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

Full title: DNA GENOTEK INC., a California Corporation, Plaintiff, v. SPECTRUM…

Court: United States District Court, S.D. California

Date published: May 2, 2023

671 F. Supp. 3d 1105 (S.D. Cal. 2023)

Opinion

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

2023-05-02

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

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.

Robert S. Huie, United States District Judge

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. Serv., 809 F.2d at 630 (quoting former Fed. R. Civ. P. 56(e)); accord Horphag Research Ltd. v. Garcia, 475 F.3d 1029, 1035 (9th Cir. 2007). To carry this burden, the non-moving party "may not rest upon mere allegation or denials of his pleadings." Anderson, 477 U.S. at 256, 106 S.Ct. 2505; see also Behrens v. Pelletier, 516 U.S. 299, 309, 116 S.Ct. 834, 133 L.Ed.2d 773 (1996) ("On summary judgment, . . . the plaintiff can no longer rest on the pleadings."). Rather, the nonmoving party "must present affirmative evidence . . . from which a jury might return a verdict in his favor." Anderson, 477 U.S. at 256, 106 S.Ct. 2505.

When ruling on a summary judgment motion, the court must view the facts and draw all reasonable inferences in the light most favorable to the non-moving party. Scott v. Harris, 550 U.S. 372, 378, 127 S.Ct. 1769, 167 L.Ed.2d 686 (2007). The court should not weigh the evidence or make credibility determinations. See Anderson, 477 U.S. at 255, 106 S.Ct. 2505. "The evidence of the non-movant is to be believed." Id. Further, the court may consider other materials in the record not cited to by the parties, but it is not required to do so. See Fed. R. Civ. P. 56(c)(3); see also Simmons v. Navajo Cnty., 609 F.3d 1011, 1017 (9th Cir. 2010) ("[A] district court has no independent duty 'to scour the record in search of a genuine issue of triable fact.' ").

III. LEGAL STANDARD FOR PATENT INFRINGEMENT

A patent infringement analysis proceeds in two steps. Niazi Licensing Corp. v. St. Jude Med. S.C., Inc., 30 F.4th 1339, 1350 (Fed. Cir. 2022); JVW Enterprises, Inc. v. Interact Accessories, Inc., 424 F.3d 1324, 1329 (Fed. Cir. 2005). In the first step, the court construes the asserted claims as a matter of law. See Niazi, 30 F.4th at 1351; JVW, 424 F.3d at 1329. In the second step, the factfinder compares the properly construed claims to the accused devices. See id.

" 'The patentee bears the burden of proving infringement by a preponderance of the evidence.' " Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1314 (Fed. Cir. 2011); see Medtronic, Inc. v. Mirowski Fam. Ventures, LLC, 571 U.S. 191, 193, 134 S.Ct. 843, 187 L.Ed.2d 703 (2014) ("A patentee ordinarily bears the burden of proving infringement."). "To prove infringement, the plaintiff bears the burden of proof to show the presence of every element or its equivalent in the accused device." Uniloc USA, Inc. v. Microsoft Corp., 632 F.3d 1292, 1301 (Fed. Cir. 2011); accord Star Sci., Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1378 (Fed. Cir. 2011). Under the doctrine of equivalents, "a product or process that does not literally infringe . . . the express terms of a patent claim may nonetheless be found to infringe if there is 'equivalence' between the elements of the accused product or process and the claimed elements of the patented invention." Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997); accord Eagle Pharms. Inc. v. Slayback Pharma LLC, 958 F.3d 1171, 1175 (Fed. Cir. 2020).

The Federal Circuit "applies two articulations of the test for equivalence." Voda v. Cordis Corp., 536 F.3d 1311, 1326 (Fed. Cir. 2008) (citing Warner-Jenkinson, 520 U.S. at 21, 117 S.Ct. 1040); see UCB, Inc. v. Watson Lab'ys Inc., 927 F.3d 1272, 1284 (Fed. Cir. 2019). Under the insubstantial differences test, " '[a]n element in the accused device is equivalent to a claim limitation if the only differences between the two are insubstantial.' " UCB, 927 F.3d at 1284 (quoting Voda, 536 F.3d at 1326). "Alternatively, under the function-way-result test, an element in the accused device is equivalent to a claim limitation if it 'performs substantially the same function in substantially the same way to obtain substantially the same result.' " Voda, 536 F.3d at 1326 (quoting Schoell v. Regal Marine Indus., Inc., 247 F.3d 1202, 1209-10 (Fed. Cir. 2001)); see Ajinomoto Co. v. Int'l Trade Comm'n, 932 F.3d 1342, 1356 (Fed. Cir. 2019).¹ "Regardless how the equivalence test is articulated, 'the doctrine of equivalents must be applied to individual limitations of the claim, not to the invention as a whole.' " Mirror Worlds, LLC v. Apple Inc., 692 F.3d 1351, 1357 (Fed. Cir. 2012) (quoting Warner-Jenkinson, 520 U.S. at 29, 117 S.Ct. 1040).

1 The Federal Circuit has explained that "[t]he function-way-result test is particularly suitable for analyzing the equivalence of mechanical devices." Crown Packaging Tech., Inc. v. Rexam Beverage Can Co., 559 F.3d 1308, 1312 (Fed. Cir. 2009); see also Warner-Jenkinson, 520 U.S. at 39, 117 S.Ct. 1040 (acknowledging that there is "substantial agreement" that the function-way-result test is "suitable for analyzing mechanical devices").

" 'Infringement, whether literal or under the doctrine of equivalents, is a question of fact.' " Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1317 (Fed. Cir. 2015) (quoting Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121, 1129-30 (Fed. Cir. 2011)). "Summary judgment of noninfringement is proper when no reasonable jury could find that every limitation recited in a properly construed claim is found in the accused device either literally or under the doctrine of equivalents." Id.; see EMD Millipore Corp. v. AllPure Techs., Inc., 768 F.3d 1196, 1201 (Fed. Cir. 2014).

IV. LEGAL STANDARD FOR CLAIM CONSTRUCTION

Because the first step in an infringement analysis is for the Court to construe the asserted claims as a matter of law, the Court sets forth the following legal standards governing claim construction. Claim construction is an issue of law for the court to decide. Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 326, 135 S.Ct. 831, 190 L.Ed.2d 719 (2015); Markman v. Westview Instruments, Inc., 517 U.S. 370, 372, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Although claim construction is ultimately a question of law, "subsidiary factfinding is sometimes necessary." Teva, 574 U.S. at 326, 135 S.Ct. 831.

"It is a 'bedrock principle' of patent law that the 'claims of a patent define the invention to which the patentee is entitled the right to exclude.' " Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). "The purpose of claim construction is to 'determin[e] the meaning and scope of the patent claims asserted to be infringed.' " O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008).

Claim terms "are generally given their ordinary and customary meaning[,]" which "is the meaning that the term would have to a person of ordinary skill in the art [("POSITA")] in question at the time of the invention." Phillips, 415 F.3d at 1312-13 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). "In some cases, the ordinary meaning of claim language as understood by a [POSITA] may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Phillips, 415 F.3d at 1314. "However, in many cases, the meaning of a claim term as understood by persons of skill in the art is not readily apparent." O2 Micro, 521 F.3d at 1360. If the meaning of the term is not readily apparent, the court must look to "those sources available to the public that show what a [POSITA] would have understood disputed claim language to mean." Phillips, 415 F.3d at 1314 (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)). "Those sources include 'the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence.' " Phillips, 415 F.3d at 1314 (quoting Innova, 381 F.3d at 1116); see Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1217-18 (Fed. Cir. 2014).

In determining the proper construction of a claim, a court should first look to the language of the claims. See Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373 (Fed. Cir. 2019) ("[C]laim construction must begin with the words of the claims themselves."); Source Vagabond Sys. Ltd. v. Hydrapak, Inc., 753 F.3d 1291, 1299 (Fed. Cir. 2014) ("a claim construction analysis must begin and remain centered on the claim language itself"). The context in which a disputed term is used in the asserted claims may provide substantial guidance as to the meaning of the term. See Phillips, 415 F.3d at 1314.

A court must also read claims "in view of the specification, of which they are a part." Markman, 52 F.3d at 979; see 35 U.S.C. § 112(b) ("The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention."). "Apart from the claim language itself, the specification is the single best guide to the meaning of a claim term." Vederi, LLC v. Google, Inc., 744 F.3d 1376, 1382 (Fed. Cir. 2014) (quoting AIA Eng'g Ltd. v. Magotteaux Int'l S/A, 657 F.3d 1264, 1272 (Fed. Cir. 2011)). For example, "[a] claim construction that excludes a preferred embodiment is rarely, if ever correct and would require highly persuasive evidentiary support." Kaufman v. Microsoft Corp., 34 F.4th 1360, 1372 (Fed. Cir. 2022) (quoting Epos Techs. Ltd. v. Pegasus Techs. Ltd., 766 F.3d 1338, 1347 (Fed. Cir. 2014)).

But "[t]he written description part of the specification does not delimit the right to exclude. That is the function and purpose of claims." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc); accord Arlington Indus., Inc. v. Bridgeport Fittings, Inc., 632 F.3d 1246, 1256 (Fed. Cir. 2011). Therefore, "it is improper to read limitations from a preferred embodiment described in the specification—even if it is the only embodiment—into the claims absent a clear indication in the intrinsic record that the patentee intended the claims to be so limited." Dealertrack, Inc. v. Huber, 674 F.3d 1315, 1327 (Fed. Cir. 2012); accord Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509, 514 (Fed. Cir. 2015).

In addition to the claim language and the specification, the patent's prosecution history may be considered if it is in evidence. Phillips, 415 F.3d at 1317. The prosecution history "consists of the complete record of the proceedings before the PTO and includes the prior art cited during the examination of the patent." Id. "Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent." Id. "Yet because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id. In addition, a court should also consult the prosecution history "so that the court can exclude any interpretation that was disclaimed during prosecution." Sorensen v. Int'l Trade Comm'n, 427 F.3d 1375, 1378 (Fed. Cir. 2005) (citing Phillips, 415 F.3d at 1317).

In most situations, analysis of the intrinsic evidence will resolve claim construction disputes. See Teva, 574 U.S. at 331, 135 S.Ct. 831; Vitronics, 90 F.3d at 1583; see also Seabed Geosolutions (US) Inc. v. Magseis FF LLC, 8 F.4th 1285, 1287 (Fed. Cir. 2021) ("If the meaning of a claim term is clear from the intrinsic evidence, there is no reason to resort to extrinsic evidence."). However, "[w]here the intrinsic record is ambiguous, and when necessary," district courts may "rely on extrinsic evidence, which 'consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.' " Power Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc., 711 F.3d 1348, 1360 (Fed. Cir. 2013) (quoting Phillips, 415 F.3d at 1317). A court must evaluate all extrinsic evidence in light of the intrinsic evidence. Phillips, 415 F.3d at 1319. "[E]xtrinsic evidence is to be used for the court's understanding of the patent, not for the purpose of varying or contradicting the terms of the claims." Genuine Enabling Tech. LLC v. Nintendo Co., 29 F.4th 1365, 1373 (Fed. Cir. 2022) (quoting Markman, 52 F.3d at 981); see Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1290 (Fed. Cir. 2015) ("Extrinsic evidence may not be used 'to contradict claim meaning that is unambiguous in light of the intrinsic evidence.' "). In cases where subsidiary facts contained in the extrinsic evidence "are in dispute, courts will need to make subsidiary factual findings about that extrinsic evidence." Teva, 574 U.S. at 332, 135 S.Ct. 831.

"[D]istrict courts are not (and should not be) required to construe every limitation present in a patent's asserted claims." O2 Micro, 521 F.3d at 1362; see Eon Corp. IP Holdings v. Silver Spring Networks, 815 F.3d 1314, 1318-19 (Fed. Cir. 2016) ("[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy."). In certain situations, it is appropriate for a court to determine that a claim term needs no construction and its plain and ordinary meaning applies. See id.; Phillips, 415 F.3d at 1314. But "[a] determination that a claim term 'needs no construction' or has the 'plain and ordinary meaning' may be inadequate when a term has more than one 'ordinary' meaning or when reliance on a term's 'ordinary' meaning does not resolve the parties' dispute." O2 Micro, 521 F.3d at 1361. When the parties present a dispute regarding the scope of a claim term, it is the court's duty to resolve the dispute. Id. at 1362; Eon, 815 F.3d at 1318.

V. SPECTRUM'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT OF THE '187 PATENT

Spectrum moves for summary judgment that the accused products do not infringe the '187 Patent because the accused products' "reagent compartment" is in the "cap," not the "container." ECF No. 231-1 at 11-14. In response, Genotek argues that Spectrum's motion should be denied because there is at least a genuine dispute of material fact as to whether the accused products satisfy the "reagent compartment" limitation under either a literal infringement analysis or a doctrine of equivalents analysis. ECF No. 242 at 10-18.

Independent claim 1 of the '187 Patent, the only independent claim in the '187 Patent, claims: "A device for receiving and preserving nucleic acid in a biological sample, said device comprising:" (1) "a containment vessel;" (2) "a sealing cap;" (3) "a reagent compartment;" and (4) "reagents." '187 Patent col. 19 ll. 34-59. In the Court's claim construction order, the Court construed the term "containment vessel" as "container," and the Court construed the term "reagent compartment" as "region or section of the containment vessel." ECF No. 177 at 23, 44.

A. Literal Infringement

Spectrum argues that the accused products do not literally infringe any claim of the '187 Patent because it is undisputed that the reagent compartment of the accused products is in the cap and not in the container, as required by the Court's claim construction of the term "reagent compartment." ECF No. 231-1 at 11. In response, Genotek argues that there is a genuine dispute of material fact as to whether the accused devices satisfy the "reagent compartment" limitation because "a 'sealing cap' is part of the 'container' in the patented invention." ECF No. 242 at 8, 10-11. On reply, Spectrum argues that Genotek's theory of infringement cannot be correct because the claim language requires that the container be separate from the cap. ECF No. 254 at 1-2. Spectrum notes that the claim language states that the containment vessel/container "has 'a top having an opening,' " and that opening is " 'for receiving a liquid sample' " and for " 'sealably receiving a sealing cap.' " Id. at 2 (citing '187 Patent col. 19 ll. 34-40).

The parties agree that the accused products each include "a funnel, a cap, and a tube." ECF No. 258 at 1 ¶ 6. The parties further agree that the accused products' "cap" "includes a compartment containing a reagent solution." Id. at 1 ¶ 7.

Genotek's theory of infringement is based on its contention that the accused products' cap and tube combined constitute the "container" (i.e., the claimed "containment vessel"). See ECF No. 242 at 8, 10-11; see also ECF No. 242-8, Wereley Expert Report ¶¶ 25, 46-57. Indeed, in a chart contained in both Genotek's opposition and Genotek's expert's report, Genotek and its expert identify the following structure (via a dotted rectangle) as constituting the claimed container/containment vessel:

Image materials not available for display. ECF No. 242 at 11; ECF No. 242-8, Wereley Expert Report ¶¶ 25, 73.

This theory of infringement fails because it is based on an untimely and flawed claim construction argument. Genotek's theory of infringement is based on its contention that the claimed "sealing cap" is part of the claimed "containment vessel." See ECF No. 242 at 8 ("a 'sealing cap' is part of the 'container' in the patented invention"); see also ECF No. 242-8, Wereley Expert Report ¶¶ 47-53, 92 (citing to the '187 Patent's specification and prosecution history and contending "the term 'container' in the context of the '187 Patent encompasses a cap and a tube").² At claim construction, Genotek did not seek a construction of the claim term "containment vessel" explaining that the "sealing cap" is part of the "containment vessel." Indeed, Genotek didn't seek a construction of the claim term "containment vessel" at all. Rather, Genotek argued that the term "containment vessel" did not require construction and instead should be given its plain and ordinary meaning. ECF No. 134 at 15; ECF No. 89 at 6; ECF No. 74-1, Ex. A at 28. As such, Genotek waived its present claim construction argument regarding the proper scope of the term "containment vessel."³ See CliniComp Int'l, Inc. v. Cerner Corp., No. 17-cv-2479-GPC-DEB, 2022 WL 16985003, at *9 (S.D. Cal. Nov. 15, 2022) ("[G]enerally, a party waives any argument with respect to the construction of a claim term when they fail to raise that issue during the claim construction phase of the case."); Finalrod IP, LLC v. John Crane, Inc., No. 7:15-cv-97, 2019 WL 4061703, at *2 (W.D. Tex. May 30, 2019) ("The Federal Circuit holds that an accused infringer waives any argument with respect to the construction of a claim term when they fail to raise that issue during the claim construction phase of a patent infringement action."); see, e.g., Cent. Admixture Pharmacy Servs., Inc. v. Advanced Cardiac Sols., P.C., 482 F.3d 1347, 1356 (Fed. Cir. 2007) ("The district court found that ACS waived any argument with respect to th[e] term ["maintaining"] by failing to raise it during the claim construction phase. We agree."); Pelican Int'l, Inc. v. Hobie Cat Co., No. 320CV02390RSHMSB, 2023 WL 2127994, at *8, 11 (S.D. Cal. Feb. 10, 2023). " 'Sound practical reasons counsel against construing additional terms based on claim construction arguments raised for the first time in summary judgment briefs.' " CliniComp, 2022 WL 16985003, at *9 (quoting Apple, Inc. v. Samsung Elecs. Co., No. 12-cv-630, 2014 WL 252045, at *3 (N.D. Cal. Jan. 21, 2014)); see O2 Micro Int'l Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355, 1364 (Fed. Cir. 2006) (explaining that patent local rules are designed to "prevent the shifting sands approach to claim construction"). Because Genotek's theory of infringement relies on an untimely claim construction that it waived, its current theory of infringement fails as a matter of law.

2 In his expert report, Dr. Wereley relies on the '187 Patent's specification and prosecution history to support his opinion that "the term 'container' in the context of the '187 Patent encompasses a cap and a tube." ECF No. 242-8, Wereley Expert Report ¶¶ 47-53, 92. Courts have held that " '[e]xpert testimony about the plain and ordinary meaning of claim terms supported by reference to specification and prosecution history would constitute impermissible claim construction.' " CAO Lighting, Inc. v. Gen. Elec. Co., No. CV 20-681-GBW, 2023 WL 1930354, at *7 (D. Del. Jan. 30, 2023) (quoting Ferring Pharms. Inc. v. PAR Pharm., Inc., No. 1:15-CV-00173-RGA, 2016 WL 6471246, at *1 (D. Del. Oct. 28, 2016)); see Optolum, Inc. v. Cree, Inc., No. 1:17CV687, 2021 WL 8533814, at *3 (M.D.N.C. Oct. 24, 2021); Contour IP Holding, LLC v. GoPro, Inc., No. 3:17-CV-04738-WHO, 2020 WL 5106845, at *4 (N.D. Cal. Aug. 31, 2020); Not Dead Yet Mfg., Inc. v. Pride Sols., LLC, 222 F. Supp. 3d 657, 661-62 (N.D. Ill. 2016); MediaTek inc. v. Freescale Semiconductor, Inc., No. 11-CV-5341 YGR, 2014 WL 971765, at *5 (N.D. Cal. Mar. 5, 2014). And those courts have excluded such testimony. See id.; see also, e.g., Cordis Corp. v. Bos. Sci. Corp., 561 F.3d 1319, 1337 (Fed. Cir. 2009) (affirming district court's refusal to permit defendant to argue the prosecution history of the asserted patent to the jury). As such, the Court strikes and excludes this claim construction analysis in Dr. Wereley's expert report.

3 In concluding that Genotek waived this particular claim construction argument, the Court notes that it is clear from Genotek's claim construction briefing that, during the claim construction phase of this case, Genotek was well aware of the non-infringement defense that is contained in the present motion for summary judgment. See ECF No. 134 at 15 ("As described in more detail below, this unusual construction [for the term 'containment vessel'] is step one in Spectrum's two-step manufacture of a non-infringement defense."); see also ECF No. 74-1, Ex. A at 34.

Further, Genotek's claim construction argument is erroneous, and had Genotek presented this argument to the Court during the claim construction phase of the case, the Court would have rejected it. Genotek's contention is that the claimed "sealing cap" is part of the claimed "containment vessel." See ECF No. 242 at 8 ("a 'sealing cap' is part of the 'container' in the patented invention"); see also ECF No. 242-8, Wereley Expert Report ¶ 92 ("the term 'container' in the context of the '187 Patent encompasses a cap and a tube"). The plain language of independent claim 1 of the '187 claim makes clear that Genotek's contention is wrong. See Phillips, 415 F.3d at 1314 (explaining that "the context in which a term is used in the asserted claim can be highly instructive").

Independent claim 1 of the '187 Patent claims: "A device for receiving and preserving nucleic acid in a biological sample, said device comprising:" (1) "a containment vessel;" (2) "a sealing cap;" (3) "a reagent compartment;" and (4) "reagents." '187 Patent col. 19 ll. 34-59; see also ECF No. 176 at 16 (Genotek explaining: "I think of the claim as having three different sections. You've got the containment vessel[,] . . . then you've got the reagent compartment . . . [a]nd then you have the sealing cap."). "Where a claim lists elements separately, 'the clear implication of the claim language' is that those elements are 'distinct component[s]' of the patented invention." Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (quoting Gaus v. Conair Corp., 363 F.3d 1284, 1288 (Fed. Cir. 2004)); see Kyocera Senco Indus. Tools Inc. v. Int'l Trade Comm'n, 22 F.4th 1369, 1382 (Fed. Cir. 2022) ("The asserted claims list th[e] elements separately . . . . There is, therefore, a presumption that those components are distinct."); Echologics, LLC v. Orbis Intelligent Sys., Inc., No. 21-CV-01147-RBM-AHG, 2022 WL 2193115, at *10 (S.D. Cal. June 17, 2022). Because claim 1 lists "a containment vessel" and "a sealing cap" separately, there is a presumption that those two components are distinct.

Further, the claim language in independent claim 1 provides that the "containment vessel" has "a top having an opening . . . said opening for receiving a liquid sample and for sealably receiving a cap." '187 Patent col. 19 ll. 36-40. The plain and ordinary meaning of the word "top" is "[t]he uppermost part, point, surface, or end." THE AMERICAN HERITAGE COLLEGE DICTIONARY 1426 (3d ed. 1997); see MERRIAM-WEBSTER DICTIONARY, https://www.merriam-webster.com/dictionary/top (defining "top" as "the highest point, level, or part of something.").⁴ If the cap is part of the containment vessel, then the containment vessel does not have a top with an opening because the uppermost part or point of the containment vessel would be the top of the cap, which is enclosed and does not have an opening for receiving a cap. This can be displayed via Genotek's own diagram in its opposition brief:

4 At the hearing, Genotek conceded that the common definition of the word "top" is "uppermost part," but it argued that the term "top" is context-specific in this situation. ECF No. 312 at 7. At claim construction, Genotek did not propose that the Court construe the term "top." See generally ECF No. 74-1, Ex. A; ECF No. 134; ECF No. 89. As such, Genotek has waived any argument that the claim term "top" means anything other than the plain and ordinary meaning of the word "top," which is "uppermost part." See Cent. Admixture Pharmacy, 482 F.3d at 1356; CliniComp, 2022 WL 16985003, at *9; Pelican, 2023 WL 2127994, at *8, 11; Finalrod, 2019 WL 4061703, at *2.

Image materials not available for display. ECF No. 242 at 11 (annotated by Court). The uppermost part/point, or "top," of what Genotek identifies as the "Container" in its diagram is the top of the cap, which is enclosed and doesn't have an opening (in particular, it doesn't have an opening for receiving a cap).

At the hearing, Genotek contended that although it is not a method claim, the claim language in independent claim 1 contemplates steps or stages where the container changes over time. See ECF No. 312 at 4-6, 8; see also ECF No. 242 at 10 ("[O]nce the cap is placed on the collection tube as intended, the cap and the collection tube form the required 'container.' "). The Court rejects this argument. Even if the Court were to assume that Genotek's contention that the apparatus described in claim 1 recites steps or stages is correct, as Genotek acknowledged at the hearing, the term "top" and the term "containment vessel" are only recited in what Genotek described as "step (a)" of the claim. ECF No. 312 at 5. As such, there is no support in the claim language for Genotek's contention that the containment vessel or the top of that containment vessel changes overtime.

In an effort to support its claim construction position, Genotek also cites figures 10 and 11 in the specification and the corresponding descriptions of those figures. ECF No. 242 at 16. Genotek contends that the specification "describes Figures 10 and 11 as being views of the 'container,' views that include 'cap 1.' Id. The Court rejects Genotek's contention. Figures 10 and 11 are views of the "container," but the corresponding descriptions in the specification specifically state that the "container" in those figures is "container 3," and figures 10 and 11 depict "container 3" as being a separate component apart from and below "cap 1." See '187 Patent figs 10, 11, col. 8 ll. 46-54, col. 15 ll. 33-39. As such, figures 10 and 11 are consistent with the notion that the "containment vessel" and the "sealing cap" are separate components of the device.⁵

5 Genotek also cites the specification's description of the "desirable features" of the "collection vessel" / "collection device of the invention." ECF No. 242 at 15 (citing '187 Patent col. 14 ll. 61-67, col. 15 ll. 1-32). DNA Genotek's citation of this passage is based on its assumption that the specification equates the terms "collection device of the invention" and "collection vessel" with the term "container." But it is unclear from the specification that this is a correct assumption. See, e.g., '187 Patent col. 6 ll. 28-33 ("The device: includes a container, . . . a means for closing the container, . . . ."); id. at col. 14 ll. 51-56 (same). Further, even if Genotek is correct, and the specification equates these terms, there is other language in the specification describing the "cap" as not only being separate from the "container," but also as being separate from "the device." See, e.g., id. at col. 15 ll. 34-35 ("[w]ith cap 1 not attached to the device, a biological sample (not shown) is applied to a first region 8 of container 3"), ("cap 1 is placed onto the device and secured via a screw thread mechanism to a tight fit, thereby sealing container 3"). Moreover, regardless of any ambiguous language contained in the specification, as explained above, the claim language itself clearly states that the claimed "containment vessel" has "a top" with "an opening" "for sealably receiving a sealing cap," mandating that the cap be a separate component from the containment vessel. '187 Patent col. 19 ll. 36-40.

Genotek also cites to extrinsic evidence consisting of an unrelated patent - U.S. Patent No. 5,643,767 - and testimony from Spectrum's experts discussing that unrelated patent. See ECF No. 242 at 11-12 (citing ECF No. 243-11, Fischetti Decl. ¶ 10; ECF No. 243-12, Ex. 12; ECF No. 243-13, Leinsing Expert Report ¶¶ 50-63). But this evidence is of no consequence because statements from or regarding an unrelated patent are irrelevant for claim construction purposes. See Apple Inc. v. Motorola, Inc., 757 F.3d 1286, 1312 (Fed. Cir. 2014) ("statements made in unrelated applications are not relevant to claim construction"); Taction Tech., Inc. v. Apple Inc., No. 21-CV-812 TWR (JLB), 2022 WL 18781398, at *15 (S.D. Cal. Sept. 28, 2022) ("[T]he two cited Apple patents are unrelated to the patents-in-suit, and, thus are not relevant to claim construction."); see also, e.g., Goldenberg v. Cytogen, Inc., 373 F.3d 1158, 1167-68 (Fed. Cir. 2004) (finding statements in another patent irrelevant to claim construction "[a]bsent a formal relationship or incorporation during prosecution" of the patent at issue).

Finally, in its claim construction briefing, Genotek contended that something that is in the cap is "outside of the containment vessel," demonstrating Genotek recognized that the containment vessel is a separate component from the cap. See, e.g., ECF No. 134 at 17 ("The specification of Provisional Application No. 60/386,398 (''398 application')—whose content the '187 patent incorporates expressly by reference—even discloses an embodiment in which the reagent compartment is outside of the containment vessel, e.g., as part of the cap." (emphasis in original)). In sum, Genotek's claim construction argument is erroneous and contrary to the language in the claims, and, therefore, the Court rejects it.

And for the same reasons, the relevant claim language makes it clear that summary judgment of no literal infringement is appropriate here. No reasonable jury could look at the diagram from Genotek and its expert and conclude that the top of the structure identified by Genotek has an opening for receiving a cap. Any person viewing the diagram would see that the uppermost part/point of the structure identified by Genotek and its expert as being the "container" is the top of the cap.⁶ See ECF No. 242 at 11; ECF No. 242-8, Wereley Expert Report ¶¶ 25, 73. As such, no reasonable jury could conclude that the accused products literally satisfy the "containment vessel having a top having an opening . . . said opening for receiving a liquid sample and for sealably receiving a cap" claim limitation based on the structure identified by Genotek.⁷ Accordingly, Spectrum is entitled to summary judgment that the accused products do not literally infringe claim 1 of '187 Patent. See Advanced Steel Recovery, 808 F.3d at 1317; EMD Millipore, 768 F.3d at 1201.

6 At the hearing, Genotek asserted that the structure identified in the diagram as the "Container" has an opening at the top of what is identified as the "tube," and that constitutes the "top" of the containment vessel. ECF No. 312 at 4, 8; see ECF No. 242 at 11. But as Genotek conceded at the hearing, that opening is "halfway down" the diagram and near the middle of the structure identified by Genotek, and not at the top. See ECF No. 312 at 5 (Court: "So in step (a), the top is halfway down the drawing, just above where the word 'tube' exists on the drawing?" Genotek: "Yes. That's right.").

7 In the parties' joint statement of undisputed material facts, the parties state: "For purposes of this motion, Spectrum does not dispute that the accused device meets the limitation of the asserted claims of the '187 patent . . . other than the 'reagent compartment' [limitation]." ECF No. 258 at 1-2 ¶ 12. However, at the hearing, Spectrum clarified that its concession that the accused products satisfy the "containment vessel" limitation is based on Spectrum's contention that the tube by itself (and only the tube) is the claimed "containment vessel." ECF No. 312 at 12. Genotek declined to accept that concession from Spectrum, and, instead, Genotek contends that the tube and cap combined are the "containment vessel." See ECF No. 242 at 8, 10-11. Genotek concedes that the claimed "reagent compartment" is in the "cap," and the diagram contained in Genotek's opposition brief displays the "reagent compartment" as being in the "cap" and not in what is identified as the "tube." See id. at 11; ECF No. 231-5, Ex. 3 ("The reagent chamber is in the SDNA-1000's cap."); ECF No. 258 at 1 ¶ 7.

B. Doctrine of Equivalents

Genotek argues that even if there is no literal infringement, the Court should deny Spectrum's motion for summary judgment because it has presented evidence that there is infringement under the doctrine of equivalents. ECF No. 242 at 15-18. In response, Spectrum argues that Genotek waived any reliance on infringement under the doctrine of equivalents because Genotek never properly asserted doctrine of equivalents theories in its infringement contentions. ECF No. 231-1 at 11-13; ECF No. 254 at 5 n.4. The Court agrees with Spectrum.

"The Court's Patent Local Rules are designed to require parties to crystallize their theories of the case early in the litigation and to adhere to those theories once they have been disclosed." CliniComp, 2022 WL 16985003, at *12 (quoting Wi-LAN Inc. v. LG Elecs., Inc., No. 18-CV-01577-H-BGS, 2019 WL 5790999, at *2 (S.D. Cal. Sept. 18, 2019)); accord O2 Micro, 467 F.3d at 1366 n.12. "The Local Rules are also designed to provide structure to discovery and to enable the parties to move efficiently toward claim construction and the eventual resolution of their dispute." Bell Semiconductor, LLC v. NXP USA, Inc., No. 22-CV-00594-H-KSC, 2023 WL 2342037, at *2 (S.D. Cal. Feb. 27, 2023) (quoting Pelican Int'l, Inc. v. Hobie Cat Co., No. 320CV02390RSHMSB, 2023 WL 2127995, at *2 (S.D. Cal. Feb. 10, 2023)). "The Patent Local Rules accomplish this 'by requiring both the plaintiff and the defendant in patent cases to provide early notice of their infringement and invalidity contentions, and to proceed with diligence in amending those contentions when new information comes to light in the course of discovery. The Local Rules thus seek to balance the right to develop new information in discovery with the need for certainty as to the legal theories.' " Id. (quoting O2 Micro, 467 F.3d at 1365-66). "A district court has wide discretion in enforcing the Patent Local Rules." Echologics, LLC v. Orbis Intelligent Sys., Inc., No. 21-CV-01147-RBM-AHG, 2022 WL 17724142, at *7 (S.D. Cal. Dec. 15, 2022) (quoting CliniComp, 2022 WL 16985003, at *12); see Howmedica Osteonics Corp. v. Zimmer, Inc., 822 F.3d 1312, 1320 (Fed. Cir. 2016) (reviewing "a district court's application of its local rules for abuse of discretion"); see also Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1321 (Fed. Cir. 2016) (" '[T]his court defers to the district court when interpreting and enforcing local rules so as not to frustrate local attempts to manage patent cases according to prescribed guidelines.' ").

"Under Patent Local Rule 3.1, a party claiming patent infringement must serve on all parties a 'Disclosure of Asserted Claims and Infringement Contentions,' and those contentions must disclose specific information regarding the party's theories of infringement in the case." Bell Semiconductor, 2023 WL 2342037, at *2 (citing Patent L.R. 3.1). In a lawsuit for patent infringement in the Southern District of California, a patentee is limited to the infringement theories and the accused products it sets forth in its infringement contentions. Id.; CliniComp, 2022 WL 16985003, at *13; see also LookSmart Grp., Inc. v. Microsoft Corp., No. 17-CV-04709-JST, 2019 WL 7753444, at *2 (N.D. Cal. Oct. 17, 2019) ("Once served, the infringement contentions constitute the universe of infringement theories."). Any infringement theories not properly disclosed pursuant to the Court's Patent Local Rules are barred from presentation at trial (whether through expert opinion testimony or otherwise). Bell Semiconductor, 2023 WL 2342037, at *3 (citing Pelican, 2023 WL 2127995, at *3). Indeed, the Federal Circuit has held that a party asserting a claim of infringement waives its right to raise infringement under the doctrine of equivalents by failing to timely disclose it in its infringement contentions. See, e.g., Teashot LLC v. Green Mountain Coffee Roasters, Inc., 595 F. App'x 983, 987-88 (Fed. Cir. 2015) (affirming district court's holding that plaintiff waived its right to raise infringement under the doctrine of equivalents by failing to timely disclose it as an infringement theory its infringement contentions); see also CliniComp, 2022 WL 16985003, at *13 ("[Plaintiff] waived its right to raise doctrine of equivalents by failing to properly disclose that theory of infringement in its infringement contentions."); PersonalWeb Techs. LLC v. Int'l Bus. Machines Corp., No. 16-CV-01266-EJD, 2017 WL 2180980, at *16 (N.D. Cal. May 18, 2017) ("Courts in this district have cited deficient infringement contentions as additional bases for granting summary judgment of noninfringement with respect to doctrine of equivalents.").

Patent Local Rule 3.1(e) provides that a party's "Disclosure of Asserted Claims and Infringement Contentions" must contain the following information, among other things: "[w]hether each element of each asserted claim is claimed to be literally present and/or present under the doctrine of equivalents in the Accused Instrumentality." S.D. Cal. Pat. L.R. 3.1(e). Courts in this district have held that a general reservation of the right to assert infringement under the doctrine of equivalents does not satisfy a plaintiff's obligation to disclose its infringement analysis as required by Patent Local Rule 3.1(e). Bell Semiconductor, 2023 WL 2342037, at *7; CliniComp, 2022 WL 16985003, at *13; Sonix Tech. Co. v. Yoshida, No. 12CV380-CAB (DHB), 2014 WL 11899474, at *3 (S.D. Cal. Dec. 12, 2014); see also Finjan, Inc. v. Proofpoint, Inc., No. 13-CV-05808-HSG, 2015 WL 9460295, at *1 (N.D. Cal. Dec. 23, 2015) ("Such a general disclaimer would be contrary to the local rule's requirement that parties crystallize their theories early in the litigation."). "Rather, in order to properly assert an infringement theory under the doctrine of equivalents in compliance with the Court's Patent Local Rules, a patentee must provide 'a limitation-by-limitation' analysis as to why and how there is infringement under the doctrine of equivalents." Bell Semiconductor, 2023 WL 2342037, at *7 (quoting Pelican, 2023 WL 2127995, at *5); CliniComp, 2022 WL 16985003, at *13 (citing Ameranth, Inc. v. Pizza Hut, Inc., No. 12CV1627 JLS NLS, 2013 WL 3894880, at *5 (S.D. Cal. July 26, 2013)); see also Mirror Worlds, 692 F.3d at 1357 (" '[T]he doctrine of equivalents must be applied to individual limitations of the claim, not to the invention as a whole.' "). The infringement contentions must explain how there is infringement under the insubstantial differences test and/or the function-way-results test. See ASUS Comput. Int'l v. Round Rock Rsch., LLC, No. 12-CV-02099, 2014 WL 1463609, at *3 (N.D. Cal. Apr. 11, 2014) ("[I]n infringement contentions, 'a party looking to rely on equivalents still has to describe how [the function/way/result or insubstantial differences] requirements are met.' "); see, e.g., Bell Semiconductor, 2023 WL 2342037, at *7 (finding contentions sufficient where they "analyze[d] equivalence on a limitation-by-limitation basis and provide specific analysis under the insubstantial differences test and the function-way-results test"); Pelican, 2023 WL 2127995, at *6 (same).

Following the Court's issuance of the claim construction order on November 29, 2022, Genotek served its amended infringement contentions on December 29, 2022. See ECF No. 231-5, Ex. 3. In those contentions, for several claim limitations, including the "reagent compartment" claim limitation, Genotek states:

To the extent this claim limitation is not literally met, the SDNA-1000 meets that limitation under the doctrine of equivalents because any differences are insubstantial and the SDNA-1000 performs substantially the same function in substantially the same way to get substantially the same result.

See, e.g., id. at 113, 116, 119, 122.

This is a general reservation of right to assert infringement under the doctrine of equivalents and is insufficient to comply with Patent Local Rule 3.1(e). The Court acknowledges that this reservation of right is done on a limitation-by-limitation basis and references the insubstantial differences test and the function-way-results tests. But simply saying the words "insubstantial" and "function"-"way"-"result" is insufficient to comply with Rule 3.1(e). Rather, the patentee must provide some analysis explaining "why and how" there is infringement under the insubstantial differences test and/or the function-way-results test.⁸ See Bell Semiconductor, 2023 WL 2342037, at *7; CliniComp, 2022 WL 16985003, at *13; Ameranth, 2013 WL 3894880, at *5; ASUS, 2014 WL 1463609, at *3. As such, because Genotek failed to properly disclose any theory of infringement under the doctrine of equivalents in its infringement contentions, Genotek waived its right to raise infringement under the doctrine of equivalents.⁹ See, e.g., Teashot, 595 F. App'x at 987-88; CliniComp, 2022 WL 16985003, at *13; Sonix, 2014 WL 11899474, at *3.

8 The Court notes that this is not an onerous burden and can generally be satisfied with just a few sentences of analysis. See, e.g., Bell Semiconductor, 2023 WL 2342037, at *7; Pelican, 2023 WL 2127995, at *6. Indeed, in his expert report, Genotek's expert Dr. Wereley sets forth a theory of infringement under the doctrine of equivalents utilizing the function-way-results test as to the "reagent compartment" limitation in five short sentences. See ECF No. 242-8, Wereley Expert Report ¶ 93.
In its opposition, Genotek contends that if Spectrum had a complaint about its ability to understand Genotek's doctrine of equivalents theory of infringement, then it should have raised the issue as a discovery dispute. ECF No. 242 at 17. The Court rejects Genotek's attempt to shift the responsibility of its infringement disclosures to Spectrum. Under the plain language of Patent Local Rule 3.1, it is the responsibility of the "party claiming patent infringement" (here, Genotek) to provide the information required by Rule 3.1(e). Pat. L.R. 3.1; see KlausTech, Inc. v. Google LLC, No. 10CV05899JSWDMR, 2018 WL 5109383, at *6 (N.D. Cal. Sept. 14, 2018) ("KlausTech attempts to shift the blame to Google for not complaining earlier about the inadequacy of its accused browser disclosures. This argument is contrary to the patent local rules which place the burden on the patentee to make explicit disclosures regarding all infringement theories."); Polaris PowerLED Techs., LLC v. VIZIO, Inc., No. SACV181571JVSDFMX, 2020 WL 4258663, at *4 (C.D. Cal. May 14, 2020) (same).

9 Genotek argues that a finding of waiver here would violate Federal Rule of Civil Procedure 83(a)(2). ECF No. 242 at 17-18. The Court rejects this argument. The Federal Circuit has affirmed the exclusion of a patentee's theory of infringement under the doctrine of equivalents where the patentee failed to timely and properly disclose that theory of infringement in its infringement contentions. See, e.g., Teashot, 595 F. App'x at 987-88. Indeed, the Federal Circuit has explained: "Because patent local rules are essentially a series of case management orders, a district court may impose any just sanction for the failure to obey them, including refusing to allow the disobedient party to support or oppose designated claims or defenses, or prohibiting that party from introducing designated matters in evidence." Phigenix, Inc. v. Genentech, Inc., 783 F. App'x 1014, 1016 (Fed. Cir. 2019) (affirming district court's striking of expert infringement opinions that failed to comply with patent local rules); accord Taction Tech., Inc. v. Apple Inc., No. 21-CV-812 TWR, 2023 WL 2977728, at *10 S.D. Cal. Apr. 17, 2023.

Further, even if the Court were to assume that Genotek did not waive infringement under the doctrine of equivalents, summary judgment of non-infringement as to claim 1 of the '187 Patent is still appropriate. " '[T]he doctrine of equivalents must be applied to individual limitations of the claim, not to the invention as a whole.' " Mirror Worlds, 692 F.3d at 1357 (quoting Warner-Jenkinson, 520 U.S. at 29, 117 S.Ct. 1040). In his expert report, Dr. Wereley only presents a theory of infringement under the doctrine of equivalents as to the "reagent compartment" limitation. See ECF No. 242-8 Wereley Expert Report ¶¶ 88, 93-94. The Court's entry of summary judgment of no literal infringement is not based on the "reagent compartment" limitation. Rather, it is based on the "a containment vessel having a top having an opening . . . said opening for receiving a liquid sample and for sealably receiving a sealing cap" limitation. Therefore, because Dr. Wereley's theory of infringement under the doctrine of equivalents relates to a different limitation, Dr. Wereley's doctrine of equivalents analysis has no effect on the Court's non-infringement determination.¹⁰

10 The Court specifically notes that in his expert report, Dr. Wereley does not assert a theory of infringement under the doctrine of equivalents as to the "containment vessel" limitation. See ECF No. 242-8, Wereley Expert Report ¶¶ 46-57. Further, in its infringement contentions, Genotek did not even reserve the right to assert infringement under the doctrine of equivalents as to the "containment vessel" limitation. See ECF No. 231-5, Ex. 3 at 81-88.

The Court acknowledges that in his expert report, Dr. Wereley states: "Even if the Court were to construe the container as the 'tube,' the Spectrum Products would meet the 'reagent chamber' limitation under the doctrine of equivalents." ECF No. 242-8, Wereley Expert Report ¶ 93. However, this assertion made by Dr. Wereley is based on an erroneous understanding of how a patent infringement analysis works. In an infringement analysis under the proper legal standard, the Court does not "construe" accused products or components of accused products. Rather, the Court construes the proper scope of the asserted claims. See Niazi, 30 F.4th at 1350-51; see also Teva, 574 U.S. at 321, 135 S.Ct. 831 (explaining that " 'construction of a patent, including terms of art within its claim' " is " 'exclusively' for 'the court' " (quoting Markman, 517 U.S. at 390, 116 S.Ct. 1384)). The patentee bears the burden of proving infringement based on those properly construed asserted claims. See Medtronic, 571 U.S. at 193, 134 S.Ct. 843; Creative Compounds, 651 F.3d at 1314. In order to satisfy that burden, the patentee "must prove the presence of each and every element or its equivalent in the accused method or device." Star Sci., 655 F.3d at 1378; see Uniloc, 632 F.3d at 1301 ("To prove infringement, the plaintiff bears the burden of proof to show the presence of every element or its equivalent in the accused device."). As such, it is the patentee's burden - not the Court's burden - to identify the relevant components/structures in the accused products that purportedly satisfy the properly construed claim limitations.

In an effort to prove infringement in this case, Genotek and its expert chose to identify the "cap" and "tube" combined as being the relevant structure of the accused products that purportedly satisfies the "containment vessel" limitation.¹¹ See ECF No. 242 at 10-11; ECF No. 242-8 Wereley Decl. ¶¶ 25, 46-47, 89; see also ECF No. 231-5, Ex. 3 at 87-88. Genotek chose to do so even though this theory of infringement relied on an untimely and erroneous claim construction argument that Genotek waived, and the Court has rejected. And Genotek chose to do so even though the identified structure does not have a "top" (i.e., an uppermost part) with an "opening" for receiving a cap and instead has an enclosed top.

11 In its opposition brief, Genotek only identifies the cap and tube combined as constituting the claimed "containment vessel." See ECF No. 242 at 8, 10-11. Genotek does not identify any other structure. See generally id. Similar, in his expert report, Dr. Wereley only contends that the cap and tube combined constitute the containment vessel. ECF No. 242-8, Wereley Expert Report ¶¶ 47-56. Dr. Wereley does not identify any other structure. See id.

In sum, Genotek has waived any theory of infringement under the doctrine of equivalents. Further, regardless of any of Genotek's arguments regarding infringement under doctrine of equivalents as to the "reagent compartment" limitation, the accused products still fail to satisfy the "containment vessel having a top having an opening . . . said opening for receiving a liquid sample and for sealably receiving a cap" claim limitation based on structure identified by Genotek. Accordingly, Spectrum is entitled to summary judgment of non-infringement as to independent claim 1 of the '187 Patent. Further, because Spectrum is entitled to summary judgment of non-infringement as to independent claim 1, Spectrum is also entitled to summary judgment of non-infringement as to asserted dependent claims 2, 4, 6-7, 20-21, 23-31, and 33, which all depend from claim 1. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989) ("One who does not infringe an independent claim cannot infringe a claim dependent (and thus containing all the limitations of) that claim."); see, e.g., Ferring B.V. v. Watson Lab'ys, Inc.-Fla., 764 F.3d 1401, 1411 (Fed. Cir. 2014) ("Because we hold that the asserted independent claims of Ferring's patents are not infringed, the asserted dependent claims are likewise not infringed."); see also ECF No. 258 at 1 ¶¶ 2-3 (listing the asserted dependent claims).

C. Genotek's Request for Reconsideration of the Court's Claim Construction

In its opposition brief, Genotek requests that the Court revisit its construction of the claim term "reagent compartment." ECF No. 242 at 14-15. A motion for reconsideration in a patent case is governed by the law of the regional circuit, here, the Ninth Circuit. See Delaware Valley Floral Grp., Inc. v. Shaw Rose Nets, LLC, 597 F.3d 1374, 1379 (Fed. Cir. 2010). A district court has inherent jurisdiction to modify, alter, or revoke a prior order. United States v. Martin, 226 F.3d 1042, 1049 (9th Cir. 2000). The Federal Circuit has specifically explained that "a district court may (and sometimes must) revisit, alter, or supplement its claim constructions . . . to the extent necessary to ensure that final constructions serve their purpose of genuinely clarifying the scope of claims for the finder of fact." In re Papst Licensing Digit. Camera Pat. Litig., 778 F.3d 1255, 1261 (Fed. Cir. 2015) (citing O2 Micro, 521 F.3d at 1359; Pfizer, Inc. v. Teva Pharm., USA, Inc., 429 F.3d 1364, 1377 (Fed. Cir. 2005)); see Conoco, Inc. v. Energy & Env't Int'l, L.C., 460 F.3d 1349, 1359 (Fed. Cir. 2006) ("[D]istrict courts may engage in 'rolling claim construction, in which the court revisits and alters its interpretation of the claim terms as its understanding of the technology evolves.' ") (quoting Guttman, Inc. v. Kopykake Enters., Inc., 302 F.3d 1352, 1361 (Fed. Cir. 2002)).

Reconsideration of a prior order is an "extraordinary remedy, to be used sparingly in the interests of finality and conservation of judicial resources." Carroll v. Nakatani, 342 F.3d 934, 945 (9th Cir. 2003); accord Berman v. Freedom Fin. Network, LLC, 30 F.4th 849, 858-59 (9th Cir. 2022); see also Marlyn Nutraceuticals, Inc. v. Mucos Pharma GmbH & Co., 571 F.3d 873, 880 (9th Cir. 2009) (" '[A] motion for reconsideration should not be granted, absent highly unusual circumstances . . . .' "). "Reconsideration [of a prior order] is appropriate if the district court (1) is presented with newly discovered evidence, (2) committed clear error or the initial decision was manifestly unjust, or (3) if there is an intervening change in controlling law." School Dist. No. 1J v. ACandS, Inc., 5 F.3d 1255, 1263 (9th Cir. 1993); accord Smith v. Clark Cnty. Sch. Dist., 727 F.3d 950, 955 (9th Cir. 2013). A motion for reconsideration may not be used to relitigate old matters, or to raise arguments or present evidence for the first time that reasonably could have been raised earlier in the litigation. Exxon Shipping Co. v. Baker, 554 U.S. 471, 486 n.5, 128 S.Ct. 2605, 171 L.Ed.2d 570 (2008); see Berman, 30 F.4th at 859 ("Reconsideration motions may not be used to raise new arguments or introduce new evidence if, with reasonable diligence, the arguments and evidence could have been presented during consideration of the original ruling.") (citing Kona Enterprises, Inc. v. Estate of Bishop, 229 F.3d 877, 890 (9th Cir. 2000)); Williams v. Cnty. of San Diego, 542 F. Supp. 3d 1070, 1071 (S.D. Cal. 2021) ("A motion for reconsideration is not a vehicle to reargue the motion or to present evidence which should have been raised before.").

As an initial matter, Genotek asserts: "If the Court amends its construction [of the term "reagent compartment"], as Spectrum urges, the Court must consider new evidence." ECF No. 242 at 1; see id. at 12-13. The Court has not amended its construction of the claim term "reagent compartment." Further, the Court notes its entry of summary judgment of non-infringement is not based on the "reagent compartment" limitation. Rather, it is based on the "a containment vessel having a top having an opening . . . said opening for receiving a liquid sample and for sealably receiving a sealing cap" limitation. As such, Genotek's request for reconsideration of the Court's construction of "reagent compartment" is moot.

Further, Genotek has failed to provide the Court with an adequate basis for reconsideration of the Court's claim construction. Genotek's request for reconsideration is based on claim language in dependent claim 30 of U.S. Patent No. 11,572,581 ("the '581 Patent"), which was issued by the United States Patent and Trademark Office ("PTO") on February 7, 2023. See ECF No. 242 at 3-5, 14-15; U.S. Patent No. 11,572,581 col. 20 ll. 62-63 (issued Feb. 7, 2023). Genotek characterizes this as "new evidence," but there is evidence in the record showing that the dependent claim at issue was first allowed by the examiner back on November 29, 2021 - almost a year before the claim construction hearing in this action and well before the parties filed their joint claim construction chart and their claim construction briefs. See ECF No. 254-2, Razai Decl. Ex. 9. A motion for reconsideration "may not be used to raise new arguments or introduce new evidence if, with reasonable diligence, the arguments and evidence could have been presented during consideration of the original ruling." Berman, 30 F.4th at 859; see Exxon Shipping, 554 U.S. at 486 n.5, 128 S.Ct. 2605; Williams, 542 F. Supp. 3d at 1071. Genotek fails to adequately explain why it could not rely on the existence of the dependent claim at issue during claim construction in this case based on the November 29, 2021 notice of allowance.

Genotek notes that "the PTO had the entire claim construction opinion before it when it allowed claim 30 of the '581 patent," and argues that the Court must consider this new prosecution history. ECF No. 242 at 15; see also ECF No. 242 at 5; ECF No. 243-8, Ex. 7. Genotek contends: "The PTO either understood the Court's claim construction the way Genotek interprets it above, or it disagreed with Spectrum's interpretation." Id. But there are several problems with this assertion regarding the prosecution history. First, Genotek fails to adequately explain the legal significance of providing the examiner with the Court's claim construction order during prosecution of the '581 Patent. Genotek implies that in light of the Court's claim construction order, the examiner could have "withdraw[n] the claims from issuance," but Genotek fails to provide the Court with any authority demonstrating that this is correct. ECF No. 242 at 5. Genotek states that by the time it provided the examiner with the claim construction order, the claims had already been allowed. See id. at 5 (referring to them as "previously allowed claims"). Genotek fails to adequately explain how a district court's recently issued claim construction order could provide an examiner with a legal basis to reject previously allowed claims. Second, Genotek does not identify any express interpretation or construction by the examiner of the term "reagent compartment." Rather, Genotek speculates as to how it thinks the examiner might have interpreted the claim term. Third, even assuming the examiner implicitly interpreted the term "reagent compartment" in the manner proposed by Genotek, Genotek fails to explain how the examiner's purported claim interpretation is material to the claim construction issues in this case. PTO examiners use the "broadest reasonable interpretation" standard to interpret claims, which is different from the Phillips standard for claim construction utilized and applied by district courts. See Seabed Geosolutions, 8 F.4th at 1287 "Under that standard, 'claims are given their broadest reasonable interpretation consistent with the specification, not necessarily the correct construction under the framework laid out in Phillips.' " Id. (quoting PPC Broadband, Inc. v. Corning Optical Commc'ns RF, LLC, 815 F.3d 734, 742 (Fed. Cir. 2016)); see also MiMedx Grp., Inc. v. Tissue Transplant Tech., Ltd., 354 F. Supp. 3d 742, 750 (W.D. Tex. 2018) (explaining that "the purpose behind the PTO's use of the BRI standard is to 'allow the examiner and the applicant to explore the broadest possible scope of the claim,' while a federal court's use of the Phillips standard is to "search 'for the one "correct" interpretation' ") (quoting Flo Healthcare Sols., LLC v. Kappos, 697 F.3d 1367, 1378 (Fed. Cir. 2012), overruled on other grounds by Williamson v. Citrix Online, LLC, 792 F.3d 1339 (Fed. Cir. 2015)). As such, the Court denies Genotek's request for reconsideration.

VI. SPECTRUM'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT OF THE '646 PATENT

Spectrum argues that it is entitled to summary judgment of non-infringement as to the '646 Patent because Genotek cannot show that the accused products preserve cells of a biological sample as required by the claims of the '646 Patent. ECF No. 231-1 at 14-18. In response, Genotek argues that Spectrum's motion should be denied because there is at least a genuine dispute of material fact over the "preserving a biological sample" claim limitation. ECF No. 242 at 18-25.

Independent claim 1 of the '646 Patent claims: "A kit for collecting and preserving a biological sample." '646 Patent col. 22 ll. 16. At claim construction, the Court held that the preamble of independent claim 1 is limiting. ECF No. 177 at 62. In addition, the Court construed the claim term "preserving a biological sample" as "preventing cells in the biological sample from having their antigens degraded such that they can be purified or enriched based on their antigens, and preventing alterations in the cellular epigenome." Id. at 65.

As an initial matter, the parties acknowledge and agree that the Court's construction of the term "preserving a biological sample" is two-part. See ECF No. 242 at 19-23; ECF No. 254 at 6-7. First, the Court's construction for that term requires that the claimed "kit" "prevent[s] cells in the biological sample from having their antigens degraded such that they can be purified or enriched based on their antigens." ECF No. 177 at 65. Second, the Court's construction requires that the claimed "kit" "prevent[s] alterations in the cellular epigenome." Id. Thus, in order to raise a genuine dispute of material fact as to the "preserving a biological sample" limitation, Genotek must present sufficient evidence from which a reasonable jury could conclude that both of those requirements in the Court's claim construction are satisfied by the accused products. See Advanced Steel Recovery, 808 F.3d at 1317.

A. "preventing cells in the biological sample from having their antigens degraded such that they can be purified or enriched based on their antigens"

Genotek asserts that the accused products "prevent[ ] cells in the biological sample from having their antigens degraded such that they can be purified or enriched based on their antigens." See ECF No. 242 at 19-20. To support this assertion, Genotek primarily relies on the opinions of its expert, Dr. Metzker. See id.

In his expert report, Dr. Metzker opines that the accused products' solution¹² prevents cells in the biological sample from having their antigens degraded such that they can be purified or enriched based on their antigens. ECF No. 242-7, Metzker Expert Report ¶ 130. To support this opinion, Dr. Metzker relies on the results of testing performed by the Applied Biomedical Science ("ABS") Institute in San Diego. See id. ¶¶ 122-29. Dr. Metzker explains this testing as follows:

12 The Court declines to refer to the accused products' solution as a "preservative" as Dr. Metzker does in his expert report. See, e.g., ECF No. 242-7, Metzker Expert Report ¶¶ 122, 126, 130. The Court notes that elsewhere in his report Dr. Metzker refers to the composition at issue as "reagents" or the "blue stabilizing solution." See id. ¶¶ 48-50. Further, the Court will not refer to the samples in Metzker's test as the "non-preserved and preserved samples" as Dr. Metzker does. See, e.g., id. ¶ 128. Rather, the Court will refer to the samples as samples with the solution and samples without the solution.

[T]wo donors provided saliva samples directly into Spectrum SDNA-1000 devices. Each donor provided six (6) saliva samples according to Step 1 of the SDNA-1000 IFU. Three of the six samples for each donor were then processed according to Step 2 SDNA-1000 IFU, 150 to release the . . . solution into the saliva samples . . . . The remaining three samples for each donor were capped without engaging the valve, and therefore the . . . solution stayed in the cap.

[ ]Three timepoints were evaluated for [the samples] for each donor: 0-hour, 24-hour, and 72-hour, which incubated at room temperature.

Id. 123-24. Based on the resulting data from these tests, Dr. Metzker opines: "these data provide strong evidence that the Spectrum Product['s] solution protects the TLR2 antigen from degradation." Id. ¶ 128 (explaining that the sample with the solution "show[s] a high percentage (41.1%) of TLR2⁺ aggregate cells whereas no such cells were found in the" sample without the solution).

But the problem with this opinion is that TLR2 is not the only antigen at issue in the testing. The testing also involved CD4, CD45, and EpCAM antigens. See id. ¶ 122, Ex. C. Dr. Metzker does not provide any specific analysis of the data related to those three antigens in his report. But importantly, Dr. Metzker concedes that "the general trend for all data in Exhibit C are the [samples with the solution] have lower cell percentages compared with" the samples without the solution. Id. ¶ 128. Indeed, a review of the testing results related to CD4, CD45, and EpCAM show that with respect to those antigens, there were many fewer cells positive for those antigens in the samples with the solution than there were in the samples without any solution after 24 and 72 hours. See id. ¶ 128, Ex. C. For example, according to the results in Exhibit C to the Metzker Report, at 24 hours, the sample without the solution from Donor 1 showed a much higher presence of cells positive for CD45 (11.0% stained and 0.10% unstained) compared to the sample with the solution (0.57% stained and 0.08% unstained). See id. Ex. C at 93; see also id. Ex. C at 94, 98, 99, 100.¹³ In assessing this data, the Court is simply employing the same method utilized by Dr. Metzker in his report - i.e., comparing the cell percentage numbers in the gates drawn by Genotek's other experts between the solution and non-solution samples from the same donor. And this assessment of the data is consistent with Dr. Metzker's concession that "the general trend" is that the "cell percentages" are "lower" for the samples with the solution. Id. ¶ 128. This data in Dr. Metzker's report regarding CD4, CD45, and EpCAM and his concession regarding that data is significant because this shows via Dr. Metzker's own testing that adding the solution to the samples actually increased the degradation of many antigens rather than preventing degradation. See id.

13 As another example, Exhibit C shows that at 72 hours, the sample without the solution from Donor 2 showed a much higher presence of cells positive for CD45 and EpCAM (0.20% unstained, 18.1% stained CD45, and 20.7% stained EpCAM) compared to the sample with the solution (0.34% unstained, 2.83% stained CD45, and 0.65% stained EpCAM). See ECF No. 242-7, Metzker Expert Report Ex. C at 100.

Further, these test results are consistent with the fact that in his expert report, Dr. Metzker also opines that the accused products satisfy the chemistry limitations in Claim 1 of the '187 Patent. See ECF No. 242-7, Metzker Expert Report ¶¶ 58-80. The specification of the '187 Patent explains: "When sputum is mixed with a composition of the present invention, cells are disrupted, nucleic acids are liberated from the cells, membranous material is solubilized, proteins are stripped from the nucleic acids, and protein digestion begins." '187 Patent col. 13 ll. 38-42; see also Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1353 (Fed. Cir. 2016) ("When a patentee 'describes the features of the "present invention" as a whole,' he implicitly alerts the reader that 'this description limits the scope of the invention.' ") (quoting Regents of Univ. of Minnesota v. AGA Med. Corp., 717 F.3d 929, 936 (Fed. Cir. 2013)); Techtronic Indus. Co. v. Int'l Trade Comm'n, 944 F. 3d 901, 907 (Fed. Cir. 2019) ("It is axiomatic that, where the specification 'describes "the present invention" as having [a] feature,' that representation may disavow contrary embodiments."). By asserting that accused products practice the claims of the '187 Patent, Dr. Metzker is conceding that the accused products' solution performs in the manner described by the '187 Patent's specification. And Spectrum also concedes that the accused solution performs in this manner, see ECF No. 231-1 at 1-2, 14-17, meaning that it is not only Dr. Metzker's opinion, but it is an undisputed fact in this case that the accused solution performs in that manner.

That Dr. Metzker's own testing demonstrates that the solution increases degradation of CD4, CD45, and EpCAM is consequential because the Court's construction of the relevant claim term requires that the accused solution prevent "cells in the biological sample from having their antigens degraded." ECF No. 177 at 65. The Court's claim construction says "cells" and "antigens" plural, not one type of antigen or cell. As such, even crediting as true Dr. Metzker's opinion that the accused products' solution protects TLR2 antigens from degradation,¹⁴ that is insufficient to satisfy the Court's construction of the relevant claim term when the other evidence in Dr. Metzker's report demonstrates that the accused products' solution increases the degradation of other antigens. Because the testimony from Dr. Metzker along with the data in his report demonstrate that the accused products increase, rather than prevent, the degradation of CD4, CD45, and EpCAM antigens, no reasonable jury could conclude the accused products satisfy the "preserving a biological sample" claim limitation as construed by the Court.¹⁵

14 Although for purposes of this summary judgment analysis, the Court credits as true Dr. Metzker's opinions regarding TLR2 antigens, see Charles Mach. Works, Inc. v. Vermeer Mfg. Co., 723 F.3d 1376, 1380 (Fed. Cir. 2013), even those opinions are highly problematic. In his expert report, in assessing TLR2, Dr. Metzker focuses entirely on "TLR2⁺ Aggregates" data while entirely ignoring the "TLR2⁺ Singlets" data shown in the graphs at issue. ECF No. 242-7, Metzker Expert Report ¶ 128. In his report, Dr. Metzker provides no explanation for why the "TLR2⁺ Singlets" data should be ignored. See id. Exhibit C to Dr. Metzker's report shows that at 72 hours, the sample without the solution from Donor 2 showed a much higher presence of cells positive for "TLR2⁺ Singlets" (22.5% stained and 0.56% unstained) compared to the sample with the solution (0.32% stained and 0.095% unstained). See ECF No. 242-7, Metzker Expert Report Ex. C at 102.

15 In its opposition, Genotek cites to certain evidence and contends that this evidence "shows that there is, at a minimum, reason to doubt the veracity of Spectrum's contentions about the extensive damage that its [solution] causes cells." ECF No. 242 at 21-23. The problem with this argument is that in the above analysis, the Court is not relying on Spectrum's statements regarding the effects of its solution. Rather, the Court is relying on the testimony and data from Genotek's own expert regarding the effects of the solution.

At the hearing, Genotek argued that Dr. Metzker's opinions regarding TLR2 should be sufficient to meet the Court's claim construction regardless of the data as to CD4, CD45, and EpCAM. See ECF No. 312 at 31-38. The Court disagrees. To support its argument, Genotek relies on a preferred embodiment described in the specification of the '187 Patent where the inventors isolated T-cells from saliva and confirmed that the T-cell's antigens remained intact by just targeting CD4, a single type of antigen. See '646 Patent col. 18 l.64-col. 19 l. 40; see also ECF No. 242-7, Metzker Report ¶ 117. But the testing in Dr. Metzker's report is not analogous to that embodiment in the specification. Dr. Metzker did not simply isolate skin cells and then test whether the accused solution preserves TLR2 and find that indeed it does. Rather, he tested whether the accused solution preserves TLR2, CD4, CD45, and EpCAM, and came back with data demonstrating that the solution increases degradation of CD4, CD45, and EpCAM, meaning that the solution at issue increases the degradation of antigens rather than preventing it. This cannot satisfy the Court's claim construction.

At the hearing, Genotek also argued that the numbers in the charts in Exhibit C are not important, and, instead, what is important is the fluorescence displayed in the charts. ECF No. 312 at 14-15, 17, 18-19. The Court rejects this argument as it has no basis at all in the actual analysis that is presented in Dr. Metzker's report. In Exhibit C to his report, Genotek's other experts drew the gates at issue, and they set forth the cell percentage numbers corresponding with those gates. See ECF No. 242-7, Metzker Expert Report at 89. And in his report, Dr. Metzker expressly cites to those cell percentage numbers (for example, 41.1%) to support his opinions. See id. ¶ 128 ("[T]he [sample with solution] show a high percentage (41.1%) of TLR2⁺ aggregate cells whereas no such cells were found in the [sample with no solution]"). Dr. Metzker makes no reference to the "fluorescence" analysis described by Genotek at the hearing. See id. Genotek's discussion of "fluorescence" at the hearing is nothing more than attorney argument. "[I]n order to defeat a properly supported motion for summary judgment," a plaintiff "must present affirmative evidence." Anderson, 477 U.S. at 257, 106 S.Ct. 2505. "Attorney argument is not evidence." Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017); accord FastShip, LLC v. United States, 892 F.3d 1298, 1309 (Fed. Cir. 2018). As such, Genotek's attorney argument regarding "fluorescence" is insufficient to raise a triable issue of fact.¹⁶

16 Further, even if the Court accepted Genotek's contention that it is not the numbers in the charts that matter, but, instead, whether visually can you see "more dots in that box . . . than otherwise," the data still supports the conclusion that the solution increases the degradation of antigens. For example, Exhibit C shows that at 72 hours, the sample without the solution from Donor 2 contained a lot "more dots" for CD45 and EpCAM in the gates drawn by Genotek's experts than in the gates for the sample with the solution. See ECF No. 242-7, Metzker Expert Report Ex. C at 100; see also id., Ex. C at 93, 94, 96, 98, 99, 101, 102.

Similarly, at the hearing, Genotek argued that it was the "quality" of the cells remaining in the samples that mattered, not the number of cells. ECF No. 312 at 16-17, 25-27. The Court rejects this argument as again Genotek's "quality over quantity" argument has no basis whatsoever in Dr. Metzker's expert report. In his expert, Dr. Metzker focused on cell percentage numbers (for example, "41.1%") to support his opinions. See ECF No. 242-7, Metzker Expert Report ¶ 128. As such, Dr. Metzker's own analysis focused on quantity. Moreover, that Genotek's "quality" argument has no basis in Dr. Metzker's actual analysis is demonstrated by Genotek's reliance and focus on paragraph 135 of Dr. Metzker's report to support its contention. Paragraph 135 of Dr. Metzker's report is from a different section of his expert report addressing a different portion of the Court's claim construction for this term. See id. ¶ 135 (contained in section B.1.b entitled "The Spectrum Products' [solution] present[s] alterations in the cellular epigenome"). In the section of his expert report that addresses the portion of the Court's claim construction at issue, Dr. Metzker makes no reference to paragraph 135 of his expert report. See id. ¶¶ 114-30. As such, Genotek's "quality over quantity" argument is untethered to Dr. Metzker's actual analysis and is again nothing more than attorney argument unsupported by any evidence in the record. See Icon Health & Fitness, 849 F.3d at 1043 ("Attorney argument is not evidence."); FastShip, 892 F.3d at 1309 (same). And it is insufficient to raise a triable issue of fact. See Anderson, 477 U.S. at 257, 106 S.Ct. 2505.

In an effort to create a triable issue of fact, Genotek also notes that in his expert report, Dr. Metzker explains that the reagent ingredients in Spectrum's solution include antimicrobial ingredients and alcohol. ECF No. 242 at 19-20 (citing ECF No. 242-7, Metzker Expert Report ¶¶ 119, 121). Genotek notes that the '646 Patent recognizes that antimicrobial agents " 'prevent damage to cells from microbial contamination.' " ECF No. 242 at 19; accord '646 Patent col. 17 ll. 15-16. Genotek also notes that the '646 Patent teaches that chemical fixing agents, such as alcohol, "are 'used to alter cell components such that the cells resist degradation.' " ECF No. 242 at 20; accord '646 Patent col. 16 ll. 48-50.

But the problem with this argument is that those ingredients are just that - they are "ingredients." They are not the entire solution. Alcohol by itself might be a chemical fixing agent, and antimicrobial ingredients by themselves might prevent damage to cells. But the accused solution is not alcohol by itself or antimicrobial ingredients by themselves. The solution is all the ingredients contained in the accused products' reagent solution combined. And the data and testimony from Genotek's own expert shows that the accused products' solution (with all of its ingredients combined) increases the degradation of antigens rather than preventing it. And Dr. Metzker's discussion of certain specific ingredients in the accused products' solution does not change that fact. In sum, summary judgment of no infringement of Claim 1 of the '646 Patent is appropriate because no reasonable jury could conclude, based on the evidence presented by Genotek, that the accused products satisfy the "prevent[ ] cells in the biological sample from having their antigens degraded such that they can be purified or enriched based on their antigens" requirement in the Court's construction of the "preserving a biological sample" claim limitation.

B. "preventing alterations in the cellular epigenome"

Genotek asserts that the accused products "prevent[ ] alterations in the cellular epigenome." ECF No. 242 at 20-21. To support this assertion, Genotek relies solely on the opinions of its expert Dr. Metzker. See id.

In his expert report, Dr. Metzker opines that the accused products' solution prevents alterations in the cellular epigenome. ECF No. 242-7, Metzker Expert Report ¶ 138. To support this opinion, Dr. Metzker describes testing that was performed, and Dr. Metzker asserts that the DNA methylation data from that testing "demonstrate no alteration in the cellular epigenome caused by demethylation" in the samples with the solution. Id. ¶¶ 133-37 ("Overall, data show that the [samples with solution] exhibit consistent methylation patterning, even after three days at room temperature."). But this is insufficient to demonstrate that the accused products' solution prevents alterations in the cellular "epigenome" within the context of the '646 Patent.

As Dr. Metzker acknowledges in his report, the '646 Patent provides a definition of the term "epigenome." ECF No. 242-7, Metzker Expert Report ¶ 131. The specification of the '646 Patent provides:

The "epigenome" means the state or pattern of alteration of genomic DNA by covalent modification of the DNA or of proteins bound to the DNA. Examples of such alteration include methylation at the 5 position of cytosine in a CpG dinucleotide, acetylation of lysine residues of histones, and other heritable or non-heritable changes that do not result from changes in the underlying DNA sequence.

'646 Patent col. 16 ll. 27-33. See Phillips, 415 F.3d at 1316 ("[T]he specification may reveal a special definition given to a claim term by the patentee . . . . In such cases, the inventor's lexicography governs."); Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1329 (Fed. Cir. 2009) (explaining that a patentee acts as his own lexicographer when the patentee " 'clearly set[s] forth a definition of the disputed claim term in either the specification or prosecution history.' "); see, e.g., Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1336 (Fed. Cir. 2020).¹⁷

17 Genotek notes that the Court's claim construction order does not contain a definition of the word "epigenome." ECF No. 242 at 6. But this is of no consequence here because in his report Dr. Metzker asserts that the above passage in the specification of the '646 Patent sets forth the proper definition for the term "epigenome." See ECF No. 242-7, Metzker Expert Report ¶ 131. As such, the Court's analysis of this issue is based on what Dr. Metzker asserts is the proper definition of the term "epigenome."

Here, the specification explains that "epigenome" encompasses the state or pattern of alteration of genomic DNA by: (1) "covalent modification of the DNA"; or (2) covalent modification "of proteins bound by the DNA." '646 Patent col. 16 ll. 27-29. And the specification then lists two explicit examples of what constitutes "alterations" to the epigenome: "methylation at the 5 position of cytosine in a CpG dinucleotide" and "acetylation of lysine residues of histones."¹⁸ Id. at col. 16 ll. 29-33. Thus, in order to prevent alterations in the cellular epigenome within the context of the '646 Patent, the accused products' solution must at the very least prevent both "methylation at the 5 position of cytosine in a CpG dinucleotide" and "acetylation of lysine residues of histones.". See id.; see also id. at col. 18 ll. 26-27 ("Histones must be chemically fixed to the DNA in order to be studied.").

18 In his expert report, Dr. Metzker explains that "histones" are proteins that form "chromatin," and "chromatin" is what forms chromosomes. ECF No. 242-7, Metzker Expert Report ¶ 35.

The cited testing in Dr. Metzker's report only concerns DNA methylation.¹⁹ See ECF No. 242 at 20 (referring to testing as "DNA methylation testing"); ECF No. 242-7, Metzker Expert Report ¶¶ 133-37 (referring to the data as "DNA methylation data"). It doesn't address histone acetylation. Indeed, at the hearing, Genotek conceded that Dr. Metzker did not do a histone acetylation test. ECF No. 312 at 45. As such, Dr. Metzker's opinions are insufficient to demonstrate that the accused products prevent alterations in the cellular "epigenome" within the context of the '646 Patent. Further, because Dr. Metzker's opinions are the only evidence Genotek relies on to demonstrate that the accused products prevent alterations in the cellular epigenome, this is another reason why Genotek has failed to raise a triable issue of material fact as to the "preserving a biological sample" limitation.²⁰

19 The Court acknowledges that in his expert report, Dr. Metzker states: "Saliva collection devices with stabilizing solutions are commonly used for epigenetic analysis and are not thought to alter the cellular epigenome." ECF No. 242-7, Metzker Expert Report ¶ 132. But the publication that Dr. Metzker cites to support this opinion also only focuses on DNA methylation. See id. (citing publication entitled "DNA methylation analysis from saliva samples for epidemiological studies").

20 Moreover, other evidence in the record states that the solution in the accused products "will destroy or disable the proteins that are attached to the nucleic acids." ECF No. 231-6, Ex. 4, Gaeta Depo. at 34. Spectrum criticizes Dr. Gaeta's testimony on the grounds that he never performed any testing to determine whether the solution alters cellular epigenomes. ECF No. 242 at 18. But on the specific issue of proteins bound to the DNA, Dr. Metzker didn't perform any testing either to rebut Dr. Gaeta's statements. In addition, again, Dr. Metzker opines that the accused products satisfy the chemistry limitations of the asserted claims of the '187 Patent. See ECF No. 242-7, Metzker Expert Report ¶¶ 58-80. Consistent with Dr. Gaeta's testimony, the specification of the '187 Patent explains that the claimed reagent composition liberates nucleic acid from cells, strips proteins from nucleic acid, and digests those proteins. See '187 Patent col. 13 ll. 38-42.

C. Conclusion

In sum, Spectrum is entitled to summary judgment of non-infringement as to independent claim 1 of the '646 Patent. Further, because Spectrum is entitled to summary judgment of non-infringement of independent claim 1, Spectrum is also entitled to summary judgment of non-infringement as to asserted dependent claims 4-8 and 11-12, which all depend from claim 1. See Wahpeton Canvas, 870 F.2d at 1552 n.9; see, e.g., Ferring, 764 F.3d at 1411; see also ECF No. 258 at 1 ¶¶ 4-5 (listing the asserted dependent claims).²¹

21 To support its motion for summary judgment of non-infringement of the '646 Patent, Spectrum attached to its reply brief a declaration from its technical expert, Dr. Lisa Nichols. See ECF No. 254-3, Nichols Decl. Genotek argues that it is improper to submit new evidence as part of a reply brief. ECF No. 242 at 25 n.2. "Ordinarily, 'where new evidence is presented in a reply to a motion for summary judgment, the district court should not consider the new evidence without giving the non-movant an opportunity to respond.' " S.E.C. v. Platforms Wireless Int'l Corp., 617 F.3d 1072, 1088 (9th Cir. 2010); accord Townsend v. Monster Beverage Corp., 303 F. Supp. 3d 1010, 1027 (C.D. Cal. 2018). The non-infringement analysis above does not cite to or rely on any opinions in the Nichols declaration, and, therefore, the issue is moot.

VII. CONCLUSION

For the reasons above, the Court grants Spectrum's motion for summary judgment that the accused products do not infringe the '187 Patent and the accused products do not infringe the '646 Patent.

SO ORDERED.