DCT

1:22-cv-01625

Mighty Oak Medical Inc v. Medacta Intl SA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01625, D. Del., 12/22/2022
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Medacta USA is a Delaware corporation, and both defendants are alleged to have committed acts of infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s MySpine line of patient-specific surgical guides infringes six patents related to patient-matched surgical guides and apparatus for use in spinal surgery.
  • Technical Context: The technology involves creating custom surgical guides based on a patient's specific anatomical data, typically from CT or MRI scans, to improve the accuracy and safety of placing instruments and implants during spinal procedures.
  • Key Procedural History: The complaint alleges an extensive pre-suit history, including Defendant's awareness of the Plaintiff's technology since at least 2012, meetings between the parties in 2014-2015 to discuss the technology and potential collaboration, and Plaintiff providing Defendant with notice of infringement, a draft complaint, and claim charts in 2017. The complaint also notes that Defendant unsuccessfully challenged the validity of the lead asserted patent, U.S. Patent No. 8,758,357, in an Ex Parte Reexamination proceeding at the USPTO, which concluded in 2019 with all claims confirmed as patentable.

Case Timeline

Date Event
2010-06-29 Earliest Priority Date for all Asserted Patents
2012-12-31 Medacta allegedly cites Plaintiff's patent publication in its own European patent application
2014-05-01 Medacta's MySpine Standard device receives FDA clearance (approximate date)
2014-06-24 U.S. Patent No. 8,758,357 Issues
2014-10-28 U.S. Patent No. 8,870,889 Issues
2014-11-01 Medacta's MySpine Standard device first used in U.S. surgeries (approximate date)
2015-02-23 Medacta sends letter to Plaintiff declining collaboration and identifying alleged prior art
2015-12-01 U.S. Patent No. 9,198,678 Issues
2017-05-09 U.S. Patent No. 9,642,633 Issues
2017-10-19 Plaintiff sends letter to Defendant alleging infringement of then-issued patents
2018-06-05 U.S. Patent No. 9,987,024 Issues
2018-12-22 Medacta files request for Ex Parte Reexamination of the '357 Patent
2019-08-26 USPTO issues Ex Parte Reexamination Certificate confirming patentability of all claims of the '357 Patent
2022-12-22 Complaint Filed

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

U.S. Patent No. 8,758,357 - “Patient Matching Surgical Guide and Method for Using the Same”

  • Patent Identification: U.S. Patent No. 8,758,357, “Patient Matching Surgical Guide and Method for Using the Same,” issued June 24, 2014. (Compl. ¶14).

The Invention Explained

  • Problem Addressed: The patent's background describes the challenges surgeons face in accurately placing instruments, such as pedicle screws, during spinal surgery due to each patient's unique or irregular anatomy. It notes that existing image-guided systems can be time-consuming and impractical for many procedures. (’357 Patent, col. 1:20-53).
  • The Patented Solution: The invention is a system for creating a customized surgical guide based on a patient's anatomical data derived from an MRI or CT scan. The guide is designed with "complementary surfaces" that precisely match the patient's unique anatomy, thereby ensuring correct placement and orientation for surgical instruments. (’357 Patent, Abstract; col. 2:56-65). A key embodiment shown is a guide that rests on the posterior elements of a vertebra to guide pedicle screws. (’357 Patent, Fig. 5).
  • Technical Importance: This patient-matching approach sought to improve surgical accuracy and safety by providing a physical, custom-fit template, which could reduce reliance on complex intra-operative imaging and mitigate the risk of instrument misplacement. (’357 Patent, col. 3:45-58).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶35).
  • The essential elements of claim 1 include:
    • A patient specific pedicle screw guide that anatomically mates with the spinous processes of a vertebral body.
    • A medial body with a longitudinal cavity on its lower surface, providing a first patient-contacting surface that mates with a first spinous process.
    • A first elongated wing extending from the medial body, terminating in a first cylindrical column, which has a second patient-contacting surface that mates with a second spinous process.
    • A second elongated wing extending from the other side of the medial body, terminating in a second cylindrical column, which has a third patient-contacting surface that mates with a third spinous process.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent, though this is standard litigation practice.

U.S. Patent No. 8,870,889 - “Patient Matching Surgical Guide and Method for Using the Same”

  • Patent Identification: U.S. Patent No. 8,870,889, “Patient Matching Surgical Guide and Method for Using the Same,” issued October 28, 2014. (Compl. ¶15).

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as its parent '357 Patent: the difficulty of accurately placing surgical instruments during spinal procedures due to variations in patient anatomy. (’889 Patent, col. 1:30-51).
  • The Patented Solution: The invention is a customized surgical guide created from patient-specific imaging data. The guide features surfaces that are "determined from and complementary to the patient's anatomy," allowing it to be matched and oriented on a specific vertebra to guide instruments along pre-planned trajectories. (’889 Patent, Abstract; col. 2:25-41).
  • Technical Importance: The technology provides a physical tool to translate a pre-operative surgical plan into practice with high fidelity, aiming to enhance the safety and efficacy of procedures like spinal fusion. (’889 Patent, col. 4:10-23).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶53).
  • The essential elements of claim 1 include:
    • A patient-specific pedicle screw guide that mates with the anatomical features of a particular vertebra.
    • A medial body configured to be positioned adjacent a vertebra.
    • A first elongated wing extending from the medial body, terminating in a first column with a lower surface that anatomically mates with a first contour of the vertebra.
    • A second elongated wing extending from the opposite side of the medial body, terminating in a second column with a lower surface that anatomically mates with a second contour of the vertebra.
    • The first and second lower surfaces are determined from and complementary to the patient's anatomy.

U.S. Patent No. 9,198,678 - “Patient-Matched Apparatus and Methods for Performing Surgical Procedures”

  • Patent Identification: 9,198,678, “Patient-Matched Apparatus and Methods for Performing Surgical Procedures,” issued December 1, 2015. (Compl. ¶16).
  • Technology Synopsis: This patent is directed to an orthopedic device for use in minimally invasive surgical procedures. The invention comprises first and second patient-specific elements configured to anatomically conform to subcutaneous anatomic features of a patient, which are coupled by an arcuate bridge, allowing for precise placement and use in a minimally invasive setting.
  • Asserted Claims: Independent claim 11. (Compl. ¶71).
  • Accused Features: The accused MySpine products are alleged to be orthopedic devices used in minimally invasive surgery that have first and second patient-specific elements conforming to subcutaneous anatomy, coupled by an arcuate bridge. (Compl. ¶72).

U.S. Patent No. 9,642,633 - “Patient-Matched Apparatus and Methods for Performing Surgical Procedures”

  • Patent Identification: 9,642,633, “Patient-Matched Apparatus and Methods for Performing Surgical Procedures,” issued May 9, 2017. (Compl. ¶17).
  • Technology Synopsis: This patent describes a patient-specific surgical guide with a body containing a bore or track oriented in a predetermined trajectory (e.g., for a pedicle screw). The guide features at least two legs extending from the body, with each leg comprising patient-specific contours configured to contact and substantially conform to subcutaneous anatomic features of a vertebra.
  • Asserted Claims: Independent claim 10. (Compl. ¶89).
  • Accused Features: The accused MySpine products are alleged to be patient-specific guides with a body having a bore adapted to guide an instrument, and at least two legs with patient-specific contours that conform to a patient's vertebral anatomy. (Compl. ¶90).

U.S. Patent No. 9,987,024 - “Patient-Matched Apparatus and Methods for Performing Surgical Procedures”

  • Patent Identification: 9,987,024, “Patient-Matched Apparatus and Methods for Performing Surgical Procedures,” issued June 5, 2018. (Compl. ¶18).
  • Technology Synopsis: This patent discloses a surgical device formed from a patient's anatomical data. The device includes a body with a first contact surface matched to a specific patient feature for placement within a first incision, and a first internal cannula with a bore aligned to guide an instrument along a predetermined trajectory through a second incision.
  • Asserted Claims: Independent claim 12. (Compl. ¶107).
  • Accused Features: The accused MySpine products are alleged to be surgical devices formed using patient anatomical data, comprising a body with a patient-matched contact surface and an internal cannula with a bore aligned to guide an instrument along a specific trajectory. (Compl. ¶108).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant's MySpine Standard, MySpine Low Profile, MySpine MC, and MySpine S2AI devices, and other similar products (collectively, the "MySpine products"). (Compl. ¶¶34, 52).

Functionality and Market Context

  • The MySpine products are described as patient-specific surgical guides used for spinal surgery. (Compl. ¶20). They are created using a patient's anatomical data to produce a guide that matches features of a patient's vertebra, thereby constraining the trajectory of surgical instruments. (Compl. ¶¶20, 36). The complaint provides an image showing the MySpine Standard and Low Profile guides positioned on a model of a spine, illustrating their intended use. (Compl. p. 7). The complaint alleges the MySpine product line has been commercially successful, receiving a Spine Technology Award in 2014, with the first product being used in U.S. surgeries by November 2014. (Compl. ¶¶20-21).

IV. Analysis of Infringement Allegations

’357 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a medial body comprising a longitudinal cavity located on a first lower surface of the medial body, such that the longitudinal cavity provides a first patient-contacting surface that mates with at least one contour of a first spinous process The accused products allegedly have a medial body with a longitudinal cavity on a lower surface that acts as a patient-contacting surface mating with a first spinous process. ¶36 col. 10:18-21
a first elongated wing extending laterally from a first side of the medial body and terminating with a first cylindrical column, wherein the first cylindrical column comprises a second lower surface comprising a second patient-contacting surface that mates with at least one contour of a second spinous process The accused products allegedly have a first elongated wing that ends in a cylindrical column, with the column's lower surface acting as a patient-contacting surface mating with a second spinous process. ¶36 col. 10:29-39
a second elongated wing extending laterally from a second side of the medial body and terminating with a second cylindrical column, wherein the second cylindrical column comprises a third lower surface comprising a third patient-contacting surface that mates with at least one contour of a third spinous process The accused products allegedly have a second elongated wing that ends in a cylindrical column, with the column's lower surface acting as a patient-contacting surface mating with a third spinous process. ¶36 col. 10:29-39
  • Identified Points of Contention:
    • Scope Questions: Claim 1 requires three separate patient-contacting surfaces that mate with a "first spinous process," a "second spinous process," and a "third spinous process." A central question for claim construction and infringement may be whether "spinous process" can be interpreted to include other posterior bony features of a vertebra, such as the inferior articular processes, which the patent specification itself references in describing the corresponding figure. (’357 Patent, col. 10:35-39). The anatomical precision of this term will be a key issue.

’889 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a medial body configured to be positioned adjacent a vertebra The accused products allegedly have a medial body designed to be placed adjacent to a patient's vertebra. ¶54 col. 10:52-53
a first elongated wing extending from a first side of the medial body and terminating with a first column, wherein the first column comprises a first lower surfaces that anatomically mates with at least one first contour of the particular vertebra The accused products allegedly have a first wing ending in a column with a lower surface that anatomically mates with a first contour of the vertebra. ¶54 col. 10:53-57
a second elongated wing extending from a second side of the medial body opposite the first side and terminating with a second column, wherein the second column comprises a second lower surface that anatomically mates with at least one second contour of the particular vertebra The accused products allegedly have a second wing ending in a column with a lower surface that anatomically mates with a second contour of the vertebra. ¶54 col. 10:58-62
wherein the first and second lower surfaces are determined from and complementary to the patient's anatomy The lower surfaces of the accused products are allegedly determined from and are complementary to the patient's anatomy. ¶54 col. 10:63-65
  • Identified Points of Contention:
    • Technical Questions: The claim requires surfaces that "anatomically mate" with vertebral contours and are "complementary to the patient's anatomy." The dispute may focus on the required degree of precision for this mating. The complaint asserts the accused products meet this limitation, but the factual evidence will need to establish whether the fit is a specific, contour-for-contour match as implied by the patent, or a more generalized fit that may not meet the claim's requirements.

V. Key Claim Terms for Construction

  • The Term: "spinous process" (’357 Patent, Claim 1)
  • Context and Importance: Claim 1 of the ’357 Patent requires three distinct patient-contacting surfaces that mate with a "first spinous process," a "second spinous process," and a "third spinous process." Practitioners may focus on this term because a vertebra only has one spinous process. The definition of this term will be critical to determine whether the claim requires contact with three separate vertebrae or if "spinous process" can be interpreted more broadly to cover other posterior bony landmarks of a single vertebra.
    • Intrinsic Evidence for a Broader Interpretation: The patent specification, in describing the embodiment of Claim 1 depicted in Figure 5, states that the cylindrical columns are located proximate to and mate with the "inferior articular process 44, 45," not a spinous process. (’357 Patent, col. 10:33-39). This suggests the patentee may have used the term "spinous process" in the claim to refer more generally to posterior bony landmarks suitable for seating the guide.
    • Intrinsic Evidence for a Narrower Interpretation: "Spinous process" is a specific and well-understood anatomical term. A defendant may argue that the claim language is unambiguous and must be given its plain and ordinary meaning, which would require the guide to contact three separate spinous processes, likely from three different vertebrae.
  • The Term: "anatomically mates" (’889 Patent, Claim 1)
  • Context and Importance: This term defines the necessary fit between the surgical guide and the patient's vertebra. The infringement analysis will likely depend on the degree of precision this term requires. Practitioners may focus on this term because the defendant could argue that its products use a standardized or less-precise fit that does not rise to the level of "mating" with the unique anatomical contours of a specific patient as taught by the patent.
    • Intrinsic Evidence for a Broader Interpretation: The patent uses various terms to describe the fit, including "complementary" and "substantially congruent," which may suggest that a perfect, molded fit is not required. (’889 Patent, col. 10:64; col. 11:47). This could support an interpretation where a close, but not exact, correspondence satisfies the "mates" limitation.
    • Intrinsic Evidence for a Narrower Interpretation: The patent's core concept is the creation of a "Patient Matched" apparatus from high-resolution imaging data to solve problems of surgical imprecision. The abstract describes "complementary surfaces based on a plurality of data points," and the detailed description refers to surfaces that are "completely congruent with the corresponding anatomical features." (’889 Patent, Abstract; col. 11:45-46). This language may support a narrower construction requiring a high-fidelity, contour-for-contour match.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant induces infringement by third parties, such as doctors and medical institutions. This is based on allegations that Defendant provides "product manuals, brochures, videos, demonstrations, and website materials" that encourage and instruct customers to use the MySpine products in a manner that directly infringes the asserted patents. (Compl. ¶¶37, 40, 55, 58).
  • Willful Infringement: The complaint alleges willful infringement based on extensive pre-suit knowledge. The allegations state that Defendant was aware of the Plaintiff’s technology and patent filings as early as 2012; engaged in detailed discussions with Plaintiff about the patents and technology in 2014; conducted its own analysis of the ’357 and ’889 patents in 2015; and received explicit notice of infringement with claim charts in 2017. (Compl. ¶¶19, 21, 22, 26, 45, 63). The complaint further supports this allegation by citing Defendant’s unsuccessful ex parte reexamination request on the ’357 patent. (Compl. ¶47).

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

  • A core issue will be one of definitional scope: can the term "spinous process," used three times in Claim 1 of the '357 Patent, be construed to cover other posterior vertebral features like the inferior articular processes, as the patent’s own specification may imply, or is it limited to its precise anatomical meaning, potentially rendering the claim difficult to infringe?
  • A key evidentiary question will be one of functional precision: does the fit of the accused MySpine guides on a patient's vertebra achieve the specific, multi-point "anatomical mating" with "complementary" surfaces as required by the claims, or do they employ a more generalized fit that falls outside the claimed scope of a highly customized, data-driven device?
  • A central question for damages will be one of intent: given the extensive and detailed pre-suit history alleged—including direct communications, Defendant’s own analysis of the patents, and a failed reexamination attempt—can Plaintiff prove that Defendant's alleged infringement was willful, potentially justifying an award of enhanced damages?