Falko-Gunter Falkner, et al. v. Inglis, et al.
On appeal from a BPAI interference decision to the Court of Appeals for the Federal Circuit (CAFC), Faulkner argued, in essence, that the Inglis applications do not adequately describe and enable the disputed invention.
The technology at issue included a method of making vaccines safer by deleting or inactivating an essential gene from the genome of a virus. In particular, the subject matter was to related vaccines in which the vector virus was a poxvirus. The Faulkner applications described poxvirus vectors in detail, including five examples of preparation and use of poxvirus vaccines. In contrast, the Inglis applications described poxvirus vectors only in general, with specific examples related instead to herpes viruses, and did not describe which sequences in the viral genome were “essential” or “non-essential.”
The CAFC upheld the decision of the BPAI that a person of ordinary skill in the art would have known what poxvirus genes are “essential,” based on undisputed testimony that at the time of the earliest Inglis filing the essential regions of the poxvirus genome had been published in professional journals readily accessible. Thus, the Inglis specifications were enabling.
The CAFC also affirmed the decision with respect to the written description requirement. This requirement, as stated in § 112, first paragraph, provides that “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” With respect to this requirement, the court set forth the following standards:
1. The absence of examples does not render a written description inadequate.
2. Although reduction to practice ordinarily provides the best evidence that an invention is complete, an invention can be “complete” even where an actual reduction to practice is absent.
3. Where accessible literature sources are clearly provided, as of the relevant date, satisfaction of the written description requirement does not require either the recitation or incorporation by reference of the subject matter of the literature.
Accordingly, the Inglis applications satisfied the written description requirement even though they did not describe particular poxvirus gene sequences corresponding to the recited “essential” sequences. One of skill in the art, in view of the state of relevant knowledge at the time of the invention, would know which genes were essential in order to inactivate the genes and practice the Inglis invention.