DETAILED ACTION
This Office Action is in response to the communication dated 01 October 2026 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, 11-22, 30, 31, and 38-46 are pending and currently under consideration for patentability; claims 1, 2, 38 43, 44, have been amended; claims 9, 10, 23-29, and 32-37 have been cancelled.
Response to Arguments
Applicant’s arguments dated 01 October 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 wherein the sensor is within a housing of the implantable pulse generator and wherein the sensor comprises an internal measurement unit comprising an accelerometer. Applicant argues that the Bolea reference does not disclose or suggest wherein the sensor that comprises the internal measurement unit comprising the accelerometer is positioned within a housing of the implantable pulse generator.
The Examiner has introduced the Ni reference to read on Applicant’s amendments more directly, rendering moot Applicant’s arguments directed towards Bolea. As described below, the Examiner respectfully submits that Bolea in view of Ni obviates the claimed limitations.
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, 13-17, 30, 31, and 38-46 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea et al. (US 2014/0228905 A1) in view of Ni et al. (US 2007/0118180 A1).
Regarding claims 1, 38, and 43, 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 configured to deliver stimulation to a nerve which innervates an upper airway muscle ([0128], figures 12A-D)
a controller 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 43 in particular, 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 claims 1, 38, and 43, although Bolea describes the use of an accelerometer for detecting patient movement ([0137]), Bolea does not explicitly disclose wherein the sensor is within a housing of the implantable pulse generator and comprises an internal measurement unit comprising an accelerometer. However, Ni also describes a system for detecting obstructive sleep apnea ([0012]: “detecting the presence of disordered breathing may involve detecting…obstructive sleep apnea”) including a sensor within a housing of an implantable pulse generator and comprising an internal measurement unit comprising an accelerometer ([0062]: “the motion detector 320 may be implemented as an accelerometer positioned in or on the housing 301 of the pulse generator 305) and configured to detect chest and/or abdominal movement by a subject during the inspiration and expiration stages of a respiratory cycle ([0062]: “motion detector 320 may be optionally configured to sense…chest wall movements associated with respiratory effort”). As Ni is also directed towards detecting 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 incorporate a sensor in the form of an accelerometer within a housing of an implantable pulse generator, similar to that described by Ni, when using the system described by Bolea, as doing so advantageously allows the resulting system to detect and treat the obstructive sleep apnea with a more compact device.
Regarding claims 2 and 44, Ni describes wherein the sensor comprises the internal measurement unit comprising the accelerometer ([0062]).
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]), and Ni describes wherein the accelerometer detects movement of the chest of the subject over time ([0062]).
Regarding claim 4, Bolea describes wherein the system comprises an acoustic sensor and/or an electrocardiogram sensor coupled to the controller ([0379], [0523]).
Regarding claim 5, 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 and 14, 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 claim 15, Bolea in view of Ni suggests the system of claim 14, but Bolea and Ni do 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 16, 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 claim 17, Bolea in view of Ni suggests the system of claim 13, including storing historical data for a subject stored in a log (Bolea: [0410]), but Bolea and Ni do 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.
Regarding claim 30, 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 claim 31, 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]).
Regarding claim 39, 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 claim 40, 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 claim 41, Bolea describes wherein the controller is configured to determine a body orientation of the subject based on data from an accelerometer ([0488]) and to determine whether the subject is asleep based on the body orientation ([0138]). 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 incorporate the body orientation determination described by Bolea and the chest wall motion determination described by Ni into the same accelerometer, as doing so advantageously reduces the number of individual components of the overall device.
Regarding claim 42, Bolea describes wherein the controller is further configured to adjust at least one characteristic of the stimulation delivered by the IPG based on a determined severity of a sleep disordered breathing event ([0487]), the at least one characteristic including voltage amplitude, current amplitude, pulse frequency, or pulse duration ([0376]).
Regarding claim 45, 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]).
Regarding claim 46, 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]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Ni, further in view of Colas et al. (US 2020/0100727 A1).
Regarding claim 11, Bolea in view of Ni suggests the system of claim 2, 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 Ni 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 Ni, as doing so advantageously allows the resulting system to extract and analyze the appropriate patient data.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Ni and Colas, further in view of Kale et al. (US 2020/0170527 A1).
Regarding claim 12, Bolea in view of Ni and Colas suggests the system of claim 11. 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, Ni, 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, Ni, and Colas, as doing so advantageously allows the resulting system to better analyze and present the patient data (please see Kale, figure 12).
Claims 18, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Ni, further in view of Morren et al. (US 2012/0065524 A1).
Regarding claim 18, Bolea in view of Ni 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 Ni 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 Ni, 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 Ni and Morren, further in view of Wen et al. (US 2019/0223782 A1).
Regarding claim 19, Bolea in view of Ni 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, Ni, 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, Ni, 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harrison et al. (US 2015/0144142 A1), which describes an obstructive sleep apnea treatment device including an accelerometer located within a housing of the device.
Stahmann et al. (US 2005/0113710 A1), which describes an implantable pulse generator including an accelerometer configured to detect chest wall movements
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, Niketa Patel, can be reached by telephone at 571-272-4156. 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
