Appeal No. 2001-1044 Page 10
Application No. 08/881,216
This argument is also unpersuasive. The specification’s Examples 3 and
7 provide no evidence that the claimed compositions have any unexpected
properties compared to the closest prior art (i.e., free terbinafine). Example 3
discloses the results of administering an intravenous pharmaceutical composition
of liposome-encapsulated terbinafine to treat systemic candidiasis, and
concludes that “[s]urprisingly, 10 out of 20 animals survived to day 21.” These
data do not overcome the rejection of record for two reasons. First, the
experiment provides no comparison of the liposome-encapsulated terbinafine
with any other antifungal agent to support the conclusion that the observed
results were surprising. “[I]t is well settled that unexpected results must be
established by factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d
1362, 1365 (Fed. Cir. 1997). See also In re Baxter-Travenol Labs., 952 F.2d
388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991) (“[W]hen unexpected results
are used as evidence of nonobviousness, the results must be shown to be
unexpected compared with the closest prior art.”).
Second, the claims on appeal are directed to topical compositions and
methods of topically treating fungal infection; there is no evidence of record that
the results seen on intravenous treatment would also apply to the claimed topical
compositions and methods. See In re Fenn, 639 F.2d 762, 765, 208 USPQ 470,
472 (CCPA 1981) (“Although it is well settled that comparative test data showing
an unexpected result will rebut a prima facie case of obviousness, the
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