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§ 101

Patenting a Nice Cool Glass of Nicotinamide Riboside? Claims Covering Milk Invalid under § 101

by Alexander Piala, PhD | Feb 23, 2023 | Patents

The US Court of Appeals for the Federal Circuit found that claims covering a naturally occurring composition were not patent eligible under 35 U.S.C. § 101 merely because one component of the composition had been “isolated.” ChromaDex, Inc. v. Elysium Health, Inc., Case No. 2022-1116 (Fed. Cir. Feb. 13, 2023) (Chen, Prost, Stoll, JJ.)

ChromaDex sued Elysium (a former ChromaDex customer) for infringement of its patent directed to dietary supplements containing nicotinamide riboside (NR). Elysium moved for summary judgment, arguing that the asserted claims were invalid under the § 101 prohibition against patenting natural phenomena. After the district court granted summary judgment, ChromaDex appealed.

The asserted claims were directed to a composition comprising:

Isolated NR
One or more of tryptophan, nicotinic acid or nicotinamide
One of 22 carriers
Increased NAD+ biosynthesis after eating.

Both parties conceded that milk satisfies every element of the asserted claims with the exception that its NR is not “isolated.” Both parties also conceded that milk is a naturally occurring material and thus not patent eligible under § 101.

On these facts, the issue presented was whether the claim limitation that the NR must be “isolated” (which does not occur in nature) was sufficient to make the claims patent eligible. The Federal Circuit responded “no.”

The Federal Circuit analyzed the asserted claims under two tests: the “markedly different characteristics” test set out in Chakrabarty, and the Alice two-step test (unsure whether Chakrabarty remains controlling precedent).

Under the Chakrabarty test, a claimed composition is not a natural phenomenon if it has “markedly different characteristics” from what occurs in nature. The Federal Circuit found that ChromaDex’s claimed composition had no markedly different characteristics from natural milk. While ChromaDex argued that isolation potentially allowed for unnaturally high concentrations of NR, the claims did not require such concentrations. The claims included compositions structurally and functionally identical to milk and therefore failed the “markedly different characteristics” Chakrabarty test.

Proceeding to the two-part Alice test, under step 1 the Federal Circuit found that the claims were directed to a product of nature because there were no structural differences between the claimed composition and natural milk. Under step two, the Court found that there was no “inventive step” because the claims were merely directed to increasing NAD+ biosynthesis, which was a natural principle that resulted from drinking milk.

Practice Note: During claim drafting, care should be taken to avoid claims that encompass all structural and functional components of a naturally occurring material.

PTO Can and Should Use Alice/Mayo Framework to Assess Eligibility

by Mike Baldwin | Sep 1, 2022 | Patents

Addressing a challenge of the Alice/Mayo framework in the context of the Administrative Procedure Act (APA) and the Fifth Amendment’s due process clause, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision finding that patent claims directed to analyzing social security benefit applications were patent ineligible under 35 U.S.C. § 101. In re Killian, Case No. 21-2113 (Fed. Cir. Aug. 23, 2022) (Taranto, Clevenger, Chen, JJ.)

Jeffrey Killian filed a patent application related to a system and method for determining eligibility for social security disability insurance (SSDI) benefits through a computer network. The examiner rejected the claims under § 101, finding that they were directed to the abstract idea of “determining eligibility for social security disability insurance . . . benefits” and lacked additional elements amounting to significantly more than the abstract idea because the additional elements were simply generic recitations of generic computer functionalities. Killian appealed to the Board, which affirmed the examiner’s rejection. The Board explained that the claims were directed to the patent ineligible abstract idea of “a search algorithm for identifying people who may be eligible for SSDI benefits they are not receiving,” and that the “determining” and “selecting” limitations of the claims could be performed by the human mind and thus were an “abstract mental process.” Killian appealed.

Killian raised several arguments that generally fell into three categories:

The Alice/Mayo standard is indefinite under the APA.
The § 101 analysis for software violated Killian’s Fifth Amendment due process rights.
Step 2 of the Alice/Mayo analysis has no basis in patent law.

Addressing the first argument, the Federal Circuit noted that the APA cannot apply to the decisions of courts because courts are not agencies. Next, the Court dismissed Killian’s argument that all § 101 decisions are void because the Alice/Mayo standard is indefinite. The Court explained that it has routinely found that mental processes are abstract ideas, including claims that were directed to data gathering, analysis and notification on generic computers. The Court found that nothing in Killian’s claims provided an inventive manner to accomplish the claimed method, and thus the § 101 rejection was entirely proper. As a final point, the Court stated that it was bound to Supreme Court precedent and only new overruling precedent would change the analysis it applied.

The Federal Circuit also rejected Killian’s due process argument. Killian argued that his due process rights were violated because he did not have an opportunity to appear in the other cases regarding patent eligibility. As an initial matter, the Court noted that no “void-for-vagueness” doctrine argument was put forward, and the doctrine requires a case-by-case analysis. The Court found that this was not a close case, as data gathering and analysis methods run afoul of established § 101 precedent. Next, the Court addressed the common law approach of not requiring “a single governing definitional context” and a comparison to previously decided cases finding it appropriate. Killian’s due process rights were found to [...]

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Recapture Rule Applies to Subject Matter Surrendered to Overcome § 101 Rejection

by Paul Devinsky | Aug 18, 2022 | Patents

Affirming a Patent Trial & Appeal Board (Board) decision, the US Court of Appeals for the Federal Circuit held, for the first time, that the rule prohibiting recapture of subject matter surrendered during prosecution applies to subject matter surrendered to overcome a § 101 patent eligibility rejection. In re McDonald, Case No. 21-1697 (Fed. Cir. Aug. 10, 2022) (Newman, Stoll, Cunningham, JJ.)

During prosecution of a parent patent application relating to displaying search results, the inventor, John McDonald, added a “processor” limitation to certain claims to overcome a § 101 rejection. McDonald subsequently filed a continuation application, which was eventually issued. McDonald then filed a reissue application seeking to broaden the claims of the continuation patent by striking all of the originally added “processor” claim language. With the reissue application, he included a declaration that the processor language was unnecessary to the patentability and operability of the relevant claims. The examiner rejected the claims as obvious, and McDonald appealed. On appeal, the Board affirmed the obviousness rejection and also rejected the reissue claims as being based on a defective declaration lacking a correctable error. The Board found that McDonald was impermissibly attempting to recapture surrendered subject matter. McDonald appealed.

Exercising de novo review, the Federal Circuit first recounted more than a century of caselaw relating to patent reissue and recapture. The Court explained that a patent may be reissued if the inventor erroneously claimed less than they had a right to claim in the original patent, but that the recapture rule bars a patentee from regaining that which was surrendered during prosecution. The Court then turned to its three-step recapture analysis in which it considers the following:

Whether, and in what aspect, the reissue claims are broader than the patent claims
If broader, whether those broader aspects of the reissue claim relate to the surrendered subject matter
If they do, whether the surrendered subject matter has crept into the reissue claim.

Applying this test, the Court concluded that McDonald sought to broaden his claims and that the surrendered subject matter crept into those broadened claims. The Court also held that McDonald did not meet the reissue statute’s “error” requirement, finding that his actions were deliberate as opposed to inadvertent or by mistake.

The Federal Circuit then addressed McDonald’s arguments that the recapture rule does not apply to subject matter surrendered to overcome a § 101 rejection. The Court conceded that its previous decisions centered on prior art rejections under § 102 and § 103 but found that the public’s reliance interest on a patent’s public record must also apply to subject matter surrendered under § 101. The Court also reiterated that it “reviews a patent family’s entire prosecution history when applying both the rule against recapture and prosecution history estoppel.” The Court thus affirmed the Board’s decision barring McDonald from reclaiming subject matter previously surrendered during prosecution.

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

by Mandy H. Kim | Aug 13, 2020 | Patents

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

by McDermott Will & Emery | Aug 13, 2020 | Patents

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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