Ex Parte KRIEGER - Page 5



              Appeal No. 2004-1823                                                                   Page 5                 
              Application No. 09/148,012                                                                                    

              other lipoproteins via SR-BI to liver and steroidogenic tissues.  Claim 1 was amended in                      
              a paper received June 26, 2000, to read as follows:                                                           
                     A method for modifying steroid production in a mammal in need of treatment by                          
              alteration of reproductive hormone levels comprising administering a compound altering                        
              the transfer of cholesterol or cholesteryl ester from high density lipoprotein or other                       
              lipoproteins [via] by specifically altering expression of or binding to cholesterol or                        
              cholesteryl ester of SR-BI to [liver or] steroidogenic tissues producing reproductive                         
              hormones.                                                                                                     
                     Claim 1 was subsequently amended in a paper received January 5, 2001, to read                          
              as follows:                                                                                                   
                     A method for modifying steroid production in a mammal in need of treatment by                          
              alteration of reproductive hormone levels comprising administering a compound directly                        
              inhibiting SR-BI or a compound selectively increasing expression of SR-BI thereby                             
              [compound] altering the transfer of cholesterol or cholesteryl ester from high density                        
              lipoprotein or other lipoproteins by specifically altering expression of or binding to                        
              cholesterol or cholesteryl ester of SR-BI to steroidogenic tissues producing reproductive                     
              hormones.                                                                                                     
                     Thereafter claim 1 was amended in a paper received July 17, 2001, to read as                           
              follows:                                                                                                      
                     A method for modifying steroid production in a mammal in need of treatment by                          
              alteration of reproductive hormone levels comprising administering a compound directly                        
              inhibiting SR-BI function or expression or a compound selectively increasing expression                       
              of SR-BI thereby directly resulting in the selective alteration of cholesterol or cholesteryl                 
              ester from high density lipoprotein or other lipoproteins by specifically altering                            
              expression of or binding to cholesterol or cholesteryl ester of SR-BI to steroidogenic                        
              tissues producing reproductive hormones, wherein the compound is selected from the                            
              group consisting of SR-BI cDNA, SR-BI anti-sense nucleic acids,                                               
              SR-BI antibodies, and SR-BI receptor binding small molecules or proteins.                                     
                     Up to this point in time, claim 1 was directed to methods for modifying steroid                        
              production by administering compounds that affected SR-BI function.  However, claim 1                         
              was amended in a paper received February 21, 2002, to read as follows:                                        
                     A method for altering fertility or treating a reproductive disorder in a mammal                        
              comprising                                                                                                    




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