Ex parte COTTER et al. - Page 8




          Appeal No. 93-4191                                                          
          Application 07/831,627                                                      



          through 4, pp. 5-11.  Thus, the examiner might consider                     
          whether                                                                     




          the specification description of the nutrient compositions                  
          would have enabled one skilled in the art to “make and use”                 
          the claimed lipid source.                                                   
               Finally, assuming arguendo the specification does enable               
          the use of a composition comprising the appropriate lipid                   
          source, the examiner should consider whether it would have                  
          enabled one skilled in the art to determine whether said                    
          compositions are capable of effective maintainance of                       
          gastrointestinal integrity and function.  That is, it does not              
          appear that the specification provides any assays or other                  
          indicia by which the effects of administering the claimed                   
          composition can be monitored.  Are breakdown products to be                 
          measured in the patient’s serum, urine, etc., or are there                  
          physiological changes which can be observed in the patient in               
          which the treatment was effective?                                          
               The examiner is cautioned that should he determine that                

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