Appeal No. 2003-0847 Page 6
Application No. 08/744,685
According to the examiner, the specification fails to enable the full scope
of the claims because “[i]t remains unclear which regions of the gamma 2A locus
are to be used in the vector to target any ‘recombinant gene’ to the gamma 2A
locus,” and “how any ‘recombinant gene’ will be expressed at such a locus.” Id.
at 9. The rejection asserts that the specification only describes the use of the
germline gamma 2A gene for homologous recombination into the gamma 2A
locus.
The rejection also contends that the specification does not address how
any “recombinant gene” will be expressed in the gamma 2A locus through the
claimed vector, such as, by providing the promoter and enhancer regions that will
be used to drive expression. According to the rejection,
it is unclear if any “recombinant gene” will actually be expressed.
Expression of any “recombinant gene” can be inhibited from
expression due to anti-sense – tertiary structure formation from a
constitutively expressed complementary gene pre-existing in the
cell. The specification does not provide an enabling description
which addressed this issue.
Id. at 10.
The rejection asserts further that “immunoglobulin gene expression is
quite unique,” and cities Paul and Morrison as evidence of the difficulties that
may be associated with immunoglobulin gene expression. See id. at 10-12. The
examiner then restates the conclusion that “[t]he specification fails to enable a
vector comprising any recombinant gene, including a human immunoglobulin
gene which targets any immunoglobulin gamma 2A locus in any mammalian
cell.” Id. at 12.
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