Ex Parte 5855920 et al - Page 6




               Appeal No. 2005-2593                                                                                 6                
               Application No. 90/005,867                                                                                            

               somatomedin C (a marker for growth hormone), DHEA-sulfate[3], serum lipids, and                                       
               testosterone” in a human patient before administration of arginine (a human growth                                    
               hormone releaser) and DHEA.  See Fahy at 8, lines 1-3.  Thus, Fahy measures                                           
               hormone levels in a human subject’s blood, including the recited “human growth                                        
               hormone” (via somatomedin C), “adrenal hormone” (DHEA), and “sex hormone”                                             
               (testosterone).  Furthermore, Fahy compares the circulating level of somatomedin C to                                 
               a predetermined level (a target range of 700-3000 units/L, particularly 1000-1600                                     
               units/L) and replenishes any measured deficiency.  See Fahy at 5, lines 15-17.                                        
                       As for testosterone, Fahy does not disclose that the measured level is                                        
               determined to be below a predetermined level or administered to any level, including a                                
               predetermined level.  As for DHEA, Fahy discloses that the amount of DHEA                                             
               administered to a patient is based on two considerations, the circulating DHEA level and                              
               the circulating insulin level, neither of which satisfies claim 1.  According to the first                            
               consideration, the amount of DHEA is not to exceed a predetermined level which is                                     
               100% greater than the level found in individuals 20-25 years of age.  Id. at 5, lines 20-                             
               25.  Significantly, this predetermined level is not a replenishment or target level.  Rather,                         
               it is an upper limit on the amount of DHEA to be administered according to the second                                 
               consideration, i.e., circulating insulin levels, which likewise does not require                                      
               replenishment to a predetermined level.  Id. at 5, lines 25-26.  As explained in Fahy (p.                             
               6, lines 17-20):                                                                                                      
                                                                                                                                    
                       3  Fahy discloses that DHEA-sulfate is an example of a DHEA precursor.  Fahy at 6, line 30.                   






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