IP Law Daily, PATENT—N.D. Cal.: Infringement suit related to DNA sequencing may move forward, (Mar 26, 2024)

By Thomas K. Lauletta, J.D.

Although the plaintiff’s patent related to an abstract idea, factual issues remained to determine whether the patent described an inventive concept for purposes of Alice step two.

The U.S. District Court in San Diego, California denied defendant Pacific Bioscience of California’s motion to dismiss plaintiff Take2 Technologies’ patent infringement complaint. The court held that the plaintiff’s patent described an abstract idea related to DNA sequencing. However, concluding that there were unresolved factual issues related to whether the plaintiff had established an inventive concept under Alice step two, the court denied the defendant’s motion to dismiss. (Take2 Technologies Ltd. v. Pacific Biosciences Of California Inc., March 25, 2024, Davila, E.).

Plaintiff Take2 Technologies (Take2) owns U.S. Patent No. 11,091,794 (“the ‘794 patent”) related to DNA sequencing. Take2 alleges that the invention disclosed in the patent improves DNA sequencing technology with respect to detecting information about modifications to the four nucleotides—adenine (A), cytosine (C), guanine (G), and thymine (T)—that form the structural basis for DNA sequences. As the ‘794 patent explains, nucleotide modifications such as methylation—the addition of a methyl group to a nucleotide base—play an important role in gene expression in mammals, and many human diseases have been associated with DNA methylation aberrations. Accordingly, the accurate measurement of base modifications could have numerous clinical implications.

The patent describes the prior procedures used to measure base modifications, including chemically treating DNA samples with bisulfite prior to sequencing—and sometimes further subjecting the DNA to a polymerase chain reaction (PCR) amplification procedure—and explains that these approaches significantly degrade the majority of the treated DNA. According to the patent, the disclosed invention allows for direct detection of modifications without enzymatic or chemical conversion of the sample DNA and without PCR amplification.

Take2 brought a suit against the defendant for patent infringement under 35 U.S.C. § 271. The defendant moved to dismiss the complaint pursuant to Federal Rule 12(b)(6), arguing that the patent was ineligible for patenting under 35 U.S.C. § 101.

Patent eligibility. The defendant moved for dismissal of the complaint on the grounds that the ‘794 patent claims are ineligible subject matter as an abstract idea. The court analyzed the question under the two-step approach of Alice Corp. Pty. Ltd. v. CLS Bank Int’l.

Alice step one. Under step one of the Alice framework, a court must decide if the patent claims at issue relate to an abstract idea. In moving for dismissal, the defendant argued that the claims of the ‘794 patent are directed to the abstract idea of using a statistical model to predict what modified bases are present in a nucleic acid strand such as DNA.”

Based largely on analogous cases, the court stated that it could not say that the ‘794 patent is directed to a technological improvement in the means or method of detecting base modifications, as argued by Take2. Rather, the court concluded that the claim is directed to an algorithmic improvement within the field of research on using optical pulse data to detect base modifications. Accordingly, the court found that the patent is directed to an abstract idea.

Alice step two. Under step two of the Alice framework, once a patent is found to relate to an abstract idea, the question then becomes whether the patent has an “inventive concept,” that is, an element or combination of elements that significantly go beyond the abstract idea.

The defendant argued that any suggestion that the claimed invention was “not well-understood, routine, or conventional” failed as a matter of law because the purported advance was merely the selection and use of new parameters in a data structure and model, and the new parameters were properties that were well-known, if not previously used in combination. Take2 argued that even if the patent claims were well-understood, routine or conventional, this was a question of fact not to be decided on a motion to dismiss.

Finding that factual issues remained to be decided, the court stated that it could not as a matter of law hold that the ‘794 patent does not disclose an inventive concept for purposes of Alice step two.

Court action. The court denied the motion to dismiss, holding that the defendant had not as a matter of law shown that the ‘794 patent lacked an inventive concept sufficient under Alice step two.

The Case is No. 5:23-cv-04166-EJD.

Attorneys: Melanie K. Sharp (Young, Conaway, Stargatt & Taylor LLP) for Take2 Technologies Ltd. Edward Robert Reines (Weil Gotshal & Manges LLP) for Pacific Biosciences of California Inc.

Companies: Take2 Technologies Ltd.; Pacific Biosciences of California Inc.

Cases: Patent CaliforniaNews GCNNews