DNA Genotek Inc. v. Spectrum Sols.

• Decision Date: 29 November 2022
• Docket Number: 3:21-CV-00516-RSH-DDL
• Parties: DNA GENOTEK INC., a California Corporation, Plaintiff, v. SPECTRUM SOLUTIONS L.L.C., a Utah Limited Liability Company, Defendant.
• Court: U.S. District Court — Southern District of California

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DNA GENOTEK INC., a California Corporation, Plaintiff, v. SPECTRUM SOLUTIONS L.L.C., a Utah Limited Liability Company, Defendant.

No. 3:21-CV-00516-RSH-DDL

United States District Court, S.D. California

November 29, 2022

ORDER: (1) CLAIM CONSTRUCTION ORDER; AND (2) DENYING AS MOOT PLAINTIFF'S MOTION FOR LEAVE TO FILE A RESPONSE TO DEFENDANT'S EVIDENTIARY OBJECTIONS [ECF No 101.]

Hon Robert S. Huie United States District Judge

In this case, Plaintiff DNA Genotek (“DNA Genotek”) alleges that Spectrum Solutions L.L.C. (“Spectrum”) infringes U.S. Patent Nos 10,619,187 (“the '187 Patent”) and 11,002,646 (“the '646 Patent”) (collectively “the patents-in-suit”). On January 7, 2022, the Parties filed their Joint Claim Construction Hearing Statement Chart, and Worksheet in accordance with Patent Local Rule 4.2. ECF No. 74. On February 18, 2022, the Parties filed their Opening Claim Construction Briefs. ECF Nos. 134, 147.^[1] On March 4, 2022, the Parties filed their Responsive Claim Construction Briefs. ECF Nos. 88, 89. On November 9, 2022, the Court emailed counsel of record a tentative claim construction order.

The Court held a claim construction hearing on Thursday, November 10, 2022. ECF No. 176. After considering the parties' briefing and the arguments presented at the hearing, the Court issues the following claim construction order.

I. BACKGROUND

DNA Genotek is the owner by assignment of the '187 Patent and the '646 Patent. See U.S. Patent No. 10,619,187, at [73] (issued Apr. 14, 2020); U.S. Patent No. 11,002,646, at [73] (issued May 11, 2021). In the present action, DNA Genotek alleges that Spectrum infringes the patents-in-suit, either literally or under the doctrine of equivalents, by making, using, offering for sale, selling and/or importing saliva DNA collection devices, including Spectrum's SDNA-1000 and SDNA-2000 products. See SAC (Aug. 4, 2021), ECF No. 20 ¶¶ 3, 18, 22-27, 35-45, 55-65.

The patents-in-suit both generally relate to devices for biological sample collection. The '187 Patent was issued on April 14, 2020 and is entitled "Compositions and Methods for Obtaining Nucleic Acids from Sputum." '187 Patent at [54], [45]. The invention disclosed in the '187 Patent "relates to compositions and methods for preserving nucleic acids at room temperature for extended periods of time and for simplifying the isolation of nucleic acids." Id. col. 1 ll. 23-26. Specifically, the invention "features a composition for preserving nucleic acids that includes a chelating agent, and a denaturing agent, where the pH of the composition is greater than 5.0." Id. col. 3 ll. 61-64.

Independent claim 1 of the '187 Patent, the only independent claim in the '187 Patent, claims:

1. A device for receiving and preserving nucleic acid in a biological sample, said device comprising:

a. one or more walls defining a containment vessel having a top having an opening, and a closed bottom having a sample receiving area for holding said biological sample, said opening for receiving a liquid sample and for sealably receiving a sealing cap, said top having an opening for receiving a biological sample from the mouth of a user and further comprising at least one marking on said one or more walls which corresponds to a fluid volume in the sample receiving area;

b. a reagent compartment having a barrier, said barrier sealing and containing reagents in said reagent compartment and capable of disestablishment to release said reagents into the sample receiving area;

c. reagents in the reagent compartment for preserving nucleic acids potentially present in the sample wherein said reagents comprise a denaturing agent, a chelator and a buffer agent; and,

d. the sealing cap, whereby the device is configured such that, when sealably closing said opening with said sealing cap, the barrier mechanically disestablishes to release said reagents to form a mixture of reagents and said biological sample wherein said buffering agent maintains a pH of said mixture equal to or above 5.0 to preserve nucleic acids potentially present in the sample.

'187 Patent col. 19 ll. 34-59.

The '646 Patent was issued on May 11, 2021 and is entitled "Devices, Solutions and Methods for Sample Collection." '646 Patent at [54], [45]. The invention disclosed in the '646 Patent generally relates to devices, solutions, and methods for collecting samples of bodily fluids containing cells. Id. at [57], col. 1 ll. 21-24. The '646 Patent also generally relates to the isolation and preservation of cells from such bodily fluids for cellular analysis. Id. at [57], col. 1 ll. 24-29.

Independent claim 1 of the '646 Patent, the only independent claim in the '646 Patent, claims:

1. A kit for collecting and preserving a biological sample, the kit comprising: a sample collection vessel, the sample collection vessel comprising:

a sample collection reservoir having an opening configured to receive the biological sample from a user into the sample collection reservoir;

a connection member disposed on an exterior portion of the sample collection vessel and adjacent to the opening;

a cap, the cap comprising:

a reagent chamber configured to store a reagent; and

a complementary connection member configured to engage the connection member of the sample collection vessel; and

a movable annular valve configured to associate with the cap and with the opening of the sample collection reservoir, the movable annular valve comprising:

an inner cylinder in fluid-tight association with the cap and comprising a sidewall, the sidewall comprising a fluid vent; and

an outer cylinder in fluid-tight association with the inner cylinder and associated with the opening of the sample collection reservoir, the outer cylinder comprising an aperture defined by an interior sidewall of the outer cylinder,

wherein the aperture accommodates at least a portion of the inner cylinder,

wherein the interior sidewall obstructs the fluid vent when the movable annular valve is closed, and

wherein the interior sidewall does not obstruct the fluid vent when the movable annular valve is open.

'646 Patent col. 22 ll. 16-47.

On March 24, 2021, DNA Genotek filed a complaint for patent infringement against Spectrum, alleging infringement of the '187 Patent. See Compl. (Mar. 24, 2021), ECF No. 1. On June 8, 2021, DNA Genotek filed its Second Amended Complaint (the "SAC," the operative complaint) against Spectrum, adding a claim for infringement of the '646 Patent. See SAC (Aug. 4, 2021), ECF No. 20. On August 18, 2021, Spectrum filed an answer to the SAC along with counterclaims against DNA Genotek for: (1) declaratory judgment of non-infringement of the patents-in-suit; (2) declaratory judgment of invalidity of the patents-in-suit; (3) declaratory judgment of unenforceability of the '187 Patent due to inequitable conduct; (4) monopolization in violation of section 2 of the Sherman Act, 15 U.S.C. § 2; and (5) attempted monopolization in violation of section 2 of the Sherman Act, 15 U.S.C. § 2. See Answer &Counterclaims (Aug. 18, 2021), ECF No. 27.

On September 2, 2021, the Court issued a scheduling order for the action. ECF No. 29. On April 1, 2022, the Court denied DNA Genotek's motion to dismiss Spectrum's counterclaims for inequitable conduct, monopolization, and attempted monopolization, and the Court denied DNA Genotek's motion to strike Spectrum's affirmative defenses of inequitable conduct, patent misuse, and unclean hands. ECF No. 111. On May 25, 2022, the Court issued an amended scheduling order. ECF No. 130. By the present claim construction charts, worksheets, and briefs, the Parties agree upon the proper construction for two claim terms, and the Parties request that the Court construe eleven disputed claim terms from the patents-in-suit. ECF Nos. 74-1, 74-2, 88, 89, 134, 147.

II. PLAINTIFF'S MOTION FOR LEAVE TO FILE A RESPONSE TO DEFENDANT'S EVIDENTIARY OBJECTIONS

As an initial matter, the Court addresses DNA Genotek's motion for leave to file a response to Defendant's Evidentiary Objections. Along with its responsive claim construction brief, Spectrum filed a document entitled "Defendant's Evidentiary Objections to the Declaration of Dr. Michael L. Metzker Filed in Support of DNA Genotek's Opening Claim Construction Brief." ECF No. 88-1. In the filing, Spectrum objects to portions of Dr. Metzker's declaration for failure to comply with the Court's Patent Local Rules, specifically Patent Local Rules 4.1(b), 4.1(d), and 4.2(d)(2).^[2] Id. at 13.

On March 21, 2022, DNA Genotek filed a motion for leave to file a response to Spectrum's evidentiary objections. ECF No. 101. In the motion, DNA Genotek argues that Spectrum's filing is improper and unauthorized because the filing of separate "evidentiary objections" is a state procedural device that is not envisioned by the Federal Rules of Civil Procedure or the Court's Patent Local Rules. Id. at 1.

The Court declines to address Spectrum's evidentiary objections. In the filing, Spectrum objects to certain portions of Dr. Metzker's declaration, specifically certain statements in paragraphs 18, 25, 34, 60, 63, and 67 of the declaration. See ECF No. 88-1 at 3-6. Although the Court is skeptical that these portions of Dr. Metzker's declaration complied with Patent Local Rule 4.2(d)(2), the Court does not rely on or reference any of the statements at issue in reaching the claim constructions set forth below. Thus, because the statements at issue from Dr. Metzker's declaration are not material to the Court's claim construction rulings, the Court need not rule on Spectrum's evidentiary objections. See Elena v. Reliance Standard Life Ins. Co., No. 21-CV-00390-GPC, 2022 WL 1174107, at *8 (S.D. Cal. Apr. 20, 2022) ("A court need not rule on evidentiary objections that are...