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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/21/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 2/21/2025 with respect to the rejection of Independent Claim 1 under 35 USC 103 as unpatentable over U.S. 2022/0134101 A1 to Scheiner et al. (“Scheiner”) in view of US 2023/0146449 A1 to Muse et al. (“Muse”) have been fully considered and are persuasive. The Examiner agrees that the combination of Scheiner and Muse does not disclose "generate a first set of predicted stimulation settings for the first stimulation signal and a second set of predicted stimulation settings for the second stimulation signal using a trained machine learning model by at least generating a coordination mode for coordinating the first set of predicted stimulation settings and the second set of predicted stimulation settings," as recited in Claim 1 as amended. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20150224307 A1 and WO 2022/246320 A1.
Applicant’s arguments regarding Independent Claim 12 are similar to Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above with respect to Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20150224307 A1 and WO 2022/246320 A1.
Applicant’s arguments regarding dependent Claims 2-11 and 13-20 are based on Applicant’s arguments regarding Independent Claims 1 and 12. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above with respect to Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20150224307 A1 and WO 2022/246320 A1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 12, and Claims 2-11 and 13-22 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Independent Claim 1, Claim 1 recites “generating a coordination mode for coordinating the first set of predicted stimulation settings and the second set of predicted stimulation settings.” The Present Specification does not appear to support such “generating a coordination mode.” Applicant has not identified any particular portion of the Present Specification that supports such “generating a coordination mode.” Accordingly, the limitation “generating a coordination mode…” constitutes new matter.
The term “coordination mode” does not itself appear in the Present Specification. Most relevantly, Para. [0110] of the Present Specification states that “The first and second sets of stimulation settings are provided such that the first and second stimulation signals are coordinated in a way which may be different from the initial coordination. For example, the initial coordination can be in a first mode (e.g., the first mode in FIG. 4A), and the determined coordination can be in a second mode ((e.g., the second mode in FIG. 4B) different from the first mode.”). While the Present Specification does describe a “first mode” and a “second mode” by which the first and second sets of stimulation parameters are coordinated, this description does not align with the term “coordination mode” as used in Claim 1. The Present Specification does not describe any particular “coordination mode” based upon which parameters are determined. Instead, a manner of adjusting parameters is described which “may” result in a change in coordination.
Claim 1 requires a tangible “coordination mode” based upon which the “first set” and “second set” of predicted parameters are generated. This requirement is further evidenced by the limitation “provide … the coordination mode to the stimulation signal generator.” No such “coordination mode” is described in the Present Specification. Instead, a manner of adjusting parameters is described which “may” (vicariously) result in a change in coordination. Accordingly, the recited “coordination mode” constitutes new matter.
Regarding Independent Claim 12, Claim 12 recites a similar limitation to that explained above with respect to Claim 1. Claim 12 contains new matter for the same reasons as does Claim 1.
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.
Claims 1-10 and 12-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150224307 A1 to Bolea (“Bolea”) in view of WO 2022/246320 A11 to Verzal et al. (“Verzal”).
Regarding Independent Claim 1, Bolea teaches:
A system for managing obstructive sleep apnea for a person, the system comprising: (Title, “Systems and methods of detecting and treating obstructive sleep apnea”);
a first implantable electrode configured to deliver a first stimulation signal proximate to a first nerve location of the person to stimulate the first nerve location and activate or deactivate at least one muscle associated with an airway of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”);
a second implantable electrode configured to deliver a second stimulation signal proximate to a second nerve location of the person to stimulate the second nerve location and activate or deactivate at least one muscle associated with the airway of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”);
a stimulation signal generator configured to deliver the first stimulation signal to the first implantable electrode and the second stimulation signal to the second implantable electrode, (Para. [0012], “The method may also include commencing a first therapy of the nerve stimulation therapy. The first therapy may include an implantable nerve stimulator generating a series of first stimulation pulses configured for delivery to a hypoglossal nerve of the subject. … The method may also include transitioning from the first therapy to a second therapy of the nerve stimulation therapy. The second therapy may include the implantable nerve stimulator generating a series of second stimulation pulses configured for delivery to the hypoglossal nerve of the subject.”);
wherein the first stimulation signal and the second stimulation signal each include a series of stimulation cycles each including a stimulation period and a non-stimulation period; (Para. [0164], “Some exemplary stimulation patterns or algorithms can include an A-0-A-0 pattern, an A-B-A-B pattern, a A-B-0-A-B-0 pattern, and a variety of others. It is believed that the insertion of some non-stimulated breaths into sequences of stimulated breaths may help to trigger the patient's own physiological response to flow limitation;” Para. [0184]);
and a controller functionally connected to the stimulation signal generator to control operation of the stimulation signal generator, (Para. [0053], “With reference back to FIG. 1, the physician programmer 30 may comprise a computer 32 configured to control and program the INS 50 via a wireless link to a programming wand 34.”);
See Paras. [0043] through [0046] of the Present Specification in support of this interpretation.
the controller configured to: generate a first set of predicted stimulation settings for the first stimulation signal and a second set of predicted stimulation settings for the second stimulation signal … (Para. [0184], “In addition, the disclosed treatment system may be provided with an option to selectively activate or otherwise energize one or more desired electrode cuffs of a plurality of electrode cuffs, which may be implanted on differing upper airway nerves or on various portions/branches of a single upper airway nerve (e.g., the hypoglossal nerve);” Para. [0083]; Paras. [0111] through [0114] (quotation omitted for brevity));
Paras. [0111] through [0114] describe the use of sensor data to define parameters of a stimulation waveform. Such waveform definition via sensor data as described at Paras. [0111] through [0114] is “generat[ing] a .. set of predicted stimulation settings for the … stimulation signal.” Para. [0184] and Para. [0083] describe such “generating” for two implanted electrodes, the first of which being a “first set…” and the second of which being a “second set.”
by at least: generating a coordination mode for coordinating the first set of predicted stimulation settings and the second set of predicted stimulation settings; (Para. [0008], “The series of stimulation pulses may be coordinated with the breathing pattern;” Para. [0009], “ The generating of the series of stimulation pulses coordinated with the breathing pattern may include the generating of a first stimulation pulse during the plurality of respiratory cycles and the generating of a second stimulation pulse during the at least one respiratory cycle corresponding to the disordered breathing event;” Para. [0083]; Para. [0184]);
Bolea coordinates stimulation to breathing pattern, which breathing pattern is also the basis of Bolea’s waveform parameters (see Paras. [0111] through [0114]). Bolea’s coordination to breathing pattern is such a “coordination mode” as claimed.
and provide the first set of predicted stimulation settings, the second set of predicted stimulation settings, and the coordination mode to the stimulation signal generator (Claim 1, “…generating a series of stimulation pulses with an implantable nerve stimulator…, the series of stimulation pulses coordinated with the breathing pattern”)
Bolea does not disclose:
using a trained machine learning model
Verzal describes “Multiple target stimulation therapy for sleep disordered breathing” (Title). Verzal is analogous art.
Verzal teaches:
using a trained machine learning model (Para. [00814], “In some examples, the constructed data model comprises a trained data model, which optionally comprises a trained machine learning model.”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bolea with the teachings of Verzal (i.e., to employ such a machine learning model as taught by Verzal in the device of Bolea) in order to facilitate appropriate stimulation of a particular target based on known information.
Regarding Claim 2, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Verzal additionally teaches:
wherein the trained machine learning model is trained using historical stimulation settings and historical patient physiological parameters (Para. [00814]), “In some such examples, the method comprises at a first time period prior to the implementing the selecting of at least one stimulation target, constructing the data model via known inputs corresponding to all of the stimulation targets relative to known outputs corresponding to the first parameter. In some examples, the constructed data model comprises a trained data model, which optionally comprises a trained machine learning model.”).
Regarding Claim 3, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
wherein each stimulation setting of the first and second sets of predicted stimulation settings includes a stimulation parameter and a corresponding value for the stimulation parameter (Para. [0116], “Turning now to FIG. 14B, there is depicted an exemplary stimulation pulse waveform 5000 that may be emitted from an INS in accordance with the principles of the present disclosure. Typically, exemplary stimulation pulse waveform 5000 may include a square wave pulse train having one or more square wave pulses 5001 of approximately 1 to 3 volts in amplitude, a duration of approximately 100 ms, and a frequency of approximately 30 Hz, assuming a 1000 ohm impedance at the electrodes and a constant current or voltage.”).
Regarding Claim 4, the combination of Bolea and Verzal renders obvious the entirety of Claim 3 as explained above.
Bolea additionally teaches:
wherein the stimulation parameter includes one or more of an amplitude, a frequency, a pulse width, a rate of amplitude change, and a duty cycle (Para. [0116], “Turning now to FIG. 14B, there is depicted an exemplary stimulation pulse waveform 5000 that may be emitted from an INS in accordance with the principles of the present disclosure. Typically, exemplary stimulation pulse waveform 5000 may include a square wave pulse train having one or more square wave pulses 5001 of approximately 1 to 3 volts in amplitude, a duration of approximately 100 ms, and a frequency of approximately 30 Hz, assuming a 1000 ohm impedance at the electrodes and a constant current or voltage.”).
Regarding Claim 5, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
further comprising one or more sensors to detect one or more physiological parameters including an apnea-hypopnea index (AHI), a posture change, a sleep stage, a sleepiness measure, a hypoxia burden level, a patient sleep quality measure, and a time of day. (Para. [0147], “In an exemplary embodiment, patterns in the sensor signals, such as an impedance signal, can be used to identify sleep stage.”)
Regarding Claim 6, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
wherein the controller is configured to evaluate the first and second sets of predicted stimulation settings based at least in part on the one or more physiological parameters (Para. [0148], “In another exemplary embodiment, the sensor signal used to generate the respiratory waveform 5500, such as an impedance signal, can be used to detect the onset of sleep”).
Regarding Claim 7, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
wherein the first stimulation signal is to activate at least one first muscle for an upper airway dilation of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”);
Bolea stimulates “a hypoglossal nerve.” Stimulation of the hypoglossal nerve “activate[s] at least one first muscle for an upper airway dilation of the person” as claimed. See Para. [0078] of the Present Specification (“In some embodiments, the upper airway dual neurostimulation can avoid stimulating or activating the nerve/muscle location(s) including, for example, styloglossus, hyoglossus, and geniohyoid.”).
wherein the second stimulation signal is to activate at least one second muscle for a caudal tracheal traction for an upper airway of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the sternohyoid.”);
Bolea stimulates “an ansa cervicalis nerve” innvervating the sternohyoid. Such stimulation of an ansa cervicalis “activate[s] at least one second muscle for a caudal tracheal traction for an upper airway of the person” as claimed. See Para. [0037] of the Present Specification (“In some embodiments, the second stimulation signal is delivered to activate one or more infrahyoid muscles to descend a hyoid-thyroid complex, which results in a trachea caudal traction that stiffens the pharyngeal lateral wall and posterior wall inferiorly as indicated by arrow 124 of FIG. 1B for ansa cervicalis nerve stimulation (ACS).”); see also Scheiner at Para. [0064] (“The ansa cervicalis (AC) may also be stimulated with the contacts 158 from the lead 34 d. These contacts 158 may provide stimulation to the AC to assist in contracting or stiffening muscles (e.g., strap muscles) within the upper airway. The muscles innervated by ansa cervicalis are generally the sternohyoid, sternothyroid, and omohyoid muscles. The stimulation of the AC with the selected lead 34 d is the activation of these muscles to cause Caudal traction (i.e., stretching the airway) (ansa cervicalis) and intrinsic pharyngeal wall tone (glossopharyngeal nerve) mechanisms for upper airway support.”)
wherein the controller is further configured to: coordinate the delivery of the first stimulation signal with the delivery of the second stimulation signal. (Para. [0008], “The series of stimulation pulses may be coordinated with the breathing pattern;” Para. [0009], “ The generating of the series of stimulation pulses coordinated with the breathing pattern may include the generating of a first stimulation pulse during the plurality of respiratory cycles and the generating of a second stimulation pulse during the at least one respiratory cycle corresponding to the disordered breathing event;” Para. [0083]; Para. [0184]).
Regarding Claim 8, the combination of Bolea and Verzal renders obvious the entirety of Claim 10 as explained above.
Bolea additionally teaches:
wherein the first stimulation signal is to activate at least one first muscle for a caudal tracheal traction for an upper airway of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the sternohyoid.”);
Bolea stimulates “an ansa cervicalis nerve” innvervating the sternohyoid. Such stimulation of an ansa cervicalis “activate[s] at least one first muscle for a caudal tracheal traction for an upper airway of the person” as claimed. See Para. [0037] of the Present Specification (“In some embodiments, the second stimulation signal is delivered to activate one or more infrahyoid muscles to descend a hyoid-thyroid complex, which results in a trachea caudal traction that stiffens the pharyngeal lateral wall and posterior wall inferiorly as indicated by arrow 124 of FIG. 1B for ansa cervicalis nerve stimulation (ACS).”); see also Scheiner at Para. [0064] (“The ansa cervicalis (AC) may also be stimulated with the contacts 158 from the lead 34 d. These contacts 158 may provide stimulation to the AC to assist in contracting or stiffening muscles (e.g., strap muscles) within the upper airway. The muscles innervated by ansa cervicalis are generally the sternohyoid, sternothyroid, and omohyoid muscles. The stimulation of the AC with the selected lead 34 d is the activation of these muscles to cause Caudal traction (i.e., stretching the airway) (ansa cervicalis) and intrinsic pharyngeal wall tone (glossopharyngeal nerve) mechanisms for upper airway support.”)
wherein the second stimulation signal is to activate at least one second muscle for an upper airway dilation of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”);
Bolea stimulates “a hypoglossal nerve.” Stimulation of the hypoglossal nerve “activate[s] at least one second muscle for an upper airway dilation of the person” as claimed. See Para. [0078] of the Present Specification (“In some embodiments, the upper airway dual neurostimulation can avoid stimulating or activating the nerve/muscle location(s) including, for example, styloglossus, hyoglossus, and geniohyoid.”).
wherein the controller is further configured to: coordinate the delivery of the first stimulation signal with the delivery of the second stimulation signal (Para. [0008], “The series of stimulation pulses may be coordinated with the breathing pattern;” Para. [0009], “ The generating of the series of stimulation pulses coordinated with the breathing pattern may include the generating of a first stimulation pulse during the plurality of respiratory cycles and the generating of a second stimulation pulse during the at least one respiratory cycle corresponding to the disordered breathing event;” Para. [0083]; Para. [0184]).
Regarding Claim 9, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
wherein the first implantable electrode is configured to deliver the first stimulation signal proximate to a hypoglossal nerve to stimulate the hypoglossal nerve and activate at least one tongue muscle. (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”).
Regarding Claim 10, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
wherein the second implantable electrode is configured to deliver the second stimulation signal proximate to an ansa cervicalis nerve to stimulate the ansa cervicalis nerve and activate one or more infrahyoid muscles. (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”).
Regarding Independent Claim 12, Bolea teaches:
A method for managing obstructive sleep apnea for a person, the method comprising: (Title, “Systems and methods of detecting and treating obstructive sleep apnea”);
providing a first implantable electrode configured to deliver a first stimulation signal proximate to a first nerve location to stimulate the first nerve location and activate or deactivate at least one muscle associated with an air way of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”);
providing a second implantable electrode configured to deliver a second stimulation signal proximate to a second nerve location of the person to stimulate the second nerve location and activate or deactivate at least one muscle associated with the airway of the person; (Para. [0083], “Co-activating sites B+D involves implanting a first electrode on a hypoglossal nerve proximal of branches innervating the genioglossus muscle and the geniohyoid muscle, and distal of branches innervating the hyoglossus muscle and the styloglossus muscle; and implanting a second electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the stemohyoid.”);
generating a first set of predicted stimulation settings for the first stimulation signal and a second set of predicted stimulation settings for the second stimulation signal (Para. [0184], “In addition, the disclosed treatment system may be provided with an option to selectively activate or otherwise energize one or more desired electrode cuffs of a plurality of electrode cuffs, which may be implanted on differing upper airway nerves or on various portions/branches of a single upper airway nerve (e.g., the hypoglossal nerve);” Para. [0083]; Paras. [0111] through [0114] (quotation omitted for brevity));
Paras. [0111] through [0114] describe the use of sensor data to define parameters of a stimulation waveform. Such waveform definition via sensor data as described at Paras. [0111] through [0114] is “generat[ing] a .. set of predicted stimulation settings for the … stimulation signal.” Para. [0184] and Para. [0083] describe such “generating” for two implanted electrodes, the first of which being a “first set…” and the second of which being a “second set.”
by at least: generating a coordination mode for coordinating the first set of predicted stimulation settings and the second set of predicted stimulation settings; (Para. [0008], “The series of stimulation pulses may be coordinated with the breathing pattern;” Para. [0009], “ The generating of the series of stimulation pulses coordinated with the breathing pattern may include the generating of a first stimulation pulse during the plurality of respiratory cycles and the generating of a second stimulation pulse during the at least one respiratory cycle corresponding to the disordered breathing event;” Para. [0083]; Para. [0184]);
Bolea coordinates stimulation to breathing pattern, which breathing pattern is also the basis of Bolea’s waveform parameters (see Paras. [0111] through [0114]). Bolea’s coordination to breathing pattern is such a “coordination mode” as claimed.
providing the first set of predicted stimulation settings, the second set of predicted stimulation settings, and the coordination mode to a stimulation signal generator; (Claim 1, “…generating a series of stimulation pulses with an implantable nerve stimulator…, the series of stimulation pulses coordinated with the breathing pattern”)
and delivering the first stimulation signal to the first implantable electrode and the second stimulation signal to the second implantable electrode according to the coordination mode, (Para. [0105], “In use, a stimulation pulse may be first delivered to portion 2783 a to stimulate the large diameter fibers of a nerve. A subsequent stimulation pulse may be then delivered to portion 2783 b to stimulate the small diameter fibers of the nerve.”);
wherein each of the first stimulation signal and the second stimulation signal has a series of stimulation cycles each including a stimulation period and a non-stimulation period. (Para. [0164], “Some exemplary stimulation patterns or algorithms can include an A-0-A-0 pattern, an A-B-A-B pattern, a A-B-0-A-B-0 pattern, and a variety of others. It is believed that the insertion of some non-stimulated breaths into sequences of stimulated breaths may help to trigger the patient's own physiological response to flow limitation;” Para. [0184]);
Bolea does not disclose:
using a trained machine learning model
Verzal describes “Multiple target stimulation therapy for sleep disordered breathing” (Title). Verzal is analogous art.
Verzal teaches:
using a trained machine learning model (Para. [00814], “In some examples, the constructed data model comprises a trained data model, which optionally comprises a trained machine learning model.”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bolea with the teachings of Verzal (i.e., to employ such a machine learning model as taught by Verzal in the device of Bolea) in order to facilitate appropriate stimulation of a particular target based on known information.
Regarding Claim 13, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Verzal additionally teaches:
further comprising training a machine learning model using historical stimulation settings and historical patient physiological parameters to obtain the trained machine learning model (Para. [00814])
Regarding Claim 14, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
wherein each stimulation setting of the first and second sets of predicted stimulation settings includes a stimulation parameter and a corresponding value for the stimulation parameter (Para. [0116]).
Regarding Claim 15, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
further comprising detecting one or more physiological parameters including an apnea-hypopnea index (AHI), a posture change, a sleep stage, and a time of day (Para. [0147])
Regarding Claim 16, the combination of Bolea and Verzal renders obvious the entirety of Claim 15 as explained above.
Bolea additionally teaches:
further comprising evaluating the first and second sets of predicted stimulation settings based at least in part on the one or more physiological parameters (Para. [0148])
Regarding Claim 17, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
wherein: the first stimulation signal is to activate at least one first muscle for an upper airway dilation of the person, (Para. [0083]);
and the method further comprises: providing the second stimulation signal to activate at least one second muscle for a caudal tracheal traction for an upper airway of the person; (Para. [0083]);
and coordinating the delivery of the first stimulation signal with the delivery of the second stimulation signal. (Para. [0008]; Para. [0009]; Para. [0083]; Para. [0184]).
Regarding Claim 18, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
wherein: the first stimulation signal is to activate at least one first muscle for a caudal tracheal traction for an upper airway of the person; (Para. [0083]);
the method further comprises: providing the second stimulation signal to activate at least one second muscle for an upper airway dilation of the person; (Para. [0083]);
and coordinating the delivery of the first stimulation signal with the delivery of the second stimulation signal. (Para. [0008]; Para. [0009]; Para. [0083]; Para. [0184]).
Regarding Claim 19, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
wherein the first implantable electrode is configured to deliver the first stimulation signal proximate to a hypoglossal nerve to stimulate the hypoglossal nerve and activate at least one tongue muscle (Para. [0083]);
Regarding Claim 20, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
wherein the second implantable electrode is configured to deliver the second stimulation signal proximate to an ansa cervicalis nerve to stimulate the ansa cervicalis nerve and activate one or more infrahyoid muscles including sternothyroid and sternohyoid (Para. [0083])
Regarding Claim 21, the combination of Bolea and Verzal renders obvious the entirety of Claim 1 as explained above.
Verzal additionally teaches
wherein the coordinating the first set of predicted stimulation settings and the second set of predicted stimulation settings further comprises: coordinating a first start time of a first stimulation cycle of the first stimulation signal in the first set of predicted stimulation settings and a second start time of a second stimulation cycle of the second stimulation signal in the second set of predicted stimulation settings. (Paras. [00515] through [00517] (quotation omitted for brevity))
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Bolea and Verzal with the teachings of Verzal Paras. [00515] through [00517] (i.e., to modify the device of combined Bolea and Verzal such that the start time of its first and second stimulation cycles is coordinated in the manner of Verzal Paras. [00515] through [00517]) in order to “increase and/or maintain upper airway patency” (Verzal at Para. [00515]).
Regarding Claim 22, the combination of Bolea and Verzal renders obvious the entirety of Claim 12 as explained above.
Verzal additionally teaches
wherein the coordinating the first set of predicted stimulation settings and the second set of predicted stimulation settings further comprises:coordinating a first stimulation amplitude of the first stimulation signal in the first set of predicted stimulation settings and a second stimulation amplitude of the second stimulation signal in the second set of predicted stimulation settings (Paras. [00515] through [00517] (quotation omitted for brevity))
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of combined Bolea and Verzal with the teachings of Verzal Paras. [00515] through [00517] (i.e., to modify combined Bolea and Verzal such that the start time of its first and second stimulation cycles is coordinated in the manner of Verzal Paras. [00515] through [00517]) in order to “increase and/or maintain upper airway patency” (Verzal at Para. [00515])
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 20150224307 A1 to Bolea (“Bolea”) in view of WO 2022/246320 A1 to Verzal et al. (“Verzal”) as applied to Claim 1 above, and further in view of previously cited U.S. 2022/0134101 A1 to Scheiner et al. (“Scheiner”).
Regarding Claim 11, the combination of Bolea and Verzal renders obvious the entirety of Claim 10 as explained above.
The combination of Bolea and Verzal does not disclose:
wherein the second stimulation signal is further configured to activate sternothyroid and sternohyoid simultaneously
Scheiner describes “Sleep apnea therapy” (Title). Scheiner is analogous art.
Scheiner teaches:
wherein the second stimulation signal is further configured to activate sternothyroid and sternohyoid simultaneously (Para. [0064], “The ansa cervicalis (AC) may also be stimulated with the contacts 158 from the lead 34 d. These contacts 158 may provide stimulation to the AC to assist in contracting or stiffening muscles (e.g., strap muscles) within the upper airway. The muscles innervated by ansa cervicalis are generally the sternohyoid, sternothyroid, and omohyoid muscles. The stimulation of the AC with the selected lead 34 d is the activation of these muscles to cause Caudal traction (i.e., stretching the airway) (ansa cervicalis) and intrinsic pharyngeal wall tone (glossopharyngeal nerve) mechanisms for upper airway support.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Bolea and Verzal with the teachings of Scheiner (i.e., to modify the device of combined Bolea and Verzal such that its second stimulation signal is further configured to active the sternothyroid and sternohyoid simultaneously) in order to cause Caudal traction, a mechanism for upper airway support, which is effective in sleep apnea treatment (Scheiner at Para. [0064]).
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 WO 2022/246320 A1 is the PCT equivalent of US 2024/0252824 A1, which was disclosed by Applicant in the IDS filed 9/4/2024.