Appeal 2007-1155
Application 10/230,575
providing methods of administering glucocorticoid receptor antagonists to
improve cognitive function in DS patients” (Specification 4: ¶ 10).
OBVIOUSNESS:
Claims 1-15 stand rejected under 35 U.S.C § 103(a) as unpatentable
over the combination of Schatzberg ‘596 and Sekijima. Claim 1 is directed
to a method of inhibiting cognitive deterioration in an adult patient with
Down’s syndrome but without dementia. Claims 2-15 ultimately depend
from claim 1. The claimed method comprises the single step of
administering a glucocorticoid receptor antagonist to an adult patient with
Down’s syndrome, but without dementia, in an amount that is effective to
inhibit cognitive deterioration. According to Appellant’s Specification,
“dementia was previously known to be treated by glucocorticoid
antagonists” (Specification 12: ¶ 43). Therefore, “Down syndrome patients
with dementia are outside the scope of this invention” (id.). In this regard,
we recognize that the claim method requires that the patient must not
otherwise be in need of treatment with a glucocorticoid receptor antagonist.
Appellant’s Specification defines the term “dementia” according to
the “American Psychiatric Association: Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition [(DSM-IV)] . . . as characterized by
multiple cognitive deficits that include impairments in memory . . .”
(Specification 6: ¶ 22). In contrast, “[t]he term ‘cognitive deterioration’
refers to a loss of ability to remember concrete facts (names or objects) or to
solve logical problems” (Specification 6: ¶ 21). According to Appellant’s
Specification, “[w]here cognitive deterioration in adults with DS is severe,
patients may meet the criteria for clinical dementia, as set forth in the DSM-
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