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This is part of a series of articles discussing recent orders of interest issued in patent cases by the United States District Court for the District of Massachusetts.
In Nextcea Inc. v. Lipotype, Inc., et al., No. 1:24-cv-12624-JEK, Judge Kobick granted Defendants' motion to dismiss, holding that the asserted patent claims were directed to unpatentable subject matter under 35 U.S.C. § 101.
Plaintiff asserted a single patent directed to methods of detecting phospholipidosis and other lysosomal storage disorders by measuring levels of a biomarker known as didocosahexaenoyl (22:6)-bis(monoacylglycerol)phosphate ("di-22:6-BMP") in biological samples. Plaintiff alleged that Defendants indirectly infringed by offering mass spectrometry-based lipid analysis services that measured bis(monoacylglycerol)phosphate (BMP) isoforms and promoting their use in diagnosing lysosomal storage disorders. Defendants moved to dismiss, arguing that the patent was invalid under § 101 as directed to a law of nature.
At Alice/Mayo Step One—whether the claims are directed to a patent-ineligible concept—the Court found that the claims were directed to a natural phenomenon, namely the correlation between elevated levels of di-22:6-BMP and certain disorders. The Court emphasized that the claims merely recited steps for obtaining a sample, measuring biomarker levels using conventional techniques, and comparing those levels to a control, without prescribing any specific treatment or novel methodology.
At Alice/Mayo Step Two—whether the claims contain an inventive concept sufficient to transform them into a patent-eligible application— the Court found that the asserted "patent amounts to no more than instructing users to adapt conventional methods to the di-22:6-BMP isoforms." The Court observed that the patent did not disclose any new laboratory techniques or recite particular treatments or dosages, and instead relied on well-known methods. The Court rejected Plaintiff's argument that the measurement of isoforms of di-22:6-BMP was not conventional and constituted an inventive concept, finding that, even if they required human action, the claims amounted to no more than the application of standard techniques to observe a natural correlation.
Accordingly, the Court granted Defendants' motion to dismiss, concluding that the asserted patent was invalid and that Plaintiff's infringement claims thus failed as a matter of law.
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