DCT
1:24-cv-01124
Magnolia Medical Tech Inc v. Kurin Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Magnolia Medical Technologies, Inc. (Washington)
- Defendant: Kurin, Inc. (Delaware)
- Plaintiff’s Counsel: Davis Polk & Wardwell LLP
- Case Identification: 1:24-cv-0428, S.D. Cal., 03/04/2024
- Venue Allegations: Venue is alleged to be proper as Defendant has a regular and established place of business in the Southern District of California and has committed the alleged acts of infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Kurin Jet blood collection systems infringe five U.S. patents related to methods and devices for reducing contamination in bodily-fluid samples.
- Technical Context: The technology addresses the problem of false-positive results in blood cultures, often used to diagnose sepsis, by diverting the initial, potentially contaminated portion of a blood draw before collecting a sample for analysis.
- Key Procedural History: The complaint notes a prior federal trial in which a jury found Defendant’s first-generation "Kurin Lock" product infringed a related patent owned by the Plaintiff. Plaintiff also alleges it provided Defendant with pre-suit notice of several 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 | Accused "Kurin Lock" Product Launch (approx.) |
| 2017-09-12 | Priority Date for ’081, ’863, and ’709 Patents |
| 2018-01-02 | ’002 Patent Issued |
| 2018-08-21 | ’053 Patent Issued |
| 2022-01-01 | Prior Jury Verdict Finding Infringement by "Kurin Lock" (approx. Summer 2022) |
| 2022-12-20 | ’081 Patent Issued |
| 2023-02-15 | Accused "Kurin Jet" Product Launch |
| 2023-02-23 | Plaintiff's Notice Letter to Defendant Identifying Patents |
| 2023-05-23 | ’863 Patent Issued |
| 2024-02-20 | ’709 Patent Issued |
| 2024-03-04 | Complaint Filing Date |
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 parenteral procurement of bodily fluids, such as blood for culture testing, can be contaminated by microbes residing on a patient's skin, leading to spurious microbial test results (false positives) ('053 Patent, col. 1:62-2:10). Such false positives can lead to unnecessary, costly, and potentially harmful anti-microbial therapies ('053 Patent, col. 2:1-10).
- The Patented Solution: The invention is a method that reduces contamination by first establishing fluid communication between a patient and a collection device, receiving an initial volume of blood into a first fluid flow path to be sequestered, and then transitioning flow to a second path to receive a subsequent, cleaner blood sample into a sample vessel ('053 Patent, col. 3:1-10; Compl. ¶66). This diverts the initial portion of the draw, which is most likely to contain skin contaminants, away from the final test sample ('053 Patent, col. 6:49-62).
- Technical Importance: This method provides a systematic way to mitigate the primary source of contamination in blood cultures, thereby improving the accuracy of critical diagnostic tests for conditions like sepsis (Compl. ¶¶16-18).
Key Claims at a Glance
- The complaint asserts independent method claim 17 ('002 Patent, col. 14:1-23; Compl. ¶66).
- 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 to a second fluid flow path after the first path receives the initial volume, such that the initial volume is sequestered; and
- receiving a subsequent blood sample into the sample vessel.
- The complaint alleges infringement of all claims of the patent (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: As with the related ’002 Patent, the technology addresses contamination of bodily fluid samples from dermally-residing microbes, which can cause false-positive test results ('053 Patent, col. 1:62-2:10).
- The Patented Solution: The patent describes a device for obtaining a blood sample that incorporates the diversion principle. The device features a first fluid flow path to receive an initial volume of blood, a second fluid flow path for a subsequent sample, and a junction between them. The device is configured to automatically transition flow from the first path to the second path, sequestering the initial, contaminated volume in the first path ('053 Patent, Abstract; col. 7:46-8:30).
- Technical Importance: This device automates the process of diverting an initial blood sample, aiming to standardize the collection procedure and reduce the potential for user error in preventing contamination (Compl. ¶¶23-24).
Key Claims at a Glance
- The complaint asserts independent device claim 1 ('053 Patent, col. 11:7-28; Compl. ¶79).
- 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 for fluid communication with a sample vessel; and
- a junction 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 of blood being sequestered in the first path when in the second state.
- The complaint alleges infringement of all claims of the patent (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 claims a fluid control device that uses a selectively permeable blood barrier and a moveable plug to manage fluid flow. A pressure differential allows an initial volume of blood into a containment channel; contact with this blood causes the barrier to change properties, which in turn builds pressure to move the plug and open a separate sampling channel ('081 Patent, Abstract; col. 2:57-3:12).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶90).
- Accused Features: The Kurin Jet's internal mechanism, which allegedly contains a containment ("waste") channel, a sampling channel, a selectively permeable barrier, and a moveable plug that shifts to open the sampling channel after the waste channel fills (Compl. ¶¶94-98).
U.S. Patent No. 11,653,863 - "Fluid Control Devices and Methods of Using the Same" (Issued May 23, 2023)
- Technology Synopsis: This patent is directed to a fluid control device with a containment channel and a sampling channel separated by a moveable plug. The plug is configured to move from a first position (blocking the sampling channel) to a second position in response to a pressure differential in the sampling channel exceeding a threshold, which occurs as a result of blood filling the containment channel ('863 Patent, Abstract; col. 2:60-3:11).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶104).
- Accused Features: The Kurin Jet's alleged use of a moveable plug between its waste and sample channels that moves in response to pressure changes caused by the filling of the waste channel (Compl. ¶¶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 claims a fluid control device with a containment channel and a sampling channel, wherein a "valve" obstructs the flow path in a first state. A blood barrier allows gas to flow, drawing an initial blood volume into the containment channel. Contact with this blood causes the barrier to build a pressure differential sufficient to transition the valve to a second state, allowing blood to flow through the sampling channel ('709 Patent, Abstract; col. 2:57-3:11).
- Asserted Claims: Independent claim 1 is asserted (Compl. ¶118).
- Accused Features: The Kurin Jet's alleged use of a valve that transitions from a first state to a second state to open a sample channel, triggered by pressure buildup resulting from the filling of a separate waste channel (Compl. ¶¶124, 126).
III. The Accused Instrumentality
Product Identification
- The accused products are all configurations of Kurin's blood-collection sets that use "Kurin Jet technology," including those marketed as 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 is a blood collection system used to reduce contamination from a patient's skin (Compl. ¶¶67, 80). When attached between a patient's venous access (e.g., a butterfly needle) and a vacuum source (e.g., a blood culture bottle), the device is alleged to first divert an initial 0.15ml of blood into a "waste channel" (Compl. ¶67). Once this channel is filled, the device allegedly allows "fresh blood" to enter a separate "sample channel" for collection (Compl. ¶67). A screenshot from a video on Kurin's website shows a clear device where an initial volume of blood fills a side channel before subsequent blood flows through a main channel (Compl. ¶71). Plaintiff identifies Defendant as its "sole commercial competitor" (Compl. ¶1).
IV. Analysis of Infringement Allegations
U.S. Patent No. 9,855,002 Infringement Allegations
| Claim Element (from Independent Claim 17) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| establishing fluid communication between a lumen-containing device and the patient; | The Kurin Jet is used with a lumen-containing device like a butterfly needle to gain venous access to a patient. | ¶68 | col. 3:65-4:4 |
| establishing fluid communication between the lumen-containing device and a first fluid flow path; | The lumen-containing device is connected to the Kurin Jet, establishing a flow path for an initial volume of blood into the device's "waste channel." | ¶69 | col. 6:4-7 |
| receiving an initial volume of blood from the patient; | The Kurin Jet receives an initial 0.15mL of blood from the patient into its "waste channel" when attached to a vacuum source. | ¶71 | col. 6:4-7 |
| 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 from the patient such that the initial volume of blood is sequestered... | Once the waste channel is filled, the device operates in a second state where fresh blood is allowed to enter the "sample channel," thereby sequestering the initial volume. | ¶72 | col. 7:46-56 |
| receiving a subsequent blood sample into the sample vessel. | After the transition, fresh blood flows through the sample channel into a sample vessel, such as a blood culture bottle or syringe. | ¶73 | col. 6:10-14 |
U.S. Patent No. 10,052,053 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first fluid flow path configured to receive a first volume of blood from the patient; | The Kurin Jet device includes a "waste channel" that is configured to receive an initial 0.15mL of blood from the patient. | ¶81 | col. 7:51-53 |
| a second fluid flow path configured to be placed in fluid communication with a sample vessel... | The Kurin Jet device includes a "sample channel" which is placed in fluid communication with a sample vessel, such as a blood culture bottle containing culture media. | ¶82 | col. 7:54-56 |
| a junction...the device configured to automatically transition...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 Kurin Jet device is alleged to automatically transition between a first state (filling the waste channel) and a second state (filling the sample channel) once the waste channel is filled, thereby sequestering the initial blood volume. | ¶83 | col. 8:20-30 |
Identified Points of Contention
- Scope Questions: The dispute may center on the definition of "sequestered." The complaint highlights that this was a key issue in prior litigation, suggesting Defendant may argue its "sidelining" of blood does not meet the patent's requirement for sequestration (Compl. ¶¶38-43). A second scope question relates to the term "automatically transition" in the ’053 Patent. The parties may dispute whether the mechanism in the Kurin Jet that switches flow paths qualifies as an "automatic" transition as contemplated by the patent, or if it operates on a different principle.
- Technical Questions: A key technical question will be how the Kurin Jet device actually achieves the transition between filling the waste channel and the sample channel. The complaint relies on marketing descriptions and animations (Compl. ¶¶71-72, 83), but the underlying physical mechanism will be critical, especially for the more detailed claims of the '081, '863, and '709 patents, which recite specific components like a "moveable plug" and "selectively permeable blood barrier."
V. Key Claim Terms for Construction
The Term: "sequestered" (from '002 Claim 17 and '053 Claim 1)
- Context and Importance: This term is critical as it defines the fate of the initial, contaminated blood volume. The complaint alleges that in prior litigation over a similar product, Defendant unsuccessfully argued its device did not "sequester" blood (Compl. ¶¶38-43). Practitioners may focus on this term because its construction will determine whether simply diverting blood into a waste channel, without necessarily trapping it permanently, constitutes infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that "an initial volume of withdrawn bodily fluid is placed in one or more pre-sample reservoirs and is not used for the incubation in culture media," suggesting a functional definition based on non-use rather than permanent isolation ('053 Patent, col. 3:6-10).
- Evidence for a Narrower Interpretation: Claim 1 of the ’053 Patent requires the blood to be "sequestered in the first fluid flow path," which could be argued to imply containment within that specific structure, not just diversion to a general waste area ('053 Patent, col. 11:26-27).
The Term: "automatically transition" (from '053 Claim 1)
- Context and Importance: This term is central to how the patented device shifts from diverting the initial sample to collecting the final sample. The infringement analysis will depend on whether the Kurin Jet's mechanism operates "automatically" as the patent requires.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract describes a device "configured to automatically transition," suggesting a focus on the device's inherent capability rather than a specific mechanism ('053 Patent, Abstract). The specification describes the transition as occurring "in response to filling the reservoir" ('053 Patent, col. 12:7-8).
- Evidence for a Narrower Interpretation: The specification discloses specific mechanical embodiments for this transition, such as a "switchable valve" that pivots (Fig. 6A-6B) and "slidably-mounted output flow-control block" (Fig. 7A-7B) ('053 Patent, col. 7:46-47, 8:21-24). A defendant may argue the term should be limited to such disclosed mechanical means that operate without user intervention after the initial setup.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement under 35 U.S.C. § 271(b) (Compl. ¶¶74, 85, 99, 113, 127). The allegations are based on Defendant's website and instructions, which allegedly instruct customers to use the Accused Products with butterfly needles and vacuum sources in a manner that directly infringes the asserted patents (Compl. ¶74).
- Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge of the patents (Compl. ¶¶53, 55). This knowledge is allegedly derived from a prior jury verdict finding infringement by Defendant's similar "Kurin Lock" product and a specific notice letter sent by Plaintiff to Defendant on February 23, 2023, which identified U.S. Patent Nos. 9,855,002; 10,052,053; 11,529,081; and the application leading to the '863 Patent (Compl. ¶55).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope and preclusion: given the prior litigation involving the "Kurin Lock" and the term "sequester," a central question will be how the court construes this and other key terms like "automatically transition." The extent to which findings from the prior case may influence the current dispute will be a significant procedural and substantive question.
- A key evidentiary question will be one of technical operation: does the actual internal mechanism of the Kurin Jet function as required by the specific mechanical limitations of the later-issued patents ('081, '863, and '709)? The infringement analysis will likely move beyond high-level animations and require detailed evidence on whether the device contains a "moveable plug" or "valve" that transitions in response to the specific pressure differentials claimed.