Appeal No. 1997-2133
Application 08/172,507
28 USPQ2d 1955, 1956 (Fed. Cir. 1993). Rejection of claimed subject matter as obvious
under 35 U.S.C. § 103 in view of a combination of prior art references requires consideration
of whether prior art would have suggested to those of ordinary skill in art that they should make
claimed composition or device, or carry out claimed process, and whether prior art would also
have revealed that such person would have reasonable expectation of success; both the
suggestion and reasonable expectation of success must be founded in prior art, not in
applicant's disclosure. In re Vaeck, 947 F.2d 488, 495,
20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
Zsebo indicates that stem cell factor may be formulated in a composition which is
lyophilized, and that ingredients in the composition such as lactose and mannitol may function
as bulking agents or tonicity modifiers. The examiner acknowledges that Zsebo does not
disclose the addition of histidine or glutamic acid as stabilizers for stem cell factor.
Lee is relied on for the disclosure that lyophilized plasma proteins, such as factor VIII,
may be stabilized in a formulation which includes sodium chloride and calcium chloride and
the amino acid histidine as buffering agent. Lee also discloses that sugars such as mannitol,
sucrose and mannose can be added prior to lyophilization. Lee, page 3, lines 10-11.
Audhya discloses the addition of amino acids such as arginine, lysine, aspartic acid and
glutamic acid to stabilize lyophilized proteins, such as thymopentin, thymoralin, growth
hormone, encephalin and tumor necrosis factor. Audhya, page 7, lines 16-17 and page 9,
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