DETAILED ACTION
This action is responsive to “RESPONSE TO RESTRICTION REQUIREMENT” filed 23 February 2026. The Examiner acknowledges the cancelation of claim 34. Claims 1-33 are 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 .
Election/Restrictions
Applicant’s election without traverse of group I directed towards claims 1-33 in the reply filed on 23 February 2026 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because: “302” is used to designate the “inner wall” [Applicant’s Specification ¶00220] of mouthpiece 300 and what appears to be an upper wall between the inner wall and the outer wall of mouthpiece 300 in Fig. 5; “304” is used to designate the “outer wall” [Applicant’s Specification ¶00220] of mouth piece 300 and what appears to be the lumen of tube 120 in Fig. 5; “1203” is used to designate the “PCB” [Applicant’s Specification ¶00291] and an additional unidentified element in Fig. 20; “4” is used to designate “900053-001 VHB, 3M, 4920” and “900029-001 BATTERY, 601220, 100 MAH, Shenzen Topway New Energy Co” in Fig. 21.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “305a” [Applicant’s Specification ¶00259], “305b” [Applicant’s Specification ¶00259].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “2104” [Fig. 8B], “702” [Fig. 12], “704” [Fig. 12], “800” [Fig. 15], “801” [Fig. 15], “802” [Fig. 15], “900” [Fig. 16], “950” [Fig. 17], “1103” [Fig. 19], “1200” [Fig. 20], “1202” [Fig. 20], “1” [Fig. 21], “2” [Fig. 21], “4” [Fig. 21], “5” [Fig. 21], “6” [Fig. 21], “8” [Fig. 21], “9” [Fig. 21], “10” [Fig. 21], “11” [Fig. 21], “1400” [Fig. 22], “1500” [Fig. 23].
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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) 1-7, 9-12, 22-23, 26-27, and 29-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Tawil (US-20120123225-A1, cited by Applicant).
Regarding claim 1, Al-Tawil teaches
An apparatus comprising:
a housing [electronics box 140 (Al-Tawil Fig. 1)]; and
a sensor contained in the housing, the sensor configured to detect a characteristic due to a biting force applied by a user [The jumper tubes 150 place the transducers 110 in fluid communication with the air tubes 150 and the individual cells of the mouth piece 200 via the manifold 130 (Al-Tawil ¶0099, Fig. 1); The transducers 110 are in the nature of pressure sensors (Al-Tawil ¶0100); During a period of sleep, the patient may begin to grind his or her teeth. This causes changes in pressure within the cells of the mouth piece 200. The transducers 110 sense the changes in pressure within the cells and convert them to electrical signals. The electrical signals may be analog voltage signals. Other examples of electrical signals that may be used include current signals or resistive changes. The changes in pressure within the cells are delivered pneumatically or fluidically, depending on the fluid used, to the transducers 110 through the respective tubes 250 (or 350). As the transducers 110 sense an increase in pressure, a corresponding voltage or other electrical signal is delivered through the electrical circuit board 144 to the processor 120, such as a micro-controller (Al-Tawil ¶0111)].
Regarding claim 2, Al-Tawil teaches
The apparatus of claim 1, further comprising a tube extending from the housing, wherein the tube has an end configured to couple to a mouthpiece [the tubes 250 are optionally bundled as they exit the mouth piece 200. This means that the tubes 250 are held together externally by a tubular sheath 255. The tubular sheath 255 protects the individual tubes 250, and also prevents them from becoming tangled and constricted (Al-Tawil ¶0072, Fig. 1); The electronics box 140 is framed by side walls 145. A front wall 145f of the electronics box 140 includes a manifold 130. The manifold 130 includes an array of nozzles 142 extending outwardly from the front wall 145f. The nozzles 142 receive respective tubes 250. The tubes 250 may be referred to as mouth piece tubes as they extend from the mouth piece 200. Preferably, the tubes 250 are bundled in the tubing sheath 255 (Al-Tawil ¶0098)].
Regarding claim 3, Al-Tawil teaches
The apparatus of claim 2, further comprising the mouthpiece [mouth piece 200 (Al-Tawil Fig. 1)], wherein the mouthpiece comprises a first cavity configured to be in fluid communication with a lumen of the tube [The mouth piece 200, or at least portions of the left 210A and right 210B sides of the mouth piece 200, is designed to be substantially hollow (Al-Tawil ¶0061); The mouth piece 300 provides an arrangement wherein integral channels communicate fluid pressure between individual cells and corresponding tubes 350 (Al-Tawil ¶0074, Fig. 3A); The jumper tubes 150 place the transducers 110 in fluid communication with the air tubes 150 and the individual cells of the mouth piece 200 via the manifold 130 (Al-Tawil ¶0099)].
Regarding claim 4, Al-Tawil teaches
The apparatus of claim 1, wherein the characteristic comprises pressure [Al-Tawil ¶0111], and wherein the apparatus is configured to provide feedback to the user if the pressure due to the biting force exceeds a pressure threshold [The signals 562 are indicative of the pressure profile generated by the processor 520. The signals 562 are transmitted to a transceiver (not shown) associated with a monitor (Al-Tawil ¶0123), wherein any measured pressure may be considered to be above a non-specific threshold and visualization of pressure signals is considered to be a form of feedback].
Regarding claim 5, Al-Tawil teaches
The apparatus of claim 4, wherein the pressure threshold has a constant value [A baseline or steady-state value representing no pressure being applied to the mouth piece 110 may be subtracted from the pressure profile to more accurately determine the actual pressure applied by the patient (Al-Tawil ¶0113)].
Regarding claim 6, Al-Tawil teaches
The apparatus of claim 4, wherein the pressure threshold is variable over time [The health care professional may compare the pressure profile to a baseline to determine if pressure readings exceed the baseline (Al-Tawil ¶0144); the baseline for bite force can vary depending on location along the dental arch (Al-Tawil ¶0145); In addition, the baseline, or "norm," will vary depending on different factors… Overall, a healthcare provider may be concerned about any nocturnal bite pressure readings that exceed, for example, an average of 25 N or greater over a 10 minute period, or, alternatively, an average of 50 N or greater, or 200 N or greater, over a 5 minute period. In one aspect, the processor compares average pressure readings from the fluid cells to a designated baseline for the patient (Al-Tawil ¶0146)].
Regarding claim 7, Al-Tawil teaches
The apparatus of claim 6, wherein the pressure threshold is variable based on an averaging pressure values associated with a non-bruxing event in a moving temporal window [Al-Tawil ¶¶0144, 0146, wherein determining an average pressure value over a window of time at different times across a sleeping is considered to read on the recited limitation].
Regarding claim 9, Al-Tawil teaches
The apparatus of claim 6, wherein the pressure threshold has a value that is larger than a baseline pressure value associated with a non-bruxing event [Al-Tawil ¶0146].
Regarding claim 10, Al-Tawil teaches
The apparatus of claim 1, further comprising a processing module configured to determine a baseline pressure value associated with a non-bruxing event [Al-Tawil ¶0113].
Regarding claim 11, Al-Tawil teaches
The apparatus of claim 10, wherein the processing module is configured to determine the baseline pressure value by averaging pressure values associated with the non-bruxing event in a moving temporal window [Al-Tawil ¶¶0113, 0144, 0146, wherein determining an average pressure value over a window of time at different times across a sleeping is considered to read on the recited limitation].
Regarding claim 12, Al-Tawil teaches
The apparatus of claim 1, further comprising a feedback signal generator configured to provide feedback to the user [Al-Tawil ¶0123, wherein providing a visualization of pressure signals is considered to be a form of feedback].
Regarding claim 22, Al-Tawil teaches
The apparatus of claim 1, further comprising a communication unit configured to communicate with an external device, wherein the communication unit comprises a wireless device and/or a cable port [As an additional feature, the bite pressure monitoring system 500 of FIG. 5A optionally also includes a transmitter 560. The transmitter 560 transmits wireless signals 562. The signals 562 are indicative of the pressure profile generated by the processor 520. The signals 562 are transmitted to a transceiver (not shown) associated with a monitor (Al-Tawil ¶0123); The signals 562 may be transmitted as radio-frequency (RF) or infrared (IR) signals. Alternatively, the signals 562 may be other wireless means such as Bluetooth, Wi-Fi, or Wi-Max (Al-Tawil ¶0124); the transceiver stores the pressure profile into a digital file on a computer. The computer may be a portable, hand-held electronic device such as a so-called smart phone, or may be a so-called tablet computer (Al-Tawil ¶0125)].
Regarding claim 23, Al-Tawil teaches
The apparatus of claim 22, wherein the external device is a cell phone, a computer, a server, a tablet, or a watch [Al-Tawil ¶0125].
Regarding claim 26, Al-Tawil teaches
The apparatus of claim 1, further comprising a non-transitory medium contained by the housing [various electrical components are seen associated with the electronics box 540. These include transducers 510, a processor 520, and an electrical circuit board 544. The transducers 510 operate in accordance with transducers 110 shown in FIG. 1 and described above. Similarly, the processor 520 operates in accordance with processor 120 of FIG. 1 described above. In this respect, the processor 520 uses operational software for processing electrical signals from the transducers 510 (Al-Tawil ¶0121)], wherein the non-transitory medium is configured to store:
a time-series of pressure values outputted by the sensor [The pressure profile represents a magnitude of pressure from within the cells as a function of time. The pressure profile may show each cell separately, or may combine or average the pressures of the cells in some way. The processor 520 stores the pressure profile in memory (Al-Tawil ¶¶0121-0122)],
a time-series of pressure threshold values,
sound data recorded during a sleeping event of the user, or
two or more of any of the foregoing.
Regarding claim 27, Al-Tawil teaches
The apparatus of claim 1, wherein the apparatus is configured to provide feedback to the user [Al-Tawil ¶0123, wherein providing a visualization of pressure signals is considered to be a form of feedback], and wherein the apparatus comprises a non-transitory medium configured to store a time at which the feedback is provided to the user [Al-Tawil ¶¶0121-0122, wherein storing the pressure profile that depicts pressure magnitude over time is considered to store the time at which the feedback is provided to the user, as the feedback is a visualization of pressure over time].
Regarding claim 29, Al-Tawil teaches
The apparatus of claim 1, wherein the apparatus is a processing module configured to couple to a mouthpiece [Al-Tawil ¶¶0072, 0098, Fig. 1].
Regarding claim 30, Al-Tawil teaches
The apparatus of claim 1, further comprising a mouthpiece, wherein the housing and the sensor are parts of a processing module that is configured to couple to the mouthpiece [Al-Tawil ¶¶0072, 0098, 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.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil, as applied to claim 6 above, in view of Osorio Martini (US-20220008243-A1), hereinafter Osorio, and O’Hare (“An Intraoral Non-Occlusal MEMS Sensor for Bruxism Detection”, NPL attached).
Regarding claim 8, Al-Tawil teaches
The apparatus of claim 6.
However, Al-Tawil fails to explicitly disclose further comprising a temperature sensor, wherein the pressure threshold is based on an output provided by the temperature sensor.
Osorio discloses an apparatus comprising a housing; and a sensor contained in the housing, the sensor configured to detect a characteristic due to a biting force applied by a user [the smart night guard measures and records teeth grinding and clenching through an embedded pressure sensor and optionally additional data such as any of respiratory rate, heart rate, and movement through an embedded accelerometer (Osorio ¶0006)]; wherein Osorio discloses wherein the apparatus further comprises a temperature sensor [the smart night guard further comprises at least one sensor. In some embodiments, the at least one sensor comprises a motion sensor, a temperature sensor, a pH sensor, a gyroscope, a geomagnetic sensor, or any combination thereof. In some embodiments, the sensor data comprises absolute orientation, angular velocity vectors, acceleration vectors, magnetic field strength vectors, linear acceleration vectors, gravity vectors, ambient temperature, or any combination thereof (Osorio ¶0007); the data gathered by the smart night guard allows output data on absolute orientation, angular velocity vectors, acceleration vectors, magnetic field strength vectors, linear acceleration vectors, gravity vectors, ambient temperature, or any combination thereof. For example, the data output by this device can be used in assessing the user's compliance to wearing the device, the user's movement while wearing the device, the user's respiratory rate, the user's heart rate, and the sleep state of the user (Osorio ¶0027)].
O’Hare discloses systems for detecting a characteristic due to biting force applied by a user, wherein O’Hare discloses measuring temperature to provide contextual information regarding an open or closed state of the user’s mouth [Pressure signal features were calculated for each 250 ms epoch of data and classified using a linear discriminant analysis (LDA) classifier. The 250 ms epoch length was selected as this is the minimum duration for a masseter EMG burst to be considered a bruxism event. The first step to calculating features from the pressure signals was to remove the undesirable baseline wander caused by pressure and temperature changes in the mouth, which are potentially caused by altering the mouth from being opened and closed plus from cold air being breathed in (O’Hare p. 156)].
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 apparatus of Al-Tawil to employ further comprising a temperature sensor, wherein the pressure threshold is based on an output provided by the temperature sensor, so as to take into account additional contextual information of the user’s mouth for detecting bruxism.
Claim(s) 13-18, 21, 24-25, 28, 31, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil, as applied to claims 1 and 12 above, in view of Radmand (US-20200038231-A1, cited by Applicant).
Regarding claim 13, Al-Tawil teaches
The apparatus of claim 12.
However, Al-Tawil fails to explicitly disclose wherein the feedback signal generator comprises: a vibrational force generator configured to provide vibration energy, a sound generator configured to provide an audio output, a light generator configured to provide light, or a current generator configured to provide an electric signal.
Radmand discloses systems for detecting a characteristic due to a biting force applied by a user, wherein Radmand discloses that the system comprises a feedback signal generator configured to provide feedback to the user, wherein the feedback signal generator comprises: a current generator configured to provide an electric signal [According to an aspect and as illustrated in FIGS. 2-4, the at least one stimulator 40 is provided near the posterior portion 22 of the mouthpiece 20, that is generally near the back of the user's mouth. The stimulator 40 is configured to provide a gentle stimulation to the tongue of the user… Such stimulation may be electrical impulses that cause the genioglossus muscle to contract and/or cause the user to reduce the amount of force being applied to occlusal and/or bite surfaces of the user's teeth (Radmand ¶0035); the stimulator 40 is activated if the pressure sensors 32 detect grinding and/or clenching by the user. According to an aspect, the stimulator 40 provides stimulation until the force applied to occlusal and/or bite surfaces of the user's teeth are below a predetermined force level. The stimulator 40 may stop stimulation once the pressure sensors 32 detect that grinding and/or clenching has substantially decreased and/or ceased, as evidenced by the detected force level (Radmand ¶0036); the strength and frequency of the electrical impulses in variant mode will depend on how quickly the oxygen saturation of hemoglobin and/or the predetermined force level is achieved (Radmand ¶0037)].
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 apparatus of Al-Tawil to employ wherein the feedback signal generator comprises: a vibrational force generator configured to provide vibration energy, a sound generator configured to provide an audio output, a light generator configured to provide light, or a current generator configured to provide an electric signal, so as to reduce clenching and/or grinding of the user’s teeth.
Regarding claim 14, Al-Tawil teaches
The apparatus of claim 12.
However, Al-Tawil fails to explicitly disclose wherein the feedback has an intensity sufficient to cause the user to stop or reduce the biting force.
Radmand discloses providing feedback to a user at an intensity sufficient to cause the user to stop or reduce the biting force [Radmand ¶0034].
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 apparatus of Al-Tawil to employ wherein the feedback has an intensity sufficient to cause the user to stop or reduce the biting force, so as to reduce clenching and/or grinding of the user’s teeth.
Regarding claim 15, Al-Tawil in view of Radmand teaches
The apparatus of claim 14, wherein the intensity of the feedback is based on a failure or a success of a previous feedback to cause a reaction from the user [Radmand ¶¶0036-0037].
Regarding claim 16, Al-Tawil teaches
The apparatus of claim 12.
However, Al-Tawil fails to explicitly disclose wherein the apparatus is configured to detect a snoring of the user, and wherein the feedback has an intensity sufficient to cause the user to stop the snoring.
Radmand discloses detecting a snoring of the user, and wherein feedback is provided to the user at an intensity sufficient to cause the user to stop the snoring [The oral appliance 10 may include a noise detector 35 configured to detect actual noise and/or vibrations caused by the user's snoring (Radmand ¶0034); the microprocessor 50 activates the stimulator if the noise detector 35 determines that the user's actual noise and/or vibrations during sleep are above the predetermined noise level (Radmand ¶0038); the stimulator 40 is activated if the noise detector 35 detects that the actual noise and/or vibrations are above a predetermined noise level. In this embodiment, the stimulator 40 provides gentle electrical stimulation to the genioglossus muscle of the user's tongue until the actual noise and/or vibrations are below the predetermined noise level (Radmand ¶0036)].
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 apparatus of Al-Tawil to employ wherein the apparatus is configured to detect a snoring of the user, and wherein the feedback has an intensity sufficient to cause the user to stop the snoring, so as to inhibit and/or limit snoring that may be caused by obstructive sleep apnea.
Regarding claim 17, Al-Tawil teaches
The apparatus of claim 12.
However, Al-Tawil fails to explicitly disclose wherein the apparatus is configured to detect an apnea event, and wherein the feedback has an intensity sufficient to cause the user to stop the apnea event.
Radmand discloses detecting a snoring of the user, wherein Radmand notes that snoring may be caused by obstructive sleep apnea, and wherein feedback is provided to the user at an intensity sufficient to cause the user to stop the snoring [Radmand ¶¶0034, 0036, 0038; Embodiments of the disclosure related generally to devices and methods for treating obstructive sleep apnea, as well as a device for providing electrical stimulation to a user's tongue to inhibit and/or limit snoring that may be caused by obstructive sleep apnea (Radmand ¶0021)].
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 apparatus of Al-Tawil to employ wherein the apparatus is configured to detect an apnea event, and wherein the feedback has an intensity sufficient to cause the user to stop the apnea event, so as to inhibit and/or limit snoring that may be caused by obstructive sleep apnea.
Regarding claim 18, Al-Tawil in view of Radmand teaches
The apparatus of claim 17, wherein the apparatus is configured to detect the apnea event based on an output from a microphone [Radmand ¶0034] and/or an output from a pulse oximeter.
Regarding claim 21, Al-Tawil teaches
The apparatus of claim 1.
However, Al-Tawil fails to explicitly disclose further comprising a light sensor, wherein the apparatus is configured to determine a sleeping parameter based on an output from the light sensor.
Radmand discloses Radmand discloses an apparatus comprising a housing and a sensor contained in the housing, wherein the sensor is configured to detect a characteristic due to a biting force applied by a user are implemented as part of a mouthpiece [Radmand ¶¶0031, ¶0038], and wherein the apparatus further comprises a light sensor, wherein the apparatus is configured to determine a sleeping parameter based on an output from the light sensor [the components positioned on and/or embedded within the mouthpiece 20 include one or more of the following components: an oxygen sensor 30 (Radmand ¶0029); The oxygen sensor 30 may be adapted to monitor and/determine the pulse and/or heart rate of the user… An exemplary pulse oximeter, for example, may include light emitting diodes configured to transmit red and infrared lights to vascular surfaces of the user's tongue and sense changes in oxygen level in the user's tongue (Radmand ¶0030), wherein as the oral appliance 10 of Radmand is configured to be worn and used while the user is asleep (Radmand ¶0028), the light sensor is considered to be configured to measure oxygen saturation while the user is asleep, such that the measured oxygen saturation is considered to be a sleeping parameter].
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 apparatus of Al-Tawil to employ a light sensor, wherein the apparatus is configured to determine a sleeping parameter based on an output from the light sensor, so as to allow for the detection of oxygen saturation levels during sleep that are considered to be indicative of obstructive sleep apnea.
Regarding claim 24, Al-Tawil teaches
The apparatus of claim 1.
However, Al-Tawil fails to explicitly disclose further comprising a rechargeable battery contained by the housing.
Radmand discloses an apparatus comprising a housing and a sensor contained in the housing, wherein the sensor is configured to detect a characteristic due to a biting force applied by a user are implemented as part of a mouthpiece, and wherein the apparatus further comprises a rechargeable battery contained by the housing [a microprocessor 50 may be provided on and/or embedded within the mouthpiece 20… the microprocessor 50 may be positioned at any location that enables it to communicate with the components included in the oral appliance 10, such as, for example, the oxygen sensor 30, the pressure sensor 32, the airflow sensor 34, the noise detector 35, the actigraphy sensor 36, the stimulator 40, the data recorder 60, and/or a battery 70 (Radmand ¶0038); the one or more pressure sensors 32 are configured to detect signs of clenching and/or grinding by the user that occur, for example, while the user is asleep (Radmand ¶0031)].
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 apparatus of Al-Tawil to employ wherein the housing has a crescent shape, so as to allow the housing to be positionable within the user’s mouth as part of a mouthpiece as this modification would amount to merely applying a known technique [incorporation of housing, sensors, and corresponding battery to power electronic systems into a mouthpiece] to a known device (method, or product) ready for improvement to yield predictable results [allow for monitoring of bruxism] [MPEP § 2143(I)(D)].
Regarding claim 25, Al-Tawil teaches
The apparatus of claim 1.
However, Al-Tawil fails to explicitly disclose wherein the housing has a crescent shape.
Radmand discloses wherein a housing and a sensor contained in the housing, wherein the sensor is configured to detect a characteristic due to a biting force applied by a user are implemented as part of a mouthpiece, and wherein the housing has a crescent shape [Radmand ¶¶0031, 0038, wherein as depicted in Radmand Fig. 2, the oral appliance 10, which is considered to define a mouthpiece and house at least pressure sensor 32, is “crescent shaped”].
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 apparatus of Al-Tawil to employ wherein the housing has a crescent shape, so as to allow the housing to be positionable within the user’s mouth as part of a mouthpiece as this modification would amount to merely applying a known technique [incorporation of housing and sensors into a mouthpiece] to a known device (method, or product) ready for improvement to yield predictable results [allow for monitoring of bruxism] [MPEP § 2143(I)(D)].
Regarding claim 28, Al-Tawil teaches
The apparatus of claim 1.
However, Al-Tawil fails to explicitly disclose further comprising a pulse oximeter.
Radmand discloses an apparatus comprising a housing and a sensor contained in the housing, wherein the sensor is configured to detect a characteristic due to a biting force applied by a user, and wherein the housing and sensor are implemented as part of a mouthpiece [Radmand ¶¶0031, ¶0038], and wherein the apparatus further comprises a pulse oximeter [the components positioned on and/or embedded within the mouthpiece 20 include one or more of the following components: an oxygen sensor 30 (Radmand ¶0029); The oxygen sensor 30 may be adapted to monitor and/determine the pulse and/or heart rate of the user (Radmand ¶0030)].
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 apparatus of Al-Tawil to employ a pulse oximeter, so as to allow for the detection of oxygen saturation levels during sleep that are considered to be indicative of obstructive sleep apnea.
Regarding claim 31, Al-Tawil teaches
The apparatus of claim 1.
However, Al-Tawil fails to explicitly disclose wherein the housing is a mouthpiece, or is implemented as a part of the mouthpiece.
Radmand discloses wherein a housing and a sensor contained in the housing, wherein the sensor is configured to detect a characteristic due to a biting force applied by a user, wherein the housing and sensor are implemented as part of a mouthpiece [Radmand ¶¶0031, 0038].
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 apparatus of Al-Tawil to employ wherein the housing is a mouthpiece, or is implemented as a part of the mouthpiece, as this modification would amount to merely applying a known technique [incorporation of housing and sensors into a mouthpiece] to a known device (method, or product) ready for improvement to yield predictable results [allow for monitoring of bruxism] [MPEP § 2143(I)(D)].
Regarding claim 33, Al-Tawil teaches
The apparatus of claim 1.
However, Al-Tawil fails to explicitly disclose wherein the housing is configured for placement in a mouthpiece.
Radmand discloses wherein a housing and a sensor contained in the housing, wherein the sensor is configured to detect a characteristic due to a biting force applied by a user are implemented within a mouthpiece [Radmand ¶¶0031, 0038].
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 apparatus of Al-Tawil to employ wherein the housing is configured for placement in a mouthpiece, as this modification would amount to merely applying a known technique [incorporation of housing and sensors into a mouthpiece] to a known device (method, or product) ready for improvement to yield predictable results [allow for monitoring of bruxism] [MPEP § 2143(I)(D)].
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil, as applied to claim 1 above, in view of Osorio Martini (US-20220008243-A1), hereinafter Osorio.
Regarding claim 19, Al-Tawil teaches
The apparatus of claim 1.
However, Al-Tawil fails to explicitly disclose further comprising an accelerometer configured to detect an orientation associated with the user.
Osorio discloses an apparatus comprising a housing; and a sensor contained in the housing, the sensor configured to detect a characteristic due to a biting force applied by the user [the smart night guard measures and records teeth grinding and clenching through an embedded pressure sensor and optionally additional data such as any of respiratory rate, heart rate, and movement through an embedded accelerometer (Osorio ¶0006)]; wherein Osorio discloses wherein the apparatus further comprises an accelerometer configured to detect an orientation associated with the user [the data output by this device can be used in assessing the user's compliance to wearing the device, the user's movement while wearing the device, the user's respiratory rate, the user's heart rate, and the sleep state of the user (Osorio ¶0027); In some embodiments, the application is configured to evaluate user compliance (e.g., using accelerometer or geophysical location data to determine if the user is going to bed on time) (Osorio ¶0050)].
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 apparatus of Al-Tawil to employ further comprising an accelerometer configured to detect an orientation associated with the user, so as to provide additional contextual information regarding bruxism.
Regarding claim 20, Al-Tawil in view of Osorio teaches
The apparatus of claim 19, wherein the apparatus is configured to monitor a sleeping behavior of the user based on the detected orientation [Osorio ¶¶0006, 0027, 0050].
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil, as applied to claim 1 above, in view of Hamrah (US-11007076-B1).
Regarding claim 32, Al-Tawil teaches
The apparatus of claim 1.
However, while Al-Tawil discloses wherein the housing is configured to detachably couple to a mouthpiece [In the arrangement of FIG. 4, the transition section 340 has a widened end 345 to make it easier for a user to insert the tubes 350 into channels 330 (Al-Tawil ¶0090, Fig. 4)], Al-Tawil fails to explicitly disclose a configuration of the housing and mouthpiece wherein the housing is configured for placement inside a mouth of the user.
Hamrah discloses an apparatus comprising a housing and a sensor contained in the housing, wherein the sensor is configured to detect a characteristic due to a biting force applied by a user [the sensing and vibration assembly 112 further comprises a power source configured to provide power for the pair of pressure sensing devices 124, the vibration device 130, and the control device 128… Also, in the illustrative embodiment, the pair of pressure sensing devices 124 are in the form of piezoelectric sensors (e.g., piezoelectric pressure sensor strips) configured to sense a compression force exerted thereon by the grinding or clenching of the teeth 164 by the user (Hamrah Col 6:53-65, Fig. 2)]; wherein the housing is configured to detachably couple to a mouthpiece, and wherein the housing is configured for placement inside a mouth of the user [the sensing and vibration assembly 112 is removable from the mouth guard body portion 102 so as to enable the mouth guard body portion 102 to be cleaned separately from the sensing and vibration assembly 112 (Hamrah Col 6:32-35, Figs. 7-8)].
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 apparatus of Al-Tawil to employ wherein the housing is configured to detachably couple to a mouthpiece, and wherein the housing is configured for placement inside a mouth of the user, as this modification would amount to mere simple substitution of one known element [housing and sensor of Al-Tawil as configured to couple with the mouthpiece] for another [housing and sensor of Hamrah as configured to couple with the mouthpiece] with similar expected results [allow for monitoring of bruxism] [MPEP § 2143(I)(B)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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