DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 8/27/26 has been entered.
Response to Arguments
Applicants’ arguments filed 8/27/26 have been fully considered but they are not persuasive.
With regards to the 103 rejection Applicants discuss each reference by picking one or two lines of the entire specification and then stating that it doesn’t teach the entirety of the quoted element: “coupling a photoplethysmography (PPG) sensor to the wireless transmitting device, wherein the PPG sensor is attached to the intraoral sensing interface, and wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person, wherein the anchored position is at a specified distance and angle from the specific tooth, and wherein the PPG sensor is used to detect cardiac functionality of the person”. This is not persuasive. With regards to Applicants selection of one or two lines out of an entire reference, Examiner notes that prior art references are relevant for all they contain, MPEP 2123.
To the extent Applicants seem to be generically arguing without Applicable specifics by arguing a specific part of each reference (which may not have even been cited as relevant) and expanding it to say it doesn’t teach the entire element Applicant quotes, Applicant's arguments seem to fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
To the extent this is an argument against the references 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 first discuss Lasry stating it doesn’t teach the above discussed quoted element. Examiner disagrees. Lasry does teach element(s) included in the claim language Applicants point to see the rejection for specific citations. As laid out in the rejection below, Lasry discloses coupling a photoplethysmography (PPG) sensor to the wireless transmitting device, wherein the PPG sensor is attached to the intraoral sensing interface and wherein the PPG sensor is located on the intraoral sensing interface and wherein the PPG sensor is used to detect cardiac functionality of the person. Lasry discloses a PPG sensor for which recite the PPG sensor to “measure blood O2 levels, heart rate and may further provide basic data to extract respiratory rate and blood pressure.” ([0059], [0117]). The PPG sensor “coupled” with the control module/electronics module and wireless transmitting device. To the extent it is argued that it does not teach things it was seemingly not applied for in the rejection this is not persuasive.
Applicants next discuss Yoon stating the limited portion they recite means the whole reference doesn’t teach the above discussed quoted element. Examiner disagrees. Yoon does teach element(s) included in the claim language Applicants point to see the rejection for specific citations. As noted for purposes of compact prosecution, Yoon discloses coupling a photoplethysmography (PPG) sensor to the wireless transmitting device, wherein the PPG sensor is attached to the intraoral sensing interface and wherein the PPG sensor is located on the intraoral sensing interface and wherein the PPG sensor is used to detect cardiac functionality of the person. To the extent it is argued that it does not teach things it was not applied for in the rejection this is not persuasive.
Applicants next discuss Lathrop stating the limited portion they recite means the whole reference doesn’t teach the above discussed quoted element. Examiner disagrees. Lathrop does teach element(s) included in the claim language Applicants point to see the rejection for specific citations. As laid out in the rejection below, Lathrop discloses “the PPG sensor is attached to the intraoral sensing interface, wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person, wherein the anchored position is at a specified distance and angle from the specific tooth, and wherein the PPG sensor is used to detect cardiac functionality of the person”. Examiner notes that Lasry, Yoon and Lathrop all recite the sensor can be encapsulated/embedded in the mouthguard. Once the sensing element is encapsulated or embedded in the mouthguard its position in the mouth guard is “specified” and constant. Since the sensor is at a set angle and distance in the device, when the user wears the device in their mouth the sensor will be at a specified distance and angle to the teeth (including the “specific tooth”). To the extent it is argued that it does not teach things it was seemingly not applied for in the rejection this is not persuasive. However, for clarity of the record Examiner notes that the Lathrop reference does also disclose the PPG sensor attached to the “intraoral sensing interface” and coupled to the wireless transmitting device see for example figs. 11-14; as well as, it discloses cardiac functionality see for example [0027].
Applicants next discuss Yammamoto, Burich, Debbarma, White and Anjanappa stating that the limited portion they recite means the whole reference doesn’t teach the above discussed quoted element. This is not persuasive. To the extent it is argued that these references do not teach things they are not currently applied for in the rejection this is not persuasive and moot.
Applicants next discuss claim 25 and claim 28. The reference discloses placing the PPG sensor next to the molars as there are only 2-3 molars on either side of the upper teeth it would be obvious to try placing them on m1 molar vs. m2 (and if wisdom teeth are present m3). To the extent Applicant again argues there is no recitation of being next to a specific tooth, see the discussion with regards to the Lathroop above.
With regards to claim 28 the “enabling . . . “ is a results effective variable related to the placement of the sensor, through routine optimization the results effective variable would be obvious. For the above reasons these arguments are not persuasive. It may be beneficial to have an interview to discuss the “palatine artery monitoring” in view of the placement next to the m1 molar.
The remaining discussion relies on the arguments discussed above and are not persuasive for the same reasons.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17366186 (‘186), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Examiner notes that the current Application was filed as CIP of the ‘186 application. Elements of claims 1, 26-27 (and by extension the dependent claims), for example “PPG”, do not seem to be present in the parent ’186 application. As such the priority for claims 1 is 01/21/2022 per Provisional Application 63/301,501.
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) 1-2, 7-10, 12-14, 18-20, 22, 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20220117777 to Lasry et al. (hereinafter Lasry) in view of US 20180310881 to Yoon et al. (hereinafter Yoon) in further view of US 20190125261 to Lathrop et al. (hereinafter Lathrop).
Regarding Claim 1, an interpretation of Lasry discloses a processor-implemented method for health monitoring ([0009], [0114], [0136]) comprising:
providing wireless connectivity between a processor and a wireless transmitting device ([0136] including “a processing agent (not shown) may be provided for additional ex-situ treatment of data . . . The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059]; Recites transmitting data wirelessly from the intraoral device to the external processing element. Also recites sending data to remote devices which are computers etc. which also have processors), wherein the wireless transmitting device is integrated within an intraoral sensing interface for use in a person ([0054] including “The electronics module 1110 may be integrated within the sleep monitoring device 1100”, [0059] see also [0071]);
coupling a photoplethysmography (PPG) sensor ([0059] including “a photoplethysmogram (PPG) sensor”, [0117] see also [0054], [0057]-[0058], [0108]) to the wireless transmitting device ([0059] including “necessary electrical connectivity between the PPG sensor and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the PPG sensor is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0117]), wherein the PPG sensor is attached to the intraoral sensing interface ([0059] including “mounted on the sleep monitoring device 1100 facing the palate of the wearer, such that the PPG sensor is in contact or close proximity with one or more blood vessels of the wearer.”, [0117]), and wherein the PPG sensor is used to detect cardiac functionality of the person ([0059] including “The PPG sensor can be used to measure . . . heart rate”, [0117]);
coupling a breathing sensor ([0060] including “a pressure transducer or a pressure switch . . . to measure variations in intraoral air pressure to indicate respiratory frequency”, [0118] see also [0108]) to the wireless transmitting device ([0060] including “necessary electrical connectivity between the pressure transducer or a pressure switch and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the pressure transducer or a pressure switch is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0118]), wherein the breathing sensor is attached to the intraoral sensing interface ([0060] including “integrated in the electronics module 1110 or mounted on or integrated within (a non-airtight compartment of) the sleep monitoring device 1100”, [0118]), and wherein the breathing sensor is used to detect pulmonary functionality of the person ([0060] including “a pressure transducer or a pressure switch . . . to measure variations in intraoral air pressure to indicate respiratory frequency”, [0118]);
coupling an inertial measurement unit (IMU) sensor ([0063] including “accelerometer and/or gyroscope sensors”, [0121] see also [0108]; discloses accelerometer and gyroscope) to the wireless transmitting device ([0054], [0063] including “necessary electrical connectivity between the one or more accelerometer and/or gyroscope sensors and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the one or more accelerometer and/or gyroscope sensors is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0121]), wherein the IMU sensor is attached to the intraoral sensing interface ([0063] including “accelerometer and/or gyroscope sensors integrated in the electronics module 1110 or mounted on or integrated within the sleep monitoring device 1100.”, [0121]), and wherein the IMU sensor is used to detect three-dimensional motion of the person ([0063] including “The one or more accelerometer and/or gyroscope sensors can be used to measure head movements and body vibrations of the wearer.”, [0121]);
coupling a temperature sensor ([0061] including “temperature sensor”, [0119] see also [0108]) to the wireless transmitting device ([0061] including “necessary electrical connectivity between the temperature sensor and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the temperature sensor is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0119]), wherein the temperature sensor is attached to the intraoral sensing interface ([0061] including “integrated in the electronics module 1110 or mounted on or integrated within the sleep monitoring device 1100”, [0119]), and wherein the temperature sensor is used to detect intraoral body temperature of the person ([0061] including “measure variations in user's temperature”, [0119] see also [0108]); and
providing health data about the person to a receiving device ([0054], [0136] including “The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059], [0071], [0108]; data is sent to remote device such as heart rate, temperature readings etc.), based on data from one or more of the PPG sensor, the breathing sensor, the IMU sensor, and the temperature sensor, wherein the health data is provided using the wireless connectivity ([0054] including “The sleep monitoring device 1100 may be used as a diagnostic aid in the context of different illnesses (apnea, cardiovascular monitoring, etc.).”, [0136] including “The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059], [0071], [0108]; health data is wirelessly sent from the intraoral device to external/remote device based on data from one or more of the claimed sensors).
An interpretation of Lasry may not explicitly disclose the wireless transmitting device is embedded in the intraoral sensing interface.
However, in the same field of endeavor (diagnostic medical systems), Yoon teaches the wireless transmitting device is embedded in the intraoral sensing interface ([0019] including “an intelligent mouthguard 100 including sensors, a battery, charging and wireless electronics circuitry. The intelligent mouthguard system comprises a printed circuit board 103 embedded in a mouthguard 100 and a software application that enables low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server.”, Figs. 1A-1B).
For purposes of compact prosecution, but not currently relied on for disclosing these elements, Examiner notes that Yoon also discloses PPG sensing ([0019], [0026]), temperature sensing ([0019], [0025]) and inertial sensing in 3D ([0019], [0024]) and transmitting the health data information based on the sensors to a remote device with processing wirelessly ([0017], [0019] including “low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server . . . configured to communicate with each of the sensors and to communicate various information to the external hub or server.”, [0021]-[0022], Fig. 1C).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include transmitting device embedded in the intraoral sensing interface for transferring data from the sensors as recited by Yoon because embedding the transmitter in the substrate provides a protective coating ([0023]).
An interpretation of Lasry may not explicitly disclose wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person; wherein the anchored position is at a specified distance and angle from the specific tooth.
However, in the same field of endeavor (medical diagnostic method), Lathrop teaches wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031] including “, the posterior portion 38 faces the rear of the mouth (e.g., near the molars),”, [0039], [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Fig. 14 see also [0022], [0041], Fig. 3; when the device is integrated into at a specific location it is adjacent the specific tooth which is relative to that position); wherein the anchored position is at a specified distance and angle from the specific tooth ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031], [0041] including “The heart rate monitoring device 78 may be completely encapsulated within the mouth guard 10. In particular, each component of the heart rate monitoring device 78 may be disposed on one or more stiff sections 18 of the flexible PCB 12.”, [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Fig. 14 see also [0022], [0039], Figs. 3, 11; when the sensor is encapsulated into at a specific location it is adjacent the specific tooth at a specified distance and angle).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in a second device as recited by Lasry to include more specifically PPG in an anchored position adjacent to the upper molars of the user as recited by Lathrop because it is merely combining prior art elements (the PPG sensor recited by Lasry with the more particular positioning as recited by Lathrop) according to known methods to yield predictable results.
Regarding Claim 2, an interpretation of Lasry further discloses wherein the health data is used to monitor four-sensor health functionality of the person ([0054], [0059]-[0063] various sensors and functionality measured, [0117]-[0121] various sensors and functionality measured see also [0142]; the reference discloses the claimed four sensors each monitoring health “functionalities” thus provides four sensor health “functionality” of the person).
Regarding Claim 7, an interpretation of Lasry further discloses coupling an electroencephalogram (EEG) sensor ([0056], [0062] including “EEG (Electroencephalography) probes”, [0120]) to the wireless transmitting device ([0056], [0062] including “necessary electrical connectivity between the EEG probes and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the EEG probes is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.)”, [0120]).
Regarding Claim 8, an interpretation of Lasry further discloses wherein the EEG sensor provides data ([0056], [0062] including “EEG (Electroencephalography) probes”, [0120]) to augment the health data ([0054], [0059]-[0063] various sensors and functionality measured, [0117]-[0121] various sensors and functionality measured; the reference discloses the initial four claimed sensors as well as the EEG sensor data).
Regarding Claim 9, an interpretation of Lasry further discloses wherein the health data that is augmented is used to monitor five- sensor health functionality of the person ([0054], [0059]-[0063] various sensors and functionality measured, [0117]-[0121] various sensors and functionality measured; the reference discloses the sensors for monitoring various elements of “functionality” of the person).
Regarding Claim 10, an interpretation of Lasry further discloses wherein the five-sensor health functionality is used to determine non-activity performance ([0037] including “The present invention relates to a sleep monitoring device” see also [0059]-[0063] various sensors and functionality measured, [0117]-[0121] various sensors and functionality measured), wherein the non-activity performance includes sleep performance of the person ([0037] including The present invention relates to a sleep monitoring device . . . can be used to provide at least some of the data helpful for specialists in the diagnosis of Obstructive Sleep Hypopnea (OSA), Central Hypopnea or other sleep disorders. ” see also [0059]-[0063] various sensors and functionality measured, [0101], [0117]-[0121] various sensors and functionality measured), wherein the sleep performance includes detecting stopping and starting of breathing while the person is sleeping ([0003] including “Obstructive Sleep Apnea (OSA) is a condition where patients have recurring episodes of . . . cessation of breathing”, [0037] including “The present invention relates to a sleep monitoring device . . . can be used to provide at least some of the data helpful for specialists in the diagnosis of Obstructive Sleep Hypopnea (OSA)” see also [0059]-[0066] various sensors and functionality measured, [0067] recites sensing for OSA, [0117]-[0124] various sensors and functionality measured, [0125] recites sensing for OSA; Sensors are recited as being for detecting OSA and OSA is recites as being the recurrence of cessation (or stopping) of breathing during sleep).
Regarding Claim 12, an interpretation of Lasry further discloses wherein the sleep performance includes detecting nighttime conditions ([0037] including “The present invention relates to a sleep monitoring device . . . can be used to provide at least some of the data helpful for specialists in the diagnosis of Obstructive Sleep Hypopnea (OSA), Central Hypopnea or other sleep disorders. ” see also [0059]-[0063] various sensors and functionality measured, [0101], [0117]-[0121] various sensors and functionality measured; OSA etc. are being interpreted as “conditions”).
Regarding Claim 13, an interpretation of Lasry further discloses wherein the sleep performance identifies sleep stages ([0063] including “indicate the wearer's sleep state (e.g. awake, REM sleep, light sleep, deep sleep)”, [0121] see also [0051], [0062], [0120]).
Regarding Claim 14, an interpretation of Lasry further discloses wherein the EEG sensor comprises one or more sets of tri- electrode intraoral contacts ([0056] including “When using three different EEG probes”, [0062] including “EEG (Electroencephalography) probes”, [0120]).
Regarding Claim 18, an interpretation of Lasry further discloses coupling an interface-embedded preprocessor to the wireless transmitting device and one or more of the PPG sensor, the breathing sensor, the IMU sensor, and the temperature sensor ([0103] including “a single processor 2124 with one or more processor cores or an array of processors, each comprising one or more processor cores.”, [0108], [0120], [0136], Fig. 16 see also [0054], [0117]-[0123]).
Regarding Claim 19, an interpretation of Lasry in view of Yoon discloses the above in claim 18.
an interpretation of Lasry may not explicitly disclose wherein the preprocessor and the wireless transmitting device comprise an integrated electronic device.
However, in the same field of endeavor (medical diagnostic methods), Yoon teaches wherein the preprocessor and the wireless transmitting device comprise an integrated electronic device ([0021] including “the printed circuit board 103 comprises an ARM Cortex microprocessor 109 with an integrated Bluetooth Low Energy (BLE) 2.4 GHz transceiver such as the Silicon Labs Blue Gecko BGM111.”).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include integrated processor and transmitting device embedded in the intraoral sensing interface as recited by Yoon because the integrated processor and transmitter maintains the smallest footprint and being embedded provides protection ([0021], [0023]).
Regarding Claim 20, an interpretation of Lasry discloses wherein the breathing sensor detects inhales and/or exhales for the person ([0060] including “a pressure transducer or a pressure switch . . . to measure variations in intraoral air pressure to indicate respiratory frequency”, [0118] see also [0108]).
Regarding Claim 22, an interpretation of Lasry further discloses wherein the breathing sensor comprises a microphone ([0065] including “The sound sensor can be used to measure variations in sound (e.g., intensity of snoring noise and breathing effort).”, [0067], [0123], [0142] see also [0059]).
Regarding Claim 25, an interpretation of Lasry may not explicitly disclose wherein the anchored position is adjacent to an upper M1 molar of the person.
However, in the same field of endeavor (medical diagnostic method), Lathrop teaches wherein the anchored position is adjacent to an upper M1 molar of the person ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031] including “When the mouth guard 10 is disposed within the user's mouth, . . . the posterior portion 38 faces the rear of the mouth (e.g., near the molars),”, [0039], [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Figs. 3, 14 see also [0022], [0031], [0041], [0043]-[0044]; The reference discloses heart rate sensor (PPG) is located posterior portion adjacent/near the molars, including where the M1 molar is located. Examiner notes there are only 2-3 molars on either side depending on whether or not there are wisdom teeth).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include more specifically PPG in an anchored position adjacent to the M1 molars of the user as recited by Lathrop because it is “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Specifically, it recites placement next to the molars as people have 2-3 molars on either side in the upper teeth thus there are limited number of options 1 out of 2 or 3 and placement next to them provides a predictable solution with a reasonable amount of success. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lasry in view of Lathrop by setting the sensor next to the M1 molar, as the Lathrop reference discloses placement adjacent the molars, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05.
Regarding Claim 28, an interpretation of Lasry may not explicitly disclose wherein the anchored position adjacent to the upper M1 molar of the person enables enhanced palatine artery monitoring.
However, in the same field of endeavor (medical diagnostic method), Lathrop teaches wherein the anchored position adjacent to the upper M1 molar of the person enables enhanced palatine artery monitoring ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031] including “When the mouth guard 10 is disposed within the user's mouth, . . . the posterior portion 38 faces the rear of the mouth (e.g., near the molars),”, [0039], [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Figs. 3, 14 see also [0022], [0031], [0041], [0043]-[0044]; The reference discloses heart rate sensor (PPG) is located posterior portion adjacent/near the molars, including where the M1 molar is located. Examiner notes there are only 2-3 molars on either side depending on whether or not there are wisdom teeth. Examiner notes that “enables enhanced palatine artery monitoring” is a results effective variable of the placement near the molar, however, Examiner would recommend an interview to discuss this feature).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include more specifically PPG in an anchored position adjacent to the M1 molars of the user as recited by Lathrop because it is “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Specifically, it recites placement next to the molars as people have 2-3 molars on either side in the upper teeth thus there are limited number of options 1 out of 2 or 3 and placement next to them provides a predictable solution with a reasonable amount of success. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lasry in view of Lathrop by setting the sensor next to the M1 molar, as the Lathrop reference discloses placement adjacent the molars, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05.
Regarding Claim 26, an interpretation of Lasry discloses product embodied in a non-transitory computer readable medium for health monitoring, the computer program product comprising code which causes one or more processors ([0009], [0114], [0136]) to perform operations of:
providing wireless connectivity between a processor and a wireless transmitting device ([0136] including “a processing agent (not shown) may be provided for additional ex-situ treatment of data . . . The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059]; Recites transmitting data wirelessly from the intraoral device to the external processing element. Also recites sending data to remote devices which are computers etc. which also have processors), wherein the wireless transmitting device is integrated within an intraoral sensing interface for use in a person ([0054] including “The electronics module 1110 may be integrated within the sleep monitoring device 1100”, [0059] see also [0071]);
coupling a photoplethysmography (PPG) sensor ([0059] including “a photoplethysmogram (PPG) sensor”, [0117] see also [0108]) to the wireless transmitting device ([0059] including “necessary electrical connectivity between the PPG sensor and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the PPG sensor is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0117]), wherein the PPG sensor is attached to the intraoral sensing interface ([0059] including “mounted on the sleep monitoring device 1100 facing the palate of the wearer, such that the PPG sensor is in contact or close proximity with one or more blood vessels of the wearer.”, [0117]), and wherein the PPG sensor is used to detect cardiac functionality of the person ([0059] including “The PPG sensor can be used to measure . . . heart rate”, [0117]);
coupling a breathing sensor ([0060] including “a pressure transducer or a pressure switch . . . to measure variations in intraoral air pressure to indicate respiratory frequency”, [0118] see also [0108]) to the wireless transmitting device ([0060] including “necessary electrical connectivity between the pressure transducer or a pressure switch and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the pressure transducer or a pressure switch is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0118]), wherein the breathing sensor is attached to the intraoral sensing interface ([0060] including “integrated in the electronics module 1110 or mounted on or integrated within (a non-airtight compartment of) the sleep monitoring device 1100”, [0118]), and wherein the breathing sensor is used to detect pulmonary functionality of the person ([0060] including “a pressure transducer or a pressure switch . . . to measure variations in intraoral air pressure to indicate respiratory frequency”, [0118]);
coupling an inertial measurement unit (IMU) sensor ([0063] including “accelerometer and/or gyroscope sensors”, [0121] see also [0108]; discloses accelerometer and gyroscope) to the wireless transmitting device ([0054], [0063] including “necessary electrical connectivity between the one or more accelerometer and/or gyroscope sensors and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the one or more accelerometer and/or gyroscope sensors is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0121]), wherein the IMU sensor is attached to the intraoral sensing interface ([0063] including “accelerometer and/or gyroscope sensors integrated in the electronics module 1110 or mounted on or integrated within the sleep monitoring device 1100.”, [0121]), and wherein the IMU sensor is used to detect three-dimensional motion of the person ([0063] including “The one or more accelerometer and/or gyroscope sensors can be used to measure head movements and body vibrations of the wearer.”, [0121]);
coupling a temperature sensor ([0061] including “temperature sensor”, [0119] see also [0108]) to the wireless transmitting device ([0061] including “necessary electrical connectivity between the temperature sensor and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the temperature sensor is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0119]), wherein the temperature sensor is attached to the intraoral sensing interface ([0061] including “integrated in the electronics module 1110 or mounted on or integrated within the sleep monitoring device 1100”, [0119]), and wherein the temperature sensor is used to detect intraoral body temperature of the person ([0061] including “measure variations in user's temperature”, [0119] see also [0108]); and
providing health data about the person to a receiving device ([0054], [0136] including “The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059], [0071], [0108]; data is sent to remote device such as heart rate, temperature readings etc.), based on data from one or more of the PPG sensor, the breathing sensor, the IMU sensor, and the temperature sensor, wherein the health data is provided using the wireless connectivity ([0054] including “The sleep monitoring device 1100 may be used as a diagnostic aid in the context of different illnesses (apnea, cardiovascular monitoring, etc.).”, [0136] including “The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059], [0071], [0108]; health data is wirelessly sent from the intraoral device to external/remote device based on data from one or more of the claimed sensors).
An interpretation of Lasry may not explicitly disclose the wireless transmitting device is embedded in the intraoral sensing interface.
However, in the same field of endeavor (diagnostic medical systems), Yoon teaches the wireless transmitting device is embedded in the intraoral sensing interface ([0019] including “an intelligent mouthguard 100 including sensors, a battery, charging and wireless electronics circuitry. The intelligent mouthguard system comprises a printed circuit board 103 embedded in a mouthguard 100 and a software application that enables low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server.”, Figs. 1A-1B). Yoon also discloses PPG sensing ([0019], [0026]), temperature sensing ([0019], [0025]) and inertial sensing in 3D ([0019], [0024]) and transmitting the health data information based on the sensors to a remote device with processing wirelessly ([0017], [0019] including “low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server . . . configured to communicate with each of the sensors and to communicate various information to the external hub or server.”, [0021]-[0022], Fig. 1C).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include transmitting device embedded in the intraoral sensing interface for transferring data from the sensors as recited by Yoon because embedding the transmitter in the substrate provides a protective coating ([0023]).
An interpretation of Lasry may not explicitly disclose wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person, wherein the anchored position is at a specified distance and angle from the specific tooth.
However, in the same field of endeavor (medical diagnostic method), Lathrop teaches wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031] including “, the posterior portion 38 faces the rear of the mouth (e.g., near the molars),”, [0039], [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Fig. 14 see also [0022], [0041], Fig. 3; when the device is integrated into at a specific location it is adjacent the specific tooth which is relative to that position) wherein the anchored position is at a specified distance and angle from the specific tooth ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031], [0041] including “The heart rate monitoring device 78 may be completely encapsulated within the mouth guard 10. In particular, each component of the heart rate monitoring device 78 may be disposed on one or more stiff sections 18 of the flexible PCB 12.”, [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Fig. 14 see also [0022], [0039], Figs. 3, 11; when the sensor is encapsulated into at a specific location it is adjacent the specific tooth at a specified distance and angle).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in a second device as recited by Lasry to include more specifically PPG in an anchored position adjacent to the upper molars of the user as recited by Lathrop because it is merely combining prior art elements (the PPG sensor recited by Lasry with the more particular positioning as recited by Lathrop) according to known methods to yield predictable results.
Regarding Claim 27, an interpretation of Lasry discloses a computer system for health monitoring ([0114], [0136], Fig. 16) comprising:
a memory which stores instructions ([0114], [0136], Fig. 16 see also [0142]; transmits data to remote computing device);
one or more processors coupled to the memory wherein the one or more processors, when executing the instructions which are stored ([0114], [0136] including “a processing agent (not shown) may be provided for additional ex-situ treatment of data”, Fig. 16 see also [0142]; transmits data to remote computing device), are configured to:
provide wireless connectivity between a processor and a wireless transmitting device ([0136] including “a processing agent (not shown) may be provided for additional ex-situ treatment of data . . . The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059]; Recites transmitting data wirelessly from the intraoral device to the external processing element. Also recites sending data to remote devices which are computers etc. which also have processors), wherein the wireless transmitting device is integrated within an intraoral sensing interface for use in a person ([0054] including “The electronics module 1110 may be integrated within the sleep monitoring device 1100”, [0059] see also [0071]);
couple a photoplethysmography (PPG) sensor ([0059] including “a photoplethysmogram (PPG) sensor”, [0117] see also [0108]) to the wireless transmitting device ([0059] including “necessary electrical connectivity between the PPG sensor and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the PPG sensor is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0117]), wherein the PPG sensor is attached to the intraoral sensing interface ([0059] including “mounted on the sleep monitoring device 1100 facing the palate of the wearer, such that the PPG sensor is in contact or close proximity with one or more blood vessels of the wearer.”, [0117]), and wherein the PPG sensor is used to detect cardiac functionality of the person ([0059] including “The PPG sensor can be used to measure . . . heart rate”, [0117]);
couple a breathing sensor ([0060] including “a pressure transducer or a pressure switch . . . to measure variations in intraoral air pressure to indicate respiratory frequency”, [0118] see also [0108]) to the wireless transmitting device ([0060] including “necessary electrical connectivity between the pressure transducer or a pressure switch and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the pressure transducer or a pressure switch is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0118]), wherein the breathing sensor is attached to the intraoral sensing interface ([0060] including “integrated in the electronics module 1110 or mounted on or integrated within (a non-airtight compartment of) the sleep monitoring device 1100”, [0118]), and wherein the breathing sensor is used to detect pulmonary functionality of the person ([0060] including “a pressure transducer or a pressure switch . . . to measure variations in intraoral air pressure to indicate respiratory frequency”, [0118]);
couple an inertial measurement unit (IMU) sensor ([0063] including “accelerometer and/or gyroscope sensors”, [0121] see also [0108]; discloses accelerometer and gyroscope) to the wireless transmitting device ([0054], [0063] including “necessary electrical connectivity between the one or more accelerometer and/or gyroscope sensors and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the one or more accelerometer and/or gyroscope sensors is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0121]), wherein the IMU sensor is attached to the intraoral sensing interface ([0063] including “accelerometer and/or gyroscope sensors integrated in the electronics module 1110 or mounted on or integrated within the sleep monitoring device 1100.”, [0121]), and wherein the IMU sensor is used to detect three-dimensional motion of the person ([0063] including “The one or more accelerometer and/or gyroscope sensors can be used to measure head movements and body vibrations of the wearer.”, [0121]);
couple a temperature sensor ([0061] including “temperature sensor”, [0119] see also [0108]) to the wireless transmitting device ([0061] including “necessary electrical connectivity between the temperature sensor and the electronics module 1110 are added during the manufacturing step (e.g., as wires or as 3D printable conductive material). In other embodiments, the temperature sensor is in wireless communication with the electronics module 1110 (e.g., Bluetooth, proprietary protocol, etc.).”, [0119]), wherein the temperature sensor is attached to the intraoral sensing interface ([0061] including “integrated in the electronics module 1110 or mounted on or integrated within the sleep monitoring device 1100”, [0119]), and wherein the temperature sensor is used to detect intraoral body temperature of the person ([0061] including “measure variations in user's temperature”, [0119] see also [0108]); and
provide health data about the person to a receiving device ([0054], [0136] including “The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059], [0071], [0108]; data is sent to remote device such as heart rate, temperature readings etc.), based on data from one or more of the PPG sensor, the breathing sensor, the IMU sensor, and the temperature sensor, wherein the health data is provided using the wireless connectivity ([0054] including “The sleep monitoring device 1100 may be used as a diagnostic aid in the context of different illnesses (apnea, cardiovascular monitoring, etc.).”, [0136] including “The WAN interface could be based on Ethernet or other wireline protocol or could be a wireless interface (e.g., 3G, WiMax, 4G/LTE, 5G, cellular network, etc.). Skilled persons will readily understand that the connection is a logical connection and that different network nodes (e.g., routers, switches, etc.) may be present thereon . . . The dynamic mandibular adjustment device 2100 may then exchange data (e.g., send and receive instructions) with the remote part. The remote part may be provided as a smartphone, a smart tablet, a portable or fixed computer or the likes. In addition, the remote part may further allow the dynamic mandibular adjustment device 2100 to communicate with the processing agent therethrough.” See also [0059], [0071], [0108]; health data is wirelessly sent from the intraoral device to external/remote device based on data from one or more of the claimed sensors).
An interpretation of Lasry may not explicitly disclose the wireless transmitting device is embedded in the intraoral sensing interface.
However, in the same field of endeavor (diagnostic medical systems), Yoon teaches the wireless transmitting device is embedded in the intraoral sensing interface ([0019] including “an intelligent mouthguard 100 including sensors, a battery, charging and wireless electronics circuitry. The intelligent mouthguard system comprises a printed circuit board 103 embedded in a mouthguard 100 and a software application that enables low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server.”, Figs. 1A-1B). Yoon also discloses PPG sensing ([0019], [0026]), temperature sensing ([0019], [0025]) and inertial sensing in 3D ([0019], [0024]) and transmitting wirelessly the health data information based on the sensors to a remote device with processing using software from memory ([0017], [0019] including “low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server . . . configured to communicate with each of the sensors and to communicate various information to the external hub or server.”, [0021]-[0022], [0036]-[0037] including “The image shows example of an interface of the system application that is implemented on the smartphone.”, Fig. 1C).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include transmitting device embedded in the intraoral sensing interface for transferring data from the sensors as recited by Yoon because embedding the transmitter in the substrate provides a protective coating ([0023]).
An interpretation of Lasry may not explicitly disclose wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person, wherein the anchored position is at a specified distance and angle from the specific tooth.
However, in the same field of endeavor (medical diagnostic method), Lathrop teaches wherein the PPG sensor is located in an anchored position on the intraoral sensing interface adjacent to a specific tooth of the person ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031] including “, the posterior portion 38 faces the rear of the mouth (e.g., near the molars),”, [0039], [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Fig. 14 see also [0022], [0041], Fig. 3; when the device is integrated into at a specific location it is adjacent the specific tooth which is relative to that position) wherein the anchored position is at a specified distance and angle from the specific tooth ([0027] including “a photoplethysmograph (PPG) heart rate monitoring device may be utilized to measure the heart rate of the user. In some embodiments, the heart rate monitoring device may be disposed within the mouth guard 10 at a location adjacent an artery in the face and/or gums for measurements”, [0031], [0041] including “The heart rate monitoring device 78 may be completely encapsulated within the mouth guard 10. In particular, each component of the heart rate monitoring device 78 may be disposed on one or more stiff sections 18 of the flexible PCB 12.”, [0044] including “the heart rate monitoring device 78 may be located in the . . . posterior portion 38 of the base member 14.”, Fig. 14 see also [0022], [0039], Figs. 3, 11; when the sensor is encapsulated into at a specific location it is adjacent the specific tooth at a specified distance and angle).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in a second device as recited by Lasry to include more specifically PPG in an anchored position adjacent to the upper molars of the user as recited by Lathrop because it is merely combining prior art elements (the PPG sensor recited by Lasry with the more particular positioning as recited by Lathrop) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lasry in view of Yoon in further view of Lathrop in further view of US 20130131465 Yoshiro Yamamoto et al. (hereinafter Yam).
Regarding Claim 3, an interpretation of Lasry further discloses wherein the four-sensor functionality of the person is used to determine activity performance ([0037] including “physical trainers or the wearer in other contexts such as tracking of the wearer's health and performance indicators in multiple contexts, including during sports sessions” see also [0059]-[0063] various sensors and functionality measured, [0117]-[0121] various sensors and functionality measured, [0142);
An interpretation of Lasry may not explicitly disclose weighting the data from one or more of the sensors to enable differentiated health functionality monitoring.
However, in the same field of endeavor (medical diagnostic methods), Yam teaches weighting the data from one or more of the sensors to enable differentiated health functionality monitoring ([0134]-[0136], [0200]-[0202], Figs. 3-4; depending on desired index to be determined it sets weights, including what measures are included in the determination, based on importance/influence on the determination).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include differing weightings to enable differentiated health functionality as taught by Yam because the use of a plurality of relevant data derives a measurement having higher accuracy ([0035]).
Claim Rejections - 35 USC § 103
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lasry in view of Yoon in further view of Lathrop in further view of Yam in further view of US 20130041590 to Burich et al. (hereinafter Burich).
Regarding Claim 4, an interpretation of Lasry may not explicitly disclose monitoring the activity performance over time.
However, in the same field of endeavor (medical diagnostic methods), Burich teaches monitoring the activity performance over time ([0122] including “performance metrics over time can be generated and maintained” see also [0124], [0302], [0335]).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include monitoring the data activity performance data over time as recited by Burich because tracking data provide information to identify over athletes/device users who are at high risk for injury to reduce the risk ([0122]).
Claim Rejections - 35 USC § 103
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lasry in view of Yoon in further view of Lathrop in further view of Shibam Debbarma et al., "A Smart Mandibular Device for Intra-oral Electroencephalogram Monitoring," 2021 IEEE Sensors, Sydney, Australia, 2021, pp. 1-4, doi: 10.1109/SENSORS47087.2021.9639704., viewed on 5/2/25. (hereinafter Debbarma).
Regarding Claim 15, an interpretation of Lasry in view of Yoon discloses the above in claim 14 including three electrodes attached to an intraoral interface for monitoring EEG (see rejection of claims 7 and 14 above).
An interpretation of Lasry may not explicitly disclose the intraoral contacts comprise a signal contact, a reference contact, and a ground contact.
However, in the same field of endeavor (medical diagnostic devices), Debbarma teaches intraoral contacts comprise a signal contact, a reference contact, and a ground contact (SECTION II. System Description, Figs. 2, 3a-d; recites three electrodes laid out in Fig. 3a. Furthermore, all three are fed into instrumentation amplifier there is a differential output based on the a “reference” electrode signal and “signal” electrodes signal).
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 gathering data from a plurality of sensors, including from a plurality of EEG electrodes/probes, and transmitting the data wirelessly to a processor in second device as recited by Lasry to include the particular electrode layout as recited by Debbarma is merely combining prior art elements (the electrodes recited by Lasry with the particular layout as recited Deb) according to known methods to yield predictable results.
Regarding Claim 16, an interpretation of Lasry in view of Yoon discloses the above in claim 14 including three electrodes attached to an intraoral interface for monitoring EEG (see rejection of claims 7 and 14 above).
An interpretation of Lasry may not explicitly disclose wherein the one or more sets of tri-electrode intraoral contacts utilize an electrically common ground contact.
However, in the same field of endeavor (medical diagnostic devices), Debbarma teaches wherein the one or more sets of tri-electrode intraoral contacts utilize an electrically common ground contact (SECTION II. System Description, Figs. 2, 3a-d; one set of contacts utilizing the ground contact).
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 gathering data from a plurality of sensors, including from a plurality of EEG electrodes/probes, and transmitting the data wirelessly to a processor in second device as recited by Lasry to include the particular electrode layout as recited by Debbarma is merely combining prior art elements (the electrodes recited by Lasry with the particular layout as recited Deb) according to known methods to yield predictable results.
Regarding Claim 17, an interpretation of Lasry in view of Yoon discloses the above in claim 7 including three electrodes attached to an intraoral interface for monitoring EEG (see rejection of claims 7 above).
An interpretation of Lasry may not explicitly disclose wherein the EEG sensor is placed in a contralateral configuration across a person's palate.
However, in the same field of endeavor (medical diagnostic devices), Debbarma teaches wherein the EEG sensor is placed in a contralateral configuration across a person's palate (SECTION II. System Description, Figs. 2, 3a-d; one contact on either side of the palate).
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 gathering data from a plurality of sensors, including from a plurality of EEG electrodes/probes, and transmitting the data wirelessly to a processor in second device as recited by Lasry to include the particular electrode layout as recited by Debbarma is merely combining prior art elements (the electrodes recited by Lasry with the particular layout as recited Deb) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lasry in view of Yoon in further view of Lathrop in further view of US 20190261889 to White (hereinafter White).
Regarding Claim 21, an interpretation of Lasry in view of Yoon discloses the above in claim 1 including sensing intraoral air pressure (see the rejection of claim 1).
An interpretation of Lasry may not explicitly disclose wherein the breathing sensor comprises a barometric pressure sensor.
However, in the same field of endeavor (medical diagnostic method), White teaches wherein the breathing sensor comprises a barometric pressure sensor ([0019] including “(1) an integrated barometric air pressure sensor, humidity sensor and air temperature sensor (e.g., a Bosch BME);”, [0024] including “air pressure within the mouth may be used to monitor the user's respiration.” See also [0003], [0019], [0043]).
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 gathering data from a plurality of sensors, intraoral air pressure sensor, and transmitting the data wirelessly to a processor in second device as recited by Lasry to include the intraoral air sensor is a barometric air sensor as recited by White is merely combining prior art elements (the pressure sensors recited by Lasry with the more particular barometric air pressure sensor as recited White) according to known methods to yield predictable results.
Claim Rejections - 35 USC § 103
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lasry in view of Yoon in further view of Lathrop in further view of US 20040202344 to Anjanappa et al. (hereinafter Anj).
Regarding Claim 23, an interpretation of Lasry further discloses using microphones for detection of bruxism ([0052] including “Bruxism data from . . . microphone(s).” see also [0065], [0067], [0123]).
An interpretation of Lasry may not explicitly disclose wherein the microphone is a bone-conduction microphone.
However, in the same field of endeavor (medical diagnostic method), Anj teaches wherein the microphone is a bone-conduction microphone ([0003] including “a tooth bone conduction microphone method and apparatus.”, [0011] fig. 3).
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 gathering data from a plurality of sensors and transmitting the data wirelessly to a processor in second device as recited by Lasry to include more specifically a bone conduction microphone as recited by Anj because it is compact, simple in design, waterproof and reliable for wearing in the mouth ([0024]-[0026]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20230190195 to Kibler et al. see Figs. 1-2 and [0039] which recites “the second PPG sensor 120 b may be coupled to a rear portion of the flexible substrate 110, adapted to be located intraorally along a second anatomical location 140 b. . . . Such second anatomical location 140 b may be seen in FIG. 1 along teeth no. 1-3 or along teeth no. 14-16.”. Teeth 1-3 and 14-16 are the upper molars.
US 10376210 see Figs. 2-3
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Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James Moss/Examiner, Art Unit 3792
Prosecution Insights