Appeal 2007-2834
Application 09/943,048
(Specification 1). In contrast, “[f]lavonoids are shown to possess anti-
inflammatory efficacy without the ulcerogenic side effects” (id.).
Treatment of inflammation with COX-2 selective inhibitors is also
“associated with decreased incidence of adverse gastric events as a result of
minimal inhibition of gastroprotective COX-1, but with equivalent anti-
inflammatory benefit through inhibition of COX-2” (id. at 2). Despite the
positive aspects of COX-2 inhibitor administration, “recent clinical reports
suggested increased thrombotic events in patients taking COX[-]2 inhibitors
suggesting the urgent need for the use of the COX[-]1 inhibitory efficacy of
aspirin to improve such serious adverse outcome when using COX[-]2
inhibitors for long term” (id. at 2-3).
The Specification discloses “a method of preventing thrombotic
complications due the long-term use of COX[-]2 inhibitors and to enhance
its anti-inflammatory and anticancer efficacy by combining it with low dose
enteric coated aspirin and flavanoids” (id. at 3).
DISCUSSION
1. CLAIMS
Claims 10-13, 15, and 18-24 are pending and on appeal. Claim 18 is
representative and reads as follows:
18. A pharmaceutical composition, comprising a therapeutic
composition for treating inflammatory disorders in a mammal,
said therapeutic composition comprising: (i) a standard
therapeutic dose of a COX[-]2 inhibitor selected from the group
consisting of celecoxib and rofecoxib; (ii) low dose aspirin in
an amount of 70-85 mg; and (iii) an antioxidant selected from
the group consisting of a flavanoid, a flavonoid, an isoflavone,
and combinations thereof.
2
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