5:25-cv-00442
Wiser Concepts LLC v. Biological Prospects LLC
I. Executive Summary and Procedural Information
Parties & Counsel:
- Plaintiff: Wiser Concepts, LLC (Kentucky)
- Defendant: Biological Prospects, LLC (d/b/a Thrive Animal Health & Equithrive) (Kentucky)
- Plaintiff’s Counsel: Reminger Co., L.P.A.
Case Identification: 5:25-cv-00442, E.D. Ky., 11/26/2025
Venue Allegations: Venue is asserted on the basis that the Defendant is domiciled within the Eastern District of Kentucky.
Core Dispute: Plaintiff alleges that Defendant’s equine nutritional supplement infringes a patent related to methods of treating equine metabolic conditions using a composition of leucine and resveratrol.
Technical Context: The technology addresses equine metabolic syndrome, a prevalent and serious health condition in horses, by providing a nutritional supplement as an alternative or complement to pharmaceutical treatments.
Key Procedural History: The complaint alleges that Plaintiff sent a notification email to Defendant identifying the patent-in-suit and the potential infringement on May 27, 2025, and that Defendant acknowledged receipt on May 30, 2025, establishing a basis for pre-suit knowledge.
Case Timeline
| Date | Event |
|---|---|
| 2018-10-25 | U.S. Patent No. 10,568,352 Priority Date (Filing Date) |
| 2020-02-25 | U.S. Patent No. 10,568,352 Issued |
| c. April 2025 | Accused MetaCare product launched |
| 2025-05-27 | Plaintiff sent infringement notification email to Defendant |
| 2025-05-30 | Defendant acknowledged receipt of notification email |
| 2025-11-26 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,568,352 - NUTRITIONAL COMPOSITIONS AND METHODS OF TREATMENT THEREWITH, Issued February 25, 2020
The Invention Explained
- Problem Addressed: The patent describes the prevalence of equine metabolic syndrome (EMS) and related conditions in horses, which are characterized by an inability to regulate insulin and can lead to obesity and laminitis, a debilitating foot disease that may require euthanasia (’352 Patent, col. 1:21-38). The background notes that existing treatments can be complicated, creating a need for better preventative and therapeutic options (’352 Patent, col. 1:33-38).
- The Patented Solution: The invention provides nutritional compositions and methods for treating or preventing EMS by administering a combination of the amino acid leucine and the polyphenol resveratrol (’352 Patent, Abstract; col. 2:5-10). The specification discloses that this specific combination produces an "unexpected and synergistic effect," leading to improvements in health parameters such as lowered insulin levels, increased high-molecular-weight adiponectin, and healthy weight loss in equines (’352 Patent, col. 7:34-42; FIG. 1).
- Technical Importance: The patented method provides a nutritional, non-pharmaceutical approach for managing a significant health risk in the equine industry.
Key Claims at a Glance
- The complaint asserts at least independent claim 1 (Compl. ¶29).
- The essential elements of independent claim 1 are:
- A method of treating or preventing equine metabolic syndrome or equine insulin dysregulation in an equine in need thereof, comprising:
- administering to the equine a nutritional composition
- including a therapeutically effective amount of leucine and resveratrol.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant's "MetaCare" pellets product (Compl. ¶20).
Functionality and Market Context
- The complaint alleges that "MetaCare" is a nutritional composition marketed for equines with claims of providing "metabolic support," supporting "optimum carbohydrate and fat metabolism, healthy body weight and appropriate insulin levels" (Compl. ¶23).
- The product is alleged to contain resveratrol as a listed active ingredient and alfalfa meal, which the complaint states is a "significant source of leucine" (Compl. ¶21). The complaint references a product description, Exhibit B, which allegedly details the product's marketing claims and ingredients (Compl. ¶23).
- To support the presence of leucine, the complaint cites an amino acid analysis, attached as Exhibit C, which allegedly found "more than 400 milligrams of leucine" in a daily serving of "MetaCare" (Compl. ¶22).
IV. Analysis of Infringement Allegations
'352 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating or preventing equine metabolic syndrome or equine insulin dysregulation in an equine in need thereof, comprising: | Defendant's marketing allegedly encourages customers to use MetaCare for these specific purposes by advertising it for "metabolic support" and maintaining "appropriate insulin levels," conditions aligned with the patent's stated purpose. | ¶23 | col. 1:21-38 |
| administering to the equine a nutritional composition | Defendant’s customers are alleged to directly infringe by administering the MetaCare product to their horses, an act allegedly induced by Defendant's instructions and marketing. | ¶24, ¶29 | col. 2:5-10 |
| including a therapeutically effective amount of leucine and resveratrol. | The MetaCare product is alleged to contain 800 mg of resveratrol per serving as a listed active ingredient. It is also alleged to contain over 400 mg of leucine per serving, sourced from its alfalfa meal component. The complaint asserts these amounts are capable of having a positive health effect. | ¶21, ¶22 | col. 4:4-9 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the claim term "nutritional composition including... leucine" is met when leucine is present as a natural constituent of an ingredient listed as "inactive" (alfalfa meal), rather than being a separately added, active component. The Defendant may argue that the invention contemplates a specific, formulated combination of active ingredients, not the incidental presence of an amino acid in a base material.
- Technical Questions: The analysis may focus on whether the alleged quantities of leucine and resveratrol in MetaCare constitute a "therapeutically effective amount." While the complaint alleges the amounts are sufficient to produce a positive effect, this is a factual question that may require expert testimony regarding the clinical impact of the accused product's specific formulation.
V. Key Claim Terms for Construction
The Term: "therapeutically effective amount"
- Context and Importance: The infringement analysis depends entirely on whether the quantities of leucine and resveratrol in the accused product meet this threshold. Its definition will determine the level of clinical efficacy Plaintiff must prove.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent provides an explicit definition, stating the term refers to an amount "that is capable of having any detectable, positive effect on any symptom, aspect, or characteristics of a disease state or condition. Such effect need not be absolute to be beneficial" (’352 Patent, col. 4:4-9). This language may support a low threshold for infringement.
- Evidence for a Narrower Interpretation: The patent's "Working Example 1" details specific dosages that produced statistically significant health improvements in a controlled study (’352 Patent, col. 7:34-47, col. 8:37-56). A defendant could argue that a "therapeutically effective amount" should be construed in light of these examples to mean an amount capable of producing a similar, statistically significant clinical outcome, not just any "detectable" effect.
The Term: "nutritional composition including"
- Context and Importance: This term is critical because the leucine in the accused product is allegedly sourced from alfalfa meal, not added as a discrete ingredient. Practitioners may focus on this term because its construction will determine whether the mere presence of a claimed element within a larger, multi-component ingredient satisfies the claim limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain meaning of "including" is broad and non-limiting. The claim language does not specify the source of the leucine or require it to be in a purified or isolated form.
- Evidence for a Narrower Interpretation: The specification describes embodiments by weight percentages of the overall composition (e.g., "leucine in an amount of 0.5% to 25% of the nutritional composition by weight") (’352 Patent, col. 1:47-49). This may suggest that the inventor contemplated formulating the composition with a specific, measured amount of leucine as a distinct component, rather than relying on its variable presence within a filler ingredient.
VI. Other Allegations
Indirect Infringement: The complaint pleads a single count for induced infringement under 35 U.S.C. § 271(b) (Compl. ¶28-32). It alleges Defendant knowingly encourages its customers to perform the patented method through its product marketing, website descriptions, and instructions for use, which are allegedly tailored to treating or preventing the conditions recited in claim 1 (Compl. ¶23). The complaint further alleges Defendant was aware of its customers' infringing use via customer reviews posted on its website (Compl. ¶24, ¶26).
Willful Infringement: The complaint alleges that Defendant's infringement has been willful, basing this on alleged pre-suit knowledge of the ’352 Patent. The complaint cites a May 27, 2025 notification email and Defendant's subsequent confirmation of receipt on May 30, 2025, as evidence of this knowledge (Compl. ¶25, ¶31).
VII. Analyst’s Conclusion: Key Questions for the Case
A core issue will be one of ingredient sourcing and claim scope: Can the claim "including... leucine" be satisfied by the presence of leucine as a natural constituent within an "inactive" ingredient like alfalfa meal, or does the patent’s context require leucine to be a specifically formulated, active component of the nutritional blend?
A key evidentiary question will be one of clinical efficacy: Does the accused product's formulation deliver a "therapeutically effective amount" of its key compounds? The case may turn on the factual dispute over whether the product is merely "capable of having any detectable, positive effect," as per the patent’s broad definition, or whether a higher, clinically significant standard of proof, guided by the patent's working examples, is required.
A central question for induced infringement will be specific intent: Can the Plaintiff prove that Defendant, by marketing a product with resveratrol as an active ingredient and alfalfa as an inactive one, specifically intended to encourage its customers to infringe a patent that requires a combination of both leucine and resveratrol for a therapeutic purpose?