United States - Written Description and Utility Requirements

Rapidly developing new fields of technology present problems for the patent system in deciding what must be known and disclosed about an invention before it can be patented. Problems also arise in seeking to strike a fair balance between giving the inventor a fair reward for his or her contribution and not permitting such an inventor to secure claims that extend beyond what was really invented. Traditional limits imposed by the prior art on overly broad claiming do not apply when there is little or no prior art. Hence, the courts tend to rely on the statutory requirements for utility and a written description (including the requirement that such description must enable one skilled in the art to practice the invention) to address these issues. During 2005, the Court of Appeals for the Federal Circuit has on a number of occasions (such as Rasmuson v. SmithKline Beecham Corp and In re Fisher) addressed the relationship between the utility requirement and the enablement requirement, referring back to its 1993 statement in In re Ziegler:

The "how to" prong of section 112 incorporates as a matter of law the requirement of 35 USC 101 that the specification disclose as a matter of fact a practical utility for the invention. If the application fails as a matter of fact to satisfy 35 USC 101, then the specification also fails as a matter of law to enable one of ordinary skill to use the invention under 35 USC 112.

In In re Fisher, it was held that a claim to DNA encoding a maize protein did not meet the utility requirement, despite a statement that the DNA could be used to detect polymorphism in maize plants because there was no indication as to how this was achieved. The Federal Circuit used the case as an opportunity to address the question of patentability of expressed sequence tags (ESTs), five of which were claimed in the application. The functions of the genes from which they were transcribed were unknown. Although seven different uses of ESTs were mentioned in the application, none was specific to any of the ESTs being claimed and a majority of the court held that this resulted in a failure to disclose any substantial or specific utility for the ESTs claimed. The court held that, in the absence of any identification of the function of the underlying protein-encoding genes, "the claimed ESTs have not been researched and understood to the point of providing an immediate well-defined real world benefit to the public meriting the grant of a patent". Judge Rader dissented and would rather have approached the issue from the perspective of obviousness.

In Capon v. Eshhar, the court approached a similar issue from the written description point of view. In an interference relating to chimeric genes where the Board of Patent Appeals and Interferences had concluded that neither party had provided an adequate written description, the Federal Circuit held that the Board had been wrong in its conclusion and remanded the case for further consideration. In doing so, the court reviewed all of its prior case law and concluded the written description requirement must be applied in the context of the particular invention and the state of the knowledge. The Board's rule that the nucleotide sequences of chimeric genes must be fully presented, although the nucleotide sequences of the component DNA are known, is an inappropriate generalization. When the prior art includes the nucleotide information, precedent does not set a per se rule that the information must be provided afresh. … The written description requirement … does not state that every invention must be described in the same way. As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution.

In both cases a key issue seems to have been that of what could be predicted from the disclosure. In the case of EST's, the art still had not developed to the point that one could predict a real world use for the fragments described. In the case of the chimeric genes, the Court felt that the PTO's prior view that DNA of the whole gene was needed to justify patentability was outdated when the DNA of the constituent parts was known and the invention lay in how to organize those known parts. Generalization as to how much information must be provided in the patent specification is therefore difficult, but it is clear that the lower the degree of predictability, the greater the disclosure needed to satisfy the description requirement.