DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on 04/14/2026. As directed by the amendment, claim 3 has been amended and claim 21 has been cancelled. As such, claims 1, 3-4, 6, 8, and 17-20 are being examined in the instant application.
Applicant has cancelled claim 21; the objection to the drawing has been withdrawn.
Applicant has amended claim 3 to address a minor informality; the objection to the claim has been withdrawn.
Response to Arguments
Applicant's arguments, on pages 5-8, filed 04/14/2026 have been fully considered but they are not persuasive.
Applicant argues “…Gerschman's platform is not a standoff feature configured to engage the vestibular oral cavity but rather a bite platform intended for occlusal engagement…” and further points to [0014] of applicant’s specification to argue the standoff feature is to create a defined spatial separation and provide stability. However, none of the features being mentioned are recited in the current claims nor has applicant precluded Gerschman’s flat surface from being a standoff feature within the current claims.
Applicant further argues against the combination of Gerschman and Syrop stating “…the claimed standoff feature is not an occlusal surface, nor is it a component designed for tooth engagement.” Similarly to above, applicant has not precluded the standoff feature to be designed for tooth engagement.
Applicant argues “The claimed rim height is not an arbitrary dimensional variation but a critical structural parameter that directly governs the ability of the device to form a vestibular seal without distorting or impinging upon the labial mucosa. This functional relationship is expressly supported by the present specification.” However, [0010] of applicant’s specification recites “In a nonlimiting example, rim 136 may be raised between about 0 mm to about 1.5 mm.” As such, [0010] of applicant’s specification shows a broader range than what is claimed, states it is a” nonlimiting example” while discussing a variety of shapes and sizes for the rim. Therefore, the applicant has not proven criticality on the claimed rim height as a critical structural parameter.
Applicant argues “Incorporating Steffling's notch feature into Reist-Kundig's metal plate would comprise structural integrity, interfere with the beading attachment and contradict Reist- Kundig's intended sealing function.” However, Reist-Kundig teaches the perimeter of the mouth enclosure to be inflatable tube 1 as seen in Reist-Kundig’s Annotated Fig. 1. As such, the modification of Steffling would have the two notch features on the perimeter/inflatable tube 1 of Reist-Kundig and not plate 2, especially as it would be the inflatable tube 1 being positioned on the frenulum as seen in Reist-Kundig’s Fig. 3.
Applicant’s arguments, see pages 8-11, filed 04/14/2026, with respect to the rejection(s) of claim(s) 1, 6, 18-21 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection has been made for the claims as shown below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-4, 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reist-Kundig (US 4305387 A) in view of Gerschman (US 20160361192 A1) and Syrop (US 20090165805 A1).
Regarding claim 1, Reist-Kundig teaches an apparatus for sealing an oral cavity to promote nasal breathing (Reist-Kundig teaches a mouth closure shown in Figs. 1-3 which brings about a sealing of the oral cavity as seen in Col. 3, lines 5-18), wherein the apparatus comprises:
a body (deformable plate 2, see Fig. 1) having, a front surface, a rear surface, wherein the rear surface is positioned opposite the front surface (the deformable plate 2 has a front surface (where tubing 4 is attached to), rear surface (towards a user’s mouth) and a rear surfaced positioned opposite the front surface as seen in Figs. 1-3), a perimeter (perimeter, see Reist-Kundig’s Annotated Fig. 1), wherein the perimeter defines a boundary between the front surface and the rear surface (the mouth closure has a perimeter which defines a boundary between the front surface and rear surface as seen in Reist-Kundig’s Annotated Fig. 1), a first side (first side, see Reist-Kundig’s Annotated Fig. 1), a second side (second side, see Reist-Kundig’s Annotated Fig. 1), wherein the first side and the second side are located on opposite edges of the body (see Reist-Kundig’s Annotated Fig. 1), a lateral axis (lateral axis, see Reist-Kundig’s Annotated Fig. 1) running from the first side to the second side (see Reist-Kundig’s Annotated Fig. 1), a first end (first end, see Reist-Kundig’s Annotated Fig. 1), a second end (second end, see Reist-Kundig’s Annotated Fig. 1), wherein the first end and the second end are located on opposite edges of the body (see Reist-Kundig’s Annotated Fig. 1), and a longitudinal axis (longitudinal axis, see Reist-Kundig’s Annotated Fig. 1) running from the first end to the second end (see Reist-Kundig’s Annotated Fig. 1), wherein the body is configured to fit into a vestibular oral cavity of a subject (the deformable plate 2 is to fit into a user’s mouth as seen in Fig. 3) and wherein the body is composed of a first material (“The plate 2 may be made of sheet metal…” see Col. 2, lines 49-53);
a rim (beading 1’, see Fig. 3), wherein the rim is coupled to the perimeter of the body to provide stabilization and limit the body from migrating (the beading 1’ is coupled to the perimeter of the body as seen in Fig. 3 and rests within the dentilabial cavity of the lower jaw between the lower lip 10 and the gum 11 carrying the teeth 12, and in the dentilabial cavity of the upper jaw between the upper lip 14 and the gum 15 carrying the teeth 16 as seen in Col. 3, lines 5-18, to aid in provide stabilization and limit the body from migrating) and is configured to rest against a superior and inferior labial mucosa (see Fig. 3 and Col. 3, lines 5-18) and wherein the rim is composed of a second material that is different from the first material (beading 1’ is made out of foamed plastic as seen in Col. 2, lines 60-63 and Col. 4, lines 53-55 which is a different material than the plate 2 made out of sheet metal);
a central region disposed between the first end and the second end (there is a central region disposed between the first end and the second end)
but does not teach wherein the rim is raised between about 0.1 to 1.5mm and
a standoff feature coupled to the rear surface of the body in the central region along the longitudinal axis, wherein the standoff feature comprises a continuous outer material with a hollow inner region and a textured surface to provide enhanced grip.
Reist-Kundig’s Annotated Fig. 1
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However, Gerschman teaches a standoff feature (arcuate bite platform 42, see Figs. 7-8) coupled to the rear surface of the body in the central region along the longitudinal axis (the arcuate bite platform 42 is coupled to the rear surface of the vestibular locator 14 in the central region along a longitudinal axis as seen in Figs. 7-8), wherein the standoff feature comprises a continuous outer material with a hollow inner region (the arcuate bite platform 42 comprises a continuous outer material with an airway conduit 16 (taken as hollow inner region) in the middle as seen in Figs. 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Reist-Kundig to include a standoff feature as taught by Gerschman to prevent unwanted teeth movement (see [0075]).
In addition, Syrop teaches “The bite surfaces are preferably provided with a cushioning texture or contour 110 to provide a more comfortable experience for the user. Such texture also preferably aids in maintaining the user's teeth in gripping contact with the bite surfaces, while at the same time reducing the surface area in contact with the teeth (see [0028]).”
Gerschman teaches an arcuate bite platform 42 for a standoff feature as seen in Figs. 7-8. Syrop teaches the bite surfaces of mouth guard 50 to have a cushioning texture 110 as seen in Fig. 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the standoff feature of apparatus taught by Reist-Kundig in view of Gerschman to include a cushioning texture as taught by Syrop to aid in maintain the user's teeth in gripping contact with the bite surfaces (see [0028]).
With respect to Claim 1, modified Reist-Kundig does not explicitly teach wherein the rim is raised between about 0.1 to 1.5mm. However, it has been held that the mere change in size does not constitute a patentable improvement in the art when said change in size does not result in a non-obvious change in functionality (see MPEP § 2144.04. IV.A.). In this case, it is unclear why having the rim raised between 0.1 to 1.5mm would substantially change the functionality of the device in a non-obvious way. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the rim to be raised between about 0.1 to 1.5mm since it has been held that the change in size involves only routine skill in the art.
Regarding claim 3, modified Reist-Kundig teaches the apparatus of claim 1, and Reist-Kundig further teaches wherein the apparatus further comprises a tab (tube 4, see Fig. 3; [0009] of applicant’s specification recites “…a "tab" is a feature of an object that projects from the surface used to grip the object.” Tube 4 is a feature of the mouth closure that projects from the surface and allows a user to grip the mouth closure as seen in Figs. 2-3), wherein the tab is coupled to the front surface of the body in the central region (see Figs. 2-3).
Regarding claim 4, modified Reist-Kundig teaches the apparatus of claim 1, but does not teach wherein the body further comprises an elastomer material.
However, Gerschman further teaches wherein the body further comprises an elastomer material (Paragraph 8 of the original disclosure states the body should be made of a thin, flexible, elastomer material which includes biocompatible thermoplastic polymers or thermoplastics elastomers. Gerschman teaches mouthpiece 12 to be made out of thermoplastic elastomer material as seen in Fig. 6 and [0076].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by modified Reist-Kundig to have the body made out of thermoplastic elastomer material as taught by Gerschman for an alternative material for a mouthpiece.
Regarding claim 6, modified Reist-Kundig teaches the apparatus of claim 1, and further teaches wherein the standoff feature comprises a continuous pad material protruding from the body (Modified Reist-Kundig teaches arcuate bite platform 42 to be made of thermoplastic elastomer material (taught by Gerschman) and Syrop further teaches the bite surfaces of mouth guard 50 to have a cushioning texture 110. As such, the arcuate bite platform 42 is a continuous pad material protruding from deformable plate 2 of Reist-Kundig).
Regarding claim 8, modified Reist-Kundig teaches the apparatus of claim 1, and Reist-Kundig further teaches wherein the rim comprises a rounded profile, wherein the rounded profile extends from the front surface of the body (beading 1’ comprises a rounded profile, wherein the rounded profile extends from the front surface of the body as seen in Figs. 2-3).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reist-Kundig (US 4305387 A) in view of Gerschman (US 20160361192 A1) and Syrop (US 20090165805 A1), as applied to claim 1 above, and further in view of Steffling (US 20160242872 A1).
Regarding claim 17, modified Reist-Kundig teaches the apparatus of claim 1, but does not teach wherein the perimeter defines at least a notch feature, wherein the at least a notch feature comprises two notches to accommodate both a superior labial frenulum and an inferior labial frenulum.
However, Steffling teaches wherein the perimeter defines at least a notch feature, wherein the at least a notch feature comprises two notches to accommodate both a superior labial frenulum and an inferior labial frenulum (Steffling teaches the perimeter of oral insert 11 to comprise of indentation 17a and 17b (taken as notch features) as seen in Fig. 1 and [0028], wherein indentation 17a and 17b accommodate both a superior labial frenulum and an inferior labial frenulum).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by modified Reist-Kundig to include two notch features as taught by Steffling to make the oral insert more comfortable to wear (see [0028]).
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reist-Kundig (US 4305387 A) in view of Gerschman (US 20160361192 A1) and Syrop (US 20090165805 A1), as applied to claim 1 above, and further in view of Al-Tawil (US 20120123225 A1).
Regarding claim 18, modified Reist-Kundig teaches the apparatus of claim 1, and further teaches wherein the apparatus comprises a plurality of components (Reist-Kundig teaches the mouth enclosure to include an inflatable tube 1, an air-supply hose 3, a deformable plate 2 and a piece of tubing 4 as seen in Figs. 1-3 and Col. 2, lines 46-49)
but does not teach wherein a component of the plurality of components is designed to be easily interchanged and combined seamlessly with other components of the apparatus.
However, Al-Tawil teaches tubes to be removable from the mouthpiece (see [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by modified Reist-Kundig to have the tube be removable as taught by Al-Tawil such that the tubing can be replaced when damaged (see [0108]). Modified Reist-Kundig teaches wherein a component of the plurality of components is designed to be easily interchanged and combined seamlessly with other components of the apparatus (Modified Reist-Kundig teaches tubing 4 to be removable and replaced (as taught by Al-Tawil) and therefore can be easily interchanged and combined seamlessly with the other components).
Claims 1 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 20080006274 A1) in view of Reist-Kundig (US 4305387 A) and Abdelmessih (US 6076526 A), as evidenced by Wagner (US 20130284184 A1).
Regarding claim 1, Thornton teaches an apparatus (lip shield 32, see Fig. 2B) for sealing an oral cavity to promote nasal breathing (lip shield 32 is placed between a user’s teeth and lips and therefore seals the user’s oral cavity as seen in Fig. 2B and [0024]), wherein the apparatus comprises:
a body having, a front surface, a rear surface, wherein the rear surface is positioned opposite the front surface (the lip shield 32 has a body with a front surface (facing the lips) and a rear surface (facing the teeth) wherein the rear surface is positioned opposite the front surface as seen in Fig. 2B), a perimeter, wherein the perimeter defines a boundary between the front surface and the rear surface (the lip shield 32 has a perimeter surrounding the lip shield that defines a boundary between the front surface and the rear surface), a first side, a second side, wherein the first side and the second side are located on opposite edges of the body, a lateral axis running from the first side to the second side (the lip shield 32 has a first side (side closer to reference number 32), and a second side on the opposite edge of the body a seen in Fig. 2B, wherein there is a lateral axis running from the first side to the second side), a first end, a second end, wherein the first end and the second end are located on opposite edges of the body, and a longitudinal axis running from the first end to the second end (the lip shield 32 has a first end (top end of the lip shield 32) and a second end (bottom end of the lip shield 32) that are located on opposite edge of the body and a longitudinal axis running from the first end to the second end), wherein the body is configured to fit into a vestibular oral cavity of a subject (lip shield 32 is placed between a user’s teeth and lips as seen in Fig. 2B and [0024]) and wherein the body is composed of a first material (the lip shield 32 is composed from a material);
a rim, wherein the rim is configured to rest against a superior and inferior labial mucosa (lip shield 32 teaches a rim around the perimeter of the lip shield 32, wherein the rim is to rest against a superior and inferior labial mucosa as seen in Fig. 2B);
a central region disposed between the first end and the second end (there is a central region of the lip shield 32 disposed between the first end and the second end)
but does not teach wherein the rim is composed of a second material that is different from the first material;
wherein the rim is coupled to the perimeter of the body to provide stabilization and limit the body from migrating and wherein the rim is raised between about 0.1 to 1.5mm; and a standoff feature coupled to the rear surface of the body in the central region along the longitudinal axis, wherein the standoff feature comprises a continuous outer material with a hollow inner region and a textured surface to provide enhanced grip.
However, Reist-Kundig teaches wherein the rim is composed of a second material that is different from the first material (beading 1’ is made out of foamed plastic as seen in Col. 2, lines 60-63 and Col. 4, lines 53-55 which is a different material than the plate 2 made out of sheet metal);
wherein the rim is coupled to the perimeter of the body to provide stabilization and limit the body from migrating (the beading 1’ is coupled to the perimeter of the body as seen in Fig. 3 and rests within the dentilabial cavity of the lower jaw between the lower lip 10 and the gum 11 carrying the teeth 12, and in the dentilabial cavity of the upper jaw between the upper lip 14 and the gum 15 carrying the teeth 16 as seen in Col. 3, lines 5-18, to aid in provide stabilization and limit the body from migrating).
Although, Thornton teaches a lip shield 32 which is made out of a first material, Thornton is silent on what material it is. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Thornton to include the beading and have the body made out of metal as taught by Reist-Kundig to prevent possible injury to the patient (see Col. 2, lines 13-20) and for a known sealing material used for oral apparatuses, as both Thornton and Reist-Kundig teaches a mouth piece that seals.
However, Abdelmessih teaches a standoff feature (dental shield 14, see Figs. 1-4) coupled to the rear surface of the body (lip shield 12, see Figs. 1-4) in the central region along the longitudinal axis (dental shield 14 is coupled to the rear surface of lip shield 12 in the central region along the longitudinal axis as seen in Figs. 1-4), wherein the standoff feature comprises a continuous outer material with a hollow inner region (the dental shield comprises a continuous outer material with a hollow inner region for center tube 16 and hole 18 as seen in Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Thornton in view of Reist-Kundig to include the dental shield a taught by Abdelmessih for a shield that can mold to the teeth of the user for comfort (see Col. 2, lines 58-62).
However, Wagner teaches a textured surface to provide enhanced grip (Wagner teaches the materials for the upper and lower members to comprise of any moldable plastic that is approved for use in oral medical devices that may be custom fitted for each user and tooth-retained via friction grip such as thermoplastics as seen in [0056]).
Abdelmessih teaches dental shield 14 to be moldable to a user’s teeth using moldable material such as using any thermal plastic material as seen in Col. 4, lines 52-62. Therefore, as evidenced by Wagner, modified Thornton teaches a standoff feature comprising a textured surface to provide enhanced grip as Wagner teaches thermoplastics to be material that is both moldable but also tooth retained via friction grip.
With respect to Claim 1, modified Thornton does not explicitly teach wherein the rim is raised between about 0.1 to 1.5mm. However, it has been held that the mere change in size does not constitute a patentable improvement in the art when said change in size does not result in a non-obvious change in functionality (see MPEP § 2144.04. IV.A.). In this case, it is unclear why having the rim raised between 0.1 to 1.5mm would substantially change the functionality of the device in a non-obvious way. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the rim to be raised between about 0.1 to 1.5mm since it has been held that the change in size involves only routine skill in the art.
Regarding claim 19, modified Thornton teaches the apparatus of claim 1, and Thornton further teaches wherein the apparatus is configured to attach to an oral apparatus (lip shield 32 is configured to attach to an oral appliance 20 with an upper arch 22 and lower arch 24 (see [0021]), post 18, locking mechanism 16 and mask 10 with body 12 and fitting 14 (see [0012]-[0013]), wherein fitting 14 is to connect mask 10 to a CPAP system (see [0018]) as seen in Fig. 1A-2B).
Claim 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton (US 20080006274 A1) in view of Reist-Kundig (US 4305387 A) and Abdelmessih (US 6076526 A), as evidenced by Wagner (US 20130284184 A1), as applied to claim 19 above, and further in view of Thornton (US 20160354231 A1; hereinafter known as Keith).
Regarding claim 20, modified Thornton teaches the apparatus of claim 19, and Thornton further teaches wherein the oral apparatus comprises a positive airway pressure therapy system (Thornton teaches lip shield 32 connected to oral appliance 20 and post 18 as seen in Fig. 2B and [0024], and further teaches locking mechanism 16 to retain mask 10 to the oral appliance 20 as seen in Fig. 1B and [0019]. Mask 10 comprises of fitting 14 that is to connect mask 10 to multiple hoses and a CPAP system as seen in [0018]) and moldable teeth parts (Thornton teaches oral appliance 20 with an upper arch 22 and lower arch 24 which can represent a bite register or wax mold suitable to the user’s teeth as seen in [0021]) and further teaches Thornton teaches mask 10 to have a body that will cover a portion of the user’s nose surrounding the nostrils as seen in [0013] and Figs. 1A-1B and delivering gas particularly to a user’s nostrils (see claim 11).
But does not teach nasal dilators.
However, Keith teaches mask 20 can be a combination mask that covers the mouth and includes nasal pillows, may be a nasal mask that covers portions of the nose, or may include nasal inserts or nasal pillows that may be positioned in and/or adjacent to the nostrils as seen in [0033].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by modified Thornton to include nasal pillows/nasal inserts as taught by Keith as it is known within the art for mask to include nasal inserts or nasal pillows (see [0033]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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