DCT

1:25-cv-01430

CAO Group Inc v. Ivoclar Vivadent Inc

Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01430, D. Del., 11/24/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because the defendant is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s teeth whitening strips infringe five patents related to peroxide gel compositions that are shelf-stable, flexible, and adhesive for dental bleaching applications.
  • Technical Context: The technology addresses challenges in consumer dental whitening by creating a gel composition for whitening strips that adheres well to teeth, avoids cracking upon flexing, and remains stable for extended storage.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with actual notice of the patents-in-suit via a letter dated April 2, 2024, approximately seven months prior to filing suit. The five patents-in-suit are alleged to be part of a single patent family, stemming from the same parent application and sharing substantively identical specifications.

Case Timeline

Date Event
2006-02-08 Earliest Priority Date for all Patents-in-Suit
2020-03-31 U.S. Patent No. 10,603,259 Issued
2020-05-12 U.S. Patent No. 10,646,419 Issued
2022-01-11 U.S. Patent No. 11,219,582 Issued
2023-11-28 U.S. Patent No. 11,826,444 Issued
2023-11-28 U.S. Patent No. 11,826,445 Issued
2024-04-02 Plaintiff allegedly sent notice letter to Defendant
2025-11-24 Complaint Filed

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

U.S. Patent No. 10,603,259 - “PEROXIDE GEL COMPOSITION”

  • Issued: March 31, 2020

The Invention Explained

  • Problem Addressed: The patent's background section describes problems with prior art dental bleaching products. Fluidic gels were messy, did not adhere well to teeth, and could be washed away by saliva. More rigid compositions, while less messy, were prone to cracking or breaking when flexed to fit a user’s dental arch. (’259 Patent, col. 2:25-4:19).
  • The Patented Solution: The invention is a dental bleaching device featuring a "gelatinous and viscoelastic" composition on a flexible backing strip. This composition uses specific thickening agents, such as polyvinylpyrrolidone (“PVP”), which allow it to be shelf-stable for up to six months, hold higher concentrations of peroxide, and conform to a user's dental arch without cracking. (’259 Patent, Abstract; col. 8:16-24). The patent provides a specific definition for "gelatinous," distinguishing it from a fluid by stating that multiple discrete units will not "coalesce" or merge into one body when placed in a container. (’259 Patent, col. 5:49-6:3).
  • Technical Importance: This technology enabled the creation of a more effective and user-friendly at-home teeth whitening product that combined high-potency bleaching with improved adhesion and comfort. (Compl. ¶11, ¶26).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1. (Compl. ¶63).
  • Claim 1 Essential Elements:
    • A dental bleaching device with a dental composition on a flexible, water-insoluble strip of backing material.
    • The device is packaged.
    • The composition comprises a peroxide bleaching agent, water as a first solvent, and a thickening agent (poly(2-ethyl-2-oxazoline) or polyvinylpyrrolidone).
    • The thickening agent is included in an amount more by weight than the water.
    • The composition is dried after being applied to the backing material.
    • The composition is "gelatinous and viscoelastic" at various stages (after drying, during storage, after removal from package, and when on teeth).
    • The composition has physical deformation properties allowing it to be positioned, bent, and conformed to teeth.
  • Plaintiff expressly reserves the right to assert additional claims. (Compl. ¶71).

U.S. Patent No. 10,646,419 - “PEROXIDE GEL COMPOSITIONS”

  • Issued: May 12, 2020

The Invention Explained

  • Problem Addressed: The complaint states that the specification of the ’419 Patent is "substantively identical" to that of the ’259 Patent and addresses the same technical problems of creating a stable, adhesive, and flexible dental bleaching strip. (Compl. ¶34; ’419 Patent, col. 2:25-4:19).
  • The Patented Solution: The ’419 Patent describes the same core technology as the ’259 Patent: a dental bleaching device comprising a gelatinous, viscoelastic peroxide composition on a flexible backing material, designed to improve user experience and whitening efficacy. (Compl. ¶34; ’419 Patent, Abstract; col. 8:16-24).
  • Technical Importance: This technology provided an improved delivery system for dental whitening agents compared to prior art trays and less adhesive strips. (Compl. ¶11).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent Claim 1. (Compl. ¶78).
  • Claim 1 Essential Elements:
    • A dental bleaching device with a flexible, planar strip of backing material with two flat sides.
    • A dental composition covers "at least substantially all of one side" of the backing material.
    • The composition comprises a peroxide bleaching agent, water, and a thickening agent (poly(2-ethyl-2-oxazoline) or polyvinylpyrrolidone).
    • The composition is dried after application.
    • The composition is "gelatinous and viscoelastic" at various stages.
    • The composition has physical deformation properties for conforming to teeth.
    • The composition has "adhesive properties" allowing it to adhere to teeth after removal from a package.
  • Plaintiff expressly reserves the right to assert additional claims. (Compl. ¶86).

U.S. Patent No. 11,219,582 - “PEROXIDE GEL COMPOSITION”

  • Issued: January 11, 2022
  • Technology Synopsis: The ’582 Patent relates to the same dental bleaching technology as the lead patents, employing a flexible backing strip with a peroxide gel composition. The specification is described as substantively identical to the other patents-in-suit, focusing on a dried, gelatinous, non-coalescent, and viscoelastic composition that flexes without cracking. (Compl. ¶40, ¶41).
  • Asserted Claims: At least independent Claim 1 is asserted. (Compl. ¶93).
  • Accused Features: The VivaStyle Teeth Whitening Strips, particularly their chemical composition, backing strip, and physical properties, are accused of infringing. (Compl. ¶¶94-99).

U.S. Patent No. 11,826,444 - “PEROXIDE GEL COMPOSITION”

  • Issued: November 28, 2023
  • Technology Synopsis: The ’444 Patent is also part of the same patent family and shares a substantively identical specification with the other patents-in-suit. The invention concerns a dental whitening device with a flexible backing and a gelatinous, non-coalescent, viscoelastic dental composition that conforms to a user's dental arch without breaking. (Compl. ¶46, ¶47).
  • Asserted Claims: At least independent Claim 1 is asserted. (Compl. ¶107).
  • Accused Features: The VivaStyle Teeth Whitening Strips are accused of infringing based on their composition (containing a whitening agent, solvent, and PVP), physical properties, and use on a flexible backing strip. (Compl. ¶¶108-112).

U.S. Patent No. 11,826,445 - “PEROXIDE GEL COMPOSITION”

  • Issued: November 28, 2023
  • Technology Synopsis: Stemming from the same patent family, the ’445 Patent shares a substantively identical specification and covers the same core technology. It describes a dental whitening device with a flexible strip and a gelatinous, non-coalescent, viscoelastic composition containing a peroxide agent and a specific thickening agent. (Compl. ¶52, ¶53).
  • Asserted Claims: At least independent Claim 1 is asserted. (Compl. ¶120).
  • Accused Features: The VivaStyle Teeth Whitening Strips are accused of infringing based on their flexible backing material and dental composition alleged to be gelatinous, non-coalescent, and viscoelastic. (Compl. ¶¶121-125).

III. The Accused Instrumentality

Product Identification

Defendant Ivoclar’s "VivaStyle Teeth Whitening Strips." (Compl. ¶57).

Functionality and Market Context

The accused product is an at-home teeth whitening system comprising flexible strips coated with a dental composition. (Compl. ¶65). The product is marketed as having "adhesive strips [that] stay in place while whitening" and contain "6% hydrogen peroxide." (Compl. ¶58). The listed ingredients include "PVPK30" and "PVPK90" (forms of polyvinylpyrrolidone), distilled water, and hydrogen peroxide. (Compl. ¶61). Instructions direct users to apply the strips to their teeth and fold them over the back. (Compl. ¶60). A photograph provided in the complaint shows the product packaging, which contains 28 strips for 14 whitening treatments. (Compl. ¶66).

IV. Analysis of Infringement Allegations

’259 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a dental bleaching device comprising a dental composition on a strip of backing material, wherein the strip of backing material is flexible and insoluble in water The VivaStyle product is a teeth whitening strip with a dental composition on a thin, flexible, and water-insoluble backing material. ¶64, ¶65 col. 8:19-24
wherein the dental bleaching device is packaged in a package The VivaStyle strips are shipped and stored in packaging, including an outer box and individual foil pouches. The complaint includes a photograph of this packaging. ¶66 col. 6:40-43
wherein the dental composition...comprises a peroxide bleaching agent, a first solvent...water; and a thickening agent...at least one of...polyvinylpyrrolidone The VivaStyle product's ingredient list discloses hydrogen peroxide (peroxide agent), distilled water (solvent), and PVPK30 (polyvinylpyrrolidone, a thickening agent). ¶67 col. 6:28-35
wherein...the thickening agent is included in an amount more by weight of the dental composition than the water The complaint alleges that PVP is listed before water on the ingredient label, which, under cosmetic labeling regulations, indicates it is present in a greater amount by predominance. ¶68 col. 6:36-39
wherein the dental composition is dried after being applied on the strip of backing material The dental compositions on the VivaStyle strips are alleged to be dried after application. ¶68 col. 8:9-11
wherein the dental composition is gelatinous and viscoelastic...when the dental composition is flexibly positioned on teeth The composition is alleged to be gelatinous and viscoelastic based on its ability to flex and deform when removed from the package and positioned on teeth, and its alleged stability for over six months at room temperature. ¶69 col. 5:49-6:3
wherein the dental composition has physical deformation properties such that...the dental composition may be positioned on surfaces of adjacent teeth in a dental arch, bend and conform... The product's instructions direct the user to line the strip to the gum line, press, and fold it over the back of the teeth, which allegedly demonstrates these physical deformation properties. ¶70 col. 8:27-34

’419 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a strip of backing material, wherein the strip of backing material is flexible and planar such that the strip of backing material has two flat sides The VivaStyle product is a flexible strip removed from a plastic film. A photograph is provided showing two flat-sided strips. ¶80 col. 12:5-7
a dental composition on one of the flat sides...such that at least substantially all of one side of the backing material is covered solely by the dental composition The strip is alleged to have backing material on one side and be fully covered with the dental composition on the other side. ¶81 col. 12:8-12
wherein the dental composition...comprises a peroxide bleaching agent, a first solvent...water; and a thickening agent...polyvinylpyrrolidone The complaint incorporates its earlier allegations regarding the product's listed ingredients: hydrogen peroxide, distilled water, and PVP. ¶82 col. 12:13-20
wherein the dental composition has adhesive properties such that...the dental composition will adhere to surfaces of adjacent teeth in a dental arch. The product is marketed as having strips that "adhere well to teeth," and user instructions describe pressing the strip to secure it. ¶85 col. 11:31-35

Identified Points of Contention

  • Scope Questions: The case may focus on the specific definition of "gelatinous" provided in the patents, which requires that the material be "non-coalescent." The dispute could turn on whether the physical properties of the accused product's gel meet this specific, limiting definition, or if a broader, more common understanding of "gelatinous" applies. (Compl. ¶28, ¶69).
  • Technical Questions: A central evidentiary question for the ’259 Patent will be whether the plaintiff can prove that the accused product's composition contains more PVP thickening agent by weight than water. The complaint's allegation rests on an inference derived from cosmetic labeling regulations rather than direct measurement, which suggests a potential point of factual dispute. (Compl. ¶68).

V. Key Claim Terms for Construction

The Term: "gelatinous"

  • Context and Importance: This term is critical because it appears in the independent claims of all five patents-in-suit. The patents provide an explicit and highly specific definition, tying "gelatinous" to the functional property of being "non-coalescent." The outcome of the infringement analysis may depend heavily on whether the court adopts this specific definition or a broader, dictionary-based one.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification first introduces the term with a standard dictionary definition: "resembling gelatin, viscous." (’259 Patent, col. 5:51-52).
    • Evidence for a Narrower Interpretation: The specification immediately follows the dictionary definition with a functional test: "a gelatinous compound...will have some degree of flex and deformation...but will not coalesce so that a specific sample or portions thereof are still determinable...they will bend as they contact the container but will not merge into one body." (’259 Patent, col. 5:56-6:3). This creates a specific, patent-defined meaning that is narrower than the ordinary dictionary definition.

The Term: "dried after being applied"

  • Context and Importance: This claim limitation, present in the '259 and '419 Patents, describes a manufacturing step. Practitioners may focus on this term because the degree of "dryness" is not quantified. The dispute could involve whether this requires the removal of substantially all solvent or merely processing the composition to a non-fluid, stable state.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes drying as a process (e.g., at 37° C. for 12-24 hours) to achieve a "visco-elastic, and gelatinous" state, which may suggest that "dried" refers to achieving this physical state rather than a specific moisture content. (’259 Patent, col. 8:9-24). The '582 Patent, from the same family, claims a composition "dried to an extent that it no longer remains in a state of fluidity," which could inform the interpretation. (Compl. ¶41).
    • Evidence for a Narrower Interpretation: The specification also describes the resulting product as "hygroscopic" and notes that it is "rehydrated" by the user with water to become more adhesive. (’259 Patent, col. 6:50-55; col. 8:25-27). This could support a narrower reading where "dried" means the removal of sufficient water to render the product hygroscopic and require rehydration for full functionality.

VI. Other Allegations

Indirect Infringement

The complaint focuses on direct infringement under 35 U.S.C. § 271(a) for "using, offering to sell, and selling" the accused product and does not plead separate counts for indirect infringement. (Compl. ¶63, ¶78).

Willful Infringement

Willfulness is alleged for all five patents-in-suit. The basis is alleged pre-suit, actual knowledge of the patents stemming from a notice letter sent on April 2, 2024, after which Defendant allegedly continued its infringing activities. (Compl. ¶55, ¶72, ¶87, ¶101, ¶114, ¶127). The complaint also alleges constructive notice based on Plaintiff's marking of its own products with the patents-in-suit. (Compl. ¶15, ¶18, ¶73).

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

  • A core issue will be one of definitional scope: can the term “gelatinous,” which the patents define with a specific “non-coalescent” functional test, be construed to cover the physical properties of the accused whitening strips’ gel, or will Defendant be able to demonstrate a material difference in physical behavior?
  • A key evidentiary question will be one of compositional proof: can Plaintiff prove through direct evidence, beyond its inference from cosmetic labeling regulations, that the accused product’s formulation contains a greater weight of polyvinylpyrrolidone than water, as required by the independent claim of the ’259 Patent?
  • A third central question will concern claim differentiation: given that the five asserted patents share a common specification but have slightly different claim language (e.g., the explicit addition of an "adhesive properties" limitation in the ’419 Patent), the case may explore whether the accused product infringes some claims but not others based on these nuanced distinctions.