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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-20 and 165-172 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, “measuring an oxygenation level of the subject in response to the delivering of the first stimulation energy, the delivering of the second stimulation energy, or both” appears to lack written description support in the originally filed disclosure. The passages cited in “remarks” and the remaining disclosure appear to describe a device capable of monitoring one or more parameters, such as blood oxygenation levels to modify or specify parameters of the stimulation delivered. The examiner was unable to find disclosure showing possession of the concept of “monitoring…in response to the delivering” of stimulation energy. In other words, if the scope of the claim requires measuring to be triggered/”in response to” delivering of stimulation, such scope does not appear to be supported by the originally-filed disclosure, as the disclosure appears to merely set forth the idea that parameters can be continuously monitored and used to control stimulation. If the scope merely requires the oxygenation levels to be in response to the delivering of the stimulation, this concept does not appear to be clearly set forth in the claims (see 112(b) rejection below).
The remaining claims are rejected by virtue of their dependency.
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.
Claims 1, 3-20 and 165-172 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.
In regards to claim 1, “measuring an oxygenation level of the subject in response to the delivering of the first stimulation energy, the delivering of the second stimulation energy, or both” is vague. It is unclear whether “measuring an oxygenation level of the subject in response to the delivering of the…stimulation energy” requires the “measuring” to be triggered/initiated “in response to the delivering” or whether the “oxygenation level” is “in response to the delivering.” The first scope does not appear to be supported by the originally filed disclosure (see above), but the second scope is not clearly set forth. As the first scope does not appear to draw support from the original disclosure, the examiner is considering the second scope for prior art purposes, but clarification is respectfully requested.
In regards to claim 14, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “within 3 to 5 days,” and the claim also recites “within 24 hours” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The examiner is considering the claim to require delivering the stimulation within 5 days of the insult to the subject.
In regards to claims 165 and 166, “the measured tissue oxygenation”/”tissue oxygenation” lacks antecedent basis. Claim 1 sets forth “an oxygenation level.”
In regards to claims 171 and 172, it is unclear whether the claims require a second, additional step of “measuring feedback” or whether this is referring back to the “measuring” step of claim 1. As an additional measuring step does not appear to draw support from the original disclosure, the examiner is considering this to require that the measuring of claim 1 can include the specifics of claims 171 and 172, but clarification is respectfully requested.
In regards to claim 173, “the feedback” lacks antecedent basis, and it is unclear whether this claim purports to broaden claim 1. For prior art purposes, the examiner is considering measuring any of the listed parameters to fall within the claim scope, but clarification is respectfully requested.
The remaining claims are rejected by virtue of their dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
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 1, 3-6, 8-10, 12, 17, 20 and 169-173 are rejected under 35 U.S.C. 102(a)(1) and (2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Williams et al. (US 2019/0201684, hereinafter “Williams”).
In regards to claim 1, Williams discloses a method of stimulating a plurality of target nerves in a subject to treat a medical condition, wherein the medical condition is a stroke (par. 0093), the method comprising: transcutaneously delivering a first stimulation energy to a supraorbital branch of a trigeminal nerve (par. 0094); transcutaneously delivering a second stimulation energy to an auricular branch of a vagal nerve (par. 0061), wherein the first and second stimulation energies are delivered in combination to treat the medical condition (par. 0093); and measuring an oxygenation level of the subject in response to the delivering of the first stimulation energy, the delivering of the second stimulation energy, or both (Figs. 1A and 1B, pars. 0088-0089, measuring blood oxygen level dependent effect in the brain cortex and the oxygenation level is in response to the delivering of the stimulation).
Although Williams does not expressly disclose that the stroke is one or more of ischemic stroke, cerebral brain damage due to ischemic stroke, hemorrhagic stroke, cerebral brain damage due to hemorrhagic stroke, or a reperfusion injury, it is the examiner’s understanding that ischemic and hemorrhagic stroke cover the scope of types of stroke (i.e., a “stroke” is necessarily caused by either an ischemic or hemorrhagic event). Alternatively and additionally, it is notorious in the art that the vast majority of strokes are caused by either an ischemic or hemorrhagic event, and it would therefore have been obvious to one having ordinary skill in the art before the effective filing date to apply the method of Williams to ischemic and/or hemorrhagic stroke to provide the predictable results of treating damage caused by stroke due to the causes of the overwhelming majority of stroke cases.
In regards to claim 3, one or more of the first or second stimulation energies are delivered by one or more of a wearable or adherable stimulation device (Fig. 2).
In regards to claim 4, one or more of the first or second stimulation energies are electrical (par. 0094).
In regards to claim 5, one or more of the first or second stimulation energies are one or more of electrical, mechanical, vibratory, acoustic, optical, or thermal (par. 0094).
In regards to claim 6, the first and second stimulation energies are delivered simultaneously (pars. 0024, 0059).
In regards to claim 8, one or more of the first or second stimulation energies are provided at a frequency between 0.2 and 500 Hz (par. 0065).
In regards to claim 9, one or more of the first or second stimulation energies are provided at an amplitude of between 0.1 and 200 mA (par. 0064).
In regards to claim 10, one or more of the first or second stimulation energies are provided at a pulse width between 1 µs and 2 s (par. 0103, 0113).
In regards to claim 12, one or more of the first or second stimulation energies are biphasic (par. 0113).
In regards to claim 17, the method further comprises determining whether reperfusion has occurred in the subject (par. 0088).
In regards to claim 20, the first and second stimulations are delivered in an amount therapeutically effective to treat the medical condition (par. 0069, 0074).
In regards to claim 169, the measured oxygen level comprises a blood oxygenation level of the subject (pars. 0088-89, “measure changes in blood oxygen level dependent (BOLD) effects in the brain”).
In regards to claim 170, the measured oxygen level comprises a cerebral oxygenation level of the subject (par. 0088, “insula, prefrontal cortex”).
In regards to claim 171, the method further comprises measuring feedback from the subject (par. 0059, “the electrical stimulation may be used in a closed-loop fashion by way of combining any form of electrical stimulation mentioned with a sensing modality that may include electrophysiological and/or CSF flow rate measurement. Additionally, non-invasive measurements of autonomic nerve activity may be performed, including, blood pressure, galvanic skin response, heart rate, and respiration variability”).
In regards to claim 172, the method further comprises adjusting one or more of the first stimulation energy or the second stimulation energy in response to the measured feedback (par. 0059, “the electrical stimulation may be used in a closed-loop fashion by way of combining any form of electrical stimulation mentioned with a sensing modality that may include electrophysiological and/or CSF flow rate measurement. Additionally, non-invasive measurements of autonomic nerve activity may be performed, including, blood pressure, galvanic skin response, heart rate, and respiration variability”).
In regards to claim 173, measuring the feedback from the subject comprises measuring one or more of a motion, a muscle contraction, a spasm, a verbal input, a visual input, a gesture, a facial expression, a cerebral oxygenation, a partial pressure of oxygen in brain tissue, a cerebral metabolic rate, a pulse rate, a blood pressure, a blood flow velocity, a pulsatility, a tissue perfusion reading, a neural activity, an electroencephalography (EEG) reading, or an electrode resistance from the subject (par. 0059, “the electrical stimulation may be used in a closed-loop fashion by way of combining any form of electrical stimulation mentioned with a sensing modality that may include electrophysiological and/or CSF flow rate measurement. Additionally, non-invasive measurements of autonomic nerve activity may be performed, including, blood pressure, galvanic skin response, heart rate, and respiration variability”).
Claims 1, 3-5, 8, 10, 14, 15, 20, 165, 167-169 and 171-173 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanov (US 10,688,274, hereinafter “Jovanov”) in view of Narayan et al. (US 2021/0154474, hereinafter “Narayan”).
In regards to claim 1, Jovanov discloses a method of stimulating a plurality of target nerves in a subject to treat a medical condition, wherein the medical condition is a stroke (col. 2, lines 34-36; col. 9, lines 11-15), the method comprising: transcutaneously delivering a first stimulation energy to a trigeminal nerve (col. 6, lines 13-22); transcutaneously delivering a second stimulation energy to an auricular branch of a vagal nerve (col. 3, lines 38-41; col. 5, lines 43-51), wherein the first and second stimulation energies are delivered in combination to treat the medical condition (col. 5, lines 15-42).
Although Jovanov does not expressly disclose that the stroke is one or more of ischemic stroke, cerebral brain damage due to ischemic stroke, hemorrhagic stroke, cerebral brain damage due to hemorrhagic stroke, or a reperfusion injury, it is the examiner’s understanding that ischemic and hemorrhagic stroke cover the scope of types of stroke (i.e., a “stroke” is necessarily caused by either an ischemic or hemorrhagic event). Further, although Jovanov discloses that the trigeminal stimulator “can be integrated into the front headband 122” (col. 6, lines 18-19; see Fig. 3), which would generally place the stimulator at a supraorbital branch of the trigeminal nerve, and measuring the physiological response of the subject in response to the delivering of the stimulation energy based on sensor data (col. 3, lines 18-28 and col. 9, lines 35-37, “closed loop control”). Jovanov does not expressly and explicitly disclose delivering the stimulation to a supraorbital branch of the trigeminal nerve, or that the measured parameter is an oxygenation level.
However, Narayan in the same field of endeavor of transcutaneous stimulation teaches trigeminal stimulation for the treatment of one or more of ischemic stroke, cerebral brain damage due to ischemic stroke, hemorrhagic stroke, cerebral brain damage due to hemorrhagic stroke, or a reperfusion injury (pars. 0006, 0009, 0035) by applying stimulation at a supraorbital branch of the trigeminal nerve (pars. 0022, 0024) to provide the predictable results of reduction of secondary brain injury by employing the endogenous protective mechanisms of the patient’s body (par. 0006), and measuring an oxygenation level (par. 0029) to provide the predictable results of closed loop control by measuring oxygenation (par. 0029) to control oxygen flow to the brain (par. 0031) and thus improve patient outcome (par. 0007). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Jovanov by providing trigeminal stimulation for the treatment of one or more of ischemic stroke, cerebral brain damage due to ischemic stroke, hemorrhagic stroke, cerebral brain damage due to hemorrhagic stroke, or a reperfusion injury by applying stimulation at a supraorbital branch of the trigeminal nerve to provide the predictable results of reduction of secondary brain injury by employing the endogenous protective mechanisms of the patient’s body; and measuring an oxygenation level to provide the predictable results of closed loop control by measuring oxygenation to control oxygen flow to the brain and thus improve patient outcome.
In regards to claim 3, one or more of the first or second stimulation energies are delivered by one or more of a wearable or adherable stimulation device (Fig. 3).
In regards to claim 4, one or more of the first or second stimulation energies are electrical (col. 3, lines 15-19).
In regards to claim 5, one or more of the first or second stimulation energies are one or more of electrical, mechanical, vibratory, acoustic, optical, or thermal (col. 3, lines 15-19).
In regards to claim 8, Narayan teaches one or more of the first or second stimulation energies are provided at a frequency between 0.2 and 500 Hz (par. 0010) to provide the same predictable results as set forth above.
In regards to claim 10, Narayan teaches one or more of the first or second stimulation energies are provided at a pulse width between 1 µs and 2 s (par. 0010) to provide the same predictable results as set forth above.
In regards to claims 14, 15, 167 and 168, Narayan teaches the first and second stimulation energies are delivered within 24 hours of an insult to the subject, or within 3 to 5 days of the insult to the subject, wherein the insult is a stroke (pars. 0006, 0035) to provide the same predictable results as set forth above.
In regards to claim 20, the first and second stimulations are delivered in an amount therapeutically effective to treat the medical condition (col. 5, lines 15-42).
In regards to claim 165, Jovanov’s modified invention further comprises adjusting one or more of the first stimulation energy or the second stimulation energy in response to the measured tissue oxygenation (Narayan, par. 0029) to provide the same predictable results as set forth above.
In regards to claim 169, Narayan teaches the measured oxygen level comprises a blood oxygenation level of the subject (par. 0029, “arterial oxygen saturation”) to provide the same predictable results as set forth above.
In regards to claim 171, Jovanov discloses further measuring feedback from the subject (col. 2, lines 23-32; col. 9, lines 35-37, “closed loop control”).
In regards to claim 172, Jovanov discloses adjusting one or more of the first stimulation energy or the second stimulation energy in response to the measured feedback (col. 2, lines 23-32; col. 9, lines 35-37, “closed loop control”).
In regards to claim 173, Jovanov discloses measuring the feedback from the subject comprises measuring one or more of a motion, a muscle contraction, a spasm, a verbal input, a visual input, a gesture, a facial expression, a cerebral oxygenation, a partial pressure of oxygen in brain tissue, a cerebral metabolic rate, a pulse rate, a blood pressure, a blood flow velocity, a pulsatility, a tissue perfusion reading, a neural activity, an electroencephalography (EEG) reading, or an electrode resistance from the subject (col. 3, lines 18-28).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Schobben et al. (US 2022/0339443, hereinafter “Schobben”). Williams discloses the essential features of the claimed invention, but does not expressly disclose that the first and second stimulation energies are delivered sequentially. However, Schobben in the same field of endeavor of electrical neural stimulation teaches providing stimulation from multiple stimulators wherein first and second stimulation energies are delivered sequentially (par. 0260) to provide the predictable results of providing effective treatment based on the specific patient and stimulator location conditions (pars. 0255, 0259, 0260). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Williams by providing stimulation from multiple stimulators wherein first and second stimulation energies are delivered sequentially to provide the predictable results of providing effective treatment based on the specific patient and stimulator location conditions.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanov in view of Narayan and further in view of Schobben. Javonov’s modified invention discloses the essential features of the claimed invention, but does not expressly disclose that the first and second stimulation energies are delivered simultaneously or sequentially. However, Schobben in the same field of endeavor of electrical neural stimulation teaches providing stimulation from multiple stimulators wherein first and second stimulation energies are delivered simultaneously or sequentially (par. 0260) to provide the predictable results of providing effective treatment based on the specific patient and stimulator location conditions (pars. 0255, 0259, 0260). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Jovanov by providing stimulation from multiple stimulators wherein first and second stimulation energies are delivered sequentially to provide the predictable results of providing effective treatment based on the specific patient and stimulator location conditions.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Hamner et al. (US 2022/0233860, hereinafter “Hamner”). Williams discloses the essential features of the claimed invention except for one or more of the first or second stimulation energies are delivered with one or more randomized stimulation parameters, the one or more stimulation parameters comprising one or more of pulse width; frequency; amplitude; pulse train duration; a delay between pulse trains; interphase duration; time between biphasic pulses; ratio of a recovery pulse to a depolarization pulse; an amount of time between altering a parameter; or a relative timing of stimulation pulse delivery between location, if using a fixed frequency. However, Hamner in the same field of endeavor of neural stimulation teaches providing stimulation wherein one or more of the first or second stimulation energies are delivered with one or more randomized stimulation parameters, the one or more stimulation parameters comprising one or more of pulse width; frequency; amplitude; pulse train duration; a delay between pulse trains; interphase duration; time between biphasic pulses; ratio of a recovery pulse to a depolarization pulse; an amount of time between altering a parameter; or a relative timing of stimulation pulse delivery between location, if using a fixed frequency (par. 0240) to provide the predictable results of synergistically improving the efficiency and efficacy of stimulation regulated by a biological signal (par. 0240). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Williams by providing stimulation wherein one or more of the first or second stimulation energies are delivered with one or more randomized stimulation parameters, the one or more stimulation parameters comprising one or more of pulse width; frequency; amplitude; pulse train duration; a delay between pulse trains; interphase duration; time between biphasic pulses; ratio of a recovery pulse to a depolarization pulse; an amount of time between altering a parameter; or a relative timing of stimulation pulse delivery between location, if using a fixed frequency to provide the predictable results of synergistically improving the efficiency and efficacy of stimulation regulated by a biological signal.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jovanov in view of Narayan and further in view of Hamner. Jovanov’s modified invention discloses the essential features of the claimed invention except for one or more of the first or second stimulation energies are delivered with one or more randomized stimulation parameters, the one or more stimulation parameters comprising one or more of pulse width; frequency; amplitude; pulse train duration; a delay between pulse trains; interphase duration; time between biphasic pulses; ratio of a recovery pulse to a depolarization pulse; an amount of time between altering a parameter; or a relative timing of stimulation pulse delivery between location, if using a fixed frequency. However, Hamner in the same field of endeavor of neural stimulation teaches providing stimulation wherein one or more of the first or second stimulation energies are delivered with one or more randomized stimulation parameters, the one or more stimulation parameters comprising one or more of pulse width; frequency; amplitude; pulse train duration; a delay between pulse trains; interphase duration; time between biphasic pulses; ratio of a recovery pulse to a depolarization pulse; an amount of time between altering a parameter; or a relative timing of stimulation pulse delivery between location, if using a fixed frequency (par. 0240) to provide the predictable results of synergistically improving the efficiency and efficacy of stimulation regulated by a biological signal (par. 0240). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Jovanov by providing stimulation wherein one or more of the first or second stimulation energies are delivered with one or more randomized stimulation parameters, the one or more stimulation parameters comprising one or more of pulse width; frequency; amplitude; pulse train duration; a delay between pulse trains; interphase duration; time between biphasic pulses; ratio of a recovery pulse to a depolarization pulse; an amount of time between altering a parameter; or a relative timing of stimulation pulse delivery between location, if using a fixed frequency to provide the predictable results of synergistically improving the efficiency and efficacy of stimulation regulated by a biological signal.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of DiLorenzo (US 2021/0322718, hereinafter “DiLorenzo”). Williams discloses the essential features of the claimed invention except for changing a rate of delivering one or more of the first or second stimulation energies in response to an occurrence of reperfusion in the subject. However, DiLorenzo in the same field of endeavor of neural stimulation teaches changing a rate of delivering one or more of the first or second stimulation energies in response to an occurrence of reperfusion in the subject (pars. 0268, 0372; closed loop control in response to sensed perfusion) to provide the predictable results of maintaining safety of stimulation (par. 0372). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Williams by changing a rate of delivering one or more of the first or second stimulation energies in response to an occurrence of reperfusion in the subject to provide the predictable results of maintaining safety of stimulation.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jovanov in view of Narayan and further in view of DiLorenzo. Jovanov’s modified invention discloses the essential features of the claimed invention except for changing a rate of delivering one or more of the first or second stimulation energies in response to an occurrence of reperfusion in the subject. However, DiLorenzo in the same field of endeavor of neural stimulation teaches changing a rate of delivering one or more of the first or second stimulation energies in response to an occurrence of reperfusion in the subject (pars. 0268, 0372; closed loop control in response to sensed perfusion) to provide the predictable results of maintaining safety of stimulation (par. 0372). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Jovanov by changing a rate of delivering one or more of the first or second stimulation energies in response to an occurrence of reperfusion in the subject to provide the predictable results of maintaining safety of stimulation.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Ackermann et al. (US 2022/0088374, hereinafter “Ackermann”). Williams discloses the essential features of the claimed invention except for one or more of the first or second stimulation energies provide a charge of between 0.5 mC to 200 mC. However, Ackerman in the same field of endeavor of neural stimulation teaches providing one or more stimulation energies providing a charge of between 0.5 mC to 200 mC (par. 0230) to provide the predictable results of effectively suppressing nerve activity (par. 0230). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Williams by providing one or more stimulation energies providing a charge of between 0.5 mC to 200 mC to provide the predictable results of effectively suppressing nerve activity.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jovanov in view of Narayan and further in view of Ackermann. Jovanov’s modified invention discloses the essential features of the claimed invention except for one or more of the first or second stimulation energies provide a charge of between 0.5 mC to 200 mC. However, Ackerman in the same field of endeavor of neural stimulation teaches providing one or more stimulation energies providing a charge of between 0.5 mC to 200 mC (par. 0230) to provide the predictable results of effectively suppressing nerve activity (par. 0230). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Jovanov by providing one or more stimulation energies providing a charge of between 0.5 mC to 200 mC to provide the predictable results of effectively suppressing nerve activity.
Claim 166 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Chowdhury et al. (US 2017/0340260, hereinafter “Chowdhury”). Williams teaches the essential features of the claimed invention, including measuring an oxygenation level of the subject as set forth above, but does not expressly disclose that the oxygenation level is measured with one or more near-infrared monitors.
However, Chowdhury in the same field of endeavor of evaluating brain function based on stimulation teaches measuring tissue oxygenation with one or more near-infrared monitors (par. 0007) to provide the predictable results of a long-accepted means for actively determining brain function in a variety of brain tissues, as the function is closely related to blood oxygenation (par. 0007).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Williams by measuring tissue oxygenation with one or more near-infrared monitors to provide the predictable results of a long-accepted means for actively determining brain function in a variety of brain tissues, as the function is closely related to blood oxygenation.
Claim 166 is rejected under 35 U.S.C. 103 as being unpatentable over Jovanov in view of Narayan, as applied to claim 1 above, and further in view of Chowdhury. Jovanov’s modified invention teaches the essential features of the claimed invention, including measuring an oxygenation level of the subject as set forth above, but does not expressly disclose that the oxygenation level is measured with one or more near-infrared monitors.
However, Chowdhury in the same field of endeavor of evaluating brain function based on stimulation teaches measuring tissue oxygenation with one or more near-infrared monitors (par. 0007) to provide the predictable results of a long-accepted means for actively determining brain function in a variety of brain tissues, as the function is closely related to blood oxygenation (par. 0007).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Jovanov by measuring tissue oxygenation with one or more near-infrared monitors to provide the predictable results of a long-accepted means for actively determining brain function in a variety of brain tissues, as the function is closely related to blood oxygenation.
Allowable Subject Matter
Claims 16 and 19 avoid the prior art, but remain rejected under section 112 above. Williams, Jovanov, Narayan and the remaining prior art, taken alone or in combination fail to disclose the combination of elements required by claims 16 and 19, including providing the first and second stimulations at a first energy ratio during a first time and a second energy ratio at a second time period following the first time period; or providing the first and second stimulation energies simultaneously at a first point and sequentially at a second point.
Response to Arguments
Applicant's arguments filed 3/10/2026 have been fully considered but they are not persuasive. Applicant argued that neither Williams nor Javonov/Narayan teach the amended claim language. However, please see the new grounds of rejection set forth above, necessitated by amendment in view of the same prior art references. Please also note the new grounds of rejection, necessitated by amendment, in view of section 112.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sitaram et al. (US 2020/0038653) is another one of many examples of utilizing near-infrared monitoring to detect brain function (par. 0083).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
Prosecution Insights