Appeal No. 1999-1231 Page 6
Application No. 08/709,554
Our review of the examiner=s evidence in light of the standard for enablement
and/or utility articulated in Brana leads us to conclude that the evidence does not
support the broad proposition that gene therapy is nonenabled.
Turning to that aspect of the examiner=s rejection that focuses on the role of
glucocorticoids in gene transfer techniques, the examiner cites Hirt as evidence that
glucocorticoids exert their biological effects by binding to glucocorticoid response
elements (GREs) in the promoter regions of glucocorticoid-regulated genes, that their
effects on the activity of glucocorticoid-inducible promoters are extensive and varied,
and Athat there are >some problems and limitations inherent in inducible expression
systems, especially in glucocorticoid-inducible expression vectors=.@ Examiner=s
Answer, pages 10-11.
Inasmuch as the examples in the specification purport to demonstrate that
glucocorticoids have an effect on gene expression that is independent of the promoter
or gene used, and the claimed method expressly requires a vector containing a gene
under the control of a promoter that does not have a GRE, the relevance of Hirt is not
immediately apparent. Nevertheless, the examiner insists that A[t]he promoter needs to
have a glucocorticoid response element for glucocorticoid to have an effect on the
promoter@ (Examiner=s Answer, page 5), and that the CMV and SV40 promoters used in
the examples may lack Athe more common glucocorticoid response element[s],@ but that
does not prove that they Ahave no GRE at all@ (Id., page 8). The examiner concludes
that A[f]or a glucocorticoid to have an effect, it is therefore apparent that there is a GRE
but for which the instant claims require there be no GRE@ (Id., page 11).
We remind the examiner that
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