Ex Parte RALLS et al - Page 3


                Appeal No. 2001-1409                                                  Page 3                  
                Application No. 09/044,214                                                                    

                Archetti et al. (Archetti), “Detection of Foot-and-Mouth Disease Virus-Infected               
                Cattle by Assessment of Antibody Response in Oropharyngeal Fluids,“ Journal of                
                Clinical Microbiology, Vol. 33, No. 1, pp. 79-84 (1995)                                       

                      Claims 1, 2, 5-9, and 12-14 stand rejected under 35 U.S.C. § 103 as                     
                obvious in view of Todd and Archetti.                                                         
                      Claims 3, 4, 10, and 11 stand rejected under 35 U.S.C. § 103 as obvious                 
                in view of Todd, Archetti, Brown, and Maes.                                                   
                      We reverse.                                                                             
                                                 Background                                                   
                      The specification discloses “a rapid immunoassay kit and method for                     
                semi-quantitatively detecting antibodies in human saliva to antigens of disease-              
                related microorganisms, e.g., antibodies to Mycobacterium tuberculosis.”  Page                
                1.  In standard screening tests for tuberculosis, a tuberculin antigen is injected            
                into the patient and results are read 48 to 72 hours later.  Specification, pages 3-          
                4.  “To continue with the Mycobacterium tuberculosis example . . ., a major                   
                advantage is that tuberculosis screening can be done rapidly—in approximately 5               
                minutes—in one visit and in a non-invasive manner.”  Id., page 5.  “The premise               
                of this use of the assay is that individuals infected with Mycobacterium                      
                tuberculosis develop antibodies to this bacterial species which are present in                
                their saliva and which react with mycobacterial antigens.  The antibodies are then            
                labeled and color development detected and read visually after addition of an                 
                appropriate enzymatic substrate, if required.”  Id.                                           








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