Ex parte ITO et al. - Page 3


                 Appeal No.  1998-1880                                                                                   
                 Application No.  08/423,865                                                                             
                 THE REJECTION UNDER 35 U.S.C. § 112, SECOND PARAGRAPH:                                                  
                        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).                                              
                        According to the examiner, claim 1, and claims 2-5 which depend from claim                       
                 1, are indefinite because “[c]laim 1 is directed to a method of determining infection                   
                 but lacks any such step.  An added correlating step is suggested.”                                      
                        According to appellants’ specification (page 3) “the inventors have                              
                 energetically studied and investigated to find out that there is a close correlation                    
                 between the intragastric ammonia concentration and H.p.-infection, and by                               
                 measuring the concentration, information on the present activity of H.p. at the time of                 
                 examination can be obtained…”  Furthermore, appellants’ specification discloses                         
                 (page 15), as a conclusion to example 1, that “[i]t has been made apparent that                         
                 higher ammonia concentrations are detected for H.p.-infected patients in                                
                 comparison with those for healthy individuals.”                                                         

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