DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/7/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-16 and 19-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, the examiner is switching from Tehrani et al. (Pub. No.: US 2008/0167695 A1) to Tehrani et al. (Pub. No.: US 2008/0154330 A1), which better addresses the most recent amendment directed at a central apnea threshold.
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.
Claim(s) 1-9, 11-12, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs et al. (Pub. No.: US 2011/0093032 A1); hereinafter referred to as “Boggs”, in view of Tehrani et al. (Pub. No.: US 2008/0154330 A1); hereinafter referred to as “Tehrani”.
Regarding claim 1, Boggs discloses a method of treating a patient's sleep apnea symptoms, the method comprising: screening the patient for an ability to overcome central apnea symptoms using a percutaneous trial neuromodulation system (e.g. see figure 8 step 806, [0054]-[0056], “Patients in whom stimulation successfully activated airway muscles may proceed to a treatment stage”) in accordance with a rhythmic air flow (e.g. see [0056]), wherein screening the patient comprises determining whether the patient has underlying obstructive apnea symptoms (e.g. see [0054]-[0056]); and configuring an implantable neuromodulation system to apply a stimulation regimen based on results from the screening using the percutaneous trial neuromodulation system (e.g. see [0057]).
Boggs discloses an electrical stimulation system and method to improve airway patency (e.g. see abstract) but is directed towards iSLN stimulation (e.g. see abstract) rather than stimulating one or both of a phrenic nerve and a diaphragm, or increase a stimulus intensity applied to one or both of the phrenic nerve and the diaphragm, in accordance with a rhythmic air flow when a diaphragm electromyographic (EMG) activity is below a central apnea threshold that is lower than a normal level of EMG activity associated with a normal respiratory pattern. Tehrani teaches that it is known to repeatedly stimulate one or both of a phrenic nerve and a diaphragm (e.g. see [0003], [0052]-[0053], [0090]), in accordance with a rhythmic air flow when a diaphragm electromyographic (EMG) activity is below a central apnea threshold that is lower than a normal level of EMG activity associated with a normal respiratory pattern (e.g. see [0051], [0063], [0068], [0079]-[0080] Note: [0068] discloses “If an EMG amplitude is below a threshold for breath detection, a central event may be detected. Stimulation may be turned off to prevent obstructions, or paced breathing may be provided”) to provide a device/method for stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention at the time the invention was made to use the stimulation regimen taught by Tehrani in the system/method of Boggs, since said modification would provide the predictable results of stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]).
Regarding claim 2, Boggs discloses the claimed invention but is silent as to determining whether the patient has underlying obstructive apnea symptoms comprises applying a central apnea stimulation regimen to treat the central apnea symptoms while monitoring the patient for the presence of obstructive apnea symptoms. Tehrani teaches that it is known to use CSA/OSA discrimination as set forth in [0051] to provide a device/method for stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the modification as taught by Tehrani in the system/method of Boggs, since said modification would provide the predictable results of stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]).
Regarding claim 3, Boggs discloses screening the patient comprises determining that the patient is able to tolerate a stimulation regimen that reduces the central apnea symptoms and/or the obstructive apnea symptoms (e.g. see [0054]-[0056]).
Regarding claim 4, Boggs implanting the implantable neuromodulation system in the patient (e.g. see [0057]).
Regarding claims 5 and 6, Boggs discloses the claimed invention but is silent as to screening the patient comprises placing temporary electrodes on the diaphragm of the patient and the temporary electrodes are used to sense EMG activity that indicates a presence of central apnea symptoms, and to stimulate the diaphragm to treat the central apnea symptoms. Tehrani teaches that it is known to use such a modification as set forth in [0051] to provide a device/method for stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use such a modification as taught by Tehrani in the system/method of Boggs, since said modification would provide the predictable results of stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]).
Regarding claim 7, Boggs discloses the sensed EMG activity is logged as data in the percutaneous trial neuromodulation system, wherein the logged data is accessible for evaluation for configuring the implantable neuromodulation system (e.g. see [0054], [0062]-[0064]).
Regarding claim 8, Boggs discloses stimulation parameters for stimulating the diaphragm are titrated to determine if effective stimulation can be tolerated by the patient and overcome central apnea symptoms of the patient (e.g. see [0054]-[0056]).
Regarding claim 9, Boggs discloses additional sensors are used to detect the presence of obstructive apnea symptoms underlying treated central apneas (e.g. see [0054]-[0056]).
Regarding claim 11, Boggs discloses one or more oxygen sensors is used to determine the presence of obstructive apnea symptoms (e.g. see [0041]).
Regarding claim 12, Boggs discloses the claimed invention but is silent as to a polysomnogram system is used to determine the presence of obstructive apnea symptoms. Tehrani teaches that it is known to use such a modification as set forth in [0010], [0042], [0046], [0049]-[0050], [0054], [0057], [0074] to provide a device/method for stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use such a modification as taught by Tehrani in the system/method of Boggs, since said modification would provide the predictable results of stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]).
Regarding claim 20, Boggs discloses the claimed invention but is silent as to the central apnea threshold is an EMG amplitude threshold that indicates diaphragm inactivity or under-activity over a predetermined period. Tehrani teaches that it is known to use such a modification as set forth in [0051], [0063], [0068], [0079]-[0080] to provide a device/method for stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use such a modification as taught by Tehrani in the system/method of Boggs, since said modification would provide the predictable results of stabilizing the airway and/or improving upper airway patency, avoiding diaphragm fatigue, improving patient comfort, reducing undesired effects of stimulation such as upper airway closure, selecting stimulation parameters, selecting therapy type providing individualized treatment and/or diagnostics, adjusting stimulation, and/or improving battery life (e.g. see [0004]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs and Tehrani, and further in view of Heruth et al. (Pub. No.: US 2016/0263382 A1); hereinafter referred to as Heruth.
Regarding claim 10, Boggs and Tehrani disclose the claimed invention but is silent as to one or more respiratory inductance plethysmography belts is used to determine the presence of obstructive apnea symptoms. Heruth teaches that it is known to use plethysmography as set forth in [0135] and figure 12 to provide a signal that may vary as a function of the changes is the thoracic or abdominal circumference of patient that accompany breathing by the patient (e.g. see [0135]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use such a modification as taught by Tehrani 695 in the system/method of Boggs and Tehrani, since said modification would provide the predictable results of a signal that may vary as a function of the changes is the thoracic or abdominal circumference of patient that accompany breathing by the patient.
Claim(s) 13-16, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tehrani in view of Tehrani et al. (Pub. No.: US 2008/0167695 A1); hereinafter referred to as “Tehrani 695”.
Regarding claim 13, Tehrani discloses the method steps (a) and (b) (e.g. see the rejection for claim 1 above and [0051], [0063], [0068], [0079]-[0080] Note: [0068] discloses “If an EMG amplitude is below a threshold for breath detection, a central event may be detected. Stimulation may be turned off to prevent obstructions, or paced breathing may be provided”) but is silent as to the hardware features of the device/system. Tehrani 695 teaches it is known to use a system for screening for sleep apnea, comprising: one or more controllers (e.g. see figure 2 element 100, [0117]); one or more electrodes (e.g. see figures 1-2, elements 21, 22, [0108]-[0109]) operably coupled to the one or more controllers and arranged to stimulate a phrenic nerve and a diaphragm of a patient; one or more sensing electrodes (e.g. see [0109]-[0110]) arranged to sense a diaphragm electromyographic (EMG) activity of the diaphragm of the patient; and a processor (e.g. see figure 2 element 105, [0118]) to provide an improved device and method for treating breathing disorders (e.g. see [0015]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use such a modification as taught by Tehrani 695 in the system/method of Tehrani, since said modification would provide the predictable results of an improved device and method for treating breathing disorders (e.g. see [0015]).
Regarding claims 14-16, Tehrani discloses the invention but is silent as to a memory configured to store EMG activity data, additional sensors to determine a presence of obstructive apnea symptoms during stimulation applied for treatment of a central sleep apnea, and the system also records obstructive apnea symptoms during periods when stimulation is not being applied. Tehrani 695 teaches it is known to use a such a modification as taught in figure 2 elements 118-120, [0121], figures 16B-16E (Note: The sensing and storing are constant. Thus, the system claim is configured to and/or capable of meeting this limitation) to provide an improved device and method for treating breathing disorders (e.g. see [0015]). It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to use a memory configured to store EMG activity data as taught by Tehrani 695 in the system/method of Tehrani, since said modification would provide the predictable results of an improved device and method for treating breathing disorders (e.g. see [0015]).
Regarding claim 19, Tehrani discloses the second threshold is higher than the normal level of EMG activity associated with the normal respiratory pattern (e.g. see [0051], [0063], [0068], [0079]-[0080]).
Regarding claim 21, Tehrani discloses the obstructive apnea threshold is an amplitude that indicates diaphragm over-activity over a predetermined period (e.g. see [0051], [0063], [0068], [0079]-[0080]).
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792