DCT

2:18-cv-03372

Innovative Health Tech Ltd v. Crawford

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-03372, D. Ariz., 10/19/2018
  • Venue Allegations: Venue is based on allegations that Defendants conduct business in the District of Arizona, that a substantial part of the events giving rise to the claims occurred there, and that Defendants maintain a product return center in Scottsdale. Plaintiff further alleges personal jurisdiction over Defendant Crawford based on his residence in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s "ZenGuard" tongue stabilizing device infringes a patent related to an oral appliance for reducing snoring and obstructive sleep apnea.
  • Technical Context: The technology concerns non-invasive medical devices that reposition the tongue to maintain an open airway during sleep, offering an alternative to more complex treatments.
  • Key Procedural History: The complaint alleges Plaintiff sent written notice of infringement to Defendants on May 16, 2018, and August 16, 2018. It further alleges one Defendant responded by summarily denying infringement, which may be used to support allegations of willful infringement.

Case Timeline

Date Event
2000-12-15 U.S. Patent No. 7,073,506 Priority Date (PCT Filing)
2006-07-11 U.S. Patent No. 7,073,506 Issued
2017-07-01 Alleged First Infringing Activity by Defendants (approx.)
2018-05-16 Plaintiff's First Pre-Suit Notice of Infringement Sent
2018-08-16 Plaintiff's Second Pre-Suit Notice of Infringement Sent
2018-10-19 Complaint Filed

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

U.S. Patent No. 7,073,506 - "TONGUE STABILIZING DEVICE"

  • Patent Identification: U.S. Patent No. 7073506, "TONGUE STABILIZING DEVICE", issued July 11, 2006 (the "’506 Patent").

The Invention Explained

  • Problem Addressed: The patent background describes snoring and sleep apnea as common disorders caused by obstruction of the upper airway (Compl. Ex. A, ’506 Patent, col. 1:15-20). It notes that existing oral appliances often required specialist fitting and the taking of jaw impressions to create a custom-tailored device, which could be costly and limit accessibility (’506 Patent, col. 1:50-55).
  • The Patented Solution: The invention is a one-piece, non-custom oral appliance made from a resiliently flexible material that stabilizes the tongue (’506 Patent, Abstract). The device has a hollow body, comprising a squeezable "bulb portion" connected to an "entry portion" by a narrower "neck portion," which fits over the end of the user's tongue and holds it in place with negative (suction) pressure (’506 Patent, col. 2:60-65; FIG. 1). This design is intended to hold the tongue forward, opening the airway to reduce snoring (’506 Patent, col. 2:4-6).
  • Technical Importance: The key purported benefit was that the device did not require specialist fitting, allowing it to be sold "over the counter" in a range of sizes, thereby reducing cost and increasing availability for individuals with sleep apnea (’506 Patent, col. 2:10-18).

Key Claims at a Glance

  • The complaint’s allegations focus on independent claim 1, though it states the accused device "reads on all the claims of IHT's '506 Patent" (Compl. ¶27).
  • Independent Claim 1 requires:
    • A one-piece tongue stabilizing device of a resiliently flexible material.
    • A body with a hollow interior to fit a user's tongue, held by negative pressure.
    • The body includes an entry portion with an opening, a squeezable expanded bulb portion, and a narrower neck portion connecting them.
    • A specific dimensional ratio: the length from the opening to the narrowest part of the neck is shorter than the length from the narrowest part of the neck to the distal end of the bulb.
    • A "cut out" into the side wall of the entry portion.
    • Integrally molded tabs extending from the bulb portion to engage the user's face or between the teeth and lips.
    • The tabs comprise a first tab extending "substantially perpendicular" to the device's longitudinal axis and a second tab extending in "substantially an opposition direction" to the first.

III. The Accused Instrumentality

Product Identification

  • The "ZenGuard" tongue stabilizing device, sold under the "ZenSleep" brand (Compl. ¶¶ 5, 8).

Functionality and Market Context

  • The complaint alleges the ZenGuard device functions to "position[s] the tongue gently forward, preventing it from falling back and obstructing the airway and eliminating snoring" (Compl. ¶27). It is described as a "flexible one-piece tongue stabilizing device with a hollow body and bulb portion for the user's tongue, and tabs that engage the user's face" (Compl. ¶27). The complaint references an image of the accused product, a light blue, single-piece oral appliance with a bulbous end and two external flaps (Compl. p. 7). The device is marketed and sold through the website www.zensleep.com (Compl. ¶6).

IV. Analysis of Infringement Allegations

’506 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A one piece tongue stabilising device formed of a resiliently flexible material... The ZenGuard device is a single, unitary component made of a flexible material. The complaint includes an image of the device to support this structural claim (Compl. p. 7). ¶27; p. 7 col. 4:41-43
...and comprising a body having a hollow interior within which the end of a user's tongue fits and is held by negative pressure...which body comprises an entry portion having an opening to the hollow interior of the device... The ZenGuard device is alleged to have a hollow body that works via suction on the tongue and an opening for the tongue to enter. A top-down view is provided to show the hollow nature of the accused product (Compl. p. 7). ¶27; p. 7 col. 2:62-65
...and a squeezable expanded bulb portion connected by a narrower diameter neck portion, and having a flexible wall section whereby the expanded bulb portion may be squeezed and released in application of the device to a user's tongue... The device is alleged to have a squeezable bulb, a narrower neck, and flexible walls, which creates the negative pressure for attachment. An overhead image shows the device's shape (Compl. p. 7). ¶27; p. 7 col. 4:45-47
...the length dimension of the device from the opening...to the narrowest part of said neck portion being shorter than the length dimension...from the narrowest part of said neck portion to the distal end of said bulb portion... The ZenGuard device is alleged to meet this specific dimensional ratio. A side-profile image comparing the accused product to Plaintiff's device is presented to support this allegation (Compl. p. 7). ¶27; p. 7 col. 5:6-11
...said body also comprising a cut out into the side wall of the entry portion... The complaint alleges the ZenGuard device has a "cut out" in its side wall, corresponding to the feature designed to accommodate the web beneath a user's tongue. ¶27; p. 7 col. 4:58-60
...and integrally moulded tabs extending from the bulb portion which in use engage the exterior of the user's face or between the user's teeth and lips...said tabs comprising a first tab...and a second tab... The ZenGuard device has two integrally molded tabs extending from its body, alleged to engage the user's face to hold the tongue forward. The complaint includes a side-view image of the tabs (Compl. p. 8). ¶27; p. 8 col. 4:61-63

Identified Points of Contention

  • Scope Questions: A central issue may be the construction of "substantially perpendicular" and "substantially an opposition direction" as applied to the tabs. The complaint's visual evidence for this element (Compl. p. 8) shows tabs on the accused device that are curved and may not be strictly perpendicular or in opposition, raising the question of how much geometric deviation these terms permit.
  • Technical Questions: The complaint alleges the accused device meets the specific length-dimension ratio recited in claim 1. What evidence, beyond a side-profile photograph, supports this allegation? The determination of infringement for this limitation may depend on precise measurements of the accused product, which are not provided in the complaint.

V. Key Claim Terms for Construction

The Term: "substantially perpendicular"

  • Context and Importance: This term of degree defines the orientation of the first tab relative to the device's axis. Its construction is critical because the visual evidence suggests the accused device's tab may not be exactly 90 degrees. Practitioners may focus on this term because its breadth will directly impact whether the geometry of the accused device falls within the claim scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that the term accommodates a range of angles suitable for anatomical fit and function, as the purpose is to "hold the tongue forward" (’506 Patent, col. 3:2-4), not to meet a strict geometric constraint.
    • Evidence for a Narrower Interpretation: A party could point to FIG. 1 of the patent, where the tabs (8, 9) are depicted at an angle that appears close to 90 degrees from the main body axis (A), arguing that the drawings illustrate the intended meaning. The absence of specific angular ranges in the specification could be argued to limit the term to something very close to a true perpendicular orientation.

The Term: "cut out into the side wall of the entry portion"

  • Context and Importance: This term defines a structural feature of the device. The complaint alleges the ZenGuard device has this feature. The dispute may turn on whether an indentation or notch in the accused product constitutes a "cut out" as described in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the feature functionally: "to accommodate the web beneath the user's tongue" (’506 Patent, col. 4:58-60). A party could argue any notch or depression that serves this purpose meets the limitation.
    • Evidence for a Narrower Interpretation: A party might argue that Figure 3, which explicitly shows the "cut out 7," illustrates a distinct V-shaped notch, and that this specific embodiment limits the scope of the term to shapes similar to what is depicted, rather than any general indentation.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges Defendants actively induce infringement by selling the ZenGuard product to consumers "knowing and intending for those consumers to use that product" in an infringing manner (Compl. ¶42).

Willful Infringement

  • The willfulness claim is supported by allegations of both pre- and post-suit knowledge. The complaint alleges that Plaintiff sent two specific pre-suit notice letters identifying the ’506 Patent (Compl. ¶33), and that Defendants not only continued their conduct but also allegedly copied a product review of Plaintiff's own device for use on the ZenSleep website (Compl. ¶35), which suggests knowledge of Plaintiff and its product.

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

  • A core issue will be one of definitional scope: can terms of degree in Claim 1, such as "substantially perpendicular" and the specific "shorter than" length ratio, be construed to read on the physical geometry of the ZenGuard device? The visual similarities alleged in the complaint set the stage for a dispute that will likely be resolved by expert testimony and precise product measurements.
  • A key evidentiary question will be one of willfulness and intent: the complaint alleges not only pre-suit notice of infringement but also the direct copying of Plaintiff's marketing materials. The case may turn on whether Plaintiff can prove this conduct was sufficiently egregious to meet the high standard for willful infringement and enhanced damages, transforming the case from a simple infringement dispute into one involving allegations of deliberate and blatant copying.