Appeal No. 2006-0274
Application No. 09/415,890
DISCUSSION
Anticipation
I. Claims 97, 99, 116, 117 and 119 stand rejected under 35 U.S.C. §102(e) over
Janoff.
To anticipate a claim, a prior art reference must disclose every limitation of the
claimed invention, either explicitly or inherently. In re Schreiber, 128 F.3d 1473, 1477,
44 USPQ2d 1429, 1431 (Fed. Cir. 1997). The examiner cites Janoff as evidence in
support of a prima facie case of anticipation.
According to the examiner (Answer, page 5),
Janoff is directed at (summary) substantially liposome free formulations for
Administration of polyene antibiotics parenterally, requiring obtaining
(instant 97(a) a solvent, (col. 4, lines 48-50) DMSO, for the polyene
antibiotics Amphotericin B or (col. 9, lines 36-39) Pimaricin, Candicidin,
Filipin or Nystatin. Instant step (b) requires mixing with another solvent,
aqueous-Janoff proceeds (lines 56-57) col. 4) to add the aqueous solution
to the solvent-drug phase; then evaporate (line 58, col. 4) off solvent (the
instant step c, removing over 50% solvent). Finally (lines 61-64, coI. 4)
as in instant step (d) reconstituting by addition of aqueous solvent is
performed. The solvent, carriers, diluents are pharmaceutically
acceptable (lines 35-37). Thus the steps of obtaining solvent, mixing with
secondary solvent, removing solvent, and reconstituting solvent are shown
by Janoff.
In rebuttal, appellants argue that the examiner has failed to present a prima facie
case of anticipation. In particular, appellants argue (Supplemental Brief, page 4)
Turning first to claims 97, 99 and 116, Appellants point out that Janoff
appears to teach dissolving the drug in DMSO or methanol, so there is no
aqueous solvent here (see col. 4, lines 49-50). It also teaches solubilizing
lipids in "a solvent such as methylene chloride," (col. 4, lines 50-52) so,
again, no aqueous solvent here. It is not until the solvents are
"evaporated under reduced pressure" that an aqueous solution is added
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