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: Fish & Richardson P.C.
• Case Identification: 1:19-cv-00097, D. Del., 03/07/2019
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because the defendant, Kurin, Inc., is a Delaware corporation and therefore resides in the district.
• Core Dispute: Plaintiff alleges that Defendant’s Kurin Lock blood collection devices infringe four patents related to systems and methods for reducing microbial contamination in bodily-fluid samples.
• Technical Context: The technology concerns medical devices that, during a blood draw, automatically divert an initial volume of blood—which may be contaminated by skin microbes from the needle insertion site—into a separate chamber before collecting the primary, cleaner sample for diagnostic testing.
• Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of Plaintiff’s technology and patents, citing communications from Defendant’s founder to Plaintiff in 2013, Defendant’s citation of Plaintiff’s patents during its own patent prosecution activities beginning in 2016, and a February 2019 press release from Defendant acknowledging awareness of Plaintiff’s patent portfolio.

Case Timeline

Date	Event
2006-12-18	Earliest Priority Date ('001, '689 Patents)
2011-10-13	Earliest Priority Date ('483 Patent)
2012-10-11	Earliest Priority Date ('139 Patent)
2013-06-04	Magnolia's website allegedly first stated its devices were "patented"
2013-06-11	Kurin's founder allegedly emailed Magnolia executives
2014-01-01	Magnolia commercially launched its Steripath® device (approx.)
2015-12-31	Kurin, Inc. was founded (approx. "late 2015")
2016-12-27	Kurin allegedly cited a Magnolia parent patent in an Information Disclosure Statement
2017-01-01	Kurin entered the market with its Kurin Lock device (approx.)
2018-01-02	U.S. Patent No. 9,855,001 Issued
2018-07-24	U.S. Patent No. 10,028,689 Issued
2018-08-07	U.S. Patent No. 10,039,483 Issued
2019-02-22	Kurin issued a press release acknowledging Magnolia's patents
2019-03-06	U.S. Patent No. 10,220,139 Issued
2019-03-07	Complaint Filed

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

U.S. Patent No. 9,855,001 - "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples With Reduced Contamination"

The Invention Explained

• Problem Addressed: The patent addresses the problem of microbial contamination in bodily-fluid samples, such as blood draws, which can lead to spurious test results and cause patients to be unnecessarily subjected to anti-microbial therapies ('001 Patent, col. 2:59-67).
• The Patented Solution: The invention is an apparatus that diverts an initial, potentially contaminated volume of bodily fluid into a "pre-sample reservoir" before the primary sample is collected for testing ('001 Patent, Abstract). A key feature is a diverter mechanism that automatically transitions from a first mode (filling the pre-sample reservoir) to a second mode (filling the main sample vessel) as a result of the fluid flow and "substantial pressure equalization" within the device, thereby sequestering the initial contaminated fluid ('001 Patent, col. 7:29-44).
• Technical Importance: This automated diversion technique was designed to reduce the high rate of false-positive blood cultures, a significant clinical problem that can lead to misdiagnosis of sepsis and unnecessary antibiotic use (Compl. ¶¶ 13-14).

Key Claims at a Glance

• The complaint asserts independent Claim 1 (Compl. ¶34).
• Claim 1 requires:
  • a reservoir configured to receive an initial volume of bodily fluid withdrawn from the patient;
  • a diverter having an inlet, a first outlet in fluid communication with the reservoir, and a second outlet, with the inlet configured to be fluidically coupled to the patient;
  • the diverter operable in a first operating mode where a subsequent volume of fluid can flow to the second outlet and the initial volume is prevented from flowing there;
  • the diverter configured to transition from the first to the second operating mode "as a result of the initial volume of bodily fluid flowing from the patient and substantial pressure equalization," thereby sequestering contaminants.
• The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,028,689 - "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination"

The Invention Explained

• Problem Addressed: The patent addresses the same problem as the ’001 Patent: contamination of parenterally-obtained bodily fluids by microbes leading to spurious test results ('689 Patent, col. 2:2-9).
• The Patented Solution: The invention is an apparatus for establishing a sampling flow path that is substantially free of microbial artifacts. It comprises an input tube, an output tube, a contaminant reservoir, and a junction. The system operates in two states: a first state directs an initial portion of fluid into the contaminant reservoir, and a second state sequesters that fluid and allows a subsequent portion to bypass the reservoir and flow to the output tube. The transition is explicitly claimed to occur "without manual intervention as a direct result of filling the contaminant reservoir." ('689 Patent, Abstract; col. 12:17-43).
• Technical Importance: This technology offers a self-contained, automated system that simplifies the process of initial specimen diversion, aiming to improve consistency and reduce user error in clinical settings (Compl. ¶19).

Key Claims at a Glance

• The complaint asserts independent Claim 17 (Compl. ¶54).
• Claim 17 requires:
  • an input tube configured to be fluidically coupled to the patient;
  • an output tube configured to be fluidically coupled to the sample vessel;
  • a contaminant reservoir fluidically coupled to the input and output tubes;
  • a junction disposed between and fluidically coupled to the tubes and reservoir;
  • the system being operable in a first state to allow a first portion of fluid into the reservoir;
  • the system being operable in a second state to sequester the first portion and allow a second portion to bypass the reservoir and flow to the output tube;
  • the system being operable to transition to the second state "without manual intervention as a direct result of filling the contaminant reservoir."
• The complaint does not explicitly reserve the right to assert dependent claims for the '689 Patent.

U.S. Patent No. 10,039,483 - "Fluid Diversion Mechanism for Bodily-Fluid Sampling"

Technology Synopsis

The patent describes a "blood sequestration device" having a housing with a fluid reservoir at least partially defined by a "seal member." The device also includes a vent that allows air to exit as blood enters the reservoir. The device is configured to first direct an initial volume of blood into the reservoir, and then allow a subsequent volume to flow to an outlet port via a separate sampling path, bypassing the sequestered initial volume ('483 Patent, Abstract).

Asserted Claims & Accused Features

• Asserted Claims: Independent Claim 1 (Compl. ¶75).
• Accused Features: The Kurin Lock device is alleged to be a blood sequestration device with a housing, a fluid reservoir defined by a "seal member" (the "white porous seal"), and a vent that allows air to exit as the reservoir fills (Compl. ¶¶ 77, 80-81).

U.S. Patent No. 10,220,139 - "Systems and Methods for Delivering A Fluid To a Patient With Reduced Contamination"

Technology Synopsis

This patent discloses a sequestration device with a "flow control mechanism" that defines two distinct lumens. The first lumen directs an initial volume of fluid to an internal reservoir. A valve within this first lumen then forms a fluid-tight seal. This action establishes a fluid flow path through the second lumen, connecting the patient port to an external fluid reservoir port and bypassing the sequestered initial volume ('139 Patent, Abstract).

Asserted Claims & Accused Features

• Asserted Claims: Independent Claim 1 (Compl. ¶95).
• Accused Features: The Kurin Lock is alleged to have a flow control mechanism defining a first lumen (the "'U' shaped side channel") and a second lumen (the collection passage), as well as a valve (the "white porous seal") that seals the first lumen and establishes a flow path through the second lumen after the initial volume is sequestered (Compl. ¶¶ 100-101).

III. The Accused Instrumentality

Product Identification

The accused products are all configurations of Kurin blood collection sets and/or Kurin Lock technology, including those marketed as Safety Slide Needle, Push Button Needle, and Peripheral IV (“PIV”) sets (collectively, the “Kurin Accused Products”) (Compl. ¶32).

Functionality and Market Context

The Kurin Accused Products are described as specimen diversion devices that "enabl[e] clinicians to automatically divert the initial aliquot of blood, which may contain skin microbes, from every draw" (Compl. ¶32). The complaint alleges the device functions by first filling a "'U' shaped side channel" with an initial volume of blood (Compl. ¶37). This channel is then sealed by a "white porous seal" that is "activated" upon contact with blood, which stops flow in or out of the side channel (Compl. ¶42). Subsequently, a "small amount of blood will bypass the contents of the side channel, flowing directly into the collection passage" to be collected in a culture bottle (Compl. ¶41). The complaint alleges that prior to Kurin’s market entry in January 2017, Magnolia was the sole manufacturer of such a device (Compl. ¶30). The complaint includes a diagram illustrating the operation of the Kurin Lock, showing the initial filling of the side channel and the subsequent bypass flow (Compl. p. 14, unnamed figure).

IV. Analysis of Infringement Allegations

9,855,001 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a reservoir configured to receive an initial volume of bodily fluid withdrawn from the patient	The Kurin Lock includes a "'U' shaped side channel" that fills with the initial flow of blood.	¶37	col. 4:51-56
a diverter having an inlet, a first outlet in fluid communication with the reservoir, and a second outlet...	The Kurin Lock includes an inlet coupled to the patient, a first outlet connected to the "'U' shaped side channel" reservoir, and a second outlet for the main collection passage.	¶38, ¶39	col. 7:2-6
the diverter operable in a first operating mode in which a) a subsequent volume of bodily fluid can flow from the inlet to the second outlet, and b) the initial volume of bodily fluid is prevented from flowing to the second outlet	The complaint does not map this element directly. It alleges distinct first and second operating modes but describes the first mode as filling the reservoir and the second mode as flowing to the second outlet. This element describes properties of the first operating mode itself.	¶40, ¶41	col. 7:56-65
the diverter configured to transition from the first operating mode to the second operating mode as a result of the initial volume of bodily fluid flowing from the patient and substantial pressure equalization...	The Kurin Lock allegedly transitions modes when a "white porous seal" at the end of the side channel is "activated" upon contact with blood, locking the channel and causing subsequent blood to bypass it. This is alleged to be the result of fluid flow and pressure equalization.	¶42	col. 7:29-44

Identified Points of Contention

• Scope Questions: A central question may be whether the Kurin Lock's mechanism for sealing its reservoir—a "white porous seal...activated to lock the channel" upon blood contact—falls within the scope of a transition occurring "as a result of...substantial pressure equalization." A dispute may arise over whether this claim language covers a mechanism based on material activation upon fluid contact, versus a mechanism based purely on fluid dynamics and pressure changes in a closed system.
• Technical Questions: What evidence does the complaint provide that the operation of the "white porous seal" is driven by pressure equalization, as required by the claim, rather than a chemical or physical property change of the seal material itself upon contact with blood? The complaint asserts this equivalence but does not detail the specific mechanics of the seal's activation (Compl. ¶42).

10,028,689 Infringement Allegations

Claim Element (from Independent Claim 17)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
an input tube configured to be fluidically coupled to the patient	The Kurin Lock includes tubing and a needle for venipuncture.	¶57	col. 3:58-63
an output tube configured to be fluidically coupled to the sample vessel	The Kurin Lock includes a separate channel and coupling for a blood culture bottle. The complaint includes a photograph of the device connected to a sample bottle (Compl. p. 20, unnamed figure).	¶58	col. 4:3-16
a contaminant reservoir fluidically coupled to the input tube and the output tube	The "'U' shaped side channel" is described as being fluidically coupled to both the input venipuncture line and the subsequent collection passage.	¶59	col. 12:21-23
a junction disposed between the inlet tube and the output tube and fluidically coupled to the input tube, the output tube, and the contaminant reservoir	The main body of the Kurin Lock device serves as the junction where the flow path splits between the side channel and the main collection passage. The complaint provides a diagram of the captured blood in this u-shaped reservoir (Compl. p. 21, unnamed figure).	¶60	col. 12:24-28
the contaminant reservoir and the junction operable in a first state to allow a first portion of biological fluid to flow into the contaminant reservoir	The device operates in a first state where "[t]he initial flow of blood—and any contaminants therein—fills a 'U' shaped side channel."	¶61	col. 12:30-32
the contaminant reservoir and the junction operable in a second state to...sequester the first portion...and...allow a second portion...to bypass the contaminant reservoir and to flow to the output tube	After the side channel is sealed, "a small amount of blood will bypass the contents of the side channel, flowing directly into the collection passage."	¶62	col. 12:33-38
the contaminant reservoir and the junction operable to transition to the second state without manual intervention as a direct result of filling the contaminant reservoir	"[W]hen in contact with blood, the seal material is activated to lock the channel...Flow—in or out—of the side channel is stopped." This is alleged to be an automatic transition resulting directly from the reservoir filling.	¶63	col. 12:39-43

Identified Points of Contention

• Scope Questions: The dispute may center on the phrase "as a direct result of filling the contaminant reservoir." The question will be whether the activation of a "porous seal" by "contact with blood" is equivalent to a transition caused by the physical act of "filling." Defendant may argue that the direct cause is a property of the seal material reacting to blood, not the volumetric state of being "filled."
• Technical Questions: What is the specific mechanism of the "white porous seal"? Is it a hydrophilic material that swells, a chemical reaction, or another mechanism? The precise nature of this activation will be critical to determining if it is a "direct result of filling" or a separate, intervening causal step.

V. Key Claim Terms for Construction

The Term: "substantial pressure equalization" (’001 Patent, Claim 1)

• Context and Importance: This term defines the trigger for the automatic transition between operating modes. The infringement analysis for the ’001 Patent hinges on whether the accused device's transition mechanism, which relies on a blood-activated seal, meets this definition. Practitioners may focus on this term because it appears to be the primary point of technical differentiation between the claim language and the accused product's alleged operation.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification explains that in embodiments using a vacuum-sealed reservoir, the pressure change "causes the blood from the vein...to be transferred into the pre-sample reservoir...until the pressures equalize," at which point "the blood tends to stop flowing" ('001 Patent, col. 5:40-45). This could support a reading where any mechanism that stops flow into the first reservoir upon its filling, thereby enabling flow to a second path, is a form of pressure equalization.
  • Evidence for a Narrower Interpretation: The detailed embodiments describe systems where flow stops due to the filling of a pre-established vacuum ('001 Patent, Fig. 3A). This could support an argument that the term is limited to this specific fluid-dynamic mechanism, and does not extend to a seal that is chemically or physically "activated" by contact with blood, as is alleged for the accused device (Compl. ¶42).

The Term: "as a direct result of filling the contaminant reservoir" (’689 Patent, Claim 17)

• Context and Importance: This phrase is critical for defining the automatic and non-manual nature of the claimed transition. The infringement case for the ’689 Patent depends on whether the activation of the accused device's "porous seal" upon contact with blood is considered a "direct result" of the reservoir being filled.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The plain language suggests a direct causal link: the filling action causes the transition. Plaintiff’s theory is that the reservoir is not "filled" until blood reaches the seal, and the contact that activates the seal is therefore a direct result of the filling process (Compl. ¶63).
  • Evidence for a Narrower Interpretation: The patent's specification describes embodiments that transition based on mechanical means, such as a switchable valve or slidable flow-control blocks, which are actuated by fluid flow and pressure ('689 Patent, Figs. 6A-7B). This could support an interpretation that the "direct result" must be a consequence of fluid mechanics (e.g., pressure buildup from filling), rather than a property of a specific material being "activated" upon contact with the fluid.

VI. Other Allegations

Indirect Infringement

The complaint alleges inducement of infringement under 35 U.S.C. § 271(b), based on Defendant providing videos on its website and YouTube that allegedly instruct clinicians on how to use the Kurin Accused Products in a manner that infringes the asserted patents (Compl. ¶¶ 51, 72).

Willful Infringement

The complaint alleges willful infringement based on pre-suit knowledge of the patents-in-suit. The basis for this allegation includes Defendant’s founder reviewing Plaintiff's website in 2013, Defendant citing Plaintiff’s parent patents in its own patent prosecution filings as early as 2016, and a February 2019 press release where Defendant's CEO acknowledged that the U.S. Patent Office had "compared" the Kurin Lock's design to "Magnolia's patents" (Compl. ¶¶ 44, 46, 47).

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

• A core issue will be one of technical equivalence: does the accused product's blood-activated "porous seal" mechanism operate "as a result of...substantial pressure equalization" as required by the '001 Patent, or is its activation by fluid contact a fundamentally different and non-infringing technical means of operation?
• A second key issue will be one of causation: for the '689 Patent, is the transition of the accused device "a direct result of filling the contaminant reservoir," or is it the result of a separate property of the seal material reacting to blood, which may place the action outside the direct causal chain required by the claim?
• A central question for damages will be willfulness: given the extensive pre-suit history alleged in the complaint—including Defendant's citations to Plaintiff's patents in its own prosecution and public statements acknowledging awareness—the court will likely need to determine whether any infringement was deliberate and willful, potentially justifying enhanced damages.