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“Method of Preparation” Claims Still Patent Eligible Under § 101 in Modified Opinion

The US Court of Appeals for the Federal Circuit denied an accused infringer’s petition for rehearing en banc and issued a modified opinion with additional analysis maintaining its prior finding that patent claims directed to a method of preparation were patent eligible. Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 19-1419 (Fed. Cir. Aug. 3, 2020) (Lourie, J.) (Reyna, J., dissenting).

In its original decision in Illumina v. Ariosa, the Federal Circuit found that claims directed to methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA were not directed to a patent-ineligible natural phenomenon. In its modified opinion, the Court again concluded that the claims were patent eligible under § 101 because they were not directed to a natural phenomenon, but to an exploitation of that natural phenomenon, by inventing a method for preparing a mixture enriched in fetal DNA that selectively removed maternal DNA. In the modified opinion, the majority further explained that the claimed size thresholds were not dictated by any natural phenomenon, but were “human-engineered parameters that optimize the amount of maternal DNA that is removed from the mixture and the amount of fetal DNA that remains in the mixture in order to create an improved end product that is more useful for genetic testing than the original natural extracted blood sample.” The Court emphasized that the claimed methods achieve more than an observation or detection of a natural phenomenon because the claims include “physical process steps that change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood.” The Court distinguished Myriad by stating that the claims were ineligible in that case because they covered a gene that the inventors isolated but did not invent, whereas in this case, the inventors claimed an innovative method using human-engineered size parameters to perform the separation—not the separated DNA itself. The Court concluded that the claimed methods were patent eligible under § 101 because they “utilize the natural phenomenon that the inventors discovered by employing physical process steps and human-engineered size parameters to selectively remove larger fragments of cell-free DNA and thus enrich a mixture in cell-free fetal DNA.”

Judge Reyna again dissented, arguing that the claims were patent ineligible under § 101 because they were directed to an undisputed natural phenomenon (i.e., the “surprising” discovery of size discrepancy of cff-DNA in a mother’s blood), and the application of the natural phenomenon used routine steps and conventional procedures that are well known in the art. He explained that “[l]ike in Alice, the claims here are directed to a natural phenomenon because they involve a fundamental natural phenomenon, that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood, to produce a ‘mixture’ of naturally-occurring substances.” Judge Reyna argued that the majority ignored the Court’s “claimed advance precedent” by reasoning that the claims belong in a distinct category of “method of preparation” claims, but such characterization should be treated [...]

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Hooked on Precedent or Something New

Highlighting internal disagreement regarding patent eligibility under § 101, a divided panel of the US Court of Appeals for the Federal Circuit issued a series of opinions revising and reissuing a previous opinion on § 101 patent eligibility for a mechanical invention and, in an even split, denied a petition for en banc review. American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, Case No. 18-1763 D.I. 134 (Fed. Cir. Oct. 3, 2019) (Dyk, J.) (Moore, J., dissenting); id. D.I. 133 (denying en banc by a 6–6 vote).

In October 2019, a divided Federal Circuit panel in American Axle v. Neapco affirmed a district court finding that method claims for a mechanical invention were invalid under 35 U.S.C. § 101. The majority specifically found that the claimed invention was nothing more than a recitation of Hooke’s law, which undoubtedly is a law of nature. Judge Moore dissented, arguing that the majority improperly expanded the § 101 eligibility inquiry beyond its statutory gatekeeping function and distorted patent eligibility under § 101 and enablement under § 112.

Neapco filed a petition for rehearing and a petition for rehearing en banc. Several amicus briefs were also filed. Notably, retired Judge Paul R. Michel, formerly the chief judge of the Federal Circuit, filed an amicus brief in support of the en banc petition because he believed the panel’s original decision “conflicts with the Supreme Court’s and [Federal Circuit’s] precedent.”

In view of the petition for rehearing, the original panel modified and reissued its opinion. The Court affirmed its original decision that two of the three independent claims were invalid under § 101 (patent claims 22 and 36); however, the Court reversed its original decision invalidating claim 1. Regarding claims 22 and 36, the majority reiterated that the claims were merely an application of Hooke’s law and that it was simply applying Supreme Court and Federal Circuit precedent, analogizing this case to the Supreme Court’s 1853 O’Reilly v. Morse decision where the Supreme Court determined the patentability of claims directed to a natural law of using electromagnetic force to transmit messages. When responding to the dissent, the majority reiterated that it was not departing from prior precedent, and that its “holding is limited to the situation where a patent claim on its face and as construed clearly invokes a natural law, and nothing else, to accomplish a desired result.”

Regarding claim 1, the majority reversed its original decision because the claim had an additional limitation that could cause the claim to not merely be an application of Hooke’s law. Because the district court did not address this limitation, the majority remanded the case so the district court could address this issue in the first instance.

Judge Moore maintained her dissent, arguing that the majority was announcing a new patentability test: the “Nothing More” test. She argued that the decision created a new test for instances when claims are directed to a natural law even though no natural law is specifically recited in the claims. Judge Moore further reiterated [...]

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