Appeal No. 2004-1731 Page 3
Application No. 09/524,113
composition comprising (a) a digestible oil … (b) a pharmaceutically acceptable
surfactant comprising a hydrophilic … and a lipophilic surfactant….” While the
examiner finds (Answer, page 5) Lacy does not “teach an emulsion composition
consisting essentially of fenofibrate with the claimed oil and emulsifiers,” the
examiner finds such a composition would have been prima facie obvious to a
person of ordinary skill in the art at the time the invention was made.1
Claim 1:
Appellants’ claim 1 is drawn to a composition consisting essentially of:
1. a fibrate dissolved in
2. at least one oil with
3. one emulsifier, selected from a Markush grouping of emulsifiers.
According to claim 1, the resulting mixture of a fibrate, oil and emulsifer forms an
emulsion upon dilution with an aqueous phase.
It is appellants’ position (Brief, page 4) that “Lacy discloses a carrier for
hydrophobic drugs comprising a digestible oil and a pharmaceutically acceptable
surfactant component for dispersing the oil in vivo.” According to appellants (id.),
“[t]he surfactant component [of Lacy’s composition] comprises a hydrophilic
surfactant component, that does not substantially inhibit the lipolysis of the oil….”
In contrast to Lacy, appellants argue (Brief, bridging paragraph, pages 4-5) “[t]he
emulsifiers used in the present invention do not exhibit or demonstrate the
property of not substantially inhibiting the lipolysis of the oil.… [T]here is no
requirement [in their claim] for a surfactant that does not substantially inhibit
lipolysis.” According to appellants’ (Brief, page 5), “[t]he inclusion of a surfactant
1 We find no argument on this record that the resulting mixture of Lacy’s components does not
form an emulsion upon dilution with an aqueous phase. Accordingly, we find that appellants’
have conceded this fact.
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