Bd. of Trustees of Leland Stanford Junior Univ. v. Chinese Univ. of Hong Kong

摘要

In an interference between Stanford University and the Chinese University of Hong Kong (CUHK) concerning methods for diagnosing fetal aneuploidies (e.g., Down's syndrome) using cell-free fetal DNA (cff-DNA) from maternal blood samples, the Patent Trial and Appeal Board (PTAB) found Stanford's claims to be unpatentable for lack of adequate written description. The claims in Stanford's originally filed application recited "targeted sequencing,'' but these claims were canceled during prosecution and replaced with claims reciting "random sequencing.'' Stanford asserts that a passage in the specification referencing Illumina products capable of massively parallel sequencing (MPS) provided adequate written support for the "random sequencing'' element of the newly added claims. In rejecting Stanford's assertion, the PTAB credited the testimony of a CUHK expert who opined that those of skill in the art could have considered the reference to Illumina products in Stanford's specification to indicate targeted sequencing. The PTAB specifically noted that the expert's testimony was supported by "published references.'' The Federal Circuit vacated the PTAB's decision, pointing out that these "published references'' were either published after Stanford's priority date, or do not focus on the Illumina platform, but rather on the Roche 454 platform, and that the Roche 454 platform is a first-generation MPS platform that came out a year earlier than Illumina's second-generation MPS platform. The court also faulted the PTAB for focusing its analysis on "whether the description does not preclude targeted MPS sequencing,'' instead of focusing on the relevant inquiry, i.e., whether the specification's reference to the Illumina platform discloses random MPS sequencing.