DCT

1:21-cv-01724

Organovo Inc v. CelLink Ab

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 6:21-cv-00769, W.D. Tex., 11/30/2021
  • Venue Allegations: Venue is alleged to be proper because Defendant is not a resident of the United States and may be sued in any judicial district. The complaint also asserts personal jurisdiction based on Defendant’s marketing activities, collaborations with Texas-based academic and commercial entities, and sales of its products within the state.
  • Core Dispute: Plaintiff alleges that Defendant’s Bio X and Bio X6 bioprinters infringe five U.S. patents related to the technology of 3D bioprinting, including automated devices for tissue fabrication and methods using self-assembling cell aggregates.
  • Technical Context: The technology at issue is 3D bioprinting, an emerging field in tissue engineering that aims to construct functional human tissues for applications in drug discovery, medical research, and therapeutic replacement.
  • Key Procedural History: The complaint alleges that Plaintiff first put Defendant on notice of certain patents-in-suit in March 2019, leading to licensing discussions. After discussions were reinitiated by Defendant in March 2021, Defendant filed a declaratory judgment action in the District of Delaware in June 2021 against four of the five patents asserted in the current complaint.

Case Timeline

Date Event
2004-02-24 Earliest Priority Date for ’116 and ’932 Patents
2009-03-01 Organovo obtains exclusive license to ’116 and ’932 patent families
2010-10-21 Earliest Priority Date for ’952 and ’369 Patents
2013-07-31 Earliest Priority Date for ’043 Patent
2014-10-07 U.S. Patent No. 8,852,932 Issues
2015-10-06 U.S. Patent No. 9,149,952 Issues
2016-04-19 U.S. Patent No. 9,315,043 Issues
2017-09-05 U.S. Patent No. 9,752,116 Issues
2018-01-02 U.S. Patent No. 9,855,369 Issues
2019-03-19 Organovo sends notice letter to Cellink regarding ’116 and ’369 Patents
2019-04-01 Licensing discussions begin between Organovo and Cellink
2021-03-22 Cellink reinitiates licensing discussions
2021-03-30 Cellink is allegedly put on notice of ’952, ’043, and ’369 patents via term sheet
2021-06-07 Cellink files declaratory judgment action in the District of Delaware
2021-11-30 Complaint Filing Date

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

U.S. Patent No. 9,149,952 - "Devices, Systems, and Methods for the Fabrication of Tissue," issued October 6, 2015 (’952 Patent)

The Invention Explained

  • Problem Addressed: The patent background describes the pressing need for tissues and organs for transplantation and the high cost of pharmaceutical research and development, noting the limitations of existing solutions ('952 Patent, col. 1:12-42). Conventional tissue engineering approaches face challenges in controlling cell distribution and creating complex, native-like tissue architectures on a scalable basis ('952 Patent, col. 9:56 - col. 10:9).
  • The Patented Solution: The invention describes an automated bioprinter system designed to precisely fabricate tissue constructs. A core element of the solution is a "means for calibrating the position of at least one cartridge," such as a laser alignment system, which ensures the accurate placement of "bio-ink" (cells) and support materials according to a pre-defined digital model ('952 Patent, Abstract; col. 2:38-44). This calibration capability is important for maintaining precision, particularly when cartridges are replaced during a printing process.
  • Technical Importance: The development of automated bioprinters with high-precision calibration systems enables the reproducible fabrication of multi-layered, geometrically complex biological structures, a foundational requirement for engineering functional tissues for research and therapeutic use ('952 Patent, col. 10:20-31).

Key Claims at a Glance

The complaint does not specify which claims of the ’952 Patent are asserted, instead referencing an external exhibit not provided with the complaint (Compl. ¶22). Independent claim 1 is representative of the apparatus claimed.

  • Independent Claim 1: A bioprinter comprising:
    • One or more printer heads, with a head comprising a means for receiving and holding a cartridge containing bio-ink and/or support material.
    • A means for dispensing the bio-ink from a selected cartridge by application of pressure.
    • A "means for determining a position of the selected cartridge in space."
    • A programmable computer processor for regulating the dispensing, communicatively coupled to the position-determining means and the dispensing means.
  • The complaint reserves the right to assert additional claims, including dependent claims (Compl. p. 6, n.2).

U.S. Patent No. 9,315,043 - "Automated Devices, Systems, and Methods for the Fabrication of Tissue," issued April 19, 2016 (’043 Patent)

The Invention Explained

  • Problem Addressed: Similar to related patents, the ’043 Patent addresses the limitations of prior art tissue engineering in achieving scalability, precise material orientation, and complex three-dimensional structures needed for functional tissues ('043 Patent, col. 1:15-41).
  • The Patented Solution: The invention discloses improvements to automated bioprinting, including a three-dimensional calibration system that uses sensors on both the printer head and the receiving surface to dynamically calculate and monitor print height ('043 Patent, col. 2:1-12). The patent also describes multi-axial nozzles capable of co-extruding different materials to form complex structures, such as a tube with a distinct core layer and mantle layer, in a single pass ('043 Patent, col. 2:25-39; Fig. 28).
  • Technical Importance: The ability to dynamically calibrate print height and co-extrude multiple materials enables the fabrication of more sophisticated biological constructs, such as vascular channels with distinct, layered cell populations, which is a critical step toward creating viable, thick tissues ('043 Patent, col. 2:25-39).

Key Claims at a Glance

The complaint does not specify which claims of the ’043 Patent are asserted, instead referencing an external exhibit not provided with the complaint (Compl. ¶29). Independent claim 1 is representative of the method claimed.

  • Independent Claim 1: A method of printing a three-dimensional (3D) structure, comprising the steps of:
    • Providing a 3D printer with specified components (printer head, dispensing means, receiving surface, etc.).
    • Providing materials to be dispensed (e.g., bio-ink).
    • Encoding the printer with a 3D structure to be printed.
    • Dispensing the materials from a deposition orifice via extrusion.
    • Depositing a first layer of the dispensed materials.
    • Repeating the depositing step to deposit subsequent layers.
  • The complaint reserves the right to assert additional claims (Compl. p. 6, n.2).

U.S. Patent No. 9,752,116 - "Self-Assembling Cell Aggregates and Methods of Making Engineered Tissue Using the Same," issued September 5, 2017 (’116 Patent)

  • Technology Synopsis: The patent addresses the shortcomings of traditional tissue engineering based on seeding individual cells onto scaffolds ('116 Patent, col. 1:24 - col. 2:11). The proposed solution is to use pre-formed, multi-cellular "cell aggregates" as building blocks, which are deposited in a defined pattern and fuse together based on natural biological principles of tissue fluidity to form a cohesive, three-dimensional structure ('116 Patent, Abstract; col. 2:14-27).
  • Asserted Claims: The complaint does not specify asserted claims (Compl. ¶36). The patent includes independent claims 1 and 5.
  • Accused Features: The complaint alleges infringement by Defendant's "importing, making, offering to sell, and selling at least the Bio X bioprinter" (Compl. ¶36).

U.S. Patent No. 9,855,369 - "Method of Printing a Three-Dimensional Structure," issued January 2, 2018 (’369 Patent)

  • Technology Synopsis: This patent claims a method of printing a 3D structure using a bioprinter. The method involves providing a printer, encoding it with a digital model, dispensing materials via extrusion, and depositing the materials layer-by-layer to form the final construct ('369 Patent, Abstract). The claims focus on the overall process of automated, layer-by-layer bio-fabrication.
  • Asserted Claims: The complaint does not specify asserted claims (Compl. ¶43). The patent includes independent claims 1 and 4.
  • Accused Features: The complaint alleges infringement through the use of "at least the Bio X bioprinter" to perform the claimed method (Compl. ¶43).

U.S. Patent No. 8,852,932 - "Self-Assembling Cell Aggregates And Methods of Making Engineered Tissue Using the Same," issued October 7, 2014 (’932 Patent)

  • Technology Synopsis: Related to the ’116 Patent, this invention describes producing engineered tissue from "cell aggregates" that act as "bio-ink" particles ('932 Patent, col. 5:1-7). The patent discloses methods of creating these aggregates (e.g., by centrifuging and extruding a cell pellet) and then arranging them in a pattern where they can fuse to form a desired 3D structure, a process guided by principles of differential cell adhesion ('932 Patent, Abstract; col. 5:19-34).
  • Asserted Claims: The complaint does not specify asserted claims (Compl. ¶50). The patent includes independent claims 1, 12, and 13.
  • Accused Features: The complaint alleges infringement by Defendant's "importing, making, offering to sell, and selling at least the Bio X bioprinter" (Compl. ¶50).

III. The Accused Instrumentality

  • Product Identification: The complaint identifies at least the Cellink Bio X and Bio X6 bioprinters as the accused instrumentalities (Compl. ¶22, ¶29).
  • Functionality and Market Context: The complaint does not provide detailed technical specifications for the accused products. It alleges they are "bioprinters" used for fabricating tissue structures (Compl. ¶22, ¶29). The complaint alleges that Defendant markets these products to academic and medical research institutions in Texas and has formed collaborations with a Houston-based startup and a Texas university researcher, suggesting a market position in the life sciences research and development sector (Compl. ¶¶ 6-8).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Exhibits F-J) that were not provided. Therefore, a claim chart summary table is omitted, and the infringement theories are summarized below in prose. No probative visual evidence provided in complaint.

  • ’952 Patent Infringement Allegations: The complaint alleges that the Bio X bioprinter directly infringes the ’952 Patent (Compl. ¶22). As the ’952 Patent claims a bioprinter apparatus, the narrative theory is that the Bio X bioprinter itself contains the structural and functional elements recited in the patent’s claims, including a printer head, a pressure-based dispensing means, a means for determining cartridge position, and a programmable processor.
  • ’043 Patent Infringement Allegations: The complaint alleges that the use of the Bio X6 bioprinter infringes the ’043 Patent (Compl. ¶29). Since the asserted patent claims a method, the narrative theory suggests that Defendant directly infringes (e.g., through testing or demonstrations) and indirectly infringes by inducing its customers to use the Bio X6 bioprinter to perform the patented method of layer-by-layer extrusion-based printing.
  • Identified Points of Contention:
    • Scope Questions (’952 Patent): A central question will be whether the positioning technology in the Bio X bioprinter constitutes the claimed "means for determining a position of the selected cartridge in space." Because this is a means-plus-function limitation, its scope will be limited to the laser-based calibration systems described in the specification and their legal equivalents ('952 Patent, col. 2:38-44). The dispute may turn on whether the accused device’s mechanism for positioning its printheads is structurally equivalent to the patent’s disclosed laser systems.
    • Technical Questions (’043 Patent): For the method claims, a key question will be whether the normal operation of the Bio X6 bioprinter performs every step of the claimed method. The analysis may focus on whether the software and hardware of the accused product, when used as intended, direct the device to perform the specific sequence of encoding, dispensing, and layer-by-layer deposition as required by the claims.

V. Key Claim Terms for Construction

’952 Patent

  • The Term: "means for determining a position of the selected cartridge in space" (from Claim 1).
  • Context and Importance: This is a means-plus-function limitation governed by 35 U.S.C. § 112(f). Its construction is critical because infringement requires the accused device to perform the identical function using a structure that is the same as, or equivalent to, the specific structures disclosed in the patent's specification. Practitioners may focus on this term because the entire infringement case for this patent could depend on whether the specific calibration technology in the Bio X printer is equivalent to the structures Organovo disclosed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses that the calibration means may be selected from "laser alignment, optical alignment, mechanical alignment, piezoelectric alignment, magnetic alignment, electrical field or capacitance alignment, ultrasound alignment, or a combination thereof" ('952 Patent, col. 2:2-6). Plaintiff may argue this list of alternatives discloses a broader set of corresponding structures.
    • Evidence for a Narrower Interpretation: The detailed description and figures primarily illustrate a laser-based system for calibration ('952 Patent, Figs. 1-3; col. 2:38-67). Defendant may argue that these specific laser-based embodiments are the only sufficiently disclosed structures corresponding to the claimed function, thereby narrowing the scope of equivalents.

’043 Patent

  • The Term: "dispensing is by extrusion" (from Claim 1).
  • Context and Importance: This term defines the physical mechanism of material deposition. The infringement analysis for this method patent will depend on whether the way the Bio X6 bioprinter deposits bio-ink qualifies as "extrusion." A narrow definition could exclude other forms of additive manufacturing, while a broad one could cover a wider range of deposition technologies.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent family describes bioprinting generally as the "three-dimensional, precise deposition of cells" ('952 Patent, col. 7:11-12). A party could argue "extrusion" should be interpreted broadly within this context to mean any process that deposits a continuous or semi-continuous stream of material, as distinct from droplet-based jetting.
    • Evidence for a Narrower Interpretation: The specification describes extrusion in the context of specific mechanisms, such as dispensing by "application of pressure" via a piston or compressed gas ('952 Patent, col. 2:8-12). Further, the ’043 patent details multi-axial nozzles for creating core/mantle structures, which implies a pressure-driven flow of viscous material through a confined orifice ('043 Patent, col. 2:25-39). A party may argue the term is limited to such pressure-driven, filament-based deposition.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all five patents-in-suit. The factual basis for these allegations is Defendant's act of "providing" the accused bioprinters to others, which allegedly enables and encourages infringement (Compl. ¶23, ¶30, ¶37, ¶44, ¶51). The complaint alleges Defendant had knowledge of the patents at least as of March 2019 and March 2021, which may be used to support the intent element for induced infringement (Compl. ¶¶ 17-19).
  • Willful Infringement: The complaint alleges willful infringement for all five patents. The stated basis is Defendant’s alleged knowledge of the patents since at least March 2019 for the '116, '369, and '932 patents, and since March 2021 for the '952 and '043 patents, followed by continued alleged infringement (Compl. ¶¶ 17-19, ¶24, ¶31). Defendant’s filing of a declaratory judgment action is also cited as evidence of its knowledge of the dispute (Compl. ¶20).

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

  • A core issue will be one of structural and functional equivalence: For the apparatus patents, can the specific laser-based calibration systems described in Organovo’s patents be construed to cover the positioning and calibration technology used in Cellink's bioprinters? For the method patents, does the operation of the accused products, as guided by their software, perform the specific, multi-step processes required by the claims?
  • A second central question will be one of definitional scope: Can the term "cell aggregates" as defined and used in the '116 and '932 patents be construed to read on the "bio-inks" that are used with, and potentially sold by, Cellink? The case may turn on whether the materials used in the accused systems meet the structural and functional (i.e., fusing) limitations of the claims.
  • Given the complaint’s detailed recitation of pre-suit communications and licensing discussions, a significant aspect of the case will be willfulness. A key question for the court will be whether Defendant’s actions after being notified of the patents—including its decision to file a declaratory judgment action and continue its allegedly infringing activities—rose to the level of objective recklessness required for an enhancement of damages.