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Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. Mar. 17, 2020)

The Federal Circuit held that the claimed invention in this case was not directed to a patent-ineligible concept because it is a method of preparing a sample for testing.


The majority explained that: "[t]his is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case." "The claims in this case are directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA. The methods include specific process steps—size discriminating and selectively removing DNA fragments that are above a specified size threshold—to increase the relative amount of fetal DNA as compared to maternal DNA in the sample."


"[W]e focus our Alice/Mayo step one analysis on what the inventors did purport to invent and what they claimed in their patents: methods for preparing a fraction of cell-free DNA by the physical process of size discriminating and selectively removing DNA fragments longer than a specified threshold. Those methods are “directed to” more than merely the natural phenomenon that the inventors discovered. Accordingly, we conclude at step one of the Alice/Mayo test that the claims are not directed to a patent-ineligible concept, and we need not reach step two of the test."


The dissent disagreed stating that the claims are directed to a patent-ineligible natural phenomenon, i.e., "that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood."


Read the case here.







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