Appeal No. 2002-0779 Page 6
Application No. 08/825,746
The examiner bears the burden of showing a claimed invention is not
enabled. See In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513
(Fed. Cir. 1993) (“When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a reasonable
explanation as to why it believes that the scope of protection provided by that
claim is not adequately enabled by the description of the invention provided in
the specification of the application.”). We agree with Appellants that the
examiner has not carried that burden in this case.
The examiner has provided the starting point for our analysis, by
conceding that the specification is adequate to enable claims to a method similar
to that of the instant claims, but limited to using a full-length p53 gene. See the
Examiner’s Answer, page 7. The only additional experimentation required to
practice the instant claims, relative to the concededly enabled claims, is
determining the parts of the p53 gene that encode a portion of the p53 protein
required for non-neoplastic cell growth. The only issue we must decide,
therefore, is whether this additional experimentation would be undue.
We agree with Appellants that the specification would have led those
skilled in the art to expect that the middle half of the p53 gene (encoding codons
132 to 309) was necessary for function, since mutations in that region resulted in
non-functional variants of p53. See the specification, page 6, and Figure 9. We
also agree with Appellants that Steinmeyer would have led those skilled in the art
to expect that the N-terminal 40 amino acids and part of the C-terminus were not
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