Appeal No. 1999-1430
Application No. 08/441,893
Appellants provide no further comment with regard to this rejection.
Accordingly, we affirm the examiner’s rejection of claims 16 and 23-25 under the
judicially created doctrine of obviousness-type double patenting.
35 U.S.C. § 112, first paragraph:
According to the examiner (Answer6, page 4) “the disclosure is enabling
only for claims limited to proteins which correspond in scope to those protein[s]
which are encoded by the nucleic acid of the allowed claims from U.S. Patent
Application Number 08/242,211, now Patent Number 5,464,937.” The examiner
finds (Answer, page 4) that “the presence of the hybridization limitation of the
instant claims has the effect of encompassing any mutant of the disclosed type II
IL-1R which retains the ability to bind IL-1.
The examiner reasons (Answer, pages 5-6) that:
The instant specification does not provide a single working example
of an IL-2 [sic] receptor whose amino acid sequence deviates from
a natural amino acid sequence and yet the claims encompass
potentially thousands of embodiments which do. Further, the
instant specification does not identify those amino acid residues in
the amino acid sequence of either of the two disclosed type II IL-1
receptors which are essential for their biological activity and
structural integrity and those residues which are either expendable
or substitutable. In the absence of this information a practitioner
would have to resort to a substantial amount of undue
experimentation in the form of insertional, deletional and
substitutional mutation analysis of over three hundred amino acid
residues before they could even begin to rationally design a
functional IL-1 receptor having other than a natural amino acid
sequence. The disclosure of two DNAs encoding two IL-1
receptors, each having it’s natural amino acid sequence, is clearly
insufficient support under the first paragraph of 35 U.S.C. § 112 for
claims which encompass any and all type II IL-1 receptor proteins,
including mutants thereof, which are encoded by a DNA which
6 Paper No. 16, mailed February 11, 1998.
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