Ex Parte 5855920 et al - Page 9




               Appeal No. 2005-2593                                                                                 9                
               Application No. 90/005,867                                                                                            

               to a human patient, claim 1 requires more.  As discussed above, the method of claim 1                                 
               requires (1) measuring hormone levels in a sample of a human’s blood, (2) determining                                 
               that the levels of human growth hormone and at least two of the listed supplemental                                   
               hormones are below “pre-determined” levels, and (3) replenishing the levels of those                                  
               hormones to the “pre-determined” levels.                                                                              
                       As explained above, Fahy, at most, suggests that one supplemental hormone                                     
               (DHEA) is determined to be below a predetermined level.  Furthermore, Fahy does not                                   
               disclose that any of the supplemental hormones listed in claim 1 are replenished to                                   
               predetermined levels.  Scow, Pierpaoli and Umbreit fail to cure the deficiencies of Fahy.                             
                                                                                                                                    
                       Specifically, neither Scow nor Pierpaoli discloses that one or more supplemental                              
               hormones listed in claim 1 are determined to be below “pre-determined” levels and are                                 
               replenished to those levels.  Umbreit, on the other hand, does suggest that estrogen is                               
               measured and determined to be below a particular level.  See EXAMPLE in Umbreit at                                    
               6.5  Specifically, the trial group discussed in Umbreit’s EXAMPLE consisted of thirty-                                
               eight men having an estradiol blood level of less than 25 pg/ml.  While estradiol and                                 
               other hormone levels were monitored throughout the trial, all of the subjects received                                
               the same dosage (1 mg) of estradiol valerate per day for one to three years.  Umbreit                                 
               indicates that when practicing estrogen therapy, “[t]he dose may depend on different                                  
               factors such as age or individual health status, including the level of the estrogen lever                            
                                                                                                                                    
                       5  Reference herein to Umbreit is to the English translation of record in the application.                    






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