Appeal No. 1999-1330
Application No. 08/527,373
Claim 1 is directed to a process of improving the treatment of a tumor using
radiation therapy comprising treating the tumor with radiation therapy wherein the cells
of the tumor have been transduced with a polynucleotide encoding wild-type p53.
Appellants indicate that transduction of radiation resistant tumor cells in this manner
can reverse the radiation resistance of such tumor cells. (Specification, page 6). The
specification explains that "'treating a tumor' as used herein means that one provides
for the inhibition, prevention, or destruction of the growth of the tumor cells." (Id.). The
wild-type p53 protein is a natural occurring protein associated with cell growth
regulation which has been found to function as an oncogene in its mutated form and a
tumor suppressor gene in its wild-type form. (Jung, page 6390, column 1, third
paragraph.)
The rejection under 35 U.S.C. § 112, first paragraph
Claims 1 - 11 stand rejected under 35 U.S.C. § 112, first paragraph, as being
based on a disclosure which “fails to provide an enabling disclosure for any ‘improved’
embodiment of cancer treatment.” (Answer, page 9). While acknowledging that the
specification “enables the reduction of cancer cell lines implanted subcutaneously in
nude mice which have been transduced to express wild-type p53 protein via adenoviral
vectors and then irradiated,” the examiner urges that “the specification fails to enable
any treatment methodology for naturally occurring cancers in humans.” (Answer, page
9). In explaining the basis of this rejection, the examiner has focused on that aspect of
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