Ex Parte LEE et al - Page 3




             Appeal No. 2003-2147                                                                              
             Application No. 09/392,243                                                                        
                   As set forth in Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200,               
             1217, 18 USPQ2d 1016, 1030 (Fed. Cir. 1991):                                                      
                   The statute requires that “[t]he specification shall conclude with one or                   
                   more claims particularly pointing out and distinctly claiming the subject                   
                   matter which the applicant regards as his invention.”  A decision as to                     
                   whether a claim is invalid under this provision requires a determination                    
                   whether those skilled in the art would understand what is claimed.  See                     
                   Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624,                       
                   225 USPQ 634, 641 (Fed. Cir. 1985) (Claims must “reasonably apprise                         
                   those skilled in the art” as to their scope and be “as precise as the subject               
                   matter permits.”).                                                                          
             Furthermore, claim language must be analyzed “not in a vacuum, but always in light of             
             the teachings of the prior art and of the particular application disclosure as it would be        
             interpreted by one possessing the ordinary skill in the pertinent art.”  In re Moore, 439         
             F.2d 1232, 1235, 169 USPQ 236, 238 (CCPA 1971).                                                   
                   The examiner argues that claim 42 is confusing because “the claim initially                 
             recites addition of a peroxide-containing compound to a composition, but then recites             
             that the added product must become undetectable when the amount of added product                  
             is measured.  It is therefore unclear how much peroxide-containing product can be                 
             added, if any.”   Answer, page 3.                                                                 
                   Appellants argue that claim 42 is not indefinite.  Brief, page 38.  Appellants argue        
             that                                                                                              
                   [i]f the concentration of the peroxide containing compound remaining in                     
                   the mucosa product, when determined using KMnO4 titration, is not                           
                   “undetectable” (i.e. is “detectable”) or if the particular subject matter does              
                   not entail “mixing the peroxide containing compound and the mucosa                          
                   tissue to form a mucosa product” as claim 42 requires, then the person                      
                   knows the particular subject matter falls outside the literal scope of claim                
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