Appeal No. 2002-0783 Page 7
Application No. 09/268,957
about 4.
It is our judgment, therefore, that a person having ordinary skill would have
arrived at the composition sought to be patented in claim 1 with a reasonable
expectation of providing a rapid onset of action1 and a controlled release of sildenafil;
and promoting the bioavailability of sildenafil while minimizing adverse side effects. We
therefore affirm the examiner's decision rejecting claim 1 under 35 U.S.C. § 103(a).
In Section D of his Appeal Brief, applicant emphasizes the amount of sildenafil
recited in claims 3 through 22. Applicant argues that the cited references would not
have suggested "from about 15 milligrams to about 50 milligrams of sildenafil" recited in
dependent claim 3; or "about 10 to about 75 milligrams of sildenafil" recited in
dependent claims 4 through 22.2 Again, we find it sufficient to note that the oral use of
the citrate salt of sildenafil had been approved by the U.S. Food and Drug
Administration (FDA) for treating male erectile dysfunction at the time applicant's
invention was made. (Specification, page 2, lines 30-33). In dose-response studies,
increasing doses of sildenafil (25 to 100 mg) reportedly increased the erectogenic
efficacy of sildenafil (Background of the Invention, applicant's specification, page 3,
lines 21 through 23). In our judgment, therefore, the amount of sildenafil recited in
1 As pointed out in the Background of the Invention section of applicant's
specification, page 4, lines 13-15, "[t]he main reason for sublingual route of drug
administration is to provide a rapid onset of action of potent drugs."
2 In independent claim 1, applicant recites a composition containing "about 10
to about 75 milligrams of sildenafil." Claims 4 through 22 depend from claim 1, "and
then specify a further limitation of the subject matter claimed." 35 U.S.C. § 112, fourth
paragraph. In each instance, that further limitation does not relate to or further restrict
the amount of sildenafil.
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