Appeal No. 1996-0605
Application 07/989,593
vitamin E and C must both be distributed within the liposome. See, e.g.,
Specification, Figure 8. While the examiner is correct in that the fat-soluble
vitamin E (alpha-tocopherol) will not sequester in the aqueous interior of the
liposome, vitamin C (ascorbic acid) certainly will. See, Specification, Figure 8.
Since, as recognized by the examiner, Lichtenberger teaches liposomal
compositions containing antioxidants E and C, we are confronted with the
problem of where Lichtenberger’s vitamin C is found if not in the aqueous interior
of the liposome.
The Stone Declaration provides the answer. Page 2 of the Stone
Declaration states, “[m]oreover, Lichtenberger at column 21, lines 65-68
suggests that the antioxidants would be added to the diluent and, therefore,
water soluble vitamins would not be encapsulated into any liposomal
preparations.” Specifically, Lichtenberger discloses,
However, for most applications it will generally be
desirable to provide the lipids in the form of a colloidal
or liposomal suspension of the selected composition
in an pharmaceutically acceptable aueous diluent.
While virtually an[y] pharmaceutically acceptable
aqueous diluent may be employed, it has generally
been found that a certain salt, for example in the form
of isotonic saline has significant anti-ulcer activity.
Further, small amounts of heavy metals (or other
polyvalent cations) or anti-oxidant chemicals with the
capability of scavenging free radicals can be added to
the diluent to provide a lipid composition of greater
anti-ulcer efficacy, stability and lumen-coating
effectiveness.
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