Interference No. 105,136 Paper 62
Wang v. Imler Page 10
examiner under 37 CFR § 1.659(a) as to Imler's '143 claims.
37. Both Berkner I and Berkner II appear to be review articles discussing the
expression of heterologous genes in adenoviral vectors.
38. Berkner I states that "[g]eneration of a transformed cell line (293) which encodes
the E1 region of the Ad5 genome (44) has been invaluable in facilitating the
isolation of Ad[ 5] mutants by complementation" (Exh. 2011 at 616).
39. According to Berkner I (Exh. 2011 at 619-620):
...it is now theoretically possible to substitute up to 7.5 Kb of
heterologous sequences into Ad, generating a viable, conditional, helper-
independent Ad vector. This is due to the large genome size, to deletions
which can be made in the dispensable E3 region and in E1 using
complementation on 293 cells, and to the fact that Ad recombinants of
106 mu (i.e. 38 Kb) in size can still be packaged into virions. Potential
deletions in the E4 regions, as mentioned above, may permit even larger
gene inserts.
40. Berkner I describes adenoviral vectors "developed so far" as having "cassettes
expressing foreign genes substituted for the E1 or E3 region and propagated in
293 cells". (Exh. 2011 at 621).
41. Berkner II indicates that substitution of either the E1 or E4 region of the
adenoviral genome with heterologous sequences results in recombinants that
may be propagated using complementing cell lines. (Exh. 2012 at 47).
42. Berkner II states that (Exh. 2012 at 47):
Generation of helper-independent Ad recombinants can be accomplished
by insertion of heterologous sequences into several different regions of
5 Adenovirus.
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