DCT
2:23-cv-00194
3D Scan Guide LLC v. Chrome Full Arch Guided Systems
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: 3D Scan Guide LLC (Delaware)
- Defendant: Chrome Full Arch Guided Systems (Jurisdiction unknown); ROE Dental Laboratory, Inc. (New York)
- Plaintiff’s Counsel: Garteiser Honea, PLLC
- Case Identification: 2:23-cv-00194, E.D. Tex., 04/27/2023
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendants maintain a regular and established business presence in the district, including at least two physical "Chrome Labs" locations.
- Core Dispute: Plaintiff alleges that Defendants’ CHROME GuidedSMILE dental surgical guide systems infringe a patent related to modular templates for drilling holes with precision.
- Technical Context: The technology lies in the field of guided dental surgery, which uses custom-fitted templates to ensure the accurate placement, trajectory, and depth of dental implants.
- Key Procedural History: The asserted patent is a reissue of U.S. Patent No. 9,050,665. The complaint alleges that Defendants have been on notice of the asserted patent family since at least November 19, 2020, via written notice, a fact which underpins the allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2005-05-20 | Priority Date for U.S. Reissue Patent No. RE 47,368 |
| 2019-04-30 | U.S. Reissue Patent No. RE 47,368 Issued |
| 2020-02-01 | Alleged date of first use for "Chrome Full Arch Guided Systems" trade name |
| 2020-11-19 | Date of alleged written notice of infringement to Defendants |
| 2023-04-27 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Reissue Patent No. RE 47,368 - "Modular template for drilling holes and method of making same"
- Issued: April 30, 2019
The Invention Explained
- Problem Addressed: The patent's background section identifies a critical need for precision in medical and dental drilling, where an improperly drilled hole can have "catastrophic and irreparable consequences" (’368 Patent, col. 1:37-38). It notes that conventional methods often fail to provide adequate means for controlling the depth of penetration of a drill bit into a target surface like a human jawbone (’368 Patent, col. 2:30-34).
- The Patented Solution: The patent describes a multi-part surgical template system. The core of the invention is a body with a custom surface that fits precisely onto a patient's anatomy (e.g., their jaw), which holds a "removable portion" containing a guideway. This guideway assembly can be composed of multiple pieces and includes a physical "stop" to control drill depth, thereby guiding an instrument along a pre-planned trajectory to a specific, safe depth (’368 Patent, Abstract; Fig. 3).
- Technical Importance: The claimed invention sought to provide a comprehensive solution for guided surgery by integrating a custom anatomical fit, precise trajectory control, and reliable depth limitation into a single, modular system (’368 Patent, col. 2:57-65).
Key Claims at a Glance
- The complaint asserts independent claim 11 of the ’368 Patent (Compl. ¶27).
- The essential elements of Claim 11 include:
- A body with a custom surface (a "negative impression") to conform to an uncut irregular surface, the body having a "receiving section."
- A "removable portion" configured to be arranged in the receiving section.
- A "removable guideway" arranged at the removable portion, which itself comprises an "inner piece" and an "outer piece," with the outer piece configured to engage an inner surface of the removable portion.
- A "means for securing" the removable portion to the body.
- The "inner piece" configured as a "stop" to limit the depth of penetration of a surgical instrument.
- The complaint alleges infringement of "at least Claim 11," which suggests the right to assert other claims may be preserved (Compl. ¶27).
III. The Accused Instrumentality
Product Identification
The accused products are Defendants' CHROME GuidedSMILE systems, including product variations such as CHROME Natural, CHROME Replica, CHROME Standard, and CHROME Zygo (Compl. ¶23).
Functionality and Market Context
- The complaint describes the accused products as multi-component systems for "preplanned, predictable guided All-On-X style surgery" (Compl. p. 14). The system allegedly includes several parts that are used sequentially: a "Pin Guide" for initial placement, a "Fixation Base" that acts as a foundation secured to the patient's jaw, and an "Osteotomy Guide" that clips into the Fixation Base to guide drilling (Compl. ¶¶ 29-31). The system is marketed as delivering "Anchored site drilling" and controlling "implant depth, trajectory, and indexing (rotation)" (Compl. p. 14, p. 24).
- An image from the complaint shows the "Pin Guide" seated on a model of a patient's teeth, which is described as the first step to ensure the surgery starts accurately. (Compl. p. 18).
- Another image depicts the "Fixation Base," a metal framework described as the foundation for the surgery into which all subsequent components clip. (Compl. p. 19).
IV. Analysis of Infringement Allegations
Claim Chart Summary
| Claim Element (from Independent Claim 11) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a body including a custom surface shaped as a negative impression of the uncut irregular surface to conform to the uncut irregular surface, the body having a receiving section | The Accused Products include a "Pin Guide" and a "Fixation Base" that have a custom surface conforming to the patient's anatomy. The "Fixation Base" allegedly serves as the foundation where other components are received (Compl. p. 19). | ¶29 | col. 6:12-16 |
| a removable portion configured to be arranged in the receiving section | The "Osteotomy Guide" is alleged to be a removable portion that seats into the "Fixation Base" (Compl. p. 20). An image of the accused "Osteotomy Guide" is presented as the removable portion containing the guideways for drilling. (Compl. p. 20). | ¶30 | col. 6:29-32 |
| a removable guideway arranged at the removable portion...wherein the removable guideway comprises an inner piece and an outer piece, and wherein the outer piece includes an outer surface configured to engage an inner surface of the removable portion | The "Osteotomy Guide" allegedly contains guideways for drills. The complaint alleges these guideways comprise inner and outer pieces, such as the "manufacturer specific implant systems" inserts mentioned in product literature (Compl. p. 20). A training video screenshot shows the guide in use. (Compl. p. 22). | ¶¶31, 32 | col. 6:36-44 |
| means for securing said removable portion to said body | The Osteotomy Guide allegedly "seats into the Fixation Base and is fixed using the proprietary CHROME Locs," which are alleged to be the means for securing (Compl. p. 20). | ¶33 | col. 6:30-32 |
| the inner piece configured as a stop for limiting a depth of penetration of said instrument into said hole | The accused "Osteotomy Guide" is alleged to "control the implant depth," which is the claimed stop function (Compl. p. 24). | ¶34 | col. 6:39-40 |
Identified Points of Contention
- Scope Questions: The claim requires a guideway with a distinct "inner piece" and "outer piece" that have a specific engagement relationship. A central question for the court will be whether the accused Osteotomy Guide's drill inserts meet this two-part structural requirement as claimed, or if they constitute a single, integrated component that functions differently.
- Technical Questions: The complaint alleges the "proprietary CHROME Locs" perform the function of "securing said removable portion to said body." As this is a means-plus-function limitation, the analysis will question whether the "CHROME Locs" are structurally equivalent to the "clip" disclosed in the patent's specification (’368 Patent, col. 6:31-32).
V. Key Claim Terms for Construction
The Term: "a removable guideway ... comprising an inner piece and an outer piece"
- Context and Importance: This limitation defines a specific, multi-part structure at the heart of the invention. The infringement analysis will turn on whether the accused products' drill guides or sleeves can be properly characterized as this two-part assembly.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party may argue that the term "comprising" suggests the list is not exhaustive and that the terms "inner piece" and "outer piece" should be interpreted functionally to cover any assembly with concentric parts that guide a drill, pointing to the general description of a "guiding assembly 136" (’368 Patent, col. 6:36-37).
- Evidence for a Narrower Interpretation: A party may argue that the patent’s only detailed embodiment shows an inner piece (138) and outer piece (140) as distinct, threadably adjustable components (see Fig. 3). This could support a narrower construction requiring two separate, and potentially adjustable, physical parts, rather than a single, monolithic sleeve (’368 Patent, col. 6:36-50).
The Term: "means for securing said removable portion to said body"
- Context and Importance: As a means-plus-function limitation under 35 U.S.C. § 112(f), its scope is not the literal meaning of the words but is restricted to the specific structures disclosed in the specification for performing the function, and their equivalents.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (Equivalence): The patent discloses "at least one clip 134" as the structure corresponding to the securing function (’368 Patent, col. 6:31-32). Plaintiff will likely argue that the accused "CHROME Locs" (Compl. p. 20) perform the same function (fixing the Osteotomy Guide to the Fixation Base) in substantially the same way to achieve the same result, making them structural equivalents.
- Evidence for a Narrower Interpretation (No Equivalence): Defendant may argue that the specific mechanical action of its "CHROME Locs" is substantially different from the simple "clip" shown conceptually in the patent. The dispute will focus on the specific structures and how they operate, raising the question of whether any differences are substantial.
VI. Other Allegations
Indirect Infringement
The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Defendants provide the accused templates to dentists and oral surgeons and provide "instructions and encouragement to reassemble the surgical guide templates in an infringing manner" (Compl. ¶¶ 40-41). Contributory infringement is based on allegations that the templates are a material part of the invention, not a staple article of commerce, and are especially adapted for infringing use (Compl. ¶45).
Willful Infringement
The complaint alleges willful infringement based on Defendants’ continued infringement after receiving alleged actual notice on November 19, 2020. It further alleges that Defendants have been "willfully blind" by maintaining a "policy or practice of not reviewing the patents of others" (Compl. ¶¶ 36-37).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of structural correspondence: Do the components of the accused multi-part CHROME system—the Fixation Base, Osteotomy Guide, and drill inserts—actually map onto the specific combination of elements recited in Claim 11, particularly the claim's requirement for a guideway composed of a distinct "inner piece" and "outer piece"?
- A key legal and factual question will be one of means-plus-function equivalence: Is the accused products' "proprietary CHROME Locs" mechanism for connecting components structurally equivalent to the "clip" disclosed in the '368 patent's specification, as required for infringement of the "means for securing" limitation?
- The case may also turn on a question of definitional scope: Can the "Fixation Base," which the complaint describes as a foundation for all subsequent components, be construed as the "receiving section" for a single "removable portion" as that term is used in the context of the patent?