Appeal No. 2003-1765 Page 4
Application No. 09/319,735
analgesic agent.” While MacLean states that topical administration should be
accomplished “in accordance with standard pharmaceutical practice” (MacLean, page
4, lines 5-8), the examiner has not established that standard practice for topical
administration dictates excipients that do not enhance transdermal or transmucosal
transmission.
As discussed above, the examiner has the initial burden of coming forward with
evidence tending to disprove novelty; conclusory statements are insufficient to
discharge the burden of establishing a prima facie case of anticipation. Inasmuch as
the examiner has not provided evidence establishing that MacLean describes a
composition which meets all of the limitations of the claims, the rejection of claims 8, 9
and 11-14 under 35 U.S.C. § 102(b) is reversed.
Obviousness
Claims 1-3, 5-9 and 11-22, directed to methods of inducing topical analgesia
without also producing a systemic effect,1 stand rejected under 35 U.S.C. § 103 as
unpatentable over MacLean. However, the statement of the rejection amounts to an
assertion that the subject matter of these claims is anticipated by MacLean, inasmuch
as the examiner concludes that “the amounts disclosed in MacLean must read on
Appellant’s claimed amounts” “because MacLean teaches successful topical
administration of the same drugs, for the same purpose” (Answer, page 5), and
moreover, “it would have been obvious to one of ordinary skill in the art that
[MacLean’s] amounts of the opioid agent are below [ ] systemic amounts” (id.). In an
apparent reference to the reasoning in In re Best, 562 F.2d 1252, 195 USPQ 430
1 Except for claim 15, which is directed to a composition.
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