Ex Parte PLASSE - Page 10




                Appeal No. 94-2477                                                                                                              
                Application 07/893,554                                                                                                          



                         In responding to the examiner’s rejection, appellant argued at page 3 of the                                           
                Appeal Brief that                                                                                                               
                         [a] surprising aspect of the present invention, then, is that at a level at                                            
                         which adverse CNS effects are substantially eliminated, appetite                                                       
                         stimulation, in fact, is maximized.  Certainly nothing in the art leads to that                                        
                         conclusion.                                                                                                            
                However, as set forth above, Table 3 of Noyes provides a factual basis upon which a                                             
                conclusion can reasonably be reached that lowering the amount of delta-9-THC will, in                                           
                fact, maximize the effect of stimulating appetite while minimizing the central nervous                                          
                system effects of this compound.                                                                                                
                         Appellant also argues at page 3 of the Appeal Brief that it was unexpected that                                        
                reducing the dose of delta-9-THC to the claimed level would so effectively stimulate                                            
                appetite that some patients gained weight.  Appellant relies upon his declaration filed                                         
                under 37 CFR § 1.132 filed on June 3, 1992, in support of this argument.  In his                                                
                declaration, appellant discusses the results obtained from a pilot study of administering                                       
                delta-9-THC for appetite stimulation in AIDS patients.  The clinical summary of that                                            
                study is attached to the declaration.  As seen from page 18 of the clinical summary, the                                        
                study did not establish a correlation between appetite change and weight change, i.e.,                                          
                stimulating a patient’s appetite did not necessarily result in the patient gaining weight.                                      
                While the group having the biggest improvement in appetite and the largest weight gain                                          
                was the group which received the claimed dosage of delta-9-THC, appellant                                                       

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