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Natural Alternatives v. Creative Compounds

Representative Claim(s)

‘084 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.

‘947 34. A human dietary supplement for increasing human muscle tissue strength comprising a mixture of creatine, a carbohydrate and free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide, wherein the human dietary supplement does not contain a free amino acid L-histidine, wherein the free amino acid beta-alanine is in an amount that is from 0.4 g to 16.0 g per daily dose, wherein the amount increases the muscle tissue strength in the human, and wherein the human dietary supplement is formulated for one or more doses per day for at least 14 days.

‘596 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.


Motion for Judgement on the Pleadings

Exception Categories: Law of Nature, Natural Phenomenon

The court noted first that it had ruled the patent invalid for patent ineligible subject matter in a related case. The court then reiterated its prior reasoning.

‘084: “Beta-alanine is the only ingredient of the supplement referenced in the language of claim 1. Thus, beta-alanine is the focus of the claim. In its specification, the ‘084 patent explains that beta-alanine is an amino acid and is “present in the muscles of humans and other vertebrates.” Thus, the ‘084 patent acknowledges that beta-alanine is a natural occurring phenomenon. Accordingly, claim 1 of ‘084 patent is directed to excluded subject matter—specifically beta-alanine, a natural phenomenon—thereby satisfying step one of the Alice inquiry.”

‘947: “The Court begins its analysis of this claim with step one of the Alice inquiry. Claim 34 claims a human dietary supplement containing a mixture of beta-alanine, creatine, and a carbohydrate. Beta-alanine is a naturally occurring phenomenon. In addition, the specification of the ‘947 patent discloses that creatine is also a naturally occurring phenomenon. (‘Creatine … is found in large amounts in skeletal muscle and other ‘excitable’ tissues (e.g., smooth muscle, cardiac muscle, or spermatozoa) . . . .’). Further, a carbohydrate is also a naturally occurring phenomenon. Thus, claim 34 is directed to excluded subject matter, specifically the natural phenomena of beta-alanine, creatine, and carbohydrates.”

“In Funk Bros. Seed Co. v. Kalo Inoculant Co., the Supreme Court held that mixing different natural phenomena together—specifically, in that case different bacterial species—is insufficient to render an invention patent eligible even though it was not previously known that the substances could be mixed together, and that the combination provided certain advantages. Thus, in the present case, mixing beta-alanine, a natural phenomenon, with a carbohydrate and creatine, two other natural phenomena, and placing that mixture in a human dietary supplement to increase the function of tissues, a conventional activity, is insufficient to render claim 34 patent eligible.”

‘596: “Claim 1 of the ‘596 patent claims a method of regulating hydronium ion concentrations in human tissue by provided the amino acid beta-alanine to human tissue via blood or blood plasma thereby increasing the carnosine content in the tissue. The Court agrees with Defendants that this claim is directed to a law of nature, specifically the principle that ingesting certain levels of beta-alanine, a natural substance, will increase carnosine concentration in human tissue and, thereby, aid in regulating the hydronium ion concentration in the tissue.”

Significantly More: No

‘084: “Because placing a natural substance into a human dietary supplement to increase the function of tissues when consumed is a conventional activity, employing a dietary supplement to administer beta-alanine—a natural phenomenon—to achieve a high level of carnosine synthesis in a human—applying a natural law—is insufficient to render the claims at issue patent eligible even accepting Plaintiff’s proposed construction for the term ‘human dietary supplement.’”

‘596: “The Court agrees with Defendants that the language in claim 1 does nothing more than simply state the law of nature and add the words apply it to human tissue. Specifically, the language in claim 1 simply acknowledges the natural law that providing beta-alanine to human tissue will increase the carnosine concentration in the tissue and aid in regulating hydronium ion concentration, and then merely instructs to do so. This is insufficient to render the claim patent-eligible.”