Ex Parte Sander-Struckmeier et al - Page 7




             Appeal No. 2005-1150                                                                              
             Application No. 09/953,450                                                                        
             would have suggested to one of ordinary skill in the art that the references should be            
             combined to arrive at the claimed treatment of diabetes Type I.                                   
                   Nevertheless, we note that during the prosecution of the application, and up until          
             the Answer was submitted, the examiner had rejected the claims under 35 U.S.C.                    
             102(b) as being anticipated by Delhaye.   It is not clear to us why the examiner dropped          
             this rejection.   We hereby reinstate the 102(b) rejection, but because the rejection was         
             withdrawn by the examiner we do so as a new ground of rejection pursuant to 37 C.F.R.             
             § 41.50(b).                                                                                       
                                           New Ground of Rejection                                             
             Claim 1                                                                                           
                   Claims 1, 3, 4, 6 and 7 are rejected under 35 U.S.C. § 102(b) as being                      
             anticipated by Delhaye.                                                                           
                   We find that Delhaye discloses treating twelve (12) patients having insulin-                
             dependent diabetes with pancreatin having lipolytic, amylolytic and proteolytic activity.         
             Delhaye, p. 700, col. 1, para. 5 and col. 2, paras. 3-5.  Specifically, Delhaye discloses         
             treating said patients with pharmaceutical preparations comprising a physiologically              
             acceptable enzyme mixture of “25,000 European Pharmacopoeia Units (EPU) lipase,                   
             22,500 EPU amylase and 1250 EPU protease” (Pancrease HL capsules) or “8,000 EPU                   
             lipase, 9,000 EPU amylase and 450 EPU protease” (Creon capsules).  Id., col. 2,                   
             paras. 3-5. According to the specification and the Appendixes attached to the Brief,              
             diabetes mellitus Type I is insulin-dependent diabetes.  Thus, we find that Delhaye               

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