Ex Parte Drucker et al - Page 7


                Appeal No. 2004-2356                                                   Page 7                  
                Application No. 09/833,740                                                                     

                endogenous GLP-2R receptor,’ the specification does not describe these                         
                additional sequences.”  Id. at 6.                                                              
                      The examiner acknowledges that “[t]he specification discloses                            
                approximately 200 bases upstream of the transcription start site of the human                  
                GLP-2R gene,” but that the human upstream sequence was not disclosed, and                      
                that “[n]o structural information for the promoter of a GLP-2R gene for any other              
                species of organism is disclosed.”  Id. at 6-7.  Thus, according to the examiner,              
                only a single species of the broadly claimed genus of a “promoter region of a                  
                GLP-2R receptor gene” is disclosed by the specification.  See id. at 6.                        
                      With respect to functional characteristics of the GLP-2R promoter, the                   
                examiner states that “[t]he only assay disclosed in the specification relating to              
                promoter function is to operably link the putative promoter sequence to a reporter             
                gene, e.g. lacZ, make a transgenic mouse containing the construct and then                     
                compare the expression of the reporter to the expression of the endogenous                     
                mouse GLP-2R receptor in various tissues.”  Id. at 4.  When that assay was                     
                conducted, however, the examiner explains “that the 1.5 kb mouse sequence                      
                directed expression of the reporter in similar but not identical tissues as the                
                endogenous GLP-2R gene.”  Id. (emphasis added).  Moreover, given the results                   
                from using the mouse sequence in a transgenic mouse, the examiner explains                     
                that it is unclear from the disclosure how the function of GLP-2R promoters from               
                organisms other than the mouse is to be assessed.  See id. at 7.                               









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