Appeal No. 2001-1044 Page 4
Application No. 08/881,216
The specification states that the disclosed liposomal preparations of
terbinafine can be administered in a variety of ways. “Administration may be
peroral, topical or parenteral. It preferably is topical or parenteral, especially
parenteral, particularly pulmonal.” Page 33. “A topical application of liposomes
containing [terbinafine] may lead to enhanced accumulation of the drug at the
site of administration, in turn leading to enhanced efficacy. . . . On pulmonal
application the liposomes comprising [terbinafine] are effective against fungal
diseases of the lung such as candidiasis.” Page 2.
Discussion
1. Obviousness
A. Birnbaum, Lopez-Berestein, and Janoff
The examiner rejected claims 18-21, 24, and 25 as obvious in view of
Birnbaum, Lopez-Berestein, and Janoff. The examiner accurately characterized
Birnbaum as disclosing the allylamines terbinafine and naftifine as antifungal
agents, but not in liposomal formulations. Examiner’s Answer, page 5. The
examiner cited Lopez-Berestein as disclosing liposomal compositions containing
an antifungal agent (specifically, nystatin), and liposomes comprising
dimyristoylphosphatidylcholine (DMPC) and dimyristoylphosphatidylglycerol
(DMPG). Id. Finally, the examiner cited Janoff as teaching liposome-
encapsulated naftifine, and suggesting that both naftifine and nystatin were
appropriate for liposomal formulation. Id. The examiner concluded that it would
have been obvious to combine the terbinafine taught by Birnbaum with the
liposomal formulation disclosed by Lopez-Berestein, because Lopez-Berestein
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