Appeal No. 2004-0456
Application No. 08/913,699
Therefore, it would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to have inserted
cDNA of Baer et al. or the genomic DNA of McLean et al. encoding the
human LCAT into the replication defective adenovirus of Benoit et al.,
either in place of, or in addition to the nucleic acid sequence encoding
apoA-1 and administered it to an individual wit the effect of stimulating
cholesterol efflux. One [would] have had a reasonable expectation of
success in making the virus since all components required were known
and Benoit et al. taught how to make them, and success in administering
the virus to patients and expressing the LCAT and apoA-1, if present, in
liver cells, since Benoit et al. taught that the virus could be administered in
vivo and the transgene expressed in liver cells. One would also [have]
had a reasonable expectation of success that at least some cholesterol
efflux would occur since Benoit et al. taught that expression of human
apoA-1 would also have that effect. One would have done so because
Benoit et al. taught that gene therapy held much promise for treating
dyslipoproteinemias by supplying the gene encoding a protein that was
deficient, e.g. apoA-1, and Baer et al. taught that LCAT protein, alone or
with apoA-1 protein could be administered to treat dyslipoproteinemias
due to LCAT deficiency, with the result of mobilizing cellular and
atherosclerotic plaque cholesterol to HDL and hence out of the cells and
bloodstream. These teachings would clearly motivate one of ordinary
skill in the art to make the recited viral vector comprising the gene
encoding human LCAT and administer it to individuals for delivery and
expression of the transgene(s) in vivo for clinical research.
Appellants respond, arguing the examiner has failed to set forth a prima facie
case of obviousness (Brief, page 6) as there is no clear and particular evidence of
record to support the Office's conclusion that one of ordinary skill in the art would have
been motivated to combine the teachings of Benoit, Baer, and McLean to arrive at the
claimed invention.
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