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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 11/25/2025. As directed by the amendment, claims 1 has been amended and claim 21 has been added. As such, claims 1, 3-4, 6, 8, and 17-21 are being examined in the instant application.
Response to Arguments
Applicant's arguments, see pages 5-10 of Remarks, filed 11/25/2025, pertaining to the
newly amended limitations have been noted. However, a new ground(s) of rejection has been
provided below to address the newly added limitations.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the groove of claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3, line 2, recites “…coupled to a front surface...” but should recite “…coupled to the front surface...” due to antecedent basis.
Appropriate correction is required.
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 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 a 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 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]).
Claims 1, 6 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 4222378 A) in view of Reist-Kundig (US 4305387 A), Goldstein (US 20110114099 A1) and Veliss (US 20080060649 A1).
Regarding claim 1, Mahoney teaches an apparatus (mouthpiece accessory 10, see Figs. 1-4) for sealing an oral cavity to promote nasal breathing (Mahoney teaches the mouthpiece to extend into the mouth of the patient 13 and to provide a seal as seen in Fig. 1 and Col. 3, lines 3-13), wherein the apparatus comprises:
a body (mouthpiece accessory 10 has a body as seen in Figs. 1-4) having, a front surface (convex front surface 18, see Fig. 2), a rear surface (concave back surface 19, see Fig. 3), wherein the rear surface is positioned opposite the front surface (the concave back surface 19 is positioned opposite the convex front surface 18 as seen in Figs. 2-4), a perimeter, wherein the perimeter defines a boundary between the front surface and the rear surface (there is a perimeter that defines a boundary between convex first surface 18 and concave back surface 19 as seen in Figs. 2-4), a first side (end 15, see Fig. 2), a second side (end 14, see Fig. 2), wherein the first side and the second side are located on opposite edges of the body (see Fig. 2), a lateral axis running from the first side to the second side (there is a lateral axis running from end 15 to end 14 as seen in Fig. 2), a first end (upper edge 16, see Fig. 2), a second end (lower edge 17, see Fig. 2), wherein the first end and the second end are located on opposite edges of the body (see Fig. 2), and a longitudinal axis running from the first end to the second end (there is a longitudinal axis running from upper edge 16 to lower edge 17 as seen in Fig. 2), wherein the body is configured to fit into a vestibular oral cavity of a subject (mouthpiece accessory 10 is configured to fit into a patient’s mouth area as seen in Figs. 1-4) and wherein the body is composed of a first material (the mouthpiece accessory can be manufactured from various elastomeric and plastic materials as seen in Col. 3, line 64 to Col. 4, line 7);
a rim (raised edge 21 and 22, see Fig. 3), wherein the rim is coupled to the perimeter of the body to provide stabilization and limit the body from migrating (raised edge 21 and 22 is coupled to the perimeter and provides a shape for good sealing characteristics as seen in Figs. 1-4 and Col. 3, lines 24-36 to aid in providing stabilizing and limit the body from migrating as it is curved to seal around the user’s lips) and is configured to rest against a superior and inferior labial mucosa (raised edge 21 and 22 can be used to rest against a superior and inferior labial mucosa if placed into a user’s mouth);
a central region disposed between the first end and the second end (there is a central region disposed between upper edge 16 and lower edge 17 as seen in Fig. 2)
but does not teach wherein the rim is composed of a second material that is different from the first material;
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).
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 Mahoney to have the rim made out of foamed plastic as taught by Reist-Kundig for a known sealing material used for oral apparatuses, as both Mahoney and Reist-Kundig teaches a mouth piece that seals.
However, Goldstein teaches a standoff feature (seal 210, see Fig. 2C and [0047]) coupled to the rear surface of the body in the central region along the longitudinal axis (seal 3 is coupled to the rear surface of respiratory shield 110 in the central region along the longitudinal axis as seen in Fig. 2C), wherein the standoff feature comprises a continuous outer material with a hollow inner region (seal 210 comprises a continuous outer material with a hollow inner region as the seal is only the rectangular outline as shown in Fig. 2C by the cross-hatching).
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 Mahoney in view of Reist-Kundig to include the seal as taught by Goldstein to help create a more secure seal around the patient’s mouth, allowing a greater ability to disrupt airflow through a patient’s mouth (see [0047]).
However, Veliss teaches a standoff feature (foam interface 80, see Figs. 13-1-13-4) comprising a textured surface to provide enhanced grip (Veliss teaches the foam interface 80 to have a cut cellular surface to provide seal and/or grip as seen in Figs. 13-3 and 13-4 and [0257])).
Goldstein teaches a seal 210 and Veliss teaches a foam interface 80 which acts as a seal. 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 Mahoney to have the standoff feature/seal to have the textured surface as taught by Veliss to provide a friction grip to prevent dislodging the seal (see [0257]).
With respect to Claim 1, modified Mahoney 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 6, modified Mahoney teaches the apparatus of claim 1, and Goldstein further teaches wherein the standoff feature comprises a continuous pad material protruding from the body (seal 210 is a continuous pad material protruding from the respiratory shield 110 as seen in Fig. 2C).
Regarding claim 19, modified Mahoney teaches the apparatus of claim 1, and Mahoney further teaches wherein the apparatus is configured to attach to an oral apparatus (Mahoney teaches opening 20 of the mouthpiece accessory to fit with the conventional mouthpiece 11 on the end of flexible tube 12 which is connected to a gas delivery apparatus as seen in Fig. 1 and Col. 2, lines 52-69 and Col. 3, lines 16-23).
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 4222378 A) in view of Reist-Kundig (US 4305387 A), Goldstein (US 20110114099 A1) and Veliss (US 20080060649 A1), as applied to claim 1 above, and further in view of Von Arx (US 8839795 B2).
Regarding claim 18, modified Mahoney teaches the apparatus of claim 1, but does not teach wherein the apparatus comprises a plurality of components, wherein a component of the plurality of components is designed to be easily interchanged and combined seamlessly with other components of the apparatus.
However, Von Arx teaches wherein the apparatus comprises a plurality of components (Von teaches a face and mouth muscle stimulator with a body 1 and removable projections 5 as seen in Figs. 1 and 5 and Col. 5, lines 42-61), wherein a component of the plurality of components is designed to be easily interchanged and combined seamlessly with other components of the apparatus (the removable projections 5 can be positioned in different zones of the body 1 to stimulate different areas of the facial muscle as seen in Figs. 1 and 5 and Col. 5, lines 42-61).
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 Mahoney to including removable projections as taught by Von Arx to help stimulate muscles used for mastication to increase their strength and mobility (see Col. 2, lines 41-45).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 4222378 A) in view of Reist-Kundig (US 4305387 A), Goldstein (US 20110114099 A1) and Veliss (US 20080060649 A1), as applied to claim 1 above, and further in view of Thornton (US 6571798 B1).
Regarding claim 20, modified Mahoney teaches the apparatus of claim 19, and further teaches wherein the oral apparatus comprises a positive airway pressure therapy system (Mahoney teaches opening 20 of the mouthpiece accessory to fit with the conventional mouthpiece 11 on the end of flexible tube 12 which is connected to a positive gas delivery apparatus as seen in Fig. 1 and Col. 2, lines 52-69 and Col. 3, lines 16-23).
But does not teach wherein the oral apparatus comprises moldable teeth parts, and nasal dilators.
However, Thornton teaches wherein the oral apparatus comprises a positive airway pressure therapy system (CPAP system supplies air to the nasal pillows 30 as seen in Col. 7, lines 62-64), moldable teeth parts (oral appliance 10 includes arches 12 and 14 which receives a deformable material which molds to a user’s upper and lower teeth as seen in Col. 4, lines 18-22), and nasal dilators (nasal pillows 30 dilates the user’s nostrils when being inserted to delivery air as seen in Col. 7, lines 4-9).
Mahoney teaches a mouthpiece accessory 10 (which create a seal) that is to connect with a gas delivery apparatus as seen in Fig. 1 and Col. 2, lines 52-69 and Col. 3, lines 16-23. Thornton teaches a device 8 for improving breathing including a venting seal 24 (see Col. 6, lines 45-51), a nasal flange 26 with nasal pillows 30 (see Col. 6, lines 61-64), an oral appliance 10 (see Col. 3, lines 55-59) and a CPAP system to supply air to the nasal pillow as seen in Fig. 1. It would have been obvious to one of ordinary skill in the art to modify the apparatus taught by modified Mahoney to include the oral appliance and nasal flange with nasal pillows as taught by Mahoney to allow for an integration of a variety of components to improve a user’s breathing as the standard interface arm allows for a multitude of products that can be adjustable on the arm (see Col. 3, lines 9-34). Furthermore, arches 12 and 14 of the oral appliance is used to help reduce or eliminate breathing problems (see Col. 6, lines 4-7) and it is well known within the art to deliver gas to either the nose or/and mouth.
Regarding claim 21, modified Mahoney teaches the apparatus of claim 1, but does not teach wherein the body further comprises a groove and wherein the groove permits a mouthguard to attach to the apparatus and lock in place.
However, Thornton teaches wherein the body (venting seal 24, see Fig. 1) further comprises a groove (opening 40, see Fig. 1) and wherein the groove permits a mouthguard to attach to the apparatus and lock in place (opening 40 has a cross section suitable to receive arm 22 connected to oral appliance 10 including arches 12 and 14 as seen in Fig. 1. Furthermore, opening 40 would lock the oral appliance 10 in place due to the shape of the cross section as seen in Fig. 1).
Mahoney teaches an opening 20 provided in the mouthguard accessory 10 as seen in Figs. 2-3 and Col. 3, lines 14-23. It would have been obvious to one of ordinary skill in the art to modify the apparatus taught by modified Mahoney to change the cross section of the opening to be the cross sectioning of the opening as taught by Thornton to allow for an integration of a variety of components to improve a user’s breathing as the cross section allows for the standard interface arm to connect and permits for a multitude of products (see Col. 3, lines 9-34).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Basil (US 1629892 A) teaches an anti-mouth breathing device with a thick rim.
Ray (US 2857911 A) teaches a respiratory mouthpiece with a rim.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785