Appeal No. 2001-1293 Page 12
Application No. 08/464,271
Appeal Brief, page 12. Appellants cite to a declaration submitted under 37 CFR
§ 1.132 as showing evidence that “the specification fully enables insertion of a
transgene into an animal.” Id. Appellants also cite Palmiter3 as showing that
“methods for creating a transgenic animal expressing an exogenous protein
under the control of a tissue specific promoter were known to those of skill in the
art.” Id. Finally, Appellants argue that “the Specification contains detailed
information about types of tissue specific promoters, the cell types for which they
are specific, enhancers for such promoters and the like that can be utilized in the
practice of the invention methods.” Id., page 13.
This argument is also not persuasive. None of the evidence cited by
Appellants – the Evans declaration, Palmiter, and the cited passages from the
specification – is directed to the aspect of the examiner’s rejection on which we
rely. Specifically, none of these sources provides evidence that, based on the
specification and what was known in the art, a skilled artisan would have been
able to practice the claimed invention with converting enzymes other than HSV-
TK without undue experimentation. Therefore, none of the cited evidence
overcomes the rejection for nonenablement.
Although Appellants elected to let the claims stand or fall together, we
think it is appropriate to treat claims 40 and 41 separately. Claims 40 and 41 are
directed to the method of claim 44, where the exogenous gene is HSV-TK. Thus,
claims 40 and 41 do not share the infirmity on which we have based our
3 Palmiter et al., “Cell lineage ablation in transgenic mice by cell-specific expression of a toxin
gene,” Cell, Vol. 50, pp. 435-443 (1987).
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