WRITTEN DESCRIPTION MUST SHOW THAT INVENTOR WAS IN POSSESSION OF INVENTION

Carnegie Mellon University v. Hoffman-La Roche Inc., [2007-1266] (September 8, 2008) [LOURIE, Bryson, Prost] The Federal Circuit affirmed judgment that the claims were invalid for failure to meet the written description requirement, and affirmed the court’s judgment of noninfringement.
DISCUSSION: Paragraph 1 of § 112 requires a written description of the invention—a requirement separate and distinct from the enablement requirement. To satisfy the written description requirement, “the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” The Federal Circuit observed that the claims of the ’708 and ’745 patents encompass a genus of recombinant plasmids that contain coding sequences for DNA polymerase or nick-translation activity from any bacterial source, in contrast, the narrow specifications of the ’708 and ’745 patents only disclose the polA gene coding sequence from one bacterial source, viz., E. coli. Significantly, the specification fails to disclose or describe the polA gene coding sequence for any other bacterial species.
The Federal Circuit said that what is needed to support generic claims to biological subject matter depends on a variety of factors, such as the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, the predictability of the aspect at issue, and other considerations appropriate to the subject matter.
As to non-infringement, patentee’s claims to E. coli were adequately supported. The Federal Circuit agreed with the district court that these claims were not infringed under the doctrine of equivalents by the substitution of Taq for E. coli. The Federal Circuit found that the “all limitations rule” restricts the doctrine of equivalents by preventing its application when doing so would vitiate a claim limitation. The Federal Circuit concluded that a finding that Taq is an equivalent of E. coli would essentially render the “bacterial source [is] E. coli” claim limitation meaningless, and would thus vitiate that limitation of the claims.