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 .
Election/Restrictions
Applicant's election with traverse of Group I, species B, directed to claims 1-10 in the reply filed on 07/09/2026 is acknowledged. The traversal is on the ground(s) that Applicant traverses on the grounds that the Office did not identify any generic claim(s) when at least claims 1-4 and 7-10 are generic with respect to Species A-K, and claims 1-10 are generic to at least Species A-C, G, H, K, and FIG. 2. This is not found persuasive because this is not found to be persuasive as according to Applicant’s specification, some embodiments also can comprise a cover or housing 20c on or as part of adjustment mechanism 20. An example housing 20c is depicted in FIG. 1D-2, to which Applicant elected in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/09/2026.
Claim Objections
Claims 2-7 are objected to because of the following informalities: while acronyms and abbreviations are permissible in patent claims, the acronym should be enclosed within parenthesis and spelled out in the claim, as for example, wearable electronic airway device (WEAD). Appropriate correction is required.
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.
Claim(s) 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman U.S. Publication No. (2023/0372145 A1) in view of ZenithZephyr Wellness Private Limited (IN 202441073005A).
With respect to claim 1, Kopelman substantially discloses a wearable electronic airway device (WEAD) (system including intraoral appliance to displace lower jaw of patient to treat sleep apnea using sensor data and control signal [0021]; to inhibit airway obstruction [0003]) comprising:
a first portion (12, fig.2A) and (upper appliance shell, para [0045]) comprising:
and
a first component of an adjustment mechanism (advancement apparatus to displace lower shell relative to upper shell may include a component located on the upper shell, para [0045]),
a second portion (lower appliance shell, para [0045]) comprising a second component of the adjustment mechanism (advancement apparatus can include component on the lower shell, para [0045]), the second component configured to selectively engage with the first component (upper advancement structure of upper shell and lower advancement structure of lower shell can be brought into engagement with each other to displace lower shell relative to upper shell, para [0028]) to adjustably couple the first portion and the second portion (to displace lower shell anteriorly relative to upper shell to a plurality of different positions, para [0045]-[0046], to displace lower shell relative to upper shell, para [0028]),
wherein, in use by a human user having upper teeth and lower teeth, the first portion is configured to be worn on the upper teeth (upper appliance shell shaped to receive teeth of patient's upper jaw, para [0045]), the lower portion is configured to be worn on the lower teeth (lower appliance shell shaped to receive teeth of the patient's lower jaw, para [0045]), and mandibular advancement or retraction is provided by adjusting a position of the second portion relative to the first portion using the adjustment mechanism (advancement apparatus can be used to displace the lower jaw to a plurality of different positions, e.g. along anterior- posterior direction, para [0045]-[0046], para [0028]).
Kopelman substantially discloses the invention as claimed but did not explicitly disclose (1) the first portion comprising a housing comprising at least one sensor, a power source, wireless communications circuitry, and a processor comprising a small language model (SLM); (2) the first portion is configured to be worn on the upper teeth such that the at least one sensor is positioned adjacent to a tooth line on a roof of an oral cavity. Kopelman however, suggests the first portion may include at least one sensor (in some embodiments a sensor is mounted on or positioned in an upper shell of an intraoral appliance, para [0076]) to monitor physiological data from the patient (para [0072]-[0076]) and which can be incorporated in any number of positions (para [0076]), wherein the device may require power (para [0134]), and wherein the device can also communicate with external components using wireless communication circuitry (para [0076]). Kopelman further suggests the at least one sensor is configured to transmit sensor data to a processor (para [0077]), wherein in certain embodiments a sensor and processor can be in a single housing component (para [0067]), wherein the processor comprises an algorithm such as machine learning and/or other artificial intelligence-based methods (para [0070], para [0079], para [0103]), and wherein wireless communication circuitry may further be used [0077].
ZenithZephyr however, teaches a wearable electronic device (wearable device, page 6 and para [002]) comprising a housing (wearable device such as in form of a pendant that houses various components, page 6 and para [002]) comprising at least one sensor (houses microphones 110 to capture audio, page 6, para [002]-[003]), a power source (wearable device such as in form of a pendant that houses various components, page 6, para [002]; the wearable device is powered by a rechargeable battery, page 8, para [019]), wireless communications circuitry (houses a Bluetooth Low Energy module 120 to enable the device to wirelessly connect to another computing device, page 6, para [002], para [004]), and a processor comprising a small language model (wearable device such as in form of a pendant that houses various components, page 6, para [002]; custom small language model for processing data, page 19, para [004]; present invention emphasizes on- device processing, page 22, para [004]) in order to provide on-device artificial intelligence processing to ensure all data is securely processed (page 22, para [004]) using a lightweight model which is optimized to run efficiently on mobile devices (page 19, para [004]).
In view of the teachings of ZenithZephyr, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Kopelman by incorporating a housing comprising at least one sensor, a power source, wireless communications circuitry, and a processor comprising a small language model (SLM) in order to provide on-device artificial intelligence processing to ensure all data is securely processed using a lightweight model which is optimized to run efficiently on mobile devices. Furthermore, it would have been obvious to a person having ordinary skill in the art to modify the device such that the housing is attached to/part of the first portion such that the first portion is configured to be worn on the upper teeth such that the at least one sensor is positioned adjacent to a tooth line on a roof of an oral cavity in order to position the sensor in a convenient location for monitoring physiological data from the patient.
With respect to claim 3, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. Kopelman further discloses the at least one sensor comprises at least one of the group consisting of: a photoplethysmography (PPG) sensor, an accelerometer, a gyroscope, a microphone, a temperature sensor, and a piezo sensor [0073]-[0076, Kopelman discloses a list of sensors for detecting various modalities, e.g., microphone, as well as other sensor type suitable for obtaining physiological information relating to the patient's sleep status and/or sleep apnea status].
With respect to claim 4, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. ZenithZephyr further teaches the power source is a rechargeable battery (rechargeable battery, page 8, para [019]).
With respect to claim 5, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. Kopelman however, teaches one of the first component or the second component of the adjustment mechanism comprises a titration screw (examples of advancement structures include screws, para [0049]), but does not explicitly teach and the other of the first component or the second component comprises a ratchet. Kopelman, teaches a component of the adjustment mechanism such as a screw can be controllable actuated to a plurality of different configurations in order to produce different amounts of jaw displacement (para [0049]) such as discrete positions (para [0046]) and including motorized or non-motorized configurations (para [0056]) but does not explicitly teach the other of the first component or the second component comprises a ratchet. However, ratchets are common components of adjustment mechanisms to provide discrete adjustment positions. Therefore, it would have been obvious to a person having ordinary skill in the art to modify the device such that the other of the first component or the second component comprises a ratchet in order to better provide a plurality of discrete adjustment positions for jaw displacement as taught by Kopelman, in para [0046].
With respect to claim 6, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. Kopelman however the titration screw is incrementally adjustable relative to the ratchet (advancement mechanism including screw and as modified ratchet for actuation to discrete/incremental positions, para [0046], para [0049]), and wherein a recommended amount of incremental adjustment for the human user is provided at least in part by the SLM based on sensor data from the at least one sensor (at least one sensor to collect data which may be used in control algorithms such as machine learning algorithms by the processor to optimize treatment/ advancement signals, para [0060]-[0061]; machine learning algorithms, which as modified comprises SLM, to provide optimization of extent and timing of mandibular advancement by the advancement apparatus, para [0048]-[0049]).
With respect to claim 7, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. Kopelman further discloses a system comprising the WEAD of claim 1 (system including intraoral appliance to displace lower jaw of patient to treat sleep apnea using sensor data and control signal, para [0021]; to inhibit airway obstruction, para [0003]); and an application operating on a computing device (in some embodiments a computer program includes a mobile application, para [0141]), the computing device configured to receive SLM-processed sensor data from the WEAD via the wireless communications circuitry (data may be collected and stored for additional processing and analysis by communication via internet or other suitable remote access, para [0099]; digital processing device such as mobile application, para [0131]-[0132], para [0141]).
With respect to claim 8, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. Kopelman further discloses a cloud-based computing system (digital processing device optionally connected to a cloud computing infrastructure, para [0131]) configured to receive the SLM-processed sensor data from the application operating on the computing device (mobile application provided to mobile digital processing device, para [0141]; digital processing device optionally connected to a cloud computing infrastructure, para [0131]).
With respect to claim 9, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. Kopelman further discloses at least one of the computing device or the cloud-based computing system is configured to further process the SLM-processed sensor data to obtain further processed sensor data (data may be collected and stored for additional processing and analysis by communication via internet or other suitable remote access, para [0099]; digital processing device such as mobile application, para [0131]-[0132], para [0141]).
With respect to claim 10, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed. Kopelman further discloses at least one of the computing device or the cloud-based computing system is configured to provide a recommended adjustment of the adjustment mechanism to change the position of the second portion relative to the first portion based on at least one of the SLM-processed sensor data or the further processed sensor data (additional processing of data such as externally by communication via internet to optimize treatment parameters for mandibular advancement treatment, para [0099]).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman/ZenithZephyr as applied to claim 1 above, and further in view of Ghuge U.S. Publication No. (2021/0145628 A1).
With respect to claim 2, the combination of Kopelman/ZenithZephyr substantially discloses the invention as claimed except the housing is removable from the first portion and the WEAD.
Ghuge however, teaches a wearable electronic airway device (WEAD) (dynamic mandibular and lingual repositioning device disclosed herein to maintain an open airway during sleep, para [0004]; see description of electronic components of device, para [0005]) comprising a first portion configured to be worn on upper teeth of a user (see 107 of maxillary piece 102 worn on upper teeth, Fig 2-3; maxillary piece 102 with teeth covering 107 for covering teeth of maxilla, para [0030]-[0031]) comprising a housing (see housing 109 of 107, Fig 2-3; housing 109, para [0030]) comprising a power source and circuitry (109 encloses power source 121 and circuit board 125, para [0030]), wherein the housing is removable from the first portion and the WEAD (housing 109 may be removable attachable to the tooth covering 107, para [0031]), wherein a removable housing for electronics may allow for modular arrangements of housings such as including sensors (see another embodiment with a removable housing 108' such as with sensor 150, Fig 11; mandibular device 101 with housing 108', para [0052]; since housing 108' is removable attachable to tooth covering 160 it can be switched for housings having different sensors, para [0059]).
In view of the teachings of Ghuge, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the housing of Kopelman/ZenithZephyr such that the housing is removable from the first portion and the WEAD in order allow for modular arrangements of housings such as including different sensors depending on a subject or application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786
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