DETAILED ACTION
This Office Action is in response to the communication dated 06 August 2026 concerning Application No. 19/039,312 filed on 28 January 2025.
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 10-31 are pending and currently under consideration for patentability; claims 10, 26, and 28 have been amended; claims 1-9 have been cancelled; and claims 30-31 have been added as new claims.
Response to Arguments
Applicant’s arguments dated 06 August 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 that the stimulation element, the sensing element, and the pulse generator are each configured to be implanted in a head or neck region of the patient via a single implant-access incision. Applicant argues that the previously applied reference of Bolea does not disclose or suggest the amended claims. The Examiner has addressed the amended claims in the updated text of the rejection below and has not relied on Bolea for teaching or suggesting the amended limitations.
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 10-20 and 25-29 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Meadows et al. (US 2010/0241195 A1).
Regarding claim 10, Meadows describes a device for treating obstructive sleep apnea ([0035]: “a mastoid bone implant embodiment of an IPG for treating obstructive sleep apnea”) comprising
a sensing element configured to sense physiologic information ([0154]: “closed loop can use sensors and signals to initiate stimulation and to regulate its output so that a desired output function is obtained…triggers may be obtained using one or more internal sensors…included in the IPG”; [0160]: “in certain embodiments a sensor, which may be in the IPG implant…monitors a respiration indicator like air flow, for example…other indicators known to those skilled in the art may be used without departing from the scope of the invention”)
a stimulation element configured to stimulate an upper airway patency-related nerve ([0037]: “the embodiment shown can be implanted to stimulate the left, right, or both HGNs [hypoglossal nerves]”)
a pulse generator comprising a control portion configured to generate a stimulation signal applied via the stimulation element ([0029]: “an implantable neurostimulator system of the present invention includes an implantable pulse generator system (IPG); and at least one electrode operatively connected to the IPG to generate accurate, selective nerve stimulation patterns”; [0047]: “the architecture of the IPG electronics may include a microcontroller…to generate the stimulus pulses”)
wherein the stimulation element, the sensing element, and the pulse generator are each configured to be implantable, via a first implant-access incision ([0037]) in a head-and-neck region of a patient ([0035]: “a mastoid bone implant embodiment of an IPG for treating obstructive sleep apnea…the mastoid bone implant 100 is implanted into the mastoid…the mastoid bone bed is close to the HGN, and provides a stable well-protected location for the mastoid bone implant”)
Regarding claim 11, Meadows describes wherein the stimulation element comprises at least one stimulation electrode and a first lead supporting the at least one stimulation electrode ([0037], [0053] - [0054]).
Regarding claim 12, Meadows describes wherein the pulse generator is connected to the first lead (figure 1A).
Regarding claim 13, Meadows describes wherein the sensing element comprises at least one sensor and a second lead supporting the at least one sensor ([0053] - [0054]; [0154] - [0155]).
Regarding claim 14, Meadows describes wherein the pulse generator is connected to the second lead (figure 1A; [0154]).
Regarding claim 15, Meadows describes wherein the sensed physiologic information comprises respiratory phase information ([0160]).
Regarding claim 16, Meadows describes wherein the respiratory phase information comprises inspiratory phase information and/or expiratory phase information ([0160]; the Examiner respectfully submits that inspiratory and expiratory phase information are components of “air flow”).
Regarding claim 17, Meadows describes wherein the control portion is configured to generate the stimulation signal in an open loop mode without synchronizing stimulation to the sensed respiratory phase information ([0144], [0154]).
Regarding claim 18, Meadows describes wherein the control portion is configured to generate the stimulation signal in a closed loop manner by synchronizing stimulation to at least a portion of the sensed respiratory phase information ([0154]).
Regarding claim 19, Meadows describes wherein the sensing element comprises an accelerometer ([0155]).
Regarding claim 20, Meadows describes wherein the sensed physiologic information comprises sleep disordered breathing behavior information ([0158], [0160]), and wherein the control portion is configured to cause initiation, termination, and/or adjustment of the stimulation to treat obstructive sleep apnea based on the SDB behavior information ([0160]).
Regarding claim 25, Meadows describes wherein the upper airway patency-related nerve comprises a hypoglossal nerve ([0037]).
Regarding claim 26, Meadows describes a device for treating obstructive sleep apnea ([0035]: “a mastoid bone implant embodiment of an IPG for treating obstructive sleep apnea”) comprising
a sensing element configured to sense physiologic information including respiratory information ([0154]: “closed loop can use sensors and signals to initiate stimulation and to regulate its output so that a desired output function is obtained…triggers may be obtained using one or more internal sensors…included in the IPG”), the respiratory information comprising inspiratory phase information and expiratory phase information ([0160]: “in certain embodiments a sensor, which may be in the IPG implant…monitors a respiration indicator like air flow, for example…other indicators known to those skilled in the art may be used without departing from the scope of the invention”; the Examiner respectfully submits that inspiratory and expiratory phase information are components of “air flow”)
a stimulation element configured to stimulate an upper airway patency-related nerve ([0037]: “the embodiment shown can be implanted to stimulate the left, right, or both HGNs [hypoglossal nerves]”)
a pulse generator comprising a control portion configured to generate a stimulation signal applied via the stimulation element ([0029]: “an implantable neurostimulator system of the present invention includes an implantable pulse generator system (IPG); and at least one electrode operatively connected to the IPG to generate accurate, selective nerve stimulation patterns”; [0047]: “the architecture of the IPG electronics may include a microcontroller…to generate the stimulus pulses”)
a lead extending outwardly from a housing of the pulse generator to support the stimulation element in a spaced apart position relative to the housing ([0037]: “HGN lead and electrode”; [0053] - [0054])
wherein the stimulation element, the sensing element, the pulse generator, and the lead are each configured to be implantable in a head-and-neck region of a patient ([0035]: “a mastoid bone implant embodiment of an IPG for treating obstructive sleep apnea…the mastoid bone implant 100 is implanted into the mastoid…the mastoid bone bed is close to the HGN, and provides a stable well-protected location for the mastoid bone implant”)
Regarding claim 27, Meadows describes wherein the sensing element is configured to be implanted at a first implant location in the head-and-neck region of the patient and the stimulation element is configured to be implanted at a second implant location in the head-and-neck region of the patient spaced apart from the first implant location ([0037], figure 1A).
Regarding claim 28, Meadows describes a device for treating obstructive sleep apnea ([0035]: “a mastoid bone implant embodiment of an IPG for treating obstructive sleep apnea”) comprising
a sensing element configured to sense physiologic information ([0154]: “closed loop can use sensors and signals to initiate stimulation and to regulate its output so that a desired output function is obtained…triggers may be obtained using one or more internal sensors…included in the IPG”; [0160]: “in certain embodiments a sensor, which may be in the IPG implant…monitors a respiration indicator like air flow, for example…other indicators known to those skilled in the art may be used without departing from the scope of the invention”)
a stimulation element configured to stimulate an upper airway patency-related nerve ([0037]: “the embodiment shown can be implanted to stimulate the left, right, or both HGNs [hypoglossal nerves]”)
a pulse generator comprising a control portion configured to generate a stimulation signal applied via the stimulation element ([0029]: “an implantable neurostimulator system of the present invention includes an implantable pulse generator system (IPG); and at least one electrode operatively connected to the IPG to generate accurate, selective nerve stimulation patterns”; [0047]: “the architecture of the IPG electronics may include a microcontroller…to generate the stimulus pulses”)
a first lead connecting the pulse generator to the stimulation element ([0037]: “HGN lead and electrode”; [0053] - [0054])
a second lead connecting the pulse generator to the sensing element ([0053] - [0054]; [0154] - [0155])
wherein the stimulation element, the sensing element, the pulse generator, the first lead, and the second lead are each configured to be implantable in a head-and-neck region of a patient ([0035]: “a mastoid bone implant embodiment of an IPG for treating obstructive sleep apnea…the mastoid bone implant 100 is implanted into the mastoid…the mastoid bone bed is close to the HGN, and provides a stable well-protected location for the mastoid bone implant”)
Regarding claim 29, Meadows describes wherein the sensing element is configured to be implanted at a first implant location in the head-and-neck region of the patient and the stimulation element is configured to be implanted at a second implant location in the head-and-neck region of the patient spaced apart from the first implant location ([0037], figure 1A).
Regarding claim 30, Meadows describes wherein the first implant-access incision is the sole implant-access incision by which the stimulation element, the sensing element, and the pulse generator are implanted ([0035], [0037], Meadows does not mention more than one implantation site).
Regarding claim 31, Meadows describes wherein the accelerometer forms a portion of the pulse generator ([0155]).
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 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Meadows in view of Dieken et al. (WO 2017/184753 A1).
Regarding claim 21, Meadows describes the device of claim 20 but does not explicitly disclose wherein the SDB behavior information comprises sleep quality information. However, Dieken also describes a device for treating obstructive sleep apnea ([0039]), including evaluating sleep quality information ([0110], [0126]). As Dieken 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 evaluate sleep quality information, in a manner similar to that described by Dieken, when using the device described by Meadows, as doing so advantageously allows the resulting device to evaluate the effectiveness of the therapy and modify parameters if necessary to ensure the patient gets optimal sleep.
Regarding claim 22, Dieken describes wherein the sleep quality information comprises an apnea-hypopnea index ([0126]).
Regarding claim 23, Meadows describes the device of claim 10 but does not explicitly disclose wherein the sensed physiologic information comprises posture information and wherein the control portion is configured to sense an awake state or a sleep state of the patient based on the posture information. However, Dieken also describes a device for treating obstructive sleep apnea ([0039]), including sensing physiologic information in the form of posture information and using a control program configured to sense an awake state or a sleep state of a patient based on the posture information ([0110], [0126]). As Dieken 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 measure posture information and deduce a patient’s sleep state, in a manner similar to that described by Dieken, when using the device described by Meadows, as doing so advantageously allows the resulting device to modify the stimulation settings based on the patient’s sleep state.
Regarding claim 24, Dieken describes wherein the control portion is configured to adjust a stimulation therapy level based on the sensed awake state or sleep state ([0195], [0217]).
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, 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
Prosecution Insights