Ex Parte Schmitke et al - Page 8

                 Appeal 2007-0913                                                                                      
                 Application 09/888,126                                                                                
                 composition, such as the insulin and the DPPC, and that such an interaction                           
                 could not have been predicted.                                                                        
                        The Specification teaches “[f]ormulations having particles                                     
                 comprising, by weight, approximately 40% to 60% DPPC, approximately                                   
                 30% to about 50% insulin and approximately 10% sodium citrate.”                                       
                 (Specification 3).  The Specification does not disclose the criticality of                            
                 formulations of approximately 60% DPPC, approximately 30% insulin and                                 
                 approximately 10% sodium citrate.                                                                     

                 PRINCIPLES OF LAW                                                                                     
                        “In rejecting claims under 35 U.S.C. § 103, the examiner bears the                             
                 initial burden of presenting a prima facie case of obviousness.  Only if that                         
                 burden is met, does the burden of coming forward with evidence or                                     
                 argument shift to the applicant.”  In re Rijckaert, 9 F.3d 1531, 1532, 28                             
                 USPQ2d 1955, 1956 (Fed. Cir. 1993) (citations omitted).                                               
                        The burden of demonstrating unexpected results rests on the party                              
                 asserting them, and “it is not enough to show that results are obtained which                         
                 differ from those obtained in the prior art: that difference must be shown to                         
                 be an unexpected difference.”  In re Klosak, 455 F.2d 1077, 1080, 173                                 
                 USPQ 14, 16 (CCPA 1972).  “Mere improvement in properties does not                                    
                 always suffice to show unexpected results.”  In re Soni, 54 F.3d 746, 751, 34                         
                 USPQ2d 1684, 1688 (Fed. Cir. 1995).  Moreover, it has been long held that                             
                 “even though applicant’s modification results in great improvement and                                
                 utility over the prior art, it may still not be patentable if the modification was                    
                 within the capabilities of one skilled in the art, unless the claimed ranges                          
                 ‘produce a new and unexpected result which is different in kind and not                               

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