DCT

2:25-cv-00461

Evolution Nutraceuticals Inc v. ThermoLife Intl LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-00461, D. Ariz., 02/12/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Arizona because Defendant Thermolife International, LLC is incorporated in Arizona, maintains a statutory agent in the district, and the accused products are sold in the district.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its dietary supplement products do not infringe Defendant’s patent, which relates to amino acid compositions containing nitrates, and that the patent is invalid.
  • Technical Context: The lawsuit concerns dietary supplements in the cardiovascular health and fitness market, specifically formulations designed to increase nitric oxide production for effects like vasodilation.
  • Key Procedural History: The complaint alleges that the patent-in-suit, U.S. Patent No. 8,455,531, has undergone at least two ex parte reexaminations at the USPTO, resulting in significant claim amendments. Plaintiff bases its non-infringement theory on statements and arguments allegedly made by the Defendant to the USPTO during a 2019 reexamination to distinguish prior art, which may give rise to a prosecution history disclaimer that limits the patent's claim scope.

Case Timeline

Date Event
2007-09-18 ’531 Patent - Earliest Priority Date
2013-06-04 ’531 Patent - Issue Date
2017-01-01 (approx.) Cardio Miracle alleges it began selling Accused Products on Amazon
2019-01-01 (approx.) Thermolife filed request for ex parte reexamination of the ’531 Patent
2025-10-21 Thermolife allegedly filed takedown notices with Amazon regarding Accused Products
2025-02-12 Complaint for Declaratory Judgment filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,455,531 - “Amino Acid Compositions”

  • Issued: June 4, 2013

The Invention Explained

  • Problem Addressed: The patent describes that conventional amino acid supplements can have limited effectiveness due to poor water solubility and bioavailability, which restricts their absorption and utility for purposes like muscle growth or vasodilation (’531 Patent, col. 4:1-5, 4:49-51).
  • The Patented Solution: The invention combines an amino acid with a nitrate or nitrite source. This combination is described as enhancing the bioabsorption and vasodilative properties of the amino acids, potentially by increasing nitric oxide production through multiple biological pathways and improving water solubility (’531 Patent, col. 17:55-59; col. 2:45-65). The patent discloses both creating new chemical compounds (amino acid salts) and creating compositions (mixtures) of separate amino acid and nitrate ingredients (’531 Patent, col. 5:26-44).
  • Technical Importance: The technology proposes a method to increase the efficacy of amino acid supplements, a major category in the sports nutrition and wellness markets, by leveraging the vasodilating properties of the nitrate-to-nitric oxide pathway (’531 Patent, col. 17:27-42).

Key Claims at a Glance

  • The complaint focuses on independent claim 62, which was amended during reexamination (Compl. ¶¶6, 93).
  • The essential elements of independent claim 62 are:
    • A solid supplement formulation comprising:
    • at least one non-ester nitrate compound; and
    • at least one isolated amino acid compound selected from a specific list (including Agmatine, Beta Alanine, Citrulline, etc.);
    • wherein the at least one isolated amino acid compound is a separate compound than the at least one non-ester nitrate compound.
  • The complaint does not explicitly reserve the right to assert dependent claims but seeks a declaration of non-infringement for any claim of the patent (Compl. ¶91).

III. The Accused Instrumentality

Product Identification

  • The "Accused Supplemental Compositions" or "Accused Products" are dietary supplements sold by Plaintiff under the brand name "Cardio Miracle" (Compl. ¶4). A photograph of the product packaging for 'Cardio Miracle' shows the product's branding and supplement facts panel (Compl. p. 6).

Functionality and Market Context

  • The Accused Products are described as a "blend of over 50 ingredients which work together synergistically to promote and sustain the body's natural production of nitric oxide" (Compl. ¶21). The complaint alleges the products are sold in various serving-size pouches and are available through online platforms, including Amazon.com (Compl. ¶¶22-23).
  • The complaint alleges that prior to Amazon takedown notices initiated by the Defendant, the Accused Products had a "high ranking" on the platform, and sales on Amazon accounted for approximately 20% of the Plaintiff's total sales of the products (Compl. ¶¶23, 78).

IV. Analysis of Infringement Allegations

This is a declaratory judgment action for non-infringement. The following chart summarizes Plaintiff Cardio Miracle's allegations as to why its products do not meet the limitations of the asserted patent claim.

’531 Patent Infringement Allegations

Claim Element (from Independent Claim 62) Alleged Non-Infringing Functionality Complaint Citation Patent Citation
A solid supplement formulation comprising: at least one non-ester nitrate compound The Accused Products contain only de minimis or trace amounts of nitrate (3.95 mg in a 10.00 g serving), which Plaintiff alleges is insufficient to satisfy this limitation based on Defendant's own prior statements to the USPTO. ¶¶34, 41, 51 col. 7:4-23
and at least one isolated amino acid compound selected from the group consisting of... The complaint does not dispute that the Accused Products contain amino acids. ¶21 col. 2:45-64
wherein the at least one isolated amino acid compound is a separate compound than the at least one non-ester nitrate compound. The complaint's theory focuses on the quantity of the nitrate compound, not whether it is separate from the amino acid. ¶7 col. 5:26-38

Identified Points of Contention

  • Scope Questions (Prosecution Disclaimer): The central issue is whether Thermolife, during reexamination, disclaimed claim scope over compositions containing only de minimis amounts of nitrates. The complaint alleges Thermolife argued to the USPTO that prior art disclosing 0.02 mg and 0.22 mg of nitrate was "far too low" and represented a "de minimis amount" that did not satisfy the claim limitations (Compl. ¶¶41-42). This raises the question of whether Thermolife is now estopped from asserting that Cardio Miracle's product, with an alleged 3.95 mg of nitrate, infringes the same claims (Compl. ¶52).
  • Technical Questions (Quantitative Sufficiency): The complaint puts the quantitative amount of nitrate at issue. It alleges that Thermolife's expert in the reexamination asserted that a "supplementary amount" of nitrate would be "over" 20-30 mg per meal (Compl. ¶49). The key technical question is whether the 3.95 mg of nitrate alleged to be in the Accused Product provides the functionality described in the patent or is merely a trace amount that has no material effect, as Plaintiff contends (Compl. ¶77).

V. Key Claim Terms for Construction

  • The Term: "non-ester nitrate compound"
  • Context and Importance: The dispute does not center on the chemical definition of this term but on whether it includes an implicit quantitative floor. The entire non-infringement case hinges on whether the allegedly de minimis amount of nitrate in the Accused Products falls outside the scope of this limitation. Practitioners may focus on this term because the Plaintiff argues the patentee gave it a specific meaning during reexamination to overcome prior art.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (No explicit quantitative limit): The plain language of the reexamined claim itself ("at least one non-ester nitrate compound") does not recite a specific minimum quantity or concentration. A party could argue that any non-zero amount satisfies the literal claim language.
    • Evidence for a Narrower Interpretation (Implicit quantitative limit): The complaint alleges that Thermolife, during reexamination, repeatedly distinguished prior art by arguing that the term required a "supplementary amount" of nitrate, not a "de minimis amount" (Compl. ¶¶41, 47-48). The complaint further cites an expert declaration submitted by Thermolife that allegedly defines a supplementary amount as "over 20-30 mg" (Compl. ¶49). These statements, if proven, could be used to argue that Thermolife disclaimed scope over products with only trace or background levels of nitrates.

VI. Other Allegations

  • Bad Faith Infringement Allegations: This is a declaratory judgment action, so the Plaintiff (Cardio Miracle) is not accused of infringement in the complaint. Instead, the Plaintiff alleges that the Defendant (Thermolife) engaged in bad faith assertions of patent infringement against it. The complaint alleges that Thermolife filed "Takedown Notices" with Amazon.com to delist Cardio Miracle's products without conducting proper testing or due diligence, knowing that the products contained only de minimis amounts of nitrate that Thermolife itself had previously argued did not meet the patent's requirements (Compl. ¶¶4, 54, 74). These allegations form the basis for state law claims, including violation of the Arizona Patent Troll Prevention Act (Compl. ¶¶150-154).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of prosecution history disclaimer: Did Thermolife’s arguments to the USPTO during reexamination—characterizing small amounts of nitrate in the prior art as “de minimis” and “far too low” to be infringing—constitute a clear and unmistakable surrender of claim scope? If so, the court must determine whether the 3.95 mg of nitrate in Plaintiff’s product falls within that disclaimed scope.
  • A second pivotal issue is the "Gillette" defense dilemma presented by the Plaintiff: If the claim term "non-ester nitrate compound" is construed broadly enough to cover the trace amounts of nitrate in the Accused Product, is the claim then rendered invalid as anticipated or obvious over prior art (such as foods and other natural supplements) that inherently contains both amino acids and trace amounts of naturally occurring nitrates?
  • A key evidentiary question will be one of factual proof and testing: The Plaintiff’s case rests heavily on its own test results showing 3.95 mg of nitrate per serving. The court will need to resolve any factual disputes over the actual composition of the Accused Products and the level of nitrate required to achieve the functional benefits described in the ’531 Patent.