Ex Parte Yoo - Page 3

                 Appeal 2007-2864                                                                                      
                 Application 10/747,798                                                                                
                        Hay, D. “Management of oral problems associated with cancer                                    
                 treatment: radiotherapy,”                                                                             
                 www.8.co.nz/hospitaldenistry/papers/Management_of_Oral_Problems_                                      
                 Associated_with_005.htm, accessed by PTO on 10/11/06.                                                 
                        Lowe, B. “Abnormal Cervical Smears – a patient’s guide,”                                       
                 www.medic8.com/healthguide/articles/abnormalcervicalsmear.html,                                       
                 accessed by PTO on 10/11/06.                                                                          
                        “What is a dermatologist?”                                                                     
                 www.aad.org/public/Parentskids/KidsConnection/Whatisderm.htm, accessed                                
                 by PTO on 10/11/06.                                                                                   

                        We affirm.                                                                                     
                                                 BACKGROUND                                                            
                        According to the Specification,                                                                
                               Many proliferative conditions are known to be associated                                
                        with papillomaviruses.  Examples include benign lesions such                                   
                        as cutaneous warts and anogenital warts and premalignant                                       
                        lesions such as epidermodysplasia verruciformis.                                               
                        Papillomaviruses are also associated with malignant lesions                                    
                        including carcinomas of the head and neck, cervix, anus, and                                   
                        penis.  In 1998, the American Cancer Society estimated that                                    
                        60,000 Americans would be diagnosed with head and neck                                         
                        cancer.  HPV has been linked to 15-46% of cases and head and                                   
                        neck squamous cell carcinoma (HNSCC).  Patients with early                                     
                        stage HNSCC or patients who are cured from advanced cancers                                    
                        have a low probability of death from their primary cancer but                                  
                        have a significant chance of dying from a second primary                                       
                        tumor.  More importantly, treatment (chemoprevention) of                                       
                        high-risk populations may reduce the development of a second                                   
                        primary tumor and therefore significantly improve survival.                                    
                        Two chemoprevention trials using 13-cis-retinoic acid (CRA)                                    
                        have demonstrated the efficacy of clinically reversing                                         
                        premalignant lesions and reducing the risk of secondary                                        
                        primary tumors.  However, CRA is toxic, poorly tolerated and                                   
                        loses its preventative effects after discontinuation of therapy.                               

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