Ex Parte PORTUGAL et al - Page 2



              Appeal No. 2004-1967                                                                Page 2                
              Application No. 09/027,439                                                                                
                     “[I]nfection [with Shigella or enterohemorrhagic E. coli] is a serious public health               
              problem in the United States and [ ] physicians are required to report cases to the                       
              Centers for Disease Control and Prevention.”  Id., page 2.  “Although the Centers for                     
              Disease Control require distinguishing among the four major species of Shigella in its                    
              reporting statistics, it is difficult to do so.”  Id., page 4.  Moreover, “[t]he genus Shigella is        
              a member of the family of Enterobacteriaceae and is thus related to Escherichia coli.                     
              [Shigella and Escherichia] DNA relatedness is very high, they are often difficult to                      
              differentiate biochemically, and they cross-react serologically.”  Id., page 3.                           
                     “Distinguishing between Shigella and E. coli is important for treating [ ] infection.”             
              Id., page 4.  The present invention is directed to “species-specific and genus-specific                   
              and, therefore, species-identifying and genus-identifying, nucleotides of [16s ribosomal                  
              RNA and 16s ribosomal DNA] from Shigella flexneri, Shigella sonnei, Shigella boydii,                      
              and Shigella dysenteriae” (id., page 5), which can be used to “distinguish[ ] Shigella                    
              from E. coli and species of Shigella from each other.”  Id.  SEQ ID NOS: 3, 4 , 5 and 6                   
              represent the nucleotide sequences of 16s rDNA of S. flexneri, S. sonnei, S.                              
              dysenteriae and S. boydii, respectively.  Id., page 12.  Finally, exemplary genus-specific                
              and species-specific probes are set forth in Table 3 of the specification.                                
                                                    THE CLAIMS1                                                         
                     Claims 55-58 are directed to nucleic acid probes which target individual species                   
              of Shigella.  According to the specification, probes are “synthetic or biologically                       
              produced nucleic acids that . . . contain specific . . . sequences that allow them to                     
              hybridize under defined predetermined stringencies, specifically and preferentially to                    



                     1 Following some discussion on the record, appellants and the examiner agreed                      
              that the Appendix accompanying the Substitute Appeal Brief dated February 2, 2004                         
              sets forth the correct claims on appeal.                                                                  

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