Appeal No. 1998-1719
Application No. 08/442,603
glucocerebrosidase could be secreted into a culture medium in
significant amounts by mammalian cells.
Barsomian declaration, ¶ 5.
Declaratory evidence as to issues of fact is entitled to substantial weight. In
re Alton, 76 F.3d 1168, 37 USPQ2d 1578 (Fed. Cir. 1996). The examiner has not
disputed Dr. Barsomian’s statements that a person of ordinary skill in the art would
expect a lysosomal enzyme such as glucocerebrosidase to be targeted to
lysosomes in mammalian cells, and that its secretion from the claimed cells was
unexpected. Rather, she argues that secretion of glucocerebrosidase from the
claimed cells does not overcome the prima facie case because “the skilled artisan
would have expected the claimed CHO cells to be useful regardless of the ability of
the cells to secrete the glucocerebrosidase.”
In order to outweigh a prima facie case of obviousness, evidence of
unobviousness must show unexpected property of a significant aspect of the
invention. See In re Eli Lilly & Co., 902 F.2d 943, 947, 14 USPQ2d 1741, 1745-46
(Fed. Cir. 1990). However, “when an applicant demonstrates substantially
improved results . . . and states that the results were unexpected, this should suffice
to establish unexpected results in the absence of evidence to the contrary.” In re
Soni, 54 F.3d 746, 751, 34 USPQ2d 1684, 1688 (Fed. Cir. 1995) (emphases in
original).
Here, Appellants have presented unrebutted evidence that the claimed cells
display not merely an improvement in a known property, but a property that was
unknown and unexpected based on the prior art. Since the disclosed utility of the
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