Appeal from decision of the Patent Office Board of Appeals rejecting claims to various specific steroid compounds for failing to comply with 35 U.S.C. §§ 101 and 112. The patent application specification stated that the claimed compounds were “of value on account of their biological properties or as intermediates in the preparation of compounds with useful biological properties as herein indicated or as is apparent to those skilled in the art.†For example, certain claimed compounds were declared to be “of value in steroid technology, in the furtherance of steroidal research and in the application of steroidal materials to veterinary or medical practice, whether as tablets, elixirs, injections, implaints, or other types of pharmaceutical preparation well known to those skilled in the art.â€
Appellants made two arguments: first, they argued that the specification was “adequate to comply with 101 and 112 because it discloses that the claimed compounds 'have present and useful biological activity of the nature known for analogous steroidal compounds,' and that 'one skilled in the art would know how to use the compounds of the claims to take advantage of their presently-existing biological activity.'†Second, they argued that “the specification adequately discloses that the compounds 'have use as intermediates in the production of aromatic steroidal hormones and other biologically useful compounds,' and that the examiner has admitted one skilled in the art would know how to use the claimed compounds as intermediates for that purpose.â€
With regard to the first argument, that the disclosure of “useful biological activity†was enough to satisfy the utility requirement, the court was not persuaded, writing that the term was too obscure to convey any explicit indication of usefulness. The court also rejected an affidavit purporting to establish that one skilled in the art would understand the usefulness of the claimed invention, writing that it is “what the compounds are disclosed to do that is determinative here. . . There is no suggestion which compounds are of value . . . or what biological properties make them useful.†Finally, the court noted that Appellants' arguments “fail to recognize that many steroid compounds may possess no activity whatsoever. It cannot be presumed that a steroid chemical compound is 'useful' under 101, or that one of skill in the art will know 'how to use' it, simply because the compound is closely related only in a structural sense to other steriod compounds known to be useful.â€
With regard to the second argument, that the compounds were useful as “intermediates,†the court also found a lack of utility. The court, citing Brenner v. Manson, found that utility is not established by a specification that merely discloses “that the intermediate exists and that it 'works,' reacts, or can be used to produce some intended product of no known use†or “that the product disclosed to be obtained from the intermediate belongs to some class of compounds which now is, or in the future might be, the subject of research to determine some specific use.†The court overruled a number of its own previous decisions, including Application of Nelson, 280 F.2d 172; Application of Wilke, 314 F.2d 558; Application of Adams, 316 F.2d 476; and Application of Szwarc, 319 F.2d 277; and held that “the practical utility of the compound, or compounds, produced from a chemical 'intermediate,' the ‘starting material’ in such a process, is an essential element in establishing patentability of that intermediate.â€
Excerpts and Summaries
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Wednesday 27 of August, 2008 20:46:17 GMT by Unknown
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Sunday 07 of September, 2008 16:08:55 GMT by Unknown