DCT

1:23-cv-01375

10X Genomics Inc v. Curio Bioscience Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01375, D. Del., 12/01/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because the defendant, Curio Bioscience, Inc., is a Delaware corporation and therefore resides in the district.
  • Core Dispute: Plaintiffs allege that Defendant’s Curio Seeker Kit, a product for spatial transcriptomics, infringes five U.S. patents related to spatially encoded biological assays.
  • Technical Context: The technology at issue, spatial transcriptomics, enables researchers to map gene activity within the physical context of a tissue sample, providing critical insights into biological processes and diseases such as cancer.
  • Key Procedural History: The complaint alleges that Plaintiffs sent two pre-suit letters to Defendant regarding potential infringement, the second of which specifically identified two of the patents-in-suit. The complaint also notes a recent jury verdict in a separate case (10x Genomics, Inc. v. NanoString Technologies, Inc.) where related patents from the same family were found to be valid and willfully infringed, a fact Plaintiffs allege Defendant was aware of.

Case Timeline

Date Event
2010-04-05 Priority Date for all Asserted Patents
2019-11-19 U.S. Patent No. 10,480,022 Issues
2020-05-26 U.S. Patent No. 10,662,468 Issues
2021-05-11 U.S. Patent No. 11,001,879 Issues
2022-11-17 Plaintiffs allege sending first notice letter to Defendant
2023-01-10 U.S. Patent No. 11,549,138 Issues
2023-02-01 Alleged Launch of Accused Curio Seeker Kit (approx. date)
2023-06-14 Plaintiffs allege sending second notice letter identifying ’468 and ’879 Patents to Defendant
2023-09-19 U.S. Patent No. 11,761,030 Issues
2023-11-17 Jury verdict in 10x Genomics, Inc. v. NanoString Technologies, Inc.
2023-12-01 Complaint Filing Date

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

U.S. Patent No. 10,480,022 - Spatially encoded biological assays

  • Patent Identification: U.S. Patent No. 10,480,022, entitled "Spatially encoded biological assays," issued November 19, 2019.

The Invention Explained

  • Problem Addressed: The patent's background describes the lack of practical methods to simultaneously analyze the spatial expression patterns of a large number of genes, proteins, or other biological molecules at high resolution (U.S. Patent No. 10,480,022, col. 1:53-63). Existing techniques like laser capture microdissection were described as expensive, laborious, and not scalable (U.S. Patent No. 10,480,022, col. 1:46-49).
  • The Patented Solution: The invention provides an assay system that generates high-resolution spatial maps of biological activity in tissue samples. This is achieved by delivering encoded probes to a biological sample in a defined spatial pattern; each probe contains both a region to interact with a specific biological target (e.g., mRNA) and a "coding tag" (e.g., a DNA barcode) that identifies the location where the probe was delivered. The results can be decoded, for example through high-throughput sequencing, to map the abundance of biological targets to their specific locations within the sample (U.S. Patent No. 10,480,022, Abstract; col. 2:9-36; Fig. 1).
  • Technical Importance: The technology combines the high-multiplexing capability of nucleic acid sequencing with the spatial context of in-situ analysis, enabling a more comprehensive understanding of biological systems (U.S. Patent No. 10,480,022, col. 2:9-19).

Key Claims at a Glance

  • The complaint references an exemplary, but unprovided, claim chart for one asserted claim (Compl. ¶29). Independent claim 1 is a representative method claim.
  • Essential elements of Independent Claim 1:
    • providing a plurality of beads, wherein the beads comprise binding agents;
    • the binding agent comprises a coding identifier (a nucleic acid sequence) that corresponds to a location;
    • the binding agent is configured to interact with a biological molecule of a tissue sample;
    • contacting the plurality of beads with the tissue sample so the interaction occurs; and
    • using the coding identifier to identify the location where the interaction occurred, thereby determining the spatial location of the biological molecule.

U.S. Patent No. 10,662,468 - Spatially encoded biological assays

  • Patent Identification: U.S. Patent No. 10,662,468, entitled "Spatially encoded biological assays," issued May 26, 2020.

The Invention Explained

  • Problem Addressed: Similar to the ’022 Patent, this patent addresses the need for reproducible, high-resolution spatial maps of biological molecules in tissues, which existing methods could not practically provide (’468 Patent, col. 1:59-63).
  • The Patented Solution: The invention discloses a method for determining the spatial location of a nucleic acid in a tissue section by contacting the section with an array of features. Each feature on the array comprises a capture agent that includes a "first sequence" to bind the target nucleic acid and a "second sequence" that acts as a coding tag to identify the feature's location on the array. By determining the sequence of the coding tag and the captured nucleic acid, the system maps the target's presence and abundance to a specific location (’468 Patent, Abstract; Fig. 1). The patent describes a workflow where probes are delivered, interact with targets, and are then analyzed to create a spatial map (’468 Patent, Fig. 2; col. 10:1-17).
  • Technical Importance: This method provides a systematic way to link sequence data directly to spatial coordinates on a tissue sample, enabling highly parallel spatial transcriptomic analysis (’468 Patent, col. 2:6-14).

Key Claims at a Glance

  • The complaint references an exemplary, but unprovided, claim chart for one asserted claim (Compl. ¶39). Independent claim 1 is a representative method claim.
  • Essential elements of Independent Claim 1:
    • contacting a tissue section with an array comprising a plurality of features;
    • each feature comprises a capture agent having (i) a first sequence that specifically binds the nucleic acid and (ii) a second sequence comprising a coding tag corresponding to the location of the capture agent;
    • determining the sequence of the coding tag and the nucleic acid bound to the capture agent; and
    • using the determined sequences to determine the presence or abundance of the nucleic acid at that location.

Multi-Patent Capsule: U.S. Patent No. 11,001,879

  • Patent Identification: U.S. Patent No. 11,001,879, "Spatially encoded biological assays," issued May 11, 2021.
  • Technology Synopsis: This patent, from the same family as the '022 and '468 Patents, also describes methods and systems for generating high-resolution spatial maps of biological molecules. It provides for assays using encoded probes with location-specific coding tags, which are delivered to a sample and decoded to associate biological targets with their locations (’879 Patent, Abstract; col. 2:25-40).
  • Asserted Claims: The complaint does not specify asserted claims but reserves the right to assert one or more claims (Compl. ¶49).
  • Accused Features: The accused features are the Curio Seeker Kit products and the associated workflow for performing spatial transcriptomics (Compl. ¶19, 24, 49).

Multi-Patent Capsule: U.S. Patent No. 11,549,138

  • Patent Identification: U.S. Patent No. 11,549,138, "Spatially encoded biological assays," issued January 10, 2023.
  • Technology Synopsis: This patent continues the themes of the asserted patent family, describing compositions and methods for spatial analysis of biological samples. It claims compositions comprising an array of capture probes on a substrate, where each probe has a nucleic acid sequence that identifies a unique location on the substrate (’138 Patent, Abstract; col. 2:48-67).
  • Asserted Claims: The complaint does not specify asserted claims but reserves the right to assert one or more claims (Compl. ¶59).
  • Accused Features: The accused features are the Curio Seeker Kit products, which are alleged to comprise the claimed arrays, and the associated workflow (Compl. ¶19, 24, 59).

Multi-Patent Capsule: U.S. Patent No. 11,761,030

  • Patent Identification: U.S. Patent No. 11,761,030, "Spatially encoded biological assays," issued September 19, 2023.
  • Technology Synopsis: This patent also relates to spatially encoded biological assays. It claims compositions that include an array of capture probes on a substrate, where the probes have a nucleic acid sequence identifying a unique location and are immobilized in a random pattern (’030 Patent, Abstract; Claim 1).
  • Asserted Claims: The complaint does not specify asserted claims but reserves the right to assert one or more claims (Compl. ¶69).
  • Accused Features: The accused features are the Curio Seeker Kit products and workflow, which are alleged to utilize the claimed compositions and methods (Compl. ¶19, 24, 69).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "Curio Seeker Kit," associated accessories and reagents, and the Curio Seeker bioinformatics pipeline and workflow (Compl. ¶24). Specific products mentioned include the Curio Seeker 3x3 kit and the Curio Seeker 10x10 kit (Compl. ¶24).

Functionality and Market Context

  • The complaint alleges the Curio Seeker Kit is a workflow "designed to preserve the spatial information of the transcriptome of a tissue sample of interest" (Compl. ¶19). The workflow allegedly involves capturing messenger RNA (mRNA) from a tissue sample onto "spatially indexed, DNA-barcoded beads" (Compl. ¶19). This is followed by reverse transcription to create complementary DNA (cDNA), library preparation, and sequencing. The sequencing data, which includes the spatial barcodes, is then allegedly used by Curio's bioinformatics pipeline to create a "transcriptomic map" (Compl. ¶19). This workflow diagram illustrates the accused process, from placing a tissue section onto spatially indexed beads through sequencing and creating a map of differential expression (Compl. p. 7).
  • The complaint alleges that Curio has positioned its Seeker Kit to "directly compete with 10x's Visium product line" (Compl. ¶18).

IV. Analysis of Infringement Allegations

The complaint references exemplary claim charts attached as Exhibits K, L, M, N, and O, but these exhibits were not filed with the complaint. As such, a detailed claim chart summary cannot be constructed. The narrative infringement theory is summarized below.

The complaint alleges that the workflow associated with the Curio Seeker Kit directly infringes claims of the asserted patents (Compl. ¶29, 39, 49, 59, 69). For a representative claim like claim 1 of the ’022 Patent, the complaint’s theory suggests that Curio’s use of DNA-barcoded beads constitutes the claimed "plurality of beads" comprising "binding agents" with "coding identifiers." The act of placing a tissue sample on these beads is alleged to be the "contacting" step, and the subsequent use of Curio's bioinformatics pipeline to analyze the barcode sequences to map gene expression constitutes "using the coding identifier to identify the location," thereby infringing the method claim (Compl. ¶19).

  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the accused product's use of pre-barcoded beads, which are then arranged on a substrate, falls within the scope of claim terms like "array comprising a plurality of features" ('468 Patent) or a method where a "coding identifier corresponds to a location at which the binding agent interacts" with the sample ('022 Patent). The sequence and timing of how the spatial location is assigned to a given barcode will be a critical point of analysis.
    • Technical Questions: The complaint alleges the Curio Seeker Kit uses "spatially indexed, DNA-barcoded beads" to create a map (Compl. ¶19). A key evidentiary question will be how this "spatial indexing" is technically achieved and whether that mechanism meets the specific limitations of the asserted claims, which describe various methods of delivering probes and encoding locations.

V. Key Claim Terms for Construction

  • The Term: "coding identifier corresponds to a location" (from ’022 Patent, Claim 1).

  • Context and Importance: The definition of this phrase is fundamental to the infringement analysis for the method claims. The dispute may turn on when and how the correspondence between a barcode (the "coding identifier") and a physical "location" on the tissue sample is established. Practitioners may focus on this term because it addresses the core inventive concept of linking a molecular identity to a spatial coordinate.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the invention broadly as delivering encoded probes in a "known spatial pattern" (’022 Patent, col. 2:25-27), which could be argued to encompass a pre-defined grid of beads where the location of each bead (and its barcode) is known before the tissue is applied.
    • Evidence for a Narrower Interpretation: The patent's figures and detailed descriptions heavily feature a combinatorial encoding scheme where different coding tags are delivered in overlapping patterns directly onto the sample to create a unique coordinate system in situ (’022 Patent, Fig. 4; col. 13:43-14:15). This could support a narrower interpretation requiring the location to be encoded after the probes are in contact with the sample.

  • The Term: "array comprising a plurality of features" (from ’468 Patent, Claim 1).

  • Context and Importance: This term is central to the apparatus claims and defines the physical substrate used in the method. The infringement question will depend on whether Curio’s substrate with affixed beads constitutes such an "array." Practitioners may focus on this term to distinguish the claimed invention from a simple collection of beads.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent does not appear to provide a specific, limiting definition of "array" or "feature," potentially allowing the terms to be given their plain and ordinary meaning, which might be broad enough to read on beads fixed to a surface.
    • Evidence for a Narrower Interpretation: The term "array" in the context of genomics often implies a regular, grid-like arrangement of probes at fixed, predetermined locations. Language in the specification describing combinatorial delivery of reagents to form a "grid" (’468 Patent, col. 13:25) could be used to argue that the term requires a more structured arrangement than what may be present in the accused product.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Curio provides "webinars and other materials" that instruct and encourage customers to use the accused kits in an infringing manner (Compl. ¶21, 30, 40). Contributory infringement is alleged on the basis that the Curio Seeker Kits are especially made and adapted for infringing use and are not staple articles of commerce (Compl. ¶31, 41).
  • Willful Infringement: Willfulness is alleged based on pre-suit knowledge. The complaint cites two letters sent to Curio, dated November 17, 2022, and June 14, 2023, the latter of which allegedly identified the ’468 and ’879 patents (Compl. ¶15). The complaint further alleges that Curio was aware of public reporting on the jury verdict against NanoString Technologies on related patents from the same family (Compl. ¶17, 33, 43).

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

  • A core issue will be one of claim scope: can claim terms such as "array comprising a plurality of features" and a "coding identifier correspond[ing] to a location" be construed to cover the accused product's architecture, which allegedly uses pre-barcoded beads arranged on a substrate to capture mRNA? The outcome will likely depend on whether the patent's language is interpreted to require in situ encoding of location versus allowing for a pre-defined spatial mapping of barcodes.
  • A second key issue will be one of intent: given the specific pre-suit notice alleged in the complaint, including identification of asserted patents and awareness of a jury verdict finding related patents valid and willfully infringed by a competitor, a central question for trial will be whether Curio's alleged infringement was willful. This determination will have significant implications for potential damages if infringement is found.