Appeal No. 2006-0274
Application No. 09/415,890
pimaricin and amphotericin B (col. 3, line 65, 66), of Janoff and the instant
invention, thus obvious to substitute if desired with equivalent available
solvents having bio compatibility [sic], drug solvation, low toxicity and/or
low flammability.
The examiner’s rejection as we understand it, primarily relies on Szoka as
evidence to support rejection of claim 133. Claim 133 is directed to the method of
preparing a pharmaceutically acceptable solvent vehicle (claim 97), wherein the solvent
vehicle comprises anhydrous N,N-dimethylacetamide and aqueous lipid.
The examiner, however, points to no evidence in Szoka to make up for the
deficiency noted above in Janoff, namely the failure to disclose a step of “(c) removing
more than 50% of the dipolar aprotic solvent and/or acid and aqueous secondary
solvent.” Thus the rejection of claims for obviousness over Janoff in view of Szoka is
reversed.
Other Issue for Consideration
While we have not found that the examiner has established a prima facie case of
anticipation over the portions of Janoff cited in the Answer, we direct the examiner’s
attention to Janoff, Column 11, line 58 to Column 12, line 5. This portion of Janoff
teaches mixing the lipid and drug in organic solvent (DMSO) with a buffered aqueous
solution (PBS) followed by evaporation of the solvent (DMSO). This portion further
states that more PBS is added and then that solution is centrifuged, the supernatant
discarded and the pellet (lipid) resuspended in PBS. Because claim 97 does not
specify how the solvent and aqueous secondary solvent are removed or require that
6
Page: Previous 1 2 3 4 5 6 7 8 9 Next
Last modified: November 3, 2007