## Facts

- Inventors sought a patent on a single claim covering five purified maize expressed sequence tags (ESTs) in a U.S. patent application.
- The ESTs were short nucleic acid sequences corresponding to expressed portions of maize genes; the application did not identify the precise structure or function of the underlying genes or encoded proteins.
- The specification asserted multiple uses, including use as molecular markers for genome mapping, measuring mRNA expression (e.g., microarrays), PCR primers, polymorphism identification, chromosome walking to locate promoters, controlling protein expression, and locating homologous sequences in other organisms.
- The PTO examiner rejected the claim for lack of utility under 35 U.S.C. § 101 and lack of enablement under 35 U.S.C. § 112(a) (then § 112, ¶ 1).
- The Board of Patent Appeals and Interferences affirmed, finding the asserted utilities not “specific and substantial” and concluding the disclosure did not enable a qualifying use.
- The applicants appealed to the U.S. Court of Appeals for the Federal Circuit.

## Issues

1. Whether claimed maize ESTs supported only by broadly stated research uses satisfy the “specific and substantial utility” requirement of 35 U.S.C. § 101.
2. Whether, when the asserted utilities do not satisfy § 101, the specification fails to enable use of the claimed ESTs under 35 U.S.C. § 112(a).

## Decision

- The Federal Circuit affirmed the Board’s rejection.
- The court held the claimed ESTs lacked “specific and substantial” utility under § 101 because the asserted uses were generic research applications not tied to any particular, presently known benefit of the claimed sequences.
- The court further held the claim was not enabled under § 112(a) because the disclosure did not teach how to use the ESTs in a manner that meets the required utility standard.
- A dissent would have treated the ESTs’ research-tool role as sufficient utility.

## Legal Principles

- To satisfy § 101, an invention must have a utility that is both:
  - **Specific**: a well-defined, particular benefit, not a use stated at a level that would apply to most inventions of the same general class; and
  - **Substantial**: a significant, presently available, practical benefit, not a speculative benefit dependent on further, undirected research.
- A claim directed to biological research intermediates may fail § 101 when the disclosure shows only general research assistance (e.g., serving as probes or markers) without identifying a concrete, currently known application for the particular claimed molecules.
- Enablement under § 112(a) requires teaching a person of ordinary skill how to use the claimed invention; if the application does not establish a qualifying specific and substantial utility, it may also fail enablement because it does not teach how to practice a patentably useful invention.

## Conclusion

The Federal Circuit upheld rejection of the EST claim because the application identified only generic research uses applicable to ESTs generally, not a specific and presently practical utility for the particular claimed sequences, and the disclosure therefore also failed to enable a qualifying use under § 112(a).


In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005)