Appeal No. 1999-1330
Application No. 08/527,373
Trademark Office (PTO) bears the initial burden of providing reasons for doubting the
objective truth of the statements made by applicants as to the scope of enablement.
Only when the PTO meets this burden, does the burden shift to applicants to provide
suitable evidence indicating that the specification is enabling in a manner
commensurate in scope with the protection sought by the claims. In re Marzocchi, 439
F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971). Factors appropriate for determining
whether undue experimentation is required to practice the claimed invention throughout
its full scope are listed in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.
Cir. 1988).
On the record before us, we find that the examiner's statements and evidence in
support of this rejection, when weighed against the appellants’ disclosure in support of
the claimed invention and arguments, fail to provide adequate evidence or reasons why
one skilled in the art would doubt the statements relating to the manner of improving the
treatment of a tumor by treating the tumor with radiation therapy wherein the cells of the
tumor have been transduced with a polynucleotide encoding wild-type p53. The
general conclusions relating to the Wands factors are not supported by facts or
evidence which would provide a reasonable basis for concluding that the present
disclosure does not enable the full scope of the claimed subject matter. We point out
that the level of unpredictability in the art is merely one of the factors to be considered
in determining whether the disclosure provided by applicants in support of a claimed
invention is sufficient to permit those skilled in the art to which the invention relates to
practice the invention without undue experimentation. That some experimentation may
be necessary, does not equate to undue experimentation. Further, it is well settled that
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