Ex parte MONTE - Page 7

                Appeal No. 1997-3537                                                                                                           
                Application No. 08/395,867                                                                                                     

                explicitly states that trypsin "leaves much of the ABBOS sequence intact" (p. 306, c. 2).                                      
                Second, Thibault explicitly states that albumin is "hydrolysable with the most difficulty by the                               
                enzyme system adopted," and explicitly states that serum albumin and immunoglobulins                                           
                are the principal "residual proteins" left by the described trypsin/chymotrypsin enzyme                                        
                system (c. 7, ll. 23-26).  Similarly, Martinez describes an "optional preliminary step prior to                                
                hydrolysis ... [of] preheating of the protein solution to insure denaturation of whey protein                                  
                fractions, e.g., serum albumin (BSA) and immunoglobulins (particularly IgG)" (c. 3, ll. 25-                                    
                28).  Thus, Martinez also suggests that the disclosed trypsin/chymotrypsin enzyme system                                       
                may not be effective to hydrolyze BSA.  Third, while Martinez states that its hydrolysate "is                                  
                preferably devoid of detectable intact milk protein" (c. 4, ll. 18-20), the examiner has not                                   
                established on this record that the loss of "detectable intact milk protein" necessarily                                       
                means that the milk proteins have been hydrolyzed, i.e., cleaved, as opposed to denatured                                      
                such that their quaternary structure is simply unfolded somewhat.  Thus, it is unclear on this                                 
                record that the enzymatic hydrolysis steps of Thibault or Martinez will inherently result in the                               
                claimed invention.  In other words, the examiner has not established a factual basis upon                                      
                which to conclude that the trypsin/chymotrypsin hydrolysis method and resulting hydrolysate                                    
                of Thibault or Martinez would reasonably be expected to hydrolyze BSA, in particular its                                       
                ABBOS sequence so as to result necessarily in the claimed invention.                                                           

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