Appeal No. 1998-1283
Application No. 08/449,731
rejection in the paragraph bridging pages 4-5 of the Examiner’s Answer. The examiner urges
that the “instant specification provides no direction, no working examples or guidance
teaching the detection of alterations at the protein level or their predictable correlation to
cancer.” The examiner, further, urges that “the specification does not disclose that it is
known or predictable that any alteration of the APC gene results in an immunologically altered
protein distinguishable antigenically and detectable by immunological methods or by any
other methods.” The examiner contends that “it has not been demonstrated that detection of
an altered protein is correlative with cancer, its prognosis, or the predisposition of a patient to
developing cancer. Thus, the examiner concludes that (Answer, page 5):
[w]ithout further guidance with regard to the availability of
antibodies or other means and their use in an assay detecting
altered APC protein as well as predictable correlations between
protein alteration and cancer, it would require undue
experimentation by one of skill in the art to practice the instant
invention.
Therefore, the issue is whether appellants’ disclosure would have enabled one skilled
in the art to make and use the claimed invention throughout its scope without undue
experimentation. The Patent and 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).
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