Ex parte KEENAN - Page 2




              Appeal No. 95-2851                                                                                        
              Application 08/012,379                                                                                    


                     Appellant’s claimed invention is a method for alleviating the tobacco withdrawal                   
              syndrome in a human by administering to the human a specified amount of a nicotine                        
              metabolite or combination of nicotine metabolites, or their pharmaceutically acceptable                   
              salts, and an article for carrying out the method.  Claims 1 and 67 are illustrative and                  
              read as follows:                                                                                          
                     1.   A therapeutic method to alleviate the tobacco withdrawal syndrome in a                        
              human comprising:                                                                                         
                     administering an amount of a nicotine metabolite or combination of nicotine                        
              metabolites or their pharmaceutically acceptable salts thereof to a human in need of                      
              such treatment, in an amount in the range of 1 to 100 milligrams per kilogram of body                     
              weight of the human per day calculated as the nicotine metabolite or combination of                       
              nicotine metabolites in the free base form that is effective to reduce or eliminate                       
              symptoms of tobacco withdrawal syndrome.                                                                  
                     67.   An article of manufacture comprising packaging material and a unit dosage                    
              form of a pharmaceutical agent contained within said packaging material, wherein:                         
                     said pharmaceutical agent comprises a nicotine metabolite or combination of                        
              nicotine metabolites or their pharmaceutically acceptable salts thereof in an amount                      
              effective to alleviate tobacco withdrawal syndrome, symptoms of nicotine withdrawal                       
              and wherein said packaging material includes instruction means which indicate that                        
              said nicotine metabolite or combination of nicotine metabolites or said pharmaceutically                  
              acceptable salts thereof can be used by a person in the range of 1 to 100 milligrams                      
              per kilogram of body weight of the person per day calculated as the nicotine metabolite                   
              or combination of nicotine metabolites in the free base form for alleviating (a) symptoms                 
              of tobacco withdrawal syndrome, (b) symptoms of nicotine withdrawal, and (c) the                          
              craving associated with the cessation of nicotine use.                                                    


                                                 THE REFERENCES                                                         
                                      References relied upon by the examiner                                            
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