Appeal No. 1997-3020
Application 08/149,101
and Trademark Office Board of Appeals summarized the point well when it
stated:
The test is not merely quantitative, since a considerable amount of
experimentation is permissible, if it is merely routine, or if the specification
in question provides a reasonable amount of guidance with respect to the
direction in which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of the invention
claimed.
Ex Parte Jackson, 217 USPQ 804, 807 (1982).
With regard to the hybrid cytokines possessing a predictable function, we note that
it is not a requirement for enablement under 35 U.S.C. § 112, first paragraph, that a
specification describe how to achieve a desired activity for a product or be able to predict
with certainty the function of a product. It is sufficient that appellants demonstrate that the
hybrid cytokines are active to some degree. In this regard we refer to the examples set
forth on pages 15 through 20 of the specification.
With regard to testing the hybrid cytokines for properties associated with their
native counterparts, it is noted that the specification on page 14, lines 17-31 describes in
vitro tests which can be used to assess the properties that a particular hybrid cytokine has.
Appellants urge that such tests are known and fully described in the cited literature
articles. Since the examiner has not established that assays are not known or would
require undue experimentation to perform in order to ascertain the various properties of a
given hybrid cytokine, we find appellants’ position reasonable that persons skilled in the art
would understand how to conduct such routine characterization studies of the inventive
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