Ex Parte Ullah et al - Page 2


            Appeal No. 2006-2471                                                         Page 2              
            Application No. 09/824,364                                                                       

            treating atherosclerosis and cardiovascular disease and cerebrovascular disease are              
            well documented.  In fact, it is not uncommon that patients having elevated cholesterol          
            levels who are at high risk for a myocardial infarction take both a statin and aspirin.          
            However, use of both a statin and aspirin may require special care to insure that drug           
            interaction, including physical and chemical incompatibility, and side effects, are kept to      
            a minimum while achieving maximum benefit from these drugs.”  Specification, page 1,             
            lines 14-25.   The application provides pharmaceutical compositions to reduce the                
            interaction of aspirin with the statin.                                                          
                                                 Discussion                                                  
            Claim construction                                                                               
                   Claims 36, 38-40, and 42-47 are on appeal.  The claims stand or fall together             
            because Appellants did not provide separate reasons for patentability of any of the              
            claims.  We select claim 46, the only independent claim, as representative.                      
                   46.   A method for lowering serum cholesterol or inhibiting or treating                   
                         atherosclerosis or reducing risk of or treating a cardiovascular event or           
                         disease, coronary artery disease or cerebrovascular disease, which                  
                         comprises administering to a patient in need of treatment a therapeutically         
                         effective amount of a pharmaceutical composition comprising a                       
                         combination of a statin cholesterol lowering agent and aspirin in a single          
                         dosage form, which dosage form reduces interaction between the statin               
                         and the aspirin, wherein the pharmaceutical composition is in the form of a         
                         tablet or capsule containing both aspirin granules and statin granules.             

                   The claim requires administering statin and aspirin in a “single dosage form.”            
            The application discloses tablets and capsules as examples of a single dosage form,              
            where both statin and aspirin are present in the same unit.  Specification, page 2, line         
            34-page 3, line 1-page 5, line 35.                                                               






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