Ex Parte CASTRO - Page 2



              Appeal No. 2003-0892                                                                  Page 2                
              Application No. 09/454,385                                                                                  
              electrophoresis to identify the target DNA or RNA sequence.                                                 
                     The references relied on by the examiner are:                                                        
              Conrad                                     5,652,099                    Jul. 29, 1997                       
              Mandecki                                   5,736,332                    Apr. 7, 1998                        
              Albrecht et al. (Albrecht)                 6,265,163                    Jul. 24, 2001                       
              Castro & Shera (Castro), “Single-Molecule Electrophoresis,” Analytical Chemistry, Vol.                      
              67, No. 18, pp. 3181-3186 (September 15, 1995)                                                              
                     Claims 1, 2, 5 and 6 stand rejected under 35 U.S.C. § 102(b) as anticipated by                       
              Mandecki; claims 1-3 and 5-7 stand rejected under 35 U.S.C. § 102(e) as anticipated                         
              by Albrecht; and claims 1-12 stand rejected under 35 U.S.C. § 103(a) as unpatentable                        
              over Conrad and Castro.                                                                                     
                     We reverse these rejections.                                                                         
                                                    BACKGROUND                                                            
                     The rapid and efficient detection of specific nucleic acid sequences in                              
                     biological samples plays a central role in a variety of fields . . . One of the                      
                     most commonly used techniques for the detection of specific nucleic acid                             
                     sequences is the Southern blot[,] . . . in which the fragments to be                                 
                     interrogated have been size-separated by gel electrophoresis and                                     
                     transferred from the gel to a nylon nitrocellulose filter.  A radioactive probe                      
                     is then added to the filter so that hybridization takes place.  After washing                        
                     away the excess probe, the band containing the target nucleic acid is                                
                     detected by exposing an X-ray film to the filter.                                                    
                     Despite its popularity, Southern blotting suffers from some limitations: it                          
                     involves a series of manually intensive procedures that cannot be run                                
                     unattended and cannot be readily automated . . .                                                     
                     The use of automated probes brings up . . . safety and environmental                                 
                     concerns.  The lack of adequate sensitivity is another limitation, which has                         
                     been partially addressed by the development of the polymerase chain                                  
                     reaction (PCR) and related target amplification methods . . . Amplification                          
                     methods, however, may introduce ambiguities resulting from                                           
                     contamination or from variability in amplification efficiency.                                       
              Specification, pages 1-2.                                                                                   
                     The present invention provides a “non-radioactive approach for the ultrasensitive                    
              detection of specific sequences” which “combines the advantages of flow-based                               


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