DCT
1:22-cv-01564
Emcyte Corp v. Cervos Medical LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: EmCyte Corp. (Florida)
- Defendant: Cervos Medical LLC (Delaware)
- Plaintiff’s Counsel: Bayard, P.A.; Akerman LLP
- Case Identification: 1:22-cv-01564, D. Del., 12/02/2022
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware limited liability company and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Platelet-Rich Plasma (PRP) preparation systems infringe patents related to a centrifuge tube assembly for separating and aspirating fluid components.
- Technical Context: The technology concerns medical devices used to process biological fluids, such as whole blood, to concentrate specific components like platelets for therapeutic use in regenerative medicine.
- Key Procedural History: The complaint notes that U.S. Patent No. 10,537,888 is a continuation of the application that issued as U.S. Patent No. 10,300,481, indicating a shared specification and priority date between the two patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2015-06-17 | Priority Date for ’481 and ’888 Patents |
| 2019-05-28 | U.S. Patent No. 10,300,481 Issues |
| 2020-01-21 | U.S. Patent No. 10,537,888 Issues |
| 2022-12-02 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,300,481 - Centrifuge Tube Assembly for Separating, Concentrating, and Aspirating Constituents of a Fluid Product, Issued May 28, 2019
The Invention Explained
- Problem Addressed: The patent describes a need for a simpler, more reliable, and less expensive centrifuge tube for preparing platelet-rich plasma (Compl. ¶9; ’481 Patent, col. 1:18-35). Conventional devices that use aspiration pipes are described as being complex, costly, and subject to malfunction, such as kinking, which can lead to cross-contamination of the separated biological components (’481 Patent, col. 1:36-46, col. 2:21-26).
- The Patented Solution: The invention is a centrifuge tube assembly that eliminates the need for internal aspiration pipes. It features a tubular receptacle containing a liquid-impermeable, slidable piston that separates the inner chamber into an upper region and a lower region (’481 Patent, Abstract). A biological fluid is introduced into the upper region through a common inlet/outlet port in the cap, which pushes the piston downward. A vent at the bottom of the receptacle allows air in the lower region to escape, neutralizing pressure (’481 Patent, col. 2:49-57). After centrifugation, the separated fluid layers can be aspirated out through the same common port, which draws the piston upward.
- Technical Importance: This design aims to simplify the manufacturing process and reduce operational failures by removing the internal piping common in prior art devices, thereby providing a more efficient method for separating and extracting biological fluids (’481 Patent, col. 2:17-26).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying which ones (Compl. ¶27). Independent claim 1 is representative of the core invention.
- Independent Claim 1 elements:
- An elongate receptacle with an interior chamber, a lower end, and a side wall.
- A cap engaging the side wall at the upper end.
- A common inlet and outlet port formed in the cap or receptacle for both injecting fluid and aspirating components.
- A vent formed through the lower end of the receptacle.
- A piston mounted and slidable within the chamber that maintains a sealing engagement with the interior side wall.
- The piston is driven toward the lower end by hydraulic pressure during injection and toward the upper end by suction during aspiration.
- The complaint reserves the right to assert additional claims (Compl. ¶29).
U.S. Patent No. 10,537,888 - Centrifuge Tube Assembly for Separating, Concentrating, and Aspirating Constituents of a Fluid Product, Issued January 21, 2020
The Invention Explained
- Problem Addressed: As a continuation of the ’481 Patent, the ’888 Patent addresses the same technical problems of complexity, cost, and potential for cross-contamination in conventional centrifuge devices (’888 Patent, col. 1:24-42).
- The Patented Solution: The ’888 Patent describes the same fundamental device: a tube with a slidable piston that separates two chambers, one communicating with a common inlet/outlet port and the other with a vent, eliminating the need for internal aspiration pipes (’888 Patent, Abstract; col. 2:45-62). The claims of the ’888 Patent, however, are directed to an assembly that explicitly includes the syringes used for injection and aspiration.
- Technical Importance: This patent extends protection to the combination of the specific centrifuge tube design with the syringes necessary for its operation, covering the complete system as used by a medical professional (’888 Patent, col. 10:31-34).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" (Compl. ¶34). Independent claim 1 is representative.
- Independent Claim 1 elements:
- A receptacle with an interior chamber.
- A piston mounted and slidable within the chamber.
- A common inlet and outlet port communicating with a first region of the chamber on one side of the piston.
- A vent communicating with a second region of the chamber on the opposite side of the piston.
- Hypodermic injecting and aspirating syringes, which are selectively interengaged with the common inlet and outlet port.
- The complaint reserves the right to assert additional claims (Compl. ¶36).
III. The Accused Instrumentality
- Product Identification: The accused products are collectively referred to as the "Cervos PRP System" (Compl. ¶15). This system includes the "Cervos PRP Single Pack," "PRP Double Pack-40CC," "PRP triple pack," a centrifuge kit, and associated buckets (Compl. ¶15). An image of a "PRP collection device" from the system is provided in the complaint. This image shows a cylindrical tube with a red base and a clear body, topped with a cap and a luer-lock style port (Compl. ¶16, Figure 1).
- Functionality and Market Context: The complaint alleges the Cervos PRP System is used to produce Platelet-Rich Plasma (PRP) from a patient's blood (Compl. ¶20). It references an instructional video that demonstrates a "step by step tutorial" for using the system (Compl. ¶20). Screenshots from this video depict a user injecting fluid into the device with a syringe and later aspirating fluid from it. One screenshot shows the transfer of "Cloudy Plasma" from the device (Compl. ¶21, Figures 2-3). The complaint alleges that Defendant manufactures, offers for sale, sells, and uses these devices (Compl. ¶¶15, 18).
IV. Analysis of Infringement Allegations
The complaint does not contain a formal claim chart. The following tables synthesize the infringement allegations based on the complaint's text and incorporated visual evidence.
’481 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an elongate receptacle having an interior chamber for receiving the fluid biological product therein, said receptacle having a lower end and a side wall that extends upwardly from said lower end | The main body of the accused "PRP collection device" is depicted as an elongate, tubular structure designed to hold fluid. | ¶16, Fig. 1 | col. 4:1-5 |
| a cap engaging said side wall and extending across an upper end of said receptacle | The accused device is shown with a cap assembly at its upper end. | ¶16, Fig. 1 | col. 4:56-59 |
| a common inlet and outlet port formed in one of said cap and said receptacle, said common inlet and outlet port configured for injecting the fluid biological product into said chamber and aspirating the constituent components from said chamber | The accused device has a port at its top where a syringe is attached to inject blood and later aspirate plasma. Figure 2 shows fluid injection, and Figure 3 shows fluid aspiration through what appears to be the same port. | ¶¶20-21, Figs. 2-3 | col. 5:10-21 |
| a vent formed through said lower end of said receptacle | The complaint does not provide specific allegations or evidence regarding a vent at the lower end of the accused device. | N/A | col. 4:44-55 |
| a piston mounted within said chamber and being slidable through said chamber while maintaining sealing engagement with an interior surface of said side wall of said receptacle...said piston being driven toward said lower end of said receptacle exclusively in response to hydraulic pressure exerted by fluid biological product injected into said chamber | The complaint does not explicitly identify a "piston" in the accused device. However, the operational principle described in the patent requires such a component to separate the fluid-filled region from a vented air region, and the video screenshots are consistent with a process that would require such a separator. | ¶¶20-21, Figs. 2-3 | col. 6:6-15, 60-64 |
’888 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a receptacle having an interior chamber for receiving the fluid biological product therein | The body of the accused "PRP collection device" shown in the complaint's figures. | ¶16, Fig. 1 | col. 4:8-12 |
| a piston mounted within said chamber and being slidable through said chamber while maintaining sealing engagement with an interior surface of a side wall of said receptacle | The complaint does not provide direct evidence of a piston, but alleges use of the "Accused Devices...as claimed in the patents-in-suit," implying the presence of a functional equivalent. | ¶21 | col. 6:16-23 |
| a common inlet and outlet port supported by said receptacle and communicating with a first region of said chamber on one side of said piston | The port at the top of the accused device, shown being used for both filling and extraction. | ¶¶20-21, Figs. 2-3 | col. 5:17-25 |
| a vent supported by said receptacle and communicating with a second region of said chamber on an opposite side of said piston | The complaint does not provide specific allegations or evidence regarding a vent. | N/A | col. 6:6-10 |
| hypodermic injecting and aspirating syringes, which are selectively interengaged with said common inlet and outlet port outside of said receptacle | The complaint explicitly references and shows screenshots of an instructional video where syringes are used to inject fluid into and aspirate fluid from the accused device. The complaint states the video shows use of a "Syringe Aspiration Technique." | ¶¶20-21, Figs. 2-3 | col. 6:46-54 |
- Identified Points of Contention:
- Evidentiary Question: A primary point of contention may be whether the accused Cervos PRP System contains a structure that functions as a "piston" as claimed. The complaint provides visual evidence of the device's external features and its use but lacks detail on its internal mechanics. The functionality of this internal component, specifically its ability to be "slidable" while "maintaining sealing engagement," will likely require discovery to resolve.
- Scope Question: For the ’481 Patent, a question arises as to whether the complaint sufficiently pleads the existence of a "vent formed through said lower end." For the ’888 Patent, a dispute may arise over whether Defendant's sale of "kits" and "packs" (Compl. ¶15) that may not include syringes meets the limitation requiring "hypodermic injecting and aspirating syringes" in the claimed assembly, which could turn on theories of divided or indirect infringement.
V. Key Claim Terms for Construction
- The Term: "piston"
- Context and Importance: This term is central to the novelty of the invention, as the slidable, sealing piston is the component that eliminates the need for prior art aspiration pipes. The infringement analysis for both patents depends on whether the accused device contains a structure that meets the definition of "piston." Practitioners may focus on this term because the complaint provides no direct evidence of the accused device's internal separating mechanism.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification refers to the component as a "liquid impermeable diaphragm or piston" (’481 Patent, col. 2:45-46), suggesting the term is not limited to a rigid, cylindrical structure but could encompass more flexible "diaphragm" type structures.
- Evidence for a Narrower Interpretation: The claims state the piston is "mounted within said chamber and being slidable" and "maintaining sealing engagement" (’481 Patent, col. 10:35-39). Embodiments show a distinct, solid component with a "generally circular, peripheral shape" and an "O-ring" to ensure a seal (’481 Patent, col. 6:9-14), which could support a narrower construction requiring a specific type of structure that actively slides and seals.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant provides an "instructional video" for using the accused devices, which illustrates a "detailed step by step tutorial" (Compl. ¶¶19-20). This allegation may support a claim for induced infringement by providing instructions on how to perform the claimed methods. The prayer for relief explicitly seeks to enjoin inducement (Compl. ¶(b)).
- Willful Infringement: The complaint alleges willfulness based on constructive knowledge of the patents-in-suit, asserting that Defendant "could not have entered the PRP preparation device market without knowledge" of the patents due to Plaintiff's market position and patent marking practices (Compl. ¶¶32, 39). It further alleges that Defendant's continued infringement after gaining knowledge constitutes willful, egregious, and bad-faith conduct warranting enhanced damages (Compl. ¶¶25, 32, 39).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of structural correspondence: does the accused Cervos device contain an internal, movable separator that meets the "piston" limitations of the asserted claims, specifically being "slidable" while "maintaining sealing engagement"? The resolution will likely depend on evidence of the accused device's internal design obtained through discovery.
- A key legal and factual question will be one of infringement theory: for the ’888 Patent, which claims an assembly including syringes, can Plaintiff prove infringement based on Defendant’s sale of kits that may not contain every element of the claim? This may turn on whether Defendant's actions constitute making or selling the full claimed combination or indirectly infringing by providing components and instructions for the end-user to complete the infringing assembly.
- A secondary but important question relates to the "vent" element: can Plaintiff provide evidence that the accused device includes a "vent formed through said lower end" as required by claim 1 of the ’481 Patent, an element for which the complaint currently provides no direct allegation or proof?