In Re Wright

999 F.2d 1557 (1993)

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Nature of the Case

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Facts

The technology relates to processes for producing live, non-pathogenic vaccines against pathogenic RNA viruses (claims 1-10, 22-37, 40, 45, and 46), vaccines produced by these processes (claims 11, 12, 15-21, 38, and 39), and methods of using certain of these claimed vaccines to protect living organisms against RNA viruses (claims 41 and 42). P presented a general description of these processes, vaccines, and methods of use, but only a single working example. The Examiner allowed claims which were specific to the particular process and vaccine disclosed in the example. The Examiner took the position that the claims were not supported by an enabling disclosure because one of ordinary skill in the art would have had to engage in undue experimentation to practice the subject matter of these claims, given their breadth, the unpredictability in the art, and the limited guidance P provided in his application. It was noted that many of Wright's claims read on vaccines against all pathogenic RNA viruses, even though RNA viruses are a very diverse and genetically complex group which includes, acquired immunodeficiency syndrome (AIDS) viruses, leukemia viruses, and sarcoma viruses. The Examiner argued that P's single working example merely evidenced that Wright had obtained successfully a particular recombinant virus vaccine and that this single success did not provide 'sufficient likelihood' that other recombinant RNA viruses could be constructed without undue experimentation, or if they were constructed, that they would be useful in the design of live viral vaccines. The Examiner also argued that the methods of identification, isolation, cloning, and recombination which Wright describes in his application in only a very general manner were not so developed in 1983 as to enable, without undue experimentation, the design and production of recombinant virus vaccines against any and all RNA viruses. The Board found that P had failed to establish that the general description of his invention was anything more than an invitation to experiment. P appealed.