Ex Parte AXEL et al - Page 8


                Appeal No.  2001-0562                                                     Page 8                   
                Application No.  08/460,478                                                                        
                forth in In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir.                     
                1993) it:                                                                                          
                       is incumbent upon the Patent Office, whenever a rejection on this                           
                       basis is made, to explain why it doubts the truth or accuracy of any                        
                       statement in a supporting disclosure and to back up assertions of                           
                       its own with acceptable evidence or reasoning which is inconsistent                         
                       with the contested statement.  Otherwise, there would be no need                            
                       for the applicant to go to the trouble and expense of supporting his                        
                       presumptively accurate disclosure.                                                          
                       On this record the examiner failed to analyze the claimed invention with                    
                reference to the factors set forth in Wands.  In addition, the examiner failed to                  
                provide the evidence necessary to support a rejection under 35 U.S.C. § 112,                       
                first paragraph.  We are unwilling to accept the examiner’s conclusion (Answer,                    
                page 21) that “[t]he facts disclosed in Orkin et al., Neve, and Friedmann illustrate               
                that gene therapy is a highly unpredictable art.”  Instead, we agree with                          
                appellants (Brief, page14) that while “[t]he cited references … offer sweeping                     
                generalizations – they do not address the invention recited in the claims on                       
                appeal … [g]eneral conclusory statements regarding the state of the art are                        
                insufficient.”                                                                                     
                       Accordingly, we reverse the rejection of claims 122 and 123 under 35                        
                U.S.C. § 112, first paragraph, as being based on an insufficient disclosure to                     
                support or enable how to make and/or use the claimed invention.                                    
                THE REJECTIONS UNDER 35 U.S.C. § 103:                                                              
                The rejection of claims 81-100, 104-118, 122 and 123:                                              
                       According to the examiner (Answer, page 14) ‘945 “teaches various                           
                methods for gene transfer to neuronal and glial cells of the central nervous                       







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