Appeal No. 2004-0494 Page 4
Application No. 09/215,831
administration of the carrier system, said surfactant comprising a hydrophilic
surfactant component….” As we understand Lacy’s disclosure, Lacy overcomes
the disadvantages of using drug in oil alone by including a hydrophilic surfactant
to the drug in oil composition.
However, as Lacy points out (column 3, lines 50-52), the majority of
hydrophilic surfactants “will inhibit the lipolysis of the digestible oil component.”
Therefore, to overcome the inhibitory effect of the hydrophilic surfactant, Lacy’s
composition must also include a lipophilic co-surfactant. Lacy, column 3, lines
52-55. Accordingly, as we understand Lacy’s disclosure, Lacy’s composition
includes four components, (1) a hydrophobic drug, (2) a digestible oil, (3) a
hydrophilic surfactant, and (4) a lipophilic surfactant. See e.g., Lacy, column 3,
lines 56-67. In contrast, appellants’ claimed invention includes only (1) a
hydrophobic drug (a fibrate), and (2) at least one monoglyceride. Therefore, as
we understand the issue on appeal, the question is whether Lacy suggests
removing two of the four components of the disclosed composition and if so, are
the two remaining components (1) a fibrate and (2) at least one monoglyceride?
We note that Lacy carves out an exception to the use of digestable oils.
Specifically, Lacy discloses (column 4, lines 1-5), “[i]f the lipophilic surfactant is
itself a digestible oil, or can serve as the source of lipolytic products, then in a
modification of the preferred carrier system a separate digestible oil component
may be omitted….” In this regard, we note that Lacy discloses (column 4, lines
36-56), “examples of lipophilic surfactants which can be used for the purposes of
the present invention are as follows: … 2. Mono- and/or di-glycerides of fatty
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