DETAILED ACTION
This Office Action is in response to the communication dated 04 August 2026 concerning Application No. 8/778,217 filed on 19 July 2024.
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 34-54 are pending and currently under consideration for patentability; claims 34, 36, 38, 40, 44, 45, and 51 have been amended; claims 1-33 previously were cancelled.
Response to Arguments
Applicant’s arguments dated 04 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 a pulse generator electrically coupled to the at least one electrode. Applicant argues that the previously cited Mechlenburg reference “does not describe a pulse generator that directly produces bursts of electrical energy but rather a receiver coil and high capacitance electrode that transfers the magnetic energy provided by the coil into electrical energy” (Arguments, p. 7). The Examiner has addressed the amended limitations in the updated text of the rejection below. The Examiner also respectfully submits that the claims, as amended, merely recite “a pulse generator electrically coupled to the at least one electrode.” This is not the same as a pulse generator “that directly produces bursts of electrical energy.” Applicant is encouraged to amend the claims in future filings to recite a pulse generator configured to produce bursts of electrical energy, in order to differentiate Applicant’s pulse generator from other pulse generators that may produce mechanical or magnetic pulses, for example.
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 34-42 and 44-54 are rejected under 35 U.S.C. 103 as being unpatentable over Mechlenburg et al. (US 2001/0018547 A1) in view of Ternes et al. (US 2015/0283383 A1).
Regarding claim 34, Mechlenburg describes a therapy delivery system for improving sleep disordered breathing ([0011]: “a device for stimulating the muscles in the upper airway area for the treatment of OSA [obstructive sleep apnea]”) comprising
an injectable microstimulator ([0102]: “miniature implantable intramuscular stimulators 160 and 162 are provided in or near the patient’s muscles that are targeted for stimulation or near the nerves that contract such muscles…they can be implanted using a hypodermic, thereby minimizing the invasiveness of the implantation surgery”) comprising at least one electrode ([0103]: “intramuscular stimulators 160 and 162 include…high capacitance electrodes 166”) and configured to deliver an electrical signal to a target site and activate the sternothyroid muscle ([0040]: “the muscles targeted for stimulation are…the left and right sternothyroid muscles 46”; the Examiner respectfully submits that )
a controller in electrical communication with the injectable microstimulator and programmed to direct delivery of the electrical signal to the target site to activate the sternothyroid muscle to improve the sleep disordered breathing ([0032]: “control unit 32…creates a spacially varying electric field having a gradient that is maximized at specific muscles and/or muscle nerves in the upper airway…thereby relieving the obstructive sleep apnea”; [0103]: “receiver coil 164 and high capacitance electrode 166 transfer the magnetic energy provided by the coil into electrical energy that is applied directly to the muscle (or nerve) contacting the intramusculuar stimulator”)
Regarding claim 34, although Mechlenburg describes that the implantable microstimulator is configured to deliver an electrical signal ([0103]: “receiver coil 164 and high capacitance electrode 166 transfer the magnetic energy provided by the coil into electrical energy that is applied directly to the muscle (or nerve) contacting the intramusculuar stimulator”) (emphasis added), Mechlenburg does not explicitly disclose a pulse generator electrically coupled to the at least one electrode. Similarly, although Mechlenburg describes delivering an electrical signal to activate the sternothyroid muscle, which, physiologically, is “proximate to the ansa cervicalis” as recited, Mechlenburg does not explicitly disclose wherein the target site is proximate to the ansa cervicalis and the electrical signal is configured to stimulate the ansa cervicalis. However, Ternes also describes a therapy delivery system for improving sleep disordered breathing ([0006]: “methods and apparatus related to apnea therapy”), including a pulse generator electrically coupled to at least one electrode ([0027]; figure 2, stimulator circuitry 206 coupled to electrode(s) 204) and delivering an electrical signal to a target site proximate to the ansa cervicalis to stimulate the ansa cervicalis ([0024]: “other targets for OSA therapy include…ans cervicalis.” As Ternes is also directed towards sleep disordered breathing therapy 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 pulse generator and to target and stimulate the ansa cervicalis, as described by Ternes, when using the system described by Mechlenburg, as doing so advantageously allows the resulting system to stimulate a target that has a known beneficial effect for treating sleep disordered breathing.
Regarding claim 35, Mechlenburg describes wherein the injectable microstimulator is configured to deliver an electrical signal to a target site to activate the sternohyoid muscle ([0040]) and the controller is programmed to direct delivery of the electrical signal to the target site to activate the sternohyoid muscle ([0032], [0104]). Ternes describes wherein the target site is proximate to the ansa cervicalis and the electrical signal stimulates the ansa cervicalis ([0024]).
Regarding claims 36 and 37, Mechlenburg describes wherein the injectable microstimulator is configured to deliver an electrical signal to a target site to activate the omohyoid muscle ([0042]) and the controller is programmed to direct delivery of the electrical signal to the target site to activate the omohyoid muscle ([0032], [0104]). Ternes describes wherein the target site is proximate to the ansa cervicalis and the electrical signal stimulates the ansa cervicalis ([0024]).
Regarding claim 38, Ternes describes wherein the stimulator is configured to deliver an electrical signal to the hypoglossal nerve to stimulate the hypoglossal nerve ([0024]) and wherein the controller is programmed to direct delivery of the electrical signal to the hypoglossal nerve ([0024]). Mechlenburg describes activating the genioglossus muscle ([0042]).
Regarding claim 39, Mechlenburg describes wherein the at least one electrode is a plurality of electrodes ([0103]).
Regarding claim 40, Mechlenburg describes a sensor configured to sense a physiological parameter indicative of the presence, onset or extent of the sleep disordered breathing ([0032], [0034]).
Regarding claim 41, Mechlenburg describes wherein the controller is programmed to activate the injectable microstimulator in response to the sensed physiological parameter to improve the sleep disordered breathing ([0032]).
Regarding claim 42, Mechlenburg describes wherein the sensor is configured to detect a sleep disordered event and the controller is programmed to activate the injectable microstimulator to activate or pace respiration after detection of the sleep disordered breathing event ([0047], [0090]).
Regarding claim 44, Mechlenburg describes a power source external to the injectable microstimulator ([0033]).
Regarding claim 45, Mechlenburg describes a method of improving sleep disordered breathing in a patient suffering therefrom ([0011]) comprising
obtaining the system of claim 34 (please see limitations of claim 34 addressed above)
delivering the electrical signal to the target site to stimulate the nerves innervating the sternothyroid muscle ([0040])
activating the sternothyroid muscle ([0040])
improving the patient's sleep disorder breathing via delivery of the electrical signal ([0032], [0040])
Ternes describes
delivering the electrical signal to the target site proximate to the ansa cervicalis to stimulate the ansa cervicalis innervating the sternothyroid muscle ([0024])
Regarding claim 46, Mechlenburg describes delivering an electrical signal to a target site innervating the sternohyoid muscle ([0040]) and activating the sternohyoid muscle ([0032], [0104]). Ternes describes wherein the target site is proximate to the ansa cervicalis and delivering the electrical signal to stimulate the ansa cervicalis ([0024]).
Regarding claims 47 and 48, although Ternes describes targeting the ansa cervicalis, neither Mechlenburg nor Ternes explicitly disclose wherein the target site is proximal to or at the branch point of the superior root of the ansa cervicalis (claim 47) or proximal to the inferior root of the ansa cervicalis (claim 48). However, as both Mechlenburg and Ternes describe selecting a target site in order to stimulate a variety of airway muscles known to have effects on sleep disordered breathing (for example, Mechlenburg at [0040] - [0042] and Ternes at [0024], [0028]), 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 select a target site that is proximal to or at the branch point of the superior root of the ansa cervicalis or proximal to the inferior root of the ansa cervicalis, as recited, as doing so would be a matter of substituting one target site with another target site, both known to affect sleep disordered breathing, to obtain predictable results, and/or choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (please see MPEP 2143). Making such modifications would also be a matter of optimizing the prior art conditions (e.g., identifying a target site with a known effect on muscle activity and sleep disordered breathing) via routine experimentation (please see MPEP 2144.05).
Regarding claim 49, Mechlenburg describes wherein delivering an electrical signal to a target site innervating the omohyoid muscle ([0042]) and activating the omohyoid muscle ([0032], [0104]). Ternes describes wherein the target site is proximate to the ansa cervicalis ([0024]).
Regarding claims 50 and 51, Ternes describes delivering an electrical signal to at target site proximate to a hypoglossal nerve ([0024]), and Mechlenburg describes activating the genioglossus muscle ([0042]).
Regarding claims 52 and 53, although Ternes describes delivering an electrical signal to at target site proximate to a hypoglossal nerve, neither Mechlenburg nor Ternes explicitly disclose wherein the target site proximate to the hypoglossal nerve is distal to or at the branch point of the hypoglossal nerve and the superior root of the ansa cervicalis (claim 52) or distal to the branch point of the hypoglossal nerve innervating tongue retractor muscles (claim 53). However, as both Mechlenburg and Ternes describe selecting a target site in order to stimulate a variety of airway muscles known to have effects on sleep disordered breathing (for example, Mechlenburg at [0040] - [0042] and Ternes at [0024], [0028]), 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 select a target site that is distal to or at the branch point of the hypoglossal nerve and the superior root of the ansa cervicalis or distal to the branch point of the hypoglossal nerve innervating tongue retractor muscles, as recited, as doing so would be a matter of substituting one target site with another target site, both known to affect sleep disordered breathing, to obtain predictable results, and/or choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (please see MPEP 2143). Making such modifications would also be a matter of optimizing the prior art conditions (e.g., identifying a target site with a known effect on muscle activity and sleep disordered breathing) via routine experimentation (please see MPEP 2144.05).
Regarding claim 54, Mechlenburg describes wherein the sleep disordered breathing is sleep apnea ([0011]).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Mechlenburg in view of Ternes, further in view of Tyler et al. (US 2017/0368297 A1).
Regarding claim 43, Mechlenburg in view of Ternes suggests the system of claim 40, including wherein the sensor is configured to detect a patient’s sleep state (Mechlenburg: [0095]), but neither Mechlenburg nor Ternes explicitly discloses wherein the controller is programmed to adjust a duty cycle of the electrical signal after automatic detection of the patient’s sleep state. However, Tyler also describes a therapy delivery system for improving sleep disordered breathing ([0035]), including a controller programmed to adjust a duty cycle of an electrical signal after automatic detection of a patient’s sleep state ([0038]). As Tyler is also directed towards sleep disordered breathing therapy 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 dynamically modify the therapy based on the patient’s sleep state, in a manner similar to that described by Tyler, when using the system described by Mechlenburg and Ternes, as doing so advantageously allows the resulting system to modify the therapy parameters to meet the patient’s changing needs.
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
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