DCT
1:25-cv-01131
Onego Bio Inc v. Clara Foods Co
Key Events
Amended Complaint
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., 01/13/2026
- Venue Allegations: Venue is asserted as proper in the District of Delaware on the basis that both Plaintiff and Defendant are Delaware corporations.
- Core Dispute: Plaintiff seeks a declaratory judgment that Defendant's patent related to compositions containing recombinant ovalbumin is invalid, unenforceable, and not infringed by Plaintiff's technology for producing animal-free egg proteins.
- Technical Context: The technology resides in the field of food biotechnology, specifically the use of precision fermentation to produce animal-free egg proteins as a sustainable and ethical alternative to conventional egg production.
- Key Procedural History: The complaint notes that a concurrent action was filed in the Western District of Wisconsin, where Defendant has moved to dismiss for lack of personal jurisdiction. The complaint also alleges that Defendant filed a "Petition for Correction of Inventorship" with the USPTO regarding the patent-in-suit, a filing Plaintiff leverages to support its claims of invalidity and unenforceability.
Case Timeline
| Date | Event |
|---|---|
| 2016-12-15 | VTT webinar allegedly attended by '784 patent inventors |
| 2018-05-17 | Second VTT webinar allegedly attended by '784 patent inventor |
| 2018-09-24 | Defendant (Every) signs NDA with VTT to learn about VTT technology |
| 2019-07-11 | Earliest Priority Date of '784 Patent |
| 2022-01-01 | Plaintiff (Onego) founded as a spin-off from VTT |
| 2024-09-24 | U.S. Patent No. 12,096,784 Issues |
| 2025-07-30 | Defendant sends email to Plaintiff regarding patent portfolio |
| 2025-08-08 | Defendant sends letter to Plaintiff regarding patent estate |
| 2025-10-29 | Defendant files Petition for Correction of Inventorship for '784 Patent |
| 2026-01-13 | Complaint Filing Date |
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 (the “’784 Patent”).
The Invention Explained
- Problem Addressed: The patent background describes a growing global food demand and the need for "alternative sustainable, non-animal-based sources of proteins" to supplement traditional animal-based sources used in daily diet and sports nutrition (Compl. ¶1; ’784 Patent, col. 1:43-54).
- The Patented Solution: The invention provides compositions containing recombinant ovalbumin protein (“rOVA”) intended for use in "egg-less food items" (’784 Patent, col. 7:31-33). These compositions are designed to provide food items with functional characteristics—such as gelling, foaming, and browning—that are at least equivalent to those provided by native egg whites (’784 Patent, col. 7:35-45). The detailed description explains methods for producing recombinant proteins and formulating them into various consumable products (’784 Patent, col. 19:19-49).
- Technical Importance: This technology offers a method for producing key egg proteins without relying on poultry, which may address sustainability concerns and supply chain vulnerabilities associated with conventional egg production (Compl. ¶23).
Key Claims at a Glance
- The complaint asserts that independent claim 8 is broad and provides its text (Compl. ¶45).
- Essential elements of independent claim 8 include:
- An ingredient composition for producing a food item, the ingredient composition 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 (e.g., claims 15, 17, and 18) purport to cover rOVA expressed by specific types of host cells, including yeast, fungal host cells, and specifically a Trichoderma species (Compl. ¶47).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Plaintiff Onego Bio Inc.’s technology for producing animal-free egg proteins, specifically recombinant ovalbumin (“rOVA”) (Compl. ¶23).
Functionality and Market Context
- Onego’s technology utilizes the fungus Trichoderma reesei in a precision fermentation process to produce rOVA suitable for large-scale manufacturing (Compl. ¶24). The complaint alleges this technology was developed by the VTT Technical Research Centre of Finland, from which Onego was established as a spin-off (Compl. ¶23).
- The resulting protein product is marketed as a "bioidentical alternative to traditional egg whites," offering the same nutritional and functional properties without the environmental and ethical issues of conventional egg production (Compl. ¶27). The complaint emphasizes that Onego’s fungus-based technology is distinct from Defendant’s yeast-based technology, which uses Pichia pastoris (Compl. ¶35).
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of noninfringement, arguing that Onego’s products and processes do not fall within the valid scope of the ’784 Patent (Compl. ¶¶102-105). The complaint does not contain a detailed element-by-element infringement analysis from the Defendant but presents Onego’s basis for noninfringement. The table below summarizes the potential infringement theory that Onego appears to be defending against, based on the complaint’s description of its own technology juxtaposed with the patent’s claim language.
’784 Patent Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An ingredient composition... comprising: a recombinant ovalbumin protein (rOVA); | Onego's technology utilizes the fungus Trichoderma reesei to produce recombinant ovalbumin (“rOVA”). | ¶24 | col. 7:35-36 |
| and one or more additional consumable ingredients; | Onego's protein product is intended for the food industry and would be combined with other ingredients to create food items. | ¶23 | col. 7:36-37 |
| 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 this element. | N/A | col. 7:38-40 |
| 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 taste, nutrition, and functionality as traditional egg whites." | ¶29 | col. 7:40-45 |
Identified Points of Contention
- Scope Questions: Onego's primary argument for noninfringement and invalidity appears to center on claim scope and enablement. A central question may be whether Claim 8, when read in light of the specification, can validly cover rOVA produced in a fungal host (Trichoderma reesei), given the complaint’s allegation that the patent only provides detailed working examples for production in a yeast host (Pichia pastoris) (Compl. ¶49, ¶67).
- Technical Questions: The case raises the technical question of whether the '784 patent provides an enabling disclosure for producing rOVA in Trichoderma reesei. Onego alleges the patent lacks essential information, such as details on expression vectors, cultivation conditions, and foam control specific to this fungal host, which would be necessary for a person skilled in the art to practice the invention without undue experimentation (Compl. ¶68).
V. Key Claim Terms for Construction
- The Term: "recombinant ovalbumin protein (rOVA)"
- Context and Importance: Practitioners may focus on this term because its construction is central to both infringement and validity. The dispute appears to hinge on whether the term is limited to the specific production methods enabled by the patent's specification. Onego’s noninfringement defense and its invalidity challenge for lack of enablement both depend on how broadly this term can be construed (Compl. ¶66-67, ¶103).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of independent claim 8 does not limit "rOVA" to any particular host organism. The existence of dependent claims that specifically add limitations for yeast (claim 15) and fungal (claim 17) hosts suggests that the independent claim was intended to be broader and not restricted to any single production method.
- Evidence for a Narrower Interpretation: The complaint alleges that while the patent claims are broad, the specification's detailed examples and instructions are limited to making rOVA from the Pichia pastoris yeast (Compl. ¶49, ¶67). Parties may argue that the scope of the claims should be limited to what the specification enables, potentially excluding production methods like Onego's fungus-based system.
VI. Other Allegations
Unenforceability Allegations
The complaint seeks a declaratory judgment that the ’784 Patent is unenforceable based on several grounds (Compl. ¶¶93-101).
- Inequitable Conduct: The complaint alleges that Defendant failed to disclose material prior art to the USPTO, specifically the 2016 VTT webinar and other VTT documents that allegedly disclose the claimed subject matter and were known to the inventors (Compl. ¶94).
- Derivation and Improper Inventorship: The complaint alleges that the named inventors on the '784 Patent derived the invention from employees of VTT, based on Defendant’s attendance at VTT webinars and subsequent technical discussions under an NDA that occurred before the patent's priority date (Compl. ¶89-90). The complaint points to Defendant's own petition to correct inventorship as an acknowledgment of inventorship issues (Compl. ¶91).
- Fraud on the USPTO: The complaint further alleges fraud based on knowingly claiming incorrect inventorship and potentially misleading the USPTO by reciting a sequence for recombinant ovomucoid (rOVD) in a claim purportedly directed to rOVA (Compl. ¶97).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of validity and enablement: Does the ’784 Patent’s specification, which the complaint alleges focuses on yeast-based production methods, provide sufficient written description and an enabling disclosure to support the broad claims as applied to the fungal host system (Trichoderma reesei) used by Plaintiff?
- A second central question will be one of derivation and inequitable conduct: Does evidence show that the named inventors of the ’784 Patent derived the claimed invention from VTT technology disclosed to them prior to the patent's priority date, and did they intentionally conceal this or other material information from the USPTO during prosecution, rendering the patent unenforceable?