Apnea Sciences Corp v. Fissiontech LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Apnea Sciences Corporation (Nevada)
  • Defendant: Fissiontech LLC (New York)
  • Plaintiff’s Counsel: Umberg Zipser LLP
• Case Identification: 1:25-cv-10328, S.D.N.Y., 12/15/2025
• Venue Allegations: Venue is alleged to be proper in the Southern District of New York because Defendant is a New York company that resides in the District, maintains a regular and established place of business there, and has committed alleged acts of infringement in the District.
• Core Dispute: Plaintiff alleges that Defendant’s "Difiney" anti-snoring mouthpieces infringe a patent related to adjustable intra-oral appliances for treating snoring and sleep apnea.
• Technical Context: The technology concerns mandibular advancement devices, which are oral appliances designed to hold a user's lower jaw in a forward position during sleep to maintain an open airway.
• Key Procedural History: The complaint alleges that when Defendant applied for FDA 510(k) clearance for its device, it cited Plaintiff’s SnoreRx product as a "predicate device," which may be relevant to establishing pre-suit knowledge of the patent-in-suit.

Case Timeline

Date	Event
2010-12-13	U.S. Patent No. 8,833,374 Priority Date
2014-09-16	U.S. Patent No. 8,833,374 Issued
c. 2015	Plaintiff allegedly began marking products with the '374 Patent
2025-12-15	Complaint Filed

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

U.S. Patent No. 8,833,374 - "Intra-Oral Mandibular Advancement Appliance"

The Invention Explained

• Problem Addressed: The patent addresses the need for an oral appliance to treat snoring and sleep apnea that can be easily and precisely adjusted by the patient over time without special tools, springs, or the assistance of healthcare personnel, unlike some conventional devices. (Compl. Ex. A, '374 Patent, col. 1:49-68).
• The Patented Solution: The invention is a two-piece appliance with an upper tray for the upper jaw and a lower tray for the lower jaw. ('374 Patent, col. 3:41-44). The position of the lower tray can be advanced relative to the upper tray by applying a "lateral compressive squeezing force" to "position control push pads" on the sides of the lower tray assembly. ('374 Patent, col. 2:48-53). This squeezing action temporarily deforms the tray, disengaging interlocking teeth from locking channels and allowing the user to slide the lower tray forward into a new, locked position. ('374 Patent, col. 2:53-59).
• Technical Importance: This design allows for fine, incremental adjustments (e.g., one millimeter) by the patient to optimize comfort and efficacy as their condition or needs change. ('374 Patent, col. 5:31-33).

Key Claims at a Glance

• The complaint asserts independent claims 1 and 15. (Compl. ¶21).
• The essential elements of independent claim 1 include:
  • An upper tray assembly and a lower tray assembly, both with an arcuate shape.
  • A position adjustment block located on each side of one of the tray assemblies.
  • A corresponding locking channel on each side of the other tray assembly, which slidably receives the adjustment block.
  • The lower tray assembly is responsive to a lateral compressive squeezing force, which deforms the assembly to release the locking engagement and permit adjustment of the lower jaw's position.
• The complaint reserves the right to assert additional claims. (Compl. Prayer for Relief ¶A).

III. The Accused Instrumentality

Product Identification

• The "Difiney" devices, including the "Anti Snoring Device" and "Advanced Anti Snoring Device 4.0." (Compl. ¶4, ¶13).

Functionality and Market Context

• The Accused Products are advertised as mouthpieces designed to open a user's airway and reduce snoring. (Compl. ¶4). Marketing materials for the Difiney device claim features such as "Customized fit" and being "Adjustable in 1mm increments." (Compl. ¶16). A comparison chart included in the complaint shows the Difiney device being marketed against competitors, including Plaintiff's SnoreRx product. (Compl. ¶15). The complaint alleges that the Accused Products and Plaintiff's products are sold in direct competition. (Compl. ¶6). A visual from Defendant's Amazon listing highlights features of the Accused Product, such as its adjustability. (Compl. ¶16).

IV. Analysis of Infringement Allegations

The complaint does not include the referenced claim chart exhibit (Exhibit B); however, it provides a narrative summary of its infringement theory. The central infringement allegation is that the Accused Products meet the limitations of claim 1, with one key element met under the doctrine of equivalents. (Compl. ¶22).

Specifically, the complaint concedes that the Accused Products do not literally meet the limitation requiring the lower tray to be responsive to a squeezing force. (Compl. ¶22). Instead, it alleges that in the Accused Products, it is the upper tray assembly that is squeezed to allow adjustment. (Compl. ¶22). Plaintiff alleges this difference is insubstantial and that the accused functionality performs substantially the same function, in substantially the same way, to achieve substantially the same result, thus infringing under the doctrine of equivalents. (Compl. ¶24).

• Identified Points of Contention:
  • Doctrine of Equivalents: The primary legal and technical question will be whether squeezing the upper tray assembly constitutes an equivalent to the claimed feature of squeezing the lower tray assembly. The analysis will likely focus on whether this modification represents an "insubstantial change."
  • Scope Questions: A central dispute may be whether applying the doctrine of equivalents to this limitation would vitiate an express claim requirement—that is, whether finding infringement would effectively read the "lower tray assembly" limitation out of the claim.
  • Technical Questions: The complaint asserts that interchanging which tray is compressed was known at the time of infringement. (Compl. ¶23). A factual question will be what evidence supports this assertion and whether such knowledge in the art supports a finding of equivalence.

V. Key Claim Terms for Construction

• The Term: "said lower tray assembly being responsive to a lateral compressive squeezing force"
• Context and Importance: This limitation is the crux of the infringement dispute. The complaint explicitly states this element is not literally met but is satisfied under the doctrine of equivalents because the accused device allegedly performs this function with its upper tray assembly. (Compl. ¶22). Therefore, the construction of "lower tray assembly" and the functional requirements tied to it will be dispositive.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that the core inventive concept is a two-tray system adjustable via squeezing one of the trays, and the specific designation of the "lower" tray in the claim is merely illustrative of the preferred embodiment.
  • Evidence for a Narrower Interpretation: The plain language of claim 1 explicitly identifies the "lower tray assembly" as the component that is deformed by squeezing. The detailed description consistently describes this mechanism in relation to the lower tray, showing "position control push pads" located on the "lower chassis." ('374 Patent, col. 2:48-53, col. 5:14-17, Fig. 2). This specificity could be used to argue that the claim is strictly limited to configurations where only the lower tray is squeezed.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant sells the Accused Products to direct infringers (e.g., end-users) and provides instructions on how to use them in an infringing manner. (Compl. ¶35). Knowledge is alleged based on Defendant's FDA 510(k) submission citing Plaintiff's product as a predicate device and on constructive notice from Plaintiff's patent marking practices since 2015. (Compl. ¶34).
• Willful Infringement: Willfulness is alleged based on the same pre-suit knowledge from the FDA submission and patent marking, as well as knowledge obtained upon service of the complaint. (Compl. ¶31). Plaintiff alleges Defendant acted in conscious disregard of its patent rights. (Compl. ¶31).

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

1. A central issue will be one of legal equivalence: Can Plaintiff prove that an adjustment mechanism activated by squeezing the upper tray is an insubstantial change from the claimed mechanism activated by squeezing the lower tray, thereby satisfying the doctrine of equivalents?
2. A related question will be one of claim vitiation: Will a court find that extending the claim scope to cover a device where the upper tray is squeezed would impermissibly nullify the specific "lower tray assembly" limitation, rendering it meaningless?
3. A key evidentiary question will concern scienter: Does Defendant’s citation of Plaintiff’s product in an FDA 510(k) submission constitute pre-suit knowledge of the patented technology sufficient to support a finding of willful infringement if liability is established?