Ex parte STROM et al. - Page 4


                     Appeal No.  2001-0893                                                                                                      
                     Application No.  08/968,905                                                                                                

                     “demonstrated not only that their IL-10/Fc chimera retains its activity – it is as                                         
                     effective as recombinant IL-10 (rIL-10) in in vitro and in vivo assays – but also that it                                  
                     conferred prolonged protection against septic shock.”  With reference to page 29-                                          
                     30 of their specification, appellants argue (Brief, fn. 2) that when “[a]pplicants                                         
                     administered 4000 U of either IL -10/Fc or rIL-10 to mice 24 hours before they                                             
                     received a lethal dose of LPS, … [a]ll of the animals treated with rIL-10 died,                                            
                     whereas 50% of the animals treated with IL-10/Fc survived….”                                                               
                             While the examiner states (Answer, page 9) that appellants “allege surprising                                      
                     results that [a]pplicants obtained prolonged protection with IL-10, however, the                                           
                     results, contrary to being surprising, would be what the prior art predicted,” the                                         
                     examiner fails to identify that portion of the prior art that “predicts” appellants’                                       
                     results.  We note that Capon disclose (column 15, lines 19-23) that “compositions                                          
                     … in which a biologically active portion of a ligand binding partner is substituted for                                    
                     the variable region of an immunoglobulin chain, are believed to exhibit improved in                                        
                     vivo plasma half-life.”  We also note that Capon contemplates (column 16, lines 48-                                        
                     55) preparing amino acid sequence variants of the binding partners with the                                                
                     objective of modifying the binding partner’s plasma half-life.  Both of these                                              
                     disclosures, however, fail to “predict” appellants’ results wherein 50% of the animals                                     
                     treated with IL-10/Fc 24 hours before receiving a lethal dose of LPS survived.  We                                         
                     are unable to find, and the examiner fails to identify the evidence supporting her                                         
                     statement that “the prior art predicted” appellants’ results.  In other words, while                                       
                     Capon contemplates that the plasma half-life of a binding partner can be extended,                                         


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