DCT

3:25-cv-00761

Onego Bio Inc v. Clara Foods Co

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-00761, W.D. Wis., 09/30/2025
  • Venue Allegations: Plaintiff Onego Bio Inc. asserts venue is proper in the Western District of Wisconsin because a substantial part of the property subject to the action—namely, Onego's manufacturing plant under construction—is located in Jefferson County, Wisconsin.
  • Core Dispute: Plaintiff seeks a declaratory judgment that Defendant’s patent related to ingredient compositions containing recombinant ovalbumin is invalid, unenforceable, and not infringed by Plaintiff's technology.
  • Technical Context: The dispute is in the field of animal-free food technology, specifically the production of egg proteins like ovalbumin using precision fermentation with microorganisms, a growing market focused on sustainable alternatives to traditional animal agriculture.
  • Key Procedural History: The complaint details a history of pre-suit licensing demands made by Defendant. It alleges that inventors of the patent-in-suit attended technical webinars presented by Plaintiff’s predecessor-in-interest (VTT) years before the patent's priority date, and that Defendant later received detailed technical information from VTT under a non-disclosure agreement. These events form the basis for Plaintiff's allegations of invalidity due to prior art, derivation, and unenforceability due to inequitable conduct.

Case Timeline

Date Event
2016-12-15 VTT webinar on recombinant protein production, allegedly attended by inventors of the '784 Patent
2018-05-17 Second VTT webinar on ovalbumin production, allegedly attended by an inventor of the '784 Patent and Defendant's CEO
2018-09-24 Defendant and VTT sign a Non-Disclosure Agreement to discuss VTT's protein production technology
2019-07-11 Earliest claimed priority date of the '784 Patent
2022-01-01 Plaintiff Onego Bio Inc. founded as a spin-off from VTT
2024-09-24 U.S. Patent No. 12,096,784 issues
2024-12-01 Plaintiff acquires land in Jefferson County, Wisconsin, for a manufacturing facility
2025-07-21 Plaintiff and Defendant send a joint letter to Wisconsin's U.S. Senators regarding biotechnology manufacturing
2025-07-30 Defendant sends email to Plaintiff regarding its patent portfolio and Plaintiff's need for a license
2025-08-08 Defendant sends letter to Plaintiff demanding Plaintiff take a patent license
2025-08-15 Defendant sends email to Plaintiff encouraging diligence of its patent portfolio
2025-09-30 Complaint for Declaratory Judgment filed

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

U.S. Patent No. 12,096,784 - “PROTEIN COMPOSITIONS AND CONSUMABLE PRODUCTS THEREOF”

  • Patent Identification: U.S. Patent No. 12,096,784, issued September 24, 2024 (’784 Patent).

The Invention Explained

  • Problem Addressed: The patent’s background section identifies a need for "alternative sustainable, non-animal-based sources of proteins" to meet growing global food demand and provide nutrients for specialized diets (e.g., athletes) ('784 Patent, col. 1:45-51).
  • The Patented Solution: The invention relates to food ingredient compositions containing recombinant ovalbumin (rOVA) produced by microorganisms. These compositions are designed to provide functional characteristics to egg-less food items—such as gelling, foaming, binding, and aeration—that are at least equivalent to the performance of native egg white in similar food products ('784 Patent, Abstract; col. 8:31-41).
  • Technical Importance: The technology aims to enable the use of microbially-produced proteins as direct functional replacements for animal-derived ingredients, a key step in creating commercially viable and sustainable food alternatives ('784 Patent, col. 1:45-51).

Key Claims at a Glance

  • The complaint identifies independent claim 8 as a representative asserted claim (Compl. ¶40).
  • Essential elements of Independent Claim 8:
    • An ingredient composition for producing a food item, comprising:
    • a recombinant ovalbumin protein (rOVA); and
    • one or more additional consumable ingredients;
    • wherein: the pH of the ingredient composition, when solubilized in an aqueous solution, is above 3.5, and
    • the ingredient composition provides to the food item at least one characteristic that is at least equivalent to a same characteristic in an otherwise similar food item that comprises native egg white and does not comprise rOVA.
  • The complaint notes that dependent claims purport to cover rOVA expressed by specific organisms, including a yeast host cell (claim 15), a fungal host cell (claim 17), and a Trichoderma species (claim 18) (Compl. ¶42).

III. The Accused Instrumentality

Product Identification

As this is a declaratory judgment action, the instrumentality at issue is Plaintiff Onego Bio Inc.’s own technology: the production of recombinant ovalbumin (rOVA) via precision fermentation using the fungus Trichoderma reesei (Compl. ¶¶21-22).

Functionality and Market Context

  • Onego’s technology utilizes Trichoderma reesei, a fungus known for high enzyme production, to manufacture rOVA for large-scale food applications (Compl. ¶22). The resulting protein product is alleged to offer the "same taste, nutrition, and functionality as traditional egg whites" (Compl. ¶27).
  • Onego was founded in 2022 as a spin-off from VTT Technical Research Centre of Finland and is expanding into the North American market with a new manufacturing facility in Wisconsin, which is expected to produce protein equivalent to the output of 6 million laying hens annually (Compl. ¶¶21, 27). This positions Onego as a direct competitor to Defendant Every in the animal-free egg protein market (Compl. ¶53).

IV. Analysis of Infringement Allegations

The complaint seeks a declaratory judgment of non-infringement and does not contain a detailed element-by-element infringement analysis or a claim chart. Instead, it presents a narrative theory of non-infringement that is primarily predicated on the alleged invalidity and unenforceability of the ’784 Patent (Compl. ¶84).

The core of the non-infringement argument is that Every has not demonstrated that its patent protection validly extends to the use of Trichoderma reesei to produce rOVA (Compl. ¶84). This argument appears linked to the complaint's assertion that the ’784 Patent is invalid under 35 U.S.C. § 112 for lacking enablement and written description for producing protein using Trichoderma reesei, alleging the specification provides no instructions or examples for this particular fungus (Compl. ¶¶44, 57). The complaint reserves the right to advance additional non-infringement arguments as the case develops (Compl. ¶85).

Identified Points of Contention

  • Scope Question: A primary issue for the court may be whether the term "recombinant ovalbumin protein," as recited in the claims, can be validly construed to encompass rOVA produced using Trichoderma reesei, given the allegation that the patent’s specification exclusively details production using the yeast Pichia pastoris (Compl. ¶44).
  • Technical Question: A related question is whether the ’784 Patent’s disclosure enables a person of ordinary skill in the art to make and use the claimed invention with a fungal host like Trichoderma reesei without undue experimentation, an issue central to the complaint's § 112 invalidity challenge (Compl. ¶57).

V. Key Claim Terms for Construction

The Term: "recombinant ovalbumin protein (rOVA)"

  • Context and Importance: The definition of this term is central to the scope of the patent. The dispute may turn on whether the term is limited by the specific organisms disclosed and enabled in the specification or if it covers rOVA produced by any recombinant method, including Onego's Trichoderma reesei process. Practitioners may focus on this term because the complaint alleges a mismatch between the broad claim language and the narrow examples in the patent's specification (Compl. ¶44).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of independent claim 8 does not limit the source of the "recombinant ovalbumin protein" ('784 Patent, col. 196:8-10). Further, dependent claims explicitly recite expression in "a yeast host cell" (claim 15), "a fungal host cell" (claim 17), and "a Trichoderma species" (claim 18, not part of the issued patent but present in the application as described at Compl. ¶42), which may suggest the inventors contemplated a broad range of host organisms.
    • Evidence for a Narrower Interpretation: The complaint alleges that while the patent claims are broad, the specification "provides no instructions or examples for making rOVA from the Trichoderma reesei fungus," focusing instead on the Pichia pastoris yeast (Compl. ¶44). A party could argue that the scope of the claims should be limited to what the patent teaches and enables.

The Term: "at least one characteristic that is at least equivalent to a same characteristic in an otherwise similar food item that comprises native egg white"

  • Context and Importance: This functional language defines the performance standard the rOVA composition must meet. Its construction will determine how equivalence is measured, which is critical for assessing both infringement and potential invalidity based on prior art that might teach similar functionality.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification lists a wide array of potential characteristics, including "gelling, foaming, whipping, fluffing, binding, springiness, aeration, coating, film forming, emulsification, browning, thickening, texturizing, humectant, clarification, and cohesiveness" ('784 Patent, col. 8:36-41). This may support a construction where demonstrating equivalence for any one of these functions meets the claim limitation.
    • Evidence for a Narrower Interpretation: The specific examples in the patent demonstrate equivalence for certain functions in specific food contexts (e.g., foaming in meringues, structure in pound cakes) ('784 Patent, Examples 31, 30). A party could argue that "at least equivalent" should be interpreted in light of these specific embodiments and test conditions.

VI. Other Allegations

The complaint includes several counts seeking declaratory judgment of invalidity and unenforceability, in addition to non-infringement.

Invalidity Allegations

  • Lack of Enablement/Written Description (§ 112): The complaint alleges the ’784 Patent fails to enable the production of protein using Trichoderma reesei (Compl. ¶57).
  • Anticipation/Obviousness (§§ 102/103): The complaint asserts the patent is invalid over prior art, citing a December 15, 2016 webinar presented by VTT (Plaintiff's predecessor) that was allegedly attended by Every's inventors and disclosed the subject matter of at least claim 8 (Compl. ¶¶62-63). It also identifies a 2018 publication by Every ("Anchel") as invalidating prior art (Compl. ¶67).
  • Improper Inventorship/Derivation (§§ 101/115): The complaint alleges that the subject matter of the claims was derived from employees of VTT, based on disclosures in the 2016 webinar and subsequent technical discussions, and not invented by the individuals named on the patent (Compl. ¶¶74-75).

Unenforceability Allegations

  • Inequitable Conduct: The complaint alleges Every and its inventors breached their duty of candor to the USPTO by failing to disclose the 2016 VTT webinar and other material prior art documents during prosecution (Compl. ¶¶38, 78).
  • Unclean Hands/Patent Misuse: The complaint alleges Every acted in bad faith by soliciting technology from VTT and then securing a patent on that same subject matter (Compl. ¶80).

False Advertising

The complaint includes a count for false advertising, alleging that Every makes false or misleading representations that its own genetically modified protein products are "equivalent," "bio-identical," or "nature-equivalent" to natural egg proteins (Compl. ¶¶4, 49, 88).

No probative visual evidence provided in complaint.

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

This declaratory judgment action appears to center on the history of interactions between the parties' predecessors, raising several critical questions for the court:

  • A primary issue will be one of prior art and derivation: What technical information was disclosed in the 2016 VTT webinar and subsequent discussions between VTT and Every? The case may turn on the factual determination of whether this information was sufficient to invalidate the ’784 Patent claims as anticipated or obvious, or to prove that the named inventors derived the invention from VTT.
  • A key question of claim scope versus enablement will likely be dispositive: Can the claims of the ’784 Patent, which facially recite fungal and Trichoderma hosts, be validly enforced against a product made with Trichoderma reesei when the patent specification allegedly fails to provide an enabling disclosure for that organism?
  • A central legal question will be one of enforceability: Did Defendant's alleged failure to disclose its knowledge of the VTT webinars and technical discussions to the USPTO during patent prosecution rise to the level of inequitable conduct, potentially rendering the entire patent unenforceable?