Ex Parte SACHS - Page 3


                   Appeal No. 2001-0870                                                                  Page 3                       
                   Application No. 08/422,381                                                                                         

                   nicotine delivered during nicotine therapy affects the long-term success of the                                    
                   therapy.  “[L]ong term patient abstinence is achieved more often in those patients                                 
                   where at least 40%, usually at least 50%, of pre-cessation blood nicotine levels                                   
                   . . . are maintained by the replacement therapy.”  Page 3.                                                         
                           The specification discloses methods for determining the optimal dosage                                     
                   for nicotine replacement therapy for a particular patient.  The disclosed method                                   
                   takes into account several factors, including “a body mass factor, a cumulative                                    
                   smoking factor, a psychological dependence factor, age, and menopausal                                             
                   status.”  Page 3.  However, not all of these factors are important for every                                       
                   patient.                                                                                                           
                           The preferred patient characteristics will vary between males and                                          
                           females.  For males, the preferred patient characteristics include at                                      
                           least the body mass factor and the cumulative smoking factor.  The                                         
                           psychological dependence factor and patient age are also useful,                                           
                           although not as predictive as the body mass factor and the                                                 
                           cumulative smoking factor.  For females, the preferred patient                                             
                           characteristics include at least the psychological dependence factor                                       
                           and age.  Menopausal status is also a significant factor, although                                         
                           less so than the previously mentioned factors.  The cumulative                                             
                           smoking factor appears to be of little relevance to predicting the                                         
                           relationship between dosage and blood nicotine levels in women.                                            
                           The specification provides further details on the meaning of, e.g., “body                                  
                   mass factor,” “cumulative smoking factor,” and “psychological dependence                                           
                   factor” on pages 6-7.                                                                                              
                                                            Discussion                                                                
                           The claims are directed to a method for determining a nicotine dosage                                      
                   based on at least, for males, the patient’s body mass factor and cumulative                                        
                   smoking factor or, for females, the patent’s psychological dependence factor and                                   





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