Claims for Expressed Sequence Tags (ESTs) Properly Rejected for Lack of Utility and Enablement

Case: In re: Fisher , No. 04-1465 (Fed Cir. 9/7/05)

The One Sentence Summary: The Federal Circuit affirmed a decision by the Patent Board of Patent Appeals and Interferences affirming the PTO's rejection of claims for expressed sequence tags ("ESTs") as unpatentable for lack of utility under 35 U.S.C. § 101 and lack of enablement under 35 U.S.C. § 112, first paragraph.



Federal Circuit Holdings:

• None of applicant's asserted uses meets the utility requirement of § 101. Section 101 provides: “Whoever invents . . . any new and useful . . . composition of matter . . . may obtain a patent therefor . . . .”
• Specific and substantial utility for an invention must be shown: "the Supreme Court announced a more rigorous test, stating: The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point – where specific benefit exists in currently available form – there is insufficient justification for permitting an applicant to engross what may prove to be a broad field. Brenner, 383 U.S. at 534-35 (emphases added). Following Brenner, our predecessor court, the Court of Customs and Patent Appeals, and this court have required a claimed invention to have a specific and substantial utility to satisfy § 101. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1563 (Fed. Cir. 1996) (“Consequently, it is well established that a patent may not be granted to an invention unless substantial or practical utility for the invention has been discovered and disclosed.”)."
• The ESTs had no utility in themselves other than as a tool to perform other experiments to understand the maize genome.
• There was no disclosure that the ESTs had actually been used for the asserted uses that applicant claimed.
• The uses asserted for the 5 claimed ESTs were not specific to those ESTs, but would apply to any EST, so they were not specific as required by § 101.
• It was not sufficient to show that the ESTs were useful as intermediates in studying maize. "Just as the claimed compounds in Kirk and Joly were useful only as intermediates in the synthesis of other compounds of unknown use, the claimed ESTs can only be used as research intermediates in the identification of underlying protein-encoding genes of unknown function. The rationale of Kirk and Joly thus applies here. In the words of the Kirk court: 'We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.' 376 F.2d at 942 (emphasis added). "
• The patent statute does not confer a monopoly until research is completed on a useful product. "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. "
• The Federal Circuit distinguished cases finding utility when in vivo testing had shown biological activity in treating specific medical conditions.
• The Federal Circuit rejected arguments by amici that granting patents on ESTs would make it difficult to research genes. This was a policy argument that should be directed to Congress.
• The Board properly found that the invention was not enabled because "the enablement requirement of § 112 incorporates the utility requirement of § 101. "
• Judge Rader dissented, arguing that the ESTs have utility as research tools.