Ex Parte KRIEGER - Page 4



              Appeal No. 2004-1823                                                                   Page 4                 
              Application No. 09/148,012                                                                                    

              specification, however, is any statement that altering SR-BI levels may “enhance or                           
              restore fertility or treat a reproductive disorder” in a female mammal.  Nor is there any                     
              statement in regard to enhancing or restoring fertility or treating a reproductive disorder                   
              in a female mammal by broadly administering a compound altering lipoprotein, LDL,                             
              HDL or cholesterol levels as required by claim 1 on appeal.                                                   
                                                        Discussion                                                          
                     We have considered the examiner’s written description and enablement                                   
              rejections but find that they are subsumed by a bigger issue involving written                                
              description.  Consequently, we make the following new ground of rejection under the                           
              provisions of 37 CFR § 41.50(b) and will subsequently discuss the examiner’s                                  
              rejections.                                                                                                   
              1.  New Ground of Rejection Under 37 CFR § 41.50(b).                                                          
                     Claims 1-10, 12, 15, 16, and 20-22 are rejected under 35 U.S.C. § 112, first                           
              paragraph (written description).                                                                              
                     In order to put the written description issue we have discovered in perspective we                     
              will trace the evolution of claim 1 from how it read when the case was originally filed to                    
              its present amended form.                                                                                     
                     Original claim 1 read as follows:                                                                      
                     A method for modifying steroid production in a mammal comprising administering                         
              a compound altering the transfer of cholesterol or cholesteryl ester from high density                        
              lipoprotein or other lipoproteins via SR-BI to liver or steroidogenic tissues.                                
                     As seen, original claim 1 comported with the written description of this application                   
              in regard to modifying steroid production in a mammal by administering a compound                             
              altering the transfer of cholesterol or cholesteryl ester from high density lipoprotein or                    




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