DCT

4:26-cv-04064

Carlsmed Inc v. Degen Medical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:26-cv-04064, D.S.C., 09/15/2026
  • Venue Allegations: Venue is alleged to be proper in the District of South Carolina because Defendant DeGen Medical, Inc. has an established place of business in the district and has allegedly committed acts of patent infringement there.
  • Core Dispute: Plaintiff alleges that Defendant’s personalized and custom-designed spinal implants, and the methods for designing them, infringe eight patents related to patient-specific medical devices and surgical planning systems.
  • Technical Context: The technology at issue relates to the field of spinal surgery, specifically using patient data and computer modeling to design and manufacture patient-specific implants intended to provide superior anatomical correction compared to standard "stock" implants.
  • Key Procedural History: Plaintiff Carlsmed notes that its aprevo® platform received FDA Breakthrough Device Designation in July 2020 and FDA 510(k) clearance in December 2020. The complaint alleges that Defendant was advised of seven of the eight patents-in-suit prior to the filing of the lawsuit.

Case Timeline

Date Event
2018-04-16 Priority Date for U.S. Patent No. 12,251,320
2019-03-13 Priority Date for U.S. Patent No. 12,491,085
2020-01-06 Priority Date for U.S. Patent No. 11,678,938
2020-07-01 Carlsmed’s aprevo® receives FDA Breakthrough Device Designation
2020-12-01 Carlsmed’s aprevo® receives FDA 510(k) clearance
2021-02-01 Carlsmed performs first surgery with aprevo®
2021-06-16 Priority Date for U.S. Patent No. 12,678,228
2022-11-29 Priority Date for U.S. Patent No. 12,622,785
2023-06-20 U.S. Patent No. 11,678,938 Issues
2023-06-22 Priority Date for U.S. Patent No. 12,708,517
2024-11-01 FDA 510(k) clearance for aprevo® cervical implants
2025-03-18 U.S. Patent No. 12,251,320 Issues
2025-07-01 First use of aprevo® cervical implants
2025-12-01 Global Spine Journal publishes aprevo® follow-up data
2025-12-09 U.S. Patent No. 12,491,085 Issues
2026-05-12 U.S. Patent No. 12,622,785 Issues
2026-05-26 U.S. Patent No. 12,636,163 Issues
2026-07-14 U.S. Patent No. 12,678,228 Issues
2026-08-18 U.S. Patent No. 12,708,517 Issues
2026-09-15 Complaint Filed
2026-09-15 Priority Date for U.S. Patent No. 12,734,040
2026-09-15 U.S. Patent No. 12,734,040 Issues

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

U.S. Patent No. 11,678,938 - "PATIENT-SPECIFIC MEDICAL SYSTEMS, DEVICES, AND METHODS"

  • Patent Identification: U.S. Patent No. 11,678,938, "PATIENT-SPECIFIC MEDICAL SYSTEMS, DEVICES, AND METHODS," issued June 20, 2023.

The Invention Explained

  • Problem Addressed: The patent's background describes that physicians determining treatment protocols often rely on a limited subset of available patient data, and conventional technologies lack the ability to leverage large data sets to optimize patient-specific treatments like surgical interventions or implant designs U.S. Patent No. 11,678,938, col. 1:36-51
  • The Patented Solution: The invention is a computer-implemented method that compares a specific patient's data to a large database of reference data from previously treated patients. Based on similarities in patient profiles and their treatment outcomes, the system generates a patient-specific surgical procedure and/or medical device design that is predicted to have a favorable outcome for the new patient U.S. Patent No. 11,678,938, abstract U.S. Patent No. 11,678,938, col. 3:1-10 This process is illustrated in a flowchart in the patent's Figure 3 U.S. Patent No. 11,678,938, FIG. 3
  • Technical Importance: This data-driven approach aims to personalize orthopedic surgery by creating optimized, patient-specific treatments, representing a shift from standardized, "stock" medical devices to individualized solutions U.S. Patent No. 11,678,938, col. 3:11-19

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 Compl. ¶18
  • The essential elements of independent claim 1 include:
    • Receiving one or more images of a patient's spinal region in a native anatomical configuration.
    • Creating a three-dimensional virtual model of the spinal region using computer-aided design software.
    • Measuring one or more native spine metric values from the virtual model.
    • Determining a corrected anatomical configuration for the patient's spinal region.
    • Generating a corrected three-dimensional virtual model of the corrected configuration.
    • Measuring at least one corrected spine metric value from the corrected model.
    • Generating a surgical plan to achieve the corrected configuration.
    • Transmitting the surgical plan for surgeon viewing.
    • After receiving surgeon approval, designing one or more patient-specific virtual intervertebral implants based on the corrected model.
  • The complaint reserves the right to assert other claims by stating infringement of "multiple claims" Compl. ¶18

U.S. Patent No. 12,251,320 - "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION"

  • Patent Identification: U.S. Patent No. 12,251,320, "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION," issued March 18, 2025.

The Invention Explained

  • Problem Addressed: The patent discloses that conventional posterior fixation systems, which use components like rods and screws, present challenges for surgeons. Specifically, bending rods to fit a patient's unique anatomy is difficult and can introduce unpredictable forces on the construct, potentially leading to screw pullout or implant fracture '320 Patent, col. 5:6-34
  • The Patented Solution: The invention provides a personalized fixation system that includes a plate with a shape that "does not conform to a single plane." A surgical planning software tool is used to determine the specific shape of the plate based on the patient's anatomy. The plate is then manufactured, for example via additive manufacturing, to this patient-specific, non-planar shape, which obviates the need for intraoperative rod bending '320 Patent, abstract '320 Patent, col. 8:36-64
  • Technical Importance: By pre-planning and manufacturing a patient-specific, non-planar plate, the invention seeks to improve the accuracy of spinal correction, reduce mechanical stress on the implant construct, and decrease surgical time and complexity '320 Patent, col. 5:35-44

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 13 Compl. ¶23
  • The essential elements of independent claim 13 include:
    • Generating a three-dimensional virtual model of a subject's spinal anatomy.
    • Receiving proposed changes from a user that alter the spatial relationship between at least two vertebrae.
    • Adjusting the virtual model based on the proposed changes.
    • Measuring the adjusted spinal anatomy in the virtual model to obtain one or more measurements (e.g., pelvic tilt, sagittal alignment, lumbar lordosis).
    • In response to receiving an indication of approval, designing one or more patient-specific implants to achieve the corrected spinal geometry.
  • The complaint reserves the right to assert other claims by stating infringement of "multiple claims" Compl. ¶23

U.S. Patent No. 12,491,085 - "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION"

  • Patent Identification: U.S. Patent No. 12,491,085, "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION," issued December 9, 2025.
  • Technology Synopsis: This patent describes an interbody implant system featuring a deployable "tooth" to provide fixation between the implant base and the patient's anatomy. The system includes a break-away bridge and a locking mechanism, aiming to improve implant stability and prevent migration or expulsion from the intervertebral space ’085 Patent, abstract ’085 Patent, col. 1:57-col. 2:4
  • Asserted Claims: The complaint asserts infringement of at least claims 1 and 11 Compl. ¶28
  • Accused Features: DeGen's alleged computer-implemented method of designing an implant is accused of infringement Compl. ¶28

U.S. Patent No. 12,622,785 - "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS"

  • Patent Identification: U.S. Patent No. 12,622,785, "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS," issued May 12, 2026.
  • Technology Synopsis: This patent discloses a computer-implemented method for manufacturing an orthopedic implant. The method involves segmenting anatomical features from an image, manipulating their spatial relationships to define a "negative space," and then filling that space with a virtual implant design which is subsequently used for manufacturing ’785 Patent, abstract ’785 Patent, col. 1:5-12
  • Asserted Claims: The complaint asserts infringement of at least claims 24 and 32 Compl. ¶33
  • Accused Features: DeGen's method for designing an orthopedic implant is accused of infringement Compl. ¶33

U.S. Patent No. 12,636,163 - "PATIENT-SPECIFIC SPINAL FUSION DEVICES AND ASSOCIATED SYSTEMS AND METHODS"

  • Patent Identification: U.S. Patent No. 12,636,163, "PATIENT-SPECIFIC SPINAL FUSION DEVICES AND ASSOCIATED SYSTEMS AND METHODS," issued May 26, 2026.
  • Technology Synopsis: The patent describes a patient-specific spinal implant that includes an intervertebral spacer with specific structural elements designed for a patient. It features retention mechanisms for securing fixation elements within the implant body, aiming to improve the anchoring of the implant to the vertebrae ’163 Patent, abstract
  • Asserted Claims: The complaint asserts infringement of at least claims 27 and 33 Compl. ¶38
  • Accused Features: DeGen is accused of infringing by making, using, offering for sale, and selling implants with the claimed structural features Compl. ¶38

U.S. Patent No. 12,678,228 - "PATIENT-SPECIFIC ANTERIOR PLATE IMPLANTS"

  • Patent Identification: U.S. Patent No. 12,678,228, "PATIENT-SPECIFIC ANTERIOR PLATE IMPLANTS," issued July 14, 2026.
  • Technology Synopsis: The patent relates to patient-specific orthopedic implant systems, including an anterior plate with a geometry contoured to mate with a specific anatomical structure. The plate includes projections with topographies designed to mate with corresponding surfaces of vertebral bodies, potentially spanning multiple vertebrae ’228 Patent, abstract
  • Asserted Claims: The complaint asserts infringement of at least claims 34 and 38 Compl. ¶43
  • Accused Features: DeGen is accused of infringing by making, using, offering for sale, and selling inserter instruments and implants with the claimed structural features Compl. ¶43

U.S. Patent No. 12,708,517 - "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS"

  • Patent Identification: U.S. Patent No. 12,708,517, "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS," issued August 18, 2026.
  • Technology Synopsis: This patent covers spinal implants and systems and methods for their design. It describes a method involving segmenting features from an anatomical image, manipulating their spatial relationships, and mapping the resulting negative space to design a virtual implant for subsequent manufacturing ’517 Patent, abstract
  • Asserted Claims: The complaint asserts infringement of at least claims 1, 10, and 19 Compl. ¶48
  • Accused Features: DeGen is accused of infringing by making, using, offering for sale, and selling implants with the claimed structural features Compl. ¶48

U.S. Patent No. 12,734,040 - "PATIENT-SPECIFIC SPINAL FUSION DEVICES AND ASSOCIATED SYSTEMS AND METHODS"

  • Patent Identification: U.S. Patent No. 12,734,040, "PATIENT-SPECIFIC SPINAL FUSION DEVICES AND ASSOCIATED SYSTEMS AND METHODS," issued September 15, 2026.
  • Technology Synopsis: This patent describes patient-specific spinal fusion devices, including an interbody implant with fixation elements and retention mechanisms. The invention focuses on the design and manufacturing methods for these patient-specific devices, which are intended to be positioned in the disc space between vertebrae ’040 Patent, abstract
  • Asserted Claims: The complaint asserts infringement of at least claims 15, 23, and 31 Compl. ¶53
  • Accused Features: DeGen is accused of infringing by making, using, offering for sale, and selling implants with the claimed structural features Compl. ¶53

III. The Accused Instrumentality

Product Identification

The accused products are DeGen Medical, Inc.'s custom-designed Solar PS implants and Impulse PS implants Compl. ¶13

Functionality and Market Context

The complaint alleges that DeGen "designs, manufactures, and supplies personalized and customized patient-specific spinal implants for use in spinal surgery" Compl. ¶13 These products are positioned as direct competitors to Carlsmed's aprevo® product and service platform Compl. ¶13 The core functionality is the creation of spinal implants tailored to an individual patient's anatomy, rather than using standard-sized stock implants.

IV. Analysis of Infringement Allegations

The complaint alleges that DeGen infringes the '938 and '320 patents by practicing computer-implemented methods for designing patient-specific medical devices Compl. ¶17 Compl. ¶23 The complaint references, but does not include, claim chart exhibits that allegedly detail how DeGen's activities practice every element of the asserted claims Compl. ¶18 Compl. ¶23 Without these exhibits, a detailed element-by-element analysis is not possible.

The narrative theory for the '938 Patent is that DeGen's process for creating its personalized implants infringes the claimed method of using patient images, creating virtual models, determining a corrected anatomy, and designing an implant based on that corrected model (Compl. ¶¶17-18).

The narrative theory for the '320 Patent is that DeGen's process for designing its custom spinal implants infringes the claimed method of generating a virtual model of a patient's spine, receiving user-proposed changes to the spinal relationship, and designing an implant to achieve the resulting corrected geometry Compl. ¶23

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

For the ’938 Patent

  • The Term: "corrected anatomical configuration"
  • Context and Importance: This term is the goal of the entire patented method; the patient-specific implant is designed to achieve this "corrected" state. The definition of what constitutes a "corrected" configuration—whether it is determined by objective mathematical rules, comparison to a database of historical outcomes, or a surgeon's subjective judgment—will be central to determining the scope of the claim and whether the accused method infringes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification suggests the system can use "large data sets to define improved or optimal surgical interventions" ('938 Patent, col. 3:11-14), which may support a construction where the "corrected" state is one that is computationally optimized based on aggregated data.
    • Evidence for a Narrower Interpretation: The specification also states the system can "apply mathematical rules for select parameters (e.g., lumbar lordosis, Cobb angles, etc.)" ('938 Patent, col. 4:42-45). This could support a narrower construction where the "corrected" configuration must be defined by specific, pre-determined geometric or clinical metrics.

For the ’320 Patent

  • The Term: "designing one or more patient-specific implants"
  • Context and Importance: This is the final, operative step of the claimed method. The dispute may center on what level of technical activity constitutes "designing." Practitioners may focus on whether this term requires the creation of entirely new implant geometries from scratch or if it can be met by selecting and modifying pre-existing templates based on the adjusted virtual model.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's abstract states the "shape of the plate is at least partially determined by the surgical planning software tool," and the plate is then manufactured using additive manufacturing '320 Patent, abstract This suggests the "designing" step results in a novel, manufacturable object, supporting a broader interpretation that includes generating new geometry.
    • Evidence for a Narrower Interpretation: The method claim requires "designing...for achieving the corrected spinal geometry" '320 Patent, cl. 13 An argument could be made that this ties the "designing" step to the functional outcome of correction, potentially allowing for a construction where modifying a standard template to meet the corrective goal falls within the claim's scope.

VI. Other Allegations

  • Indirect Infringement: The complaint does not contain specific factual allegations to support a claim of indirect infringement.
  • Willful Infringement: The complaint alleges willful infringement for each asserted patent. The basis for willfulness is the allegation that DeGen continued its infringing activities "despite being advised of the" patents-in-suit Compl. ¶20 Compl. ¶25 Compl. ¶30 Compl. ¶35 Compl. ¶40 Compl. ¶45 Compl. ¶50 Furthermore, the complaint alleges pre-filing notice was provided for all patents-in-suit except for the '040 Patent, suggesting a basis for willfulness founded on both pre- and post-suit knowledge Compl. ¶14

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

  1. A core issue will be one of "process equivalence": does DeGen's accused process for creating "personalized and customized" spinal implants read on the specific, multi-step computer-implemented methods recited in Carlsmed's patents, or does it employ a sufficiently distinct design methodology to avoid infringement?
  2. The case may also turn on a question of "claim scope": can the term "corrected anatomical configuration" ('938 Patent) be construed broadly to cover any computer-aided adjustment to a patient's anatomy, or is it limited to a more rigorous process involving optimization against historical patient data, as described in the patent's specification?
  3. A key evidentiary question will be the "impact of notice": the complaint alleges that DeGen was notified of seven of the eight asserted patents before the lawsuit was filed. The content and specificity of this alleged notice will be critical for the willfulness claim and the potential for enhanced damages.