Appeal No. 2001-1293 Page 10
Application No. 08/464,271
the art as predictive of other enzymes being expressed at an adequate level to
cause cell ablation in the presence of the appropriate nontoxic precursor
compound.
Finally, the specification shows that a substantial amount of
experimentation is required to carry out the experiments required to make new
constructs comprising other genes and to test such constructs in vitro and in vivo
to determine whether tissue-specific expression of the transgene can be
achieved and whether such expression results in tissue-specific cell ablation in
intact organisms. See pages 20-37 (working examples showing tissue-specific
ablation using the HSV-TK system).
We can assume, based on the technical sophistication of the references,
that the level of skill in the art was high. However, as we have found supra, the
balance of the Wands factors indicates that the claims are not commensurate in
scope with the disclosure. Therefore, we agree with the examiner that claim 44
does not meet the enablement requirement of 35 U.S.C. § 112, first paragraph.
Appellants argue that
the sole act required in the practice of the invention, as defined by
claim 44 is “administering to said organism an amount of said latent
toxin effective to trigger generation of said cell toxin by enzymatic
conversion of the latent toxin”. This act implicitly requires that the
practitioner choose a latent toxin that is “effective” to promote the
required result of being converted by the enzyme expressed in the
target tissue, but it does not require the practitioner to create a
transgenic animal.
That the organism to be treated already contains a tissue-type or
cell line that comprises endogenous thymidine kinase and DNA
encoding and expressing an exogenous enzyme under the control
of a tissue specific promoter is a precondition analogous to that in
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