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.
Status of Claims
Claims 28-47 are pending and under consideration for patentability; claims 1-27 were cancelled and claims 28-47 were added as new claims via a Preliminary Amendment dated 07 April 2026.
Information Disclosure Statement
The Information Disclosure Statements submitted on 30 June 2025, 28 July 2025, 15 October 2025, 02 February 2026, and 05 June 2026 have been acknowledged and considered by the Examiner.
Claim Objections
Claims 36 and 44 are objected to because of the following informalities.
Claims 36 and 44 contain minor typographical and/or grammatical errors.
Claim 36, line 3: Applicant is advised to change “the respiratory cycle” to “the respiration cycle”
Claim 44, line 2: Applicant is advised to change “the stimulation system” to “a stimulation system”
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 28, 33-36, 38, and 43-46 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea et al. (US 2014/0228905 A1) in view of Colas et al. (US 2020/0100727 A1).
Regarding claims 28 and 38, Bolea describes a system and method for treating obstructive sleep apnea ([0002]), comprising
an inertial measurement unit, wherein the IMU is configured to detect chest and/or abdominal movement by a patient during the inspiration and expiration stages of a respiratory cycle, and to generate chest and/or abdominal positional data based on the detected movement ([0364])
a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle ([0128])
a controller coupled to the stimulation system and to the IMU ([0127]), wherein the controller is configured to
determine a respiratory cycle of the patient by filtering the chest and/or abdominal positional data ([0274])
cause the stimulation system to stimulate the nerve based on the respiratory cycle of the patient ([0137], [0379])
Regarding claims 28 and 38, Bolea does not explicitly disclose wherein the inertial measurement unit comprises an accelerometer and a gyroscope and wherein the controller is configured to perform a principal component analysis on the filtered chest and/or abdominal positional data. However, Colas also describes a system and method for treating obstructive sleep apnea ([0162]), including wherein an inertial measurement unit may comprise an accelerometer and a gyroscope ([0080]) and wherein a controller is configured to perform a principal component analysis on filtered chest and/or abdominal positional 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 an accelerometer and gyroscope and use principal component analysis in a manner similar to that described by Colas when using the system and method described by Bolea, as doing so advantageously allows the resulting system to extract and analyze the appropriate patient data.
Regarding claim 33, Colas describes wherein the accelerometer comprises a 3-axis accelerometer ([0087]).
Regarding claims 34 and 43, Bolea describes wherein the controller is configured to determine a signal-to-noise of the positional data ([0246]).
Regarding claims 35 and 44, Bolea describes wherein the controller is configured to operate in an asynchronous mode when the SNR of the positional data falls below a predetermined threshold ([0515]).
Regarding claims 36 and 45, Bolea in view of Colas suggests the system of claim 35 and the method of claim 44, but Bolea and Colas do not explicitly disclose wherein the asynchronous mode comprises a mode wherein the controller is configured to cause the stimulation system to stimulate the nerve throughout a full respiration cycle, wherein the start of the respiration 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 a respiration cycle, wherein the start of the respiration 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 46, Bolea in view of Colas suggests the method of claim 43, but neither Bolea nor Colas explicitly disclose wherein the SNR is determined using historical positional data for the patient stored in a log. However, as Bolea describes the use of historical positional data for delivering stimulation ([0266], [0285], [0297], [0490]), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use similar historical positional data stored in a log for determining SNR, as doing so advantageously allows the resulting method to calculate a more accurate SNR value.
Claims 29, 32, 39, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Colas, further in view of Kale et al. (US 2020/0170527 A1).
Regarding claims 29 and 39, Bolea in view of Colas suggests the system of claim 28 and the method of claim 38, but neither Bolea nor Colas explicitly disclose wherein the PCA comprises use of a covariance matrix. However, Kale also describes analyzing data for assessment of sleep apnea ([0099]), including use of a covariance matrix ([0090]). 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 matrix analysis similar to that described by Kale when using the system described by Bolea and Colas, as doing so advantageously allows the resulting system to better analyze and present the patient data (please see Kale, figure 12).
Regarding claims 32 and 42, Bolea in view of Colas suggests the system of claim 28 and the method of claim 38. Bolea further describes receiving a signal comprising 3D chest and/or abdominal movement data from the IMU ([0137], [0488]) and processing the signal using at least one filter ([0274]). Colas further describes wherein the accelerometer comprises a 3-axis accelerometer ([0087]). Bolea 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 positional data into a single dimension. However, Kale also describes analyzing data for assessment of sleep apnea ([0099]), including generating a covariance matrix based on a 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 positional 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 and Colas, as doing so advantageously allows the resulting system to better analyze and present the patient data (please see Kale, figure 12).
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Colas and Kale, further in view of Lawrence et al. (US 6,038,337).
Regarding claims 30 and 40, Bolea in view of Colas and Kale suggest the system of claim 29 and the method of claim 29, but Bolea, Colas, and Kale do not explicitly disclose wherein the covariance matrix is generated using a rolling or stepped window. However, Lawrence also describes the use of principal component analysis, including using a stepped window (col 4:6-11, col 5:22-28, claims 1, 3). As Lawrence is also directed towards using principal component analysis, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a stepped window similar to that described by Lawrence when using the system and method described by Bolea, Colas, and Kale, as doing so advantageously allows the resulting system to use a more accurate representation of the patient’s data.
Claims 37 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Colas, further in view of Morren et al. (US 2012/0065524 A1).
Regarding claims 37 and 47, Bolea in view of Colas suggests the system of claim 34 and the method of claim 43, including the use of a three-axis accelerometer (Colas: [0087]) and combining signals from multiple vectors to increase SNR more effectively (Bolea: [0279). Bolea and Colas 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 Colas, as doing so advantageously allows the resulting system to generate the highest quality signal while minimizing noise.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 28-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,263,342 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite systems and methods for treating obstructive sleep apnea comprising an inertial measurement unit comprising an accelerometer and a gyroscope, a stimulation system, and a controller configured to determine a respiratory cycle of the patient using principal component analysis and stimulate a nerve based on the respiratory cycle. A brief, but non-exhaustive matching of the pending claims and the issued claims is provided via the table below. The Examiner has expanded upon the analysis of independent claim 28 for clarity.
U.S. Application No. 19/096,542
Pending Claims
U.S. Patent No. 12,263,342 B2
Issued Claims
28.
A system for treating obstructive sleep apnea, comprising: an inertial measurement unit (IMU) comprising an accelerometer and a gyroscope, wherein the IMU is configured to detect chest and/or abdominal movement by a patient during the inspiration and expiration stages of a respiratory cycle, and to generate chest and/or abdominal positional data based on the detected movement;
a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle; and
a controller coupled to the stimulation system, and to the IMU,
wherein the controller is configured to:
determine a respiratory cycle of the patient by: a) filtering the chest and/or abdominal positional data, and b) performing a principal component analysis (PCA) on the filtered chest and/or abdominal positional data; and
cause the stimulation system to stimulate the nerve based on the respiratory cycle of the patient.
1.
A system for treating obstructive sleep apnea, comprising:
an inertial measurement unit (IMU) comprising an accelerometer and a gyroscope, wherein the IMU is configured to detect chest and/or abdominal movement by a patient during the inspiration and expiration stages of a respiratory cycle, and to generate chest and/or abdominal positional data based on the detected movement; and
a stimulator comprising:
a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle; and
a controller coupled to the stimulation system, and to the IMU;
wherein the controller is
configured to determine a respiratory cycle of the patient by a) filtering the chest and/or abdominal positional data, and b) performing a principal component analysis (PCA) on the filtered chest and/or abdominal positional data, wherein the PCA comprises use of a covariance matrix generated using a rolling or stepped window of at least 4 seconds; and
configured to cause the stimulation system to stimulate the nerve based on the respiratory cycle of the patient.
29
1
30
1
31
1
32
11
33
2
34
12
35
13
36
14
37
17
38
22
39
22
40
22
41
22
42
25
43
24
44
24
45
13
46
16
47
17
Claims 28, 29, 32-39, 42-45, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11-22, 30, 31, and 38-46 of copending Application No. 18/184,405 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite systems and methods for treating obstructive sleep apnea comprising an inertial measurement unit comprising an accelerometer and a gyroscope, a stimulation system, and a controller configured to determine a respiratory cycle of the patient using principal component analysis and stimulate a nerve based on the respiratory cycle. A brief, but non-exhaustive matching of the pending claims and the issued claims is provided via the table below. The Examiner has expanded upon the analysis of independent claim 28 for clarity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 19/096,542
Pending Claims
U.S. Application No. 18/184,405
Reference Claims
28.
A system for treating obstructive sleep apnea, comprising: an inertial measurement unit (IMU) comprising an accelerometer and a gyroscope, wherein the IMU is configured to detect chest and/or abdominal movement by a patient during the inspiration and expiration stages of a respiratory cycle, and to generate chest and/or abdominal positional data based on the detected movement;
a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle; and
a controller coupled to the stimulation system, and to the IMU,
wherein the controller is configured to:
determine a respiratory cycle of the patient by: a) filtering the chest and/or abdominal positional data, and b) performing a principal component analysis (PCA) on the filtered chest and/or abdominal positional data; and
cause the stimulation system to stimulate the nerve based on the respiratory cycle of the patient.
1.
A system for treating obstructive sleep apnea, comprising:
a sensor comprising an inertial measurement unit (IMU) comprising an accelerometer, the sensor configured to detect chest and/or abdominal movement by a subject during the inspiration and expiration stages of a respiratory cycle, and to generate chest and/or abdominal positional and/or velocity data based on the detected movement; and
a stimulator comprising:
an implantable pulse generator ("IPG") configured to deliver stimulation to a nerve which innervates an upper airway muscle, wherein the sensor is within a housing of the IPG; and
a controller configured to cause the IPG to stimulate the nerve based on the positional and/or velocity data generated by the sensor.
11.
The system of claim 2, wherein the controller is configured to determine a respiratory cycle of the subject by:
a) filtering chest and/or abdominal movement data detected by the sensor; and
b) performing a principal component analysis (PCA) on the filtered chest and/or abdominal movement data.
29
12
32
12
33
1, 2
34
13
35
14
36
15
37
18
38
1, 11
39
12
42
12
43
13
44
14
45
15
47
18
Claims 30 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11-22, 30, 31, and 38-46 of copending Application No. 18/184,405 in view of Lawrence.
Regarding claims 30 and 40, the ‘405 application substantially recites the limitations of claims 29 and 39, but the ‘405 application does not explicitly recite wherein the covariance matrix is generated using a rolling or stepped window. However, Lawrence also describes the use of principal component analysis, including using a stepped window (col 4:6-11, col 5:22-28, claims 1, 3). As Lawrence is also directed towards using principal component analysis, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a stepped window similar to that described by Lawrence when using the system and method recited by the ‘405 application, as doing so advantageously allows the resulting system to use a more accurate representation of the patient’s data.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 46 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11-22, 30, 31, and 38-46 of copending Application No. 18/184,405 in view of Bolea.
Regarding claim 46, the ‘405 application substantially recites the limitations of claim 43, but the ‘405 application does not explicitly recite wherein the SNR is determined using historical positional data for the patient stored in a log. However, as Bolea describes the use of historical positional data for delivering stimulation ([0266], [0285], [0297], [0490]), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use similar historical positional data stored in a log for determining SNR, as doing so advantageously allows the resulting method to calculate a more accurate SNR value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kent et al. (US 2016/0106977 A1), which describes a system and method for treating obstructive sleep apnea including an internal measurement unit comprising an accelerometer ([0048]) and a stimulation system configured to deliver stimulation to a patient’s tongue ([0044]).
Dieken et al. (US 2020/0147376 A1), which describes a system and method for treating obstructive sleep apnea including an internal measurement unit comprising an accelerometer ([0158]) and a stimulation system configured to deliver stimulation to a nerve which innervates an upper airway muscle ([0104]).
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 3796
