Appeal No. 2006-1245 Page 15
Application No. 10/294,106
0.0065% for compound 5 (page 18, line 24).
These percentages can be converted to micrograms per gram, the units used by
Appellants to describe the “effective amount” limitation:12 compound 1 is present in dry
leaves at 68 micrograms per gram, compound 2 at 78 micrograms per gram, compound
3 at 55 micrograms per gram, compound 4 at 32 micrograms per gram, and compound
5 at 65 micrograms per gram.
As discussed supra, the specification states that compositions having as little as
one microgram of the claimed withanolides per gram of total weight will selectively
inhibit COX-2. Specification, page 26, lines 5-7. Thus, dried leaves of W. somnifera
inherently contain concentrations of the claimed withanolides ranging from 32 times, to
as high as 78 times, the concentration required to induce selective inhibition of COX-2.
This evidence provides ample reason to believe that the leaf, root, and whole
plant preparations, disclosed by Thakur as being administered to treat inflammatory
disorders, inherently meet the claim limitation requiring administration of an amount of
the claimed withanolides effective to inhibit COX-2. The therapeutic benefits, disclosed
by Thakur, of the W. somnifera preparations on inflammatory disorders including
arthritis and conjunctivitis, provide additional evidence that the claimed withanolides are
present in the whole plant, leaves and roots, in concentrations sufficient to selectively
inhibit COX-2.
Therefore, based on Thakur’s disclosure of using therapeutic compositions
inherently containing the claimed withanolides to treat inflammatory conditions,
12 1% by weight is equal to 1 gram per 100 grams of leaves, so 0.001% is equal to 1 milligram per 100
grams of leaves, or 10 micrograms per gram of leaves.
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