By Thomas Long, J.D.
Claims for methods of administering beta-alanine to increase muscles’ working capacity were valid treatment claims, not merely directed to natural laws. Claims for the supplement products and means of making them were directed to specific formulations, not natural phenomena.
Dietary supplements maker Creative Compounds, LLC, failed to failed to demonstrate, in the context of a motion for judgment on the pleadings, that the claims five patents, owned by Natural Alternatives International, Inc., and related to use of the amino acid beta-alanine to increase the working capacity of muscle, were not patent-eligible under Natural Alternatives’ proposed claim constructions, the U.S. Court of Appeals for the Federal Circuit has held in a split decision. Applying the proposed claim constructions, the Federal Circuit determined that the factual allegations in Natural Alternatives’ infringement complaint, together with all reasonable inferences, plausibly established the eligibility of the representative claims. Method claims in the patents described taking certain specific steps and dosage forms to administer beta-alanine to achieve desired benefits, and as such were eligible treatment claims that were not merely directed to natural laws. Claims related to the dietary supplement products themselves were not invalid as directed to natural phenomena on the face of the pleadings because they were directed to specific treatment formulations that incorporated natural products but had different characteristics and were used in a manner in which beta-alanine as it appeared in nature could not. Finally, claims directed to means of making the products were directed to the manufacture of a human dietary supplement with certain characteristics; the supplement was not a product of nature and its use to achieve a given result was not directed to a law of nature. The district court’s dismissal of the Natural Alternatives’ infringement complaint against a rival supplement maker was reversed. A dissenting judge opined that the majority’s eligibility analysis relied on an erroneous claim construction and would send the case back to the district court for further proceedings revisiting the eligibility question under a proper claim construction (Natural Alternatives International, Inc. v. Creative Compounds LLC, March 15, 2019, Moore, K.).
Natural Alternatives owned patents, substantially similar specifications, relating to dietary supplements containing the amino acid beta-alanine. With histidine, another amino acid, beta-alanine can form dipeptides that are found in muscles. Variations in dipeptide concentrations affect the anaerobic work capacity of athletes. The asserted patents generally related to the use of beta-alanine in a dietary supplement to increase the anaerobic working capacity of muscle and other tissue. The patents at issue in the current appeal were U.S. Patent Nos. 5,965,596 ("the ’596 patent"), 7,825,084 ("the ’084 patent"), 7,504,376 ("the ’376 patent"), 8,993,610, 8,470,865 ("the ’865 patent"), and RE45,947.
Natural Alternatives brought several lawsuits to enforce the patents in the District of Southern California. One defendant, Creative Compounds, moved for judgment on the pleadings, which the district court granted on the ground 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 them patent eligible. Natural Alternatives appealed.
Method Claims—proposed constructions. Several of the asserted patents claimed methods of treatment using beta-alanine ("the Method Claims"). Claim 1 of the ’596 patent and claim 1 of the ’865 patent were treated as representative of the Method Claims. Those claims contained several limitations involving the effectiveness of the amount of beta-alanine, such as "providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue" (emphasis added by court). Natural Alternatives’ proposed construction of the "effective" limitations was "elevates beta-alanine above natural levels to cause an increase in the synthesis of beta-alanylhistidine dipeptide in the tissue." The claims also contained the limitation "dietary supplement," for which Natural Alternatives proposed the "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." Natural Alternatives also defined the claim term "increasing anaerobic working capacity" as "increasing the amount of work performed by a muscle under lactate producing conditions."
Method Claims—natural laws. The district court held both representative Method Claims to have been directed to natural laws, which are generally ineligible under Section 101. It held that claim 1 of the ’865 patent was directed to the natural law that "ingesting certain levels of beta-alanine, a natural substance, will increase the carnosine concentration in human tissue and, thereby, increase the anaerobic working capacity in a human." It held that claim 1 of the ’596 patent was directed to the natural law that "ingesting certain levels of beta-alanine, a natural substance, will increase the carnosine concentration in human tissue and, thereby, aid in regulating hydronium ion concentration in the tissue."
The Federal Circuit disagreed. The Method Claims were directed to patent-eligible new ways of using an existing product, in the appellate court’s view. Because administering certain quantities of beta-alanine to a human subject altered that subject’s natural state, and the claims required that an infringer actually administer the dosage form claimed in the manner claimed to achieve the desired results, they were treatment claims and as such were patent-eligible. The claims clearly fell within the scope of Section 101, which allowed for patents on "any new and useful process," including "a new use of a known ... composition of matter, or material." According to the Federal Circuit, the Method Claims covered 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. Therefore, that the Method Claims were not directed to ineligible subject matter.
Product Claims. The district court also considered the patent eligibility of a number of claims to dietary supplements ("the Product Claims"). Claim 6 of the ’376 patent and claim 1 of the ’084 patent was treated as representative of the claims in those patents. Claim 6 of the ’376 patent depended on claims 1 and 5. In its opinion, the district court also held representative claim 34 of the ’947 patent ineligible. Key to the eligibility analysis were the claim terms "dietary supplement" and "human dietary supplement," which Natural Alternatives proposed to 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 held that the Product Claims were directed to ineligible subject matter. It held claim 6 of the ’376 patent was directed to the natural phenomena of beta-alanine and glycine and claim 1 of the ’084 patent was directed to the natural phenomenon of beta-alanine.
Again, the Federal Circuit disagreed. Although beta-alanine was a natural product, the Product Claims were not directed to beta-alanine. The Product Claims were directed to specific treatment formulations that incorporated natural products, but they had different characteristics and could be used in a manner that beta-alanine as it appeared in nature could not. Therefore, the Product Claims were patent-eligible.
Manufacturing Claims. Finally, the Federal Circuit addressed the district court’s determination of ineligibility regarding claims directed to making the supplement product ("Manufacturing Claims"). The appellate court reversed the district court’s decision on these claims because the Manufacturing Claims were not directed to the natural law or product of nature, but instead were an application of the law and new use of that product. The supplement was not a product of nature, and the use of the supplement to achieve a given result was not directed to a law of nature; a claim to the manufacture of a non-natural supplement could not be directed to the law of nature or natural product, in the Federal Circuit’s view.
Dissenting opinion. Circuit Judge Jimmie V. Reyna wrote in dissent. In Judge Reyna’s view, the majority relied on an erroneous claim construction. Claim 1 of the ’084 patent, according to Judge Reyna, was merely directed to beta-alanine, a naturally occurring substance, and the majority had "imported" limitations into the claims. The dissenting judge also contended that other constructions proposed by Natural Alternatives had improperly imported limitations that contradicted the plain meaning of the terms. Judge Reyna wrote that he would remand because the district court and the majority relied on an erroneous claim construction.
This case is No. 2018-1295.
Attorneys: Kevin M. Bell (Porzio Bromberg & Newman, P.C.) for Natural Alternatives International, Inc. Kevin John O’Shea (O’Shea Law LLC) for Creative Compounds LLC.
Companies: Natural Alternatives International, Inc.; Creative Compounds LLC
MainStory: TopStory Patent FedCirNews
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