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 .
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 21 July 2026 has been entered.
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 24 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.
Regarding claim 24, the description that the discharge circuit in the compliance indicator system is the one configured to infer the amount of time that the oral appliance was in the mouth of the patient is indefinite. At the same time this claim depends on claim 1 in which describes that the only sensor that is configured to infer the amount of time that the oral appliance was in the mouth of the patient is the output of one sensor sensing at least one opening or closing of the storage case by the positioning of the hinge. For that reason, it is not understood which sensor is the one providing the indication of the claimed infer amount of time in the mouth of the patient, or if it is the information of both sensors. For examination purposes, the discharge circuit will be interpreted as an extra sensor that works in combination with the sensor sensing the opening and closing of the storage case described in claim 1.
Claim Objections
Claim 24 objected to because of the following informalities: In lines 2-3 of the claim describes “when the compliance indicator system infers that the oral appliance in the mouth of the patient…”. It is believed that the intention is to describe “when the compliance indicator system infers that the oral appliance is in the mouth of the patient…” Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-4, 6-8, 10-13, 15-17, 19-20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 20160100924 A1).
[AltContent: ][AltContent: arrow][AltContent: textbox (Lid sensor)][AltContent: textbox (Hinge)][AltContent: ][AltContent: textbox (Oral appliance)][AltContent: arrow][AltContent: textbox (Body of the storage case)]
PNG
media_image1.png
590
404
media_image1.png
Greyscale
[AltContent: textbox (Processor)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Sensor)]
PNG
media_image2.png
532
390
media_image2.png
Greyscale
[AltContent: arrow][AltContent: textbox (Computer-program instructions)][AltContent: arrow][AltContent: textbox (Processor)][AltContent: arrow][AltContent: textbox (Memory)]
PNG
media_image3.png
598
442
media_image3.png
Greyscale
Regarding claims 1 and 22, Wilson et al. disclose a storage case (100) for an oral appliance (200), the storage case (100) including:
a body having a shape and size for storing the oral appliance (200), the body including a hinge (14) that facilitates opening and closing of the storage case (100) (see annotated Fig 1 above, and [0027]); and
a compliance indicator system including:
a sensor (30) configured to provide a compliance signal that is associated with a time that the oral appliance is within the storage case (see [0032], [0049] – “programs 28 may include, but not limited to, a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”, [0052] – “the processing unit 21 may comprise a clock or timer program 28 (FIG. 9) which may record the time of a sensor event, the time between sensor events, or any other temporal parameter”), the sensor (30) configured to sense at least one of opening or closing of the storage case by positioning of the hinge (14) (see annotated Fig. 1 and [0053] – the processing unit 21 may detect the input or the lack of input from the lid sensor 30 for a period of time or at a certain time, such as a user bed time, indicating that the lid has not been opened to take the oral appliance for its use);
a processor (21) (see the processor unit in annotated Fig. 8 above);
memory (25) coupled to the processor (21) (see annotated Fig. 8-9 above – where the processor unit 21 includes the memory 25), the memory (25) including
computer-program instructions (28) that, when executed by the processor (21) (see annotated Fig. 9 and [0043] – “a processing unit 21 may receive input from an occupancy sensor 32, lid sensor 30, or any other sensor detecting how much time and at what times a dental appliance 200 is in or out of a case 100”, [0045] – “a processing unit 21 may be a digital device that, in terms of hardware architecture, generally includes a processor 22, a data store 24, and memory 25”; and [0049] – “software in memory 25 can include one or more software programs, each of which includes an ordered listing of executable instructions for implementing logical functions”), cause the compliance indicator system to:
infer an amount of time that the oral appliance was in the mouth of a patient based only on the compliance signal from the sensor sensing at least one of opening or closing of the storage case by positioning of the hinge, wherein the compliance signal is generated by activation of deactivation of the sensor by movement of the hinge, and output a compliance measure based on the inferred amount of time (see [0006] – “there exists a need for novel apparatuses for recording and reporting the amount of time a dental appliance is worn by a user”, [0036] – “a case 100 may comprise a lid sensor 30 such as a magnetic sensor that is operable to detect if the lid 11 is open”; “a lid sensor 30 may comprise a Hall effect sensor which may be positioned on the floor 18, base 12, and/or lid 11 and which may detect increases or decreases, and therefore proximity, in an electric field generated by the magnetic material of a magnet 40 (FIG. 1) which may be complementarily positioned on the floor 18, base 12, and/or lid 11 to detect if the lid 11 is open, closed, and/or partially opened or closed”, [0053] – “If the lid sensor 30 does not detect that the lid has been opened or otherwise operated, the processing unit 21 may operate the communications array 23 to send a wireless electronic communication to an external access client device 300A, 300B, such as with a Bluetooth or WiFi wireless communication to notify a user that the lid 11 has not been opened for a period of time or at a certain time”, and [0056] – “a processing unit 21 may receive input from an occupancy sensor 32, lid sensor 30, or any other sensor detecting how much time and at what times a dental appliance 200 is in or out of a case 100”; therefore, the sensor 30 is capable of sensing or not the magnet 40 of the lid 11 for indicating opening or closing of the lid 11 in which in addition the same sensor, through the programing, indicates how much time and when the dental appliance is in or out of the case 100) (for claim 1); and wherein the compliance measure is based on whether the inferred amount of time is over a minimum amount of time according to a treatment plan (for claim 22) (see [0054] – “the processing unit 21 may receive input from an occupancy sensor 32 that a dental appliance 200 is detected, such as by being in the cavity 13, for a period of time. Once the period of time meets or exceeds a threshold, such as meeting or exceeding the period of time for a user to eat a meal, the processing unit 21 may operate a communications array 23”, due to Wilson also describes that the lid sensor 30 can be used to indicate if the appliance is in the storage case, it is understood that the input can also come from the lid sensor 30 instead of the occupancy sensor 32).
Regarding claim 2, Wilson et al. discloses that the compliance measure is determined based on a treatment plan of the patient, and indicates an extent of compliance with the treatment plan of the patient (see [0049] – “The software in memory 25 can include one or more software programs, each of which includes an ordered listing of executable instructions for implementing logical functions… includes a suitable operating system (O/S) 27 and programs 28…that provides scheduling, input-output control, file and data management, memory management, and communication control and related services. The programs 28 may include various applications… e.g., exemplary programs 28 may include, … a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”; therefore, if it includes an input-output control and programs that it can be configured, it is understood that the configuration is based on the treatment plant of the patient).
Regarding claim 3, Wilson et al. disclose that the compliance measure indicates an extent of compliance with one or more of a plurality of different stages of the treatment plan (see [0006] – the device will remind the user to wear the appliance, and in [0007] – it includes an alert device).
Regarding claim 4, Wilson et al. disclose that the treatment plan comprises an amount of time per day that the oral appliance is to be worn (see [0049] – “programs 28 may include, but not limited to, a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”).
Regarding claim 6, Wilson et al. disclose that the closure of the storage case and positioning the hinge in a closed position closes a circuit of the compliance indicator system, thereby activating the sensor (see [0036] – the lid sensor 30 can be a Hall effect sensor, a “pressure switch, an electrical circuit, or any other method configured to detect if the lid is open, closed, or optionally not open or closed. In further embodiments, a case 100 may comprise a reed switch, a pressure sensor, a contact sensor, a button mount, an ambient light sensor, or any other suitable sensor to detect if the lid 11 is open, closed, or partially opened or closed”; therefore, the sensor is activated or not and send the signal when the electrical circuit is closed or open).
Regarding claim 7, Wilson et al. disclose that closure of the storage case and positioning the hinge in a closed position opens a circuit of the compliance indicator system, thereby deactivating the sensor (see [0049] – “programs 28 may include, but not limited to, a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”, [0052] – “the processing unit 21 may comprise a clock or timer program 28 (FIG. 9) which may record the time of a sensor event, the time between sensor events, or any other temporal parameter”), the sensor (30) configured to sense at least one of opening or closing of the storage case by positioning of the hinge (14) (see annotated Fig. 1 and [0053] – the processing unit 21 may detect the input or the lack of input from the lid sensor 30 for a period of time or at a certain time, such as a user bed time, indicating that the lid has not been opened to take the oral appliance for its use; therefore, due to the processing unit 21 is configured to interpret the input or the lack of form the lid sensor as a sensor event, it is understood that the lid sensor 30 is deactivated when the hinge is in a closed position).
Regarding claim 8, Wilson et al. disclose that the compliance signal indicates whether the oral appliance was in the storage case over a threshold period of time (see [0006] – the device will remind the user to wear the appliance, and in [0007] – it includes an alert device).
Regarding claim 10, Wilson et al. disclose that the compliance indicator system further includes an alarm that is configured to activate when the time that the oral appliance is within the storage case is greater than a threshold time period (see [0006] – the device will remind the user to wear the appliance, and in [0007] – it includes an alert device).
Regarding claim 11, Wilson et al. disclose that the compliance measure includes an indication of whether or not the patient is complying with a patient treatment plan (see [0006] – the device will remind the user to wear the appliance, and in [0007] – it includes an alert device).
Regarding claim 12, Wilson et al. disclose a method of measuring an extent of compliance of usage of an oral appliance, the method including:
providing a compliance signal associated with a time that the oral appliance is within a storage case using a sensor (30) configured to sense at least one of opening or closing of the storage case based on a position of a storage case hinge (14) (see annotated Fig. 1 above, [0032], [0049] – “programs 28 may include, but not limited to, a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”, [0052] – “the processing unit 21 may comprise a clock or timer program 28 (FIG. 9) which may record the time of a sensor event, the time between sensor events, or any other temporal parameter”; and [0053] – the processing unit 21 may detect the input or the lack of input from the lid sensor 30 for a period of time or at a certain time, such as a user bed time, indicating that the lid has not been opened to take the oral appliance for its use);
wherein the sensor (30) is part of a compliance indicator system integrated into the storage case (100) (see Fig. 1 and 8 above – where the lid sensor is located inside the case 100), the compliance indicator system including:
a processor (see the processor unit in annotated Fig. 8 above);
memory (25) coupled to the processor (21) (see annotated Fig. 8-9 above – where the processor unit 21 includes the memory 25), the memory (25) including computer-program instructions that, when executed by the processor (see [0043] – “a processing unit 21 may receive input from an occupancy sensor 32, lid sensor 30, or any other sensor detecting how much time and at what times a dental appliance 200 is in or out of a case 100”, [0045] – “a processing unit 21 may be a digital device that, in terms of hardware architecture, generally includes a processor 22, a data store 24, and memory 25”; and [0049] – “software in memory 25 can include one or more software programs, each of which includes an ordered listing of executable instructions for implementing logical functions”), cause the compliance indicator system to:
infer an amount of time that the oral appliance was in the mouth of a patient based only on the compliance signal from the sensor sensing at least one of opening or closing of the storage case by positioning of the hinge, wherein the compliance signal is generated by activation or deactivation of the sensor by movement of the hinge, and output a compliance measure based on the inferred amount of time (see [0006] – “there exists a need for novel apparatuses for recording and reporting the amount of time a dental appliance is worn by a user”, [0036] – “a case 100 may comprise a lid sensor 30 such as a magnetic sensor that is operable to detect if the lid 11 is open”; “a lid sensor 30 may comprise a Hall effect sensor which may be positioned on the floor 18, base 12, and/or lid 11 and which may detect increases or decreases, and therefore proximity, in an electric field generated by the magnetic material of a magnet 40 (FIG. 1) which may be complementarily positioned on the floor 18, base 12, and/or lid 11 to detect if the lid 11 is open, closed, and/or partially opened or closed”, [0053] – “If the lid sensor 30 does not detect that the lid has been opened or otherwise operated, the processing unit 21 may operate the communications array 23 to send a wireless electronic communication to an external access client device 300A, 300B, such as with a Bluetooth or WiFi wireless communication to notify a user that the lid 11 has not been opened for a period of time or at a certain time”, and [0056] – “a processing unit 21 may receive input from an occupancy sensor 32, lid sensor 30, or any other sensor detecting how much time and at what times a dental appliance 200 is in or out of a case 100”; therefore, the sensor 30 is capable of sensing or not the magnet 40 of the lid 11 for indicating opening or closing of the lid 11 in which in addition the same sensor, through the programing, indicates how much time and when the dental appliance is in or out of the case 100).
Regarding claim 13, Wilson et al. disclose that the compliance measure is determined based on a treatment plan of the patient, and indicates an extent of compliance with the treatment plan of the patient (see [0049] – “The software in memory 25 can include one or more software programs, each of which includes an ordered listing of executable instructions for implementing logical functions… includes a suitable operating system (O/S) 27 and programs 28…that provides scheduling, input-output control, file and data management, memory management, and communication control and related services. The programs 28 may include various applications… e.g., exemplary programs 28 may include, … a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”; therefore, if it includes an input-output control and programs that it can be configured, it is understood that the configuration is based on the treatment plant of the patient).
Regarding claim 15, Wilson et al. disclose that the treatment plan includes an amount of time per day that the oral appliance is to be worn (see [0049] – “programs 28 may include, but not limited to, a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”).
Regarding claim 16, Wilson et al. disclose that the compliance measure includes the inferred amount of time (see [0049] – “a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”).
Regarding claim 17, Wilson et al. disclose outputting the compliance measure comprises outputting the compliance measure from the storage case to a remote device (see [0042] – “a communications array 23 may comprise a Bluetooth receiver and transmitter and which enables wireless communication to a network or an external access client device”), [0048] – “System output can be provided via a communications array 23, a light emitting device 39, a vibration device 38, and/or a sound device 35”, and [0042] – “communications array 23 which is operable to send and receive wireless and/or wired communications…”, and communications array 23 “may comprise a Bluetooth receiver and transmitter and which enables wireless communication to a network or an external access client device (FIG. 10) such as cell phones, smart phones 300A, tablet computers, laptop computers 300B, wearable computers such as watches, Google Glasses, etc. and the like”).
Regarding claim 19, Wilson et al. disclose that inferring the amount of time that the oral appliance was in the mouth comprises inferring the amount of time in a remote computing device. (see [0042] – “a communications array 23 may comprise a Bluetooth receiver and transmitter and which enables wireless communication to a network or an external access client device”; and [0049] – “The software in memory 25 can include one or more software programs, each of which includes an ordered listing of executable instructions for implementing logical functions… includes a suitable operating system (O/S) 27 and programs 28…that provides scheduling, input-output control, file and data management, memory management, and communication control and related services. The programs 28 may include various applications… e.g., exemplary programs 28 may include, … a clock or timer program which may be configured to track input form an I/O interface 20 and to correlate the input with a time stamp or time period”; and [0050] – “System output can be provided via a communications array 23, a light emitting device 39, a vibration device 38, and/or a sound device 35”, “processing unit 21 and communications array 23 may communicate the input directly to external access client 300A, 300B, devices through Bluetooth, Wifi, NFC, or other wireless communications, thereby triggering a notification such as a text message, email message, push notification, application notification, and the like on an external access client device”; therefore, it includes an input-output control and programs that it can be configured to monitor time of the use or not of the oral appliance, and the storage case provides the means to communicate alarms triggered by the time programed through messages, notifications, etc., to the external access client device).
Regarding claim 20, Wilson et al. disclose that the closure of the storage case and positioning the hinge in a closed position activates or deactivates the sensor (see [0036] – the lid sensor 30 can be a Hall effect sensor, a “pressure switch, an electrical circuit, or any other method configured to detect if the lid is open, closed, or optionally not open or closed. In further embodiments, a case 100 may comprise a reed switch, a pressure sensor, a contact sensor, a button mount, an ambient light sensor, or any other suitable sensor to detect if the lid 11 is open, closed, or partially opened or closed”; therefore, the sensor is activated or not and send the signal when the electrical circuit is closed or open).
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.
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 20160100924 A1) as applied to claim 1 and 12 above, and further in view of Grabner (AT 409216 B).
With respect to claims 21 and 23:
Regarding claim 21, Wilson discloses the claimed invention substantially as claimed, as set forth above for claim 1.
However, Wilson does not disclose that the compliance measure is a cumulative time period based on multiple compliance signals.
Regarding claim 23, Wilson discloses the claimed invention substantially as claimed, as set forth above for claim 12.
However, Wilson does not disclose further including gathering multiple compliance signals and calculating the compliance measure based on the multiple compliance signals.
With respect to claims 21 and 23:
Grabner teaches a monitoring method and system for wearing a corrective device, including a removable orthodontic appliance. “Where at least one physical signal representative of the wearing state is generated in the area of the brace, which is used to determine the wearing time” (see page 1, lines 8-9). The intention is to have a way to determine and monitor the wearing habits of the appliance by the patient as precise as possible (see page 5, lines 15-17). This is done by assigning values to a signal and record the sum of values to determine the time and date of the wearing periods (see page 5, lines 18-22, and page 6, last paragraph). One way of providing the physical signal is by the use of at least one sensor designed as a magnetic field sensor (see page 7, lines 17-19).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the signal generated by the Hall effect lid sensor of Wilson, with the system of the recording the sum of values in a period of time used by the magnetic field sensor of Grabner, in order to record the total amount of time the appliance is in the case or used by the patient, in order to determine how compliance the patient is in following the treatment plan for a rapid and successful treatment.
Allowable Subject Matter
Claim 24 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 24, the prior arts of Wilson and Grabner do not disclose that the compliance indicator system includes discharge circuit that is configured to discharge power form a power source when the compliance indicator system infers that the oral appliance in the mouth of the patient or that the oral appliance is in the storage case, wherein a comparison of a predetermined power level and a power level of the power source after the power is discharged is used to infer the amount of time that the oral appliance was in the mouth of the patient
Response to Arguments
Applicant's arguments filed 21 July 2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 12 rejection, applicant argues that the added language in combination with the steps described in the method is not found in the prior art of Willson.
The Office disagrees, Willson discloses that the storage case 100 includes in the interior a sensor 30 and a magnetic material 40 locate in the lid 11, that indicates when the lid is open or close. Said sensor 30 is in communication with a processing unit 21, that notify if the lid has not been opened for a period of time or for a certain time, in this way indicating how much time and at what times the dental appliance is in or out of a storage case 100. Even when it can use other sensors, like the occupancy sensor 32, processing unit 21 uses the lid sensor 30 to detect how much time and at what times a dental appliance is in or out of a storage case 100 (see [0006, 0036, 0053 and 0056]). Therefore, if the processing unit 21 in combination with the sensor 30 and magnetic material 40 detect how much time the dental appliance is in or out of a storage case, it is understood that it is inferring the amount of time the oral appliance is in the mouth of the patient based on the opening or closing of the lid of the storage case.
For that reason, based that the method described in the claims is found in the prior art of Willson, making the rejection proper and will be maintained.
Regarding claims 21 and 23 rejection, for the reasons given above, it is understood that the rejection is proper and will be maintained.
The Office understands that the steps of the method described in the claims are found in the prior arts of Willson and Grabner, making the claims not ready for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIRAYDA ARLENE APONTE whose telephone number is (571)270-1933. The examiner can normally be reached M-F 8-5.
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, Eric Rosen can be reached at 571-270-7855. 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.
/MIRAYDA A APONTE/Examiner, Art Unit 3772 /ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
Prosecution Insights