Opinion
CV-21-00034-TUC-RCC
03-30-2022
BioSpyder Technologies Incorporated, Plaintiff, v. HTG Molecular Diagnostics Incorporated, Defendant.
ORDER
Honorable Raner C. Collins, Senior United States District Judge.
Pending before the Court are Defendant HTG Molecular Diagnostics Incorporated's ("HTG") Motion for Partial Summary Judgment of Patent Infringement (Docs. 83, 91) and Plaintiff BioSpyder Technologies Incorporated's ("BioSpyder") Cross Motion for Summary Judgment of Patent Noninfringement (Doc. 101). These matters have been fully briefed. (Docs. 83, 91, 101-02, 106, 110, 113, 117-19.) The Court held oral argument on March 22, 2022. For the following reasons, the Court will deny partial summary judgment of patent infringement and grant summary judgment of noninfringement.
On March 28, 2022, BioSpyder filed a Notice of Supplemental Authority seeking to "respond to HTG's new argument" presented during oral argument regarding Lowe v. Shieldmark, Inc., No. 2021-2164, 2022 WL 636100 (Fed. Cir. Mar. 4, 2022). (Doc. 196.) In response, HTG asserts that the Notice of Supplemental Authority "is an unauthorized brief filed without leave." (Doc. 197 at 2.) There is no local rule or Federal Rule of Civil Procedure governing a Notice of Supplemental Authority. However, in this district, “[t]he purpose of a Notice of Supplemental Authority is to inform the Court of a newly decided case that is relevant to the dispute before it; it is not a venue for submission of additional argument or factual evidence.” Myers v. Freed, No. CV-19-05683-PHX-SMB, 2020 WL 6048327, at *1 (D. Ariz. Oct. 13, 2020); see also B Street Grill & Bar LLC v. Cincinnati Ins. Co., 525 F.Supp.3d 1008, 1013 (D. Ariz. 2021) (striking as improper both parties' notices of supplemental authority but agreeing to consider the cited cases). The Court will consider Lowe to the extent necessary for the Court's ruling on the present motions. The Court will not consider an additional argument presented in the Notice of Supplemental Authority.
I. Relevant Background
Plaintiff BioSpyder and Defendant HTG develop, market, and sell gene expression profiling technology. Counterclaim Defendant Dr. Bruce Seligmann was formerly the Chief Scientific Officer ("CSO") at HTG. When he worked for HTG, Dr. Seligmann was involved in creating a nuclease protection assay that HTG subsequently patented under U.S. Patent No. 8, 741, 564 ("'564 Patent"). Simplified, a nuclease protection assay functions to identify whether a particular biological sample contains a certain target nucleic acid molecule ("target").
Dr. Seligmann transitioned to a consulting position with HTG and later became the Co-Founder and CSO at BioSpyder. After Dr. Seligmann joined BioSpyder, BioSpyder began developing TempO-Seq, a nuclease protection assay that HTG argues infringes on its '564 Patent. In August 2016, the first of BioSpyder's patent applications that involved TempO-Seq's nuclease protection assay was published. According to HTG, it did not learn about the allegedly infringing technology until 2020. Between June and August 2020, HTG sent BioSpyder a series of letters informing BioSpyder that TempO-Seq infringed on the '564 Patent.
On August 12, 2020, BioSpyder filed the present action in the Northern District of California seeking a declaratory judgment of patent noninfringement. In its answer, HTG raised Counterclaim I, alleging that TempO-Seq literally infringed on the '564 Patent. The case was transferred to the District of Arizona, at which point HTG filed an amended answer, asserting twelve additional counterclaims against BioSpyder as well as against Dr. Seligmann, CellSensus, and MDDx. The Court dismissed six of the counterclaims on February 17, 2022. (Doc. 170.)
On July 14, 2021, HTG filed the pending Motion for Partial Summary Judgment on its patent infringement counterclaim. (Docs. 83, 91.) BioSpyder then filed a Response and Cross Motion for Summary Judgment of Noninfringement. (Doc. 101.) The parties assert that the patent infringement question is suitable for resolution at summary judgment because the only dispute in this case is how to construe Claim 1 of the '564 Patent, which is an issue of law for the Court. The Court's construction of Claim 1 will resolve the question of whether TempO-Seq literally infringes on the '564 Patent.
In its Response and Cross Motion for Summary Judgment, BioSpyder referenced the doctrine of equivalents while discussing the summary judgment standard. (Doc. 101 at 14, 24.) However, BioSpyder made no explicit argument as to why this Court should consider the doctrine of equivalents on the present motions nor why TempO-Seq does not equivalently infringe. The only application to the case at hand was the following footnote: "The doctrine of equivalents is a patent law doctrine that in certain limited situations allows for a finding of infringement even if each element of a claim is not literally present. HTG has never accused TempO-Seq of infringing the '564 Patent under the doctrine of equivalents." (Id. at 24 n. 10.) In its Reply to the Motion for Partial Summary Judgment, HTG then presented, for the first time, the argument that TempO-Seq also infringes under the doctrine of equivalents. (Doc. 106 at 17-18.) At the close of its argument, HTG notes, "BioSpyder does not even purport to move for summary judgment under the doctrine of equivalents." (Id. at 18.) BioSpyder then briefly addressed why it asserts TempO-Seq does not infringe under the doctrine of equivalents in its Reply to the Cross Motion for Summary Judgment. (Doc. 119 at 13.) At oral argument, HTG urged the Court to decline to consider the doctrine of equivalents because it was not properly before the Court and had not been sufficiently briefed. Similarly, BioSpyder stated that it had not based its claims on the doctrine of equivalents and only mentioned the doctrine initially in case it formed part of HTG's argument. The Court agrees and will not address whether TempO-Seq infringes on the '564 Patent under the doctrine of equivalents. Moreover, the issue was substantively raised for the first time in a reply brief. See United States v. Bohn, 956 F.2d 208, 209 (9th Cir. 1992) (holding, in general, courts decline to consider arguments raised for the first time in a reply).
II. HTG's '564 Patent
The '564 Patent describes a method of using a nuclease protection probe ("probe")- a molecule with a genetic sequence that is complementary to all or a portion of the genetic sequence in the target. (Doc. 84-9 at 20.) Because the probe has a sequence complementary to the target's sequence, the probe will bind to the target, thereby making it possible to later identify the presence of the target through further analysis. In the '564 Patent, the probe is accompanied by one or two "flanking sequences." (Id.) The flanking sequences provide an amplification sequence necessary for later analysis of the sample. (Id.) The flanking sequence(s) can be at one end or at both ends of the probe. (Id.) Figure 6 from the '564 Patent depicts various embodiments of the probe and the flanking sequences, which are referred to here as "wings." (Id. at 10.)
(Image Omitted) (Id.)
In the language of the '564 Patent, the probe and the flanking sequence(s) make up what HTG refers to as the "NPPF" or "nuclease protection probe comprising a flanking sequence." (Id. at 60.) The following illustration from the '564 Patent depicts one embodiment of an NPPF with flanking sequences at both ends of the probe.
(Image Omitted) (Id. at 4.) In this illustration, 102 is the probe, while 104 and 106 are the flanking sequences. Altogether, 102, 104, and 106 form an NPPF. The NPPF binds to the target at 102. Figure 2 in the '564 Patent shows the NPPF binding to the target:
(Image Omitted) (Id. at 5.) In Figure 2, the NPPF is labeled as 202 and the thick black line represents the target. (Id. at 21.) Once the probe binds to the target, the probe-target portion of the NPPF becomes a double-stranded molecule. To isolate this double-stranded molecule-and complete the assay-the '564 Patent prescribes adding a digestion enzyme called a "nuclease specific for single-stranded molecules." (Id. at 60.) The '564 Patent specification discusses the use of "endonucleases, exonucleases, and combinations thereof. Any of a variety of nucleases can be used." (Id. at 32.) The specification goes on to say, "One of skill in the art can select an appropriate nuclease." (Id.) An endonuclease digests all singlestranded molecules at any point in the sequence, while an exonuclease will only digest from a free end of the nucleic acid molecule. (Doc. 101 at 7 n. 4.)
At this stage in the assay, the flanking sequences are vulnerable to digestion by the nuclease because they have not bound to the target and remain single-stranded. Therefore, the '564 Patent claims a step of "contacting the sample with a nucleic acid molecule comprising a sequence complementary to the flanking sequence (CFS) under conditions sufficient for the flanking sequence to specifically bind to the CFS." (Id. at 60.) The CFSs, therefore, serve to protect the flanking sequence(s) from digestion by the nuclease because, once bound to each other, they form double-stranded molecules that are protected from both endonucleases and exonucleases. Figure 2 of the '564 Patent is again illustrative:
(Image Omitted) (Id. at 5.) As identified previously, 202 is the NPPF and the thick black line is the target. The additional portion of the figure, labeled 204, are the CFSs. (Id. at 21.)
The '564 Patent assay then prescribes amplifying the sample with an amplification primer, generating copies of the target called amplicons. (Id. at 60.) The amplicons are analyzed to identify the target's sequence. (Id.)
The text of Claim 1 of the '564 Patent is particularly relevant to the Court's inquiry. The text reads:
1. A method of determining a sequence of at least one target nucleic acid molecule in a sample, comprising:
contacting the sample with at least one nuclease protection probe comprising a flanking sequence (NPPF) under conditions sufficient for the NPPF to specifically bind to the target nucleic acid molecule,
wherein the NPPF comprises:
a 5'-end and a 3'-end,
a sequence complementary to a region of the target nucleic acid molecule, permitting specific binding between the NPPF and the target nucleic acid molecule,
a flanking sequence located 5', 3', or both, to the sequence complementary to the target nucleic acid molecule, wherein the flanking sequence comprises at least 12 contiguous nucleotides not found in a nucleic acid molecule present in the sample, providing a universal amplification sequence, and wherein the flanking sequence is complementary to at least a portion of an amplification primer;
contacting the sample with a nucleic acid molecule comprising a sequence complementary to the flanking sequence (CFS) under conditions sufficient for the flanking sequence to specifically
bind to the CFS;
contacting the sample with a nuclease specific for single-stranded nucleic acid molecules under conditions sufficient to remove unbound nucleic acid molecules, thereby generating a digested sample comprising NPPFs hybridized to the target nucleic acid molecule and to the CFS(s);
amplifying NPPFs in the digested sample with the amplification primer, thereby generating NPPF amplicons;
and sequencing at least a portion of the NPPF amplicons, thereby determining the sequence of the at least one target nucleic acid molecule in the sample.(Id.)
III. BioSpyder's TempO-Seq
TempO-Seq is a nuclease protection assay that performs the same function as the '564 Patent-detecting the presence of a target in a sample through the use of a probe (i.e., "detector oligos" in BioSpyder's terms), amplification primer, nuclease digestion, and sequencing of the digested sample. However, in TempO-Seq, the amplification primer binding site, which BioSpyder refers to as the "start here sequence," is located in between two portions of the probe, rather than at the end(s). Once inserted into the middle of the probe, the start here sequence forms a loop that does not bind to the target and remains single-stranded. BioSpyder illustrates this below:
(Image Omitted) (Doc. 101 at 11.) TempO-Seq then uses only a 3' exonuclease that does not digest the single-stranded loop because the loop is protected by two double-stranded molecules made up of the probe bound to the target. In other words, no free end exists for the exonuclease to access. In TempO-Seq, only the portion of the probe to the left of the loop is analyzed in subsequent stages. The portion of the probe to the right of the loop is nonetheless a sequence complementary to the target and binds to the target, something necessary to protect the loop from digestion.
IV. Parties' Arguments a. HTG
HTG argues that TempO-Seq literally infringes on all elements of Claim 1 of the '564 Patent. (Doc. 91.) In HTG's view, TempO-Seq contains a flanking sequence that flanks the portion of the sequence complementary to the target that is sequenced in subsequent analysis (i.e., the portion of the probe to the left of the loop). (Id. at 17.) This alleged flanking sequence includes the amplification primer binding site (i.e., the loop) and the unsequenced portion of the probe to the right of the loop, as depicted below in the red box. (Id.)
(Image Omitted) (Id.) The NPPF in TempO-Seq, HTG argues, meets all the structural requirements for an NPPF as outlined in the second element of Claim 1 because the probe has a 5'-end and a 3'-end, and because the portion of the probe to the left of the flanking sequence is complementary to the target, thereby permitting it to bind to the target. (Id. at 16-18.) The alleged flanking sequence in TempO-Seq is also complementary to at least a portion of an amplification primer, specifically, at the primer binding site loop. (Id. at 18.)
Moreover, HTG contends that TempO-Seq contains a CFS that is a portion of the target itself. (Id. at 18-19.) Specifically, in TempO-Seq, the portion of the target that binds to the portion of the probe to the right of the loop serves the protective function of the CFS in the '564 Patent. Under this interpretation, it follows that the CFS is, by definition, a sequence complementary to the flanking sequence because it binds to the un-sequenced portion of the probe that HTG alleges is part of the flanking sequence. This is depicted below:
(Image Omitted) (Id.) According to HTG, nothing in Claim 1 requires the target and the CFS to be separate components. (Doc. 113 at 9-11.) Instead, Claim 1 as written should be interpreted broadly to encompass the possibility that the CFS sequence is contained within the target. (See id.) HTG reasons that BioSpyder's proposed claim construction would impermissibly limit Claim 1 to a specific embodiment in the '564 Patent by requiring the CFS to be a separate addition to the sample. (Id. at 7.) HTG further asserts that the CFS does not need to be complementary to the entire flanking sequence to qualify under Claim 1 because the patent specification contemplates a CFS "complementary to all or a portion of a flanking sequence." (Doc. 91 at 12-13.)
Further, HTG argues that the contact between the sample and the CFS required by Claim 1 can occur even if the CFS is part of the target because "contacting" does not equal "adding." (Doc. 113 at 9-12.) HTG emphasizes that the '564 Patent defines contact as merely "direct physical association" and Claim 1 requires the CFS to be brought into contact with the sample "under conditions sufficient for the flanking sequence to specifically bind to the CFS." (Id. at 9-11.) In other words, there is no contact until conditions are sufficient. Therefore, the CFS's binding function does not depend on being added to the sample, but rather it depends on the creation of sufficient conditions for binding. (See id. at 10.) These conditions result, for example, after cell lysis, a process by which the cells containing the target are broken open, exposing the target to the rest of the sample. (Id.) Only after cell lysis, HTG argues, can the target come into direct physical association with the sample. (Id.) Thus, although the target (and, therefore, the CFS) existed in the sample, no contact had yet occurred.
HTG also asserts that nothing in the prosecution history of the '564 Patent supports the construction that the CFS and target are separate because the examiner's statements "only point to the existence of a protective CFS as a point of novelty . . . . But the examiner said nothing about designing a protective flanking sequence in a particular way and did not address using a sequence already present in part of the sample as a CFS." (Id. at 16-17.) HTG further emphasizes that the Court cannot rely too heavily on the examiner's statements over the language of the claim itself. (Id. at 17.)
Finally, HTG contends that the '564 Patent's claims and specification contemplate the possibility of both endonucleases and exonucleases; thus, the 3' exonuclease that TempO-Seq prescribes falls within Claim 1. (Doc. 91 at 19-20.) Although the patent embodiments use the S1 endonuclease, HTG refutes the argument that Claim 1 is limited to the S1 endonuclease because Claim 9 explicitly lists both exonucleases and endonucleases. (Doc. 113 at 22-23.)
b. BioSpyder
In contrast, BioSpyder argues that TempO-Seq contains several fundamental differences when compared to the '564 Patent that preclude a finding of literal infringement and support a finding of noninfringement. (Doc. 101.) Specifically, BioSpyder asserts that TempO-Seq cannot use a CFS because it does not contain a flanking sequence. (Id. at 13.) In BioSpyder's interpretation, TempO-Seq inserts the loop into the middle of the probe, eliminating the need for a flanking sequence. (Id.) BioSpyder also argues that the target and the CFS cannot be the same molecule because the '564 Patent contemplates them as separate components that must be contacted in the sample. (Id. at 15-22.) As BioSpyder summarizes, "You cannot practice the claimed method of contacting the sample with a CFS by instead contacting the sample with itself." (Id. at 16.)
According to BioSpyder, nothing in Claim 1's language, nor in the specification or prosecution history, supports the construction that the CFS and target are one and the same. (Id. at 15-22.) The text of the claim, BioSpyder argues, lists the CFS and target separately, implying they are distinct components. (Id. at 17.) Moreover, the CFS and the target serve different functions. (Id. at 19.) The specification also repeatedly refers to the CFS as a distinct component from the target, using language like "the target nucleic acid molecule, as well as the CFS," or discussing the CFS being "added to the sample." (Id. at 20.) BioSpyder also points to the patent examiner's statements in the reasons for allowance to argue that the '564 Patent was approved "because of the introduction of the novel CFS." (Id. at 22.) The examiner noted:
The closest prior art to the allowed claims is the subject matter of Church et al. . . . however, the subject matter of Church et al. does not include contacting with a protective polynucleotide to the flanking segment described in the instant claims as CFS. Thus, the instantly claimed invention is neither taught nor suggested by the prior art of record.(Id. at 9.)
Furthermore, BioSpyder argues that Claim 1 requires a CFS that is complementary to the entirety of the flanking sequence, not merely a portion of the flanking sequence. (Id. at 23.) Thus, the flanking sequence that HTG identifies in TempO-Seq fails to conform to Claim 1 because only the un-sequenced portion of the probe to the right of the loop is complementary to the CFS, not the loop itself. (Id.)
Finally, BioSpyder contends that TempO-Seq does not use a "nuclease specific for single-stranded nucleic acid molecules" under Claim 1's definition. (Id. at 13.) The '564 Patent specification, BioSpyder highlights, states: "In particular examples, a nuclease is specific for single-stranded nucleic acids, such as S1 nuclease, Mung bean nuclease, Ribonuclease A, or Ribonuclease T1.” (Id. at 26 (quoting Doc. 84-9).) BioSpyder underscores that all four of the enumerated nucleases are endonucleases, which, because the loop remains single-stranded in TempO-Seq, TempO-Seq cannot use. (Id.)
Because TempO-Seq does not contain at least one, if not several, of the elements outlined in Claim 1 of the '564 Patent, BioSpyder argues that summary judgment of infringement cannot issue and, instead, summary judgment of noninfringement is warranted.
V. Standard of Review
The Court may grant summary judgment if the pleadings and supporting documents, viewed in the light most favorable to the nonmoving party, "show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986) (quoting Fed.R.Civ.P. 56(c)); see also Nike, Inc. v. Wolverine World Wide, Inc., 43 F.3d 644, 646 (Fed. Cir. 1994) ("Summary judgment is appropriate in a patent case, as in other cases, when there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law."). An issue is genuine when the disputed facts "could reasonably be resolved in favor of either party." Ellison v. Robertson, 357 F.3d 1072, 1075 (9th Cir. 2004) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250-51 (1986)). A disputed fact is material if it "might affect the outcome of the suit under the governing law." Anderson, 477 U.S. at 248.
The moving party carries the initial burden of proof and must identify the portions of the record, if any, that demonstrate there is no genuine issue of material fact. Celotex, 477 U.S. at 323; Vivid Techs, Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 806 (Fed. Cir. 1999) ("When the moving party does not have the burden of proof on the issue that is the subject of the summary judgment motion . . . the movant nonetheless bears the initial burden of coming forward with sufficient evidence to demonstrate that there is no material issue of fact that would preclude summary judgment, and that it is entitled to judgment as a matter of law."). The burden then shifts to the nonmovant to demonstrate that a genuine issue of material fact remains for trial. Id. The nonmoving party does not need to show the material issues of fact are irrefutable, First Nat'l Bank of Ariz. v. Cities Serv. Co., 391 U.S. 253, 288-89 (1968); however, there must exist "specific facts showing that there is a genuine issue for trial." Fed.R.Civ.P. 56(c)(1); Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). If "the moving party has the burden of proof on a claim or defense raised in a summary judgment motion, it must show that the undisputed facts establish every element of the claim or defense." Meyers v. Brooks Shoe, Inc., 912 F.2d 1459, 1461 (Fed. Cir. 1990), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992).
On cross motions for summary judgment, the Court "review[s] each motion . . . separately, giving the nonmoving party for each motion the benefit of all reasonable inferences." Brunozzi v. Cable Commc'ns, Inc., 851 F.3d 990, 995 (9th Cir. 2017), cert. denied, 138 S.Ct. 167 (2017). The Court may consider either party's evidence in the opposing party's motion when deciding whether to grant either summary judgment motion. See Fair Hous. Council v. Riverside Two, 249 F.3d 1132, 1136-37 (9th Cir. 2001). A party cannot create a genuine issue of material fact by making barren assertions in its legal memoranda. See VarigAirlines v. Walter Kidde & Co., 690 F.2d 1235, 1238 (1982).
Furthermore, in a patent case, "[s]ummary judgment on the issue of infringement (or noninfringement) is proper when no reasonable jury could find that every limitation recited in a properly construed claim either is or is not found in the accused device either literally or under the doctrine of equivalents." PC Connector Sols. LLC v. SmartDisk Corp., 406 F.3d 1359, 1364 (Fed. Cir. 2005).
VI. Discussion
A. Literal Infringement Standard
A patentee seeking to establish literal infringement bears the burden of establishing by a preponderance of the evidence that the accused technology meets every limitation laid out in the patent. Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1535 (Fed. Cir. 1991). Even in a declaratory action for patent noninfringement, the burden is on the patentee to show that the allegedly infringing technology does in fact infringe on every element in the patent. See Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191, 198 (2014) (holding in a licensee's action for declaratory judgment of patent noninfringement, "the burden of persuasion is with the patentee, just as it would be had the patentee brought an infringement suit"); see also Under Sea Indus., Inc. v. Dacor Corp., 833 F.2d 1551, 1557 (Fed. Cir. 1987) ("The burden is always on the patentee to show infringement."). The question of whether an accused product infringes on the patent involves two steps: claim construction and comparison of the accused device to the patent. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), affd, 517 U.S. 370 (1996). A dispute over the meaning of a claim term does not, alone, raise a genuine issue of material fact that precludes a finding of summary judgment. See, e.g., Laitram Corp. v. Morehouse Indus., Inc., 143 F.3d 1456, 1461 (Fed. Cir. 1998).
a. Claim Construction
First, in claim construction, the Court "determines] the meaning and scope of the patent claims asserted to be infringed." Markman, 52 F.3d at 976. The Court has the discretion to construe claims in the context of a summary judgment motion. Id. at 981.
"[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude." Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004). Therefore, claim construction focuses primarily on "intrinsic evidence" including the words of the claims themselves as well as the specification and prosecution history. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1316-17 (Fed. Cir. 2005) (en banc)); Cont'l Circuits LLC v. Intel Corp., 915 F.3d 788, 796 (Fed. Cir. 2010).
"It is the text of the claim itself, not the idealized or exemplar versions of the design set forth in the specification, or explanations in the prosecution history, that ultimately controls." Grupo Bimbo, S.A. B. De C.V. v. SnakKing, Corp., CV 13-02147-AB (VBKx), 2014 WL 12591935, at *2 (C.D. Cal. Dec. 2, 2014). Although they provide useful context, "preferred embodiments or specific examples in the specification" should not limit the claimed invention. See Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998); see also Lowe v. ShieldMark, Inc., No. 2021-2164, 2022 WL 636100, at *5 (Fed. Cir. Mar. 4, 2022) (holding that the district court erred in construing the claim to require a "shoulder" when this language appeared nowhere in the claim itself and only derived from an embodiment in the specification); Baxalta Inc. v. Genentech, Inc., 972 F.3d 1341, 1349 (Fed. Cir. 2020). Additionally, the Federal Circuit has cautioned against relying too heavily on the statements of patent examiners. 3M Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1332 (Fed. Cir. 2013). "[A]n examiner's statement during reexamination [is], at most, representative of how one of skill in the art would understand the term." Id.
Moreover, "[t]he words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history" of the patent. Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). There are two exceptions to this general rule: first, "when a patentee sets out a definition [other than the ordinary and customary meaning] and acts as his own lexicographer," and second, "when the patentee disavows the full scope of a claim term either in the specification or during prosecution." Id.
If the claim uses different words to describe different components it creates a rebuttable presumption that the components are indeed separate. See 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)) ("Where a claim lists elements separately, 'the clear implication of the claim language' is that those elements are 'distinct components]' of the patented invention."); Engel Indus., Inc. v. Lockformer Co., 96 F.3d 1398, 1404-05 (Fed. Cir. 1996) (holding that "[s]ince a return portion is 'also provided'" in the claim, the return portion and the "second portion" in the patented device "logically cannot be one and the same"); MiTile, Ltd. v. Hasbro, Inc., 984 F.Supp.2d 525, 530-31 (E.D. Va. 2013) (holding the "communications unit" and "proximity sensor" were distinct components in part because the claim listed the two separately and "[t]he claims do not suggest that the communications unit overlaps structurally with the proximity sensor").
A patentee can rebut this presumption by demonstrating, based on the claims and specification, that the two components "need not be two separate pieces." Retractable Techs., Inc. v. Becton, Dickinson & Co., 653 F.3d 1296, 1304 (Fed. Cir. 2011) (holding different components need not be separate when the specification indicated that the components could be connected by a weld); Tyco, 616 F.3d at 1254 (finding separateness where "[t]here [was] nothing in the asserted claims to suggest that the hinged arm and the spring means can be the same structure" and similarly concluding that nothing in the specification suggested these could be the same structure).
For instance, in Linear Technology Corporation v. International Trade Commission, the Federal Circuit considered a patent that claimed a "second circuit" and "third circuit" component. 566 F.3d 1049, 1055 (Fed. Cir. 2009). It declined to construe the claim to require the circuits be "entirely separate and distinct" because "nothing in the claim language or specification" indicated they were separate and the "specification expressly disclose[d] that the 'second circuit' and 'third circuit' can share common components." Id. The Federal Circuit therefore concluded that the components "must only perform their stated functions." Id. Nonetheless, in Grupo Bimbo, a district court similarly relied on the language in the specification and construed a patent claim to include as separate components an "exit conveyor" and an "acceleration conveyor" because "[a]t no point d[id] the specification discuss the exit conveyor and the acceleration conveyor as a single unit or as performing overlapping functions." 2014 WL 12591935, at *5. Rather, "the specifications provide that the acceleration conveyor is situated 'at the end of the exit conveyor' and as 'work[ing] with greater speed' than the exit conveyor." Id. The district court found that "[t]hese relative descriptions clearly envision two conveyors which may be compared to one another in both position and speed." Id. Therefore, the Court considers whether the specification discloses the possibility that separately listed components may perform as a single unit or with overlapping functions when determining whether the patentee has overcome the presumption of separateness.
b. Accused Device Comparison
The second step involves "comparing the properly construed claims to the device accused of infringing" to determine if the accused product or process contains each limitation of the properly construed claim. Markman, 52 F.3d at 976. Once the Court has construed the patent's claims, "summary judgment may follow when it is shown that the infringement issue can be reasonably decided only in favor of the movant, when all reasonable factual inferences are drawn in favor of the non-movant." Voice Techs. Grp. Inc. v. VMC Sys., Inc., 164 F.3d 605, 612 (Fed. Cir. 1999).
B. '564 Patent and TempO-Seq
As the Court construes Claim 1, TempO-Seq lacks the '564 Patent's separate CFS. Because TempO-Seq lacks at least one of the claim elements, the Court will deny summary judgment on patent infringement and grant summary judgment on noninfringement.
The parties present three primary disputes regarding the proper construction of Claim 1: (1) whether the CFS may exist within the target; (2) if so, whether the CFS can complement only a portion of the flanking sequence; and (3) if so, whether Claim 1 prescribes use of a 3' exonuclease when it claims use of a "nuclease specific for singlestranded molecules."
The Court begins with the first of these disputes-whether Claim 1 requires that the CFS and the target are separate and distinct components. The Court finds that it does. As previously stated, Claim 1 patents a method of identifying "at least one target nucleic acid molecule in a sample" by first contacting the sample with at least one NPPF then "contacting the sample with a [CFS] under conditions sufficient for the flanking sequence to specifically bind to the CFS." The text of Claim 1 lists the requirement of a target in the sample separately from the requirement of a CFS. Specifically, contacting the sample with a CFS is enumerated as a separate step within the claimed nuclease protection assay.
Furthermore, although the claim language dominates, the specification also supports the Court's construction that the CFS is a distinct component not already included in the sample itself. The '564 Patent specification, like Claim 1, repeatedly refers to the CFS as something separate from the target. The following quotations from the specification are examples of points where the CFS is described separately from and with relative language to the target:
Quotations are unaltered apart from the emphasis noted.
"This results in the generation of NPPF molecules that have bound thereto the target nucleic acid molecule, as well as the CFS . . . ." (Doc. 84-9 at 23 (emphasis added).)
"After allowing the target nucleic acid molecule, as well as the CFS(s), to bind to the NPPFs . . . ." (Doc. 84-9 at 23 (emphasis added).)
"This generates a digested sample that includes intact NPPFs present as double stranded adducts hybridized to CFSs and target nucleic acid." (Doc. 84-9 at 23 (emphasis added).)
"The sample, NPPFs and CFSs are incubated under conditions sufficient for NPPFs to specifically bind to their respective target nucleic acid molecule, and for CFSs to bind to its their complementary sequence on the NPPF flanking sequence." (Doc. 84-9 at 29 (emphasis added).)
"[I]ncubation of the sample with a nuclease specific for ss nucleic acid molecules results in degradation of any ss nucleic acid molecules, leaving intact double-stranded nucleic acid molecules, including NPPFs that have bound thereto and CFSs and target nucleic acid molecule." (Doc. 84-9 at 29 (emphasis added).)
"This leaves intact double-stranded nucleic acid molecules, including NPPFs that have bound thereto and CFSs and target nucleic acid molecule . . . and well as regions of the NPPF that hybridized to target only (but not CFS), or that hybridized to CFS only (but not target)." (Doc. 84-9 at 30 (emphasis added).)
"The plurality of NPPFs, along with the CFSs, are incubated with the sample under conditions sufficient for the NPPFs to specifically hybridize to their respective target nucleic acids and their respective CFSs." (Doc. 84-9 at 31 (emphasis added).)
"In one example, each CFS is added to the sample at a final concentration of about at least 6-times the amount of probe . . . ." (Doc. 84-9 at 31 (emphasis added).)
Although the Court cannot limit Claim 1 to embodiments in the specification that find no support in the claim's text, the Court finds that the claim's text itself, in the context of the above referenced language from the specification, creates the presumption that Claim 1 discloses the CFS as a separate and distinct component from the target in the sample. Put another way, the Court declines to read in an embodiment that was never disclosed in Claim 1 or in the specification where the CFS is part of the target.
Unlike patentees in cases like Linear Technology Corporation, HTG has not sufficiently demonstrated that the claim or the specification teach that the CFS and target can be the same molecule. Based on the Court's reading of the '564 Patent, nothing suggests that the target molecule can also serve the protective CFS function, even considering separate sequences contained in the molecule.
Furthermore, despite HTG's compelling argument regarding cell lysis, the Court finds that Claim 1's contact requirement between the sample and the CFS supports the notion that the CFS is distinct from the sample, and therefore, from the target contained within the sample. The Court recognizes that "contact" in the '564 Patent means only "direct physical association." This definition is not limited to "adding" something to the sample, as BioSpyder suggests. However, the Court cannot interpret Claim 1 to mean that a molecule contained within the sample can nonetheless come into direct physical association with the sample at some separate stage of the assay.
Thus, the Court construes Claim 1 to mean that the target nucleic acid molecule contained within the sample is a separate component from the sequence complementary to the flanking sequence (CFS) that must come into direct physical association with the sample. As the parties agree, TempO-Seq does not contain a separate CFS. Therefore, TempO-Seq does not meet one of the elements required by Claim 1 of the '564 Patent. It follows that no reasonable jury could find literal patent infringement because, in order to find patent infringement, the accused method must practice all elements of the patent claim. Therefore, on these cross motions for summary judgment, it is not necessary to further resolve whether TempO-Seq contains a flanking sequence because the CFS can be complementary to only a portion of the flanking sequence, or whether the claimed "nuclease for single-stranded molecules" includes a 3' exonuclease based on Claim 9's text.
Accordingly, IT IS ORDERED that HTG's Motion for Partial Summary Judgment is DENIED. (Docs. 83, 91.) IT IS FURTHER ORDERED that BioSpyder's Cross Motion for Summary Judgment is GRANTED. (Doc. 101.)