DCT
1:25-cv-08680
Haemonetics Corp v. Fresenius Kabi USA LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Haemonetics Corporation (Massachusetts)
- Defendant: Fresenius Kabi USA, LLC (Delaware/Illinois); Fresenius Kabi AG (Germany); Fenwal, Inc. (Delaware/Illinois)
- Plaintiff’s Counsel: Proskauer Rose LLP
- Case Identification: 1:25-cv-08680, N.D. Ill., 10/06/2025
- Venue Allegations: Plaintiff alleges venue is proper because Defendants Fresenius Kabi USA, LLC and Fenwal, Inc. reside and have regular and established places of business in the Northern District of Illinois, and because all Defendants have allegedly committed acts of infringement in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Aurora Xi Plasmapheresis System infringes three patents related to systems and methods for optimizing the collection of plasma from donors.
- Technical Context: The technology at issue involves automated plasmapheresis systems, which separate plasma from whole blood for use in plasma-derived medicinal products, a significant sector of the healthcare industry.
- Key Procedural History: The complaint is a First Amended Complaint, superseding an original complaint filed on July 25, 2025. The complaint alleges that Defendants had knowledge of the asserted patents at least as of the filing date of the original complaint.
Case Timeline
| Date | Event |
|---|---|
| 2016-09-XX | Accused Aurora Xi System receives initial FDA clearance |
| 2017-05-30 | Earliest Priority Date for all Asserted Patents |
| 2020-09-01 | U.S. Patent No. 10,758,652 issues |
| 2022-12-XX | Accused Aurora Xi System receives additional FDA clearance |
| 2024-12-24 | U.S. Patent No. 12,171,916 issues |
| 2025-01-07 | U.S. Patent No. 12,186,474 issues |
| 2025-01-24 | FDA clearance for Accused Aurora Xi System's "Adaptive Nomogram" feature |
| 2025-07-25 | Original Complaint Filing Date |
| 2025-10-06 | First Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,758,652 - "System and Method for Collecting Plasma"
- Patent Identification: U.S. Patent No. 10758652, titled “System and Method for Collecting Plasma,” issued on September 1, 2020 (Compl. ¶59).
The Invention Explained
- Problem Addressed: The patent’s background section states that prior art plasma collection systems are unable to determine the actual volume of pure plasma collected because the product is a mixture of plasma and anticoagulant (’652 Patent, col. 1:37-44; Compl. ¶46). These systems stop collection based on the total volume of the mixture, which can result in collecting less plasma than permitted by regulators and fails to optimize the yield based on individual donor physiology (Compl. ¶47).
- The Patented Solution: The invention is a system with a controller that calculates the volume of anticoagulant being collected and uses that value to determine the volume of pure plasma collected ('652 Patent, col. 2:61-65). The system is configured to stop the plasma collection process only when a predetermined target volume of pure plasma has been reached, rather than a target volume of the plasma/anticoagulant mixture (Compl. ¶81; '652 Patent, col. 3:1-4).
- Technical Importance: This approach allows for the collection of a greater volume of plasma, on average, from each donor, thereby increasing the efficiency and yield of the overall plasma supply chain (Compl. ¶49).
Key Claims at a Glance
- The complaint asserts independent claim 11 (Compl. ¶81).
- The essential elements of claim 11 include:
- A venous-access device for drawing and returning blood.
- A blood component separation device for separating plasma.
- A blood draw line controlled by a blood draw pump.
- An anticoagulant line to introduce anticoagulant.
- A controller configured to: (1) calculate a volume of anticoagulant in the collected plasma as it is collected, (2) calculate a volume of pure plasma based on the anticoagulant volume, and (3) stop the blood draw pump when a target volume of pure plasma is collected.
- The complaint also asserts dependent claims 13, 14, 15, 16, 17, and 18, and reserves the right to assert additional claims (Compl. ¶80).
U.S. Patent No. 12,171,916 - "System and Method for Collecting Plasma"
- Patent Identification: U.S. Patent No. 12171916, titled “System and Method for Collecting Plasma,” issued on December 24, 2024 (Compl. ¶62).
The Invention Explained
- Problem Addressed: The patent addresses the same general problem as the ’652 Patent: the inefficiency of prior art plasma collection systems that do not tailor the collection volume to individual donors (’916 Patent, col. 1:49-57).
- The Patented Solution: The invention described in the '916 Patent is a plasma collection system featuring a controller that is explicitly programmed to "receive donor parameters electronically from a control system" ('916 Patent, claim 14; Compl. ¶133). The controller uses these electronically-received parameters to determine a target plasma volume and then controls the system to operate the necessary "draw and return phases" to achieve that target (Compl. ¶133).
- Technical Importance: This system architecture automates the individualization of plasma collection by integrating electronic donor data into the operational logic of the collection device, improving efficiency and repeatability (Compl. ¶53).
Key Claims at a Glance
- The complaint asserts independent claim 14 (Compl. ¶132).
- The essential elements of claim 14 include:
- A venipuncture needle, blood separator, donor line with a first pump, and anticoagulant line with a second pump.
- A touchscreen for operator input.
- A controller programmed to: control system operation, couple to the touchscreen, receive donor parameters electronically from a control system, determine a target plasma volume based on those parameters, and control the system to operate draw and return phases.
- The complaint does not explicitly reserve the right to assert other claims of the ’916 Patent.
U.S. Patent No. 12,186,474 - "System and Method for Collecting Plasma"
- Patent Identification: U.S. Patent No. 12186474, titled “System and Method for Collecting Plasma,” issued on January 7, 2025 (Compl. ¶65).
The Invention Explained
- Technology Synopsis: This patent claims a plasma collection system where a controller is programmed to receive at least a donor's weight, height, and hematocrit. It uses these specific parameters to determine a target volume for the plasma product prior to withdrawing any whole blood from the donor, basing the calculation on the donor's total blood volume and/or plasma volume. The controller then manages a plurality of draw and return cycles to meet this pre-calculated target. (Compl. ¶155).
- Accused Features: The complaint alleges that the Aurora Xi System's "Adaptive Nomogram" functionality infringes by receiving donor-specific parameters like weight, height, and hematocrit to determine a target collection volume (Compl. ¶¶164-165).
Key Claims at a Glance
- Asserted Claims: Independent claim 9 and dependent claim 14 (Compl. ¶154).
III. The Accused Instrumentality
Product Identification
- The Aurora Xi Plasmapheresis System, including its "Adaptive Nomogram" software feature (Compl. ¶¶4, 69, 76).
Functionality and Market Context
- The Aurora Xi System is used to perform plasmapheresis, a procedure that involves collecting whole blood from a donor, separating it to remove plasma, and returning the remaining blood components to the donor (Compl. ¶76).
- The complaint focuses on the "Adaptive Nomogram" feature, which allegedly received FDA clearance on January 24, 2025 (Compl. ¶76). This feature is alleged to calculate the volume of plasma to collect by considering "each donor's individual characteristics," which reportedly enables an "average 11.5% increase in plasma collection per donation" (Compl. ¶76).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
U.S. Patent No. 10,758,652 Infringement Allegations
| Claim Element (from Independent Claim 11) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a venous-access device for drawing whole blood from a subject and returning blood components to the subject | The Accused Products have a venous-access device for drawing whole blood from a subject and returning blood components. | ¶84 | col. 5:14-16 |
| a blood component separation device for separating the drawn blood into a plasma component...configured to send the plasma component to a plasma container | The Accused Products have a blood component separation device for separating drawn blood into a plasma component and a second blood component. | ¶85 | col. 5:16-18 |
| a controller configured to control the operation of the blood component separation device and the blood draw pump... | The Accused Products have a controller configured to control the operation of the blood component separation device and the blood draw pump. | ¶88 | col. 5:27-30 |
| the controller configured to calculate (1) a volume of anticoagulant in the collected plasma component as the plasma component is being collected... | The controllers of the Accused Products are configured to calculate a volume of anticoagulant in the collected plasma component as it is being collected. | ¶89 | col. 8:10-18 |
| and (2) a volume of pure plasma collected within the plasma container based, at least in part, upon the volume of anticoagulant... | The controllers of the Accused Products are also configured to calculate a volume of pure plasma collected within the plasma container based on the volume of anticoagulant. | ¶90 | col. 8:18-24 |
| the controller configured to stop the blood draw pump when a target volume of pure plasma is collected within the plasma container. | The controllers of the Accused Products are configured to stop the blood draw pump when a target volume of pure plasma is collected. | ¶91 | col. 3:1-4 |
Identified Points of Contention
- Technical Question: The central dispute may concern the actual operation of the accused "Adaptive Nomogram." The complaint alleges the system calculates a "volume of pure plasma," but it does not provide direct evidence (e.g., source code, internal documents) of the specific algorithm used. A key question for discovery will be whether the accused system performs the two-step calculation required by the claim (calculating anticoagulant volume, then using it to calculate pure plasma volume) or if it arrives at an optimized total volume through a different, non-infringing method.
- Scope Questions: The definition of "calculate" will be critical. The question may arise whether an indirect calculation or estimation of pure plasma, derived from a formula that uses donor characteristics as inputs, meets the claim limitation, or if a more direct measurement-and-subtraction method is required.
U.S. Patent No. 12,171,916 Infringement Allegations
| Claim Element (from Independent Claim 14) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a touchscreen configured to receive input from an operator | The Accused Products have a touchscreen configured to receive input from an operator. | ¶140 | col. 4:67-5:1 |
| a controller programmed to control operation of the system, the controller coupled to the touchscreen... | The Accused Products have a controller programmed to control the operation of the system. The controllers are coupled to the touchscreen. | ¶141, ¶142 | col. 10:50-52 |
| and programmed to receive donor parameters electronically from a control system... | The controllers of the Accused Products are programmed to receive donor parameters electronically from a control system. | ¶142 | col. 10:52-54 |
| to determine a target volume for plasma product and/or raw plasma based at least in part on the donor parameters... | The controllers of the Accused Products are programmed to determine a target volume for plasma product and/or raw plasma based at least in part on the donor parameters. | ¶143 | col. 10:54-56 |
| and to control the system to operate draw and return phases... | The controllers of the Accused Products are also programmed to control the system to operate draw and return phases. | ¶144 | col. 10:57-61 |
Identified Points of Contention
- Scope Questions: The construction of "receive donor parameters electronically from a control system" will likely be a primary point of contention. The question is whether this limitation is met by an operator manually keying donor parameters into the device’s touchscreen, or if it requires the device to receive data from a separate, external system (e.g., a networked donor management database).
- Technical Question: Fact discovery will need to establish precisely how the accused Aurora Xi System receives donor parameters. The complaint does not specify the mechanism, and the distinction between manual entry on an integrated screen versus automated data transfer from a separate computer system may be dispositive for infringement of this patent.
V. Key Claim Terms for Construction
"a volume of pure plasma" (’652 Patent, claim 11)
- Context and Importance: This term is central to the novelty asserted in the ’652 Patent. The infringement analysis will depend on whether the accused system's output can be characterized as a "volume of pure plasma," as distinct from the total volume of the plasma-anticoagulant mixture collected. Practitioners may focus on this term because it defines the endpoint of the patented method.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines the term by what it is not: "plasma only—without the volume of any anticoagulant mixed with the plasma" ('652 Patent, col. 8:3-6). This functional definition could support an interpretation where any calculation that accurately determines the plasma-only volume, regardless of the specific mathematical steps, falls within the claim scope.
- Evidence for a Narrower Interpretation: The specification describes a process of first calculating the percentage of anticoagulant and then using that to determine the pure plasma volume ('652 Patent, col. 8:10-24). A defendant may argue that this context limits the claim to methods that explicitly calculate and subtract the anticoagulant component, rather than methods that might use a different algorithm to arrive at a final target volume.
"receive donor parameters electronically from a control system" (’916 Patent, claim 14)
- Context and Importance: This term distinguishes the claimed invention from systems where parameters are set based on non-electronic inputs (e.g., manual dial settings based on a paper nomogram). The scope of "control system" will be critical. Practitioners may focus on this term because it relates to the system's architecture and data input method.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent claims a "system for collecting plasma" that includes the controller and a touchscreen ('916 Patent, claim 14). An argument could be made that the "control system" is the device's own integrated system, and when an operator enters data via the touchscreen, the controller is "receiv[ing]" it "electronically from" a component of that system.
- Evidence for a Narrower Interpretation: The phrasing "from a control system" could suggest a source external to the plasma collection device itself, such as a separate computer or a central network server. This interpretation could be advanced to argue that mere manual entry on the device's own screen is not what was patented, as the data does not originate "from" the system but is input "to" it.
VI. Other Allegations
Indirect Infringement
- The complaint alleges both induced and contributory infringement for all three asserted patents. Inducement allegations are based on Defendants allegedly providing instruction materials, training, and services that encourage infringing use (Compl. ¶¶124-125, 146-147, 173-174). Contributory infringement is alleged on the basis that the accused systems are a material component of the invention, are especially adapted for infringing use, and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶¶126, 148, 175).
Willful Infringement
- The complaint alleges that Defendants have had knowledge of the asserted patents "at least since the filing of the first Complaint on July 25, 2025" (Compl. ¶¶67-68). This forms the basis for an allegation of post-filing willful infringement, for which Plaintiff seeks treble damages (Prayer for Relief, D).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional operation: does the accused "Adaptive Nomogram" perform the specific, two-step calculation required by the ’652 Patent—first determining an anticoagulant volume, then using it to calculate a "volume of pure plasma"—or does it employ a fundamentally different algorithm to achieve an optimized yield? This presents a key evidentiary question for discovery.
- The case may also turn on a question of definitional scope: can the term "receive... from a control system" in the ’916 Patent be construed to cover manual data entry by an operator onto the device's own touchscreen, or does it require data transmission from an external, networked source? The resolution of this claim construction issue will likely determine the infringement outcome for the later patents.
- Finally, a central question will be one of quantification: if infringement is found, what is the economic value attributable to the patented features that allegedly enable an "11.5% increase in plasma collection"? This will be critical for determining a reasonable royalty and assessing the impact of any post-filing willful infringement.