DCT
1:18-cv-10681
Syneron Medical Ltd v. Jeisys Medical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Syneron Medical Ltd. (Israel), Candela Corporation (Delaware), and Massachusetts General Hospital (Massachusetts)
- Defendant: Jeisys Medical, Inc. (Korea) and Perigee Medical LLC (California)
- Plaintiff’s Counsel: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- Case Identification: 1:18-cv-10681, D. Mass., 04/09/2018
- Venue Allegations: Plaintiffs allege venue is proper in the District of Massachusetts based on Defendants’ substantial business in the state, including infringing activities, soliciting business, and deriving revenue from customers in Massachusetts.
- Core Dispute: Plaintiffs allege that Defendants’ INTRAcel and INTRAcel Pro radio frequency micro-needle devices infringe two patents related to methods and apparatuses for dermatological treatment and tissue reshaping.
- Technical Context: The technology involves using an array of micro-needles to deliver radio frequency (RF) energy directly into the dermal layer of the skin, creating controlled patterns of thermal injury to stimulate collagen growth and improve skin appearance.
- Key Procedural History: The complaint states the patented technology was developed at Plaintiff Massachusetts General Hospital (MGH) and exclusively licensed to Plaintiff Syneron. Plaintiffs’ commercial product embodying the patents, the Profound system, received 510(k) clearance for wrinkle treatment from the U.S. Food and Drug Administration in 2011.
Case Timeline
| Date | Event |
|---|---|
| 2004-04-01 | Earliest Priority Date for '899 and '357 Patents |
| 2009-01-01 | Syneron acquires Primaeva, which was commercializing the technology |
| 2010-01-01 | Syneron acquires Candela |
| 2011-01-01 | Plaintiff's ePrime product receives FDA 510(k) clearance |
| 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 Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,510,899 - Method and Apparatus for Dermatological Treatment and Tissue Reshaping (Issued Dec. 6, 2016)
The Invention Explained
- Problem Addressed: The patent’s background section describes the shortcomings of prior art skin treatments. Ablative laser skin resurfacing (LSR) is effective but causes significant pain, long recovery times, and other side effects. Conversely, non-ablative collagen remodeling (NCR) techniques are safer but have "limited efficacies" and often produce results "far below the patient's expectations." ('899 Patent, col. 2:5-18, col. 3:5-17).
- The Patented Solution: The invention proposes a "minimally invasive" apparatus that uses an array of micro-needles to penetrate the skin and deliver electromagnetic energy, such as radio frequency (RF) pulses, directly to targeted areas within the dermis ('899 Patent, col. 4:6-15). This method creates "a pattern of small localized regions of thermal damage" (fractional wounding) to stimulate a wound healing response and new collagen growth, while leaving the outer skin layer (epidermis) largely intact, thereby combining safety with efficacy ('899 Patent, Abstract; col. 5:19-29). The system, as shown in Figure 3, includes the needle array, an energy source, and a control module to regulate the energy delivery ('899 Patent, Fig. 3).
- Technical Importance: This approach seeks to provide the therapeutic benefits of dermal injury, which stimulates skin remodeling, without the significant side effects associated with damaging the epidermal barrier common to earlier ablative treatments ('899 Patent, col. 4:51-58).
Key Claims at a Glance
- The complaint asserts independent claims 1, 15, and 20 (Compl. ¶29).
- 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, with the needles configured for application of radio frequency (RF) energy from an RF energy source.
- A control module for controlling the delivery of RF energy to the needles.
- The controlled delivery is to induce a "pattern of fractional damage" in the dermal layer.
- The controlled delivery is also configured to "stimulate formation of new collagen in the skin."
- The complaint does not explicitly reserve the right to assert dependent claims, but infringement is alleged for "one or more claims" (Compl. ¶28).
U.S. Patent No. 9,095,357 - Method and Apparatus for Dermatological Treatment and Tissue Reshaping (Issued Aug. 4, 2015)
The Invention Explained
- Problem Addressed: As a parent to the '899 patent with a nearly identical specification, the '357 patent addresses the same technical problem: the trade-off between efficacy and safety in existing dermatological treatments like LSR and NCR ('357 Patent, col. 2:5-18, col. 3:5-17).
- The Patented Solution: The patented solution is a method of using an array of needles to deliver RF energy to create "fractional wounding" in the dermis, sparing the epidermis and promoting collagen growth ('357 Patent, Abstract; col. 4:6-15). This approach aims to provide effective tissue remodeling with minimal side effects ('357 Patent, col. 3:47-53).
- Technical Importance: The method provides a way to precisely target dermal tissue for thermal injury, which was a significant step in balancing the goals of effective wrinkle reduction and patient safety ('357 Patent, col. 4:51-58).
Key Claims at a Glance
- The complaint asserts independent claims 1, 12, and 17 (Compl. ¶34).
- Independent Claim 1 (a method claim) includes the following essential elements:
- Inserting a plurality of needles (configured to receive RF energy from a source) into a dermal layer of skin.
- Regulating the delivery of RF energy from the source to the needles.
- The regulation is to induce a "pattern of fractional damage" in the dermal layer.
- The regulation is also configured to "stimulate formation of new collagen in the skin."
- The complaint alleges infringement of "one or more claims" of the '357 patent (Compl. ¶33).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are the Jeisys INTRAcel and INTRAcel Pro products (Compl. ¶1).
Functionality and Market Context
The complaint alleges these are "aesthetic medical devices that deliver radio frequency ('RF') energy through micro-needles to small, localized regions of the dermis" (Compl. ¶24). The system is described as using a "handheld applicator with a needle array located on a disposable tip" connected to a "console containing an RF energy source and a controller" (Compl. ¶25). This process is alleged to cause "fractional wounding," which in turn stimulates the formation of new collagen to smooth skin and reduce wrinkles (Compl. ¶24). The complaint includes an image of the accused INTRAcel device, showing a console on wheels with a connected handheld applicator (Compl. p. 4, Image). Defendants are alleged to import and sell these products to dermatologists and clinics across the U.S., positioning them in competition with Plaintiffs' own product line (Compl. ¶27).
IV. Analysis of Infringement Allegations
Although the complaint references claim chart exhibits that were not attached to the publicly filed document, the narrative allegations provide a basis for summarizing the infringement theory (Compl. ¶¶ 24-26, 29, 34).
'899 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a housing configured to support a plurality of needles arranged for insertion into a dermal layer of skin, the plurality of needles...further configured for application of radio frequency (RF) energy from a RF energy source | The accused products allegedly use a console and handheld applicator (the housing) with a disposable tip containing a "needle array" to deliver RF energy into the dermis. | ¶25 | col. 5:29-35 |
| a control module for controlling delivery of the RF energy from the RF energy source to the plurality of needles to induce a pattern of fractional damage... | The accused products' console allegedly contains a "controller" that controls the application of RF energy from the RF source to the needles to cause "fractional wounding." | ¶¶25, 26 | col. 5:35-41 |
| wherein the controlled delivery of the RF energy is configured to stimulate formation of new collagen in the skin | The fractional wounding caused by the accused products allegedly results in a healing process that leads to the "formation of new collagen, a volumizing agent that pushes out wrinkles." | ¶24 | col. 5:25-29 |
'357 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| inserting a plurality of needles into a dermal layer of skin, the plurality of needles being...further configured to receive radio frequency (RF) energy... | The complaint alleges that end users are instructed to operate the accused products by inserting the micro-needles into the skin to deliver RF energy provided by the system. | ¶¶24, 36 | col. 5:63-65 |
| regulating delivery of the RF energy...to induce a pattern of fractional damage by the RF energy in the dermal layer... | The system's controller allegedly regulates the application of RF energy to the needles, which causes a "pattern of thermal damage in isolated regions within the dermis (fractional wounding)." | ¶¶24, 26 | col. 6:3-6 |
| wherein the regulation of the delivery of the RF energy is configured to stimulate formation of new collagen in the skin | The alleged purpose and result of the regulated energy delivery is to trigger a healing process that "results in the formation of new collagen" to smooth the skin. | ¶24 | col. 5:25-29 |
- Identified Points of Contention:
- Scope Questions: A central question may be the scope of the term "pattern of fractional damage." The patents disclose creating distinct, separated regions of thermal injury, either spherical or elongated ('899 Patent, col. 6:21-35, col. 7:12-24). The factual dispute will likely focus on whether the thermal effect created by the accused INTRAcel devices meets the specific pattern requirements of the claims as construed by the court.
- Technical Questions: The infringement analysis will likely scrutinize the capabilities of the accused products' "controller." The patents describe a "control module" capable of varying current characteristics and delivering energy to individual needles or groups in specific sequences ('899 Patent, col. 5:35-54). A key technical question will be what level of control the accused devices actually provide and whether it meets the functional requirements of the claims.
V. Key Claim Terms for Construction
The Term: "control module" (in '899 Patent Claim 1 and other device claims)
- Context and Importance: This term is central because its construction will define the level of sophistication and control required by the invention. Infringement will depend on whether the accused "controller" performs the functions of the claimed "control module."
- Intrinsic Evidence for a Broader Interpretation: The claim itself defines the term functionally as being "for controlling delivery of the RF energy...to induce a pattern of fractional damage." A party could argue any controller achieving this end result satisfies the limitation.
- Intrinsic Evidence for a Narrower Interpretation: The specification describes a module that "permits variation of the characteristics of the RF electrical current" and generates current for "selectable or predetermined durations, intensities, and sequences" ('899 Patent, col. 5:35-54). A party could argue these detailed functions are required, limiting the term to more advanced controllers.
The Term: "pattern of fractional damage" (in '357 Patent Claim 1 and '899 Patent Claim 1)
- Context and Importance: This term describes the core therapeutic mechanism and outcome of the invention. Its definition is critical to determining whether the thermal effect produced by the accused devices infringes.
- Intrinsic Evidence for a Broader Interpretation: A party might argue the term should be given its plain meaning in the context of the field, covering any treatment that damages microscopic zones of tissue while sparing the tissue in between.
- Intrinsic Evidence for a Narrower Interpretation: The specification illustrates specific patterns, such as "approximately spherical" damage regions around monopolar needles and "elongated" regions between bipolar needles ('357 Patent, col. 6:21-35, col. 7:12-24). Further, claim 12 of the '357 Patent requires that "at least two adjacent regions of thermal damage have an undamaged region therebetween," suggesting a requirement for separation that a party could argue informs the meaning of the term in other claims.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. Inducement is based on Defendants allegedly "encouraging, instructing, and aiding" end users to operate the accused products in an infringing manner (Compl. ¶¶ 31, 36). Contributory infringement is based on allegations that the accused products are a material part of the invention, are especially adapted for infringement, and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶¶ 32, 37).
- Willful Infringement: Willfulness is alleged based on Defendants having knowledge of the patents "at least as early as the filing of this Complaint" and continuing their accused activities with "intent, or willful blindness" (Compl. ¶¶ 31, 36). The complaint does not allege any pre-suit knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim scope: can the term "control module" be satisfied by a simple controller, or must it possess the specific, advanced capabilities described in the specification, such as individual needle sequencing and intensity variation? The outcome of this construction will significantly impact the infringement analysis.
- A key evidentiary question will be one of technical implementation: what is the precise thermal "pattern of fractional damage" created by the accused INTRAcel devices in operation? The case may turn on factual evidence comparing the shape, size, and spacing of the thermal zones created by the accused products to the specific embodiments and claim language of the patents-in-suit.
- The viability of the method claims in the '357 Patent against the manufacturer Defendants will depend on proof of intent for indirect infringement. The focus will be on the evidence Plaintiffs can gather regarding Defendants' user instructions, marketing materials, and training protocols that allegedly encourage or instruct clinicians to perform the patented method steps.