Ex Parte RALLS et al - Page 5


                       Appeal No. 2001-1409                                                                                    Page 5                            
                       Application No. 09/044,214                                                                                                                

                                 saliva samples were obtained by either the use of cotton swabs or                                                               
                                 the collection of free saliva following salt stimulation.  A filter is a                                                        
                                 porous substance through which a liquid or gas is passed . . . in                                                               
                                 order to remove constituents such as suspended matter.  The                                                                     
                                 cotton balls used for obtaining the saliva samples taught by Archetti                                                           
                                 are a filter.  Further, it was taught by Archetti that the saliva                                                               
                                 samples were then homogenized by adding 3-mm beads and                                                                          
                                 vortexing prior to assaying and it was well known to those of                                                                   
                                 ordinary skill in the art at the time the invention was made that                                                               
                                 samples should be treated prior to use in an assay in order to                                                                  
                                 achieve more accurate results.  Samples are commonly                                                                            
                                 centrifuged, separated by a filter or collected by a filter prior to use                                                        
                                 in assays and the incorporation of a separation device, albeit a                                                                
                                 column or filter would have been an obvious addition to the kit                                                                 
                                 disclosed by Todd at the time the invention was made because                                                                    
                                 Archetti et al. specifically teaches [sic] the use of a filter when using                                                       
                                 saliva samples, i.e., cotton balls.                                                                                             
                       Id., pages 3-4.                                                                                                                           
                                 Appellants argue that the cited references do not support a prima facie                                                         
                       case of obviousness.  See the Appeal Brief, pages 11-14 (emphasis in original):                                                           
                                 TODD teach only a dipstick assay wherein the solid phase                                                                        
                                 substrate is immersed into an antibody labeled reaction mixture and                                                             
                                 relies on chemical binding of the antigen to the membrane.  TODD                                                                
                                 is not concerned with filtering of the saliva. . . .  Moreover, TODD is                                                         
                                 a one step method which teaches away from the multi-step                                                                        
                                 methods as time-consuming.  TODD is an assay with reaction                                                                      
                                 times that vary from 15 minutes to several hours over a variety of                                                              
                                 different environmental conditions. . . .  [The claimed invention] is a                                                         
                                 five minute, dry test, conducted at room temperature, which makes                                                               
                                 it very useful in a doctor’s office or other clinical setting.  The                                                             
                                 recited sample filter prevents the particulates from being trapped                                                              
                                 with the antibodies and antigen of interest.  Thus, TODD does not                                                               
                                 anticipate nor suggest the claimed immunodiagnostic kit nor the                                                                 
                                 immunodiagnostic method.                                                                                                        
                                 . . . .                                                                                                                         
                                 The secondary reference, ARCHETTI, merely adds the concept of                                                                   
                                 homogenization. . . .                                                                                                           
                                 . . . Homogenization does not filter out particulates but merely                                                                
                                 disperses them, thus it is not applicable to the instant invention.                                                             





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