DCT

1:18-cv-02565

Osteoplastics LLC v. 3D Systems Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-02565, D. Colo., 10/08/2018
  • Venue Allegations: Venue is alleged in the District of Colorado based on Defendants having regular and established places of business within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Virtual Surgical Planning (VSP) services and computer-aided design methods for creating custom medical implants infringe six patents related to producing three-dimensional models of implants.
  • Technical Context: The technology relates to computer-aided design of patient-specific medical implants using medical imaging data, a field critical to advancing personalized reconstructive and orthopedic surgery.
  • Key Procedural History: The complaint details pre-suit communications, including a letter from Plaintiff to Defendants dated December 22, 2017, which allegedly provided notice of infringement and included claim charts for three of the asserted patents. This correspondence is cited as a basis for willful infringement.

Case Timeline

Date Event
1999-08-11 Earliest Priority Date for Asserted Patents
2014-07-15 U.S. Patent No. 8,781,557 Issues
2016-03-22 U.S. Patent No. 9,292,920 Issues
2016-05-03 U.S. Patent No. 9,330,206 Issues
2017-01-01 Approx. date Defendants received actual notice of ’557, ’920, and ’206 patents
2017-04-18 U.S. Patent No. 9,626,756 Issues
2017-06-06 U.S. Patent No. 9,672,617 Issues
2017-06-06 U.S. Patent No. 9,672,302 Issues
2017-12-22 Plaintiff sends letter with claim charts to Defendants
2018-01-31 Defendants' counsel responds to Plaintiff's letter
2018-06-12 Plaintiff's counsel emails Defendants' counsel requesting a response
2018-10-08 Complaint Filed

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

U.S. Patent No. 8,781,557 - "Producing a Three Dimensional Model of an Implant"

Issued July 15, 2014

The Invention Explained

  • Problem Addressed: The patent’s background describes prior art methods for fabricating prosthetic implants as often producing imprecise fits, which can lead to surgical complications, patient pain, and potential rejection of the implant (’557 Patent, col. 4:36-52). Manual, slice-by-slice segmentation of medical images to create 3D models is identified as a time-consuming and error-prone process (’557 Patent, col. 2:6-21).
  • The Patented Solution: The invention proposes a method for determining the shape of a medical implant by using a "template" that represents a "normative shape" of the anatomical tissue, such as an average or ideal form (’557 Patent, Abstract). This template is computationally superimposed onto a 3D image of a patient's anatomy (e.g., a skull with a defect) to span the defective portion. The shape of the implant is then determined based on the portion of the template that covers the defect, creating a custom-fit "drop in" replacement (’557 Patent, col. 10:45-67).
  • Technical Importance: This computer-aided methodology was designed to improve the accuracy and efficiency of creating patient-specific implants, aiming to reduce surgical time and improve clinical outcomes compared to mass-produced or manually designed prosthetics (’557 Patent, col. 4:10-21).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶28, Ex. 9).
  • Claim 1 is a method claim with the essential elements:
    • obtaining computer readable image data of a target tissue having a defect;
    • rendering a 3-dimensional representation of the target tissue from the image data;
    • superimposing a template representing a normative anatomical shape onto the 3D representation; and
    • deforming the template to the 3D representation to create a deformed template used to determine the implant shape.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,292,920 - "Methods and Systems for Producing an Implant"

Issued March 22, 2016

The Invention Explained

  • Problem Addressed: The patent addresses the same general problem as the ’557 Patent: the need for accurate and efficient methods to design custom medical implants from patient imaging data (’920 Patent, col. 4:50-56).
  • The Patented Solution: The invention claims a system, comprising a processor and memory, configured to design an implant by first identifying a "plurality of anatomical landmarks" on a computer-readable image of the patient (’920 Patent, col. 31:4-10). A three-dimensional template is then "warped" to the patient's image based on these identified landmarks. The final implant shape is determined from this landmark-guided warped template, aiming to ensure an anatomically correct fit (’920 Patent, Abstract; col. 31:11-16).
  • Technical Importance: The use of specific anatomical landmarks as control points for the template-warping process provides a structured, repeatable basis for fitting a normative model to an individual patient's unique anatomy, potentially increasing the accuracy of the final implant design.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶28, Ex. 10). The complaint contains a typographical error, listing this patent as U.S. Patent No. 9,929,920.
  • Claim 1 is a system claim with the essential elements:
    • A system with a processor and memory configured to:
    • receive a computer-readable image of a patient's anatomy with a defect;
    • identify a plurality of anatomical landmarks on the image;
    • obtain a three-dimensional template;
    • warp the template to the image based on the identified anatomical landmarks; and
    • determine a three-dimensional implant shape based on the warped template.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,330,206 - "Producing a Three Dimensional Model of an Implant"

  • Issued: May 3, 2016
  • Technology Synopsis: This patent, a continuation of the patent that issued as the ’557 Patent, discloses a method for creating a custom implant. The method involves deforming a 3D template, which represents a normative anatomical shape, to match a 3D representation of a patient's tissue to determine the shape of the implant needed to repair a defect (’206 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶28, Ex. 11).
  • Accused Features: The complaint alleges that Defendants' VSP services, which involve the computer-aided design of custom implants, practice the claimed method (Compl. ¶¶8, 26-27).

U.S. Patent No. 9,626,756 - "Methods and Systems for Producing an Implant"

  • Issued: April 18, 2017
  • Technology Synopsis: This patent, related to the '920 Patent, claims methods for producing an implant by superimposing a shape onto a 3D image of a patient's tissue to span a defect. The final implant shape is determined based on the shape that spans the defective portion, with the method specifying the use of a computer processor (’756 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶28, Ex. 12).
  • Accused Features: The complaint alleges that Defendants' methods for computer-aided design of custom implants practice the claimed invention (Compl. ¶¶8, 26-27).

U.S. Patent No. 9,672,617 - "Methods and Systems for Producing an Implant"

  • Issued: June 6, 2017
  • Technology Synopsis: This patent, also related to the '920 Patent, claims methods for producing an implant by deforming a 3D template based on anatomical landmarks identified on a patient's image data. The process involves using a processor to perform the steps of identifying landmarks, warping the template, and determining the final implant shape (’617 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶28, Ex. 13).
  • Accused Features: The complaint alleges that Defendants' VSP services practice the claimed methods for designing custom medical devices (Compl. ¶¶8, 26-27).

U.S. Patent No. 9,672,302 - "Methods and Systems for Producing an Implant"

  • Issued: June 6, 2017
  • Technology Synopsis: This patent claims methods for designing an implant that involve obtaining an image of a patient's tissue, generating a 3D representation, superimposing a "normative shape" (template) onto that representation to span a defect, and determining the implant's shape based on the superimposed normative shape (’302 Patent, Abstract).
  • Asserted Claims: The complaint asserts independent claim 1 (Compl. ¶28, Ex. 14).
  • Accused Features: The complaint accuses Defendants' methods of performing computer-aided design of custom medical devices of practicing the claimed invention (Compl. ¶¶8, 26-27).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants’ "Virtual Surgical Planning ('VSP') services" and the associated "Accused Systems" and "Accused Methods" used to perform computer-aided design of custom medical devices (Compl. ¶¶8, 27).

Functionality and Market Context

  • The complaint alleges that Defendants provide services in the United States that involve the computer-aided design of custom implants (Compl. ¶¶8, 26). These services are alleged to include the use of specific commercial software products, namely "Materialise's Mimics Innovation Suite of Software (including Mimics and 3-Matic software), and/or 3D Systems Geomagic Freeform Software or systems" (Compl. ¶27). The core accused functionality is the process of using patient-specific imaging data to computationally design a custom-fitting medical implant. No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that are not provided; therefore, the infringement allegations are summarized in prose based on the complaint's narrative.

  • '557 Patent Infringement Allegations
    • The complaint alleges that Defendants' VSP services directly infringe the method of claim 1 (Compl. ¶¶26-28). The narrative theory suggests that in designing custom implants, Defendants necessarily perform the claimed steps of: (a) obtaining patient medical image data, (b) rendering a 3D representation from that data, (c) computationally "superimposing" a "template" or normative shape to cover an anatomical defect, and (d) "deforming" that template to determine the final implant shape (Compl. ¶28, Ex. 9).
  • '920 Patent Infringement Allegations
    • The complaint alleges that Defendants' "Accused Systems," which include the software suites used in their VSP services, constitute an infringing system under claim 1 (Compl. ¶¶27-28). The infringement theory is that these systems are configured with a processor and memory to perform the claimed functions: receiving patient image data, identifying anatomical landmarks, warping a 3D template based on those landmarks, and determining an implant shape from the result (Compl. ¶28, Ex. 10).
  • Identified Points of Contention:
    • Scope Questions: A central question for the method claims (e.g., in the ’557 Patent) may be whether the Defendants' computer-aided design process, which could involve digital sculpting or other CAD tools, meets the specific claim limitations of "superimposing" and "deforming" a "template." For the system claims (e.g., in the ’920 Patent), a dispute may arise over whether the accused software is specifically configured to operate "based on the plurality of anatomical landmarks" as recited, or if it uses alternative surface-fitting or boundary-matching algorithms.
    • Technical Questions: A key factual question will be what the accused software systems actually do. What evidence does the complaint provide that the accused process for designing an implant performs the specific function of warping a template based on identified anatomical landmarks, as required by claim 1 of the ’920 Patent? The case may turn on whether the accused software's functionality matches the particular sequence of steps and component interactions described in the asserted claims.

V. Key Claim Terms for Construction

  • The Term: "template" (asserted in claim 1 of the ’557 and ’920 patents)

    • Context and Importance: The definition of "template" is critical, as infringement hinges on whether the digital models, reference shapes, or design tools used in Defendants' VSP services qualify as a "template" under the patents' claims. Practitioners may focus on this term because its scope will determine whether a wide range of CAD techniques fall within the claims.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines the template broadly as "representing a normative shape of an external anatomical surface of the tissue of interest" (’557 Patent, Abstract). This could support a construction that includes any reference geometry, such as a mirrored image of the patient's own contralateral anatomy or a model selected from a digital library (’557 Patent, col. 6:1-6).
      • Evidence for a Narrower Interpretation: The specification also provides examples where the template is derived from "appropriate normative average surfaces" created by averaging data from multiple subjects (’557 Patent, col. 10:58-63). This language could support a narrower construction requiring the template to be a pre-compiled, population-averaged anatomical model, potentially excluding models derived solely from the patient's own anatomy.

  • The Term: "warp" / "deforming" (asserted in claim 1 of the ’557 and ’920 patents)

    • Context and Importance: This term describes the core action performed on the "template." The infringement analysis will depend on whether the specific computational processes used by the accused software (e.g., digital sculpting, surface fitting, mesh manipulation) constitute "warping" or "deforming."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent uses the terms generally to describe the process of fitting the template to the patient's anatomy, stating the template is "superimposed... via warping" (’557 Patent, col. 10:48-52). This may support a broad definition covering any computational process that alters a reference shape to fit a target shape.
      • Evidence for a Narrower Interpretation: The specification discloses specific algorithms for this process, such as using a "thin plate spline" to warp a wireframe template to landmarks (’557 Patent, col. 4:41-43). This could be used to argue that "warping" is limited to specific mathematical deformation algorithms and does not cover manual digital sculpting or other distinct CAD functionalities.

VI. Other Allegations

  • Indirect Infringement: The complaint does not contain separate counts for indirect infringement and focuses its allegations on Defendants' direct performance of the accused methods and use of the accused systems (Compl. ¶¶26-27).
  • Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. It pleads that on December 22, 2017, Defendants received a letter that "identified the ’557, ’920, and ’206 patents" and "included infringement claim charts" (Compl. ¶16). The complaint further alleges that Defendants continued their infringing activities and made "no attempt to change the Accused Systems and Methods" after receiving this notice (Compl. ¶¶29-30).

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

  • A core issue will be one of definitional scope: can the term "template," as used in the patents, be construed to cover the digital tools and reference models used in Defendants' commercial VSP software, or is it limited to the specific pre-compiled, population-averaged models described in the specification?
  • A key evidentiary question will be one of operational equivalence: does the accused software's workflow for designing an implant perform the specific, landmark-driven "warping" process required by claims like claim 1 of the '920 patent, or is there a fundamental mismatch in the technical operation of the accused systems?