DCT

6:21-cv-00144

ThermoLife Intl LLC v. Human Power Of N Co

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 6:21-cv-00144, W.D. Tex., 02/11/2021
  • Venue Allegations: Venue is alleged to be proper because the Defendant is incorporated in Texas and maintains a regular and established place of business within the Western District of Texas.
  • Core Dispute: Plaintiff alleges that Defendant’s dietary supplement products infringe three patents related to compositions and methods using amino acids, nitrates, and/or nitrites to enhance physical performance.
  • Technical Context: The technology concerns nutritional supplements designed to improve physiological efficiency and performance during exercise by modulating the body's nitric oxide pathways.
  • Key Procedural History: Plaintiff previously sued Defendant in the District of Arizona in 2016 for infringement of the ’140 Patent, a case that was voluntarily dismissed without prejudice by Plaintiff in 2018 due to changes in venue law. The complaint also alleges that the ’140 and ’531 Patents have been reexamined by the USPTO. Plaintiff alleges it provided Defendant with specific pre-suit notice of infringement for all three asserted patents, including warning letters for the ’531 Patent (2016) and the ’968 Patent (2019).

Case Timeline

Date Event
2007-02-26 Priority Date for ’140 and ’968 Patents
2007-09-18 Priority Date for ’531 Patent
2013-06-04 U.S. Patent No. 8,455,531 Issues
2014-01-01 Earliest Alleged Infringement by Defendant ("at least 2014")
2015-11-10 U.S. Patent No. 9,180,140 Issues
2016-06-27 Prior Lawsuit Filed on ’140 Patent in D. Ariz.
2016-12-30 Alleged Warning Letter Sent Regarding ’531 Patent
2018-01-01 Prior Lawsuit on ’140 Patent Voluntarily Dismissed
2019-12-27 Alleged Warning Notice Sent Regarding ’968 Patent
2020-02-11 U.S. Patent No. 10,555,968 Issues
2021-02-11 Complaint Filed

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

U.S. Patent No. 9,180,140 - “Performance enhancing composition and use thereof” (Issued Nov. 10, 2015)

  • The Invention Explained:
    • Problem Addressed: The patent’s background section notes that while nitric oxide (NO) is known to play a role in exercise physiology, information on how to supplement it for healthy athletes is "both insufficient and contradictory" (’140 Patent, col. 2:15-18). It further notes that studies on administering exogenous NO are scarce (’140 Patent, col. 2:18-21).
    • The Patented Solution: The invention is a method of enhancing physical performance by administering inorganic nitrate and/or nitrite, which are then converted in the body to bioactive NO through a pathway distinct from the conventional L-arginine-based methods (’140 Patent, col. 2:25-45). This administration is claimed to result in reduced oxygen consumption (VO2) during exercise, indicating improved muscular efficiency (’140 Patent, Abstract; col. 3:50-55).
    • Technical Importance: The invention proposed a novel biological pathway for performance enhancement (the nitrate-nitrite-NO pathway) at a time when many supplements focused on the less direct L-arginine pathway (’140 Patent, col. 2:22-24).
  • Key Claims at a Glance:
    • The complaint asserts independent claim 1 and reserves the right to assert others (Compl. ¶¶ 28, 31).
    • Essential Elements of Independent Claim 1:
      • A method for non-therapeutically reducing oxygen consumption (VO2) of a human and enhancing physical performance of a human during physical exercise.
      • The method comprises orally administering inorganic nitrate and/or nitrite to the human up to three days prior to the exercise.
      • The administration is in a dose of about 0.01-10 mmol inorganic nitrate/kg bodyweight/day and/or of about 0.001-1 mmol inorganic nitrite/kg bodyweight/day.
      • The administration results in reduced oxygen consumption (VO2) and enhanced physical performance compared to performance in the absence of such administration.

U.S. Patent No. 8,455,531 - “Amino acid compositions” (Issued Jun. 4, 2013)

  • The Invention Explained:
    • Problem Addressed: The patent seeks to design new amino acid compositions with properties, such as improved bioabsorption and increased vasodilative characteristics, that are lacking in conventional amino acid or nitrate/nitrite supplements when taken alone (’531 Patent, col. 1:21-25; col. 2:54-67).
    • The Patented Solution: The invention, as amended by reexamination, is a solid supplement formulation that is a composition of at least two separate compounds: a non-ester nitrate compound and an isolated amino acid selected from a specific list (’531 Reexam. Cert. C1, col. 2:20-33). By combining these separate ingredients, the formulation aims to leverage the benefits of each component synergistically (’531 Patent, col. 25:1-26:53).
    • Technical Importance: This approach provided a way to create more bioavailable and potent nutritional supplements by physically combining known performance-enhancing ingredients (amino acids and nitrates) rather than creating new, chemically-bonded molecules.
  • Key Claims at a Glance:
    • The complaint asserts independent claim 62 and reserves the right to assert others (Compl. ¶¶ 28, 52).
    • Essential Elements of Independent Claim 62 (as reexamined):
      • A solid supplement formulation comprising:
      • at least one non-ester nitrate compound; and
      • at least one isolated amino acid compound selected from a group including Agmatine, Beta Alanine, Citrulline, L-Histidine, and others.
      • The at least one isolated amino acid is a separate compound from the at least one non-ester nitrate compound.

U.S. Patent No. 10,555,968 - “Performance enhancing composition and use thereof” (Issued Feb. 11, 2020)

  • Technology Synopsis: The patent describes a composition for enhancing performance, manifested as reduced oxygen uptake during exercise (’968 Patent, Abstract). The solution involves a composition comprising a nitrite salt and a botanical source of nitrate, where the two components are present in a specific molar ratio (5:1 to 100:1 nitrate-to-nitrite) and the nitrite is provided in a specific dosage range (’968 Patent, col. 18:45-53).
  • Asserted Claims: The complaint asserts independent claim 45 (Compl. ¶67).
  • Accused Features: The SuperBeets and BeetElite products are accused of infringement. The complaint alleges these products are compositions containing a nitrite salt (sodium nitrite) and a botanical source of nitrate (from beets) that meet the claimed molar ratio and dosage requirements (Compl. ¶¶ 68-73, 79-80).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are the "SuperBeets," "BeetElite," and "Neo40" dietary supplement products (Compl. ¶17).
  • Functionality and Market Context:
    • The accused products are formulated as powders or tablets containing inorganic nitrates and nitrites, allegedly derived from botanical sources like beets (Compl. ¶19). The Neo40 product is also alleged to contain the amino acid L-citrulline (Compl. ¶20, ¶57).
    • The products are marketed, sold, and promoted with claims of enhancing physical performance, such as by improving energy, stamina, and oxygen efficiency during exercise (Compl. ¶¶ 23, 42). The complaint notes they are sold through major distributors like Amazon.com and GNC Corporation (Compl. ¶21).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,180,140 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for non-therapeutically reducing oxygen consumption (VO2) of a human and enhancing physical performance of a human during physical exercise, the method comprising: Defendant markets and sells the Accused Products with instructions encouraging customers to consume them to enhance exercise performance (Compl. ¶34). Defendant's marketing materials for BeetElite, for instance, claim it "Promotes oxygen efficiency" and "significantly reduces oxygen cost of exercise" (Compl. ¶42, Ex. 5, 8). ¶¶30, 34, 42 col. 3:50-55
orally administering inorganic nitrate and/or nitrite to said human up to three days prior to the human performing physical exercise Defendant instructs customers to orally consume its products daily and/or prior to exercise (Compl. ¶34). The Neo40 product label, for example, provides instructions for daily oral consumption of tablets (Compl. p. 15, ¶57). ¶¶31, 34 col. 7:1-9
in a dose of about 0.01-10 mmol inorganic nitrate/kg bodyweight/day and/or of about 0.001-1 mmol inorganic nitrite/kg bodyweight/day; The complaint alleges that the recommended daily dosages of the Accused Products, based on independent lab testing, provide amounts of nitrate/nitrite that fall within the claimed range for Americans of average bodyweight (Compl. ¶¶36-37). ¶¶31, 36-37 col. 10:59-65
wherein administration of said inorganic nitrate and/or nitrite will result in reduced oxygen consumption (VO2) in and enhanced physical performance of said human... as compared with... performance... in the absence of administration... The complaint cites scientific studies, including one on the Neo40 product, and marketing materials promoted by Defendant, which allegedly report that administration of the products results in reduced oxygen consumption, lower respiratory exchange rate, and enhanced work efficiency compared to placebo (Compl. ¶35). ¶¶31, 35 col. 4:10-18
  • Identified Points of Contention:
    • Scope Question: A potential point of dispute may be the term "non-therapeutically." Defendant could argue that a supplement marketed to "enhance physical performance" provides a therapeutic benefit, thereby falling outside the scope of the claim.
    • Technical Question: The allegation that the products deliver a dose within the claimed range relies on calculations using "average" body weights and third-party lab testing (Compl. ¶¶36-37). The factual accuracy of the lab tests and the applicability of average weights to the entire class of users may become a point of contention.

U.S. Patent No. 8,455,531 Infringement Allegations

Claim Element (from Independent Claim 62) Alleged Infringing Functionality Complaint Citation Patent Citation
A solid supplement formulation comprising: The Neo40 product is sold as a solid "tablet" and Defendant has described it in other court proceedings as a "supplement" that it "creates and markets" (Compl. ¶¶55, 57). The complaint includes a visual of the Neo40 product label, which identifies the product as a "Supplement" in tablet form (Compl. p. 15, ¶57). ¶¶52, 55, 57 col. 2:20-21
at least one non-ester nitrate compound; and The Neo40 product is alleged to contain "Beet Root Powder (root)" and "Sodium Nitrite," both of which are identified as non-ester nitrate/nitrite compounds (Compl. ¶¶57-58). ¶¶52, 57-58 col. 2:22-23
at least one isolated amino acid compound selected from the group consisting of Agmatine, Beta Alanine, Citrulline, L-Histidine, Norvaline, Ornithine, Aspartic Acid, Cysteine, Glycine, Lysine, Methionine, Proline, Tyrosine, and Phenylalanine, The Neo40 product ingredients list explicitly includes "L-citrulline," which is one of the amino acids enumerated in the claim (Compl. ¶57). ¶¶52, 57 col. 2:24-30
wherein the at least one isolated amino acid is a separate compound than the at least one non-ester nitrate compound. The complaint alleges that L-citrulline and the non-ester nitrate sources (Beet Root Powder, Sodium Nitrite) are included as separate and distinct ingredients in the Neo40 formulation. The product label lists "L-citrulline" and "Beet Root Powder" as distinct items within the "Proprietary Nitric Oxide Blend" (Compl. ¶57). ¶¶52, 57 col. 2:31-33
  • Identified Points of Contention:
    • Scope Question: The infringement analysis hinges on the interpretation of "separate compound." The question for the court will be whether a simple mixture of distinct powdered ingredients (e.g., L-citrulline and beet root powder) that are subsequently blended and pressed into a tablet satisfies this limitation, or if a higher degree of physical or chemical separation within the final dosage form is required.
    • Technical Question: Infringement relies on the assertion that "Beet Root Powder" is a "non-ester nitrate compound" (Compl. ¶58). A technical dispute could arise over the precise chemical state of nitrate as it exists naturally within processed beet root powder.

V. Key Claim Terms for Construction

Term: “non-therapeutically” (’140 Patent, Claim 1)

  • Context and Importance: This term appears in the preamble of the asserted method claim and is critical for defining the boundary between the patented method and regulated medical treatments. Practitioners may focus on this term because its interpretation will determine whether supplements marketed for athletic performance enhancement—a use that improves bodily function—fall within the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide an explicit definition, suggesting the term should be given its plain and ordinary meaning. The specification's focus on "sport drinks, energy drinks and energy bars" for "athletes" and "non-athletes" suggests an intended scope covering the nutritional supplement field, distinguishing it from the treatment of diagnosed diseases (’140 Patent, col. 1:8-10, 1:20-24).
    • Evidence for a Narrower Interpretation: An argument could be made that any method intended to alter or enhance a physiological function is inherently "therapeutic." The specification's reference to effects like reducing blood pressure could be used to argue that the patent's context is not entirely divorced from therapeutic outcomes (’140 Patent, col. 5:22-24).

Term: “separate compound” (’531 Patent, Claim 62)

  • Context and Importance: This term is the core of the infringement theory for the ’531 Patent. The case may turn on whether combining powdered ingredients into a homogenous tablet constitutes a formulation of "separate" compounds. Practitioners may focus on this term because the reexamination process specifically introduced this language, indicating its significance in establishing patentability over the prior art.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The reexamined claim recites a "solid supplement formulation comprising" the separate compounds, which may support an interpretation that the "separateness" refers to the chemical identity of the ingredients before they are formulated, not their physical arrangement in the final tablet (’531 Reexam. Cert. C1, col. 2:20-33). The patent contrasts such compositions with chemically-bonded compounds like "Arginine Nitrate" (’531 Patent, col. 8:50-55), suggesting "separate" means not chemically bonded together.
    • Evidence for a Narrower Interpretation: A defendant might argue that in the context of a "solid supplement formulation," the term "separate" implies some form of physical partition in the final product (e.g., layers, distinct granules, micro-encapsulation). The specification does not appear to offer explicit examples of such partitioning, but the argument would center on giving the term its full functional meaning within the claim's context.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement of the ’140 Patent, stating Defendant encourages its customers to perform the patented method through its "Recommended Daily Dosages," promotional materials, websites, and marketing claims that instruct users to take the products to achieve reduced oxygen consumption and enhance performance (Compl. ¶¶ 34, 41-42). It is also alleged that the products are not suitable for substantial noninfringing uses when taken as directed (Compl. ¶43).
  • Willful Infringement: Willfulness is alleged for all three patents. The complaint asserts that Defendant had knowledge of the ’140 Patent since at least June 2016 due to a prior lawsuit (Compl. ¶40), knowledge of the ’531 Patent since at least a December 2016 warning letter (Compl. ¶63), and actual notice of the ’968 Patent from a December 2019 warning letter sent while the patent was pending (Compl. ¶86).

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

  • A core issue will be one of claim construction and scope: can the term “separate compound” in the ’531 Patent be construed to cover a simple mixture of powdered ingredients pressed into a homogenous tablet, as alleged, or does it require a form of physical partitioning that the accused product lacks? Similarly, does the term “non-therapeutically” in the ’140 Patent exclude the marketing of supplements for athletic performance enhancement?
  • A key evidentiary question will be one of factual infringement: can Plaintiff produce sufficient evidence to show that Defendant’s products, when used as directed by a consumer, necessarily practice the asserted method of the ’140 Patent? This will likely involve a battle of experts over the interpretation of scientific studies and the accuracy of dosage calculations based on product testing and population averages.
  • A third central issue will be willfulness: given the extensive history of alleged pre-suit notice, including a prior lawsuit and multiple specific warning letters, the court will have to determine whether Defendant’s continued sales constituted objectively reckless conduct sufficient to warrant enhanced damages under 35 U.S.C. § 284.