Ex Parte JUNE - Page 8




              Appeal No. 1999-1245                                                                                     
              Application No. 08/245,282                                                                               


              lines 23-35, for example).  Answer, page 5.   According to the examiner (Answer, page                    
              6):                                                                                                      
                            Appellant’s claimed invention recites the “contacting of the T cell                        
                     with an agent which acts intracellularly” to inhibit the production of D-3                        
                     phosphoinositides.   Thus, the claimed invention encompasses any and all                          
                     agents which can act intracellularly to inhibit production of D-3                                 
                     phosphoinositides.  These agents include wortmannin, quercetin, and                               
                     herbimycin A (recited in the specification), for example, but also include                        
                     antisense to D-3 phosphoinositides, or vectors encoding antisense                                 
                     transcripts to D-3 phosphoinositides.  Appellant’s specification provides                         
                     absolutely no guidance to the skilled artisan on appropriate DNA or RNA                           
                     sequences which may even be potentially used as the latter agents.                                
                     Thus, the examiner concludes that (Answer, page 7):                                               
                     ... the specification fails to provide a single working example for the                           
                     numerously claim in vivo embodiments of the claimed invention.                                    
                     Therefore, in view of the quantity of experimentation necessary to                                
                     determine the parameters listed above, the lack of direction or guidance                          
                     provided by the specification, the absence of working examples for in vivo                        
                     intracellular T cell modulation, the breadth of the claims, and the                               
                     unpredictable and undeveloped state of the art with respect to in vivo cell                       
                     intracellular transformation with any and all agents, it would have required                      
                     undue experimentation for one skilled in the art to practice the claimed                          
                     invention.                                                                                        
                     In our view the examiner has failed to provide sufficient evidence to support a                   
              finding of lack of enablement of the claimed invention.  In re Mills, 470 F.2d 649, 651,                 
              176 USPQ 196, 198 (CCPA 1972) holds that “[a]ll the disclosures in a reference must                      
              be evaluated . . . a reference is not limited to the disclosure of specific working                      
              examples.”   For example, the specification, pages 11-13, provides detailed disclosure                   
              regarding screening assays for identifying inhibitors and activators of PI3K which can                   

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