Ex Parte H. Shih - Page 12


               Appeal No. 2006-0650                                                                      Page 12                  
               Application No. 10/007,613                                                                                         

               proteolytic enzyme composition and (2) method groups, Appellant morphed original                                   
               claim 39, which was directed to a proteolytic enzyme composition, into a “system” claim                            
               for disinfecting articles susceptible to prion contamination.  In addition to the presence                         
               of the enzyme, the claim was amended to include: “articles” (e.g., instruments to be                               
               sterilized); “means for heating” articles, and “means for exposing said articles to                                
               proteolytic enzymes.”  Amendment filed 9/23/2003.   Later, in response to prior art                                
               rejections, Appellant added the “wherein clause,” stating that it expressly characterized                          
               the recited articles by requiring “two distinctive physical states [temperature] at two                            
               different durations.” Amendment filed 4/16/2004, page 21.  Basically, Appellant was                                
               amending the composition claim to include the restricted method limitations, i.e., heating                         
               articles to a temperature that causes the prion to become susceptible to proteolytic                               
               digestion, followed by contacting with a proteolytic enzyme under suitable temperature                             
               conditions to digest the prion protein.                                                                            
                      As we understand it, Appellant is claiming the system as it performs a                                      
               disinfection process, where the articles are first held at about 40-150°C to make the                              
               prion susceptible to proteolysis, and then at about 50-65°C for digestion (“exposure”) by                          
               a proteolytic enzyme.   (Claim 71 recites different ranges, but the concept is the same.)                          
               This is consistent with the statement in the application that the invention includes a two-                        
               step sequence involving two temperature exposures. Specification, page 10.  Although                               
               the claims recite temperature ranges, we understand this to mean that the article is                               
               brought to a temperature within the range, and that it may also pass through other                                 
               temperatures within the recited range.                                                                             







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