Appeal No. 1997-4379
Application No. 08/278,437
Background
The present invention is directed to “conformationally and chemically stable
analogs of cyclic bioactive peptides containing disulfide linkages" (Specification, page
6). According to appellants, "disulfide bonds exist primarily to ensure conformational
rigidity" (Specification, page 1). When subject to "even mild reducing conditions," the
destruction of the disulfide bond "usually destroys the bioactivity of the peptide" (id.).
The invention provides "analogs of cyclic bioactive peptides containing disulfide
linkages which have improved chemical and biological activity while substantially
retaining the overall 3-dimensional peptide conformation and bioactivity" (Specification,
page 2). This is done by modifying the disulfide bond by "one of four methods: (a)
sulfide contraction, (b) isoteric substitution, (c) thioketal expansion, or (d) alkylation
expansion" (Specification, paragraph bridging pages 2 and 3).
Discussion
Rejection under 35 U.S.C. § 112, first paragraph:
The examiner rejected claims 1 through 5 and 14 through 18 under
35 U.S.C. § 112, first paragraph, as based on a non-enabling disclosure (Examiner’s
Answer, page 4). We shall not sustain this rejection.
It is well settled that the examiner bears the initial burden of providing reasons
why a supporting disclosure does not enable a claim. In re Marzocchi, 439 F.2d 220,
223, 169 USPQ 367, 369 (CCPA 1971). It has long been held that "[t]o be enabling,
the specification of a patent must teach those skilled in the art how to make and use the
full scope of the claimed invention without 'undue experimentation.'" Genentech, Inc. v.
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