Appeal No. 2002-1631 Page 5
Application No. 08/213,433
prophylactic examples would not have allowed one skilled in the art to “overcome the
art recognized unpredictabilities in gene therapy” (id., page 11) to treat pre-existing
tumors, without undue experimentation. In particular, we note the examiner’s reliance
on Mulligan,4 which “caution[s] that ‘a number of key technical issues need to be
resolved before gene therapy can be safely and effectively applied in the clinic.’” Id.,
page 13.
The references relied on by the examiner support her assertion that many
aspects of gene therapy, especially gene delivery and expression, were regarded as
highly unpredictable at the time the present application was filed, and we accept, for the
sake of argument, that the amount of experimentation required to practice the claimed
invention would have been considerable. Nevertheless, we believe that in this case,
these factors figure too heavily in the examiner’s determination that it would have
required undue experimentation to practice the claimed invention. As explained in
In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988) (citations omitted):
The determination of what constitutes undue experimentation in a given
case requires the application of a standard of reasonableness, having due
regard for the nature of the invention and the state of the art. [ ] 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.
Similarly, in In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436, 1442 (Fed. Cir.
1995), the court articulated a relativistic (or contextual) standard of enablement based
on the nature of the invention and the state of the art:
. . . Usefulness in patent law, and in particular in the context of
pharmaceutical inventions, necessarily includes the expectation of further
research and development. The stage at which an invention in this field
becomes useful is well before it is ready to be administered to humans.
4 Mulligan, R.C., “The Basic Science of Gene Therapy,” Science, Vol. 260, pp.
926-932 (May 14, 1993).
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