NATURAL ALTERNATIVES INTL. v. CREATIVE COMPOUNDS, LLC, decided March 15, 2019, Statutory Subject Matter

U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376, 8,993,610, 8,470,865, and RE45,947 are directed to dietary supplements containing beta-alanine (pages 2-3).  The claims recite “effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue,” which is interpreted to elevate beta-alanine above natural levels to cause an increase in synthesis in tissue, and “dietary supplement,” which is interpreted to be an addition to human diet rather than a natural or conventional food (pages 7-8).  Administering alters the subject’s natural state (page 8).  The claims are directed to a new way to use an existing product, so are patent eligible as treatment claims (pages 9-10).  The results to be obtained, the compound to achieve the results, and dosage provided through the “effective” limitation where the specification indicates how to calculate the effective dosage indicate patent eligibility (pages 10-12).  The effective dose exceeds naturally occurring levels so provides for a natural product in unnatural quantities (pages 12-13).

Hindsight: Rather than reciting the ability to observe the natural law, reciting a specific compound in a dosage greater than natural with an effect in the subject may make the claim patent eligible.  Any way to indicate specific treatment above and beyond the discovery that the compound is used by the human body in a particular way may be important.