In an appeal from a decision of the Board of Patent Appeals and Interferences ("the Board") in an interference involving a patent application and an issued patent covering a mutant poxvirus vaccine, the Federal Circuit affirmed the Board’s priority award and held, inter alia, that for purposes of providing adequate written description it is not required of a specification to disclose (1) examples; (2) actual reduction to practice of the invention; and (3) the known structure of a biological macromolecule. Falko-Gunter Falkner et al. v. Stephen Inglis et al. , Case Nos. 05-1324 (May 26, 2006) (Gajarsa J.).
Falkner held a patent ("the Falkner patent") and Inglis filed a patent application ("the Inglis application"), both claiming vaccines made from a poxvirus vector having deleted or inactivated essential genes so as to reduce the risk of infection by the virus because it can not replicate in an inoculee. An interference proceeding resulted in the Board according the Inglis application the benefit of several earlier-filed applications, dating back to September 25, 1990, and the Falkner patent the benefit of earlier filed applications dating back to April 29, 1994, resulting in several of the claims in the Falkner patent being invalidated. On appeal, Falkner argued that the Board's decision invalidating its claims was incorrect because the specifications from Inglis's benefit applications failed to adequately describe and enable a poxvirus-based vaccine, and thus Inglis was not entitled to priority.
The Federal Circuit commenced its review by noting that, even though the early applications provided a detailed example of an embodiment that comprised not a poxvirus, but a herpes virus, including the identity of the deleted essential sequences therein, the differences between herpes viruses and poxviruses were sufficiently well known to have aided the person of ordinary skill in the art in the construction of poxvirus vaccines without undue experimentation. The Court also noted that, as of the time of filing of the earliest Inglis application, publications in readily accessible professional journals had disclosed the DNA sequence of the poxvirus genome along with the locations of the "essential regions, " rendering the absence of incorporation by reference unproblematic. Turning to written description, the Court pointed out that the absence of examples involving poxviruses in the Inglis applications does not render the written description inadequate. Furthermore, the Court agreed with the Board that the lack of actual production by Inglis of a poxvirus vaccine is not dispositive because an actual reduction to practice is not required for written description. Finally, the Court held that where accessible literature sources clearly provided, as of the relevant date, genes and their nucleotide sequences, in this case the "essential genes" of the poxvirus, satisfaction of the written description requirement does not require either the recitation or incorporation by reference of such genes and sequences. Accordingly, there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure.
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