Appeal No. 95-2662
Application 07/771,262
As set forth in the claims above, the present invention is directed to modified
peptides or proteins which comprise a C-terminal extension of two or more tandem units of
a carboxyl terminal peptide (CTP) derived from human chorionic gonadotropin (amino acid
residues at positions 112-118 through 145 of the native beta subunit). In particular, the
invention concerns the modification of pharmaceutical peptides. Specification, p. 1, para.
1. According to the specification, the addition of the CTP extension to a peptide results in
an increase in its in vivo stability. Specification, p. 1, para. 1; p. 2, lines 11-29.
Enablement
The examiner argues that:
Enablement of the current specification as filed is not commensurate in scope with
claims to modification of any peptide or protein other than FSH or LH. Applicants
have demonstrated the attachment of the tandem CTP extension only to a single
protein, FSH. ... there is no basis for the assumption that said extension would
confer similar properties to other hormones, growth factors, cytokines, or other
unrelated proteins. In the absence of any alternative embodiments, there is no
basis to conclude that the innumerable claimed embodiments of the invention would
function in an analogous manner to the single exemplified species [Answer, p. 5].
It is well established that the examiner may reject the claims as being based on a
non-enabling disclosure when s/he has reason to conclude that one skilled in the art would
be unable to carry out the claimed invention without undue experimentation.
In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991);
In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971)(“a specification
disclosure which contains a teaching of the manner and process of making and using the
invention in terms which correspond in scope to those used in describing and defining the
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