DCT
5:19-cv-01548
RK Solutions LLC v. Shinhigh Intl Corp
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: RK Solutions, LLC (Utah) and Axcess Global Sciences, LLC (Utah)
- Defendant: Shinhigh International Corp. (California)
- Plaintiff’s Counsel: Brown, Neri, Smith & Khan LLP; Law Office of Ryan E. Hatch, PC
- Case Identification: 5:19-cv-01548, C.D. Cal., 08/19/2019
- Venue Allegations: Venue is alleged to be proper in the Central District of California because Defendant resides in the district, has committed alleged acts of infringement there, and maintains a regular and established place of business in the district.
- Core Dispute: Plaintiffs allege that Defendant’s line of beta-hydroxybutyrate (BHB) dietary supplements infringes a patent related to compositions and methods for causing weight loss.
- Technical Context: The technology relates to chemical compositions for use as dietary supplements, specifically leveraging butyric acid and its derivatives to suppress appetite and thereby manage weight.
- Key Procedural History: The asserted patent was the subject of an Inter Partes Review (IPR), Trial No. IPR2019-01141, filed with the Patent Trial and Appeal Board on June 3, 2019, prior to the filing of this complaint. An IPR Certificate issued on September 2, 2021, confirmed the cancellation of claims 1, 14, and 17—the three independent claims asserted in this litigation.
Case Timeline
| Date | Event |
|---|---|
| 2000-10-10 | '356 Patent Priority Date |
| 2003-09-02 | '356 Patent Issue Date |
| 2019-06-03 | Inter Partes Review (IPR2019-01141) filed against '356 Patent |
| 2019-08-19 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,613,356 - "Weight loss medication and method," issued September 2, 2003
The Invention Explained
- Problem Addressed: The patent identifies a need for weight loss medications that avoid the significant side effects, limited duration of use, and potential for addiction associated with prior art drugs that act on the central nervous system or inhibit fat absorption ('356 Patent, col. 1:25-46).
- The Patented Solution: The invention proposes the oral administration of butyrate and its closely related chemical compounds to suppress appetite ('356 Patent, col. 2:18-22). The specification theorizes that the presence of these compounds in the stomach signals to receptors that there is stagnant food, which in turn signals to the brain via the vagus nerve to suppress appetite, effectively mimicking the feeling of fullness ('356 Patent, col. 3:9-39). The formulation may also include gas-generating substances like sodium bicarbonate to facilitate the dispersion of the active ingredients in the stomach ('356 Patent, col. 4:45-58).
- Technical Importance: The use of butyrate compounds is presented as advantageous because they are naturally occurring substances in the mammalian intestine, suggesting they would have minimal toxicity and could be used for longer periods than other weight loss medications ('356 Patent, col. 2:27-33, 49-52).
Key Claims at a Glance
- The complaint asserts independent claims 1, 14, and 17 (Compl. ¶11).
- Independent Claim 1 (Method): A process for causing weight loss or avoidance of weight gain in a mammal, which includes the element of:
- Orally administering to the mammal butyric acid or one or more of its pharmaceutically effective and acceptable salts or derivatives, selected from a specific list of compounds including betahydroxybutyric acid and its salts.
- Independent Claim 14 (Composition): A composition of matter, which includes the elements of:
- A capsule capable of dissolving in a mammal's stomach.
- The capsule contains, in an amount effective for weight loss, one or more compounds selected from the same specific list as in claim 1.
- Independent Claim 17 (Composition): A composition of matter, which includes the elements of:
- A tablet capable of dissolving in a mammal's stomach.
- The tablet contains, in an amount effective for weight loss, one or more compounds selected from the same specific list as in claim 1.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Defendant’s "BHB Products," which are identified as including calcium betahydroxybutyrate, magnesium betahydroxybutyrate, sodium betahydroxybutyrate, and potassium betahydroxybutyrate (Compl. ¶6).
Functionality and Market Context
- The complaint alleges these BHB Products are sold in the form of tablets and capsules (Compl. ¶9). They are advertised and marketed for the purpose of weight loss and avoidance of weight gain (Compl. ¶17). The complaint alleges that Defendant offers these products for sale on its websites and other channels of trade (Compl. ¶¶19-20). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'356 Patent Infringement Allegations (Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A process for causing weight loss, or avoidance of weight gain, in mammals, | End-users, including Defendant's customers, use the BHB Products in processes for causing weight loss or avoidance of weight gain. | ¶21 | col. 8:65–col. 9:11 |
| comprising oral administration to said mammals | The BHB Products are orally administered. | ¶16 | col. 8:66-67 |
| of ... one or more pharmaceutically effective and acceptable salts or derivatives of butyric acid selected from the group consisting of ... betahydroxybutyric acid, sodium betahydroxybutyrate, calcium betahydroxybutyrate, potassium betahydroxybutyrate, magnesium betahydroxybutyrate... | The accused BHB Products are alleged to be compositions containing sodium, calcium, potassium, and magnesium betahydroxybutyrate. | ¶6 | col. 9:5-11 |
'356 Patent Infringement Allegations (Claim 14)
| Claim Element (from Independent Claim 14) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition of matter comprising a capsule capable of dissolving in the stomach of a mammal, | Defendant sells BHB Products in the form of capsules that are capable of dissolving in the stomach of a human. | ¶¶19, 26 | col. 10:8-10 |
| wherein said capsule contains, in an amount effective for weight loss or avoidance of weight gain in said mammal, | The capsules allegedly contain the compounds in an amount effective for weight loss, as evidenced by Defendant’s marketing of the products for that purpose. | ¶19 | col. 10:10-12 |
| one or more of the compounds selected from the group consisting of ... sodium betahydroxybutyrate, calcium betahydroxybutyrate, potassium betahydroxybutyrate, magnesium betahydroxybutyrate ... | The accused BHB Products are alleged to include sodium, calcium, magnesium, and potassium betahydroxybutyrate. | ¶¶19-20 | col. 10:17-23 |
'356 Patent Infringement Allegations (Claim 17)
| Claim Element (from Independent Claim 17) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition of matter comprising a tablet capable of dissolving in the stomach of a mammal, | Defendant sells BHB Products in the form of tablets that are capable of dissolving in the stomach of a human. | ¶¶20, 16 | col. 10:36-38 |
| wherein said tablet contains, in an amount effective for weight loss or avoidance of weight gain in said mammal, | The tablets allegedly contain the compounds in an amount effective for weight loss, as evidenced by Defendant’s marketing of the products for that purpose. | ¶20 | col. 10:38-40 |
| one or more of the compounds selected from the group consisting of ... sodium betahydroxybutyrate, calcium betahydroxybutyrate, potassium betahydroxybutyrate, magnesium betahydroxybutyrate ... | The accused BHB Products are alleged to include sodium, calcium, magnesium, and potassium betahydroxybutyrate. | ¶¶20, 28 | col. 10:47-51 |
Identified Points of Contention
- Factual Question: A primary question will be whether the accused BHB Products factually contain the specific salts of betahydroxybutyrate as alleged. While the complaint makes these allegations, they are based "on information and belief" and reference an "Exhibit B" which was not included with the complaint filing, requiring factual discovery for substantiation (Compl. ¶¶19, 20).
- Scope Question: The claims require the compound to be present in "an amount effective for weight loss or avoidance of weight gain." The dispute may center on what constitutes an "effective" amount and whether the accused products meet that threshold, which may be a matter for both claim construction and factual evidence.
V. Key Claim Terms for Construction
- The Term: "an amount effective for weight loss or avoidance of weight gain" (from claims 14 and 17)
- Context and Importance: This term is critical because it defines the dosage threshold required for a composition to be infringing. The infringement analysis will depend on whether the amount of the active ingredient in the accused products meets this functional requirement. Practitioners may focus on this term to argue that the accused products either do or do not contain a sufficient quantity of the claimed compounds to achieve the patented effect.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not explicitly define a minimum effective amount in the claims themselves, which could support an argument for a broader interpretation that covers any non-trivial amount present in a product marketed for weight loss. The specification describes a wide range of possible dosages, from a "starting dose" of 40 mg three times a day up to 1.15 grams three times a day ('356 Patent, col. 7:41-51).
- Evidence for a Narrower Interpretation: A party could argue the term is limited by the dosage levels described in the patent's "Dosages and Tests" and "Test Data" sections ('356 Patent, col. 3:42-60; col. 7-8). For example, the specification notes that a human volunteer's successful dose "averaged 280 mg twice a day" and another's escalated to "1150 mg three times a day" ('356 Patent, col. 7:8-9, 7:50-51). This could support an argument that an "effective amount" must fall within the range of doses demonstrated to be effective in the patent's own examples.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Defendant encourages infringement through "advertising in public and marketing the features, benefits and availability of the BHB Products" and "providing instructions on how to use the BHB Products" (Compl. ¶22). Contributory infringement is alleged on the basis that the BHB Products have "no substantial non-infringing uses" and were "especially made or adapted for use in the infringement" (Compl. ¶¶22-23).
- Willful Infringement: The complaint alleges that "Defendant has had knowledge of the '356 Patent since at least the service of the Complaint in this action" (Compl. ¶15). This allegation appears to support a claim for post-suit willfulness only, as it does not plead any facts suggesting Defendant had knowledge of the patent prior to the lawsuit being filed.
VII. Analyst’s Conclusion: Key Questions for the Case
- A foundational issue is procedural and jurisdictional: given that all asserted independent claims (1, 14, and 17) were subsequently cancelled in a pre-existing IPR proceeding, a threshold question is whether Plaintiffs have any surviving cause of action, potentially rendering the complaint moot.
- A key evidentiary question will be one of factual composition: what is the precise chemical makeup and dosage of the accused BHB Products? The viability of the infringement claims, as pleaded, depends entirely on factual proof that the products contain the specific compounds listed in the claims in a sufficient quantity.
- A central question of claim interpretation will be the scope of functional language: how will the court construe the term "an amount effective for weight loss"? The outcome of this construction could determine whether the dosages in the accused products fall within the scope of the claims, assuming the asserted claims were still valid.