In Natural Alternatives Int’l., Inc. v. Creative Compounds, LLC, Appeal No. 2018-1295 (Fed. Cir., March 15, 2019) a divided panel of the Fed. Cir. held that claims to methods of increasing the anaerobic working capacity in a human subject by administering an amount of a dietary supplement comprising beta-alanine, its ester or amide, effective to increase beta-alanyl histidine dipeptide synthesis in the subject’s tissue via the blood (Moore, Reyna and Wallach, Moore writing, Reyna concurring in part, dissenting in part.) A two-component composition claim comprising glycine and beta-alanine and these derivatives, and either beta-alanine dipeptide or beta-alanyl histidine dipeptide, that is a dietary supplement, was also found to be patent eligible. The panel found that the broadest composition claim reciting only beta-alanine was also patent-eligible:
- A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4-16 grams, wherein the supplement provides a unit dosage form of beta-alanine.
Claims to the use of beta-alanine in manufacturing a human dietary supplement for oral consumption by supplying the beta-alanine as a single ingredient or in combination with at least one other ingredient, in a manufacturing step of the human dietary supplement, whereby oral consumption of the 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. See, U.S. Pat. Nos. 5,965,596; 8,933,610; 8,470,865 and RE45,947.