DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments made to claims 1, 7, 8, 11, 13-16, and 18, the cancellation of claims 4-6, 10, 12, 19, and 20, and the addition of new claims 21-27 in the response filed 8/2/26 are acknowledged.
Claims 1-3, 7-9, 11, 13-18, and 21-27 are now pending in the application and are examined below.
Response to Arguments
Applicant's arguments filed 8/2/26 have been fully considered but they are not persuasive. Applicant argues on p. 8-9 that Shelly fails to disclose the newly added limitations regarding the IMU and sound measuring device being specifically positioned relative to the mouthpieces of the device. However, Shelly discloses the inertial measurement unit (IMU) 14 coupled to an anterior portion of the lower mouthpiece 34 (fig. 2, posture sensor 14 coupled to and being positioned between the upper and lower mouthpieces 32/34 at the anterior); a sound measuring device 20 coupled to a posterior portion of the upper mouthpiece 34 (fig. 2, physiological sensor 20 resides at the anterior portion between the upper and lower mouthpieces; therefore, since the entire device 10 is connected, physiological sensor 20 is coupled to a posterior portion of the upper mouthpiece 34 via the body of the upper mouthpiece 34). Shelly further discloses a processor 18 configured to detect a condition of the user based on analysis of the data generated by the IMU 14 and the data generated by the sound measuring device 20 (fig. 2 and [0037], [0040], controller 18 comprises processing units and determines whether the user experiences a sleep disordered breathing event based on the posture sensor 14 and/or physiological sensor 20). Applicant argues on p. 10-11 that secondary references Bashyam, Bergmann, and Wilfong fail to make up for the deficiencies of Shelly. However, the rejection of independent claims 1 and 15 are maintained in view of Shelly for the reasons discussed above.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “inertial measurement unit” in claim claims 1 and 15; “sound measuring device” in claims 1 and 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (please see [00117] and [0075]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 25-27 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.
Regarding claim 25, the claim recites the limitation “the upper mouthpiece” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 26 and 27, the claims are rejected under 35 U.S.C. 112(b) by virtue of their dependence on claim 25.
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.
Claim(s) 1, 3, 7, 11, 13, 15, 17, 18, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelly et al. US 2020/0197655 A1.
Regarding claim 1, Shelly discloses an oral appliance 10 (fig. 2 and [0026], system 10 includes mouthpiece 13), comprising:
a mouthpiece 13 configured to be positioned in an oral cavity of a user (fig. 2 and [0029], mouthpiece 13 is worn on the lower and upper jaws), the mouthpiece comprising:
an upper mouthpiece 32 configured to be positioned on an upper jaw of the user (fig. 2 and [0029], upper jaw portion 32 of mouthpiece 13), and
a lower mouthpiece 34 configured to be positioned on a lower jaw of the user (fig. 2 and [0029], lower jaw portion 34 of mouthpiece 13);
an inertial measurement unit (IMU) 14 coupled to an anterior portion of the lower mouthpiece 34, the IMU 14 configured to generate data based on movement of the lower jaw of the user (fig. 2, posture sensor 14 coupled to and being positioned between the upper and lower mouthpieces 32/34 at the anterior; and [0030], posture sensor 14 may include an accelerometer to convey information related to acceleration, orientation, movement, etc.; thus, accelerometer 14 is capable of conveying information based on the movement of the lower jaw);
a sound measuring device 20 coupled to a posterior portion of the upper mouthpiece 34, the sound measuring device 20 configured to generate data based on noises of the user (fig. 2, physiological sensor 20 resides at the anterior portion between the upper and lower mouthpieces; therefore, since the entire device 10 is connected, physiological sensor 20 is coupled to a posterior portion of the upper mouthpiece 34 via the body of the upper mouthpiece 34; and [0031], physiological sensor 20 may include a microphone 38 to generate an output based on sounds made by the user); and
a processor 18 coupled to the mouthpiece 13, the processor 18 configured to detect a condition of the user based on analysis of the data generated by the IMU 14 and the data generated by the sound measuring device 20 (fig. 2 and [0037], [0040], controller 18 comprises processing units and determines whether the user experiences a sleep disordered breathing event based on the posture sensor 14 and/or physiological sensor 20).
Regarding claim 3, Shelly discloses the condition of the user includes at least one of normal breathing, abnormal breathing, awake periods, breath intensity, changes in breath sound intensity, snore sound quality, upper airway collapse, obstructive sleep apnea, sleep disordered breathing ([0040], controller 18 determines whether the user experiences a sleep disordered breathing event), total sleep time, sleep disturbances followed by arousal, jaw clenching, grinding, swallowing, a respiratory disease, or a neurodegenerative disorder.
Regarding claim 7, Shelly discloses a storage chip 26 configured to store and record the data generated by the IMU 14 and the data generated by the sound measuring device 20 (fig. 2 and [0050], electronic storage 26 stores information received from sensors 14/20); and a battery 28 configured to provide power to at least one of the IMU 14, the sound measuring device 20, the processor 18, or the storage chip 26 ([0051], power supply 28 powers the sensors 14/20, controller (which comprises processors) 18, and storage 26).
Regarding claim 11, Shelly discloses the IMU 14 comprising at least one of a gyroscope or an accelerometer ([0030], posture sensor 14 may include an accelerometer or gyroscope).
Regarding claim 13, Shelly discloses the processor 18 being configured to determine awake periods or arousal during sleep of the user based on detection of at least one of jaw clenching, grinding, lateral movements, or swallowing ([0040], the controller 18 (which comprises the processors) may use airflow along with accelerometer information to detect arousals that follow sleep disordered breathing events; the accelerometer would be capable of detecting movement during clenching, grinding, or swallowing).
Regarding claim 15, Shelly discloses a system 10 (fig. 2 and [0026], system 10), comprising:
an inertial measurement unit (IMU) 14 configured to be positioned on a lower jaw of a user, the IMU 14 configured to generate data based on movement of the lower jaw of the user (fig. 2, posture sensor 14 being between the upper and lower mouthpieces 32/34 and thus positioned on top of the lower jaw when worn; and [0030], posture sensor 14 may include an accelerometer to convey information related to acceleration, orientation, movement, etc., which would be capable of generating data based on movement of the lower jaw);
a sound measuring device 20 configured to be positioned on an upper jaw of the user, the sound measuring device 20 configured to generate data based on vocal and/or respiratory noises of the user (fig. 2, physiological sensor 20 being coupled to the upper mouthpiece 32 and thus positioned on/connected to the upper jaw when worn; and [0031], physiological sensor 20 may include a microphone 38 to generate an output based on sounds made by the user, which are capable of being vocal and/or respiratory); and
a processor 18 configured to detect a condition of the user based on analysis of the data generated by the IMU 14 and the data generated by the sound measuring device 20 (fig. 2 and [0037], [0040], controller 18 comprises processing units and determines whether the user experiences a sleep disordered breathing event based on the posture sensor 14 and/or physiological sensor 20).
Regarding claim 17, Shelly discloses the condition of the user includes at least one of normal breathing, abnormal breathing, awake periods, breath intensity, changes in breath sound intensity, snore sound quality, upper airway collapse, obstructive sleep apnea, sleep disordered breathing ([0040], controller 18 determines whether the user experiences a sleep disordered breathing event), total sleep time, sleep disturbances followed by arousal, jaw clenching, grinding, swallowing, a respiratory disease, or a neurodegenerative disorder.
Regarding claim 18, Shelly discloses a storage chip 26 configured to store and record the data generated by the IMU 14 and the data generated by the sound measuring device 20 (fig. 2 and [0050], electronic storage 26 stores information received from sensors 14/20); and a battery 28 configured to provide power to at least one of the IMU 14, the sound measuring device 20, the processor 18, or the storage chip 26 ([0051], power supply 28 powers the sensors 14/20, controller (which comprises processors) 18, and storage 26).
Regarding claim 24, Shelly discloses the processor 18 being configured to determine awake periods or arousal during sleep of the user based on detection of at least one of jaw clenching, grinding, lateral movements, or swallowing ([0040], the controller 18 (which comprises the processors) may use airflow along with accelerometer information to detect arousals that follow sleep disordered breathing events; the accelerometer would be capable of detecting movement during clenching, grinding, or swallowing).
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) 2 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al. US 2020/0197655 A1 in view of Bashyam US 2014/0135868 A1.
Regarding claim 2, Shelly discloses the claimed invention as discussed above.
Shelly is silent on a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user.
However, Bashyam teaches an oral appliance (fig. 6A and [0068]) comprising a stimulator 603 to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user (fig. 6A and [0068], stimulator electrodes 603 target the genioglossus muscle; [0074], closed loop operation is implemented whereby the stimulation therapy is modulated according to information conveyed by the sensors, including an accelerometer).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral appliance of Shelly with a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user, as taught by Bashyam, to train the tongue to be properly positioned according to the patient’s needs.
Regarding claim 16, Shelly discloses the claimed invention as discussed above.
Shelly is silent on a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user.
However, Bashyam teaches an oral appliance (fig. 6A and [0068]) comprising a stimulator 603 to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user (fig. 6A and [0068], stimulator electrodes 603 target the genioglossus muscle; [0074], closed loop operation is implemented whereby the stimulation therapy is modulated according to information conveyed by the sensors, including an accelerometer).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral appliance of Shelly with a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user, as taught by Bashyam, to train the tongue to be properly positioned according to the patient’s needs.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al. US 2020/0197655 A1 in view of Bergmann US 2020/0155033 A1.
Regarding claim 8, Shelly discloses the claimed invention as discussed above.
Shelly is silent on the upper mouthpiece comprising a buccal wall, a lingual wall, and an occlusal wall extending between the buccal wall and the lingual wall and the sound measuring device being secured to or embedded within the occlusal wall, such that the sound measuring device is configured to be positioned adjacent to an upper second molar region of the user.
However, Bergmann teaches an analogous upper mouthpiece 1 for monitoring the user (fig. 1 and [0028]-[0029], mouthguard 1 also having a microphone and accelerometer) comprising a buccal wall, a lingual wall, and an occlusal wall extending between the buccal wall and the lingual wall (fig. 1 shows the mouthguard 1 having a buccal/convex wall, lingual/concave wall, and an occlusal wall (the bottom connecting wall) and the sound measuring device 11 being secured to or embedded within the occlusal wall, such that the sound measuring device 11 is configured to be positioned adjacent to an upper second molar region of the user (fig. 1 and [0029], the mic 11 is secured on PCB 10; PCB 10 is secured to the occlusal wall, since all components of the device 1 are secured to each other; therefore, the mic 11 can be considered adjacent/near the upper molar region of the user).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper mouthpiece of Shelly to comprise a buccal wall, a lingual wall, and an occlusal wall extending between the buccal wall and the lingual wall and the sound measuring device being secured to or embedded within the occlusal wall, such that the sound measuring device is configured to be positioned adjacent to an upper second molar region of the user, as taught by Bergmann, to be securely held on anterior and posterior surfaces of the teeth.
Regarding claim 9, Shelly discloses the claimed invention as discussed above.
Shelly is silent on the sound measuring device comprising a micro-electromechanical system (MEMS) microphone.
However, Bergmann teaches an analogous mouthpiece 1 for monitoring the user (fig. 1 and [0028]-[0029], mouthguard 1 also having a microphone and accelerometer), wherein the sound measuring device 11 comprises a micro-electromechanical system (MEMS) microphone ([0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sound measuring device of Shelly to be a micro-electromechanical system (MEMS) microphone, as taught by Bergmann, to allow the sound measuring device to remain light and discreet.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al. US 2020/0197655 A1 in view of Wilfong et al. US 5,407,713.
Regarding claim 14, Shelly discloses the claimed invention as discussed above.
Shelly is silent on an amplifier configured to pre-amplify a signal from the sound measuring device, wherein the sound measuring device is configured to record sound at 10 kHz.
However, Wilfong teaches a noise analysis microphone (col. 37, lines 61-62) and an amplifier configured to pre-amplify a signal from the sound measuring device, wherein the sound measuring device is configured to record sound at 10 kHz (col. 38, lines 11-13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral appliance of Shelly with an amplifier configured to pre-amplify a signal from the sound measuring device, wherein the sound measuring device is configured to record sound at 10 kHz, as taught by Wilfong, to pick up the appropriate noise in the relevant bandwidth generated by the wearer during use.
Claim(s) 21, 23, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al. US 2020/0197655 A1 in view of Hamrah et al. US 11,007,076 B1.
Regarding claim 21, Shelly discloses the claimed invention as discussed above.
Shelly further discloses the sound measuring device 20 comprising two sound measuring devices ([0031], physiological sensor 20 may comprise one or more sensors) each positioned at different locations ([0034], sensors 20 may be disposed on a plurality of locations of device 13).
Shelly is silent on the two sound measuring devices each being positioned at different posterior portions of the upper mouthpiece.
However, Hamrah teaches a mouthguard 100 comprising two analogous sensors 124/124 each being positioned at different posterior portions 106/106 of an analogous mouthpiece 102 (fig. 3 and col. 8, lines 2-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the two sound measuring devices/sensors of Shelly to each be positioned at different posterior portions of the upper mouthpiece, as taught by Hamrah, to ensure sound is adequately picked up from inside the user’s throat and mouth.
Regarding claim 23, Shelly in view of Hamrah discloses the claimed invention as discussed above.
Shelly further discloses the processor 18 being further configured to detect breathing patterns associated with sleep-disordered breathing, total sleep time, and/or total number of sleep disturbances followed by arousals during respiratory events in response to data from the two sound measuring devices 20 ([0033], the information in the output signals from the physiological sensor 20 is used to determine whether the user experiences arousals or microarousals, which would be representative of the breathing pattern associated with any sleep disordered breathing that the user has; as previously discussed, [0031] discloses physiological sensor 20 may comprise one or more sensors; [0037], [0040], controller 18 comprises information processing capabilities and determines whether the user experiences a sleep disordered breathing event based on output signals from physiological sensor 20).
Regarding claim 25, Shelly discloses the claimed invention as discussed above.
Shelly further discloses the sound measuring device 20 comprising two sound measuring devices ([0031], physiological sensor 20 may comprise one or more sensors) each positioned at different locations ([0034], sensors 20 may be disposed on a plurality of locations of device 13).
Shelly is silent on the two sound measuring devices each being positioned at different posterior portions of the upper mouthpiece.
However, Hamrah teaches a mouthguard 100 comprising two analogous sensors 124/124 each being positioned at different posterior portions 106/106 of an analogous mouthpiece 102 (fig. 3 and col. 8, lines 2-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the two sound measuring devices/sensors of Shelly to each be positioned at different posterior portions of the upper mouthpiece, as taught by Hamrah, to ensure sound is adequately picked up from inside the user’s throat and mouth.
Regarding claim 27, Shelly in view of Hamrah discloses the claimed invention as discussed above.
Shelly further discloses the processor 18 being further configured to detect breathing patterns associated with sleep-disordered breathing, total sleep time, and/or total number of sleep disturbances followed by arousals during respiratory events in response to data from the two sound measuring devices 20 ([0033], the information in the output signals from the physiological sensor 20 is used to determine whether the user experiences arousals or microarousals, which would be representative of the breathing pattern associated with any sleep disordered breathing that the user has; as previously discussed, [0031] discloses physiological sensor 20 may comprise one or more sensors; [0037], [0040], controller 18 comprises information processing capabilities and determines whether the user experiences a sleep disordered breathing event based on output signals from physiological sensor 20).
Allowable Subject Matter
Claims 22 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim(s) 22 and 26, the prior art of record when applied alone or in combination neither anticipates nor renders obvious the two sound measuring devices being positioned inside the upper mouthpiece and the upper mouthpiece further comprises two ports each with a filter configured to prevent fluid from entering the upper mouthpiece, wherein each of the two sound measuring devices are positioned adjacent one of the two ports. Shelly in view of Hamrah is the closest prior art of record and discloses claims 21 and 25 as discussed above. However, Shelly and Hamrah fail to disclose or teach the limitations of claims 22 and 26. Furthermore, no other reference to date has been found in the prior art that would be able to properly modify Shelly and/or Hamrah to address its deficiencies.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Logan et al. US 2012/0172679 A1 discloses a mouthguard for monitoring biometric and environmental data
Smith US 2014/0152464 A1 discloses a compliance monitoring system for a mandibular repositioning device
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ALIREZA NIA can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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