DCT
4:23-cv-01458
3D Scan Guide LLC v. National Dentex Labs LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: 3D Scan Guide LLC (Delaware)
- Defendant: National Dentex Labs LLC (Delaware)
- Plaintiff’s Counsel: Garteiser Honea, PLLC
- Case Identification: 4:23-cv-01458, S.D. Tex., 04/19/2023
- Venue Allegations: Plaintiff alleges venue is proper because Defendant maintains a regular and established business presence in the Southern District of Texas, citing a specific business address in Houston.
- Core Dispute: Plaintiff alleges that Defendant’s guided dental surgery kits infringe a patent related to modular surgical templates that provide guidance for drilling location, trajectory, and depth.
- Technical Context: The technology at issue involves custom-fabricated surgical guides, often created using 3D printing and digital modeling, used in dental implant procedures to enhance precision.
- Key Procedural History: The patent-in-suit is a reissue of a prior patent, which itself was a continuation of an earlier patent in the same family. Plaintiff alleges it provided Defendant with written notice of infringement on November 19, 2020, more than two years before filing the complaint.
Case Timeline
| Date | Event |
|---|---|
| 2005-05-20 | Priority Date for U.S. Patent No. RE47,368 |
| 2007-05-01 | Issue Date for U.S. Patent No. 7,210,881 (related patent) |
| 2015-06-09 | Issue Date for U.S. Patent No. 9,050,665 (patent reissued as RE47368) |
| 2019-04-30 | Issue Date for U.S. Patent No. RE47,368 |
| 2020-11-19 | Alleged written actual notice of infringement sent to Defendant |
| 2023-04-19 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Reissue Patent No. RE47,368 E - "Modular Template for Drilling Holes and Method of Making Same"
The Invention Explained
- Problem Addressed: The patent’s background section identifies the risk of catastrophic consequences from improperly drilled holes in medical procedures, particularly dental implant surgery. It notes that prior art methods suffered from imprecision and lacked effective means for controlling the depth of penetration of a drill bit into a patient's jawbone (’368 Patent, col. 1:33-2:38).
- The Patented Solution: The invention is a modular surgical template designed to guide a drilling instrument with precision. The template includes a main body with a custom-molded surface that conforms to the patient's unique anatomy (e.g., jaw or teeth), ensuring it is seated correctly. This body contains a removable portion which holds a guideway for the drill. The system also incorporates a physical stop to limit how deep the drill can penetrate, thereby controlling location, trajectory, and depth (’368 Patent, Abstract; col. 4:53-61).
- Technical Importance: The claimed combination of a custom-fit body, a modular/removable guideway, and an integrated depth stop represented an approach to improve the safety and accuracy of surgical drilling procedures (’368 Patent, col. 2:33-38).
Key Claims at a Glance
- The complaint asserts independent claim 11 (Compl. ¶25).
- The essential elements of Claim 11 are:
- A body with a custom surface shaped as a negative impression of the uncut irregular surface and 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, where the outer piece is configured to engage an inner surface of the removable portion.
- Means for securing the removable portion to the body.
- The inner piece is configured as a stop for limiting the depth of penetration of the instrument.
III. The Accused Instrumentality
Product Identification
- NDX nSequence and nSequence Guided Prosthetics Kit (Compl. ¶21).
Functionality and Market Context
- The accused products are described as a "proprietary, 3D facially-driven, digital workflow with patient-specific surgical guides" for dental implant surgery (Compl., p. 8). The system is alleged to be "stackable," consisting of a "Bone Foundation Guide (BFG)" that acts as a base jig, onto which a separate "Surgical Guide" is seated and secured (Compl., p. 10, 12). This "Surgical Guide" contains cylinders into which "Keys" can be placed to guide a drill (Compl., p. 13). The complaint presents an image from Defendant's materials describing how the BFG "will function as a seating jig for all the other surgical and prosthetic guides" (Compl., p. 10).
- The complaint alleges the products generate "substantial financial revenues" and are marketed as "revolutionizing the way all-on-x and immediate implant reconstruction cases are ... performed" (Compl. ¶24; p. 8).
IV. Analysis of Infringement Allegations
RE47,368 Infringement Allegations
| 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 "Bone Foundation Guide (BFG)" allegedly has a custom surface that conforms to the patient's bone and acts as a "seating jig" or receiving section for other components. | ¶27 | col. 4:36-39 |
| a removable portion configured to be arranged in the receiving section | The "Surgical Guide" is alleged to be a removable portion that is seated onto the BFG. | ¶28 | col. 6:28-29 |
| a removable guideway arranged at the removable portion...wherein the removable guideway comprises an inner piece and an outer piece... | The "Surgical Guide" contains "Master Cylinders" (alleged outer piece) and insertable "Keys" (alleged inner piece) that together form a removable guideway. A screenshot depicts a "Key" being inserted into a "Master Cylinder" of the surgical guide (Compl., p. 14). | ¶¶29-30 | col. 6:31-39 |
| means for securing said removable portion to said body | "Plastic pins" are used to secure the "Surgical Guide" to the "BFG." An image from a procedural guide shows the insertion of plastic pins to secure the guide (Compl., p. 15). | ¶31 | col. 6:29-31 |
| the inner piece configured as a stop for limiting a depth of penetration of said instrument into said hole | The combination of the drill and the "Key Series" inserted into the "Master Cylinders" is alleged to limit the depth of the drill. A video screenshot shows a drill creating an osteotomy through this assembly, which allegedly functions as a depth stop (Compl., p. 16). | ¶32 | col. 6:36-38 |
Identified Points of Contention
- Scope Questions: A central dispute may concern whether the accused product's "Master Cylinders" and separate insertable "Keys" meet the claim's requirement for a "removable guideway" that "comprises an inner piece and an outer piece." The defense may argue its two-part system of a cylinder integrated into the guide and a separate insertable key is technically distinct from the nested "inner piece" and "outer piece" structure described in the patent.
- Technical Questions: What evidence demonstrates that the accused "Key" (alleged inner piece) functions as a "stop" in the manner claimed? The complaint relies on marketing videos, which may not provide sufficient technical detail to prove that the component is "configured as a stop" rather than simply as a drill guide. Further, the claim requires the "outer piece" to have an "outer surface configured to engage an inner surface of the removable portion," and it is unclear from the complaint how the accused "Master Cylinder" (alleged outer piece) meets this specific structural limitation.
V. Key Claim Terms for Construction
The Term: "removable guideway... comprises an inner piece and an outer piece"
- Context and Importance: Practitioners may focus on this term because the plaintiff's infringement theory depends on mapping the accused product's "Master Cylinders" and "Keys" to the claimed "outer" and "inner" pieces, respectively. The definition will determine whether the accused product's architecture falls within the claim's scope.
- Intrinsic Evidence for a Broader Interpretation: The specification describes the components generally as "a guiding assembly 136 [that] includes an inner piece 138, and an outer piece 140" (’368 Patent, col. 6:31-33), which a plaintiff might argue encompasses any nested two-part guide system.
- Intrinsic Evidence for a Narrower Interpretation: The primary embodiment shown in Figure 3 depicts the inner piece (138) and outer piece (140) as two distinct, threaded components that screw into each other and into the template body. A defendant could argue this specific, mechanically-interlocking arrangement limits the scope of the terms, potentially excluding the accused product's potentially simpler "key-in-cylinder" design.
The Term: "means for securing said removable portion to said body"
- Context and Importance: This term is in means-plus-function format under 35 U.S.C. § 112(f). Its construction is critical because infringement will require showing the accused structure (plastic pins) is the same as or structurally equivalent to the corresponding structure disclosed in the patent's specification.
- Intrinsic Evidence for Interpretation: The specified function is "securing said removable portion to said body." The specification discloses the corresponding structure as "any suitable fastener, such as by at least one clip 134" (’368 Patent, col. 6:29-31). The analysis will turn on whether the accused "plastic pins" are equivalent to the disclosed "clip."
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating Defendant provides instructional materials and videos that direct and encourage oral surgeons to assemble and use the accused kits in a manner that allegedly infringes the ’368 Patent (Compl. ¶¶38-39). It also pleads contributory infringement, alleging the surgical guide templates are a material part of the invention, not a staple commodity, and are especially adapted for infringing use (Compl. ¶43).
- Willful Infringement: Willfulness is alleged based on both post-suit knowledge (from the date of service of the complaint) and pre-suit knowledge, citing "written actual notice as of November 19, 2020" (Compl. ¶34). The complaint further alleges Defendant maintains a policy of willful blindness by instructing employees not to review the patents of others (Compl. ¶35).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the claim terms "inner piece" and "outer piece," which the patent illustrates as a nested, threaded assembly, be construed broadly enough to read on the accused product's system of a "Master Cylinder" integrated into a guide and a separate, insertable "Key"?
- A second central question will be one of structural equivalence: for the "means for securing" limitation, are the accused product's "plastic pins" structurally equivalent to the "clip" disclosed in the patent's specification for performing the function of securing the removable portion to the body?
- A key evidentiary question will be whether the plaintiff can prove, with technical evidence beyond the marketing materials cited in the complaint, that the accused components perform the precise functions required by the claims—particularly whether the "Key" is "configured as a stop" and how the "Master Cylinder" meets the specific engagement requirements of the "outer piece."