Appeal No. 2001-2661 Page 4
Application No. 09/164,350
above the temperature of the pretransition of the lipid component for a time sufficient to
form MLCVs containing said at least one biologically active compound. Further, claim 1
expressly requires that said method be performed without the use of an organic solvent,
a freeze-thawing step, or a dehydration step.
In setting forth rejections of the appealed claims under 35 U.S.C. § 102(a) and
35 U.S.C. § 103(a), the examiner relies heavily on Example 2 (page 15) of Popescu.
For the sake of completeness, we here reproduce that example in its entirety:
Example 2 (sonication-fusion procedure for preparation of the vaccine):
Hydrate the lipid [dimyristoylphosphatidylcholine (DMPC)] in aqueous
buffer at a concentration of 100-300 mg/mL. Sonicate in a bath sonicator
at 30-45/C until clear. Sterile filter through a 0.2 micron filter. Add
antigen, IL-2 and serum albumin. Cool sample 4-15/C. This may be
temperature cycled any number of times from -80/C to 15/C as the low
temperature to 23/C to 50/C as the high temperature. The sample may
be diluted as necessary, and washed by centrifugation as in Example 1.
Having carefully reviewed Popescu's Example 2, we agree with paragraph 5 of
the Popescu declaration (Rule 132 declaration executed May 19, 2000) that "the
method disclosed therein calls for cooling the sample to 4-15/C. But the pretransition
temperature for DMPC (multilamellar vesicles) is 15.5/C. See Dufour, page 5582,
Table III. In other words, in Example 2 of Popescu, unilamellar vesicles are mixed or
incubated with a biologically active compound in aqueous solution below the
pretransition temperature, not above the pretransition temperature of the lipid
component as expressly required by claim 1 on appeal.
Additionally, to the extent that the examiner relies on the optional temperature
cycling protocol outlined in Example 2 of Popescu, such would appear to require a
freeze-thaw step precluded by the terms of claim 1.
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