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
Applicant’s amendments to claims 6, 11, and 14-15 filed 06/02/2026 is acknowledged by the examiner.
In light of the amendments to the claims, any previous claim objections and 35 USC 112(b) rejections are overcome. They are therefore withdrawn.
Claims 1-20 are currently pending and are under examination.
Response to Arguments
Applicant's arguments filed 06/02/2026 have been fully considered but they are not persuasive.
Applicant’s argument: Neither Coscina nor Herman teaches or suggests a commissural support having “a body extending away from the clip, the body configured for long-term support of and contact with a commissure at a corner of the mouth of the patient,” or a commissural support “configured to extend the commissure away from a center of the opening in the mouth of the patient,” as recited by amended claim 6. Coscina explicitly describes these [handles 74, 76] as “tray manipulating handles” whose sole purpose is to facilitate withdrawal of the impression tray from the mouth. See Coscina Col. 5 lines 50-55. Coscina further states that “[t]he handles are short strong angulated members designed so as not to interfere with the sides of the mouth or with the placement and removal of the impressions.” See Coscina Col. 8 lines 4-8. Even the largest of these handles is explicitly designed not to contact or interfere with the sides of the mouth, and would not provide long-term support of and contact with a commissure of the mouth of the patient.
Examiner’s response: In response to applicant's argument that the handles of Coscina are not designed to contact or interfere with a commissure at a corner of the mouth, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Although in Col. 7 lines 58-61 Coscina states that the handles are designed so as to not interfere with the sides of the mouth, this statement is very broad and does not specifically state that the handles are designed so as to not interfere with the commissure of the mouth. The sides of the mouth in Col. 7 lines 58-61 of Coscina could also be the cheek area of the mouth as the sides of the mouth. Further, Col. 7 lines 58-61 of Coscina also states that the handles are “designed so as not to interfere with the sides of the mouth OR with the placement and removal of the impressions,” therefore this “or” statement still makes the Coscina reference open.
Allowable Subject Matter
Claims 1-5 are allowable.
Claims 8 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art drawn to Coscina (US 3,878,610) in view of Herman et al. (referred to as “Herman”) (US 2013/0066236 A1) and Coscina in view of Quartey et al. (referred to as “Quartey”) (US 2024/0065814 A1) fails to show or make obvious the claimed combinations of elements, particularly the limitations set forth in independent claim 5 and dependent claims 8 and 15, which recites features not taught or suggested by the prior art drawn to Coscina in view of Herman and Coscina in view of Quartey.
Coscina in view of Herman and Coscina in view of Quartey fails to disclose or fairly suggest the front wall having an upper edge defining a ridge and the clip having a lip configured to engage the ridge, wherein the clip of the at least one commissural support is configured to removably snap into the desired position on the mouthguard tray with the lip engaged with the ridge of the mouthguard tray and the at least one clip arm inserted into at least one of the plurality of openings of the mouthguard tray.
Further, no other reference has been found in the prior art search to date that would be able to properly modify Coscina in view of Herman, and Coscina in view of Quartey.
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 patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6-7 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coscina (US 3,878,610) in view of Herman et al. (referred to as “Herman”) (US 2013/0066236 A1).
Regarding claim 6, Coscina discloses an oral commissural splint (see Figs. 7-9 which shows an oral commissural splint), comprising:
a mouthguard tray (60) configured to be removably retained within a mouth of a patient through an opening in the mouth of the patient (see Figs. 7-9; maxillary tray 60 is a mouthguard tray and is configured to be removably retained within a mouth of a patient through an opening in the mouth of the patient), the mouthguard tray (60) having a front wall (72) (see Figs. 7-9; labial wall 72 of maxillary tray 60 is a front wall); and
at least one commissural support (74, 76) configured to securely couple to the mouthguard tray (60) (see Figs. 7-9; the handles 74, 76 are commissural supports and are securely coupled or connected to the maxillary tray 60), the at least one commissural support (74, 76) having a body extending away (see Figs. 7-9; the handles 74, 76 have a body, which is the whole physical structure of the handles, that extend away), the body configured for long-term support of a commissure at a corner of the mouth of the patient when the at least one commissural support (74, 76) is coupled to the mouthguard tray (60) and the mouthguard tray (60) is inserted into the mouth of the patient (see Figs. 7-9; the body of the handles 74, 76 are capable of long-term support of a commissure at a corner of the mouth of the patient when the handles 74, 76 are connected to the maxillary tray 60 and the maxillary tray 60 is inserted into the mouth of the patient, as each patient’s mouth/lips are different in size/shape), wherein the at least one commissural support (74, 76) is further configured to extend the commissure away from a center of the opening in the mouth of the patient (see Figs. 7-9; handles 76 is capable of extending the commissure away from a center of the opening in the mouth of the patient, as the handles 76 are arranged at the sides of the tray 60 and as each patient’s mouth/lips are different in size/shape).
Coscina is silent on the front wall having a plurality of openings spaced along a lower edge of the front wall; and the at least one commissural support having a clip with at least one clip arm configured to positionally hold the commissural support in relation to the mouthguard tray, and a body extending away from the clip.
However, Herman teaches an analogous mouthguard tray (20) (see Fig. 1; dental appliance 20), and an analogous front wall (22+25) (see Fig. 1; side 22+middle portion 25 make up a front wall of the dental appliance 20), and the front wall (22+25) having a plurality of openings (71,73,75,77,79) spaced along a lower edge of the front wall (22+25) (see Fig. 1 and [0086]; the side 22+middle 25 have female fittings 71,73,75,77,79 which are a plurality of openings that are spaced long a lower edge of the side 22+middle 25); and the analogous at least one commissural support (500) having a clip with at least one clip arm (551, 554) configured to positionally hold the commissural support (500) in relation to the mouthguard tray (20) (see Figs. 1 and 9 and [0086]; the handle 500 is an analogous at least one commissural support, and the handle 500 has a clip, which is structures of 561+563+565+567+surfaces 551+554 as these elements work together to fasten into the female fittings 71,73,75,77,79 of dental appliance 20, and thus the clip has at least one clip arm which are surfaces 551+554 that is configured to positionally hold the handle 500 in relation to the dental appliance 20, as the surfaces 551+554 biases against surface 71,74 of the dental appliance 20), and a body extending away from the clip (see Figs. 1 and 9 and [0086]; the body of handle 500 is the whole physical structure of the handle, which extends away from the clip, which is the structures of 561+563+565+567+surfaces 551+554), providing at least one commissural support that is removable from the mouthguard tray as needed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the front wall (22+25) of Coscina to have a plurality of openings (71, 73, 75, 77, 79) spaced along a lower edge of the front wall as taught by Herman and to have modified the at least one commissural support (74, 76) of Coscina to have a clip with at least one clip arm (551+554) configured to positionally hold the commissural support in relation to the mouthguard tray, and a body extending away from the clip as taught by Herman to have provided an improved oral commissural splint that has at least one commissural support that is removable from the mouthguard tray as needed.
Regarding claim 7, Coscina in view of Herman discloses the invention as discussed in claim 6. Coscina in view of Herman further discloses the mouthguard tray (60 of Coscina) further having a tooth platform (62 of Coscina) having an upper surface with a plurality of textured structures (70 of Coscina) on the upper surface (see Figs. 7-9 of Coscina and Col. 7 lines 4-9 of Coscina; the maxillary tray 60 of Coscina has floor portion 62 of Coscina which is a tooth platform as a user’s teeth is configured to engage with the floor portion 62 of Coscina, and the floor portion 62 of Coscina has an upper surface with a grid-like or serrated inner surface 70 of Coscina, which is a plurality of textured structures), wherein the front wall (72 of Coscina) extends up from the tooth platform (62 of Coscina) (see Fig. 9 of Coscina which shows a sectional view of the tray and shows the labial wall portion 72 of Coscina extending up from the floor portion 62 of Coscina) and wherein the plurality of textured structures (70 of Coscina) are configured to mechanically engage a mold within the mouthguard tray (60 of Coscina), the mold formed of a dental impression material (see Figs. 7-9 of Coscina and Col. 7 lines 4-9 of Coscina; the grid-like or serrated inner surface 70 of Coscina is configured to mechanically engage a mold within the maxillary tray 60 of Coscina as it is for improved retention of dental impression material).
Regarding claim 9, Coscina in view of Herman discloses the invention as discussed in claim 6. Coscina in view of Herman further discloses wherein a position of a first commissural support (74 of Coscina) of the at least one commissural support (74,76 of Coscina) with respect to the mouthguard tray (60 of Coscina) is independent of a position of a second commissural support (76 of Coscina) of the at least one commissural support (74,76 of Coscina) with respect to the mouthguard tray (60 of Coscina) (see Figs. 7-9 of Coscina; as previously modified above, see claim 6, a position of handle 74 of Coscina is independent of a position of handle 76 of Coscina).
Regarding claim 10, Coscina in view of Herman discloses the invention as discussed in claim 9. Coscina in view of Herman further discloses wherein the first commissural support (74 of Coscina) and the second commissural support (76 of Coscina) are positionable such that the position of the first commissural support (74 of Coscina) is closer to a center of the mouthguard tray (60 of Coscina) than the position of the second commissural support (76 of Coscina) (see Fig. 7 of Coscina; the handle 74 of Coscina is positionable, as previously modified above, see claim 6, closer to a center of the maxillary tray 60 of Coscina than the position of handles 76 of Coscina).
Claim(s) 11-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coscina in view of Quartey et al. (referred to as “Quartey) (US 2024/0065814 A1).
Regarding claim 11, Coscina discloses an oral commissural splint (see Figs. 7-9 which shows an oral commissural splint), comprising:
a mouthguard tray (60) configured to be removably retained within a mouth of a patient through an opening in the mouth of the patient (see Figs. 7-9; maxillary tray 60 is a mouthguard tray and is configured to be removably retained within a mouth of a patient through an opening in the mouth of the patient); and
at least one commissural support (74, 76) configured to couple to the mouthguard tray (60) (see Figs. 7-9; the handles 74, 76 are commissural supports and are coupled or connected to the maxillary tray 60), wherein the at least one commissural support (74, 76) remains in the spatial position to support and contact a commissure at a corner of the mouth of the patient when the mouthguard tray (60) is inserted into the mouth of the patient over an extended period of time exceeding a day (see Figs. 7-9; the handles 74, 76 remain in the spatial position and is capable of supporting and contacting a commissure at a corner of the mouth of the patient when the maxillary tray 60 is inserted into the mouth of the patient over an extended period of time exceeding a day, as each patient’s mouth/lips are different in size/shape and the handles 76 are arranged at the sides of tray 60), wherein the at least one commissural support (74, 76) is further configured to extend the commissure away from a center of the opening in the mouth of the patient (see Figs. 7-9; handles 76 is capable of extending the commissure away from a center of the opening in the mouth of the patient, as the handles 76 are arranged at the sides of the tray 60 and as each patient’s mouth/lips are different in size/shape).
Coscina is silent on the at least one commissural support configured to movably couple to the mouthguard tray with the at least one commissural support movable between desired spatial positions in relation to the mouthguard tray, wherein the at least one commissural support remains in each of the desired spatial positions when placed there to support a commissure at a corner of the mouth of the patient when the mouthguard tray is inserted into the mouth of the patient.
However, Quartey teaches an analogous at least one commissural support (14,15) (see Figs. 1-6), and the at least one commissural support (14, 15) configured to movably couple to the analogous mouthguard tray (30) with the at least one commissural support (14, 15) movable between desired spatial positions in relation to the mouthguard tray (30) (see Figs. 1-6 and [0059]-[0060]; stiffener bars 14, 15 are analogous commissural supports as they are capable of supporting a commissure at a corner of the mouth of the patient as each patient’s mouth/lips are different in size/shape, and stiffener bars 14, 15 are movable between desired spatial positions in relation to tray 30, as the stiffener bars 14, 15 are slidable within slots 23, 22, respectively, and thus can be moved between desired spatial positions to either shorten or lengthen the stiffener bars 14, 15), wherein the at least one commissural support (14, 15) remains in each of the desired spatial positions when placed there to support a commissure at a corner of the mouth of the patient when the mouthguard tray is inserted into the mouth of the patient (see Figs. 1-6; the stiffeners 14, 15 remain in each of the desired spatial positions when placed there and is capable of supporting a commissure at a corner of the mouth of the patient when the tray 30 is inserted into the mouth of the patient, as each patient’s mouth/lips are different in shape/size), providing at least one commissural support that is both removable and able to be shortened/lengthened depending on a user’s needs.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one commissural support (74, 76) of Coscina to movably couple to the mouthguard tray with at least one commissural support movable between desired spatial positions in relation to the mouthguard tray, wherein the at least one commissural support remains in each of the desired spatial positions when placed there to support a commissure at a corner of the mouth of the patient when the mouthguard tray is inserted into the mouth of the patient as taught by Quartey to have provided an improved oral commissural splint that has at least one commissural support that is both removable and able to be shortened/lengthened depending on a user’s needs.
Regarding claim 12, Coscina in view of Quartey discloses the invention as discussed in claim 11. Coscina in view of Quartey further discloses the mouthguard tray (60 of Coscina) having a front wall (72 of Coscina) (see Figs. 7-9 of Coscina; labial wall 72 of Coscina of the maxillary tray 60 of Coscina is a front wall).
Quartey further teaches the analogous front wall (13+12+11) having a plurality of openings (22, 23) spaced along the front wall (13+12+11) (see Figs. 1-9; segments 13, 12, 11 is an analogous front wall and has slots 22, 23 which are a plurality of openings spaced along the segment 13), providing at least one commissural support that is both removable and able to be shortened/lengthened depending on a user’s needs.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the front wall (72 of Coscina) in the device of Coscina in view of Quartey to have a plurality of openings (22, 23) spaced along the front wall as taught by Quartey to have provided an improved oral commissural splint that has at least one commissural support that is both removable and able to be shortened/lengthened depending on a user’s needs.
Regarding claim 13, Coscina in view of Quartey discloses the invention as discussed in claim 12.
Quartey further teaches wherein the analogous at least one commissural support (14, 15) having a clip (16+19+17) with at least one clip arm (16) configured to hold the clip (16+19+17) to the mouthguard tray (30) (see Figs. 1-6 and [0059]-[0060]; the stiffeners 14, 15 have ridges 16,19+indexing bumpers 17 which make up a clip, as these elements work together to hold the tray 30 to stiffeners 14,15, and ridges 16+19 are clip arms as they are configured to hold the indexing bumpers 17 to the tray 30, as the ridges 16+19 are fitted into slots 22, 23) and a body extending away from the clip (16+19+17) (see Figs. 1-6; the portion in between indexing bumpers 17 and handle 18 is a body as this portion extends away from the clip16+19+17), the body configured to support the commissure at the corner of the mouth of the patient when the mouthguard tray is inserted into the mouth of the patient (see Figs. 1-6; the body, which is the portion in between indexing bumpers 17 and handle 18 is configured to or capable of supporting the commissure at the corner of the mouth of the patient when the tray 30 is inserted into the mouth of the patient as each patient’s mouth/lips are different in shape/size), providing the at least one commissural support to be stable when attached to the mouthguard tray such that it does not harm a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one commissural support (74, 76 of Coscina) in the device of Coscina in view of Quartey to have a clip with at least one clip arm configured to hold the clip to the mouthguard tray and a body extending away from the clip, the body configured to support the commissure at the corner of the mouth of the patient when the mouthguard tray is inserted into the mouth of the patient as taught by Quartey to have provided an improved oral commissural splint that provides at least one commissural support to be stable when attached to the mouthguard tray such that it does not harm a user.
Regarding claim 14, Coscina in view of Quartey discloses the invention as discussed in claim 13. Coscina in view of Quartey further discloses wherein the at least one commissural support (74, 76 of Coscina) is configured to removably snap into the desired position on the mouthguard tray (60 of Coscina) with the at least one clip arm (16 of Quartey) inserted into an opening (23 of Quartey) of the plurality of openings (22, 23 of Quartey) of the mouthguard tray (60 of Coscina) (see Figs. 1-6 of Quartey and [0059]-[0060] of Quartey; as previously modified above, the handles 74, 76 of Coscina are configured to removably snap into the desired position on the maxillary tray 60 of Coscina with the ridges 16 of Quartey being inserted into slot 23 of Quartey).
Regarding claim 16, Coscina in view of Quartey discloses the invention as discussed in claim 13. Coscina in view of Quartey further discloses wherein the body is integral with the clip (16+19+17 of Quartey) (as previously modified above, see claim 13, the body of clip 16+19+17 of Quartey which is the portion in between handle 18 of Quartey and indexing bumper 17 of Quartey is integral or necessary for completeness with the clip 16+19+17 of Quartey).
Regarding claim 17, Coscina in view of Quartey discloses the invention as discussed in claim 11. Coscina in view of Quartey further discloses the mouthguard tray (60 of Coscina) further having a tooth platform (62 of Coscina) having an upper surface with a plurality of textured structures (70 of Coscina) on the upper surface (see Figs. 7-9 of Coscina and Col. 7 lines 4-9 of Coscina; the maxillary tray 60 of Coscina has floor portion 62 of Coscina which is a tooth platform as a user’s teeth is configured to engage with the floor portion 62 of Coscina, and the floor portion 62 of Coscina has an upper surface with a grid-like or serrated inner surface 70 of Coscina, which is a plurality of textured structures), wherein the plurality of textured structures (70 of Coscina) are configured to mechanically engage a mold within the mouthguard tray (60 of Coscina), the mold formed of a dental impression material (see Figs. 7-9 of Coscina and Col. 7 lines 4-9 of Coscina; the grid-like or serrated inner surface 70 of Coscina is configured to mechanically engage a mold within the maxillary tray 60 of Coscina as it is for improved retention of dental impression material).
Regarding claim 18, Coscina in view of Quartey discloses the invention as discussed in claim 11. Coscina in view of Quartey further discloses wherein a position of the at least one commissural support (74,76 of Coscina) with respect to the mouthguard tray (60 of Coscina) is adjustable (as previously modified above by Quartey, see claim 11, the position of the handles 74, 76 of Coscina with respect to maxillary tray 60 of Coscina is adjustable via a sliding motion, see [0059]-[0060] of Quartey and Figs. 1-6 of Quarety).
Regarding claim 19, Coscina in view of Quartey discloses the invention as discussed in claim 11. Coscina in view of Quartey further discloses wherein a position of a first commissural support (74 of Coscina) of the at least one commissural support (74,76 of Coscina) with respect to the mouthguard tray (60 of Coscina) is independent of a position of a second commissural support (76 of Coscina) of the at least one commissural support (74,76 of Coscina) with respect to the mouthguard tray (60 of Coscina) (see Figs. 7-9 of Coscina; as previously modified above, see claim 6, a position of handle 74 of Coscina is independent of a position of handle 76 of Coscina).
Regarding claim 20, Coscina in view of Quartey discloses the invention as discussed in claim 19. Coscina in view of Quartey further discloses wherein the first commissural support (74 of Coscina) and the second commissural support (76 of Coscina) are positionable such that the position of the first commissural support (74 of Coscina) is closer to a center of the mouthguard tray (60 of Coscina) than the position of the second commissural support (76 of Coscina) (see Fig. 7 of Coscina; the handle 74 of Coscina is positionable, as previously modified above, see claim 11, closer to a center of the maxillary tray 60 of Coscina than the position of handles 76 of Coscina as handle 74 of Coscina is closer to the center than handles 76 of Coscina).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBIN HAN whose telephone number is (408)918-7579. The examiner can normally be reached Monday - Thursday, 9-5 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786