Ex Parte KARPF et al - Page 7


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

                    for “at least two cycles” (col. 3, line 63) of up to 210 days, but can be continued                                  
                    for “as long as it takes” (col. 5, line 31).                                                                         
                            Strein also teaches oral administration of alendronate (col. 4, line 65) and                                 
                    that “suitable dosages” are set out in U.S. Patent 4,822,609 (Flora), which Strein                                   
                    incorporates by reference (col. 5, lines 14-17).3  Flora teaches that suitable daily                                 
                    doses of alendronate are from about 0.0025 to 0.033 mg P/kg of body weight                                           
                    (col. 5, lines 39-41).  Since P makes up 25% of the molecular weight of                                              
                    alendronate, Flora’s dosage range corresponds to 0.01 to 0.132 mg                                                    
                    alendronate/kg of body weight, or 0.5 to 6.6 mg alendronate for a 50 kg (110 lb.)                                    
                    patient.  The disclosed range overlaps the range recited in the instant claims.                                      
                            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), Strein meets all the limitations of the instant claims.  See In re                                   
                    Woodruff,  919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990) (“It is a                                      
                    general rule that merely discovering and claiming a new benefit of an old process                                    
                    cannot render the process again patentable.”).                                                                       
                            With regard to claims 7-12, as discussed above, the preamble language                                        
                    merely recites the purpose of the claimed method and adds no limitations to the                                      
                    claims.  Claims 7-12 thus read on administration of alendronate to any patient for                                   
                    a substantial period of time and, like claims 1-6 and 13-24, are anticipated by                                      
                    Strein.                                                                                                              


                                                                                                                                         
                    3 A copy of Flora is included with this decision.                                                                    

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