Appeal 2007-1159
Application 09/839,946
mammalian tissue by precipitation under certain dialysis conditions (Conley,
abstract).
Appellants assert that the Declaration of Merry R. Sherman, Ph.D,
filed under 37 CFR § 1.132 and attached as Exhibit D to the Brief, supports
their conclusion that “the authors of Lee would not be expected to have
produced an uricase preparation in which at least about 90% of the uricase
was in a tetrameric form; instead, more than 10% of the uricase would have
been present in a non-tetrameric aggregated form.” (Br. 12-13 (emphasis in
original).) Dr. Sherman at paragraph 5 of the Declaration, referencing the
Specification at page 16, lines 5-8, states that “while mammalian uricases in
vivo (i.e., associated with the peroxisome) exist as a tetramer, isolated
purified preparations of natural and recombinant uricase, as indicated in the
present specification and as disclosed by Lee, usually contain a mixture of
aggregated non-tetrameric forms of the enzyme, in addition to the tetrameric
form.”
Page 16, lines 5-8 of the Specification, states:
Purified preparations of naturally occurring and
recombinant uricases usually contain a mixture of aggregates of
the enzyme, in addition to the tetrameric (140 kDa) form. The
percentage of each uricase preparation that is in the tetrameric
form generally varies from approximately 20% to 90%.
The Specification, as referenced by the Declaration of Dr. Sherman,
thus states that uricase preparations containing up to 90% of uricase in the
tetrameric form were known in the prior art. Moreover, as discussed above,
claim 50 encompasses uricase preprations containing only approximately
90% of the uricase in tetrameric form. Therefore, claim 50 encompasses
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