Ex Parte Pickar - Page 7

                Appeal No. 2006-3012                                                                              
                Application No. 09/808,878                                                                        

                suggested to those skilled in the art that the use of 1.5 mg MPA in                               
                combination with about 0.3 to about 0.45 mg CEE would have been                                   
                reasonably successful in providing relief of vasomotor symptoms of                                
                menopause.”  (Br. 8.)                                                                             
                       The evidence of record does not support Appellant’s position that                          
                those skilled in the art would have expected the lower dosages of MPA and                         
                CEE disclosed by Plunkett to be unsuccessful in controlling hot flushes.  The                     
                Second Lobo Declaration does not support the weight Appellant puts on it.                         
                In that declaration, Dr. Lobo declares that “[f]or the past 20 years, the                         
                dosage of 0.625 mg CEE has been accepted as the minimum dosage of                                 
                estrogen necessary to relieve the symptoms of menopause, including hot                            
                flushes and bone loss.”  ¶ 2.  As support for this statement, Dr. Lobo cites                      
                Sobel2 and Kronenberg.3  These references, however, do not state that 0.625                       
                mg/day of CEE was accepted as the minimum effective dosage.                                       
                       Sobel states that the standard dose of conjugated estrogens was 0.625                      
                mg (page 313).  Kronenberg states that the “most commonly used regimen                            
                for treating hot flashes in the United States is 0.625 to 1.25 mg of oral                         
                conjugated equine estrogens (Premarin)” (page 109, emphasis added).  A                            
                dose that is “standard” or a regimen that is “most commonly used,”                                
                however, is not necessarily the same as a dosage or regimen that is                               
                considered the minimum effective dose.  Rather, a standard or most                                
                                                                                                                 
                2 Sobel, “Progestins in preventative hormone therapy,” Obstetrics and                             
                Gynecology Clinics of North America, Vol. 21, No. 2, pp. 299-319 (1994).                          
                3 Kronenberg, “Chap. 9  Hot Flashes,” in Treatment of the Postmenopausal                          
                Woman:  Basic and Clinical Aspects, R.A. Lobo (ed.), Raven Press, NY, pp.                         
                97-117 (1994).                                                                                    
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