Appeal No. 2004-2356 Page 10
Application No. 09/833,740
and the tissue-specific promoter function of the claimed promoter regions is not
the type of structure-function correlation envisioned by the Federal Circuit in
Enzo Biochem. First, the position of the promoter being defined as the 5'-
flanking region upstream of the transcription start site of the GLP-2R gene may
be a physical characteristic of the promoter, but it in no way describes the
structure, i.e., the sequence of the promoter region. Second, Enzo Biochem
describes a hybridization assay wherein the conditions dictate that all species
within the genus will be structurally similar. The functional assay described by
the specification, i.e., operably linking the putative promoter sequence to a
reporter gene, making a transgenic mouse containing the construct, and then
comparing the expression of the reporter to the expression of the endogenous
mouse GLP-2R receptor in various tissues does not dictate that all of the species
within the genus will be structurally similar. In fact, functional variants
possessing as little as 75% sequence homology are contemplated by the
specification. See Specification, page 15.
With respect to claim 9, appellants argue that “[t]he subject matter of claim
9 is fully described in the specification because the specification sets forth the
recited sequence and teaches that the invention includes promoter regions
comprising that sequence.” Appeal Brief, page 18. Appellants argue further that
“Lilly does not apply to claim 9 because claim 9 does not define the promoter
region by function only.” Id.
Appellants’ arguments are not convincing, because as noted by the
examiner and as acknowledged by appellants, the specification only provides a
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