DCT
2:21-cv-10312
Trutek Corp v. BlueWillow Biologics Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Trutek Corp. (New Jersey)
- Defendant: BlueWillow Biologics, Inc. (Delaware)
- Plaintiff’s Counsel: Stanley H. Kremen
- Case Identification: [Trutek Corp.](https://ai-lab.exparte.com/party/trutek-corp) v. [BlueWillow Biologics, Inc.](https://ai-lab.exparte.com/party/bluewillow-biologics-inc), 4:21-cv-10312, E.D. Mich., 02/10/2021
- Venue Allegations: Venue is alleged to be proper because the defendant has an established place of business in the Eastern District of Michigan and the tort of patent infringement allegedly occurred within the state.
- Core Dispute: Plaintiff alleges that Defendant’s over-the-counter nasal antiseptic product infringes a patent related to methods for electrostatically blocking and inactivating airborne contaminants.
- Technical Context: The technology involves topical formulations applied near the nasal passages that create an electrostatic charge to attract and neutralize airborne particles such as allergens and viruses.
- Key Procedural History: The complaint notes that the asserted patent is part of a larger family of patents owned by the Plaintiff. Prior to filing suit, Plaintiff alleges it conducted an investigation that included purchasing the accused product and commissioning third-party laboratory reports (attached as exhibits) to analyze and compare the electrostatic properties of the parties' respective products.
Case Timeline
| Date | Event |
|---|---|
| 2008-07-07 | '802 Patent Priority Date |
| 2012-04-24 | '802 Patent Issue Date |
| 2020 | Accused Product "NanoBio Protect" launched (approximate) |
| 2020-06-23 | Plaintiff purchased accused product for testing |
| 2021-01-14 | Plaintiff purchased accused product for further testing |
| 2021-02-10 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,163,802 - "Electrostatically Charged Multi-Acting Nasal Application, Product, and Method"
The Invention Explained
- Problem Addressed: The patent describes the body’s nasal passages as a primary entry point for a wide variety of harmful airborne substances, including viruses, bacteria, and toxic particulates. It posits that conventional defenses like dust masks or reflexive sneezing are often ineffective, particularly against microscopic or motile microorganisms that can overcome simple physical barriers. (’802 Patent, col. 2:11-41).
- The Patented Solution: The invention is a "multi-acting" formulation applied to the skin near the nostrils that creates an electrostatic field. This field first attracts and captures oppositely charged airborne contaminants. Then, a "biocidic agent" within the formulation inactivates or kills the captured microorganisms, preventing them from causing infection even if they are later dislodged. (’802 Patent, Abstract; col. 2:1-7).
- Technical Importance: The claimed invention seeks to provide a protective barrier that not only filters contaminants but also actively neutralizes them at the point of entry before they can be inhaled. (’802 Patent, col. 3:42-51).
Key Claims at a Glance
- The complaint asserts at least independent method Claim 1, independent formulation Claim 2, and dependent Claim 7. (Compl. ¶30).
- Independent Claim 1 recites a method with the following essential elements:
- Applying a formulation to the skin or tissue of nasal passages in a thin film.
- Electrostatically attracting particulate matter to the film.
- Holding the particulate matter in place by "adjusting the adhesion" and "cohesion" of the formulation.
- Inactivating the particulate matter with at least one ingredient that renders it harmless.
- Independent Claim 2 recites a formulation comprising a cationic agent and a biocidic agent that performs the functions of attracting, holding, and inactivating particulate matter.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant's over-the-counter pharmaceutical product named NanoBio® Protect ("NANOBIO"). (Compl. ¶14).
Functionality and Market Context
- The NANOBIO product is a nasal antiseptic advertised for application to a customer's nasal passages. (Compl. ¶15). The complaint alleges the product functions by forming positively charged "NanoBio Droplets" that attract and bind to negatively charged particles like bacteria and viruses. (Compl. ¶15). The complaint includes a visual from the defendant's website, attached as Exhibit 1, which describes the accused product's mechanism of action. (Compl. ¶15). The formulation allegedly contains benzalkonium chloride (BZK), an ingredient that "kill[s] them via membrane disruption." (Compl. ¶15). A "Frequently Asked Questions" page from the defendant's website, attached as Exhibit 2, is also provided to support the alleged mechanism of action. (Compl. ¶15).
- The complaint alleges that third-party testing confirmed the NANOBIO product exhibits a surface electrostatic charge. (Compl. ¶17). It is sold over-the-counter at national pharmacies like CVS and online via Amazon.com, positioning it as a competitor to Plaintiff's own products. (Compl. ¶¶14, 22).
IV. Analysis of Infringement Allegations
'802 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for electrostatically inhibiting harmful particulate matter...wherein a formulation is applied to skin or tissue of nasal passages of the individual in a thin film... | The NANOBIO product is advertised for, and intended to be applied to, a customer's nasal passages. | ¶15 | col. 10:19-23 |
| a) electrostatically attracting the particulate matter to the thin film; | The product allegedly forms "positively charged 'NanoBio Droplets'" which attract negatively charged particles like bacteria and viruses. Third-party testing allegedly confirmed the product has a surface electrostatic charge. | ¶15, ¶17 | col. 10:24-25 |
| b) holding the particulate matter in place by adjusting the adhesion of the thin film to permit said thin film to stick to the skin or tissue and by adjusting the cohesion of the formulation... | The positively charged "NanoBio Droplets" are alleged to "adhere to nasal membranes" and "attract and bind to these particles." | ¶15 | col. 10:26-31 |
| c) inactivating the particulate matter by adding at least one ingredient that would render said particulate matter harmless. | The product contains benzalkonium chloride (BZK), which allegedly adheres to germs and "kill[s] them via membrane disruption." The complaint refers to this as the "kill" step. | ¶15 | col. 10:32-34 |
- Identified Points of Contention:
- Scope Questions: Claim 1 requires "holding the particulate matter in place by adjusting the adhesion...and...cohesion of the formulation." A question for the court will be whether the complaint's allegation that the accused product merely "adheres" and "binds" is sufficient to meet this potentially more active limitation, or if Plaintiff must prove Defendant engaged in a specific formulation process of "adjusting" these properties.
- Technical Questions: The complaint's infringement theory rests heavily on marketing statements from the Defendant's website. A central question will be what technical evidence exists to demonstrate that the NANOBIO product's use by a consumer constitutes performance of every step of the claimed method, particularly as described in the patent.
V. Key Claim Terms for Construction
The Term: "inactivating"
- Context and Importance: This term is central to the final step of Claim 1 and is the basis for the "kill" portion of the "catch, hold, and kill" infringement theory. (Compl. ¶13). Practitioners may focus on this term because its definition will determine whether the alleged "membrane disruption" by BZK falls within the claim's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification uses the terms "neutralized, killed, inactivated, and rendered harmless" together, suggesting they may be viewed as covering a range of effects beyond simple cell death. (’802 Patent, col. 3:39-41). The claim language itself uses the phrase "render said particulate matter harmless." (’802 Patent, col. 10:33-34).
- Evidence for a Narrower Interpretation: The patent repeatedly refers to the use of a "biocidic agent" to achieve this function, which may suggest a requirement for a direct killing mechanism rather than merely trapping or neutralizing a particle. (’802 Patent, Abstract; col. 10:66-67).
The Term: "adjusting the adhesion...and...cohesion"
- Context and Importance: This language defines the "holding" mechanism in Claim 1(b). The infringement case depends on mapping the accused product's ability to "bind" and "adhere" onto this limitation. Practitioners may focus on this term because it appears to require an action ("adjusting") rather than just describing an inherent state ("adhesive").
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the selection of specific ingredients (e.g., thickeners, gellants) during the design of a formulation inherently constitutes "adjusting" its physical properties to achieve a desired outcome, thus reading on any product properly formulated to be sticky. (’802 Patent, col. 4:51-58).
- Evidence for a Narrower Interpretation: A party could argue that the term "by adjusting" requires proof of an affirmative, deliberate tuning of these specific properties for the claimed purpose, which may be a higher standard than simply formulating a product that is inherently adhesive.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant's website advertises and instructs customers on how to apply the NANOBIO product to their nasal passages. (Compl. ¶15). These allegations may form the basis for a claim of induced infringement, asserting that Defendant encourages its customers to perform the steps of the patented method. The prayer for relief requests an injunction against active inducement. (Compl., Prayer for Relief ¶3).
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement and does not plead facts suggesting Defendant had knowledge of the '802 Patent prior to the lawsuit's filing.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and proof: can the description of the accused product as inherently "adhering" and "binding" satisfy the claim limitation of "holding...by adjusting the adhesion...and...cohesion"? The outcome may depend on whether this is interpreted as requiring an active formulation process or merely a resulting property.
- A second central question will be one of indirect infringement: as the primary asserted claim is a method claim performed by the end-user, the case will likely turn on whether Plaintiff can prove that Defendant's marketing and instructions for the NanoBio® Protect product direct users to perform each and every step of the method as claimed in the '802 Patent.