Appeal No. 2004-0482 Page 6
Application No. 09/216,247
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 invention. 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 basis.” In re Warner, 379 F.2d
1011, 1017, 154 USPQ 173, 178 (CCPA 1967). For the foregoing reasons, it is
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