Appeal No. 2001-1686 Page 2
Application No. 08/363,998
(b) a gene sequence operably linked to a promoter sequence so
that said gene sequence will be expressed in said neuronal
cell, and
expressing said gene sequence in said neuronal cell.
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
use the invention commensurate in scope with the claims. Upon careful review
of the record before us and consideration of the issue on appeal, we reverse.
BACKGROUND
The specification asserts that the “delivery and expression of
heterologous or native genes into cells of the nervous system to alter normal
cellular biochemical and physiologic processes in a stable and controllable
manner is of substantial value in the fields of medical and biological research.”
Specification, page 1. In order to perform such delivery, the specification
teaches the use of herpes simplex virus 1 (HSV-1) mutants as vectors for gene
delivery, wherein the virus is mutated so that it has a deletion(s) in a gene(s)
necessary for viral replication in neuron. See id. at 4.
As noted by the specification, HSV-1 is a double-stranded DNA virus that
is replicated and transcribed in the nucleus of the cell. The virus contains
approximately 70 genes, and the five immediate early genes encode infected cell
proteins (ICPs) 0, 4, 22, 27 and 47, the major regulatory proteins of the virus.
The immediate early proteins regulate expression of proteins of the early and
late classes, and the proteins of the early class are responsible for viral DNA
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