One of the murkier areas of patent law is subject matter eligibility—when are patent claims directed to laws of nature, natural phenomenon or abstract ideas and when are they directed to patentable applications of those laws, phenomenon or ideas?

The Federal Circuit recently issued decisions in XY, LLC v. Trans Ova Genetics, LC (Fed. Cir. July 31, 2020), and Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. Aug. 3, 2020), holding that the patent claims were directed to patent-eligible subject matter.  These decisions reaffirmed that at least two categories of inventions are/remain patent eligible.  Notably, both decisions found that the inventions were not “directed to” laws of nature, natural phenomenon or abstract ideas, and thus did not go on to consider whether the other method steps were “well known” or “conventional.” Drafting claims to fit into the categories described below will make it easier to survive a challenge under 35 U.S.C. § 101.

Improvements to Known Industrial or Laboratory Processes Through Specific Application of Mathematical Algorithms are Patent-Eligible

An invention is not rendered patent-ineligible simply because it involves an abstract concept—“applications” of abstract concepts “to a new and useful end” are eligible for patent protection.  The claims are considered in their entirety to determine whether they are, as a whole, directed towards ineligible subject matter.

XY’s patent claims were directed to an improved method of flow cytometry resulting in enhanced discrimination between populations of particles, such as separating X- from Y-bearing sperm.  The improved method reconfigured data to enhance separation between data points by geometric transformation, such as by using a signal processor that converts signal data “into n-dimensional parameter data to which at least one alteration,” such as rotational alteration, may be applied.  For example, embodiments of the claimed invention “may involve rotating data to increase a separation of data from male-determining cells to female-determining cells.” The claimed process, however, included the physical steps of establishing a fluid stream in the flow cytometry apparatus with detectors and entraining particles from the sample in the fluid stream in the apparatus.

The Federal Circuit determined in XY, LLC that XY’s patent claims, as a whole, were not directed to a mathematical equation, but were directed towards an improved method of operating a flow cytometry apparatus to classify and sort particles.  The Federal Circuit analogized XY’s invention to the claims held patent-eligible in Diamond v. Diehr, 450 U.S. 175, 187 (1981), where the Supreme Court held that claims to a method of operating a rubber-molding press using a computer and the well-known Arrhenius equation were patent eligible.  Although the claims in XY, LLC used mathematical formulae to “to improve classification and separation of individual particles,” that abstract idea improved the prior art separation method “only when combined with the specific detectors and other flow cytometry limitations in the claims.”

Method of Preparation Claims Are Patent Eligible

“A claim to otherwise statutory subject matter does not become ineligible by its use of a law of nature or natural phenomenon.”

The inventors on the Illumina patents discovered the existence of “cell-free fetal DNA in maternal plasma and serum.” A method was needed to distinguish and separate the tiny amount of fetal DNA from the vast amount of maternal DNA in the mother’s bloodstream. The inventors discovered that the fetal DNA was almost always smaller than 500 base pairs and that the maternal DNA was almost always larger than 500 base pairs. Seventy percent of all DNA fragments smaller than 300 base pairs were fetal.  The claimed methods were directed to preparing a fraction of cell-free DNA that is enriched in fetal DNA by size discrimination and removing the larger DNA fragments (> 500 base pairs or > 300 base pairs).

The Federal Circuit held that the claims were not directed to the natural phenomenon that cell-free fetal DNA tends to be shorter than cell-free maternal DNA, but instead were directed to a patent-eligible method of using that natural phenomenon.  The claims were to methods for preparing a fetal DNA-enriched fraction of cell-free DNA, including specific process steps such as size discrimination and removal of DNA fragments above a certain size.  Not only were the size thresholds human-engineered and not dictated by natural phenomenon (the size of fetal and maternal DNA overlap in nature), but the process used concrete, physical steps to change the composition of the mixture from the naturally-occurring one in the mother’s blood to one enriched with fetal DNA.  The correlation between size and type of DNA was not even mentioned in the claims.  The Federal Circuit held that the “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 human-engineered threshold,” are “directed to” more than merely the natural phenomenon that the inventors discovered.

This alert does not purport to be a substitute for advice of counsel on specific matters.

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