On February 14, 2018, the Commission affirmed ALJ Pender’s initial determination of non-infringement but based on modified grounds related to the construction of the claim term “single-molecule sequencing.” In re Certain Single-Molecule Nucleic Acid Sequencing Systems and Reagents, Consumables, and Software for use with Same, Inv. 337-TA-1032.

In this investigation, Pacific Biosciences of California (“PacBio”) filed a complaint alleging that Oxford Nanopore Technologies Ltd.; Oxford Nanopore Technologies, Inc. and Metrichor, Ltd. (collectively “Oxford Nanopore”) infringed several of its patent claims that require the performance of “single-molecule sequencing.” In principle, there are several “single-molecule sequencing” methods available, including sequencing by template-dependent synthesis and nanopore sequencing. Oxford Nanopore, eponymously, uses nanopore sequencing.

On May 23, 2017, Administrative Law Judge Pender issued an order construing the claim term “single-molecule sequencing” to be limited to template-dependent synthesis. In support, he pointed to the specification’s statement that “The present invention is generally directed to improve[ments] . . . for carrying out nucleic acid sequence analysis, and particularly sequence analysis that employs template dependent synthesis in identifying the nucleotide sequence of target nucleic acids.” Judge Pender further noted that the patents do not teach any non-template dependent synthesis. Finally, Judge Pender concluded that “[n]owhere” in the intrinsic record “is it suggested that sequencing can be accomplished by any technique other than template dependent synthesis.” Based on Judge Pender’s construction, PacBio stipulated that Oxford Nanopore’s products did not infringe its claims, and Judge Pender issued an initial determination of non-infringement on July 19, 2017. PacBio then petitioned for commission review.

On February 14, 2018, the Commission affirmed Judge Pender’s decision on modified grounds. The Commission noted that the prosecution history is explicit that “Single-molecule sequencing includes, for example, . . . nanopore sequencing,” and Judge Pender’s dismissal of the prosecution history as irrelevant was, therefore, incorrect. Nevertheless, it concluded that the specification’s statement that the “present invention” relates to “template dependent synthesis” was unambiguous, and thus the claims were limited to this method of sequencing. “[T]he prosecution history [could] not trump or expand the content of the specification to include nanopore sequencing.”

Takeaway

The Commission reviews an ALJ’s initial determination de novo and they will take a close look at the issues, even if they are highly technical. Parties should be aware that the Commission is willing to get its elbows dirty where it feels appropriate.