In reviewing a decision from the Patent Trial and Appeal Board (PTAB) deciding three interferences involving competing claims directed to testing methods for fetal aneuploidies, the US Court of Appeals for the Federal Circuit reversed a priority award to the junior party, remanding the case back to the PTAB to reconsider its finding that the senior party’s claims were unpatentable for failure of written description. Stanford University v. Chinese University of Hong Kong, Case No. 15-2011 (Fed. Cir., June 27, 2017) (O’Malley, J).

Aneuploidies are a condition in which a fetus has either an abnormally high number of chromosomes (e.g., Down’s syndrome) or an abnormally low number (e.g., Turner’s syndrome). Prior art techniques for diagnosing fetal aneuploidies involved invasive amniocentesis or chorionic villus sampling. Less invasive methods, such as ultrasonography and biochemical marker detection, were also used, but those techniques offered suboptimal accuracy. The interference was directed to an invention that used “second generation massively parallel sequencing (MPS) and PCR amplification of chromosome DNA.”

In order to provoke the interference, senior party Stanford copied claims from the junior party’s patent that were diverted to random sequencing. In its specification, senior party disclosed MPS with digital PCR “using the Illumina sequencing platform.” In the interference proceedings between Stanford and junior party Chinese University of Hong Kong, the PTAB found that Stanford’s claims were unpatentable for lack of written description as it related specifically to random sequencing, rejecting senior party’s expert evidence that the Illumina platform could be useful for both random and targeted sequencing.

Stanford appealed directly to a district court under 35 USC § 146, but soon thereafter the Federal Circuit issued its decision in Biogen v. Japanese Found. For Cancer Res. (IP Update, Vol. 18, No. 6), holding that, for post-America Invents Act interferences, the Federal Circuit is the exclusive appellate tribunal from PTAB interference decisions. The appeal was then transferred to the Federal Circuit.

The Federal Circuit rejected Stanford’s argument that Biogen was incorrectly decided and refused to consider discovery, including expert reports, taken while the case was pending before the district court. “Given that the district court did not have subject matter jurisdiction to review the Board’s interference decisions, Stanford’s attempt to include evidence elicited during proceedings there is inappropriate—the activities in the district court are a nullity.”

Based only on the record before the US Patent and Trademark Office, and applying the substantial evidence standard of review, the Federal Circuit concluded that the PTAB erred in relying on certain testimony from the junior party’s expert as to how a person of skill in the art would have understood Stanford’s specifications and the implications of certain references disclosed in them. The Court agreed with Stanford that the junior party’s expert testimony failed to cite support for its conclusions and to consider evidence presented by Stanford on those issues. The Federal Circuit explained that the PTAB should not have relied on the junior party expert testimony in question without at least accounting for the evidence presented by Stanford, as that left the Court “with no reviewable record to conclude that the disclosed methods or platforms would have been applicable to … [the] priority date.”

The Court further faulted the PTAB for adopting the junior party’s expert’s conclusion that a reference in Stanford’s specification to the Illumina platform could only disclose either random or focused MPS when it could have disclosed both. “The Board frames its finding in terms of an erroneous premise: the Board’s task was to determine whether the […] patent’s written description discloses random MPS sequencing, as recited in the later-added claims, not whether the description does not preclude targeted MPS sequencing” (emphasis in original).

The Federal Circuit therefore vacated the PTAB’s decision, finding that the PTAB, in relying only on the junior party’s expert evidence, had failed to cite substantial evidence to support its findings. The Court instructed the PTAB to consider, on remand, whether a person of ordinary skill would have understood that the patent’s specification disclosed random MPS sequencing and would have known, as of the priority date, that the specification’s reference to certain products indicated the inventors were in possession of random MPS sequencing based on the products/platforms cited in the specification.