Ex Parte PLASSE - Page 9




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



                205 USPQ 215, 219 (CCPA 1980)(citations omitted).  Furthermore, Noyes clearly                                                   
                suggests that administration of delta-9-THC for the purpose of stimulating appetite                                             
                while minimizing central nervous system effects is best obtained using a low dosage.                                            
                Thus, one of ordinary skill in the art would have had ample reason, suggestion, or                                              
                motivation from the applied prior art to use a lesser amount of delta-9-THC for the                                             
                purpose of increasing or stimulating appetite.                                                                                  
                         Further factual support for the conclusion of prima facie obviousness is found in                                      
                Regelson.  Regelson describes the results obtained from a clinical study in which delta-                                        
                9-THC was administered in the form of 2.5 mg capsules of a suspension of the agent in                                           
                sesame oil, as in claims 4, 8 and 12 on appeal, to advanced cancer patients.  The daily                                         
                dosage used in that study was as low as 5 mg/day as in the present invention.  See                                              
                Table 1.  Significantly, Regelson found that all groups involved gained weight during the                                       
                study.  See, e.g., first full paragraph of page 769.  Thus, at the time of the present                                          
                invention, one of ordinary skill in the art knew that delta-9-THC, in the form of 2.5 mg                                        
                capsules containing a suspension of the active agent in sesame oil, administered in                                             
                amounts as low as 5 mg/day resulted in advanced cancer patients gaining weight.                                                 
                Thus, this hypothetical person would have had a reasonable expectation that                                                     
                administering the same agent to patients having symptomatic HIV infection would result                                          
                in weight gain.                                                                                                                 


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