Appeal No. 1999-1157
Application No. 08/482,321
keep in mind that the issue is whether there would have been
motivation to substitute the attenuator-deleted trp promoter for Cohen
et al’s lac promoter, not for an intact trp promoter. Thus, while the
ordinarily skilled artisan might possibly have been motivated to
substitute the attenuator-deleted trp promoter for an intact trp
promoter in order to achieve increased gene expression … he or she
simply would not have known whether substitution of the lac promoter
of Cohen et al with the attenuator-deleted trp promoter would have
provided increased gene expression. In other words, as of the filing
date of the present application, there simply was no way to compare
the efficiencies of the attenuator-deleted trp promoter and the lac
promoter employed by Cohen et al.
We agree with appellants. The examiner has provided no evidence
suggesting that the trp promoter mutants of appellants’ claimed invention would
provide an increase in the expression of a heterologous gene relative to the lac
promoter of Cohen. As appellants explain, each of the examiner’s arguments
concerning an increased level of expression resulting from a trp promoter mutant
are relative to the wild-type trp promoter.
Appellants provide the Kleid Declaration4 to support their argument
concerning unexpected results. Kleid explains (Declaration, page 5) that “[t]he
yields obtained by the method of the present invention were unpredictable and
unexpected at the time this invention was made … [t]he relative heterologous
protein yields from small-scale fermentations are apparent from Figures 3, 7 and 11
of the present application.”
Figure 7, of the specification, compares the level of expression of a
heterologous gene, human growth hormone (HGH), resulting from the use of the lac
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