DCT

3:25-cv-00392

Raydiant Oximetry Inc v. Alc Medical Holdings LLC

I. Executive Summary and Procedural Information

Parties & Counsel:
- Plaintiff: Raydiant Oximetry, Inc. (Delaware)
- Defendant: ALC Medical Holdings LLC (Delaware)
- Plaintiff’s Counsel: Greenberg Traurig, LLP
Case Identification: 3:25-cv-00392, N.D. Cal., 01/10/2025
Venue Allegations: Plaintiff alleges venue is proper because Defendant is subject to personal jurisdiction in the district, has directed enforcement activities there, and a substantial part of the events giving rise to the claims occurred in the district, including a consulting agreement between the inventor and Plaintiff that provides for exclusive jurisdiction in Santa Clara County.
Core Dispute: Plaintiff seeks a declaratory judgment that its "DAISY" medical device does not infringe Defendant’s patent related to postpartum hemorrhage mitigation devices.
Technical Context: The technology concerns medical devices designed to control and monitor postpartum hemorrhage (PPH), a leading cause of maternal mortality, by applying negative pressure to the uterus and evacuating blood.
Key Procedural History: The complaint outlines a contentious history between Plaintiff and the patent’s inventor, who is also the controlling member of the Defendant. This history includes a consulting agreement, disputes over inventorship of a provisional application to which the patent-in-suit claims priority, and multiple cease-and-desist letters from Defendant’s counsel accusing Plaintiff of infringement and demanding cessation of development of its "DAISY" device.

Case Timeline

Date	Event
2021-11-01	Raydiant and inventor Ms. Cobb enter into a Consulting Agreement.
2022-04-06	Priority date of ’408 Patent (filing of Provisional App. 63/328,257).
2022-12-XX	Defendant's counsel first threatens Raydiant regarding its prototype.
2023-03-16	Application for ’408 Patent filed.
2023-12-12	U.S. Patent No. 11,839,408 issues.
2024-12-11	Defendant sends cease-and-desist letter alleging infringement.
2025-01-10	Complaint for Declaratory Judgment filed.

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

U.S. Patent No. 11,839,408 - "Systems, Devices, and Methods for Uterine Hemostasis," Issued December 12, 2023

The Invention Explained

Problem Addressed: The patent addresses postpartum hemorrhage (PPH), where the uterus fails to contract after childbirth, leading to uncontrolled bleeding (’408 Patent, col. 4:5-11). It notes the difficulty in accurately diagnosing and quantifying blood loss using traditional visual estimation, which is often inaccurate and complicated by the presence of other bodily fluids (’408 Patent, col. 6:3-19).
The Patented Solution: The invention is a device, inserted into the uterus, that applies negative pressure (suction) to cause "mechanical hemostasis"—physically encouraging the uterine wall to contract and stop bleeding—while simultaneously evacuating blood for accurate measurement (’408 Patent, Abstract; col. 8:16-24). The device includes a flexible tube with a suction line extension, an "anchoring mechanism" to hold it in place, and a slidable "placement marker" for customizing the fit to the patient's uterus (’408 Patent, col. 1:21-40; Fig. 1).
Technical Importance: The device aims to provide a proactive treatment for uterine atony and a quantitative tool for monitoring blood loss, addressing shortcomings in traditional PPH management (’408 Patent, col. 6:58-65).

Key Claims at a Glance

The complaint seeks a declaratory judgment of non-infringement of "any claim of the patent-in-suit" (Compl. ¶32). Independent claim 1 is representative.
Independent Claim 1:
- a flexible tube comprising: a distal end; a proximal tip with a suction line extension for placement in a uterine cavity; a tube center; and at least one lumen around the tube center comprising a suction line;
- the suction line being in communication with a source of negative pressure for applying negative pressure to the uterine cavity, thereby causing mechanical hemostasis;
- a placement marker configured for movement along the suction line extension for personalization of the device to a size of the uterus, the placement marker covering one or more ports; and
- an anchoring mechanism proximate to the suction line extension, configured for maintaining the suction line extension in a desired position within the uterine cavity.
The complaint does not specify particular dependent claims.

III. The Accused Instrumentality

Product Identification

Plaintiff’s "DAISY" device and other "post-partum hemorrhage devices" (Compl. ¶¶ 17, 35A).

Functionality and Market Context

The complaint describes the DAISY device as a "post-partum hemorrhage mitigation device" and a "prototype" that Plaintiff has been developing (Compl. ¶¶ 20, 24). It does not provide any specific technical details regarding the structure or operation of the DAISY device itself. The controversy arises from Defendant's assertion that the "current prototype is derived from her January [2022] invention" and infringes the ’408 Patent (Compl. ¶¶ 17, 24).

IV. Analysis of Infringement Allegations

As a complaint for declaratory judgment of non-infringement, the filing does not contain a claim chart or detailed infringement allegations against the Plaintiff's device. Instead, it establishes a justiciable controversy by referencing cease-and-desist letters from the Defendant that accuse Plaintiff's DAISY device of infringement (Compl. ¶¶ 20, 24). The complaint asserts blanket non-infringement of any claim, either directly or indirectly (Compl. ¶32).

The complaint does not provide sufficient detail for a claim chart analysis. No probative visual evidence provided in complaint.

Identified Points of Contention: Based on the patent claims and the general nature of the dispute, the core questions for infringement will likely involve factual and legal comparisons between the DAISY device and specific claim limitations.
- Scope Questions: The analysis will likely focus on whether the DAISY device contains structures that meet the definitions of the claimed "placement marker" and "anchoring mechanism." For example, does the DAISY device have any component that is "configured for movement along the suction line extension for personalization" as required for the "placement marker" in claim 1?
- Technical Questions: A central evidentiary issue will be whether the DAISY device, in its actual operation, includes a distinct "anchoring mechanism" for maintaining position separate from any other component, or if its positioning is achieved through other means not covered by the claims. The specific configuration and function of any ports on the DAISY device will also be compared against limitations such as those in dependent claim 5, which requires a "one-hundred-and-eighty-degree spiral configuration."

V. Key Claim Terms for Construction

1. "placement marker"
- Context and Importance: This term appears in independent claim 1 and is a key structural element. Claim 1 requires the marker to be "configured for movement along the suction line extension for personalization... to a size of the uterus" and to cover "one or more ports." Whether the DAISY device has a component that performs this specific combination of functions will be a critical point of the non-infringement analysis.
- Intrinsic Evidence for Interpretation:
  - Evidence for a Broader Interpretation: The term "placement marker" itself is generic. Parties seeking a broader construction may argue that any feature indicating or adjusting placement depth could qualify.
  - Evidence for a Narrower Interpretation: The claim itself provides significant narrowing language, defining its function for "personalization" and its structure as being movable and covering ports (’408 Patent, col. 16:45-49). The specification describes it as an "hourglass shaped placement marker" that can "slide up and cover ports" (’408 Patent, col. 12:61-65; col. 15:28-29). This specific embodiment (Fig. 4, 460) may be used to argue for a narrower construction limited to structures with similar characteristics.
2. "anchoring mechanism"
- Context and Importance: This is another key element of independent claim 1, defined by its function of "maintaining the suction line extension in a desired position within the uterine cavity" (’408 Patent, col. 16:50-54). The existence and nature of such a mechanism in the DAISY device is a likely point of dispute.
- Intrinsic Evidence for Interpretation:
  - Evidence for a Broader Interpretation: A party could argue the term covers any feature that helps resist displacement, regardless of its specific form. The claim language is primarily functional.
  - Evidence for a Narrower Interpretation: The specification discloses several specific embodiments, including a "collapsible anchoring mechanism" like an umbrella (Fig. 4, 450), an "inflatable anchoring mechanism" (Fig. 2A, 220), and a "wavy placement anchor" (Fig. 4, 470) (’408 Patent, col. 2:25-28, 2:33-34, 2:59-60). A party arguing for a narrower scope may contend that the term should be limited to these disclosed structures or their equivalents, rather than encompassing any incidental feature that helps with positioning.

VI. Other Allegations

Willful Infringement: The complaint states that the Defendant, in a December 11, 2024 letter, alleged that Plaintiff’s "failure to comply with the demands" to cease development by January 10, 2025 "constitutes willful infringement" (Compl. ¶24). This allegation of willfulness originates from the Defendant (the patent holder) and forms part of the basis for the Plaintiff’s reasonable apprehension of suit.

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

This declaratory judgment action appears poised to center on fundamental questions of claim scope and factual infringement, precipitated by a contentious business and development history between the parties.

A core issue will be one of definitional scope: Will the claim terms "placement marker" and "anchoring mechanism" be construed broadly based on their functional language, or will they be narrowed by the specific embodiments described in the '408 patent's specification? The outcome of claim construction will likely determine the infringement analysis.
A key evidentiary question will be one of structural and functional correspondence: Assuming a claim construction is reached, does the Plaintiff's DAISY device, as a matter of fact, contain any physical components that perform the specific functions of the claimed "placement marker" (i.e., movable personalization) and "anchoring mechanism" (i.e., maintaining position)? The case will turn on a direct comparison of the accused device's features against the court's interpretation of the patent's claims.