Ex Parte ZAVADA et al - Page 13


                    Appeal No. 2001-1970                                                                     Page 13                        
                    Application No. 08/260,190                                                                                              

                    experimentation when considered relative to other antisense-based therapeutic                                           
                    methods.                                                                                                                
                            Finally, we must also disagree with the examiner concerning the probative                                       
                    value of the Gruenert declaration.  Dr. Gruenert declared that the in vitro results                                     
                    provided in the specification were reasonably predictive of in vivo efficacy.  See                                      
                    ¶¶ 3-5.  Dr. Gruenert also declared that the published literature at the time of                                        
                    filing would have supported an expectation of success in using MN antisense                                             
                    oligonucleotides to inhibit MN gene expression in vivo.  See ¶ 6.  Finally, Dr.                                         
                    Gruenert declared that the screening procedure disclosed in the specification,                                          
                    together with the published literature at the time of filing, would have enabled                                        
                    those skilled in the art to identify therapeutically useful oligonucleotides.  See                                      
                    ¶¶ 7-8.                                                                                                                 
                            Of course, “Appellant’s opinion on the ultimate legal issue is not evidence                                     
                    in the case. . . .  [However,] some weight ought to be given to a persuasively                                          
                    supported statement of one skilled in the art.”  In re Lindell, 385 F.2d 453,                                           
                    155 USPQ 521, 524 (CCPA 1967) (emphasis added).  Here, the conclusions set                                              
                    out in the Gruenert declaration were well-reasoned and supported by evidence,                                           
                    either in the specification or in cited prior art references.                                                           
                            The lack of “factual evidence”, as the examiner put in, in addition to that                                     
                    provided in the specification, is not a fatal flaw in a Rule 132 declaration.                                           
                    Declaratory evidence can support patentability in a number of ways.  In this case,                                      
                    the declaratory evidence was presented to show how the guidance provided by                                             
                    the specification, combined with the state of the art, would have been viewed by                                        





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