Ex Parte Herndon - Page 5



                 Appeal No. 2004-2170                                                                                       Page 5                      
                 Application No. 09/901,429                                                                                                             
                 seen” (id., page 30), and “[t]he net balance of protein synthesis and breakdown                                                        
                 achieved anabolic levels” (id., page 29), while “[f]at-free mass, corresponding to the                                                 
                 sum of lean mass and bone mass . . . was preserved . . . In comparison, ten untreated                                                  
                 time control subjects lost 9% of their fat-free mass . . .” (id.).  “In summary,” according                                            
                 to the specification, “long term $ blockade decreases lean mass catabolism in severely                                                 
                 burned children” (id., page 32).  Thus, to meet every element of the claimed invention,                                                
                 propranolol treatment must have a positive effect on muscle protein net balance as                                                     
                 compared with non-treated controls.                                                                                                    
                          On the other hand, Herndon administered propranolol at an initial dosage of 2                                                 
                 mg/kg body weight per day, for five days, and observed a decrease in heart rate and                                                    
                 lipolysis, but “failed to document an effect of propranolol . . . on protein kinetics[,]” even                                         
                 though “two independent approaches for assessing net protein breakdown” were used                                                      
                 (Herndon, page 1304).  It may be that a five day course of propranolol was not long                                                    
                 enough to improve protein kinetics, or it may simply be that there were other differences                                              
                 in methodology that resulted in Herndon’s failure to document an effect on protein                                                     
                 kinetics.  In any case, the examiner has not explained how Herndon’s finding that                                                      
                 propranolol had no effect on protein kinetics can be consistent with the examiner’s                                                    
                 assertion that Herndon’s method results in an improvement in skeletal muscle protein                                                   
                 kinetics.                                                                                                                              
                          On this record, the examiner has not established that Herndon anticipates every                                               
                 element of the claims on appeal.  The rejection of claims 1-7 and 9-12 is reversed.                                                    
                                                                   REVERSED                                                                             







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