Subject Matter Eligibility in the 21st Century: Echoes of pre-§ 103 Obviousness*

By Kevin E. Noonan --

The evolution of subject matter eligibility after the Supreme Court's decisions in Prometheus v. Mayo, Alice v. CLS Bank, and Association for Molecular Pathology v. Myriad Genetics has resulted in a regime of predictable unpredictability and certain uncertainty (a recent cogent treatment of the phenomenon in computer science technology patenting can be found in "The Narrow Pathway to Patent Eligibility in the Federal Circuit").  The situation is reminiscent of the state of obviousness in mid-Twentieth century prior to enactment of § 103 of the patent statute, when whether a patented invention was protected was a matter of judicial subjectivity.  As a consequence and as recognized by Justice Jackson, "the only patent which is valid is one which this court has not been able to get its hands on," Jungerson v. Ostby, 335 U.S. 560, 571 (1949).

A brief survey of seminal obviousness cases illustrated this similarity:

• Hotchkiss v. Greenwood (1850) standard:  an inventor's invention must have "more" than what an "ordinary or skillful mechanic" would provide.

• Cuno Engineering Corp. v. Automatic Devices Corp. (1941):  the inventive act had to come into the mind of an inventor in a "flash of genius" and not as a result of tinkering.  "The new device, however useful it may be, must reveal the flash of creative genius, not merely the skill of the calling."

• Graham v. John Deere (1966):  interprets the statute to conform to the Court's requirements that a patentable invention must be distinguished over the relevant prior art.

• Sakraida v. Ag Pro, Inc. (1976):  necessary to show some "synergy" between those known elements and denied patentability because the invention "simply arrange[d] old elements with each performing the same function it had been known to perform."

• Sakraida expressly disregarded by Federal Circuit in Stratoflex, Inc. v. Aeroquip Corp. (Fed. Cir. 1983):  "[a] requirement for 'synergism' or a 'synergistic effect' is nowhere found in the statute . . . virtually all patents are 'combination patents,' if by that label one intends to describe patents having claims to inventions formed of a combination of elements."

• "Teaching, Suggestion, or Motivation" (TSM) test developed by Federal Circuit, set aside by Supreme Court in KSR v. Teleflex but based on Graham and tied to the statute and prior art.

Even the semantics of subject matter eligibility (SME) determinations and their analysis conjures the subjectivity and uncertainties of obviousness; how more defined or reliable is the existence of an "inventive concept" and the "flash of genius," "synergy," or something "more" that the endeavors of an "ordinary mechanic"?  The history of how the Patent Office, Patent Trial and Appeal Board, numerous district courts, and the Federal Circuit have implemented the two-part Mayo/Alice test shows that subjectivity and unreliability.  It isn't far-fetched to consider that these consequences are not definitive for the same reasons obviousness without reliance on prior art was subject to subjective considerations (hindsight in obviousness); it is often more productive to recognize a "know it when you see it" approach ala Justice Potter Stewart (on entirely different circumstances and subject matter).  Indeed, one of the organizing principles (to the extent they can be understood) of subject matter ineligibility is often based on overbroad claiming (as in Morse v. O'Reilly, a case cited in support of SME deficiencies that had been better recognized for over a century as having failed to satisfy the disclosure requirements under Section 112).

The history of Federal Circuit jurisprudence (that has led some members of that Court to bemoan the outcome of these cases; see Judge Moore's dissent in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC ) are set forth below:

There are some certainties in these cases, nevertheless.  For example, diagnostic methods are almost per se ineligible.  There has been some eligibility traction in formulating claims based on natural laws in the context of a novel assay employing the natural law in certain situations; however, the consequences can be relying on new assays for each circumstance and avoiding "routine, well-understood, and conventional" assays.  More frequently claims are drafted in the context of a method of treatment informed by the results of diagnostic assay (see "Natural Alternatives International, Inc. v. Creative Compounds, LLC (Fed. Cir. 2019)" and "Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019)").  Such claims are susceptible to two well-recognized caveats:  inherent prior art anticipation (when individuals identified as treatment recipients received drug prior to development of the diagnostic assay; novel pharmaceuticals can avoid this outcome), and the "divided infringement" problem, when infringement is effectuated by separate practitioners of the recited limitations of the treatment method (wherein, for example, who administers the test is different from who administered the treatment and either actor cannot be characterized as being under the "direction and control" of the other).  The most coherent calculus for method claims to pass SME muster was enunciated by Judge Lourie in his Vanda decision, illustrating the advantages of claiming specifically and thereby avoiding overbreadth:

At bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.  They are different from Mayo.  They recite more than the natural relationship between CYP2D6 metabolizer genotype and the risk of QTc prolongation.  Instead, they recite a method of treating patients based on this relationship that makes iloperidone safer by lowering the risk of QTc prolongation.  Accordingly, the claims are patent eligible [emphasis added].

Similarly, natural products are per se generally ineligible, although Cellzdirect and Illumina decisions suggest isolated natural product having specific utility not possessed by product in nature may be eligible when properly/adequately claimed.  Generally, formulations and combinations not arising in nature can be eligible and while databases of biological information are often per se ineligible, their use may be (as in XY).

An Illustration of when formulations have failed to be eligible is Chromadex v. Elysium Health (Fed. Cir. 2023) (which is explained at least in part as being granted in 2005, prior to the imposition of current standards of SME).  The claims of U.S. Patent No. 8,197,807 are directed to dietary supplements comprising nicotinamide ribonucleotide, converted in vivo to NAD+, a co-enzyme involved in redox reactions:

Claimed were compositions formulated with other components as set forth in the table (reproduced in the opinion), which had in common many similarities to milk except for the limitation that the nicotinamide ribonucleotide ([NR]) was isolated.  The Federal Circuit's analysis resembled in many respects an obviousness assessment and characterized the claims as "reading on" milk with the exception that [NR] is "isolated."  But under Myriad being "isolated" is not enough (in contrast to the state of SME when these claims were prosecuted under, inter alia, In re Bergy).  The opinion also noted that the claims were "very broad," consistent with overbreadth being a hallmark of claims failing to recite eligible subject matter, and with the distinctions with Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC, where the Court recognized that claims to a natural product (beta-alanine) were patent-eligible for reciting "specific treatment formulations that incorporate[d] natural products" and that those formulations "ha[d] different characteristics and c[ould] be used in a manner that beta-alanine as it appears in nature cannot."

To the extent a claiming strategy can be elucidated from these cases it might be to assiduously avoid overbroad claiming, based on current application of Section 112 criteria (Judge Lourie's Vanda specificity example).  A useful analogy might be to adopt a "pointillist approach" that avoids overbreadth and preemption by reciting a plurality of narrow claims directed to specific embodiments, as illustrated by Georges Seurat's "A Sunday Afternoon on the Island of La Grande Jatte" (also analogous to Twentieth Century television transmission; see "The Last Lone Inventor" for further descriptions).

There is another way to look at the issue of SME and the 'judicial exceptions" contained in Shahshahani, "Against the abstract ideas exclusion," 40 Berkeley Technology Law Journal (forthcoming 2025).  In this paper the rationales for SME are applied to conventional abstract ideas and natural laws and found wanting.  Rather than accepting the conventional wisdom for the need to protect inventions that are "building blocks" due to perceived risks of inhibiting future innovation (by preemption), Professor Shahshahani argues that such building block inventions are important to incentivize by patents because their recognition and the application of natural laws and abstract ideas provides the capacity for development of future inventions employing them.  One illustration of this analysis is that while natural law often predates human discovery of it and could fall under the eligibility limitations in Parker v. Flook, human knowledge of the law provides the opportunity and ability to apply such natural laws and thus the applications thereof should not be precluded from eligibility.  The deficiencies of the conventional rationale for the judicial exceptions are further developed by recognizing that evidence supporting the conventional wisdom regarding preemption is not always correct, citing evidence that patents on genes did not inhibit genetic research, as shown by Bhaven Sampat & Heidi Williams, How Do Patents Affect Follow-On Innovation? Evidence from the Human Genome, 109 AMER. ECON. REV. 203, 217-19, 232 (2019) (existence of "gene patents" did not inhibit genetic research ) and Janet Freilich & Sepehr Shahshahani, Measuring Follow-On Innovation, 52 RES. POL'Y 104854 (2023) (finding that gene patents close to expiration caused an increase in follow-on research but those that were far from expiration had no effect).  This scholarship suggests that a reevaluation of the premises upon which the exceptions (natural laws, natural phenomena, abstract ideas) are based ("tying up" and thereby inhibiting fundamental building blocks necessary for future innovation) should be reconsidered for not being valid and not having the deleterious effects ascribed to them.  While perhaps not being (at the present time) a strategy for successfully arguing patent eligibility before the PTO or a district court in the absence of the Supreme Court addressing SME concerns (having denied certiorari to do so in almost 100 cases), further empirical evidence on the continued viability of SME restrictions may someday spur a necessary and beneficial reassessment.

* Taken from a presentation at the American Conference Institute's 23rd Annual Advanced Summit on Life Sciences Patents, presented on May 19th, 2025 in New York City.

Comments

[Max Drei]

Why not return to the words of the patents clause and make eligibility dependent on the claimed subject matter being a "discovery" within the ambit of the "useful arts"?

In other words, prescribe that the claimed matter must be in a field of technology, and that it must correspond to a solution of a technical problem.

Merely reciting in a claim the problem to be solved doesn't cut the mustard. A "do it on a computer" claim also not.

The enquiry into what is or is not "technical" is objective rather than subjective. It will track progress in the useful arts. What we think of as "technical" is (hopefully) going to change at ever-increasing speed, but this (European) test of eligibilty can keep up, effortlessly.

[Prof. Josh Sarnoff]

"One illustration of this analysis is that while natural law often predates human discovery of it and could fall under the eligibility limitations in Parker v. Flook, human knowledge of the law provides the opportunity and ability to apply such natural laws and thus the applications thereof should not be precluded from eligibility."
What is missing from the analysis is this. If we think that the discovery of the natural law is itself ineligible, why would we want to permit patents on uncreative applications of that discovery? And if we do want to do so, why not just permit patents on the discovery itself (thereby dominating both creative and uncreative applications, as no one will be sued for thinking or writing the discovery but only for applying it). So we should either permit patents on scientific and natural discoveries, or we should do precisely what the current doctrine (without regard to preemption, which is a red herring) does - require a different kind and amount of creativity than just applying a natural discovery in order to establish a "patent eligible invention."

[Max Drei]

The expression"natural law" troubles me, especially after seeing the Wikipedia entry for it. I ask you, what has patent eligibility to do with ethics and morals? But never mind. Let us suppose that, in context here, "natural law" means scientific law. OK then, let us take the law of gravity as an example, for debate. Is anybody seriously suggesting that it should have been possible, back then, for Isaac Newton to have patented his discovery, to have secured in it exclusive rights to enjoin everybody who thereafter starts to use gravity for commercial purposes? What nonsense is that then?

[Kevin E Noonan]

Where we differ, Josh, is in your assumption of inventions subjectively rejected/invalidated on Section 101 grounds comprising "uncreative applications of that discovery." Such limitations on patenting truly "uncreative applications of that discovery" are better assessed under non obviousness.

Thanks for the comment.

[Kevin E Noonan]

No, Max, no one is arguing that gravity should be eligible for patenting. But making subjective assessments of patent claims on the basis of a "natural law" is a shortcut for invalidating inventions that some sectors would prefer not have the benefits of patent protection. In the high tech space I direct your attention to my partner Mike Borella's many posts on this blog and the thorough mess that has been created by our courts on rational thought on this issue. My own humble efforts are, I presume, known to you.

Thanks for the comment.