Appeal No. 1996-2009
Application No. 07/982,193
made out a prima facie case of obviousness.
We now turn to the second scenario, whereby the
prima facie case of obviousness is predicated on
substituting Izban's cell-specific promoter for, rather
than including it with, Lebkowski's p40. Here also the
examiner has not shown that there would have been a
reasonable expectation of success in obtaining the
claimed vector by replacing p40 with Izban's promoter.
To reinforce the prima facie case of obviousness
under the second scenario, the examiner (Examiner's
Answer, p. 7) relies on this passage in Lebkowski (p.
3991):
Theoretically, all sequences between the two AAV
inverted repeats can be deleted and replaced by
exogenous DNA. In this case, 3,500 to 4,000 bases
of DNA could be accommodated, allowing for the
potential introduction of two genes into a given
cell by a single AAV vector.
As we understand it, the examiner reasons that this
passage would have suggested to those of ordinary skill
to delete the entire sequence between the ITRs in the AAV
expression vector, which would include p40, resulting in
an open section, and to insert therein not only exogenous
DNA but Izban's cell-specific promoter in place of the
deleted p40.
The difficulty with the examiner's reasoning is that
rather than supporting the prima facie case of
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