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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 2, 2026 has been entered.
Response to Arguments
Applicant’s remarks filed June 2, 2026 have been fully considered and are persuasive as to all previous objections and rejections in view of the accompanying claim amendments. However, after further search and consideration, new grounds of rejection are made in view of additional prior art references.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0375528 A1 to Flanagan (hereinafter “Flanagan”) in view of US 2021/0022913 A1 to Damen et al. (hereinafter “Damen”).
Regarding Claims 1 and 19, Flanagan teaches a mandibular advancement device (MAD) (“mandibular advancement device” 4) comprising:
an upper splint fabricated to fit onto an upper dentition of an individual in need thereof (see e.g. FIG. 2; element 4 points to both the upper and lower splint/tray);
a lower splint physically separated from the upper splint and fabricated to fit onto a lower dentition of the individual in need thereof (see e.g. FIG. 2; element 4 points to both the upper and lower splint/tray),
a sensing block (2) dimensioned to be removably [attached to one of the splints] (see e.g. Para. 55 discussing attachment location and various advantages of being removable) (see e.g. FIGS. 2 and 7), wherein the sensing block comprises:
a sensor configured to measure a physiological parameter associated with a blood oxygen saturation level of the individual inside the oral cavity in substantially real time when the sensing block is inserted into the pocket and is lip sealed completely in the oral cavity and when the mandibular advancement device advances a mandible of the individual (see e.g. Para. 56: “The housing includes a lens 10 which allows the (optional) pulse oximeter chip optical access to the buccal mucosa so that data on heart rate and blood oxygen saturation can be obtained.”; also see Para. 67, 69, 96-98, 119, 121), and
a wireless communication component configured to transmit data associated with the blood oxygen saturation level wirelessly from within the oral cavity to an external device disposed outside the oral cavity when the sensing block is inserted into the pocket and is lip sealed completely inside the oral cavity and when the upper or lower splint is fitted onto the respective upper or lower dentition (see e.g. Para. 60: “Data, once collected, is transferred by a wired or wireless means, such as by the Bluetooth radio and antenna to the external smart phone APP”; also see e.g. FIGS. 1 5-6 and 8), and
at least one component comprising a rechargeable or replaceable battery, a battery recharging circuit, or an on-board memory (see e.g. FIG. 5 showing all of these).
Flanagan teaches that the one or more sensing blocks (2) may be attached to the MAD in a variety of removable ways as discussed in e.g. Para. 55, but fails to specify a “pocket” in one of the splints into which the sensing block is inserted. However, such a configuration was known in an extremely similar device; Damen illustrates a similar MAD (see e.g. title, abstract) including at least one sensing block (41 and/or 42) inserted into a pocket (compartment) formed in one of the splints/trays (see e.g. FIGS. 3-4 and Paras. 69-71). The use of such a pocket/compartment allows the sensing block to sit flush with the rest of the splint outer surface, which enhances comfort (see e.g. Para. 71: “An outer surface of the cover 41, 42 is positioned flush with an outer surface of the maxillary splint body 100 to improve comfort in wearing the device in the oral cavity”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Flanagan to form a pocket for receiving the sensing block, as seen in Damen, because it would advantageously allow the sensing block to sit flush with the splint outer surface (rather than protrude) which would predictably enhance comfort for the wearer.
Regarding Claims 2-4, Flanagan’s device is fully capable of being used on a patient who has received a prescription as recited in these claims. For instance, Flanagan’s device (which includes a sensor for measuring oxygen saturation as discussed above in the rejection of claim 1) is fully capable of being used on a patient who has received a prescription for oxygen saturation to be measured as requested by a health care professional, which meets the language of claim 2. Similarly, Flanagan’s device is fully capable of being used on a patient who has received a prescription that “comprises modifying a starting bite position” (as in claim 3) and that “comprises information associated with an anterior discluder, splint options, or a titration mechanism” (as in claim 4).
Regarding Claim 5, Flanagan teaches wherein the device comprises two or more sensors including the sensor, and wherein all the sensors are on one splint, either the upper or the lower splint, of the MAD (see e.g. FIG. 5 showing various sensor types; see e.g. FIG. 2 showing one configuration where all the sensors are in a single sensing block on a single splint).
Regarding Claim 6, Flanagan teaches that the sensing block may be split into two or more sensing blocks distributed at different positions on the MAD (see e.g. Paras. 71-73) and that various attachment points are contemplated (see e.g. Para. 55: “It is understood that this mounting location is not the only potential mounting location which might be used”). While Flanagan doesn’t explicitly show a sensor incorporated into or attached to the lower splint, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Flanagan to distribute one or more of the sensors on the lower splint since Flanagan teaches that splitting the components is desirable for making use of the limited space in the oral cavity (see e.g. Para. 71: “The splitting of the electronics module being advantageous to ensure that the electronics modules fits more easily or comfortably into the highly limited intraoral space”), and such a modification would amount to a mere rearrangement of parts which involves only routine skill in the art (see MPEP § 2144.04(VI)(C)) particularly here where the mere repositioning of sensor(s) on the lower splint would not yield any change in function compared to positioning those sensor(s) on the upper splint.
Regarding Claim 7, Flanagan teaches wherein the device comprises a plurality of sensors including the sensor, and wherein the plurality of sensors comprises a physiological sensor, a physical sensor, a chemical sensor, or a positional sensor (see e.g. FIG. 5 showing various sensor types).
Regarding Claim 8, Flanagan teaches wherein the physiological sensor is configured to measure patient data comprising blood oxygen levels, body temperature, respiration rate, or heart rate (see e.g. Para. 56: “The housing includes a lens 10 which allows the (optional) pulse oximeter chip optical access to the buccal mucosa so that data on heart rate and blood oxygen saturation can be obtained.”; also see Para. 67, 69, 96-98, 119, 121).
Regarding Claims 9-11, these claims only modify alternatives from claim 7 which need not be shown since the “physiological sensor” in the list of alternatives was shown in Flanagan in the rejections of claims 7-8 above.
Regarding Claim 12, Flanagan teaches wherein the sensing block further comprises a control module for activating an I/O bus to connect to external components (see e.g. FIG. 5 showing the various components; see e.g. Para. 70; see e.g. Para. 72: “each split electronics module can interact via Bluetooth (or other wired or wireless means) with other split elements of the electronics module and each split element of the electronics module can interact via Bluetooth (or other wired or wireless means) with the external smart phone”).
Regarding Claim 13, Flanagan teaches wherein, among the upper splint and the lower splint, a splint without the sensing block is configured to mechanically fail before the other splint comprising the sensing block fails mechanically (either splint is capable of failing first, depending on the forces experienced; so, for example, in the embodiment of FIG. 2 of Flanagan where the sensing block is on the upper splint, it is entirely possible that the lower splint could mechanically fail first without the upper splint mechanically failing).
Regarding Claim 14, Flanagan teaches wherein the wireless communication component is configured to communicate wirelessly using a radio signal, an infrared signal, or a magnetic signal (Bluetooth radio waves; see e.g. Paras. 33, 50, 60, 70, 72, 109).
Regarding Claim 15, Flanagan teaches wherein the external device comprises software, optionally software on an app, a smartphone, a smart tablet, a laptop computer or a desktop computer (see e.g. smart phone 6 and/or terminal/computer 8; see e.g. Para. 50: “The electronics module sends data which it records with its on-board sensors systems to an external smart phone 6 APP by wired or wireless means such as Bluetooth and ultimately to a remote computer, smart phone or tablet 8 via the internet or cloud.”).
Claims 12, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan in view of Damen as applied to claim 1 above, and further in view of US 2017/0196727 A1 to Giridharagopalan (hereinafter “Giridharagopalan”).
Regarding Claim 16, Flanagan as modified fails to specifically teach that the software is configured to log a position of the lower dentition in time. Another reference, Giridharagopalan, teaches a similar MAD which logs the position of the lower dentition in time (see e.g. Paras. 22 and 28). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Flanagan to log the position of the lower dentition in time, as seen in Giridharagopalan, because this would be inherently valuable diagnostic information of the patient, and as such its collection and presentation to the wearer and/or a health care provider would be inherently advantageous.
Regarding Claims 12, 17-18 and 20, Flanagan as modified fails to specifically teach that the MAD comprises a stepper motor and that feedback control from the data is used by the processor to control the motor to activate a change in a positional relationship of the upper splint to the lower splint. Another reference, Giridharagopalan, teaches a similar MAD including feedback control from a processor/controller to control a stepper motor that activates a change in positional relationship between the upper and lower splints in response to sensed data, for example including oxygen saturation data (see e.g. the abstract and Paras. 20-22, 24-25, 29) for providing various benefits (see e.g. Paras. 6-9). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Flanagan to incorporate a motor and automated feedback control of the motor based on the sensed data, as seen in Giridharagopalan, because it is taught to be advantageous for allowing adjustments to be made more regularly, intelligently and accurately (see e.g. Paras. 6-8 of Giridharagopalan).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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