DCT
1:23-cv-00077
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 Qfix (Delaware)
- Defendant: Klarity Medical Products, LLC (Delaware)
- Plaintiff’s Counsel: RatnerPrestia
- Case Identification: 1:23-cv-00077, D. Del., 10/18/2023
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation and has systematically transacted business in the state.
- Core Dispute: Plaintiff alleges that Defendant’s patient immobilization masks, which are used in medical treatments like stereotactic radiosurgery, infringe two patents related to adjustable immobilization apparatuses.
- Technical Context: The technology concerns non-invasive devices that use moldable thermoplastic masks to securely immobilize a patient's anatomy, which is critical for the precise delivery of radiation therapy.
- Key Procedural History: The complaint alleges that Plaintiff sent a letter to Defendant on December 5, 2022, providing actual notice of U.S. Patent No. 11,364,088. This correspondence forms the primary basis for the allegation of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2014-02-19 | Earliest Priority Date for '088 and '516 Patents |
| 2022-06-21 | U.S. Patent No. 11,364,088 ('088 Patent) Issues |
| 2022-12-05 | Plaintiff sends notice letter to Defendant re: '088 Patent |
| 2023-10-03 | U.S. Patent No. 11,771,516 ('516 Patent) Issues |
| 2023-10-18 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,364,088 - ADJUSTABLE IMMOBILIZER APPARATUS AND METHOD FOR IMMOBILIZING A PATIENT
- Patent Identification: U.S. Patent No. 11,364,088, entitled “ADJUSTABLE IMMOBILIZER APPARATUS AND METHOD FOR IMMOBILIZING A PATIENT,” issued June 21, 2022.
The Invention Explained
- Problem Addressed: The patent describes conventional patient immobilization systems that rely on a series of loose, separate "shim" components that must be manually added or removed to tighten the fit of a thermoplastic mask. This process is described as "cumbersome" and time-consuming, particularly when adjustments are needed between treatment sessions due to patient anatomical changes ('088 Patent, col. 4:20-38).
- The Patented Solution: The invention is a patient immobilization apparatus with integrated adjustment mechanisms. It features a frame coupled to a thermoplastic preform, with multiple "separate locks" that attach the frame to a patient support. Crucially, each lock is associated with a "separate adjuster" that allows a clinician to finely adjust the distance between the frame and the support at each lock point, without disassembling the device or using loose shims ('088 Patent, col. 2:1-12; Fig. 4A-4C). This allows for independent adjustment at each location to achieve a secure and repeatable fit.
- Technical Importance: This approach sought to improve the efficiency, accuracy, and repeatability of patient setup for high-precision procedures like stereotactic radiosurgery, where sub-millimeter accuracy is required ('088 Patent, col. 1:47-52).
Key Claims at a Glance
- The complaint asserts independent claim 1.
- The essential elements of Claim 1 are:
- An immobilization apparatus comprising: a frame; a preform of low melting temperature thermoplastic coupled to the frame;
- "separate locks" mounted to the frame to lock the apparatus to a patient support, each with a movable plunger;
- "separate adjusters" associated with each lock to selectively adjust the distance between the frame and the support along the plunger's axis;
- The adjusters are separate, allowing for independent adjustment at each lock point; and
- Each adjuster is configured to "extend about the plunger axis" of its corresponding lock.
- The complaint does not assert any dependent claims but reserves the right to do so.
U.S. Patent No. 11,771,516 - ADJUSTABLE IMMOBILIZER APPARATUS AND METHOD FOR IMMOBILIZING A PATIENT
- Patent Identification: U.S. Patent No. 11,771,516, entitled “ADJUSTABLE IMMOBILIZER APPARATUS AND METHOD FOR IMMOBILIZING A PATIENT,” issued October 3, 2023.
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the '088 Patent, this patent addresses the same technical problem of creating an efficient and integrated adjustment system for patient immobilization devices ('516 Patent, col. 4:20-38).
- The Patented Solution: The patented solution is substantively the same as that of the '088 Patent, describing an apparatus with integrated locks and independent adjusters ('516 Patent, Abstract). The key claims include minor linguistic variations from the '088 Patent.
- Technical Importance: The technical importance is identical to that of the '088 Patent, focusing on improving the precision and efficiency of patient setup in radiotherapy ('516 Patent, col. 1:45-50).
Key Claims at a Glance
- The complaint asserts independent claim 1.
- The essential elements of Claim 1 are nearly identical to Claim 1 of the '088 patent, but with the addition of the phrase "when the separate locks are mounted to the frame" in several limitations. The key elements are:
- An immobilization apparatus comprising: a frame; a preform of low melting temperature thermoplastic coupled to the frame;
- "separate locks" configured to be mounted to the frame, each with a movable plunger;
- "separate adjusters" associated with each lock to selectively adjust the distance between the frame and the support "when the separate locks are mounted to the frame";
- The adjusters are separate, allowing for independent adjustment at each lock point "when the separate locks are mounted to the frame"; and
- Each adjuster is configured to "extend about the plunger axis" of its corresponding lock "when the separate locks are mounted to the frame."
- The complaint does not assert any dependent claims but reserves the right to do so.
III. The Accused Instrumentality
Product Identification
- The accused products are the "Klarity SRS Masks employing Klarity's Simple Shim System" (Compl. ¶ 17).
Functionality and Market Context
- The complaint alleges the accused products are patient immobilization systems used for stereotactic radiosurgery that compete directly with Plaintiff's "Integrated Shim™" system (Compl. ¶¶ 10, 16, 18).
- Functionally, the system is alleged to include a thermoplastic mask on a frame, multiple separate locks to secure the frame to a patient support, and separate adjusters that permit independent height adjustment at each lock location (Compl. ¶¶ 29-33). The complaint references "Klarity's Simple Shim SRS Instructions for Use" as documentary evidence showing how the product is intended to be used (Compl. ¶ 22). This document, attached as Exhibit 3 to the complaint, allegedly provides instructions that lead to infringement.
IV. Analysis of Infringement Allegations
'088 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a frame; | The Klarity SRS mask includes a frame. | ¶29 | col. 6:50-64 |
| a preform formed from a low melting temperature thermoplastic and configured to be formed to an anatomy of the patient, the preform being coupled to the frame; | The mask includes a preform made of "Klarity Blue™ thermoplastic," which is formed to a patient's head and coupled to the frame. | ¶30 | col. 6:15-24 |
| separate locks mounted to the frame each configured to lock the immobilization apparatus relative to the patient support, each of the separate locks having a plunger extending along a plunger axis, and each of the plungers being movable along the respective plunger axis between a locked position and an unlocked position; | The mask includes multiple separate locks mounted on the frame, each with a plunger movable between locked and unlocked positions to secure the mask to a patient support. | ¶31 | col. 7:15-18 |
| separate adjusters each configured to be associated with a corresponding one of the separate locks and each configured to selectively adjust a distance between the frame and the patient support along the plunger axis of the corresponding one of the separate locks; | The "Simple Shim System" includes separate adjusters provided at each lock that selectively adjust the distance between the frame and patient support along the plunger's axis. | ¶32 | col. 7:38-49 |
| the separate adjusters being separate from one another such that the distance...is adjustable independent of the distance...at another one of the separate locks, each of the separate adjusters being further configured to extend about the plunger axis of the corresponding one of the separate locks. | The adjusters are separate, allowing for independent height adjustment at each pin location. The adjusters are alleged to extend about the plunger axis. | ¶33 | col. 6:50-62 |
'516 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a frame; | The Klarity SRS mask includes a frame. | ¶57 | col. 6:57-61 |
| a preform formed from a low melting temperature thermoplastic and configured to be formed to an anatomy of a patient, the preform being coupled to the frame; | The mask includes a preform made of "Klarity Blue™ thermoplastic," which is formed to a patient's head and coupled to the frame. | ¶58 | col. 6:21-30 |
| separate locks configured to be mounted to the frame, each configured to lock the immobilization apparatus relative to the patient support, each of the separate locks having a plunger extending along a plunger axis, and each of the plungers being configured to be movable...between a locked position and an unlocked position... | The mask includes multiple separate locks mounted on the frame, each with a movable plunger to lock the mask to a patient support. | ¶59 | col. 10:25-33 |
| separate adjusters each configured to be associated with a corresponding one of the separate locks and each configured to selectively adjust a distance between the frame and the patient support...when the separate locks are mounted to the frame; | The "Simple Shim System" includes separate adjusters associated with each lock to selectively adjust the distance between the frame and support when the locks are mounted to the frame. | ¶60 | col. 10:34-41 |
| the separate adjusters being separate from one another such that a distance...is adjustable independent of a distance...at another one of the separate locks when the separate locks are mounted to the frame, each of the separate adjusters being further configured to extend about the plunger axis...when the separate locks are mounted to the frame. | The adjusters are separate, allowing for independent height adjustment when mounted to the frame. The adjusters are alleged to be configured to extend about the plunger axis when mounted to the frame. | ¶61 | col. 11:1-12 |
- Identified Points of Contention:
- Scope Questions: The patents describe an invention that improves upon prior art "shims" by integrating the adjustment mechanism ('088 Patent, col. 4:20-46). A principal question for the court will be whether the components of the accused "Simple Shim System" constitute the claimed "separate adjusters," or if they are merely a form of the separate "shim" components the patent sought to replace. The naming of the accused product itself suggests this will be a central dispute.
- Technical Questions: The claims require each adjuster to "extend about the plunger axis" of its corresponding lock. The infringement analysis will raise the question of whether the accused product's adjustment mechanism has this specific coaxial or surrounding geometric relationship. Evidence detailing the mechanical operation and structure of the "Simple Shim System" will be critical to resolving this issue.
V. Key Claim Terms for Construction
The Term: "separate adjusters"
- Context and Importance: This term is at the heart of the invention and the dispute. The patents distinguish the invention from prior art "loose and/or separate 'shim' components" ('088 Patent, col. 4:25-27). Defendant's product is named the "Simple Shim System." Therefore, the construction of "separate adjusters" will be critical to determining whether the accused product infringes, or whether it falls into the category of prior art that the patentee sought to improve upon.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests the term is not limited to a single structure, stating the adjuster "can take many forms including but not limited to a stepped slider, a wedge, a wheel, and a cam" ('088 Patent, col. 7:44-46). This may support a construction that covers a range of mechanical means for adjustment.
- Evidence for a Narrower Interpretation: The primary embodiment shown and described in detail is a highly integrated, co-located lock and adjuster mechanism (135) that is "inseparable from frame 120" without disassembly ('088 Patent, col. 7:55-58; Fig. 4A-4C). A party may argue that "adjusters" should be limited to such integrated, non-removable mechanisms to distinguish them from the "loose" shims of the prior art.
The Term: "extend about the plunger axis"
- Context and Importance: This limitation defines the spatial and functional relationship between the adjusting component and the locking component. Practitioners may focus on this term because infringement will depend on whether the accused device's mechanism has this specific coaxial or surrounding relationship.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue "about" should be given its ordinary meaning of "around" or "near," not necessarily requiring strict coaxiality.
- Evidence for a Narrower Interpretation: The detailed embodiment in Figure 4C shows the shaft (150) of the adjuster having a through-hole (154) through which the plunger (160) passes. This depiction of one component physically surrounding the other along its axis ('088 Patent, col. 8:30-34) could support a narrower construction requiring a coaxial or telescoping arrangement.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for the '088 Patent. Inducement is based on the allegation that Defendant provides instructions and marketing materials that encourage and direct customers to use the accused system in an infringing manner (Compl. ¶¶ 48-49). Contributory infringement is based on the allegation that the accused system is a material part of the invention, is not a staple article of commerce, and is especially made for an infringing use (Compl. ¶ 50).
- Willful Infringement: The complaint alleges willful infringement of the '088 Patent based on Defendant's alleged continued infringement after receiving a notice letter from Plaintiff on December 5, 2022 (Compl. ¶¶ 39, 41-43). The '516 patent issued after the complaint was filed, so willfulness is only alleged for the '088 patent.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "separate adjusters," which the patents frame as an integrated improvement over prior art "shims," be construed to cover the components of Defendant’s accused "Simple Shim System"? The outcome may depend on whether the court views the accused components as integrated mechanisms or as a new form of the disfavored separate shims.
- A second key question will be one of structural and functional equivalence: does the accused system’s adjustment mechanism physically "extend about the plunger axis" as required by the claims, or is there a fundamental difference in the mechanical configuration and operation of its locking and adjusting components compared to the patented design?
- Finally, the willfulness allegation raises an issue of objective recklessness: assuming infringement is found, did Defendant's continued sales of the accused product after receiving the December 5, 2022 notice letter constitute conduct that was objectively reckless in the face of a high likelihood of infringing a valid patent?