Appeal No. 2002-0779 Page 8
Application No. 08/825,746
claims are limited to portions of the wild-type human p53 gene. Thus, the
unpredictability evidenced by the references is not relevant to the claimed
method. The examiner also cites several references as evidence that gene
therapy was considered highly unpredictable as of the application’s effective filing
date. See the Examiner’s Answer, pages 12-13. However, the examiner has
conceded that the instant claims would be enabled if limited to the full-length p53
gene. The examiner has not explained why the asserted unpredictability of gene
therapy raises an enablement problem for the instant claims but not for claims to
the same method, carried out using a full-length p53 gene. In view of the Office’s
conclusion that claims limited to using a full-length p53 gene to supply p53
function are enabled by the instant specification, we do not find the examiner’s
concerns regarding gene therapy to be well-founded.
Summary
The examiner has not adequately shown that it would have required
undue experimentation to determine which parts of the p53 gene encode portions
of p53 required for non-neoplastic cell growth. Therefore, and since the
examiner has conceded that the presently claimed method would be enabled if
limited to the full-length p53 gene, we agree with Appellants that a prima facie
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