Appeal No. 2001-1044 Page 9
Application No. 08/881,216
Appellants also argue that the references do not provide the requisite
expectation of success. See the Appeal Brief, page 4:
Berestein would provide no basis for predicting the properties of
liposomes containing terbinafine. This is especially true with
terbinafine since it was well known prior to this invention that
terbinafine is highly lipophilic and binds strongly to lipoproteins in
plasma. . . . Therefore, at the time of this invention, the expectation
would have been that terbinafine in liposomes would have bound to
the lipid component of the liposomes. Consequently, the
expectation would have been that formulating terbinafine in
liposomes would have offered not only no improvement but
possibly a reduced or total lack of efficacy.
This argument is not persuasive. As previously discussed, the cited
references taught that both nystatin and terbinafine were hydrophobic antifungal
agents, that naftifine (an analog of terbinafine) was suitable for use in liposomes,
and that liposome encapsulation was expected to increase the topical efficacy of
the hydrophobic antimycotic nystatin. These teachings would have led those of
ordinary skill in the art to reasonably expect that liposome-encapsulated
terbinafine would at least retain it antifungal activity. “Obviousness does not
require absolute predictability of success. . . . For obviousness under § 103, all
that is required is a reasonable expectation of success.” In re O’Farrell,
853 F.2d 894, 903-04, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). The references
would have provided the required reasonable expectation of success.
Finally, Appellants point to the specification’s Examples 3 and 7 as
providing evidence of unexpected results to rebut any prima facie case based on
the examiner’s references. See the Appeal Brief, pages 4-5.
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