. That is, however, a
substantial difference, as the instant methods only require the nucleic acid ligand
to bind to bFGF, and thus bypass the difficulties of requiring expression.
Moreover, as noted by the examiner, the issue with anti-sense therapy is the
ability of the anti-sense nucleotide to reach the target nucleic acid in sufficient
quantities to inhibit the disease phenotype, which again, is not required by the
instantly claimed methods. See Examiner’s Answer, page 4. Thus, the
discussion of the problems with gene therapy and anti-sense therapy do not
support the examiner’s proposition that the instant claims are not enabled, as the
nucleic acids of the instantly claimed methods act as a binding partner to bFGF,
and do not require expression, nor must they bind to a target nucleic acid in
order to inhibit the disease phenotype.
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