To satisfy the written description requirement, the claimed method as a whole must be described by the patent specification.
The Federal Circuit recently affirmed a Patent Trial and Appeal Board (Board) decision finding that Dr. Stephen Quake and Dr. Christina Fan’s (collectively, “Quake”) asserted claims were unpatentable for lack of written description under 35 U.S.C. § 112. See Quake v. Lo, Nos. 2018-1779, 2018-1780, 2018-1782, 2019 U.S. App. LEXIS 20407 (Fed. Cir. July 10, 2019) (Before Reyna, Chen, and Hughes, Circuit Judges) (Opinion for the Court, Chen, Circuit Judge).
The claims were directed to a method for determining the presence of a chromosomal abnormality, called aneuploidy, in fetuses. Aneuploidy occurs when a fetus is born with either an abnormally high or low number of chromosomes. The claimed detection was accomplished using a method called massively parallel sequencing (MPS). Specifically, the claims recited a “random” MPS method, which amplified and sequenced all DNA in a sample rather than specific, targeted sequences of DNA. Quake, based out of Stanford University, and Dr. Dennis Lo (“Lo”) based out of Chinese University of Hong Kong began developing the claimed methods around the same time and requested interferences with respect to a number of applications to determine who invented the method first.
Prior to this decision, the Board previously found the disclosures in Quake’s specification were insufficient in light of Section 112 and found the claims unpatentable for lack of written description. Quake appealed, and in 2017 the Federal Circuit vacated and remanded the decision with instructions to consider whether the patent’s written description disclosed random MPS. On remand, the Board again found that Quake’s specification was insufficient, this time with respect to random MPS.
First, Quake’s specification only described detection of target DNA sequences. Quake’s asserted U.S. Patent No. 8,008,018 (“the ’018 patent”) outlined four method steps, two of which were detecting target DNA in a “large number of reaction samples” and then performing analysis on the “target sequences.” The Court noted that the ‘018 specification used the term “target” more than sixty times and the disclosure seemed to be consistently focused on target sequences, not random. With respect to MPS, the specification only contained two paragraphs out of 30-plus columns relating to massively parallel sequencing. Quake’s U.S. Patent Application No. 12/393,833, which shared a specification with the ‘018 patent and was also at issue, shared similar deficiencies.
The main issue on appeal was whether the shared specification for Quake’s asserted patent and application sufficiently described using random MPS to detect fetal aneuploidy. The Federal Circuit agreed with the Board that the specification did not meet the requirements of Section 112. In reaching its decision, the Board found that the two paragraphs of disclosure relating to MPS only described MPS generally, without referencing targeted versus random MPS, and the disclosures were insufficient to demonstrate that the inventors possessed a method of determining fetal aneuploidy via MPS.
The Method as a Whole Was Not Expressly Described
Compliance with the written description requirement of Section 112 is a question of fact, judged from the perspective of a skilled artisan as of the patent’s filing date. With respect to express disclosure, the Court first noted that “the term ‘random MPS’ is never mentioned in the ‘018 patent, [and] the process of amplifying all the DNA in a sample before sequencing is never described.” Since the method as a whole was not expressly described, the Court then turned to whether the disclosure could have nonetheless reasonably conveyed to a skilled artisan that Quake had possession of the claimed subject matter.
The first paragraph of the specification pertaining to MPS cited a patent application to Balasubramanian (U.S. Patent App. No. 2003/0022207). The Board found, and the Court agreed, that the teachings of this application could be used in either random or targeted MPS, and that Quake’s citation to the application was consistent with the specification’s discussion of detecting target sequences. With respect to the second paragraph of MPS disclosure, the specification was ultimately directed to chromosomal identification utilizing targeted MPS, even if the passage could possibly cover random MPS as well. While these disclosures perhaps supported disclosure of random sequencing, the Court found that “substantial evidence supports the Board’s finding that those two items together are not adequate to convey using random MPS to determine fetal aneuploidy as claimed.” Therefore, the Federal Circuit agreed that the specification for the ‘018 patent did not adequately disclose using random MPS to detect fetal aneuploidy and affirmed the Board.