DCT
1:24-cv-01289
Qfix Systems LLC v. Klarity Medical Products LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Qfix Systems, LLC and Anholt Technologies, Inc. d/b/a CQ Medical (Delaware)
- Defendant: Klarity Medical Products, LLC (Delaware)
- Plaintiff’s Counsel: Buchanan Ingersoll & Rooney, P.C.
- Case Identification: 1:24-cv-01289, D. Del., 11/25/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation and has allegedly transacted business and committed acts of infringement in the state.
- Core Dispute: Plaintiff alleges that Defendant’s Klarity BiteLok® device, an accessory for patient positioning, infringes two patents related to methods for mechanically securing such accessories to thermoplastic immobilization masks used in radiotherapy.
- Technical Context: The technology addresses the challenge of reliably attaching positioning aids to low-friction thermoplastic sheets that are custom-molded to patients for radiation treatment, aiming to improve positional accuracy and repeatability.
- Key Procedural History: U.S. Patent No. 11,992,430 is a continuation of the application that issued as U.S. Patent No. 11,523,929 and is subject to a terminal disclaimer, legally linking the enforceable terms of the two patents.
Case Timeline
| Date | Event |
|---|---|
| 2016-05-23 | Priority Date for ’929 and ’430 Patents |
| 2022-12-13 | ’929 Patent Issued |
| 2024-05-28 | ’430 Patent Issued |
| 2024-11-25 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,523,929 - ACCESSORY DEVICE, A PATIENT IMMOBILIZATION SYSTEM, AND A METHOD OF FORMING A PATIENT IMMOBILIZATION SYSTEM, issued December 13, 2022
The Invention Explained
- Problem Addressed: The patent’s background identifies a need for improved methods of attaching accessories, such as bite plates, to low-temperature (LT) thermoplastic sheets used in radiotherapy. The sheets often have low-friction, anti-stick surfaces, making it difficult to securely bond accessories to them (ʼ929 Patent, col. 3:32-38).
- The Patented Solution: The invention is an accessory device with a "patient fixation portion" (e.g., a mouthpiece) and a "lock portion" that extends outward. A clinician forms a softened LT thermoplastic sheet around this lock portion. As the sheet cools and hardens, it creates a rigid mechanical interlock that physically secures the accessory to the immobilization mask without requiring adhesives or secondary fasteners (ʼ929 Patent, Abstract; col. 4:8-17).
- Technical Importance: The invention aims to provide a simpler, more reliable single-piece system for integrating positioning accessories with custom immobilization masks, thereby improving the ease of use and repeatability of patient setup for treatment (ʼ929 Patent, col. 4:51-54).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶24).
- Essential elements of claim 1 include:
- An accessory device comprising a "patient fixation portion" and a "lock portion".
- The device is configured to be engaged by forming a proximal surface of the LT thermoplastic sheet "around the lock portion".
- This engagement causes the sheet to "conform to the lock portion" and "prevents unintended separation" of the device from the sheet.
- The "lock portion does not penetrate" the thermoplastic sheet from its proximal to its distal surface.
- The proximal surface of the sheet is "positionable proximal the patient".
U.S. Patent No. 11,992,430 - ACCESSORY DEVICE, A PATIENT IMMOBILIZATION SYSTEM AND A METHOD OF FORMING A PATIENT IMMOBILIZATION SYSTEM, issued May 28, 2024
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as its parent '929 Patent: the difficulty of reliably attaching accessories to low-friction thermoplastic immobilization masks (ʼ430 Patent, col. 1:25-38).
- The Patented Solution: The core inventive concept is identical to the ’929 Patent, using a "lock portion" to create a mechanical interlock with a molded thermoplastic sheet (ʼ430 Patent, Abstract). The asserted claim adds a distinct functional feature to the device.
- Technical Importance: The technology provides the same benefits of improved reliability and simplicity as the ’929 Patent, with the addition of the specific feature recited in its asserted claim (ʼ430 Patent, col. 4:45-56).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶44).
- The first five essential elements of claim 1 are substantively identical to those of claim 1 of the ’929 Patent.
- Claim 1 adds a sixth essential element: "wherein the accessory device has an "air passage" such that air may pass through the accessory device" (ʼ430 Patent, col. 9:31-33).
III. The Accused Instrumentality
Product Identification
- The Klarity BiteLok® device (Compl. ¶16).
Functionality and Market Context
- The complaint alleges the Klarity BiteLok is an accessory device used for patient positioning during radiotherapy treatment (Compl. ¶16). It is designed for use with a low-temperature thermoplastic sheet, which is formed around a portion of the device to secure it to an immobilization mask (Compl. ¶25, 45). Plaintiff identifies Defendant Klarity as a direct competitor in the market for patient positioning products (Compl. ¶15). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’929 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An accessory device configured to position a patient relative to an immobilization device including a low temperature thermoplastic sheet... | The Klarity BiteLok is an accessory device configured for this purpose. | ¶25 | col. 1:40-44 |
| a patient fixation portion configured for fixation on or insertion into the patient during use; | The Klarity BiteLok is alleged to include such a patient fixation portion. | ¶26 | col. 4:21-23 |
| a lock portion extending distally from the patient fixation portion generally along a lock portion axis; | The Klarity BiteLok is alleged to have a lock portion extending from its patient fixation portion. | ¶27 | col. 1:46-49 |
| wherein the accessory device is configured to be engaged by...forming the proximal surface of the low temperature thermoplastic sheet around the lock portion...such that the...sheet conforms to the lock portion and when engaged prevents unintended separation... | The Klarity BiteLok is alleged to be configured for engagement by a thermoplastic sheet in this manner, preventing separation. | ¶28 | col. 1:49-56 |
| wherein when engaged, the lock portion does not penetrate the low temperature thermoplastic sheet from the proximal surface...to a distal surface... | The lock portion of the Klarity BiteLok is alleged not to penetrate the thermoplastic sheet when engaged. | ¶29 | col. 6:18-22 |
| wherein the proximal surface of the low temperature thermoplastic sheet is positionable proximal the patient and the distal surface...is opposite from the proximal surface. | This describes the alleged orientation of the thermoplastic sheet when used with the Klarity BiteLok. | ¶30 | col. 7:30-31 |
’430 Patent Infringement Allegations
The allegations for the first five elements of claim 1 of the '430 Patent are substantively identical to those for the '929 Patent, as described in the table above (Compl. ¶45-50).
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| ... | ... | ... | ... |
| wherein the accessory device has an air passage such that air may pass through the accessory device. | The Klarity BiteLok is alleged to include an air passage allowing air to pass through it. | ¶51 | col. 7:40-45 |
Identified Points of Contention
- Scope Questions: A central question may be the required degree of "conformity" between the thermoplastic sheet and the "lock portion" to satisfy the claim limitation of preventing "unintended separation." The dispute may focus on whether a simple friction fit is sufficient or if a more complex mechanical interlock is required by the claims.
- Technical Questions: For the ’430 Patent, a key factual question is whether the accused Klarity BiteLok possesses a structure that functions as an "air passage" within the meaning of the claim. The complaint’s assertion (Compl. ¶51) will require evidentiary support demonstrating the existence and function of such a feature.
V. Key Claim Terms for Construction
The Term: "lock portion"
- Context and Importance: This term defines the central structural feature of the invention responsible for creating the mechanical interlock. Its construction will determine the range of shapes and configurations that can be found to infringe.
- Intrinsic Evidence for a Broader Interpretation: The specification discloses numerous embodiments with varied geometries for the lock portion, including ridges, notches, holes, and projections of different shapes (e.g., T-shape, Y-shape, fan shape), suggesting the term is not limited to one specific form (ʼ929 Patent, col. 5:36-58).
- Intrinsic Evidence for a Narrower Interpretation: The specification describes the function as providing a "rigid mechanical interlock" (ʼ929 Patent, col. 4:16). A defendant may argue this requires a structure with specific interlocking features, such as undercuts or the "inverted Christmas tree" geometry, to distinguish it from a simple post.
The Term: "air passage" ('430 Patent only)
- Context and Importance: This term is the sole element distinguishing asserted claim 1 of the ’430 patent from its parent. The infringement analysis for this patent will likely hinge on the construction of this term.
- Intrinsic Evidence for a Broader Interpretation: The claim language itself is broad: "an air passage such that air may pass through the accessory device" (ʼ430 Patent, col. 9:31-33). A plaintiff could argue that any channel or opening meeting this functional description falls within the claim scope.
- Intrinsic Evidence for a Narrower Interpretation: The specification provides a specific example of an "air passage" in the context of a "palate vacuum outlet" system (ʼ430 Patent, Fig. 10A; col. 7:22-45). A defendant may argue this context limits the term to a feature with a similar structure or purpose, rather than any incidental opening in the device.
VI. Other Allegations
Indirect Infringement
- The complaint alleges both induced and contributory infringement for both patents.
- Inducement: The allegations are based on Defendant marketing, selling, and providing instructions for the Klarity BiteLok, allegedly with the knowledge and intent that its customers would use the product in an infringing manner. The complaint references "Instructions for Use" and an "informational video" as evidence of such instructions (Compl. ¶20, 38, 58-59).
- Contributory Infringement: The allegations are based on the assertion that the Klarity BiteLok is specially made and adapted for an infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶39, 60).
Willful Infringement
- The complaint does not contain an explicit allegation of willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope: What level of structural complexity and interlocking capability is required for a feature to be considered a "lock portion" that "conforms" to the thermoplastic sheet to "prevent unintended separation"? The resolution of this question will define the boundary of the patented invention and be critical to the infringement analysis for both patents.
- A key evidentiary question for the ’430 patent will be one of technical fact: Does the accused Klarity BiteLok device possess a physical feature that can be properly characterized as an "air passage" under the court's construction of that term, or is the complaint's allegation unsupported by the product's actual design?
- A central question for indirect infringement will be the content of Defendant's instructions: Do Klarity's user manuals and marketing materials actively instruct or encourage users to perform the claimed method step of forming a thermoplastic sheet around the BiteLok's lock portion, which could establish the specific intent required for induced infringement?