DCT

1:23-cv-00223

Serendia LLC v. Cynosure LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00223, D. Del., 03/01/2023
  • Venue Allegations: Venue is alleged in the District of Delaware based on Defendant Cynosure, LLC’s incorporation in the state.
  • Core Dispute: Plaintiff alleges that Defendant’s Potenza radio frequency (RF) microneedling systems infringe six patents related to methods and apparatuses for dermatological treatment.
  • Technical Context: The technology involves using an array of microneedles to deliver controlled RF energy into the dermis for aesthetic skin tightening and revitalization.
  • Key Procedural History: The complaint notes that a parallel complaint was filed at the International Trade Commission (ITC), signaling a multi-front litigation strategy. Plaintiff also alleges that licensed products have been marked with the patent numbers-in-suit.

Case Timeline

Date Event
2008-08-06 Earliest Priority Date for ’536, ’774, ’812 Patents
2011-06-14 Earliest Priority Date for ’836, ’379, ’444 Patents
2016-04-26 U.S. Patent No. 9,320,536 Issues
2016-11-01 U.S. Patent No. 9,480,836 Issues
2017-10-03 U.S. Patent No. 9,775,774 Issues
2018-08-28 U.S. Patent No. 10,058,379 Issues
2020-12-22 U.S. Patent No. 10,869,812 Issues
2022-08-09 U.S. Patent No. 11,406,444 Issues
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 prior art dermatological treatments as facing challenges in effectively delivering energy to the dermis layer of the skin without causing unwanted damage to the outer epidermal layer (’536 Patent, col. 2:24-41).
  • The Patented Solution: The invention proposes a system featuring a hand-held device with a disposable, "releasably couplable" cartridge containing an array of microneedles (’536 Patent, col. 10:4-11). This apparatus is designed to controllably deploy the needles into the skin and deliver energy, such as electrical or light-based energy, to effect treatment while providing a user-friendly, modular system (’536 Patent, Figs. 9A-9D; col. 10:42-53).
  • Technical Importance: This modular approach with disposable cartridges is designed to facilitate safe, repeatable, and customizable dermatological treatments. (Compl. ¶23).

Key Claims at a Glance

  • The complaint asserts the independent claims of the patent (Compl. ¶29). Independent claim 11 is representative of the apparatus.
  • Claim 11 Elements:
    • A user holdable device with a proximal end
    • A releasably couplable deployable needle assembly, which is mechanically separable from the proximal end
    • The needle assembly includes a plurality of extendable needles and is movable to extend the needles from the assembly's end surface
    • At least one electrical contact on the needle assembly remains electrically coupled to a contact on the user holdable device during extension
    • A motor to cause the needle extension
    • A signal generator to energize the needles

U.S. Patent No. 9,480,836 - "Skin Treatment Apparatus and Method," issued November 1, 2016

The Invention Explained

  • Problem Addressed: The patent background describes prior art high-frequency skin treatments that deliver energy between a pair of needles, which can lead to side effects like burning of the epidermis and dermis, potentially causing scarring (’836 Patent, col. 2:5-20). The use of insulated needles to mitigate this introduces other problems, such as pain and possible allergic reactions (’836 Patent, col. 2:20-29).
  • The Patented Solution: The invention claims an apparatus with a plurality of bipolar electrodes (needles) and a radio frequency (RF) generation module that provides an Alternating Current (AC) RF signal. The configuration is designed to cause energy to be applied in a way that coagulation occurs around each electrode individually, rather than creating an energy arc between them (’836 Patent, Abstract; Claim 1). This is consistent with the "Na effect" described in the complaint (Compl. ¶21).
  • Technical Importance: This approach seeks to localize the thermal effect to the tissue immediately surrounding each microneedle within the dermis, thereby minimizing damage to the epidermis and the tissue between the needles. (’836 Patent, col. 4:6-12).

Key Claims at a Glance

  • The complaint asserts the independent claims of the patent (Compl. ¶40). Independent claim 1 is representative.
  • Claim 1 Elements:
    • A plurality of electrodes, being bipolar and configured for insertion into skin
    • An RF generation module electrically coupled to the electrodes
    • The module is configured to provide an Alternating Current (AC) RF signal to the electrodes
    • The signal is configured to cause coagulation around each electrode rather than coagulating between the electrodes

U.S. Patent No. 9,775,774 - "Method, System, and Apparatus for Dermatological Treatment," issued October 3, 2017

  • Technology Synopsis: As a member of the same family as the ’536 Patent, this patent relates to systems and methods for dermatological treatment using a device with a modular, deployable needle assembly for delivering energy to skin tissue (Compl. ¶¶8, 13).
  • Asserted Claims: The complaint asserts the independent claims of the patent (Compl. ¶51).
  • Accused Features: The complaint alleges that the Potenza RF microneedling device infringes by embodying the claimed system and method (Compl. ¶50).

U.S. Patent No. 10,058,379 - "Electrically Based Medical Treatment Device and Method," issued August 28, 2018

  • Technology Synopsis: As a member of the same family as the ’836 Patent, this patent relates to medical treatment devices that use bipolar electrodes to apply RF energy to create a therapeutic effect, such as coagulation, in the tissue immediately surrounding each individual electrode rather than between them (Compl. ¶¶8, 15).
  • Asserted Claims: The complaint asserts the independent claims of the patent (Compl. ¶62).
  • Accused Features: The complaint alleges that the Potenza device infringes by using RF energy with microneedles in the claimed manner (Compl. ¶61).

U.S. Patent No. 10,869,812 - "Method, System, and Apparatus for Dermatological Treatment," issued December 22, 2020

  • Technology Synopsis: As a member of the same family as the ’536 Patent, this patent relates to dermatological treatment systems that include a user-holdable device and a releasably couplable, deployable needle module for controlled energy delivery (Compl. ¶¶8, 17).
  • Asserted Claims: The complaint asserts the independent claims of the patent (Compl. ¶73).
  • Accused Features: The complaint alleges that the Potenza system, including its handpiece and disposable tips, infringes the claimed apparatus (Compl. ¶72).

U.S. Patent No. 11,406,444 - "Electrically Based Medical Treatment Device and Method," issued August 9, 2022

  • Technology Synopsis: As a member of the same family as the ’836 Patent, this patent relates to medical devices using bipolar electrodes with an AC RF signal configured to cause coagulation primarily around each individual electrode, a concept termed the "Na effect" (Compl. ¶¶8, 19, 21).
  • Asserted Claims: The complaint asserts the independent claims of the patent (Compl. ¶84).
  • Accused Features: The complaint alleges that the Potenza device’s method of applying RF energy through its microneedles infringes the patent (Compl. ¶83).

III. The Accused Instrumentality

Product Identification

The accused products include the Potenza RF microneedling dermatological treatment device and its components, such as needle assemblies (Compl. ¶24).

Functionality and Market Context

The complaint describes the Potenza as a device used for treating and tightening skin on areas including the face, scalp, chin, and neck (Compl. ¶25). Plaintiff Serendia alleges that it competes directly with Defendant Cynosure in the market for RF microneedling systems (Compl. ¶26). The complaint does not provide specific technical details on the Potenza's operation, instead referencing external exhibits that were not filed with the complaint document (Compl. ¶¶24, 29, 40, 51, 62, 73, 84). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references, but does not include, claim chart exhibits detailing its infringement theories (Compl. ¶¶29, 40). The narrative theory for the ’836 patent family is that the accused Potenza device employs bipolar microneedles and an RF generator that applies an AC signal, causing coagulation to form in distinct zones around each individual needle tip in the dermis, thereby practicing the claimed invention (Compl. ¶¶21, 23, 39). For the ’536 patent family, the complaint’s theory is that the Potenza system, with its handpiece and disposable needle tips, constitutes the claimed "user holdable device" with a "releasably couplable deployable needle assembly" for performing dermatological treatments (Compl. ¶¶24, 28).

  • Identified Points of Contention:
    • Scope Questions: For the ’836 patent family, a central question may be whether the energy field generated by the accused Potenza device is "configured to cause coagulation around each electrode rather than coagulating between the electrodes" (’836 Patent, Claim 1). The distinction between energy application around versus between electrodes appears to be a primary point of novelty asserted by the patent, raising the question of how broadly this limitation will be construed and whether the accused device falls within that scope.
    • Technical Questions: The complaint's infringement allegations are conclusory. A key evidentiary question will be what proof Plaintiff can offer to demonstrate that the Potenza device's electrical and physical operations meet each limitation of the asserted claims. Specifically for the ’836 patent family, this may require technical evidence, such as thermal imaging or electromagnetic field modeling, to establish how and where coagulation zones are formed during the device's operation.

V. Key Claim Terms for Construction

  • The Term: "coagulation around each electrode rather than coagulating between the electrodes" (from claim 1 of the ’836 Patent).

    • Context and Importance: This phrase appears to be the central technical distinction over the prior art described in the patent. The construction of this term will be critical to the infringement analysis, as it defines the specific mode of energy delivery required. Practitioners may focus on this term because it draws a fine, but potentially dispositive, line between the claimed invention and prior art systems.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification states that "each needle may independently form an energy field about its tip" (’836 Patent, col. 4:58-60), which might support a construction that does not require perfectly isolated energy fields, so long as the primary effect is centered on the needles.
      • Evidence for a Narrower Interpretation: Figure 5 of the patent is described as showing an embodiment where the "heated area around the needle end tips may be oval or tear shaped" and "heat may not be concentrated between needles" (’836 Patent, col. 3:27-31; Fig. 5). This figure, depicting distinct and separate coagulation zones, may be used to argue for a narrower construction requiring clear separation of the thermal effects.

  • The Term: "releasably couplable deployable needle assembly" (from claim 11 of the ’536 Patent).

    • Context and Importance: The infringement analysis for the ’536 patent family will depend on whether the accused Potenza device's handpiece and disposable tip fall within the scope of this structural limitation. Defendant may argue that its product's specific coupling mechanism is different from what is described and enabled in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself is general. Plaintiff may argue that it should be given its plain and ordinary meaning, covering any device with a detachable needle cartridge that can be deployed.
      • Evidence for a Narrower Interpretation: The specification discloses detailed mechanical structures for coupling and decoupling the needle assembly, including specific arrangements of connecting arms, tabs, and recesses (’536 Patent, Figs. 10A-10D). A defendant may argue these specific embodiments limit the scope of the claim term to those structures and their equivalents.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Cynosure provides "demonstrative and informational webinars, videos, and other materials" with the intent to encourage its customers to use the accused products in a manner that directly infringes the asserted patents (Compl. ¶¶33, 44, 55, 66, 77, 88).
  • Willful Infringement: Willfulness is alleged based on knowledge of the patents acquired no later than the filing date of the complaint and the parallel ITC complaint (Compl. ¶¶30, 41, 52, 63, 74, 85). This suggests the claim for willfulness is based on alleged post-suit knowledge.

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

  • A core issue will be one of technical operation: Does the accused Potenza device apply RF energy in a manner that creates distinct coagulation zones "around each electrode," as claimed in the ’836 patent family, or does it function more like prior art systems that apply energy "between the electrodes"? The resolution of this factual question will likely require extensive expert discovery and analysis.
  • A second key issue will be one of structural scope: Does the mechanical interface between the Potenza handpiece and its disposable tips meet the limitations of a "releasably couplable deployable needle assembly" as that term is construed in light of the ’536 patent family's specification and figures? The outcome may turn on whether the claims are interpreted broadly or are limited to the specific embodiments disclosed.
  • A final procedural question is the impact of the parallel ITC investigation. An ITC proceeding often runs on an expedited schedule and could influence the district court litigation through early claim construction rulings or findings on infringement and validity, potentially shaping settlement leverage for both parties.