Appeal No. 2001-1245
Application 08/430,661
DISCUSSION
The statement of the rejection appears on page 3 of the Examiner's Answer and
due to its brevity we reproduce it as follows:
Fukushima teaches lipid-drug complexes and a method of preparation of
the complexes. The method differs from the instant method in that the solvent is
evaporated after the addition of the aqueous medium. This step is deemed to be
a manipulatable parameter by an artisan since it is well known in the art that the
solvent can be removed before or after the addition of the aqueous medium as is
also evidenced from the references of GB [Moro] and HOFF [Heyne] (note the
abstracts). An artisan would be motivated to manipulate the basic steps taught
by Fukushima to obtain the best possible results based on the knowledge in the
art as shown by GB [Moro] or HOFF [Heyne]
In reviewing the issues presented in this appeal, there are three requirements of
claim 77 which are key in deciding the appeal, (1) adding an aqueous phase to the
product of step (c), (2) the complex comprising a polyene antifungal agent and (3) the
polyene antifungal agent comprised from about 25 to 50 mole percent of the complex.
As can be seen from the examiner's statement of rejection, only the sequence of steps
is addressed. The examiner has made no finding in the statement of the rejection in
regard to the polyene antifungal agent being used as the active agent or that the
polyene antifungal agent being used in the amount required by claim 77. Thus, the
examiner's statement of the rejection is incomplete, and as a result is difficult to review.
Also hindering review of the examiner's position on appeal is that the statement
of the rejection only states what one of ordinary skill in the art would have purportedly
been "motivated" to do and does not set forth what one of ordinary skill in the art would
have found obvious. The latter is the statutory standard of 35 U.S.C. § 103(a) while the
former is but one factor to take into account in reaching a conclusion as to whether the
subject matter of a given claim as a whole would have been obvious.
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