Appeal No. 2001-1245
Application 08/430,661
(c) combining the product of step (a) and the product of step (b) so as to
obtain a mixture of the lipid solution and the agent solution;
(d) adding an aqueous phase to the product of step (c); and
(e) removing organic solvent from the mixture of step (d),
wherein the complex has no captured volume, wherein the complex is
substantially free of liposomes and wherein the relative amount of polyene
antifungal agent used is such that the agent comprises from about 25 to 50 mole
percent of the complex.
The references relied upon by the examiner are:
Fukushima et al. (Fukushima) 4,687,762 Aug. 18, 1987
Moro et al. (Moro) GB 2041871A Sep. 17, 1980
Heyne1 EP 0,069,307 Jan. 12, 1983
Claims 77 through 81, 83 through 85, 89, 91 and 92 stand rejected under 35
U.S.C. § 103(a). As evidence of obviousness, the examiner relies upon Fukushima by
itself or Fukushima and Moro or Fukushima and Heyne. We reverse.
BACKGROUND
As seen from claim 77, the claimed invention is directed to a method of preparing
a drug-lipid complex which comprises a series of five steps. The complex contains a
polyene antifungal agent and a lipid which comprises a fatty acid or a phospholipid. As
explained in the last clause of claim 77, the complex has no captured volume, is
substantially free of liposomes and the relative amount of polyene antifungal agent used
in the method is such that the agent comprises from about 25 to 50 mole percent of the
complex.
1 The record copy of this document is in the German language. For reasons unclear from the record, the
examiner did not request a translation of the document and was satisfied to consider its disclosure on the
basis of the English language abstract attached thereto. Appellants attached a translation of the
underlying European Patent Application to the Reply Brief. Our consideration of the issues on appeal has
been based upon the full text translation supplied by appellants to whom we express our appreciation.
2
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