Appeal No. 2002-0779 Page 5
Application No. 08/825,746
therapeutic gene delivery to target cell in vivo, and the breadth of
the claims, it would have required undue experimentation to
practice the invention as claimed.
Examiner’s Answer, page 8.
Appellants argue that the references relied on by the examiner are not
relevant to the instant claims, because they deal either with the effects of
mutations on protein function, while the instant claims are limited to portions of
the wild-type p53 sequence. See the Appeal Brief, pages 2-4. Appellants argue
that the specification and prior art provide ample guidance to allow those skilled
in the art to practice the claimed invention without undue experimentation.
Appellants point to the specification’s Figure 9, which shows that, of the 393
codons in the p53 gene, the bulk of mutations the inactivate p53 fall between
codons 132 and 309. Appellants argue that these data would have led those
skilled in the art to expect that at least the portion of p53 between codons 132
and 309 was “required for non-neoplastic growth,” as recited in the claims.
Appellants also point to the prior art reference by Steinmeyer providing
additional guidance. Appellants characterize Steinmeyer as disclosing that 40
amino acids at the N-terminus and an unspecified portion of the C-terminus of
p53 were not required for DNA binding. Since “[b]inding to DNA is the
mechanism by which wild-type p53 exerts its biological effect.” Appellants assert
that “by the priority date of the present application, those of skill in the art knew
that portions of p53 were biologically active and would have understood that
portions of p53 as recited in claims 4 and 12 need not contain C- or N-terminal
amino acids to be functional.” Appeal Brief, page 5.
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