Appeal No. 2003-0338 Page 4
Application No. 08/486,451
combine the prior art references.” Ecolochem, Inc. v. Southern California Edison
Co., 227 F.3d 1361, 1371, 56 USPQ2d 1065, 1073 (Fed. Cir. 2000). We begin
our analysis with independent claim 21.
The Prestrelski reference is drawn to the formation of dried protein
compositions. The reference teaches the use of a reconstitution stabilizer,
wherein the reconstitution stabilizer is an excipient that prevents aggregation.
The refererence then states that:
Excipients possessing the necessary characteristics for the present
invention are well-known in the art and generally function by the
mechanisms of charge replusion, steric hindrance, hydrophobic
binding or specific high-affinity binding to the dried protein.
Exemplary excipients include various osmolytes, various salts,
water soluble synthetic and natural polymers, surfactants, sulfated
polysaccharides, carrier proteins, buffers and the like.
Prestrelski, column 4, lines 19-27. The reference goes on to explain that:
Exemplary osmolytes include, but are not limited to, amino acids
(e.g., histidine, salts of histidine, glycine, salts of aspartic acid, salts
of glutamic acid, salts of lysine, salts of arginine, serine, praline,
alanine); polyhydric alcohols (e.g. sorbitol, inositol, mannitol, xylitol
and glycerol; sugars (trehalose, lactose, sucrose, glucose,
galactose, maltose, mannose and fructose) and methylamines
(e.g., trimethyamine-N-oxide, N,N-dimethyl-glycine, aminobutyric
acid, taurine, sarcosine, betaine or salts thereof).
Id. at lines 34-43.
With respect to the proteins, Prestrelski presents a long laundry list of
proteins, of which thromboprotein is just one. There is nothing in the examples
or the remainder of the reference that would lead one to the combination of
thrombopoeitin and histidine. A broad disclosure of a genus comprising
hundreds if not thousands of protein compositions does not render any particular
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