Appeal No. 2002-0779 Page 4
Application No. 08/825,746
the instant claims were held to be patentably distinct from claims to a method of
supplying p53 function to cells using a full-length p53 gene. See the Examiner’s
Answer, page 6.
Claims directed to the use of the full length p53 gene were elected
for prosecution in the parent application. The parent application
08/035,366, is currently part of an interference before the board,
Interference 104,066. . . . [T]he office acknowledges that methods
of supplying a wild-type full length p53 gene to cells is [sic] enabled
by the instant application. . . . However, the instant case is directed
to patentably distinct methods of using portions of the p53 gene.
Specification, page 7 (emphasis in original).
Thus, the issue presented is whether, even though a method of supplying
p53 function to a cell using a full-length p53 gene is enabled, it would have
required undue experimentation to practice the same method using a part of the
p53 gene that encode a functional portion of the p53 protein. The examiner
concluded that
in view of the art recognized unpredictability of determining from
sequence data alone whether any “portion” of a gene would be able
to fold correctly and exhibit wild type protein activity, the state of the
art concerning p53 at the time of filing (i.e. 1992), the lack of
guidance provided by the specification concerning the importance
of amino acid residues outside of the 132-309 region which affect
protein folding and/or p53 activity, the lack of guidance provided by
the specification concerning the sequence or characteristics of any
“portion” of p53 which is required for non-neoplastic growth, the
lack of working examples either in vitro or in vivo which use a wild
type p53 gene sequence which is a “portion” of the complete full
length wild type sequence, the art recognized unpredictability of
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