Ex Parte RALLS et al - Page 4


                Appeal No. 2001-1409                                                  Page 4                  
                Application No. 09/044,214                                                                    

                                                 Discussion                                                   
                      The claims are directed to an immunoassay method and kit.  Claim 1 is                   
                representative of the kit claims.  Claim 1 is directed to a kit comprising disease-           
                specific antigens immobilized on a solid flow-through substrate, a blocking agent,            
                a filter, secondary antibodies specific to the antibodies of interest, and a label to         
                detect the disease-specific antibodies.  Claim 8 is representative of the method              
                claims and is directed to a method comprising the following steps:  immobilizing              
                disease-specific antigens on a solid flow-through substrate, blocking the                     
                substrate, gathering a saliva sample and separating particulate matter from the               
                sample by filtration or centrifugation, spotting the treated saliva sample on the             
                solid substrate, contacting the substrate with a label, and “[d]etecting and reading          
                the intensity of the label in less than 5 minutes.”                                           
                      The examiner rejected both the method claims and the kit claims as                      
                obvious in view of Todd and Archetti.  In addition, the examiner rejected                     
                dependent claims 3, 4, 10, and 11 as obvious in view of Todd, Archetti, Brown,                
                and Maes.  Both rejections rely on the same combination of Todd and Archetti.                 
                      The examiner characterized Todd as teaching an immunoassay (kit and                     
                method) for detecting specific antibodies using immobilized antigen and a label,              
                where the sample tested can be saliva.  She acknowledged that Todd does not                   
                disclose a separating device (i.e., centrifuge or filter), but cited Archetti as              
                meeting this limitation.  Examiner’s Answer, pages 2-3.  She concluded that it                
                      would have been obvious to one of ordinary skill in the art at the                      
                      time the invention was made to remove undesired materials from                          
                      the saliva samples prior to assaying because Archetti discloses that                    





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