DETAILED ACTION
The amendment filed on 12/11/25 has been received and considered. By this amendment, claim 1 is amended. Claims 1-20 are pending in the application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 orientation of the sensing block toward an inner lining of the oral cavity 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There are no drawings or description supporting the orientation of the sensing block toward an inner lining of the oral cavity.
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.
Claim 1 is 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. It is unclear if the “at least one component” is all of the components (battery, circuit, memory) or just one of them. Clarity is requested by adding “one of” after “comprises” if it is only one. Examiner interprets the claim as requiring only one of the components for the purpose of rejecting this claim as currently written.
Claim Objections
Claim 1 is objected to because of the following informalities:
“sensing block is inserted into pocket” should read “sensing block is inserted into the pocket”
“one component comprises rechargeable” should read “one component comprises a rechargeable”
Appropriate correction is required throughout the claim.
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.
Claim(s) 1-10, 13-15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Logan et al. (PG Pub. 2012/0172679).
Regarding Claim 1, Logan discloses a mandibular advancement device (MAD) comprising:
An upper splint fabricated to fit onto an upper dentition of an individual in need thereof;
A lower splint physically separated from the upper splint and fabricated to fit onto a lower dentition of the individual in need thereof (see appliance 110; par. 34), wherein the upper or lower splint comprises a pocket (see extension portion of recessed compartment 111; par. 34 and modified Fig. 2 below); and
A sensing block (see PCB 144; par. 35) dimensioned to be removably inserted into the pocket and to be secured and reside completely inside an oral cavity and to be lip sealed completely when the sensing block is received inserted into the pocket, wherein the sensing block comprises:
A sensor (see sensor 142; par. 35) configured to be positioned on a cavity-facing surface of the sensing block and oriented toward an inner lining of the oral cavity (see Fig. 2) and measure a blood oxygen saturation level (see par. 47 and 80) of the individual from the inner lining of the oral cavity inside the oral cavity of the individual in substantially real time (see par. 11 and 82) while lip sealed completely (see par. 54 and 65) when the sensing block is inserted into the pocket and the upper or lower splint is fitted onto the respective upper or lower dentition, and
A wireless communication component (see transmitter; par. 59-60) configured to be lip sealed completely and transmit data associated with the blood oxygen saturation level wirelessly from within the oral cavity to an external device (see external monitoring system in par. 59 or repeater in par. 60) disposed outside the oral cavity while secured completely inside the oral cavity and lip sealed completely when the sensing block is inserted into the pocket and the upper or lower splint is fitted onto the respective upper or lower dentition (see Fig. 2), and
At least one component configured to be secured and reside completely inside the oral cavity and to be lip sealed completely, wherein the at least one component comprises a rechargeable or replaceable battery, a battery recharging circuit, and an on-board memory (see batteries and local data; par. 45, 57 and 69).
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Regarding Claim 4, Logan discloses wherein the custom treatment feature comprises an anterior discluder, splint options, or a titration mechanism (see timing and dosage; par. 67).
Regarding Claim 5, Logan discloses wherein the device comprises two or more sensors, and wherein all the sensors are on one splint, either the upper or the lower splint, of the MAD (see par. 10 and 35).
Regarding Claim 6, Logan discloses wherein one of the at least two or more sensors is attached to or incorporated into or onto the upper splint and one of the at least two or more sensors is attached to or incorporated into or onto the lower splint (see “upper and lower jaw configuration; par. 34).
Regarding Claim 7, Logan discloses wherein the at least one sensor comprises a physiological sensor, a physical sensor, a chemical sensor, or a positional sensor (see par. 49).
Regarding Claim 8, Logan discloses wherein the physiological sensor measures patient data comprising blood oxygen levels (see par. 80), body temperature (see par. 86), respiration rate, or heart rate, or any variability in the data from a moment to another.
Regarding Claim 9, Logan discloses wherein the physical sensor detects vibration in the breathing, airflow rate, oxygen concentration of inhaled air, carbon dioxide concentration of exhaled air, atmospheric pressure, air pressure inside the patient’s oral cavity, noise, pressure exerted on the MAD by the patient’s teeth, or actigraphic data (see par. 80 and 96).
Regarding Claim 10, Logan discloses wherein the chemical sensor detects saliva pH, saliva glucose concentration, saliva conductivity, stress markers, salivary cortisol, blood oxygen saturation level, blood pH, blood glucose levels, blood insulin levels, or inflammatory markers (see par. 47 and 99).
Regarding Claims 13-14, Logan discloses wherein the at least one sensor comprises a communication component configured for wireless communication with a base (see observer monitoring system or computer network; par. 70), wherein the wireless communication is in the form of a radio, an infrared, or a magnetic communication (see par. 70).
Regarding Claim 15, Logan discloses wherein the base comprises software, optionally software on an app, a smartphone, a smart tablet, a laptop computer or a desktop computer (see par. 34).
Regarding Claim 17, Logan discloses wherein the base and the mandibular advancement device operate in a feedback system (see par. 49), and when data obtained by the at least one sensor is communicated with the base, the base analyzes the data and, based on a pre-scripted routine, relays a command to the mandibular advancement device to take an action in response (see par. 67).
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.
Claim(s) 2-3, 11-12, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Logan et al. (PG Pub. 2012/0172679) in view of Giridharagopalan (PG Pub. 2017/0196727).
Regarding Claim 2, Logan generally discloses the use of the monitoring from inside the mouth for diagnostic assessment (see par. 67, 86, and 99) requested by a health professional (see par. 33), but does not explicitly disclose a prescription. Giridharagopalan discloses wherein the at least one sensor measures a biological or biophysical aspect requested by a health care professional in a prescription (see algorithm; par. 20 and 22). It would have been obvious to one of ordinary skill in the art at the time of the invention to include instructions to request physiological parameters to appropriately address any concerns or make improvements (see par. 9 and 11).
Regarding Claim 3, Giridharagopalan discloses wherein the prescription comprises modifying a starting bite position (see par. 9 and 29). It would have been obvious to instruct the user on starting bite position to ensure a greater degree of accuracy (see par. 9).
Regarding Claim 11, Logan discloses using the pressure sensor and airflow sensor to determine appropriate positioning of the MAD in the mouth (see par. 52 and 66), but not a positional sensor. Giridharagopalan discloses wherein the positional sensor detects and records the position of the MAD in a mouth with respect to a predetermined reference location (see par. 20 and 24). It would have been obvious to one of ordinary skill in the art at the time of the invention to use a positional sensor to sense and record the position of the MAD with respect to a predetermined reference location because Giridharagopalan teaches they all help to appropriately adjust the MAD location (see par. 24).
Regarding Claim 12, Logan discloses manual adjustment of the MAD placement (see par. 54, 56, 84), but does not disclose a motor connected to the MAD. Giridharagopalan discloses wherein a sensing block (see front screw driven device 48; par. 27) comprises a control module (see controller 14; par. 24) for activating a stepper motor, or an I/O bus to connect to external components (see motor 56; par. 25). It would have been obvious to one of ordinary skill in the art at the time of the invention to use a stepper motor so the MAD can appropriately moved in real time (see par. 9).
Regarding Claim 16, Logan discloses collecting and storing data over time (see par. 34, 52, and 84), but does not explicitly disclose tracking the position of the MAD in time. Giridharagopalan discloses wherein the base software logs the position of the lower dentition in time (see par. 22 and 28). It would have been obvious to one of ordinary skill in the art at the time of the invention to log the position of the MAD in order to determine alert conditions (see par. 22).
Regarding Claims 18 and 19, Giridharagopalan discloses wherein the mandibular advancement device further comprises a motor, and the action comprises a communication to the motor from the base to activate a change in the positional relationship of the upper splint positioned on the upper dentition to the lower splint positioned on the lower dentition (see par. 11 and 29). It would have been obvious to one of ordinary skill in the art at the time of the invention to use a stepper motor so the MAD can appropriately moved in real time (see par. 9).
Regarding Claim 20, see rejections of claims 13, 17, and 18 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Damen et al. (PG Pub. 2021/0022913) discloses a pocket (see compartment 105; par. 69) that holds the sensors in the oral cavity (see Fig. 3).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/N.P/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792