IN BIOLOGICAL INVENTIONS WRITTEN DESCRIPTION REQUIRES MORE THAT CHARACTERIZATION OF A SINGLE SPECIES

In Re Alonso, [2008-1079] (October 30, 2008) [STEARNS, Michel, Mayer] The Federal Circuit affirmed the BPAI decision reversing the Examiner’s rejection of claim 92 for lack of enablement and sustaining the rejection for lack of adequate written description.
DISCUSSION: Whether an applicant has complied with the written description requirement is a finding of fact, to be analyzed from the perspective of one of ordinary skill in the art as of the date of the filing of the application. The written description requirement of 35 U.S.C. §112, ¶1, is straightforward: “The specification shall contain a written description of the invention . . . .” To satisfy this requirement, the specification must describe the invention in sufficient detail so “that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. The requirement is rigorous, but not exhaustive: "[I]t is unnecessary to spell out every detail of the invention in the specification; only enough must be included to convince a person of skill in the art that the inventor possessed the invention."
After noting the articles by the inventor acknowledged the differences in the antibodies used to practice the invention, the Federal Circuit agreed with the BPA that the single antibody described in the Specification is insufficiently representative to provide adequate written descriptive support for the genus of antibodies required to practice the claimed invention. The Federal Circuit has previously said that “a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.” The Federal Circuit said that the specification teaches nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method.