DCT

1:20-cv-00405

Osteoplastics LLC v. ConforMIS Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00405, D. Del., 03/20/2020
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant is a Delaware corporation and has allegedly committed acts of patent infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s software platform for the computer-aided design of custom medical devices infringes seven patents related to methods for producing three-dimensional models of implants.
  • Technical Context: The technology concerns computer-aided design and manufacturing (CAD/CAM) for creating patient-specific medical implants, a field significant for advancing customized orthopedic and craniofacial surgery.
  • Key Procedural History: The complaint notes that the asserted patents originated from research conducted at Case Western Reserve University in the 1990s and that the inventors formed a company that practiced the patented inventions. No prior litigation, licensing, or post-grant proceedings are mentioned in the complaint.

Case Timeline

Date Event
1999-08-11 Earliest Priority Date for all Asserted Patents
2014-07-15 U.S. Patent No. 8,781,557 Issues
2016-03-01 U.S. Patent No. 9,275,191 Issues
2016-03-22 U.S. Patent No. 9,929,920 Issues
2016-05-03 U.S. Patent No. 9,330,206 Issues
2017-04-18 U.S. Patent No. 9,626,756 Issues
2017-06-06 U.S. Patent No. 9,672,302 Issues
2017-06-06 U.S. Patent No. 9,672,617 Issues
2020-03-20 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

  • Patent Identification: U.S. Patent No. 8781557, "Producing a Three Dimensional Model of an Implant," issued July 15, 2014 (the "’557 Patent").
  • The Invention Explained:
    • Problem Addressed: The patent's background section describes prior art methods for 3D surface segmentation from medical images as often being time-consuming, imprecise, and heavily dependent on operator skill, particularly in areas with poor image contrast or artifacts from existing hardware (Compl. Ex. 1, ’557 Patent, col. 1:41-2:20). This imprecision can lead to poorly fitting prosthetic implants (Compl. Ex. 1, ’557 Patent, col. 4:39-51).
    • The Patented Solution: The invention is a method for designing a custom medical implant by first obtaining a computer image of a patient's anatomy that includes a defective area. A "template," which represents a "normative" or ideal anatomical shape, is then computationally superimposed over the image to span the defect. The final shape of the implant is determined as a function of the geometry of both the patient's defective portion and the superimposed template, allowing for a custom-fit "drop in" replacement (Compl. Ex. 1, ’557 Patent, Abstract; col. 4:58-6:6).
    • Technical Importance: The method aims to improve the precision and efficiency of creating patient-specific implants, potentially reducing complications during and after surgery (Compl. Ex. 1, ’557 Patent, col. 3:11-21).
  • Key Claims at a Glance:
    • The complaint asserts at least Claim 1 (Compl. ¶19).
    • Independent Claim 1 of the ’557 Patent includes the following essential elements:
      • A method for determining a shape of a medical device to be implanted into a subject.
      • Obtaining a computer readable image including a defective portion and a non-defective portion of a tissue of interest.
      • Superimposing on the image a template representing a normative shape of an external anatomical surface of the tissue to span the defective portion.
      • Determining a 3-dimensional shape of the implant based on the respective shapes of the defective portion as seen in the template and the non-defective portion of the tissue of interest.
    • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,275,191 - Methods and Systems for Producing an Implant

  • Patent Identification: U.S. Patent No. 9275191, "Methods and Systems for Producing an Implant," issued March 1, 2016 (the "’191 Patent").
  • The Invention Explained:
    • Problem Addressed: The patent addresses the same technical problems as the ’557 Patent: the imprecision and labor-intensive nature of conventional slice-based segmentation methods for designing custom implants from medical scans (Compl. Ex. 7, ’191 Patent, col. 1:43-2:36).
    • The Patented Solution: The invention is a computer-implemented method for determining an implant's shape. The method involves obtaining an image of tissue with both defective and non-defective portions, superimposing a shape onto the image to cover the defective area, and then determining the final three-dimensional implant shape based on the shape that spans the defect (Compl. Ex. 7, ’191 Patent, Abstract; col. 28:49-62). The specification describes this superimposed shape as a "template" that can be based on a normative or average shape (Compl. Ex. 7, ’191 Patent, col. 4:50-57).
    • Technical Importance: This approach facilitates the creation of precisely fitting "drop in" implants, aiming to minimize complications and improve patient outcomes (Compl. Ex. 7, ’191 Patent, col. 3:11-20).
  • Key Claims at a Glance:
    • The complaint asserts at least Claim 1 (Compl. ¶19).
    • Independent Claim 1 of the ’191 Patent includes the following essential elements:
      • A computer implemented method of obtaining data for determining a 3-dimensional implant shape to be implanted in a subject.
      • Obtaining a computer readable image including a defective portion and a non-defective portion of tissue in the subject.
      • Superimposing on the image a shape to span the defective portion.
      • Determining the 3-dimensional shape of the implant based on the shape that spans the defective portion.
    • The complaint does not explicitly reserve the right to assert dependent claims.

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

  • Patent Identification: U.S. Patent No. 9330206, "Producing a Three-Dimensional Model of an Implant," issued May 3, 2016 (Compl. ¶8).
  • Technology Synopsis: The technology relates to methods for fabricating implants to replace bony structures. It addresses the imprecision of prior art techniques by providing a system for producing a "drop in" replacement implant that fits precisely within the contours of a missing segment of bone (Compl. Ex. 3, ’206 Patent, col. 1:19-27).
  • Asserted Claims: At least Claim 1 (Compl. ¶19).
  • Accused Features: The accused features are Defendant's systems and methods for designing and manufacturing medical devices, including its iFit software platform (Compl. ¶18).

Multi-Patent Capsule: U.S. Patent No. 9,929,920 - Methods and Systems for Producing an Implant

  • Patent Identification: U.S. Patent No. 9929920, "Methods and Systems for Producing an Implant," issued March 22, 2016 (Compl. ¶7).
  • Technology Synopsis: The complaint does not provide a copy of this patent. Based on its title and shared patent family, it appears to relate to the same technology for designing custom implants described for the ’557 and ’191 Patents.
  • Asserted Claims: At least Claim 1 (Compl. ¶19).
  • Accused Features: The accused features are Defendant's systems and methods for designing and manufacturing medical devices, including its iFit software platform (Compl. ¶18).

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

  • Patent Identification: U.S. Patent No. 9626756, "Methods and Systems for Producing an Implant," issued April 18, 2017 (Compl. ¶9).
  • Technology Synopsis: The complaint does not provide a copy of this patent. Based on its title and shared patent family, it appears to relate to the same technology for designing custom implants described for the ’557 and ’191 Patents.
  • Asserted Claims: At least Claim 1 (Compl. ¶19).
  • Accused Features: The accused features are Defendant's systems and methods for designing and manufacturing medical devices, including its iFit software platform (Compl. ¶18).

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

  • Patent Identification: U.S. Patent No. 9672617, "Methods and Systems for Producing an Implant," issued June 6, 2017 (Compl. ¶10).
  • Technology Synopsis: The complaint does not provide a copy of this patent. Based on its title and shared patent family, it appears to relate to the same technology for designing custom implants described for the ’557 and ’191 Patents.
  • Asserted Claims: At least Claim 1 (Compl. ¶19).
  • Accused Features: The accused features are Defendant's systems and methods for designing and manufacturing medical devices, including its iFit software platform (Compl. ¶18).

Multi-Patent Capsule: U.S. Patent No. 9,672,302 - Producing a Three-Dimensional Model of an Implant

  • Patent Identification: U.S. Patent No. 9672302, "Producing a Three-Dimensional Model of an Implant," issued June 6, 2017 (Compl. ¶11).
  • Technology Synopsis: The complaint does not provide a copy of this patent. Based on its title and shared patent family, it appears to relate to the same technology for designing custom implants described for the ’557 and ’191 Patents.
  • Asserted Claims: At least Claim 1 (Compl. ¶19).
  • Accused Features: The accused features are Defendant's systems and methods for designing and manufacturing medical devices, including its iFit software platform (Compl. ¶18).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Defendant’s "Accused Systems" and "Accused Methods," which include ConforMIS's proprietary software such as the "iFit software platform" (Compl. ¶18).
  • Functionality and Market Context: The complaint alleges that Defendant provides "virtual surgical planning ('VSP')" services and performs the "computer-aided design of custom medical devices, such as implants" using the accused software (Compl. ¶5). The complaint asserts that the use of these systems constitutes the infringing methods (Compl. ¶18). The complaint does not provide technical details, exhibits, or screenshots illustrating the specific operation of the iFit software.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim charts in an "Exhibit 8" to describe how the accused systems and methods allegedly practice Claim 1 of each Asserted Patent (Compl. ¶19). This exhibit was not included with the complaint document provided for analysis. In its absence, the infringement theory is summarized below based on the narrative allegations.

The core of Plaintiff’s infringement allegation is that Defendant's use of its proprietary software, such as the iFit platform, to perform computer-aided design of custom medical implants constitutes performance of the methods claimed in the Asserted Patents (Compl. ¶¶5, 18-19). This suggests that the software's workflow for designing an implant from patient-specific data is alleged to meet the steps of obtaining image data, using a template or similar construct to model the implant shape over a defective area, and determining the final 3D implant model based on that process.

  • Identified Points of Contention:
    • Scope Questions: A central dispute may arise over the scope of claim terms such as "template" and "normative shape." The question for the court will be whether the specific algorithms, data models, or geometric constructs used by the iFit software fall within the patent's definition of these terms. For example, does the software's method of generating a surface constitute "superimposing" a "template," or does it use a fundamentally different technical approach, such as surface extrapolation?
    • Technical Questions: The complaint does not describe the specific technical operations of the accused software. A key factual question will be what evidence the complaint provides that the accused iFit platform actually performs each step of the claimed methods. The analysis will require a detailed comparison between the patented method steps and the actual functioning of the accused software.

V. Key Claim Terms for Construction

  • The Term: "template representing a normative shape" (’557 Patent, Claim 1)
  • Context and Importance: This term is the central concept of the patented solution. The outcome of the infringement analysis may depend heavily on whether the computational model used by Defendant's software is found to be a "template representing a normative shape." Practitioners may focus on this term because its construction will determine whether a wide range of computational modeling techniques, or only a specific subset, are covered by the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification suggests "normative shape" can be determined from "a substantially mirror image of the target tissue" for bilateral structures or from "appropriate normative average surfaces" derived from population data (Compl. Ex. 1, ’557 Patent, col. 9:55-63). This may support a construction that includes both simple geometric mirroring and more complex statistical models.
    • Evidence for a Narrower Interpretation: The detailed description places significant emphasis on creating average surfaces from multiple specimens using complex "homology-based 3D surface averaging" techniques (Compl. Ex. 1, ’557 Patent, col. 4:46-57). A party might argue that "normative shape" should be limited to these disclosed statistical or population-based averages, rather than encompassing simpler mirroring techniques.
  • The Term: "superimposing on the image a shape" (’191 Patent, Claim 1)
  • Context and Importance: This term defines the core action performed with the template or shape. The infringement question may turn on whether the Defendant's software performs an action that can be characterized as "superimposing."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the process as superimposing a template "via warping," which could be construed broadly to cover various methods of digital alignment, registration, or fitting of one dataset to another (Compl. Ex. 7, ’191 Patent, col. 9:48-52).
    • Evidence for a Narrower Interpretation: The specification discloses specific and complex algorithms for achieving this, such as a "Simulated Annealing-based Surface Extraction (SASE) process" and fitting based on "ridge curves" (Compl. Ex. 7, ’191 Patent, col. 20:56-61). This could support an argument that "superimposing" requires more than a simple digital overlay and should be construed in light of these specific, advanced fitting techniques.

VI. Other Allegations

The complaint does not provide sufficient detail for analysis of indirect or willful infringement. The complaint alleges direct infringement under 35 U.S.C. § 271(a) and/or (g) but does not plead specific facts to support knowledge or intent required for claims of induced, contributory, or willful infringement (Compl. ¶19). While the prayer for relief requests enhanced damages and attorneys' fees, the body of the complaint does not establish a factual basis for willfulness or exceptionality (Prayer ¶¶3, 5).

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

  • A core issue will be one of definitional scope: How will the court construe the term "template representing a normative shape"? The case may turn on whether this term is broad enough to read on the specific computational methods used by the accused iFit software, or if it is limited to the specific statistical averaging and mirroring techniques disclosed in the patent specifications.
  • A key evidentiary question will be one of technical operation: Does the accused iFit platform's process for designing a custom implant perform the specific steps recited in the asserted claims? The complaint's high-level allegations will need to be substantiated with evidence demonstrating a direct correspondence between the software's functionality and each limitation of the asserted claims.