DETAILED ACTION
This Office Action is responsive to the Amendment filed 16 June 2026. Claims 1 – 2, 4 - 5, 7 – 8, 11 - 12, 15, 18 – 21, 23, 26 – 28, 34 and 55 are now pending. The Examiner acknowledges the amendments to claims 1 – 2, 5, and 15, as well as the cancellation of claim 3.
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 Objections
Claim 1 are objected to because of the following informalities:
Claim 1, line 7, “for treatment of a sleep condition” should read --for a treatment of a sleep condition--.
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.
Claim 15 is 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 15, line 7, it is unclear whether the limitation “urging the user into a desired sleeping position” refers to “the signal” or “the external device” or both.
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.
Claims 27- 28, 34 and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kopelman (US 20160199215 A1).
Regarding claim 27, Kopelman teaches a method for adjusting an oral appliance ([0005], [0021] – [0022], [0025], [0027], [0036] – [0037]) comprising:
receiving sensor data from one or more sensors (“one or more sensors” [0066] Figure 5; [0006] – [0008], [0021] – [0024], [0026] – [0027], [0072], [0079], [0081], [0085], [0089], [0092], [0094]) external to a user using an oral appliance (“intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]) for the treatment of a sleep condition ([0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]) for the treatment of a sleep condition ([0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]);
automatically determining an adjustment associated with the oral appliance based on the sensor data ([0021] – [0028], [0066] – [0072], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]); and
facilitating applying the determined adjustment to the oral appliance in response to automatically determining the adjustment ([0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]).
Regarding claim 28, Kopelman teaches all limitations of claim 27. Kopelman teaches facilitating applying the determined adjustment includes
i) presenting a display of one or more adjustment parameters to facilitate manual adjustment of the oral appliance based on the one or more adjustment parameters (“the digital processing device includes a display to send visual information to a user” [0135]);
ii) actuating one or more actuators of an oral appliance receptacle to apply the determined adjustment to the oral appliance, wherein the oral appliance receptacle is configured to receive the oral appliance when not used by the user;
iii) transmitting an adjustment signal to the oral appliance (“Processors as described herein can execute instructions to transmit control signals to an intraoral appliance in response to detection of sleep apnea symptoms. The control signals can cause the intraoral appliance to displace the lower jaw to a position and for a duration provided by the machine learning algorithm to treat the sleep apnea event effectively while decreasing unwanted side effects.” [0005], [0021] – [0027]);
iv) dynamically adjusting the oral appliance based on the determined adjustment while the user is sleeping ([0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]); or
v) any combination of i-iv ([0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]).
Regarding claim 34, Kopelman teaches all limitations of claim 27. Kopelman teaches automatically determining the adjustment associated with the oral appliance (“intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]) based on the sensor data ([0021] – [0027], [0047] – [0048], [0061], [0063], [0066], [0070], [0078] – [0079], [0082], [0084], [0086] – [0087], [0090], [0095] – [0097], [0100] – [0113], [0116] – [0129]) includes determining a state or event associated with the user ([0065], [0072], [0079] [0099] – [0100], [0082], [0113]), the state or event being
i) a pre- sleep state (“the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep” [0072]),
ii) a post-onset-of-sleep state (“the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep” [0072]; “can identify irregularities in the sleep patterns” [0065]; [0079] [0099] – [0100], [0082], [0113]),
iii) an apnea event (“onset of sleep apnea event” [0006] – [0008], [0021] – [0023], [0058], [0069]), or
iv) any combination of i-iii ([0072], [0079], [0099] – [0100], [0082], [0113]),
wherein the determined adjustment is a preset adjustment for the determined state or event ([0072], [0079], [0097], [0099] – [0100], [0082], [0113]).
Regarding claim 55, Kopelman teaches all limitations of claim 27. Kopelman teaches a computer program product (“digital processing device” [0137]; “computer program” [0138]) tangible embodied in a non-transitory machine-readable storage medium ([0023], [0137]), comprising instructions ([0005], [0023], [0137] – [0139]) which, when executed by a computer (“computer” [0138]; [0137] – [0139]), cause the computer to carry out ([0005], [0137] – [0139]) the method of claim 27.
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.
Claims 1 – 2, 4 – 5, 7 – 8, 11, 18 – 20, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman (US 20160199215 A1) in view of Rahilly (US 20130325183 A1).
Regarding claim 1, Kopelman teaches a system ([0005]) comprising:
a control system including one or more processors (“one or more processors” [0021] – [0023], [0025], [0027] – [0029], [0053], [0060] – [0061], [0066] - [0070], [0075] – [0080], [0086], [0088], [0092] – [0093], [0099], [0102]); and
a memory (“memory”, [0006] – [0007], [0021], [0023], [0066], [0070], [0099], [0117], [0134], [0137]),
the control system coupled to the memory ([0021], [0066], [0070], [0099]),
the memory having stored thereon machine readable instructions ([0023], [0137] – [0139]) which, when executed on the one or more processors ([0023], [0137] – [0139]),
causes the one or more processors to perform operations (“one or more processors” [0021] – [0023], [0025], [0027] – [0029], [0053], [0060] – [0061], [0066] - [0070], [0075] – [0080], [0086], [0088], [0092] – [0093], [0099], [0102]) including:
receiving sensor data from one or more sensors (“one or more sensors” [0066] Figure 5; [0006] – [0008], [0021] – [0024], [0026] – [0027], [0072], [0079], [0081], [0085], [0089], [0092], [0094]) external to a user using an oral appliance (“intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]) for treatment of a sleep condition ([0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]);
automatically determining an adjustment associated with the oral appliance based on the sensor data ([0021] – [0028], [0066] – [0072], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]); and
facilitating applying the determined adjustment to the oral appliance in response to automatically determining the adjustment ([0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]),
wherein the facilitating applying the determined adjustment includes actuating one or more actuators (“actuator 508” [0066], [0068] Figure 5; [0028], [0050] – [0051], [0053] – [0056], [0069]) of an oral appliance ([0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]) to apply the determined adjustment to the oral appliance (“intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]).
Kopelman does not teach the one or more actuators of an oral receptacle and wherein the receptacle is configured to receive the appliance when not used by the user.
However, Rahilly discloses a “receptacle adapted for removable placement on a retention tray” (abstract) and teaches one or more actuators (“actuator 242” [0034] Figure 3) of a receptacle (“receptacle 200” [0032] Figure 3),
wherein the receptacle (200) is configured to receive an appliance (“medication” [0006], [0041]) when not used by the user ([0006], [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kopelman to incorporate one or more actuators in a receptacle and wherein the receptacle is configured to receive the appliance when not used by the user, as taught by Rahilly, for the benefit of protecting the appliance ([0006]) while maintaining hygiene.
Regarding claim 2, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the facilitating applying the determined adjustment includes presenting a display of one or more adjustment parameters (Kopelman: “a display to send visual information to a user”, [0135]; [0136]) to facilitate manual adjustment of the oral appliance (Kopelman: “intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]) based on the one or more adjustment parameters (Kopelman: [0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102], [0135] – [0136]).
The limitation “to facilitate manual adjustment of the oral appliance based on the one or more adjustment parameters” is intended use. Since Kopelman teaches the device has adjustment of the oral appliance based on the adjustment parameters, (Kopelman: [0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102], [0135] – [0136]), the device of Kopelman is capable of performing the intended use as claimed.
Regarding claim 4, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the oral appliance is a mandibular repositioning device (Kopelman: [0005], [0030] – [0031], [0035], [0038], [0041], [0044] – [0048], [0053] - [0054], [0058], [0060] – [0061], [0068], [0079], [0083] – [0084], [0091] – [0092], [0097], [0099] – [0101]), and
wherein the sleep condition is a sleep disordered breathing condition (Kopelman: [0005], [0030], [0061], [0063], [0068] - [0070], [0102]), and
wherein the sleep disordered breathing condition is obstructive sleep apnea (Kopelman: “obstructive sleep apnea” [0005], [0069], [0057] – [0070]) or snoring (Kopelman: “snoring” [0005], [0030], [0061], [0063], [0069] [0102]).
Regarding claim 5, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the facilitating applying the determined adjustment includes transmitting an adjustment signal to the oral appliance (Kopelman: “to transmit control signals to an intraoral appliance in response to detection of sleep apnea symptoms. The control signals can cause the intraoral appliance to displace the lower jaw to a position and for a duration provided by the machine learning algorithm to treat the sleep apnea event effectively while decreasing unwanted side effects”, [0005], [0021] – [0027]).
Regarding claim 7, Kopelman and Rahilly teach all limitations of claim 5. The modified invention of Kopelman and Rahilly teaches the operations further comprise:
receiving additional sensor data from the one or more sensors (Kopelman: [0005], [0021] – [0027], [0047] – [0048], [0061], [0063], [0066], [0070], [0078] – [0079], [0082], [0084], [0086] – [0087], [0090], [0095] – [0097], [0100] – [0113], [0116] – [0129]),
wherein the additional sensor data is associated with use of the oral appliance after dynamically adjusting the oral appliance based on the determined adjustment (Kopelman: [0005], [0021] – [0027], [0047] – [0048], [0061], [0063], [0066], [0070], [0078] – [0079], [0082], [0084], [0086] – [0087], [0090], [0095] – [0097], [0100] – [0113], [0116] – [0129]);
automatically determining an additional adjustment associated with the oral appliance based on the additional sensor data (Kopelman: [0005], [0021] – [0027], [0047] – [0048], [0061], [0063], [0066], [0070], [0078] – [0079], [0082], [0084], [0086] – [0087], [0090], [0095] – [0097], [0100] – [0113], [0116] – [0129]); and
facilitating applying the determined additional adjustment to the oral appliance in response to automatically determining the additional adjustment (Kopelman: [0005], [0021] – [0027], [0047] – [0048], [0061], [0063], [0066], [0070], [0078] – [0079], [0082], [0084], [0086] – [0087], [0090], [0095] – [0097], [0100] – [0113], [0116] – [0129]). Examiner interprets the usage of “machine learning” to read on the limitation of claim 7.
Regarding claim 8, Kopelman and Rahilly teach all limitations of claim 5. The modified invention of Kopelman and Rahilly teaches automatically determining the adjustment associated with the oral appliance (Kopelman: “intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]) based on the sensor data (Kopelman: [0021] – [0027], [0047] – [0048], [0061], [0063], [0066], [0070], [0078] – [0079], [0082], [0084], [0086] – [0087], [0090], [0095] – [0097], [0100] – [0113], [0116] – [0129]) includes determining a state or event associated with the user (Kopelman: [0065], [0072], [0079] [0099] – [0100], [0082], [0113]), the state or event being
i) a pre- sleep state (Kopelman: “the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep” [0072]),
ii) a post-onset-of-sleep state (Kopelman: “the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep” [0072]; “can identify irregularities in the sleep patterns” [0065]; [0079] [0099] – [0100], [0082], [0113]),
iii) an apnea event (Kopelman: “onset of sleep apnea event” [0006] – [0008], [0021] – [0023], [0058], [0069]), or
iv) any combination of i-iii (Kopelman: [0072], [0079], [0099] – [0100], [0082], [0113]),
wherein the determined adjustment is a preset adjustment for the determined state or event (Kopelman: [0072], [0079], [0097], [0099] – [0100], [0082], [0113]).
Regarding claim 11, Kopelman and Rahilly teach all limitations of claim 5. The modified invention of Kopelman and Rahilly teaches automatically determining the adjustment associated with the oral appliance based on the sensor data (Kopelman: [0021] – [0028], [0066] – [0072], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]) includes predicting a future apnea event (Kopelman: “The controller and/or processor can be configured to collect data on the patient's apnea patterns over time and use such data to predict an onset of an apnea event.” [0035]; “in order to determine whether a sleep apnea event is imminent” [0058]; [0072], [0079], [0097], [0099] – [0100], [0082], [0113]),
wherein the determined adjustment is a pre-apnea adjustment for avoiding or minimizing the future apnea event (Kopelman: “The controller and/or processor can be configured to collect data on the patient's apnea patterns over time and use such data to predict an onset of an apnea event.” [0035]; “in order to determine whether a sleep apnea event is imminent” [0058]; [0072], [0079], [0097], [0099] – [0100], [0082], [0113]).
Regarding claim 18, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the operations further comprise:
receiving subjective feedback from the user (Kopelman: [0030], [0050], [0061], [0092], [0096], [0098]); and
associating the subjective feedback with the sensor data (Kopelman: [0030], [0050], [0061], [0092], [0096], [0098]),
wherein automatically determining the adjustment is further based on the subjective feedback associated with the sensor data (Kopelman: [0030], [0050], [0061], [0092], “The use of feedback data to train and update the machine learning algorithm can further improve the patient-specific characteristics of the algorithm and accuracy of the algorithm in determining effective treatment plans for the patient's sleep apnea.” [0096], [0098]).
Regarding claim 19, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the operations further comprise determining a sleep stage (Kopelman: “patient status during sleep”[0060]; “sleep patterns” [0065] and [0072]) based on the sensor data (Kopelman: “the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep” [0072]; “can identify irregularities in the sleep patterns” [0065]; [0079] [0099] – [0100], [0082], [0113])),
wherein automatically determining the adjustment (Kopelman: [0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]) comprises using the determined sleep stage (Kopelman: “the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep” [0072]; “can identify irregularities in the sleep patterns” [0065]; [0079] [0099] – [0100], [0082], [0113]).
Regarding claim 20, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches automatically determining the adjustment (Kopelman: [0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]) includes:
determining physiological data from the sensor data (Kopelman: “sensors embedded in the appliance and/or external to the appliance can be configured to, when worn, continuously collect data to build a patient-specific profile including patient status during sleep, e.g. sleep sounds, airflow, temperature, heart rate, EKG, sleep position, and the like.” [0060]; “Physiological information that can be monitored by the sensors described herein includes, without limitation: breathing sounds, snoring sounds, breathing rate, respiratory air flow, chest expansion, oxygen level, cardiac data (e.g., heart rate, EKG data), sleeping position, sleeping movements, blood pressure, brain activity (e.g., EEG data) and/or variants thereof and/or combinations thereof.” [0073]; [0074] – [0075]),
wherein the physiological data comprises a breathing rate (Kopelman: [0060], [0073] – [0076]), a heart rate ([0060], [0073] – [0075]), or a blood oxygenation level (Kopelman: [0073] – [0075]);
identifying a desired change in the physiological data (Kopelman: “The sensor data can be indicative of events and/or patient symptoms, such as symptoms associated with the onset of a sleep apnea event, and/or a lessening of symptoms associated with a sleep apnea event. In some embodiments, the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep.” [0072]); and
determining the adjustment based on the desired change in the physiological data (Kopelman: “The sensor data can be indicative of events and/or patient symptoms, such as symptoms associated with the onset of a sleep apnea event, and/or a lessening of symptoms associated with a sleep apnea event. In some embodiments, the sensor data is indicative of sleep patterns of the patient and/or physiological information of the patient during sleep.” [0072]; [0073] – [0076]).
Regarding claim 23, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the one or more sensors (Kopelman: “one or more sensors” [0066] Figure 5; [0006] – [0008], [0021] – [0024], [0026] – [0027], [0072], [0079], [0081], [0085], [0089], [0092], [0094]) comprise a non-contact sensor (Kopelman: “the sensors may be external to the patient, such as an external microphone to detect breathing sounds, an external camera to detect sleep position, an EKG machine to determine heart rate, and/or variants thereof and/or combinations thereof” [0075]) spaced apart from the user (Kopelman: [0075]), and
wherein at least one of the one or more sensors is housed in a smartphone (Kopelman: “mobile smart phone” [0133]; “iPhone” [0143]) or tablet (Kopelman: “iPad” [0143]).
Regarding claim 26, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the operations further comprise:
accessing at least one historical determined adjustment associated with the oral appliance based on historical sensor data from a previous use of the oral appliance (Kopelman: “Instructions executed by the processors can comprise machine learning algorithms that optimize both the detection of symptoms and the course of treatment based on or in response to patient-specific factors and data, such as previous sleep apnea events of the patient” [0005]; “previous sleep patterns” [0024] – [0025], [0067], [0084], [0100]; [0030], [0050], [0061], [0092], [0094], [0096], [0098]); and
determining effectiveness of the at least one historical determined adjustment based on at least one of the sensor data and historical sensor data (Kopelman: “Updating the machine learning algorithm can comprise training the algorithm using the stored data as training data. Updating the machine learning algorithm can comprise updating the correlations, models, classifications, or other data structures used by the machine learning algorithm to generate the determinations and predictions described herein. This approach allows the system to continue learning and adapting to the patient's sleep patterns and sleep apnea patterns, as well as to continue improve the effectiveness of the mandibular advancement treatment regimen in treating the sleep apnea. Accordingly, the treatment system can become increasingly customized to the patient as the system is used over time.” [0100]),
wherein automatically determining the adjustment is further based on the determined effectiveness of the historical determined adjustment (Kopelman: [0100]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman and Rahilly, as applied in claim 1, in view of McCreery (US 20200121492 A1).
Regarding claim 12, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the oral appliance (Kopelman: “intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]).
Kopelman does not teach the oral appliance includes an electrical stimulator for applying electrical stimulus to the user,
wherein applying the determined adjustment includes activating the electrical stimulator or adjusting a setting of the electrical stimulator, and
wherein the electrical stimulator includes one or more electrodes for directing the electrical stimulus to a tongue muscle or tongue nerve of the user.
However, McCreery discloses an “intraoral stimulation device configured to be positioned in a mouth of a patient” (abstract) and teaches an electrical stimulator for applying electrical stimulus to the user ([0117]),
wherein applying the determined adjustment includes activating the electrical stimulator or adjusting a setting of the electrical stimulator (“The biofeedback training application 350 (see FIG. 10) may apply the conditioning electrical stimulus through the electrode(s) 114 (see FIG. 1)” [0117]), and
wherein the electrical stimulator ([0117]) includes one or more electrodes (“electrode(s) 182” [0117] Figure 7) for directing the electrical stimulus to a tongue muscle or tongue nerve of the user (“directly stimulate the nerves that extend the tongue” [0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kopelman and Rahilly to incorporate an electrical stimulator for applying electrical stimulus to the user, wherein applying the determined adjustment includes activating the electrical stimulator or adjusting a setting of the electrical stimulator, and wherein the electrical stimulator includes one or more electrodes for directing the electrical stimulus to a tongue muscle or tongue nerve of the user, as taught by McCreery, for the benefit of adjusting the tongue to more from the undesired position to the desired position (McCreery: abstract).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman and Rahilly in view of Oexman et al (US 20110010014 A1, hereinafter “Oexman”).
Regarding claim 15, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches the operations further comprise:
determining that the user is using the oral appliance based on the received sensor data; and transmitting a signal to an external device (Kopelman: “an external device” [0035]; [0037], [0060], [0075] – [0076], [0099]) in response to determining that the user is using the oral appliance (Kopelman: [0060], [0075] – [0076], [0099]),
wherein the signal, when received by the external device, adjusts a setting of the external device (Kopelman: [0060], [0075] – [0076], [0099]).
Kopelman does not teach urging the user into a desired sleeping position.
However, Oexman discloses “controlling a bedroom environment and to providing data to a person relating to their sleep experience” ([0003]) and teaches an external device (“adjustable head support member 500” [0047]) urging the user into a desired sleeping position ([0047]).
The limitation “to urging the user into a desired sleeping position” is intended use. Since Oexman teaches the device can be controlled and provides the optimal support characteristics for the person, ([0047]), the device of Oexman is capable of performing the intended use as claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sys
tem of Kopelman such that the external device urging the user into a desired sleeping position, as taught by Oexman, for the benefit of promoting better sleep environment (Oexman: [0003]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman and Rahilly, as applied in claim 1, in view of Hindin (US 20080076094 A1).
Regarding claim 21, Kopelman and Rahilly teach all limitations of claim 1. The modified invention of Kopelman and Rahilly teaches automatically determining the adjustment (Kopelman: [0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]).
Kopelman does not teach automatically determining the adjustment includes: estimating an autonomic tone of the user based on the sensor data; identifying a desired change in the autonomic tone; and determining the adjustment based on the desired change in the autonomic tone.
However, Hindin discloses a “system and method for facilitating adjustment of an oral appliance” (abstract) and teaches estimating an autonomic tone of the user based on the sensor data (“heart rate variability” [0016]; “observing any physiological data from the sensors at Step S16” [0018]); identifying a desired change in the autonomic tone ([0018]); and determining the adjustment based on the desired change in the autonomic tone (“make further adjustments to the appliance at Step S18 in response to the data received at Step S16.” [0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kopelman and Rahilly such that automatically determining the adjustment includes estimating an autonomic tone of the user based on the sensor data; identifying a desired change in the autonomic tone; and determining the adjustment based on the desired change in the autonomic tone, as taught by Hindin, for the benefit of providing a safe and beneficial modifications of the oral appliance for the user (Hindin: abstract and [0030]).
Response to Arguments
Applicant’s arguments, see page 7, filed 16 June 2026, with respect to drawing objection have been fully considered and are persuasive in light of the amendments. The drawing objection of 6 April 2026 has been withdrawn.
Applicant’s arguments, see page 7, filed 16 June 2026, with respect to claim objections have been fully considered and are persuasive in light of the amendments. The claim objections for claims 2, 3 and 5 of 6 April 2026 has been withdrawn.
Applicant’s arguments, see page 7, filed 16 June 2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive in light of the amendments. The 35 U.S.C. 112(b) rejections for claim 1 of 6 April 2026 has been withdrawn.
Applicant's arguments, see pages 8 - 9, filed 16 June 2026 have been fully considered but they are not persuasive. Applicant contends “when looking to Kopelman, which discloses an intraoral appliance with its own embedded actuator (actuator 508, see Kopelman at para. [0066], [0068], Figure 5) that displaces the mandible in response to control signals from a processor while the appliance is worn in the patient's mouth. It is clear that Kopelman's actuator 508 is only internal to the oral appliance itself and operates during in-mouth use. As indicated in the Office Action, Kopelman is thereby unable to disclose or suggest the claimed "wherein facilitating applying the determined adjustment includes actuating one or more actuators of an oral appliance receptacle to adjust one or more adjustable aspects of the oral appliance, wherein the oral appliance receptacle is configured to receive the oral appliance when not used by the user."”
However, Kopelman discloses “the systems comprising: one or more sensors configured to monitor the patient for symptoms associated with sleep apnea; an intraoral appliance worn by the patient; one or more processors; and memory comprising instructions executable by the one or more processors to cause the one or more processors to: receive a set of sensor data from the one or more sensors, detect, using a machine learning algorithm, onset of a sleep apnea event based on the set of sensor data, and transmit a control signal to the intraoral appliance to cause the intraoral appliance to displace a lower jaw of the patient from a first position to a second position in order to treat the sleep apnea event.”. Thus, Kopelman in combination of Rahilly read on the limitation due to Kopelman’s usage of using a processor and memory to “facilitating applying the determined adjustment includes actuating one or more actuators” (Kopelman: [0021] – [0028], [0066] – [0072], [0077], [0081] – [0082], [0085] – [0086], [0089] – [0090], [0094] – [0096], [0102]) in combination with Rahilly’s usage of one or more actuators (Rahilly: “actuator 242” [0034] Figure 3) of a receptacle (Rahilly: “receptacle 200” [0032] Figure 3), wherein the receptacle (Rahilly: 200) is configured to receive an appliance (Rahilly: “medication” [0006], [0041]) when not used by the user (Rahilly: [0006], [0041]). See rejection above.
Applicant's arguments, see pages 8 - 10, filed 16 June 2026 have been fully considered but they are not persuasive. Applicant contends “While Applicant emphasizes that the foregoing excerpt does not mirror the specific limitations recited in claim 1, it is clear that Rahilly's receptacle 200 and its actuator 242 are fundamentally different in function and purpose from the oral appliance receptacle recited in amended claim 1. For instance, Rahilly discloses a receptacle adapted for removable placement on a retention tray in an automated dispensing machine used in healthcare facilities to store and secure medications (see Rahilly's Abstract; [0006], [0032], [0041]; Figure 3). The reference clearly describes that Rahilly's actuator 242 is a latching actuator that is "configured to selectably move in a first direction thereby urging the lid latch to move away from the latched position" and "selectably move in a second direction... thereby urging the tray latch to move away from the latched position" (see Rahilly at [0034]; Figure 3). It follows that Rahilly's actuator 242 only performs latching and unlatching functions. In other words, Rahilly's actuator 242 only locks and unlocks a lid of a drawer system 312 and secures or releases the receptacle 200 from a drawer tray in the drawer system 312, as seen in Rahilly's FIGS. 3 and 7A which are reproduced below for convenience” and “there is no articulated rationale in the prior art record that would motivate a person of ordinary skill to modify Rahilly's latching actuators 242, or any receptacle 200, to include "actuators of an oral appliance receptacle to adjust one or more adjustable aspects of the oral appliance” as claimed”.
However, Kopelman teaches the the facilitating applying the determined adjustment includes actuating one or more actuators (“actuator 508” [0066], [0068] Figure 5; [0028], [0050] – [0051], [0053] – [0056], [0069]) of an oral appliance ([0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]) to apply the determined adjustment to the oral appliance (“intraoral appliance 506” [0066], [0068] – [0069] Figure 5; [0021] – [0023], [0026] – [0028], [0032], [0041] – [0046], [0053] – [0055], [0076], [0083], [0085], [0087], [0091], [0098]). Rahilly teaches one or more actuators (“actuator 242” [0034] Figure 3) are in a receptacle (“receptacle 200” [0032] Figure 3), wherein the receptacle (200) is configured to receive an appliance (“medication” [0006], [0041]) when not used by the user ([0006], [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kopelman to incorporate one or more actuators in a receptacle and wherein the receptacle is configured to receive the appliance when not used by the user, as taught by Rahilly, for the benefit of protecting the appliance ([0006]) while maintaining hygiene. Thus, the references in combination read on the limitations of claim 1 due to how it is currently written and how certain aspects are not positively recited. See rejections above.
Applicant's arguments, see page 10, filed 16 June 2026 have been fully considered but they are not persuasive. Applicant contends “Applicant also respectfully asserts that a person having ordinary skill in the art would have no reason to look to Rahilly's medication dispensing cabinet latching system for teaching "actuators of an oral appliance receptacle to adjust one or more adjustable aspects of the oral appliance" as claimed.”.
However, Kopelman and Rahilly are in the field of medical devices, which entails it is in the same field of endeavor. Thus, the references in combination read on the limitations of claim 1 due to how it is currently written and how certain aspects are not positively recited. See rejections above.
Conclusion
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 JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights