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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 April 2026 has been entered.
Status of Claims
Claims 1-8, 11-22, 30, 31, and 38-46 are pending and currently under consideration for patentability; claims 1, 11, and 13 have been amended; claims 9, 10, 23-29, and 32-37 have been cancelled; and claims 38-46 have been added as new claims.
Response to Arguments
Applicant’s arguments dated 14 April 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 remove the limitations reciting wherein the controller is coupled to the stimulation system and to the sensors. Applicant has added new claims 38-46. The Examiner has addressed the amended limitations and new claims in the updated text of the rejection below.
Regarding the previous rejection, Applicant argues that Mashiach, although describing a flexible carrier implanted between the genioglossus, geniohyoid, and mylohoid muscles, does not teach or suggest an implantable pulse generator sewn into a fascia a mylohyoid muscle. Applicant further argues that Mashiach’s description of “securing” an implantable pulse generator at a location is not analogous to Applicant’s claim of “sewing” an implantable pulse generator at a location. Although the Examiner respectfully disagrees with both of these arguments (for example, because the flexible carrier is a portion of the implant and is implanted at substantially the same location as recited in Applicant’s claim and because multiple securement mechanisms are considered as art-recognized equivalents), the Examiner has introduced herein the Hohenhorst reference, which more directly reads on an implantable pulse generator sewn into the fascia of the mylohyoid muscle. The Examiner respectfully submits that Applicant’s arguments regarding the Mashiach reference have been rendered moot.
Claim Rejections - 35 USC § 102
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 38-46 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Bolea et al. (US 2014/0228905 A1).
Regarding claim 38, 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]), wherein the sensor comprises an inertial measurement unit comprising an accelerometer ([0137], [0488])
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 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 the accelerometer ([0488]) and to determine whether the subject is asleep based on the body orientation ([0138]).
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 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])
an acoustic sensor and/or an electrocardiogram sensor coupled to the controller ([0379], [0523])
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])
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 44, Bolea describes wherein the sensor comprises an inertial measurement unit comprising an accelerometer ([0137], [0488]).
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 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, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Hohenhorst et al. (US 2010/0294284 A1).
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 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 1, 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, Hohenhorst also describes systems and methods for treating obstructive sleep apnea ([0010] - [0011]), including wherein an implantable pulse generator is sewn into position ([0359], [0394]) and wherein the implantable pulse generator may be positioned in fascia of the mylohyoid muscle ([0396]). As Hohenhorst 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 suture, or sew, the implantable pulse generator described by Bolea at a location similar to that described by Hohenhorst, as doing so advantageously allows the resulting system to target the desired muscles for apnea treatment.
Regarding claim 2, 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 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 Hohenhorst suggests the system of claim 14, but Bolea and Hohenhorst 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 Hohenhorst suggests the system of claim 13, including storing historical data for a subject stored in a log (Bolea: [0410]), but Bolea and Hohenhorst 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]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Hohenhorst, further in view of Colas et al. (US 2020/0100727 A1).
Regarding claim 11, Bolea in view of Hohenhorst 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 Hohenhorst 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 Hohenhorst, 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 Hohenhorst and Colas, further in view of Kale et al. (US 2020/0170527 A1).
Regarding claim 12, Bolea in view of Hohenhorst 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, Hohenhorst, 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, Hohenhorst, 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 Hohenhorst, further in view of Morren et al. (US 2012/0065524 A1).
Regarding claim 18, Bolea in view of Hohenhorst 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 Hohenhorst 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 Hohenhorst, 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 Hohenhorst and Morren, further in view of Wen et al. (US 2019/0223782 A1).
Regarding claim 19, Bolea in view of Hohenhorst 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, Hohenhorst, 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, Hohenhorst, 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
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Conclusion
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 3796
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