Ex Parte Levy et al - Page 3


                Appeal No. 2006-1083                                                                                 Page 3                    
                Application No. 09/799,251                                                                                                     

                                                                 The Claims                                                                    
                         Claim 1 is representative of the subject matter on appeal:                                                            
                         1.  A unit dosage form composition suitable for once daily administration to a                                        
                human comprising                                                                                                               
                         active components which consist essentially of                                                                        
                         (1) a physiologically effective amount of at least one hormone selected from the                                      
                group consisting of steroidal estrogen, estradiol, estrone, medroxyprogesterone,                                               
                norethindrone, norethisterone, progestin, norgestrel, and progesterone, and                                                    
                         (2) at least one carotenoid wherein said carotenoid is in an amount effective to                                      
                prevent the adverse effects which may result from the administration of said hormone,                                          
                         said composition being substantially free of any other active components.                                             
                         “As used throughout [the] specification, ‘hormone’ refers to steroidal estrogens,                                     
                progestins, and nonsteroid estrogens (phytoestrogens) derived from higher plants”                                              
                (Specification, page 9), while “‘steroidal estrogen’ or ‘estrogen’ refers to estradiol,                                        
                estrone, [and] estriol” (id.), and “‘progestin’ refers to . . . progesterone,                                                  
                medroxyprogesterone, norethindrone, norethistrone, [and] norgestrel” (id.).                                                    
                                                                 Discussion                                                                    
                         The examiner rejected claims 1-10 under 35 U.S.C. § 103 as unpatentable in view                                       
                of Jackson1 and Shlyankevich.2  Jackson describes dietary supplements “designed to                                             
                meet a woman’s health needs at each particular stage of her life” (Jackson, column 3,                                          
                lines 49-50).  “[E]ach of the dietary supplements . . . provides a variety of nutrients,                                       
                including antioxidants to increase the resistance of LDL cholesterol to oxidation,                                             
                elements to enhance calcium absorption and utilization, nutrients to address iron                                              

                                                                                                                                               
                1 Jackson et al., U.S. Patent 5,807,586, issued September 15, 1998.                                                            
                2 Shlyankevich, U.S. Patent 5,424,331, issued June 13, 1995.                                                                   





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