Appeal No. 2006-1245 Page 13
Application No. 10/294,106
unfractionated plant or preparation thereof also inherently contains the five withanolides
recited in the first Markush group. Further, we note that the specification states, at page
17, lines 1-7, that “[s]ince both roots and leaves of W. somnifera contain similar
withanolides, consumption of W. somnifera root powder or leaf extract as a dietary
supplement can decrease the inflammatory pain, the risk of cancer formation and
progression of tumors at levels which suppress the COX-2 enzyme.” Based on this
evidence, one of ordinary skill would have concluded that unfractionated preparations of
leaves, roots, or the entire plant, inherently contained the claimed withanolides.
The COX-2 enzyme is active in inflamed tissue, such as that of arthritic patients.
University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 917, 69 USPQ2d
1886, 1888 (Fed. Cir. 2004) (“COX-2 is expressed in response to inflammatory stimuli,
and is thought to be responsible for the inflammation associated with diseases such as
arthritis.”). COX-2 enzyme is also active “not only in inflamed cells[,] but also [in]
various tumor cells.” Specification, page 3, lines 14-16.
Based on the analysis above, Thakur’s disclosure of the therapeutic uses of W.
somnifera provide a number of instances wherein the recited withanolides were
inherently provided to a mammal.
Specifically, Thakur discloses that “Ashwagandha is a folk remedy for . . . arthritis
. . . inflammation . . . rheumatism.” Thakur, page 531, right column. “For . . .
inflammations and swellings, the leaves are applied steeped in warm castor oil. Leaf
juice is useful in conjunctivitis.” Id. “In Ayurveda, leaves are used in treating tumors . . .
and the roots . . . [are] useful in . . . inflammations . . . .” Id., at page 532, left column.
“In Unani, the roots are used in . . . inflammations [and]. . . arthritis . . . .” Id. “Powdered
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