Appeal No. 2001-1686 Page 3
Application No. 08/363,998
replication. Post-mitotic neurons harbor latent stage HSV-1, and once latent, the
virus can be retained by the neuron for the life of the cell. See id. at 11-12.
The claims are drawn to methods of administering a mutant HSV-1 to a
neuronal cell of the central nervous system, wherein one of the immediate early
genes has been replaced by a gene operably linked to a promoter, resulting in
the expression of the gene in the neuronal cell. See Claim 54. According to
appellants, the method has both in vitro and in vivo uses, including studying DNA
sequences and cellular factors that regulate expression of neural specific genes,
production of animal models, and gene therapy. See Appeal Brief, pages 10-11.
DISCUSSION
The claims stand rejected under 35 U.S.C. § 112, first paragraph, on the
grounds that the specification does not enable any person skilled in the art to
which it pertains, or with which it is most nearly connected, to use the invention
commensurate in scope of the claims. The Answer contends that
the specification, while being enabling for methods of studying cell
type specific differences in processing and cellular fate; methods to
study DNA sequences and cellular factors which regulate
expression of neural specific genes; and methods for studying
cellular fate and interactions between the central and peripheral
nervous system by directly administering into said neuronal cell an
HSV-1 mutant as a vector for gene delivery comprising a deletion in
an immediate early gene replaced by a gene sequence operably
linked to a promoter sequence so that the gene sequence will be
expressed in the neuronal cell, and expressing the gene sequence
[in] [sic] said neuronal cells, does not reasonably provide
enablement for to [sic] study neurological diseases, to study
neuronal physiology or to control expression of protein and assess
its capacity to modulate cellular events in the central and peripheral
nervous systems; to elucidate the processing, regulation and
functional domains of neural peptides; to study mutations such as
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