8:21-cv-01346
ConforMIS Inc v. Bodycad USA Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Conformis, Inc. (Delaware)
- Defendant: Bodycad Laboratories, Inc. (Canada); Bodycad USA Corp. (Delaware); and Exactech, Inc. (Florida)
- Plaintiff’s Counsel: Haynes and Boone, LLP; Stearns Weaver Miller Weissler Alhadeff & Sitterson, P.A.
- Case Identification: 8:21-cv-01346, M.D. Fla., 09/10/2021
- Venue Allegations: Venue is based on Defendants regularly conducting business, maintaining established places of business, and committing alleged acts of patent infringement within the Middle District of Florida. Defendant Exactech, Inc. is incorporated in Florida.
- Core Dispute: Plaintiff alleges that Defendants’ patient-specific knee implant and osteotomy systems infringe six patents related to customized orthopedic implants, design methods, and surgical tools.
- Technical Context: The technology concerns a shift in orthopedic surgery from standardized, "off-the-shelf" joint implants to patient-specific devices designed and manufactured using individual patient imaging data.
- Key Procedural History: The complaint alleges a history of competition and that Defendants had knowledge of the asserted patents prior to the lawsuit. Specifically, it notes that Defendants’ FDA 510(k) submissions for the accused products listed Plaintiff’s products as predicate devices, and that one of Defendants’ own patents cites the asserted patents.
Case Timeline
| Date | Event |
|---|---|
| 2002-10-07 | U.S. Patent No. 7,799,077 Priority Date |
| 2002-11-07 | U.S. Patent No. 8,077,950 Priority Date |
| 2002-12-04 | U.S. Patent No. 8,638,998 Priority Date |
| 2003-10-02 | U.S. Patent No. 8,974,539 Priority Date |
| 2008-03-05 | U.S. Patent No. 9,180,015 Priority Date |
| 2009-02-25 | U.S. Patent No. 9,387,079 Priority Date |
| 2010-09-21 | U.S. Patent No. 7799077 Issued |
| 2011-12-13 | U.S. Patent No. 8077950 Issued |
| 2014-01-28 | U.S. Patent No. 8638998 Issued |
| 2015-03-10 | U.S. Patent No. 8974539 Issued |
| 2015-11-10 | U.S. Patent No. 9180015 Issued |
| 2016-07-12 | U.S. Patent No. 9387079 Issued |
| 2019-12-05 | FDA 510(k) Clearance for "BC Reflex Uni Knee System" |
| 2020-03-25 | FDA 510(k) Clearance for "FINE Osteotomy around the knee" |
| 2020-11-24 | Exactech and Bodycad Announce Exclusive Distribution Agreement |
| 2021-09-10 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,974,539 - “Patient-Adapted and Improved Articular Implants, Designs and Related Guide Tools”
The Invention Explained
- Problem Addressed: The patent addresses the limitations of conventional joint implants, which are typically available only in standard sizes, forcing surgeons to make compromises that may not perfectly fit a patient’s unique anatomy (Compl. ¶¶20-22).
- The Patented Solution: The invention is a femoral implant for knee repair that is patient-specific. It solves the fit problem by creating an implant where the articulating surface has a curvature that is "derived from patient-specific image data," such as an MRI or CT scan, to match the individual patient's knee joint (’539 Patent, Abstract; col. 19:42-45). This allows for a customized anatomical fit rather than a generic one.
- Technical Importance: This patient-specific approach was designed to provide a "precise anatomic fit" and better preserve healthy tissue, aiming to improve function and create a more natural feel compared to traditional, off-the-shelf implants (Compl. ¶23).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶41).
- Claim 1 requires:
- A femoral implant for repairing a knee joint of a patient.
- The implant comprises a condylar portion with an articulating surface and a bone-facing surface.
- The articulating surface has a sagittal curvature that is "derived from patient-specific image data" of the patient's knee joint.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 9,387,079 - “Patient-Adapted and Improved Articular Implants, Designs and Related Guide Tools”
The Invention Explained
- Problem Addressed: Like the ’539 Patent, this invention targets the problem of improperly fitting standard-sized implants and the resulting compromises a surgeon must make, which can lead to poor patient outcomes (Compl. ¶¶20-22).
- The Patented Solution: This invention refines the patient-specific concept by claiming a femoral implant whose articular surface has a curvature that "substantially replicat[es]" the patient's own condyle curvature. The solution further requires this replicated curvature to be located "approximately in the same location" as the original curvature, aiming for a more precise anatomical restoration than simply being derived from patient data (’079 Patent, Abstract; col. 20:30-36).
- Technical Importance: By substantially replicating the patient's natural joint surface, the technology seeks to restore more natural joint kinematics, preserving more of the patient's joint and minimizing surgical trauma (Compl. ¶24).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶59).
- Claim 1 requires:
- A patient-specific femoral implant for a portion of a femur.
- The implant has a condylar portion with a bone-facing surface and an opposite articular surface.
- The articular surface has a patient-specific curvature that "substantially replicat[es] a corresponding curvature of at least a portion of the patient's condyle."
- This replicated curvature is located "approximately in the same location" as the patient's original curvature when the implant is seated.
- The complaint does not explicitly reserve the right to assert dependent claims.
Multi-Patent Capsules
Patent Identification: U.S. Patent No. 7,799,077, “Minimally Invasive Joint Implant With 3-Dimensional Geometry Matching the Articular Surfaces,” issued September 21, 2010 (Compl. ¶14).
Technology Synopsis: The patent describes a multi-component articular implant where at least a portion of its surface has a three-dimensional shape that "substantially conforms with or duplicates the shape" of a patient's existing, substantially uncut cartilage or bone surface (’077 Patent, col. 45:60-65). The components are designed to engage with each other in a slideable and rotatable manner, aiming for a minimally invasive repair that preserves the patient's anatomy.
Asserted Claims: Independent claim 65 (Compl. ¶77).
Accused Features: The Reflex Uni Accused System (Compl. ¶77).
Patent Identification: U.S. Patent No. 8,077,950, “Methods for Determining Meniscal Size and Shape and For Devising Treatment,” issued December 13, 2011 (Compl. ¶15).
Technology Synopsis: This patent claims a method for designing an implant. The method involves obtaining image data for a joint, fusing at least two imaging planes from that data, segmenting the image data of an articular surface, and converting the segmented data into a surface for the implant (’950 Patent, col. 19:65-col. 20:3).
Asserted Claims: Independent claim 9 (Compl. ¶95).
Accused Features: The processes used to design and make the Reflex Uni Accused System and the Fine Osteotomy Accused System (Compl. ¶95).
Patent Identification: U.S. Patent No. 8,638,998, “Fusion of Multiple Imaging Planes for Isotropic Imaging in MRI and Quantitative Image Analysis Using Isotropic or Near-Isotropic Imaging,” issued January 28, 2014 (Compl. ¶16).
Technology Synopsis: This patent claims a method of making a joint replacement device. The process includes obtaining data from a first and second image volume, transforming the data from both volumes into a common coordinate system, and using the referenced data to design or select the device (’998 Patent, col. 15:1-12).
Asserted Claims: Independent claim 1 (Compl. ¶113).
Accused Features: The processes used to design and make the Reflex Uni Accused System (Compl. ¶113).
Patent Identification: U.S. Patent No. 9,180,015, “Implants for Altering Wear Patterns of Articular Surfaces,” issued November 10, 2015 (Compl. ¶17).
Technology Synopsis: The patent describes an implant specifically for correcting an articular surface "wear pattern." The implant body has a topography that is derived from the wear pattern and is configured to alter that wear pattern to a "revised wear pattern," suggesting a biomechanical correction rather than just a surface replacement (’015 Patent, col. 62:1-8).
Asserted Claims: Independent claim 1 (Compl. ¶131).
Accused Features: The Fine Osteotomy Accused System (Compl. ¶131).
III. The Accused Instrumentality
Product Identification
The complaint names two product lines: the "Reflex Uni Accused System" (also marketed as "BC Reflex Uni" or "Truliant Reflex Uni") for unicondylar knee replacement, and the "Fine Osteotomy Accused System" for knee osteotomy procedures (Compl. ¶¶27-28).
Functionality and Market Context
Both systems are described as patient-specific surgical solutions that use proprietary software and 3D printing to create personalized implants and surgical guides (Compl. ¶¶27-28, 34-35). Defendants market the Reflex Uni system with the phrase "Our implants are tailored especially for you" (Compl. p. 12, Ex. N at 1). This marketing visual shows a customized knee implant fitted between the femur and tibia (Compl. p. 12). The Fine Osteotomy system is marketed as using "3D printed patient-specific surgical guide adapted to you" and a plate "perfectly adapted to your situation" (Compl. ¶35, p. 13). The complaint alleges these systems are direct competitors to Plaintiff's products in the patient-specific implant market (Compl. ¶30).
IV. Analysis of Infringement Allegations
U.S. Patent No. 8,974,539 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A femoral implant for repairing a knee joint of a patient, comprising: a condylar portion having an articulating surface and a bone-facing surface, | The Reflex Uni Accused System includes a femoral component with an articulating surface that fits onto the patient's femur. | ¶¶34, 43 | col. 6:49-51 |
| wherein the articulating surface has a sagittal curvature derived from patient-specific image data of the knee joint of the patient. | The system allegedly uses patient-specific information and 3D printing to create implants "tailored especially for you," which the complaint alleges meets the "derived from" requirement. | ¶¶34, 43 | col. 19:42-45 |
Identified Points of Contention:
- Scope Questions: The central dispute may concern the meaning of "derived from patient-specific image data." The question for the court will be what level of connection is required between the raw patient image data and the final implant curvature. Does using patient data to merely select or scale a pre-existing design meet this limitation, or does it require the curvature to be newly generated based on the data?
- Technical Questions: What evidence does the complaint provide, beyond marketing statements, that the accused process actually uses patient-specific image data to define the implant's sagittal curvature? The complaint alleges the use of proprietary software but does not detail its specific function or inputs (Compl. ¶27).
U.S. Patent No. 9,387,079 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a condylar portion having a bone-facing surface for abutting at least a portion of a condyle of the patient's knee and an articular surface generally opposite the bone-facing surface; | The Reflex Uni Accused System includes a femoral component that abuts the patient's condyle. | ¶¶34, 61 | col. 6:49-51 |
| the articular surface having a patient-specific curvature... substantially replicating a corresponding curvature of at least a portion of the patient's condyle... | Defendants' marketing states the system enables a "personalized restoration based on your precise anatomical specifications," which the complaint alleges constitutes substantial replication of the patient's anatomy. | ¶¶35, 61 | col. 20:30-36 |
| and being located approximately in the same location as the corresponding curvature of the patient's condyle when the bone-facing surface abuts the condyle. | The complaint alleges that by creating a personalized implant designed to "obtain fit and proper placement," the accused system necessarily places the replicated curvature in the same anatomical location. | ¶¶27, 61 | col. 20:30-36 |
Identified Points of Contention:
- Scope Questions: This analysis will likely focus on the term "substantially replicating." This suggests a higher standard than the "derived from" language of the ’539 Patent. A key legal question will be how much deviation from the patient's natural anatomy is permissible while still constituting "substantial replication."
- Technical Questions: Does the accused system's software create a true anatomical copy of the patient's condylar surface, or does it generate an idealized or "best-fit" surface that approximates the patient's anatomy but does not "replicate" it? The complaint's evidence is based on marketing claims of "personalized restoration" rather than a technical description of the design algorithm (Compl. ¶35).
V. Key Claim Terms for Construction
The Term: "derived from patient-specific image data" (’539 Patent, Claim 1)
- Context and Importance: This term is central to the infringement analysis for the ’539 Patent. The outcome of the case may depend on whether Defendants' process of creating "tailored" implants falls within the scope of this phrase. Practitioners may focus on this term because it establishes the required link between the patient's unique anatomy and the resulting implant.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes creating "anatomic or patient-specific implants and jigs...using the MRI or CT data," which could be read broadly to encompass any use of the data to inform the final design, including selecting a best-fit from a library (’539 Patent, col. 19:42-45).
- Evidence for a Narrower Interpretation: The abstract describes a "method for designing a patient-adapted implant" where patient data is used to "create a model of the patient's joint" and "design the implant component," suggesting a more direct creation process rather than simple selection or scaling (’539 Patent, Abstract).
The Term: "substantially replicating a corresponding curvature" (’079 Patent, Claim 1)
- Context and Importance: This term is the core of the asserted claim in the ’079 Patent and sets a potentially higher bar for infringement than the ’539 Patent. The dispute will likely center on the degree of fidelity required between the implant's surface and the patient's original anatomy.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "substantially" inherently allows for some degree of variation. The specification's discussion of achieving a "near anatomic fit" could support an interpretation that does not require a perfect mirror image of the patient's condyle (’079 Patent, col. 20:30-32).
- Evidence for a Narrower Interpretation: The patent's abstract describes designing the implant so that its "articular surface substantially replicat[es]" the patient's condyle, with the goal of being placed in the same location. This emphasis on replication and location could support a narrower construction requiring a very close anatomical match to restore natural joint function.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement based on Defendants actively encouraging and instructing customers and distributors to use the accused systems through "product information and specification sheets, online instruction materials on their website, and online invitations to become a distributor" (Compl. ¶¶48, 66). Contributory infringement is alleged on the basis that the accused systems are "specially made using joint information derived from image data of an individual patient's joint" and thus are not "staple articles of commerce" and lack substantial non-infringing uses (Compl. ¶¶53, 71).
- Willful Infringement: The complaint alleges that Defendants have been aware of the asserted patents since at least 2017. The bases for this allegation of pre-suit knowledge include Defendants' citation to Conformis's research in advertisements, listing Conformis products as predicate devices in FDA submissions, a former Conformis executive now working for Exactech, and one of Bodycad's own patents citing the asserted patents (Compl. ¶¶30-32). The complaint asserts that Defendants have been willfully blind to their infringement (Compl. ¶48).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: does the term "derived from," in the context of the ’539 Patent, require direct generation of an implant's surface from patient data, or can it be construed more broadly to cover selecting and scaling a pre-existing design based on that data? This question is sharpened by the more specific "substantially replicating" language in the ’079 Patent, which will require the court to determine the degree of anatomical fidelity needed to infringe.
- A key evidentiary question will be one of technical proof: the complaint relies on marketing claims of "personalized" and "tailored" implants to support its infringement allegations. The case will likely turn on whether discovery uncovers technical evidence showing that Defendants' proprietary software and manufacturing processes actually perform the specific steps recited in the claims, or if the "personalization" is a marketing characterization of a process that falls outside the patents' technical scope.