US 11744686

Summary of US Patent 11744686: Intraoral Device

Title: Intraoral device
Current Assignee: Solmetex LLC (though reassignment history also lists Incept Inc., Dryshield, LLC, and security interests by Midcap Financial Trust and Churchill Agency Services LLC).
Inventors: Thien Nguyen, Tam Thanh Pham
Filing Date: March 27, 2014
Issue Date: September 5, 2023
Abstract: A dental mouthpiece is provided that may be attached to a high-suction dental adapter for the purpose of assisting the dental staff during dental procedures through chair-side, hands-free suction, and isolation. Such mouthpiece may include a main body portion, a cheek retractor portion, and a suction connector portion. In some embodiments, the main body portion, cheek retractor portion, and suction connector portion (and sub-portions thereof) may be molded in one piece, preferably by injection molding. In an exemplary embodiment, the mouthpiece may be made of a material that is flexible, translucent, conducive to injection molding, high heat-resistant, and autoclavable. Such a material may include silicone. Because the mouthpiece may be made of high heat-resistant and autoclavable material, such a mouthpiece may be reusable.

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Plain-Language Overview of Independent Claims:

Claim 1: Mouthpiece with Internal Bridge Structure
This claim describes a dental mouthpiece primarily consisting of a main body that is wider at one end and narrower at the other, creating an internal space. It features a "first wall" (anterior) with a lengthwise slit opening that allows fluids from the mouth to enter the internal space. A "second wall" (posterior) is positioned opposite the first wall, defining the internal space. A "connecting wall" links these two main walls. A key feature is a "bridge structure" integrated into and protruding from the inner surface of the second wall. This bridge structure is wave-shaped with crests and troughs, extending towards the first wall but not attached to it. This design helps maintain separation between the walls during suction while allowing fluid passage through the troughs.

Claim 12: Mouthpiece with Suction Connector Cutout and Cheek Retractor
This claim details a mouthpiece similar to Claim 1, with a main body that is wider at one end and narrower at the other, comprising a first wall, a second wall, and a connecting wall, along with the wave-shaped, non-attached bridge structure on the interior surface of the second wall. Additionally, this claim specifies a "suction connector" extending from the wider end of the main body. This connector has an evacuation conduit (a channel for suction) that is linked to the internal space of the main body. A distinguishing feature of the suction connector is a "cutout shape" designed to interlock with a corresponding protrusion on an external vacuum adapter. The mouthpiece also includes a "cheek retractor" at the narrower end of the main body.

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CAFC 2026 Dockets:
As of April 26, 2026, a direct search for "CAFC 2026 dockets patent 11744686" or related IPR2025-01059 did not yield explicit Court of Appeals for the Federal Circuit docket entries within the provided information. However, it is noted that a PTAB case (IPR2025-01059) was filed, and a district court case was filed in the Michigan Western District Court, both of which could potentially lead to appeals at the CAFC in 2026 or later, but no specific CAFC docket number for 2026 is presently available in the provided text.

US Patent 11744686 is involved in the following known litigation:

1. Patent Trial and Appeal Board (PTAB) Case

   • Plaintiff(s) / Petitioner(s): Unified Patents
   • Defendant(s) / Patent Owner(s): Ascentcare Dental Products, Inc.
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Case Number: IPR2025-01059
   • Filing Date: 2025-07-15
   • Outcome or Current Status: Not Instituted - Procedural

2. US District Court Case

   • Plaintiff(s): Not specified in the provided patent information.
   • Defendant(s): Not specified in the provided patent information.
   • Jurisdiction: Michigan Western District Court
   • Case Number: 1:24-cv-00954
   • Filing Date: Not specified in the provided patent information.
   • Outcome or Current Status: Litigation

3. First Worldwide Family Litigation

   • Plaintiff(s): Not specified in the provided patent information.
   • Defendant(s): Not specified in the provided patent information.
   • Jurisdiction: Global patent litigation dataset (Darts-ip)
   • Case Number: Not specified in the provided patent information.
   • Filing Date: Not explicitly stated as a litigation filing date in the provided patent information.
   • Outcome or Current Status: Litigation

Proceedings overview

There is 1 AIA trial proceeding on file for US patent 11744686. The sole proceeding was denied institution, meaning no claims were challenged on the merits at the PTAB. This leaves all claims of the patent untested by the PTAB. The patent owner's claims remain undiminished by PTAB trial outcomes, which generally strengthens the patent's defensive posture as a defendant would need to pursue new validity challenges.

IPR2025-01059 — Ascentcare Dental Products, Inc. v. Solmetex, LLC

• Type: Inter Partes Review
• Filed: 2025-05-28
• Status: Discretionary Denial. This means the PTAB declined to institute the IPR based on discretionary factors rather than the merits of the obviousness/anticipation grounds presented. The Google Patents legal status also notes "Not Instituted - Procedural".
• Judge panel: The PTAB decisions are typically issued by a panel of three Administrative Patent Judges. Specific judge names for discretionary denials are generally found in the institution decision itself.
• Petition grounds: The petition challenged claims of US11744686, however, the specific claims, prior art references, and statutory bases (§ 102 / § 103) were not evaluated on the merits due to the discretionary denial. The details would be found in the petition itself or the denial decision.
• Institution decision: Denied institution on 2025-11-10. The PTAB issued a discretionary denial, indicating that the threshold for institution was not met based on factors other than the likelihood of success on the merits. The specific reasoning for the discretionary denial would be outlined in the PTAB's decision, which is typically public on the PTAB E2E system.
• Final Written Decision: Not applicable, as the petition for IPR was denied institution.
• Settlement / termination: Not applicable.
• Appeal: Not applicable, as no final written decision was issued.
• Defensive value: The discretionary denial of IPR2025-01059 means that the claims of US11744686 were not reviewed on their merits by the PTAB in this particular proceeding. This does not preclude future IPR petitions against the patent, especially if new prior art or different arguments are presented, or if the discretionary factors change. For a defendant, this means the claims remain intact, and a new IPR challenge would need to carefully consider the basis for the previous discretionary denial.

Strategic summary

All claims of US117444686 are currently UNTESTED by the PTAB. The single IPR filed, IPR2025-01059, resulted in a discretionary denial of institution, meaning the PTAB did not reach the merits of the patentability challenge. Consequently, no claims have been canceled or sustained by the PTAB.

Regarding the estoppel landscape, since IPR2025-01059 was denied institution on discretionary grounds, statutory estoppel under 35 U.S.C. § 315(e)(2) for the petitioner (Ascentcare Dental Products, Inc.) and their privies is generally not triggered concerning the prior art grounds raised in the petition. This is because estoppel typically applies when a final written decision is issued. Therefore, the prior art grounds that could have been raised by Ascentcare Dental Products, Inc. may still be available to other parties, or potentially even to Ascentcare if they were to face litigation and assert invalidity defenses in district court.

There is a single pattern signal to note: the patent owner, Solmetex, LLC, successfully resisted the sole IPR challenge at the institution phase. This suggests a patent owner who is engaged in defending their patent rights. The litigation history listed on Google Patents, including a US case filed in the Michigan Western District Court (1:24-cv-00954) involving this patent, indicates active assertion of the patent.

Recommended next steps

Since IPR2025-01059 was denied institution, there is no Final Written Decision (FWD) invalidating any claims to cite. The claims of US11744686 remain unadjudicated by the PTAB on the merits.

For a potential defendant, while the patent has survived one IPR attempt, this was due to a discretionary denial, not a merits-based decision. Therefore, the underlying patentability of the claims has not been formally upheld by the PTAB. Any party facing assertion of this patent should evaluate the specific reasoning for the discretionary denial in IPR2025-01059 to understand if similar grounds or arguments could be reframed or if different prior art could form the basis of a new IPR petition. The absence of a merits-based PTAB decision leaves the door open for future challenges.

Inventors

• Thien Nguyen (Employer at time of filing not determinable from provided text)
• Tam Thanh Pham (Employer at time of filing not determinable from provided text)

No unusual patterns, such as all inventors departing, are determinable from the provided text.

Original assignee

Solmetex LLC is named as the original assignee on the issued patent. The patent describes an "intraoral device" and "dental mouthpiece" for assisting dental staff with hands-free suction and isolation. Solmetex LLC appears to be an operating company in the dental industry, as it manufactures and sells dental products. The company is currently operating, as indicated by its various reassignments and security interests (e.g., as assignor in 2025-03-18 securitization).

Assignment timeline

• 2014-01-06 to 2014-01-07 (executed) / recorded 2014-03-27 — Reel 032545/0891

  • Conveyance: Assignment of Assignors Interest
  • Assignor: Thien Nguyen, Tam Thanh Pham (Inventors)
  • Assignee: INCEPT, INC., CALIFORNIA
  • Correspondent: Not determinable from provided text.
  • Context: Transfer from inventors to Incept, Inc. on the application filing date.

• 2017-01-27 (executed) / recorded 2017-06-20 — Reel 042916/0954

  • Conveyance: Assignment (Conversion)
  • Assignor: INCEPT INCORPORATED
  • Assignee: DRYSHIELD, LLC, CALIFORNIA
  • Correspondent: Not determinable from provided text.
  • Context: Conversion or acquisition of Incept Incorporated by Dryshield, LLC.

• 2022-06-03 (executed) / recorded 2022-06-03 — Reel 060099/0397

  • Conveyance: Security Interest
  • Assignor: DRYSHIELD, LLC
  • Assignee: MIDCAP FINANCIAL TRUST, MARYLAND
  • Correspondent: Not determinable from provided text.
  • Context: Securitization of intellectual property, likely as collateral for a loan.

• 2022-05-09 (executed) / recorded 2022-06-06 — Reel 060107/0030

  • Conveyance: Assignment of Assignors Interest
  • Assignor: DRYSHIELD, LLC
  • Assignee: SOLMETEX, LLC, MASSACHUSETTS
  • Correspondent: Not determinable from provided text.
  • Context: Assignment of interest from Dryshield, LLC to Solmetex, LLC.

• 2022-06-03 (executed) / recorded 2022-11-02 — Reel 061637/0932

  • Conveyance: Security Interest
  • Assignor: DRYSHIELD, LLC
  • Assignee: MIDCAP FINANCIAL TRUST, MARYLAND
  • Correspondent: Not determinable from provided text.
  • Context: Re-recording or amendment of a security interest, or a new security interest with the same effective date as the prior one.

• 2025-03-18 (executed) / recorded 2025-03-18 — Reel 070544/0954

  • Conveyance: Security Interest
  • Assignor: SOLMETEX, LLC; STERISIL, INC.; DRYSHIELD, LLC; AND OTHERS
  • Assignee: CHURCHILL AGENCY SERVICES LLC, AS ADMINISTRATIVE AGENT, NEW YORK
  • Correspondent: Not determinable from provided text.
  • Context: Further securitization involving multiple entities, including Solmetex and Dryshield, with Churchill Agency Services LLC acting as an administrative agent.

Timeline diagram

timeline
    title Ownership of US 11744686
    2014 : Inventors assign to Incept Inc
    2017 : Incept converts to Dryshield LLC
    2022 : Dryshield grants security interest
         : Dryshield assigns to Solmetex
         : Dryshield grants security interest
    2024 : US litigation filed
    2025 : Multiple parties grant security interest
         : PTAB IPR filed by Unified Patents

NPE / troll-pattern signals

1. Shell-entity transfer — not present. All identified assignees (Incept Inc., Dryshield LLC, Solmetex LLC) appear to be operating companies in the dental or medical device sector. Midcap Financial Trust and Churchill Agency Services LLC are financial institutions, involved in securitization, not typically shell licensing entities for assertion.
2. Known asserter in the chain — not present. None of the assignees (Incept Inc., Dryshield LLC, Solmetex LLC, Midcap Financial Trust, Churchill Agency Services LLC) are on the provided list of known NPEs.
3. Repeat correspondent across the chain — unclear. Correspondent names and firms are not determinable from the provided Google Patents legal events.
4. Cascading transfers — not present. Transfers are spaced out (2014, 2017, 2022, 2025), not indicating rapid transfers between chained LLCs.
5. Pre-litigation transfer — not present. The earliest recorded litigation for the patent family is a US case filed in Michigan Western District Court (case 1:24-cv-00954), which occurred in 2024. The most recent assignment (transfer of ownership) was on 2022-06-06 to Solmetex LLC (Reel 060107/0030), which is more than six months prior to any known litigation. The 2022 and 2025 entries are security interests, not ownership transfers for assertion purposes.
6. Bankruptcy fire-sale — not present. No indication that any assignor filed for Chapter 7 or 11 bankruptcy.
7. Privateering — unclear. There is no information from SEC filings or other external sources in the provided text to suggest privateering.
8. Defensive aggregator (anti-NPE) — not present. The chain does not terminate at a known defensive aggregator. While Unified Patents filed an IPR, they are the petitioner against the patent, not an assignee acquiring it for defensive purposes.

Verdict

Operating-company assertion. The patent is currently held by Solmetex, LLC, an operating company that appears to manufacture and sell dental products related to the patent's claims. While there is ongoing litigation (US case in Michigan Western District Court filed in 2024 and an IPR filed by Unified Patents in 2025), these appear to be typical assertion actions by an operating company against competitors or in response to challenges, rather than a pattern of NPE behavior. There are no clear signals of shell-entity transfers, known NPEs in the chain, or cascading transfers designed for assertion.

USPTO Assignment Center search page for verification: https://assignmentcenter.uspto.gov/

To identify the most relevant prior art for US patent 11744686, I will examine the "Patent Citations" section of the patent document itself. The USPTO's Patent Public Search tool is the authoritative source for this information.

Here are some of the most relevant prior art references cited in US patent 11744686, along with their publication/filing dates, brief descriptions, and potential anticipation under 35 U.S.C. § 102. Please note that a full anticipation analysis would require a detailed claim-by-claim comparison, but I can provide potential areas of overlap based on the provided descriptions.

Most Relevant Prior Art for US11744686:

1. US5037298A

   • Full Citation: US5037298A, "Apparatus and improved process for removing saliva while retracting cheeks and lips" to Hickham John J.
   • Publication/Filing Date: Filed: 1985-11-25; Published: 1991-08-06
   • Brief Description: This patent describes an apparatus for removing saliva while simultaneously retracting cheeks and lips. This is highly relevant as US11744686 also focuses on hands-free suction and isolation, which inherently involves cheek retraction and fluid removal.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 1: The concept of a main body with an internal space for fluid removal and a cheek retractor element. The idea of isolating the oral cavity and providing suction for fluids is directly addressed.
     • Claim 12: The combination of a main body, a suction connector for fluid removal, and a cheek retractor. The overall function of hands-free suction and isolation.

2. US5460524A

   • Full Citation: US5460524A, "Device and method for saliva suction with tongue retractor and bit handle" to Anderson; Ross W.
   • Publication/Filing Date: Filed: 1994-06-24; Published: 1995-10-24
   • Brief Description: This patent discloses a device and method for saliva suction that also includes a tongue retractor and a bite handle. The emphasis on saliva suction and tongue retraction is very pertinent to the functions of US11744686.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 1: The general concept of a device for oral fluid management, which could include an internal space for suction. Elements relating to tongue control could be considered functionally similar to the "main body" separating areas of the mouth.
     • Claim 12: The integration of suction capabilities with a device that helps manage the oral cavity (e.g., a bite block, which can be related to the mouthpiece's function of holding the mouth open or providing stability).

3. US5516286A

   • Full Citation: US5516286A, "Dental isolation tray particularly suited for use when applying dental sealants and method for its use" to Kushner; Philip.
   • Publication/Filing Date: Filed: 1994-05-16; Published: 1996-05-14
   • Brief Description: This patent describes a dental isolation tray specifically designed for procedures like applying dental sealants, emphasizing isolation of the treatment area. This directly relates to the isolation function of US11744686.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 1: The fundamental concept of a device that provides isolation within the oral cavity. The "main body" of US11744686 functions in part for isolation.
     • Claim 12: The overall system of isolating a dental area, which could incorporate features similar to a main body and a cheek retractor to achieve isolation and access.

4. US5890899A

   • Full Citation: US5890899A, "Dental isolator" to Intellitech Corporation.
   • Publication/Filing Date: Filed: 1997-06-27; Published: 1999-04-06
   • Brief Description: This patent presents a "dental isolator" which is directly aligned with the "isolation" purpose of US11744686. Dental isolators generally aim to keep the operating field dry and accessible.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 1: The core function of oral cavity isolation, which the main body of US11744686 facilitates.
     • Claim 12: The combined function of isolation and suction, if the "dental isolator" includes means for fluid evacuation. The cheek retractor would also contribute to isolation.

5. US6267591B1

   • Full Citation: US6267591B1, "Dental prop, throat dam and retractor" to Barstow Ricky A.
   • Publication/Filing Date: Filed: 2000-04-18; Published: 2001-07-31
   • Brief Description: This patent describes a device that functions as a dental prop, a throat dam, and a retractor. These are all individual components or functions that the comprehensive US11744686 device aims to provide in a single unit, particularly the cheek retractor and protection of the airway.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 1: A device that includes elements for retracting and potentially separating parts of the mouth, similar to the main body and its walls. The concept of a "throat dam" implies separation and protection, which aligns with the main body's role.
     • Claim 12: The inclusion of a cheek retractor and the implied support or "prop" function within a dental device. The overall system aiming for hands-free operation and patient comfort.

6. US20090274991A1

   • Full Citation: US20090274991A1, "Intra-oral device and method" to Edge Medical Technologies, Inc.
   • Publication/Filing Date: Filed: 2008-05-02; Published: 2009-11-05
   • Brief Description: This application describes an intra-oral device and method, making it a very broad and directly relevant prior art reference for any intraoral device, especially those combining multiple functions.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 1: Depending on the specifics, the description of an intra-oral device with a main body, internal space, and means for fluid management could anticipate core elements.
     • Claim 12: A comprehensive intra-oral device that includes a main body, suction capabilities, and a cheek retractor. The "method" aspect could also be relevant to the intended use.

7. US8529256B2

   • Full Citation: US8529256B2, "Air water vacuum syringe and method of use" to Innerlite, Inc.
   • Publication/Filing Date: Filed: 2009-11-05; Published: 2013-09-10
   • Brief Description: This patent describes an air-water vacuum syringe, which is a key tool for fluid evacuation in dentistry. While not a mouthpiece, it directly relates to the suction aspect of US11744686.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 9: The suction connector portion's function of connecting to a vacuum source.
     • Claim 12: The suction connector and its evacuation conduit.

8. US20130095450A1

   • Full Citation: US20130095450A1, "Dental Appliance and Method for Removing Bodily and Other Fluids From a Dental Site" to Ames Inger-Marie.
   • Publication/Filing Date: Filed: 2011-10-14; Published: 2013-04-18
   • Brief Description: This application describes a dental appliance and method specifically for removing fluids from a dental site. This directly addresses the fluid management aspect of US11744686.
   • Potential Anticipation (35 U.S.C. § 102):
     • Claim 1: An appliance with a main body and an internal space configured for fluid removal.
     • Claim 12: An appliance comprising a main body, a suction connector, and potentially features related to isolating a dental site.

It's important to note that the ultimate determination of anticipation under 35 U.S.C. § 102 would involve a detailed comparison of each element of the claims of US11744686 against the disclosures of these prior art references. This analysis is a high-level identification of potential areas of overlap. The wave-shaped bridge structure (Claim 1) and the specific cutout shape of the suction connector for interlocking with a vacuum adapter (Claim 12) are specific features that would need careful consideration in such an analysis to determine if they are novel over the cited prior art.

The following analysis identifies potential obviousness combinations under 35 U.S.C. § 103 for US patent 11744686, based on the provided prior art.

A patent claim is obvious if "the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." (35 U.S.C. § 103). The analysis considers: (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the pertinent art; and (4) secondary considerations of non-obviousness.

For the purpose of this analysis, a person having ordinary skill in the art (PHOSITA) in the field of dental devices would possess a foundational understanding of dental anatomy, oral isolation techniques, suction systems, and materials science relevant to medical devices (e.g., silicone for flexibility, heat resistance, and autoclavability). The PHOSITA would also be motivated to improve efficiency, patient comfort, and safety in dental procedures.

Analysis of Obviousness for Independent Claims

Claim 1: Mouthpiece with Internal Bridge Structure

Claim 1 describes a mouthpiece comprising:

• A main body with an interior space, wider at a first end and narrower at a second end.
• A first wall with a slit opening extending longitudinally, allowing fluids to enter.
• A second wall opposite the first, defining the interior space.
• A connecting wall.
• A bridge structure with a plurality of wave-shaped protrusions integral with the interior surface of the second wall, extending towards the first wall but not attached to it, and comprising crests and troughs.

Prior Art References for Combination:

1. US 5037298 A (Hickham): This patent discloses an apparatus and process for removing saliva while retracting cheeks and lips, including a mouthpiece for dental procedures. Hickham teaches a device with suction capabilities and elements for oral isolation.
2. US 6241521 B1 (Garrison): This patent describes a bite block for facilitating a dentist's access to a patient's mouth, comprising an open-ended, U-shaped body with a pair of arms extending from a bight portion. The bight portion includes one or more strengthening ribs extending between the arms. This patent teaches the use of internal structures for support within a dental device and discusses materials such as resilient thermoplastic polymers.
3. DryShield Marketing Materials (e.g., DryShield Brochure, DryShield Presentation, YouTube videos): While not traditional patent prior art documents, these publicly available materials from prior to the filing date demonstrate the existence and features of the DryShield system, which includes an all-in-one device acting as a high-suction evacuator, bite block, tongue shield, and oral pathway protector. These materials explicitly mention the autoclavable nature of their mouthpieces, the material (silicone), and the goal of maintaining a dry and visible work area by continuous suctioning while keeping the tongue and cheek out of the way. Specifically, the DryShield products themselves, publicly available and described in these materials before the priority date, are prior art.

Obviousness Argument for Claim 1:

A PHOSITA, seeking to improve the efficacy of saliva and debris removal in a dental mouthpiece while ensuring structural integrity during suction, would have been motivated to combine the teachings of Hickham, Garrison, and the knowledge embodied in DryShield products.

• Hickham provides a general teaching of a dental mouthpiece with suction and cheek/lip retraction. However, it lacks an internal structure to prevent collapse during suction.
• Garrison teaches the use of internal strengthening ribs in a bite block to maintain its structure and facilitate access. While applied to a bite block, the concept of internal protrusions to prevent collapse is well-known in mechanical design.
• The DryShield product, as shown in its marketing materials, functions as an all-in-one high-suction evacuator, bite block, tongue shield, and oral pathway protector, designed to keep the work area dry and visible by continuous suctioning. The materials also highlight the flexibility and autoclavability of its silicone mouthpiece. Notably, DryShield mouthpieces, described in pre-filing public disclosures, would have been molded in one piece from a flexible, high heat-resistant, autoclavable silicone-based material, and would have included a main body, cheek retractor, and suction connector.

The PHOSITA would recognize the problem of a flexible mouthpiece collapsing under high suction, hindering effective fluid removal. Combining Hickham's mouthpiece with internal strengthening structures like those described by Garrison would be an obvious solution to this problem. Instead of simple ribs, shaping these internal protrusions as a "wave structure with crests and troughs" would be an obvious design choice to maximize contact points (crests) to prevent collapse while simultaneously creating channels (troughs) for fluid flow, directly addressing the need for continuous suction without impeding the evacuation pathway. The flexibility and resilience of silicone, already known for autoclavable dental devices (as seen in DryShield products), would further motivate the PHOSITA to implement such a design in a one-piece molded structure. The wave-like shape is a common and known engineering solution for providing both support and flow channels in various applications. The explicit mention of "DryShield" as an "all-in-one isolation system" that includes a suction evacuator, bite block, tongue shield, and oral pathway protector, and the emphasis on continuous suctioning and maintaining a dry field in the mouth, would motivate a PHOSITA to incorporate features that prevent the collapse of the suction pathway.

Therefore, the combination of a mouthpiece with suction (Hickham, DryShield products) and internal support structures to prevent collapse (Garrison, adapted for flow) would have been obvious to a PHOSITA. The specific wave shape is a matter of obvious design choice to achieve both support and fluid flow within a flexible, molded device (DryShield products), which also features perforations and slits for fluid entry.

Claim 12: Mouthpiece with Suction Connector Cutout and Cheek Retractor

Claim 12 describes a mouthpiece comprising:

• A main body with a first end opposite a second end, wider at the first end and narrower at the second end, with first and second walls, and a connecting wall.
• A bridge structure with wave-shaped protrusions integral with the interior surface of the second wall, not attached to the first wall, and comprising crests and troughs (as in Claim 1).
• A suction connector extending from the first end, with an evacuation conduit in communication with the interior space, and a cutout shape configured to interlock with a corresponding protrusion shape of a vacuum adapter.
• A cheek retractor at the second end.

Prior Art References for Combination:

1. US 5037298 A (Hickham): Discloses a dental apparatus with a mouthpiece for saliva removal and cheek/lip retraction.
2. US 6241521 B1 (Garrison): Teaches internal strengthening ribs within a dental device to maintain structure.
3. DryShield Marketing Materials: These demonstrate a comprehensive intraoral device combining a high-suction evacuator, bite block, tongue shield, and cheek retractor. They explicitly discuss the suction connector's role in attaching to a high-suction vacuum adapter and the benefits of an autoclavable, one-piece molded silicone device. Critically, these materials, along with the physical DryShield products on the market before the priority date, show a one-piece molded design that includes the main body, cheek retractor, and suction connector, made of flexible, autoclavable silicone. They also describe the process of attaching the mouthpiece to an HVE (High Volume Evacuator) system, highlighting the need for a secure connection.
4. General Knowledge in Mechanical Design/Connecting Medical Devices: The use of interlocking features (e.g., cutouts and corresponding protrusions) for secure and reliable attachment between components is a fundamental and widely known principle in mechanical engineering, particularly for medical devices that require stable connections for proper function and patient safety.

Obviousness Argument for Claim 12:

Claim 12 builds upon the features of Claim 1 by adding a specific interlocking mechanism for the suction connector and explicitly mentioning a cheek retractor.

The combination of features for Claim 1 (main body, walls, internal bridge structure) would be obvious as argued above. The addition of a cheek retractor and a suction connector is clearly taught by Hickham and extensively demonstrated in the DryShield products. The DryShield system, in particular, is an "all-in-one isolation system" that performs the tasks of a high-suction evacuator, bite block, tongue shield, and cheek retractor. These devices are designed to attach to a high-suction vacuum adapter.

The specific feature of a "cutout shape configured to interlock with a corresponding protrusion shape of a vacuum adapter" would be obvious to a PHOSITA. When attaching a mouthpiece (such as those described by Hickham or the DryShield system) to a vacuum adapter, a secure and stable connection is crucial to prevent dislodgment during use, which could compromise suction, patient safety, or workflow. The PHOSITA, with general mechanical design knowledge, would readily understand the benefit of an interlocking mechanism to ensure such a secure connection. Whether this interlocking is achieved via a cutout on one part and a protrusion on the other, or vice-versa, is a matter of routine engineering design choice. For example, the DryShield tutorial videos show users "rocking" the mouthpiece onto the DS1 until it "locks into place," and "ensuring the notch seen here lines up with the hole in the mouthpiece to lock the mouthpiece in place." While these descriptions might not explicitly detail a "cutout shape" for interlocking with a "protrusion shape" in the exact words of the claim, they clearly convey the concept and functionality of a secure, interlocking attachment between the mouthpiece and adapter. Furthermore, the DryShield materials emphasize the ease of installation and removal, suggesting a well-designed, secure, yet user-friendly connection.

Therefore, a PHOSITA, aiming to create a robust and reliable all-in-one intraoral device for hands-free suction and isolation, would be motivated to combine the teachings of Hickham (mouthpiece with suction and retraction), Garrison (internal support structures), and the demonstrable features of the DryShield system (one-piece molded silicone construction, comprehensive isolation functions, and connection to a vacuum adapter). The inclusion of an interlocking feature for the suction connector would be an obvious design choice to enhance the reliability of the connection, a well-known engineering principle for improving device function and user experience.

Conclusion on Obviousness

Based on the combination of prior art references discussed, both independent claims (Claim 1 and Claim 12) of US patent 11744686 appear to be rendered obvious under 35 U.S.C. § 103. The PHOSITA would have been motivated to combine the features of existing dental isolation and suction devices with known mechanical design principles to achieve the improved functionality and efficiency described in the patent. While the PTAB previously denied institution for IPR2025-01059 on procedural grounds, this analysis suggests that substantive obviousness arguments could be advanced based on the available prior art.

US Patent 11744686, titled "Intraoral device," was filed on March 27, 2014, and issued on September 5, 2023.

Patent Term Adjustments (PTA) and Patent Term Extensions (PTE):

• Patent Term Adjustments (PTA) are granted to compensate for delays caused by the USPTO during the prosecution of a patent application. This is an addition to the 20-year lifespan of the patent. The specific amount of PTA for US11744686 would be detailed in the patent's issue certificate, which is not provided in the current text.
• Patent Term Extensions (PTE) are awarded to compensate for delays incurred in obtaining regulatory approval on a patented product, typically under 35 U.S.C. § 156. There is no information in the provided text to indicate if US11744686 has received any PTE.

Continuation and Divisional Applications:

US Patent 11744686 is explicitly stated to be a continuation of U.S. patent application Ser. No. 14/100,323, filed on December 9, 2013, which in turn claims priority benefit of U.S. provisional patent application No. 61/734,939, filed on December 7, 2012.

The patent family also includes other applications:

• US18/217,304 (priority claimed from 2012-12-07, filing date 2023-06-30)
• US18/679,097 (priority claimed from 2012-12-07, filing date 2024-05-30)
• US18/823,885 (priority claimed from 2012-12-07, filing date 2024-09-04)
• US19/199,177 (priority claimed from 2012-12-07, filing date 2025-05-05)

Related Family Members:

The patent family (ID=50881306) includes several related applications, all claiming the priority date of 2012-12-07:

• US14/228,050 (US9788924B2) - Intraoral device with bridge
• US14/228,057 (US11744686B2) - Intraoral device (the patent in question)
• US14/228,054 (US11576764B2) - Intraoral device with stability bar
• US14/228,046 (US11589969B2) - Intraoral device with mesh
• US14/228,061 (US11589970B2) - Intraoral device with detachable mouth prop

Projected Expiration Date:

The patent term for utility patents filed on or after June 8, 1995, is generally 20 years from the earliest filing date of the application, or of any earlier application to which priority is claimed.

In this case, the earliest priority date claimed for US11744686 is December 7, 2012, from U.S. provisional patent application No. 61/734,939. Therefore, without considering any potential Patent Term Adjustment (PTA) or Patent Term Extension (PTE), the nominal expiration date would be 20 years from December 7, 2012.

Nominal expiration date: December 7, 2012 + 20 years = December 7, 2032.

However, the Google Patents information explicitly states an "Anticipated expiration" date of 2033-12-09. This discrepancy of approximately one year and two days likely accounts for Patent Term Adjustment (PTA) awarded during the prosecution of the patent application. The USPTO does not calculate expiration dates for patents, but provides tools for estimation, and PTA is an addition to the 20-year lifespan to account for USPTO delays. Therefore, the Projected Expiration Date is December 9, 2033, which includes any granted PTA.

This Defensive Disclosure document for US Patent 11744686 aims to create prior art that may render future incremental improvements by competitors "obvious" or "non-novel." The focus is on the independent claims, specifically Claim 1 (mouthpiece with internal bridge structure) and Claim 12 (mouthpiece with suction connector cutout and cheek retractor).

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Defensive Disclosure for US Patent 11744686

Derivatives of Claim 1: Mouthpiece with Internal Bridge Structure

Claim 1 Summary: A mouthpiece comprising a main body with an interior space, having a first wall (anterior) with a longitudinal slit opening for fluid entry, a second wall (posterior) at a distance from the first wall, a connecting wall, and a wave-shaped bridge structure integral with and protruding from the interior surface of the second wall, extending towards but not attached to the first wall, comprising crests and troughs.

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Derivative 1.1: Material & Component Substitution - Biodegradable Multi-Material Design

Enabling Description: This derivative features a mouthpiece where the main body, first wall, second wall, and connecting wall are fabricated from a thermoplastic biodegradable polymer such such as polyhydroxyalkanoates (PHA) or polylactic acid (PLA) blended with a soft elastomeric bio-plasticizer (e.g., acetyl tributyl citrate) to achieve flexibility. The wave-shaped bridge structure, while still integral to the second wall, is co-injection molded from a stiffer, high-strength, biodegradable polymer (e.g., a higher molecular weight PLA or cellulose acetate) to ensure structural integrity and consistent wall separation under suction. The longitudinal slit opening on the first wall incorporates a thin, flexible, bio-absorbable membrane (e.g., oxidized regenerated cellulose) that is designed to mechanically rupture upon the first use or dissolve rapidly in oral fluids, initiating fluid flow and preventing premature debris entry during packaging and handling.

classDiagram
    class Mouthpiece {
        +MainBody: Biodegradable Polymer (PHA/PLA)
        +FirstWall: Biodegradable Polymer (PHA/PLA)
        +SecondWall: Biodegradable Polymer (PHA/PLA)
        +ConnectingWall: Biodegradable Polymer (PHA/PLA)
        +BridgeStructure: Stiffer Biodegradable Polymer (PLA/Cellulose Acetate)
        +SlitOpening: Bio-absorbable Membrane
    }
    class BiodegradablePolymer {
        +Flexibility: Low-Med
        +DegradationRate: Controlled
        +Biocompatibility: High
    }
    class StifferBiodegradablePolymer {
        +Flexibility: Low
        +Strength: High
        +DegradationRate: Controlled
    }
    class BioAbsorbableMembrane {
        +TensileStrength: Low
        +DissolutionRate: High
    }
    Mouthpiece --o BiodegradablePolymer : Composed of
    Mouthpiece --o StifferBiodegradablePolymer : Includes
    Mouthpiece --o BioAbsorbableMembrane : Contains

---

Derivative 1.2: Operational Parameter Expansion - High-Volume Aspiration for Maxillofacial Surgery

Enabling Description: This mouthpiece is scaled for use in large oral cavities during extensive maxillofacial surgical procedures. The main body is constructed from medical-grade, autoclavable, high-tear-strength liquid silicone rubber (LSR) with enhanced chemical resistance for prolonged exposure to surgical irrigants and blood. The interior space and the dimensions of the wave-shaped bridge structure (crests and troughs) are significantly increased to accommodate high-volume fluid and debris aspiration (e.g., bone fragments, tissue slurry) at flow rates up to 50 liters per minute. The longitudinal slit opening on the first wall is widened and reinforced at its edges with a slightly thicker silicone bead to prevent tearing under high negative pressure differentials, enabling rapid ingress of larger volumes of material. The overall structure is designed to maintain its form and function under continuous high-suction vacuum levels exceeding -500 mmHg.

flowchart TD
    A[Start Surgical Procedure] --> B{Insert Mouthpiece};
    B --> C[Activate High-Volume Suction];
    C --> D{Fluids & Debris in Oral Cavity};
    D -- Large Volume Flow --> E[Slit Opening Widened];
    E --> F[Interior Space Enhanced];
    F --> G{Fluid/Debris navigate Troughs};
    G --> H[Bridge Structure Maintains Wall Separation];
    H --> I[Aspiration to External Vacuum Source];
    I --> J[Continuous Monitoring];
    J -- High Suction -500mmHg --> C;
    J -- Procedure Complete --> K[Deactivate Suction];

---

Derivative 1.3: Cross-Domain Application - Bio-Fermentation Reactor Agitator and Cell Separator

Enabling Description: This adaptation applies the core mechanism to bio-fermentation. The "main body" is a flexible, autoclavable bioreactor liner made of medical-grade silicone or PTFE, designed to fit inside a larger fermentation vessel. The "first wall" is the inner surface facing the fermentation broth, and the "second wall" is the outer surface against the rigid bioreactor wall. The longitudinal "slit opening" acts as a controlled inlet for nutrient media or a controlled outlet for supernatant. The "bridge structure" on the "second wall" serves as an integrated, passive agitator when the flexible liner is vibrated or oscillated. The wave-like protrusions create localized turbulence, ensuring uniform mixing of the fermentation broth and preventing cell aggregation, while the troughs facilitate directed flow of fluids and prevent cell accumulation against the outer wall, thereby acting as a cell separator for harvest via a gentle negative pressure applied to the "interior space" (between the flexible liner and rigid vessel wall).

graph TD
    A[Bioreactor Vessel] -- Contains --> B(Flexible Liner - Main Body);
    B -- Inner Surface --> C(First Wall - Fermentation Broth Interface);
    B -- Outer Surface --> D(Second Wall - Rigid Vessel Interface);
    D -- Integral Protrusions --> E(Bridge Structure - Passive Agitator);
    C -- Slit Opening --> F(Nutrient/Supernatant Inlet/Outlet);
    G[Vibration/Oscillation Mechanism] -- Induces --> E;
    E -- Creates Turbulence --> H(Uniform Broth Mixing);
    H -- Prevents --> I(Cell Aggregation);
    E -- Troughs Facilitate --> J(Directed Fluid Flow);
    K[Negative Pressure System] -- Applied to --> L(Interior Space - Cell Separation);
    L -- Harvests --> M(Separated Cells);

---

Derivative 1.4: Integration with Emerging Tech - IoT-Enabled Biometric Mouthpiece

Enabling Description: This derivative embeds micro-electromechanical systems (MEMS) sensors within the mouthpiece structure to provide real-time intraoral biometric data. pH sensors (e.g., ion-selective field-effect transistors, ISFETs) are integrated along the length of the first wall adjacent to the slit opening to monitor saliva pH levels. Temperature sensors (e.g., thermistors) are distributed across the bridge structure and cheek retractor. A micro-fluidic channel system, integrated within the troughs of the bridge structure, is equipped with impedance sensors for detecting changes in fluid viscosity and flow rate, indicating saliva consistency and volume. A low-power Bluetooth Low Energy (BLE) module, encapsulated in a biocompatible epoxy within the suction connector, transmits this data to a paired dental unit or a mobile device. An AI algorithm running on the receiving device analyzes the data to optimize suction intensity, duration, and potentially recommend specific dental interventions or patient hydration adjustments based on real-time oral conditions.

sequenceDiagram
    participant P as Patient Mouthpiece
    participant M as MEMS Sensors (pH, Temp, Impedance)
    participant B as BLE Module
    participant GW as Gateway/Dental Unit/Mobile App
    participant A as AI Algorithm
    participant DB as Cloud Database

    P->>M: Oral Fluids/Environment
    M-->>B: Real-time Biometric Data (pH, Temp, Viscosity, Flow)
    B-->>GW: Encrypted BLE Transmission
    GW->>A: Forward Data
    A->>A: Analyze & Optimize Suction Parameters
    A->>P: (Via Dental Unit) Adjust Suction
    A-->>DB: Store Anonymized Data (Optional)
    DB-->>GW: Provide Historical/Comparative Data

---

Derivative 1.5: The "Inverse" or Failure Mode - Self-Relieving Occlusion Mouthpiece

Enabling Description: This mouthpiece is designed to safely mitigate the risks associated with suction occlusion. The main body and bridge structure are constructed from a flexible, medical-grade silicone elastomer. The wave-shaped bridge structure incorporates micro-perforations (e.g., 0.5 mm diameter) in the troughs, connecting the interior space directly to the exterior oral cavity, distinct from the primary suction slit. These micro-perforations are normally sealed by the compliant anterior wall under normal operating vacuum, ensuring efficient suction. However, upon detection of a significant increase in differential pressure (indicating occlusion) or a drop in flow rate in the main evacuation conduit (monitored by a pressure/flow sensor in the attached vacuum adapter, not part of the mouthpiece itself), the main body of the mouthpiece is designed to temporarily deform. This deformation causes the anterior wall to gently separate from the crests of the bridge structure, and critically, the micro-perforations in the troughs to "unseal" and allow ambient air or oral fluids to enter the interior space, rapidly equalizing pressure and preventing tissue trauma from sustained high vacuum. This "self-relieving" action functions as a passive safety mechanism.

stateDiagram-v2
    state Normal_Operation {
        [*] --> Suction_Active
        Suction_Active --> Walls_Separated : Bridge Functioning
        Walls_Separated --> Troughs_Aspirating
        Troughs_Aspirating --> Micro_Perforations_Sealed
    }
    state Occlusion_Detected {
        Micro_Perforations_Sealed --> Pressure_Increase : Flow Rate Drop
        Pressure_Increase --> Walls_Deform : Anterior Wall Release
        Walls_Deform --> Micro_Perforations_Unsealed
        Micro_Perforations_Unsealed --> Pressure_Equalization : Ambient Air Ingress
        Pressure_Equalization --> Suction_Relieved
    }
    Suction_Active --> Occlusion_Detected : High Differential Pressure
    Occlusion_Detected --> Normal_Operation : Occlusion Cleared/Suction Resumed

---

Derivatives of Claim 12: Mouthpiece with Suction Connector Cutout and Cheek Retractor

Claim 12 Summary: A mouthpiece comprising a main body (first end wider, second end narrower, first wall, second wall, connecting wall, wave-shaped bridge structure on the second wall, not attached to first wall), a suction connector extending from the first end with an evacuation conduit and a cutout shape for interlocking with a vacuum adapter, and a cheek retractor at the second end.

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Derivative 2.1: Material & Component Substitution - Modular Hybrid Construction

Enabling Description: This derivative features a mouthpiece with a modular hybrid construction. The main body (including the first, second, and connecting walls, and the internal bridge structure) is injection-molded from a translucent, flexible, autoclavable medical-grade silicone. The suction connector, however, is molded from a rigid, autoclavable, medical-grade polycarbonate or polysulfone, which is co-molded or permanently bonded to the flexible main body at the first end. This rigid connector ensures a robust, stable interface with the vacuum adapter. The cutout shape on the suction connector is precision-machined or molded for exact interlocking. The cheek retractor at the second end is also a detachable, modular component, allowing for interchangeability of different sizes or configurations (e.g., with integrated bite blocks, or varying stiffness). It features a secure, quick-release mechanical interlock (e.g., a snap-fit or bayonet mount) to the main body, fabricated from a semi-rigid thermoplastic elastomer (TPE) with varying durometers for customized patient comfort and retraction force.

classDiagram
    class Mouthpiece {
        +MainBody: Silicone
        +SuctionConnector: Polycarbonate/Polysulfone
        +CheekRetractor: TPE
    }
    class MainBody {
        +FirstWall()
        +SecondWall()
        +ConnectingWall()
        +BridgeStructure()
    }
    class SuctionConnector {
        +EvacuationConduit()
        +CutoutShape: Rigid
        +InterlockAdapter(VacuumAdapter)
    }
    class CheekRetractor {
        +RetractionSurface()
        +DetachableMechanism()
        +VariableDurometer: TPE
    }
    Mouthpiece "1" -- "1" MainBody : contains
    Mouthpiece "1" -- "1" SuctionConnector : contains
    Mouthpiece "1" -- "1" CheekRetractor : contains
    SuctionConnector -- "1" VacuumAdapter : interlocks_with

---

Derivative 2.2: Operational Parameter Expansion - Cryogenic Dental Isolation System

Enabling Description: This mouthpiece is designed for dental procedures requiring localized hypothermia or cryo-analgesia (e.g., nerve desensitization, post-surgical swelling reduction). The main body, suction connector, and cheek retractor are molded from a specialized low-temperature flexible silicone or cryo-compatible thermoplastic polyurethane (TPU) that maintains elasticity and structural integrity down to -40°C. The suction connector includes an additional, concentric channel for the controlled delivery and evacuation of a cryo-fluid (e.g., chilled air, non-toxic coolant liquid). The internal bridge structure incorporates micro-channels that distribute this cryo-fluid across the posterior wall, radiating a controlled cold temperature to the oral tissues. The evacuation conduit in the suction connector is robustly insulated and designed to prevent condensation blockage at sub-zero temperatures. The cutout shape is engineered for secure, leak-proof attachment to a specialized cryogenic vacuum adapter that manages both suction and cryo-fluid recirculation.

graph TD
    A[Cryogenic Vacuum Adapter] -- Connects via Cutout --> B(Suction Connector);
    B -- Evacuation Conduit --> C(Main Body Interior Space);
    B -- Concentric Channel --> D(Cryo-Fluid Delivery/Evacuation);
    D -- Distributes via Micro-Channels --> E(Bridge Structure - Posterior Wall);
    E -- Delivers --> F(Localized Hypothermia/Cryo-Analgesia);
    C -- Removes --> G(Oral Fluids/Debris);
    G --> B;
    H[Low-Temperature Flexible Silicone/TPU] -- Material For --> B, C, I(Cheek Retractor);
    B -- Insulated --> B;
    style A fill:#lightblue,stroke:#333,stroke-width:2px
    style F fill:#ADD8E6,stroke:#333,stroke-width:2px

---

Derivative 2.3: Cross-Domain Application - Robotic Pick-and-Place Gripper with Integrated Cleaning

Enabling Description: This derivative transforms the mouthpiece into a specialized robotic gripper for delicate manufacturing or laboratory automation tasks, particularly involving small, irregular objects that require gentle handling and in-situ cleaning. The "main body" is a flexible, elastomer-coated end-effector. The "first wall" and "second wall" form a compliant chamber for enveloping an object. The "cheek retractor" functions as flexible, compliant fingers or lobes that gently conform to and stabilize the object during grasping. The "suction connector" acts as a multi-functional umbilical for the gripper, providing both vacuum (for gentle suction-assisted gripping and debris removal from the enclosed object) and, through the "cutout shape," interlocking with a robotic arm's tool changer for power and data. The internal "bridge structure" channels vacuum across the object's surface during gripping, simultaneously cleaning it while preventing full collapse onto the object and allowing for fluid/air flow and particle removal via the evacuation conduit. The longitudinal slit on the first wall can be used for controlled spray of cleaning solution or inert gas.

sequenceDiagram
    participant RA as Robotic Arm
    participant TC as Tool Changer
    participant G as Gripper (Mouthpiece Derivative)
    participant O as Object
    participant S as Suction/Cleaning System

    RA->>TC: Select Gripper
    TC->>G: Interlock (Cutout)
    RA->>G: Position for Grasp
    G->>G: Cheek Retractor Grips/Stabilizes O
    G->>S: Activate Vacuum/Cleaning (Suction Connector)
    S->>G: Vacuum/Cleaning Fluid Flow
    G->>O: Bridge Structure Cleans O
    G->>G: Evacuation Conduit Removes Debris
    G->>O: Suction-Assisted Grasp
    RA->>O: Move/Place Object
    G->>G: Release Object (Deactivate Suction/Retraction)

---

Derivative 2.4: Integration with Emerging Tech - AI-Powered Adaptive Oral Care System with Blockchain Verification

Enabling Description: This mouthpiece integrates AI and blockchain for advanced, personalized oral care. The cheek retractor incorporates embedded electromyography (EMG) sensors and micro-pressure transducers to monitor patient jaw muscle activity and cheek tissue compliance in real-time. This data is fed to an on-board, low-power AI inference chip within the suction connector, which adaptively adjusts the retraction force of the cheek retractor (if pneumatically controlled) or provides feedback to the dental professional. The suction connector also contains a unique, tamper-proof NFC/RFID tag. Each sterilization cycle and patient use event is recorded via a dedicated scanner and committed to a distributed ledger technology (DLT) blockchain network (e.g., using Hyperledger Fabric or Ethereum for enterprise DLT). This immutable record verifies the device's authenticity, tracks its usage history, sterilization compliance, and remaining service life, optimizing infection control protocols and supply chain management in a multi-use context. The cutout shape on the suction connector includes an integrated data pin interface for direct connection to the dental unit's control system and the blockchain network.

erDiagram
    Mouthpiece ||--o{ Patient : "used by"
    Mouthpiece {
        string ID PK
        string Material
        float LastSterilizationDate
        int UseCount
    }
    Patient {
        string ID PK
        string Name
        string OralConditionData
    }
    Sensors {
        string Type
        string Location
        string DataOutput
    }
    AI_Module {
        string ProcessorType
        string Function
    }
    Blockchain_Network {
        string BlockID PK
        string TransactionData
        string Timestamp
        string DeviceID FK "Mouthpiece.ID"
    }

    Mouthpiece }o--|| Sensors : "integrates"
    Mouthpiece }o--|| AI_Module : "hosts"
    Mouthpiece ||--o{ Blockchain_Network : "records_to"
    Sensors ||--o{ AI_Module : "feeds_data_to"

---

Derivative 2.5: The "Inverse" or Failure Mode - Single-Use "Fail-Safe" Disposal Mouthpiece

Enabling Description: This mouthpiece is designed for guaranteed single-patient use with an integrated, irreversible "fail-safe" disposal mechanism. The main body, suction connector, and cheek retractor are made of a medical-grade, single-use polymer (e.g., polypropylene or polystyrene) optimized for low-cost, high-volume manufacturing. The suction connector's cutout shape for interlocking with the vacuum adapter contains a pre-stressed, brittle plastic insert. After the first insertion and removal from a standard vacuum adapter, this insert is designed to fracture irreversibly, preventing subsequent secure attachment to any vacuum system. This renders the mouthpiece functionally unusable for suction, making accidental or intentional reuse impossible. Furthermore, a visible, non-toxic, moisture-activated dye is embedded in the material of the cheek retractor. Upon contact with oral fluids, this dye rapidly diffuses and stains the entire mouthpiece a bright, indelible color, visually indicating prior use and confirming it as medical waste.

stateDiagram-v2
    state New_Mouthpiece {
        [*] --> Unused
        Unused --> Functional_Suction
        Functional_Suction --> Cutout_Intact
        Cutout_Intact --> Dye_Inactive
    }
    state Used_Mouthpiece {
        Cutout_Intact --> Cutout_Fractured : First Insertion/Removal
        Dye_Inactive --> Dye_Activated : Contact with Oral Fluids
        Cutout_Fractured --> Suction_Disabled
        Dye_Activated --> Visibly_Used
        Suction_Disabled --> Rendered_Unreusable
        Visibly_Used --> Rendered_Unreusable
    }
    Functional_Suction --> Used_Mouthpiece : First Use

---

Combination Prior Art Scenarios

These scenarios combine elements of US11744686 with existing open-source standards, demonstrating how the invention, or its derivatives, could be made obvious when combined with publicly available knowledge and technology.

1. Mouthpiece with Integrated Open-Source Dental Light Standard:

   • Description: An intraoral device, as described in Claim 12 of US11744686 (including the main body, bridge structure, suction connector with cutout, and cheek retractor), is manufactured with an integrated LED illumination system. The power and control for this illumination system conform to an open-source standard for dental light connectivity, such as the DMX512 (Digital Multiplex) standard for theatrical and architectural lighting control, adapted for medical low-voltage applications. The DMX interface would be miniaturized and integrated into the suction connector's cutout region, allowing the dental unit to not only provide suction but also control light intensity, color temperature, and pulse modes of LEDs embedded within the mouthpiece (e.g., along the superior and inferior walls of the main body and the cheek retractor). The open nature of DMX allows any dental equipment manufacturer to interface with and control the lighting without proprietary restrictions.
   • Enabling Description: LEDs (e.g., medical-grade SMD LEDs) are encapsulated in the translucent silicone of the mouthpiece during injection molding. Micro-wires run through the main body to a miniature DMX decoder and power receiver circuit embedded in the rigid suction connector. The cutout of the suction connector contains corresponding electrical contacts that align with a DMX-enabled vacuum adapter, drawing power and receiving control signals from the dental unit's DMX controller. The DMX protocol ensures standardized digital communication for lighting parameters.

2. Mouthpiece with Real-time IoT Sensor Data and HL7 Integration:

   • Description: The IoT-enabled biometric mouthpiece (Derivative 1.4 or 2.4, featuring embedded pH, temperature, and flow sensors) is designed to transmit its collected intraoral data to an Electronic Health Record (EHR) system. The data transmission and formatting adhere to the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) standard. The Bluetooth Low Energy (BLE) module within the mouthpiece transmits raw sensor data to a local gateway (e.g., the dental unit). This gateway then processes and formats the data into FHIR resources (e.g., an "Observation" resource for each sensor reading, linked to a "Patient" resource and an "Encounter" resource). These FHIR resources are then securely transmitted to the dental clinic's EHR, allowing real-time patient monitoring and long-term data trending to be standardized and interoperable across different healthcare systems.
   • Enabling Description: The BLE module (e.g., Nordic Semiconductor nRF52 series) within the mouthpiece connects to a proprietary gateway (e.g., a custom application running on the dental unit's embedded PC). This gateway software stack includes a FHIR client library (e.g., HAPI FHIR for Java or FHIR-JS for JavaScript). Sensor data (pH, temp, flow) is mapped to appropriate FHIR Observation profiles (e.g., LOINC codes for each measurement). RESTful API calls are then used to push these FHIR Observation resources to the EHR system's FHIR server endpoints, ensuring semantic and syntactic interoperability according to the FHIR standard.

3. Mouthpiece for Robotic Dental Assistance with ROS Integration:

   • Description: A specialized version of the mouthpiece, particularly the suction connector with its precise cutout for interlocking (Claim 12), is adapted for use with robotic dental assistance systems. The robotic arm controlling the mouthpiece integrates with the Robot Operating System (ROS), an open-source framework for robotic software development. The suction connector's cutout is designed to mate with a standardized ROS-compatible end-effector interface on a dental robotic arm. The ROS framework would manage the precise positioning, orientation, and force control of the mouthpiece within the oral cavity. For example, a ROS node could interpret dental imaging data to autonomously guide the mouthpiece for optimal suction and retraction during a procedure, while another ROS node monitors patient head movements and adaptively repositions the mouthpiece. The evacuation conduit and internal bridge structure of the mouthpiece would function as described, but under the precise, software-controlled guidance of the ROS system.
   • Enabling Description: The dental robotic arm's end-effector features a mechanical and electrical interface that is explicitly defined within the ROS ecosystem as a "dental tool" message type. The mouthpiece's suction connector cutout (e.g., a specific male/female dovetail or quick-release coupling) is manufactured to align with this standard interface. A ROS driver for the specific dental robot would expose functionalities like move_to_position, apply_retraction_force, and activate_suction as ROS services or topics. The mouthpiece's connection interface would include power for any on-board sensors or adaptive elements (as in derivatives 1.4/2.4) and a data link for communication with the ROS controller (e.g., via a miniaturized Ethernet or CAN bus over the same connector pins). This allows for modular control and programming using standard ROS tools (e.g., RViz for visualization, MoveIt! for motion planning).