DCT

1:17-cv-06301

Mtderm GmbH v. Oreladel BH Corp

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-06301, E.D.N.Y., 10/27/2017
  • Venue Allegations: Venue is alleged to be proper as Defendant is a New York corporation that resides, maintains a regular and established place of business, and has conducted acts of infringement within the Eastern District of New York.
  • Core Dispute: Plaintiffs allege that Defendant’s permanent make-up machines and associated single-use needle cartridges infringe a patent related to modular, hygienic ink application devices designed to prevent cross-contamination.
  • Technical Context: The technology addresses hygiene and safety in the permanent make-up and tattoo industries by separating a reusable motorized handle from a sterile, fully disposable module containing the needle and ink reservoir.
  • Key Procedural History: The original patent, U.S. Patent No. 6,505,530, underwent an ex parte reexamination requested by Plaintiff MT.DERM, which resulted in the issuance of a Reexamination Certificate on November 4, 2015. This proceeding amended key claims, a fact that may be central to claim construction. The complaint also alleges that Defendant was notified of the alleged infringement prior to the lawsuit.

Case Timeline

Date Event
1999-10-22 '530 Patent Priority Date
2003-01-14 U.S. Patent No. 6,505,530 Issue Date
2015-11-04 Reexamination Certificate ('530 C1) Issue Date
2017-03-29 Plaintiff alleges sending notice of infringement to Defendant
2017-05-05 Plaintiff alleges Defendant refused delivery of subsequent notice
2017-10-27 Complaint Filing Date

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

U.S. Patent No. 6,505,530 - "Ink Application Device for Tattooing or for Making Permanent Make-Up"

  • Patent Identification: U.S. Patent No. 6,505,530, "Ink Application Device for Tattooing or for Making Permanent Make-Up," issued January 14, 2003. The patent was subsequently amended by a Reexamination Certificate issued on November 4, 2015 (hereinafter "Reexamined '530 Patent").

The Invention Explained

  • Problem Addressed: The patent's background describes the significant health risks associated with applying permanent make-up and tattoos, specifically the transmission of infectious diseases like AIDS and hepatitis through contaminated equipment and ink supplies ('530 Patent, col. 1:15-28). It highlights the difficulty and cost of properly sterilizing multi-use device parts that come into contact with a customer's bodily fluids ('530 Patent, col. 1:29-46).
  • The Patented Solution: The invention is an ink application device divided into two distinct, releasably connected modules. The first is a reusable "base module," which contains the handle and the integrated needle drive (motor) ('530 Patent, Abstract). The second is a "unitary sterilized disposable module" which integrates all components that could become contaminated, including the needle, needle nozzle, and an ink-receiving portion, into a single, pre-sterilized unit that is discarded after one use ('530 Patent, col. 2:20-24, Fig. 1). This design aims to ensure sterility for each procedure by making the contaminated parts easily and entirely replaceable.
  • Technical Importance: This modular system was designed to simplify hygienic procedures and provide a reliable method to prevent cross-contamination between clients, a critical concern for both practitioners and customers in the cosmetic and tattoo fields ('530 Patent, col. 2:34-45).

Key Claims at a Glance

  • The complaint asserts infringement of representative independent claim 1 of the Reexamined '530 Patent, as well as numerous other apparatus and method claims (Compl. ¶21-23).
  • The essential elements of the amended independent claim 1 are:
    • a basic module having a handle and an integrated needle drive;
    • a unitary sterilized disposable module including an outer housing and a needle, which is supported by a needle nozzle at one end and by a portion that can contact the needle drive at the other, with the needle being movable within the housing;
    • an ink receiving portion disposed around the needle within the module; and
    • means for allowing simultaneous removal of the entire unitary sterilized disposable module from the basic module. ('530 Reexamination Certificate, col. 2:21-38).
  • The complaint reserves the right to amend its preliminary infringement chart and assert additional claims upon further discovery (Compl. ¶21, fn. 1).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant’s "ORON57 permanent makeup machine" and its "NPM Line of Needles" cartridges, which are collectively referred to as the "Infringing Products" (Compl. ¶8-9).

Functionality and Market Context

  • The complaint alleges that the ORON57 machine is a permanent make-up device that functions as the claimed "basic module" by providing a handle and an integrated needle drive (Compl. ¶24). The various "NPM Line of Needles" products are alleged to be needle cartridges that function as the claimed "unitary sterilized disposable module," designed to be operatively inserted into the ORON57 device (Compl. ¶24). Plaintiffs allege that these products compete directly with their own manufactured and sold devices (Compl. ¶10).

IV. Analysis of Infringement Allegations

The complaint alleges infringement based on a preliminary claim chart attached as Exhibit C, but this exhibit was not filed with the complaint (Compl. ¶21). In lieu of a table, the narrative infringement theory is as follows:

The complaint alleges that Defendant’s "ORON57 permanent makeup machine," when combined with one of the "NPM Line of Needles" cartridges, forms an infringing system that meets all the limitations of the asserted claims of the Reexamined '530 Patent (Compl. ¶22). Specifically, the ORON57 machine is alleged to be the "basic module," while the NPM needle cartridge is alleged to be the "unitary sterilized disposable module" (Compl. ¶24). The use of this combined system by end-users is alleged to directly infringe the method claims of the patent (Compl. ¶23). No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: The infringement analysis may turn on whether the accused "NPM Line of Needles" cartridges meet the definition of a "unitary sterilized disposable module." The term "unitary" was added during reexamination, suggesting it is a key limitation. A central question for the court will be whether this term requires a single-piece construction or if it can read on a multi-part assembly that functions as a single unit.
  • Technical Questions: A factual dispute may arise over whether the accused cartridges contain an "ink receiving portion" as claimed, and whether the mechanism for attaching and detaching the cartridges from the ORON57 machine constitutes the claimed "means for allowing simultaneous removal of the entire" module.

V. Key Claim Terms for Construction

The Term: "unitary sterilized disposable module"

Context and Importance

This term, introduced during reexamination, is central to the patent's scope and the infringement case. Practitioners may focus on this term because its addition likely created prosecution history that could be used to argue for a narrower construction and limit the applicability of the doctrine of equivalents. The dispute will likely center on whether Defendant's multi-component cartridges can be considered "unitary."

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification suggests that the module can be constructed from multiple parts, stating it is "comprised of parts made of a medically compatible plastic material." This is contrasted with an "alternative embodiment" where "it can also be formed as one piece" ('530 Patent, col. 3:52-55). This may support an interpretation where "unitary" refers to the module's integrated function and disposal as a single unit, not its initial construction.
  • Evidence for a Narrower Interpretation: The explicit addition of "unitary" during reexamination suggests an intent to distinguish the invention from prior art that may have had disposable, but not necessarily single-unit, components. The claim's requirement for "simultaneous removal of the entire unitary sterilized disposable module" could be argued to support a construction requiring a single, inseparable piece at the time of use and disposal ('530 Reexamination Certificate, col. 2:35-38).

The Term: "means for allowing simultaneous removal of the entire unitary sterilized disposable module"

Context and Importance

This limitation is drafted in means-plus-function format under 35 U.S.C. § 112(f). Its scope is therefore limited to the corresponding structures described in the patent's specification and their equivalents. The infringement analysis for this element will be a two-step process: identifying the disclosed structure and then determining if the accused device's connection mechanism is equivalent.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation (i.e., multiple possible structures): The specification describes the connection in general terms as one that can be "established and released in a simple manner" ('530 Patent, col. 2:50-52). It also discloses multiple drive connection types, including a magnetic coupling and a mechanical clamping device like a collet chuck ('530 Patent, col. 4:26-34, 4:51-55). This could support a range of equivalent structures.
  • Evidence for a Narrower Interpretation (i.e., specific structure): Figures 1 and 2 depict a physical connection where the housing of the disposable module (1) engages with the housing of the base module (20). A party could argue that the "means" is limited to this specific type of friction-fit or threaded housing-to-housing interface, as opposed to just the needle-to-drive connection.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement. The inducement allegation is based on Defendant marketing and selling the ORON57 machine and NPM needle cartridges, which are "specifically designed to be operatively inserted" into one another, and "suggesting combinations" that allegedly infringe (Compl. ¶24). The contributory infringement allegation claims the products are a "material part of the invention" and not a "staple article of commerce suitable for non-infringing use" (Compl. ¶26).

Willful Infringement

  • The complaint alleges that Defendant's infringement is willful. This is primarily based on allegations of pre-suit knowledge, stating that Plaintiffs' counsel sent correspondence to Defendant on or about March 29, 2017, providing notice of infringement, and that Defendant subsequently refused delivery of another letter on May 5, 2017 (Compl. ¶30-31). Continued sales after this alleged notice form the basis of the willfulness claim (Compl. ¶29, ¶32).

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

  • A core issue will be one of definitional scope and prosecution history: can the term "unitary sterilized disposable module," which was added during reexamination, be construed to cover Defendant’s accused multi-component needle cartridges? The outcome will likely depend on the weight given to the patent's specification versus the arguments made to the USPTO during reexamination.
  • A second key issue will be one of structural equivalence: does the mechanism for attaching and detaching Defendant's needle cartridges from its handpiece perform the same function in substantially the same way to achieve the same result as the "means for allowing simultaneous removal" disclosed in the '530 patent's specification?
  • Finally, a critical factual question for willfulness and potential enhanced damages will be proof of knowledge: can Plaintiffs establish that Defendant received actual notice of the alleged infringement on the dates specified in the complaint, and thereafter engaged in conduct that was objectively and subjectively reckless?