DCT

3:21-cv-00516

DNA Genotek Inc v. Spectrum Solutions LLC

I. Executive Summary and Procedural Information

Parties & Counsel:
- Plaintiff: DNA Genotek Inc. (Canadian)
- Defendant: Spectrum Solutions LLC. (Utah)
- Plaintiff’s Counsel: Morrison & Foerster LLP
Case Identification: 3:21-cv-00516, S.D. Cal., 08/04/2021
Venue Allegations: Plaintiff alleges venue is proper in the Southern District of California based on Defendant’s sales of accused products within the district, use of the products by local hospitals, and proposed business operations in San Diego. Plaintiff also cites a 2017 Settlement Agreement in which Defendant consented to exclusive jurisdiction in this district for related disputes.
Core Dispute: Plaintiff alleges that Defendant’s saliva collection devices infringe two patents related to compositions for preserving nucleic acids and mechanical designs for sample collection kits.
Technical Context: The technology relates to non-invasive biological sample collection kits that stabilize nucleic acids (DNA/RNA) at room temperature, which is a critical enabling technology for genetic testing, diagnostics, and large-scale research.
Key Procedural History: The complaint details a significant history of litigation between the parties, including two prior patent infringement lawsuits filed in 2015 and 2016 that were resolved by a Settlement and License Agreement in 2017. Plaintiff subsequently sued Defendant for breach of that agreement, a case that was settled and dismissed in 2018. This history suggests Defendant has long been aware of Plaintiff's patent portfolio in the field of saliva-based diagnostics.

Case Timeline

Date	Event
2002-06-07	’187 Patent Priority Date
2011-06-19	’646 Patent Priority Date
2015-07-30	Prior patent infringement suit filed by Plaintiff against Defendant (D. Del.)
2016-06-20	Prior patent infringement suit filed by Plaintiff against Defendant (S.D. Cal.)
2017-02-06	Parties enter into Settlement and License Agreement
2018-04-25	Plaintiff files motion to dismiss breach of contract lawsuit against Defendant
2020-04-14	’187 Patent Issued
2020-04-14	Alleged date of Defendant's awareness of the ’187 Patent
2021-05-11	’646 Patent Issued
2021-08-04	Complaint Filing Date

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

U.S. Patent No. 10,619,187 - “Compositions and Methods for Obtaining Nucleic Acids from Sputum”

The Invention Explained

Problem Addressed: The patent describes the difficulty of using saliva as a reliable source for DNA, as it requires methods to overcome the viscosity caused by mucins and prevent degradation of nucleic acids by enzymes and microorganisms, problems that make traditional blood collection seem preferable despite being invasive and requiring trained personnel (’187 Patent, col. 1:38-2:65).
The Patented Solution: The invention provides a chemical composition that, when mixed with a saliva sample, simultaneously reduces viscosity, inhibits enzymes that degrade nucleic acids, and stabilizes the DNA or RNA for extended periods at room temperature. This is achieved through a combination of a chelating agent to bind metal ions, a denaturing agent to inactivate enzymes, and a buffer to maintain an optimal pH (’187 Patent, Abstract; col. 3:46-59).
Technical Importance: This technology enables stable, non-invasive collection of high-quality nucleic acids from saliva, facilitating large-scale, remote, and at-home sample gathering for genetic testing, diagnostics, and research (’187 Patent, col. 2:35-58).

Key Claims at a Glance

The complaint asserts infringement of Claim 1, an independent claim (Compl. ¶30).
The essential elements of Claim 1 are:
- A containment vessel with walls, a top opening, a closed bottom, and at least one marking corresponding to a fluid volume.
- A reagent compartment containing reagents and sealed by a barrier that is "capable of disestablishment" to release the reagents.
- Reagents within the compartment comprising a denaturing agent, a chelator, and a buffer agent.
- A sealing cap configured so that closing the cap on the vessel "mechanically disestablishes" the barrier, releasing the reagents to form a mixture with the sample that maintains a pH of 5.0 or above.
The complaint asserts infringement of "one or more claims" of the patent, reserving the right to assert additional claims (Compl. ¶29).

U.S. Patent No. 11,002,646 - “Devices, Solutions and Methods for Sample Collection”

The Invention Explained

Problem Addressed: The patent identifies safety and usability issues with existing sample collection devices, noting that some rely on sharp objects or thin, pierceable membranes that risk exposing the user to potentially toxic preservative solutions (’646 Patent, col. 3:15-36).
The Patented Solution: The invention is a sample collection kit, comprising a tube and a cap, that uses a mechanical valve system to release a preservative solution. As the cap is screwed onto the tube, an "inner cylinder" and "outer cylinder" assembly within the cap interacts with a feature in the tube, causing a "fluid vent" to open and release the solution without requiring the user to puncture a membrane or perform complex actions (’646 Patent, Abstract; col. 22:16-47).
Technical Importance: The design provides a safer and more intuitive user experience for mixing a biological sample with a preservative, which is critical for the reliability and widespread adoption of at-home and field-based collection kits (’646 Patent, col. 3:4-14).

Key Claims at a Glance

The complaint asserts infringement of Claim 1, an independent claim (Compl. ¶53).
The essential elements of Claim 1 are:
- A sample collection vessel with a reservoir and an exterior connection member.
- A cap with a reagent chamber and a complementary connection member.
- A "movable annular valve" comprising an inner cylinder with a fluid vent and an outer cylinder with an aperture.
- The valve is configured such that the aperture accommodates the inner cylinder, and an interior sidewall of the outer cylinder obstructs the fluid vent when the valve is closed but does not obstruct it when the valve is open.
The complaint asserts infringement of "one or more claims" of the patent, reserving the right to assert additional claims (Compl. ¶52).

III. The Accused Instrumentality

Product Identification

The accused products are the Spectrum Model Nos. SDNA-1000 and SDNA-2000 saliva collection devices, collectively referred to as the "Spectrum Product" (Compl. ¶7).

Functionality and Market Context

The Spectrum Product is a kit for collecting and preserving nucleic acids from saliva, consisting of a collection tube and a cap containing a DNA stabilizing reagent (Compl. ¶¶ 26, 27). The complaint includes a step-by-step graphic from Defendant's website illustrating that a user spits into the tube and then screws on the cap to release the stabilizing fluid (Compl. ¶25). The complaint alleges the release mechanism involves a "movable annular valve" with inner and outer cylinders, where closing the cap causes the barrier to "mechanically disestablish" and release the reagent (Compl. ¶¶ 26, 27). A photograph provided in the complaint shows the disassembled components of the sealing cap (Compl. ¶26).
These products are marketed for diagnostic applications, including COVID-19 testing, and are sold to customers and distributors that include hospitals in the Southern District of California (Compl. ¶¶ 5, 13).

IV. Analysis of Infringement Allegations

’187 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
(a) one or more walls defining a containment vessel having a top having an opening...and further comprising at least one marking on said one or more walls which corresponds to a fluid volume...	The Spectrum Product includes a tube (containment vessel) for collecting a saliva sample, which has an opening at the top and a "V"-shaped bottom. A black wavy line on the wall serves as a fill line marking.	¶¶34-35	col. 18:53-56
(b) a reagent compartment having a barrier, said barrier sealing and containing reagents...and capable of disestablishment to release said reagents...	The cap includes a reagent compartment holding a stabilizing fluid. The barrier is a sleeve valve with a movable inner post and a fixed outer ring that occludes the reagent until the post slides to reveal vents.	¶¶37-38	col. 6:16-24
(c) reagents in the reagent compartment...wherein said reagents comprise a denaturing agent, a chelator and a buffer agent...	The cap contains a DNA stabilizing solution that includes a denaturing agent, a chelator, and a buffer agent.	¶¶40-41	col. 4:57-60
(d) the sealing cap, whereby the device is configured such that, when sealably closing said opening...the barrier mechanically disestablishes to release said reagents...wherein said buffering agent maintains a pH...equal to or above 5.0...	The cap is threaded onto the collection tube. This action mechanically disestablishes the sleeve valve's barrier, releasing the reagent to mix with the saliva. The buffering agent in the mixture allegedly maintains a pH above 5.0.	¶¶43-44	col. 19:50-59

Identified Points of Contention:
- Scope Questions: The infringement analysis may focus on whether the accused product's sliding "sleeve valve comprising a moveable...inner post and fixed...outer ring" (Compl. ¶38) falls within the scope of the claim term "barrier" that "mechanically disestablishes." The Defendant might argue that the term, in the context of the patent's embodiments, implies a permanent, one-way action like puncturing a seal or pivoting a disc, rather than a reversible sliding motion.
- Technical Questions: A key evidentiary question is whether the complaint provides sufficient support for the allegation that the accused product's "buffering agent maintains a pH of said mixture equal to or above 5.0" (Compl. ¶44). The claim requires this specific functional outcome in the final mixture, and the complaint asserts it without presenting empirical data.

’646 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
[(i.a)] a sample collection reservoir having an opening... [(i.b)] a connection member disposed on an exterior portion of the sample collection vessel...	The Spectrum Product includes a vial with a "spit to here" indicator for use as a sample reservoir. The vial has threads on its exterior wall that serve as the connection member.	¶58	col. 1:50-54
[(ii.a)] a cap...comprising...a reagent chamber configured to store a reagent; and [(ii.b)] a complementary connection member configured to engage the connection member...	The Spectrum Product includes a cap for storing reagent which engages the vial via complementary threads.	¶¶60-61	col. 2:20-25
[(iii)] a movable annular valve...comprising: [(iii.a)] an inner cylinder...comprising a fluid vent; and [(iii.b)] an outer cylinder...comprising an aperture...	The complaint alleges the Spectrum Product includes a moveable annular valve. It uses annotated engineering drawings from a U.S. patent application to illustrate the alleged inner cylinder, outer cylinder, sidewall, fluid vent, and aperture.	¶¶63-64; p. 17-18	col. 22:25-36
[(iii.c)] wherein the aperture accommodates at least a portion of the inner cylinder... [(iii.d)] wherein the interior sidewall obstructs the fluid vent when...closed, and [(iii.e)]...does not obstruct the fluid vent when...open.	The complaint again relies on annotated engineering drawings to allege that the aperture accommodates the inner cylinder (p. 18, Fig. 3), the interior sidewall obstructs the vents when closed (p. 18, Fig. 4), and does not obstruct them when open (p. 18, Fig. 5).	¶¶63-65; p. 18	col. 22:37-47

Identified Points of Contention:
- Scope Questions: A central issue will be one of structural correspondence. The complaint relies heavily on engineering drawings from a patent application (U.S. 2020/0397418A1) to show that the accused product meets the claim limitations (Compl. p. 17-18). The analysis will question whether this application accurately depicts the commercial product and, if so, whether that product's components and mechanics precisely map onto the specific structural and functional limitations of the "movable annular valve" as defined in Claim 1 of the asserted ’646 patent.
- Technical Questions: The infringement theory depends on the exact interaction between the claimed "inner cylinder," "outer cylinder," "fluid vent," and "interior sidewall." A potential point of dispute is whether the accused device's mechanism performs the specific dual functions of obstructing the vent when closed and not obstructing it when open, as required by limitations (iii.d) and (iii.e), or if it operates via a different mechanical principle.

V. Key Claim Terms for Construction

’187 Patent:
- The Term: "barrier...mechanically disestablishes"
- Context and Importance: This phrase defines the core release mechanism of the claimed device. Its construction will determine whether the accused product's sliding "sleeve valve" infringes, as this is the component alleged to be the claimed "barrier."
- Intrinsic Evidence for Interpretation:
  - Evidence for a Broader Interpretation: The claim language is functional, defining the barrier by what it does ("sealing and containing reagents") and its capability ("capable of disestablishment to release said reagents") (’187 Patent, col. 19:45-49). The patent specification describes multiple example mechanisms, including puncturing a barrier or using a "pivoting sealing disc," suggesting the term is not limited to a single embodiment (’187 Patent, col. 6:16-24).
  - Evidence for a Narrower Interpretation: A defendant may argue that the term "disestablishes" implies a permanent or irreversible change in the barrier's state, consistent with the examples of puncturing a seal or pivoting a disc completely out of the fluid path. This could be used to argue that a sliding valve, which may be reversible, is outside the claim scope.
’646 Patent:
- The Term: "movable annular valve"
- Context and Importance: This is the central component of the claimed invention. The infringement case for the ’646 patent hinges on whether the accused device contains a structure that meets the definition of this term and its specific sub-elements (inner/outer cylinder, vent, etc.).
- Intrinsic Evidence for Interpretation:
  - Evidence for a Broader Interpretation: The claim itself provides a detailed definition of the "movable annular valve" through its required structural components and their functional relationships (e.g., how the sidewall obstructs the vent) (’646 Patent, col. 22:25-47). A party could argue that any structure meeting these detailed functional and structural requirements is a "movable annular valve," regardless of other design variations.
  - Evidence for a Narrower Interpretation: A defendant could focus on the specific language used, such as "annular" or "fluid-tight association," to argue for a narrower construction limited to the precise geometries and tolerances depicted in the patent's figures (e.g., ’646 Patent, Fig. 1A-1B). The term "valve" itself, while generally broad, is constrained here by the explicit recitation of its required internal components and their specific interactions.

VI. Other Allegations

Indirect Infringement: The complaint does not contain a separate count for indirect infringement but alleges facts that may support it. It references the defendant's "user instructions and marketing materials" and includes a step-by-step graphic from the defendant's website that instructs users on how to operate the device in an infringing manner (Compl. ¶¶ 25, 35). These allegations could form the basis for a claim of induced infringement.
Willful Infringement: The complaint alleges pre-suit knowledge of the patents. It claims Spectrum was aware of the ’187 patent "at least as early as April 14, 2020" and was aware of the ’646 patent "before the filing of this Second Amended Complaint" (Compl. ¶¶ 19-20). The extensive prior litigation history between the parties further supports an allegation that Defendant was aware of Plaintiff's intellectual property in this technology area (Compl. ¶¶ 13-14).

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

A core issue will be one of definitional scope and claim construction: for the ’187 patent, can the accused product's sliding "sleeve valve" be construed as a "barrier" that "mechanically disestablishes," or is that claim language limited to mechanisms that are irreversibly opened, such as by piercing or displacing a seal?
A second central issue will be one of structural correspondence and evidence: for the ’646 patent, does the physical mechanism of the commercial Spectrum Product precisely map onto the detailed structural and functional limitations of the "movable annular valve" recited in Claim 1, and can the engineering drawings from a third-party patent application, cited in the complaint, serve as sufficient evidence of this correspondence?
A key evidentiary question will be one of functional performance: regarding the ’187 patent, what objective evidence will be presented to prove that the reagents in the accused device, when mixed with saliva, actually achieve and maintain the specific claimed chemical property of a "pH of said mixture equal to or above 5.0"?