DCT
2:22-cv-00158
AIM High Investment Group LLC v. Spectrum Laboratories LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Aim High Investment Group, LLC (Nevada)
- Defendant: Spectrum Laboratories, LLC (Ohio)
- Plaintiff’s Counsel: Gile Law Group Ltd.
- Case Identification: 2:22-cv-00158, D. Nev., 01/28/2022
- Venue Allegations: Venue is alleged to be proper in the District of Nevada because Defendant is registered to conduct business in Nevada and maintains a regular and established place of business within the jurisdiction.
- Core Dispute: Plaintiff seeks a declaratory judgment that its synthetic urine product does not infringe Defendant’s patents, and that those patents are invalid, primarily arguing its product lacks the "biocide" required by the patent claims in a sufficient concentration.
- Technical Context: The technology involves compositions for synthetic urine, which are stabilized with biocides to prevent bacterial degradation and extend shelf life for use in applications such as calibrating urinalysis equipment.
- Key Procedural History: This declaratory judgment action was precipitated by a letter from Defendant on August 7, 2020, alleging that Plaintiff's product infringes the patents-in-suit. Subsequent correspondence identified the alleged infringement as being based on the presence of a specific biocide in a trace amount (less than one part per billion), which Plaintiff disputes.
Case Timeline
| Date | Event |
|---|---|
| 2004-01-28 | Priority Date for U.S. Patent No. 7,192,776 |
| 2007-03-20 | Issue Date for U.S. Patent No. 7,192,776 |
| 2013-05-06 | Priority Date for U.S. Patent No. 9,128,105 |
| 2015-09-08 | Issue Date for U.S. Patent No. 9,128,105 |
| 2020-08-07 | Defendant sends letter to Plaintiff alleging infringement |
| 2020-08-28 | Plaintiff sends response letter denying infringement |
| 2022-01-28 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,192,776 - "Synthetic Urine and Method of Manufacturing Same," Issued March 20, 2007
The Invention Explained
- Problem Addressed: The patent describes that existing synthetic urine compositions are susceptible to bacterial degradation ("sepsis") unless used immediately, which makes them "unattractive candidates for mass production and/or consumer sales" due to a lack of shelf stability (’776 Patent, col. 2:35-40).
- The Patented Solution: The invention is a synthetic urine solution that incorporates a biocide to control or eliminate bacteria, thereby preventing sepsis and preserving the product for extended periods (’776 Patent, col. 2:56-58; col. 3:29-33). The solution also contains water, creatinine, and an ionic compound to adjust the specific gravity to mimic that of human urine (’776 Patent, Abstract). This formulation is designed to be a stable, reliable "clean" sample for comparison and calibration purposes.
- Technical Importance: By introducing a biocide to ensure long-term stability, the invention aimed to make mass-produced synthetic urine a viable commercial product.
Key Claims at a Glance
- The complaint identifies independent claims 1, 5, and 10 as being at issue (Compl. ¶20).
- Independent Claim 1 (Composition): A synthetic urine solution comprising (1) water with a specific pH; (2) dissolved creatinine and a biocide, where the biocide is "selected in relative concentrations to minimize sepsis"; (3) a dissociated ionic compound to adjust specific gravity; and (4) the biocide is selected from a specified list of chemicals.
- Independent Claim 5 (Method): A method of manufacturing synthetic urine by (1) providing water; (2) dissolving creatinine and a biocide from the specified list in concentrations "to minimize sepsis"; and (3) adjusting the specific gravity.
- Independent Claim 10 (Method): A method of manufacturing synthetic urine by (1) providing water with a specific pH; (2) dissolving creatinine and an ionic compound; (3) "adding a biocide" from the specified list; and (4) "removing bacteria from said solution."
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 9,128,105 - "Urea-Based Synthetic Urine and Method of Manufacturing Same," Issued September 8, 2015
The Invention Explained
- Problem Addressed: This patent builds on the ’776 Patent, noting that prior art synthetic urine compositions lacked both shelf-stability and the presence of urea, a key component of natural urine (’105 Patent, col. 2:46-52).
- The Patented Solution: The invention adds a "urea-based compound" to the formulation of water, creatinine, and a biocide, creating a more realistic and authentic synthetic urine substitute (’105 Patent, Abstract). The inclusion of the biocide remains central to providing the necessary shelf-stability for a commercially viable product.
- Technical Importance: The addition of urea aimed to increase the authenticity of the synthetic urine, potentially making it more suitable for advanced or more rigorous testing applications where urea presence is expected.
Key Claims at a Glance
- The complaint identifies independent claims 1, 4, and 8 as being at issue (Compl. ¶21).
- Independent Claim 1 (Composition): A synthetic urine solution similar to claim 1 of the ’776 Patent (water, creatinine, biocide in concentrations "to minimize sepsis," ionic compound, and a specified biocide list), but with the additional required element of "at least one urea compound."
- Independent Claim 4 (Method): A manufacturing method similar to claim 5 of the ’776 Patent (dissolving creatinine and a biocide in concentrations "to minimize sepsis"), but with the additional step of "providing at least one urea compound in conjunction with the synthetic urine solution."
- Independent Claim 8 (Method): A manufacturing method similar to claim 10 of the ’776 Patent (dissolving creatinine and an ionic compound, adding a biocide, removing bacteria), but with the additional step of "providing at least one urea compound in conjunction with the synthetic urine solution."
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- Plaintiff’s "XStream" product, described as a "laboratory-made urine product" (Compl. ¶2, 4).
Functionality and Market Context
- The complaint focuses on the chemical composition of the XStream product, alleging what it lacks. The central allegation is that the product "does not contain any of the specific biocides claimed in the Patents-in-Suit" (Compl. ¶12).
- Plaintiff alleges that its own lab analysis of the Accused Product "detected no presence of MIT," which is the biocide Defendant allegedly found in trace amounts (Compl. ¶14). The complaint further argues that even if a trace amount were present, it would not be in a "relative concentration to minimize sepsis" as required by the claims (Compl. ¶23).
- The complaint does not provide detail on the product's market positioning beyond its general description as a synthetic urine product.
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The core of the declaratory judgment complaint is Plaintiff's assertion of non-infringement. The following tables summarize the basis for these assertions as presented in the complaint.
'776 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| creatinine and a biocide, said creatinine and biocide dissolved within said water to form a solution... and said creatinine and biocide selected in relative concentrations to minimize sepsis | The complaint alleges the Accused Product does not contain any of the claimed biocides and that Plaintiff does not add any such biocide during manufacturing. | ¶4, 12, 19 | col. 5:37-41 |
| wherein said biocide is selected from the group consisting of [list of chemical compounds] | The complaint alleges that the Accused Product does not contain the specific biocide methylisothiazolinone ("MIT"), which is a member of the claimed "isothiazolines" group and was allegedly identified by Defendant. | ¶13-14 | col. 5:42-53 |
| selected in relative concentrations to minimize sepsis | The complaint alleges that any trace amount of a biocide that may be present is not in a relative concentration sufficient to minimize sepsis and is "orders of magnitude less" than the concentration provided as an example in the patent's specification. | ¶23, 29 | col. 5:39-41 |
'105 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| creatinine and a biocide, said creatinine and biocide dissolved within said water to form a solution... and said creatinine and biocide selected in relative concentrations to minimize sepsis | The complaint alleges the Accused Product does not contain any of the claimed biocides and that Plaintiff does not add any such biocide during manufacturing. | ¶4, 12, 19 | col. 7:42-46 |
| wherein said biocide is selected from at least one of [list of chemical compounds] | The complaint alleges that the Accused Product does not contain the specific biocide methylisothiazolinone ("MIT"), which is a member of the claimed "isothiazolines" group and was allegedly identified by Defendant. | ¶13-14 | col. 7:49-60 |
| selected in relative concentrations to minimize sepsis | The complaint alleges that any trace amount of a biocide that may be present is not in a relative concentration sufficient to minimize sepsis and is "orders of magnitude less" than the concentration provided as an example in the related '776 patent's specification. | ¶23, 29 | col. 7:45-46 |
- Identified Points of Contention:
- Factual Question: The primary dispute is factual: does the XStream product contain a biocide listed in the patents' claims, such as methylisothiazolinone? The parties present conflicting accounts based on their respective testing (Compl. ¶13-14).
- Scope Questions: The case raises a significant question regarding claim scope: if a trace amount of a biocide is detected (e.g., less than 1 ppb as alleged by Defendant), does this meet the claim limitation of a "biocide... selected in relative concentrations to minimize sepsis"? The complaint contrasts this trace amount with the patent's only quantitative example, which it calculates as 263,100 ppb, arguing that such a minuscule amount has no functional purpose and thus falls outside the claim's scope (Compl. ¶28-29).
V. Key Claim Terms for Construction
- The Term: "biocide... selected in relative concentrations to minimize sepsis"
- Context and Importance: The definition of this term is central to the dispute. The entire infringement analysis appears to turn on whether the alleged sub-part-per-billion level of a biocide in the Accused Product satisfies this limitation. Practitioners may focus on this term because it links the mere presence of a chemical to its functional purpose, creating a potential battleground over quantitative thresholds.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification states that "use as a biocide requires smaller concentrations" without setting a specific floor (’776 Patent, col. 4:61-62). Defendant may argue that because the claim does not recite a minimum concentration, any detectable amount of a listed biocide that has some minimal effect on bacteria meets the "minimize sepsis" requirement.
- Evidence for a Narrower Interpretation: The specification provides a single quantitative example of an effective concentration: "an oxidizing biocide such as sodium hypochlorite can be added in amounts as small as 1 mL per 3.8 L of water" (’776 Patent, col. 4:63-65). Plaintiff cites this to argue that an effective concentration is in the parts-per-million range (263 ppm) and that an amount "several orders of magnitude lower" (< 1 ppb) is not a "concentration to minimize sepsis" but rather a functionally nonexistent trace contaminant (Compl. ¶28-29). The claims' repeated use of the functional language "to minimize sepsis" may support an interpretation that requires a functionally effective amount, not just any detectable presence.
VI. Other Allegations
- Indirect Infringement: The complaint does not provide sufficient detail for analysis of indirect infringement. The allegations focus on Plaintiff's direct actions of manufacturing and selling the accused XStream product.
- Willful Infringement: The complaint, being a declaratory judgment action by the accused infringer, does not allege willfulness. However, it establishes a basis for a potential future willfulness claim by the patentee (Defendant) by acknowledging receipt of an infringement notice letter dated August 7, 2020 (Compl. ¶11). This establishes pre-suit knowledge of the patents and the infringement allegations.
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to center on a dispute over barely detectable quantities of a chemical and the functional meaning of claim language. The key questions for the court will likely be:
A core issue will be one of claim construction: Can the phrase "relative concentrations to minimize sepsis" be satisfied by any detectable trace amount of a claimed biocide, or does it require a minimum concentration demonstrably effective for that purpose, as suggested by the patent's own quantitative example?
A key evidentiary question will be one of factual proof: Can Defendant prove, by a preponderance of the evidence, that Plaintiff's XStream product actually contains a biocide from the patents' specified lists? This may evolve into a technical battle between the parties' respective lab analyses.
A central invalidity question is tied to the scope of the claims: If the claims are construed broadly enough to cover trace contaminants, are they invalid under 35 U.S.C. § 112 for indefiniteness or lack of enablement, as Plaintiff alleges the patents do not teach a person of skill how to practice the invention at such minuscule, functionally irrelevant concentrations?