Appeal No. 1999-1330
Application No. 08/527,373
which states that tumors supplied with functional p53 may
become susceptible to apoptosis normally associated with
the DNA damage induced by radiation and chemotherapy.
This passage, however, is mere speculation on the part of
Wills that one may treat tumors with a combination of p53
gene therapy and radiation.
However, as pointed out by the examiner (Answer, page 15), to the extent that the
suggestion of Wills may be speculation, this statement, when combined with the
teaching of Nabeya which teaches that an advantage is obtained when the amount of
wild-type p53 is increased in cells subject to chemotherapy, raises the expectation that
similar advantage would be obtained by combining the gene therapy relating to wild-
type p53 with radiation therapy in the treatment of tumors and tumor cells. As pointed
out by the examiner this interpretation is bolstered by the description in Wills at page
1086, paragraph bridging cols. 1 and 2, which provides:
Wild-type p53 has recently been identified as a necessary
component for apoptosis induced by irradiation or treatment
with some chemotherapeutic agents. Due to the high
prevalence of p53 mutations in human tumors, it is possible
that tumors which have become refractory to chemotherapy
and irradiation treatments may have become so due in part
to the lack of wild-type p53. By resupplying functional p53 to
these tumors, it is possible that they will now become
susceptible to apoptosis normally associated with the DNA
damage induced by radiation and chemotherapy. (Citations
omitted).
Nabeya confirms the Wills proposition, at least with regard to chemotherapy, and would
reasonably suggest the likelihood of similar results if increased levels of cellular wild-
type p53 were combined with radiation therapy.
Appellants, further, rely on Jung as establishing that there is no correlation
between mutations in the p53 gene and radiation sensitivity or radiation resistance.
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