Natural Alternatives International, Inc. v. Allmax Nutrition, Inc. (S.D. Cal. 2017)

By Donald Zuhn --

Last month, in Natural Alternatives International, Inc. v. Allmax Nutrition, Inc., District Judge Marilyn L. Huff of the U.S. District Court for the Southern District of California denied a Motion for Reconsideration filed by Plaintiff Natural Alternatives International, Inc. ("NAI"), and determined that NAI's claim for patent infringement remained dismissed with prejudice.  In its complaint, NAI alleged, inter alia, that Defendant Allmax Nutrition, Inc. ("Allmax") infringed NAI's U.S. Patent Nos. 5,965,596; 7,504,376; 7,825,084; and RE45,947 by offering to sell and selling dietary supplements containing beta-alanine in the United States.

In response to NAI's complaint, Allmax filed a motion to dismiss for lack of personal jurisdiction, and NAI countered with a first amended complaint adding HBS International Corp. ("HBS") as a Defendant.  Allmax again responded by filing a motion to dismiss for lack of personal jurisdiction, which the District Court denied.  Allmax then filed a motion for judgment on the pleadings and HBS filed a motion to dismiss, both of which the District Court granted, with the Court determining that all four patents-in-suit were invalid under 35 U.S.C. § 101 for claiming ineligible subject matter.  NAI then moved for reconsideration of the District Court's order dismissing NAI's claim for patent infringement on the grounds that the patents-in-suit are invalid under 35 U.S.C. § 101.

The patents-in-suit are directed to compositions, dietary supplements, and methods of regulating hydronium ion concentrations in a subject/human.  In particular, representative claim 1 of the '596 patent recites:

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.

Representative claims 1, 7, 8, and 11 of the '376 patent recite:

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-alanylhistidine di-peptide.

7.  A composition comprising at least 0.2, 0.3, 0.4, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5 or 5 grams of a peptide or an ester comprising a beta-alanine per dosage.

8.  A composition comprising at least 0.2, 0.3, 0.4, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 grams of a peptide or an ester comprising a beta-alanine in an injectable form per dosage.

11.  A composition for humans comprising at least 200, 250, 300, 450, 500, 550, 600, 650, 700, 750 or 800 mg of a beta-alanine per dosage.

Representative claims 1, 5, 9, and 13 of the '084 patent recite:

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.

5.  A composition for increasing beta-alanylhistidine dipeptide in a subject, comprising a mixture of creatine and anserine or balenine in an amount for increasing beta-alanylhistidine dipeptide in a subject.

9.  A dietary supplement, comprising a mixture of creatine and anserine or balenine.

13.  A method of regulating hydronium ion concentration in a tissue of a subject, comprising administration of a composition comprising a mixture of creatine and anserine or balenine to the subject to increase beta-alanylhistidine dipeptide synthesis in a tissue, whereby the anaerobic working capacity of the tissue is increased.

Representative claims 34 and 35 recite:

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.

35.  A human dietary supplement for increasing human muscle tissue strength comprising a mixture of creatine monohydrate, 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.

In its motion for reconsideration, NAI argued that the District Court had clearly erred, in its order dismissing NAI's claim for patent infringement, in concluding that the patents-in-suit are invalid under 35 U.S.C. § 101 for claiming ineligible subject matter.  Allmax and HBS contended that NAI's motion for reconsideration should be denied because the motion offered arguments and evidence that NAI either already presented, or could have previously presented, to the Court, and because all of the new arguments presented in the motion lacked merit.  Stating that "Plaintiff's attempt to relitigate Defendants' Alice motions through a motion for reconsideration is improper," the District Court denied NAI's motion for reconsideration.

The Court also noted that NAI, in its motion for reconsideration, "generally argues that the scientific evidence in [its first amended complaint] and the patents-in-suit confirm that the inventive concept of the patents-in-suit is to unnaturally over-supplement the normal/natural levels of beta-alanine in the diet of an individual unnaturally over time to achieve an unnatural high level of carnosine synthesis in the individual."  The Court indicated, however, that even if it were to accept NAI's argument regarding the inventive concept of the patents-in-suit:

[T]his "inventive concept" would still be insufficient to render the patents-in-suit subject matter eligible under § 101.  This "inventive concept" as described by Plaintiff still only describes a natural law: the relationship between supplementing the level of beta-alanine in an individual's diet with the carnosine synthesis that occurs in the individual's tissue.  Plaintiff contends that if the patents are directed to achieving an unnaturally high level of carnosine synthesis, then the patents are not directed to a natural law and are subject matter eligible.  . . .  Plaintiff is wrong.  Even if the patents-in-suit relate to achieving an unnaturally high level of carnosine synthesis, the relationship between beta-alanine supplements in one's diet and the achievement of an unnaturally high level of carnosine synthesis is still a natural process that exists in principle apart from any human action and, thus, is a natural law.

Noting that the Supreme Court's decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) is instructive to the instant case, the District Court explained that "here, Plaintiff's proposed inventive concept merely sets forth a law of nature—the relationship between a diet containing beta-alanine supplements and the level of carnosine synthesis in the individual's tissue."

NAI also argued in its motion for reconsideration that the District Court erred by refusing to adopt NAI's proposed claim constructions.  However, the Court reminded NAI that in performing its prior Alice analysis, the Court accepted NAI's claim constructions.  Moreover, the Court noted that "Plaintiff's claim construction argument is based on its incorrect assumption that its proposed construction for the term 'human dietary supplement' renders the claims patent eligible and valid under § 101."  Explaining that "the patents-in-suit acknowledge in their specifications that placing a natural substance into a dietary supplement to increase the function of tissues is conventional activity," the Court stated that:

Because placing a natural substance into a human dietary supplement to increase the function of tissues 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."

In response to NAI's argument that the Court refused to consider and apply U.S. Patent and Trademark Office guidance regarding subject matter eligibility, the District Court stated that "[t]he Court could not have erred by failing to consider PTO guidance that Plaintiff failed to present to the Court."  The Court also noted that the USPTO guidance was not binding on the Court.

The District Court therefore denied NAI's motion for reconsideration and determined that NAI's claim for patent infringement remained dismissed.

Natural Alternatives International, Inc. v. Allmax Nutrition, Inc. (S.D. Cal. 2017)
Order Denying Plaintiff's Motion for Reconsideration by District Judge Huff

Comments

[EG]

Hey Don,

The determination in this suit by the district court that the claimed invention is patent-ineligible is, itself, patently absurd on its face. What the district court did in this case is also shameful. Just more evidence that the Mayo/Alice framework is nonsensical.

[Atari Man]

How are claims 34 and 35 ineligible under 101? Where do the things claimed occur in nature? Please, Judge Huff, show me where I can find in nature the mixtures recited in claims 34 and 35.

Another case of a judge making her life easier by conflating the 102 and 103 inquiries with 101, without having to go through a Markman hearing first. Phooey on youey.

[skeptical]

This appears to NOT be an isolated incident.

See http://www.ipwatchdog.com/2017/09/17/patent-battle-generic-inomax-leaves-five-mallinckrodt-patents-invalid/

[Martin H Snyder]

I have a hard time following this ruling. Isn't every drug's action a natural phenomenon?

[Skeptical]

Mr. Snyder,

The short answer is "yes."

Drug's work (have utility) ONLY through a natural reaction. That is what is especially pernicious here. There are no drugs that have utility (in and of themselves) WITHOUT the "act of nature."

So (if the logic here stands), you have the Hobson's choice of no utility (in and of the drug itself) or a reliance on a "law of nature" - either of which removes patent eligibility.

Those advocating for the Supreme Court (being Supreme) and legislating from the bench should be careful of that which they wish for, as they may well get it.

[Atari Man]

Skeptical, I'll see your "yes" and raise you: all of science is predicated on natural phenomena, the idea that things will always behave the same way under identical conditions. This decision, taken to its logical conclusion, would mean that nothing is patentable, because everything is a natural phenomenon.

[EG]

Atari Man/Skeptical,

For what you said is why 35 USC 101 should be interpreted AS WRITTEN, with NO EXCEPTIONS allowed. That's why SCOTUS' nonsensical Mayo/Alice framework has unhinged the determination of patent-eligibility from any sense of logic or law.

[skeptical]

Atari Man,

All that we have is a Flash of Genius to peer into what happens anyway (in nature).

We, as humans, must still operate in THIS universe, and according to the laws of this universe.

The problem is not "the logical conclusion" or even "taking the logical conclusion too far."

The problem is forgetting that patents are a good thing and that we WANT patents - more of them, faster, and with more assurance that they will be enforced.

The key then is to stay away from the slippery slope of "exceptions" to begin with.

ESPECIALLY when things like "abstract" and "significantly more" are NOT defined and left up to some later judicial member to consider "I know it when I see it."