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Natural Alternatives v. Creative Compounds

Representative Claim(s)

Representative Claim(s):

US 5,965,596 – claim 1

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.

US 8,470,865 – claim 1

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.

US 7,504,376 – claim 6

6) [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, wherein the composition is a dietary supplement or a sports drink] wherein the dietary supplement or sports drink is a supplement for humans.

US 7,825,084 – claim 1

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 pro-vides a unit dosage of beta-alanine.

US 8,993,610 – claim 1

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 dipeptide, 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.

Posture:

Appeal from decision of the District Court

Exception Category: None

Method Claims

“The Method Claims at issue are treatment claims. They 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. We hold, therefore, that the Method Claims are not directed to ineligible subject matter.” pp. 1345.

“While 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. In Mayo, the Court held the claims did not do significantly more than simply describe the natural “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. at 77. The Method Claims similarly rely on the relationships between the administration of beta-alanine and beta-alanylhistidine dipeptide synthesis, but under Natural Alternatives’ constructions, the Method Claims require specific steps be taken in order to bring about a change in a subject, altering the subject’s natural state. Unlike the claims in Mayo, the Method Claims at issue are treatment claims.

Like the claims in Vanda, the Method Claims contain specific elements that clearly establish they are doing more than simply reciting a natural law. Like the Vanda claims, which specify a patient population to be treated, the Method Claims specify particular results to be obtained by practicing the method. Claim 1 of the ʼ596 patent is directed to a “method of regulating hydronium ion concentrations in a human tissue,” and claim 1 of the ʼ865 patent is directed to a “method of increasing anaerobic working capacity in a human subject.” Similarly, both the Vanda claims and the Method Claims specify a compound to be administered to achieve the claimed result. Claim 1 of the ʼ596 patent achieves the result through the administration of the specific compound beta-alanine, and claim 1 of the ʼ865 patent requires use of one of the three specified forms of beta-alanine. The claims in Vanda further specified the dosages of the compound to be administered. The Method Claims likewise contain a dosage limitation by virtue of the “effective” limitation. As we looked to the specification in Vanda to determine the significance of the dosing ranges, 887 F.3d at 1135, here, the specification provides a method for calculating dosage based on a subject’s weight, ʼ596 patent 5:48-50. This goes far beyond merely stating a law of nature, and instead sets forth a particular method of treatment.” pp. 1345-1346.

Product Claims

“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, 100 S. Ct. 2204, 65 L. Ed. 2d 144 (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.

In the Product Claims, beta-alanine and glycine are incorporated into particular dosage forms. Claim 6 of the ʼ376 patent is directed to a “dietary supplement or sports drink” that uses a combination of glycine and one of the specified forms of beta-alanine. Under Natural Alternatives’ claim constructions, the quantity of beta-alanine must be sufficient to “effectively increase[] athletic performance,” and the specification provides a method for determining such an amount. Similarly, the “dietary supplement” in claim 1 of the ʼ084 patent uses the product beta-alanine at a dosage of “between about 0.4 grams to 16 grams” to “effectively increase[] athletic performance.” In each case, the natural products have been isolated and then incorporated into a dosage form with particular characteristics. At 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. Accordingly, neither claim is directed to ineligible subject matter.” pp. 1348-1349.

Manufacturing Claims

“The district court held claim 1 of the ʼ610 patent 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.” J.A. 24. We do not agree. 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 ʼ610 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.” pp. 1350.