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 .
Response to Arguments
Applicant’s arguments filed 4/10/2026 with respect to the rejection of Independent Claims 1 and 12 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”) have been fully considered and are persuasive. Independent Claims 1 and 12 have been amended significantly to elaborate upon the configuration of the recited controller. The Examiner agrees that the combination of Bolea and Verzal does not teach such a configuration. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of US 2023/0201597 A1.
Applicant’s arguments regarding dependent Claims 2-11 and 13-22 are based on Applicant’s arguments regarding Claims 1 and 12. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of US 2023/0201597 A1.
Applicant’s arguments regarding the rejection of Claims 1 and 12, and Claims 2-11 and 13-22 by dependency, under 35 U.S.C. 112(a) as failing to comply with the written description requirement have been fully considered and are persuasive. Applicant’s amendments have resolved the cited written description issues. Therefore, the rejection has been withdrawn.
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.
Claim 1-10 and 12-22 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 20150224307 A1 to Bolea (“Bolea”) in view of US 2023/0201597 A1 to Haddock et al. (“Haddock”) and previously cited WO 2022/246320 A1 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 pers on 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, (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.
Bolea does not disclose:
the controller configured to: receive a set of initial stimulation settings for the first stimulation signal and a set of initial stimulation settings for the second stimulation signal to determine one or more predicted responses of the person given the first and second stimulation signals with the set of initial stimulation settings being applied to the person by using a trained machine learning model;
receive, after the first and second stimulation signals with the set of initial stimulation settings are delivered proximate to the first nerve location and the second nerve location, respectively, data corresponding to an actual response of the person to the delivery of the first and second stimulation signals with the set of initial stimulation settings;
compare the predicted response to the actual response;
refine the trained machine learning model based on the comparison;
determine, after refining the machine learning model, a set of predicted stimulation settings for the first stimulation signal and a set of predicted stimulation settings for the second stimulation signal by using the machine learning model to determine one or more predicted responses of the person given the first and second stimulation signals with the set of predicted stimulation settings being applied to the person;
and provide the set of predicted stimulation settings for the first stimulation signal and the set of predicted stimulation settings for the second stimulation signal to the stimulation signal generator.
Haddock describes “Methods and systems for providing stimulation to a patient's brain using one or more electrode leads implanted in the patient's brain…” using “[a] control algorithm … to maintain the network activation within a predetermined ranges” (Abstract). Haddock is reasonably pertinent to the problem faced by the inventor and is thus analogous art.
Haddock teaches:
the controller configured to: receive a set of initial stimulation settings for the first stimulation signal and a set of initial stimulation settings for the second stimulation signal to determine one or more predicted responses of the person given the first and second stimulation signals with the set of initial stimulation settings being applied to the person by using a trained … model; (Claim 1, “…use a network activation model to estimate a network activation value based on the extracted one or more EP features, wherein the network activation value is indicative of an underlying state of activity in the patient's brain, and use the network activation value to adjust the stimulation;” Claim 4, “…using the network activation model to predict a change in the EP features that will result from the adjustment of the stimulation, using the network activation model to predict new EP features based on the adjustment to the stimulation…;” Paras. [0109] through [0110]; Fig. 13);
receive, after the first and second stimulation signals with the set of initial stimulation settings are delivered proximate to the first nerve location and the second nerve location, respectively, data corresponding to an actual response of the person to the delivery of the first and second stimulation signals with the set of initial stimulation settings; (Claim 4, “recording new EPs following the adjustment to the stimulation, extracting one or more features of the recorded new EPs…;” Paras. [0109] through [0110]; Fig. 13);
compare the predicted response to the actual response; (Claim 4, “…comparing the extracted features of the recorded new EPs to the new EP features predicted by the activation model…;” Paras. [0109] through [0110]; Fig. 13);
refine the trained … model based on the comparison; (Claim 4, “…adjusting the network activation model based on the comparison;” Paras. [0109] through [0110]; Fig. 13);
determine, after refining the … model, a set of predicted stimulation settings for the first stimulation signal and a set of predicted stimulation settings for the second stimulation signal by using the… model to determine one or more predicted responses of the person given the first and second stimulation signals with the set of predicted stimulation settings being applied to the person; (Claim 1, “…use the network activation value to adjust the stimulation;” Paras. [0109] through [0110]; Fig. 13);
and provide the set of predicted stimulation settings for the first stimulation signal and the set of predicted stimulation settings for the second stimulation signal to the stimulation signal generator. (Claim 1, “…using stimulation circuitry of the IPG to cause a first one or more of the plurality of electrodes to provide electrical stimulation to the patient's brain…;” Paras. [0109] through [0110]; Fig. 13).
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 Haddock (i.e., to modify the device of Bolea such that its controller is configured to predict the result of a stimulation using a model, perform the stimulation to get an actual result, compare the predicted result to the actual result, refine model based on the comparison, predict stimulation parameters again, and provide the predicted parameters to the signal generator in the manner of Haddock for both of Bolea’s first and second stimulation signals) in order to efficiently obtain parameters that achieve desired effects without undesired side effects (Haddock at Para. [0010]).
The combination of Bolea and Haddock teaches a such “model” as claimed, but differs from the invention of Claim 1 in that its model is not a “machine learning” model. The combination of Bolea and Haddock thus does not disclose:
a “machine learning” model
Verzal describes “Multiple target stimulation therapy for sleep disordered breathing” (Title). Verzal is analogous art.
Verzal teaches:
a “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 combined Bolea and Haddock with the teachings of Verzal (i.e., to employ such a machine learning model as taught by Verzal as the model of combined Bolea and Haddock) in order to facilitate appropriate stimulation of a particular target based on known information.
Regarding Claim 2, the combination of Bolea, Haddock 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, Haddock and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
wherein each stimulation setting of the set of initial stimulation settings for the first and second stimulation signals and the set of predicted stimulation settings for the first and second stimulation signals 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, Haddock 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, Haddock 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 at least one of an apnea-hypopnea index (AHI), a posture change, a sleep stage, a sleepiness measure, a hypoxia burden level, a patient sleep quality measure, an oxygen desaturation index (ODI), or 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, Haddock and Verzal renders obvious the entirety of Claim 1 as explained above.
Bolea additionally teaches:
wherein the controller is configured to evaluate at least one of the first and second set of predicted stimulation settings for the first and second stimulation signals or the predicted response of the person 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, Haddock 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, Haddock 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, Haddock 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, Haddock 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.”);
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:
receiving, at a controller operatively coupled to the first implantable electrode and the second implantable electrode, a set of initial stimulation settings for the first stimulation signal and a set of initial stimulation settings for the second stimulation signal to determine one or more predicted responses of the person given the first and second stimulation signals with the set of initial stimulation settings being applied to the person using a trained … model;
receiving, after the first and second stimulation signals with the set of initial stimulation settings are delivered proximate to the first nerve location and the second nerve location, respectively, data corresponding to an actual response of the person to the delivery of the first and second stimulation signals with the set of initial stimulation settings;
comparing the predicted response to the actual response;
refining the trained … model based on the comparison;
determining, after refining the … model, a set of predicted stimulation settings for the first stimulation signal and a set of predicted stimulation settings for the second stimulation signal by using the … model to determine one or more predicted responses of the person given the first and second stimulation signals with the set of predicted stimulation settings being applied to the person;
providing the set of predicted stimulation settings for the first stimulation signal and the set of predicted stimulation settings for the second stimulation signal to a stimulation signal generator;
and delivering the first stimulation signal to the first implantable electrode and the second stimulation signal to the second implantable electrode according to set of predicted stimulation settings for the first and second stimulation signals,
Haddock describes “Methods and systems for providing stimulation to a patient's brain using one or more electrode leads implanted in the patient's brain…” using “[a] control algorithm … to maintain the network activation within a predetermined ranges” (Abstract). Haddock is reasonably pertinent to the problem faced by the inventor and is thus analogous art.
Haddock teaches:
receiving, at a controller operatively coupled to the first implantable electrode and the second implantable electrode, a set of initial stimulation settings for the first stimulation signal and a set of initial stimulation settings for the second stimulation signal to determine one or more predicted responses of the person given the first and second stimulation signals with the set of initial stimulation settings being applied to the person using a trained … model; (Claim 1; Claim 4; Paras. [0109] through [0110]; Fig. 13);
receiving, after the first and second stimulation signals with the set of initial stimulation settings are delivered proximate to the first nerve location and the second nerve location, respectively, data corresponding to an actual response of the person to the delivery of the first and second stimulation signals with the set of initial stimulation settings; (Claim 4; Paras. [0109] through [0110]; Fig. 13);
comparing the predicted response to the actual response; (Claim 4; Paras. [0109] through [0110]; Fig. 13);
refining the trained … model based on the comparison; (Claim 4; Paras. [0109] through [0110]; Fig. 13);
determining, after refining the … model, a set of predicted stimulation settings for the first stimulation signal and a set of predicted stimulation settings for the second stimulation signal by using the… model to determine one or more predicted responses of the person given the first and second stimulation signals with the set of predicted stimulation settings being applied to the person; (Claim 1; Paras. [0109] through [0110]; Fig. 13);
providing the set of predicted stimulation settings for the first stimulation signal and the set of predicted stimulation settings for the second stimulation signal to a stimulation signal generator; (Claim 1; Paras. [0109] through [0110]; Fig. 13);
and delivering the first stimulation signal to the first implantable electrode and the second stimulation signal to the second implantable electrode according to set of predicted stimulation settings for the first and second stimulation signals, (Claim 1; Paras. [0109] through [0110]; Fig. 13);
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 Haddock (i.e., to modify the method of Bolea such that it predicts the result of a stimulation using a model, performs the stimulation to get an actual result, compares the predicted result to the actual result, refines the model based on the comparison, predicts stimulation parameters again, and provides the predicted parameters to the signal generator in the manner of Haddock for both of Bolea’s first and second stimulation signals) in order to efficiently obtain parameters that achieve desired effects without undesired side effects (Haddock at Para. [0010]).
The combination of Bolea and Haddock teaches a such “model” as claimed, but differs from the invention of Claim 1 in that its model is not a “machine learning” model. The combination of Bolea and Haddock thus does not disclose:
a “machine learning” model
Verzal describes “Multiple target stimulation therapy for sleep disordered breathing” (Title). Verzal is analogous art.
Verzal teaches:
a “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 combined Bolea and Haddock with the teachings of Verzal (i.e., to employ such a machine learning model as taught by Verzal as the model of combined Bolea and Haddock) in order to facilitate appropriate stimulation of a particular target based on known information.
Regarding Claim 13, the combination of Bolea, Haddock 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, Haddock and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
wherein each stimulation setting of the set of initial stimulation settings for the first and second stimulation signals and the set of predicted stimulation settings for the first and second stimulation signals includes a stimulation parameter and a corresponding value for the stimulation parameter (Para. [0116]).
Regarding Claim 15, the combination of Bolea, Haddock and Verzal renders obvious the entirety of Claim 12 as explained above.
Bolea additionally teaches:
further comprising detecting one or more physiological parameters including at least one of an apnea-hypopnea index (AHI), a posture change, a sleep stage, a sleepiness measure, a hypoxia burden level, a patient sleep quality measure, an oxygen desaturation index (ODI), or a time of day (Para. [0147])
Regarding Claim 16, the combination of Bolea, Haddock and Verzal renders obvious the entirety of Claim 15 as explained above.
Bolea additionally teaches:
further comprising evaluating at least one of the set of predicted stimulation settings for the first and second stimulation signals or the predicted response of the person based at least in part on the one or more physiological parameters (Para. [0148])
Regarding Claim 17, the combination of Bolea, Haddock 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, Haddock 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, Haddock 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, Haddock 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, Haddock and Verzal renders obvious the entirety of Claim 1 as explained above.
Verzal additionally teaches
wherein the controller is further configured to coordinate the set of predicted stimulation settings for the first stimulation signal and the set of predicted stimulation settings for the second stimulation signal, wherein the coordinating further comprises: coordinating a first start time of a first stimulation cycle of the first stimulation signal in the set of predicted stimulation settings for the first stimulation signal and a second start time of a second stimulation cycle of the second stimulation signal in the set of predicted stimulation settings for the second stimulation signal (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, Haddock and Verzal with the teachings of Verzal Paras. [00515] through [00517] (i.e., to modify the device of combined Bolea, Haddock 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, Haddock and Verzal renders obvious the entirety of Claim 12 as explained above.
Verzal additionally teaches
wherein the controller is further configured to coordinate the set of predicted stimulation settings for the first stimulation signal and the set of predicted stimulation settings for the second stimulation signal, wherein the coordinating further comprises: coordinating a first stimulation amplitude of the first stimulation signal in the set of predicted stimulation settings for the first stimulation signal and a second stimulation amplitude of the second stimulation signal in the set of predicted stimulation settings for the second stimulation signal. (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 previously cited US 20150224307 A1 to Bolea (“Bolea”) in view of US 2023/0201597 A1 to Haddock et al. (“Haddock”) and previously cited 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, Haddock and Verzal renders obvious the entirety of Claim 10 as explained above.
The combination of Bolea, Haddock 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, Haddock and Verzal with the teachings of Scheiner (i.e., to modify the device of combined Bolea, Haddock 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
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.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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