Appeal No. 2004-2356 Page 3
Application No. 09/833,740
inhibition of cell death.” Specification, page 2. The receptor for the GLP-2
peptide (GLP-2R) “is expressed in a highly tissue specific manner predominantly
in gut endocrine cells and in the brain,” although “little is known about either the
expression or function of the GLP-2R in different regions of the [central nervous
system].” Id. at 4.
According to the specification,
[t]he present invention exploits the promoter region of the
GLP-2 receptor gene. The GLP-2 receptor gene (“GLP-2R gene”)
is characterized as that region of genomic DNA that mediates
production of a GLP-2 receptor having the structural and functional
properties reported in the literature . . . .
In other words, the GLP-2R receptor gene includes not only
the coding region and the 5'-UTR . . . but also a 5' flanking region,
described here, which functions as a tissue-specific promoter in
vivo. More specifically, it has been discovered that the promoter
region which drives expression of the endogenous GLP-2R gene
coding region begins 5' to the first base of the 5'-UTR and extends
upstream therefrom to include, minimally, the number of bases
necessary to drive transcription at levels above detectable
background. Thus, the promoter region comprises at least about
1,000 bases upstream of the transcription start site, suitably at least
1,200 bases upstream thereof, and desirably at least 1,400 bases
5' thereof. The maximum size of the promoter region can extend
beyond 8,000 bases upstream of the transcription start site, and
desirably incorporates those components, such as transcriptional
factor binding sites and upstream activator sequences, through
which expression of the endogenous GLP-2R gene normally is
regulated.
Id. at 10.
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