Appeal No. 2002-0779 Page 3
Application No. 08/825,746
method of “supplying wild-type p53 function to a cell which carries mutant p53
alleles. The wild-type p53 gene or a part of the gene may be introduced into the
cell in a vector such that the gene remains extrachromosomal. . . . If a gene
portion is introduced and expressed in a cell carrying a mutant p53 allele, the
gene portion should encode a part of the p53 protein which is required for non-
neoplastic growth of the cell.” Page 13. “More preferred is the situation where
the wild-type p53 gene or a part of it is introduced into the mutant cell in such a
way that it recombines with the endogenous mutant p53 gene present in the cell.
Such recombination would require a double recombination event which would
result in the correction of the p53 gene mutation. Vectors for introduction of
genes both for recombination and for extrachromosomal maintenance are known
in the art and any suitable vector may be used.” Id.
Discussion
Claim 4 is directed to a method of supplying p53 function to a cell (which
has lost p53 function) by introducing into the cell a portion of the human wild-type
p53 gene, where the portion of p53 encoded by the gene is “required for non-
neoplastic growth” of the cell. Claim 12 adds the limitation that the portion of p53
that is introduced includes the part of p53 that is mutated in the cell to be treated.
The examiner rejected all of the claims on the basis that undue
experimentation would have been required to practice the claimed method.
However, the examiner has acknowledged that a similar method using a full-
length p53 gene is enabled. See the Examiner’s Answer, pages 6-7. According
to the examiner, a restriction requirement was made in a parent application and
Page: Previous 1 2 3 4 5 6 7 8 9 10 Next
Last modified: November 3, 2007