Ex Parte DIMARCHI et al - Page 7



              Appeal No. 2004-0250                                                               Page 7                
              Application No. 09/226,412                                                                               

                     14.  A method of treating diabetes, comprising administering to a subject in                      
              need thereof a therapeutically effective amount of the powder formulation according to                   
              claim 1.                                                                                                 
                     15.  A method of treating diabetes according to claim 14, wherein said insulin                    
              analogue is LysB28ProB29 human insulin or AspB28 human insulin.                                          
                     Appellants argue that method claims 14 and 15 of Jensen are patentably distinct                   
              from the method claims of the present application because:                                               
                     In contrast to the claims in the Jensen ‘028 patent, the claims in the                            
                     present application do not recite three of the four limitations required by                       
                     the Jensen ‘028 claims.  Specifically, the claims in the present application                      
                     do not recite                                                                                     
                            (1) an enhancer,                                                                           
                            (2) the percent weight crystalline parameter, or                                           
                            (3) the molar ratio parameter required by the claims of the Jensen ‘028                    
                            patent.                                                                                    
                    Thus, the claims in the present application do not anticipate the claims in                       
                     the Jensen ‘028 patent.                                                                           
                     Further, the claims in the present application do not render obvious the                          
                     claims in the Jensen ‘028 patent.  Nowhere in the claims in the present                           
                     application is there a suggestion of (1) an enhancer, (2) a percent weight                        
                     crystalline requirement, or (3) a molar ratio parameter of insulin analog to                      
                     enhancer.  In addition, one of ordinary skill in the art would not be                             
                     motivated by the claims of the present invention to use an enhancer, or to                        
                     use 50% by weight of crystalline particles, or to use a particular ratio of                       
                     insulin analog to enhancer.                                                                       
              Reply Brief, page 5.                                                                                     
                     Appellants are correct in stating that the claims in the present application do not               
              recite an enhancer, the percent weight crystalline parameter or the molar ratio                          
              parameter set forth in claims 14 and 15 of Jensen.  However, appellants’ analysis does                   
              not view the present claims in light of relevant prior art in determining whether the                    
              present claims render the Jensen claims obvious under 35 U.S.C. § 103.  The relevant                     








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