Ex Parte Loria - Page 2


                Appeal No. 2004-0761                                                     Page 2                  
                Application No. 09/794,531                                                                       

                                                  Background                                                     
                       ”∆5-Androstenediol (AED) is a naturally-occurring metabolite of                           
                dehydroepiandrosterone (DHEA), the most abundant product of the adrenal                          
                glands. . . .  AED exists in two epimeric forms:  ∆5-androstene-3-β,17α-diol                     
                (αAED) and ∆5-androstene-3-β,17β-diol (βAED). . . .  βAED has                                    
                immunostimulating properties and immune upregulating properties.  αAED has                       
                been shown to induce apoptosis in transformed cells in vitro.”  Specification,                   
                page 2.                                                                                          
                                                   Discussion                                                    
                       Claim 1, the broadest claim on appeal, is directed to a two-step method of                
                treating cancer (or precancer, or metastatic cancer).  In the first step of the                  
                claimed method, αAED or an ether or ester derivative thereof is administered to                  
                the patient, and in a second, subsequent step, βAED or an ether or ester                         
                derivative is administered.                                                                      
                       The examiner rejected all of the claims as obvious in view of Loria and                   
                Berkow.  The examiner cited Berkow, however, only for its teaching that                          
                “aminoglutethimide and orchiectomy are useful in treating prostate cancer.”                      
                Examiner’s Answer, page 5.  This teaching seems to be relevant only to certain                   
                dependent claims, and therefore we need not discuss Berkow further.                              
                       The examiner cited Loria’s teachings that αAED inhibits tumor growth, and                 
                that the combination of αAED and βAED inhibited proliferation of breast cancer                   
                cells in vitro.  See the Examiner’s Answer, page 4.  The examiner also noted that                







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