Appeal No. 1997-2139
Application No. 08/114,595
BACKGROUND
The claimed invention relates to recombinant adeno-associated virus (AAV), its
production and use, e.g., for transferring exogenous genes into human cell lines and in
gene therapy regimens (specification, p. 2, ll. 9-19). According to the specification,
[i]n recombinant AAV, key viral genes [i.e., "essential" genes] (such as
cap, lip and rep) are replaced by the exogenous gene of interest.
Methods for producing recombinant AAV therefore rely on co-transfecting
the AAV vector carrying the gene of interest, together with a helper AAV
plasmid that expresses all of the essential AAV genes, into adenovirus- or
herpes-infected [host] cells which supply the helper functions necessary
for AAV replication and the production of new viral particles.
The use of cells infected with helper adenovirus or herpes virus
does not create a problem, it is the transfection of the essential AAV
genes which is the limiting step for the production of high titre AAV virus.
[Page 5, ll. 3-15.]
The AAV production methods described in the specification do not require a
transfection step (specification, p. 2, ll. 15-16; p. 6, ll. 10-12; p. 32, ll. 2-6). Rather,
essential AAV genes are introduced into a recombinant viral vector, i.e., adenovirus or
herpes virus, e.g., by inserting the AAV gene(s) into the viral genome or, more
generally, by deleting a viral gene and introducing the essential AAV gene(s) in its place
(specification, para. bridging pp. 8-9). The recombinant virus expressing the essential
gene(s) then supplies the(se) gene(s) to the host cells by infection (specification, p. 32,
ll. 20-28).
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