PATENTS FOR DIETARY SUPPLEMENTS AND PATENT ELIGIBLE SUBJECT MATTER–GUIDANCE FROM NATURAL ALTERNATIVES INTERNATIONAL INC. VS CREATIVE COMPOUNDS, LLC, (Fed. Cir. 3/15/2019) © 2019 William O’Meara

A frequent issue in patent prosecution and litigation involving dietary supplements, is whether patent claims are directed to “patent eligible subject matter.” Section 35 U.S.C. 101 defines patent eligible subject matter as “any new and useful process, machine, composition of matter or any new and useful improvement thereof.” This definition of 101 patent eligible subject matter is subject to certain U.S. Supreme Court created exceptions. These exceptions define “patent ineligible subject matter.” Patent ineligible subject matter includes “laws of nature, natural phenomena and abstract ideas.” Thus, claims determined by a court to be directed to “laws of nature, natural phenomena or abstract ideas,” without more, are patent ineligible.

In the recent case, NATURAL ALTERNATIVES INTERNATIONAL INC. VS CREATIVE COMPOUNDS, LLC, (Fed. Cir. 3/15/2019) [“NATURAL ALTERNATIVES”], the CAFC reversed a decision of the District Court of the Federal District of California. In the District Court case, the court dismissed patent infringement litigation, pursuant to defendant’s motion for judgment on the pleadings,
finding that the asserted claims of U.S. Patent Nos. 5,965,596; 7,825,084; 7,504,376; 8,993,610; 8,470,865; and RE45,947 were directed to patent ineligible subject matter under 35 USC 101, as determined by the “Alice Test.” The CAFC reversed and remanded, finding that the asserted claims were not directed to patent ineligible subject matter.

The claims of the patents at issue generally relate to the use of beta-alanine in a dietary supplement to “increase the anaerobic working capacity of muscle and other tissue.”

Claim Construction

In deciding defendant’s motion on the pleadings, both the District Court and the CAFC construed the claims at issue in accordance with the proposed claim construction of the nonmoving party, NATURAL ALTERNATIVES. This claim construction appears to have been a significant factor in the CAFC’s reversal of the District Court’s decision that all the claims under consideration were directed to patent ineligible subject matter.

NATURAL ALTERNATIVES construction of the “effective…” limitations in the method of treatment claims discussed immediately below is “elevates beta-alanine above natural levels to cause an increase in the synthesis of beta-alanylhistidine dipeptide in the tissue.” NATURAL ALTERNATIVES construed “dietary supplement” as “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.” It construed “increasing anaerobic working capacity” as “increasing the amount of work performed by a muscle under lactate producing conditions.”

However, in Judge Reyna’s separate opinion, dissenting in part, she disagreed with the majority’s use of NATURAL ALTERNATIVE’S proposed claim construction on grounds that some limitations do not appear in the “plain language of the claims;” that NATURAL ALTERNATIVE’S construction is internally inconsistent with the claim language and written description of some of the patents; and that it is contrary to the plain meaning of the claim terms. She also noted that the patentee had not acted as its own lexicographer by setting forth a definition of the disputed claim term other than its plain and ordinary meaning.

Patent Eligible/Ineligible Subject Matter and
The “Alice Test”

Determining whether the subject matter of a claim is patent ineligible under the 35 U.S.C. 101 exceptions, is the central focus of NATURAL ALTERNATIVES. In this case, the CAFC provides useful guidance for applicants seeking patents involving health supplements including methods of using health supplements and methods of making health supplements as well as the health supplement products.

The CAFC summarized the Alice Test, the test it used to determine if patent claims were directed to patent ineligible subject matter under 35 U.S.C. 101, as follows:
[The First Step of ALICE] …“we first determine whether the claims at issue are ‘directed to” a patent ineligible concept,’ Alice, 573 U.S. at 216-217. [Author’s Note: If it is determined the claims are not directed to a patent ineligible concept, that determination ends use of the Alice Test, and then other tests for patentability , e.g., 35 U.S.C. 103, are applied.]
[The Second Step of ALICE] “….If we determine that the claims are directed to a patent ineligible concept, we consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether additional elements ‘transform the nature of the claim’ into a patent eligible application, i.e., whether there is an ‘inventive concept.’ Alice, 573 U.S. at 271 (quoting Mayo, 566 U.S. at 78-79).

In NATURAL ALTERNATIVES, the CAFC determined, in applying the First Step of the Alice Test, that all the claims at issue were NOT directed to a patent ineligible concept. Thus, the CAFC did not reach the Second Step of Alice and determined that none of the claims at issue were patent ineligible and reversed and remanded the case to the District Court.

Claims to Methods of Treatment with Health Supplements

Representative claims discussed by the CAFC in NATURAL ALTERNATIVES and the CAFC’s reasons for concluding those claims are not patent ineligible are discussed below.

(Claim 1 of ‘596 patent)

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-alanyl histidine 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.

(Claim 1 of ‘865 patent)

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.

In finding the above claim from the ‘865 patent was patent ineligible the District court held the claim was directed to the natural laws that “ingesting certain levels of beta-alanine, a natural substance, will increase the carnosine concentration in human tissue and, thereby, increase anaerobic working capacity in a human.” The District Court made a similar statement regarding the claim of the ‘596 patent. The CAFC disagreed.

The CAFC quotes the Supreme Court Mayo decision for the general proposition that a “new use” of an existing product is patent eligible subject matter.

In regard to the above claims from the ‘596 and ‘865 patents, the CAFC notes that both claims are “treatment claims,” which are patent eligible, quoting Vanda Pharmaceuticals Inc. v. West -Ward Pharmaceuticals International Ltd. 887 F. 3d 1117, 1134-36 (Fed. Cir. 2018). The CAFC explains, “Administering certain quantities of beta-alanine to a human subject alters the subject’s natural state. Specifically, homeostasis is overcome, and the subject’s body will produce greater levels of creatine. This, in turn, results in specific physiological benefits for athletes engaged in certain intensive exercise…..The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits.”

In further analysis of these method claims, the CAFC equates them, with approval, to the claims in Vanda which specify particular results to be obtained by practicing the method. Also, the Vanda claims and the subject claims “specify a compound to be administered to achieve the claimed result.” In addition, the claims of Vanda and the subject claims both specify a dosage—in the subject claims by virtue of an “effective” limitation. The CAFC also notes the similarities between the claims of Vanda in which the specification indicates the significance of the dosing ranges and in the NATURAL ALTERNATIVES claims, where the specification (as opposed to the claims) provides a method for calculating dosage based on the subject’s weight.

With regards to the method of treatment claims at issue, the CAFC states that the method claims are treatment claims that 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. The CAFC points out that the existence of prior art food supplements containing the natural product recited in the claims does not establish that the dietary supplement in the claims, which provides a dose well in excess of the normal levels of beta-alanine, would have been well-understood, routine and conventional, and, therefore, the claims are not patent ineligible.

Claims to Health Supplement Products

The CAFC discussed the two product claims set forth below.

(Dependent Product claim, claim 6 from the ‘376 patent)

1. 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-alanine di-peptide.

5. The composition of claim 1, wherein the composition is a dietary supplement or a sports drink.

6. The composition of claim 5, wherein the dietary supplement or sports drink is a supplement for humans.

(Product claim 1 of the ‘084’ patent)

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.

The District Court had held these product claims of the ‘376 patent and the ‘084’ patent are directed to “patent ineligible subject matter.” It held claim 6 of the ‘376 patent is directed to the natural phenomena of beta-alanine and glycine and claim 1 of the ‘084 patent is directed to the natural phenomenon of beta-alanine. The CAFC disagreed, noting that a claim to “a …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” citing Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

The CAFC noted that that in the product claims, beta-alanine and glycine are incorporated into particular dosage forms in both claims, which like the methods of treatment claims are directed to specific treatment formulations that incorporate natural products, but they have different characteristics and can be used in a manner that the product as it appears in nature cannot.

The CAFC notes that claim 6 directed to a dietary supplement or sports drink with a “sufficient to effectively increase” limitation, the meaning of which is explained in the specification. The CAFC explains that claim 1 of the ‘084 patent uses this phrase along with a dosing range in grams. Thus, in the product claims, like the method of treatment claims, 1) the use of the product (dietary supplement) 2) the specificity of the amounts of the naturally occurring chemicals used in a dose and 3) the result obtained on a subject (increased athletic performance), distinguishes the product from the naturally occurring chemicals glycine and beta-alanine. The CAFC also noted that at oral argument it was submitted that glycine and beta-alanine could have synergistic effects, and supporting evidence was submitted including an expert report.

Claims to Methods of Manufacturing

(Claim 1 of the ‘610 patent)

1. Use of beta-alanine in manufacturing a human dietary supplement for oral consumption:

supplying the beta alanine, which in 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 in 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.

In its review of this Manufacturing claim the CAFC disagreed with the District Court’s finding that “this claim 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.” The CAFC instead found the manufacturing claims are not directed to a product of nature and that use of the supplement to achieve a given result is not directed to a law of nature. Rather, the Manufacturing claims are an application of that law and a new use of that product. The CAFC then refers to its analysis of the product and method of treatment claims and explains that a manufacturing method claim is even further removed from “natural law” and “product of nature” than the method of treatment and product claims previously discussed.

SUMMARY OF ARGUMENTS AND APPLICATION DRAFTING INSIGHTS

Make Meaning of Claims Terms Clear to Show Claims Do More Than Merely Recite a Law of Nature or an Arbitrary Use of a Natural Product

It appears that the majority’s opinion relied on NATURAL ALTERNATIVES’ somewhat strained construction of certain claim terms to reach its determination that the claims were not directed to 101 patentable ineligible subject matter. Judge Reyna’s dissent criticized this construction, and, but for the fact that this appeal was from a decision on a motion for judgement on the pleadings, the dissent’s position might have prevailed. However, with the expanded meaning of claim terms provided by the NATURAL ALTERNATIVES’ construction, the majority was able to find sufficient differences between the subject claims and the natural substance and laws of nature associated with beta-alanine, to determine the claims were not patent ineligible. It is unclear if this determination will stand up when the District Court reconsiders the matter on remand, and the matter of claim interpretation is fully considered on the merits. The 101 issues that will likely be revisited in this case on remand, would be presented in a better light for NATURAL ALTERNATIVES if NATURAL ALTERNATIVES had included definitions of critical terms in the patent specifications.

ARGUMENTS TO SHOW PATENT ELIGIBLILITY OF METHOD OF TREATMENT CLAIMS

1) A “new use” of an existing product is patent eligible subject matter.
2) “Treatment claims” are patent eligible.
3) When drafting treatment claims, specify particular results to be obtained by practicing the method.
4) When drafting treatment claims specify a compound to be administered to achieve the claimed result.
5) When drafting treatment claims specify a dosage.
6) Indicate the significance of the dosing ranges, at least in the specification (such as by describing a method for calculating dosage based on the subject’s weight).
7) Argue synergistic results when possible.
8) “Method of treatment claims not only embody a discovery, they require 1) that an infringer actually administer the dosage form claimed 2) in the manner claimed, 3) altering the athlete’s physiology 4) to provide the described benefits.” To draft a method of treatment claims with the greatest chance for success: specify the subject to be dosed (e.g. a human); specify the composition of the dose; specify the amount/weight/volume of the dose; specify the manner of dosing (e.g., at least 1 gram per day for at least 30 days); specify the result to be obtained on the subject in as much scientific detail as available, see paragraph 9 below.
9) In analyzing method claim 1 of the ‘865 patent, the CAFC discussed why administering certain quantities of beta-alanine to a human subject alters the subject’s natural state. “Specifically, homeostasis is overcome, and the subject’s body will produce greater levels of creatine. This, in turn, results in specific physiological benefits for athletes… The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits.” “These are treatment claims and as such they are patent eligible. [Treatment claims] fall clearly within the scope of Section 101, which allows for patents on any new and useful process,” including “a new use of a known…composition of matter, or material 35 U.S.C. 100(b), 101. As the Supreme Court explained in Mayo, such patents on a new use of an existing drug are “typical.” 566 U.S. at 87.”
10) The NATURAL ALTERNATIVES specification’s allegation of use of the product to “effectively increase athletic performance” was found sufficient by the CAFC to establish the claimed subject matter has “significant utility,” i.e., a rejection for lack of utility under 35 U.S.C. 101 would be improper.
11) The CAFC in NATURAL ALTERNATIVES noted with approval that the patent specification and a submitted article by an expert explained the science as to why the claimed substance was different from the art and was effective in causing the claimed result. Although not expressly stated by the CAFC, this information in the patent specification and in the expert’s article amounted to evidence of operability/practical utility of the invention under 35 U.S.C. 101.

ARGUMENTS TO SHOW PATENT ELIGIBLILITY OF PRODUCT CLAIMS

1) Same arguments as method of treatment claims, if any of the product claims has any method of treatment type limitation. In drafting product claims, consider adding method of treatment and/or method of manufacture limitations to at least some product claims.
2) “A …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” citing Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).
3) Claimed product has different characteristics and can be used in a manner that the product as it appears in nature cannot– the natural component products have been isolated and incorporated into a dosage form with particular characteristics (causing an increase in athletic performance in a person consuming the product) that the natural products do not have.
4) The use of the product (dietary supplement) is different from previous uses (new use of old product is patentable)
5} Specify the amounts of the naturally occurring substance used in a dose, explain it is not what a human would ordinarily consume as food, etc.
6) Indicate the result obtained on a subject (increased athletic performance).
7) Argue synergistic result and include supporting evidence in application or in expert declarations, etc.
8) Include test results, affidavits of experts, scientific reasoning, etc., to support 101 usefulness of claims.

ARGUMENTS TO SHOW PATENT ELIGIBLILITY OF METHOD OF MAKING (MANUFACTURING) CLAIMS
1) If the manufacturing steps, without product or method of treatment type limitations are unique, draft claims to those steps alone.
2) But, include various features/limitations from treatment claims and product claims, such as recited above, in separate or dependent manufacturing claims

CONCLUSIONS

Reasons given by the CAFC for determining the claims at issue were not patent ineligible under 35 U.S.C. 101, provides useful arguments that a patent applicant or litigant may assert to counter a charge that a claim is directed to a patent ineligible concept.

In its analysis of NATURAL ALTERNATIVES, the CAFC divided the claims it analyzed into three groups: method of treatment claims, product claims, and methods of manufacturing claims. However, none of the analyzed claims have claim limitations that fall exclusively into a single one of the three claim categories. In other words, the product claims contain novel method of use type limitations, the method claims contain novel product type limitations, and the method of manufacturing claim contains novel limitations of all three claim types. The CAFC has provided reasons under each claim category as to why a claim in that category should not be considered patent ineligible. However, most of the CAFC’s reasons for finding a claim not patent ineligible are applicable to all types of claims. This CAFC reasoning can be used when responding to a charge, in litigation or patent prosecution, that a claim is patent ineligible. The CAFC’s reasoning can also be used as a guide when drafting patent applications for dietary supplements.

In view of Judge Reyna’s dissenting opinion, express definitions of claim terms such as “dietary supplement” and “effective to…,” should be included in the application to help avoid claim rejections for patent ineligible subject matter. Such definitions may be provided in the specification or in the claims or both.