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Illumina, Inc. v. Ariosa Diagnostics, Inc.

United States Court of Appeals for the Federal Circuit

March 17, 2020, Decided



 [*1368]  Lourie, Circuit Judge.

Illumina, Inc. and Sequenom, Inc. (collectively, "Illumina") appeal from a decision of the United States District Court for the Northern District of California that claims 1-2, 4-5, and 9-10 of U.S. Patent 9,580,751 (the "'751 patent") and claims 1-2 and 10-14 of U.S. Patent 9,738,931 (the "'931 patent") are invalid [**2]  under 35 U.S.C. § 101 as directed to an ineligible natural phenomenon. Illumina, Inc. v. Ariosa Diagnostics, Inc., 356 F. Supp. 3d 925 (N.D. Cal. 2018) ("Decision"). Because we conclude that the claims are directed to patent-eligible subject matter, we reverse.


"In 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste." Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373 (Fed. Cir. 2015). They applied for a patent, and, in 2001, they obtained U.S. Patent 6,258,540, which claimed a method for detecting the small fraction of paternally inherited cell-free fetal DNA in the plasma and serum of a pregnant woman. Id. In 2015, we held that the claims of that patent were invalid under 35 U.S.C. § 101 because they were directed to "matter that is naturally  [*1369]  occurring"—i.e., the natural phenomenon that cell-free fetal DNA exists in maternal blood. Id. at 1376.

The present case involves two patents that are unrelated to the patent held invalid in Ariosa, but rather claim priority from a European patent application filed in 2003. The '751 and '931 patents at issue in this case, which are related to each other and have largely identical specifications, begin by acknowledging the natural phenomenon that was at issue in Ariosa: "[I]t has been shown that in the case [**3]  of a pregnant woman extracellular fetal DNA is present in the maternal circulation and can be detected in maternal plasma . . . ." '751 patent col. 1 ll. 23-25. The patents then identify a problem that was the subject of further research on cell-free fetal DNA in maternal blood:

[T]he major proportion (generally >90%) of the extracellular DNA in the maternal circulation is derived from the mother. This vast bulk of maternal circulatory extracellular DNA renders it difficult, if not impossible, to determine fetal genetic alternations [sic] . . . from the small amount of circulatory extracellular fetal DNA.

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952 F.3d 1367 *; 2020 U.S. App. LEXIS 8327 **; 2020 U.S.P.Q.2D (BNA) 10182


Prior History:  [**1] Appeal from the United States District Court for the Northern District of California in No. 3:18-cv-02847-SI, Senior Judge Susan Y. Illston.

Illumina, Inc. v. Ariosa Diagnostics, Inc., 356 F. Supp. 3d 925, 2018 U.S. Dist. LEXIS 215905 (N.D. Cal., Dec. 24, 2018)



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Civil Procedure, Summary Judgment, Entitlement as Matter of Law, Appropriateness, Patent Law, Infringement Actions, Appeals, Appeals, Summary Judgment Review, Standards of Review, Subject Matter