By Donald Zuhn —

Last week, in Natural Alternatives International, Inc. v. Creative Compounds, LLC, the Federal Circuit reversed and remanded a decision by the U.S. District Court for the Southern District of California granting a motion for judgment on the pleadings filed by Creative Compounds, LLC that the asserted claims of U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376, 8,993,610, 8,470,865, and RE45,947 are not patent eligible.  In reversing the District Court, the Federal Circuit found that Creative Compounds had failed to demonstrate that the asserted claims were not patent eligible in view of Natural Alternatives' proposed claim constructions.

The patents at issue, which are owned by Natural Alternatives International, Inc., relate to dietary supplements containing beta-alanine.  Beta-alanine is an amino acid, which together with the amino acid histidine, can form dipeptides that are found in muscles, which in turn are involved in the regulation of intracellular pH during muscle contraction and development of fatigue.  Variations in dipeptide concentrations affect the anaerobic work capacity of individual athletes.  The asserted claims relate to the use of beta-alanine in a dietary supplement to increase the anaerobic working capacity of muscle and other tissue.

Natural Alternatives has asserted the patents at issue in multiple suits in the Southern District, including against Creative Compounds.  Creative Compounds responded by moving for judgment on the pleadings, which the District Court granted.  The District Court determined that all of the asserted claims were directed to patent ineligible subject matter under 35 U.S.C. § 101 and lacked an inventive concept sufficient to render the claims patent eligible.  Although the District Court indicated that it had accepted Natural Alternatives' proposed claim constructions in performing its eligibility analysis, the Federal Circuit, applying those same proposed claim constructions, determined that "the complaint's factual allegations, together with all reasonable inferences, plausibly establish the eligibility of the representative claims."

The majority opinion, authored by Judge Moore and joined by Judge Wallach, addresses three types of asserted claims:  (1) methods of treatment using beta-alanine ("the Method Claims"), (2) dietary supplements ("the Product Claims"), and (3) uses of beta-alanine in manufacturing a human dietary supplement ("the Manufacturing Claims").  Regarding the Method Claims, the opinion notes that claim 1 of the '596 patent and claim 1 of the '865 patent are representative (emphasis in the opinion):

Claim 1 of the '596 patent recites:

1.  A method of regulating hydronium ion concentrations in a human tissue comprising:
    providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue; and
    exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the human tissue.

Claim 1 of the '865 patent recites:

1.  A method of increasing anaerobic working capacity in a human subject, the method comprising:
    a)  providing to the human subject an amount of an amino acid to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the tissue, wherein said amino acid is at least one of:
        i)  beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide;
        ii)  an ester of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; or
        iii)  an amide of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; and
    b)  exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the tissue,
    wherein the amino acid is provided through a dietary supplement.

The opinion also notes that Natural Alternatives proposed the following constructions:
• "effective" means to "elevate[] beta-alanine above natural levels to cause an increase in the synthesis of beta-alanyl-histidine dipeptide in the tissue";
• "dietary supplement" means "an addition to the human diet, which is not a natural or conventional food, which effectively increases athletic performance when administered to the human over a period of time"; and
• "increasing anaerobic working capacity" means "increasing the amount of work performed by a muscle under lactate producing conditions".

The District Court determined that claim 1 of the '596 patent and claim 1 of the '865 patent are directed to natural laws, finding that these claims are directed to the natural laws that "ingesting certain levels of beta-alanine, a natural substance, will increase the carnosine [a dipeptide] concentration in human tissue and, thereby, increase the anaerobic working capacity in a human," or "thereby, aid in regulating hydronium ion concentration in the tissue."  The panel majority, however, did not agree with the District Court, explaining that:

Administering certain quantities of beta-alanine to a human subject alters that subject's natural state.  Specifically, homeostasis is overcome, and the subject's body will produce greater levels of creatine.  This, in turn, results in specific physiological benefits for athletes engaged in certain intensive exercise.  The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete's physiology to provide the described benefits.  These are treatment claims and as such they are patent eligible [citations omitted].

In support of its determination that the Method Claims are patent eligible treatment claims, the panel majority cited to the Court's decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), noting that Vanda stands for the proposition that claims directed to particular methods of treatment are patent eligible.  In summarizing the Court's decision in Vanda, the panel majority explains that:

The claims in Vanda involved a method of treating patients with schizophrenia that first required performing a genetic test to determine if a patient was a CYPD2D6 performer.  Based on the results of that test, a particular dose of iloperidone was selected and internally administered.  As a result, the risk of QTc prolongation, a dangerous side effect, was decreased.  We held that the claims were not directed to a natural relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation.  While we acknowledged that the inventors had recognized the underlying relationships, we explained that those were not what was claimed.  Instead, the claims were directed to a patent-eligible method of using iloperidone to treat schizophrenia, "a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome" [citations omitted].

In distinguishing Vanda from the Supreme Court's decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), the majority opinion notes that "[u]nlike the claims held ineligible in Mayo, which required only the observation of a natural law, the Vanda claims required a doctor to affirmatively administer a drug to alter a patient's condition from their natural state," adding that the claims in Mayo "did not . . . require any actual action be taken based on the measured level of metabolite," and thus, were not treatment claims.  The opinion also notes that "[t]his was expressly recognized in Mayo, which distinguished the Mayo claim from 'a typical patent on a new drug or a new way of using an existing drug,' because the Mayo claim did not 'confine [its] reach to particular applications' of the natural laws relied upon."  And according to the panel majority, "[t]he fact that the human body responds to the treatment through biochemical processes does not convert the claim into an ineligible one."

With respect to the Method Claims, the opinion notes that these claims "are directed to patent eligible new ways of using an existing product, beta-alanine," and therefore, "fall[] clearly within the scope of § 101, which allows for patents on 'any new and useful process,' including 'a new use of a known . . . composition of matter, or material.'"  Moreover, "[w]hile the Method Claims have similarities to the claims found ineligible in Mayo, as they utilize an underlying natural law, this is not sufficient to establish that they are directed to that law."  According to the panel majority, "[u]nlike the claims in Mayo, the Method Claims at issue are treatment claims," and "[l]ike the claims in Vanda, the Method Claims contain specific elements that clearly establish they are doing more than simply reciting a natural law."  In particular, the opinion notes that the Method Claims specify a patient population to be treated, particular results to be obtained by practicing the method, a compound to be administered to achieve the claimed result, and the dosages of the compound to be administered (via the "effective" limitation in the Method Claims).  Thus, the Method Claims "go[] far beyond merely stating a law of nature, and instead set[] forth a particular method of treatment."  The panel majority therefore concludes that "[t]he Method Claims at issue are treatment claims," which "cover using a natural product in unnatural quantities to alter a patient's natural state, to treat a patient with specific dosages outlined in the patents," and as such, these claims are not directed to ineligible subject matter.

Regarding step two of the Alice/Mayo analytic framework for assessing subject matter eligibility, the panel majority indicates that Creative Compounds' citation to disclosure in the asserted patents in support of its argument that placing a natural substance into a dietary supplement for administration to a human, in order to increase the function of tissues is a conventional, well-known activity, "does not establish that the dietary supplement in the claims, which provides a dose well in excess of the normal levels of beta-alanine, would have been well-understood, routine, and conventional."  (In a footnote, the opinion notes that "the record contains an expert declaration stating that 'one 3.2 gram daily supplement of beta-alanine is the equivalent to eating at least 109 Big Macs per day.'")  The opinion also explains that:

While a fact-finder may ultimately determine that the dietary supplement limitation was well-understood, routine, and conventional, absent a clear statement to that effect in the specification, complaint, or other material properly before the court, when disputed such a determination may not be made on a motion for judgment on the pleadings.

Notwithstanding the panel majority's step two analysis, the opinion concludes that "[u]nder Natural Alternatives' proposed claim constructions, the Method Claims are not directed to an exception to § 101 under the first step of the Alice test," and "[t]herefore, judgment on the pleadings was inappropriate."

Turning to the Product Claims, the opinion notes that the District Court treated claim 6 of the '376 patent (which depends from claims 1 and 5) and claim 1 of the '084 patent as representative of the Product Claims in the asserted patents.  Claims 1, 5, and 6 of the '376 patent recite (emphasis in the opinion):

1.  A composition, comprising:
    glycine; and
    a) an amino acid selected from the group consisting of a beta-alanine, an ester of a beta-alanine, and an amide of a beta-alanine, or
    b) a di-peptide selected from the group consisting of a beta-alanine di-peptide and a beta-alanylhistidine di-peptide.

5.  The composition of claim 1, wherein the composition is a dietary supplement or a sports drink.

6.  The composition of claim 5, wherein the dietary supplement or sports drink is a supplement for humans.

Claim 1 of the '084 patent recites:

1.  A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.

The opinion also notes that Natural Alternatives proposed the following construction:
• "dietary supplement" and "human dietary supplement" mean "an addition to the human diet, which is not a natural or conventional food, which effectively increases athletic performance and is manufactured to be used over a period of time."

The District Court determined that claim 6 of the '376 patent and claim 1 of the '084 patent are directed to ineligible subject matter, finding that these claims are directed to "the natural phenomena of beta-alanine and glycine" and "the natural phenomenon of beta-alanine."  As with the Method Claims, however, the panel majority again did not agree with the District Court, explaining that:

Although beta-alanine is a natural product, the Product Claims are not directed to beta-alanine.  A claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and "the potential for significant utility."  See Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).  Just as the Method Claims are directed to specific methods of treatment that employ a natural law, the Product Claims are directed to specific treatment formulations that incorporate natural products, but they have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot.

With respect to those "different characteristics," the panel majority notes that "[u]nder Natural Alternatives' claim constructions, the quantity of beta-alanine must be sufficient to 'effectively increase[] athletic performance.'"  The opinion concludes that "[a]t this stage in the litigation, it has been sufficiently alleged that these characteristics provide significant utility, as the claimed dosage forms can be used to increase athletic performance in a way that naturally occurring beta-alanine cannot," and therefore, finds that the Product Claims are not directed to ineligible subject matter.  The opinion also notes that even if the Product Claims were directed to ineligible subject matter, judgment on the pleadings would still have been inappropriate under step two of the Alice/Mayo analytic framework because the Product Claims, like certain Method Claims, contain a dietary supplement limitation, and "the specification does not contain language supporting the idea that this limitation was well-understood, routine, and conventional."

Turning to the Manufacturing Claims, the opinion notes that the District Court treated claim 1 of the '610 patent as representative of the Manufacturing Claims in the asserted patents.  Claim 1 of the '610 patent recites (emphasis in the opinion):

1.  Use of beta-alanine in manufacturing a human dietary supplement for oral consumption;
    supplying the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, as a single ingredient in a manufacturing step of the human dietary supplement or
    mixing the beta-alanine, which is not part of a di-peptide, polypeptide or oligopeptide, in combination with at least one other ingredient for the manufacture of the human dietary supplement,
    whereby the manufactured human dietary supplement is for oral consumption of the human dietary supplement in doses over a period of time increases beta-alanyl histidine levels in muscle tissue sufficient to delay the onset of fatigue in the human.

The opinion also notes that Natural Alternatives proposed the following constructions:
• "[u]se of beta-alanine in manufacturing a human dietary supplement" means "making an addition to the human diet using beta-alanine, which is not a natural or conventional food, to be administered over a period of time and that effectively increases athletic performance."
• "supplying the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, as a single ingredient in a manufacturing step of the human dietary supplement" means "providing the free amino acid beta-alanine, an ester of beta-alanine or an amide of beta-alanine in a step of making an addition to the human diet using beta-alanine as the only active ingredient, which is not a natural or conventional food, which effectively increases athletic performance when administered to a human over a period of time."
• "mixing the beta-alanine, which is not part of a dipeptide, polypeptide or oligopeptide, in combination with at least one other ingredient for the manufacture of the human dietary supplement" means "making an addition to the human diet, which is not a natural or conventional food, and which effectively increases athletic performance when administered to a human over a period of time, using the free amino acid beta-alanine, an ester of beta-alanine or an amide of beta-alanine and at least one other ingredient."

The District Court determined that claim 1 of the '610 patent is directed to ineligible subject matter, finding that this claim is directed to "the natural phenomenon beta alanine and the natural law that ingesting certain levels of beta-alanine will increase the carnosine concentration in human tissue."  As with the Method Claims and Product Claims, however, the panel majority again did not agree with the District Court, explaining that:

The Manufacturing Claims are not directed to the natural law or product of nature, but instead are an application of the law and new use of that product.  Claim 1 of the ’610 patent is even further removed from the natural law and product of nature at issue in the Method Claims and Product Claims, respectively.  It is directed to the manufacture of a human dietary supplement with certain characteristics.  The supplement is not a product of nature and the use of the supplement to achieve a given result is not directed to a law of nature.  We do not see, therefore, how a claim to the manufacture of a non-natural supplement would be directed to the law of nature or natural product.

Finding that the asserted claims are not directed to ineligible subject matter under step one of the Alice test, the Federal Circuit reversed the District Court's decision that these claims are directed to ineligible subject matter and remanded for further proceedings.  The panel majority concludes by noting that "[w]e live in the natural world, and all inventions are constrained by the laws of nature," adding that "[a]s the Supreme Court has warned, we must be careful not to overly abstract claims when performing the Alice analysis."

In an opinion concurring-in-part and dissenting-in-part, Judge Reyna explained that he was dissenting from the majority's "broad stroke of eligibility, primarily because I conclude that the majority's § 101 analysis relies on an erroneous claim construction," but was concurring in the result reached by the majority to remand for further proceedings because he expected that this would permit the District Court to revisit the § 101 question under a proper claim construction.  In the instant case, Judge Reyna believed that "the ordinary meaning 'may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words,'" citing Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc).  Moreover, Judge Reyna indciated that he is concerned with the majority's analysis because "it relies on a claim construction that improperly imports limitations into the claims and is contradicted by the written description."

Aside from this concern, Judge Reyna suggested that on remand the District Court "could include a formal claim construction and a potential revisit of the § 101 issue," and therefore inquired as to "whether anything meaningful has been achieved in these circumstances."  He concluded his opinion by declaring that "[t]his case, and the general development of the law concerning § 101 analysis at the pleading stage, causes me to ask whether the time has come for this court to reconsider whether a Rule 12(c) motion based on § 101 should be decided before claim construction."

Natural Alternatives International, Inc. v. Creative Compounds, LLC (Fed. Cir. 2019)
Panel: Circuit Judges Moore, Reyna, and Wallach
Opinion by Circuit Judge Moore; opinion concurring-in-part and dissenting-in-part by Circuit Judge Reyna