Appeal No. 2006-1245 Page 2
Application No. 10/294,106
Prostaglandins in turn cause inflammatory responses in the body. Inhibition of COX-1
enzyme may result in the formation of ulcers in many human[s] and hence the selective
inhibition of COX-2 enzyme by compounds has a major advantage over non-selective
nonsteroidal anti-inflammatory drug[s] (NSAIDs) sold over the counter (OTC).”
Specification, page 3, citations omitted.
The plant Withania somnifera, “known as Aswagandha, is well known for its use
in Ayurvedic medicine. The Aswagandha root extract was reported as a folk remedy for
adenopathy, arthritis, asthma, hypertension, inflammations, and rheumatism. The
leaves of W. somnifera were also used as a cure for several illnesses including tumors,
inflammations, conjunctivitis and tuberculosis . . . . The major chemical constituents
reported from W. somnifera are called withanolides. ” Pages 1-2, citations omitted.
The specification discloses that several novel, as well as known, withanolides
were isolated from the leaves of W. somnifera. Pages 7-8. A number of the isolated
withanolides demonstrated the ability to selectively inhibit the COX-2 enzyme, relative to
the COX-1 enzyme. Page 8. Suitable routes of administering pharmaceutical
compositions containing the withanolides include oral, rectal, intraperitoneal, intranasal,
subcutaneous, and intravenous. Pages 26-30.
Discussion
1. Claim construction
Claims 1, 3-5 and 10-16 are pending; however, claims 4 and 10-14 have been
withdrawn from consideration by the examiner. Answer, page 2.
We note that page 2 of the Appeal Brief lists claim 4 as pending and on appeal.
We also note that the Final Action of July 25, 2003, included claim 4 in the rejections set
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