Appeal No. 2004-0494 Page 6
Application No. 09/215,831
do] not substantially inhibit the in vivo lipolysis of digestible oils.” According to
Lacy (column 8, lines 19-23), “with this class of hydrophilic surfactants there is no
necessity to include any lipophilic surfactant component at all….” Accordingly,
Lacy discloses (column 8, lines 24-30):
[I]n a further aspect, the present invention provides a carrier
system for a hydrophobic drug which comprises:
(a) a digestible oil,
(b) a transesterification product of polyoxy-ethylene glycol
with glycerol esters of capric and/or caprylic acids as
hydrophilic surfactant, and
(c) optionally a lipophilic surfactant.
Lacy discloses that Labrasol (glyceryl caprylate/caprate and PEG-8
caprylate/caprate) and Softigen 767 (PEG-6 caprylic/capric glycerides) as
examples of this type of hydrophilic surfactant. See Lacy, column 8, lines 31-37.
Since this composition includes (1) a hydrophobic drug, (2) a digestible oil, and
(3) a hydrophilic surfactant, this embodiment of Lacy’s disclosure also does not
support the examiner’s position.
Therefore, while it may be true that Lacy suggests, under certain
circumstances, that a digestible oil or a lipophilic surfactant are not necessary,
and may be removed from Lacy’s composition, for the foregoing reasons we find
nothing in Lacy to suggest that even if these components were removed they
would lead to appellants’ claimed composition or the claimed method of using the
composition. In this regard, we remind the examiner that “[t]he Patent Office has
the initial duty of supplying the factual basis for its rejection. It may not, because
it may doubt that the invention is patentable, resort to speculation, unfounded
assumptions or hindsight reconstruction to supply deficiencies in its factual
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