DETAILED ACTION
This Office Action is in response to the communication dated 25 November 2025 concerning Application No. 18/184,405 filed on 15 March 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 1-8, 11-28, 30, 31, and 33-35 are pending and currently under consideration for patentability; claims 1 and 23 have been amended; claims 9, 10, 29, 32, 36, and 37 have been cancelled.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 10 October 2025 has been acknowledged and considered by the Examiner.
Response to Arguments
Applicant’s arguments dated 28 November 2025 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 recite that the implantable pulse generator is sewn into a fascia of the mylohyoid muscle, similar to a limitation appearing in now-cancelled claim 10. The Examiner has addressed the amended limitation in the updated text below.
Applicant argues that the Weadock reference is based on a fundamentally different principle of operation (magnetism vs. electrical stimulation), and therefore that Weadock’s disclosure of positioning an anchor near the mylohyoid muscle cannot be combined with Bolea’s electrical stimulation device. Applicant further argues that the location of Weadock’s anchor is for a specific purpose, to maintain the magnet at a fixed distance relative to an anchoring point, which is specific to a magnetic mechanism and cannot be applied to electrical stimulation. The Examiner respectfully submits that the relevant teaching of Weadock is that a sleep apnea treatment device can be positioned at least partially near the mylohyoid muscle. The treatment mode described by Weadock may be different than that of Bolea, but Weadock nonetheless describes an implantation site near the mylohyoid muscle. Although the Examiner respectfully disagrees with Applicant’s conclusion that Weadock’s teachings cannot be combined with those of Bolea, the Examiner has introduced herein the Mashiach reference, which addresses Applicant’s concerns with Weadock and which more directly reads on the amended limitations. Mashiach describes an implantable pulse generator device configured to treat obstructive sleep apnea (figure 13), including positioning a carrier containing electrodes near a mylohyoid muscle ([0277]). The Examiner respectfully directs Applicant to the discussion of the Mashiach reference 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 1-8, 13, 14, 16, 23, 24, 27, 28, 30, 31, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea et al. (US 2014/0228905 A1) in view of Mashiach (2016/0030740 A1).
Independent Claims
Regarding claim 1, Bolea describes a system for treating obstructive sleep apnea ([0002]), comprising:
a sensor configured to detect chest and/or abdominal movement by a subject during the inspiration and expiration stages of a respiratory cycle ([0127], [0364]), and to generate chest and/or abdominal positional and/or velocity data based on the detected movement ([0137], [0364])
a stimulator ([0127]) comprising
an implantable pulse generator positioned in a neck of the subject ([0136]) and configured to deliver stimulation to a nerve which innervates an upper airway muscle ([0128], figures 12A-D)
a controller coupled to the stimulation system and to the sensor ([0127])
wherein the controller is configured to cause the IPG to stimulate the nerve based on the positional and/or velocity data generated by the sensor ([0137], [0379])
Regarding claim 23, Bolea describes a method of treating obstructive sleep apnea in a subject ([0002]) comprising
detecting chest and/or abdominal movement by the subject during the inspiration and expiration stages of a respiratory cycle using a sensor ([0127], [0364])
generating, by the sensor, chest and/or abdominal positional and/or velocity data based upon the detected movement, wherein the chest and/or abdominal positional and/or velocity data comprises information describing movement of the chest and/or abdomen of the subject, and optionally the subject’s orientation ([0137], [0364])
determining, by a controller coupled to the sensor ([0127]), a respiratory waveform corresponding to a respiratory cycle of the subject, using the chest and/or abdominal positional and/or velocity data ([0274], [0282])
stimulating a nerve innervating an upper airway muscle of the subject based on the respiratory waveform using an implantable pulse generator positioned in a neck of the subject ([0127] - [0128], [0136])
Regarding claims 1 and 23, although Bolea describes accessing the mylohyoid muscle during the implantation process ([0196]), Bolea does not explicitly disclose wherein the IPG is sewn into a fascia of a mylohyoid muscle of the subject. However, Mashiach also describes systems and methods for treating obstructive sleep apnea ([0139], [0186]), including wherein an implantable pulse generator is secured to a mylohyoid muscle of a subject (figure 13, [0277]). As Mashiach is also directed towards treating obstructive sleep apnea 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 secure, or sew, the implantable pulse generator described by Bolea at a location similar to that described by Mashiach, as doing so advantageously allows the resulting system to target the desired muscles for apnea treatment.
Dependent Claims
Regarding claims 2 and 24, Bolea describes wherein the sensor comprises an inertial measurement unit comprising an accelerometer ([0137], [0488]).
Regarding claim 3, Bolea describes wherein the positional and/or velocity data comprises movement of the chest and/or abdomen of the patient over time ([0364]).
Regarding claim 4, Bolea describes wherein the system comprises an acoustic sensor and/or an electrocardiogram sensor coupled to the controller ([0379], [0523]).
Regarding claims 5 and 35, Bolea describes wherein the controller is configured to determine an apnea-hypopnea index ([0637], [0649]) based on the positional and/or velocity data ([0533], data from accelerometer) and an audio signal detected by the acoustic sensor ([0379]) and/or a heart rate signal detected by the ECG sensor ([0523]).
Regarding claim 6, Bolea describes wherein the controller is further configured to cause the IPG to stimulate the nerve based on an audio signal detected by the acoustic sensor ([0379]).
Regarding claim 7, Bolea describes wherein the controller is further configured to cause the IPG to stimulate the nerve based on a heart rate signal detected by the ECG sensor ([0329], [0418] - [0419]).
Regarding claim 8, Bolea describes wherein the system is configured to filter chest and/or abdominal movement data detected by the sensor using at least one band-pass filter ([0274]).
Regarding claims 13, 14, and 27, Bolea describes wherein the controller is configured to determine a signal-to-noise of the positional and/or velocity data ([0246]) and to operate in an asynchronous mode when the SNR of the positional and/or velocity data falls below a predetermined threshold ([0515]).
Regarding claims 16 and 28, Bolea describes wherein the asynchronous mode comprises a mode wherein the controller is configured to cause the IPG to stimulate the nerve for approximately 2.5 seconds ([0515]).
Regarding claims 30 and 33, Bolea describes wherein the controller is further configured to synchronize stimulation of the nerve with a respiratory cycle of the subject based on chest and/or abdominal movement detected by the sensor ([0423], [0465]).
Regarding claims 31 and 34, Bolea describes wherein the controller is further configured to synchronize stimulation of the nerve with a respiratory cycle of the subject ([0423]) based on the chest and/or abdominal movement detected by the sensor ([0329]) and/or an audio signal comprising breath sounds generated by the subject, detected using the acoustic sensor ([0379]).
Claims 11 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Mashiach, further in view of Colas et al. (US 2020/0100727 A1).
Regarding claims 11 and 25, Bolea in view of Mashiach suggests the system of claim 1 and the method of claim 23, including wherein the controller is configured to determine a respiratory cycle of the subject by filtering chest and/or abdominal movement data detected by the sensor (Bolea: [0274]). However, Bolea and Mashiach do not explicitly disclose performing principal component analysis on the filtered chest and/or abdominal movement data. Colas also describes a system and method for treating obstructive sleep apnea ([0162]), including performing principal component analysis on chest and/or abdominal movement data ([0121]). As Colas is also directed towards monitoring sleep apnea 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 PCA analysis similar to that described by Colas when using the system and method described by Bolea and Mashiach, as doing so advantageously allows the resulting system to extract and analyze the appropriate patient data.
Claims 12 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Mashiach and Colas, further in view of Kale et al. (US 2020/0170527 A1).
Regarding claims 12 and 26, Bolea in view of Mashiach and Colas suggests the system of claim 11 and the method of claim 25. Bolea further describes receiving a signal comprising 3D chest and/or abdominal movement data from the accelerometer component of the sensor, wherein the accelerometer comprises a 3-axis accelerometer ([0137], [0488]) and processing the signal using at least one filter ([0274]). Bolea, Mashiach, and Colas do not explicitly disclose generating a covariance matrix based on the processed signal, computing eigenvectors and eigenvalues for the covariance matrix, and constructing a projection matrix that transforms the 3D chest and/or abdominal movement data into a single dimension. However, Kale also describes analyzing cardiac data, including for assessment of sleep apnea ([0099]), including generating a covariance matrix based on the processed signal ([0090]), computing eigenvectors and eigenvalues for the covariance matrix ([0048]), and constructing a projection matrix that transforms the 3D chest and/or abdominal movement data into a single dimension ([0091]). As Kale is also directed towards analyzing patient data for assessment of apnea 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 covariance and eigenvalue decomposition analysis similar to that described by Kale when using the system described by Bolea, Mashiach, and Colas, as doing so advantageously allows the resulting system to better analyze and present the patient data (please see Kale, figure 12).
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea.
Regarding claim 15, Bolea describes the system of claim 14, but Bolea does not explicitly disclose wherein the asynchronous mode comprises a mode wherein the controller is configured to cause the IPG to stimulate the nerve throughout at least one full respiration cycle, wherein the start of the respiratory cycle is predicted based on previously logged respiratory rate data. However, Bolea describes both that asynchronous intervals may be set to a rate similar to a respiratory cycle ([0515]) and that historical data may be used to estimate starts of respiratory cycles ([0298]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the asynchronous mode such that the IPG stimulates the nerve throughout at least one full respiration cycle, wherein the start of the respiratory cycle is predicted based on previously logged respiratory rate data, as doing so advantageously allows the resulting system to use the previously logged respiratory data and synchronize the stimulation to the patient’s respiratory cycle.
Regarding claim 17, Bolea describes the system of claim 13, including storing historical data for a subject stored in a log ([0410]), but does not explicitly disclose wherein the SNR is determined using historical positional and/or velocity data for the subject stored in the log. However, as Bolea describes that the system may store, recall, and analyze historical data ([0298]), the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to determine the SNR using historical data, as doing so advantageously allows the system to better analyze the performance of previously-used parameters.
Claims 18, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Mashiach, further in view of Morren et al. (US 2012/0065524 A1).
Regarding claim 18, Bolea in view of Mashiach suggests the system of claim 13, including the use of a three-axis accelerometer (Bolea: [0488]) and combining signals from multiple vectors to increase SNR more effectively (Bolea: [0279). Bolea and Mashiach do not explicitly disclose wherein the SNR is determined based upon at least two out of the three axes of an accelerometer or gyroscope. However, Morren also describes a system for increasing SNR and removing motion artifacts ([0020]), including wherein the SNR is determined based on at least two axes out of the three axes of an accelerometer ([0056] - [0057]). As Morren is also directed towards analyzing accelerometer data 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 use the data from at least two of the axes of the accelerometer, in a manner similar to that described by Morren, when using the system described by Bolea and Mashiach, as doing so advantageously allows the resulting system to generate the highest quality signal while minimizing noise.
Regarding claim 21, Bolea describes wherein the accelerometer is a 3-axis accelerometer and the controller is configured to determine a body orientation of the patient ([0488]).
Regarding claim 22, Bolea describes wherein the controller is configured to determine whether the subject is asleep based on the body orientation ([0138]).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Mashiach and Morren, further in view of Wen et al. (US 2019/0223782 A1).
Regarding claim 19, Bolea in view of Mashiach and Morren suggests the system of claim 18, including wherein the accelerometer is a 3-axis accelerometer (Bolea: [0488]) and the controller is configured to determine the SNR of at least two out of the three axes of the accelerometer (Morren: [0056] - [0057]), but Bolea, Mashiach, and Morren do not explicitly disclose determining whether the SNR is above a predetermined threshold and to use the strongest component signal to determine the respiratory cycle of the subject. However, Wen also describes a system for monitoring obstructive sleep apnea, including determining whether an SNR of a signal is above a predetermined threshold ([0075]). As Wen is also directed at monitoring sleep apnea 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 use an SNR threshold, similar to that described by Wen, when using the system described by Bolea, Mashiach, and Morren, in order to use the strongest component signal to determine the respiratory cycle of a subject, as doing so advantageously ensures that the optimal data is used for further analysis.
Regarding claim 20, Wen describes wherein the gyroscope is a 3-axis gyroscope ([0061]) and the controller is configured to determine whether the SNR of at least two out of the three axes of the gyroscope are above a predetermined threshold ([0075]) and to use the strongest component signal to determine the respiratory cycle of the subject (please see above discussion in reference to claim 19).
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
THIS ACTION IS MADE FINAL. 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