Case 3:21-cv-00516-RSH-DDL Document 177 Filed 11/29/22 PageID.8413 Page 1 of 72
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`
`DNA GENOTEK INC., a California
`Corporation,
`
`Plaintiff,
`
`v.
`SPECTRUM SOLUTIONS L.L.C., a Utah
`Limited Liability Company,
`
`Defendant.
`
` Case No.: 3:21-CV-00516-RSH-DDL
`
`ORDER:
`
`(1) CLAIM CONSTRUCTION
`ORDER; AND
`
`(2) DENYING AS MOOT
`PLAINTIFF’S MOTION FOR
`LEAVE TO FILE A RESPONSE TO
`DEFENDANT’S EVIDENTIARY
`OBJECTIONS
`
`[ECF No. 101.]
`
`In this case, Plaintiff DNA Genotek (“DNA Genotek”) alleges that Spectrum
`Solutions L.L.C. (“Spectrum”) infringes U.S. Patent Nos. 10,619,187 (“the ’187 Patent”)
`and 11,002,646 (“the ’646 Patent”) (collectively “the patents-in-suit”). On January 7, 2022,
`the Parties filed their Joint Claim Construction Hearing Statement, Chart, and Worksheet
`in accordance with Patent Local Rule 4.2. ECF No. 74. On February 18, 2022, the Parties
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`IPR Petition - USP 11,536,632
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`filed their Opening Claim Construction Briefs. ECF Nos. 134, 147.1 On March 4, 2022,
`the Parties filed their Responsive Claim Construction Briefs. ECF Nos. 88, 89. On
`November 9, 2022, the Court emailed counsel of record a tentative claim construction
`order.
`The Court held a claim construction hearing on Thursday, November 10, 2022. ECF
`No. 176. After considering the parties’ briefing and the arguments presented at the hearing,
`the Court issues the following claim construction order.
`I.
`BACKGROUND
`DNA Genotek is the owner by assignment of the ’187 Patent and the ’646 Patent.
`See U.S. Patent No. 10,619,187, at [73] (issued Apr. 14, 2020); U.S. Patent No. 11,002,646,
`at [73] (issued May 11, 2021). In the present action, DNA Genotek alleges that Spectrum
`infringes the patents-in-suit, either literally or under the doctrine of equivalents, by making,
`using, offering for sale, selling and/or importing saliva DNA collection devices, including
`Spectrum’s SDNA-1000 and SDNA-2000 products. See SAC (Aug. 4, 2021), ECF No. 20
`¶¶ 3, 18, 22-27, 35-45, 55-65.
`The patents-in-suit both generally relate to devices for biological sample collection.
`The ’187 Patent was issued on April 14, 2020 and is entitled “Compositions and Methods
`for Obtaining Nucleic Acids from Sputum.” ’187 Patent at [54], [45]. The invention
`disclosed in the ’187 Patent “relates to compositions and methods for preserving nucleic
`acids at room temperature for extended periods of time and for simplifying the isolation of
`nucleic acids.” Id. col. 1 ll. 23-26. Specifically, the invention “features a composition for
`preserving nucleic acids that includes a chelating agent, and a denaturing agent, where the
`pH of the composition is greater than 5.0.” Id. col. 3 ll. 61-64.
`Independent claim 1 of the ’187 Patent, the only independent claim in the ’187
`Patent, claims:
`
`On July 19, 2022, DNA Genotek filed a Corrected Opening Claim Construction
`1
`Brief. ECF No. 134.
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`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.
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`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.
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`On March 24, 2021, DNA Genotek filed a complaint for patent infringement against
`Spectrum, alleging infringement of the ’187 Patent. See Compl. (Mar. 24, 2021), ECF No.
`1. On June 8, 2021, DNA Genotek filed its Second Amended Complaint (the “SAC,” the
`operative complaint) against Spectrum, adding a claim for infringement of the ’646 Patent.
`See SAC (Aug. 4, 2021), ECF No. 20. On August 18, 2021, Spectrum filed an answer to
`the SAC along with counterclaims against DNA Genotek for: (1) declaratory judgment of
`non-infringement of the patents-in-suit; (2) declaratory judgment of invalidity of the
`patents-in-suit; (3) declaratory judgment of unenforceability of the ’187 Patent due to
`inequitable conduct; (4) monopolization in violation of section 2 of the Sherman Act, 15
`U.S.C. § 2; and (5) attempted monopolization in violation of section 2 of the Sherman Act,
`15 U.S.C. § 2. See Answer & Counterclaims (Aug. 18, 2021), ECF No. 27.
`On September 2, 2021, the Court issued a scheduling order for the action. ECF No.
`29. On April 1, 2022, the Court denied DNA Genotek’s motion to dismiss Spectrum’s
`counterclaims for inequitable conduct, monopolization, and attempted monopolization,
`and the Court denied DNA Genotek’s motion to strike Spectrum’s affirmative defenses of
`inequitable conduct, patent misuse, and unclean hands. ECF No. 111. On May 25, 2022,
`the Court issued an amended scheduling order. ECF No. 130. By the present claim
`construction charts, worksheets, and briefs, the Parties agree upon the proper construction
`for two claim terms, and the Parties request that the Court construe eleven disputed claim
`terms from the patents-in-suit. ECF Nos. 74-1, 74-2, 88, 89, 134, 147.
`II.
`PLAINTIFF’S MOTION FOR LEAVE TO FILE A RESPONSE TO
`DEFENDANT’S EVIDENTIARY OBJECTIONS
`
`As an initial matter, the Court addresses DNA Genotek’s motion for leave to file a
`response to Defendant’s Evidentiary Objections. Along with its responsive claim
`construction brief, Spectrum filed a document entitled “Defendant’s Evidentiary
`Objections to the Declaration of Dr. Michael L. Metzker Filed in Support of DNA
`Genotek’s Opening Claim Construction Brief.” ECF No. 88-1. In the filing, Spectrum
`objects to portions of Dr. Metzker’s declaration for failure to comply with the Court’s
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`Patent Local Rules, specifically Patent Local Rules 4.1(b), 4.1(d), and 4.2(d)(2).2 Id. at 1-
`3.
`On March 21, 2022, DNA Genotek filed a motion for leave to file a response to
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`Spectrum’s evidentiary objections. ECF No. 101. In the motion, DNA Genotek argues that
`Spectrum’s filing is improper and unauthorized because the filing of separate “evidentiary
`objections” is a state procedural device that is not envisioned by the Federal Rules of Civil
`Procedure or the Court’s Patent Local Rules. Id. at 1.
`The Court declines to address Spectrum’s evidentiary objections. In the filing,
`Spectrum objects to certain portions of Dr. Metzker’s declaration, specifically, certain
`statements in paragraphs 18, 25, 34, 60, 63, and 67 of the declaration. See ECF No. 88-1 at
`3-6. Although the Court is skeptical that these portions of Dr. Metzker’s declaration
`complied with Patent Local Rule 4.2(d)(2), the Court does not rely on or reference any of
`the statements at issue in reaching the claim constructions set forth below. Thus, because
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`Patent Local Rule 4.1(b) provides: “Simultaneously with exchange of the
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`‘Preliminary Claim Constructions[,]’ . . . [w]ith respect to any such witness, percipient or
`expert, the parties must also provide a brief description of the substance of that witness’s
`proposed testimony.” S.D. Cal. Pat. L.R. 4.1(b). Similarly, Patent Local Rule 4.1(d)
`provides: “Simultaneously with exchange of the ‘Responsive Claim Constructions[,]’ . . .
`[w]ith respect to any such witness, percipient or expert, the parties must also provide a brief
`description of the substance of that witness’s proposed testimony.” Id. 4.1(d). Patent Local
`Rule 4.2(d)(2) further provides: “The Joint Hearing Statement must include: . . . [w]hether
`any party proposes to call one or more witnesses, including experts, at the Claim
`Construction Hearing, the identify of each such witness, and for each expert, a summary
`of each opinion to be offered in sufficient detail to permit a meaningful deposition of that
`expert.” Id. 4.2(d).
`
`“A district court has wide discretion in enforcing the Patent Local Rules.” Finjan,
`Inc. v. Proofpoint, Inc., No. 13-CV-05808-HSG, 2015 WL 9460295, at *1 (N.D. Cal. Dec.
`23, 2015). The Federal Circuit has “concluded that the exclusion of evidence is often an
`appropriate sanction for a party’s failure to comply with the patent local rules.” Phigenix,
`Inc. v. Genentech, Inc., 783 F. App’x 1014, 1020 (Fed. Cir. 2019) (citing O2 Micro Int’l
`Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355, 1369 (Fed. Cir. 2006); Wong v. Regents
`of Univ. of California, 410 F.3d 1052, 1060 (9th Cir. 2005)).
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`the statements at issue from Dr. Metzker’s declaration are not material to the Court’s claim
`construction rulings, the Court need not rule on Spectrum’s evidentiary objections. See
`Elena v. Reliance Standard Life Ins. Co., No. 21-CV-00390-GPC, 2022 WL 1174107, at
`*8 (S.D. Cal. Apr. 20, 2022) (“A court need not rule on evidentiary objections that are not
`material to its ruling.”); see, e.g., Williams v. Cnty. of San Diego, 523 F. Supp. 3d 1183,
`1193–94 (S.D. Cal. 2021) (declining to rule on evidentiary objections that were not
`material to the district court’s ruling); F.T.C. v. John Beck Amazing Profits, LLC, 865 F.
`Supp. 2d 1052, 1062 (C.D. Cal. 2012) (“The Court need not address these objections
`because the Court did not rely on any portion of the evidence to which Defendants
`objected.”). Further, because the Court declines to rule on Spectrum’s evidentiary
`objections, the Court denies as moot DNA Genotek’s motion for leave to file a response to
`those evidentiary objections.
`III. LEGAL STANDARD FOR CLAIM CONSTRUCTION
`“A determination of infringement involves a two-step analysis. ‘First, the claim must
`be properly construed to determine its scope and meaning. Second, the claim as properly
`construed must be compared to the accused device or process.’” Omega Eng’g, Inc. v.
`Raytek Corp., 334 F.3d 1314, 1320 (Fed. Cir. 2003) (quoting Carroll Touch, Inc. v. Electro
`Mech. Sys., Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993)); see Niazi Licensing Corp. v. St.
`Jude Med. S.C., Inc., 30 F.4th 1339, 1350 (Fed. Cir. 2022). The first step of the
`infringement analysis — referred to as claim construction — is now before the Court.
`Claim construction “is exclusively within the province of the court [to decide],” not the
`jury. Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996); see Teva Pharm.
`USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 326 (2015) (holding claim construction is an issue
`of law for the court to decide).
`“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) (quoting Innova/Pure Water, Inc. v. Safari
`Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). “The purpose of claim
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`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 in question
`at the time of the invention, i.e., as of the effective filing date of the patent application.”
`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 person of ordinary skill in the art 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 1314.3
`“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 a term is
`not readily apparent, a court must objectively look to “those sources available to the public
`that show what a person of skill in the art would have understood disputed claim language
`to mean.” Phillips, 415 F.3d at 1314 (quoting Innova, 381 F.3d at 1116). “Those sources
`include ‘the words of the claims themselves, the remainder of the specification, the
`prosecution history, and extrinsic evidence.’” Id.; see Ericsson, Inc. v. D-Link Sys., Inc.,
`773 F.3d 1201, 1217-18 (Fed. Cir. 2014).4
`Courts first look to the language and context of the claims themselves. See Homeland
`Housewares, LLC v. Whirlpool Corp., 865 F.3d 1372, 1375 (Fed. Cir. 2017) (holding that
`claim construction “begins and ends” with a claim’s actual words); Source Vagabond Sys.
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`“General purpose dictionaries” may be instructive in determining whether the
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`ordinary meaning of claim language as understood by a person of skill in the art is readily
`apparent. Phillips, 415 F.3d. at 1314.
`4
`The specification is the “written description” of the invention which enables one
`skilled in the art to make and use the invention and discloses the best mode of carrying out
`the invention. See 35 U.S.C. § 112(a).
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`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” (quoting Innova,
`381 F.3d at 1116)). Claims are interpreted subject to the standard canons of claim
`construction. See, e.g., id. at 1300. For example, because a term that appears in multiple
`claims should generally be construed consistently, “[o]ther claims of the patent in question,
`both asserted and unasserted . . . [can] be valuable sources of enlightenment as to the
`meaning of the [disputed] claim term.” Phillips, 415 F.3d at 1314 (citing Vitronics, 90 F.3d
`at 1582). On the other hand, courts presume the use of different words or phrases in separate
`claims “to indicate that the claims have different meanings and scope” under the doctrine
`of “claim differentiation.” Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1369
`(Fed. Cir. 2007).
`Furthermore, “the person of ordinary skill is deemed to read the claim term not only
`in the context of the particular claim in which the disputed term appears, but [also] in the
`context of the entire patent, including the specification.” Phillips, 415 F.3d at 1314 (citing
`Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)). The
`specification “is always highly relevant to the claim construction analysis. Usually it is
`dispositive; it is the single best guide to the meaning of a disputed term.” Vitronics, 90 F.3d
`at 1582; accord Phillips, 415 F.3d at 1317 (“It is entirely appropriate for a court, when
`conducting claim construction, to rely heavily on the written description for guidance as to
`the meaning of the claims.”). For example, the specification “may reveal a special
`definition given to a claim term by the patentee that differs from the [plain and ordinary]
`meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”
`Phillips, 415 F.3d at 1316. Similarly, “[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
`Tech. Ltd. v. Pegasus Tech. Ltd., 766 F.3d 1338, 1347 (Fed. Cir. 2014)). As such, a court
`must read claims “in view of the specification, of which they are a part.” Markman v.
`Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996);
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`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.”).
`But another principle of claim construction is that “[t]he written description part of
`the specification does not delimit the right to exclude. That is the function and purpose of
`claims.” Markman, 52 F.3d at 980. As the Federal Circuit in Phillips explained, there is a
`“distinction between using the specification to interpret the meaning of a claim and
`importing limitations from the specification into the claim.” 415 F.3d at 1323. 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 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 most situations, an analysis of the intrinsic evidence alone will resolve any
`ambiguity in a disputed claim term.” Vitronics, 90 F.3d at 1583; see 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,
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`Spectrum Ex. 1007
`IPR Petition - USP 11,536,632
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`Case 3:21-cv-00516-RSH-DDL Document 177 Filed 11/29/22 PageID.8423 Page 11 of 72
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`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); see 24/7 Customer,
`Inc. v. LivePerson, Inc., 235 F. Supp. 3d 1102, 1107 (N.D. Cal. 2016) (“Within the class
`of extrinsic evidence, dictionaries, and especially technical dictionaries, ‘can assist the
`court in determining the meaning of particular terminology to those of skill in the art’
`because they ‘endeavor to collect the accepted meanings of terms used in various fields of
`science and technology.’” (quoting Phillips, 415 F.3d at 1318)).
`While sometimes useful, “it is improper to rely on extrinsic evidence” where the
`intrinsic evidence alone is sufficient. Vitronics, 90 F.3d at 1583. Indeed, 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.’” (quoting Phillips, 415 F.3d at 1324)). 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.
`Nevertheless, “district 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. In some
`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 disagreement. Id. at 1362; see Eon Corp. IP Holdings v.
`Silver Spring Networks, 815 F.3d 1314, 1318 (Fed. Cir. 2016).
`
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`Spectrum Ex. 1007
`IPR Petition - USP 11,536,632
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`Case 3:21-cv-00516-RSH-DDL Document 177 Filed 11/29/22 PageID.8424 Page 12 of 72
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`1 IV. CONSTRUCTION OF THE AGREED UPON CLAIM TERMS FROM THE
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`'187 PATENT
`A.
`DNA Genotek's
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`"nucleic acid"
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`Spectrum's
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`Court's
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`Proposed Construction
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`Proposed Construction
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`Construction
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`"a chain of nucleotides,
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`"a chain of nucleotides,
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`"a chain of nucleotides,
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`including
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`including deoxyribonucleic
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`including deoxyribonucleic
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`deoxyribonucleic acid
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`acid (DNA) or ribonucleic
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`acid (DNA) or ribonucleic
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`(DNA) or ribonucleic
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`acid (RNA)"
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`acid (RNA)"
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`acid (RNA)"
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`"biological sample"
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`B.
`DNA Genotek's
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`Spectrum's
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`Court's
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`Proposed Construction
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`Proposed Construction
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`Construction
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`"any sample containing
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`"any sample containing
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`"any sample containing
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`nucleic acids that has
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`nucleic acids that has been
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`nucleic acids that has been
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`been obtained from or
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`obtained from or deposited
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`obtained from or deposited by
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`deposited by an animal" by an animal"
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`an animal"
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`In their Joint Claim Construction Worksheet, the Parties agree upon the proper
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`19
`20 construction for the claim terms "nucleic acid" and "biological sample" in the '187 Patent.
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`21 See ECF No. 74-2 at 4-5, 7. These two proposed constructions are well supported by the
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`22
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`intrinsic record. The '187 Patent's specification sets forth express definitions for the terms
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`23
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`"biological sample" and "nucleic acid." See ' 187 Patent col. 7 11. 16-19, col. 7 11. 28-31.
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`24 The Parties' joint proposed constructions for these claim terms align with those express
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`25 definitions set forth in the specification. As such, the Court adopts the Parties' proposed
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`26 constructions for these two claim terms. See Phillips, 415 F.3d at 1316 ("[T]he
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`specification may reveal a special definition given to a claim term by the patentee . ... In
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`such cases, the inventor's lexicography governs."); Edwards Lifesciences LLC v. Cook
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`Spectrum Ex. 1007
`IPR Petition - USP 11,536,632
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`Case 3:21-cv-00516-RSH-DDL Document 177 Filed 11/29/22 PageID.8425 Page 13 of 72
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`l
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`2
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`3
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`Inc. , 582 F.3d 1322, 1329 (Fed. Cir. 2009) (explaining that a patentee acts as his own
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`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
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`4 Serano, Inc., 976 F.3d 1326, 1336 (Fed. Cir. 2020). The Court construes the claim term
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`5 "nucleic acid" as "a chain of nucleotides, including deoxyribonucleic acid (DNA) or
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`ribonucleic acid (RNA)," and the Court construes the claim term "biological sample" as
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`7 "any sample containing nucleic acids that has been obtained from or deposited by an
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`8 animal."
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`9 V. CONSTRUCTION OF THE DISPUTED CLAIM TERMS FROM THE '187
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`10 PATENT
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`11
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`12
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`13
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`A.
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`"preserving/preserve"
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`DNA Genotek's
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`Spectrum's
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`Proposed Construction
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`Proposed Construction
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`Court's
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`Construction
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`14 The term is definite,
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`The term is indefinite.
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`"slowing degradation of
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`does not require
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`construction, and should
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`be accorded plain and
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`ordinary meaning.
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`If construction is
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`required, the term
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`should be construed as
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`"slowing degradation
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`of'/"slows degradation
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`24 of'
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`nucleic acid[ s] at room
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`temperature for extended
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`periods of time"/"slows
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`degradation of nucleic acids at
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`room temperature for
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`extended periods of time"
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`25
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`28
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`Spectrum argues that the claim term "preserving/preserve" in the ' 187 Patent is
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`indefinite. ECF No. 147 at 5-10. In response, DNA Genotek contends that the term is not
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`Spectrum Ex. 1007
`IPR Petition - USP 11,536,632
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`Case 3:21-cv-00516-RSH-DDL Document 177 Filed 11/29/22 PageID.8426 Page 14 of 72
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`indefinite and the claim term should be given its plain and ordinary meaning. ECF No. 134
`at 5-12.
`“Definiteness is a statutory requirement for patentability.” Niazi, 30 F.4th at 1346.
`Under 35 U.S.C. § 112 ¶ 2, a patent must “conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the applicant regards as the
`invention.” 35 U.S.C. § 112 ¶ 2 (pre-AIA).5
`“A claim fails to satisfy this statutory requirement and is thus invalid for
`indefiniteness if its language, when read in light of the specification and the prosecution
`history, ‘fail[s] to inform, with reasonable certainty, those skilled in the art about the scope
`of the invention.’” Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1369–70 (Fed. Cir.
`2014) (quoting Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014)). This
`“reasonable certainty” standard “reflects a ‘delicate balance’ between ‘the inherent
`limitations of language’ and providing ‘clear notice of what is claimed.’” Guangdong
`Alison Hi-Tech Co. v. Int’l Trade Comm’n, 936 F.3d 1353, 1359 (Fed. Cir. 2019). “Th[e]
`standard ‘mandates clarity, while recognizing that absolute precision is unattainable.’”
`Nevro Corp. v. Bos. Sci. Corp., 955 F.3d 35, 39 (Fed. Cir. 2020) (quoting Nautilus, 572
`U.S. at 910); see also BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir.
`2017) (“‘Reasonable certainty’ does not require ‘absolute or mathematical precision.’”).
`“General principles of claim construction apply to indefiniteness allegations.”
`HZNP Medicines LLC v. Actavis Lab’ys UT, Inc., 940 F.3d 680, 688 (Fed. Cir. 2019). The
`party asserting indefiniteness bears “the burden of proving indefiniteness by clear and
`convincing evidence.” BASF, 875 F.3d at 1365 (citing Biosig Instruments, Inc. v. Nautilus,
`Inc., 783 F.3d 1374, 1377 (Fed. Cir. 2015)); see also Microsoft Corp. v. i4i Ltd. P’ship,
`
`
`
`“Congress amended § 112 when it enacted the Leahy–Smith America Invents Act
`5
`(‘AIA’).” In re Durance, 891 F.3d 991, 1002 n.9 (Fed. Cir. 2018). “However, the amended
`version of § 112 applies only to patent applications ‘filed on or after’ September 16, 2012.”
`Id. Here, the Parties agree that the pre-AIA version of § 112 applies to the ’187 Patent. See,
`e.g., ECF No. 147 at 5; ECF No. 134 at 19.
`
`14
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`3:21-CV