Ex Parte Sander-Struckmeier et al - Page 11




             Appeal No. 2005-1150                                                                              
             Application No. 09/953,450                                                                        
             have been obvious to one of ordinary skill in the art to include a microbial lipase in the        
             pharmaceutical preparation used to treat the diabetes patients.  Accordingly, we hold             
             that the method set forth in claim 5 is unpatentable under 35 U.S.C. § 103 in view of             
             Delhaye.                                                                                          


             Claim 2                                                                                           
                   Claim 2 stands on a different footing.  The method described therein requires the           
             use of an enzyme mixture of microbially-synthesized lipases, proteases and amylases.              
             Although Delhaye teaches the advantages of using a microbially-synthesized lipase in              
             vivo, the publication is silent with respect to the other microbially-synthesized enzymes         
             recited in the claim.  Upon return of the application to the corps, the examiner may wish         
             to perform an additional search of the prior art to determine whether microbially-                
             synthesized pancreatic amylases and proteases were known in the art and, if so,                   
             whether these enzymes were also known to be more resistant to acid inactivation in                
             vivo.  Assuming, arguendo, that the examiner finds such teachings, he may wish to                 
             consider whether said teachings, in combination with Delhaye, would have rendered the             
             method recited in claim 5 obvious to one having ordinary skill in the art.                        
                   This decision contains a new ground of rejection pursuant to 37 CFR § 41.50(b)              
             (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz.               
             Pat. Office 21 (September 7, 2004)).  37 CFR § 41.50(b) provides "[a] new ground of               
             rejection pursuant to this paragraph shall not be considered final for judicial review."          

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