Appeal No. 1997-3242
Application 07/929,834
The claimed invention is directed to methods of designing compounds that will bind
to a critical site within the minor groove of a ribonucleic acid molecule and inhibit its
function. The method comprises five fundamental steps: (a) identifying a nucleotide
sequence (i.e., the primary structure) in an RNA molecule that is critical to its function; (b)
determining the secondary structure of the region where the critical site is located; (c)
determining the tertiary structure of the region where the critical site is located, and its
position relative to the major and minor grooves of the molecule; (d) determining the
sequence of nucleotides and structure flanking the critical site that is specific to the critical
region and within the minor groove; and (e) designing a compound that will specifically
bind the critical site within the minor groove and inhibit RNA function. See, e.g., claim 1.
The examiner concedes that “steps (a)-(d) [were] known in the prior art at the time
of the instant invention as being reasonably reliably performed.” Examiner’s Answer, page
15. Nevertheless, following an analysis of step (e) under the Wands factors, the examiner
concludes that the specification enables nothing more than “trial and error methodology,”
which “is not design but instead a screening method of the type that is well known as
random mutagenesis.” Id., page 10.
Thus, the dispositive issue is this: having identified both the sequence and the local
three-dimensional structure of a critical site within the minor groove of a target RNA
molecule by performing steps (a) through (d) of the claimed method, would it have required
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