Appeal No. 2001-1044 Page 5
Application No. 08/881,216
discloses the advantages of liposomal formulation and because Janoff suggests
liposomal formulation of the closely related allylamine naftifine. Id.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness.” In re Rijckaert, 9 F.3d
1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993). “Where claimed subject
matter has been rejected as obvious in view of a combination of prior art
references, a proper analysis under § 103 requires, inter alia, consideration of
two factors: (1) whether the prior art would have suggested to those of ordinary
skill in the art that they should make the claimed composition or device, or carry
out the claimed process; and (2) whether the prior art would also have revealed
that in so making or carrying out, those of ordinary skill would have had a
reasonable expectation of success.” In re Vaeck, 947 F.2d 488, 493, 20
USPQ2d 1438, 1443 (Fed. Cir. 1991) (citation omitted).
We agree with the examiner that the cited references support a prima
facie case of obviousness. Claim 18, the broadest claim subject to this ground of
rejection, is directed to a topical pharmaceutical composition comprising
terbinafine encapsulated in liposomes which contain specified phospholipids,
including a mixture of dimyristoylphosphatidylcholine and dimyristoyl-
phosphatidylglycerol.
Birnbaum discloses that terbinafine is a known antifungal agent belonging
to the class of allylamines, and is an analog of naftifine, the original allylamine
antimycotic. See the abstract. Birnbaum also teaches that terbinafine is active
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