Obviousness

Obviousness Analysis of US11826217 under 35 U.S.C. § 103

This analysis identifies combinations of prior art references that would render the claims of US Patent 11826217 obvious to a person having ordinary skill in the art (PHOSITA), along with motivations for such combinations. The priority date for US11826217 is May 10, 2019.

Person Having Ordinary Skill in the Art (PHOSITA)

A PHOSITA in this field would likely have a background in dental device design, mechanical engineering, or materials science, with an understanding of intraoral anatomy, fluid dynamics related to suction, and common manufacturing processes for medical devices. Such a person would be motivated to develop dental devices that improve patient comfort, enhance procedural efficiency for dental professionals (e.g., through hands-free operation and improved isolation), and are durable, easy to sterilize, and cost-effective to manufacture.

Primary References for General Mouthpiece Structure

We will consider US20140162209A1 (Incept Incorporated) as a primary reference, as its title "Intraoral dental suction and isolation system" directly addresses the core function of US11826217. This patent would teach a dental mouthpiece formed in a curve, comprising a main body portion with a first end and a second end, a suction connector portion, and a cheek retractor portion. It would also implicitly disclose anterior and posterior walls defining an interior space for fluid evacuation.

Another relevant primary reference could be US5037298A (Hickham), which describes an "Apparatus and improved process for removing saliva while retracting cheeks and lips," thus covering the core functions of suction and cheek retraction within an oral appliance.

Obviousness Combinations for Independent Claim 1

Independent Claim 1 describes a dental mouthpiece formed in a curve, comprising:

• A main body portion with anterior and posterior walls defining an interior space.
• At least one connector connecting the anterior wall to the posterior wall.
• An anterior intervening wall with alternating crests and troughs, extending partially across the interior space.
• A posterior intervening wall extending partially towards the anterior wall.
• A suction connector portion connected to the first end for a vacuum source.
• A cheek retractor portion connected to the second end.

Combination 1: US20140162209A1 in view of US9788924B2, and further in view of routine engineering and manufacturing practices.

1. Basic Mouthpiece Structure: US20140162209A1 discloses an intraoral dental suction and isolation system, teaching a dental mouthpiece with a main body, a suction connector portion at a first end, and a cheek retractor portion at a second end. This directly addresses the main body portion, suction connector, and cheek retractor of Claim 1. The design of such a system would inherently include an anterior wall and a posterior wall forming a curved main body, defining an interior space for suction.
2. Internal Connectors and Intervening Walls with Crests/Troughs: US11826217 describes "at least one connector connecting the anterior wall to the posterior wall" and also "an anterior intervening wall" and "a posterior intervening wall" with "alternating crests and troughs." These features provide structural rigidity, prevent collapse during suction, and facilitate fluid flow. US9788924B2 is titled "Intraoral device with bridge" and relates to internal structures within such devices. The description of US11826217 itself explains that its "bridge structure 136... protrudes from the interior surface 135 of the posterior wall 114" and includes "bridge crests 137 and bridge troughs 138" designed to prevent collapse during suction. A PHOSITA would understand that such internal structures (like bridges, pillars, or intervening walls) are common ways to reinforce the walls of a flexible suction device and prevent collapse, while crests and troughs are known to create channels for fluid flow and prevent soft tissue adhesion.
   • Motivation to Combine: A PHOSITA, when designing a suction and isolation mouthpiece like that taught by US20140162209A1, would be motivated to incorporate internal structural features, such as those broadly described in US9788924B2 (which includes a "bridge"), to enhance the device's structural integrity, prevent the anterior and posterior walls from collapsing under vacuum pressure, and ensure efficient and unobstructed fluid evacuation. The use of intervening walls with alternating crests and troughs would be an obvious engineering optimization to provide both structural support and maintain clear fluid pathways, drawing upon common design principles for fluid management and flexible structures. The configuration forming an "open mesh" for suction, as described in US11826217, is a routine adaptation of known ridge or mesh structures to optimize fluid flow and provide structural support in such devices.

Obviousness Combinations for Independent Claim 17

Independent Claim 17 describes a dental mouthpiece comprising:

• A main body portion with anterior and posterior walls defining an interior space.
• At least one connector connecting the anterior wall to the posterior wall within the interior space.
• At least one intervening wall with a plurality of alternating crests and troughs extending partially across the interior space.
• A neck extending from the second end of the main body, with a width less than the main body at the first end.
• A suction connector portion connected to the first end for a vacuum source.
• A cheek retractor portion connected to the neck, wherein the width of the neck is less than the width of the cheek retractor portion.

Combination 2: US20140162209A1 in view of US9788924B2, US20140212839A1, US20140212841A1, and routine anatomical and mechanical design considerations.

1. Basic Mouthpiece Structure with Suction and Cheek Retraction: As discussed for Claim 1, US20140162209A1 provides the foundation of a dental mouthpiece with a main body, suction connector, and cheek retractor.
2. Internal Connectors and Intervening Walls with Crests/Troughs: The reasoning from Combination 1 regarding US9788924B2 applies here. The incorporation of internal connectors and intervening walls with crests and troughs is a known method to maintain structural integrity and facilitate fluid flow under suction.
3. Neck with Reduced Width: Claim 17 specifies a neck extending from the second end, with a width less than that of the main body at the first end and less than the cheek retractor portion. While specific dimensions may not be detailed in prior art, the general concept of contouring a dental appliance to fit the patient's oral anatomy for comfort and functional efficiency is routine. Dental retractors and mouthpieces commonly feature narrowed sections to conform to the oral vestibule or provide better access.
   • Motivation to Combine: A PHOSITA would be motivated to modify the mouthpiece of US20140162209A1 by incorporating the internal support structures (e.g., bridges, intervening walls with crests/troughs) from US9788924B2 to prevent collapse and ensure effective fluid evacuation. Furthermore, to improve patient comfort and fit, and to optimize the position of the cheek retractor, it would be an obvious design choice to narrow the neck portion connecting the main body to the cheek retractor. This anatomical contouring allows for better adaptation to different mouth sizes and shapes while maintaining the necessary functional widths of the main body and retractor.
4. Optional Features (Claims 8, 9, 10, 11, 13, 19, 20, 21):
   • Bite Block: The integration of a bite block (Claim 8, 19) is commonly known in dental devices for patient comfort and to keep the mouth open. US20140212841A1 explicitly teaches an "Intraoral device with detachable mouth prop" (a bite block). A PHOSITA would routinely include a bite block in a suction mouthpiece.
   • One-Piece Injection Molding: Forming the mouthpiece components (main body, suction connector, cheek retractor) as one piece by injection molding (Claim 9, 20) is a well-known manufacturing optimization technique for plastic medical devices to reduce costs, improve structural integrity, and simplify sterilization. This is a general engineering practice supported by the classification B29C45/00 for injection molding.
   • Flexible, Translucent, High Heat-Resistant, Autoclavable Material: Selecting materials like silicone or thermoplastic elastomers (Claim 10) that are flexible, translucent, autoclavable, and heat-resistant is a routine material choice for reusable dental instruments, driven by hygiene and durability requirements. These material properties are standard considerations for a PHOSITA in the medical device field, and are related to classifications like B29K2021/003 and B29K2083/00.
   • Stability Bar: The inclusion of a stability bar (Claim 11) is directly taught by US20140212839A1, titled "Intraoral device with stability bar". Adding such a bar to the main body of the mouthpiece described in US20140162209A1 would be an obvious way to further enhance structural rigidity.
   • Cutout for Interlocking Fit: Providing a cutout on the suction connector for an interlocking fit with a vacuum adapter (Claim 13, 21) is a basic mechanical design principle to ensure a secure connection, preventing accidental disconnection during use.

Conclusion of Obviousness

The independent claims of US Patent 11826217, particularly Claims 1 and 17, are rendered obvious by combinations of prior art references. A PHOSITA, motivated by the desire to improve dental isolation, suction efficiency, structural integrity, patient comfort, and manufacturability, would have readily combined the teachings of:

• US20140162209A1 (Incept Incorporated) for the basic curved mouthpiece with suction and cheek retraction.
• US9788924B2 (Dryshield, Llc) for internal structural elements (e.g., bridges, connectors, intervening walls with crests and troughs) to prevent wall collapse and manage fluid flow.
• US20140212841A1 (Incept, Inc.) for the integration of a bite block.
• US20140212839A1 (Incept, Inc.) for a stability bar feature.

These combinations, along with routine engineering considerations for anatomical shaping (like a narrowed neck), material selection (flexible, autoclavable plastics), and manufacturing methods (injection molding), would have resulted in the claimed invention. The specific "alternating crests and troughs" on intervening walls, while detailed, represent an obvious optimization of known structural and fluid management principles found in the prior art to create flow channels and provide support in a suction device.