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 .
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.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 14 lacks a transitional phrase. Without transitional phrase, the scope of a claim is unclear because it is unclear whether or not claims should be interpreted as open or close-ended. See MPEP 2111.03.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim does not include any steps and recites a “method for detecting of bruxism where in use if made of a bruxism detection and feedback system according to claim 1”. MPEP 2173.05(g) states the following:
"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.
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) 1-3 and 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Pub. No.: US 2020/0086133 A1); hereinafter referred to as Wang, in view Garcia Molina et al. (Pub. No. US 2019/0083028 A1); hereinafter referred to as “Garcia”, and further in view of Martinot (WO 2020/193778 A1).
Regarding claims 1 and 14-16, Wang et al. (Pub. No.: US 2020/0086133 A1) discloses a bruxism detection and feedback system (e.g. see figure 1 element 100) comprising: an in-ear device comprising: an in-ear portion (e.g. see [0062]) configured to be placed in an ear canal, wherein preferably the in-ear portion is at least partially made from a shape conforming material that conforms to a shape of the ear canal; a heart rate sensor to measure a heart rate, a microvibration sensor to measure microvibrations and/or a breathing rate sensor to measure a breathing rate when the in-ear portion is placed in the ear canal (e.g. see [0064]); and a bruxism sensor (e.g. see [0073], “grinding the user's teeth”) configured for measuring a characteristic signal which is characteristic of a bruxism event when the in-ear portion is placed in the ear canal, a processor (e.g. see figure 2A element 202A) connected to the heart rate sensor, the microvibration sensor and/or the breathing rate sensor for receiving the measured heart rate, microvibrations, and/or measured breathing rate, and connected to the bruxism sensor for receiving the measured characteristic signal; and a feedback device (e.g. see [0093]) connected to the processor, wherein the feedback device is configured to provide a feedback stimulus when the feedback device receives a bruxism event signal from the processor (e.g. see [0077], figure 5, steps 502-508, [0088]-[0094]) and send the bruxism event signal to the feedback device when the processor determines the occurrence of the bruxism event (e.g. see [0077], figure 500, steps 502-508, [0088]-[0094]).
Wang discloses the invention but is silent as to the processor is configured to determine the occurrence of a microarousal event by comparing the measured heart rate, the measured microvibrations and/or the measured breathing rate to a target heart rate and/or a target breathing rate; increase a measuring rate of the bruxism sensor when the occurrence of the microarousal event is determined by the processor; receive the characteristic signal measured by the bruxism sensor. Garcia teaches it is known to determine the occurrence of a microarousal event by comparing the measured heart rate, the measured microvibrations and/or the measured breathing rate to a target heart rate and/or a target breathing rate (e.g. see [0048] discloses “A total amount of time that an individual is awake after sleep onset (“WASO”) is, in one embodiment, another measure with which deductions are capable of being applied to a sleep session score. WASO includes not only time awake, but also micro-arousals, and more generally any amount of time that a user spends awake (e.g., user activity detected by sensor(s) 108 exceeding a threshold value) after sleep onset is identified”. Further [0025] discloses “sensor(s) 108 may correspond to one or more accelerometers, one or more gyroscopes, one or more pulse rate monitors, one or more breath monitoring devices, and/or one or more electroencephalography (“EEG”) devices); increase a measuring rate of the bruxism sensor when the occurrence of the microarousal event is determined by the processor”); increase a measuring rate of the bruxism sensor when the occurrence of the microarousal event is determined by the processor (e.g. see [0025] discloses “A sampling rate—how often sensor(s) 108 take a measurement—is configurable by user device 110 and can depend on a type of sensor that sensor(s) 108 correspond to, as well as a type of measurement that sensor(s) 108 is attempting to obtain. Furthermore, sensor(s) 108 are capable of being configured by user 170 and/or by one or more other devices of system 100 (e.g., sleep score assessment system 120) to modify a sample rate for sensor(s) 108 depending on a particular functionality desired”) to allow the processor to adjust a sample rate for sensor(s) depending on a particular functionality desired (e.g. see [0025]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to adjust a sampling rate based on the detection of a micro-arousal as taught by Garcia in the system of Wang, since said modification would provide the predictable results of allowing the processor to adjust a sample rate for sensor(s) depending on a particular functionality desired.
Wang and Garcia disclose the claimed invention but are silent as to the processor is configured to determine the occurrence of a bruxism event by comparing the characteristic signal measured at the increased measuring rate to a target characteristic. Martinot teaches it is known to use such a modification as set forth in p16, lines 15-24, p18, lines 16-22, p19, lines 10-17, and p36, line 10-p37, line 2to provide identification of mandibular movements that are specifically and exclusively those developed during onset of bruxism (e.g. see p35, line 31-p36, line 9). It would have been obvious to one having ordinary skill in the art at the time the invention was made to determine the occurrence of a bruxism event by comparing the characteristic signal measured at the increased measuring rate to a target characteristic as taught by Martinot in the system of Wang and Garcia, since said modification would provide the predictable results of identification of mandibular movements that are specifically and exclusively those developed during onset of bruxism.
Regarding claim 2, Wang discloses the bruxism sensor is an acoustic sensor for measuring an acoustic signal, when the in-ear portion is placed in the ear canal, wherein the occurrence of the bruxism event by the processor is determined by comparing the measured acoustic signal to a target acoustic signal (e.g. see figure 3 steps 302 and 304, [0072]-[0075]).
Regarding claim 3, Wang discloses the heart rate sensor and/or the breathing rate sensor are formed by the acoustic sensor (e.g. see [0032], [0035], [0064], [0073]).
Regarding claim 11, Wang discloses the system is configured to determine an intensity, frequency and/or type of the feedback stimulus by using a reinforcement learning algorithm (e.g. see [0059], [0093]).
Regarding claim 12, Wang discloses the feedback stimulus is an electrical stimulus (e.g. see [0093], [0125], [0131]).
Regarding claim 13, Wang discloses the processor is further configured to determine a type of bruxism event and wherein the processor is configured to determine a type of feedback stimulus based on the type of the bruxism event (e.g. see figure 500, steps 502-508, [0088]-[0094]).
Claim(s) 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang, Garcia, and Martinot as applied to claim 1 above, and further in view of Ellspermann (Pub. No.: US 2019/0343452 A1).
Regarding claim 5, Wang, Garcia, and Martinot disclose the claimed invention but are silent as to the in-ear device further comprises a sealing portion to seal the ear canal when the in-ear portion is placed in the ear canal. Ellspermann teaches it is known to use such a modification as set forth in [0054] to provide benefits for patients sleeping or otherwise using the bruxism monitoring/prevention device at night time (e.g. see [0054]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a sealing portion to seal the ear canal as taught by Ellspermann in the system/method of Wang, Garcia, and Martinot, since said modification would provide the predictable results of providing benefits for patients sleeping or otherwise using the bruxism monitoring/prevention device at night time.
Regarding claim 6, Wang, Garcia, and Martinot disclose the claimed invention but are silent as to the in-ear portion comprises an impermeable pouch that conforms to a shape of the ear canal and wherein the bruxism sensor is provided in the impermeable pouch for measuring the characteristic signal in a medium filling the pouch. Ellspermann teaches it is known to use such a modification as set forth in [0054] (“sealed bulb”) to provide benefits for patients sleeping or otherwise using the bruxism monitoring/prevention device at night time (e.g. see [0054]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a sealing pouch as taught by Ellspermann in the system/method of Wang, Garcia, and Martinot, since said modification would provide the predictable results of providing benefits for patients sleeping or otherwise using the bruxism monitoring/prevention device at night time.
Regarding claim 7, Wang, Garcia, and Martinot disclose the claimed invention but are silent as to the pouch is filled with an incompressible fluid. Ellspermann teaches it is known to use such a modification as set forth in [0036] (“fluid-filled bulb”) to provide benefits for patients sleeping or otherwise using the bruxism monitoring/prevention device at night time (e.g. see [0054]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a fluid filled pouch as taught by Ellspermann in the system/method of Wang, Garcia, and Martinot, since said modification would provide the predictable results of providing benefits for patients sleeping or otherwise using the bruxism monitoring/prevention device at night time.
Regarding claim 8, Wang, Garcia, and Martinot disclose the claimed invention but are silent as to the in-ear device is personalized such that the in-ear portion extends to the second bend of the ear canal when the in-ear portion is placed in the ear canal. Ellspermann teaches it is known to use such a modification as set forth in figure 15 to provide an improved bruxism treatment system (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an in-ear portion that extends to the second bend of the ear canal as taught by Ellspermann in the system/method of Wang, Garcia, and Martinot, since said modification would provide the predictable results of an improved bruxism treatment system.
Regarding claim 9, Wang, Garcia, and Martinot disclose the claimed invention but are silent as to the processor is further configured to determine when the bruxism event terminates. Ellspermann teaches it is known to use such a modification as set forth in [0061] (“bruxism events may be identified, detailing varying force and duration of the bruxism events”) to provide an improved bruxism treatment system (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to determine when the bruxism event terminates as taught by Ellspermann in the system/method of Wang, Garcia, and Martinot, since said modification would provide the predictable results of an improved bruxism treatment system.
Regarding claim 10, Wang, Garcia, and Martinot disclose the claimed invention but are silent as to the in-ear portion is at least partially made from a shape conforming material and wherein the shape conforming material is silicone. Ellspermann teaches it is known to use such a modification as set forth in figure 6, “memory foam”, [0062] to provide an improved bruxism treatment system (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use in-ear portion is at least partially made from a shape conforming material and wherein the shape conforming material is silicone as taught by Ellspermann in the system/method of Wang, Garcia, and Martinot, since said modification would provide the predictable results of an improved bruxism treatment system.
Allowable Subject Matter
Claims 4 is 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.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792