Ex parte HERSHENSON - Page 4




                 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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