DETAILED ACTION
This Office Action is in response to the communication dated 07 January 2026 concerning Application No. 18/549,576 filed on 07 September 2023.
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 .
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 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.
Status of Claims
Claims 1-15 are pending and currently under consideration for patentability; claims 1-3, 8, 9, 14, and 15 have been amended; claims 16-32 previously were cancelled.
Response to Arguments
Applicant’s arguments dated 07 January 2026 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claims to recite use of a magnetometer configured to detect a magnetic field generated by a magnet disposed in either the lower arch component or the upper arch component of an intra-oral device. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 6-10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan (US 2020/0375528 A1) in view of Mills (US 3,822,694).
Regarding claims 1, 8, and 15, Flanagan describes an intra-oral device, a method of determining efficacy of using an intra-oral device, and a computer program product ([0014]) comprising
a lower arch component and an upper arch component (figure 4, upper and lower components of mandibular advancement device 4), wherein the lower arch component is configured to be advanced relative to the upper arch component ([0004], extending the lower jaw component)
sensors configured for detecting characteristics of a patient ([0018], [0050]), wherein the sensors are disposed in the upper arch component or the lower arch component (figure 2, [0055]), wherein the characteristics comprise indicators of sleep apnea on the patient ([0051]), wherein the sensors comprise a magnetometer ([0062])
a processor in communication with the sensors to receive the detected characteristics ([0053] - [0054]), the processor configured to determine, based on the detected characteristics, an efficacy of the intra-oral device in reducing the sleep apnea of the patient ([0014], [0113])
Regarding claims 1, 8, and 15, although Flanagan describes that the device is a mandibular advancement device with integrated sensors, Flanagan does not explicitly disclose wherein the sensors detect the displacement of the lower arch component relative to the upper arch component. Flanagan also does not explicitly disclose wherein the magnetometer is configured to detect a magnetic field generated by a magnet disposed in either the lower arch component or the upper arch component and the processor is configured to determine, based on the magnetic field, the displacement of the lower arch component relative to the upper arch component. However, Mills also describes an oral device, including sensors configured to detect the displacement of the lower arch component relative to the upper arch component (col 3:4-12), a magnetometer configured to detect a magnetic field generated by a magnet disposed in either the lower arch component or the upper arch component (Abstract, col 2:46-62), and a processor configured to determine, based on the magnetic field, the displacement of the lower arch component relative to the upper arch component (Abstract, col 3:4-25). As Mills is also directed towards oral devices for patient use and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a magnetometer configured to detect mandibular movement, similar that described by Mills, when using the device described by Flanagan, as doing so advantageously allows the resulting device to accurately track the movements of the upper and lower mandibular structures. The Examiner respectfully submits that, as Flanagan describes that mandibular movement may affect the efficacy of the sleep apnea therapy ([0004]), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the displacement of the mandibular components to determine the efficacy of the resulting intra-oral device in reducing the sleep apnea of the patient, as recited.
Regarding claims 2 and 9, Flanagan describes wherein the sensors comprise a pulse oximeter sensor ([0056]), an accelerometer ([0062]), a temperature sensor ([0066]), and a microphone ([0068]).
Regarding claims 3 and 10, Flanagan describes wherein the processor is further configured to determine, based on the detected characteristics, compliance of the patient to using the intra-oral device according to a prescribed oral appliance therapy ([0079]).
Regarding claims 6 and 13, Flanagan describes wherein the detected characteristics include third characteristics comprising a blood oxygen level ([0067]), a heart rate ([0067]), a mouth position ([0062]), and a breathing activity ([0066]), wherein the third characteristics are used to determine whether a sleep apnea occurs on the patient ([0015], [0051]).
Regarding claims 7 and 14, Flanagan describes wherein the detected characteristics include fourth characteristics comprising a head position ([0062]), a position of the intra-oral device ([0062]), and a breathing activity ([0066]), wherein the fourth characteristics are determined when the patient is asleep ([0051]). Mills describes wherein the monitored characteristics include a mandibular position (Abstract).
Claims 4, 5, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan in view of Mills, further in view of Sharma (US 2020/0237551 A1).
Regarding claims 4 and 11, Flanagan describes wherein the detected characteristics include first characteristics comprising a temperature ([0066]), a heart rate ([0067]), and a blood oxygen level of the patient ([0067]), wherein the first characteristics are used to determine whether the intra-oral device is being used by the patient ([0079]). Neither Flanagan nor Mills explicitly disclose measuring a blood pressure of the patient. However, Sharma also describes an intra-oral device used for treating sleep apnea ([0007]), including sensors configured to measure a blood pressure of the patient ([0180]). As Sharma is also directed towards intra-oral devices and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate blood pressure measurement, similar to that described by Sharma, when using the device described by Flanagan and Mills, as doing so advantageously allows the resulting device to use an additional metric to determine the patient’s apnea state.
Regarding claims 5 and 12, Flanagan describes wherein the detected characteristics include second characteristics comprising a heart rate ([0067]). Sharma describes wherein the measured characteristic includes a blood pressure ([0180]) and wherein the second characteristics are used to determine whether the patient is asleep ([0180]).
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792