Ex parte BODIAN et al. - Page 9




               Appeal No. 95-1364                                                                                                 
               Application No. 07/919,287                                                                                         


                              pathway, in a patient without producing any therapeutic benefit or physiologically                  
                              detectable effect.                                                                                  
               Examiner’s Answer, p. 6.                                                                                           
                      We do not agree with the examiner’s implicit position that claims which read on affecting                   
               biochemical pathways necessarily do not set forth a viable utility.  We know of no such per se rule.   It may      
               be that, based on appropriate evidence, claims directed to effecting biochemical pathways can be held to           
               lack utility.  However, we do not have to make that determination in this appeal because the rejected claims       
               set forth a utility not just a pathway.  Claim 23 specifically states that the method is for “treating a viral     
               condition . . . using a therapeutically effective amount of a compound . . . .”  “Viral condition” is defined      
               in the specification as                                                                                            
                              rubella, yellow fever, rabies, influenza, Korean hemorrhagic fever, common colds,                   
                              respiratory syncytial virus, measles, mumps, HIV, hepatitis B, Herpes simplex,                      
                              CMV, chicken pox, smallpox, Marburg virus, hemorrhagic fever, Lassa fever and                       
                              African swine fever.                                                                                
               Specification, p. 4, line 34 - p. 5, line 4.  The claim also requires the use of a “therapeutically effective      
               amount” of the compound.  This phrase requires that the compound have a beneficial effect on a viral               
               condition such as influenza.  The claim does not encompass affecting a biochemical pathway without                 
               producing a therapeutic benefit or physiologically detectable effect as asserted by the examiner.                  
                      Additionally, as with claims 1, 5-6, 8-9, 14-16, 26-27 and 31-36, the examiner has failed to                
               support the holding of lack of utility with any evidence which would present doubts as to the objective truth      
               of the statements of utility in the specification and claims.                                                      
                      The rejection of claims 23-25 under 35 U.S.C. § 101 is reversed.                                            
               The rejections under 35 U.S.C.  112, ¶ 1                                                                           
                      The standards for establishing a prima facie case of lack of enablement is similar to that for lack         
               of utility:                                                                                                        


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