DCT
1:24-cv-00728
Brainlab AG v. Klarity Medical Products LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Brainlab AG (Germany) and Brainlab, Inc. (Illinois)
- Defendant: Klarity Medical Products, LLC (Delaware)
- Plaintiff’s Counsel: Ashby & Geddes; Tucker Ellis LLP
- Case Identification: Brainlab AG v. Klarity Medical Products, LLC, 1:24-cv-00728, D. Del., 06/20/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware limited liability corporation and allegedly sells or offers for sale infringing products throughout the United States, including in Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s patient immobilization masks, designed for use with Plaintiff’s Image-Guided Radiotherapy systems, infringe three patents related to head immobilization systems featuring a specific releasable locking mechanism.
- Technical Context: The technology at issue involves medical devices for precisely and securely immobilizing a patient's head during Image-Guided Radiotherapy (IGRT), a procedure used to deliver targeted radiation for cancer treatment.
- Key Procedural History: The complaint does not mention any prior litigation between the parties, Inter Partes Review (IPR) proceedings involving the patents-in-suit, or prior licensing history.
Case Timeline
| Date | Event |
|---|---|
| 2017-04-20 | Earliest Priority Date for all Asserted Patents |
| 2022-03-22 | U.S. Patent 11,278,368 Issues |
| 2023-05-09 | U.S. Patent 11,642,190 Issues |
| 2024-03-26 | U.S. Patent 11,937,985 Issues |
| 2024-06-20 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,278,368 - "Cranial Immobilization System," issued March 22, 2022
The Invention Explained
- Problem Addressed: The patent describes conventional patient immobilization masks as being potentially time-consuming to attach and adjust, which increases the possibility of handling errors during critical medical procedures (’368 Patent, col. 1:39-44).
- The Patented Solution: The invention is a head immobilization system comprising a support rail structure and a separate mask frame. The two parts connect via a releasable mechanism using pins on one component and corresponding receptacles on the other. A one-way "catch-mechanism," featuring interlocking saw-toothing, allows the mask frame to be pushed onto the support rail and securely locked in place in a ratchet-like fashion. A separate release mechanism must be activated to disengage the lock and remove the mask frame, a design intended to be fast and easy to handle (’368 Patent, Abstract; col. 2:52-64).
- Technical Importance: This design aims to provide quick, reproducible, and secure immobilization of a patient's head, which is critical for the accuracy of high-precision treatments like stereotactic radiosurgery and radiotherapy (’368 Patent, col. 1:13-17).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶50).
- The essential elements of claim 1 include:
- A head immobilization system comprising a "support rail structure" and a "mask frame".
- The mask frame is releasably connected to the support rail via at least two "pins" protruding from a first interface section and at least two "pin-receptions" on a second interface section.
- A "catch-mechanism" for each pin/reception pair includes interlocking "saw-toothing" that allows the pin to be pushed into the reception but prevents its withdrawal.
- A "release mechanism" includes "grasping sections" that, when pressed together, disengage the saw-toothing to allow the pin to be removed.
- The complaint notes its analysis is an "illustrative example," suggesting it may reserve the right to assert other claims (Compl. ¶50).
U.S. Patent No. 11,642,190 - "Cranial Immobilization System," issued May 9, 2023
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’368 Patent, this patent addresses the same problem of making patient immobilization faster, easier, and less prone to error (’190 Patent, col. 1:41-47).
- The Patented Solution: The invention describes a head immobilization system with a similar architecture. The asserted independent claim focuses on a configuration where "pins" with "saw-toothing" protrude from the "support rail structure" itself. The "mask frame" contains corresponding "pin-receptions" with their own "saw-toothing" to interlock with the pins. A "release mechanism" with "grasping sections" is included on the mask frame to disengage the lock (’190 Patent, col. 9:55-10:2; col. 10:49-65).
- Technical Importance: The technology provides a robust and user-friendly method for achieving the highly accurate patient positioning required for modern radiotherapy techniques (’190 Patent, col. 1:14-18).
Key Claims at a Glance
- The complaint asserts independent claim 16 (Compl. ¶61).
- The essential elements of claim 16 include:
- A head immobilization system comprising a "support rail structure" and a "mask frame".
- The support rail includes at least two "pins" protruding from it, each having "saw-toothing".
- The mask frame includes at least two "pin-receptions" that also have "saw-toothing" to interlock with the pins, allowing insertion but preventing removal.
- A "release mechanism" on the mask frame includes "grasping sections" that, when pressed together, disengage the saw-toothing to allow removal of the mask.
- The complaint's analysis is presented as an "illustrative example," suggesting it may reserve the right to assert other claims (Compl. ¶61).
U.S. Patent No. 11,937,985 - "Cranial Immobilization System," issued March 26, 2024
Technology Synopsis
This patent, also in the same family, is directed to a mask system for immobilizing a patient's head. It claims a system including a deformable mask sheet, a pin extending from a support rail, and a mask frame. The mask frame has plural interface sections, each with a "releasable pin receiver" having a "sawtooth catch structure" that engages a corresponding sawtooth structure on the pin to create a progressive, one-way lock that is disengaged by a release mechanism (’985 Patent, Abstract; col. 9:55-col. 10:11).
Asserted Claims
The complaint asserts independent claim 1 (Compl. ¶72).
Accused Features
The complaint alleges that the Klarity Dynamic Mask sets, when used with the Brainlab ExacTrac Dynamic system, infringe this patent. The accused features are the mask frame's alleged releasable pin receivers and release mechanism, which are designed to couple with the pins on the Brainlab system's support rail (Compl. ¶¶ 29-31, 72).
III. The Accused Instrumentality
Product Identification
- The accused products are the "Klarity Green Dynamic Mask set" and the "Klarity White Dynamic Mask set," collectively referred to as "Klarity® Dynamic Masks for BrainLab Systems" (Compl. ¶¶ 32, 49; Exhibit E).
Functionality and Market Context
- The complaint alleges that the accused masks are thermoplastic medical devices "specially designed" and marketed as "compatible with BrainLab systems" for immobilizing patients during radiation therapy (Compl. ¶¶ 28, 30; Exhibit E).
- The core accused functionality is the mechanism by which the Klarity masks couple to the support rail of Plaintiff's ExacTrac Dynamic® system. This allegedly involves sawtooth receptacles on the Klarity mask frame engaging with sawtooth pins on the Brainlab support rail to lock the mask into place (Compl. ¶30). The complaint includes a visual from Klarity's website showing the accused mask being worn by a patient and attached to the support rail structure (Compl. ¶29, p. 7).
- The products are alleged to include a release feature, described in an annotated image as "buckles" that are pressed to remove the mask (Compl. ¶31, p. 8).
- Plaintiff alleges that Klarity markets its masks as a "preferred option" and an "upgrade" over other masks, including Brainlab's, causing competitive harm (Compl. ¶¶ 36, 38-39).
IV. Analysis of Infringement Allegations
'368 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A head immobilization system for immobilizing a patient's head...the system comprising: | The complaint alleges Klarity sells a head immobilization system, specifically the Klarity Dynamic Mask sets, for use with the Brainlab ExacTrac Dynamic system (Compl. ¶¶ 49-50). | ¶50 | col. 1:10-12 |
| a support rail structure adapted to be coupled to a patient rest and configured to extend at least on both lateral sides of the patient's head; | The complaint identifies the support rail on the ExacTrac Dynamic® system, showing it as an elevated structure alongside the patient's head (Compl. ¶50). | ¶50 | col. 2:18-22 |
| a mask frame adapted to be coupled to at least one deformable upper mask sheet, wherein the mask frame is releasably connected to the support rail structure via a first interface section and a second interface section, with at least two pins protruding from the first interface section... and at least two pin-receptions provided at the second interface section... | The accused instrumentality is the Klarity mask frame, which is releasably connected to the support rail. The complaint alleges the system includes pins and pin-receptions that facilitate this connection (Compl. ¶50). | ¶50 | col. 2:2-10 |
| a catch-mechanism for each pin-reception and each corresponding pin, wherein the catch-mechanism includes saw-toothing... which interlocks with saw-toothing of the corresponding pin-reception... and the catch-mechanism interlocks to prevent the pin from moving... in a second, opposite direction; | The complaint points to a "rectangular structure protruding inwardly from the top section of the mask frame" as the catch mechanism, which allegedly includes saw-toothing that interlocks with the corresponding pin reception (Compl. ¶50). | ¶50 | col. 2:11-19 |
| a release mechanism that includes grasping sections that, while pressed together, cause the saw-toothing of the pin-reception to move away from the saw-toothing of the corresponding pin to allow the pin to move... in the second direction. | The complaint alleges the Klarity mask includes a release mechanism with "two upwardly extending grasping sections that when pressed together cause the sawtooth structures...to disengage." A provided image shows these sections being pressed (Compl. ¶50). | ¶50 | col. 10:33-39 |
- Identified Points of Contention:
- Scope Questions: The claim is for a "head immobilization system" comprising both a support rail and a mask frame. The complaint alleges that Klarity sells the mask frame component. This raises the question of whether selling one component of a patented system can constitute direct infringement under 35 U.S.C. § 271(a). The analysis may turn on whether Klarity can be held responsible for "making" or "selling" the entire claimed system, or if the case will rely more heavily on the allegations of indirect infringement.
- Technical Questions: A key technical question is whether the "upwardly extending grasping sections" on the Klarity mask (Compl. ¶50, p. 14) function in the manner required by the claim, specifically by being "pressed together" to cause the release. The complaint's own visual evidence labels these as "buckles" to be pressed to "remove the mask," which may support its theory but also raises the question of whether simply pressing a tab is equivalent to pressing "grasping sections" together. The complaint includes a close-up visual of the alleged catch mechanism, showing interlocking sawtooth-like structures on the accused product (Compl. ¶50, p. 14).
'190 Patent Infringement Allegations
| Claim Element (from Independent Claim 16) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A head immobilization system comprising: | The complaint alleges Klarity's masks are head immobilization systems compatible with Brainlab systems (Compl. ¶61). | ¶61 | col. 9:55-56 |
| a support rail structure that includes at least two pins protruding from the support rail structure, wherein each pin includes saw-toothing formed along a surface of the pin; | The complaint identifies the support rail of the ExacTrac Dynamic® system, noting that its "upwardly protruding sections are the saw-toothed pins" (Compl. ¶61). | ¶61 | col. 9:57-61 |
| a mask frame comprising: at least two pin-receptions that include saw-toothing, wherein each one of the pin-receptions is... configured to receive one of the pins such that the saw-toothing of the pin interlocks with the saw-toothing of the corresponding pin-reception... | The accused Klarity mask frame allegedly includes at least two pin receptions with a sawtooth surface that receives and interlocks with the sawtooth pin from the support rail. A close-up image of this alleged feature is provided (Compl. ¶61). | ¶61 | col. 10:1-8 |
| a release mechanism that includes grasping sections that, while pressed together, cause the saw-toothing of at least one of the pin-receptions to move away from the saw-toothing of the corresponding pin to allow the pin to be removed from the pin-reception. | The complaint alleges the Klarity mask has a release mechanism with "two upwardly extending grasping sections that when pressed together cause the sawtooth structures...to disengage." An annotated image shows how pressing "buckles" removes the mask (Compl. ¶61). | ¶61 | col. 10:9-15 |
- Identified Points of Contention:
- Scope Questions: This claim structure—with pins on the support rail and receptions on the mask frame—appears to map more closely to the facts alleged, where Klarity's mask frame is the accused product sold for use with Brainlab's support rail. However, the same fundamental question of direct infringement liability for a system claim remains.
- Technical Questions: The complaint provides a visual from Klarity's website showing the accused mask being removed by pressing tabs labeled "buckles" (Compl. ¶61, p. 19). The functional equivalence between this "pressing" action and the claim's requirement that "grasping sections" be "pressed together" will be a central technical dispute.
V. Key Claim Terms for Construction
The Term: "grasping sections" (’368 Patent, Claim 1; ’190 Patent, Claim 16)
- Context and Importance: This term is critical to the "release mechanism" element. The infringement analysis will depend on whether the tabs or "buckles" on the accused Klarity masks fall within the scope of this term. Practitioners may focus on this term because the complaint's own evidence shows a "pressing" action, and the outcome will depend on whether "grasping" implies a more specific user action (e.g., pinching between two fingers) than simply pressing a surface.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims require that the sections, "while pressed together," cause a release. This functional language could be argued to encompass any structure that achieves release through compressive force, regardless of its specific shape or how it is actuated by a user.
- Evidence for a Narrower Interpretation: The specification discloses an embodiment where the grasping sections are "ring-shaped" and form a "double-lever" (’368 Patent, col. 5:6-9; col. 12:16-17). A defendant could argue that the term implies a structure that is physically grasped, like the disclosed rings, rather than a simple tab that is pushed.
The Term: "saw-toothing" (’368 Patent, Claim 1; ’190 Patent, Claim 16)
- Context and Importance: This term defines the interlocking surfaces of the catch mechanism. The physical structure of the corresponding surfaces on the accused mask must be found to meet this definition.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the function of the interlocking parts as a "one-directional ratchet" that provides "automatic locking functionality" (’368 Patent, col. 3:5-10). This may support a construction that covers any surface geometry that achieves this one-way locking function.
- Evidence for a Narrower Interpretation: The specification provides a more detailed description, stating the "teeth feature a horizontal upper side, wherein the lower side is beveled," which facilitates the sliding engagement in one direction and locking in the other (’368 Patent, col. 5:65-col. 6:1). A defendant may argue that the term "saw-toothing" should be limited to structures with this or a similar asymmetric tooth profile.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. It supports inducement by alleging Klarity provides "Instructions for Use" that explicitly instruct users to combine the accused masks with Brainlab's systems in an infringing manner and markets the masks as "compatible with Brainlab systems" (Compl. ¶¶ 52, 54, 63, 65). The complaint supports contributory infringement by alleging the masks have a unique coupling design and therefore no substantial non-infringing uses (Compl. ¶¶ 53, 64, 75).
- Willful Infringement: Willfulness is alleged based on the assertion that Klarity "specifically designed" its masks to work with Brainlab's patented system (Compl. ¶¶ 56, 67, 78). The complaint also makes a general allegation of pre-suit knowledge of the patents, but does not provide specific facts to support when or how such knowledge was obtained (Compl. ¶¶ 55, 66, 77).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of liability for a system claim: Can Brainlab establish that Klarity, by selling only the mask set component, is directly infringing claims directed to a multi-component "head immobilization system"? The resolution may depend on theories of divided infringement or, more likely, on the strength of the evidence supporting the parallel claims for indirect infringement.
- The outcome will likely turn on claim construction: A central dispute will be whether the accused product's release "buckles" and interlocking surfaces fall within the scope of the claim terms "grasping sections" and "saw-toothing". The court's interpretation—whether it adopts a broader functional meaning or a narrower structural one based on the patent's disclosed embodiments—will be pivotal.
- A key evidentiary question will be the basis for willful infringement: While the complaint alleges intentional design for compatibility, its claims of pre-suit knowledge of the patents are conclusory. The viability of a willfulness finding, particularly for pre-suit damages, will depend on what evidence of actual knowledge emerges during discovery.