DCT

1:21-cv-01610

Bay Materials LLC v. 3M Co

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-01610, D. Del., 11/15/2021
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant 3M Company is incorporated in and resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Clarity Aligners Flex product line infringes two patents related to multi-layer polymer sheet materials used for orthodontic clear aligners.
  • Technical Context: The technology concerns composite thermoplastic materials designed to overcome the performance trade-offs inherent in single-material clear dental aligners, a major segment of the orthodontics market.
  • Key Procedural History: The complaint alleges that in January 2021, prior to launching the accused product, 3M initiated discussions with Bay Materials to license the patented technology but did not secure a license. Subsequent to the complaint filing, both patents-in-suit underwent Inter Partes Review (IPR) proceedings. The IPR for the ’263 patent resulted in the cancellation of all asserted claims, including independent claims 1 and 11. The IPR for the ’630 patent concluded with the patentability of asserted claims 1-4, 7-11, and 13 being confirmed. This procedural history significantly alters the landscape of the dispute, potentially focusing the litigation on the surviving ’630 patent.

Case Timeline

Date Event
2017-05-31 Earliest Priority Date for ’263 and ’630 Patents
2018-04-01 3M allegedly obtains sheets of Plaintiff's Zendura FLX product
2018-11-01 Bay Materials announces commercial release of Zendura FLX
2020-01-01 3M allegedly obtains additional sheets of Zendura FLX
2020-12-22 U.S. Patent No. 10,870,263 Issues
2021-01-05 Bay Materials announces issuance of ’263 Patent
2021-01-13 Alleged meeting between Bay Materials and 3M regarding a potential license
2021-03-16 U.S. Patent No. 10,946,630 Issues
2021-04-23 FDA grants marketing approval for Clarity Aligners Flex
2021-07-12 3M announces commercial launch of Clarity Aligners Flex
2021-11-15 Complaint Filed

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

U.S. Patent No. 10,870,263 - "Dual Shell Dental Appliance and Material Constructions," issued December 22, 2020

The Invention Explained

  • Problem Addressed: The patent describes a deficiency in existing dental aligners, which are typically made from a single material. Stiff materials can exert excessive, uncomfortable forces on teeth, while soft, highly elastic materials may lack the sustained force needed for tooth movement and can be prone to staining and stress cracking (’263 Patent, col. 5:4-24).
  • The Patented Solution: The invention is a composite polymeric sheet with a multi-layer structure, referred to as a "dual shell." It consists of two hard outer layers (A and C) that provide rigidity and accurate tooth engagement, bonded to a soft, elastomeric inner core (B) that provides gentle, sustained restoring forces. This A-B-C construction, depicted in Figure 1A, aims to combine the benefits of both hard and soft materials in a single sheet for fabricating aligners (’263 Patent, Abstract; col. 1:50-59; Fig. 1A).
  • Technical Importance: This layered approach offered a method to engineer dental aligners with an optimal balance of rigidity for precise force application and flexibility for patient comfort and ease of use, while also improving durability and stain resistance over single-layer designs (’263 Patent, col. 5:25-38).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 11, along with various dependent claims (’263 Patent, col. 25:1-26:21; Compl. ¶58).
  • Independent Claim 1: A polymeric sheet composition comprising:
    • At least two outer layers (A and C) and an elastomeric inner layer (B).
    • One or both outer layers comprise a thermoplastic polymer with a flexural modulus from 1,000 to 2,500 MPa.
    • The inner layer comprises an elastomeric material with a hardness from A 60 to D 85.
  • Independent Claim 11: A polymeric sheet composition comprising:
    • At least two rigid outer layers (A and C), at least two soft inner layers (B and B'), and at least a rigid inner layer (D).
    • The rigid layers (A, C, D) comprise a thermoplastic polymer with a modulus from 1,000 to 2,500 MPa.
    • The soft inner layers (B, B') comprise an elastomeric material with a hardness from A 60 to D 85.
  • The complaint reserves the right to assert additional claims (Compl. ¶58).

U.S. Patent No. 10,946,630 - "Dual Shell Dental Appliance and Material Constructions," issued March 16, 2021

The Invention Explained

  • Problem Addressed: As with the related ’263 patent, this patent addresses the technical challenge of creating a dental aligner material that is simultaneously strong, flexible, durable, and resistant to environmental factors like staining (’630 Patent, col. 1:31-41).
  • The Patented Solution: The patent discloses a similar multi-layer polymeric sheet. The core innovation is the combination of hard outer layers, specified as polyester or co-polyester, with a soft elastomeric inner layer. This structure allows the final dental appliance to apply consistent, gentle orthodontic forces over time while maintaining its shape and resisting degradation (’630 Patent, Abstract; col. 5:25-38).
  • Technical Importance: The invention provides an engineered material that allows for the fabrication of clear aligners with improved performance characteristics, aiming to enhance the efficacy of orthodontic treatment and patient compliance compared to aligners made from conventional single-layer plastics (’630 Patent, col. 5:25-38).

Key Claims at a Glance

  • The complaint asserts independent claim 1, along with various dependent claims (’630 Patent, col. 21:5-18; Compl. ¶79).
  • Independent Claim 1: A polymeric sheet composition comprising:
    • At least two outer layers (A and C) and an elastomeric inner layer (B).
    • One or more outer layers is a polyester or co-polyester with a flexural modulus from 1,000 to 2,500 MPa.
    • The inner layer is an elastomeric material with a hardness from A80 to D75.
    • The overall sheet composition has a flexural modulus from 750 to 2,000 MPa.
  • The complaint reserves the right to assert additional claims (Compl. ¶79).

III. The Accused Instrumentality

Product Identification

  • The accused products are multilayer polymeric orthodontic materials and appliances sold under the brand name "Clarity™ Aligners Flex," including the "Clarity Aligners Flex + Force aligner system" (Compl. ¶27).

Functionality and Market Context

  • The Clarity Aligners Flex product is described by 3M as a "flexible 5-layer material" made from copolyesters and designed to move teeth using "continuous gentle force" (Compl. ¶28, ¶30).
  • The complaint includes a diagram from 3M's materials illustrating the product’s layered structure (Compl. ¶30). This diagram shows a proprietary 5-layer blend of materials, labeled as outer skin, inner skin, core, inner skin, and outer skin (Compl. p. 8, Figure).
  • The complaint alleges this structure is designed with distinct functional layers: outer layers to resist staining and scratching, and inner layers to provide mechanical durability, force persistence, and flexibility (Compl. ¶31).
  • A bar chart in the complaint compares the .625mm thickness of the 5-layer Clarity Aligners Flex to the .75mm thickness of the 1-layer Clarity Aligners Force product (Compl. p. 9, Figure).
  • The accused product is positioned in the market as an orthodontic treatment to fix dental malocclusion and was commercially launched in the U.S. on July 12, 2021 (Compl. ¶27, ¶29).

IV. Analysis of Infringement Allegations

’263 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A polymeric sheet composition, comprising: at least two outer layers A and C and an elastomeric inner layer B... The Accused Products are a five-layer polymeric material, which the complaint maps to the claimed A-B-C structure by identifying the two "outer skin" layers as A and C and the central "core" layer as B. ¶30, ¶59 col. 1:50-53
...wherein one or both of the outer layers A and C individually comprise a thermoplastic polymer having a flexural modulus of from about 1,000 MPa to 2,500 Mpa... On information and belief, the outer layers are comprised of a Tritan thermoplastic polymer alleged to have a flexural modulus of about 1,550 MPa, which is within the claimed range. ¶59 col. 7:20-25
...and the inner layer B is comprised of an elastomeric material having a hardness from about A 60 to D 85. On information and belief, the inner layer is comprised of an Ecdel 9967 elastomeric material alleged to have a Shore hardness of A95 or D55, which is within the claimed range. ¶59 col. 7:31-33
  • Identified Points of Contention:
    • Scope Questions: A primary question is whether the accused product's five-layer "Outer-Inner-Core-Inner-Outer" structure can be mapped to the three-layer A-B-C structure of claim 1. The court may need to determine if the presence of the two "inner skin" layers between the "core" (B) and "outer skins" (A, C) means the accused product does not meet the claim limitations, or if the product can be seen as "comprising" the claimed structure. The infringement theory may fit the five-layer structure of asserted claim 11 more directly, but all asserted claims of the '263 patent were cancelled in IPR.
    • Technical Questions: The complaint's allegations regarding the specific material compositions (Tritan, Ecdel) and their physical properties (modulus, hardness) are made "on information and belief," supported by citations to 3M's own patent applications and marketing materials (Compl. ¶37-41). A central evidentiary question is whether discovery will confirm that the commercially sold products actually contain these materials and exhibit these precise properties.

’630 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A polymeric sheet composition, comprising: at least two outer layers A and C and an elastomeric inner layer B... The Accused Products are described as a multi-layer polymer sheet, which the complaint alleges meets this structural limitation. ¶80 col. 1:50-53
...wherein one or more of the outer layers A and C is a polyester or co-polyester having a flexural modulus of from about 1,000 MPa to 2,500 MPa... The outer layers are alleged to be made of a Tritan thermoplastic polymer, a type of copolyester, with a flexural modulus of about 1,550 MPa, which falls within the claimed range and material type. ¶80 col. 21:5-12
...the inner layer B is comprised of an elastomeric material having a hardness from about A80 to D75... On information and belief, the inner layers are made of Ecdel 9967, an elastomer alleged to have a Shore hardness that falls within the claimed A80 to D75 range. ¶80 col. 21:12-14
...and the polymeric sheet composition has a flexural modulus of from about 750 MPa to 2,000 MPa. On information and belief, the overall polymeric sheet composition has a flexural modulus of about 1,300 MPa, falling within the claimed range. Another visual from the complaint, a bar chart, depicts the elastic modulus of the accused product as between 1.0 and 1.5 GPa (1000-1500 MPa) (Compl. p. 9, Figure). ¶80 col. 21:15-18
  • Identified Points of Contention:
    • Scope Questions: Similar to the ’263 patent, a key dispute may arise over whether the five-layer accused product literally infringes the three-layer structure recited in claim 1 of the ’630 patent.
    • Technical Questions: The infringement case rests on allegations of material composition and properties made on "information and belief." The central factual dispute will likely concern whether the accused product, as sold, actually exhibits the specific flexural modulus and hardness values required by the claims.

V. Key Claim Terms for Construction

  • The Term: "elastomeric inner layer B" (and relatedly, "middle layer B")

    • Context and Importance: This term's construction is critical to infringement. The patents' primary independent claims describe a three-layer A-B-C structure, while the accused product has a five-layer structure. Plaintiff maps the product's central "core" to the claimed "inner layer B." Practitioners may focus on this term because Defendant will likely argue that the "core" is not an "inner layer B" because it is not directly between the two outer layers, but is separated by intermediate "inner skin" layers.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The open-ended "comprising" language of the claims may support an argument that the intermediate layers are merely additional, unclaimed elements that do not negate infringement. The specification focuses on the functional relationship, where layer B provides a "restoring force" between layers A and C (’263 Patent, col. 8:62-64), a function the "core" layer allegedly performs.
      • Evidence for a Narrower Interpretation: The specification consistently depicts "layer B" as being contiguous with "layer A" and "layer C" in figures like FIG. 1A. Language describing the invention as "two outer layers A and C and a middle layer B" (’263 Patent, col. 2:50-51) may support an argument that "middle" implies direct adjacency, excluding a structure with intervening layers.

  • The Term: "flexural modulus"

    • Context and Importance: The claims of both patents depend on specific numerical ranges for the flexural modulus of the layers and the overall composition. The precise definition and method of measurement for this property in a composite, multi-layer material will be central to determining whether the accused product falls within the claimed ranges.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent does not mandate a single, exclusive testing protocol, which could allow for arguments that any scientifically valid measurement method demonstrating the property falls within the scope.
      • Evidence for a Narrower Interpretation: The specification explicitly states that "Flexural modulus may be measured by the test listed in ASTM D790" (’263 Patent, col. 7:13-14). Parties may argue this reference limits the term's construction to results obtained using that specific standard. The complaint itself references 3M technical data allegedly based on a similar standard, ASTM D 790 (Compl. ¶41), suggesting the parties may converge on this standard but dispute its application or results.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both inducement and contributory infringement. The inducement theory is based on 3M’s alleged affirmative acts of encouraging infringement, such as providing user instructions, product documentation, and professional training classes on how to use the Clarity Aligners Flex system (Compl. ¶71-72, ¶89-90). The contributory infringement theory is based on allegations that the accused products are not staple articles of commerce and are especially made for the infringing use (Compl. ¶73-76, ¶91-94).
  • Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. It claims that 3M was aware of the patented technology and the ’263 patent specifically, citing a January 2021 meeting where 3M allegedly sought a license (Compl. ¶9, ¶70). The complaint further alleges that 3M’s use of the name "Flex" was intended to copy Plaintiff's "FLX" product designation (Compl. ¶70, ¶88).

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

  • A core issue will be one of structural scope: Can the three-layer A-B-C structure recited in the asserted independent claims of the ’630 patent be construed to read on the accused product's five-layer "Outer-Inner-Core-Inner-Outer" construction? This question will likely dominate claim construction and may require analysis under the doctrine of equivalents if literal infringement fails.
  • A key evidentiary question will be one of technical proof: Can Bay Materials demonstrate through discovery that the materials used in 3M's commercially sold Clarity Aligners Flex product possess the specific hardness and flexural modulus values required by the ranges in the asserted claims of the ’630 patent? The outcome may depend on battles over testing methodology and expert testimony.
  • A dispositive procedural question is the impact of the IPR proceedings: With all asserted claims of the ’263 patent now cancelled, the case against that patent is effectively terminated. The litigation will necessarily narrow to the claims of the ’630 patent, which survived its own IPR challenge, fundamentally reshaping the scope and potential value of the lawsuit.