DCT

1:18-cv-10682

Syneron Medical Ltd v. Lumenis Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-10682, D. Mass., 04/09/2018
  • Venue Allegations: Plaintiffs allege venue is proper in the District of Massachusetts based on Defendants' business operations in the state, which are alleged to include infringing activities, soliciting business, and deriving substantial revenue from customers in Massachusetts.
  • Core Dispute: Plaintiffs allege that Defendants’ Legend+ line of radio frequency micro-needle products infringes two patents related to methods and devices for dermatological treatment and tissue reshaping.
  • Technical Context: The technology concerns aesthetic medical devices that deliver radio frequency (RF) energy through an array of micro-needles to create controlled thermal injury in the dermis, intended to stimulate collagen growth and improve skin appearance.
  • Key Procedural History: The two patents-in-suit share a common specification and priority date, with the '899 patent being a continuation of the application that led to the '357 patent. Plaintiff Massachusetts General Hospital (MGH) is the original assignee of the patents and has granted an exclusive license to co-plaintiff Syneron.

Case Timeline

Date Event
2004-04-01 Patent Priority Date ('899 and '357 Patents)
2015-08-04 U.S. Patent No. 9,095,357 Issues
2016-12-06 U.S. Patent No. 9,510,899 Issues
2018-04-09 Complaint Filing Date

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

U.S. Patent No. 9,510,899 - “Method and Apparatus for Dermatological Treatment and Tissue Reshaping”

  • Patent Identification: U.S. Patent No. 9,510,899, issued December 6, 2016.

The Invention Explained

  • Problem Addressed: The patent describes a need for improved skin treatments, noting that prior art methods were either too harsh and required significant recovery time (e.g., ablative laser skin resurfacing) or had limited clinical effectiveness (e.g., non-ablative collagen remodeling) ('899 Patent, col. 2:5-19, col. 3:5-19).
  • The Patented Solution: The invention is an apparatus that uses an array of fine needles to penetrate the skin and deliver energy, such as radio frequency (RF) current, directly into the dermal layer ('899 Patent, col. 4:1-12). This approach creates a "pattern of small localized regions of thermal damage" within the dermis, which is intended to stimulate a wound-healing response and new collagen growth while sparing the outer epidermal layer from damage, thereby balancing efficacy with safety ('899 Patent, col. 3:61-65; Fig. 3).
  • Technical Importance: The technology aimed to provide the collagen-remodeling benefits of more aggressive treatments without the associated epidermal injury, post-procedural discomfort, and lengthy healing periods ('899 Patent, col. 3:48-53).

Key Claims at a Glance

  • The complaint asserts independent claims 1, 15, and 20. (Compl. ¶30).
  • Independent Claim 1, a device claim, includes the following essential elements:
    • A housing configured to support a plurality of needles arranged for insertion into a dermal layer of skin.
    • The needles are configured for application of radio frequency (RF) energy from an RF energy source.
    • A control module for controlling delivery of the RF energy to the needles to induce a pattern of fractional damage in the dermal layer.
    • The controlled delivery of RF energy is configured to stimulate formation of new collagen in the skin.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 9,095,357 - “Method and Apparatus for Dermatological Treatment and Tissue Reshaping”

  • Patent Identification: U.S. Patent No. 9,095,357, issued August 4, 2015.

The Invention Explained

  • Problem Addressed: As the parent of the '899 patent, the '357 patent addresses the same technical problem: the shortcomings of prior art skin treatments, which were either overly aggressive or insufficiently effective ('357 Patent, col. 2:36-53).
  • The Patented Solution: The invention is a method for treating skin that involves inserting an array of needles into the dermis and regulating the delivery of RF energy through those needles ('357 Patent, col. 4:24-33). The method creates "fractional damage" in the dermis to induce a healing response and stimulate collagen production, thereby improving skin quality without the side effects associated with damaging the epidermis ('357 Patent, Abstract; col. 3:59-65).
  • Technical Importance: The method provided a new approach for achieving dermal remodeling by delivering energy in a minimally invasive, precisely targeted manner ('357 Patent, col. 4:1-12).

Key Claims at a Glance

  • The complaint asserts independent claims 1, 12, and 17. (Compl. ¶35).
  • Independent Claim 1, a method claim, includes the following essential steps:
    • Inserting a plurality of needles into a dermal layer of skin, where the needles are configured to receive RF energy.
    • Regulating delivery of the RF energy to the needles to induce a pattern of fractional damage in the dermal layer.
    • The regulation of the RF energy is configured to stimulate formation of new collagen in the skin.
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendants' "Legend+ RF micro-needle devices" and associated products. (Compl. ¶1).

Functionality and Market Context

The complaint alleges the Legend+ is an aesthetic medical device system comprising a console with an RF energy source and controller, and a handheld applicator with a disposable needle array tip (Compl. ¶26). This system is alleged to deliver RF energy through the micro-needles into the dermis to cause "fractional wounding" and thereby improve skin aesthetics (Compl. ¶¶25, 27). The complaint includes a photograph of the accused Legend+ device, which displays the console and callouts for various applicators, including a "VoluDerm applicator gen36 micro-needle tip for face and neck." (Compl. p. 3). Plaintiffs allege Defendants import and sell these products to clinics and dermatologists across the United States (Compl. ¶28).

IV. Analysis of Infringement Allegations

The complaint references, but does not include, claim chart exhibits detailing the infringement allegations. The analysis below is based on the narrative infringement theory presented in the body of the complaint.

'899 Patent Infringement Allegations (Device Claims)

The complaint alleges that the Legend+ devices infringe one or more claims of the '899 Patent. (Compl. ¶29). The narrative theory suggests that the Legend+ system, with its console, controller, and micro-needle applicator, constitutes a "skin treatment device" that meets the limitations of the asserted claims. (Compl. ¶¶26-27). It alleges the device is used to deliver RF energy to create "fractional wounding," which in turn leads to the "formation of new collagen" and smoothes the skin, mapping to the functional limitations of the claims. (Compl. ¶25). The complaint states that a claim chart for independent claims 1, 15, and 20 is attached as Exhibit 3. (Compl. ¶30).

'357 Patent Infringement Allegations (Method Claims)

The complaint alleges that the use of the Legend+ products infringes one or more claims of the '357 Patent. (Compl. ¶34). The asserted method claims are allegedly practiced when a user, such as a dermatologist, operates the Legend+ device to insert the micro-needles into a patient's skin and deliver RF energy to induce fractional damage for aesthetic improvement. (Compl. ¶¶25, 27). This alleged sequence of actions corresponds to the steps recited in the asserted method claims. The complaint states that a claim chart for independent claims 1, 12, and 17 is attached as Exhibit 4. (Compl. ¶35).

Identified Points of Contention

  • Scope Questions: A potential dispute may arise over the construction of "stimulate formation of new collagen" ('899 Patent, cl. 1; '357 Patent, cl. 1). The defense could argue that the accused product's mechanism for "skin aesthetics" improvement (Compl. ¶27) is functionally distinct from the specific biological stimulation of collagen formation as taught in the patents.
  • Technical Questions: What evidence demonstrates that the accused product creates a "pattern of fractional damage" with "undamaged region[s] therebetween" as required by '899 Patent claim 15 and '357 Patent claim 12? The complaint's allegations on this point are conclusory.
  • Technical Questions: What is the operational configuration of the accused device's applicators, such as the "TriPollar" and "VoluDerm" applicators shown in the complaint's visual evidence? (Compl. p. 3). Answering this question will be central to determining whether the device operates using "bipolar pairs" to create damage between needle tips, as required by '899 Patent claim 20 and '357 Patent claim 17.

V. Key Claim Terms for Construction

"pattern of fractional damage"

(appearing in '899 Patent, cl. 1 and '357 Patent, cl. 1)

  • Context and Importance: This term is central to the invention's core concept of creating discrete, spaced-apart thermal injuries. The dispute will likely focus on whether the pattern of thermal effects produced by the accused Legend+ device falls within the scope of this term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the goal as creating "small localized regions of thermal damage within the dermis" and "fractional wounding," which could support a broad reading covering various patterns of non-contiguous injury ('357 Patent, col. 3:63-65, col. 4:11).
    • Evidence for a Narrower Interpretation: The specification also describes specific patterns, such as "approximately spherical" damage regions around monopolar needles or "elongated" regions between bipolar needles ('357 Patent, col. 6:33-35, col. 7:21-23). Other independent claims explicitly require "undamaged regions between the damaged regions" ('357 Patent, cl. 20), which could be used to argue that the term "fractional damage" itself implies such separation.

"control module"

(appearing in '899 Patent, cl. 1)

  • Context and Importance: Practitioners may focus on this term because the capabilities of the accused device's controller must map onto the structural and functional limitations of this claim element.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the module as permitting "variation of the characteristics of the RF electrical current" and providing "application-specific settings" ('899 Patent, col. 5:32-47). This language could support construing the term to cover any system allowing a user to adjust basic energy parameters.
    • Evidence for a Narrower Interpretation: The specification also states the module "generates a current directed to and from specified needles for selectable or predetermined durations, intensities, and sequences" ('899 Patent, col. 5:47-50). This language may support a narrower construction requiring more advanced functionality, such as individual needle control or complex, pre-programmed treatment sequences.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Defendants encourage and instruct end-users (e.g., dermatologists) on how to operate the Legend+ products in an infringing manner (Compl. ¶¶32, 37). Contributory infringement is based on allegations that Defendants provide the Legend+ device, a component that is especially made for an infringing use and is not a staple article of commerce (Compl. ¶¶33, 38).

Willful Infringement

The complaint alleges willful infringement, asserting that Defendants have had knowledge of the patents "at least as early as the filing of this Complaint" and have acted with "intent, or willful blindness." (Compl. ¶¶32, 37). This pleading primarily supports a theory of post-filing willfulness.

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

  • A key evidentiary question will be one of operational correspondence: What technical evidence will Plaintiffs provide to demonstrate that the energy delivered by the accused Legend+ device creates the specific "pattern[s] of fractional damage" recited in the asserted claims, particularly the patterns requiring undamaged tissue between thermal injuries or damage created between bipolar needle pairs?
  • The case may also turn on a question of functional scope: Can Plaintiffs prove that the general "improvement in skin aesthetics" (Compl. ¶27) allegedly provided by the accused device is equivalent to the claimed function of "stimulat[ing] formation of new collagen" ('899 Patent, cl. 1), or will the court require proof of a more specific biological mechanism that aligns with the patent's teachings?