Appeal No. 2001-1044 Page 8
Application No. 08/881,216
reasonably expect that combining the cited references would produce a topical
pharmaceutical composition of liposome-encapsulated terbinafine. We therefore
conclude that the examiner has met the initial burden of showing prima facie
obviousness.
Appellants argue that the references would not have led a person of
ordinary skill in the art to combine their respective teachings. See the Appeal
Brief, pages 3-4:
Nystatin is a macrolide antibiotic compound and is thus wholly
different from terbinafine. First, there would be no motivation to
encapsulate a molecule of a different structural class based on
Berestein. . . . Nor is it obvious what the results of such
modification would be. Second, it is clear that a reason for
encapsulating nystatin in liposomes is to reduce systemic toxicity
(col. 6, lines 61-62). . . . [T]oxicity is not an issue with terbinafine.
Therefore, there is no motivation to prepare a liposome-
encapsulated terbinafine composition.
This argument is not persuasive. It is true that nystatin and terbinafine
belong to different classes of antimycotics. However, as discussed above, a
person of ordinary skill in the art would have been motivated to replace Lopez-
Berestein’s nystatin with terbinafine in view of the similar hydrophobic nature of
the two antimycotics, by Janoff’s suggestion that the terbinafine analog naftifine
was suitable for incorporation in liposomes, and by Lopez-Berestein’s suggestion
that liposome encapsulation would be expected to increase the topical efficacy of
nystatin. We therefore find that the references would have provided the required
“reason, suggestion, or motivation” to combine their respective teachings.
See Pro-Mold and Tool Co. v. Great Lakes Plastics Inc., 75 F.3d 1568, 1573,
37 USPQ2d 1626, 1629 (Fed. Cir. 1996).
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