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 of group II in the reply filed on 12/10/2025 is acknowledged. Applicant’s election was made without traversal arguments, and thus is considered to be made without traverse.
Applicant’s amendments of claims 1-14, and 16-25, and the cancelation of claim 15 change the scope of each claim such that each claim is drawn to the elected invention of group II.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following features must be shown or the feature(s) canceled from the claim(s).
control module provided in the mounting module, and the charging device in which the bruxism relieving device can be disposed of claim 1
the mounting module comprising the first and second sensor units of claim 3
the first sensor unit comprising the vibration member of claim 4
the mounting module comprising a third sensor unit of claim 16
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the specification appears to be written by an individual who is not familiar with proper idiomatic English, or suffer from being a machine translation of the foreign application. For example:
specification pg 1: “a case in which life-threatening occurs”
specification pg 2: “Furthermore, it is the best to simultaneously solve bruxism and sleep-related breathing disorders because a problem that substantially occurs during sleep cannot be properly solved if the sleep-related breathing disorders that are accompanied by the bruxism are not solved although only the bruxism is relieved”
specification pg 8: “the present disclosure for solving the above object”.
The above list is exemplary and does not include every grammatical inconsistency found throughout the specification. Thus, Applicant should review their specification and amend the specification to be written in proper idiomatic English.
Appropriate correction is required.
Claim Objections
Claims 1-10, 12, 14, 16, 18, 20, 22, and 25 are objected to because of the following informalities:
Claim 1 recites the limitation “so that bruxism” in line 5. This limitation, while not unclear, should be amended to recite “so that the bruxism” because bruxism was presented earlier in the claims.
Claim 1 recites the limitation “on oral information” in line 8. This limitation, while not unclear, should be amended to recite “on a set of oral information” to properly present the limitation.
Claim 1 recites the limitation “while the bruxism relieving device is mounted” in line 8. This limitation, while not unclear, should be amended to recite “while the bruxism relieving device is mounted within the mouth” to maintain clarity in the claims.
Claim 2 recites the limitation “between upper teeth and lower teeth” in line 2. This limitation, while not unclear, should be amended to recite “a plurality/set/number of upper teeth and a plurality/set/number of lower teeth” to properly present the limitation. Subsequent recitations of “the upper teeth and the lower teeth” in claims 2 and 10 should be amended to be consistent with this amendment.
Claim 2 recites the limitation “sense pressure information” in line 3. This limitation should be amended to recite “a pressure” to properly present the limitation.
Claim 3 recites the limitation “to measure intensity of light” in line 5. This limitation, while not unclear, should be amended to recite “to measure a level of light intensity” to properly present the limitation. Subsequent recitations of “brightness information” found in claims 8-11, 16-17, and 19 should be amended to be consistent with this amendment.
Claim 4 recites the limitation “generate vibration”. This limitation, while not unclear, should be amended to recite “generate a vibration”. to properly present the limitation.
Claim 5 recites the limitation “determining, as a bruxism state”. This limitation, while not unclear, should be amended to recite “determining a bruxism state”.
Claim 5 recites the limitation “to be preset pressure or more”. This limitation, while not unclear should be amended to recite “to be greater than or equal to a preset pressure” to properly present the limitation of “preset pressure” and for clarity purposes.
Claim 6 recites the limitations “generate first/second vibration”. This limitation should be amended to recite “generate a first/second vibration” to properly present the limitations.
Claim 6 recites the limitation “when the pressure information is determined to be the preset pressure or more even through the first vibration”. This limitation should be amended to recite “when the pressure information is determined to be greater than or equal to the preset pressure after the first vibration” to be grammatically correct.
Claim 7 as written is grammatically incorrect and comprises multiple issues that render the claim indefinite. The claim should be amended to recite “wherein when the pressure information is determined to be greater than or equal to the preset pressure after the second vibration has been generated, the control module raises strength of the second vibration step by step, but stops the second vibration after determining the pressure information less than the preset pressure”.
Claim 8 recites the limitation “generate brightness information” in line 2. This limitation should be amended to recite “generate a brightness information”.
Claim 9 recites the limitation “be first brightness” in line 5. This limitation should be amended to recite “a first brightness”.
Claim 10 as written is grammatically incorrect and comprises multiple issues that render the claim indefinite. The claim should be amended to recite “configured such that when the brightness information is determined to be greater than the first brightness, the control module determines if the brightness information is less than or equal to a second brightness that is greater than the first brightness, and when the brightness information is less than or equal to the second brightness, the control module determines that the mouth has been open and the upper teeth and lower teeth have not come into contact”.
Claim 12 recites the limitation “generate sound information”. This limitation should be amended to recite “a sound information” to properly present the limitation.
Claim 12 recites the limitation “to sleep-related breathing disorders”. This limitation should be amended to recite “to one or more sleep-related breathing disorders” to properly present the limitation. Claims 13-14 should be amended to be consistent with this amendment.
Claim 12 recites the limitation “generate saturation information”. This limitation should be amended to recite “a saturation information” to properly present the limitation.
Claim 12 recites the limitation “by measuring oxygen saturation”. This limitation should be amended to recite “measuring an oxygen saturation of the mouth” to properly present the limitation and for clarity purposes.
Claim 14 recites the limitation “raise strength”. This limitation should be amended to recite “raise a strength” to properly present the limitation.
Claim 16 recites the limitation “configured to generate time information”. This limitation should be amended to recite “generate a time information” to properly present the limitation.
Claim 16 recites the limitation “from timing”. This limitation should be amended to recite “from a time” to properly present the limitation and be grammatically correct.
Claim 18 recites the limitation “from timing”. This limitation should be amended to recite “from the time” to maintain consistency and be grammatically correct.
Claim 20 recites the limitation “wherein the server is configured to generate the setting values of the sleep times of the first sensor unit and the second sensor unit”. This limitation should be removed from the claim as it is redundant in view of claim 19 which recites the same limitation.
Claim 22 recites the limitation recites the limitation “whether sleep-related breathing disorders”. This limitation should be amended to recite “whether one or more sleep-related breathing disorders” to properly present the limitation. Claims 23-25 should be amended to be consistent with this amendment.
Claim 25 recited the limitation “he warning signal”. This limitation should be amended to recite “the warning signal”.
The claims appears to be written by an individual who is not familiar with proper idiomatic English, or suffer from being a machine translation of the foreign application. Thus, the above list may not include every objectionable issue. Applicant is advised to thoroughly review the claims and amend them to be in proper idiomatic English.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 and 16-25 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.
Claim 1 recites the limitation “configured to control the mounting module step by step” in line 8. This limitation renders the claim indefinite as it is unclear as to what steps, and/or structures are encompassed by the recitation “step by step”. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 1 recites the limitation “the charging device the bruxism relieving device; and” in line 11. This recitation renders the claim indefinite because the recitation lacks additional structures, or limitations to define the recited structures, rendering the claim unclear as to what is being limited or claimed. For the purpose of examination, Examiner will omit this recitation from examination, as it appears to be a typographical inclusion.
Claim 1 recites the limitation “a server configured to collect sensing information” in line 13. This recitation renders the claim indefinite because it is unclear as to if the sensing information is new information, or the same oral information to be sensed by the mounting module. For the purpose of examination, Examiner will interpret sensing information as being the oral information recited earlier in the claim.
Claim 1 recites the limitation “a server configured to…generate a setting value” in line 14. This recitation renders the claim indefinite because the claim and specification do not state what this value is (i.e. a pressure value, a time value, etc.) which renders the claim unclear as to what is being claimed in the recitation “setting value”. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 3 recites the limitation “pressure information” in line 3. This limitation renders the claim indefinite as it is unclear if “pressure information” is new information, or the same oral information to be sensed by the mounting module. For the purpose of examination, Examiner will interpret pressure information as being a subset of the oral information recited earlier in claim 1.
Claim 4 recites the limitation “so that the bruxism is reduced based on the pressure information by the control module” in line 3. This limitation renders the claim indefinite because it is unclear if bruxism is reduced in every time for every individual using the device, and it is unclear as to how the pressure information transmitted to the control module reduces bruxism. For the purpose of examination, Examiner will interpret this limitation as “and to generate vibrations which are configured to reduce the bruxism”.
Claim 5 recites the limitation “a case” in line 3. This limitation renders the claim indefinite as it is unclear if “a case” is referring to the bruxism state recited earlier in the claim, or is different from the bruxism state. For the purpose of examination, Examiner will interpret this limitation as “determining a bruxism state in which the pressure information”.
Claim 6 recites the limitation “generate first vibration” in line 2 and “generate second vibration” in line 3. This limitation renders the claim indefinite as it is unclear if the first and second vibrations of claim 6 are the same vibration presented earlier in claim 4, or are new vibrations in addition to the vibration presented earlier in claim 4. For the purpose of examination, Examiner will interpret this limitation as “wherein the vibration generated by the control module is a first vibration…and a second vibration”.
The term “relatively higher” in claim 6 is a relative term which renders the claim indefinite. The term “relatively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as “higher”.
Claim 8 recites the limitation “brightness information” in line 2. This limitation renders the claim indefinite as it is unclear if “brightness information” is new information, or the same oral information to be sensed by the mounting module. For the purpose of examination, Examiner will interpret brightness information as being a subset of the oral information recited earlier in claim 1.
Claim 8 recites the limitation “an intensity of light” in line 3. This limitation renders the claim indefinite as it is unclear if this intensity is a new intensity of light, or the same intensity of light recited in claim 3. For the purpose of examination, Examiner will interpret this limitation as being the same intensity of light as recited in claim 3.
The term “relatively greater” in claim 10 is a relative term which renders the claim indefinite. The term “relatively” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as “greater”.
Claim 10 recites the limitation “and determines…the upper teeth and the lower teeth have not come into contact with each other when the brightness information is the second brightness or less”. This limitation renders the claim indefinite as it is unclear how a brightness information can be fully predictive of upper and lower teeth not coming into contact with each other. This limitation is further unclear because “the second brightness or less” includes brightness levels down to, and below the first brightness which is indicative of the mouth being closed with the teeth in contact with one another. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 11 recites the limitation “the control module determines that the mounting module is in a state in which the mounting module has been separated from the mouth”. This limitation renders the claim indefinite because it is unclear as to if “the state in which the mounting module has been separated from this mouth” recited in claim 11, is a state when the mounting module is separated from the mouth and disposed on the charging module, or is referring to a different state. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 12 recites the limitation “a fourth sensor unit…a fifth sensor unit”. These limitations render the claim indefinite as it is unclear how there can be a fourth and fifth sensor unit, when a third sensor unit is not claimed in any of the claims from which claim 12 depends. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 12 recites the limitation “sound information” in line 3. This limitation renders the claim indefinite as it is unclear if “sound information” is new information, or the same oral information to be sensed by the mounting module. For the purpose of examination, Examiner will interpret sound information as being a subset of the oral information recited earlier in claim 1.
Claim 12 recites the limitation “saturation information” in line 6. This limitation renders the claim indefinite as it is unclear if “saturation information” is new information, or the same oral information to be sensed by the mounting module. For the purpose of examination, Examiner will interpret saturation information as being a subset of the oral information recited earlier in claim 1.
Claim 16 recites the limitation “a third sensor unit”. This limitation renders the claim indefinite as it is unclear how there can be a third sensor unit, when a first and second sensor unit are not claimed in claim 1. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 16 recites the limitation "the pressure information" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a pressure information”
Claim 16 recites the limitation “pressure information” in line 3. This limitation renders the claim indefinite as it is unclear if “pressure information” is new information, or the same oral information to be sensed by the mounting module. For the purpose of examination, Examiner will interpret pressure information as being a subset of the oral information recited earlier in claim 1.
Claim 16 recites the limitation "the brightness information" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a brightness information”
Claim 16 recites the limitation “brightness information” in line 3. This limitation renders the claim indefinite as it is unclear if “brightness information” is new information, or the same oral information to be sensed by the mounting module. For the purpose of examination, Examiner will interpret brightness information as being a subset of the oral information recited earlier in claim 1.
Claim 16 recites the limitation "the first sensor unit” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a first sensor unit”.
Claim 16 recites the limitation "the second sensor unit” in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a second sensor unit”.
Claim 18 recites the limitation “a sleep time” in line 2. This limitation renders the claim indefinite as it is unclear if Applicant is claiming a sleep time of the user, or a dormant time of the sensors (i.e. a period where the sensors are off). For the purpose of examination, Examiner will interpret this limitation as a dormant time of the sensors.
Claim 18 recites the limitation “from timing at which the bruxism relieving device is mounted within the mouth”. This limitation renders the claim indefinite as it is unclear if this is a new timing, or the same timing at which the mounting module is mounted recited in claim 16. For the purpose of examination, Examiner will interpret this limitation as being the same timing.
Claim 18 recites the limitation “a working time that elapses after the pressure information is generated”. This limitation renders the claim indefinite as it is unclear if the recited working time which elapses, is a new time or is the same time as the elapse time recited in claim 16. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 19 recites the limitation “wherein the server is configured to generate setting values”. This limitation renders the claim indefinite as it is unclear if the recited setting values in claim 19 are new values, or the same values recited in claim 1. For the purpose of examination, Examiner will interpret the values of claim 19 as being the same as recited in claim 1.
Claim 19 recites the limitation “a server configured to…generate a setting value”. This recitation renders the claim indefinite because the claim and specification do not state what this value is (i.e. a pressure value, a time value, etc.) which renders the claim unclear as to what is being claimed in the recitation “setting value”. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 19 recites the limitation “sleep times”. This limitation renders the claim indefinite as it is unclear if the recited sleep times in claim 19 are new times, or the same sleep time recited in claim 18. For the purpose of examination, Examiner will interpret the sleep times of claim 19 as being the same as recited in claim 18.
Claim 21 recites the limitation “to modify the setting value (singular)”. This limitation renders the claim indefinite as it is unclear of which of the setting values (plural) recited in claim 19 are being modified in claim 21. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 22 is indefinite as the claim depends from canceled claim 15 which renders the dependency of claim 22 unclear. For the purpose of examination, Examiner will interpret claim 22 as being dependent from claim 12 because claim 22 appears to be further limiting the fourth and fifth sensors recited in claim 12.
Claim 22 recites the limitation “the information” in line 3. This limitation renders the claim indefinite as it is unclear as to which information (sound or saturation information) applicant is referring to, or if applicant is referring to both sets of information. For the purpose of examination, Examiner will interpret this limitation as “the sound information and the saturation information”.
Claim 22 recites the limitation “while operating in conjunction with the bruxism relieving device”. This limitation renders the claim indefinite as it is unclear as to if Applicant is claiming while the server, or the sensors are operating in conjunction with the bruxism relieving device. For the purpose of examination, Examiner will interpret this limitation as “while the server is operating in conjunction with the bruxism relieving device”.
Claim 23 recites the limitation “when it is determined”. The use of the pronoun “it” renders the claim indefinite as it is unclear which previously recited limitation “it” is referring to. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 24 recites the limitation “a generation of at least any one of a warning sound, text, vibration, and an alarm by a user terminal of the bruxism relieving device”. This limitation renders the claim indefinite as it is unclear if the recited notifications are in addition to, or are the warning signal recited in claim 23. For the purpose of examination, Examiner will interpret this limitation as “a generation of the warning signal includes at least one of”.
Claim 24 recites the limitation “a user terminal of the bruxism relieving device”. This limitation renders the claim indefinite as it is unclear if Applicant is claiming that the bruxism relieving device (a mouth guard placed inside the user’s mouth) has a user terminal (i.e. a phone, pc, tablet). For the purpose of examination, Examiner will interpret this limitation as “a user terminal operatively connected to the bruxism relieving device”
Claim 24 recites the limitation “a generation of…an alarm”. This limitation renders the claim indefinite as it is unclear if the alarm recited in claim 24 is the same generated alarm recited in claim 23, or a new alarm. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 25 recites the limitation "the outside" in line 2. There is insufficient antecedent basis for this limitation in the claim. This limitation is also unclear as Applicant has not recited what the outside is of (i.e. the outside of the user’s mouth, the outside of their bed, the outside of their house, etc.). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 25 recites the limitation "the wearer" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a wearer”.
Claim 25 recites the limitation “a dangerous state”. This limitation renders the claim indefinite as it is unclear as to what Applicant considers to be “a dangerous state”. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claims 2, 7, 9, 13-14, 16-17, and 20 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim and therefore, containing the same offending limitations.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 8-11, 16-19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanjani et al. (US 2021/0244501 A1) (hereinafter Shanjani).
In regards to claim 1, Shanjani discloses a bruxism management system (system; see [0007]) that relieves bruxism occurring during sleep (the system includes an intraoral appliance such as a nightguard for treating bruxism, and can be used for treating an underlying condition (bruxism) and monitoring physiological characteristics to track the efficacy of that treatment; see [0124] and [0265]), the bruxism management system comprising:
a bruxism relieving device (intraoral appliance and 300; see [0112] and [0137]; see figures 3a with respect to 300, and the figures with respect to the different embodiments of the intraoral appliance) comprising:
a mounting module (intraoral appliance) that is configured to be mounted within a mouth (intraoral appliances are configured to be mounted within a mouth; see figure 50b) so that bruxism is relieved when the bruxism occurs (the intraoral appliance is between the user’s teeth, and thus, relieves grinding of the user’s teeth when it occurs), the mounting module being configured to sense a state of the mouth (see [0265]); and
a control module (300) provided in the mounting module (see [0154] and [0222]) and configured to control the mounting module step by step so that the bruxism is reduced based on oral information sensed by the mounting module (300 controls the intraoral appliance through data received from sensors and transmission of said data, and executing instructions for managing the operation of the appliance (see [0137], [0258], and [0260] in reference to the instructions being starting or stopping sensing, and/or activating or deactivating the ECI (Electronic Compliance Indicator or monitoring device 300; see [0017]) and sending the data to a user interface to display the data and notifications to the user; thus, 300 is capable of controlling the mounting module for treating/reducing bruxism, step by step through the steps of sensing, processing, and transmitting the data received to the user and is configured as claimed);
a charging device (inductive power hub; see [0143]) in which the bruxism relieving device is configured to be disposed (intraoral appliance, when placed on the indicative power hub is disposed within a perimeter of the inductive power hub) when separated from the mouth (see [0143]), the charging device the bruxism relieving device and
a server (application software; see [0257]; see figure 40; a server is a software system that provides data, resources, or services to other computers; the application software provides data processing and displaying (provide data) and encouraging mechanisms (resources), and thus, is a server) configured to collect sensing information sensed while the bruxism relieving device is mounted (see [0141-0142], and [0257]) and to generate a setting value of the control module (application software manages the operation of 300 (see [0260]); thus, the application software is capable of generating a setting value of 300 and is configured as claimed).
In regards to claim 2, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the mounting module (intraoral appliance) is configured to be provided between upper teeth and lower teeth within the mouth (see figure 50a), and to sense pressure that occurs as the upper teeth and the lower teeth come into contact with each other (300 may include pressure sensors (see [0138]) which can be utilized to sense grinding or clenching of teeth (see [0310])).
In regards to claim 3, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the mounting module (intraoral appliance) comprises:
a first sensor unit (first 306; see [0138] that 306 may include five or more sensors; see figure 3a) configured to sense pressure information occurring within the mouth (one of the 306 may be a pressure sensor which senses pressure information occurring within the mouth; see [0138]); and
a second sensor unit (second 306; see [0138]; see figure 3a) configured to measure intensity of light that is incident on the mounting module (one of the 306 may be a light sensor which senses an intensity of light which reaches the sensor positioned on the oral appliance; see [0138]).
In regards to claim 8, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the second sensor unit (second 306) is configured to generate brightness information based on an intensity of light that is incident on the mounting module (see discussion of claim 2) and transmits the generated brightness information to the control module (300 receives data from sensors (see [0137]), and thus receives the brightness information generated and transmitted from second 306).
In regards to claim 9, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the control module (300) is configured to determine whether the mouth is in a closed state based on the brightness information transmitted by the second sensor unit, and is configured to determine that the mouth has been closed when the brightness information is determined to be first brightness or less (300 receives data from sensors, and processes the data (see [0137]) to determine a characteristic of the patient's intraoral cavity or airway based on measurements from the intraoral sensors (see [0020]); electrical sensors allow measurement of physiological characteristics of a patient to detect whether the patient has an open or closed mouth (see [0286]); 300 is configured to distinguish between different signal strengths received from the sensors to reduce false positives (see [0076] and [0246]; see figure 26 and 29b); thus, 300 is capable of determining whether the mouth is open or closed based on the signal strength of the processed brightness information generated and transmitted by the second 306 and is thus, configured as claimed).
In regards to claim 10, Shanjani discloses the invention as discussed above.
Shanjani further discloses when the brightness information is determined to be more than the first brightness, the control module determines whether the brightness information is second brightness or less that is relatively greater than the first brightness, and determines that the mouth has been opened and the upper teeth and the lower teeth have not come into contact with each other when the brightness information is the second brightness or less (see discussion of claim 9 above that 300 is capable of determining when a mouth is open or closed based on the signal strength of the brightness information received from the second 306; thus, 300 is capable of differentiating between and determine a first signal strength caused by a first brightness (i.e. a brightness when in the appliance is in the mouth), and a second signal strength caused by a second brightness which is greater than the first brightness (i.e. a brightness when the appliance is in the mouth and the mouth is open; see [0246] and figure 29b); thus, 300 configured as claimed; furthermore, a second signal strength caused by a second greater brightness with respect to the first brightness can be configured to be indicative of a user’s mouth being opened, allowing 300 to determine the mouth is open and the upper teeth and the lower teeth have not come into contact with each other as claimed).
In regards to claim 11, Shanjani discloses the invention as discussed above.
Shanjani further discloses when the brightness information is determined to be more than the second brightness, the control module determines that the mounting module is in a state in which the mounting module has been separated from the mouth (the monitoring device 300 is configured to differentiate between different signal strengths, and differentiate based on the signal strengths when the intraoral appliance is separated from the mouth; see [0246]; see figure 29a); thus, 300 is capable of determining the intraoral device is separated from the mouth based on brightness information which is determined by the signal strength to be more than the second brightness; thus, 300 is configured as claimed).
In regards to claim 16, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the mounting module (300) comprises a third sensor unit (308; see [0137]; see figure 3a) configured to generate time information (timestamps; see [0140]) by matching the pressure information and the brightness information measured by the first sensor unit (first 306) and the second sensor unit (second 306) while the mounting module is mounted within the mouth (308 generates a timestamp representing when the stored data (the pressure and brightness information generated by first and second 306) was obtained; see [0220]), and an elapse time from timing at which the mounting module is mounted (processed data can include date and time of when the appliance was used (see [0220]); thus, 300 through 308 and the processor, associate or match an initial time when the device is mounted, and an elapse time from the initial mounting to when the data is sensed).
In regards to claim 17, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the server (application software) is configured to recognize that the bruxism relieving device (intraoral appliance) is separated and charged by the charging device (inductive power hub; the application software is configured to recognize that the intraoral device is mounted within the user’s mouth (separated from the charging device), and receiving data from the intraoral device (charged with power); see [0220], [0255] and [0258]), and is configured to receive , from the control module (300), the time information in which the pressure information and brightness information of the first sensor unit and the second sensor unit have been matched with the elapse time (the application software receives the timestamped data indicative of when the intraoral device is mounted in the user’s mouth, and the timestamped pressure and brightness data which is indicative of an elapse time from 300 (See [0220-0221] and [0258]; see figure 19 and 40).
In regards to claim 18, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the server (application software) is configured to determine a sleep time when the pressure information is generated from timing at which the bruxism relieving device is mounted within the mouth based on the time information transmitted by the control module and a working time that elapses after the pressure information is generated (the application software is configured to manage the operation of the appliance and/or 300 (ECI) including stopping timing/sensing/recording, and de-activating 300 (determining a sleep time), and starting timing/sensing/recording, and activating 300 (determine a working time; see [0260]); all of the steps (including sensing and transmitting data) can be performed by explicit instructions provided by a processor of a device external to the patient's intraoral cavity, e.g., a separate computing device or system (such as the application software; see [0218] and [0221]); thus, the application software is configured as claimed).
In regards to claim 19, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the server is configured to generate setting values of sleep times of the first sensor unit and the second sensor unit (as discussed above, the application software is configured to generate setting values of sleep times of the first and second sensor) based on the sleep time and the working time so that the bruxism relieving device measures the pressure information and the brightness information after the bruxism relieving device is mounted within the mouth (the application software is configured to help the user manage the operation of the appliance and/or 300 (ECI) including stopping timing/sensing/recording, and de-activating 300 (determining a sleep time), and starting timing/sensing/recording, and activating 300 (determine a working time; see [0260]); thus, the application software, through a user’s input, is capable of setting values of sleep times of the first sensor unit and the second sensor unit based on the sleep time and working time so that the first and second sensors only measure data when the intraoral device is mounted within the mouth).
In regards to claim 21, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the server (application software) is configured to accumulate the pressure information, the brightness information, and the time information that are transmitted by the control module (300; see [0220-0221] and [0258]), and to modify the setting value of the sleep time based on the accumulated information (the application software is configured to help the user manage the operation of the appliance and/or 300 (ECI) including stopping timing/sensing/recording, and de-activating 300 (determining a sleep time), and starting timing/sensing/recording, and activating 300 (determine a working time; see [0260]); thus, the application software, through a user’s input, is capable of modifying the setting values of sleep time based on the accumulated information).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani in view of Lee (KR 20120093474 A) (examiner relies on a machine translation of Lee provided by Espacenet).
In regards to claim 4, Shanjani discloses the invention as discussed above.
Shanjani further discloses that the oral appliance may include a vibration motor (see [0205]), but does not disclose wherein the first sensor unit comprises a vibration member configured to transmit the pressure information to the control module and to generate vibration so that the bruxism is reduced based on the pressure information by the control module.
However, Lee teaches an analogous bruxism relieving system (system as seen in figure 1) comprising an analogous mounting module (100; see [0021]; see figure 1) which comprises an analogous control module (120; see [0021]; see figure 1) and first sensor unit (115; see [0021]; see figure 1); wherein the first sensor unit (115) comprises a vibration member (vibration sensing aspect of 115; see [0021]) configured to transmit the pressure information to the control module (120; see [0023]) and to generate vibration (see [0029-0030]) so that the bruxism is reduced based on the pressure information by the control module (120; see [0014] bruxism is reduced based on the vibration initiated by 115 sensing bruxism/pressure) for the purpose of creating a stimulus to stop the patient from grinding their teeth (see [0030]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first sensor unit of the control module as disclosed by Shanjani and to have included the vibration member configured to transmit the pressure information and to generate vibrations in response to a bruxism event as taught by Lee in order to have provided an improved bruxism management system that would add the benefit of creating a stimulus in response to a detected bruxism event to stop the patient from grinding their teeth (see [0030]).
In regards to claim 5, Shanjani as now modified by Lee discloses the invention as discussed above.
Shanjani as now modified by Lee further discloses wherein the control module (300 of Shanjani) is configured to control the vibration member (vibration sensing aspect of 115 of Lee included into first 306 of Shanjani) by determining, as a bruxism state, a case in which the pressure information is determined to be preset pressure (pressure according to a patient’s teeth grinding symptoms; see Lee [0022]) or more based on the pressure information received from the first sensor unit (first 306 of Shanjani as now modified by Lee; see Lee [0024] in reference to the control unit 120 generating a signal in response to pressure sensed by 115; thus, 300 of Shanjani is configured similarly when combined with Lee).
In regards to claim 6, Shanjani as now modified by Lee discloses the invention as discussed above.
Shanjani as now modified by Lee further discloses wherein the control module (300 of Shanjani as now modified by Lee) is configured to generate first vibration (first intensity of the signal generated by the vibration member of Lee; see Lee [0024]) by operating the vibration member based on the pressure information (see Lee [0024]), and to generate second vibration (increased intensity of the signal generated by the vibration member of Lee; see Lee [0024]) having a relatively higher number of vibrations (an increased intensity of vibrations includes a higher number of vibrations) than the first vibration when the pressure information is determined to be the preset pressure or more even through the first vibration (see Lee [0024] in reference to adjusting the intensity of the signal generated in proportion to the noise, vibration, pressure, etc.; thus, increasing the vibration intensity when the pressure information is greater than a first preset value indicative of bruxism).
In regards to claim 7, Shanjani as now modified by Lee discloses the invention as discussed above.
Shanjani as now modified by Lee further discloses wherein when the pressure information is determined to be the preset pressure or more even in a state in which the second vibration has been generated, the control module (300 of Shanjani) raises strength of the vibration step by step, but stops the vibration by determining a case in which the pressure information is determined to be less than the preset pressure as a stop of the bruxism (see Lee [0024] and [0058] in reference to the intensity of the signal generated being proportional to the pressure sensed and said increase in intensity can be in stages until the bruxism is alleviated).
Claim(s) 12-14 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani in view of Lee as applied to claim 4 above, and further in view of Won (WO 2017/119638 A1) (examiner relies on a machine translation of Won provided by Espacenet).
In regards to claim 12, Shanjani as now modified by Lee discloses the invention as discussed above.
Shanjani further discloses wherein the mounting module (300) further comprises:
a fourth sensor unit (fourth 306; see [0138]; see figure 3a) configured to generate sound information by sensing a sound attributable to sleep-related breathing disorders (one of the 306 may be a sound sensor which senses sound information occurring within the mouth; see [0138]) said sound information can sense a breathing rate and can be attributable to obstructive sleep apnea; see [0269]) and to transmit the generated sound information to the control module (300; 306 transmits sensed information to 302 and 304 of 300; see [0137]); and
a fifth sensor unit (fifth 306; see [0138]; see figure 3a) configured to generate saturation information by measuring gas saturation (one of the 306 may be a gas flow sensor which senses gas saturation or breathing occurring within the mouth; see [0138]) in order to determine whether the sleep-related breathing disorders occurs (see [0207]) and to transmit the saturation information to the control module (300; each 306 transmits sensed information to 300; see [0137]).
Shanjani as now modified by Lee does not disclose the fifth sensor is configured to generate saturation information by measuring oxygen saturation.
However, Won teaches an analogous sleep-disorder monitoring, and warning system (system seen in figures 1 and 2) comprising an analogous device (1; see pg 12-13; see figure 4) which has the analogous function to monitor a sleeping individual and treat a detected sleep disorder (see pg 1 and 2); comprising an analogous sensor (120; see pg 13; see figure 1); wherein the sensor is an oxygen saturation sensor configured to generate saturation information by measuring oxygen saturation (see pg 14) for the purpose of detecting levels of decreased oxygen saturation which may be harmful to a user (see pg 28).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas flow sensor as disclosed by Shanjani as now modified by Lee and to have formed the gas flow sensor as an oxygen saturation sensor as taught by Won in order to have provided an improved fifth sensor that would add the benefit of detecting levels of decreased oxygen saturation which may be harmful to a user (see pg 28).
In regards to claim 13, Shanjani as now modified by Lee and Won discloses the invention as discussed above.
Shanjani as now modified by Won further discloses wherein the control module (300 of Shanjani) is configured to determine whether the sleep-related breathing disorders occur based on the sound information and the saturation information transmitted by the fourth sensor unit (fourth 306 of Shanjani) and the fifth sensor unit (fifth 306 of Shanjani as now modified by Won; 300 of Shanjani is configured to receive and process information received from the sensors (see Shanjani [0137]; thus, 300 of Shanjani is capable of receiving and processing the information received by the fourth and fifth sensors to determine whether the sleep-related breathing disorders occur based on the received information similar to what is described in [0207] of Shanjani).
In regards to claim 14, Shanjani as now modified by Lee and Won discloses the invention as discussed above.
Shanjani as now modified by Lee and Won further discloses wherein the control module (300 of Shanjani) is configured to raise strength of the vibration by controlling the vibration member (vibration sensing aspect of 115 of Lee included into first 306 of Shanjani) when the sleep-related breathing disorders are determined to have occurred based on the sound information and the saturation information (see Lee [0022] that the intensity of the vibration is configured to increase based in proportion to the information sensed by the sensors; thus, 300 of Shanjani as now modified by Lee is similarly capable of raising the strength of the vibrations based on the sound information and saturation information sensed by the fourth and fifth 306 of Shanjani), and is configured to operate the vibration member with a maximum output when the oxygen saturation of the saturation information is a preset oxygen saturation numerical value or less (see Won pg 28 in reference to blood oxygen saturation is determined to be less than 85%, a vibration stimulus of considerable intensity is applied; considerable intensity is considered a maximum output; thus, the control module controlling the vibration member of Shanjani as now modified by Lee is similarly considered to output maximum vibration in response to a blood oxygen saturation level less than 85%).
In regards to claim 22, Shanjani as now modified by Lee and Won discloses the invention as discussed above (see 112b interpretation above).
Shanjani further discloses wherein the server (application software) is configured to be connected to the control module (300) in real time (see [0221] that the remote device (i.e. the application software) can give instructions to the monitoring device to retrieve information in real time; also note [0140] describing 308 as a “real-time” clock, which implies the information gathered is in real-time) in order to determine whether sleep-related breathing disorders (sleep apnea) occur based on the information (sound information of Shanjani, and saturation information as taught by Won) transmitted by the fourth sensor unit and fifth sensor unit (fourth 306, and fifth 306 modified by Won) of the bruxism relieving device (intraoral appliance) while operating in conjunction with the bruxism relieving device (see [0207]; 300, which is connected to the application software conveys sensed information to the application software, determines a sleep apnea event; thus, the application software through the controller determines whether sleep apnea occurs based on the information provided by 300).
In regards to claim 23, Shanjani as now modified by Lee and Won discloses the invention as discussed above.
Shanjani further discloses wherein the server is configured to determine whether the sleep-related breathing disorders occur based on the sound information and the saturation information that are transmitted by the fourth sensor unit and the fifth sensor unit (see discussion of claim 22 above), and is configured to transmit a warning signal so that an alarm is generated in order to reduce the sleep-related breathing disorders (see [0260] that the application software is capable of generating an alarm, email, text message, etc. in response to an event detected by the intraoral device) when it is determined that the sleep-related breathing disorders continue even although the control module has controlled the vibration member with a maximum output (see Won pg 28 in reference to a vibration stimulus of considerable intensity (i.e. a maximum output) is applied in response to a dire sleep-related breathing disorder event; thus, the application software being capable of generating an alarm, email, text message, etc. in response to a detected event, is capable of generating an alarm when the intraoral device detects the persistence of sleep-related breathing event after application of a maximum output vibration).
In regards to claim 24, Shanjani as now modified by Lee and Won discloses the invention as discussed above.
Shanjani further discloses wherein the server (application software) is configured to perform a generation of at least any one of a warning sound, text, vibration, and an alarm by a user terminal (see [0260]) of the bruxism relieving device in order to reduce the sleep-related breathing disorders through the warning signal (an alarm, email, or text as described in [0260] may wake the user and thereby reduce the sleep-related breathing disorder).
In regards to claim 25, Shanjani as now modified by Lee and Won discloses the invention as discussed above.
Shanjani further discloses wherein the server (application software) is configured to notify the outside of a danger to the wearer (notifying other connected users; see [0260]) by transmitting location information (geographic location of the appliance; see [0007]) to the outside along with the warning signal if sleep-related breathing disorders of the wearer continues and the wearer is determined to be in a dangerous state even though he warning signal has been used for reducing the sleep-related breathing disorders of the wearer (the application software is capable of generating an alarm, email, text message, etc., and notifying other connected users in response to a detected event; thus, the application software is capable of notifying the connected users of a danger to the wearer in response to the claimed situation).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani in view of Lee (US 2019/0365311 A1).
In regards to claim 20, Shanjani discloses the invention as discussed above.
Shanjani further discloses wherein the server (application software) is configured to generate the setting values of the sleep times of the first sensor unit and the second sensor unit (the application software is configured to help the user manage the operation of the appliance and/or 300 (ECI) including stopping timing/sensing/recording, and de-activating 300 (determining a sleep time), and starting timing/sensing/recording, and activating 300 (determine a working time; see [0260]); thus, the application software is capable generating the setting values of the sleep times of the first sensor unit and second sensor unit through user interaction as claimed), and is configured to modify an operating timing setting value at which the control module operates the mounting module by transmitting the setting values to the control module through a case (3101; see [0248]; see figure 31a) which houses the bruxism relieving device (see figure 31a; 3101 allows for data transmission between the intraoral appliance and the application software on a user’s phone (see [0017] and [0248]) and thus, is capable of transmitting the setting values set by the application software to the intraoral appliance).
Shanjani does not disclose the case is the charging device.
However, Lee teaches an analogous bruxism management system (system; see [abstract]) comprising an analogous bruxism relieving device (110 and 112; see [0013]; see figure 1) and server (120; see [0013]; see figure 1); further comprising an analogous case (300; see [0022]; see figure 3); wherein the case is a charging device (see [0022]) for the purpose of charging the mouth guard while storing the mouth guard (See [0022]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the case which is capable of transmitting data between the intraoral device and the application software as disclosed by Shanjani and to have formed the case as a charging device as taught by Lee in order to have provided an improved case that would add the benefit of charging the mouth guard while storing the mouth guard (See [0022]). Additionally, to have formed the case of Shanjani to include the induction coils as taught by Lee (thereby forming the case of Shanjani as the inductive power hub described in [0143] of Shanjani) would add the additional benefits of allowing the intraoral device to charge while exchanging information with the application software, ensuring the intraoral device can send and receive all data without interruption due to a lack of power.
Conclusion
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786