DCT

3:24-cv-00428

Magnolia Medical Tech Inc v. Kurin Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-00428, S.D. Cal., 03/04/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the Southern District of California because Defendant's principal place of business is in San Diego, constituting a regular and established place of business, and because acts of infringement allegedly occurred within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Kurin Jet line of blood collection products infringes five patents related to methods and devices for reducing contamination in blood samples by diverting and sequestering an initial volume of the draw.
  • Technical Context: The technology addresses the problem of false-positive results in blood culture tests, often caused by skin contaminants collected during venipuncture, which can lead to misdiagnosis of conditions like sepsis and unnecessary antibiotic treatment.
  • Key Procedural History: The complaint alleges this is the second patent infringement lawsuit between the parties. In a prior case, a 2022 jury verdict found that Defendant's first-generation "Kurin Lock" device infringed one of Plaintiff's patents. Plaintiff also alleges it provided Defendant with pre-suit notice of at least three of the patents-in-suit via a letter dated February 23, 2023.

Case Timeline

Date Event
2006-12-18 Priority Date for ’002 and ’053 Patents
2017-01-01 Kurin commercially launches first-generation "Kurin Lock" device
2017-09-12 Priority Date for ’081, ’863, and ’709 Patents
2018-01-02 U.S. Patent No. 9,855,002 Issues
2018-08-21 U.S. Patent No. 10,052,053 Issues
2022-07-01 Jury verdict finds Kurin's "Kurin Lock" infringes Magnolia patent (approx. date)
2022-12-20 U.S. Patent No. 11,529,081 Issues
2023-02-15 Kurin announces commercial release of accused "Kurin Jet" device
2023-02-23 Magnolia sends letter to Kurin identifying patents-in-suit
2023-05-23 U.S. Patent No. 11,653,863 Issues
2024-02-20 U.S. Patent No. 11,903,709 Issues
2024-03-04 Complaint Filed

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

U.S. Patent No. 9,855,002, "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples With Reduced Contamination," issued January 2, 2018

The Invention Explained

  • Problem Addressed: The patent describes the problem of contamination of parenterally-obtained bodily fluids, such as blood, by microbes residing on the skin, which can lead to spurious microbial test results and cause patients to undergo unnecessary treatments (Compl. ¶¶16-18; citing the technological field).
  • The Patented Solution: The invention is a method for procuring a blood sample with reduced contamination. The method involves establishing fluid communication with a patient, receiving an initial, contaminant-prone volume of blood into a first flow path, and then transitioning the flow at a junction to a second flow path to collect a subsequent, cleaner blood sample for testing. The initial volume is sequestered and not used for the culture test (Compl. ¶66). The patent specification describes this process as a way to wash potentially dislodged microbes into a pre-sample reservoir before the actual sample is collected (Compl. Ex. 1, p. 16, col. 6:1-11).
  • Technical Importance: This method provides a systematic approach to mitigate a known source of error in blood culture testing, aiming to improve diagnostic accuracy for critical conditions like sepsis (Compl. ¶15).

Key Claims at a Glance

  • The complaint asserts independent method claim 17 (Compl. ¶65).
  • Essential elements of claim 17 include:
    • establishing fluid communication between a lumen-containing device and the patient;
    • establishing fluid communication between the lumen-containing device and a first fluid flow path;
    • receiving an initial volume of blood from the patient;
    • transitioning at a junction between the first and a second fluid flow path as a result of the first flow path receiving the initial volume, such that the initial volume is sequestered and fluid communication is established with a sample vessel via the second flow path; and
    • receiving a subsequent blood sample into the sample vessel.
  • The complaint alleges infringement of "all claims," reserving the right to assert dependent claims (Compl. ¶64).

U.S. Patent No. 10,052,053, "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples With Reduced Contamination," issued August 21, 2018

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem of microbial contamination in bodily-fluid samples leading to false positives and unnecessary medical burdens on patients and the healthcare system (’053 Patent, col. 2:1-10).
  • The Patented Solution: The invention is a device for obtaining a blood sample with reduced contamination. The device comprises a first fluid flow path to receive an initial blood volume, a second fluid flow path to communicate with a sample vessel, and a junction between them. The core of the invention is that the device is "configured to automatically transition" from a first state (directing blood to the first path) to a second state (directing blood to the second path) once the first volume is received and sequestered (’053 Patent, col. 11:8-25). This automation avoids the need for manual user intervention to switch the flow path after the initial diversion volume is collected (’053 Patent, col. 7:56-8:2).
  • Technical Importance: By automating the transition between diverting the initial draw and collecting the test sample, the device aims to simplify the process for clinicians and ensure the diversion occurs correctly and consistently (Compl. ¶¶19-21).

Key Claims at a Glance

  • The complaint asserts independent device claim 1 (Compl. ¶78).
  • Essential elements of claim 1 include:
    • a first fluid flow path configured to receive a first volume of blood from the patient;
    • a second fluid flow path configured to be placed in fluid communication with a sample vessel; and
    • a junction in fluid communication with both flow paths, where the device is configured to automatically transition from a first state (where blood flows via the first path) to a second state (where blood flows via the second path), with a portion of the first volume being sequestered in the first path when in the second state.
  • The complaint alleges infringement of "all claims," reserving the right to assert dependent claims (Compl. ¶77).

U.S. Patent No. 11,529,081, "Fluid Control Devices and Methods of Using the Same," issued December 20, 2022

  • Technology Synopsis: This patent describes a fluid control device with a "containment channel" for an initial blood volume and a "sampling channel" for the subsequent test sample. The device incorporates a "selectively permeable blood barrier" that initially allows gas to flow to create a pressure differential for drawing blood into the containment channel, and a "moveable plug" that subsequently shifts position to open the sampling channel (’081 Patent, Abstract; col. 1:57-2:7).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶89).
  • Accused Features: The complaint alleges the Kurin Jet is a fluid control device with a "waste channel" (containment channel) and a "sample channel," a selectively permeable blood barrier, and a moveable plug that shifts to allow blood to flow into the sample channel after the waste channel is filled (Compl. ¶¶91, 94-96).

U.S. Patent No. 11,653,863, "Fluid Control Devices and Methods of Using the Same," issued May 23, 2023

  • Technology Synopsis: This patent discloses a fluid control device similar to the ’081 Patent, featuring a housing with a containment channel and a sampling channel. The invention is characterized by a selectively permeable blood barrier and a moveable plug that shifts from a first to a second position in response to a pressure differential exceeding a threshold, which occurs as a result of the initial volume of blood filling the containment channel (’863 Patent, Abstract; col. 2:2-20).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶103).
  • Accused Features: The complaint alleges the Kurin Jet embodies a housing with a waste and sample channel, a blood barrier, and a moveable plug that transitions in response to a pressure differential created by the initial blood draw, thereby meeting the claim limitations (Compl. ¶¶105, 108-112).

U.S. Patent No. 11,903,709, "Fluid Control Devices and Methods of Using the Same," issued February 20, 2024

  • Technology Synopsis: This patent describes a fluid control device using a "valve" (rather than a "moveable plug") that is configured to substantially obstruct flow when in a first state. The device uses a selectively permeable blood barrier to help draw an initial volume into a containment channel; contact with this blood then helps build a pressure differential that transitions the valve to a second state, allowing subsequent blood to flow through a sampling channel to the outlet (’709 Patent, Abstract; col. 2:7-22).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶117).
  • Accused Features: The complaint alleges the Kurin Jet's internal moveable component functions as the claimed "valve," which transitions states based on pressure changes resulting from the initial blood draw filling the "waste channel" (Compl. ¶¶119, 122, 124, 126).

III. The Accused Instrumentality

Product Identification

The accused products are all configurations of Kurin's blood-collection sets that incorporate or use the "Kurin Jet" technology, including Venipuncture Collection Sets, Peripheral IV Collection Sets, and Low-Volume Syringe Collection Sets (Compl. ¶7).

Functionality and Market Context

The complaint alleges the Kurin Jet device is intended for use as a blood collection system that "sidelines the initial 0.15ml of blood, which may contain contaminants from the patient's own skin" (Compl. ¶67). The device allegedly operates in two distinct states: a first state where, upon connection to a vacuum source (like a blood culture bottle or syringe), the initial blood volume is "immediately sidelined into the waste channel," and a second state where, "[o]nce the waste channel is filled, fresh blood is allowed to enter the sample channel" (Compl. ¶¶71, 72). The complaint provides screenshots from a "Kurin Jet in Action" video that purports to show this internal two-state transition (Compl. pp. 17-18). Plaintiff identifies Defendant as its "sole commercial competitor" (Compl. ¶1).

IV. Analysis of Infringement Allegations

’002 Patent Infringement Allegations

Claim Element (from Independent Claim 17) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of using a sample procurement device... the method comprising: establishing fluid communication between a lumen-containing device and the patient; The Accused Products are used with a lumen-containing device (e.g., a butterfly needle) to gain venous access to a patient, thereby establishing fluid communication. ¶68 col. 5:19-24
establishing fluid communication between the lumen-containing device and a first fluid flow path; Upon gaining venous access and attaching a vacuum source, the Accused Products establish fluid communication between the needle and the device's "waste channel." ¶69 col. 5:25-36
receiving an initial volume of blood from the patient; The Accused Products are configured to draw an initial 0.15mL of blood from the patient into the waste channel. The complaint includes a screenshot from a video showing the device in an initial state where blood has begun to enter. ¶71 col. 5:30-33
transitioning at a junction between the first fluid flow path and a second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood... such that the initial volume of blood is sequestered and such that fluid communication is established between the lumen-containing device and a sample vessel... The Accused Products are alleged to be configured to operate in two distinct states. After the initial blood fills the "waste channel," the device transitions, establishing a new flow path to a "sample channel" that connects to the sample vessel (e.g., blood culture bottle). ¶72 col. 7:29-44
receiving a subsequent blood sample into the sample vessel. Once the waste channel is filled, "fresh blood is allowed to enter the sample channel" for collection into the attached sample vessel (e.g., a syringe or culture bottle). ¶73 col. 6:12-16
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the term "transitioning at a junction" in this method claim requires a specific type of user action or if the passive, flow-driven change within the accused device constitutes the claimed "transitioning."
    • Technical Questions: The analysis may focus on whether the accused device's "waste channel" and subsequent "sample channel" function as the claimed "first fluid flow path" and "second fluid flow path" that meet at a "junction" as contemplated by the patent. The complaint's visual evidence from the "Kurin Jet in Action" video will be a focal point for demonstrating this alleged transition (Compl. p. 18).

’053 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A device... comprising: a first fluid flow path configured to receive a first volume of blood from the patient; The Accused Products contain a "waste channel," which is alleged to be the claimed first fluid flow path, configured to receive an initial 0.15mL of blood. ¶81 col. 7:45-51
a second fluid flow path configured to be placed in fluid communication with a sample vessel, the sample vessel containing a culture media; The Accused Products contain a "sample channel," alleged to be the second fluid flow path, which is placed in fluid communication with a sample vessel, such as a blood culture bottle or syringe. ¶82 col. 7:51-54
a junction in fluid communication with the first fluid flow path and the second fluid flow path, the device configured to automatically transition at the junction from a first state... to a second state... a portion of the first volume of blood being sequestered in the first fluid flow path when the device is in the second state... The Accused Products are alleged to operate in two distinct states. The complaint alleges that "[o]nce the waste channel is filled, fresh blood is allowed to enter the sample channel," constituting an automatic transition where the initial blood is sequestered in the waste channel. ¶83 col. 8:1-24
whereby sequestering the portion of the first volume of blood sequesters contaminants... The device's alleged function of sidelining the initial 0.15mL of blood is claimed to sequester skin contaminants, thereby reducing contamination in the subsequent sample. ¶84 col. 11:21-25
  • Identified Points of Contention:
    • Scope Questions: The definition of "automatically transition" will be a critical point of contention. The question will be whether the fluid-dynamic mechanism within the accused device, which is triggered by the filling of the waste channel, meets the legal construction of this term as used in the patent.
    • Technical Questions: Evidence will focus on the internal mechanics of the Kurin Jet. The screenshots from the marketing video, showing an internal component shifting position as blood fills the device, are presented as direct evidence of this automatic transition and sequestration (Compl. pp. 24-25). A potential dispute is whether this mechanism is structurally and functionally equivalent to the "junction" described in the patent's specification.

V. Key Claim Terms for Construction

  • The Term: "a junction... configured to automatically transition" (’053 Patent, Claim 1)

  • Context and Importance: This term is the central feature of the asserted independent claim of the ’053 Patent. The infringement dispute will likely depend on whether the internal mechanism of the Kurin Jet, which redirects blood flow after an initial volume is collected, falls within the court's construction of this phrase. Practitioners may focus on this term because the allegation of an "automatic" feature distinguishes the invention from methods requiring manual steps to switch flow paths.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the transition in functional terms, stating that in some embodiments, "the diversion mechanism 512 can be either manually or automatically switched" (’053 Patent, col. 7:24-26). This could support a construction where "automatic" means any transition not requiring direct, contemporaneous user manipulation of the junction itself once the process starts.
    • Evidence for a Narrower Interpretation: The specification provides specific examples of diversion mechanisms, including a "switchable valve 602" that pivots (FIG. 6A) and "slidably-mounted" flow-control blocks (FIG. 7A) (’053 Patent, col. 7:55-8:24). A defendant may argue these embodiments limit the scope of "junction" to these or similar mechanical structures, and that the accused product operates differently.

  • The Term: "transitioning at a junction... such that the initial volume of blood is sequestered" (’002 Patent, Claim 17)

  • Context and Importance: This phrase describes the core functional step of the asserted method claim. The dispute may turn on what actions constitute "transitioning" and what state constitutes "sequestered." The complaint alleges the accused device's operation performs this method step automatically.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent describes the overall goal as placing an initial volume "in one or more pre-sample reservoirs" that is "not used for the incubation in culture media" (’002 Patent, Abstract). This could support a broad functional interpretation where any process that isolates the initial draw meets the "sequestered" limitation.
    • Evidence for a Narrower Interpretation: The detailed description discusses the use of distinct, separate "pre-sample reservoirs 104" and "sample vessels 106," often with separate septa for needle insertion (’002 Patent, col. 4:51-54). A defendant might argue that "sequestered" requires isolation in a physically separate container, rather than a temporarily used internal channel within an integrated device.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for all five patents-in-suit. The allegations are based on Defendant's website, marketing materials, and user instructions, which allegedly instruct customers on how to use the Accused Products in an infringing manner, for example by connecting them to a needle and a vacuum source to perform the patented methods (Compl. ¶¶74, 85, 99, 113, 127).
  • Willful Infringement: The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. The basis includes a February 23, 2023 notice letter from Plaintiff's CEO to Defendant's CEO identifying U.S. Patent Nos. 9855002, 10052053, 11529081, and the application that led to the '863 Patent (Compl. ¶55). The complaint also cites the prior jury verdict of infringement against Defendant's first-generation product as evidence of knowledge of Plaintiff's patent portfolio and the risk of infringement (Compl. ¶51).

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

  • A core issue will be one of claim construction: how will the court define the term "automatically transition" as recited in the asserted device patents? The case may depend on whether this term is construed broadly to cover any mechanism that redirects flow without direct user interaction after initiation, or more narrowly to the specific valve and slide-block embodiments described in the patent specifications.
  • A second central issue will be one of willfulness: considering the prior litigation between the parties that resulted in a jury verdict of infringement against Defendant's previous product, and the explicit pre-suit letter identifying a majority of the asserted patents, what evidence will be required to determine if the alleged infringement by the new "Kurin Jet" product was deliberate and egregious, potentially justifying enhanced damages?
  • A key evidentiary question will be one of technical operation: does the internal mechanism of the accused Kurin Jet, as depicted in its marketing videos, perform the same function in substantially the same way to achieve the same result as the patented inventions? The analysis will focus on whether the fluid dynamics of filling a "waste channel" to trigger a flow-path change is equivalent to the patented concepts of a "junction," "moveable plug," or "valve."