Appeal No. 2001-1675 Page 4
Application No. 08/442,077
given solvent-water ratio and by changing the ratio, one can produce a
population of different sized liposomes which will still be uniform in size[].”
The examiner further relies on either the skill in the art, or the disclosure
of Cubicciotti, Teipel or Cambiaso to demonstrate that the creation of a standard
curve is “a routine practice in the art of chemistry.” However, none of Cubicciotti,
Teipel or Cambisao disclose liposomes, let alone “teach or suggest [a] liposome
preparation at organic solvent concentrations of about 15% or less, or varying
organic solvent concentration so as to achieve a desired mean liposome size” as
is required by the claimed invention. Reply Brief, page 2. In addition, both
Tenzel and Leigh teach liposome preparation at organic solvent concentrations
“higher than the maximum employed in applicant’s claimed method.” Brief, page
3; see also, Reply Brief, page 2.
We note the examiner’s explanation of the general principle relating to
“compound-solvent interactions”, concluding (Answer, page 6) that “if too much [
] solvent is present, the composition becomes a dilute solution of the membrane
lipid in organic solvent….” The examiner, however, simply does not identify
where the claimed limitation -- of a solvent concentration that is at most about
15% -- is taught by the combination of references relied upon.
As set forth in In re Kotzab, 217 F.3d 1365, 1369-70, 55 USPQ2d 1313,
1316 (Fed. Cir. 2000):
A critical step in analyzing the patentability of claims pursuant to
section 103(a) is casting the mind back to the time of invention, to
consider the thinking of one of ordinary skill in the art, guided only
by the prior art references and the then-accepted wisdom in the
field…. Close adherence to this methodology is especially
important in cases where the very ease with which the invention
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