Ex Parte Walke et al - Page 2


             Appeal No. 2006-2131                                                           Page 2               
             Application No. 10/309,422                                                                          

                                                  Background                                                     
                   The specification discloses polynucleotides encoding human peptides (referred                 
             to generically as a “novel human proteins” or NHPs) that “share sequence similarity with            
             mammalian GPI-anchored P137 protein, cerebellin and C1Q proteins.”  Page 1.  The                    
             proteins are also characterized as “shar[ing] structural similarity with mammalian                  
             membrane proteins (tumor associated markers) and secreted proteins and peptides                     
             such as, but not limited to, cerebellin, C1Q, and collagens” (page 1, line 29 to page 2,            
             line 3) and being “similar to those related to eucaryotic GPI-anchored P137 protein[ ]              
             (which is thought to facilitate transport of materials across epithelial surfaces), tumor-          
             associated proteins, and precursors of secreted proteins” (page 15, lines 29-32).                   
                   The specification does not disclose the biological function of any of the disclosed           
             proteins or their degree of similarity to any known proteins, but contemplates “processes           
             for identifying compounds that modulate, i.e., act as agonists or antagonists, of NHP               
             expression and/or NHP activity . . . .  Such compounds can be used as therapeutic                   
             agents for the treatment of any of a wide variety of symptoms associated with biological            
             disorders or imbalances.”  Page 2, lines 24-30.                                                     
                   The NHP proteins are disclosed to be useful “in assays for screening for                      
             compounds that can be [used] as pharmaceutical reagents useful in the therapeutic                   
             treatment of mental, biological, or medical disorders and diseases.  Given the similarity           
             information and expression data, the described NHPs can be targeted (by drugs, oligos,              
             antibodies, etc[.]) in order to treat disease, or to therapeutically augment the efficacy of,       
             for example, chemotherapeutic agents used in the treatment of diseases such as, but                 
             not limited to, cancer, inflammation, [and] hormonal disorders.”  Page 16.                          





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