Appeal No. 2001-0733 Page 10
Application No. 09/095,429
(Fed. Cir. 1990). The instant rejection does not contain a sufficient teaching that
would allow one to arrive at the instantly claimed polypeptide with a reasonable
expectation of success, given the unpredictability and uncertainty in the art as
set forth in the Ardelt and Youle declarations.
The second rationale set forth by the examiner in his response to
arguments, i.e., that one of ordinary skill in the art would be motivated to make a
recombinant protein with similar characteristics to that of the native protein also
fails. If the examiner is not relying on the presence of the pyroglutamyl residue
in the active site of the protein, no motivation has been set forth by the rejection
as to why one of ordinary skill in the art would seek to change the methionine at
position 23 rather than the glutamine at position 1. The examiner cites Louis in
the rejection as an example of the state of the art. Louis teaches the production
of recombinant HIV-1 protease, wherein the HIV-1 is expressed as a fusion
protein. In order to liberate the protease from the fusion protein, a linker of ten
amino acids was added, wherein the linker is cleavable by the protease. See
Examiner’s Answer, page 10. Thus, one of ordinary skill could have also
expressed the claimed rONC protein as a fusion protein, which obviates the
need for a start codon, and also does not require mutation of the nucleic acid
encoding the native protein at the methionine at position 23, as cyanogens
bromide would no longer be required for use as the cleaving agent. The
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