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.
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 applicant regards as his invention.
Claim 4 and 7 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.
Claim 4 recites the limitation "after titration" in “wherein the trigeminal stimulation is delivered for between 20 and 120 minutes after titration”. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “after titration” to mean after an increase or decrease in voltage stimulation as recited in claim 3. Appropriate correction to be dependent on claim 3, or further clarification on titration, is required.
Claim 7 recites the limitation " wherein the electrical stimulation of 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 5 ms, frequency between 1 Hz and 200 Hz, duty cycle between 1 - 30 seconds ON and 2 - 30 minutes OFF." without a conjunctive or disjunctive element to delineate how the list of limitations affects increasing the intensity of the stimulation. Examiner interprets the claims to indicate any one of the list of elements may satisfy the stimulation constraints. Appropriate correction [i.e., by adding “and”, “or”, etc.] is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 6, 8-15 and 18-23 are rejected under under 35 U.S.C. 102(a)(1) as being anticipated by Narayan et al. (US20210154474).
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 ([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].
Regarding claim 2, Narayan-Shah 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 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%, decrease the patient’s peripheral oxygen saturation 5-20%, increase the patient’s cerebral blood flow 5-20%, 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 6, Narayan 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 8, Narayan 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 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 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 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 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 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].
Regarding claim 15, Narayan 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 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 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 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 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 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]).
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 4, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan et al. (US20210154474).
Regarding claim 4, Narayan teaches all of the limitations of claim 1. 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 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 7, Narayan 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. ([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.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Narayan et al. (US20210154474) in view of 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 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 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jumbe et al. (US 20240172949) discloses wearable device for measuring intracranial pressure of a subject. This system takes sensors to measure various physiological parameters including heart rate, blood flow, blood pressure, and more. This system can also provide electrical stimulation of human nerves to stimulate a physiological response.
Miller et al. (US20250144416) discloses a system that contains a pulse generator device for trigeminal nerve stimulation.
Simon et al. (US20230128537) discloses a system for treating a neurological disorder. The device uses an electrode in contact with the skin of a patient and a power source coupled the electrode. The power source generates and transmits an electrical impulse.
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792