DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
With regards to the specification objection for “claim 1, 10 and 14 recite variations of “classifying . . . individually,”.” the objection is withdrawn in view of the claim amendments.
With regards to the specification and drawings objection related to “The disclosure is objected to because of the following informalities: [0042] states “the third anatomical location 140 c may be defined along the interior part of the oral cavity near the soft palate and the uvula”.” the objection is withdrawn in view of the claim amendments.
With regards to the claim objection for “Claims 4 and 11 recite “where an airway collapses and sound creates”,” the objection is withdrawn in view of the amendment.
With regards to the claim objection for “Claim 10 is objected to because of the following informalities: Claim 10 recites “placing, intraorally, the second PPG sensor along a second anatomical location defined along an interior part of an oral cavity facing outward toward the labial mucosa. obtaining a plurality of second PPG”” the objection is withdrawn in view of the amendment.
With regards to the 101 rejections of claims 10-13 the rejection is withdrawn in view of the amendment including additional elements, in considering the amended elements in combination with previously recited elements Examiner has determined the claims recite additional elements that amount to significantly more than the judicial exception.
With regards to the previous 112a the rejection for “Claims 1, 10 and 14 recite “to classify one or more sleep stages of the user, individually, or in combination”.” is withdrawn in view of the amendments.
With regards to the discussion of 112b for “Claims 1, 10, 17 recite variations of “relating to a plurality of cardiorespiratory parameters” and later recite “the plurality of cardiorespiratory parameters based on the plurality of first PPG signal.”.” the rejections are withdrawn in view of the amendments.
With regards to the discussion of 112b for “Claims 1, 10, 17 recite variations of “of the user relating to a plurality of muscular parameters” and later recite “the plurality of muscular parameters based on the plurality of second PPG signals is configured to classify one or more sleep stages of the user”.” the rejections are withdrawn in view of the amendments.
With regards to the discussion of 112b for “Claims 1, 10, 17 recite variations of “of the user relating to a plurality of muscular parameters” and later recite “the plurality of muscular parameters based on the plurality of second PPG signals is configured to classify one or more sleep stages of the user”.” the rejections are withdrawn in view of the amendments.
With regards to the discussion of 112b for “Claims 1, 17 recite variations of “wherein the plurality of muscular parameters based on the plurality of second PPG signals is configured to classify one or more sleep stages of the user, individually, or in combination with the plurality of cardiorespiratory parameters based on the plurality of first PPG signal.”” the rejections are withdrawn in view of the amendments.
With regards to the discussion of 112b for “Claims 8 and 16 contain the trademark/trade name “Bluetooth”. ” the rejections are withdrawn in view of the amendments.
Applicant’s arguments, see Pgs. 15-16, filed 10/8/25, with respect to 103 rejection of claim 10 have been fully considered and are persuasive. The 103 rejection of claims 10 (and by extension it’s dependents) has been withdrawn. As claim 10 recites the method obtaining “a plurality of muscular parameters, including from the Buccinator, Medial Pterygoid, and Masseter muscles” and Applicant is explicitly arguing that while Satokawa “describes measuring changes in tissue oxygenation blood volume of the masseter muscle. However, Sat fails to disclose other muscular parameters, including the Buccinator and Medial Pterygoid, using such NIRS system.”, Examiner does find this argument persuasive. Applicants are taking the interpretation that a determination for each muscle(Buccinator, Medial Pterygoid, and Masseter) individually must be made, to that end, Examiner agrees the references do not disclose this. However, Examiner notes some of the other arguments directed to claim 10 were not persuasive see below. Additionally, see the 112a rejection below in view of the amendments.
Applicant's arguments filed 10/8/25 have been fully considered but they are not persuasive. With regards to the 103 rejections Applicants first argument is directed to claim 1 and 14 specifically arguing that “Lat merely describes a heart rate monitoring device for measuring the heart rate of the user. It appears that the action equates the heart rate monitoring device with the first PPG sensor. However, the same heart rate monitoring device cannot be equated with the second PPG device”. Examiner disagrees. The Lathrop reference discloses consistently gathering PPG data, see [0027] including “For example, a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. . . . If multiple wavelengths are utilized by the heart rate monitoring device other physiological parameters may be monitored via pulse oximetry such as peripheral capillary oxygen saturation (SpO2).” Explaining the heart rate monitor is a PPG sensor and that it can sense more than just heart rate. Then later recites multiple “heart rate monitor” (i.e. the PPG sensor) in [0041] including “the mouth guard 10 may include more than one heart rate monitoring device 78 (e.g., 2, 3, 4 or more devices 78). . . . to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.” and again recites it can gather multiple wavelengths of light to determine a plurality of physiological parameters. Per Applicants specification (see for example fig. 7) reciting “IR” wavelength (IR = infrared) as the wavelength of light “corresponding to” muscular parameters. As shown above Lathrop discloses a plurality of wavelengths including infrared in [0043] including “a plethysmographic signal may be obtained at at least a couple of wavelengths (e.g., red and infrared)”. Lathrop discloses PPG sensor in the same location as claimed which continuously measures infrared, as such it discloses “second PPG sensor measures wavelengths of light corresponding to a plurality of muscular parameters correlated to different muscular activities”. The sensing in that location of IR “corresponds” to the claimed muscles. To the extent it is “during sleep” this is an intended use of the device, the prior art device is structurally capable of performing the intended use. To the extent Applicants are reading in elements to the claims, with regards to Applicants seemingly arguing measurements of each muscle independently, this is improper (Examiner also notes the 112a rejection below). For the above reasons Applicants argument is not persuasive.
Applicants next argue that based on the first argument Lathrop does not disclose classifying. This is not persuasive for the reasons discussed above. Additionally, to the extent this is arguing against the reference individually, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants next argue against Yoon which was not recited for what Applicants are arguing against it for, thus this not persuasive and see discussion above about arguing against references individually.
Next Applicants discuss EMG, Examiner notes that Attorney arguments are not evidence on the record see MPEP 2145(I). As such this is not persuasive, to the extent it relies on arguments discussed previously it is not persuasive for the same reasons.
Applicant next discusses the rejection of claim 10 in view of Lathrop, Yoon, Radmand, Satokawa and Kahlert. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant is attacking the references individually for elements which they are not relied upon, for example Satokawa wasn’t relied upon for measuring during sleep, likewise Radmand wasn’t relied upon for disclosing explicitly determining muscle parameters. As such this is not persuasive.
With regards to the discussion of classifying using Kahlert, Examiner does not find this persuasive. The Kahlert reference discloses using a plurality of different data such as HR, HRV, muscle data etc. from multiple sensing modalities (including PPG) and discloses that muscle parameters would assist in sleep staging. Kahlert was not recited for disclosing muscle parameters. Thus, this is not persuasive.
With regards to the discussion of EMG see discussion for EMG above.
As discussed above the arguments regarding the art rejections were not persuasive (with the exception of the one argument for claim 10), the discussion of the dependent claims depends on the arguments discussed above and are not persuasive for the reasons discussed above.
Priority
Applicants claims 1, 10 and 14 recite variations of “including from the Buccinator, the Medial Pterygoid, and the Masseter muscles of the user”, while the masseter is discussed in Applicants claims 1, 10 and 14 recite variations of “including from the Buccinator, the Medial Pterygoid, and the Masseter muscles of the user”, while the masseter is discussed in the Provisional Application, 63/292,426 (‘426) from which this Application claims priority, the other muscles are not mentioned.
Applicants claims 1, 10 and 14 recite variations of “classifying one or more sleep stages of the user”, however, there does not appear to be support for this in the ‘426.
Applicants claims 1, 10 and 14 recite variations of “including from the Buccinator, the Medial Pterygoid, and the Masseter muscles of the user”, while the masseter is discussed in ‘426 the other muscles are not mentioned.
Applicants claims 1, 10 and 14 recite variations of “muscle parameters”, however, there does not appear to be support for this in the ‘426.
Applicants claims 4 and 11 recite “defined along the interior part of the oral cavity near a soft palate and a uvula, where an airway collapses and creates sound.” which also does not appear to have support in ‘426.
Applicants claims 5 and 12 recite “closest to the salivary glands/ducts, whereby saliva exists in a substantially higher volume” which also does not appear to have support in ‘426.
Examiner also notes that Fig. 8 in the drawings from 12/21/22 is not in the figures provided in the provisional application.
In view of the above discussion of ‘426 not providing disclosure for the discussed elements the priority date for the current Application claims 1-17 appears to be 12/21/22.
Applicant Admitted Prior Art
In [0029] of the provisional application, 63/292,426, from which the current Application claims priority, Applicant’s state “A recent study clearly confirms that the PPG signal can determine muscle activity.”. As such Applicants are acknowledging that PPG signals are known to determine muscle activity.
Claim Rejections - 35 USC § 112a
Claims 10-13 are 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.
Claim 10 recites “a plurality of muscular parameters, including from the Buccinator, Medial Pterygoid, and Masseter muscles of the user based on the processing of the plurality of second PPG signals”. However, there does not appear to be sufficient support for this in the specification and it appears to be new matter. Based on Applicants [0026] (Pg Pub) discussing fig. 7 “FIG. 7 illustrates a graph depicting intraorally monitoring masseter muscle activity by using a second photoplethysmography (PPG) sensor.” As such, there is support for the monitoring of the masseter muscle by itself. Furthermore, there is support, for the interpretation that it isn’t directly measuring the three muscles but that since the muscles in the area move together the gathered data would be “corresponding to” all three. That being said claim 10 is claiming data from all three directly/explicitly, which does not have support. The specification does not disclose doing this nor does it disclose how this is being done as claimed (for example, through hardware or software) because it merely recites abstractly gathering data “relating to a plurality of muscular parameters, including from the Buccinator, the Medial Pterygoid, and the Masseter muscles of the user”. If this is a processing step there are missing steps for separating out the data for each of the three muscles (see MPEP 2161.01). The claims recite the second PPG sensor, one sensor gathering data from all three muscles but the specification does not provide sufficient written description for this and it is new matter.
Examiner notes that Claims 1 and 14 recite slightly different claim language stating “the second PPG sensor measures wavelengths of light corresponding to a plurality of muscular parameters correlated to different muscular activities”. Currently Examiner is interpreting this as not requiring actual sensing of all three muscles just data “corresponding to” muscle parameters which are “correlated with” those muscle activities. While not currently claimed, as such If Applicants are meaning to interpret the elements of claims 1 and 14 to be equivalent to that of claim 10 and affirmatively requiring sensing from all three muscles then the above discussion for the 112a rejection of claim 1 likewise would apply to claims 1 and 14 (and their dependents).
Claim Rejections - 35 USC § 112b
Claims 1-17 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.
Claims 1 and 14 recite variations of “wherein the second PPG sensor measures wavelengths of light corresponding to a plurality of muscular parameters, correlated to different muscular activities during various stages of sleep are based on the second PPG signals”, there is an issue with the underlined portion. The first part defines that wavelengths of light are measured, those wavelengths “correspond to” a plurality of muscular parameters which themselves are “correlated to” stages of sleep. This only explicitly recites measuring the wavelengths, the claim doesn’t actually claim determining the “muscular parameters” or the “muscle activities”, just gathering wavelengths related to them. Then states “based on” the second PPG signals. What’s based on the second PPG signals? It’s unclear what this last part requires. There may be something missing from the claim? For one possible example, in arguendo, Applicants may have meant to recite determining the “muscular parameters” and determined what “muscle activities” have occurred based on the second PPG signals? However, that is not what’s currently claimed. Related to this there is also an issue with “wherein the plurality of muscular parameters is configured” because the as discussed above the first portion doesn’t actually recite determining “muscle parameters” it measures wavelengths which “correspond” to them thus what is actually being used in the classify part. As discussed above the claim does not clearly define the metes and bounds of the claim and the claim is indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-9, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190125261 to Braxton Lathrop et al. (hereinafter Lathrop) in view of US 20150305671 to Yong-kyu Yoon et al. (hereinafter Yoon) in further view of US 11033750 to Radmand (hereinafter Radmand) in further view of US 20190343456 to Joachim Kahlert (hereinafter Kahlert).
Regarding Claim 1, an interpretation of Lathrop discloses an intraoral monitoring device for a mouthpiece adapted to be received intraorally in a dentition of a user (abstract, [0023]), the intraoral monitoring device comprising:
a flexible substrate of the mouthguard ([0025] including “flexible PCB 12 encapsulated within a base member 14”, Figs. 1, 11, 14); and
a plurality of sensors integrated on a flexible printed circuit board (PCB) and coupled to the flexible substrate ([0023]-[0024] including “The one or more electronic devices may be disposed on one or more of the stiff sections of the flexible PCB”, [0041], [0045]), the plurality of sensors comprising:
a first photoplethysmography (PPG) sensor ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user.”, [0043]-[0044], Fig. 14) that includes a plurality of different wavelength first PPG signal emitting LEDs emitting light at different wavelengths chosen from at least two of the list of wavelengths consisting of infrared and red, and a photodetector for detecting such signals ([0043] including “an emitter 86 and a detector 88. Light from the emitter 86 (e.g., at one or more certain wavelengths) . . . the emitter 86 may emit light from one or more LEDs . . . The reflected or transmitted light may be detected with the detector 88, such as photodiode or photo-detector . . . a plethysmographic signal may be obtained at at least a couple of wavelengths (e.g., red and infrared)”, Figs. 13-14) coupled along an anterior portion of the flexible substrate ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user.”, [0043]-[0044], Fig. 14), and adapted to be located intraorally along a first anatomical location defined along a mid-line of a maxilla, facing outward to the labial mucosa, directly at a septal branch of a superior labial artery in a front lip ([0027], [0043]-[0044] including “For example, the heart rate monitoring device 78 may be located adjacent the septal artery, the inferior labial artery, or the superior labial artery.”, Figs. 13-14), to provide a plurality of first PPG signal, consistently, during sleep of the user wherein the first PPG sensor measures a plurality of cardiorespiratory parameters based on the first PPG signals, including cardiovascular parameters including a heart rate and a blood oxygen saturation of the user ([0027] including “If multiple wavelengths are utilized by the heart rate monitoring device other physiological parameters may be monitored”, [0041] including “to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044] including “a plethysmographic signal may be obtained at at least a couple of wavelengths (e.g., red and infrared) to determine the SpO2 and/or heart rate”, Fig. 14; to the extent “during sleep . . . “ is an intended use of the device the prior art device disclosed is structurally capable of performing the intended use), and
a second PPG sensor that includes a plurality of different wavelength second PPG signal emitting LEDs and a photodetector for detecting such signals ([0027], [0041] including “the mouth guard 10 may include more than one heart rate monitoring device 78 (e.g., 2, 3, 4 or more devices 78) . . . the device 78 to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044] including “an emitter 86 and a detector 88. Light from the emitter 86 (e.g., at one or more certain wavelengths) . . . the emitter 86 may emit light from one or more LEDs . . . The reflected or transmitted light may be detected with the detector 88, such as photodiode or photo-detector . . . a plethysmographic signal may be obtained at at least a couple of wavelengths”, Figs. 13-14) coupled to a rear portion of the flexible substrate ([0027], [0041] including “the mouth guard 10 may include more than one heart rate monitoring device 78 (e.g., 2, 3, 4 or more devices 78).”, [0043]-[0044], Fig. 14), adapted to be located intraorally along a second anatomical location defined along an interior part of an oral cavity facing outward toward the labial mucosa ([0027], [0043]-[0044], Fig. 14), to provide a plurality of second PPG signals, consistently, during sleep of the user, wherein the second PPG sensor measures wavelengths of light corresponding to a plurality of muscular parameters correlated to different muscular activities during various stages of sleep are based on the second PPG signals ([0027] including “If multiple wavelengths are utilized by the heart rate monitoring device other physiological parameters may be monitored”, [0041] including “to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044] including “a plethysmographic signal may be obtained at at least a couple of wavelengths (e.g., red and infrared)”, Fig. 14; to the extent “during sleep . . . “ is an intended use of the device the prior art device disclosed is structurally capable of performing the intended use. Examiner notes that based on Applicants specification [0040], Infrared (IR) light wavelengths are “wavelengths of light corresponding to a plurality of muscular parameters”. The reference discloses IR wavelength emission and measurement thus it discloses “measures wavelengths of light corresponding to a plurality of muscular parameters correlated to different . . . ”), including muscular activities from the Buccinator, the Medial Pterygoid, and the Masseter muscles of the user ([0027], [0041] including “to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044], Fig. 14), wherein the second PPG sensor measures wavelengths intraorally along mucosa ([0027], [0043]-[0044], Fig. 14 see also [0023]-[0024]).
An interpretation of Lathrop may not explicitly disclose the substrate adapted to be coupled to the mouthpiece.
However, in the same field of endeavor (medical diagnostic systems), Yoon teaches the substrate adapted to be coupled to the mouthpiece ([0025] including “flexible printed circuit board including a flexible substrate”, [0026] including “Since both the thin substrate and PDMS layer are flexible . . . deformable and can be fit in the uneven trench of the mouth guard”; PCB is attached to substrate and the combination is coupled to the mouthguard. Examiner notes that the discussion in MPEP 2144.04 of making separable supports this being obvious).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have combined the prior art elements of the mouthguard intraoral sensing device with a PCB coupled to the substrate of the mouthguard as recited by Lathrop to include a substrate and PCB coupled together and coupled to the mouthguard as recited by Yoon according to known methods to yield the predictable result of a smart mouthguard which has the substrate coupled to the PCB both coupled to the mouthguard.
An interpretation of Lathrop may not explicitly disclose PPG sensor measures a plurality of cardiorespiratory parameters including respiratory rate.
However, in the same field of endeavor (medical diagnostic devices), Radmand teaches a PPG sensor measures a plurality of cardiorespiratory parameters including respiratory rate (Col 6:18-47, Col 7:3-11 including “the integrated PPG sensor 206 is configured to determine the respiratory rate of the user”) while a user is asleep to classify sleep stages based on the PPG data (Col 5:66-Col 6:17 including “The light source 304 is configured to emit light to the user's oral mucosa and the photodetector 306 is configured to measure the light reflected from the user's gum or oral mucosa. The PPG sensor 206 generates data or a waveform that can be interpreted and provide pertinent health-related information.”, Col 9:34-58).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device gathering a plurality of data including from multiple PPG sensors as recited by Lathrop to include sensing respiration rate for determining sleep stages using a mouthguard sensing device as recited by Radmand because gathering the data for sleep staging with an intraoral mouthguard are comfortable and do not interfere with natural sleeping like previous systems which included being tethered to multiple devices (Col 2:58-Col 3:12).
An interpretation of Lathrop may not explicitly disclose classifying one or more sleep stages of the user based on the plurality of muscular parameters in combination with the plurality of cardiorespiratory parameters.
However, in the same field of endeavor (medical diagnostic devices), Kahlert teaches classifying one or more sleep stages of the user based on the plurality of muscular parameters in combination with the plurality of cardiorespiratory parameters ([0131], [0141] including “sleep staging may be made more accurate when muscle tension is added as input next to HR, HRV, RR, RRV and activity.” See also [0154]; Discloses use of a parameters based on a variety of sensing modalities including PPG. Users’ parameters vary through the night these changes are sensed and used in the sleep staging).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a plurality of sensors including gathering PPG data for sleep staging and gathering muscle parameters from PPG as recited by Lathrop in view of Yoon in further view of Radmand to more particularly include classifying sleep stages using a plurality of data including muscle parameters as recited by Kahlert because including muscle parameters can make the staging more accurate ([0141]).
Regarding Claim 4, an interpretation of Lathrop in view of Yoon in further view of Radmand in further view of Kahlert discloses the above in claim 1, as discussed in the rejection of claim 1 Lathrop discloses the use of plurality of sensors ([0027] including “The electronic devices 16 may include devices for monitoring one or more physiological parameters of the user (e.g., athlete) . . . Although the heart rate monitoring device is described in detail below, other devices may be utilized to determine physiological parameters of the user. For example, accelerometers may be utilized”, [0041]) located on the mouthguard/substrate at a plurality of locations including coupled along a first side portion of the flexible substrate and adapted to be located intraorally along a third anatomical location defined along the interior part of the oral cavity near a soft palate and a uvula, where an airway collapses and creates sound ([0024] including “the electronic devices disposed on the stiff sections of the flexible PCB of the mouth guard may be utilized to monitor a physiological parameter of the user.”, [0027], Figs. 3-4 see also [0044]-[0045]).
An interpretation of Lathrop may not explicitly disclose at least one microphone or acoustic sensor coupled to measure a snoring intensity of the user.
However, in the same field of endeavor (medical diagnostic devices), Kahlert teaches at least one microphone or acoustic sensor coupled to measure a snoring intensity of the user ([0140] including “a microphone is added for additional or more specific analysis of sleep disordered breathing (in particular snoring and apnea).”; to the extent “to measure a snoring . . .” is a intended use of the device, the device recited by the prior art is functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a plurality of sensors as recited by Lathrop in view of Yoon to include an intraoral microphone as recited by Kahlert because it adds more specific analysis of sleep disordered breathing in particular snoring ([0140]).
With regards to the positioning of the elements in the claimed positions, the Lathrop reference discloses electronic elements (including sensors) being positioned at various positions with the claimed sensors disclosed by Lathrop and Kahlert as discussed above. Positioning the “microphone” at an intraoral position as claimed would be obvious over the teachings of Lathrop, Yoon and Kahlert is an obvious matter of design choice in view of MPEP 2144.04(VI)(C) including “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).”
Regarding Claim 5, an interpretation of Lathrop in view of Yoon in further view of Radmand in further view of Kahlert discloses the above in claim 4, as discussed in the rejection of claim 1 Lathrop discloses the use of plurality of sensors ([0027] including “The electronic devices 16 may include devices for monitoring one or more physiological parameters of the user (e.g., athlete) . . . Although the heart rate monitoring device is described in detail below, other devices may be utilized to determine physiological parameters of the user. For example, accelerometers may be utilized”, [0041]) located on the mouthguard/substrate at a plurality of locations including coupled along a first side portion of the flexible substrate and adapted to be located intraorally along a fourth anatomical location, proximate to the third anatomical location defined within the oral cavity of the user along the maxilla arch closest to the salivary glands/ducts, whereby saliva exists in a substantially higher volume ([0024] including “the electronic devices disposed on the stiff sections of the flexible PCB of the mouth guard may be utilized to monitor a physiological parameter of the user.”, [0027], Figs. 3-4 see also [0044]-[0045]; Mouthguard defines plurality of locations for sensing devices which are proximate to each other including locations meeting the additionally location elements recited see the recited paragraphs and figures for more specific locations).
An interpretation of Lathrop may not explicitly disclose at least one pH sensor to measure a pH level of the saliva to monitor sleep quality.
However, in the same field of endeavor (medical diagnostic devices), Yoon teaches at least one pH sensor to measure a pH level of the saliva to monitor sleep quality (abstract, [0018], [0028], [0043] including “The diagnostic mouth guard can also include a temperature sensor, a pH sensor and/or an inertia sensor.”; to the extent “to measure . . .” is a intended use of the device, the device recited by the prior art is functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a PCB coupled to the substrate of the mouthguard wherein the PCB includes a wireless communication module as recited by Lathrop to include pH sensor on the mouthguard sensing device which wirelessly sends data to other computing devices/platforms as recited by Yoon because the use of the mouthguard with the networked device(s) diagnosis, quantifies, and manages interventions for bruxism ([0018], [0045]).
An interpretation of Lathrop may not explicitly disclose at least one microphone or acoustic sensor coupled to measure a snoring intensity of the user.
However, in the same field of endeavor (medical diagnostic devices), Kahlert teaches at least one microphone or acoustic sensor coupled to measure a snoring intensity of the user ([0140] including “a microphone is added for additional or more specific analysis of sleep disordered breathing (in particular snoring and apnea).”; to the extent “to measure a snoring . . .” is a intended use of the device, the device recited by the prior art is functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a plurality of sensors as recited by Lathrop in view of Yoon to include an intraoral microphone as recited by Kahlert because it adds more specific analysis of sleep disordered breathing in particular snoring ([0140]).
With regards to the positioning of the elements in the claimed positions, the Lathrop reference discloses electronic elements (including sensors) being positioned at various positions with the claimed sensors disclosed by Lathrop, Yoon and Kahlert as discussed above. Positioning the “pH sensor” and “microphone” at intraoral positions as claimed would be obvious over the teachings of Lathrop, Yoon and Kahlert is an obvious matter of design choice in view of MPEP 2144.04(VI)(C) including “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).”
Regarding Claim 6, an interpretation of Lathrop further discloses at least one accelerometer ([0027] including “The electronic devices 16 may include devices for monitoring one or more physiological parameters of the user (e.g., athlete) . . . Although the heart rate monitoring device is described in detail below, other devices may be utilized to determine physiological parameters of the user. For example, accelerometers may be utilized”, [0045], Figs. 3-4, 11, 14), wherein each of the at least one accelerometer and other sensors may be coupled along a second side portion of the flexible substrate ([0024] including “the electronic devices disposed on the stiff sections of the flexible PCB of the mouth guard may be utilized to monitor a physiological parameter of the user.”, [0027] including “The electronic devices 16 may include devices for monitoring one or more physiological parameters of the user (e.g., athlete) . . . Although the heart rate monitoring device is described in detail below, other devices may be utilized to determine physiological parameters of the user. For example, accelerometers may be utilized”, [0041], [0045], Figs. 3-4, 11, 14; the Lathrop mouthguard defines plurality of locations for sensing devices which are proximate to each other including locations for mounting sensors including the location elements recited see the recited paragraphs and figures for more specific locations. Examiner notes that claim 6 does not depend from claim 4 thus there is no recited “first side portion” as such and for clarity of the record Examiner believes it is clear that the second side portion is a side portion).
An interpretation of Lathrop may not explicitly disclose at least one temperature sensor; at least one pressure sensor.
However, in the same field of endeavor (medical diagnostic systems), Yoon teaches at least one temperature sensor (abstract including “diagnostic mouth guard includes a plurality of pressure sensors . . . mouth guard may also include temperature, pH and/or inertia sensors.”, [0028], [0030]); at least one pressure sensor (abstract including “diagnostic mouth guard includes a plurality of pressure sensors . . . mouth guard may also include temperature, pH and/or inertia sensors.”, [0018], [0024]). Examiner notes that Yoon also recites the use of at least one accelerometer ([0028]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a PCB coupled to the substrate of the mouthguard wherein the PCB includes a wireless communication module as recited by Lathrop to include temperature and pressure sensors on the mouthguard sensing device which wirelessly sends data to other computing devices/platforms as recited by Yoon because the use of the mouthguard with the networked device(s) diagnosis, quantifies, and manages interventions for bruxism ([0018], [0045]).
With regards to the positioning of the elements in the claimed positions, the Lathrop reference discloses electronic elements (including sensors) being positioned at various positions with the claimed sensors disclosed by Lathrop and Yoon as discussed above. Positioning the “accelerometer”, “temperature sensor” and “pressure sensor” at intraoral positions as claimed would be obvious over the teachings of Lathrop and Yoon is an obvious matter of design choice in view of MPEP 2144.04(VI)(C) including “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).”
Regarding Claim 7, an interpretation of Lathrop further discloses a microcontroller integrated with the flexible printed circuit board (PCB) on the flexible substrate ([0025], [0029] including “controllers (having memory devices and processors) . . . the processor of the electronic devices 16 may include one or more general purpose microprocessors, one or more application specific processors (ASICs), one or more field programmable logic arrays (FPGAs), or any combination thereof”, [0041], [0043], Figs. 3, 11-14) to be communicably coupled to the plurality of sensors to analyze data received by the plurality of sensors ([0041], [0043] including “the controller 90 may fully process the detected signals to determine the one or more physiological parameters and then transmit”, Figs. 3, 11-14).
Regarding Claim 8, an interpretation of Lathrop further discloses a module integrated on the flexible printed circuit board (PCB) and coupled to the flexible substrate ([0025], [0029] including “wireless communication devices (Bluetooth, ultra-wide band, etc.)”), proximate to the first PPG sensor, and adapted to be located intraorally along a fifth anatomical location defined along a center of an oral cavity where an amount of saliva is substantially low ([0025] including “One or more electronic devices 16 may be integrated on one or more of the stiff sections of the flexible PCB 12”, [0029], [0031], Figs. 3, 11-14; the Lathrop mouthguard defines plurality of locations for electronic devices (sensors, processors, wireless elements etc.) which are proximate to each other including locations for mounting sensors including the location elements recited see the recited paragraphs and figures for more specific locations) to transmit the data received by the plurality of sensors or the microcontroller to an external computing device ([0025], [0029] including “wireless communication devices (Bluetooth, ultra-wide band, etc.)”), [0042]-[0043]; to the extent “to transmit . . . “ is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use) the module located at the fifth anatomical location ensures that minimal power is consumed for data transmission ([0025], [0029] including “wireless communication devices (Bluetooth, ultra-wide band, etc.)”).
With regards to the positioning of the elements in the claimed positions, the Lathrop reference discloses electronic elements (including sensors) being positioned at various positions with the claimed electronic elements disclosed by Lathrop as discussed above. Positioning the “Bluetooth module” at intraoral positions as claimed would be obvious over the teachings of Lathrop and Yoon is an obvious matter of design choice in view of MPEP 2144.04(VI)(C) including “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).”
Regarding Claim 9, an interpretation of Lathrop further discloses a battery, and a charging circuitry electrically coupled to the battery ([0042] including “Power provided by the wireless charging coil 78 may be stored in an energy storage device 82 (e.g., battery such as a lithium-ion polymer battery).”, [0029] including “wireless charging devices, energy storage devices (capacitors, etc.)”), wherein the battery and the charging circuitry are coupled to the flexible substrate and integrated with the PCB ([0025] including “One or more electronic devices 16 may be integrated on one or more of the stiff sections of the flexible PCB 12”, [0029], [0042]) and adapted to be located intraorally along a sixth anatomical location defined along a distal portion of the maxillary dentition ([0024]-[0025], [0029], [0042]; the Lathrop mouthguard defines plurality of locations for electronic devices (sensors, processors, wireless elements etc.) which are proximate to each other including locations for mounting sensors including the location elements recited see the recited paragraphs and figures for more specific locations).
With regards to the positioning of the elements in the claimed positions, the Lathrop reference discloses electronic elements (including sensors and other circuitry) being positioned at various positions with the claimed sensors disclosed by Lathrop and Yoon as discussed above. Positioning the “battery” and “charging circuitry” at intraoral positions as claimed would be obvious over the teachings of Lathrop and Yoon is an obvious matter of design choice in view of MPEP 2144.04(VI)(C) including “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).”
Regarding Claim 14, an interpretation Lathrop a system for obtaining a sleep pattern of a user (abstract, [0023]; to the extent “for obtaining . . .” is an interpretation of use of the device the system recited by the prior art is structurally capable of performing the intended use), the system comprising:
a network ([0025], [0029] including “wireless communication devices (Bluetooth, ultra-wide band, etc.)”), [0042]-[0043] including “The wireless communications device . . . may utilize any suitable wireless communication protocol, such as an ultra-wideband (UWB) communication standard, a Bluetooth communication standard, or any 802.11 communication standard.”); and
an intraoral monitoring device for a mouthpiece adapted to be received intraorally in a dentition of a user (abstract, [0023]), the intraoral monitoring device communicably coupled to the network ([0025], [0029] including “wireless communication devices (Bluetooth, ultra-wide band, etc.)”), [0042]-[0043] including “The wireless communications device . . . may utilize any suitable wireless communication protocol, such as an ultra-wideband (UWB) communication standard, a Bluetooth communication standard, or any 802.11 communication standard.”), the intraoral monitoring device, comprising:
a flexible substrate of the mouthguard ([0025] including “flexible PCB 12 encapsulated within a base member 14”, Figs. 1, 11, 14); and
a plurality of sensors integrated on a flexible printed circuit board (PCB) and coupled to the flexible substrate ([0023]-[0024] including “The one or more electronic devices may be disposed on one or more of the stiff sections of the flexible PCB”, [0041], [0045]), the plurality of sensors comprising:
a first photoplethysmography (PPG) sensor that includes a plurality of different wavelength first PPG signal emitting LEDs emitting light at different wavelengths chosen from at least two of the list of wavelengths consisting of infrared and red, and a photodetector for detecting such signals coupled along an anterior portion of the flexible substrate ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user.”, [0041], [0043]-[0044] including “an emitter 86 and a detector 88. Light from the emitter 86 (e.g., at one or more certain wavelengths) . . . the emitter 86 may emit light from one or more LEDs . . . The reflected or transmitted light may be detected with the detector 88, such as photodiode or photo-detector . . . a plethysmographic signal may be obtained at at least a couple of wavelengths (e.g., red and infrared)”, Fig. 14), and adapted to be located intraorally along a first anatomical location defined along a mid-line of a maxilla, facing outward to the labial mucosa, directly at a septal branch of a superior labial artery in a front lip ([0027], [0043]-[0044] including “For example, the heart rate monitoring device 78 may be located adjacent the septal artery, the inferior labial artery, or the superior labial artery.”, Fig. 14), to provide a plurality of first PPG signal, consistently, during sleep of the user, wherein the first PPG sensor measures a plurality of cardiorespiratory parameters, obtained based on the plurality of first PPG signals, including a heart rate, a respiratory rate, and a blood oxygen saturation of the user ([0027], [0041] including “to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044], Fig. 14; to the extent “during sleep . . . “ is an intended use of the device the prior art device disclosed is structurally capable of performing the intended use), and
a second PPG sensor coupled to a rear portion of the flexible substrate ([0027], [0041] including “the mouth guard 10 may include more than one heart rate monitoring device 78 (e.g., 2, 3, 4 or more devices 78) . . . the device 78 to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044] including “an emitter 86 and a detector 88. Light from the emitter 86 (e.g., at one or more certain wavelengths) . . . the emitter 86 may emit light from one or more LEDs . . . The reflected or transmitted light may be detected with the detector 88, such as photodiode or photo-detector . . . a plethysmographic signal may be obtained at at least a couple of wavelengths”, Fig. 14 see also [0023]-[0024]), adapted to be located intraorally along a second anatomical location defined within an oral cavity facing outward toward the labial mucosa ([0027], [0043]-[0044], Fig. 14), to provide a plurality of second PPG signals, consistently, during sleep of the user, wherein the second PPG sensor measures wavelengths of light corresponding to a plurality of muscular parameters, correlated to different muscular activities during various stages of sleep are based on the second PPG signals ([0027] including “If multiple wavelengths are utilized by the heart rate monitoring device other physiological parameters may be monitored”, [0041] including “to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044] including “a plethysmographic signal may be obtained at at least a couple of wavelengths (e.g., red and infrared)”, Fig. 14; to the extent “during sleep . . . “ is an intended use of the device the prior art device disclosed is structurally capable of performing the intended use. Examiner notes that based on Applicants specification [0040], Infrared (IR) light wavelengths are “wavelengths of light corresponding to a plurality of muscular parameters”. The reference discloses IR wavelength emission and measurement thus it discloses “measures wavelengths of light corresponding to a plurality of muscular parameters correlated to different . . . ”), including muscular activities from the Buccinator, the Medial Pterygoid, and the Masseter muscles of the user ([0027], [0041] including “to acquire a plethysmographic signal at one or more wavelengths to determine one or more physiological parameters of the user.”, [0043]-[0044], Fig. 14 see also [0023]-[0024]; to the extent “during sleep . . . “ is an intended use of the device the prior art device disclosed is structurally capable of performing the intended use) wherein the second PPG sensor measures wavelengths intraorally along mucosa([0027], [0043]-[0044], Fig. 14 see also [0023]-[0024]).
An interpretation of Lathrop may not explicitly disclose one or more computing devices or platforms communicably coupled to the network; the substrate adapted to be coupled to the mouthpiece.
However, in the same field of endeavor (medical diagnostic systems), Yoon teaches one or more computing devices or platforms communicably coupled to the network ([0018] including “Applications (apps) or other programs executed by the external processing unit 106”, [0039] including “Captured data may also be transmitted to allow the clinician to evaluate the current conditions of the user.”, [0040] including “the system interfaces wirelessly with an external processing unit 106 such as, e.g., a mobile device or PC.”, [0041] including “applications such as, e.g., eMOCHA (electronic Mobile Open-source Comprehensive Health Application), can offer secure, highly flexible and adaptable mHealth app platforms”); the intraoral monitoring device communicably coupled to the one or more computing devices or platforms via the network ([0018], [0039]-[0041]); the substrate adapted to be coupled to the mouthpiece ([0025] including “flexible printed circuit board including a flexible substrate”, [0026] including “Since both the thin substrate and PDMS layer are flexible . . . deformable and can be fit in the uneven trench of the mouth guard”; PCB is attached to substrate and the combination is coupled to the mouthguard).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a PCB coupled to the substrate of the mouthguard wherein the PCB includes a wireless communication module as recited by Lathrop to include a coupled substrate/PCB which is coupled to the mouthguard which wirelessly to other computing devices/platforms as recited by Yoon because the use of the mouthguard with the networked device(s) diagnosis, quantifies, and manages interventions for bruxism ([0018], [0045]).
An interpretation of Lathrop may not explicitly disclose PPG sensor measures a plurality of cardiorespiratory parameters including respiratory rate.
However, in the same field of endeavor (medical diagnostic devices), Radmand teaches a PPG sensor measures a plurality of cardiorespiratory parameters including respiratory rate (Col 6:18-47, Col 7:3-11 including “the integrated PPG sensor 206 is configured to determine the respiratory rate of the user”) while a user is asleep to classify sleep stages based on the PPG data (Col 5:66-Col 6:17 including “The light source 304 is configured to emit light to the user's oral mucosa and the photodetector 306 is configured to measure the light reflected from the user's gum or oral mucosa. The PPG sensor 206 generates data or a waveform that can be interpreted and provide pertinent health-related information.”, Col 9:34-58).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device gathering a plurality of data including from multiple PPG sensors as recited by Lathrop to include sensing respiration rate for determining sleep stages using a mouthguard sensing device as recited by Radmand because gathering the data for sleep staging with an intraoral mouthguard are comfortable and do not interfere with natural sleeping like previous systems which included being tethered to multiple devices (Col 2:58-Col 3:12).
An interpretation of Lathrop may not explicitly disclose classifying one or more sleep stages of the user based on the plurality of muscular parameters in combination with the plurality of cardiorespiratory parameters.
However, in the same field of endeavor (medical diagnostic devices), Kahlert teaches classifying one or more sleep stages of the user based on the plurality of muscular parameters in combination with the plurality of cardiorespiratory parameters ([0131], [0141] including “sleep staging may be made more accurate when muscle tension is added as input next to HR, HRV, RR, RRV and activity.” See also [0154]; Discloses use of a parameters based on a variety of sensing modalities including PPG. Users’ parameters vary through the night these changes are sensed and used in the sleep staging).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a plurality of sensors including gathering PPG data for sleep staging and gathering muscle parameters from PPG as recited by Lathrop in view of Yoon in further view of Radmand to more particularly include classifying sleep stages using a plurality of data including muscle parameters as recited by Kahlert because including muscle parameters can make the staging more accurate ([0141]).
Regarding Claim 15, an interpretation of Lathrop further discloses a microcontroller integrated with the flexible printed circuit board (PCB) on the flexible substrate ([0025], [0029] including “controllers (having memory devices and processors) . . . the processor of the electronic devices 16 may include one or more general purpose microprocessors, one or more application specific processors (ASICs), one or more field programmable logic arrays (FPGAs), or any combination thereof”, [0041], [0043], Figs. 3, 11-14) to be communicably coupled to the plurality of sensors to analyze data received by the plurality of sensors ([0041], [0043] including “the controller 90 may fully process the detected signals to determine the one or more physiological parameters and then transmit”, Figs. 3, 11-14).
Regarding Claim 16, an interpretation of Lathrop further discloses a module integrated on the flexible printed circuit board (PCB) and coupled to the flexible substrate ([0025], [0029] including “wireless communication devices (Bluetooth, ultra-wide band, etc.)”), proximate to the first PPG sensor, and adapted to be located intraorally along a center of an oral cavity where an amount of saliva is substantially low ([0025] including “One or more electronic devices 16 may be integrated on one or more of the stiff sections of the flexible PCB 12”, [0029], [0031], Figs. 3, 11-14; the Lathrop mouthguard defines plurality of locations for electronic devices (sensors, processors, wireless elements etc.) which are proximate to each other including locations for mounting sensors including the location elements recited see the recited paragraphs and figures for more specific locations) to transmit the data received by the plurality of sensors or the microcontroller to an external computing device ([0025], [0029] including “wireless communication devices (Bluetooth, ultra-wide band, etc.)”), [0042]-[0043]; to the extent “to transmit . . . “ is an intended use of the device the device recited by the prior art is structurally capable of performing the intended use).
With regards to the positioning of the elements in the claimed positions, the Lathrop reference discloses electronic elements (including sensors) being positioned at various positions with the claimed electronic components disclosed by Lathrop as discussed above. Positioning the “Bluetooth module” at intraoral positions as claimed would be obvious over the teachings of Lathrop and Yoon is an obvious matter of design choice in view of MPEP 2144.04(VI)(C) including “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).”
Regarding Claim 17, an interpretation of Lathrop may not explicitly disclose one or more computing devices or platforms comprise one or more of a mobile application platform, a device management platform, a data management platform, and a remote patient monitoring platform.
However, in the same field of endeavor (medical diagnostic systems), Yoon teaches one or more computing devices or platforms comprise one or more of a mobile application platform ([0040] including “the system interfaces wirelessly with an external processing unit 106 such as, e.g., a mobile device or PC.”, [0041] including “applications such as, e.g., eMOCHA (electronic Mobile Open-source Comprehensive Health Application), can offer secure, highly flexible and adaptable mHealth app platforms”, [0045] including “cell phone configured to implement an “mHealth” (mobile-health) monitoring system” see also [0018], [0039]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the mouthguard intraoral sensing device with a PCB coupled to the substrate of the mouthguard wherein the PCB includes a wireless communication module as recited by Lathrop to include the mouthguard which wirelessly to other computing devices application platform as recited by Yoon because the use of the mouthguard with the networked device(s) diagnosis, quantifies, and manages interventions for bruxism ([0018], [0045]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
IE 20210099 to Curley (cited in IDS – 11/12/25) including Pg. 4:23-35, Pg. 5:5-11
US 20200375528 (cited in IDS – 5/11/26) including [0056], [0096]-[0098]
Chiho Satokawa et al. Evaluation of tissue oxygen saturation of the masseter muscle during standardised teeth clenching. J Oral Rehabil. 2020; 47: 19–26. https://doi.org/10.1111/joor.12863, viewed on 3/28/25 see NF rejection dated 4/10/25
US 20240237944 to Cogan et al. (also WO 2022234145 – the priority date is 5/7/21) – Examiner notes Figs. 8-9 seem almost identical to the current applications 1-2. The ‘944 Application and the current application each have an inventor which is not included in the inventor list of the other Application; thus, it is being interpreted as prior art under 35 USC 102(a)(2) and it does not require a provisional double patenting rejection currently. See 35 USC 102(a)(2), MPEP 2154.01(c), MPEP 2154.02(a), MPEP 2155.01.
WO 2021167855 to Reza Radmand
US 20200008738 to Frank Dillon et al. see Fig. 3
Seo-Joon Lee et al. s-Guard: Multisensor Embedded Obstructive Sleep Apnea and Bruxism Real-Time Data Transmission Intraoral Appliance Device. Applied Sciences. 2021; 11(9):4182. https://doi.org/10.3390/app11094182. https://www.mdpi.com/2076-3417/11/9/4182. viewed on 3/26/25 – discloses detachable sensor (such as PPG, temp and motion)/electronic module from a mandibular advancement device (MAD) see figs. 4-5
WO 2022183236 see Abstract, figs. 1A-4
Sharmistha Bhadra et al., "Smart Mandibular Advancement Device for Intraoral Monitoring of Cardiorespiratory Parameters and Sleeping Postures," in IEEE Transactions on Biomedical Circuits and Systems, vol. 15, no. 2, pp. 248-258, April 2021, doi: 10.1109/TBCAS.2021.3065824. https://ieeexplore.ieee.org/document/9376900, viewed on 3/26/25 – includes at least one author who is not listed as an inventor. The other author Seyedfakhreddin Nabavi, is presumably inventor Seyed Nabavi. Furthermore, it appears to recite many of claimed elements.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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