Appeal No. 95-4471
Application No. 07/963,475
In explaining the need for undue experimentation to practice the invention, the
examiner states (Answer, page 5):
(1) It would require an undue amount of experimentation to determine
whether or not a gene falls within the claimed functional limitations and (2)
even if a gene were shown to fall within the functional limitations it would
require undue experimentation to determine whether it was functional in the
claimed invention, that is, the gene has aberrant expression which is
correlated with the presence of a fibrotic disease.
In addressing the sufficiency of the guidance provided by the specification the
examiner states (Supp. Answer, page 2):
The specification offers no guidance as to which of the myriad genes
within the scope of these claims will function and which will not.
The examiner has conceded that the disclosure is at least enabled for those cDNAs
and related proteins specifically exemplified by the specification. (Suppl. Answer, page 1).
However, the examiner reads the claims as encompassing more than the use of these
cDNAs. Thus, it is this aspect of the claimed method which the examiner considers to lack
sufficient enabling support in the disclosure.
It would appear from the examiner's explanation of the rejection that it would be
necessary to identify all, or at least a reasonable number, of other cDNAs, and related
proteins, in order to enable the present claims within the meaning of 35 U.S.C. § 112, first
paragraph. We do not agree. The steps of the claimed diagnostic method are clear.
While the claims may encompass the use of ECM related PCR primers, and cDNAs of
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