Appeal No. 1995-2723
Application 07/858,747
disruption of the initiation codon by a single point mutation altering mRNA
stability which results in rapid turnover of the mRNA as taught by Wisdom et
al, further in view of . . . methods for producing several single base
substitution mutations introduced within a DNA template region as a way of
generating a high frequency of desired nucleotide changes of a genotype as
taught by Kunkel and analyzing the frequency of at least some codon pairs
(encoding the same amino acid) as disclosed by Hatfield et al. to create a
method for reducing the effect of inhibitory/instability sequences within the
coding region of a mRNA as a whole for the expected advantages of
increasing the stability and/or utilization of a mRNA produced which would
otherwise not be expressed or which would be poorly expressed to achieve
higher levels of expression.
The examiner bears the initial burden of presenting a prima facie case of
obviousness. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444
(Fed. Cir. 1992). On the record before us, we conclude that the examiner has made out a
prima facie case of unpatentability of the claimed subject matter. Both Schwartz and
Wisdom are concerned with the identification of those regions of a gene which
express an unstable mRNA which contribute to that instability. Both make use of
mutational means which would be expected to effect the expression of the INS region and
both study the effects of such mutations to determine the effect on the mRNA stability and
expression. It appears to us that Schwartz teaches everything except the multiple point
mutation of the INS sequence. The use of a particular mutation process would reasonably
appear to be an arbitrary matter of designer choice. The examiner has cited references
which suggest that this mutagenesis method is known to those skilled in this art. In
addition we note page 32, lines 10-25 of the specification where the appellants indicated
that the particular mutagenesis process used in the claimed invention is known in the art.
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