Appeal No. 2004-0456
Application No. 08/913,699
It is the examiner’s position that (Answer, pages 3-4):
Benoit discloses replication defective adenoviruses, which are either Ad2
or Ad5 of human origin, and therefore animal origin, which comprises
nucleotide sequences encoding one or more gene products involved in
cholesterol and lipid metabolism, e.g. apoA-1 and lack sequences
necessary for viral replication, such as all or part of E1A and E1B
regions... The reference teaches that the gene can be present in the
adenovirus as cDNA or genomic DNA (gDNA) ... and that the gene should
comprise sequences necessary for its expression in infected cells and
may also comprises sequences for secretion if the protein is normally
secreted...Benoit et al. also discloses prophetic methods of administering
such vectors to patients suffering from dyslipoproteinemias, and
associated atherosclerosis by gene therapy with viral vectors such as
retroviral vectors, adeno-associated viral vectors ... and that the
replication defective adenovirus infects liver cells in vivo. ...The reference
teaches pharmaceutical compositions comprising one or more of the
replication defective recombinant adenoviruses at a concentration of
between 104 to 1014 pfu/ml of virus... . The reference teaches that apoA-1
is the main protein of HDL and activates the lecithin:cholesterol
acyltransferase (LCAT) responsible for efflux of cholesterol from cells.
The examiner admits that Benoit does not teach the replication defective
recombinant viruses comprising a nucleic acid sequence encoding LCAT. Answer,
page 4. In order to make up for this deficiency, the examiner relies on Baer and
McLean. According to the examiner, (Id., at pages 4-5):
Baer et al. disclose the cDNA sequence encoding human LCAT,
which includes the signal peptide for secretion of LCAT. The reference
also discloses methods of treating dyslipoproteinemias resulting from
LCAT deficiency using purified LCAT protein alone or together with apoA-
1, and teaches that LCAT would reduce plasma cholesterol and cellular
cholesterol by mobilizing cholesterol to HDL in serum and then out of the
bloodstream, and would perhaps also aid in mobilizing cholesterol from
atherosclerotic plaques...
McLean et al. teach the genomic DNA encoding human LCAT
protein complete with its signal peptide for secretion...
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