Appeal No. 2001-1730 Page 5
Application No. 08/603,182
N.V., Aramide Maatschappij v.o.f. v. United States Int’l Trade Comm’n, 808 F.2d
1471, 1481, 1 USPQ2d 1241, 1246 (Fed. Cir. 1986). In this regard, Appellants
note (Reply Brief, bridging page 3 and 4), Man teach the lack of predictability of
success in aggregating proteins. As we understand the reference, Man teaches
(page 252) that aggregating large proteins is not generally advisable or
necessary. We also note Man’s observation (page 258) that similar proteins
(creatine kinase) derived from different sources (human muscle and human
brain), responded very differently to attempts at increasing immunogenicity
through polymerization; polymerizing the muscle kinase increased immune
response while polymerizing the brain kinase did not. Thus, to the extent that a
hirudin polymer would have been contemplated by one of ordinary skill in the art,
Man demonstrates that the results are unpredictable enough to yield very
different results with two similar proteins. In our opinion, Man demonstrates that
the prior art does not provide a reasonable expectation of success in producing
an immunogenic hirudin polymer.
While Maurer teach both the carrier protein method and the polymerization
method for the immunogenicity of molecules, Maurer provides no suggestion that
the two methods are equivalent for hirudin or hirudin-like molecules. Consistent
with the teachings of Man, Appellants note (Reply Brief, page 4), Maurer teach
(page 57) that there is no absolute correlation between increased antigen size
and increased immunogenicity. Furthermore, even if there was a suggestion in
the art to combine the cited references, as we understand the evidence of record,
neither Maurer nor Man support a finding that a person of ordinary skill in the art
Page: Previous 1 2 3 4 5 6 7 8 Next
Last modified: November 3, 2007