Appeal No. 2002-1547 Page 4
Application No. 09/259,434
content of 52.2% at a concentration of 0.1 mg/ml and 57.8% at 1.1 mg/ml. See
page 22.
Discussion
Claim 1 is representative of the claimed invention, and is directed to a
composition comprising isolated Apolipoprotein AI-Milano dimers purified to at
least 90% homogeneity.
The examiner rejected the claims as obvious in view of Sirtori. The
examiner characterized Sirtori as
teach[ing] that Apolipoprotein A1-Milano has the capacity to
naturally form dimers with itself . . . and the Apolipoprotein A1-
Milano dimers have a prolonged half-life, and thus remain in the
circulation for longer periods and exert their arterial protective
activity better than normal Apolipoprotein A1. . . . Sirtori et al.
expressed Apolipoprotein A1-Milano in yeast and characterized its
structure.
Examiner’s Answer, page 3. She concluded that
[i]t would have been obvious to a person of ordinary skill in the art
to make purified Apolipoprotein A1-Milano dimers because Sirtori et
al. teach that these dimers naturally form and, though Sirtori et al.
do not show that the Apolipoprotein A1-Milano used in their
experiments were dimers, dimers of Apolipoprotein A1-Milano
naturally occur and have arterial protective activity. . . . [I]t would
have been obvious to a person of ordinary skill in the art to treat
cardiovascular diseases associated with thrombosis with active
dimers of Apolipoprotein A1-Milano because one would expect that
these dimers would have been part of the composition of Sirtori et
al.
Id., pages 4-5.
Appellants argue that
Sirtori does not make obvious a method for achieving dimer
concentrations that are at least 90% pure. The purification scheme
disclosed by Sirtori teaches away from the purification of Apo-A1-M
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