Take2 Technologies Limited v. Pacific Biosciences of California, Inc.

Background

Take2 Technologies Limited and The Chinese University of Hong Kong sued Pacific BioSciences of California, Inc. for allegedly infringing United States Patent No. 11,091,794 under 35 U.S.C. § 271. The patent is titled “Determination of Base Modifications of Nucleic Acids.” The plaintiffs alleged that the invention improved DNA sequencing by detecting nucleotide modifications, including methylation, without chemically or enzymatically converting the DNA sample and without polymerase chain reaction amplification.

Claim 1 describes a method that receives data from optical signals produced during DNA sequencing, including nucleotide identity, position, pulse width, and interpulse duration. The method creates a data structure for a window of nucleotides, inputs that structure into a trained model, and uses the model to determine whether a nucleotide at a target position has a modification. The plaintiffs alleged infringement of “at least claim 1” and later clarified that they intended to assert several dependent claims as well.

Pacific BioSciences moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), arguing that the patent was ineligible under 35 U.S.C. § 101. A Rule 12(b)(6) motion tests whether the complaint adequately states a legally viable claim. The action was originally filed in the District of Delaware and was later transferred to the Northern District of California. The court heard argument on the motion on February 22, 2024.

Patent-Eligibility Framework

The court applied the two-step framework from Alice Corp. v. CLS Bank International. At step one, the court asks whether the claim is directed to an abstract idea or another excluded category of subject matter. At step two, if the claim is directed to an abstract idea, the court asks whether the claim includes an “inventive concept”—an element or combination of elements that adds significantly more than the abstract idea itself.

At the motion-to-dismiss stage, the court must accept well-pleaded factual allegations as true. The court explained that whether claim elements are well-understood, routine, and conventional can present a factual question that cannot be resolved against the patentee on a motion to dismiss when the complaint adequately alleges an inventive concept.

Court’s Analysis

The court rejected the plaintiffs’ argument that the subject matter was too technically complex for the court to evaluate without expert assistance. The court stated that reviewing the legal sufficiency of patent-infringement claims is part of the judicial system regardless of the complexity of the technology.

At Alice step one, the court found that Claim 1 was directed to an abstract idea. The court characterized the claim as receiving particular sequencing inputs, creating a data structure, applying those inputs to a model trained to predict a nucleotide modification, and determining whether the modification was present. The court compared the claim to cases involving mathematical calculations, statistical modeling, and the selection and analysis of data.

The court distinguished cases involving a technological improvement achieved through a changed physical configuration or a device that used techniques not previously employed. According to the court, Claim 1 did not change the physical means or method of detecting base modifications; instead, it claimed an algorithmic improvement involving optical pulse data and other sequencing information.

At Alice step two, however, the court declined to hold that Claim 1 lacked an inventive concept as a matter of law. The claim included the use of a sequence window and the placement of a target nucleotide within that window. The court also considered the complaint’s allegations about the claimed invention’s unconventional nature, including allegations concerning a scientific publication and statements by Pacific BioSciences describing the invention as a new development. The court found that Pacific BioSciences had not sufficiently addressed the sequence-window aspect of the claim and that the parties’ arguments about whether the claimed combination was conventional raised factual questions.

Dependent Claims and Disposition

The court did not evaluate the dependent claims because Pacific BioSciences’s motion did not address the dependent claims asserted by the plaintiffs. The court therefore found that Claim 1 was directed to an abstract idea, found that Pacific BioSciences had not shown as a matter of law that Claim 1 lacked a sufficient inventive concept under Alice step two, and denied the motion to dismiss.

The parties were ordered to meet and confer within 10 days after entry of the order and submit a joint proposed scheduling order for the remainder of the action. They were also ordered to inform the court whether any portion of the complaint needed to remain under seal.