Appeal No. 2002-1631 Page 4
Application No. 08/213,433
to a treatment regime that would lead to the inhibition of tumor promoter-induced AP-1
transcription activity [sufficient] to provide a therapeutic effect to a mammal,” Answer,
page 2.
The examiner concedes that working examples 1 through 7 of the specification
demonstrate that “AP-1 induced transcription is inhibited when TAM67 DNA2 is
expressed” in transfected cells, and that “transgenic mice which express TAM67 . . . do
not form papillomas and carcinomas when treated topically with . . . tumor promoting
compounds.” Answer, page 5. Thus, it does not appear that the examiner questions
whether TAM67 DNA, expressed at sufficient levels, can inhibit tumor promotion and /or
progression. Nevertheless, in concluding that the present treatment claims are not
enabled, the examiner argues that appellants have merely “provided a laundry list of c-
jun deletion mutants . . . dosage amount[s] . . . route[s] of delivery . . . and delivery
vehicles” (id., pages 7-8) with “no correlation [to] treatment of tumors or cancers where
the tumors or cancers did not contain the TAM67 DNA sequence prior to tumor or
cancer induction” (id., page 9, emphasis added).3
If we can summarize the basis of the examiner’s conclusion, it is that “gene
therapy in general was regarded as unpredictable by the art at the time of filing,”
especially “in the realm of expression and delivery of the gene” (Answer, page 4), and
the guidance provided by the specification’s descriptions of treatment protocols and
2 TAM67 is a DNA construct encoding a particular c-jun deletion mutant.
3 Example 8 of the specification purports to show that the size of “papillomas and
squamous carcinomas . . . decreases in mice treated with [ ] TAM67 nucleic acid
sequence or corresponding protein/peptide” (page 33). Nevertheless, there is no
evidence that the experiment described in this example was ever actually performed,
and the description of the protocol is so sketchy as to be meaningless. Therefore, we
are unable to accord it any weight.
Page: Previous 1 2 3 4 5 6 7 8 Next
Last modified: November 3, 2007