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 Preliminary Amendment This Office Action is responsive to the amendment filed on 11 Mar 2024. As directed by the amendment: no claims have been amended, claim 1 has been canceled, and claims 2-25 have been added. Thus, claims 2-25 are presently pending in this application. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 2-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “ near a first cranial nerve target ” in claims 2 (line 13), 19 (line 6), and 23 (line 8) is a relative term which renders the claim indefinite. The term “ near ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to how far away the neurostimulation therapy signal is to be provided from the first cranial nerve target. For the purposes of examination, “or near” in claims 2, 19, and 23 will be omitted. Claims 3-18, 20-22, and 24-25 are also rejected because they are dependent on claims 2, 19, and 23. Claim 10 recites “to update one or more characteristics of the neurostimulation therapy signal” (lines 2-3). It is unclear as to whether “one or more characteristics of the neurostimulation therapy signal” are included in the “characteristics of the neurostimulation therapy signal” recited in claim 2 (line 9). For the purposes of examination, the “one or more characteristics” will be interpreted as “ one or more of the characteristics of the neurostimulation therapy signal” established in claim 1. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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 . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 2-5, 8, 13-17, 19, 22-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach (US Publication No. 2013/0085558). Regarding claim 2, Mashiach discloses a system (paragraph [0051], implant unit 110) comprising: an implantable neuromodulation device housing (Figs. 4-5, paragraph [0052], flexible carrier 161) configured for implantation in an anterior cervical region of a patient (Fig. 2, paragraph [0051], "implant unit 110 may be configured to be implanted for modulation of a nerve associated with a muscle of the subject's tongue 130"; paragraph [0095], "a neuromodulator implanted in a subcutaneous location in a patient's neck"; Fig. 12, paragraph [0133], "implant unit 110...may be configured for implantation through derma (i.e. skin) on an underside of a subject's chin"; paragraph [0134], "implant unit 110 is located proximate to the medial terminal fibers 1054"; paragraph [0138]); a power storage circuit disposed inside the device housing (paragraph [0119], "onboard power source"; paragraph [0120], "implant unit 110 may be self-sufficient, including its own power source"); a first physiologic status sensor coupled to a processor circuit (paragraph [0115], "Processor 144 may be configured to determine or derive various physiologic data"; paragraph [0119], "Such a processor may also be configured to monitor various sensors associated with the implant unit"; paragraph [0120], "the processor of implant unit 110 could be configured to monitor conditions in the body of a subject (via one or more sensors or other means)"); a signal generator circuit disposed inside the device housing (Figs. 4 and 6, paragraph [0056], "circuitry 180...may be mounted on or integrated with flexible carrier 161"; paragraphs [0056], [0064]-[0065], [0101]-[0102], [0104]) and configured to use power from the power storage circuit to generate a neurostimulation therapy signal (paragraph [0085], "circuitry 180 of implant unit 110 may include components having a maximum operating voltage or power level that may contribute to a practical threshold energy limit of implant unit 110"; paragraph [0087], "implant unit 110 may be constructed with circuitry 180 specifically chosen to generate signals at the electrodes of at least the lower power threshold"), wherein characteristics of the neurostimulation therapy signal are based on instructions received from the processor circuit (paragraph [0116], "processor 144 may select parameters for a particular modulation control signal or series of modulation control signals for addressing a specific condition relating to the determined physiologic data"; paragraph [0121], "In response to the received physiological signal, the at least one processor may send a control signal, such as a closed loop control signal, to the implanted circuit"; paragraphs [0115]-[0116], [0118], [0125], [0128]); and a first electrode lead coupled to the signal generator circuit (Figs. 3-6, 10A-C, 11-13, paragraphs [0054]-[0057], electrodes 158a and 158b), wherein the first electrode lead includes a therapy delivery electrode configured to provide the neurostimulation therapy signal at or near a first cranial nerve target in the patient (paragraph [0132], cranial nerve XII/hypoglossal nerve; paragraph [0051], "any nerve of the peripheral nervous system (both spinal and cranial)"; paragraph [0054], "implant electrodes 158a and 158b may be configured for implantation into the body of a subject in the vicinity of one or more nerves"; paragraphs [0073]-[0076]). Mashiach further discloses that the device housing is configured to be implanted in any locations or orientations within an anterior cervical region of a patient (housing 110 implanted anterior cervical region of a patient 100, Fig. 1; see 1070, Fig. 12 and 161, Fig. 13; paragraphs [0039], [0133]-[0134], [0138]), at or under a mandible of the patient (sub-mandibular region, paragraphs [0039], [0133]-[0134], [0138]; Claim 1), in any locations or orientations within one or more cervical triangle regions (implant locations of Figs. 12, 13, and 15; paragraphs [0039], [0133]-[0134], [0138]; Claim 1). Mashiach does not explicitly disclose that the device housing is configured for implantation in an anterior cervical region of a patient between a mylohyoid muscle of the patient and a digastric muscle of the patient. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the implant to be located in any of these anterior cervical regions of the patient, including between a mylohyoid muscle and a digastric muscle that bound respective portions of the anterior cervical region of the patient, since Mashiach discloses any of multiple suitable submandibular regions within a variety of cervical triangle regions as described in detail above in order to target specific nerve locations to treat the breathing disorders or sleep apnea, since such a modification would have involved a mere change in the form or shape of the implant components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Furthermore, it is noted that there are no limitations in the system that structurally limits the implantable neuromodulation device housing to be implanted in this particular region. The location of implantation of the implantable neuromodulation device housing is considered to be intended use. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Regarding claim 3, the system of claim 2 is obvious over Mashiach, as explained above. Mashiach further discloses that the processor circuit is configured to update one or more characteristics of the neurostimulation therapy signal based on information received from the first physiological status sensor (paragraph [0116], "processor 144 may select parameters for a particular modulation control signal or series of modulation control signals for addressing a specific condition relating to the determined physiologic data"; paragraphs [0109]-[0114], [0128]). Regarding claim 4, the system of claim 3 is obvious over Mashiach, as explained above. Mashiach further discloses that the one or more characteristics of the neurostimulation therapy signal include a pulse amplitude, pulse duration, waveform morphology, frequency, or signal burst pattern of the neurostimulation therapy signal (paragraphs [0096]-[0097]). Regarding claim 5, the system of claim 3 is obvious over Mashiach, as explained above. Mashiach further discloses that the first physiological status sensor is an electrical activity sensor (paragraph [0094], "detected level of neural activity in a sensory neuron"; paragraph [0128], level of brain activity). Regarding claim 8, the system of claim 5 is obvious over Mashiach, as explained above. Mashiach further discloses that the electrical activity sensor is configured to sense electroneurogram information about the patient (paragraph [0094], "a detected level of neural activity in a sensory neuron"). Regarding claim 13, the system of claim 3 is obvious over Mashiach, as explained above. Mashiach further discloses that the first physiologic status sensor is an implantable pressure sensor (paragraph [0095], "signals from an implant indicative of blood pressure"; paragraph [0122], blood pressure). Regarding claim 14, the system of claim 3 is obvious over Mashiach, as explained above. Mashiach further discloses that the neurostimulation therapy signal is configured to treat obstructive sleep apnea (OSA) (paragraphs [0034], [0037], [0039], [0093], [0126]), hypertension (paragraphs [0034], [0037], [0051], [0095], [0131], [0143]-[0144]), epilepsy (paragraph [0035]), depression (paragraph [0035]), craniofacial pain syndrome (paragraphs [0037], [0051], [0094], [0131], [0140]-[0141]), and migraine headaches (paragraphs [0034],[0037], [0051], [0094]). Regarding claim 15, the system of claim 2 is obvious over Mashiach, as explained above. Mashiach further discloses that the instructions from the processor circuit to the signal generator circuit are based at least in part on physiologic status information about the patient received using the first physiologic status sensor (paragraph [0116], "processor 144 may select parameters for a particular modulation control signal or series of modulation control signals for addressing a specific condition relating to the determined physiologic data"; paragraph [0121], "In response to the received physiological signal, the at least one processor may send a control signal, such as a closed loop control signal, to the implanted circuit"; paragraphs [0109]-[0114], [0128]). Regarding claim 16, the system of claim 15 is obvious over Mashiach, as explained above. Mashiach further discloses that the physiological status information includes information about a respiration (paragraphs [0091], [0098], [0106], [0126], [0128]), heart rate (paragraph [0128], pulse), blood pressure (paragraphs [0095], [0122], [0128]), neural activation (paragraph [0094], "detected level of neural activity in a sensory neuron"; paragraph [0128], level of brain activity), or muscular activation (paragraph [0115], "Monitoring the degree of coupling can also provide such physiologic data as whether a patient's tongue is moving or vibrating ( e.g , whether the patient is snoring)", tongue movement can be indicative of muscular activation or the tongue) of the patient. Regarding claim 17, the system of claim 16 is obvious over Mashiach, as explained above. Mashiach further discloses that the physiological status information includes information about respiration of the patient (paragraphs [0091], [0098], [0106], [0126], [0128]), and that the neurostimulation therapy signal is configured to treat a breathing disorder or a sleep disorder of the patient (paragraphs [0034], [0037], [0039], [0093], [0126], [0128]). Regarding claim 19, Mashiach discloses a method comprising: providing an implantable neurostimulation device housing in an anterior cervical region of a patient between a mylohyoid muscle of the patient and a digastric muscle of the patient; providing a first electrode lead, coupled to a portion of the device housing and to a signal generator circuit inside the device housing (Figs. 4 and 6, paragraph [0056], "circuitry 180...may be mounted on or integrated with flexible carrier 161"; paragraphs [0056], [0064]-[0065], [0101]-[0102], [0104]) and configured to use power from the power storage circuit to generate a neurostimulation therapy signal (paragraph [0085], "circuitry 180 of implant unit 110 may include components having a maximum operating voltage or power level that may contribute to a practical threshold energy limit of implant unit 110"; paragraph [0087], "implant unit 110 may be constructed with circuitry 180 specifically chosen to generate signals at the electrodes of at least the lower power threshold"), at or near a first cranial nerve target in the patient (paragraph [0037], "implant unit 110 may be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve", wherein the signal generator circuit is coupled to power storage circuitry that is inside the device housing (paragraph [0119], "onboard power source"; paragraph [0120], "implant unit 110 may be self-sufficient, including its own power source"); using at least one sensor, sensing a physiologic status-indicating signal from the patient (paragraph [0115], "Processor 144 may be configured to determine or derive various physiologic data"; paragraph [0119], "Such a processor may also be configured to monitor various sensors associated with the implant unit"; paragraph [0120], "the processor of implant unit 110 could be configured to monitor conditions in the body of a subject (via one or more sensors or other means)"; and in response to information from the physiologic-status indicating signal, providing first electrical signals to the first cranial nerve target using the signal generator circuit and an electrode (Figs. 3-6, 10A-C, 11-13, paragraphs [0054]-[0057], electrodes 158a and 158b) of the first electrode lead (paragraph [0116], "processor 144 may select parameters for a particular modulation control signal or series of modulation control signals for addressing a specific condition relating to the determined physiologic data"; paragraph [0121], "In response to the received physiological signal, the at least one processor may send a control signal, such as a closed loop control signal, to the implanted circuit"; paragraphs [0115]-[0116], [0118], [0125], [0128]). Mashiach further discloses that the device housing is configured to be implanted in any locations or orientations within an anterior cervical region of a patient (housing 110 implanted anterior cervical region of a patient 100, Fig. 1; see 1070, Fig. 12 and 161, Fig. 13; paragraphs [0039], [0133]-[0134], [0138]), at or under a mandible of the patient (sub-mandibular region, paragraphs [0039], [0133]-[0134], [0138]; Claim 1), in any locations or orientations within one or more cervical triangle regions (implant locations of Figs. 12, 13, and 15; paragraphs [0039], [0133]-[0134], [0138]; Claim 1). Mashiach does not explicitly disclose that the device housing is configured for implantation in an anterior cervical region of a patient between a mylohyoid muscle of the patient and a digastric muscle of the patient. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the implant to be located in any of these anterior cervical regions of the patient, including between a mylohyoid muscle and a digastric muscle that bound respective portions of the anterior cervical region of the patient, since Mashiach discloses any of multiple suitable submandibular regions within a variety of cervical triangle regions as described in detail above in order to target specific nerve locations to treat the breathing disorders or sleep apnea, since such a modification would have involved a mere change in the form or shape of the implant components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Regarding claim 22, the method of claim 19 is obvious over Mashiach, as explained above. Mashiach further discloses that the one or more characteristics of the neurostimulation therapy signal include a pulse amplitude, pulse duration, waveform morphology, frequency, or signal burst pattern of the neurostimulation therapy signal (paragraphs [0096]-[0097]). Regarding claim 23, Mashiach discloses an implantable neurostimulation device (paragraph [0051], implant unit 110) comprising: an implantable neuromodulation device housing (Figs. 4-5, paragraph [0052], flexible carrier 161) configured for implantation in an anterior cervical region of a patient (Fig. 2, paragraph [0051], "implant unit 110 may be configured to be implanted for modulation of a nerve associated with a muscle of the subject's tongue 130"; paragraph [0095], "a neuromodulator implanted in a subcutaneous location in a patient's neck"; Fig. 12, paragraph [0133], "implant unit 110...may be configured for implantation through derma (i.e. skin) on an underside of a subject's chin"; paragraph [0134], "implant unit 110 is located proximate to the medial terminal fibers 1054"; paragraph [0138]); a power storage circuit disposed inside the device housing (paragraph [0119], "onboard power source"; paragraph [0120], "implant unit 110 may be self-sufficient, including its own power source"); a signal generator circuit disposed inside the device housing (Figs. 4 and 6, paragraph [0056], "circuitry 180...may be mounted on or integrated with flexible carrier 161"; paragraphs [0056], [0064]-[0065], [0101]-[0102], [0104]) and configured to use power from the power storage circuit to generate a neurostimulation therapy signal (paragraph [0085], "circuitry 180 of implant unit 110 may include components having a maximum operating voltage or power level that may contribute to a practical threshold energy limit of implant unit 110"; paragraph [0087], "implant unit 110 may be constructed with circuitry 180 specifically chosen to generate signals at the electrodes of at least the lower power threshold"); a first implantable lead comprising a first electrode (Figs. 3-6, 10A-C, 11-13, paragraphs [0054]-[0057], electrodes 158a and 158b), wherein the first electrode is configured for implantation at or near a first cranial nerve target (paragraph [0132], cranial nerve XII/hypoglossal nerve; paragraph [0051], "any nerve of the peripheral nervous system (both spinal and cranial)"; paragraph [0054], "implant electrodes 158a and 158b may be configured for implantation into the body of a subject in the vicinity of one or more nerves"; paragraphs [0073]-[0076]), and wherein the first electrode is configured to receive the neurostimulation therapy signal from the signal generator circuit (paragraph [0064], "circuitry 180 connecting secondary antenna 152 with implant electrodes 158a and 158b"; paragraph [0065]); one or more sensors configured to sense a physiologic status-indicating signal from the patient (paragraph [0115], "various physiologic data based on the determined degree of coupling between primary antenna 150 and secondary antenna 152"; ; and a processor circuit configured to use information from the one or more sensors (paragraph [0115], "Processor 144 may be configured to determine or derive various physiologic data"; paragraph [0119], "Such a processor may also be configured to monitor various sensors associated with the implant unit"; paragraph [0120], "the processor of implant unit 110 could be configured to monitor conditions in the body of a subject (via one or more sensors or other means)") to control the signal generator circuit to generate the neurostimulation therapy signal (paragraph [0116], "processor 144 may select parameters for a particular modulation control signal or series of modulation control signals for addressing a specific condition relating to the determined physiologic data"; paragraph [0121], "In response to the received physiological signal, the at least one processor may send a control signal, such as a closed loop control signal, to the implanted circuit"; paragraphs [0115]-[0116], [0118], [0125], [0128]). Mashiach further discloses that the device housing is configured to be implanted in any locations or orientations within an anterior cervical region of a patient (housing 110 implanted anterior cervical region of a patient 100, Fig. 1; see 1070, Fig. 12 and 161, Fig. 13; paragraphs [0039], [0133]-[0134], [0138]), at or under a mandible of the patient (sub-mandibular region, paragraphs [0039], [0133]-[0134], [0138]; Claim 1), in any locations or orientations within one or more cervical triangle regions (implant locations of Figs. 12, 13, and 15; paragraphs [0039], [0133]-[0134], [0138]; Claim 1). Mashiach does not explicitly disclose that the device housing is configured for implantation in an anterior cervical region of a patient between a mylohyoid muscle of the patient and a digastric muscle of the patient. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the implant to be located in any of these anterior cervical regions of the patient, including between a mylohyoid muscle and a digastric muscle that bound respective portions of the anterior cervical region of the patient, since Mashiach discloses any of multiple suitable submandibular regions within a variety of cervical triangle regions as described in detail above in order to target specific nerve locations to treat the breathing disorders or sleep apnea, since such a modification would have involved a mere change in the form or shape of the implant components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Furthermore, it is noted that there are no limitations in the system that structurally limits the implantable neuromodulation device housing to be implanted in this particular region. The location of implantation of the implantable neuromodulation device housing is considered to be intended use. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Regarding claim 25, the implantable neurostimulation device of claim 23 is obvious over Mashiach, as explained above. Mashiach further discloses that the one or more sensors comprises a pressure sensor (paragraph [0095], "signals from an implant indicative of blood pressure"; paragraph [0122], blood pressure). Claims 6, 9-10, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach (US Publication No. 2013/0085558) in view of Bolea et al. (US Publication No. 2008/0103545), hereinafter Bolea . Regarding claim 6, the system of claim 5 is obvious over Mashiach, as explained above. Mashiach does not explicitly disclose that the electrical activity sensor is configured to sense impedance information about the patient. However, Bolea teaches an implantable system for neuromodulation of cranial nerves (Fig. 1, paragraph [0047], neurostimulator system 10; paragraphs [0082], [0093]) comprising an electrical activity sensor that is configured to sense impedance information about the patient (Fig. 1, respiration sensors 74, paragraphs [0053], [0056], [0070]-[0075]). 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 modify Mashiach with the teachings of Bolea so that the electrical activity sensor is configured to sense impedance information about the patient, because doing so allows the device to effectively monitor physiological parameters such as activity level or motion in order to selectively apply stimulation for closed-loop therapy such as to optimize treatment based on periods such as sleep/wake periods ( Bolea , paragraphs [0056]-[0057], [0224]). Regarding claim 9, the system of claim 3 is obvious over Mashiach, as explained above. Although Mashiach further discloses a physiologic status sensor that is configured to sense movement, vibration, position, or orientation information about the patient (paragraphs [0091]-[0093], [0098]-[0099], [0107], [0110]-[0126]), Mashiach does not explicitly disclose that the first physiologic status sensor is an implantable sensor that includes an accelerometer or a gyroscope. However, Bolea teaches an implantable system for neuromodulation of cranial nerves (Fig. 1, paragraph [0047], neurostimulator system 10; paragraphs [0082], [0093]) comprising a physiologic status sensor that is an implantable sensor that includes an accelerometer that is configured to sense movement, vibration, position or orientation information about the patient (paragraphs [0056]-[0057]). 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 modify Mashiach with the teachings of Bolea so that the first physiologic status sensor is an implantable sensor that includes an accelerometer or a gyroscope that is configured to sense movement, vibration, position, or orientation information about the patient, because doing so allows the device to effectively monitor physiological parameters such as activity level or motion in order to selectively apply stimulation for closed-loop therapy such as to optimize treatment based on periods such as sleep/wake periods ( Bolea , paragraphs [0056]-[0057], [0224]). Regarding claim 10, the system of claim 9 is obvious over Mashiach and Bolea , as explained above. Mashiach further discloses a second physiologic status sensor (paragraph [0120], "processor of implant unit 110 could be configured to monitor conditions in the body of a subject (via one or more sensors or other means)"), wherein the processor circuit is configured to update the one or more characteristics of the neurostimulation therapy signal based on information received from the second physiologic status sensor (paragraph [0116], "processor 144 may select parameters for a particular modulation control signal or series of modulation control signals for addressing a specific condition relating to the determined physiologic data"; paragraphs [0109]-[0114], [0128]). Mashiach does not explicitly disclose that the one or more characteristics of the neurostimulation therapy signal are based on information received from the accelerometer or gyroscope. However, Bolea further teaches that the one or more characteristics of the neurostimulation therapy signal are based on information received from the accelerometer or gyroscope (paragraph [0057], "the one or more characteristics of the neurostimulation therapy signal are based on information received from the accelerometer or gyroscope"). Regarding claim 21, the method of claim 19 is obvious over Mashiach, as explained above. Mashiach does not explicitly disclose that sensing the physiologic status-indicating signal from the patient includes sensing an impedance characteristic or electrical activity information about the patient using the electrode of the first electrode lead or using a different second electrode. However, Bolea teaches an implantable system for neuromodulation of cranial nerves (Fig. 1, paragraph [0047], neurostimulator system 10; paragraphs [0082], [0093]) wherein sensing the physiologic status-indicating signal from the patient includes sensing an impedance characteristic or electrical activity information about the patient using the electrode of the first electrode lead or using a different second electrode (Fig. 1, respiration sensors 74, paragraphs [0053], [0056], [0070]-[0075]). 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 modify Mashiach with the teachings of Bolea so that sensing the physiologic status-indicating signal from the patient includes sensing an impedance characteristic or electrical activity information about the patient using the electrode of the first electrode lead or using a different second electrode, because doing so allows the device to effectively monitor physiological parameters such as activity level or motion in order to selectively apply stimulation for closed-loop therapy such as to optimize treatment based on periods such as sleep/wake periods ( Bolea , paragraphs [0056]-[0057], [0224]). Regarding claim 24, the implantable neurostimulation device of claim 23 is obvious over Mashiach, as explained above. Mashiach further discloses that the first electrical signals are configured to treat a breathing disorder or a sleep disorder of the patient (paragraphs [0034], [0037], [0039], [0093], [0126], [0128]). Although Mashiach further discloses a physiologic status sensor that is configured to sense motion information about the patient (paragraphs [0091]-[0093], [0098]-[0099], [0107], [0110]-[0126]), Mashiach does not explicitly disclose that the first physiologic status sensor is an implantable sensor that includes an accelerometer or a gyroscope. However, Bolea teaches an implantable system for neuromodulation of cranial nerves (Fig. 1, paragraph [0047], neurostimulator system 10; paragraphs [0082], [0093]) comprising a physiologic status sensor that is an implantable sensor that includes an accelerometer that is configured to sense movement, vibration, position or orientation information about the patient (paragraphs [0056]-[0057]). 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 modify Mashiach with the teachings of Bolea so that the one or more sensors comprises an accelerometer configured to sense motion information about the patient, because doing so allows the device to effectively monitor physiological parameters such as activity level or motion in order to selectively apply stimulation for closed-loop therapy such as to optimize treatment based on periods such as sleep/wake periods ( Bolea , paragraphs [0056]-[0057], [0224]). Claims 7, 11, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach (US Publication No. 2013/0085558) in view of Toong et al. (US 20200129762 A1), hereinafter Toong . Regarding claim 7, the system of claim 5 is obvious over Mashiach, as explained above. Mashiach does not explicitly disclose that the electrical activity sensor comprises an electrode of the first electrode lead. However, Toong teaches a method for detecting and treating sleep apnea (paragraph [0040]) wherein an electrode of a first electrode lead both senses electrical activity and provides stimulation (paragraphs [0052], [0086]). 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 modify Mashiach with the teachings of Toong so that the electrical activity sensor comprises an electrode of the first electrode lead, because doing so allows the device to detect and then reduce the number of apnea or hypopnea episodes during sleep, thereby improving the sleep architecture of individuals with obstructive sleep apnea (OSA) or obstructive sleep hypopnea (Toong, paragraph [0231]). Regarding claim 11, the system of claim 3 is obvious over Mashiach, as explained above. Mashiach does not explicitly disclose that the first physiologic status sensor is an implantable chemical sensor configured to measure information about one or more chemicals inside the patient. However, Toong teaches a method for detecting and treating sleep apnea (paragraph [0040]) wherein an implantable chemical sensor is configured to measure information about one or more chemicals inside the patient (paragraphs [0068], [0112], [0142]-[0143], [0201], [0204]). 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 modify Mashiach with the teachings of Toong so that the first physiologic status sensor is an implantable chemical sensor configured to measure information about one or more chemicals inside the patient, because doing so allows the device to detect and then reduce the number of apnea or hypopnea episodes during sleep, thereby improving the sleep architecture of individuals with obstructive sleep apnea (OSA) or obstructive sleep hypopnea (Toong, paragraph [0231]). Regarding claim 18, the system of claim 17 is obvious over Mashiach, as explained above. Mashiach further discloses that the first electrode lead includes a therapy delivery electrode configured to provide the neurostimulation therapy signal at or near a hypoglossal nerve in the patient (paragraphs [0037], [0112]-[0135], [0139]). Although Mashiach further discloses a physiologic status sensor that is configured to sense the information about the respiration of the patient (paragraphs [0091]-[0093], [0098]-[0099], [0107], [0110]-[0126]), Mashiach does not explicitly disclose that the first physiologic status sensor comprises an accelerometer configured to sense the information about the respiration of the patient. However, Toong teaches a method for detecting and treating sleep apnea (paragraph [0040]) wherein an accelerometer is configured to sense information about the respiration of the patient (paragraphs [0259]-[0262]). 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 modify Mashiach with the teachings of Toong so that the first physiologic status sensor comprises an accelerometer configured to sense the information about the respiration of the patient, because doing so allows patients to diagnose OSA without the inconvenience and expense of a sleep study in a clinic (Toong, paragraph [0231]), and allows the system to apply stimulation when an apnea episode is detected (Toong, paragraph [0250]). Regarding claim 20, the method of claim 19 is obvious over Mashiach, as explained above. Mashiach further discloses that the first electrical signals are configured to treat a breathing disorder or a sleep disorder of the patient (paragraphs [0034], [0037], [0039], [0093], [0126], [0128]). Although Mashiach further discloses a physiologic status sensor that is configured to sense the information about the respiration of the patient (paragraphs [0091]-[0093], [0098]-[0099], [0107], [0110]-[0126]), Mashiach does not explicitly disclose that the first physiologic status sensor comprises an accelerometer configured to sense the information about the respiration of the patient. However, Toong teaches a method for detecting and treating sleep apnea (paragraph [0040]) wherein an accelerometer is configured to sense information about the respiration of the patient (paragraphs [0259]-[0262]). 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 modify Mashiach with the teachings of Toong so that the first physiologic status sensor comprises an accelerometer configured to sense the information about the respiration of the patient, because doing so allows patients to diagnose OSA without the inconvenience and expense of a sleep study in a clinic (Toong, paragraph [0231]), and allows the system to apply stimulation when an apnea episode is detected (Toong, paragraph [0250]). Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mashiach (US Publication No. 2013/0085558) in view of Tehrani et al. (US 20060167523 A1), hereinafter Tehrani . Regarding claim 12, the system of claim 3 is obvious over Mashiach, as explained above. Mashiach does not explicitly disclose that the first physiologic status sensor is an implantable plethysmography sensor. However, Tehrani teaches a device and method for improving upper airway functionality by electrically stimulating tissue (Abstract) comprising an implantable plethysmography sensor (paragraph [0090]). 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 modify Mashiach with the teachings of Tehrani so that the first physiologic status sensor is an implantable plethysmography sensor, because doing so allows the device to detect an episode of obstructive sleep apnea (Tehrani, paragraph [0090]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT CHRISTINE SISON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4661 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 8 am - 5 pm PT, Mon - Fri . 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Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHRISTINE SISON/ Examiner, Art Unit 3796 /Jennifer Pitrak McDonald/ Supervisory Patent Examiner, Art Unit 3796