DCT

2:25-cv-02374

Cervos Medical LLC v. Biopsybell SRL

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-02374, E.D. Pa., 05/09/2025
  • Venue Allegations: Venue is asserted based on Defendant Stem Genix being a Pennsylvania limited liability company and both defendants allegedly having regular and consistent contacts with the Commonwealth of Pennsylvania.
  • Core Dispute: Plaintiffs allege that Defendants’ "Marrow Stem" bone marrow aspiration device and its use infringe three patents related to bone marrow aspiration technology.
  • Technical Context: The technology concerns medical devices for bone marrow aspiration, a procedure for harvesting stem and progenitor cells from bone for use in regenerative therapies.
  • Key Procedural History: The complaint alleges a notable prior business relationship where Defendant Stem Genix was a distributor for Plaintiffs’ "Marrow Cellution" device. Following the termination of this relationship, Stem Genix allegedly began selling the competing "Marrow Stem" device, which is manufactured by Defendant Biopsybell. The complaint further alleges that Biopsybell, in a 510(k) premarket notification to the FDA, identified Plaintiffs’ device as the "predicate device" for its own Marrow Stem product. Plaintiffs also claim to have sent a notice letter to Biopsybell identifying the patents-in-suit, which allegedly received no response.

Case Timeline

Date Event
2014-10-17 Earliest Priority Date for '669, '193, and '659 Patents
2019-07-XX Stem Genix becomes distributor for Plaintiffs' device
2020-03-XX Biopsybell allegedly accesses Plaintiffs' product website
2020-11-06 Biopsybell submits 510(k) notification for Marrow Stem device
2020-11-XX Biopsybell allegedly launches the Marrow Stem device
2023-01-31 U.S. Patent No. 11,564,669 ('669 Patent) Issues
2023-02-14 U.S. Patent No. 11,576,659 ('659 Patent) Issues
2024-03-05 U.S. Patent No. 11,918,193 ('193 Patent) Issues
2024-07-10 Plaintiffs terminate Stem Genix's distributor status
2025-02-11 Plaintiffs send notice letter to Biopsybell regarding patents-in-suit
2025-05-09 Complaint Filed

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

U.S. Patent No. 11,564,669 - "Bone Marrow Aspiration Device and Method"

  • Patent Identification: U.S. Patent No. 11,564,669, "Bone Marrow Aspiration Device and Method," issued January 31, 2023. (Compl. ¶19).

The Invention Explained

  • Problem Addressed: The patent describes the drawbacks of traditional bone marrow aspiration needles, which are stiff and can become stuck in bone. This necessitates multiple punctures to obtain a sufficient sample volume, causing patient trauma and potentially contaminating the aspirate with peripheral blood, which reduces its quality. ('669 Patent, col. 1:26-51).
  • The Patented Solution: The invention is a bone marrow aspiration device featuring a cannula with a closed distal tip and at least one side port for aspiration. This device incorporates a screw mechanism that allows a clinician to precisely and controllably reposition the cannula within the bone space by rotating a handle. This enables the aspiration of marrow from multiple depths through a single puncture point, leveraging the patient's body to facilitate withdrawal of the cannula. ('669 Patent, Abstract; col. 2:1-16, col. 6:10-20). The use of side ports is designed to preferentially draw marrow while avoiding peripheral blood that can fill the channel created by the device's entry. ('669 Patent, col. 6:15-20).
  • Technical Importance: This design aims to enhance the quality and yield of bone marrow aspirate while minimizing patient trauma and procedure time compared to traditional multi-puncture techniques. ('669 Patent, col. 1:40-51).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶69, ¶119).
  • The essential elements of claim 1 include:
    • A cannula with a closed distal end configured to penetrate bone and at least one side aperture spaced proximally from the closed end.
    • A handle at the proximal end of the cannula.
    • A screw mechanism distal to the handle, comprising a threaded jacket and a lead screw, through which the cannula extends.
    • The screw mechanism is configured to allow adjustment of the cannula's exposed length and to reposition the cannula to different depths within the bone by rotating the handle.
  • The complaint does not explicitly reserve the right to assert dependent claims but alleges infringement of "one or more claims." (Compl. ¶119).

U.S. Patent No. 11,918,193 - "Bone Marrow Aspiration Device and Method"

  • Patent Identification: U.S. Patent No. 11,918,193, "Bone Marrow Aspiration Device and Method," issued March 5, 2024. (Compl. ¶20).

The Invention Explained

  • Problem Addressed: Like its related patents, the '193 Patent addresses the shortcomings of conventional bone marrow aspiration, including sample contamination and patient trauma from multiple punctures. ('193 Patent, col. 1:20-51).
  • The Patented Solution: The invention is a device structurally and functionally similar to that of the '669 Patent, featuring a cannula with a closed tip and side ports, a handle, and a screw mechanism for controlled repositioning. The key distinguishing feature recited in claim 1 is that the threaded jacket of the screw mechanism "taper[s] at its distal end." ('193 Patent, Claim 1). This tapered design creates a smaller contact surface with the patient's skin. ('193 Patent, col. 14:58-62; Fig. 6A).
  • Technical Importance: The technology provides the same core benefits of single-puncture, multi-depth aspiration, with the tapered jacket potentially offering improved stability or patient comfort at the insertion site. ('193 Patent, col. 1:52-56).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶68, ¶126).
  • The essential elements of claim 1 are substantively identical to claim 1 of the '669 Patent, with the additional limitation:
    • The threaded jacket of the screw mechanism tapers at its distal end.
  • The complaint alleges infringement of "one or more claims." (Compl. ¶126).

U.S. Patent No. 11,576,659 - "Bone Marrow Aspiration Device and Method"

  • Patent Identification: U.S. Patent No. 11,576,659, "Bone Marrow Aspiration Device and Method," issued February 14, 2023. (Compl. ¶21).

Technology Synopsis

This patent claims methods of using a bone marrow aspiration device. The core of the claimed method involves positioning an introducer cannula in a patient's bone, moving that cannula to a second, different depth using a mechanism that provides leverage on the patient, and aspirating bone marrow at these different depths. ('659 Patent, Claim 1, Claim 14). This patent protects the specific technique of use enabled by the device patents.

Asserted Claims

The complaint asserts at least independent claim 1. (Compl. ¶72, ¶133).

Accused Features

Defendants are accused of direct infringement through their own use and of inducing infringement by end-users (e.g., medical professionals) by providing instructions, training, video tutorials, and step-by-step diagrams that allegedly direct users to perform the patented method with the Marrow Stem device. (Compl. ¶72-76, ¶133-134).

III. The Accused Instrumentality

Product Identification

  • The accused product is the "Marrow Stem" bone marrow aspiration device. (Compl. ¶46).

Functionality and Market Context

  • The complaint alleges that the Marrow Stem device is a bone marrow aspiration product manufactured by Defendant Biopsybell and distributed by Defendant Stem Genix. (Compl. ¶50, ¶56). It is alleged to replicate key features of Plaintiffs' "Marrow Cellution" device, including its handle design and a screw-based mechanism for controlled cannula movement. (Compl. ¶56). A promotional image for the Marrow Stem device from Biopsybell’s website annotates a "MICROMETRIC GEAR" that provides "0,5 cm cannula retraction every 360° rotation." (Compl. p. 13, ¶57).
  • The complaint alleges a direct competitive conflict, noting Stem Genix is a former distributor of Plaintiffs' product that now promotes the accused Marrow Stem device, at times side-by-side with Plaintiffs' product. (Compl. p. 10, ¶47). Furthermore, the complaint alleges that in an FDA 510(k) filing, Biopsybell described the "Mechanism of Action" for its Marrow Stem device as enabling the collection of "bone marrow samples at different heights through the rotation of the rotating spacer," a function that aligns with the purpose of the patented invention. (Compl. p. 16, ¶65).

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,564,669 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a cannula having a proximal end and a distal end...the distal end of the cannula being closed...the cannula defining at least one side aperture spaced proximally from the closed distal end; The Marrow Stem device is alleged to replicate Plaintiffs' design. Defendants' website, in describing the competing product, allegedly copied text explaining the benefits of a "closed tip aspiration cannula that restricts aspiration through the side holes." ¶56, ¶102-103, p. 25 col. 6:10-20
a handle at the proximal end of the cannula; The accused Marrow Stem device is depicted with a T-shaped handle at its proximal end. An image from Biopsybell’s website shows this handle. ¶56-57, p. 13 col. 6:35-44
a screw mechanism distal to the handle, the mechanism comprising a threaded jacket and a lead screw...the cannula extending through a central lumen defined by the lead screw... The accused device is advertised as having a "MICROMETRIC GEAR" for controlled cannula retraction, and its mechanism of action is described in an FDA filing as using a "rotating spacer" to collect samples from different heights. This corresponds to the function of the claimed screw mechanism. ¶56-57, p. 13; p. 16 col. 2:6-10
...the length of the lead screw enabling the mechanism to reposition the cannula to different depths within the bone with rotation of the handle. The marketing for the accused device specifies "0,5 cm cannula retraction every 360° rotation," which directly alleges the functionality of repositioning the cannula to different depths via rotation of a mechanism. ¶57, p. 13 col. 2:11-16

U.S. Patent No. 11,918,193 Infringement Allegations

The allegations for the '193 Patent are substantively identical to those for the '669 Patent for the common claim elements, as described above. The analysis for the distinguishing element is below.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
...the threaded jacket tapering at its distal end... The complaint does not provide sufficient detail for analysis of this specific element, as the provided images are not granular enough to determine the geometry of the accused device's jacket. N/A col. 14:58-62

Identified Points of Contention

  • Scope Questions: A potential point of dispute may be whether the "MICROMETRIC GEAR" and "rotating spacer" of the accused Marrow Stem device meet the claim limitations of a "screw mechanism" comprising a "threaded jacket" and a "lead screw." Defendants may argue their mechanism is structurally different, raising a question of claim construction for the court.
  • Technical Questions: A key evidentiary question will be whether the physical Marrow Stem device actually possesses the features alleged, such as a closed-tip cannula with side ports. The complaint relies heavily on marketing materials and an FDA filing (Compl. p. 13, p. 16), and a central factual dispute will be to confirm through discovery and device inspection that these descriptions accurately reflect the as-sold product.

V. Key Claim Terms for Construction

  • The Term: "screw mechanism"

  • Context and Importance: This term is central to the functionality of the patented invention. The defendants' description of their product's "MICROMETRIC GEAR" (Compl. ¶57) suggests a similar function but uses different terminology. The outcome of the infringement analysis may turn on whether the accused gear falls within the scope of the claimed "screw mechanism."

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the mechanism's function as being able "to move the introducer cannula and the aspiration cannula in tandem" and to be "configured to move the introducer cannula...proximally with leverage on the patient." ('669 Patent, col. 2:1-5, col. 2:17-19). Plaintiffs may argue that any structure performing this function, like the accused "gear," meets the definition.
    • Evidence for a Narrower Interpretation: The patent consistently describes the "screw mechanism" as a "screw assembly that includes a threaded jacket and a lead screw." ('669 Patent, col. 2:6-8; Figs. 1B, 3D). Defendants may argue that the claim term should be limited to this specific two-part structure, which they may contend their "micrometric gear" is not.

  • The Term: "the distal end of the cannula being closed"

  • Context and Importance: This feature distinguishes the invention from traditional open-ended trocars and is critical to the patent's goal of reducing blood contamination. Infringement by the accused device, which is also a type of trocar, depends on it having this feature.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term "closed" is not explicitly defined, so it could be argued to mean any configuration that prevents aspiration primarily from the distal-most tip, thereby achieving the stated goal of avoiding peripheral blood that fills the entry channel. ('669 Patent, col. 6:15-20).
    • Evidence for a Narrower Interpretation: The specification contrasts the invention with "a traditional bone marrow aspiration needle" which is described as an "aspiration cannula (also referred to as a cannulated trocar)." ('669 Patent, col. 1:26-30). Defendants might argue "closed" requires a fully solid, non-perforated tip, as depicted in the patent figures (e.g., '193 Patent, Fig. 7B), to distinguish it from all forms of traditional trocars.

VI. Other Allegations

Indirect Infringement

  • The complaint makes specific allegations of induced infringement of the '659 method patent. It states that Defendants provide "expert clinical training and support" (Compl. ¶73), instructions, and a "step by step diagram" (Compl. ¶75). The complaint includes a three-step visual from Biopsybell's website that allegedly demonstrates the infringing use of the device. (Compl. p. 18, ¶75-76). These allegations provide a factual basis for the claim that Defendants specifically intended for end-users to perform the patented method.

Willful Infringement

  • The complaint alleges willfulness based on both pre-suit and post-suit knowledge. It claims Defendants knew of Plaintiffs' patented technology due to Biopsybell's access to Plaintiffs' website, Stem Genix's status as a former distributor, and Biopsybell's FDA 510(k) filing that names Plaintiffs' device as a predicate. (Compl. ¶55, ¶64, ¶82). More pointedly, the complaint alleges Plaintiffs sent an email on February 11, 2025, to a principal of Biopsybell that "identified the Patents-in-Suit and set forth concerns that the sale of the Marrow Stem device infringed," to which Biopsybell allegedly did not respond. (Compl. ¶81).

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

  • A central issue will be one of technical and factual equivalence: Does the accused "Marrow Stem" device, upon physical inspection, embody the specific structures claimed in the patents, such as the "closed" cannula tip and the "screw mechanism"? The case will likely depend on evidence developed during discovery to prove or disprove a direct correspondence between the accused product and the claim limitations.
  • A second key issue will be one of knowing infringement and intent: Given the prior business relationship, the alleged copying of marketing materials, the FDA filing referencing Plaintiffs' product, and the specific, unanswered pre-suit notice letter, a core question for the fact-finder will be whether Defendants' conduct constitutes willful infringement, potentially exposing them to enhanced damages.
  • Finally, for the '659 method patent, the case will present a question of inducement: Do the training materials, instructions, and diagrams that Defendants provide to medical professionals actively encourage and teach the specific, patented steps of repositioning the aspiration device to draw marrow from multiple depths, thereby constituting inducement to infringe?