Appeal No. 2001-1293 Page 8
Application No. 08/464,271
the claims or the latent toxin(s) that the encoded enzyme would act on to convert
into a cell toxin.
The only guidance provided in the specification with regard to other
enzymes is that “[o]ther enzymes which can be used in the practice of the
present invention are non-mammalian, i.e., enzymes which are not native to the
host cells contemplated for the generation of a transgenic cell population.” Page
15. Essentially, this passage simply states that other exogenous enzymes that
can be used are exogenous enzymes. This “guidance” does nothing to reduce
the experimentation that the skilled artisan would have to undertake in order to
practice the invention as broadly as it is claimed.
“Whether undue experimentation is needed is not a single, simple factual
determination, but rather is a conclusion reached by weighing many factual
considerations.” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.
Cir. 1988). Those considerations include “(1) the quantity of experimentation
necessary, (2) the amount of direction or guidance presented, (3) the presence
or absence of working examples, (4) the nature of the invention, (5) the state of
the prior art, (6) the relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the claims.” Id.
Here, most of the Wands factors tend to show that the claims are not fully
enabled. Claim 44 reads on a method of using any enzyme that converts any
nontoxic compound into a toxic compound. Thus, the claims are very broad;
much broader than the guidance and working examples provided in the
specification, which are limited to HSV-TK.
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