Description of DNA Sequences Not Required in Specification Where Already Described in Prior Art

Case: Capon v. Eshhar, Case No. 03-1480, -1481 (Fed. Cir. 8/12/05)

The One Sentence Summary: The Federal Circuit vacated and remanded a Board of Patent Appeals ruling in a patent interference proceeding concerning a chimeric gene, wherein the Board cancelled all of the claims of the two competing parties for failing to adequately describe DNA sequences in the specification.


Federal Circuit Holdings:

• In an interference action before the Board of Patent Appeals to determine which of two competing applicants was the first inventor of common subject matter, the Board instead ruled that neither party met the written description requirement of the patent statute.
• The patents at issue describe chimeric genes designed to enhance the immune system. A chimeric gene is an artificial gene that combines segments of DNA in a way that does not occur in nature. The Board found that precedent required that a specification for chimeric genes must fully describe the specific DNA sequences that produce the gene.
• The Federal Circuit vacated and remanded the Board's ruling because it had failed to take into account the state of scientific knowledge regarding chimeric genes and the fact the necessary DNA sequences were disclosed in prior art. The precedent cited by the Board was no longer applicable because the science of chimeric genes had evolved and both the DNA sequences themselves, and the method for linking them, were known. As the Federal Circuit noted, the invention was not "discovering which DNA segments are related to the immune response, for that is in the prior art, but in the novel combination of the DNA segments to achieve a novel result."
• The court also held that the determination of whether a specification adequately describes an invention is done on a case by case basis, and it was error for the Board to rule that section 112 imposes a per se rule requiring recitation in the specification of the claimed DNA sequences where those sequences were already known in the field. Id at 13 ("The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence").
• Also at issue was the Board's ruling that the specifications did not adequately support the breadth of all the claims presented. In rejecting all the claims, the Board argued that the claims were too broad because they might have included "inoperative species" and proven unsuccessful. The court noted that in the "unpredictable" fields of science, it is appropriate to recognize the variability in the science when determining the scope of the claims. The court held it was for the Board to reject all of the claims without analyzing them on a claim by claim basis. It also held it was error to automatically reject the claims merely because they might prove unsuccessful.