DCT
1:25-cv-01131
Onego Bio Inc v. Clara Foods Co
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Onego Bio Inc. (Delaware)
- Defendant: Clara Foods Co. d/b/a The EVERY Company (Delaware)
- Plaintiff’s Counsel: Stamoulis & Weinblatt LLC; Husch Blackwell LLP
- Case Identification: 1:25-cv-01131, D. Del., 09/10/2025
- Venue Allegations: Venue is alleged to be proper in the District of Delaware as both Plaintiff and Defendant are Delaware corporations.
- Core Dispute: Plaintiff Onego Bio seeks a declaratory judgment that Defendant Every's U.S. Patent No. 12,096,784 is invalid, unenforceable, and not infringed by Onego's technology, in response to Every's alleged enforcement and licensing demands.
- Technical Context: The technology relates to the production of animal-free egg proteins, specifically ovalbumin, via precision fermentation, a significant and competitive area within the sustainable food technology sector.
- Key Procedural History: The complaint alleges that Every has demanded licensing fees from Onego and informed third parties of a potential infringement issue. The complaint further alleges that the patented technology was previously disclosed in a 2016 webinar presented by a research partner of Onego and attended by the patent’s named inventors, raising issues of invalidity due to prior art and derivation.
Case Timeline
| Date | Event |
|---|---|
| 2016-12-15 | VTT Technical Research Centre of Finland holds webinar allegedly disclosing the patented technology |
| 2018-09-24 | Defendant Every signs Non-Disclosure Agreement with VTT |
| 2019-07-11 | U.S. Patent No. 12,096,784 Priority Date |
| 2022-01-01 | Plaintiff Onego Bio Inc. founded as a spin-off from VTT |
| 2024-09-24 | U.S. Patent No. 12,096,784 Issue Date |
| 2025-09-10 | 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, "PROTEIN COMPOSITIONS AND CONSUMABLE PRODUCTS THEREOF," issued September 24, 2024.
The Invention Explained
- Problem Addressed: The patent addresses the growing global demand for protein and the need for sustainable, non-animal-based alternatives to traditional sources like eggs for use in food, dietary supplements, and sports nutrition ('784 Patent, col. 1:40-52).
- The Patented Solution: The invention provides compositions containing recombinant ovalbumin protein (rOVA) for use in food items. These compositions are designed to provide functional characteristics, such as gelling, foaming, and binding, that are at least equivalent to those of native egg white, thereby enabling the creation of egg-less food products ('784 Patent, col. 8:35-48; Abstract).
- Technical Importance: This technology allows for the production of functional egg proteins without relying on poultry, which may address sustainability, ethical, and supply chain concerns associated with conventional egg production (Compl. ¶¶ 18, 22).
Key Claims at a Glance
- The complaint focuses on independent claim 8 (Compl. ¶37).
- Essential elements of Independent Claim 8:
- An ingredient composition for producing a food item.
- The composition comprises a recombinant ovalbumin protein (rOVA) and one or more additional consumable ingredients.
- When solubilized in an aqueous solution, the composition has a pH above 3.5.
- The composition provides the food item with at least one characteristic that is at least equivalent to the same characteristic in a similar food item made with native egg white instead of rOVA.
- The complaint notes that dependent claims 15-18 further specify the expression of rOVA in yeast or fungal host cells, including Trichoderma species (Compl. ¶39).
III. The Accused Instrumentality
Product Identification
- Onego Bio's technology for producing recombinant ovalbumin ("rOVA") using the fungus Trichoderma reesei through a precision fermentation process (Compl. ¶19).
Functionality and Market Context
- Onego’s process utilizes the fungus Trichoderma reesei, noted for its high enzyme production capabilities, to manufacture rOVA suitable for large-scale production (Compl. ¶19). The complaint alleges that this technology creates a protein that is "bioidentical" to traditional egg whites, offering the same nutritional and functional properties (Compl. ¶22).
- The complaint positions Onego’s product as a sustainable and ethical alternative to conventional eggs, with a "90% smaller environmental footprint" and the capacity to produce protein equivalent to millions of laying hens annually (Compl. ¶24). The complaint explicitly contrasts Onego’s fungus-based technology with Every's yeast-based (Pichia pastoris) technology (Compl. ¶¶ 26-27).
IV. Analysis of Infringement Allegations
This is a declaratory judgment action for non-infringement. The table below summarizes how Onego's instrumentality could be mapped to the claims, forming the basis of the controversy that gives rise to this action.
No probative visual evidence provided in complaint.
'784 Patent Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An ingredient composition for producing a food item, the ingredient composition comprising: a recombinant ovalbumin protein (rOVA)... | Onego produces recombinant ovalbumin (rOVA) via its precision fermentation process using the fungus Trichoderma reesei. | ¶19 | col. 8:35-37 |
| ...and one or more additional consumable ingredients; | The complaint does not provide sufficient detail for analysis of Onego's final ingredient compositions. | N/A | col. 8:37-38 |
| wherein: the pH of the ingredient composition, when solubilized in an aqueous solution, is above 3.5, | The complaint does not provide sufficient detail for analysis of the pH of Onego's products. | N/A | col. 8:41-43 |
| 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. | Onego alleges its protein offers "the same nutritional and functional properties" as traditional egg whites. | ¶22 | col. 8:43-48 |
- Identified Points of Contention:
- Scope Questions: The primary dispute concerns whether the patent, whose specification allegedly focuses on yeast-based production, can be validly asserted against Onego's fungus-based process. This raises the question of whether the claims are enabled and supported by the written description for the full scope of potential host organisms, including Trichoderma reesei (Compl. ¶¶ 41, 47).
- Technical Questions: A key question relates to invalidity based on prior art. The complaint alleges that a 2016 webinar attended by Every’s inventors disclosed the subject matter of at least claim 8 before the patent's priority date (Compl. ¶¶ 52-53). Whether the webinar's content was enabling and publicly available will be a central factual issue.
V. Key Claim Terms for Construction
- The Term: "recombinant ovalbumin protein (rOVA)"
- Context and Importance: The definition of this term is critical because Onego’s core non-infringement and invalidity arguments hinge on whether the claim scope validly extends to rOVA produced by its specific fungal host, Trichoderma reesei. Practitioners may focus on this term because the complaint alleges the patent’s specification fails to enable its production in fungus, potentially limiting the term’s effective scope (Compl. ¶¶ 41, 47).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of independent claim 8 contains no limitation regarding the host organism used to produce the rOVA (Compl. ¶38). Dependent claims 17 and 18 explicitly recite expression in "a fungal host cell" and "a Trichoderma species," respectively, which may suggest that the independent claim was intended to be broad enough to encompass these embodiments ('784 Patent, col. 8:35-48; Compl. ¶39).
- Evidence for a Narrower Interpretation: The complaint alleges that the patent’s specification provides detailed instructions and examples only for producing rOVA from the yeast Pichia pastoris, while providing "no instructions or examples for making rOVA from the Trichoderma reesei fungus" (Compl. ¶41). This alleged lack of support in the specification could be used to argue that the term "rOVA" should be construed as being limited to what the patent actually enables and describes.
VI. Other Allegations
- Indirect Infringement: Not applicable as this is a complaint for declaratory judgment.
- Willful Infringement: Not applicable as this is a complaint for declaratory judgment.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of validity based on enablement and written description: Does the '784 patent's specification, which allegedly focuses on yeast-based systems, provide sufficient technical disclosure to enable a person of ordinary skill in the art to make and use the claimed invention across its potential full scope, including rOVA produced by the fungal host Trichoderma reesei?
- A key factual dispute will concern prior art and inventorship: Does the content of the 2016 VTT webinar constitute an invalidating public disclosure of the composition recited in claim 8? Further, what evidence exists to support the allegation that the subject matter of the '784 patent was derived from technology developed and disclosed by VTT, potentially rendering the patent invalid for improper inventorship?