Ex Parte CHEN et al - Page 5




              Appeal No. 2004-1734                                                                                       
              Application No. 08/942,369                                                                                 
                                                      Background                                                         
                     According to the appellants, bacterial-urinary tract infections are common human                    
              and veterinary diseases.  Brief, p. 2.  The primary causative agents are said to be the                    
              primary gram-negative organisms which include E. coli, Klebsiella spp., Enterobacter                       
              spp., Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia reterri,                       
              Acinetobacter spp. and Enterococcus faecalis.  Id.                                                         
                     As indicated by the claims above, the present invention is directed to a method of                  
              detecting the presence of a urinary tract infection and its susceptibility to an                           
              antimicrobial agent.  The appellants state that this is accomplished, in part, by the use                  
              of a uropathogenic-specific medium.  Brief, p. 2.  According to the appellants, said                       
              medium                                                                                                     
                     allows only the growth of the primary urinary Gram-negative pathogens and                           
                     allows for substantially less growth of any other bacteria of a biological matrix                   
                     (specification, p. 12, line 11 et seq.; p. 19, Table 1).  The specification defines the             
                     primary Gram-negative urinary pathogens as the group of bacteria which cause                        
                     at least 85-90% of the human and veterinary urinary tract infections                                
                     (specification, p. 10, line 19 et seq.) [emphases omitted].  Brief, p. 2.                           
                     The invention involves a multi-compartment assay device which comprises a first                     
              compartment containing a medium capable of sustaining the growth of the total                              
              microorganisms in a urine sample; a second compartment containing a uropathogenic-                         
              specific medium; and a third compartment containing the uropathogenic-specific                             
              medium and an antimicrobial agent.  According to the appellants, the present invention                     
              differs from previous methods in that it enables one to collect a non-sterile urine sample                 
              and make a simultaneous determination of the presence and susceptibility of any                            
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