DETAILED ACTION
This Office Action is in response to the communication dated 10 July 2026 concerning Application No. 18/392,491 filed on 21 December 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 22-49 are pending and currently under consideration for patentability; claims 22, 37, and 41 have been amended; claims 1-21 previously were cancelled; claim 49 has been added as a new claim.
Response to Arguments
Applicant’s arguments dated 10 July 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 characterizing an increase in the volume of the airway produced by motion of an upper airway muscle. Applicant argues that the previously presented reference of Boggs does not disclose such a feature. The Examiner has addressed the amended language in the updated text of the rejection 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 22-48 are rejected under 35 U.S.C. 103 as being unpatentable over Boggs et al. (US 2011/0093032 A1) in view of Papay (US 2017/0296815 A1).
Independent Claims
Regarding claims 22, 37, and 41, Boggs describes a method of treating a patient having an airway with a reduced volume during sleep with a neuromodulation system at least partially implanted in the patient ([0039]), the method comprising:
titrating stimulation energy ([0069], [0081]) to be delivered to at least one target nerve or target muscle using an electrode of the neuromodulation system ([0039]), wherein titrating the stimulation energy comprises
delivering the stimulation energy with an initial parameter to the at least one target nerve or target muscle using the electrode of the neuromodulation system ([0054], initial evaluation; [0057], determining optimum stimulation parameters)
obtaining evoked electromyography data using a sensor of the neuromodulation system, the eEMG data characterizing activity of an upper airway muscle associated with patency of the airway in response to the stimulation energy ([0054])
based on eEMG data, characterizing an increase in a volume of the airway in response to the stimulation energy ([0054], the increase in volume of the airway is characterized by an increase in airway patency; figures 16-19)
based on the increase in the volume of the airway, determining a therapeutic parameter of the stimulation energy, the therapeutic parameter being associated with a desired increase in the volume of the airway in response to the stimulation energy ([0057], [0094], determining optimum stimulation parameters based on the measured airway patency)
while the patient is asleep, delivering the stimulation energy with the therapeutic parameter to the at least one target nerve or target muscle using the neuromodulation system to produce the desired increase in the volume of the airway, thereby improving airflow through the airway ([0106], performing overnight trial while the patient is sleeping; [0053])
Regarding claim 37 in particular, Boggs describes an electrode configured to be implanted proximate to at least one target nerve or target muscle of the patient ([0039]), a sensor configured to be implanted proximate an airway muscle associated with patency of the airway ([0041], [0054]), and a computing device comprising a non-transitory memory storing instructions and a processor configured to access the non-transitory memory and execute the instructions ([0159] - [0160]).
Regarding claim 41 in particular, Boggs describes comparing the eEMG data to reference data associated with a desired volume of the airway ([0040], restoring airway patency, which would require comparing airway patency to a previous state; [0043]).
Regarding claims 22, 37, and 41, although Boggs characterizes an increase in airway volume, Boggs does not explicitly disclose characterizing an increase in a volume of the airway produced by a motion of the upper airway muscle in response to the stimulation energy. However, Papay also describes a system and method for treating sleep disordered breathing ([0004]), including characterizing an increase in a volume of the airway produced by a motion of an upper airway muscle in response to a stimulation energy ([0076]: “where the sensing component 52 is an EMG electrode, for example, the activity of one or more muscles of the anterior lingual musculature (e.g., a genioglossus muscle or a suprahyoid muscle) can be detected”; [0077]: “therapy signal(s) from the neuromuscular stimulator 16 can be delivered…to displace the posterior base of the tongue in an anterior direction (and/or change the surface morphology of the posterior tongue base to allow and increase oropharyngeal airway volume…the therapy signal(s) can be relayed to the electrode 24 to achieve selective muscle activation; that is, targeted activation of less than all of the muscles comprising the anterior lingual musculature”). As Papay is also directed towards treating sleep disordered breathing 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 monitoring the volume of the upper airway, in a manner similar to that described by Papay, when using the method described by Boggs, as doing so advantageously allows the resulting method to adjust the therapy based on the patient’s airway response.
Dependent Claims
Regarding claims 23, 38, and 42, Boggs describes wherein the therapeutic parameter is different from the initial parameter (claims 14-18, adjusting stimulation parameters; [0057], determining optimum stimulation parameters).
Regarding claims 24, 39, and 43, Boggs describes wherein the initial parameter and the therapeutic parameter each comprise at least one of an amplitude of the stimulation energy, a pulse width of the stimulation energy, a frequency of the stimulation energy, or a waveform shape of the stimulation energy ([0126], [0161]).
Regarding claim 25, Boggs describes wherein the initial parameter and the therapeutic parameter each comprise a location of the electrode relative to the at least one target nerve or target muscle ([0098, [0101]).
Regarding claims 26, 40, and 44, Boggs describes wherein the electrode comprises a plurality of electrodes ([0039], [0043]), and wherein the initial parameter and the therapeutic parameter each comprise a configuration of the plurality of electrodes ([0039], [0134]).
Regarding claim 27, Boggs describes wherein determining the therapeutic parameter comprises evaluating an amplitude of the eEMG data (figures 10-13).
Regarding claims 28 and 45, Boggs describes wherein titrating the stimulation energy is controlled through a software application on a computing device ([0160]).
Regarding claims 29 and 46, Boggs describes wherein the computing device is remote from the patient ([0160]).
Regarding claims 30 and 47, Papay describes wherein characterizing the increase in the volume of the airway is performed automatically by the software application ([0078]).
Regarding claims 31 and 48, Papay describes wherein, after delivering the stimulation energy with the therapeutic parameter to the at least one target nerve or target muscle while the patient is asleep, re-titrating the stimulation energy ([0078], the treatment modality is continually titrated).
Regarding claim 32, Boggs describes wherein the upper airway muscle is an anterior lingual muscle ([0051]).
Regarding claim 33, Boggs describes wherein the upper airway muscle is a genioglossus muscle ([0051]).
Regarding claim 34, Boggs describes wherein the target muscle is the upper airway muscle ([0051]).
Regarding claim 35, Boggs describes wherein the target nerve is a hypoglossal nerve ([0051]).
Regarding claim 36, Boggs describes wherein the electrode and sensor are the same structure ([0105]).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs in view of Papay, further in view of Cho et al. (US 2004/0138719 A1).
Regarding claim 49, Boggs in view of Papay suggests the method of claim 22, but neither Boggs nor Papay explicitly disclose, while the patient is asleep, monitoring physiological data indicative of respiration with the sensor, and wherein delivering the stimulation energy with the therapeutic parameter comprises delivering the stimulation energy in response to the physiological data on a breath-by-breath basis. However, Cho also describes a method of treating sleep disordered breathing ([0012]), including monitoring physiological data indicative of respiration with a sensor and delivering stimulation energy in response to the physiological data on a breath-by-breath basis ([0044], [0060]). As Cho is also directed towards treating sleep disordered breathing 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 monitor the patient on a breath-by-breath basis, similar to that described by Cho, when using the method described by Boggs and Papay, as doing so advantageously allows the resulting method to adjust the therapy based on the patient’s response.
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