OrthoPediatrics Corp v. WishBone Medical Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: OrthoPediatrics Corp. (Delaware) and Orthex, LLC (Florida)
  • Defendant: WishBone Medical, Inc. (Indiana) and Nick A. Deeter (Indiana)
  • Plaintiff’s Counsel: Dentons US LLP
• Case Identification: 3:20-cv-000929, N.D. Ind., 10/30/2020
• Venue Allegations: Venue is alleged to be proper in the Northern District of Indiana because Defendant WishBone maintains an office and employees in the district, and has allegedly committed acts of infringement there.
• Core Dispute: Plaintiffs allege that Defendant’s Smart Correction® External Fixation System infringes a patent related to a computer-implemented method for aligning orthopedic external fixators.
• Technical Context: The technology concerns software-guided orthopedic surgery, which uses medical imaging and computer algorithms to improve the accuracy and efficiency of correcting bone deformities with external fixation devices.
• Key Procedural History: The complaint alleges that Defendant WishBone had knowledge of the patent-in-suit since at least June 2019, prior to the filing of the lawsuit. It also references prior state court litigation between the parties and alleges that Defendant Nick Deeter is a former employee of Plaintiff OrthoPediatrics Corp.

Case Timeline

Date	Event
2013-06-03	Defendant Nick Deeter resigns from Plaintiff OrthoPediatrics Corp.
2013-09-27	U.S. Patent No. 10,258,377 Priority Date
2016-01-01	Defendant WishBone Medical, Inc. started (approximate date)
2019-04-16	U.S. Patent No. 10,258,377 Issued
2019-06-01	Alleged first date of Defendant's knowledge of the '377 Patent
2020-10-13	FDA Clearance announced for Accused System
2020-10-30	Complaint Filed

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

U.S. Patent No. 10,258,377 - Point and click alignment method for orthopedic surgeons, and surgical and clinical accessories and devices

• Issued: April 16, 2019.

The Invention Explained

• Problem Addressed: Prior to the invention, postoperative adjustment of external ring fixators for correcting bone deformities was a largely manual process. Surgeons relied on experience and "eye-ball" estimations from X-rays to calculate the necessary adjustments, a method subject to guesswork and potential human error ('377 Patent, col. 1:28-35; Compl. ¶37).
• The Patented Solution: The patent describes a computer-implemented "point-and-click" method to automate and improve the accuracy of this process. A surgeon or practitioner uses a computer to inscribe points and lines over two separate medical images (e.g., X-rays taken from different angles) that are displayed on a screen. An algorithm then processes the 2D coordinates from these user-defined points to calculate the 3D orientation of the bone and fixator, and determines the precise mechanical adjustments required to achieve the desired alignment ('377 Patent, Abstract; col. 1:48-65).
• Technical Importance: The claimed method aims to replace subjective estimation with objective, data-driven calculation, thereby improving the efficiency, ease of use, and accuracy of complex orthopedic corrections (Compl. ¶¶ 38, 40).

Key Claims at a Glance

• The complaint asserts infringement of independent claim 1 (Compl. ¶64).
• The essential elements of independent claim 1 include:
  • Providing a computer with an input screen capable of detecting and registering position data.
  • Providing an algorithm that computes orientation data according to specific equations.
  • Taking at least two medical images from different angles showing a bone and a six-axis external fixator, and displaying them on the screen.
  • Marking points or lines on the screen to create position data representing the bone and/or fixator hardware.
  • Using the algorithm to extract 2D coordinates, calibrate the images, and produce 3D coordinates for the angular orientations of the bone and fixator, and the coordinates of the fixator ring's center.
  • Further calculating, via the algorithm, a pivot point and necessary adjustments.
  • The algorithm defines coordinates and uses a specific sequence of Euler angle rotations (yaw, then pitch, then roll) and specific equations to model the system.
• The complaint also asserts infringement of dependent claims 2-5 and reserves the right to assert additional claims (Compl. ¶¶ 63, 69, 71).

III. The Accused Instrumentality

Product Identification

• Defendant WishBone Medical's "Smart Correction® External Fixation System" ("the Accused System") (Compl. ¶43).

Functionality and Market Context

• The Accused System is described as a "software based deformity correction and fracture reduction tool" used in conjunction with a physical "Computer Assisted Circular Hexapod Fixator" (Compl. ¶44). The system's promotional materials, as cited in the complaint, instruct users to obtain two radiographic images (e.g., A/P and M/L views) and use the web-based software to perform "Bone Segment Mapping" by using a mouse to "locate the chosen axis for each bone segment" on the displayed images (Compl. ¶¶ 65-66). The complaint alleges the software then calculates a "schedule of frame adjustment in order to achieve the desired correction" (Compl. ¶68). The complaint includes a screenshot from the Accused System's software showing a user interface for deformity parameter input and bone segment mapping (Compl. ¶18).

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,258,377 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A point and click method to implement intended manipulation of an external fixator frame by an orthopedic professional...	The Accused System is described as a "point and click method" where a user is instructed to "locate the chosen axis for each bone segment" using a mouse. A screenshot shows a computer interface for mapping bone segments (Compl. ¶18).	¶65	col. 1:48-51
c) taking at least two medical images of a patient to create two views...with said at least two views being oriented from different angles and displayed on said input screen;	The system's brochure allegedly instructs users that it is "necessary to obtain two radiographic images (one in the A/P plane and one in the M/L)." A promotional video screenshot shows two distinct views of the fixator model, labeled "Frontal View" and "Side View" (Compl. ¶19).	¶66	col. 1:55-58
d) marking by said orthopedic professional one or more points or one or more lines on said input screen to create said position data, with said position data's representing either or both of a position or positions of a bone...or one or more elements of said external fixator hardware;	The system allegedly instructs users to create "virtual frame" models and to "locate the chosen axis for each bone segment in both the frontal and laterial images." A video screenshot shows the process of "Overlaying the x-ray image and the computerized x-ray template" (Compl. ¶20).	¶66	col. 2:35-40
e) extracting, using said algorithm, two or more sets of two dimensional coordinates...calibrating said images, and thereby producing three-dimensional x, y and z coordinates for i) angular orientations of bone or bone segments; ii) angular orientations of said external fixator hardware, and iii) coordinates of a center of said ring;	The software allegedly contains an algorithm that extracts 2D coordinates and renders 3D coordinates. A video screenshot depicts the user "Marking mid-diaphyseal axis" (Compl. ¶21), which the complaint alleges is part of this process.	¶67	col. 6:50-65
f) further calculating, via said algorithm, at least one pivot point as output...to depict...one or more adjustments...necessary to achieve an intended bone manipulation configuration...	The software allegedly "calculates the schedule of frame adjustment in order to achieve the desired correction." A screenshot from the brochure illustrates the software displaying "Distraction and Rotation" values after deformity correction is complete (Compl. ¶23).	¶68	col. 7:1-4
g) defining orthogonal coordinates...assigning Euler angles in the following sequence Rotate an angle Ψ (yaw) around the z-axis Rotate an angle θ (pitch) around the y-axis Rotate an angle φ (roll) around the x-axis wherein the coordinates qᵢ...are given by the equation qᵢ=T+RB*pᵢ...	The complaint alleges, "On information and belief," that the Accused System practices this step by using the recited equations or an equivalent. No specific evidence is provided for this element beyond this assertion.	¶67	col. 4:11-20; col. 15:10-24

Identified Points of Contention

• Technical Questions: A principal point of contention will likely be claim element 1(g). The complaint asserts infringement of this highly specific mathematical step based only on "information and belief." A key question for discovery will be whether the Accused System's proprietary algorithm actually implements the specific sequence of Euler angle rotations (yaw, then pitch, then roll) and the precise equations recited in the claim. The plaintiff’s case may depend on proving that the accused software’s internal operations match these detailed limitations, either literally or under the doctrine of equivalents.
• Scope Questions: The interpretation of "calibrating said images" in element 1(e) may become a focus. The parties may dispute what level of technical processing is required to meet this limitation. Does it require a specific mathematical transformation to reconcile scales and perspectives between the two images, or can it be met by a more general process of visual alignment by the user, as some of the complaint's visual evidence might suggest?

V. Key Claim Terms for Construction

The Term: "algorithm which computes orientation data... according to equations set forth in g) below" (claim 1(b))

• Context and Importance: This limitation directly links the functional step of providing an algorithm (1(b)) to the highly detailed mathematical framework in step 1(g). The construction of "according to" is critical, as it will define how closely the accused software's calculations must match the patent's specific equations and Euler angle sequence to infringe.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that the term "according to" does not require literal, line-for-line identity with the equations but rather a general conformance or functional correspondence. The patent's summary describes the invention in more general terms as a "point-and-click (P&C) method" for automated repositioning, which could support an argument that the specific equations are merely one exemplary way to implement the broader concept ('377 Patent, col. 1:48-54).
  • Evidence for a Narrower Interpretation: A party will likely argue that the claim's explicit recitation of a specific rotational sequence (yaw, then pitch, then roll) and mathematical equations makes this a defining and limiting feature of the claim. The detailed description provides a thorough explanation of this specific "Stewart Platform" mathematical construct, suggesting its centrality to the invention ('377 Patent, col. 3:65 - col. 5:17). This precision suggests the inventors intended to claim this specific mathematical approach.

The Term: "calibrating said images" (claim 1(e))

• Context and Importance: This term describes a key data processing step, but the patent does not provide an explicit definition. Its construction will determine what specific actions the accused software must perform on the two 2D images to be deemed infringing.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party could argue "calibrating" simply means reconciling the two images to enable a 3D calculation, such as by adjusting their scales to match, a process that might be inferred from the need to combine AP and LM views ('377 Patent, col. 9:31-37).
  • Evidence for a Narrower Interpretation: A party could point to language in the specification discussing the use of an object with known dimensions (like the fixator ring itself) to provide an "independent scale for the image," arguing that "calibrating" requires such a specific, independent scaling step rather than just a relative adjustment ('377 Patent, col. 8:62 - col. 9:4).

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement by asserting that WishBone provides instructions to its customers, via a brochure and an instructional video, that encourage and direct them to use the Accused System in a manner that performs the patented method (Compl. ¶¶ 69, 71). The complaint also pleads contributory infringement, alleging the Accused System was made for the purpose of infringement and has no substantial non-infringing uses (Compl. ¶72).
• Willful Infringement: Willfulness is alleged based on pre-suit knowledge. The complaint asserts that WishBone has been aware of the '377 Patent "at least since June 2019," citing knowledge obtained by the CEO of an allegedly affiliated company (Compl. ¶74).

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

• A central issue will be one of evidentiary proof versus claim specificity: Can Plaintiffs, through discovery, uncover evidence that the Accused System's proprietary software algorithm performs the highly specific sequence of Euler angle rotations and mathematical computations required by claim 1(g)? The complaint’s current reliance on "information and belief" for this critical element suggests that the outcome may turn on whether the accused code is found to be a technical match to the patent's precise mathematical framework.
• The case will also likely involve a key question of claim construction: How will the court define the phrase "according to equations set forth in g) below"? A decision that this requires literal identity with the patent's formulas would create a high bar for infringement, while a broader construction permitting functionally equivalent mathematical models could significantly lower that threshold.