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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 14th, 2024, as well as January 27, May 5th, July 30th, and October 20th 2025 are being considered by the examiner.
Priority
The current application claims benefit of provisional application 63/497,995, filed on April 24th, 2023. Examiner acknowledges the applicant’s claim for priority.
Status of Claims
In the response dated August 14th, 2026, Applicant amended claims 1, 3, 4, 7, and 14. Claims 1-23 are pending.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
112 Claim rejections
Regarding claim 4, Applicant’s arguments have been considered and are persuasive. Examiner withdraws claim 4’s rejection under 35 U.S.C. 112.
Regarding claim 7, Applicant’s arguments have been considered but are unpersuasive. Claim 7’s amended recitation “the subject's trigeminal nerve is titrated by gradually increasing intensity to between 0.5 V and 45 V by increasing 0.5 V per 30 seconds for more than 5 minutes, with pulse width between 0.1 ms and 5ms, a frequency between 1 Hz and 200 Hz, duty cycle between 1 - 30 seconds ON and 2 - 30 minutes OFF, or a combination thereof” remains unclear as to whether the combination of stimulation parameters comprises a manner in which the trigeminal nerve is titrated “by gradually increasing intensity to between 0.5 V and 45 V” using the list of stimulation parameters or if “gradually increasing intensity to between 0.5 V and 45 V by increasing 0.5 V per 30 seconds for more than 5 minutes” is one of multiple parameter adjustments in which the trigeminal nerve is titrated.
102 Claim Rejections
Regarding claims 1-3, 6, 8-15 and 18-23, Applicant’s arguments have been considered and the newly amended claims require new grounds for rejection.
103 Claim Rejections
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Regarding claims 4, 5, 7,16, and 17, Applicant’s arguments have been considered and the newly amended claims require new grounds for rejection.
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 1-3, 6, 8-15 and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan et al. (US20210154474) in view of Andersson et al. (Diving Response, 2002) and further in view of Smith et al. (US20160310315).
Regarding claim 1, Narayan teaches a closed-loop method for treating a disorder of cerebral perfusion, the method comprising: ([0006] “In the present invention, TNS can modulate both SNS and PNS activities to activate the endogenous pressor response, improve cerebral perfusion and decrease inflammation, leading to reduction of secondary brain injury”) receiving sensor data associated with a patient’s vascular status; ([0030] “During operation, the pressure transducer 330 and its analog front-end record arterial pressure of an animal (e.g., a human patient) 350 and send it to the microcontroller 305.” Where sending physiological signal via a pressure transducer to a microcontroller comprises receiving sensor data associated with a patient’s vascular status) determining, based on the sensor data, a need for increased cerebral perfusion by the patient; ([0030] “the analog to digital converter (A/D) 335 of the microcontroller 305 samples the recorded pressure signal and compares it with a threshold value preset by a user via the GUI 325. When the recorded signal is lower than the threshold, the digital to analog (D/A) converter 340 of the microcontroller 305 sends voltage and/or current pulses with given parameters preset by the GUI 325 to the current stimulation isolator 310” where sampling the pressure signals to determine that the signal is below a threshold comprises determining the need for current stimulation to the trigeminal nerves.”) by applying a non-invasive trigeminal stimulation to the patient’s forehead. ([0030] “The stimulation isolator 310 delivers the stimulation voltages 345 to the trigeminal nerve (e.g., via the face) using a stimulation electrode (e.g., 315 or 320). The stimulation on the trigeminal nerve increases the blood pressure until the sampled blood pressure signal is equal to the targeted value.” Where stimulation of the trigeminal nerve to increase blood pressure comprises an oxygen conserving reflux via a non-invasive nerve stimulation) and activating or maintaining an oxygen conserving reflex in the patient by applying a non-invasive trigeminal stimulation to the patient's forehead ([0005] and [0008] “stimulation of ophthalmic nerve and maxillary nerve” which would activate or maintain the oxygen conserving reflex since instant application discloses “Activating or maintaining the oxygen conserving reflex may comprise applying the non-invasive trigeminal stimulation in a stimulation pattern that is closed-loop and targets the patient's trigeminal ophthalmic nerve branch, the patient's trigeminal maxillary nerve branch, or a combination thereof.” in [0013]) by adjusting the applied non-invasive trigeminal stimulation to maintain a decrease in the patient's peripheral oxygen saturation… and cerebral blood flow ([0029]” The microcontroller 305 can have circuitry and/or software programming for causing non-invasive trigeminal nerve stimulation to be triggered in the stimulation isolator 310 using a physiologic feedback loop, based on … arterial oxygen saturation… cranial diffusions”).
Regarding claim 1, Narayan does not explicitly teach decreasing oxygen saturation by between 5-20% and an increase in the patient's cerebral blood flow by between 5-30%.
Regarding claim 1, Andersson teaches a decrease in the patient's peripheral oxygen saturation by between 5-20% ([Abstract] a reduction in oxygen saturation from eupneic control was 6.8%). It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have explicitly stimulated the trigeminal nerve to decrease oxygen saturation by between 5-20% as taught and suggested by Andersson. This would have improved a patient’s anaerobic capability during hematologic shock. Narayan would have come across Andersson as they are both in the same field of endeavor of trigeminal nerve stimulation.
Regarding claim 1, Smith teaches an increase in the patient's cerebral blood flow by between 5-30%. ([0005] “increases in the cerebral blood blow in humans were seen to increase by 14% [while triggering the dive reflex]”). It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have explicitly stimulate the trigeminal nerve to increase the cerebral blood flow in humans by 14%, as taught and suggested by Smith. This would have improved a patient’s anaerobic capability during hematologic shock. Narayan would have come across Smith as they are both in the same field of endeavor of trigeminal nerve stimulation.
Regarding claim 2, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein activating or maintaining the oxygen conserving reflex comprises applying the non-invasive trigeminal stimulation in a stimulation pattern that is closed loop and targets the patient’s trigeminal ophthalmic nerve branch, the patient’s trigeminal maxillary nerve branch, or a combination thereof. ([0005] and [0008])
Regarding claim 3, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein activating or maintaining the oxygen conserving reflex comprises applying the non-invasive trigeminal stimulation in a closed-loop manner in which a current or a voltage applied is titrated to increase the patient’s systolic blood pressure by 5-10 mmHg, decrease the patient’s heart rate 5-10%, and/or decrease the patient’s respiration rate 10-30%. (see [0029] above; see also [0011] “In some embodiments, at least one of a stimulation voltage or a current is increased gradually (e.g., steps of 0.5 V) to reach an elevated systemic and/or systolic blood pressure (e.g., of 5-15 mmHg as compared to a baseline pre-stimulation blood pressure during active stimulation” where an increase of 5-15 mmHg comprises increasing the patient’s systolic pressure of 5-10mmHg)
Regarding claim 4, Narayan-Andersson-Smith teaches all of the limitations of claim 3. Narayan also teaches wherein the trigeminal stimulation is delivered for between 20 and 120 minutes after titration. ([0022] “at variable time intervals (e.g., 3-20 min)”) MPEP 2144.05(I) states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” [In re Wertheim, 541 F.2d 257]. There is no criticality of overlapping ranges and Applicant has not indicated in the specification that different ranges would produce unexpectedly different results than from the prior art range. One of ordinary skill in the art would have recognized the ranges as obvious variants that could be achieved through routine optimization.
Regarding claim 5, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein the trigeminal stimulation has parameters that include an intensity of between 0.5 V and 45 V, ([0010] “In some embodiments, the non-invasive neurostimulation has an intensity of 2-20 V”) with a pulse width between 0.1 ms and 5 ms, a frequency between 1 Hz and 200 Hz, ([0010] “In some embodiments, the non-invasive neurostimulation has a frequency of 15-140 Hz” where the range of frequency comprises low and higher frequency bandwidths) and a duty cycle between 0.5-30 seconds ON and 1–30 minutes OFF. ([0010] “In some embodiments, a duration of active stimulation is between 0.5 and 2 minutes. In some embodiments, a duration of non-stimulation duration is between 3 and 20 minutes.”) MPEP 2144.05(I) states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” [In re Wertheim, 541 F.2d 257]. There is no criticality of overlapping ranges and Applicant has not indicated in the specification that different ranges would produce unexpectedly different results than from the prior art range. One of ordinary skill in the art would have recognized the ranges as obvious variants that could be achieved through routine optimization.
Regarding claim 6, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein the sensor data includes heart rate data, blood pressure data, data on a patient’s cerebral blood flow and/or perfusion, or a combination thereof. ([0015] “In some embodiments, the closed-loop trigeminal nerve stimulation is conducted based on a systemic or a systolic blood pressure of the animal. In some embodiments, the closed-loop trigeminal nerve stimulation is conducted based on a heart rate of the animal” where the closed-loop stimulation system receives a human’s heart rate and blood pressure data to conduct stimulation)
Regarding claim 7, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein the electrical stimulation of the subject’s trigeminal nerve is titrated by gradually increasing intensity to between 0.5 V and 45 V ([0010] “In some embodiments, the non-invasive neurostimulation has an intensity of 2-20 V”) by increasing 0.5 V ([0011] “In some embodiments, at least one of a stimulation voltage or a current is increased gradually (e.g., steps of 0.5 V)”) per 30 seconds for more than 5 minutes with pulse width between 0.1 ms and 5 ms, ([0024] “As above, rectangular-wave pulses (e.g., 0.25-1 ms duration) are delivered for variable durations (e.g., 0.5-2 min) at variable time intervals (e.g., 3-20 min), and stimulus intensity is set to increase the blood pressure” where the rectangular wave pulses [comprising pulse widths] are delivered for variable durations [comprising per 30 seconds] for variable time intervals [comprising for more than 5 minutes]) frequency between 1 Hz and 200 Hz, ([0010] “In some embodiments, the non-invasive neurostimulation has a frequency of 15-140 Hz” where the range of frequency comprises low and higher frequency bandwidths) duty cycle between 1 - 30 seconds ON and 2 - 30 minutes OFF, or a combination thereof. ([0010] “In some embodiments, a duration of active stimulation is between 0.5 and 2 minutes. In some embodiments, a duration of non-stimulation duration is between 3 and 20 minutes.”) MPEP 2144.05(I) states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” [In re Wertheim, 541 F.2d 257]. There is no criticality of overlapping ranges and Applicant has not indicated in the specification that different ranges would produce unexpectedly different results than from the prior art range. One of ordinary skill in the art would have recognized the ranges as obvious variants that could be achieved through routine optimization.
Regarding claim 8, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein the closed-loop stimulation activation is based at least in part on periodic sampling of feedback markers including one or more of: the patient’s heart rate, the patient’s blood pressure, the patient’s respiration rate, the patient’s peripheral oxygen saturation, the patient’s cerebral blood perfusion, the patient’s pupillary response, and/or the patient’s blood markers. ([0012] “In some embodiments, the closed-loop trigeminal nerve stimulation is conducted based on a systemic or a systolic blood pressure of the animal. In some embodiments, the closed-loop trigeminal nerve stimulation is conducted based on a heart rate of the animal.”)
Regarding claim 9, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein determining the need for trigeminal nerve stimulation or further inducing oxygen conservation is based on sensor data ([0029] “microcontroller 305 can have circuitry and/or software programming for causing non-invasive trigeminal nerve stimulation to be triggered in the stimulation isolator 310 using a physiologic feedback loop, based on, for example: blood pressure; pulse rate; arterial oxygen saturation; plethysmography; central venous pressure; transcranial doppler; and/or near infrared spectroscopy (e.g., cranial diffusions)” where feedback loops based on oxygen saturation or cranial diffusion comprises determining the need for current stimulation to the trigeminal nerves based on sensor data) associated with decreased cerebral perfusion due to stroke, subarachnoid hemorrhage, traumatic brain injury, vascular cognitive impairment, vascular dementia, and/or Alzheimer’s disease. ([0035] “For example, when a cerebral aneurysm (“Berry aneurysm”) ruptures and is treated by either surgically or by endovascular techniques (clipping, coiling or stenting), even those patients who survive the initial insult may be at risk of subsequent massive stroke and death from vasospasm. In addition, any brain surgery can cause brain edema and interference with cerebral blood flow. In addition, the invention could find ready application in situations in which brain lesions are treated endovascularly or after ischemic stroke to maximize perfusion” where a patient treating an ischemic stroke comprises decreased cerebral perfusion due to stroke)
Regarding claims 10 and 11, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches stimulation of ophthalmic nerve and maxillary nerve branches ([0005] and [0008]), which would activate or maintain the oxygen conserving reflex includes inducing a diving reflex and trigeminocardiac reflex in the patient since instant application discloses “Activating or maintaining the oxygen conserving reflex may comprise applying the non-invasive trigeminal stimulation in a stimulation pattern that is closed-loop and targets the patient's trigeminal ophthalmic nerve branch, the patient's trigeminal maxillary nerve branch, or a combination thereof.” in [0013].
Regarding claim 12, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein determining the need for oxygen conservation is based on sensor data ([0029] “microcontroller 305 can have circuitry and/or software programming for causing non-invasive trigeminal nerve stimulation to be triggered in the stimulation isolator 310 using a physiologic feedback loop, based on, for example: blood pressure; pulse rate; arterial oxygen saturation; plethysmography; central venous pressure; transcranial doppler; and/or near infrared spectroscopy (e.g., cranial diffusions)” where feedback loops based on oxygen saturation or cranial diffusion comprises determining the need for current stimulation to the trigeminal nerves based on sensor data) associated with stroke, subarachnoid hemorrhage, traumatic brain injury, vascular cognitive impairment, vascular dementia, and/or Alzheimer’s disease. ([0035] “For example, when a cerebral aneurysm (“Berry aneurysm”) ruptures and is treated by either surgically or by endovascular techniques (clipping, coiling or stenting), even those patients who survive the initial insult may be at risk of subsequent massive stroke and death from vasospasm. In addition, any brain surgery can cause brain edema and interference with cerebral blood flow. In addition, the invention could find ready application in situations in which brain lesions are treated endovascularly or after ischemic stroke to maximize perfusion” where a patient treating an ischemic stroke comprises decreased cerebral perfusion due to stroke)
Regarding claim 13, Narayan-Andersson-Smith teaches all of the limitations of claim 1. Narayan also teaches wherein activating the oxygen conserving reflex includes increasing a cerebral perfusion pressure ([0006] “In the present invention, TNS can modulate both SNS and PNS activities to activate the endogenous pressor response, improve cerebral perfusion and decrease inflammation, leading to reduction of secondary brain injury)
Regarding claim 14, Narayan-Andersson-Smith teaches an apparatus for treating a disorder of cerebral perfusion in a patient, the apparatus comprising: ([0006] “In the present invention, TNS can modulate both SNS and PNS activities to activate the endogenous pressor response, improve cerebral perfusion and decrease inflammation, leading to reduction of secondary brain injury) a sensor configured to generate sensor data associated with a patient’s vascular status; ([0029] “The device 300 can be an automated closed-loop resuscitation system including a microcontroller 305, …a pressure transducer 330 in electrical communication with the microcontroller 305.” Where the pressure transducer [i.e., a sensor] is configured to generate sensor data associated with a patient’s vascular status) a controller, communicatively coupled to the sensor, and configured to provide closed-loop stimulation based on data from the sensor indicating a need for oxygen conservation by the patient; and ([0029] “The device 300 can be an automated closed-loop resuscitation system including a microcontroller 305, a stimulation isolator 310 in electrical communication with the microcontroller 305, electrodes 315, 320 in electrical communication with the stimulation isolator 310… software programming for causing non-invasive trigeminal nerve stimulation to be triggered in the stimulation isolator 310 using a physiologic feedback loop, based on, for example: blood pressure; pulse rate; arterial oxygen saturation;” where the sensor’s measurement of oxygen saturation provides an indication for stimulation to the controller) a stimulus electrode ([0022] “stimulation electrodes”), communicatively coupled to the controller, and configured to deliver non-invasive trigeminal stimulation to the patient’s trigeminal nerve from the controller ([0029] “The device 300 can be an automated closed-loop resuscitation system including a microcontroller 305, a stimulation isolator 310 in electrical communication with the microcontroller 305, electrodes 315, 320 in electrical communication with the stimulation isolator 310… software programming for causing non-invasive trigeminal nerve stimulation to be triggered in the stimulation isolator 310 using a physiologic feedback loop, based on, for example: blood pressure; pulse rate; arterial oxygen saturation” where the electrodes stimulate a patient based on an indication for stimulation from the sensor’s measurement of oxygen saturation) to activate an oxygen conserving reflex in the patient ([0005] and [0008] “stimulation of ophthalmic nerve and maxillary nerve”, which would activate or maintain the oxygen conserving reflex since instant application discloses “Activating or maintaining the oxygen conserving reflex may comprise applying the non-invasive trigeminal stimulation in a stimulation pattern that is closed-loop and targets the patient's trigeminal ophthalmic nerve branch, the patient's trigeminal maxillary nerve branch, or a combination thereof.” in [0013].) by adjusting the applied non-invasive trigeminal stimulation to maintain a decrease in the patient's peripheral oxygen saturation… and cerebral blood flow ([0029]” The microcontroller 305 can have circuitry and/or software programming for causing non-invasive trigeminal nerve stimulation to be triggered in the stimulation isolator 310 using a physiologic feedback loop, based on … arterial oxygen saturation… cranial diffusions”).
Regarding claim 14, Narayan does not explicitly teach decreasing oxygen saturation by between 5-20% and an increase in the patient's cerebral blood flow by between 5-30%.
Regarding claim 14, Andersson teaches a decrease in the patient's peripheral oxygen saturation by between 5-20% ([Abstract] a reduction in oxygen saturation from eupneic control was 6.8%). It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have explicitly stimulated the trigeminal nerve to decrease oxygen saturation by between 5-20% as taught and suggested by Andersson. This would have improved a patient’s anaerobic capability during hematologic shock. Narayan would have come across Andersson as they are both in the same field of endeavor of trigeminal nerve stimulation.
Regarding claim 14, Smith teaches an increase in the patient's cerebral blood flow by between 5-30%. ([0005] “increases in the cerebral blood blow in humans were seen to increase by 14% [while triggering the dive reflex]”). It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have explicitly stimulate the trigeminal nerve to increase the cerebral blood flow in humans by 14%, as taught and suggested by Smith. This would have improved a patient’s anaerobic capability during hematologic shock. Narayan would have come across Smith as they are both in the same field of endeavor of trigeminal nerve stimulation.
Regarding claim 15, Narayan-Andersson-Smith teaches all of the limitations of claim 14. Narayan also teaches wherein the stimulus electrode is included within a wearable patch configured to be worn on the patient’s forehead. ([0021] “FIG. 1A shows a human patient 100 receiving non-invasive neurostimulation of the trigeminal nerve via targeting of the ophthalmic division (the first major division of the trigeminal nerve that supplies the skin over the forehead and around the eyes) using one pair of electrodes”)
Regarding claim 18, Narayan-Andersson-Smith teaches all of the limitations of claim 14. Narayan also teaches wherein the sensor data includes at least one of a patient’s blood pressure and a patient’s heart rate. ([0029] “the microcontroller 305 can have circuitry and/or software programming for causing non-invasive trigeminal nerve stimulation to be triggered in the stimulation isolator 310 using a physiologic feedback loop, based on, for example: blood pressure; pulse rate; arterial oxygen saturation; plethysmography; central venous pressure; transcranial doppler; and/or near infrared spectroscopy (e.g., cranial diffusions)”)
Regarding claim 19, Narayan-Andersson-Smith teaches all of the limitations of claim 14. Narayan also teaches wherein the controller is configured to implement a closed-loop feedback system by periodically sampling the sensor data and activating the oxygen conserving reflex based on the sensor data. ([0011] “a stimulation voltage or a current is increased gradually (e.g., steps of 0.5 V) to reach an elevated systemic and/or systolic blood pressure” where feedback loops-based stimulation would involve periodical sampling of blood pressure)
Regarding claims 20 and 21, Narayan-Andersson-Smith teaches all of the limitations of claim 14. Narayan also teaches stimulation of ophthalmic nerve and maxillary nerve branches ([0005] and [0008]), which would activate or maintain the oxygen conserving reflex includes inducing a diving reflex and trigeminocardiac reflex in the patient since instant application discloses “Activating or maintaining the oxygen conserving reflex may comprise applying the non-invasive trigeminal stimulation in a stimulation pattern that is closed-loop and targets the patient's trigeminal ophthalmic nerve branch, the patient's trigeminal maxillary nerve branch, or a combination thereof.” in [0013].
Regarding claim 22, Narayan-Andersson-Smith teaches all of the limitations of claim 14. Narayan also teaches wherein the controller is configured to increase cerebral perfusion pressure. ([0006] “In the present invention, TNS can modulate both SNS and PNS activities to activate the endogenous pressor response, improve cerebral perfusion and decrease inflammation, leading to reduction of secondary brain injury)
Regarding claim 23, Narayan-Andersson-Smith teaches all of the limitations of claim 14. Narayan also teaches wherein the non-invasive trigeminal stimulation includes stimulating the patient’s trigeminal ophthalmic nerve branch, the patient’s trigeminal maxillary nerve branch, or a combination thereof ([0005] and [0008]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan et al. (US20210154474) in view of Andersson et al. (Diving Response, 2002) and further in view of Smith et al. (US20160310315) and Cook et al. (US20160339242).
Cook’s disclosure, similar to Narayan, creates a pulse generating electrode stimulation apparatus for cranial nerve stimulation to treat neurological conditions. Industry has a long felt need that nerve stimulation “methods are invasive and may have considerable costs and side effects”, see paragraph [0007]. Thus, Narayan would have come across Cook “providing a system and device configured to stimulate the trigeminal nerve that is minimally invasive”, see paragraph [0005].
Regarding claim 16, Narayan-Andersson-Smith teaches all of the limitations of claim 15. Narayan does not explicitly teach, as taught by Cook wherein the controller is integrated with the wearable patch. ([0016] “FIG. 2A depicts an example of a subject wearing one embodiment of an electrode assembly and pulse generator” and [0057] “In some embodiments, the electrodes 105 and the generator 15 may be a single unit, e.g. the generator 15 is connected directly to and positioned generally on the electrode.” Where the generator [comprising the controller] and the electrodes [i.e., the patch] are a wearable patch). 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 Narayan with the teachings of Cook, with a reasonable expectation of success, by integrating the controller and electrodes into a wearable patch since integrating controller and electrode into a single unit is an art-recognized equivalent to yield predictable results of providing stimulation therapy device in a single unit.
Regarding claim 17, Narayan-Andersson-Smith teaches all of the limitations of claim 14. Narayan does not explicitly teach, as taught by Cook wherein the controller is configured to wirelessly receive the sensor data. ([0043] “the generator 15 and the electrode assembly 10 communicate wirelessly” and [0034] “the pulse generator can inform a physician or other care provider that the patient may be having a seizure (based on processing implanted or external EEG data, or other physiologic data such as autonomic nervous system indices (e.g. heart rate variability))” where the physiological data is received by the pulse generator [i.e., the controller]) 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 include wireless communication means of Cook in the device of Narayan with a reasonable expectation of success in order to provide a wireless connection to the sensor and controller since a providing a wireless connection to a sensor is an art-recognized equivalent to yield predictable results of providing stimulation therapy device in a single unit.
Conclusion
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
Golanov et al. (Diving Response in Rats, 2016) indicates that “electrical TNS may be ideal for the treatment of these various pathologies”
Li (Percutaneous Trigeminal Nerve Stimulation Induces Cerebral Vasodilation in a Dose-Dependent Manner. Neurosurgery. 2021) discusses the increases in cerebral perfusion pressure from cranial nerve stimulation.
THIS ACTION IS MADE FINAL. 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.
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
