Appeal No. 2004-0291
Application No. 09/091,561
[T]he question of undue experimentation is a matter of degree. The fact
that some experimentation is necessary does not preclude enablement;
what is required is that the amount of experimentation “must not be unduly
extensive.” Atlas Powder Co., v. E.I. Dupont De Numbers & Co., 750 F.2d
1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984).
The Patent 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).
In our view, the examiner has not provided sufficient argument or evidence to
support his position that the isolation and purification experimentation outlined in the
specification, for example the techniques for determining antibody specificity at pages 7
and 17-18, would not amount to routine experimentation or would be undue
experimentation in the present case. In our view, the examiner has failed to establish in
a meaningful way, that the Wands factors (in particular, the state of the art and the
relevant skill of those in the art), have been considered with respect to the enablement
issue in this case. The examiner has not established with appropriate evidence that the
experimentation required to obtain monoclonal antibodies or Fab fragments in
accordance with the claims would have been undue.
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