Appeal No. 2004-2356 Page 9
Application No. 09/833,740
GLP-2R promoter regions. As noted by the rejection, the specification teaches a
sequence of about 1.5 kb from upstream of the transcription start site of the
mouse GLP-2R gene, and also teaches approximately 200 bases upstream of
the transcription start site of the human GLP-2R gene. The claim, however,
encompasses any mammalian homolog of the murine nucleotide sequence.
With respect to function, the only function disclosed by the specification is
an assay wherein the promoter is operably linked to a reporter gene, which is
then used to make a transgenic mouse, wherein the expression of the reporter is
compared to the expression of the endogenous mouse GLP-2R receptor in
various tissues. The only promoter for which data from the assay is provided in
the specification is the mouse promoter, and as also noted by the specification,
the 1.5 kb mouse sequence directed expression of the reporter in similar but not
identical tissues as the endogenous GLP-2R gene. Thus, although the promoter
region is defined as being “at least the last 1,000 nucleotides upstream of the
transcription start site,” there is no description of how other mammalian
promoters would be expected to perform in the assay. And given the fact that
the 1.5 kb mouse sequence did not direct expression in the identical tissues as
the endogenous promoter, the skilled artisan would not expect all mammalian
promoters to give identical results in the assay. We thus find that there is no
disclosure of structure coupled with function that would allow one skilled in the art
to visualize or recognize the identity of the members of the genus.
Moreover, the correlation between the nucleotide sequences as located in
the 5'-flanking region upstream of the transcription start site of the GLP-2R gene
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