Ex Parte Lal et al - Page 2


                  Appeal No. 2005-0102                                                                                       Page 2                      
                  Application No. 09/840,787                                                                                                             

                  the amino acid sequence shown in the specification’s SEQ ID NO:19.  See page 18.                                                       
                  The specification discloses that “HRM-19 is 351 amino acids in length and has  . . . one                                               
                  potential mitochondrial carrier motif, P31LDVVKVRL.  HRM-19 has sequence homology                                                      
                  with C. elegans C16C10 (g577542) and is found in cDNA libraries associated with cell                                                   
                  proliferation, cancer and immune response.”  Id.                                                                                       
                           The specification does not disclose any specific activity or function possessed by                                            
                  either HRM-19 or proteins having mitochondrial carrier motifs.  Regarding “human                                                       
                  regulatory molecules” generally, the specification discloses that                                                                      
                           [r]egulatory protein molecules function to control gene expression.  These                                                    
                           molecules turn individual or groups of genes on and off in response to                                                        
                           various inductive mechanisms of the cell or organism; act as transcription                                                    
                           factors by determining whether or not transcription is initiated, enhanced,                                                   
                           or repressed; and splice transcripts as dictated in a particular cell or                                                      
                           tissue.                                                                                                                       
                  Page 1.                                                                                                                                
                           The specification discloses that HRMs are useful in therapy, particularly for                                                 
                  cancers:                                                                                                                               
                           In one embodiment, where HRM is an inhibitor, HRM . . . may be                                                                
                           administered to a subject to treat a cancer such as adenocarcinoma,                                                           
                           leukemia, lymphoma, melanoma, myeloma, sarcoma, and terato-                                                                   
                           carcinoma.  Such cancers include, but are not limited to, cancers of the                                                      
                           adrenal gland, bladder, bone, bone marrow, brain, breast, cervix, gall                                                        
                           bladder, ganglia, gastrointestinal tract, heart, kidney, liver, lung, muscle,                                                 
                           ovary, pancreas, parathyroid, penis, prostate, salivary glands, skin,                                                         
                           spleen, testis, thymus, thyroid, and uterus.                                                                                  
                           . . .                                                                                                                         
                           In a further embodiment where HRM is promoting cell proliferation,                                                            
                           antagonists which decrease the expression or activity of HRM may be                                                           
                           administered to treat a cancer such as adenocarcinoma, leukemia,                                                              
                           lymphoma, melanoma, myeloma, sarcoma, and teratocarcinoma.  Such                                                              
                           cancers include, but are not limited to, cancers of the adrenal gland,                                                        
                           bladder, bone, bone marrow, brain, breast, cervix, gall bladder, ganglia,                                                     
                           gastrointestinal tract, heart, kidney, liver, lung, muscle, ovary, pancreas,                                                  





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