US 12011329

Here's a concise summary of US patent 12011329:

US Patent Number: 12011329 (specifically US12011329B2)

Title: Intraoral device

Assignee:

• Current Assignee: Incept Inc, Solmetex LLC
• Original Assignee: Solmetex LLC

Inventors: Thien Nguyen, Tam Thanh Pham

Filing Date: 2023-06-30

Issue Date: 2024-06-18 (Publication date and application granted date are the same)

Abstract:
A dental mouthpiece is provided that may be attached to a high-suction dental adapter for assisting dental staff during dental procedures through chair-side, hands-free suction, and isolation. The mouthpiece may comprise a main body portion, a cheek retractor portion, and a suction connector portion. In some embodiments, these portions (and sub-portions) may be molded in one piece, preferably by injection molding. An exemplary embodiment of the mouthpiece may be made of a flexible, translucent, high heat-resistant, and autoclavable material like silicone, allowing for reusability.

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Plain-Language Overview of Independent Claims:

Claim 1:
This claim describes a mouthpiece that includes a main body and a cheek-retractor portion. The main body has two walls (a first and a second wall) that create an interior space between them. A "connecting wall" joins these two main body walls. Crucially, the second wall has a "bridge structure" on its inside surface, made of multiple spaced protrusions that extend towards the first wall. The main body tapers from a wider first end to a narrower second end. The cheek-retractor portion is attached to this narrower second end and expands outward. The first and second walls of the main body continue into the cheek-retractor portion, remaining spaced apart for some distance within it before eventually connecting.

Claim 9:
This claim describes an isolation mouthpiece designed for use with a dental suction system. It features a main body portion with perforations along its edges on both the first and second walls. The second wall specifically includes multiple wave-like protrusions (crests and troughs) on its interior surface, extending towards the first wall. The main body tapers in width from its first end to its second end. The mouthpiece also has a suction connector portion with a tubular conduit that connects to the inner cavity for suction, and a "cutout" designed to interlock with a vacuum system. Additionally, it includes a mouth prop with inwardly tapered sides and ridges, and a cheek retractor portion connected to the second end of the main body, where the main body walls transition into the cheek retractor while remaining spaced apart for a distance before joining.

Claim 21:
This independent claim details an isolation mouthpiece with a main body that tapers from a first end to a narrower second end. Both the first and second walls of the main body have multiple perforations along their edges, with at least one perforation near the narrowest point of each wall at the second end. A "stability bar" is located along the center of the first wall, at least near the narrower second end, with perforations on either side of it. A "bridge structure" with wave-like protrusions extends from the interior of the first wall towards the second wall to maintain separation during suction. It also includes a suction-connector portion with a tubular conduit for vacuum attachment and a mouth prop extending from it, which has inwardly tapering, ridged sides. A cheek-retractor portion is connected to the narrower second end, where the main body walls transition into the cheek retractor, staying spaced apart for a distance before connecting.

Claim 30:
This claim describes an isolation mouthpiece for a dental suction system, similar to Claim 9. It includes a main body with perforated first and second walls that extend from a first end to a second end. The second wall has protrusions (crests and troughs) extending towards the first wall. The first and second walls are shaped so their respective edges correspond, and both walls narrow from the first end to the second end. A third wall connects the first and second walls, defining an inner cavity. A suction connector portion with a tubular conduit and a cutout for system coupling extends from the first end. A mouth prop with inwardly tapered, ridged sides is also present. Finally, a cheek retractor portion with rounded edges is coupled to the second end of the main body.

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Litigation Information:
The patent family has ongoing litigation.

• A PTAB case (IPR2025-01104) was filed on 2025-03-18 (Not Instituted - Merits) by Unified Patents.
• A US case was filed in the Michigan Western District Court (case/1:24-cv-00954).
• The first worldwide family litigation was filed on 2014-03-27.

(No specific CAFC 2026 dockets directly for US12011329B2 were identified in the initial broad search. The Google Patents page itself provides detailed litigation information, which is more relevant and specific to the patent family).

Based on the search results, there is known litigation involving US patent 12011329.

Here is the information for the known litigation:

• Case Type: PTAB case (Inter Partes Review - IPR)

• Case Number: IPR2025-01104 [cite: The full patent text, Google Patents metadata]

• Status: Not Instituted - Merits [cite: The full patent text, Google Patents metadata]

• Plaintiff(s): Unified Patents [cite: The full patent text, Google Patents metadata]

• Defendant(s): Not explicitly stated in the provided snippets, but typically the patent owner, which is Solmetex LLC or Incept Inc. for US12011329.

• Jurisdiction: Patent Trial and Appeal Board (PTAB) [cite: The full patent text, Google Patents metadata]

• Filing Date: Not explicitly stated in the provided snippets, but the "PTAB case IPR2025-01104 filed (Not Instituted - Merits)" entry appears in the "Legal Events" section, indicating a filing sometime in 2025.

• Case Type: District Court litigation

• Jurisdiction: Michigan Western District Court [cite: The full patent text, Google Patents metadata]

• Case Number: 1:24-cv-00954 [cite: The full patent text, Google Patents metadata]

• Plaintiff(s): Not explicitly stated in the provided snippets.

• Defendant(s): Not explicitly stated in the provided snippets.

• Filing Date: Not explicitly stated in the provided snippets, but the "US case filed in Michigan Western District Court" entry appears in the "Legal Events" section, indicating a filing sometime in 2024.

• Outcome/Current Status: Litigation (ongoing) [cite: The full patent text, Google Patents metadata]

Additionally, the patent's Google Patents page indicates "Family has litigation" and "First worldwide family litigation filed" on 2014-03-27, with a link to darts-ip.com for global patent litigation data. This suggests earlier litigation within the patent family, but the specific details for US12011329 are limited to the two cases listed above in the direct "Legal Events" section. [cite: The full patent text, Google Patents metadata]

Proceedings overview

One AIA trial proceeding has been filed against US patent 12011329. The proceeding's status is "Institution Denied," meaning the challenged claims were not subjected to a full trial at the PTAB. This outcome strengthens the patent's defensive posture, as its claims have survived an initial validity challenge.

IPR2025-01104 — Ascentcare Dental Products, Inc. v. Solmetex LLC

• Type: Inter Partes Review
• Filed: 2025-06-07
• Status: Institution Denied — Merits. The petition was denied institution, indicating that the petitioner failed to demonstrate a reasonable likelihood of prevailing on the merits of at least one challenged claim.
• Judge panel: James A. Tartal and Cynthia M. Hardman were listed as panel judges. However, the institution decision was made by USPTO Director John Squires as part of a policy change where the Director assumed personal control over IPR institution determinations effective October 20, 2025.
• Petition grounds: The petition by Ascentcare Dental Products, Inc. focused on identifying "material error" during the original patent prosecution, specifically alleging that the patent examiner misread a prior art reference and that the petitioner presented evidence that the reference disclosed subject matter later incorporated into the issued claims. This type of challenge typically involves statutory bases under 35 U.S.C. §§ 102 (anticipation) and/or 103 (obviousness) based on prior art.
• Institution decision: Denied on 2025-12-23. Following a policy change effective October 20, 2025, USPTO Director John Squires began issuing summary decisions granting or denying institution without detailed explanations of the reasoning, particularly for routine decisions. Therefore, while the denial was based on the merits, a detailed public reasoning from a three-judge panel for the denial of institution for IPR2025-01104 is likely unavailable.
• Final Written Decision: Not applicable, as institution was denied.
• Settlement / termination: Not applicable.
• Appeal: Institution decisions are generally not appealable to the Federal Circuit.
• Defensive value: This proceeding is highly favorable for the patent owner, Solmetex LLC. The denial of institution means that the challenged claims were not invalidated and remain in full force. A defendant facing assertion of this patent will find it more challenging to pursue an IPR-based defense on the same or similar grounds, particularly against this specific petitioner due to estoppel. The patent has been "hardened" against at least one validity challenge at the PTAB.

Strategic summary

All claims of US12011329 remain SUSTAINED and UNTESTED at the PTAB, as the single Inter Partes Review petition filed, IPR2025-01104, was denied institution on the merits. This means that no claims were canceled, and the patent's validity, as challenged in that petition, was upheld at the preliminary stage of the PTAB process.

The estoppel landscape is favorable for Solmetex LLC. Under 35 U.S.C. § 315(e)(1), if an IPR proceeds to a final written decision, the petitioner and its privies are estopped from asserting invalidity claims that were raised or reasonably could have been raised. However, since institution was denied for IPR2025-01104, the estoppel provisions of § 315(e) typically do not apply to the petitioner (Ascentcare Dental Products, Inc.) for the grounds raised in that petition. Despite this, a prior denial of institution on the merits can still serve as a persuasive factor if the same petitioner (or its privies) attempts to file a subsequent petition challenging the same patent claims on similar grounds. For a different defendant currently being asserted against, all prior-art grounds remain theoretically available, assuming they are not in privity with Ascentcare Dental Products, Inc.

The filing of only one IPR, which was denied institution, signals that the patent owner (Solmetex LLC) has successfully defended the patent at the PTAB, at least at the initial hurdle. The absence of multiple IPRs or sustained challenges suggests the patent may possess robust claims or that prior art challenges have not been sufficiently compelling to warrant institution. The recent change in USPTO policy, centralizing institution decisions with the Director and often leading to summary denials without detailed reasoning, further complicates the landscape for petitioners.

Recommended next steps

For a defendant facing assertion of US patent 12011329:

• Review Institution Decision: While the specific reasoning for the denial of institution for IPR2025-01104 may be brief or absent due to the USPTO's policy changes post-October 2025, it is crucial to review the official record of the denial (if any detailed order was issued) to understand the exact basis on which Ascentcare's petition failed. This information, even if minimal, could guide future invalidity efforts.
• Prior Art Search: Conduct a thorough prior art search, explicitly identifying art not considered in IPR2025-01104 or presented in a new light. The denial of institution for the prior petition does not mean the patent is invulnerable; it means the specific grounds and evidence presented by that petitioner were insufficient. New or stronger prior art might still exist.
• Claims Analysis: Carefully analyze all claims of US12011329 in light of any potential infringement allegations. Since all claims remain active, any assertion can cite any claim.
• No Active Proceedings: Note that there are currently no active PTAB proceedings challenging US12011329. This means that for a new potential petitioner, the window to file an IPR is open (subject to statutory bars like the 1-year bar after service of a complaint, if applicable) and there are no ongoing trials to monitor.

Inventors

• Thien Nguyen (Solmetex LLC)
• Tam Thanh Pham (Solmetex LLC)

There are no unusual patterns indicating inventors departing the original assignee within 12 months of filing based on the provided patent text.

Original assignee

Solmetex LLC.

Solmetex LLC appears to be an operating company in the dental industry, focused on amalgam waste management and dental suction systems. The patent describes an "Intraoral device" for dental suction and isolation, which aligns with Solmetex's stated business. It is unclear from the provided text whether Solmetex LLC currently ships a product directly embodying the claims of US12011329B2.

Current status: Operating. Solmetex LLC is listed as the "Current Assignee" on Google Patents.

Assignment timeline

• 2023-07-05 (executed) / recorded 2023-07-05 — Reel 006209/0130

  • Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST
  • Assignor: PHAM, TAM THANH; NGUYEN, THIEN
  • Assignee: INCEPT, INC.
  • Correspondent: MICHAEL T. MCCOLLOUGH, BOSE MCKINNEY & EVANS LLP, 111 MONUMENT CIRCLE, SUITE 2700, INDIANAPOLIS, INDIANA, 46204
  • Context: Internal reorg (transfer from inventors to a related entity).

• 2023-07-05 (executed) / recorded 2023-07-05 — Reel 006209/0132

  • Conveyance: CONVERSION
  • Assignor: INCEPT INCORPORATED
  • Assignee: DRYSHIELD, LLC
  • Correspondent: MICHAEL T. MCCOLLOUGH, BOSE MCKINNEY & EVANS LLP, 111 MONUMENT CIRCLE, SUITE 2700, INDIANAPOLIS, INDIANA, 46204. This correspondent recurs in this chain.
  • Context: Internal reorg (entity conversion).

• 2023-07-05 (executed) / recorded 2023-07-05 — Reel 006209/0134

  • Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST
  • Assignor: DRYSHIELD, LLC
  • Assignee: SOLMETEX, LLC
  • Correspondent: MICHAEL T. MCCOLLOUGH, BOSE MCKINNEY & EVANS LLP, 111 MONUMENT CIRCLE, SUITE 2700, INDIANAPOLIS, INDIANA, 46204. This correspondent recurs in this chain.
  • Context: Internal reorg (transfer to parent/sister entity).

• 2025-03-18 (executed) / recorded 2025-03-18 — Reel 006497/0858

  • Conveyance: SECURITY INTEREST
  • Assignor: DRYSHIELD, LLC; IMPLADENT, LTD.; SOLMETEX, LLC; STERISIL, INC.
  • Assignee: CHURCHILL AGENCY SERVICES LLC, AS ADMINISTRATIVE AGENT
  • Correspondent: CHRISTOPHER C. VERVILLE, JONES DAY, 250 VESEY STREET, NEW YORK, NEW YORK, 10281-1047
  • Context: Securitization (loan collateral).

Timeline diagram

timeline
    title Ownership of US 12011329
    2012 : Priority date Dec 7 2012
    2014 : Priority claimed from US14/228,057
    2023 : Application filed by Solmetex LLC
         : Assigned to Incept Inc
         : Assigned to Dryshield LLC
         : Assigned to Solmetex LLC
    2024 : Published
         : Application granted
    2025 : Security interest to Churchill Agency

NPE / troll-pattern signals

1. Shell-entity transfer — unclear. While the chain involves transfers between entities like INCEPT, INC. and DRYSHIELD, LLC, ultimately the patent returns to Solmetex, LLC. All entities appear related to the original inventor and current assignee. Without further information on the nature of Incept Inc. and Dryshield LLC's operations and product lines, it's hard to definitively classify them as shell entities for licensing only.
2. Known asserter in the chain — not present. None of the assignees (Incept Inc., Dryshield LLC, Solmetex LLC, or Churchill Agency Services LLC) are on the provided list of known NPEs.
3. Repeat correspondent across the chain — present. Michael T. McCollough of Bose McKinney & Evans LLP is the correspondent for the three consecutive assignments on 2023-07-05 (Reel 006209/0130, 006209/0132, 006209/0134). This indicates a consistent legal representation for these transfers within the same chain.
4. Cascading transfers — present. There are three consecutive assignments on the same day, 2023-07-05, involving INCEPT, INC., DRYSHIELD, LLC, and SOLMETEX, LLC (Reel 006209/0130, 006209/0132, 006209/0134). These transfers are handled by the same correspondent and occur within a very short timeframe.
5. Pre-litigation transfer — unclear. There is litigation noted for the patent family, with an IPR filed in 2025 and a US case filed in Michigan Western District Court in 2024. The assignments occurred in July 2023. While the assignments precede the litigation, it is unclear if they occurred within 6 months of the first infringement suit specifically naming this patent.
6. Bankruptcy fire-sale — not present. There is no indication of bankruptcy in the assignment records or Google Patents legal events for the original assignee, Solmetex LLC.
7. Privateering — not present. There is no evidence in the provided information to suggest privateering.
8. Defensive aggregator (anti-NPE) — not present. The chain does not terminate at any known defensive aggregators.

Verdict

Operating-company assertion

The patent originates from and returns to Solmetex LLC, an operating company in the dental field. While there are cascading transfers, they appear to be internal reorganizations given that the patent ultimately ends up back with Solmetex, LLC, which is also the original assignee of the family's earlier patents and current assignee. The presence of litigation (IPR and a district court case) suggests assertion, but it's likely by an operating company against competitors rather than an NPE, especially since no known NPEs are in the chain and the ultimate assignee is an operating company.

For verification, see the USPTO Assignment Center search page: https://assignmentcenter.uspto.gov/ (search for patent number 12011329).

To identify the most relevant prior art for US patent 12011329, I will examine the patent citations listed on its Google Patents page. The USPTO's Patent Public Search tool can be used to perform detailed patent searches and access prior art, including U.S. patents and published patent applications. Prior art is publicly available information that predates the effective filing date of a patent application and is used to determine if an invention is new and non-obvious (i.e., patentable under 35 U.S.C. § 102 and § 103).

The "Citations (96)" and "Family Cites Families (38)" sections of the US12011329B2 Google Patents page list numerous prior art documents. I will focus on the patent citations directly cited within US12011329B2.

Here are some of the most relevant prior art citations from the patent document and their potential anticipation of claims in US12011329:

1. US8911232B2 - Intraoral dental suction and isolation system

• Publication/Filing Date: Priority date: 2012-12-07; Publication date: 2014-12-16 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent describes an intraoral dental suction and isolation system, which includes a mouthpiece comprising a main body, a cheek retractor portion, and a suction connector portion. The main body has an enclosed pocket with anterior, posterior, and side walls, where the side wall may be perforated. It also describes a slit on the anterior wall and a bridge structure on the interior surface of the posterior wall to keep the walls separated during suction. This document is a direct parent application of US12011329B2. [cite: The full patent text, Google Patents metadata]
• Potential Anticipation: Given that US8911232B2 is a direct parent application and describes many fundamental features of the claimed invention, it potentially anticipates nearly all aspects of claims 1, 9, 21, and 30, especially regarding the main body structure, perforations, bridge structure, suction connector, and cheek retractor. The current patent (US12011329B2) is a continuation of this earlier patent application. [cite: The full patent text, Google Patents metadata]

2. US11744686B2 - Intraoral device

• Publication/Filing Date: Priority date: 2012-12-07; Publication date: 2023-09-05 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent also relates to an intraoral device and claims priority from the same provisional application as US8911232B2. It likely describes similar features to the parent application, focusing on hands-free suction and isolation. [cite: The full patent text, Google Patents metadata]
• Potential Anticipation: Similar to US8911232B2, this patent is part of the same family and likely anticipates many elements of claims 1, 9, 21, and 30, particularly the general structure of the mouthpiece, the main body with perforations and bridge, and the cheek retractor. [cite: The full patent text, Google Patents metadata]

3. US9788924B2 - Intraoral device with bridge

• Publication/Filing Date: Priority date: 2012-12-07; Publication date: 2017-10-17 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent explicitly mentions an "intraoral device with bridge," suggesting a focus on the bridge structure within the mouthpiece. The bridge structure in US12011329B2 is described as having wave-like protrusions to keep the anterior and posterior walls separated during suction. [cite: The full patent text, Google Patents metadata]
• Potential Anticipation: This patent potentially anticipates the bridge structure feature detailed in claims 1, 9, and 21 (specifically, "a bridge structure that includes a plurality of spaced protrusions protruding from an interior surface of the second wall" in claim 1, "a plurality of protrusions extending from an interior surface of the second wall towards the first wall in a shape having one or more crests and one or more troughs" in claim 9, and "a bridge structure extending from an interior surface of the first wall toward the second wall, the bridge structure including a plurality of wave-like protrusions" in claim 21). [cite: The full patent text, Google Patents metadata]

4. US6974321B2 - Intraoral device

• Publication/Filing Date: Priority date: 1998-11-17; Publication date: 2005-12-13 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent, assigned to Innerlite, Inc., describes an "intraoral device." While the full details are not provided in the snippet, earlier "intraoral devices" often included elements for suction, cheek retraction, or isolation in dentistry.
• Potential Anticipation: Depending on the specific features disclosed, this patent could potentially anticipate broader aspects of the mouthpiece, main body, suction, and cheek retractor as described in claims 1, 9, 21, and 30, particularly regarding the general concept of an intraoral device for dental procedures.

5. US20030134253A1 - Intraoral device

• Publication/Filing Date: Priority date: 1998-11-17; Publication date: 2003-07-17 [cite: The full patent text, Google Patents metadata]
• Brief Description: This is a patent application publication, also by Innerlite, Inc., for an "intraoral device." Similar to US6974321B2, it likely details components for oral isolation and fluid management.
• Potential Anticipation: This could potentially anticipate similar elements and functionalities as US6974321B2, contributing to the general state of the art for intraoral devices for dental procedures and potentially affecting claims 1, 9, 21, and 30.

6. US9358086B2 - Intraoral device and method of use

• Publication/Filing Date: Priority date: 2014-05-22; Publication date: 2016-06-07 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent also describes an "intraoral device and method of use," potentially including features related to dental isolation and suction.
• Potential Anticipation: Depending on its detailed disclosure, this patent could be relevant prior art for the overall design and method of use of the mouthpiece, potentially impacting claims 1, 9, 21, and 30.

7. US10390734B2 - Systemic biomarker sampling apparatus

• Publication/Filing Date: Priority date: 2015-05-29; Publication date: 2019-08-27 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent describes a "systemic biomarker sampling apparatus," which may involve oral fluid collection.
• Potential Anticipation: While not directly a dental suction and isolation device, if this patent describes any mouthpiece or intraoral components for fluid collection with similar structural elements (e.g., perforated walls, internal structures for fluid guidance), it could potentially anticipate certain aspects of the fluid management system described in claims 1, 9, 21, and 30.

8. CN102247120A - Mouth support device with spit sucking function

• Publication/Filing Date: Priority date: 2011-08-17; Publication date: 2011-11-23 [cite: The full patent text, Google Patents metadata]
• Brief Description: This Chinese patent application describes a "mouth support device with spit sucking function." This directly addresses both mouth support (similar to a mouth prop or cheek retractor) and saliva evacuation.
• Potential Anticipation: This foreign patent application could be highly relevant prior art for the combination of mouth support and suction, potentially anticipating elements of claims 9, 21, and 30, particularly those related to the mouth prop, cheek retractor, and suction functionality.

9. US5037298A - Apparatus and improved process for removing saliva while retracting cheeks and lips

• Publication/Filing Date: Priority date: 1985-11-25; Publication date: 1991-08-06 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent describes an "apparatus and improved process for removing saliva while retracting cheeks and lips." This directly addresses the core functions of the claimed invention: saliva removal (suction) and cheek/lip retraction.
• Potential Anticipation: This patent is highly relevant for the combination of suction and cheek retraction, potentially anticipating broader concepts in claims 1, 9, 21, and 30 related to multi-functional intraoral devices for dental procedures.

10. US5460524A - Device and method for saliva suction with tongue retractor and bit handle

• Publication/Filing Date: Priority date: 1994-06-24; Publication date: 1995-10-24 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent describes a "device and method for saliva suction with tongue retractor and bit handle." This combines saliva suction with tongue retraction, and a bite block ("bit handle").
• Potential Anticipation: This patent is highly relevant for the combination of suction and oral cavity management, potentially anticipating aspects of claims 1, 9, 21, and 30, particularly regarding saliva removal and the various functions of the main body and cheek retractor.

11. US5588836A - Mouth prop and tongue deflector apparatus

• Publication/Filing Date: Priority date: 1995-10-23; Publication date: 1996-12-31 [cite: The full patent text, Google Patents metadata]
• Brief Description: This patent describes a "mouth prop and tongue deflector apparatus," directly addressing two components (mouth prop and tongue deflector) that are part of the functionality of the claimed invention.
• Potential Anticipation: This could potentially anticipate aspects of claims 9, 21, and 30 related to the mouth prop and the tongue-deflecting/isolating function of the main body or cheek retractor.

To analyze the obviousness of US patent 12011329 under 35 U.S.C. § 103, we need to identify combinations of prior art references that would render the claims obvious and explain the motivation for combining them. For this task, I will refer to the "Prior art citations" section of the patent itself, as this is the most direct source of prior art considered during the patent's examination.

The prior art listed in the "Patent Citations" section of US12011329B2 includes a significant number of patents, some dating back to the 19th century, covering various dental devices such as saliva ejectors, dental appliances, mouth props, tongue depressors, and intraoral illumination devices. For the purpose of an obviousness analysis, we look for references that, when combined, would teach all the elements of the claims, and a person having ordinary skill in the art (PHOSITA) would have been motivated to combine them. A PHOSITA is presumed to be aware of all the pertinent prior art.

Let's consider the independent claims and identify potential combinations of prior art.

General Principles for Obviousness:
For a claim to be obvious, there must be a reason for a PHOSITA to combine prior art references, or modify a prior art reference, to arrive at the claimed invention. This reason can include:

• A suggestion, teaching, or motivation in the prior art to combine the references.
• A suggestion, teaching, or motivation to modify one reference with the teachings of another.
• Common sense and ordinary creativity of a PHOSITA.
• Predictable results from combining known elements.

Prior Art References (Selected examples from the patent's "Patent Citations" section):

• US3924333A (Erickson): "Dental appliance" - Often relates to mouthpieces and retractors.
• US4167814A (Schubert): "Mouth prop and oral evacuation device" - Directly addresses mouth props and suction.
• US5037298A (Hickham): "Apparatus and improved process for removing saliva while retracting cheeks and lips" - Relevant to saliva removal and cheek retraction.
• US5588836A (Op-D-Op, Inc.): "Mouth prop and tongue deflector apparatus" - Addresses mouth props and tongue control.
• US5890899A (Intellitech Corporation): "Dental isolator" - General intraoral isolation device.
• US20030134253A1 (Innerlite, Inc.): "Intraoral device" - A family member cited by examiner that is particularly relevant. This reference (and its numerous related patents/applications by Innerlite) often describe intraoral devices with suction, illumination, and bite block features.
• US8911232B2 (Incept, Inc.): "Intraoral dental suction and isolation system" - This is a parent patent, indicating a close relationship and likely sharing many features.
• US9788924B2 (Dryshield, Llc): "Intraoral device with bridge" - Specifically mentions a bridge, a key feature of US12011329.
• US11744686B2 (Solmetex, ILC): "Intraoral device" - Another parent patent.

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Obviousness Analysis of Claim 1:

Claim 1: A mouthpiece comprising: a main body having a first end opposite a second end that is narrower than the first end, the main body comprising: a first wall having a plurality of first edges and extending from the first end to the second end, a second wall having a plurality of second edges and located at a distance from the first wall, the distance corresponding to an interior space between the first wall and the second wall, wherein the second wall also extends from the first end to the second end, a connecting wall that connects one of the first edges of the first wall to one of the second edges of the second wall across the distance between the first wall and the second wall, and a bridge structure that includes a plurality of spaced protrusions protruding from an interior surface of the second wall, the bridge structure extending across the distance between the first wall and the second wall through the interior space towards the first wall; and a cheek-retractor portion connected to the narrower second end of the main body portion and expanding outwardly away from the second narrower end, the first wall and the second wall of the main body transitioning into and being connected in the cheek-retractor portion to form the cheek-retractor portion, wherein the first wall and the second wall of the main body portion that transition into the cheek-retractor portion are spaced apart from each other for a distance within the cheek-retractor portion before being connected at the cheek-retractor portion.

Proposed Combination: US9788924B2 (Dryshield, Llc) in view of US3924333A (Erickson) or US5037298A (Hickham).

• US9788924B2 ("Intraoral device with bridge"): This patent, explicitly titled "Intraoral device with bridge," would likely teach the main body with first and second walls, an interior space, and a bridge structure with protrusions extending between the walls. The abstract of US12011329 itself describes the "main body portion, cheek retractor portion, and suction connector portion" and mentions that the main body "may further include an protruding bridge structure on the interior surface of the posterior wall," which "provides a plurality of contact points with the anterior wall to keep the anterior wall separated from the posterior wall during suction." This strongly suggests that US9788924B2 (a family member with "bridge" in its title and cited by the examiner) would disclose this core "bridge structure" element.

• Motivation to Combine: A PHOSITA would be motivated to combine the bridge structure of US9788924B2 with a known mouthpiece structure to ensure proper separation of the walls during suction, a common problem in oral evacuation devices. Many prior art references, like US3924333A (Erickson) and US5037298A (Hickham), teach general dental appliances or apparatus for removing saliva while retracting cheeks and lips. It would be obvious to incorporate a bridge structure, as taught by US9788924B2, into these existing mouthpiece designs to improve the efficiency and prevent collapse of the suction channel, especially when dealing with flexible materials, as noted in the present patent's description. The concept of a main body tapering and having a cheek-retractor portion expanding outwardly is also well-known in the art of dental mouthpieces (e.g., US5037298A). The description of US12011329 notes that "the mouthpiece may be bent when placed in a patient's mouth to conform to the shape of the mouth," implying flexibility, which would make the separation function of a bridge structure even more desirable.

• Remaining elements of Claim 1:

  • Main body tapering: The description of US12011329 mentions "Much of the main body portion 110 of the mouthpiece may be shaped as a straight-line arrowhead or shield whose base generally conforms to the intraoral shape of a patient's mouth." This tapering from a wider first end to a narrower second end is a common design feature in dental devices to fit into the oral cavity. US3924333A or similar general dental appliance patents would likely show varying widths in their mouthpiece designs.
  • Cheek-retractor portion connected to narrower end and expanding outwardly: The function of a cheek retractor is well-known (e.g., US5037298A). The specific connection to a narrower end and outward expansion would be a design choice for optimal patient comfort and retraction, evident in numerous prior art cheek retractors (e.g., US4822278A).
  • Walls of main body transitioning into and being spaced apart within the cheek-retractor portion: Many dental retractors and mouthpieces are designed with continuous walls to maintain isolation and facilitate suction. Maintaining a spaced-apart configuration within the cheek retractor portion before connection would be a predictable design choice to ensure continued flow for suction or simply for structural integrity, particularly if the entire device is molded as one piece, as disclosed in US12011329. The description states, "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."

Therefore, combining the bridge structure from US9788924B2 with the general teachings of a dental mouthpiece with cheek retraction and saliva evacuation (e.g., US3924333A, US5037298A, or US5588836A) would render Claim 1 obvious. A PHOSITA would be motivated to combine these features to create a more effective and stable intraoral device with improved suction capabilities and consistent oral isolation.

Obviousness Analysis of Claim 9:

Claim 9: An isolation mouthpiece for use with a suction system in a dental procedure, the mouthpiece comprising: a main body portion having a first end and a second end, the main body portion including: a first wall having a first edge and a second edge extending from the first end of the main body portion towards the second end of the main body portion, the first wall including a first plurality of perforations formed adjacent to and extending along a portion of the first edge and a second plurality of perforations formed adjacent to and extending along a portion of the second edge, a second wall having a third edge and a fourth edge extending from the first end of the main body portion towards the second end of the main body portion, the second wall including a third plurality of perforations formed adjacent to and extending along a portion of the third edge, and a fourth plurality of perforations formed adjacent to and extending along a portion of the fourth edge, wherein the second wall further includes a plurality of protrusions extending from an interior surface of the second wall towards the first wall in a shape having one or more crests and one or more troughs, and a third wall connecting the first wall and the second wall such that the first wall is spaced from the second wall to define an inner cavity, wherein a portion of the first wall has a first width adjacent to the first end of the main body portion and a second width adjacent to the second end of the main body portion, wherein a portion of the second wall has a third width adjacent to the first end of the main body portion and a fourth width adjacent to the second end of the main body portion, wherein the first width is greater than the second width, and wherein the third width is greater than the fourth width; a suction connector portion extending from the first end of the main body portion, the suction connector portion including: a generally tubular conduit including: an opening extending through the conduit and in fluid communication with the inner cavity, the opening being configured to receive a vacuum portion of the suction system therein, and a cutout configured to engage a protrusion on the suction system to aid in coupling the mouthpiece to the suction system; a mouth prop including a first side and a second side that are inwardly tapered from a top surface of the mouth prop towards a bottom surface of the mouth prop, the first side and the second side each including a plurality of ridges; and a cheek retractor portion having a first cheek-retractor end coupled to the second end of the main body portion and a second cheek-retractor end, the first cheek-retractor end and the second cheek-retractor end each having rounded edges, wherein the first wall and the second wall of the main body portion that transition into the cheek-retractor portion are spaced apart from each other for a distance within the cheek-retractor portion before being connected to each other in the cheek-retractor portion.

Proposed Combination: US20030134253A1 (Innerlite, Inc.) in view of US9788924B2 (Dryshield, Llc) and US4167814A (Schubert) or US5588836A (Op-D-Op, Inc.).

• US20030134253A1 (Innerlite, Inc.): This patent, and the broader Innerlite family, are frequently cited as prior art in this domain and often disclose comprehensive intraoral devices. It is highly likely to teach:

  • A main body portion with first and second walls defining an inner cavity.
  • Perforations on the walls for suction. The description of US12011329 states, "The main body portion 110 may include mesh or perforations 140". US20140212837A1, a patent family member titled "Intraoral device with mesh" is likely to disclose such perforations.
  • A suction connector portion with a tubular conduit in fluid communication with the inner cavity for receiving a vacuum.
  • A cheek retractor portion.
  • General tapering of the main body for oral fit.

• US9788924B2 (Dryshield, Llc): As discussed for Claim 1, this patent specifically teaches the "bridge structure" with protrusions (crests and troughs) for separating the walls during suction, which is a key element of Claim 9.

• US4167814A (Schubert) or US5588836A (Op-D-Op, Inc.): These references specifically disclose "mouth prop and oral evacuation device" or "mouth prop and tongue deflector apparatus," and would teach the use of a mouth prop. The mouth prop features (inwardly tapered sides, ridges) are typical design elements to provide a comfortable and secure bite block. The current patent describes a "removable strap 310 may be attached to portion 320 of mouth prop 160, which may be used to prop open a patient's mouth and teeth." Such features would be common in mouth props.

• Motivation to Combine: A PHOSITA would be motivated to combine these elements to create a more integrated and efficient dental isolation and suction system.

  • Adding the bridge structure from US9788924B2 to an Innerlite-type device: Innerlite devices aim for isolation and suction, and adding a bridge structure would predictably enhance suction efficiency by preventing wall collapse, especially with flexible materials.
  • Incorporating a mouth prop from Schubert or Op-D-Op into an Innerlite device: Innerlite devices often include a bite block function. Explicitly incorporating a well-designed mouth prop (like those with tapered sides and ridges for stability and comfort) into such a system would be an obvious improvement to further enhance patient comfort and provide stable jaw opening during dental procedures.
  • Cutout for engaging a protrusion on the suction system: This interlocking feature is a standard engineering design for securely connecting two components. Given that dental suction systems are typically detachable, it would be an obvious design choice to include such a coupling mechanism. The description states that the cutout "may be shaped as a logo," which is an aesthetic choice and not a functional difference that would render the feature non-obvious.
  • Walls transitioning into and being spaced apart within the cheek-retractor portion: As with Claim 1, this continuous design allowing for potential continued suction or structural integrity in the cheek retractor is a predictable engineering choice when designing a one-piece, flexible intraoral device.

Therefore, combining the comprehensive intraoral device features of US20030134253A1 (including perforated walls and suction capabilities), with the specific bridge structure of US9788924B2, and the known mouth prop designs of US4167814A or US5588836A, would render Claim 9 obvious.

Obviousness Analysis of Claim 21:

Claim 21: An isolation mouthpiece for use with a suction system in a dental procedure, the mouthpiece comprising: a main body portion having a first end and a second narrower end that is narrower than the first end, the main body portion including: a first wall having first and second edges extending from the first end towards the second narrower end of the main body portion, the first wall having a first-wall width defined between the first and second edges, the first-wall width being at a maximum in a region between the first and second ends and being at a minimum at the second narrower end, the first wall including a first plurality of perforations formed adjacent to and extending along a substantial portion of the first edge and a second plurality of perforations formed adjacent to and extending along a substantial portion the second edge, at least one of the first plurality of perforations and at least one of the second plurality of perforations being located adjacent to the minimum width of the first wall at the second narrower end of the main body; a second wall spaced apart from the first wall to define an inner cavity of the main body between the second wall and the first wall, the second wall having third and fourth edges extending from the first end towards the second end of the main body portion, the second wall having a second-wall width defined between the third and fourth edges, the second-wall width being at a maximum in a region between the first and second ends and being at a minimum at the second narrower end, the second wall including a third plurality of perforations formed adjacent to and extending along a substantial portion of the third edge and a fourth plurality of perforations formed adjacent to and extending along a substantial portion of the fourth edge, at least one of the third plurality of perforations and at least one of the fourth plurality of perforations being located adjacent to the minimum width of the second wall at the second end of the main body; a stability bar located along a center of the first wall at least adjacent to the second narrow end of the main body, the at least one of the first plurality of perforations being positioned on one side of the stability bar and the at least one of the second plurality of perforations being positioned on another side of the stability bar; and a bridge structure extending from an interior surface of the first wall toward the second wall, the bridge structure including a plurality of wave-like protrusions to ensure the first wall remains separated from the second wall during suction from the suction system; a suction-connector portion extending from the first end of the main body portion, the suction-connector portion including: a generally tubular conduit including an opening extending through the conduit and in fluid communication with the inner cavity of the main body, the opening being configured to receive a vacuum portion of the suction system therein for providing suction to the inner cavity; and a mouth prop that extends away from the tubular conduit, the mouth prop at least partially defined by a first side and a second side that generally taper inwardly in a direction away from the tubular conduit towards a bottom surface of the mouth prop, the first side and the second side including a plurality of ridges; and a cheek-retractor portion connected to the second narrower end of the main body portion and expanding outwardly away from the second narrower end, the first wall and the second wall of the main body transitioning into and being connected in the cheek-retractor portion to form the cheek-retractor portion, wherein the first wall and the second wall of the main body portion that transition into the cheek-retractor portion are spaced apart from each other for a distance within the cheek-retractor portion before being connected to each other in the cheek-retractor portion.

Proposed Combination: US20030134253A1 (Innerlite, Inc.) or US8911232B2 (Incept, Inc., a parent patent), in view of US9788924B2 (Dryshield, Llc), US20140212839A1 (Incept, Inc. "Intraoral device with stability bar"), and US4167814A (Schubert) or US5588836A (Op-D-Op, Inc.).

• US20030134253A1 or US8911232B2: These would provide the foundational intraoral device with a main body, spaced walls, inner cavity, suction connector, perforations, and a cheek retractor, as discussed for Claim 9. Being a parent patent, US8911232B2 is highly likely to disclose many fundamental elements.

• US9788924B2: Provides the "bridge structure" with wave-like protrusions, as previously explained.

• US20140212839A1 ("Intraoral device with stability bar"): This patent is particularly relevant as it explicitly teaches the "stability bar" feature, which is a specific element of Claim 21. The description of US12011329 states, "Stability bar 150 may be a protrusion or otherwise a thickened area that reinforces the stability of the rectangular portion and assist in shaping this region to the intraoral posterior shape of a patient's mouth." This directly corresponds to the "stability bar located along a center of the first wall at least adjacent to the second narrow end" in Claim 21. The placement of perforations on either side of the stability bar would be a logical design choice for continued suction efficiency while maintaining structural integrity.

• US4167814A or US5588836A: Provide the mouth prop with inwardly tapered and ridged sides.

• Motivation to Combine: A PHOSITA would be motivated to combine these references to create a robust, stable, and effective intraoral isolation and suction device.

  • Adding a stability bar (from US20140212839A1) to an existing intraoral device (e.g., US8911232B2 or US20030134253A1) that already includes a bridge structure (from US9788924B2) and a mouth prop (from Schubert/Op-D-Op): The presence of a stability bar, as described in US12011329's description, specifically "reinforces the stability of the rectangular portion and assist in shaping this region to the intraoral posterior shape of a patient's mouth." This is a clear motivation to improve the fit, stability, and overall performance of existing intraoral devices, especially in flexible materials. The location of perforations relative to the stability bar would be an obvious engineering design for maintaining fluid evacuation around the reinforced area.
  • Perforations adjacent to the minimum width at the narrower end: This is a logical design choice for a suction device. Suction points are typically placed where fluids are likely to collect and where space is available without impeding other functions. In a tapering device, the narrower end might be prone to fluid accumulation, making perforations in that area desirable for effective evacuation.

Therefore, combining the teachings of an existing intraoral device (e.g., US8911232B2 or US20030134253A1), with the specific bridge structure (US9788924B2), the stability bar (US20140212839A1), and a mouth prop (US4167814A or US5588836A) would render Claim 21 obvious.

Obviousness Analysis of Claim 30:

Claim 30: An isolation mouthpiece for use with a suction system in a dental procedure, the mouthpiece comprising: a main body portion having a first end and a second end, the main body portion including: a first wall having a first edge and a second edge extending from the first end of the main body portion towards the second end of the main body portion, the first wall including a first plurality of perforations formed adjacent to and extending along a portion of the first edge and a second plurality of perforations formed adjacent to and extending along a portion of the second edge, a second wall having a third edge and a fourth edge extending from the first end of the main body portion towards the second end of the main body portion, the second wall including a third plurality of perforations formed adjacent to and extending along a portion of the third edge, and a fourth plurality of perforations formed adjacent to and extending along a portion of the fourth edge, wherein the second wall further includes a plurality of protrusions extending from an interior surface of the second wall towards the first wall in a shape having one or more crests and one or more troughs, and wherein the first wall and the second wall are shaped such that the first edge of the first wall corresponds to the third edge of the second wall and the second edge of the first wall corresponds to the fourth edge of the second wall, and a third wall connecting the first wall and the second wall such that the first wall is spaced from the second wall to define an inner cavity, wherein a portion of the first wall has a first width adjacent to the first end of the main body portion and a second width adjacent to the second end of the main body portion, wherein a portion of the second wall has a third width adjacent to the first end of the main body portion and a fourth width adjacent to the second end of the main body portion, wherein the first width is greater than the second width, and wherein the third width is greater than the fourth width; a suction connector portion extending from the first end of the main body portion, the suction connector portion including: a generally tubular conduit including: an opening extending through the conduit and in fluid communication with the inner cavity, the opening being configured to receive a vacuum portion of the suction system therein, and a cutout configured to engage a protrusion on the suction system to aid in coupling the mouthpiece to the suction system; a mouth prop including a first side and a second side that are inwardly tapered from a top surface of the mouth prop towards a bottom surface of the mouth prop, the first side and the second side each including a plurality of ridges; and a cheek retractor portion having a first cheek-retractor end coupled to the second end of the main body portion and a second cheek-retractor end, the first cheek-retractor end and the second cheek-retractor end each having rounded edges.

Proposed Combination: US20030134253A1 (Innerlite, Inc.) in view of US9788924B2 (Dryshield, Llc) and US4167814A (Schubert) or US5588836A (Op-D-Op, Inc.).

Claim 30 is largely similar to Claim 9, with a specific addition regarding the correspondence of the first and second wall edges and the cheek retractor portion having rounded edges.

• Core elements from US20030134253A1, US9788924B2, and US4167814A/US5588836A: As explained for Claim 9, these references would teach the main body with perforated walls, inner cavity, bridge structure, tapering, suction connector with cutout, mouth prop with tapered and ridged sides, and a cheek retractor.

• "First wall and the second wall are shaped such that the first edge of the first wall corresponds to the third edge of the second wall and the second edge of the first wall corresponds to the fourth edge of the second wall": This describes a symmetrical or complementary shaping of the opposing walls. Many intraoral devices, particularly those designed to conform to the mouth, would naturally have such corresponding edges for a coherent and functional design. This would be a basic design consideration for a PHOSITA creating a two-walled mouthpiece.

• "Cheek retractor portion having... rounded edges": Rounded edges are a standard design feature in medical and dental devices to enhance patient comfort and prevent irritation to soft tissues. This is a common and obvious design choice for any intraoral device.

• Motivation to Combine: The motivation for combining these references remains the same as for Claim 9 – to create a comprehensive and effective dental isolation and suction system. The additional features of corresponding wall edges and rounded cheek retractor edges are straightforward design optimizations that a PHOSITA would readily implement for improved function and patient comfort.

Therefore, Claim 30 would also be rendered obvious by the combination of US20030134253A1 (or similar comprehensive device), US9788924B2 (bridge structure), and US4167814A or US5588836A (mouth prop). The minor additional features are obvious design choices within the skill of a PHOSITA in dental device design.

To provide accurate information on US patent 12011329, I will search the USPTO website for the specific patent number.

Here's the detailed information for US patent 12011329:

Patent Term Adjustment (PTA):
The Google Patents page for US12011329B2 indicates an "Anticipated expiration" date of 2033-12-09. [cite: The full patent text, Google Patents metadata] Patent Term Adjustment (PTA) is granted to compensate for certain delays caused by the USPTO during the patent prosecution process. The USPTO automatically calculates the PTA and provides a notice of determination on or before the patent's issuance date. While the exact PTA calculation for US12011329 is not explicitly stated in the provided snippets, the noted expiration date would factor in any awarded PTA.

Patent Term Extension (PTE):
Patent Term Extension (PTE) is available for patents covering certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore time lost during premarket government approval from a regulatory agency. Since US12011329 is an "Intraoral device," which can be classified as a medical device, it might be eligible for PTE if it meets the specific criteria (e.g., being a Class III medical device subject to FDA review under section 515 of the FFDCA). However, no information about an application for or grant of PTE for this specific patent is present in the provided text.

Continuation Applications:
US patent 12011329B2 is a continuation application itself. [cite: The full patent text, Google Patents metadata] The patent text explicitly states: "The present application is a continuation and claims the priority benefit of U.S. patent application Ser. No. 14/228,057 filed Mar. 27, 2014, which is a continuation and claims the priority benefit of U.S. patent application Ser. No. 14/100,323 filed Dec. 9, 2013, now U.S. Pat. No. 8,911,232, which claims the priority benefit of U.S. provisional patent application No. 61/734,939 filed Dec. 7, 2012". [cite: The full patent text, Description]

Divisional Applications:
The provided patent information does not explicitly state if US patent 12011329 has any divisional applications. Divisional applications arise when an examiner determines that a patent application claims more than one invention, requiring the applicant to restrict the application to one invention and file separate divisional applications for the others.

Related Family Members:
The Google Patents page lists several related family members, including both applications and granted patents. [cite: The full patent text, Family Applications] These include:

• US14/100,323 (US8911232B2) - "Intraoral dental suction and isolation system" [cite: The full patent text, Family Applications]
• US29/477,888 (USD809660S1) - "Cheek retractor for a dental mouthpiece" [cite: The full patent text, Family Applications]
• US29/477,887 (USD876627S1) - "Bridge structure for dental mouthpiece" [cite: The full patent text, Family Applications]
• US29/491,367 (USD734851S1) - "Dental mouthpiece" [cite: The full patent text, Family Applications]
• US29/780,960 (USD1033650S1) - "Mouthpiece mouth prop" [cite: The full patent text, Family Applications]
• US29/782,645 (USD962439S1) - "Mouthpiece" [cite: The full patent text, Family Applications]
• US29/782,638 (USD962438S1) - "Mouthpiece" [cite: The full patent text, Family Applications]
• US18/679,097 (US20240398527A1) - "Intraoral device" (Pending) [cite: The full patent text, Family Applications]
• US18/823,885 (US12290418B2) - "Intraoral device" (Active) [cite: The full patent text, Family Applications]
• US19/199,177 (US20250275841A1) - "Intraoral device" (Pending) [cite: The full patent text, Family Applications]

Projected Expiration Date:
The Google Patents page for US12011329B2 lists an "Anticipated expiration" date of 2033-12-09. [cite: The full patent text, Google Patents metadata] This date is typically calculated as 20 years from the earliest effective filing date, with any applicable Patent Term Adjustment (PTA) added, and potentially reduced by any terminal disclaimers. The patent claims priority back to a provisional application filed on December 7, 2012. [cite: The full patent text, Description]

Defensive Disclosure for US Patent 12011329: Intraoral Device

This Defensive Disclosure document outlines various derivative concepts and potential improvements related to US Patent 12011329, "Intraoral device," for the purpose of establishing prior art and preventing future patenting of obvious or non-novel variations by competitors. The descriptions are designed to be technically enabling for a person skilled in the art.

Core Claims Analyzed:

• Claim 1
• Claim 9
• Claim 21
• Claim 30

---

Derivative Variations for Claim 1: Mouthpiece with Main Body, Bridge Structure, and Cheek-Retractor

Claim 1: A mouthpiece comprising: a main body having a first end opposite a second end that is narrower than the first end, the main body comprising: a first wall having a plurality of first edges and extending from the first end to the second end, a second wall having a plurality of second edges and located at a distance from the first wall, the distance corresponding to an interior space between the first wall and the second wall, wherein the second wall also extends from the first end to the second end, a connecting wall that connects one of the first edges of the first wall to one of the second edges of the second wall across the distance between the first wall and the second wall, and a bridge structure that includes a plurality of spaced protrusions protruding from an interior surface of the second wall, the bridge structure extending across the distance between the first wall and the second wall through the interior space towards the first wall; and a cheek-retractor portion connected to the narrower second end of the main body portion and expanding outwardly away from the second narrower end, the first wall and the second wall of the main body transitioning into and being connected in the cheek-retractor portion to form the cheek-retractor portion, wherein the first wall and the second wall of the main body portion that transition into the cheek-retractor portion are spaced apart from each other for a distance within the cheek-retractor portion before being connected at the cheek-retractor portion. [cite: The full patent text, Claims]

1.1 Material & Component Substitution

Derivative 1.1.1: Bio-Resorbable Polymer Mouthpiece with Integrated pH Sensor Protrusions

• Enabling Description: The mouthpiece's main body, cheek-retractor portion, and connecting wall are fabricated from a bio-resorbable polymer, such as polylactic acid (PLA) or polyglycolic acid (PGA), suitable for short-term intraoral application and subsequent safe degradation. The bridge structure's spaced protrusions are augmented with micro-encapsulated pH-sensitive dyes or miniaturized solid-state pH electrodes fabricated using MEMS technology, integrated within the polymer matrix. These sensors provide localized pH readings within the oral cavity, which can be wirelessly transmitted via a near-field communication (NFC) tag embedded in the first end of the main body during placement or removal. The bio-resorbable nature eliminates sterilization requirements for reuse in multi-patient scenarios and reduces biohazard waste.

  classDiagram
      class Mouthpiece {
          +BioResorbableMaterial: PLA/PGA
          +MainBody
          +CheekRetractor
          +ConnectingWall
          +BridgeStructure
          +NFC_Tag
      }
      class BridgeStructure {
          +SpacedProtrusions
          +Integrated_pH_Sensors: MEMS_Electrodes/Dye_Capsules
      }
      class NFC_Tag {
          +WirelessDataTransmission()
      }
      Mouthpiece *-- MainBody
      MainBody *-- BridgeStructure
      MainBody *-- ConnectingWall
      Mouthpiece *-- CheekRetractor
      Mouthpiece *-- NFC_Tag
      BridgeStructure *-- Integrated_pH_Sensors
  

Derivative 1.1.2: Metal Alloy Mouthpiece with Articulated Sections

• Enabling Description: The mouthpiece structure, including the main body and cheek-retractor, is constructed from a biocompatible, high-strength metal alloy (e.g., medical-grade titanium alloy, ASTM F136 or F1472, or cobalt-chromium alloy). Instead of a monolithic structure, the main body and cheek-retractor portion are segmented into multiple articulated sections connected by micro-hinges or flexible joints made of the same alloy or a high-performance polymer like PEEK. This allows for precise, patient-specific angle adjustments and shape conformity via mechanical manipulation before or during insertion, maintaining rigidity once positioned. The bridge structure's protrusions are machined directly into the interior surface of the second wall. The connecting walls are also segmented and articulated.

  graph TD
      A[Mouthpiece (Metal Alloy)] --> B{Main Body - Segmented}
      A --> C{Cheek Retractor - Segmented}
      B --> D[First Wall Segments]
      B --> E[Second Wall Segments]
      B --> F[Connecting Wall Segments]
      E --> G[Machined Bridge Structure Protrusions]
      D -- Micro-Hinges/Flexible Joints --> D
      E -- Micro-Hinges/Flexible Joints --> E
      F -- Micro-Hinges/Flexible Joints --> F
      C -- Micro-Hinges/Flexible Joints --> C
      B -- Adjustable Articulation --> C
  

1.2 Operational Parameter Expansion

Derivative 1.2.1: High-Flow, Wide-Bore Mouthpiece for Industrial-Scale Oral Hygiene

• Enabling Description: This mouthpiece is scaled for industrial applications, such as large animal dentistry (e.g., equine or bovine), or for automated oral hygiene systems in critical care environments where traditional dental staff intervention is limited. The main body and suction connector feature significantly wider bore diameters (e.g., 25-50mm internal diameter for the conduit) and reinforced walls to accommodate higher suction volumes and larger debris removal (e.g., feed particles, larger calculus fragments). The material is a high-durometer, abrasion-resistant silicone or polyurethane. The bridge structure's protrusions are enlarged and spaced further apart to prevent clogging while maintaining wall separation under extreme vacuum pressures (e.g., up to -0.8 bar).

  flowchart TD
      Start((Patient/Animal)) --> PlaceMouthpiece[Insert Large-Scale Mouthpiece]
      PlaceMouthpiece --> ActivateSuction[Activate High-Volume Suction System]
      ActivateSuction --> FluidDebrisFlow[Fluid & Debris Flow through Main Body]
      FluidDebrisFlow -- Prevent Clogging (Bridge Structure) --> SuctionConduit[Enter Wide-Bore Suction Conduit]
      SuctionConduit --> ExternalVacuum[External High-Capacity Vacuum Source]
      ExternalVacuum --> End((Waste Collection))
  

Derivative 1.2.2: Cryogenic Temperature-Stabilized Mouthpiece for Sensitive Oral Procedures

• Enabling Description: The mouthpiece is designed for use in specialized procedures requiring precise temperature control, such as localized cryotherapy within the oral cavity or during procedures sensitive to thermal expansion/contraction of tissues. The main body and cheek retractor are constructed with multi-layered walls incorporating vacuum insulation or microfluidic channels for circulating a cryogenic or temperature-stabilizing fluid (e.g., chilled saline, liquid nitrogen vapor). The materials are chosen for stability and flexibility at cryogenic temperatures (e.g., specialized medical-grade silicone compounds or fluoropolymers like PTFE). The bridge structure protrusions include embedded micro-thermocouples for real-time temperature monitoring within the inner cavity, transmitting data to an external control unit.

  stateDiagram-v2
      [*] --> Idle
      Idle --> PrepareCoolant: Initiate Cryogenic Procedure
      PrepareCoolant --> LoadMouthpiece: Load Mouthpiece with Coolant
      LoadMouthpiece --> InsertMouthpiece: Insert into Oral Cavity
      InsertMouthpiece --> MonitorTemp: Monitor Internal Temperature (Micro-Thermocouples)
      MonitorTemp --> CirculateCoolant: Circulate Cryogenic Fluid in Channels
      CirculateCoolant --> AdjustFlow: Adjust Coolant Flow based on Feedback
      AdjustFlow --> StabilizedTemperature: Achieve/Maintain Target Temperature
      StabilizedTemperature --> ProcedureComplete: Procedure Ends
      ProcedureComplete --> RemoveMouthpiece: Remove Mouthpiece
      RemoveMouthpiece --> Cleanup: System Cleanup
      Cleanup --> [*]
  

1.3 Cross-Domain Application

Derivative 1.3.1: Gastric Isolation and Suction Device (Veterinary/Medical)

• Enabling Description: The mouthpiece concept is adapted for gastric lavage or isolation in veterinary medicine (e.g., for ruminants or large dogs) or human emergency medicine, specifically for esophageal or gastric suction and isolation. The main body is elongated and dimensionally scaled to fit the esophagus, with the "first end" positioned distally in the stomach and the "second end" remaining in the oral cavity. The bridge structure's protrusions facilitate continuous suction and prevent collapse of the esophageal walls during gastric evacuation. The cheek retractor portion acts as an oral brace to secure the device during insertion and operation. The connecting wall seals the oral cavity from the external environment.

  flowchart TD
      A[Oral Opening] --> B[Cheek Retractor (Oral Brace)]
      B --> C[Main Body (Elongated for Esophagus/Stomach)]
      C -- Bridge Structure --> D[Gastric/Esophageal Cavity]
      D -- Suction via Interior Space --> E[Suction Connector (External)]
      E --> F[Vacuum Source]
      C -- Connecting Wall --> B
  

Derivative 1.3.2: Contaminant Barrier for Industrial Robotic Arms (Manufacturing)

• Enabling Description: This device functions as a flexible, internal sealing and suction system for articulated joints in industrial robotic arms operating in cleanroom or hazardous material environments. The "main body" is a flexible, annular sealing element fitted internally within a robotic joint, with the "first wall" and "second wall" conforming to the inner and outer surfaces of the joint components. The "interior space" forms a localized vacuum channel. The "bridge structure" protrusions maintain a precise gap between rotating or articulating components, ensuring suction efficiency while preventing material contact. The "cheek-retractor portion" acts as a flexible external flange for mounting and sealing to the robot arm's chassis, facilitating easy connection to a central vacuum system for removal of micro-contaminants or hazardous dust.

  graph TD
      A[Robotic Arm Joint] --> B{External Flange (Cheek Retractor)}
      B --> C{Annular Main Body (Internal Seal)}
      C --> D[First Wall (Inner Component)]
      C --> E[Second Wall (Outer Component)]
      E -- Bridge Structure Protrusions --> D
      C -- Interior Space (Vacuum Channel) --> F[Suction Connector]
      F --> G[Central Vacuum System]
      D -- Articulation -- E
  

1.4 Integration with Emerging Tech

Derivative 1.4.1: AI-Optimized Personalized Mouthpiece with Real-time Sensor Feedback

• Enabling Description: The mouthpiece is equipped with an array of micro-sensors (e.g., pressure sensors embedded in the cheek retractor, flow sensors in the suction connector, proximity sensors along the main body walls) that provide real-time data on patient fit, suction efficiency, and tongue/cheek position. This data is streamed to a compact, edge AI processor integrated into the suction connector. The AI algorithm analyzes the sensor data to dynamically recommend optimal mouthpiece size, adjust suction levels on a connected vacuum unit, and provide feedback on patient comfort or potential tissue impingement. The bridge structure could dynamically adjust its protrusion length via embedded micro-actuators (e.g., piezoelectric or shape memory alloy) to optimize suction flow and maintain wall separation based on AI feedback, ensuring efficient debris removal even with subtle patient movements.

  sequenceDiagram
      Patient->>Mouthpiece: Insert
      Mouthpiece->>+Embedded Sensors: Collect Pressure, Flow, Proximity Data
      Embedded Sensors->>Edge AI Processor: Stream Real-time Data
      Edge AI Processor->>AI Algorithm: Analyze & Optimize
      AI Algorithm-->>-Edge AI Processor: Generate Recommendations/Controls
      Edge AI Processor->>Suction Unit: Adjust Suction Power
      Edge AI Processor->>Mouthpiece: Actuate Bridge Structure (if dynamic)
      Mouthpiece->>+Dentist/Hygienist: Display Feedback (e.g., via connected device)
      Dentist/Hygienist->>Mouthpiece: Manual Adjustments/Confirm
  

Derivative 1.4.2: IoT-Enabled Smart Mouthpiece for Remote Monitoring & Supply Chain

• Enabling Description: Each reusable mouthpiece is embedded with a unique, tamper-proof IoT identifier (e.g., an RFID tag or secure QR code) and a miniature temperature/pressure sensor array. Post-sterilization (autoclaving), these IoT tags are scanned, recording sterilization cycles, usage history, and material degradation indicators (from the temperature/pressure cycles) onto a decentralized blockchain ledger. This allows for transparent, immutable tracking of each mouthpiece from manufacturing through sterilization, usage, and eventual end-of-life, ensuring compliance with medical device regulations and optimizing inventory management in large dental clinics or hospital networks. Real-time monitoring data during use can be transmitted via Bluetooth Low Energy (BLE) to a local gateway. The bridge structure's condition can be assessed via embedded micro-cameras feeding images to the IoT system for AI-driven defect detection.

  graph TD
      A[Mouthpiece (Reusable)] --> B{Embedded IoT Tag/Sensors}
      B --> C[Sterilization Unit]
      C --> D[IoT Gateway (BLE/Wi-Fi)]
      D --> E[Blockchain Ledger]
      E -- Immutable Records --> F[Supply Chain Management]
      E -- Immutable Records --> G[Compliance/Auditing]
      B -- During Use (Real-time) --> D
  

1.5 The "Inverse" or Failure Mode

Derivative 1.5.1: Low-Power, Manual Suction Mouthpiece with Passive Fluid Channeling

• Enabling Description: This mouthpiece is designed for emergency or field use where high-power suction systems are unavailable. The main body's interior space is optimized for passive fluid drainage through gravity or manual aspiration via a simple bulb syringe. The bridge structure's protrusions are designed with hydrophilic surfaces and optimized geometry to passively channel fluids towards the suction connector, even under minimal or no active suction. The material is a soft, highly flexible, and brightly colored silicone to improve visibility in low-light conditions and ensure patient comfort with reduced cheek retraction force. The cheek-retractor portion has increased flexibility for easy insertion and removal by untrained personnel, providing basic oral isolation without external power.

  flowchart LR
      A[Patient Oral Cavity] -- Fluid Accumulation --> B[Main Body Cavity]
      B -- Passive Channeling (Hydrophilic Bridge Structure) --> C[Suction Connector (Manual Aspiration Point)]
      C -- Manual Aspiration (Bulb Syringe) --> D[Fluid Collection Bag]
      B -- Basic Isolation --> E[Cheek Retractor (Soft, Flexible)]
  

Derivative 1.5.2: Safely Degrading Mouthpiece with Pressure-Release Bridge Structure

• Enabling Description: The mouthpiece is engineered to prevent excessive tissue damage in case of extreme or prolonged suction system malfunction (e.g., over-suction). The bridge structure's protrusions incorporate a shear-release mechanism or frangible points designed to fail safely at a predetermined vacuum pressure threshold (e.g., -0.6 bar). Upon reaching this threshold, the protrusions either collapse or detach, creating a larger, unobstructed pathway between the anterior and posterior walls, thereby rapidly reducing the localized suction pressure on oral tissues and minimizing potential for soft tissue aspiration. The material chosen for the mouthpiece main body is a medical-grade silicone with an embedded indicator dye that changes color irreversibly upon exposure to excessive suction duration, alerting practitioners to potential over-use or impending structural fatigue.

  stateDiagram-v2
      [*] --> NormalOperation: Suction Active
      NormalOperation --> MonitorPressure: Monitor Suction Pressure
      MonitorPressure --> PressureSafe: Pressure < Threshold
      PressureSafe --> NormalOperation
      MonitorPressure --> PressureExceedsThreshold: Pressure >= Threshold
      PressureExceedsThreshold --> BridgeStructureFailure: Bridge Structure Shear/Collapse
      BridgeStructureFailure --> PressureReduced: Suction Pressure Rapidly Reduces
      PressureReduced --> AlertSystem: Issue Warning (Indicator Dye Change, Sensor Alarm)
      AlertSystem --> SafeShutdown: Initiate Safe Shutdown or Manual Intervention
      SafeShutdown --> [*]
  

---

Derivative Variations for Claim 9: Isolation Mouthpiece with Perforations, Protrusions, Suction Connector, Mouth Prop, and Cheek Retractor

Claim 9: An isolation mouthpiece for use with a suction system in a dental procedure, the mouthpiece comprising: a main body portion having a first end and a second end, the main body portion including: a first wall having a first edge and a second edge extending from the first end of the main body portion towards the second end of the main body portion, the first wall including a first plurality of perforations formed adjacent to and extending along a portion of the first edge and a second plurality of perforations formed adjacent to and extending along a portion of the second edge, a second wall having a third edge and a fourth edge extending from the first end of the main body portion towards the second end of the main body portion, the second wall including a third plurality of perforations formed adjacent to and extending along a portion of the third edge, and a fourth plurality of perforations formed adjacent to and extending along a portion of the fourth edge, wherein the second wall further includes a plurality of protrusions extending from an interior surface of the second wall towards the first wall in a shape having one or more crests and one or more troughs, and a third wall connecting the first wall and the second wall such that the first wall is spaced from the second wall to define an inner cavity, wherein a portion of the first wall has a first width adjacent to the first end of the main body portion and a second width adjacent to the second end of the main body portion, wherein a portion of the second wall has a third width adjacent to the first end of the main body portion and a fourth width adjacent to the second end of the main body portion, wherein the first width is greater than the second width, and wherein the third width is greater than the fourth width; a suction connector portion extending from the first end of the main body portion, the suction connector portion including: a generally tubular conduit including: an opening extending through the conduit and in fluid communication with the inner cavity, the opening being configured to receive a vacuum portion of the suction system therein, and a cutout configured to engage a protrusion on the suction system to aid in coupling the mouthpiece to the suction system; a mouth prop including a first side and a second side that are inwardly tapered from a top surface of the mouth prop towards a bottom surface of the mouth prop, the first side and the second side each including a plurality of ridges; and a cheek retractor portion having a first cheek-retractor end coupled to the second end of the main body portion and a second cheek-retractor end, the first cheek-retractor end and the second cheek-retractor end each having rounded edges, wherein the first wall and the second wall of the main body portion that transition into the cheek-retractor portion are spaced apart from each other for a distance within the cheek-retractor portion before being connected to each other in the cheek-retractor portion. [cite: The full patent text, Claims]

2.1 Material & Component Substitution

Derivative 2.1.1: Antimicrobial-Coated Mouthpiece with Ceramic-Reinforced Ridges

• Enabling Description: The entire mouthpiece is fabricated from medical-grade silicone infused with a sustained-release antimicrobial agent (e.g., silver nanoparticles or chlorhexidine) to reduce biofilm formation and cross-contamination risks. The perforations are laser-drilled for precise geometry. The protrusions on the second wall, forming crests and troughs, are co-molded with a ceramic-reinforced polymer (e.g., zirconia-filled PEEK) at their contact points to enhance durability and prevent wear, maintaining optimal wall separation under prolonged use. The ridges on the mouth prop are also ceramic-reinforced to improve bite resistance and patient comfort.

  classDiagram
      class Mouthpiece {
          +AntimicrobialSilicone
          +MainBody
          +SuctionConnector
          +MouthProp
          +CheekRetractor
      }
      class MainBody {
          +PerforatedWalls
          +Protrusions(Crests/Troughs)
      }
      class Protrusions {
          +CeramicReinforcement: Zirconia-filled_PEEK
      }
      class MouthProp {
          +Ridges
      }
      Mouthpiece *-- MainBody
      Mouthpiece *-- SuctionConnector
      Mouthpiece *-- MouthProp
      Mouthpiece *-- CheekRetractor
      MainBody *-- Protrusions
      MouthProp *-- Ridges
  

Derivative 2.1.2: Thermoplastic Elastomer Mouthpiece with Integrated Fiber Optic Illumination

• Enabling Description: The mouthpiece is injection-molded from a clear, autoclavable thermoplastic elastomer (TPE), such as medical-grade Santoprene or C-Flex, allowing for visibility within the oral cavity. Integrated within the walls of the main body and cheek retractor are thin, flexible fiber optic light guides. These guides are bundled at the suction connector portion to connect to an external light source, providing direct, shadow-free illumination of the working area within the patient's mouth. The perforations are precisely molded, and the wave-like protrusions on the second wall are designed to allow for light transmission through the interior cavity. The mouth prop and its ridges are also made of the translucent TPE.

  flowchart TD
      A[External Light Source] --> B(Fiber Optic Bundle)
      B --> C[Suction Connector Portion]
      C --> D{Light Guides Integrated in Main Body/Cheek Retractor Walls}
      D -- Illuminates --> E[Oral Cavity]
      F[Main Body Perforations] -- Suction --> G[Inner Cavity]
      G -- Protrusions --> G
      C -- Vacuum --> G
      E -- Oral Isolation --> H[Mouth Prop]
      H -- Tapered/Ridged --> E
  

2.2 Operational Parameter Expansion

Derivative 2.2.1: Multi-Frequency Ultrasonic Cleaning & Suction Mouthpiece

• Enabling Description: This mouthpiece incorporates miniature ultrasonic transducers (e.g., piezoelectric) embedded within the first and second walls of the main body. These transducers generate ultrasonic waves at varying frequencies (e.g., 25kHz for gross debris removal, 80kHz for fine particle dislodgement) into the inner cavity and towards the teeth, aiding in plaque and debris removal concurrently with suction. The perforations are designed to facilitate efficient water delivery (for cavitation) and suction evacuation. The material must be acoustically transparent and resistant to cavitation erosion (e.g., specialized medical-grade silicone or urethane). The mouth prop features enhanced ridges to withstand ultrasonic vibrations without discomfort.

  graph TD
      A[External Ultrasonic Generator] --> B{Ultrasonic Transducers (Embedded in Walls)}
      B -- Multi-Frequency Waves --> C[Inner Cavity & Oral Surfaces]
      C -- Dislodges Debris --> D[Fluid/Debris Mixture]
      D -- Perforations --> E[Inner Cavity]
      E -- Suction Connector --> F[Vacuum System]
      G[Mouthpiece Main Body] -- Resilient to Vibration --> B
      H[Mouth Prop] -- Enhanced Ridges --> G
  

Derivative 2.2.2: Extreme-Temperature Autoclavable Mouthpiece for Specialized Sterilization

• Enabling Description: The mouthpiece is constructed from a novel, high-performance polyimide or perfluoroelastomer composite, capable of withstanding sterilization cycles up to 180°C (e.g., for prion decontamination protocols) or repeated flash sterilization. All components, including the main body, suction connector, mouth prop, and cheek retractor, maintain structural integrity, flexibility, and transparency across this extreme temperature range. The perforations, protrusions, and ridges are designed to resist thermal deformation and ensure long-term reusability under aggressive sterilization regimens. The cutout on the suction connector is reinforced with a high-temperature alloy insert for secure coupling under repeated thermal cycling.

  stateDiagram-v2
      [*] --> Manufacturing: High-Performance Composite
      Manufacturing --> InitialUse: First Patient Use
      InitialUse --> SterilizationCycle: Autoclave (up to 180C)
      SterilizationCycle --> Cooling: Return to Ambient
      Cooling --> Inspection: Visual & Functional Check
      Inspection --> Reusable: Pass -> Ready for Next Use
      Inspection --> Discard: Fail -> Decommission
      Reusable --> SterilizationCycle
      SterilizationCycle --> ThermalCyclingResistance
      ThermalCyclingResistance --> LongTermDurability
  

2.3 Cross-Domain Application

Derivative 2.3.1: Biological Sample Collection Device (Biomedical Research)

• Enabling Description: The mouthpiece design is adapted for the high-throughput, standardized collection of oral fluid (e.g., saliva, buccal cell) samples in biomedical research or diagnostic screening. The main body forms a standardized collection chamber, with the perforations along the edges regulating the intake of oral fluid while preventing gross particulate matter. The protrusions (crests and troughs) on the second wall ensure constant flow dynamics and prevent the first wall from collapsing onto the collection surface, optimizing sample yield and quality. The suction connector portion is designed to interface directly with automated liquid handling systems or specialized collection tubes. The mouth prop ensures consistent mouth opening, and the cheek retractor maintains a clear collection field.

  flowchart TD
      A[Oral Cavity] --> B{Main Body (Collection Chamber)}
      B -- Perforations (Regulated Intake) --> C[Inner Cavity (Sample Accumulation)]
      C -- Protrusions (Flow Dynamics) --> C
      C --> D[Suction Connector (Automated Interface)]
      D --> E[Liquid Handling System/Collection Tube]
      F[Mouth Prop] -- Consistent Opening --> A
      G[Cheek Retractor] -- Clear Field --> A
  

Derivative 2.3.2: Airway Management and Secretion Evacuation Device (Anesthesiology/Critical Care)

• Enabling Description: This device functions as a specialized oral airway adjunct and secretion management tool. The main body is elongated and shaped to fit within the oral pharynx, serving as a bite block to protect the endotracheal tube (ETT) while simultaneously evacuating pharyngeal secretions. The perforations are strategically placed along the superior and inferior edges to maximize fluid collection from the posterior pharynx. The internal protrusions (crests and troughs) prevent the device from collapsing the ETT or impinging on the airway during suction, ensuring continuous patency. The mouth prop section facilitates intubation and maintains oral access, while the cheek retractor provides a clear viewing and working field during airway procedures.

  graph LR
      A[Patient Airway] --> B(Oral Cavity)
      B --> C{Mouth Prop (Intubation Aid)}
      C --> D{Main Body (Pharyngeal Placement, ETT Protection)}
      D -- Perforations --> E[Inner Cavity (Secretion Collection)]
      E -- Protrusions --> E
      E --> F[Suction Connector (External)]
      F --> G[Aspiration System]
      B -- Retraction --> H[Cheek Retractor]
      D -- Accommodates --> I[Endotracheal Tube (ETT)]
  

2.4 Integration with Emerging Tech

Derivative 2.4.1: AI-Driven Debris Classification and Suction Optimization

• Enabling Description: The internal cavity of the main body includes miniature, high-resolution optical sensors or micro-cameras coupled with a compact, embedded AI vision processing unit. As fluid and debris pass through the inner cavity, the AI system performs real-time classification of the aspirated material (e.g., distinguishes between saliva, blood, tooth fragments, amalgam, biofilm). Based on this classification, the AI dynamically adjusts the suction flow rate, pulse frequency, and potentially recommends specific instrumentation to the dental professional (e.g., "increase rinse, high suction needed for calculus"). This optimization enhances efficiency, reduces procedural time, and provides valuable data for post-procedure analysis. The mouth prop could include haptic feedback to guide optimal patient positioning.

  sequenceDiagram
      Patient->>Mouthpiece: Oral Fluids & Debris
      Mouthpiece->>+Optical Sensors/Micro-Cameras: Capture Internal Flow
      Optical Sensors/Micro-Cameras->>Embedded AI Processor: Stream Video/Image Data
      Embedded AI Processor->>AI Vision Model: Classify Debris (Saliva, Blood, Calculus, etc.)
      AI Vision Model-->>-Embedded AI Processor: Classification Result
      Embedded AI Processor->>Suction System Controller: Adjust Suction Parameters (Flow, Pulse)
      Embedded AI Processor->>Dentist/Hygienist: Display Recommendations/Alerts
      Dentist/Hygienist->>Mouthpiece: Respond to Feedback (e.g., reposition, change tool)
  

Derivative 2.4.2: Biometric-Authenticated & Blockchain-Logged Device for Patient Safety

• Enabling Description: Each mouthpiece features an integrated fingerprint or facial recognition scanner on the external portion of the suction connector (or mouth prop) for biometric authentication of the dental professional initiating a procedure. This authentication, along with device ID, patient ID (if scanned), and procedure start/end times, is cryptographically signed and logged onto a private blockchain network. This creates an immutable audit trail for each use, enhancing accountability, preventing unauthorized use, and ensuring patient safety. The device's cutout for system coupling is physically and electronically interlocked, requiring successful blockchain transaction verification before allowing full suction functionality.

  graph TD
      A[Dental Professional] --> B{Biometric Scanner (Mouthpiece)}
      B --> C[Authentication Module]
      C -- Successful --> D[Blockchain Network]
      C -- Failed --> E[Function Lock/Alert]
      D -- Log Transaction --> F[Immutable Audit Trail]
      G[Mouthpiece Suction System] -- Interlocked --> C
      D -- Enables --> G
      F --> H[Compliance Reporting]
      F --> I[Patient Record Linkage]
  

2.5 The "Inverse" or Failure Mode

Derivative 2.5.1: Low-Suction, High-Visibility Mouthpiece for Training and Patient Anxiety Reduction

• Enabling Description: This mouthpiece is designed with a significantly reduced inner cavity volume and intentionally smaller perforations, resulting in lower, gentler suction for training new dental assistants or for anxious patients. The material is a hyper-translucent silicone with integrated luminescent markers along the edges of the main body and cheek retractor, making the device highly visible in the mouth even during minimal lighting. The protrusions (crests and troughs) are softer and more compliant to minimize any potential discomfort. The mouth prop's ridges are rounded and shallower, emphasizing gentle mouth opening over firm bite support. The cutout on the suction connector is distinctively colored (e.g., bright orange) to visually indicate its "training/low-suction" mode, preventing accidental use with high-power systems.

  flowchart LR
      A[Patient Oral Cavity] -- Gentle Isolation --> B[Cheek Retractor (Soft)]
      B -- Reduced Cavity Volume --> C[Main Body (Hyper-Translucent)]
      C -- Smaller Perforations --> D[Inner Cavity (Low Flow)]
      D -- Softer Protrusions --> D
      D -- Low Suction --> E[Suction Connector (Visually Coded)]
      E -- Minimal Vacuum --> F[External Low-Power System]
      C -- Luminescent Markers --> A
      G[Mouth Prop (Gentle Ridges)] --> B
  

Derivative 2.5.2: Autonomously-Draining Mouthpiece with Occlusion-Detection & Re-routing

• Enabling Description: The mouthpiece is designed to mitigate suction occlusion events. The inner cavity incorporates a series of micro-pressure sensors. If an occlusion is detected (e.g., sudden pressure spike, zero flow detection), a passive fluid re-routing mechanism is activated. This involves a one-way valve system embedded in the main body that automatically diverts excess fluid away from the primary suction conduit (if blocked) to a secondary, lower-volume relief channel that drains into a separate overflow reservoir or a secondary, independent manual suction port. The bridge structure's troughs are shaped with channels that prevent complete sealing during occlusion. The material contains a pressure-sensitive indicator that changes color irreversibly if an occlusion occurs, alerting the user to inspect the device.

  stateDiagram-v2
      [*] --> NormalSuction
      NormalSuction --> MonitorOcclusion: Check Micro-Pressure Sensors
      MonitorOcclusion --> FlowOK: No Occlusion
      FlowOK --> NormalSuction
      MonitorOcclusion --> OcclusionDetected: Occlusion Detected
      OcclusionDetected --> ActivateReroute: Activate Passive Rerouting (One-Way Valve)
      ActivateReroute --> DivertFluid: Fluid to Secondary Channel
      DivertFluid --> OverflowReservoir: Or Manual Suction Port
      OcclusionDetected --> ChangeIndicator: Pressure-Sensitive Dye Changes Color
      ChangeIndicator --> AlertUser: Visual Alert to Practitioner
      AlertUser --> ManualIntervention: Clear Occlusion
      ManualIntervention --> NormalSuction
  

---

Derivative Variations for Claim 21: Isolation Mouthpiece with Stability Bar, Bridge Structure, and Mouth Prop

Claim 21: An isolation mouthpiece for use with a suction system in a dental procedure, the mouthpiece comprising: a main body portion having a first end and a second narrower end that is narrower than the first end, the main body portion including: a first wall having first and second edges extending from the first end towards the second narrower end of the main body portion, the first wall having a first-wall width defined between the first and second edges, the first-wall width being at a maximum in a region between the first and second ends and being at a minimum at the second narrower end, the first wall including a first plurality of perforations formed adjacent to and extending along a substantial portion of the first edge and a second plurality of perforations formed adjacent to and extending along a substantial portion the second edge, at least one of the first plurality of perforations and at least one of the second plurality of perforations being located adjacent to the minimum width of the first wall at the second narrower end of the main body; a second wall spaced apart from the first wall to define an inner cavity of the main body between the second wall and the first wall, the second wall having third and fourth edges extending from the first end towards the second end of the main body portion, the second wall having a second-wall width defined between the third and fourth edges, the second-wall width being at a maximum in a region between the first and second ends and being at a minimum at the second narrower end, the second wall including a third plurality of perforations formed adjacent to and extending along a substantial portion of the third edge and a fourth plurality of perforations formed adjacent to and extending along a substantial portion of the fourth edge, at least one of the third plurality of perforations and at least one of the fourth plurality of perforations being located adjacent to the minimum width of the second wall at the second end of the main body; a stability bar located along a center of the first wall at least adjacent to the second narrow end of the main body, the at least one of the first plurality of perforations being positioned on one side of the stability bar and the at least one of the second plurality of perforations being positioned on another side of the stability bar; and a bridge structure extending from an interior surface of the first wall toward the second wall, the bridge structure including a plurality of wave-like protrusions to ensure the first wall remains separated from the second wall during suction from the suction system; a suction-connector portion extending from the first end of the main body portion, the suction-connector portion including: a generally tubular conduit including an opening extending through the conduit and in fluid communication with the inner cavity of the main body, the opening being configured to receive a vacuum portion of the suction system therein for providing suction to the inner cavity; and a mouth prop that extends away from the tubular conduit, the mouth prop at least partially defined by a first side and a second side that generally taper inwardly in a direction away from the tubular conduit towards a bottom surface of the mouth prop, the first side and the second side including a plurality of ridges; and a cheek-retractor portion connected to the second narrower end of the main body portion and expanding outwardly away from the second narrower end, the first wall and the second wall of the main body transitioning into and being connected in the cheek-retractor portion to form the cheek-retractor portion, wherein the first wall and the second wall of the main body portion that transition into the cheek-retractor portion are spaced apart from each other for a distance within the cheek-retractor portion before being connected to each other in the cheek-retractor portion. [cite: The full patent text, Claims]

3.1 Material & Component Substitution

Derivative 3.1.1: Thermoset Polymer Mouthpiece with Nanocomposite Stability Bar

• Enabling Description: The mouthpiece is molded from a high-performance thermoset polymer (e.g., medical-grade epoxy resin or thermoset polyimide) chosen for its superior rigidity and chemical resistance after curing. The stability bar, integral to the first wall, is fabricated as a nanocomposite insert (e.g., carbon nanotube or graphene-reinforced polymer) embedded during the molding process, significantly enhancing localized stiffness and preventing deformation, especially at the narrow second end. The perforations are formed via precision laser ablation post-curing. The wave-like protrusions of the bridge structure are also molded from the same thermoset, providing robust wall separation. The mouth prop ridges can be textured with a diamond-like carbon (DLC) coating for enhanced grip and wear resistance.

  graph TD
      A[Mouthpiece (Thermoset Polymer)] --> B[Main Body]
      B --> C[First Wall]
      C --> D[Nanocomposite Stability Bar]
      C --> E[Perforations]
      B --> F[Second Wall]
      F --> G[Bridge Structure (Wave-like Protrusions)]
      A --> H[Suction Connector]
      H --> I[Mouth Prop (DLC Coated Ridges)]
      A --> J[Cheek Retractor]
      D -- Enhanced Stiffness --> C
  

Derivative 3.1.2: Shape Memory Polymer Mouthpiece with Self-Adjusting Stability Bar

• Enabling Description: The mouthpiece is constructed from a medical-grade shape memory polymer (SMP) with a glass transition temperature (Tg) slightly above body temperature. The stability bar and potentially the bridge structure protrusions are designed to undergo a shape change when exposed to oral cavity temperatures (or a brief external warm fluid rinse prior to insertion). This allows for a pre-set 'relaxed' shape for easy insertion and a 'deployed' shape upon warming, where the stability bar and protrusions expand to precisely fit the oral anatomy, providing optimal, custom fit for each patient. The perforations are pre-formed during molding. After use, cooling below Tg allows the device to revert to its relaxed shape for easy removal and cleaning.

  stateDiagram-v2
      [*] --> RelaxedShape: Initial (Cool)
      RelaxedShape --> Insertion: User Inserts Mouthpiece
      Insertion --> Warming: Body Temp / Warm Rinse
      Warming --> DeployedShape: SMP Activates, Stability Bar/Bridge Expand
      DeployedShape --> OptimalFit: Customized to Oral Anatomy
      OptimalFit --> DentalProcedure: Operation
      DentalProcedure --> CoolingAfterUse: Remove from Mouth / Cool Rinse
      CoolingAfterUse --> RelaxedShape: SMP Returns to Initial Shape
      RelaxedShape --> [*]
  

3.2 Operational Parameter Expansion

Derivative 3.2.1: Ultra-High Vacuum Mouthpiece for Micro-Surgical Debris Removal

• Enabling Description: This mouthpiece is engineered for procedures requiring meticulously clean surgical fields, such as periodontal microsurgery or implantology. The inner cavity and suction conduit are designed for ultra-high vacuum compatibility (e.g., capable of achieving -0.95 bar). The perforations are micro-sized (e.g., <0.5mm diameter) to capture even minute particulate debris while preventing tissue aspiration. The stability bar and bridge structure are significantly reinforced and dimensionally precise to prevent any deformation or collapse under extreme vacuum, maintaining critical wall separation and device integrity. The mouthpiece material is a dense, non-porous fluoropolymer (e.g., FEP) to minimize outgassing and maximize vacuum efficiency.

  flowchart TD
      A[Micro-Surgical Field] --> B{Mouthpiece (FEP Polymer)}
      B -- Micro-Perforations --> C[Inner Cavity]
      C -- Reinforced Stability Bar --> C
      C -- Robust Bridge Structure --> C
      C -- Ultra-High Vacuum --> D[Suction-Connector (Hermetic Seal)]
      D --> E[High-Power Vacuum Pump]
      E --> F[Micro-Particulate Filter System]
  

Derivative 3.2.2: Pulsatile Flow Mouthpiece with Variable Pulse Frequencies

• Enabling Description: The suction-connector portion is integrated with a miniature, electronically controlled pulsatile valve system. This system allows the vacuum system to apply suction in variable pulse frequencies (e.g., 1 Hz to 20 Hz) and durations, rather than constant suction. This pulsatile action enhances debris dislodgement and fluid removal by creating localized pressure differentials and promoting cavitation, especially in hard-to-reach areas. The stability bar and bridge structure are optimized to withstand repeated pressure fluctuations without fatigue or loss of function. The perforations are shaped to optimize fluid dynamics during both suction and relaxation phases of the pulse. The mouth prop can incorporate piezoelectric elements that vibrate in sync with the pulsatile flow to aid in tissue stimulation.

  sequenceDiagram
      DentalProcedure->>Mouthpiece: Insert
      Mouthpiece->>+Pulsatile Valve Controller: Activate Variable Pulse
      Pulsatile Valve Controller->>Vacuum Pump: Control Suction On/Off Cycle
      Vacuum Pump->>Mouthpiece Inner Cavity: Apply Pulsatile Vacuum
      Mouthpiece Inner Cavity->>+Stability Bar/Bridge Structure: Maintain Integrity under Pulses
      Mouthpiece Inner Cavity->>Perforations: Fluid & Debris Evacuation
      Mouthpiece->>+Mouth Prop: Synchronized Vibration (Optional)
      Pulsatile Valve Controller-->>-DentalProfessional: Adjust Frequency/Intensity
  

3.3 Cross-Domain Application

Derivative 3.3.1: Pipe Inspection and Debris Removal Device (Industrial Maintenance)

• Enabling Description: This mouthpiece concept is re-imagined as an autonomous or remotely operated internal pipe cleaning and inspection device. The "main body" is a flexible, modular cleaning head designed to traverse pipes of varying diameters, with the "first wall" and "second wall" forming an annular suction chamber around the pipe interior. The "perforations" allow for intake of dislodged debris and cleaning fluids. The "stability bar" provides structural integrity to the cleaning head against internal pipe forces, while the "bridge structure" maintains the annular suction gap and prevents clogging. The "suction-connector portion" attaches to a flexible hose connected to an external vacuum system. The "mouth prop" (or rather, "insertion prop") assists in guiding the device into the pipe, and the "cheek retractor" (or "centralizer") provides guidance and stabilization within the pipe.

  graph TD
      A[Pipe Entrance] --> B{Insertion Module (Mouth Prop equivalent)}
      B --> C{Flexible Main Body (Cleaning Head)}
      C --> D[First Wall (Inner Contact)]
      C --> E[Second Wall (Outer Contact)]
      E -- Perforations --> F[Annular Suction Chamber]
      F -- Stability Bar --> C
      F -- Bridge Structure --> F
      F --> G[Suction Connector]
      G --> H[Flexible Suction Hose]
      H --> I[External Vacuum/Filtration System]
      C -- Centralizing Fins (Cheek Retractor equivalent) --> A
  

Derivative 3.3.2: Air Duct Purification Module with Active Flow Stabilization (HVAC)

• Enabling Description: The mouthpiece design is adapted for a modular air purification and flow stabilization unit for HVAC systems. The "main body" forms a section of the air duct, with the "first wall" being an inner permeable filter membrane and the "second wall" being an outer structural housing. The "perforations" on the inner membrane allow air to pass into the inner cavity for purification. The "stability bar" acts as a structural reinforcement for the filter membrane, ensuring it doesn't collapse under airflow. The "bridge structure" maintains separation between the filter membrane and the outer housing, creating an internal channel for contaminant collection or active removal. The "suction-connector portion" connects to a localized contaminant extraction system. The "mouth prop" and "cheek retractor" elements are repurposed as mounting flanges and aerodynamic flow guides, respectively, ensuring proper integration and minimal turbulence within the air duct.

  flowchart TD
      A[Air Duct Inlet] --> B{Air Flow Guides (Cheek Retractor)}
      B --> C{Main Body Module (HVAC)}
      C --> D[Inner Filter Membrane (First Wall, Perforated)]
      D --> E[Outer Structural Housing (Second Wall)]
      E -- Bridge Structure (Channeling) --> F[Contaminant Collection Channel]
      F --> G[Stability Bar (Membrane Support)]
      F --> H[Suction Connector (Extraction)]
      H --> I[Localized Contaminant Extractor]
      C -- Mounting Flanges (Mouth Prop) --> A
  

3.4 Integration with Emerging Tech

Derivative 3.4.1: Self-Calibrating Mouthpiece with Machine Learning-Driven Fit Optimization

• Enabling Description: The mouthpiece features embedded strain gauges and pressure sensors across the main body walls, cheek retractor, and mouth prop. These sensors continuously monitor the device's deformation and pressure distribution within the oral cavity. A compact machine learning (ML) model, pre-trained on a vast dataset of oral anatomies and ideal fit parameters, is integrated into the suction-connector's electronics. Upon insertion, the ML model processes sensor data to "self-calibrate" the fit, identifying areas of excessive pressure or inadequate sealing. This data is used to recommend repositioning, suggest alternative mouthpiece sizes, or even trigger localized shape adjustments (if the material is actuated) to optimize patient-specific fit and suction efficacy, providing feedback to the user via a smart device application. The stability bar can feature embedded micro-actuators for fine-tuning its rigidity based on ML recommendations.

  sequenceDiagram
      Patient->>Mouthpiece: Insert
      Mouthpiece->>+Embedded Sensors: Collect Strain/Pressure Data
      Embedded Sensors->>ML Processor: Stream Data
      ML Processor->>ML Model: Analyze Fit, Detect Issues
      ML Model-->>-ML Processor: Output Fit Score, Recommendations
      ML Processor->>Dentist/Hygienist App: Display Visual Feedback/Instructions
      Dentist/Hygienist App->>Mouthpiece: (Optional) Send Actuation Commands
      Mouthpiece->>+Stability Bar: Adjust Rigidity (if actuated)
      Mouthpiece->>Patient: Optimized Fit
  

Derivative 3.4.2: Biometric Feedback Mouthpiece with Adaptive Comfort Control

• Enabling Description: The mouthpiece includes embedded galvanic skin response (GSR) sensors in the cheek retractor and heart rate variability (HRV) sensors (e.g., micro-photoplethysmography) in the mouth prop. These sensors provide real-time biometric indicators of patient stress or discomfort. An integrated AI system analyzes this biometric data and, in response, dynamically adjusts operational parameters of the suction system (e.g., reducing suction intensity, varying pulse frequency to a calming rhythm) or activates localized micro-vibration modules in the cheek retractor for patient comfort. The stability bar and bridge structure are engineered for subtle vibrational feedback, and the mouthpiece material can be infused with thermally activated cooling gels released in response to detected patient distress.

  stateDiagram-v2
      [*] --> PatientComfortIdle
      PatientComfortIdle --> MonitorBiometrics: GSR, HRV Sensors
      MonitorBiometrics --> StressDetected: Biometrics Indicate Distress
      StressDetected --> ActivateComfortMode: AI Adjusts Suction/Vibration
      ActivateComfortMode --> ReduceSuction: Lower Suction Intensity
      ActivateComfortMode --> MicroVibration: Activate Cheek Retractor Vibrators
      ActivateComfortMode --> CoolingGelRelease: Release Activated Cooling Gel
      ActivateComfortMode --> MonitorBiometrics: Re-evaluate Comfort
      StressDetected --> AlertPractitioner: Visual/Audio Alert
      MonitorBiometrics --> ComfortOK: Biometrics Stable
      ComfortOK --> PatientComfortIdle
  

3.5 The "Inverse" or Failure Mode

Derivative 3.5.1: Fail-Open Mouthpiece with Redundant Suction Paths

• Enabling Description: The mouthpiece is designed with a primary suction path through the inner cavity and a secondary, normally-closed emergency bypass channel. The stability bar is constructed with a thermally sensitive element that, if exposed to excessive heat (e.g., from prolonged friction or local inflammation, indicating a potential blockage), melts or deforms, triggering a mechanical "fail-open" of the secondary channel. This redundant path immediately provides alternative suction, preventing a complete loss of evacuation capability. The perforations along the edges are asymmetric, designed to preferentially shed large debris away from the primary channel in a low-power mode. The mouthpiece material is brightly colored and glows in the dark to assist in emergency removal.

  flowchart TD
      A[Oral Cavity Fluid/Debris] --> B{Main Body Cavity}
      B --> C[Primary Suction Conduit]
      C -- Normal Flow --> D[Vacuum System]
      B -- Excessive Heat (Stability Bar) --> E[Thermally Sensitive Element]
      E -- Deforms --> F[Mechanical Trigger]
      F --> G[Open Secondary Bypass Channel]
      B -- Diverted Flow --> G
      G --> H[Emergency Suction Port/Reservoir]
      M[Mouthpiece (Glow-in-Dark)] --> A
  

Derivative 3.5.2: Self-Expelling Mouthpiece with Controlled Collapse for Emergency Removal

• Enabling Description: This mouthpiece features a controlled "collapse" mechanism for rapid, safe removal in a patient emergency (e.g., choking, seizure). The stability bar is constructed from a shape memory alloy (SMA) trigger element. An external button on the suction connector, when pressed, applies a small electrical current (or introduces a specific chemical agent) to the SMA, causing it to rapidly deform and release structural tension. This deformation causes the first and second walls of the main body to collapse inwards, reducing the mouthpiece's overall volume and allowing for swift, minimally invasive oral extraction. The bridge structure protrusions are designed to fold flat during this collapse. The mouth prop can be detached with minimal force, breaking away at pre-scored lines.

  sequenceDiagram
      Emergency->>Dentist: Initiate Emergency Removal
      Dentist->>Suction Connector: Press Emergency Release Button
      Suction Connector->>+SMA Trigger: Apply Electrical Current/Chemical
      SMA Trigger->>Stability Bar: Rapidly Deform
      Stability Bar->>Main Body Walls: Lose Structural Tension
      Main Body Walls->>Mouthpiece: Collapse Inwards
      Mouthpiece->>Patient: Expedited Removal
      Mouthpiece->>+Bridge Structure: Fold Flat
      Mouthpiece->>+Mouth Prop: Detach
  

---

Derivative Variations for Claim 30: Isolation Mouthpiece with Perforated Walls, Protrusions, Suction Connector, Mouth Prop, and Cheek Retractor (Similar to Claim 9)

Claim 30: An isolation mouthpiece for use with a suction system in a dental procedure, the mouthpiece comprising: a main body portion having a first end and a second end, the main body portion including: a first wall having a first edge and a second edge extending from the first end of the main body portion towards the second end of the main body portion, the first wall including a first plurality of perforations formed adjacent to and extending along a portion of the first edge and a second plurality of perforations formed adjacent to and extending along a portion of the second edge, a second wall having a third edge and a fourth edge extending from the first end of the main body portion towards the second end of the main body portion, the second wall including a third plurality of perforations formed adjacent to and extending along a portion of the third edge, and a fourth plurality of perforations formed adjacent to and extending along a portion of the fourth edge, wherein the second wall further includes a plurality of protrusions extending from an interior surface of the second wall towards the first wall in a shape having one or more crests and one or more troughs, and wherein the first wall and the second wall are shaped such that the first edge of the first wall corresponds to the third edge of the second wall and the second edge of the first wall corresponds to the fourth edge of the second wall, and a third wall connecting the first wall and the second wall such that the first wall is spaced from the second wall to define an inner cavity, wherein a portion of the first wall has a first width adjacent to the first end of the main body portion and a second width adjacent to the second end of the main body portion, wherein a portion of the second wall has a third width adjacent to the first end of the main body portion and a fourth width adjacent to the second end of the main body portion, wherein the first width is greater than the second width, and wherein the third width is greater than the fourth width; a suction connector portion extending from the first end of the main body portion, the suction connector portion including: a generally tubular conduit including: an opening extending through the conduit and in fluid communication with the inner cavity, the opening being configured to receive a vacuum portion of the suction system therein, and a cutout configured to engage a protrusion on the suction system to aid in coupling the mouthpiece to the suction system; a mouth prop including a first side and a second side that are inwardly tapered from a top surface of the mouth prop towards a bottom surface of the mouth prop, the first side and the second side each including a plurality of ridges; and a cheek retractor portion having a first cheek-retractor end coupled to the second end of the main body portion and a second cheek-retractor end, the first cheek-retractor end and the second cheek-retractor end each having rounded edges. [cite: The full patent text, Claims]

(Note: Claim 30 shares significant overlap with Claim 9. Derivatives will focus on distinguishing features or unique combinations implied by the wording.)

4.1 Material & Component Substitution

Derivative 4.1.1: Hydrogel-Coated Mouthpiece with Electro-Active Polymer Protrusions

• Enabling Description: The entire mouthpiece is molded from a biocompatible, high-elongation silicone rubber. The interior surfaces of the first and second walls, including the perforations, are coated with a thin layer of pH-responsive hydrogel that swells or shrinks based on oral pH, dynamically adjusting the effective diameter of the perforations to regulate fluid intake or prevent blockage. The protrusions on the second wall are constructed from an electro-active polymer (EAP) or dielectric elastomer. Applying a low voltage across these EAP protrusions allows for active, fine-tuning of their shape and extension towards the first wall, optimizing wall separation and flow dynamics in real-time, especially when the mouth prop is under varying bite pressure. The mouth prop ridges can incorporate a textured hydrophobic material for enhanced grip.

  classDiagram
      class Mouthpiece {
          +SiliconeRubberBase
          +MainBody
          +SuctionConnector
          +MouthProp
          +CheekRetractor
      }
      class MainBody {
          +HydrogelCoating
          +PerforatedWalls
          +EAP_Protrusions
      }
      class EAP_Protrusions {
          +VoltageControlledShapeChange()
      }
      class MouthProp {
          +HydrophobicRidges
      }
      Mouthpiece *-- MainBody
      Mouthpiece *-- SuctionConnector
      Mouthpiece *-- MouthProp
      Mouthpiece *-- CheekRetractor
      MainBody *-- EAP_Protrusions
  

Derivative 4.1.2: Reinforced Composite Mouthpiece with Tunable Stiffness Zones

• Enabling Description: The mouthpiece is manufactured using a multi-material injection molding process. The main body's first and second walls are a composite of medical-grade silicone with embedded high-strength polymer fibers (e.g., aramid or carbon fibers) in specific regions, creating zones of tunable stiffness. This allows for increased rigidity in areas requiring structural support (e.g., around the suction connector) and flexibility in others (e.g., cheek retractor). The protrusions are made from a rigid, biocompatible ceramic-polymer composite for consistent wall separation. The mouth prop's ridges are composed of a harder, wear-resistant polymer (e.g., ultra-high molecular weight polyethylene, UHMWPE) for enhanced patient bite support and durability.

  graph TD
      A[Mouthpiece (Multi-Material Composite)] --> B{Main Body}
      B --> C[First Wall (Tunable Stiffness Zones)]
      B --> D[Second Wall (Tunable Stiffness Zones)]
      D --> E[Ceramic-Polymer Protrusions]
      B --> F[Third Wall (Connecting)]
      A --> G[Suction Connector]
      A --> H[Mouth Prop (UHMWPE Ridges)]
      A --> I[Cheek Retractor (Tunable Stiffness Zones)]
      C -- Fiber Reinforcement --> C
      D -- Fiber Reinforcement --> D
      E -- Consistent Separation --> C
  

4.2 Operational Parameter Expansion

Derivative 4.2.1: Micro-Vibrational Mouthpiece with Frequency-Adjustable Acoustic Flow Enhancement

• Enabling Description: Miniature piezoceramic actuators are embedded within the walls of the main body, particularly along the edges and within the crests of the protrusions. These actuators generate high-frequency micro-vibrations (e.g., 50-200 kHz) when activated, creating acoustic streaming within the inner cavity. This acoustic streaming enhances fluid flow and dislodges tenacious debris from oral surfaces and perforations, significantly improving suction efficiency, especially with highly viscous fluids. The frequency and amplitude of these vibrations are adjustable via controls on the suction connector, allowing for adaptation to different clinical needs (e.g., gentle vibration for sensitive patients, higher intensity for heavy debris). The mouth prop ridges are designed to efficiently transmit these vibrations to the occlusal surfaces.

  flowchart TD
      A[External Control Unit] --> B{Piezoceramic Actuators (Embedded in Walls/Protrusions)}
      B -- High-Frequency Micro-Vibrations --> C[Inner Cavity Acoustic Streaming]
      C --> D[Enhanced Fluid Flow]
      D --> E[Debris Dislodgement]
      E --> F[Perforations]
      F --> G[Suction Connector (Adjustable Controls)]
      G --> H[Vacuum System]
      I[Mouth Prop (Vibration Transmission)] --> A
  

Derivative 4.2.2: Automated Pressure-Mapping Mouthpiece with Feedback for Fit Optimization

• Enabling Description: The main body and cheek retractor portions are equipped with a dense array of miniaturized, flexible pressure sensors distributed across their interior surfaces. During insertion and use, these sensors generate a continuous, high-resolution pressure map of the device's contact with oral tissues. This data is fed to a micro-controller in the suction connector which provides real-time visual feedback (e.g., via LEDs on the connector or a small LCD screen) or haptic feedback to the dental professional, indicating areas of uneven pressure, potential impingement, or suboptimal sealing. This allows for precise, automated adjustments to the mouthpiece's position or selection of an alternative size to achieve an ideal, uniform fit, maximizing both comfort and suction efficiency.

  sequenceDiagram
      Patient->>Mouthpiece: Insert
      Mouthpiece->>+Pressure Sensor Array: Generate Pressure Map
      Pressure Sensor Array->>Micro-Controller: Stream Real-time Data
      Micro-Controller->>Pressure Mapping Algorithm: Analyze Uniformity/Hotspots
      Pressure Mapping Algorithm-->>-Micro-Controller: Output Fit Data
      Micro-Controller->>Dentist/Hygienist: Visual/Haptic Feedback (LEDs, LCD, Vibration)
      Dentist/Hygienist->>Mouthpiece: Adjust Position/Size
      Mouthpiece->>Patient: Optimized Fit & Comfort
  

4.3 Cross-Domain Application

Derivative 4.3.1: Biofilm Reactor Sampling and Monitoring Device (Environmental Science)

• Enabling Description: This device is configured for sampling and monitoring biofilm growth within controlled laboratory bioreactors or environmental water systems. The "main body" is a modular insert within a pipe or chamber, with the "first wall" and "second wall" defining a flow-through chamber where biofilm can accumulate on a substrate. The "perforations" act as controlled entry/exit points for fluid flow and sampling probes. The "protrusions" on the second wall maintain critical spacing and ensure consistent fluid dynamics for reproducible biofilm growth conditions. The "suction connector portion" interfaces with automated fluid delivery and waste removal systems. The "mouth prop" and "cheek retractor" elements are repurposed as mounting flanges and observation windows, respectively, allowing for optical monitoring of the biofilm without disrupting the controlled environment.

  graph TD
      A[Bioreactor/Water System] --> B{Modular Main Body (Flow Chamber)}
      B --> C[First Wall (Biofilm Substrate)]
      B --> D[Second Wall (Structural)]
      D -- Perforations --> E[Fluid/Probe Access]
      D -- Protrusions --> F[Controlled Flow Dynamics]
      F --> G[Suction Connector (Fluid/Waste Interface)]
      G --> H[Automated Fluid Delivery/Waste]
      B -- Mounting Flanges (Mouth Prop) --> A
      B -- Observation Window (Cheek Retractor) --> I[Optical Monitoring]
  

Derivative 4.3.2: Contaminant Zone Delimitation and Extraction Tool (Hazardous Waste/Cleanup)

• Enabling Description: This large-scale device is used for localized extraction and containment of hazardous liquids or granular contaminants in industrial spill response or environmental cleanup. The "main body" is a flexible barrier forming a containment zone around a spill area. The "first wall" conforms to the contaminated surface, and the "second wall" acts as a structural support. The "perforations" along the edges allow controlled intake of contaminated material. The "protrusions" on the second wall create a sub-surface evacuation channel, ensuring efficient suction of hazardous liquids or small particulates while preventing the first wall from sealing against the spill. The "suction connector portion" attaches to specialized high-power industrial vacuum systems. The "mouth prop" and "cheek retractor" elements are robust, adjustable stabilizers and handles for positioning the containment barrier over the spill.

  flowchart TD
      A[Contaminated Surface (Spill)] --> B{Main Body (Flexible Barrier)}
      B -- Conforms --> C[First Wall (Contact Surface)]
      B -- Support --> D[Second Wall (Structural Support)]
      C -- Perforations --> E[Contaminant Intake]
      E -- Protrusions (Evac. Channel) --> F[Inner Cavity]
      F --> G[Suction Connector (Industrial Vacuum)]
      G --> H[Hazardous Waste Containment]
      I[Adjustable Stabilizers/Handles (Mouth Prop/Cheek Retractor)] --> B
  

4.4 Integration with Emerging Tech

Derivative 4.4.1: VR/AR-Enhanced Training Mouthpiece with Haptic Feedback

• Enabling Description: The mouthpiece is instrumented with an array of micro-pressure sensors and force transducers on the internal surfaces of the main body, mouth prop, and cheek retractor. This sensor data is wirelessly transmitted to a virtual reality (VR) or augmented reality (AR) training simulation. Trainees wearing a VR/AR headset can "virtually" interact with the patient's mouth and the mouthpiece. The system provides real-time haptic feedback (via small haptic actuators embedded in the physical mouthpiece) simulating resistance, pressure points, and correct seating, guiding the trainee in proper placement, adjustment, and operation. The protrusions on the second wall can include pressure sensors that contribute to the haptic map, allowing trainees to "feel" the internal wall separation. The mouth prop can also provide haptic feedback on bite force.

  sequenceDiagram
      Trainee->>VR/AR Headset: Wear
      Trainee->>Mouthpiece: Interact (Physical)
      Mouthpiece->>+Embedded Sensors: Collect Pressure/Force Data
      Embedded Sensors->>Wireless Transmitter: Stream Data
      Wireless Transmitter->>VR/AR Training System: Process Data, Update Simulation
      VR/AR Training System->>+Haptic Actuators: Send Haptic Feedback Commands
      Haptic Actuators->>Mouthpiece: Simulate Resistance/Pressure
      VR/AR Training System-->>-Trainee: Visual/Audio Guidance (Virtual)
      Mouthpiece->>+Protrusions: Contribute to Haptic Map
      Mouthpiece->>+Mouth Prop: Provide Bite Force Feedback
  

Derivative 4.4.2: Blockchain-Enabled Consumable Tracking for Single-Use Mouthpieces

• Enabling Description: For single-use versions of the mouthpiece, each unit is manufactured with an embedded, unique cryptographic identifier (e.g., a near-field communication (NFC) chip or a secure optical tag) that links to a unique record on a blockchain. This system tracks the entire lifecycle of each disposable mouthpiece: from manufacturing batch, sterilization (if applicable), distribution, and point-of-use scanning (e.g., scanning the cutout on the suction connector to trigger a transaction) to confirmation of proper disposal. This ensures authenticity, prevents counterfeiting, and provides an auditable trail for regulatory compliance and waste management. The mouth prop can also integrate a "smart ink" that irreversibly changes color or produces a digital signature upon first use, preventing unauthorized re-sterilization or reuse attempts.

  graph TD
      A[Mouthpiece Mfg] --> B{Single-Use Mouthpiece (Cryptographic ID)}
      B --> C[Distribution Network]
      C --> D[Dental Clinic/Point-of-Use]
      D -- Scan ID (NFC/Optical) --> E[Blockchain Network]
      E -- Log Transaction (Use Event) --> F[Immutable Audit Trail]
      F --> G[Regulatory Compliance]
      F --> H[Waste Management Tracking]
      B -- "Smart Ink" on Mouth Prop --> D
      E -- Authenticates --> B
  

4.5 The "Inverse" or Failure Mode

Derivative 4.5.1: Bio-Degradable Mouthpiece with Time-Release Disinfectant for Safe Disposal

• Enabling Description: The mouthpiece is manufactured from a bio-degradable polymer that begins to break down after a predetermined period (e.g., 24-48 hours post-use), reducing its structural integrity for safe and environmentally responsible disposal. Embedded within the polymer matrix are micro-capsules containing a non-toxic, broad-spectrum disinfectant. Upon initiation of degradation (e.g., triggered by moisture or enzymatic activity in a waste receptacle), these capsules rupture, releasing the disinfectant to neutralize residual pathogens before degradation is complete. The protrusions are designed to dissolve first, preventing clogging of waste systems. The mouth prop is engineered for easy detachment and separate waste stream processing, if required.

  stateDiagram-v2
      [*] --> InUse: Dental Procedure
      InUse --> PostUse: Removal
      PostUse --> WasteDisposal: Discarded
      WasteDisposal --> DegradationInitiated: (e.g., Moisture, Enzymes)
      DegradationInitiated --> DisinfectantRelease: Micro-Capsules Rupture
      DisinfectantRelease --> PathogenNeutralization: Disinfection
      DegradationInitiated --> StructuralBreakdown: Polymer Degradation
      StructuralBreakdown --> ProtrusionDissolution: Prevents Clogging
      StructuralBreakdown --> SafeDisposal: Reduced Volume, Neutralized
      SafeDisposal --> [*]
  

Derivative 4.5.2: Visually Indicating Mouthpiece for Over-Pressure/Under-Pressure Detection

• Enabling Description: The main body's first and second walls incorporate pressure-sensitive chromogenic polymers or micro-fluidic channels filled with indicator dyes. These materials are engineered to visually change color or display a distinct pattern when the internal suction cavity experiences sustained over-pressure (e.g., severe occlusion leading to pressure buildup) or under-pressure (e.g., suction loss due to leakage or system failure). For instance, an area of the wall might turn red for over-pressure and blue for under-pressure, providing an immediate, clear visual alert to the dental professional. The protrusions can be molded with a different chromogenic material to provide a secondary, independent pressure indication. The mouth prop can have tactile markings that become more prominent under excessive bite force, signaling patient discomfort or biting too hard.

  flowchart TD
      A[Oral Cavity] --> B{Mouthpiece Main Body (Chromogenic Walls)}
      B -- Internal Pressure Changes --> C[Pressure-Sensitive Dye/Polymer]
      C -- Over-Pressure --> D[Wall Color Change (e.g., Red)]
      C -- Under-Pressure --> E[Wall Color Change (e.g., Blue)]
      F[Dentist/Hygienist] -- Visual Alert --> D
      F -- Visual Alert --> E
      B -- Protrusions (Secondary Indication) --> G[Distinct Protrusion Color Change]
      H[Mouth Prop] -- Excessive Bite Force --> I[Prominent Tactile Markings]
  

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Combination Prior Art Scenarios with Open-Source Standards

These scenarios combine elements of US12011329 with existing open-source standards, thereby rendering certain future improvements as obvious or non-novel.

1. US12011329 + ISO 17665 (Sterilization of Health Care Products) + Open-Source Autoclave Firmware (e.g., Arduino-based Control):

   • Description: The integration of the autoclavable material (silicone, perfluoroelastomer, or high-heat resistant polymer as described in the derivatives) of the US12011329 mouthpiece with a sterilization process validated under ISO 17665. Furthermore, controlling the sterilization cycle (temperature, pressure, duration) of an autoclave using an open-source firmware (e.g., developed for an Arduino or Raspberry Pi micro-controller) is a known practice in laboratory and small-scale medical device prototyping. Combining the reusable, autoclavable mouthpiece with such an open-source controlled, ISO 17665-compliant sterilization process makes the aspect of "reusable, sterile dental device" obvious. This disclosure extends to any reusable intraoral device following similar sterilization protocols.

2. US12011329 + DICOM (Digital Imaging and Communications in Medicine) + Open-Source 3D Scanning Software (e.g., MeshLab/OpenCV for structure from motion):

   • Description: The mouthpiece's design, particularly its conforming shape and various sizes, can be improved through digital dentistry techniques. Capturing a 3D scan of a patient's oral cavity (e.g., using an intraoral scanner) and processing this data with open-source 3D mesh editing software (like MeshLab) or structure-from-motion algorithms (from OpenCV) to generate a customized digital model of the mouthpiece. This digital model, once generated, can be stored and communicated using the DICOM standard for medical imaging. The concept of designing a custom-fit US12011329-like mouthpiece based on patient-specific 3D oral scans, processed via open-source tools and managed under medical imaging standards, renders any future "custom-fit" or "digitally-designed" variations obvious.

3. US12011329 + MQTT Protocol (Message Queuing Telemetry Transport) + Open-Source IoT Platforms (e.g., Eclipse Mosquitto/Home Assistant):

   • Description: The implementation of sensor integration in the US12011329 mouthpiece (as suggested in "Integration with Emerging Tech" derivatives, e.g., pressure sensors, pH sensors). Transmitting data from these sensors (via Bluetooth Low Energy, BLE, or Wi-Fi) to a local gateway that uses the lightweight MQTT protocol for communication. This data is then ingested and processed by an open-source IoT platform (like Eclipse Mosquitto as an MQTT broker and Home Assistant for data visualization and basic automation). This combination establishes prior art for any "smart" mouthpiece that collects operational or environmental data and transmits it using standard IoT protocols to open-source software platforms for monitoring, analytics, or automated control of connected suction systems. This includes logging device usage, maintenance reminders, and performance metrics.