DCT
7:24-cv-10020
Koru Medical Systems Inc v. Innovative Health Sciences LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Koru Medical Systems, Inc. (Delaware)
- Defendant: Innovative Health Sciences, LLC (Delaware)
- Plaintiff’s Counsel: Venable LLP
- Case Identification: 7:24-cv-10020, S.D.N.Y., 12/31/2024
- Venue Allegations: Venue is alleged to be proper in the Southern District of New York because Defendant has a principal place of business in the district and has allegedly committed infringing acts there.
- Core Dispute: Plaintiff alleges that Defendant’s Insignis Syringe Infusion System infringes a patent related to precision variable flow rate infusion systems.
- Technical Context: The technology concerns medical devices that control the flow rate of therapeutic fluids delivered to a patient, a field where precision and safety are critical to prevent patient harm from incorrect dosing.
- Key Procedural History: The complaint alleges a unique history where Defendant’s founder, Andrew Sealfon, is the former President and CEO of Plaintiff and the first-named inventor on the patent-in-suit. Plaintiff alleges Defendant’s product is a "copycat" of its own system, developed using Mr. Sealfon’s intimate knowledge. The complaint also notes that a pre-suit notice letter was sent to Defendant in June 2023 and that Defendant’s FDA 510(k) submission for the accused system identifies Plaintiff’s product as the "Predicate Device."
Case Timeline
| Date | Event |
|---|---|
| 2015-03-04 | Priority Date for ’839 Patent (Provisional App. 62/128,501 filed) |
| 2016-02-24 | Non-provisional application for ’839 Patent filed |
| 2016-10-01 | KORU releases its Precision Flow Rate Controller™ |
| 2018-07-01 | Andrew Sealfon terminated as President, CEO, and Chairman of KORU |
| 2018-12-01 | Andrew Sealfon resigns from KORU’s Board of Directors |
| 2019-01-22 | Andrew Sealfon founds Defendant IHS |
| 2020-07-14 | U.S. Patent No. 10,709,839 issues |
| 2021-01-01 | IHS receives approval to sell Insignis System in the European Union |
| 2021-07-20 | IHS issues press release touting EU approval of Insignis System |
| 2023-06-12 | KORU sends notice letter to IHS regarding the ’839 Patent |
| 2024-01-29 | IHS submits FDA 510(k) premarket notification for Insignis System |
| 2024-03-01 | FDA approves IHS’s 510(k) submission |
| 2024-10-01 | IHS attends IgNS conference and presents Accused Products |
| 2024-12-31 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 10,709,839, “Precision Variable Flow Rate Infusion System and Method,” issued July 14, 2020.
- The Invention Explained:
- Problem Addressed: The patent’s background describes a need for an infusion system that is safer than constant flow pumps (which can create dangerous pressure) but more versatile and precise than existing constant pressure systems. (’839 Patent, col. 1:50-54, col. 2:1-16). Prior art systems were either complex, imprecise, or required using a different set of tubing for every desired flow rate, which created cost and complexity. (’839 Patent, col. 2:1-10).
- The Patented Solution: The invention is a system that combines two key components: (1) a specialized flexible tubing with a "pre-defined flow rate" that acts as a maximum safety limit, and (2) a separate, user-adjustable flow rate controller. (’839 Patent, Abstract). This dual-component approach ensures that even if the adjustable controller is set to its maximum, the overall flow rate cannot exceed the safe maximum established by the specialized tubing, thereby safeguarding against overdose. (’839 Patent, col. 4:5-10).
- Technical Importance: This approach aimed to provide the safety of a constant pressure system with the precision and adjustability of more complex programmable pumps, but in a more cost-effective and user-friendly package. (’839 Patent, col. 1:49-54).
- Key Claims at a Glance:
- The complaint asserts independent claims 1 and 19. (Compl. ¶46).
- Independent Claim 1 recites a system comprising:
- A "first flexible flow rate tubing" with a "known length" and a "pre-defined flow rate" that does not exceed a maximum dosage rate.
- An "adjustable flow rate controller" with an inlet, outlet, and a "fluid pathway modifier" that allows adjustment from a maximum rate to a "zero flow rate."
- A "flow rate scale visually indicating variable flow rates."
- The tubing is coupled to the controller's inlet.
- The combined flow rates of the tubing and the controller are "equal to or less than the maximum dosage flow rate."
- The system is "pre-calibrated with sterile gas correlated to an intended liquid" to tune the flow rate scale.
- The complaint does not explicitly reserve the right to assert dependent claims, but its infringement allegations are for "one or more claims." (Compl. ¶46).
III. The Accused Instrumentality
- Product Identification: The Insignis Syringe Infusion System ("Insignis System"), which includes the Insignis Syringe Driver, the Intravenous Controller, and the OneSett Subcutaneous Administration Set ("Accused Products"). (Compl. ¶¶ 23, 28, 36).
- Functionality and Market Context:
- The Insignis System is described as a non-electric infusion system for delivering medications. (Compl. ¶24). It consists of a "Driver" that provides constant force to a syringe, which acts as the fluid reservoir. (Compl. ¶29). This driver connects to an infusion set (either the Intravenous Controller or the OneSett), which includes tubing and a "selectable rate flow controller." (Compl. ¶¶ 29, 30). This controller has a dial that enables a user to select from a range of continuous infusion flow rates, including a "0 ml/hr" setting. (Compl. ¶¶ 31, 32). A figure in the complaint depicts the components of the Insignis System. (Compl. p. 6, Fig. at ¶28). The complaint alleges that following FDA approval in March 2024, IHS began marketing and offering to sell the system in the United States, including at medical conferences. (Compl. ¶¶ 35, 41-42).
IV. Analysis of Infringement Allegations
’839 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a precision variable flow rate infusion system for delivering a liquid driven by a constant pressure pump from a reservoir... | The Accused Products are precision variable flow rate infusion systems that deliver liquid via a constant pressure pump (the Driver) from a reservoir (the syringe). | ¶¶47-48 | col. 9:26-30 |
| a first flexible flow rate tubing having a known length... and a pre-defined flow rate... not exceeding the maximum dosage flow rate... | The Accused Products have a first flexible flow rate tubing of a known length and internal diameter that establishes a first known flow rate not exceeding the maximum dosage rate. | ¶49, ¶51 | col. 9:54-60 |
| an adjustable flow rate controller having an inlet and an outlet, at least one internal fluid pathway... and a fluid pathway modifier structured and arranged to modify the... pathway... from a maximum adjuster flow rate to a zero flow rate... | The Accused Products have an adjustable flow rate controller with a fluid pathway modifier that can modify the pathway to provide a range of flow rates from a maximum rate to a zero flow rate. | ¶53 | col. 10:45-50 |
| a flow rate scale visually indicating variable flow rates from the maximum dosage flow rate to the zero flow rate... | The Accused Products' controller has a flow rate scale visually indicating variable flow rates. A figure shows a dial on the Intravenous Controller with markings for different flow rates. | ¶54; p. 7, Fig. at ¶32 | col. 18:1-4 |
| wherein the combination of the pre-defined flow rate and the maximum adjuster flow rate determine a maximum delivery flow rate... | The combination of the Accused Products' pre-defined flow rates and maximum adjuster flow rate determine the maximum delivery flow rate of liquid from the reservoir. | ¶59 | col. 18:12-21 |
| wherein the variable flow rate infusion system is pre-calibrated with sterile gas correlated to an intended liquid to provide the flow rate scale tuned for each assembly... | The Accused Products are pre-calibrated with sterile gas correlated to an intended liquid to provide a tuned flow rate scale for each assembly. | ¶61 | col. 18:22-28 |
- Identified Points of Contention:
- Technical Questions: A key question will be whether the tubing in the Accused Products is merely standard medical tubing or if it has the special "pre-defined flow rate" characteristic required by the claim, which functions as an independent rate-limiting element. The complaint alleges this (Compl. ¶49), but this will be a central point of proof. Another technical question is whether Defendant actually uses the claimed method of "pre-calibrat[ion] with sterile gas," a specific manufacturing step alleged by Plaintiff but which may be difficult to prove without discovery. (Compl. ¶61).
- Scope Questions: The infringement analysis may hinge on how broadly the term "pre-defined flow rate" (as applied to the tubing) is construed. The question for the court will be whether this term requires the tubing itself to be the primary rate-limiting component, as suggested by the patent’s specification, or if it can be read more broadly to cover any system where the tubing's known physical characteristics are simply factored into an overall system calibration. At an industry conference, IHS presented the Accused Products with a poster titled "IMPROVING THE PATIENT SUBCUTANEOUS INFUSION EXPERIENCE." (Compl. p. 10, Fig. at ¶41).
V. Key Claim Terms for Construction
The Term: "pre-defined flow rate" (of the "first flexible flow rate tubing")
Context and Importance: This term is central because it distinguishes the invention from systems that use generic tubing where all flow control resides in the separate controller. The patent's core concept is a combination of a rate-limiting tube and an adjuster. Practitioners may focus on this term because its construction will determine whether the claim covers any system with known tubing dimensions or only systems where the tubing itself is specifically engineered to create a hard-ceiling flow rate.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that any tubing has a "pre-defined" rate once its length and diameter are known and fixed in manufacturing, even if it is not the primary flow-limiting element.
- Evidence for a Narrower Interpretation: The specification distinguishes the invention from "general medical tubing" and states the claimed tubing is "specifically manufactured to have a specific length and inside diameter so as to achieve a very specific and pre-defined flow rate." (’839 Patent, col. 6:36-45). It further states that this tubing "establishes the maximum fluid flow rate" for the system. (’839 Patent, col. 8:60-62). This suggests the term requires the tubing to be a distinct, engineered, rate-capping component.
The Term: "pre-calibrated with sterile gas correlated to an intended liquid"
Context and Importance: This is a process limitation that defines how the "flow rate scale" is made accurate. Infringement of this element requires not just an accurate scale, but one achieved through the specific method recited. Practitioners may focus on this term because it presents a high evidentiary bar for the plaintiff and a clear potential non-infringement argument for the defendant if a different calibration method is used.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue this covers any two-step calibration process where a non-liquid medium (like gas) is used for mass-production testing based on an initial liquid-based benchmark, regardless of the precise gas or correlation method.
- Evidence for a Narrower Interpretation: The specification details a specific calibration process where a system is first calibrated with an "actual liquid," and then "a sterile gas is passed through" the same system to establish a benchmark gas flow rate that can be used to "certify a plurality of substantially similar embodiments." (’839 Patent, col. 16:20-37). This language supports a narrow reading requiring this specific liquid-to-gas correlation method.
VI. Other Allegations
- Indirect Infringement: The complaint does not contain a separate count for indirect infringement. However, the pre-suit notice letter sent to Defendant’s CEO explicitly warned of "acts that would constitute direct or indirect infringement," which may be used to support allegations of intent. (Compl. ¶26).
- Willful Infringement: The complaint makes extensive allegations to support willfulness. It claims Defendant had knowledge of the patent since its inception through its founder, Andrew Sealfon, who is the patent’s lead inventor and Plaintiff’s former CEO. (Compl. ¶63). It further alleges that Mr. Sealfon used his "intimate knowledge" of Plaintiff's technology to develop a "copycat" product. (Compl. ¶22). Finally, it alleges actual notice was provided via a letter on June 12, 2023, that identified the patent and its claims, well before the accused product was marketed in the U.S. (Compl. ¶¶ 26, 63).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of corporate history and intent: How will the allegation that Defendant’s founder is the patent’s inventor and Plaintiff’s former CEO influence the analysis of infringement, particularly for the willfulness claim? The narrative of a "copycat" product developed by a former insider is a powerful theme that will likely feature prominently.
- A key evidentiary question will be one of technical proof: Can Plaintiff demonstrate that the Accused Products meet the highly specific limitations of claim 1? This includes proving not only that the system's tubing has the claimed "pre-defined flow rate" properties, but also that Defendant employs the exact "pre-calibrated with sterile gas" manufacturing process recited in the claim.
- The case will also turn on a question of claim scope: Can the term "pre-defined flow rate," in the context of the patent's specification, be construed to cover any tubing with known physical properties, or is it limited to tubing specifically engineered to act as the primary rate-limiting component of the system? The resolution of this question could be determinative of infringement.