DCT
3:11-cv-00638
Stephens v. DR Greens Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Dr. Greens, Inc. (California)
- Defendant: James Matthew Stephens (an individual) and Spectrum Laboratories, LLC (Ohio)
- Plaintiff’s Counsel: Gary L. Eastman, APLC
- Case Identification: 3:11-cv-00638, S.D. Cal., 04/19/2012
- Venue Allegations: Venue is alleged to be proper based on Defendants’ business dealings in California, including contracts with California corporations and advertising and sales within the state.
- Core Dispute: Plaintiff seeks a declaratory judgment that its synthetic urine product does not infringe U.S. Patent No. 7,192,776, and that the patent is invalid, unenforceable, and has been misused by the Defendants.
- Technical Context: The lawsuit concerns synthetic urine formulations, a product category used for applications such as calibrating urinalysis equipment and other purposes where a chemically stable, "clean" urine sample is required.
- Key Procedural History: This First Amended Complaint follows a complex history between the parties. Plaintiff alleges that Defendants sent a cease and desist letter in July 2009. In response, Plaintiff filed a prior lawsuit in August 2009 ("First Lawsuit"), which was later voluntarily dismissed in November 2010 after Plaintiff was unable to serve Defendant Stephens. The complaint alleges that during and after this period, Defendants sent "Legal Action Notification" letters to the retail industry, broadly asserting patent rights. Plaintiff also alleges that Defendant Stephens executed a nunc pro tunc assignment of the patent to Spectrum LLC in January 2010, retroactively effective to March 2008, in a move Plaintiff characterizes as tactical.
Case Timeline
| Date | Event |
|---|---|
| 2001 | Alleged first sales of "Quick Fix" product by Defendants to Plaintiff |
| 2004-01-28 | '776 Patent application filed |
| 2007-03-20 | '776 Patent issues |
| 2009-07-22 | Defendants send cease and desist letter to Plaintiff |
| 2009-08-03 | Plaintiff responds to cease and desist letter, asserting non-infringement and invalidity |
| ~2009-08 | Plaintiff files "First Lawsuit" for declaratory judgment |
| ~2009-09-08 | Defendants begin circulating "Legal Action Notification" letters to retailers |
| 2010-01-04 | Defendant Stephens records nunc pro tunc assignment of '776 Patent to Spectrum LLC |
| 2010-11-17 | Plaintiff dismisses "First Lawsuit" without prejudice |
| 2011-02-11 | Defendants send renewed demand letter to Plaintiff |
| 2012-04-19 | Complaint Filing Date (First Amended Complaint) |
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 specification describes the need for a reliable, stable, and inexpensive synthetic urine substitute. Such a substitute is useful for establishing a "clean" baseline for calibrating urinalysis equipment, as real urine can contain interfering substances that compromise test accuracy ('776 Patent, col. 1:41-50). The background also notes that existing synthetic urine formulations can degrade over time due to microbial contamination, a process known as sepsis, making them unsuitable for mass production or long-term storage ('776 Patent, col. 2:35-40).
- The Patented Solution: The invention is a stable, water-based synthetic urine solution that includes creatinine (a key indicator of human origin for urinalysis) and, critically, a biocide to inhibit microbial growth and prevent sepsis ('776 Patent, Abstract; col. 3:20-29). The patent presents the inclusion of a biocide as a departure from prior art, which it claims focused only on mimicking the chemical components of urine without addressing long-term stability ('776 Patent, col. 4:35-44). The solution's specific gravity is also adjusted using ionic compounds to match that of human urine ('776 Patent, Abstract).
- Technical Importance: The claimed solution aims to provide a commercially viable synthetic urine that is both an accurate chemical proxy for urinalysis calibration and stable enough for widespread distribution and storage, by actively preventing the bacterial decomposition that would otherwise alter its chemical properties ('776 Patent, col. 2:45-51).
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement and invalidity for all claims of the '776 Patent (Compl. ¶¶ 86, 97; Prayer for Relief ¶¶ a, b). The primary independent claim is Claim 1.
- Independent Claim 1:
- A synthetic urine solution comprising:
- water having a pH between 3 and 10;
- creatinine and a biocide, said creatinine and biocide dissolved within said water to form a solution exhibiting a specific gravity and said creatinine and biocide selected in relative concentrations to minimize sepsis;
- at least one dissociated ionic compound also dissolved within said solution to adjust the specific gravity of the solution to between 1.005 g/cm³ and 1.025 g/cm³; and
- wherein said biocide is selected from the group consisting of 2-bromo-4-hydroxyacetophenone, bronopols, carbamates, chlorothioethers, 2-2-Dibromo-3-nitrilopropionamide, 2-(Decylthio)ethanamine, glutaraldehydes, isothiazolines, Methylene bis(thiocyanate), polyquat, Alkyldimethylbenzylammonium chloride, sulfones, Bis(tributyltin) oxide, tertbuthylazines, Tetrachloro-2,4,6-cyano-3-benzonitrile, 2(thiocyanomethylthio)benzothiazole, thiones, Tetrakish(hydroxymethyl)phosphonium sulfate, Tributyltetradecylphosphonium chloride, peroxides, hypochlorites, and super oxides.
- The complaint does not explicitly reserve the right to assert dependent claims but seeks judgment on "each claim" (Compl., p. 50).
III. The Accused Instrumentality
Product Identification
The product at issue is Plaintiff's "Agent X," a synthetic urine product (Compl. ¶2).
Functionality and Market Context
- The complaint describes Agent X as a synthetic urine sold by Dr. Greens (Compl. ¶2). The central allegation of non-infringement is that Agent X has never included any of the specific biocides listed in the closed Markush group of the '776 Patent's claims (Compl. ¶¶ 21-22).
- The complaint positions Agent X as a competitor to Defendants' "Quick Fix" product in the retail synthetic urine market (Compl. ¶¶ 4, 15). The dispute arose after Defendants sent letters to the trade, including to Plaintiff's customers, warning of potential infringement of the '776 Patent by synthetic urine products generally (Compl. ¶¶ 34, 36). As visual evidence of this, the complaint provides a "Legal Action Notification" letter sent by "Spectrum Labs" which states that Spectrum's "Quick Fix" is the "only patented product of its kind" and warns retailers to "avoid offering for sale, or selling, any potentially infringing products" (Compl., Ex. E, p. 67).
IV. Analysis of Infringement Allegations
This case is a declaratory judgment action for non-infringement. The following chart summarizes Plaintiff's core assertion that its Agent X product is missing a required element of the '776 Patent's claims.
'776 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ...creatinine and a biocide... dissolved within said water... | Plaintiff asserts that its Agent X product does not contain a biocide as claimed. | ¶22 | col. 6:36-39 |
| wherein said biocide is selected from the group consisting of [list of 20 chemical groups]... | Plaintiff specifically alleges that Agent X "has never included one of the specific biocides claimed in the '776 Patent." | ¶22 | col. 6:45-54 |
- Identified Points of Contention:
- Factual Question: The dispositive question for literal infringement appears to be a factual one: does the chemical composition of the Agent X product include any of the biocides recited in the closed Markush group of Claim 1? The complaint unequivocally asserts that it does not (Compl. ¶22). Defendants' pre-suit correspondence suggests a belief that it does, or at least a desire to obtain the formula to confirm (Compl., Ex. J, p. 81).
- Scope Questions: The case raises the question of whether the list of biocides in Claim 1 constitutes a "closed" Markush group. If so, infringement would require the presence of a listed substance. If argued to be "open," the analysis could broaden to equivalents, but the plain language ("selected from the group consisting of") strongly suggests a closed group, which appears to be the basis for Plaintiff's non-infringement theory.
V. Key Claim Terms for Construction
- The Term: "biocide"
- Context and Importance: The presence of a specific "biocide" is a core limitation of the asserted claims. The entire non-infringement case, as pled, rests on the assertion that Agent X lacks a biocide from the list required by Claim 1. Therefore, the scope of this term, as defined and limited by the claim language, is central. Practitioners may focus on whether the Markush group is closed, which would make the non-infringement analysis a straightforward compositional test.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides a broad functional definition, stating a "biocide can be generically defined as substances used to control or eliminate microbial populations in a sample" ('776 Patent, col. 4:45-48). This language, if read in isolation, might support a broader interpretation of the term's general meaning within the patent.
- Evidence for a Narrower Interpretation: Independent Claim 1 explicitly limits the term with the phrase "wherein said biocide is selected from the group consisting of..." followed by a specific list of twenty chemical compounds or classes ('776 Patent, col. 6:45-54). The use of the transitional phrase "consisting of" is legally understood to create a closed group, meaning the claim covers only solutions containing a biocide from that exhaustive list. This provides strong intrinsic evidence that the scope is strictly limited to the recited members.
VI. Other Allegations
- Indirect Infringement: The complaint asserts that Plaintiff has not contributorily infringed or induced others to infringe any claim of the '776 Patent (Compl. ¶88).
- Willful Infringement: Plaintiff asserts it has not willfully infringed the '776 Patent (Compl. ¶88). The complaint extensively details Defendants' alleged bad-faith conduct, including sending infringement notices despite allegedly knowing the patent was invalid due to an on-sale bar and that Agent X was non-infringing (Compl. ¶¶ 29, 75, 102). These allegations form the basis for Plaintiff's claims of patent misuse and unfair competition, rather than a defense against a willfulness charge.
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action appears poised to turn on three primary questions, two of which challenge the patent's validity and enforceability, while the third focuses on non-infringement.
- A central validity question will be one of statutory compliance: Did Defendants' sales of their "Quick Fix" product starting in 2001, as alleged in the complaint, constitute a public use or on-sale event under 35 U.S.C. § 102(b) that would invalidate the '776 Patent, which was filed in 2004?
- A key infringement question will be one of compositional fact: Does Plaintiff's "Agent X" product contain a biocide that is a member of the specific, closed Markush group recited in Claim 1 of the '776 Patent?
- A critical issue for the patent misuse and unfair competition claims will be one of enforcement conduct: Did Defendants, by circulating "Legal Action Notification" letters to the trade, engage in bad-faith enforcement with the knowledge that the '776 Patent was likely invalid or not infringed, thereby exceeding the legitimate scope of their patent rights?