Appeal No. 2001-0545 Page 4
Application No. 08/442,423
The rejection analogizes the use of nucleic acid ligands to gene therapy,
which, according to the rejection, “the art taught was [ ] unpredictable without
some parameters being taught for achieving effective treatment.” Examiner’s
Answer, page 3. The rejection concentrates on the problems of delivery of the
nucleic acid, stating that “[t]here is no evidence of record that sufficient ligand
could be administered by various routes of delivery in the various target tissues
to affect a useful inhibition of angiogenesis.” Id. at 4.
The rejection also discusses anti-sense therapy, which, it is alleged, is
also closely related to the claimed methods. According to the examiner, “[t]he art
recognized that the major problem to be over come [sic] for antisense therapy to
be successful is for the oligonucleotides to reach the target nucleic acid in
sufficient quantities to inhibit the disease phenotype.” Id.
The examiner considers the working examples, but questions the results
of the assay examining the ability of one of the identified bFGF ligands, 21A, to
inhibit bFGF induced neovascularization of the rat cornea. The rejection states
that:
[T]his data is not seen as providing sufficient guidance to the
artisan so as to enable the methods as claimed for any disclosed
use in treating tumor proliferation, tumor metastasis, diabetic
retinopathy, rheumatoid arthritis or any other gene therapy type
protocols. . . . The rat cornea model as described in example 6
does not naturally become angiogenic unless perturbed to do so.
In fact, historically, the model was developed to assay for the
angiogenic potential of various compound [sic], especially growth
factors. Thus, the rat cornea model of example 6 does not
correlate to any naturally occurring disease or condition.
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 Next
Last modified: November 3, 2007