Materialise NV v. Osteoplastics LLC

1. Case Identification

• Case #: IPR2021-00352
• Patent #: 9,275,191
• Filed: December 29, 2020
• Petitioner(s): Materialise NV.
• Patent Owner(s): Osteoplastics, LLC
• Challenged Claims: 1-13

2. Patent Overview

• Title: Methods and Systems for Producing an Implant
• Brief Description: The ’191 patent describes a computer-implemented method for fabricating a patient-specific 3D implant. The method involves obtaining a computer-readable image of a patient's tissue that includes both a defective portion and a non-defective portion, superimposing a 3D template onto the image, and deforming the template using anatomical landmarks to determine the final implant shape.

3. Grounds for Unpatentability

Ground 1: Obviousness over Rekow and Vannier - Claims 1-13 are obvious over Rekow in view of Vannier.

• Prior Art Relied Upon: Rekow (Patent 5,027,281) and Vannier (a November 1997 publication titled “Three-Dimensional Dental Imaging by Spiral CT”).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Rekow disclosed all the core steps of the claimed method in the context of creating dental prosthetics. Rekow taught a CAD/CAM system that acquires 3D data of a defective tooth, retrieves a standardized "generic form" (template) from a database, superimposes the template on the scanned data, uses landmarks for alignment, and deforms (scales) the template to fit the patient’s anatomy before fabrication. The primary difference was that Rekow used optical scanning for data acquisition. Vannier taught the known benefits of using spiral computed tomography (CT) to acquire superior, higher-detail 3D volumetric data of dental structures compared to other methods. For dependent claims, Rekow taught using templates from other individuals (claim 2), representing image data as slices or scan lines (claims 3-4), and determining optimal adjacency (claim 6). Vannier taught voxel-based data (claim 5).
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the teachings to improve Rekow’s system. Petitioner asserted a POSITA would have replaced Rekow’s older optical scanning technology with Vannier’s superior spiral CT imaging to achieve the known benefits of improved data quality, higher detail, and better diagnostic value for creating a 3D model.
  • Expectation of Success: A POSITA would have had a high expectation of success, as this combination represented a simple substitution of one known 3D data acquisition technology for another for its intended and well-understood purpose.

Ground 2: Obviousness over Eufinger, Dean93, and Dean98 - Claims 1-13 are obvious over Eufinger in view of Dean93 and Dean98.

• Prior Art Relied Upon: Eufinger (Patent 5,798,924), Dean93 (a June 1993 publication titled "Spline-Based Approach for Averaging Three-Dimensional Curves and Surfaces"), and Dean98 (a July 1998 publication titled "Average African American Three-Dimensional Computed Tomography Skull Images").
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that Eufinger taught a computer-implemented method for creating custom endoprostheses by superimposing a 3D "should-be" reference model onto a patient's actual 3D model (generated from CT data). Eufinger disclosed deforming the reference model to fit the patient's "special anatomical features" (landmarks) to determine the implant shape. The patent inventor, David Dean, co-authored Dean93 and was the lead author of Dean98. These references disclosed creating and using deformable, landmark-based "average" 3D templates generated from multiple specimens. Dean98 explicitly taught that these average templates were "especially useful...[to] constrain the design of a prosthetic implant."
  • Motivation to Combine: A POSITA would have been motivated to incorporate the advanced average template generation method of Dean93 and Dean98 into Eufinger's implant design system. Using a robust "average" template, as taught by Dean, would improve the "exactness of the geometric adaptation" taught by Eufinger, particularly in cases of significant trauma where a patient's own anatomy is an incomplete reference. The patent's own provisional application acknowledged the apparent utility of using average surface images for prosthetic design, citing both Dean and Eufinger.
  • Expectation of Success: A POSITA would have expected success because all three references operate in the same technical field and address the same problem of deforming a normative model to fit patient-specific anatomy to design an implant.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under §325(d) because the primary prior art was either not considered or not substantively applied by the examiner. The Rekow and Vannier references (Ground 1) were never before the examiner. The Eufinger, Dean93, and Dean98 references (Ground 2) were submitted in a voluminous Information Disclosure Statement (IDS) but were never discussed or applied. Petitioner asserted the examiner materially erred, especially since the highly relevant Dean references were authored by the inventor and discussed in the provisional applications but omitted from the final application.
• Petitioner also argued against discretionary denial under §314(a) and the Fintiv factors. It asserted that the scheduled trial date in a parallel litigation was four months beyond the statutory deadline for a Final Written Decision (FWD), the litigation was in its early stages, and Petitioner was not a party to that litigation. Petitioner contended these factors, combined with the strength of the petition, weighed heavily against discretionary denial.

5. Relief Requested

• Petitioner requests institution of inter partes review and cancellation of claims 1-13 of the ’191 patent as unpatentable.