DCT

1:23-cv-00225

Serendia LLC v. Lutronic Aesthetics Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Serendia, LLC v. Lutronic Aesthetics, Inc., 1:23-cv-00225, D. Del., 03/01/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s radio frequency (RF) microneedling devices infringe six patents related to systems and methods for dermatological treatment.
  • Technical Context: The technology at issue is RF microneedling, a cosmetic procedure that uses fine needles to deliver radio frequency energy into the dermis for skin rejuvenation and tightening.
  • Key Procedural History: The complaint notes that a parallel complaint was filed at the International Trade Commission (ITC), indicating a multi-front litigation strategy by the Plaintiff.

Case Timeline

Date Event
2008-08-06 Earliest Priority Date for U.S. Patent Nos. 9,320,536; 9,775,774; 10,869,812
2011-06-14 Earliest Priority Date for U.S. Patent Nos. 9,480,836; 10,058,379; 11,406,444
2016-04-26 U.S. Patent No. 9,320,536 Issued
2016-11-01 U.S. Patent No. 9,480,836 Issued
2017-10-03 U.S. Patent No. 9,775,774 Issued
2018-08-28 U.S. Patent No. 10,058,379 Issued
2020-12-22 U.S. Patent No. 10,869,812 Issued
2022-08-09 U.S. Patent No. 11,406,444 Issued
2023-03-01 Complaint Filed

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

U.S. Patent No. 9,320,536 - "Method, System, and Apparatus for Dermatological Treatment"

Issued April 26, 2016

The Invention Explained

  • Problem Addressed: The patent describes the desirability of treating dermatological tissue but does not specify a particular problem in its background section ('536' Patent, col. 1:16-18). The complaint alleges the inventions improve upon prior technology that could cause pain and scarring (Compl. ¶23).
  • The Patented Solution: The invention provides a system for treating skin that includes a hand-held device coupled to a disposable cartridge containing a plurality of needles ('536 Patent, col. 2:50-59). The system is described as enabling different operational modes, such as "cut," "blend," and "coagulation," by controlling parameters like signal intensity, time, and needle deployment depth, as illustrated in a system processing algorithm ('536 Patent, FIG. 12).
  • Technical Importance: This modular approach with disposable cartridges and user-selectable treatment modes suggests a design focused on providing procedural flexibility and safety in a clinical setting (Compl. ¶22-23).

Key Claims at a Glance

The complaint does not identify specific asserted claims but indicates that the "independent claims" of the '536 Patent are asserted (Compl. ¶29). The first independent claim, Claim 1, is a method claim with the following essential elements:

  • Placing a user holdable device releasably couplable deployable needle module end surface on or near dermatological tissue to be treated.
  • The device includes a proximal end and the releasably couplable deployable needle module, which is mechanically separable from the proximal end.
  • The module includes a needle assembly with a plurality of needles, where the assembly is movable within the module to extend the needles from the end surface.
  • During movement, at least one electrical contact of the needle assembly remains electrically coupled to at least one electrical contact of the device's proximal end.
  • Communicating electrical signals from the proximal end to the needle assembly via the electrical contacts.

U.S. Patent No. 9,480,836 - "Skin Treatment Apparatus and Method"

Issued November 1, 2016

The Invention Explained

  • Problem Addressed: The patent describes problems with prior art RF skin treatments, noting that delivering energy between needles can burn the epidermis and dermis, causing scarring ('836' Patent, col. 2:16-19). It also notes that using insulated needles to mitigate this can cause pain, allergic reactions, or insulation failure ('836 Patent, col. 2:21-26).
  • The Patented Solution: The invention proposes an apparatus using a plurality of bipolar electrodes (needles) energized by an alternating current (AC) RF signal. This configuration is described as concentrating heat to cause coagulation in an oval or tear-shaped area around each individual needle tip in the dermis, rather than between the needles, thereby minimizing damage to the epidermis ('836 Patent, col. 3:13-26; FIG. 5). This targeted coagulation is referred to in the complaint as the "Na effect" (Compl. ¶21).
  • Technical Importance: By localizing the thermal effect to the area immediately surrounding each needle, the invention purports to offer a safer and more precise method of RF microneedling with reduced side effects (Compl. ¶23-24).

Key Claims at a Glance

The complaint indicates the "independent claims" are asserted (Compl. ¶40). The first independent claim, Claim 1, is an apparatus claim with the following essential elements:

  • A plurality of electrodes, the electrodes being bipolar and configured to be insertable into skin to be treated.
  • A radio frequency (RF) generation module electrically coupled to the plurality of electrodes.
  • The RF generation module is configured to provide an Alternating Current (AC) RF signal to the plurality of electrodes.
  • The module is configured to cause coagulation around each electrode rather than coagulating between the electrodes.

Multi-Patent Capsule: U.S. Patent No. 9,775,774

  • Patent Identification: "Method, System, and Apparatus for Dermatological Treatment", Issued October 3, 2017.
  • Technology Synopsis: As a continuation of the '536 Patent, this patent further describes a dermatological treatment system with a handle and a disposable, deployable needle cartridge. Its claims are directed to an apparatus rather than a method, focusing on the structural arrangement of the components.
  • Asserted Claims: The complaint asserts the "independent claims" (Compl. ¶51).
  • Accused Features: The accused "Genius" device is alleged to embody the claimed apparatus (Compl. ¶50).

Multi-Patent Capsule: U.S. Patent No. 10,058,379

  • Patent Identification: "Electrically Based Medical Treatment Device and Method", Issued August 28, 2018.
  • Technology Synopsis: As a continuation of the '836 Patent, this patent further details the method and apparatus for applying RF energy to create coagulation around individual needles. The claims specify operational parameters, such as an RF frequency of "about 2.0 MHz" and the creation of an "oval shaped" energy application area.
  • Asserted Claims: The complaint asserts the "independent claims" (Compl. ¶62).
  • Accused Features: The accused "Genius" device's operation is alleged to meet the claimed method and apparatus features (Compl. ¶61).

Multi-Patent Capsule: U.S. Patent No. 10,869,812

  • Patent Identification: "Method, System, and Apparatus for Dermatological Treatment", Issued December 22, 2020.
  • Technology Synopsis: As a continuation in the family of the '536 Patent, this patent claims both a method and an apparatus for treating dermatological tissue. The claims focus on the mechanical and electrical features of the user-holdable device with a "releasably couplable deployable needle module."
  • Asserted Claims: The complaint asserts the "independent claims" (Compl. ¶73).
  • Accused Features: The structure and use of the "Genius" device are alleged to infringe (Compl. ¶72).

Multi-Patent Capsule: U.S. Patent No. 11,406,444

  • Patent Identification: "Electrically Based Medical Treatment Device and Method", Issued August 9, 2022.
  • Technology Synopsis: As a continuation in the family of the '836 Patent, this patent claims an apparatus and method where energy is "substantially applied to body segments around each electrode." The claims emphasize the arrangement of electrodes such that nearest electrodes have opposite polarities.
  • Asserted Claims: The complaint asserts the "independent claims" (Compl. ¶84).
  • Accused Features: The "Genius" device's electrode configuration and energy delivery are alleged to infringe (Compl. ¶83).

III. The Accused Instrumentality

Product Identification

  • The accused products include the Lutronic "Genius" device and its associated components, such as needle assemblies (Compl. ¶24).

Functionality and Market Context

  • The Genius device is identified as an RF microneedling system used for aesthetic dermatological treatments, such as skin tightening (Compl. ¶24, ¶26). The complaint alleges that Plaintiff Serendia markets a competing device, the Scarlet SRF, placing the parties in direct competition (Compl. ¶25-26). The complaint does not provide sufficient detail for a technical analysis of the Genius device's specific operational mechanisms.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that were not provided with the filed complaint document (Compl. ¶29, 40, 51, 62, 73, 84). The infringement allegations are therefore summarized below in narrative form.

  • '536 Patent Family ('536, '774', '812' Patents) Allegations:
    The complaint alleges that the accused Genius system infringes claims directed to a dermatological treatment apparatus and its method of use. The infringement theory appears to rest on the Genius system's architecture, which allegedly includes a hand-held device ("proximal end") and a disposable cartridge ("releasably couplable deployable needle module") that contains needles and is mechanically separable but remains electrically connected to the handle to receive signals for treating tissue (Compl. ¶28, 50, 72).

  • '836 Patent Family ('836, '379', '444' Patents) Allegations:
    The complaint alleges that the accused Genius device infringes claims directed to an apparatus and method for applying RF energy via bipolar needles. The core of this allegation is that the Genius device provides an AC RF signal that causes coagulation in the tissue around each individual electrode rather than creating an electrical arc between electrodes (Compl. ¶39, 61, 83). This functionality is what the complaint terms the "Na effect" (Compl. ¶21).

  • Identified Points of Contention:

    • Structural Questions ('536 Family): A potential point of contention is whether the accused Genius device's cartridge mechanism meets the specific structural and functional claim limitations of a "releasably couplable deployable needle module" and a "mechanically separatably" component. The dispute may focus on the precise manner in which the Genius cartridge attaches to and operates with the handpiece.
    • Technical Questions ('836 Family): A central technical question will be one of functional operation: does the accused Genius device, as a matter of physics and biology, actually generate coagulation primarily around each needle as claimed? The determination of infringement may depend on expert evidence analyzing the device's electrical output and the resulting biophysical effects in tissue, and whether this effect is distinct from prior art systems where energy flows between needles.

V. Key Claim Terms for Construction

  • Term: "coagulation around each electrode rather than coagulating between the electrodes" (from Claim 1 of the '836 Patent).
    • Context and Importance: This phrase defines the novel "Na effect" and is the central point of distinction asserted for the '836 patent family. The entire infringement case for these patents may depend on whether the accused device's function falls within the scope of this term.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes this as a general outcome of using bipolar needles with AC signals, where "each needle may independently form an energy field about its tip" ('836 Patent, col. 4:58-61). This could support a reading where any system achieving this independent field effect infringes.
      • Evidence for a Narrower Interpretation: Figure 5 depicts distinct, tear-shaped heated areas (909) around each needle with no overlap ('836 Patent, FIG. 5). A defendant may argue this requires a complete or near-complete absence of coagulation between the needles, and that any significant inter-needle effect would fall outside the claim.
  • Term: "releasably couplable deployable needle module" (from Claim 1 of the '536 Patent).
    • Context and Importance: This term defines the disposable cartridge at the heart of the '536 patent family's system claims. Practitioners may focus on this term because infringement depends on the accused Genius cartridge mapping onto this claimed structure.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The abstract describes a "dermatological treatment apparatus including a user holdable device coupled to an acupuncture plate" ('536 Patent, Abstract). This general language could support a broad definition of any detachable treatment head.
      • Evidence for a Narrower Interpretation: The specification details a specific coupling mechanism with "connecting/locking arms" (924C) and "deflecting tabs" (924B) that engage with recesses ('536 Patent, FIG. 10A-10D; col. 12:5-10). A defendant may argue that the term should be limited to a module with these or structurally equivalent coupling features.

VI. Other Allegations

  • Indirect Infringement: For each asserted patent, the complaint alleges induced infringement under 35 U.S.C. § 271(b) and contributory infringement under § 271(c). The inducement allegations are based on Lutronic allegedly distributing the accused products and providing "demonstrative and informational webinars, videos, and other materials" that instruct and encourage customers to use the products in an infringing manner (e.g., Compl. ¶31-34).
  • Willful Infringement: Willfulness is alleged for all asserted patents. The basis for willfulness is Defendant’s alleged knowledge of the patents, which the complaint asserts occurred "no later than the filing date of this complaint and the parallel complaint filed at the International Trade Commission" (e.g., Compl. ¶30, 35).

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

This litigation appears to center on two distinct theories of infringement, corresponding to the two asserted patent families. The resolution of the case may depend on the following key questions:

  • A core issue will be one of functional operation: can Plaintiff provide sufficient technical evidence to demonstrate that the accused Genius device generates RF energy in a manner that causes coagulation primarily around each needle, consistent with the "Na effect" claimed in the '836 patent family, as opposed to flowing between the needles?
  • A second central issue will be one of structural scope: does the accused Genius device's disposable cartridge possess the specific mechanical and electrical coupling features of the "releasably couplable deployable needle module" as construed from the language and figures of the '536 patent family?
  • Regarding damages, a key question will be one of knowledge and intent: can Plaintiff establish that Defendant had knowledge of the asserted patents prior to the filing of the complaint? The current allegations for willfulness are tied to the date of filing, which may limit the scope of potential enhanced damages if no pre-suit knowledge is proven.