Ex parte MONTE - Page 6

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

                BSA antibodies form against ABBOS and subsequently bind to p69, pancreatic beta-cell                                           
                surface proteins, causing the development of diabetes" (answer, p. 6).                                                         
                         According to the examiner,                                                                                            
                         [i]t would  have been obvious ... to prepare an infant milk formula ... as                                            
                         claimed since Thibault and Martinez clearly suggest using proteases to                                                
                         reduce large peptides in infant milk (BSA)-containing foods, and Karjalainen                                          
                         teaches that BSA is not desirable in infant milk formulae due to the presence                                         
                         of ABBOS (a large peptide). ... [R]emoval [of ABBOS prior to infant                                                   
                         digestion] alters the appearance of BSA to an infant's immune system which                                            
                         prevents the creation of antibodies against ABBOS so that the p69 amino                                               
                         acid section is not affected.  [Answer, para. bridging pp. 6-7.]                                                      
                         However, the examiner has not pointed out, and we do not find, where Karjalainen                                      
                discloses or suggests using enzymatically hydrolyzed BSA in milk formulas to prevent                                           
                onset of milk-induced diabetes.  Rather, Karjalainen appears to suggest preventing                                             
                exposure to cow's milk early in life to prevent onset of milk-induced diabetes by analogy to                                   
                a diabetes-prone rodent model.                                                                                                 
                         Furthermore, to the extent the examiner relies on inherency to establish that "the                                    
                hypoallergenic milk formulation is basically the same as the milk formulation claimed"                                         
                (answer, p. 9), that reliance appears misplaced for several reasons.  First, both Thibault                                     
                and Martinez use enzyme mixtures comprising trypsin and chymotrypsin.  Karjalainen                                             

                         6Karjalainen "suggests that an active, antigen-driven immune response against the BSA-derived                         
                ABBOS peptide is a feature of the autoimmune response in patients with insulin-dependent diabetes.  This                       
                likens the disease in humans to that in diabetes-prone rodents, in which the prevention of exposure to cow's                   
                milk early in life prevents the development of the disease." (p. 307, c. 1, ll. 1-7, footnote omitted, emphasis                
                                                                     - 6 -                                                                     

Page:  Previous  1  2  3  4  5  6  7  8  9  10  Next 

Last modified: November 3, 2007