Ex Parte MIWA et al - Page 4




                Appeal No. 1997-1817                                                                                                            
                Application No. 08/139,693                                                                                                      


                reply brief (Paper No. 17, entered July 18, 1996) for the appellants' arguments                                                 
                thereagainst.                                                                                                                   
                                                                  OPINION                                                                       
                1.  Rejection of claims 1-16 under § 112, ¶1 as based on a nonenabling specification                                            
                         According to the examiner, the specification only enables "specific 'Trigger                                           
                Factors'" because, while the specification recites two specific "Trigger Factors," that                                         
                "recitation fails to establish a genus of 'Trigger Factor'(s) thereby placing this genus in                                     
                the skilled Artisan's possession" (answer, p. 3).2  The examiner bases his opinion on                                           
                the unpredictability of the pharmaceutical art and the failure of the specification to                                          
                identify the compound class(es) which possesses the required "trigger factor" activity                                          
                (answer, p. 11).                                                                                                                
                         Here, as pointed out by appellants, the specification provides both a specific                                         
                definition of "trigger factor" and examples thereof, i.e., TNF and anti-Fas antibody (see                                       
                e.g., brief, p. 9; reply brief, p. 5; specification, p. 4, ll. 14-19 and p. 17, ll. 3-16).                                      
                Moreover, the prior art suggests that other "trigger factors" are known.  For example,                                          
                Forsdyke discusses activation of HIV-bearing T-cells as part of a polyclonal                                                    
                homeostatic response to "a lectin-like factor (lymphokine, growth factor)" (p. 26, col. 1,                                      

                         2The examiner cited "MPEP §§ 706.03(n) and 706.03(z)" (answer, p. 3).  These sections are                              
                entitled "Correspondence of Claim and Disclosure" and "Undue Breadth," respectively, and last appeared                          
                in the Sixth Edition of the MPEP (Jan. 1990).  See Rev. 1 of the Sixth Edition of the MPEP (Sept. 1995).                        
                We observe that both of these sections remained unchanged since at least Rev. 6 of the Fifth Edition of                         
                the MPEP (Oct. 1987).  Neither section refers to 35 U.S.C. § 112, first paragraph, in whole or by                               
                requirement, and thus we will not further refer in this decision to either of these MPEP sections.                              
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