Blue Water Innovations LLC v. Vevazz LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Blue Water Innovations, LLC (Nevis; residing and operating in Florida)
  • Defendant: Vevazz, LLC (Unknown; offices in Florida, Texas, Colorado)
  • Plaintiff’s Counsel: Louis R. Gigliotti, PA
• Case Identification: 2:20-cv-00208, M.D. Fla., 05/04/2020
• Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts infringing acts in the district and a substantial part of the events giving rise to the claims occurred there.
• Core Dispute: Plaintiff alleges that Defendant’s non-invasive fat reduction devices infringe three patents related to the use of optical emitters, such as LEDs, to stimulate the release of lipids from fat cells.
• Technical Context: The technology at issue falls within the aesthetic medical device market, specifically non-invasive phototherapy systems for body contouring and fat reduction.
• Key Procedural History: The complaint notes that U.S. Patent No. 9,044,595 underwent ex parte reexamination, resulting in the issuance of a Reexamination Certificate on August 19, 2019. This procedure confirms the patentability of the amended or new claims over the prior art considered by the USPTO during the proceeding.

Case Timeline

Date	Event
2012-03-05	Priority Date for ’595, ’641, and ’314 Patents
2015-06-02	U.S. Patent No. 9,044,595 Issued
2016-11-22	U.S. Patent No. 9,498,641 Issued
2017-11-07	U.S. Patent No. 9,808,314 Issued
2019-08-19	Reexamination Certificate for ’595 Patent Issued
2020-05-04	Complaint Filed

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

U.S. Patent No. 9,044,595 (with Reexamination Certificate US 9,044,595 C1) - "System and method for reducing lipid content of adipocytes in a body"

• Patent Identification: U.S. Patent No. 9,044,595, "System and method for reducing lipid content of adipocytes in a body," Issued June 2, 2015.

The Invention Explained

• Problem Addressed: The patent addresses the shortcomings of conventional fat-reduction methods, which it characterizes as being invasive, risky, having delayed results (e.g., liposuction, cryogenics), or being ineffective long-term (e.g., behavior modification) (’595 Patent, col. 1:23-49).
• The Patented Solution: The invention proposes a non-invasive system that uses an array of LEDs to illuminate a region of the body with light at a specific wavelength (e.g., 635 nm). This phototherapy is intended to stimulate lipolysis—the breakdown and release of lipids from adipocytes (fat cells)—without damaging the cells or surrounding tissue. A controller is used to set key parameters like power density and treatment time to achieve this effect (’595 Patent, Abstract; col. 4:1-14).
• Technical Importance: This technology provided a non-invasive approach to body contouring that sought to produce faster results than other non-invasive techniques while avoiding the risks and trauma of surgical procedures (’595 Patent, col. 3:9-16).

Key Claims at a Glance

• The complaint asserts independent claims 22 and 25, which were added or amended during reexamination (Compl. ¶33, ¶38).
• Independent Claim 22 (new) essential elements:
  • A system for reducing lipid content of adipocytes.
  • An array of LEDs configured to illuminate a body region at a peak wavelength of "about 635 nm."
  • A controller to determine a selective power density and a time period sufficient to deliver approximately 40-70 J/cm² to the adipocytes within 5-120 minutes.
  • The array is configured to be oriented toward the body region.
• Independent Claim 25 (new) essential elements:
  • A system with an array of LEDs to directly illuminate a body region at a wavelength between 630-660 nm.
  • A negative limitation: the array does "not including any optical components to collimate the light."
  • A controller to determine wavelength, power density, and time period to stimulate lipolysis.
  • The array is configured to be oriented toward the body region.
• The complaint reserves the right to assert dependent claims 23-24 (Compl. ¶37).

U.S. Patent No. 9,498,641 - "Fat reducing device and method utilizing optical emitters"

• Patent Identification: U.S. Patent No. 9,498,641, "Fat reducing device and method utilizing optical emitters," Issued November 22, 2016.

The Invention Explained

• Problem Addressed: The patent identifies issues with prior art laser devices, including non-uniform skin coverage from rotating beams and the potential for cell damage or eye injury from highly concentrated light energy, which necessitates low-power, less effective treatments (’641 Patent, col. 2:19-50).
• The Patented Solution: The invention describes a device with a large, stationary array of optical emitters that can uniformly illuminate a target area. A key feature is a controller with a specific electronic architecture—including an internal signal generator, a rectifier, and a solid-state relay—that provides a modulated power output to the array. This modulation, based on a reference waveform, is claimed to optimize the treatment's effectiveness (’641 Patent, Abstract; Fig. 5a).
• Technical Importance: The combination of a large, uniform-output emitter array with a specific method of power modulation offered a way to deliver energy safely and effectively over a broader area than was practical with conventional scanning laser systems (’641 Patent, col. 5:41-51).

Key Claims at a Glance

• The complaint asserts independent claim 1 (Compl. ¶49).
• Independent Claim 1 essential elements:
  • A device with an output array of optical emitters.
  • A controller with user interface devices.
  • In the "on-position," the array produces red light at "approximately 635 nm" and "approximately 40,000 Lux" to reduce lipid content.
  • The controller includes an "internal signal generator," a "rectifier," and a "solid state relay."
  • These components function to provide a "modulated power output" based on the reference waveform, delivering power "only during a positive portion" of that waveform.
• The complaint reserves the right to assert dependent claims 2-8 (Compl. ¶53).

U.S. Patent No. 9,808,314 - "Fat reducing device and method utilizing optical emitters"

• Patent Identification: U.S. Patent No. 9,808,314, "Fat reducing device and method utilizing optical emitters," Issued November 7, 2017.
• Technology Synopsis: This patent claims a method for reducing lipid content. The method comprises the steps of providing a device with an array of optical emitters, positioning it at a discrete distance, and directing its optical output to deliver red light at approximately 313.6 Lux at a wavelength of approximately 635 nm for 1 to 8 minutes. This is specified to result in a total energy delivery of 2.88 Joules to the subcutaneous adipocytes (’314 Patent, Claim 1).
• Asserted Claims: Independent claim 1 is asserted (Compl. ¶62).
• Accused Features: Defendant is accused of infringing the method claims through its "training program," which allegedly instructs customers on how to use the accused devices in a way that performs the patented method steps (Compl. ¶65).

III. The Accused Instrumentality

Product Identification

• The "Vevazz Laser Like Lipo Machine," also marketed as "Vevazz Contouring" (Compl. ¶41, ¶54, ¶67).

Functionality and Market Context

• The complaint alleges the accused devices are fat-reducing systems that comprise an array of LEDs and a controller to illuminate a region of a patient's body (Compl. ¶36, ¶52). They are allegedly sold to medical professionals for use in aesthetic practices (Compl. ¶12).
• The complaint characterizes the accused products as "cheaply made 'knock-off[s]'" that sell for a fraction of the price of Plaintiff's systems (Compl. ¶15). It alleges Defendant has sold over 300 systems, generating sales in excess of $7,500,000 (Compl. ¶16).
• Visual Evidence: No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

’595 Patent Infringement Allegations

Claim Element (from Independent Claim 22)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
an array of LEDs configured to illuminate a region of a body at a selective peak wavelength of about 635 nm;	Defendant's devices are alleged to comprise an array of LEDs for illuminating a region of a body.	¶36	col. 4:62-64
a controller connected to the array of LEDs to determine a selective power density and selective time period to stimulate lipolysis in the adipocytes;	Defendant's devices are alleged to comprise a controller connected to the array of LEDs to output light at the claimed power density.	¶36	col. 4:7-14
wherein said selective time period is no less than is sufficient to deliver approximately 40-70 J/cm² to the adipocytes during a time frame of between 5-120 minutes;	The complaint makes a conclusory allegation that Defendant's devices comprise all limitations of the claim, but provides no specific facts regarding the energy density or time period of operation.	¶35	col. 4:32-34
wherein said array of LEDs is further configured to be oriented toward the region of the body.	The complaint alleges Defendant's devices are systems for reducing lipid content in a body, which implies orientation toward the body.	¶35	col. 3:39-41

• Identified Points of Contention:
  • Technical Question: The complaint offers no specific factual allegations to support its claim that the accused devices meet the quantitative limitations of claim 22, specifically the delivery of "approximately 40-70 J/cm²" of energy. The infringement analysis will require extrinsic evidence to determine if the accused devices operate within this claimed range.
  • Scope Question: Claim 25 contains a negative limitation requiring the array to "not includ[e] any optical components to collimate the light." A point of contention may be whether any components in the accused devices, such as lenses or reflectors, perform a collimating function that would place them outside the scope of this claim.

’641 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
an output array that includes a main body... a plurality of optical emitters...	Defendant's devices are alleged to comprise "an output array" and "a plurality of optical emitters."	¶52	col. 6:10-16
a controller that is in communication with the array...	Defendant's devices are alleged to comprise "a controller that is in communication with the array."	¶52	col. 6:17-18
said controller including... an internal signal generator for creating a reference waveform, a power input module, a rectifier and a solid state relay...	The complaint does not allege that the accused controller includes these specific electronic components.	¶52	col. 8:15-18
said rectifier and relay functioning to provide a modulated power output to the array based on the created reference waveform... only during a positive portion...	The complaint does not allege that the accused controller provides a modulated power output or that it operates based on the positive portion of a waveform.	¶51	col. 8:21-34

• Identified Points of Contention:
  • Technical Question: Claim 1 recites a highly specific controller architecture (signal generator, rectifier, relay) and a specific mode of operation (modulated output based on the positive portion of a waveform). The complaint lacks any factual allegations that the accused Vevazz controller contains this specific hardware or performs this function. This suggests a potential mismatch between the claimed invention and the accused device's actual implementation.
  • Scope Question: The claim recites an optical output of "approximately 40,000 Lux." The definition of "approximately" and the proper methodology for measuring this value "at the array" will be a central issue for claim construction and infringement analysis.

V. Key Claim Terms for Construction

’595 Patent: "about 635 nm" (Claim 22)

• The Term: "about 635 nm"
• Context and Importance: The precise wavelength of light is fundamental to the patent's theory of stimulating lipolysis. The scope of "about" will determine how much deviation from 635 nm is permitted for an infringing device. Practitioners may focus on this term because the reexamined claim narrowed the wavelength from a broader range discussed in the specification, suggesting the 635 nm value is of particular importance.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification discusses a wider wavelength range of 630-660 nm for stimulating collagen or reducing pain, which could be used to argue that "about" should encompass a similarly broad range (’595 Patent, col. 4:29-31).
  • Evidence for a Narrower Interpretation: The specification repeatedly identifies 635 nm as the exemplary wavelength for lipolysis (’595 Patent, col. 4:51-52). The fact that claim 22 was added during reexamination with the specific "about 635 nm" language, rather than the broader 630-660 nm range used in claim 25, may suggest a more restrictive meaning was intended.

’641 Patent: "modulated power output" (Claim 1)

• The Term: "modulated power output"
• Context and Importance: This term describes a key functional aspect of the controller. Infringement of claim 1 hinges on whether the accused device's power delivery can be characterized as "modulated" in the specific manner required by the claim.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue the term simply means the power supplied to the array varies over time, rather than being a constant stream.
  • Evidence for a Narrower Interpretation: The claim itself defines the functional mechanism for achieving this modulation: "said rectifier and relay functioning to provide a modulated power output to the array based on the created reference waveform... only during a positive portion of the created reference waveform." This language, combined with the detailed circuit diagram in Figure 5a, strongly supports an interpretation that the term is not generic but is limited to the specific electrical means and method disclosed in the patent (’641 Patent, col. 8:21-34).

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement for all three patents. The allegations are based on Defendant providing "instructions, advertisements and training to customers" that allegedly direct them to use the accused devices in a manner that infringes the patent claims (Compl. ¶42, ¶55, ¶68).
• Willful Infringement: Willfulness is alleged for all three patents on the basis that Defendant had "actual or constructive knowledge" of Plaintiff's patents (Compl. ¶44, ¶57, ¶70). The complaint does not plead specific facts regarding pre-suit notice or other evidence of egregious conduct.

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

1. A central issue will be one of evidentiary proof: Can the Plaintiff demonstrate that the accused "Vevazz" devices operate within the specific, quantitative parameters required by the asserted claims, such as the energy density (J/cm²) in the ’595 patent or the Lux output and total energy delivery (Joules) in the ’314 patent? The complaint's conclusory allegations on these points suggest this will be a primary area of factual dispute.

2. A key infringement question for the ’641 patent will be one of technical identity: Does the controller in the accused device contain the specific electronic architecture recited in claim 1—including a signal generator, rectifier, and solid-state relay—to produce a "modulated power output" based on the positive portion of a reference waveform, or is there a fundamental difference in the device's electrical operation?