Appeal No. 2004-2356 Page 6
Application No. 09/833,740
highly stringent conditions to known sequences because such conditions dictate
that all species within the genus will be structurally similar.” Enzo Biochem, 323
F.3d at 967, 63 USPQ2d at 1615.
According to the rejection, claims 1-5, and 9 “are broadly directed to a
recombinant DNA construct comprising ‘a promoter region of a GLP-2 receptor
gene’, (GLP-2R promoter), which comprises at least the last 1000 nucleotides
upstream of the start site of transcription of either the murine nucleotide
sequence of SEQ ID NO: 1 (isolated from mouse) or a mammalian homolog of
the nucleotide sequence of SEQ ID NO: 1.” Examiner’s Answer, page 3.
With respect to disclosed structures, i.e., sequences, of GLP-2R
promoters, the examiner notes that the specification “describes the promoter as
comprising at least 1000 base pairs upstream of the transcription start site,” and
also requiring “‘the number of bases necessary to drive transcription at levels
above detectable background,’” as well as “‘transcription factor binding sites and
upstream activator sequences, through which expression from the endogenous
GLP-2R gene normally is regulated.’” Id. at 3-4 (quoting paragraph 43 of the
specification). The examiner goes on to note that all that is disclosed by the
specification, however, is “a sequence of about 1.5 kb from upstream of the
transcription start site (a SmaI-PstI fragment, nucleotides 182-1673 of SEQ ID
NO: 1) of the mouse GLP-2R gene . . . .” Id. at 4. Moreover, according to the
examiner, if additional DNA regulatory sequences are needed “‘to correctly
specify transgene transcription in all cells and tissues expressing the
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