Appeal No. 2001-1245
Application 08/430,661
Nor has the examiner taken into account the requirement of the claims that the
polyene antifungal agent must comprise from about 25 to 50 mole percent of the
complex. We note that Fukushima does provide some information in regard to the
percent incorporation of the drug in the complex in that invention. See, e.g., Table 1.
However, those data are based upon drug/phospholipid w/w %. The examiner has not
presented a reasoned analysis why the percent drug incorporation described in
Fukushima would necessarily teach or suggest the requirement of claim 77 on appeal
that the polyene antifungal agent comprise from about 25 to 50 mole percent of the
complex.
The examiner's consideration of the issue of the sequence of steps required by
claim 77 vis-à-vis the sequence of steps described in Fukushima is equally lacking. The
examiner agrees that Fukushima prepares the drug/lipid complex of that invention using
a sequence of steps in which a solvent solution of a water-insoluble drug and a
phospholipid is first treated to remove the solvent by evaporation to leave behind a
drug-containing phospholipid film. It is after the solvent is removed that an aqueous
phase is introduced in the process. This is the exact opposite of what is required by
claim 77 on appeal in that the aqueous phase according to the claimed method is added
to product at step (c) which comprises a solvent solution of the lipid and polyene
antifungal agent. As seen from the statement of rejection, the examiner has "deemed"
the step to be a " manipulatable parameter." The examiner then asserts that "it is well
known in the art that the solvent can be removed before or after the addition of the
aqueous medium."
6
Page: Previous 1 2 3 4 5 6 7 8 9 Next
Last modified: November 3, 2007