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 .
Priority
The current application claims benefit of provisional application No. 63607444, filed on December 6th, 2023. Examiner acknowledges the applicant’s claim for priority.
Claim Objections
Claim 19 reads “a nerve of patient” and should read “a nerve of a patient”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-18 and 23-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolea at al. (US20160089540).
Regarding claim 1, Bolea teaches a method of treating obstructive sleep apnea in a patient, the method comprising: ([00654]” the hypoglossal nerve stimulation system 100 is intended to treat obstructive sleep apnea (OSA) by increasing neuromuscular activity of the genioglossus muscle via stimulation of the hypoglossal nerve”) measuring, with a plurality of electrodes, thoracic impedance of the patient; ([0151] “ring electrodes for sensing bio-impedance” and [0152] “the respiratory/trans-thoracic impedance sensing circuit of the present disclosure may be preferred” where bio-impedance is thoracic impedance) and stimulating, with a nerve stimulation device implanted in the patient, a nerve of the patient based on the thoracic impedance, ([0656] “respiration via the respiration sensing lead 1200 using bio-impedance and stimulates the hypoglossal nerve via the stimulation lead 1300 synchronous with inspiration”) wherein the nerve is associated with sleep apnea. ([0707] “providing hypoglossal nerve stimulation therapy to a patient for the treatment of obstructive sleep apnea”)
Regarding claim 23, Bolea teaches a nerve stimulation device configured to treat obstructive sleep apnea in a patient, the nerve stimulation device comprising: ([00654]” the hypoglossal nerve stimulation system 100 is intended to treat obstructive sleep apnea (OSA) by increasing neuromuscular activity of the genioglossus muscle via stimulation of the hypoglossal nerve”) a housing ([0453] “a hermetically sealed housing”); a processor in the housing ([0459] “The INS circuit 1130 utilizes a microprocessor to control telemetry communications with the programmer system 2100, operating the sensing circuits to monitor respiration via the RSLs 1200”); a non-volatile memory device in the housing ([0459] “microprocessor contains built-in support circuits (RAM, Flash Memory”); a controller in the housing ([0459] “The INS circuit 1130 utilizes a microprocessor to control telemetry communications with the programmer system”); a power supply in the housing ([0452] “a hermetically sealed housing 1120 for containing the associated electronics 1130 and battery 1140”); and a plurality of electrodes coupled to the housing, ([0461] “Electrode switching circuits (one for each RSL 1200) allows the INS 1100 to monitor one of several different vectors from the two separate 4 electrode RSLs 1200. The INS housing 1120 may also be used as both an excitation and sensing electrode”) wherein the non-volatile memory device comprises computer-readable instructions which, when executed by the controller ([0491] “predictive algorithm is contained in software and executed by a microprocessor resident in the INS circuitry”), cause the plurality of electrodes to measure thoracic impedance of the patient ([0152] “the respiratory/trans-thoracic impedance sensing circuit of the present disclosure may be preferred”) and to deliver electrical stimulation to a nerve of the patient based on the thoracic impedance, ([0656] “respiration via the respiration sensing lead 1200 using bio-impedance and stimulates the hypoglossal nerve via the stimulation lead 1300 synchronous with inspiration”) wherein the nerve is associated with sleep apnea. ([0707] “providing hypoglossal nerve stimulation therapy to a patient for the treatment of obstructive sleep apnea”)
Regarding claim 2, Bolea teaches all of the limitations of claim 1. Bolea also teaches wherein the nerve is a hypoglossal nerve of the patient. ([0159-0160] “nerve and/or direct muscle stimulation sites are shown for stimulating muscles… of the right and left hypoglossal nerve”)
Regarding claim 3, Bolea teaches all of the limitations of claim 1. Bolea also teaches wherein the nerve is an ansa cervicalis nerve of the patient. ([0159-1060] “nerve and/or direct muscle stimulation sites are shown for stimulating muscles… innervated by the ansa cervicalis nerve”)
Regarding claim 4, Bolea teaches all of the limitations of claim 1. Regarding claim 25, Bolea teaches all of the limitations of claim 23.Bolea also teaches wherein the stimulating the nerve is performed in response to a value of the thoracic impedance indicating the patient started to inhale or is about to inhale. ([0491] “an algorithm is used to predict respiratory period and determine the start of the stimulation burst … a respiratory period is determined by calculating the time between peaks in the bio-impedance signal”)
Regarding claim 5, Bolea teaches all of the limitations of claim 1. Regarding claim 26, Bolea teaches all of the limitations of claim 23 using a controller. Bolea also teaches wirelessly transmitting the thoracic impedance from the plurality of electrodes to the nerve stimulation device. ([0150] “respiratory sensor(s) may be internal/implanted or external, and may be connected to the neurostimulator via a wired or wireless link”)
Regarding claim 6, Bolea teaches all of the limitations of claim 5. Regarding claim 27, Bolea teaches all of the limitations of claim 26. Bolea also teaches wherein the plurality of electrodes is attached to the patient’s chest. ([0440] “The bifurcated RSL 1200 design enables RSL 1200 to sense bio-impedance on… each side of the patient's chest,”)
Regarding claim 7, Bolea teaches all of the limitations of claim 5. Regarding claim 27, Bolea teaches all of the limitations of claim 26. Bolea also teaches wherein the plurality of electrodes is attached to the patient’s abdomen. ([Fig. 51C] and [0365] “respiratory sensor(s) 916/918 may be integrated into the ENS 920 and attached to a conventional respiratory belt 922 to measure respiratory effort about the abdomen and/or chest”)
Regarding claim 8, Bolea teaches all of the limitations of claim 1. Regarding claim 28, Bolea teaches all of the limitations of claim 23. Bolea wherein the plurality of electrodes is implanted in the patient. ([0155] “stimulation lead (not shown) may be implanted in a subcutaneous tunnel”)
Regarding claim 9, Bolea teaches all of the limitations of claim 1. Regarding claim 29, Bolea teaches all of the limitations of claim 23. Bolea also teaches wherein the plurality of electrodes comprises a first electrode on a housing of an implantable pulse generator of the nerve stimulation device and a second electrode coupled to the nerve stimulation device and connected to the housing by a first lead. ([0461] “Electrode switching circuits (one for each RSL 1200) allows the INS 1100 to monitor one of several different vectors from the two separate 4 electrode RSLs 1200. The INS housing 1120 may also be used as both an excitation and sensing electrode”)
Regarding claim 10, Bolea teaches all of the limitations of claim 8. Bolea also teaches wherein the stimulating is performed with the second electrode. ([0478] “The INS 1100 generates the stimulation output for delivery to the hypoglossal nerve by way of the STL 1300.”)
Regarding claim 11, Bolea teaches all of the limitations of claim 9. Regarding claim 32 and 30, Bolea teaches all of the limitations of claim 23. Bolea also teaches wherein the stimulating is performed with a third electrode coupled to the housing of the nerve stimulation device by a second lead separate from the first lead. ([0461] “Electrode switching circuits (one for each RSL 1200) allows the INS 1100 to monitor one of several different vectors from the two separate 4 electrode RSLs 1200. The INS housing 1120 may also be used as both an excitation and sensing electrode”)
Regarding claim 12, Bolea teaches all of the limitations of claim 9. Regarding claim 31, Bolea teaches all of the limitations of claim 23. Bolea also teaches wherein the stimulating is performed with a third electrode coupled to the housing of the nerve stimulation device by the first lead. ([0461] “Electrode switching circuits (one for each RSL 1200) allows the INS 1100 to monitor one of several different vectors from the two separate 4 electrode RSLs 1200. The INS housing 1120 may also be used as both an excitation and sensing electrode”)
Regarding claim 13, Bolea teaches all of the limitations of claim 1. Bolea also teaches wherein the measuring comprises measuring trans-thoracic impedance of the patient. ([0152] “that facilitate connection of the of the respiratory/trans-thoracic impedance sensing circuits of the present disclosure (discussed in greater detail below) to stimulation lead 60 for measuring the impedance of lead 60.”)
Regarding claim 14, Bolea teaches wherein the measuring comprises measuring intra-thoracic impedance of the patient. ([0150] “the respiratory sensor(s) may be internal/implanted… The respiratory sensor(s) may measure… lung impedance, respiratory drive, upper airway EMG, changes in tissue impedance in and around the lung(s)”)
Regarding claim 15, Bolea teaches all of the limitations of claim 1. Regarding claim 17, Bolea teaches all of the limitations of claim 1. Bolea also teaches further comprising measuring, with an inertial measurement unit of the nerve stimulation device, movement of the patient’s chest. ([0485] “The INS 1100 circuitry may contain a three-axis accelerometer 1150 that can be used to determine the patient's body position”)
Regarding claim 16, Bolea teaches all of the limitations of claim 15. Bolea also teaches wherein the stimulating is further based on the movement of the patient’s chest. ([0487] “When a motion event is determined, stimulation may be turned off or turned down until motion stops”)
Regarding claim 18, Bolea teaches all of the limitations of claim 17. Bolea also teaches further comprising titrating stimulation parameters of the nerve stimulation device based on the motion of the patient’s chest. ([0487] “When a motion event is determined, stimulation may be turned off or turned down until motion stops”)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea at al. (US20160089540) in view of Verzal et al. (WO2022246320).
Regarding claim 19, Bolea teaches a method of treating obstructive sleep apnea in a patient, the method comprising: ([0707] “a method of providing hypoglossal nerve stimulation therapy to a patient for the treatment of obstructive sleep apnea”) measuring, with at least one bioimpedance electrode, bioimpedance of tissue; stimulating, with a nerve stimulation device implanted in the patient, a nerve of patient based on the bioimpedance, ([0656] “respiration via the respiration sensing lead 1200 using bio-impedance and stimulates the hypoglossal nerve via the stimulation lead 1300 synchronous with inspiration”) wherein the nerve is associated with sleep apnea. ([0707] “providing hypoglossal nerve stimulation therapy to a patient for the treatment of obstructive sleep apnea”)
Regarding claim 19, Bolea does not explicitly teach, as taught by Verzal bioimpedance of tissue at a back of the patient’s throat ([Fig. 14B] the IPG 533 may be used for sensing impedance in combination with sensing elements such as electrodes implanted in the head-and-neck region 520). Verzal and Bolea both tackle sleep apnea treatment through localized nerve stimulation. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bolea to explicitly integrate sensors into the nerve stimulator in the neck region, as taught and suggested by Versal, with a reasonable expectation of success. Bolea would include this “to better tailor the stimulation therapy to the particular anatomical features” [00887].
Regarding claim 22, Bolea-Verzal as a combination teaches all of the limitations of claim 19. Regarding claim 25, Bolea-Verzal as a combination teaches all of the limitations of claim 23. Bolea also teaches wherein the stimulating the nerve is performed in response to a value of the thoracic impedance indicating the patient started to inhale or is about to inhale. ([0491] “an algorithm is used to predict respiratory period and determine the start of the stimulation burst … a respiratory period is determined by calculating the time between peaks in the bio-impedance signal”)
Regarding claim 20, Bolea-Verzal as a combination teaches all of the limitations of claim 19. Bolea also teaches wherein the nerve is a hypoglossal nerve of the patient. ([0159] “nerve and/or direct muscle stimulation sites are shown for stimulating muscles… of the right and left hypoglossal nerve”)
Regarding claim 21, Bolea-Verzal as a combination teaches all of the limitations of claim 19. Bolea also teaches wherein the nerve is an ansa cervicalis nerve of the patient. ([0159] “nerve and/or direct muscle stimulation sites are shown for stimulating muscles… innervated by the ansa cervicalis nerve”)
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kapnisakis et al. (WO2004112606) discloses detecting sleep apnea using bioimpedance measurements including the steps applying a set of electrodes to a patient to obtain a trans-cervical bioimpedance signal from the patient.
Bolea et al. (US20120010532) discloses an implanted pulse generator sends stimulation through a lead to a cuff electrode placed on or near the hypoglossal nerve, which helps move the tongue forward. A second implanted or external sensing system monitors breathing so the stimulation can be timed to the breathing cycle.
Boggs Jr at al. (US20110093032) stimulates afferent airway-related nerves to trigger a natural upper-airway dilator reflex, which then activates airway-opening muscles and helps prevent airway collapse.
Makansi et al (US20110099032) combines a wearable magnetic field generator with a tiny injectable receiver placed near the hypoglossal nerve so stimulation can be delivered wirelessly and more precisely.
Scheiner et al. (US20220134101) uses one IMD with multiple channels/leads to stimulate different airway- and breathing-related targets based on the apnea mechanism being treated
Ni et al. (US20110202119) disclosure teaches using trial stimulation and response feedback to choose the best vein, site, and settings for therapy
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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