Ex Parte SHAH et al - Page 2


                 Appeal No. 2001-1020                                             Page ~PAGE  ~2~                        
                 Application No. 09/063,524                                                                              

                        The examiner relies on the following references:                                                 
                 Goodman and Gilman’s The Pharmacological Basis of Therapeutics (Goodman                                 
                 & Gilman), pp. 1420-1429 (7th ed. 1985)                                                                 
                 Physicians’ Desk Reference (PDR), pp. 2594-2596 (48th ed. 1994)                                         

                        Claims 1-3, 17, and 18 stand rejected under 35 U.S.C. § 102(b) as                                
                 anticipated by either the PDR or Goodman & Gilman.                                                      
                        We reverse.                                                                                      
                                                      Background                                                         
                        The specification discloses that “naturally occurring estrogenic                                 
                 compositions of substantial purity and low toxicity such as PREMARIN                                    
                 (conjugated equine estrogens)” are a standard treatment for hormone-related                             
                 disorders including osteoporosis.  Page 1.  The specification also discloses that                       
                 “3β-hydroxy-5,7,9-estratriene-17-one 3-sulfate ester sodium salt is a minor                             
                 component in PREMARIN.”  Id.  The specification discloses that 3β-hydroxy-                              
                 5,7,9-estratriene-17-one 3-sulfate ester sodium salt is present in PREMARIN at                          
                 something less than one percent.  See page 2, lines 8-11.                                               
                                                      Discussion                                                         
                        The claims are directed to a pharmaceutically acceptable salt of 3β-                             
                 hydroxy-5,7,9-estratriene-17-one 3-sulfate ester (claims 1 and 2); the sodium salt                      
                 of 3β-hydroxy-5,7,9-estratriene-17-one 3-sulfate ester, at least 1% pure (claim 3);                     
                 and pharmaceutical compositions consisting essentially of 3β-hydroxy-5,7,                               
                 9-estratriene-17-one, or a pharmaceutically acceptable salt of its 3-sulfate ester,                     
                 and a pharmaceutical carrier (claims 17 and 18).                                                        





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