Ex Parte KARPF et al - Page 5


                    Appeal No. 1997-1830                                                                                                 
                    Application No. 08/389,860                                                                                           

                            Having considered the record, we conclude that the examiner failed to                                        
                    properly consider the evidence submitted by Appellants to rebut the prima facie                                      
                    case of obviousness.  The declaration by Dr. Karpf contains factual assertions,                                      
                    supported by citations to the scientific literature, which cast doubt on the                                         
                    examiner’s position that a person of ordinary skill in the art would have found                                      
                    Rosini suggestive of treating osteoporosis-related symptoms with alendronate.                                        
                    The examiner made no serious attempt to address the facts asserted in the Karpf                                      
                    declaration.                                                                                                         
                            Considering the evidence of record as a whole, as we must, we find that                                      
                    Rosini would not have rendered the claimed method obvious.  The rejection                                            
                    under 35 U.S.C. § 103 is reversed.                                                                                   
                                                        New Grounds of Rejection                                                         
                            Under the provisions of 37 CFR § 1.196(b), we make the following new                                         
                    grounds of rejection:                                                                                                
                            (1)  Claims 1-24 are rejected under 35 U.S.C. § 102(b) as unpatentable                                       
                    over Rodan.  Rodan teaches administration of alendronate to patients with                                            
                    osteoporosis, including postmenopausal (i.e., elderly) women (page 375, left-                                        
                    hand column).  Rodan teaches alendronate administration for up to 10 years                                           
                    (page 376, right-hand column); oral administration of 5-80 mg alendronate (page                                      
                    374, right-hand column); and daily doses of 5 mg (page 376, right-hand column).                                      
                    Since the preamble language in the instant claims adds at most the limitation that                                   
                    the claimed method be carried out on osteoporotic women (claims 1-6 and 13-                                          
                    24), Rodan meets all the limitations of the instant claims.  See In re Woodruff,                                     

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