Appeal No. 1999-1231 Page 3
Application No. 08/709,554
second, that Aanti-inflammatory topical glucocorticoids . . . reverse the inhibitory effects
of IL-1β and lipopolysaccharide and even enhance expression of reporter genes above
and beyond expression seen in untreated transfected cells.@ Specification, pages 3-4.
Based, at least in part, on studies described in Examples 10 through 16 of the
specification, appellants conclude that the enhanced gene expression observed with
glucocorticoids Ais specific to glucocorticoids, as opposed to other types of steroids, but
not to a particular glucocorticoid;@ it Ais independent of promoter, reporter gene and
cationic lipid used;@ and it Adoes not involve increased plasmid-lipid uptake, but rather
an intracellular mechanism which does not involve new protein synthesis.@ Id., page 4.
Instead, appellants suggest that their results demonstrate Athat either transcription [is]
increased or [ ] mRNA [is] stabilized in the cytoplasm by glucocorticoids.@ Id., page 30.
DISCUSSION
Enablement
According to the examiner, A[t]he intended use of the invention is for increasing
cellular expression of a gene . . . after delivery of said gene . . . into a biological tissue
of a human . . . so as to have a therapeutically enhancing effect,@ but A[t]he specification
does not reasonably provide enablement for methods of increasing cellular expression
of a gene in vivo [or] for treatment methods.@ Examiner=s Answer, page 5. Appellants
acknowledge that the claimed invention is indeed Adirected [to] a method of enhancing
gene expression concomitant with gene therapy@ (Brief, page 8), but argue that Athe
unpredictability of gene therapy . . . does not preclude [the] specification from enabling
the claimed invention@ (Id.), inasmuch as the invention Ais directed [to] a method of
improving the current limitations of gene therapy@ (Id., page 6).
In reviewing the examiner=s analysis in support of the rejection under the first
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