DNA Genotek Inc. v. Spectrum Sols. L.L.C.

671 F.Supp.3d 1105

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

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

United States District Court, S.D. California

Signed May 2, 2023

Brian M. Kramer, Candice F. Heinze, Drew Alan Hillier, John R. Lanham, Morrison & Foerster LLP, San Diego, CA, David D. Cross, Pro Hac Vice, Morrison & Foerster LLP, Washington, DC, for Plaintiff.

Benjamin B. Anger, Knobbe Martens, San Diego, CA, Brandon Geoffrey Smith, Stephen W. Larson, Joseph F. Jennings, Nicholas M. Zovko, Ali S. Razai, Knobbe Martens Olson and Bear LLP, Irvine, CA, for Defendant.

ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT

[ECF No. 231.]

Robert S. Huie, United States District Judge

On January 30, 2023, Defendant Spectrum Solutions L.L.C. ("Spectrum") filed a motion for summary judgment of non-infringement of the asserted patents. ECF No. 231. On February 17, 2023, Plaintiff DNA Genotek Inc., ("Genotek") filed a response in opposition to Spectrum's motion for summary judgment. ECF No. 243. On February 27, 2023, Spectrum filed a reply. ECF No. 254. On February 27, 2023, the parties filed their joint statement of undisputed material facts. ECF No. 258.

The Court held a hearing on the matter on April 20, 2023. For the reasons below, the Court grants Spectrum's motion for summary judgment.

I. BACKGROUND

Genotek is the owner by assignment of U.S. Patent Nos. 10,619,187 ("the '187 Patent") and 11,002,646 ("the '646 Patent") (collectively "the asserted patents"). 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, Genotek alleges that Spectrum infringes Claims 1, 2, 4, 6-7, 20-21, 23-31, and 33 of the '187 Patent and Claims 1, 4-8, and 11-12 of the '646 Patent. ECF No. 258 at 1 ¶¶ 2, 4 (listing the asserted claims). Specifically, Genotek alleges that Spectrum infringes the asserted claims, either literally or under the doctrine of equivalents, by making, using, offering for sale, selling and/or importing Spectrum's SDNA-1000, SDNA-2000, and SDNA-3000 products (collectively "the accused products"). See SAC (Aug. 4, 2021), ECF No. 20 ¶¶ 3, 18, 22-27, 35-45, 55-65; ECF No. 258 at 1 ¶¶ 1, 2, 4.

The asserted patents 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, 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, 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 Genotek for: (1) declaratory judgment of non-infringement of the asserted patents; (2) declaratory judgment of invalidity of the asserted patents; (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 Genotek's motion to dismiss Spectrum's counterclaims for inequitable conduct, monopolization, and attempted monopolization, and the Court denied 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.

On November 29, 2022, the Court issued a claim construction order construing the agreed upon and disputed claim terms from the asserted patents. ECF No. 177. By the present motion, Spectrum moves for summary judgment that the accused products do not infringe either of the asserted patents. ECF No. 231-1 at 1-2, 18.

II. LEGAL STANDARD FOR SUMMARY JUDGMENT

Summary judgment is appropriate under Federal Rule of Civil Procedure 56 if the moving party demonstrates "that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Material facts are facts that, under the governing substantive law, may affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A dispute as to a material fact is genuine if there is sufficient evidence for a reasonable jury to return a verdict for the non-moving party. Id. "Disputes over irrelevant or unnecessary facts will not preclude a grant of summary judgment." T.W. Elec. Serv., Inc. v. Pac. Elec. Contractors Ass'n, 809 F.2d 626, 630 (9th Cir. 1987).

A party seeking summary judgment always bears the initial burden of demonstrating that there is no genuine dispute as to any material fact. Celotex, 477 U.S. at 323, 106 S.Ct. 2548. A moving party without the ultimate burden of proof at trial can satisfy its burden in two ways: (1) by presenting "evidence negating an essential element of the nonmoving party's claim or defense;" or (2) by demonstrating "that the nonmoving party does not have enough evidence of an essential element to carry its ultimate burden of persuasion at trial." Nissan Fire & Marine Ins. Co. v. Fritz Companies, Inc., 210 F.3d 1099, 1102 (9th Cir. 2000). Once the moving party establishes the absence of a genuine dispute as to any material fact, the burden shifts to the nonmoving party to "set forth, by affidavit or as otherwise provided in Rule 56, 'specific facts showing that there is a genuine issue for trial.' " T.W. Elec. Se...