Ex Parte De La Monte et al - Page 9


                    Appeal No. 2006-0299                                                                        Page 9                        
                    Application No. 09/964,412                                                                                                

                    those of skill in the art would not have considered the problems cited by the                                             
                    examiner to be a source of undue experimentation in this particular field.                                                
                    Moreover, it is well settled that a therapeutic method need not be ready for broad                                        
                    clinical application in order to be enabled.  See In re Brana, 51 F.3d 1560, 1567,                                        
                    34 USPQ2d 1436, 1442 (Fed. Cir. 1995):  “Usefulness in patent law, and in                                                 
                    particular in the context of pharmaceutical inventions, necessarily includes the                                          
                    expectation of further research and development.  The stage at which an                                                   
                    invention in this field becomes useful is well before it is ready to be administered                                      
                    to humans.”5                                                                                                              





















                                                                                                                                              
                    5  The Brana court wrote in terms of of “usefulness,” but the rejection on appeal was based on 35                         
                    U.S.C. § 112, first paragraph.  See 51 F.3d at 1564, 34 USPQ2d at 1439.                                                   





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