Ex Parte 5855920 et al - Page 20




               Appeal No. 2005-2593                                                                               20                 
               Application No. 90/005,867                                                                                            

               346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) (arguments in the brief do not                                       
               take the place of evidence in the record).                                                                            
                       Finally, the appellant argues that the references do not provide any motivation for                           
               a kit comprising the recited hormones which establishes a regimen for replenishing the                                
               hormones to pre-determined physiological levels.  Brief at 24.  Significantly, the phrase                             
               “said kit for establishing a regimen for the replenishment” of the recited hormones to                                
               predetermined physiological levels is merely functional language and does not further                                 
               limit the structure of the kit.  Cf. In re Casey, 370 F.2d 576, 580, 152 USPQ 235, 238                                
               (CCPA 1967) (the manner or method in which a machine is to be utilized is not germane                                 
               to the issue of the patentability of the machine itself).  In any event, the appellant has                            
               failed to establish that the amount of human growth hormone and DHEA administered in                                  
               Fahy and the amount of estrogen administered in                                                                       




               Umbreit is not sufficient to establish a regimen for replenishing these hormones to                                   
               predetermined physiological levels.12                                                                                 
                       For the reasons set forth above, the rejection of claim 30 under 35 U.S.C. § 103                              
               is affirmed.                                                                                                          

                                                                                                                                    
                       12  Again, we note that the amount of human growth hormone and the amount of at least two of the              
               listed supplemental hormones “for establishing a regimen” for replenishing those hormones to                          
               predetermined physiological                                                                                           
               levels is dependent on a number of factors including the hormone levels in the particular patient, the                
               hormone replenishment levels, and the length of the regimen.                                                          






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