DCT

1:26-cv-00538

10X Genomics Inc v. Element Biosciences Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00538, D. Del., 05/08/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Element Biosciences, Inc. is a Delaware corporation and therefore resides in the district.
  • Core Dispute: Plaintiffs allege that Defendant's AVITI24 Platform for biological analysis, and its related services, infringe four patents related to methods for in situ analyte detection and sequencing.
  • Technical Context: The technology relates to spatial and single-cell genomics, specifically methods for identifying and sequencing large numbers of biological molecules (analytes) like RNA and proteins within the original context of a cell or tissue sample.
  • Key Procedural History: The complaint alleges that Defendant had extensive pre-suit knowledge of the patents-in-suit. This is based on Plaintiffs' assertion of the parent '737 Patent in widely publicized litigations against NanoString Technologies and Vizgen, in which Plaintiffs served document and deposition subpoenas on Defendant. The complaint further alleges that the Chairman of Defendant's Scientific Advisory Board was retained as an expert witness regarding the validity of the '737 Patent in the Vizgen litigation. These allegations may be significant for Plaintiffs' claims of willful infringement.

Case Timeline

Date Event
2011-12-22 Earliest Priority Date for '737, '276, and '277 Patents
2012-01-01 10x Genomics founded
2013-03-12 Earliest Priority Date for '358 Patent
2015-01-01 10x Genomics' first product launch
2016-01-01 10x Genomics launches Chromium platform
2017-01-01 Element Biosciences founded
2020-01-01 10x Genomics acquires ReadCoor, Inc.
2021-06-01 '737 Patent Issued
2022-04-01 Element Biosciences launches AVITI sequencer
2022-12-08 10x Genomics launches Xenium Platform
2023-01-31 '276 Patent Issued
2023-01-31 '277 Patent Issued
2023-11-28 10x serves document subpoena on Element in prior litigations
2024-01-01 Element announces pre-orders for AVITI24 platform
2024-03-29 Vizgen discloses Element's advisory board chair as expert in related litigation
2024-04-10 10x serves deposition subpoena on Element in prior litigation
2024-12-01 Alleged first shipment of Element's AVITI24 platform
2025-04-01 '358 Patent Issued
2026-04-18 10x Genomics announces Atera platform
2026-05-08 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,021,737 - "Compositions and Methods For Analyte Detection"

  • Patent Identification: U.S. Patent No. 11,021,737 ("the '737 Patent"), "Compositions and Methods For Analyte Detection," issued June 1, 2021 Compl. ¶26

The Invention Explained

  • Problem Addressed: The patent's background section describes how prior art methods for multiplexed detection of analytes in tissue, such as fluorescence in-situ hybridization (FISH), were "limited to the number of colors available to the microscopy" Compl. ¶29 '737 Patent, col. 64:29-30 Performing sequential rounds of detection to overcome this limitation was undesirable as it required "multiple lengthy probe incubations and damaging stripping steps" Compl. ¶29 '737 Patent, col. 27:45-46
  • The Patented Solution: The invention proposes a method that uses a "detection reagent" composed of a probe (which binds the target analyte) and a nucleic acid label Compl. ¶28 This label contains one or more "pre-determined subsequences" that act as a barcode. Instead of identifying analytes by a single color, the invention identifies them by detecting a "temporal order of signal signatures" generated from these subsequences over multiple cycles Compl. ¶28 '737 Patent, col. 4:31-45 This temporal barcoding scheme allows for a multiplicative increase in the number of distinct analytes that can be detected simultaneously Compl. ¶34 '737 Patent, col. 19:64-20:2
  • Technical Importance: This approach sought to dramatically increase the multiplexing capacity of in situ assays beyond the limitations imposed by the number of available, spectrally distinct fluorophores Compl. ¶30 '737 Patent, col. 19:58-62

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 24 Compl. ¶28
  • Independent Claim 1 recites a method with the essential elements:
    • (a) contacting a cell or tissue sample comprising an analyte with a detection reagent, where the reagent has a probe that binds the analyte and a nucleic acid label with pre-determined subsequences;
    • (b) detecting a temporal order of signal signatures associated with the pre-determined subsequences; and
    • (c) using the temporal order of signal signatures to identify the analyte.
  • The complaint reserves the right to assert dependent claims, such as those directed to sequencing the subsequence or when the analyte is RNA Compl. ¶39

U.S. Patent No. 11,566,276 - "Compositions and Methods For Analyte Detection"

  • Patent Identification: U.S. Patent No. 11,566,276 ("the '276 Patent"), "Compositions and Methods For Analyte Detection," issued January 31, 2023 Compl. ¶40

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the '737 Patent: the multiplexing limitations of conventional techniques like FISH and immunohistochemistry, which are constrained by the number of available optical colors and risk damaging the sample with repeated stripping steps Compl. ¶43 '276 Patent, col. 65:14-15 '276 Patent, col. 27:45-46
  • The Patented Solution: The '276 Patent claims a method similar to the '737 Patent but is specifically directed to detecting two different analytes (a "first analyte" and a "second analyte") using two distinct detection reagents Compl. ¶42 A key step involves "using a location" of the respective temporal signal signatures to "determine that said first analyte and said second analyte are both located in said cell," thereby adding an explicit spatial co-localization element to the temporal detection scheme Compl. ¶42 '276 Patent, col. 16:1-8
  • Technical Importance: This method enables the confirmed co-detection of multiple different types of analytes (e.g., RNA and protein) within a single cell, preserving crucial spatial context that is lost in bulk analysis techniques Compl. ¶51 '276 Patent, col. 65:13-20

Key Claims at a Glance

  • The complaint asserts independent claims 1, 9, and 26 Compl. ¶42
  • Independent Claim 1 recites a method with the essential elements:
    • (a) providing a biological sample with cells comprising a first and a second analyte;
    • (b) contacting the sample with a first and a second detection reagent, each with unique predetermined sequences, to bind to the respective analytes;
    • (c) detecting, in a temporally sequential manner, the predetermined sequences for each reagent to obtain a first and second temporal order of signal signatures;
    • (d) using the temporal orders to identify the first and second analytes; and
    • (e) using the location of the first and second temporal orders of signal signatures to determine that both analytes are located in the same cell.
  • The complaint reserves the right to assert dependent claims, such as when the analytes are messenger RNA or protein molecules Compl. ¶53

U.S. Patent No. 11,566,277 - "Compositions and Methods For Analyte Detection"

  • Patent Identification: U.S. Patent No. 11,566,277 ("the '277 Patent"), "Compositions and Methods For Analyte Detection," issued January 31, 2023 Compl. ¶54

Technology Synopsis

The '277 Patent addresses the same limitations of prior art in situ analysis as its parent patents Compl. ¶57 Its claimed method adds a specific data processing step to the temporal detection process: "using at least one distinguishable feature common to images of said plurality of images to obtain a plurality of aligned images" Compl. ¶56 This step is designed to correct for potential physical drift or movement of the sample during the sequential, multi-cycle imaging process before the temporal order of signals is used to identify the analyte Compl. ¶67

Asserted Claims

Independent claims 1, 8, 15, and 18 Compl. ¶56

Accused Features

Defendant's AVITI24 platform and workflow, which are alleged to practice the claimed methods Compl. ¶92

U.S. Patent No. 12,264,358 - "Method of Selectively Sequencing Amplicons in a Biological Sample"

  • Patent Identification: U.S. Patent No. 12,264,358 ("the '358 Patent"), "Method of Selectively Sequencing Amplicons in a Biological Sample," issued April 1, 2025 Compl. ¶68

Technology Synopsis

This patent addresses the challenge of obtaining sufficiently bright imaging signals in a cell or tissue sample without the signals overlapping, which would obscure the data Compl. ¶72 The claimed solution is a multi-step method for sequencing RNA that involves (1) generating "circularized nucleic acid molecules" from the target RNA, (2) amplifying them via "rolling circle amplification" to create a plurality of amplicons, and (3) using "selective sequencing primers" to sequence only a subset of the amplicons at any given time, which is alleged to reduce signal density and improve spatial resolution Compl. ¶¶70-72

Asserted Claims

Independent claims 1 and 19 Compl. ¶70

Accused Features

Defendant's AVITI24 platform and workflow, which are alleged to practice the claimed methods Compl. ¶100

III. The Accused Instrumentality

Product Identification

The "Accused Instrumentalities" are identified as Defendant Element's "AVITI24 platform and workflow" and its "AVITI24 Technology Access Program" service Compl. ¶24 These include the AVITI24 instrument, software, and associated reagents and consumables, such as the "Teton chemistry" Compl. ¶24

Functionality and Market Context

The complaint alleges the AVITI24 is a "benchtop sequencing instrument" that Element pivoted to offer for "in situ multiomics," promising the "examination of DNA, RNA, proteins, phosphoproteins, and cell structure within single cells" Compl. ¶¶20-21 The complaint highlights Defendant's marketing of the AVITI24 platform for "Spatial sequencing without fragmented workflows" in FFPE and fresh frozen samples Compl. p. 8 A marketing image from Defendant's website depicting "Tissue profiling on AVITI24" shows multicolored cellular images and describes "Spatial sequencing without fragmented workflows" for FFPE and fresh frozen samples Compl. p. 8 Plaintiffs allege that Element launched this platform over a year after 10x launched its competing Xenium platform Compl. ¶21

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Attachments A-D) that were not included with the filing; therefore, a prose summary of the infringement allegations is provided below.

'737 Patent Infringement Allegations

The complaint alleges that Defendant's use of the AVITI24 platform and its associated services directly infringes the method claims of the '737 Patent Compl. ¶76 The infringement theory is that the AVITI24 system, when used as instructed, performs a method of identifying analytes in a cell or tissue sample by contacting the sample with detection reagents (Element's Teton chemistry) and then detecting a "temporal order of signal signatures" associated with predetermined subsequences on those reagents to identify the analytes (Compl. ¶¶28; Compl. ¶76). This is alleged to map onto the "in situ multiomics" and "direct-in-sample-sequencing-in-cells" functionality advertised by Defendant Compl. ¶¶22-23

'276 Patent Infringement Allegations

The infringement theory for the '276 Patent is that the AVITI24 platform is used to practice a method of detecting at least two distinct analytes (e.g., RNA and protein) within the same cell Compl. ¶84 The complaint alleges the platform uses separate detection reagents for each analyte and detects their respective temporal signal signatures. Crucially, the theory alleges that the method uses the location of these signal signatures to determine that both analytes are co-located within the same cell, directly corresponding to the spatial co-localization step of claim 1 Compl. ¶42 Compl. ¶84 Defendant's marketing of "spatial sequencing" and analysis of multiple analyte types is cited in support of this theory Compl. ¶21 Compl. p. 8

Identified Points of Contention

  • Scope Questions: A central dispute for the '737, '276, and '277 patents may be whether the detection process used by the AVITI24 system constitutes detecting a "temporal order of signal signatures" as the claims require. The case may turn on whether the term, as defined in the patents, can be construed to read on Defendant's "Direct In Sample Sequencing" technology Compl. p. 8
  • Technical Questions: For the '276 Patent, a key question for the court will be whether the accused method performs the claimed step of "using a location... to determine" co-localization. The analysis may focus on whether the AVITI24 system's software makes this determination algorithmically, or if it merely presents co-localized data to a user who then performs the determinative step. For the '358 Patent, a primary technical question will be whether the accused Teton chemistry workflow actually performs the specific steps of generating "circularized nucleic acid molecules" and amplifying them via a "rolling circle amplification reaction" as required by the claims Compl. ¶70

V. Key Claim Terms for Construction

Term 1: "detecting a temporal order of signal signatures" ('737 Patent, Claim 1)

  • Context and Importance: This term is the core inventive concept asserted to overcome the color-limitation of prior art methods. Infringement will depend on whether the sequence of detection events in the accused AVITI24 system constitutes a "temporal order" as understood in the context of the patent.
  • Intrinsic Evidence for a Broader Interpretation: The specification describes the general method as "detecting in a temporally-sequential manner said plurality of the pre-determined subsequences" '737 Patent, col. 4:36-39 Plaintiffs may argue this language supports a broad construction covering any multi-step, sequential detection process.
  • Intrinsic Evidence for a Narrower Interpretation: The patent provides specific examples of temporal detection, such as sequencing-by-synthesis or cyclical hybridization with decoder probes '737 Patent, FIG. 3 '737 Patent, claims 5-6 Practitioners may focus on whether the term is limited to such explicit, cyclical readout schemes, which Defendant may argue its method does not perform.

Term 2: "using a location ... to determine that said first analyte and said second analyte are both located in said cell" ('276 Patent, Claim 1)

  • Context and Importance: This term defines the key spatial co-localization step. The dispute will likely center on whether the accused method itself performs this "determination," or if it merely provides data from which a user can infer co-localization.
  • Intrinsic Evidence for a Broader Interpretation: The specification emphasizes the invention's ability to preserve the "spatial orientation" of analytes and provide "positional information" '276 Patent, col. 2:24-31 Plaintiffs may argue that any process which registers and reports the coordinates of two signals as being within a single cellular boundary meets this limitation.
  • Intrinsic Evidence for a Narrower Interpretation: The claim language "using ... to determine" suggests an active, conclusive step. Practitioners may focus on this language because it raises the question of whether the accused system must contain a specific algorithm that takes location data as an input and outputs a conclusion of co-localization, a potentially narrower interpretation that Defendant may advocate for.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement. Inducement is alleged based on Defendant's distribution of "user guides, sample and slide preparation manuals, training decks, and published articles" that allegedly instruct customers to use the AVITI24 platform in an infringing manner (Compl. ¶¶78; Compl. ¶86; Compl. ¶94; Compl. ¶102). Contributory infringement is alleged on the basis that the AVITI24 platform and its Teton chemistry are specifically designed for the infringing methods and have no substantial non-infringing use (Compl. ¶¶79; Compl. ¶87; Compl. ¶95; Compl. ¶103).

Willful Infringement

The complaint makes extensive allegations of willful infringement based on both pre- and post-suit knowledge. Pre-suit knowledge is alleged based on: (1) Plaintiffs' prior, widely-publicized litigations involving the parent '737 Patent against competitors; (2) document and deposition subpoenas served directly on Defendant in those cases; (3) the alleged role of the Chairman of Defendant's Scientific Advisory Board as a disclosed validity expert on the '737 Patent in the prior litigation; and (4) Defendant's citation of the asserted patent family during its own patent prosecution (Compl. ¶¶77; Compl. ¶85; Compl. ¶93; Compl. ¶101). Post-suit knowledge is based on a notification letter and the filing of the complaint (Compl. ¶¶77; Compl. ¶81).

VII. Analyst's Conclusion: Key Questions for the Case

  • A core issue will be one of definitional scope: can the patented concept of detecting a "temporal order of signal signatures," which is rooted in cyclical, probe-based decoding, be construed to cover the "Direct In Sample Sequencing" technology of the accused AVITI24 platform?
  • A key evidentiary question will be one of technical mechanism: does the accused AVITI24 system and its associated chemistry practice the specific biological and data-processing steps recited in the claims-particularly the generation of "circularized nucleic acid molecules" and "rolling circle amplification" for the '358 Patent, and the algorithmic step of "using a location ... to determine" co-localization for the '276 Patent?
  • A central legal question will be one of intent: do the detailed allegations of Defendant's awareness of the patents through prior litigation, subpoenas, and the involvement of its advisory board chairman constitute the kind of "egregious" conduct that would support a finding of willful infringement and justify enhanced damages?
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