DCT
1:17-cv-00061
K2M Inc v. OrthoPediatrics Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: K2M, Inc. (Virginia)
- Defendant: OrthoPediatrics Corp. (Delaware); OrthoPediatrics US Distribution Corp. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:17-cv-00061, D. Del., 08/21/2017
- Venue Allegations: Venue is asserted based on Defendants' incorporation in Delaware and their conducting of business in the state.
- Core Dispute: Plaintiff alleges that Defendant’s RESPONSETM Spine System, specifically its JIMINY rod reducer instrument, infringes patents related to surgical devices for correcting spinal deformities.
- Technical Context: The technology involves mechanical instruments used in complex spinal surgeries to precisely and controllably seat a corrective rod into bone anchors affixed to a patient's vertebrae.
- Key Procedural History: This First Amended Complaint asserts two patents from the same family. The application leading to the ’816 Patent was a continuation of an earlier application, and the ’664 Patent is a divisional of the ’816 Patent’s application. Following the filing of this lawsuit, the ’816 Patent was subject to two Inter Partes Review (IPR) proceedings (IPR2018-00429, IPR2018-00521). The U.S. Patent and Trademark Office ultimately issued a certificate confirming the patentability of asserted claim 16, among others.
Case Timeline
| Date | Event |
|---|---|
| 2006-01-01 | OrthoPediatrics was founded (approximated from Compl. ¶22) |
| 2007-07-13 | Earliest Priority Date for ’816 and ’664 Patents |
| 2014-07-11 | OrthoPediatrics filed for JIMINY trademark registration |
| 2015-01-01 | OrthoPediatrics introduced its RESPONSETM spine system (approximated from Compl. ¶23) |
| 2017-01-03 | U.S. Patent No. 9,532,816 issued |
| 2017-05-23 | U.S. Patent No. 9,655,664 issued |
| 2017-08-21 | First Amended Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,532,816 - Rod Reduction Device and Method of Use
The Invention Explained
- Problem Addressed: The patent addresses the difficulty in spinal fusion surgery of properly inserting and securing a spinal rod into a series of bone screws. The background notes that conventional instruments did not provide a way to reduce the rod into the screw head in a "controlled, measured way" that also allowed for easy adjustments during the procedure (’816 Patent, col. 1:53-2:10).
- The Patented Solution: The invention is a hand-held surgical instrument featuring a "screw jack mechanism" moveably engaged with a "grasping fork assembly" (’816 Patent, Abstract). As a surgeon turns a controlling member, a threaded shaft advances a "rod contact member" distally. This action first causes the grasping fork members to pivot inward to securely grip the head of a bone screw, and then pushes the spinal rod down into a receiving slot in the screw head, all through a single, continuous rotational action (’816 Patent, col. 6:25-49; FIG. 1).
- Technical Importance: The device is designed to provide a surgeon with a single instrument that can both securely grasp a bone anchor and controllably reduce the rod, aiming to make a complex part of spinal surgery less "difficult, tiresome and time consuming" (’816 Patent, col. 1:60-63).
Key Claims at a Glance
- The complaint asserts independent claim 16 (Compl. ¶29).
- Independent Claim 16 requires:
- A housing defining a longitudinal axis, which includes first and second grasping members that define a plane and are configured to grasp a bone anchor.
- A rotatable member that extends through the housing along the longitudinal axis.
- A rod contact member at the distal end of the rotatable member, which is translatable along the longitudinal axis when the rotatable member is rotated.
- The rotatable member and rod contact member are translatable "within the plane" defined by the grasping members.
- The complaint reserves the right to assert other claims (Compl. ¶34).
U.S. Patent No. 9,655,664 - Rod Reduction Device and Method of Use
The Invention Explained
- Problem Addressed: The technical problem is identical to that described in the parent ’816 Patent: the need for a more controlled and efficient way to seat spinal rods into bone screws (’664 Patent, col. 2:6-14).
- The Patented Solution: The ’664 Patent claims the method of using the rod reduction device. The claimed method comprises the steps of coupling the device (which includes a rotatable member "threadably coupled" with the body) to a bone anchor, securing the device by engaging its grasping members with the anchor, and then rotating the member to cause a rod contact member to advance a spinal rod towards the anchor's housing (’664 Patent, Claim 1).
- Technical Importance: The claimed method provides a structured surgical technique for leveraging the mechanical advantages of the device described in the patent family to improve surgical workflow and precision (’664 Patent, col. 2:15-22).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶43).
- Independent Claim 1 requires the steps of:
- Coupling a specific rod reducing device (including a rotatable member, rod contact member, and a body with two elongated grasping members) to a bone anchor.
- Securing the device to the anchor by engaging the grasping members with the anchor's rod-receiving housing.
- Rotating the rotatable member to cause the rod contact member to move within the plane of the grasping members, thereby advancing a rod toward the housing.
- The complaint reserves the right to assert other claims (Compl. ¶52).
III. The Accused Instrumentality
Product Identification
The accused products are rod reducing systems and kits marketed as the RESPONSETM Spine System, which include the "JIMINY rod reducer instrument" (Model No. 01-1003-5000) (’816 Compl. ¶28; ’664 Compl. ¶42).
Functionality and Market Context
The complaint alleges the JIMINY instrument is used to treat spinal deformity and is promoted as enabling "simple" rod reduction (Compl. ¶¶23-24). The infringement allegations are based on the instrument's mechanical components and their operation during spinal surgery (Compl. ¶¶30-33). The complaint supplies annotated images of the accused instrument, identifying a "Housing," "First grasping member," "Second grasping member," "Rotatable Member," and "Rod contact member" (Compl. pp. 7-8). This image of the accused product shows its primary components, which are alleged to correspond to the elements of the asserted claims (Compl. ¶30, p. 7).
IV. Analysis of Infringement Allegations
’816 Patent Infringement Allegations
| Claim Element (from Independent Claim 16) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a housing defining a longitudinal axis, the housing including first and second grasping members configured to grasp a portion of a bone anchor therebetween, the first and second grasping members defining a plane; | The JIMINY instrument is alleged to include a housing with a longitudinal axis and first and second grasping members for grasping a bone anchor. An annotated image in the complaint identifies these structures on the accused product (Compl. ¶30, p. 7). | ¶30 | col. 5:4-7 |
| a rotatable member extending through the housing along the longitudinal axis; and | The JIMINY instrument is alleged to include a rotatable member extending through its housing along the longitudinal axis. | ¶31 | col. 4:1-5 |
| a rod contact member positioned at a distal end of the rotatable member, the rod contact member translatable along the longitudinal axis in response to rotation of the rotatable member about the longitudinal axis... | The JIMINY instrument is alleged to include a rod contact member on its rotatable member that translates along the longitudinal axis when the rotatable member is turned. A cutaway image shows the relationship between the rotatable member and rod contact member (Compl. ¶32, p. 7). | ¶32 | col. 4:38-42 |
| wherein the rod contact member and the rotatable member are translatable within the plane defined by the first and second grasping members. | The JIMINY instrument's rod contact member and rotatable member are alleged to be translatable within the plane defined by the grasping members. An annotated photograph shows the relative positioning of these components (Compl. ¶33, p. 8). | ¶33 | col. 6:40-55 |
Identified Points of Contention
- Scope Questions: A central question may be the interpretation of "housing including first and second grasping members." The defense could argue that the accused JIMINY instrument has a housing and a separate "grasping fork assembly," and that the grasping members are not "included" in the housing in the manner required by the claim.
- Technical Questions: The claim requires the components to be translatable "within the plane" of the grasping members. The litigation may require expert testimony to determine if the accused device's mechanical movement is geometrically co-planar as claimed, or if its operational movement deviates from that plane.
’664 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method...comprising: coupling a rod reducing device to a bone anchor...the rod reducing device including: a rotatable member, a rod contact member...a body including first and second elongated grasping members...the rotatable member threadably coupled with the body...the...members defining a plane...movable within the plane; | Plaintiff alleges the JIMINY rod reducer is a device with all the recited structural features, and that Defendant's promotional materials and instructions direct users to couple it to a bone anchor. | ¶¶44-45 | col. 5:7-16 |
| securing the rod reducing device to the bone anchor by engaging the first and second elongated grasping members with the rod-receiving housing so that the rod-receiving housing is disposed between the first and second elongated grasping members; and | Plaintiff alleges that Defendant's promotional materials and instructions describe securing the JIMINY instrument to the bone anchor by engaging the grasping members with the anchor's housing. | ¶46 | col. 6:36-40 |
| rotating the rotatable member thereby causing the rod contact member to move relative to the body within the plane to advance a rod disposed between the first and second elongated grasping members toward the rod-receiving housing. | Plaintiff alleges that Defendant's promotional materials and instructions describe rotating the instrument's rotatable member to cause the rod contact member to advance a rod toward the bone anchor housing. | ¶47 | col. 6:40-49 |
Identified Points of Contention
- Scope Questions: For this method claim, the dispute will likely focus on whether the actions instructed by the Defendant for using the JIMINY device meet every limitation of the claimed steps. The requirement that the rotatable member is "threadably coupled with the body" is more specific than in the '816 patent claim and will require a direct structural correspondence in the accused device.
- Technical Questions: An evidentiary question will be whether Defendant's instructions for use (e.g., in surgical technique guides) direct users to perform the discrete steps of "securing" the device and then "rotating" to advance the rod in the sequence claimed. If the actions are simultaneous or ordered differently in practice, it could support a non-infringement defense.
V. Key Claim Terms for Construction
’816 Patent, Claim 16
- The Term: "housing including first and second grasping members"
- Context and Importance: The relationship between the "housing" and the "grasping members" is foundational to the claim's structure. Practitioners may focus on this term because if "including" is construed narrowly to mean integrally formed, and the accused device has a modular design with a separate housing and grasping fork, it could present a straightforward non-infringement argument.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification refers to a "grasping fork assembly 14" which has a "fork assembly body 42" and "elongated grasping members 64, 66" (’816 Patent, col. 5:4, col. 5:61-63). This suggests the "housing" (body 42) and "grasping members" are distinct parts of a larger assembly, supporting a view that "including" means "comprising" or "assembled with."
- Evidence for a Narrower Interpretation: The claim language itself recites "a housing...the housing including..." which could be argued to imply a more integrated unit than language like "a housing coupled to a grasping assembly." Figure 1 (elements 42 and 14) could be interpreted as showing the grasping members extending from the housing body, potentially supporting a narrower definition.
’664 Patent, Claim 1
- The Term: "movable within the plane"
- Context and Importance: This term defines the geometry of motion for the device's key components. The infringement analysis for the method claim depends on whether the accused device, when used as instructed, operates according to this specific spatial constraint.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's overall description focuses on the general downward advancement of the rod contact member to reduce the rod, which may support an interpretation where "within the plane" does not require strict geometric co-planarity but rather a movement that is substantially aligned with the grasping members (’664 Patent, col. 6:40-49).
- Evidence for a Narrower Interpretation: The term "plane" has a precise geometric meaning. The specification describes a complex interaction where the rod contact member moves over "cam surfaces 84, 86," causing the grasping members to move inward (’664 Patent, col. 6:31-36). A defendant could argue this describes a three-dimensional interaction, not a simple translation "within" a two-dimensional plane.
VI. Other Allegations
- Indirect Infringement: Plaintiff alleges induced infringement for both patents. For the ’816 Patent, the complaint alleges that Defendant supplies the JIMINY instrument with knowledge and intent that customers will directly infringe by using it (Compl. ¶37). For the method claims of the ’664 Patent, inducement is a central theory, based on Defendant allegedly instructing users on the infringing method via "promotional and marketing materials, supporting materials, instructions, product manuals, and/or technical information" (Compl. ¶50). Plaintiff also alleges contributory infringement for the ’664 Patent (Compl. ¶51).
- Willful Infringement: The complaint alleges that Defendants had knowledge of the patents and their infringement "since the filing of this amended complaint" (Compl. ¶36, ¶49). This frames the willfulness allegation as being based on post-filing conduct rather than pre-suit knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute may turn on the following key questions:
A core issue will be one of definitional scope: can the claim term "housing including first and second grasping members" be construed to read on the accused JIMINY instrument, which appears to have a distinct housing body and grasping fork members? The answer will depend on whether "including" requires an integrated structure or simply an assembly.
A second central issue will be one of geometric and functional correspondence: does the accused instrument's mechanism, which involves a rotatable member and rod contact member, operate "within the plane defined by the first and second grasping members" as required by both asserted claims? This presents a mixed question of claim construction and factual evidence regarding the accused product's precise mode of operation.
Finally, for the asserted method patent ('664), a key evidentiary question will be whether the plaintiff can demonstrate that the defendant's instructions and marketing materials teach every step of the claimed method, thereby establishing the specific intent required to prove induced infringement.