Ex parte COTTER et al. - Page 7




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



                     an energy source.”  For example, will any patient taking                                                                                                          
                     antibiotics be afflicted with the claimed physiological                                                                                                           
                     condition, or just those patients taking certain antibiotics?                                                                                                     
                     Is there a diagnostic assay available to those skilled in the                                                                                                     
                     art to identify the claimed patient type?                                                                                                                         
                                In addition, the examiner might consider whether the                                                                                                   
                     specification would have enabled the claimed method for                                                                                                           
                     maintaining gastrointestinal integrity by administering a                                                                                                         
                     composition comprising a lipid source that upon hydrolysis                                                                                                        
                     yields short chain fatty acids.  For example, it appears that                                                                                                     
                     the examples in the specification only disclose compositions                                                                                                      
                     which comprise preformed short chain fatty acids (SCFA) and,                                                                                                      
                     not compositions which comprise a lipid source which upon                                                                                                         
                     hydrolysis yields short chain fatty acids.   Specification,                               4                                                                       
                     Examples 1                                                                                                                                                        

                                4If the medium chain triglycerides (MCTs) used in the                                                                                                  
                     exemplified compositions hydrolyze to form SCFAs in vivo, then                                                                                                    
                     it would appear that the compositions described in references                                                                                                     
                     such as Cotter ‘807 which contain MCTs, especially those                                                                                                          
                     described as triglycerides of C  fatty acids, will of                                                                                                             
                                                                                        6                                                                                              
                     necessity hydrolyze in vivo to form SCFAs.  Thus, the issue                                                                                                       
                     becomes whether the prior art teaches or suggests                                                                                                                 
                     administering MCTs to patients meeting the requirements of                                                                                                        
                     claim 1.                                                                                                                                                          
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