Ex Parte Harrigan et al - Page 6


                Appeal No. 2006-0429                                                                            Page 6                   
                Application No. 10/348,399                                                                                               

                3.  Claims 1, 4-7, and 9                                                                                                 
                        Under the provisions of 37 CFR § 41.50(b), we enter the following new ground of                                  
                rejection:  claims 1, 4-7, and 9 are rejected under 35 U.S.C. § 103 as obvious in view of                                
                Coe, Cary, and the PDR Sinequan® entry.  As discussed above, Coe discloses a group                                       
                of aryl fused azapolycyclic compounds useful in treating a variety of conditions,                                        
                including “chemical dependencies and addictions (e.g., dependencies on, or addictions                                    
                to nicotine (and/or tobacco products) . . .).”  See page 1, lines 7-17.  See also page 76,                               
                lines 17-20 (claim directed to composition for treating nicotine addiction).  One of the                                 
                disclosed compounds is 4,5-difluoro-10-aza-tricyclo [6.3.1.02,7] dodeca-2(7),3,5,-triene                                 
                hydrochloride.  Page 6, line 13.                                                                                         
                        Cary teaches that “[a]nxiolytics have been administered to treat nicotine                                        
                withdrawal.  Anxiolytics counter the mild anxiety symptoms that occur during smoking                                     
                cessation treatment.”  Page 3, lines 20-22.                                                                              
                        The PDR entry for Sinequan® (doxepin hydrochloride; page 2366, middle column                                     
                under “Description”) discloses that it is useful in treating anxiety (page 2366, right-hand                              
                column, under “Indications”); i.e., it is an anxiolytic.                                                                 
                        It would have been obvious to a person of ordinary skill in the art at the time the                              
                invention was made to combine the 4,5-difluoro-10-aza-tricyclo [6.3.1.02,7] dodeca-                                      
                2(7),3,5,-triene hydrochloride disclosed by Coe with the anxiolytic doxepin hydrochloride                                
                because Coe teaches that the first compound is useful in treating nicotine addiction and                                 
                Cary teaches that anxiolytics such as doxepin hydrochloride are useful in treating the                                   
                anxiety that accompanies smoking cessation.                                                                              







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