Appeal No. 1999-1231 Page 2
Application No. 08/709,554
administering to said human a vector adapted to express said gene, wherein
said gene is under control of a promoter that does not have a glucocorticoid response
element and wherein administration of said gene treats a pathophysiological state in
said human; and
administering to said human a pharmacologically effective dose of a
glucocorticoid in an amount sufficient to increase the cellular expression of said gene,
wherein said increase in said expression of said gene in said tissue enhances said
treatment of a pathophysiological state in said human.
The references relied on by the examiner are:
Hirt et al. (Hirt), AInducible Protein Expression Using a Glucocorticoid-Sensitive Vector,@
Methods in Cell Biology, Vol. 43, pp.247-262 (1994)
Günzburg et al. (Günzburg), AVirus Vector Design in Gene Therapy,@ Molecular
Medicine Today, Vol. 1, No. 9, pp. 410-417 (1995)
Marshall, ALess Hype, More Biology Needed for Gene Therapy,@ Science, Vol. 270,
p. 1751 (1995)
Ledley, ANonviral gene Therapy: The Promise of Genes as Pharmaceutical Products,@
Human Gene Therapy, Vol. 6, pp. 1129-1144 (September 1995)
Coghlan, AGene Dream Fades Away,@ New Scientist, Vol. 148, pp. 14-15 (November,
1995)
Claims 1-17 stand rejected under the first paragraph of 35 U.S.C. ' 112, as
based on a non-enabling disclosure. In addition, claims 1-17 stand rejected under the
second paragraph of 35 U.S.C. ' 112.
We reverse the examiner=s rejections.
BACKGROUND
According to the specification, the present invention Ahas direct relevance to the
use of gene therapy in vivo@ and is based on Atwo findings which have a substantial
effect on transfection in cell culture and which have parallels in vivo.@ First, according
to appellants, is the finding that AIL-1β and . . . lipopolysaccharide (LPS) suppress
transfection/expression of [reporter genes] transfected into [cells] . . . by cationic lipid;@
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