DETAILED ACTION
This is the initial Office action for non-provisional application 19/532,606 filed February 6, 2026, which is a continuation of non-provisional application 19/266,433 filed July 11, 2025, which is a continuation of non-provisional application 18/738,661 (now US Patent 12,376,987) filed June 10, 2024, which is a continuation of non-provisional application 17/935,603 (now US Patent 12,029,679) filed September 27, 2022, which is a continuation of non-provisional application 16/784,750 (now US Patent 11,484,435) filed February 7, 2020, which claims priority from provisional application 62/936,032 filed November 15, 2019. Claims 1-15, as originally filed, are currently pending.
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 . 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a protrusive flange … positioned to have an engaging side engaged against the driving side of a driver flange, respectively” in lines 5-7; however, it is unclear if the limitation “a driver flange” recited in line 7 is intending to introduce an additional driver flange or refer to a previously recited driver flange. Claim 1 previously recites “a right back teeth portion and/or a left back teeth portion and a driver flange protruding laterally outward from either or both thereof, each driver flange has a driving side” in lines 2-4 implying there is a driver flange protruding from the right back teeth portion having a driving side and/or a driver flange protruding from the left back teeth portion having a driving side (i.e., a right driver flange and/or a left driver flange). Further, the recitation of “a protrusive flange” in line 5 implies that there may be one or more protrusive flanges such that it’s unclear if the protrusive flange is required to engage against only one of the right driver flange or left driver flange depending on which back teeth portion of the maxillary piece includes a driver flange of there is intended to be a right protrusive flange and a left protrusive flange to engage each drive flange respectively. As best can be determined, it would be more clear if the above limitation recited in lines 5-7 of claim 1 instead recited “a protrusive flange … positioned to have an engaging side engaged against the driving side of [[a]] one of the driver flange(s)
Claims 10 and 11 each depend from claim 1 but refer to “θ2” which is first recited in claim 6. Therefore, it is suggested that claims 10 and 11 each be amended to depend from claim 6 rather than claim 1.
Claims 12 and 13 each recite the limitation “the arcuate surface”; however, there is in sufficient antecedent basis for this limitation in the claims. It is suggested that the limitation “the arcuate surface” be amended to “an arcuate surface”.
Claim 13 depends from claim 1 but refers to “θ1” which is first recited in claim 2. Therefore, it is suggested that claim 13 be amended to depend from claim 2 rather than claim 1.
Claim 15 recites the limitation “the on-board sensor”; however, there is in sufficient antecedent basis for this limitation in the claims. It is suggested that claim 15 be amended to depend from claim 14 which previously introduces “an onboard sensor”.
Claims 2-9 and 14 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia Reyes et al. (WO 2017/149523).
Regarding claim 1, Garcia Reyes discloses a mandibular repositioning device (intra-oral mandibular adjustment device) (Fig. 1; page 1, lines 4-11) comprising:
a maxillary piece (upper splint 1) configured to cover teeth of a user comprising a right back teeth portion and/or a left back teeth portion (adjacent opposite outer faces 20) and a driver flange (follower 19) protruding laterally outward from either or both thereof, each driver flange (19) has a driving side with a convex surface (Figs. 1 & 4; page 8, lines 16-17; page 10, lines 12-14); and
a mandibular piece (lower splint 2) configured to cover teeth of the user and comprising a protrusive flange (extension 15) extending cranially therefrom and positioned to have an engaging side engaged against the driving side of one of the driver flanges (19), wherein the engaging side of the protrusive flange (15) has a concave surface (contact surface 3a) which mates with the convex surface of the driver flange (19) when a mouth of a user is closed and is in capable of continuous contact thereagainst as the user moves their jaw downward thereby providing gradual arcuate incremental forward mandibular movement as the concave surface (3a) of the protrusive flange (15) smoothly glides against the convex surface of the driver flange (19) (Figs. 1, 3, & 6-7c; page 8, lines 16-19 & 28-33; page 10, lines 4-9; page 21, lines 11-13).
Regarding claim 9, Garcia Reyes discloses that, where the mouth is closed, the convex surface of the driver flange (19) aligns with a lower portion of the concave surface (3a) of the protrusive flange (15) (Fig. 1).
Claim Rejections - 35 USC § 103
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.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia Reyes as applied to claim 1 above, in view of Flanagan (US 2016/0324681).
Garcia Reyes discloses the invention substantially as claimed, as described above, but fails to teach an onboard sensor in one or both of the mandibular piece and the maxillary piece on in wireless communication with an external controller station.
Flanagan discloses a mandibular repositioning device comprising a maxillary piece (upper jaw tray 2 + actuation band 6), mandibular piece (lower jaw tray 4), and an onboard sensor (in circuit board 22) in one or both of the mandibular piece and the maxillary piece on in wireless communication with an external controller station (outside devices such as tablets, PCs or smart phones), wherein the onboard sensor may be a body position sensor (accelerometer) or a sound sensor (microphone) (Figs. 1, 6, & 16; ¶ 0030, 0038, 0040, 0046, 0065, 0070, & 0078).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the mandibular repositioning device taught by Garcia Reyes to include an onboard sensor in one or both of the mandibular piece and the maxillary piece on in wireless communication with an external controller station as taught by Flanagan for the purpose of enabling the device to detect snoring and sending data from the sensor to a physician to monitor the user.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US Patent 12,318,325 (reference patent ‘325). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations therein are substantially recited in claim 1 of reference patent ‘325 including a mandibular repositioning device comprising a maxillary piece configured to cover teeth of a user (“a maxillary piece comprising a tooth covering”) comprising a right back teeth portion and/or a left back teeth portion (“a right side proximate a back teeth mold and/or on a left side proximate a back teach mold”) and a driver flange protruding laterally outward from either or both thereof (“a driver flange protruding laterally on a right side proximate a back teeth mold and/or on a left side proximate a back teach mold”), each driver flange has a driving side with a convex surface (“each driver flange having an anterior side with a convex curvature”), and a mandibular piece configured to cover teeth of a user (“a mandibular piece comprising a tooth covering”) comprising a protrusive flange extending cranially therefrom and positioned to have an engaging side engaged against the driving side of a driver flange, respectively, (“a protrusive flange extending cranially therefrom positioned to have a posterior side engaged with the anterior side of each driver flange”) wherein the engaging side of each protrusive flange has a concave surface which mates with the convex surface of the driver flange when the mouth is closed (“the posterior side of each protrusive flange has a base and a most cranial point, and has a concave-to-convex curvature from the base toward the most cranial point, wherein a convex portion of the concave-to-convex curvature engages the convex curvature of the driver flange in a rest position”) and is in continuous contact thereagainst as a user moves their jaw downward (“downward movement of the mandibular piece moves the convex portion of the posterior side of the protrusive flange along and in contact with the convex curvature of the driver flange”), thereby providing gradual arcuate incremental forward mandibular movement as the concave surface of the protrusive flange smoothly glides against the convex surface of the driver flange (“thereby moving a user's mandible forward”).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US Patent 11,819,449 (reference patent ‘449). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations therein are substantially recited in claim 1 of reference patent ‘449 including a mandibular repositioning device comprising a maxillary piece configured to cover teeth of a user (“a maxillary piece comprising a backmost teeth mold and a tooth covering”) comprising a right back teeth portion and/or a left back teeth portion (“a right side proximate the backmost teeth mold and/or on a left side proximate the backmost teeth mold”) and a driver flange protruding laterally outward from either or both thereof (“a driver flange protruding laterally outward on a right side proximate the backmost teeth mold and/or on a left side proximate the backmost teeth mold”), each driver flange has a driving side with a convex surface (“each driver flange having an anterior side with a convex curvature”), and a mandibular piece configured to cover teeth of a user (“a mandibular piece comprising a tooth covering”) comprising a protrusive flange extending cranially therefrom and positioned to have an engaging side engaged against the driving side of a driver flange, respectively, (“a protrusive flange configured to extend cranially therefrom positioned to have a posterior side engaged with the anterior side of each driver flange”) wherein the engaging side of each protrusive flange has a concave surface which mates with the convex surface of the driver flange when the mouth is closed (“the posterior side of each protrusive flange has a concave-to-convex curvature a base of the protrusive flange toward a most cranial point of the protrusive flange and a convex portion of the concave-to convex curvature engages the convex curvature of the driver flange in a rest position”) and is in continuous contact thereagainst as a user moves their jaw downward (“downward movement of the mandibular piece moves the convex portion of the posterior side of the protrusive flange along and in contact with the convex curvature of the driver flange”), thereby providing gradual arcuate incremental forward mandibular movement as the concave surface of the protrusive flange smoothly glides against the convex surface of the driver flange (“thereby moving a user's mandible forward”).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 20 of US Patent 12,485,036 (reference patent ‘036). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations therein are substantially recited in claims 1 and 20 of reference patent ‘036 including a mandibular repositioning device comprising a maxillary piece configured to cover teeth of a user (claim 1: “a maxillary piece configured to cover teeth of a user”) comprising a right back teeth portion and/or a left back teeth portion (claim 1: “a right side back teeth mold and/or a left side back teeth mold”) and a driver flange protruding laterally outward from either or both thereof (claim 1: “a driver flange protruding laterally outward on either or both of the right side and left side back teeth mold”), each driver flange has a driving side with a convex surface (claim 1: “the driver flange having an anterior side with a convex curvature”), and a mandibular piece configured to cover teeth of a user (claim 1: “a mandibular piece comprising a tooth covering”) comprising a protrusive flange extending cranially therefrom and positioned to have an engaging side engaged against the driving side of a driver flange, respectively, (claim 1: “a protrusive flange extending cranially therefrom positioned to have a posterior side engaged with the anterior side of the driver flange”) wherein the engaging side of each protrusive flange has a concave surface which mates with the convex surface of the driver flange when the mouth is closed and is in continuous contact thereagainst as a user moves their jaw downward (claim 1: “the posterior side of the protrusive flange has a concave curvature from a base of the protrusive flange toward a most cranial point of the protrusive flange which engages the convex curvature of the driver flange in a rest position and for continuous contact thereagainst as a user moves their jaw downward”), thereby providing gradual arcuate incremental forward mandibular movement as the concave surface of the protrusive flange smoothly glides against the convex surface of the driver flange (claim 1: “the posterior side of the protrusive flange and the anterior side of the driver flange have a posterior lean in a respective vertical axis”; claim 20 “the posterior lean is configured to provide anterior advancement per degree of mouth opening”).
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 6 of US Patent 11,484,435 (reference patent ‘435). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the limitations therein are substantially recited in claim 1 of reference patent ‘435 including a mandibular repositioning device comprising a maxillary piece configured to cover teeth of a user (“a maxillary piece having a second teeth covering”) comprising a right back teeth portion and/or a left back teeth portion (“a second left molar portion and a second right molar portion”) and a driver flange protruding laterally outward from either or both thereof (“a second housing proximate to each of a second left molar portion and a second right molar portion, wherein each second housing of the maxillary piece … has a driver”), each driver flange has a driving side with a convex surface (“the driver has a convexly-shaped head”), and a mandibular piece configured to cover teeth of a user (“a mandibular piece having a first teeth covering”) comprising a protrusive flange extending cranially therefrom and positioned to have an engaging side engaged against the driving side of a driver flange, respectively, (“a protrusive flange extending cranially from each of a left molar portion and a right molar portion”) wherein the engaging side of each protrusive flange has a concave surface which mates with the convex surface of the driver flange when the mouth is closed (“the protrusive flange has a concavely-shaped posterior surface, the driver has a convexly-shaped head shaped to match the concavely-shaped posterior surface of the protrusive flange”) and is in continuous contact thereagainst as a user moves their jaw downward, thereby providing gradual arcuate incremental forward mandibular movement as the concave surface of the protrusive flange smoothly glides against the convex surface of the driver flange (“as the mandibular piece moves downward with jaw opening the concavely-shaped posterior surface of the protrusive flange of the mandibular piece slides against the convexly-shaped head for gradual arcuate incremental forward mandibular movement”).
Regarding claim 2, the limitations therein are substantially recited in claim 5 of reference patent ‘435.
Regarding claim 3, the limitations therein are substantially recited in claim 6 of reference patent ‘435.
Claims 1, 14, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of US Patent 12,029,679 (reference patent ‘679). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the limitations therein are substantially recited in claim 1 of reference patent ‘679 including a mandibular repositioning device comprising a maxillary piece configured to cover teeth of a user (“a maxillary piece having a second teeth covering”) comprising a right back teeth portion and/or a left back teeth portion (“a second left molar portion and a second right molar portion”) and a driver flange protruding laterally outward from either or both thereof (“a second housing proximate to each of a second left molar portion and a second right molar portion, wherein each second housing of the maxillary piece … has a driver”), each driver flange has a driving side with a convex surface (“the driver has a convexly-shaped head”), and a mandibular piece configured to cover teeth of a user (“a mandibular piece having a first teeth covering”) comprising a protrusive flange extending cranially therefrom and positioned to have an engaging side engaged against the driving side of a driver flange, respectively, (“a protrusive flange extending cranially from each of a left molar portion and a right molar portion”) wherein the engaging side of each protrusive flange has a concave surface which mates with the convex surface of the driver flange when the mouth is closed (“the protrusive flange has a concavely-shaped posterior surface, the driver has a convexly-shaped head shaped to match the concavely-shaped posterior surface of the protrusive flange”) and is in continuous contact thereagainst as a user moves their jaw downward, thereby providing gradual arcuate incremental forward mandibular movement as the concave surface of the protrusive flange smoothly glides against the convex surface of the driver flange (“as the mandibular piece moves downward with jaw opening, the concavely-shaped posterior surface of the protrusive flange of the mandibular piece slides against the convexly-shaped head for gradual arcuate incremental forward mandibular movement”).
Regarding claim 14, the limitations therein are substantially recited in claim 1 of reference patent ‘679 (“either or both of the mandibular piece and maxillary piece include a sensor in operative communication with at least one of the on-board circuit boards; and a controller station in wireless communication with the mandibular repositioning device while used by the user, the controller station comprising… a receiver… wherein the receiver is configured to receive data from the sensor of the mandibular repositioning device, while used by the user”).
Regarding claim 15, the limitations therein are substantially recited in claim 7 of reference patent ‘679.
Claims 1, 14, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 16 of US Patent 12,376,987 (reference patent ‘987). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the limitations therein are substantially recited in claims 1 and 8 of reference patent ‘679 including a mandibular repositioning device comprising a maxillary piece configured to cover teeth of a user (claim 1: “a maxillary piece having a second teeth covering”) comprising a right back teeth portion and/or a left back teeth portion and a driver flange protruding laterally outward from either or both thereof (claim 1: “a mandibular piece having … a housing proximate each of a left molar portion and a right molar portion, a protrusive flange extending cranially from each housing … a second driver configured to engage the protrusive flange of the mandibular piece”), each driver flange has a driving side with a convex surface (claim 8: “the second driver has a convexly-shaped head”), and a mandibular piece configured to cover teeth of a user (claim 1: “a mandibular piece having a first teeth covering”) comprising a protrusive flange extending cranially therefrom and positioned to have an engaging side engaged against the driving side of a driver flange, respectively, (claim 1: “a housing proximate each of a left molar portion and a right molar portion, a protrusive flange extending cranially from each housing”) wherein the engaging side of each protrusive flange has a concave surface which mates with the convex surface of the driver flange when the mouth is closed (claim 8: “the protrusive flange has a concavely-shaped anterior surface mated to the second driver”) and is in continuous contact thereagainst as a user moves their jaw downward, thereby providing gradual arcuate incremental forward mandibular movement as the concave surface of the protrusive flange smoothly glides against the convex surface of the driver flange (claim 1: “thereby moving the protrusive flange along an anterior surface of the second driver, and wherein as the mandibular piece moves downward with jaw opening forward mandibular movement occurs”).
Regarding claim 14, the limitations therein are substantially recited in claims 1 and 16 of reference patent ‘987 (claim 1: “a mandibular piece having … a protrusion …enclosing a sensor therein”; claim 16: “a controller station in wireless communication with the mandibular lingual repositioning device while used by the user, the controller station comprising… a receiver… wherein the receiver is configured to receive data from the sensor of the mandibular lingual repositioning device, while used by the user”).
Regarding claim 15, the limitations therein are substantially recited in claim 1 of reference patent ‘987.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-15 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-15 of copending Application No. 19/266,433 (reference application ‘433). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Regarding claims 1-15, the limitations therein are recited verbatim in claims 1-15, respectively, of reference application ’433.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 6/24/2026
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