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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-10 in the reply filed on 5/15/2026 is acknowledged.
Claims 1-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/2026.
Claim Rejections - 35 USC § 112(b)
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 1-10 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 1 recites the limitation "the basal forebrain" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends amending the claim to “a basal forebrain.”
Claims 2-10 are rejected due to their dependency from claim 1.
Claim 2 recites the limitation "the degeneration of a patient’s Nucleus Basalis of Meyert" in line 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends amending the claim to “a degeneration...”.
Claim 3 recites, “the subsector or region of a patient’s brain in need of functional improvement.” It is unclear what constitutes a patient’s brain in “need of functional improvement.” One of ordinary skill in the art would not be able to agree on what a brain is that is in need of functional improvement in comparison to a brain that is not in need of functional improvement. Claims 9 and 10 are rejected for the same issue.
Regarding claim 3, the use of the terms “region of a patient’s forebrain in need of functional improvement” in claim 3 is a relative term which renders the claim indefinite. The terms “functional improvement” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be able to agree on a definition for which forebrains are those in need of functional improvement, and which brains are those that are not in need of functional improvement. Therefore, the scope of the claim cannot be determined, and the claim is rendered indefinite.
Claim 4 recites, “the device” in line 1. It is unclear if this is the optical device from claim 1 or if it is a different device. The claim is therefore rendered indefinite.
Claim 4 recites, “a plurality of optical devices.” However, claim 1, which claim 4 is dependent from, only claims “the optical device” in the singular form. It is unclear how many optical devices there are, or if they are the same structure as the optical device of claim 1. The claim is therefore indefinite.
Claim 5 recites, “a plurality of segmented electrodes.” However, claim 4, which claim 5 is dependent from, recites “the electrode.” It is unclear how many electrodes there are, or if the electrodes of claim 5 are the same electrodes from claim 4 (which is also referred to as “a first electrode” in claim 1.”). The claim is therefore indefinite.
Claim 7 recites the limitation "the electrical signal" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends amending the claim to “an electrical signal.”
Claim 8 recites the limitation "the optical signal" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends amending the claim to “an optical signal.”
Claim 9 recites the limitation "the optical PBM" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 3, 9, and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2, 9, and 10 merely recite intended results or effects from the method of treating a patient, and do not recite limitations in regards to steps performed in the method. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, and 8-10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Flaherty et al. (US 10576283 B2, "Flaherty").
Regarding claim 1, Flaherty teaches A method of treating a patient comprising: optically (para. (45): "the stimulator is configured to stimulate tissue with a stimulation energy selected from the group consisting of:…optical stimulation such as visible, ultraviolet or infrared light stimulation…") modulating a target of at least one subsector or anatomic region of the basal forebrain (Fig. 1; para. (24): " In some embodiments, stimulator 100 and one or more stimulation elements 150 are constructed and arranged to stimulate brain tissue selected from the group consisting of: fornix; entorhinal cortex; hippocampus; anterior thalamic nucleus; amygdala; mammillary bodies; parahippocampal cortex; temporal neocortex; septal nuclei; nucleus basalis of Meynert"); by photobiomodulation (PBM) (para. (9): "The stimulation energy can comprise light energy, and the stimulation difference comprises a difference in a light energy deliver parameter selected from the group consisting of: intensity; average intensity; peak intensity; power level; average power level; peak power level; frequency; phase; pulse width; modulation; and combinations thereof."; para. (3): "(30) In some embodiments, stimulation element 150 is configured to deliver at least light energy, and the difference in light energy delivered between stimulation parameters 105a and 105b can comprise a difference in a light energy delivery parameter selected from the group consisting of: intensity; average intensity; peak intensity; power level; average power level; peak power level; frequency; phase; pulse width; modulation; and combinations of these.") generated from a first optical device (stimulation element 150; para. (30)) located at, adjacent to, or near the basal forebrain (Fig. 1; para. (24): " In some embodiments, stimulator 100 and one or more stimulation elements 150 are constructed and arranged to stimulate brain tissue selected from the group consisting of: fornix; entorhinal cortex; hippocampus; anterior thalamic nucleus; amygdala; mammillary bodies; parahippocampal cortex; temporal neocortex; septal nuclei; nucleus basalis of Meynert"); and electrically modulating (para. (9): "The stimulation energy can comprise electrical energy, and the stimulation difference comprises a difference in an electrical energy deliver parameter selected from the group consisting of: voltage level; average voltage level; peak voltage level; current level; average current level; peak current level; power level; average power level; peak power level; frequency; phase; duty cycle; pulse width; modulation.") a portion of the basal forebrain (Fig. 1; para. (24): " In some embodiments, stimulator 100 and one or more stimulation elements 150 are constructed and arranged to stimulate brain tissue selected from the group consisting of: fornix; entorhinal cortex; hippocampus; anterior thalamic nucleus; amygdala; mammillary bodies; parahippocampal cortex; temporal neocortex; septal nuclei; nucleus basalis of Meynert") with an electrical stimulus generated from a first electrode (para. (9): "The at least one of the first stimulation element or the second stimulation element can comprise an electrode.") positioned on a structure (Fig. 1; stimulator 100) that also carries the optical device (para. (33): "In these embodiments, the first and second stimulation elements 150 can be positioned on a single lead or multiple leads…"; Additionally, para. (9) mentions that the stimulation in the first mode can be different than the stimulation in the second mode: "…the stimulator is configured to deliver stimulation energy, and the stimulation energy delivered in the first mode is different than the stimulation energy delivered in the second mode...The stimulation energy delivered in the first mode can comprise energy selected from the group consisting of: electrical energy… light energy;…") Lastly, Fig. 2 supports that brain tissue is stimulated in the first mode (step 530) and the second mode (step 550)).
Regarding claim 2, Flaherty teaches the method of claim 1 (see above), wherein the combination of optical modulating and electrical modulating prevents the degeneration of a patient's Nucleus Basalis of Meynert. (para. (27 and 28): "In some embodiments, the brain tissue stimulated comprises brain tissue selected from the group consisting of:… nucleus basalis of Meynert.").
Regarding claim 3, Flaherty teaches the method of claim 1 (see above), wherein the target is selected for the subsector or region of patient's basal forebrain in need of functional improvement. (para. (67): " System 10 can be constructed and arranged to produce clinical benefits to the patient by modulating neurophysiologic activity in pathological circuits. The pathological circuits can be causing functional impairment in the neural elements and circuits underlying cognitive and/or memory functions, and the stimulation provided by system 10 can improve clinical and/or neurobiological outcomes that result from these pathological circuits. Stimulation provided by system 10 can be used to modulate dysfunctional networks, such as to therapeutically manipulate the levels of one or more deleterious proteins.").
Regarding claim 8, Flaherty teaches the method of claim 1 (see above), wherein the optical signal is generated in response to a determination that the patient has awoken from a period of sleep (para. (15): "The patient parameter can comprise a patient awakeness parameter, and the stimulator can transition from the first mode to the second mode as the patient falls asleep or transitions from one sleep state to another (e.g. as determined by one or more sensors)."; para. (55): "(55) In some embodiments, the stimulator is configured to stimulate in the first mode when the patient is in a first state of sleep and to stimulate in the second mode when the patient is in a second state of sleep, wherein the first state of sleep is different than the second state of sleep.").
Regarding claim 9, Flaherty teaches the method of claim 1 (see above), wherein the optical PBM is issued to cause an increased blood flow and improved neural network activity in the region or the subsector in need of functional improvement. (para. (53): "In some embodiments, the system is configured to increase blood flow of the hippocampus, increase angiogenesis and/or promote trophic release of endothelial growth factor, BDNF and/or a neuroprotective agent.").
Regarding claim 10, Flaherty teaches the method of claim 9 (see above), wherein the optical PBM is provided prior to executing tasks to condition the functional area to enhance execution of a function or task associated with the region or the subsector in need of functional improvement. (para. (63): "In some embodiments, stimulation is initiated and/or modified to achieve an acute goal (e.g. by a caregiver or the patient), such as to perform an acute task or activity in which a memory recall effect is desirable, such as can be caused by a transition between the stimulation modes of the present inventive concepts.").
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 10576283 B2, "Flaherty") in view of Wells et al. (US 20110172725 A1, "Wells").
Regarding claim 4, Flaherty teaches the method of claim 1 (see above). However, Flaherty does not expressly teach wherein the device is a lead having proximal and distal ends, the proximal end configured for attachment to an implantable pulse generator and the distal end comprising the electrode and a plurality of optical devices located at a first longitudinal position along the lead such that each optical device provides a spatially selective optical output.
Wells, in the same field of endeavor of neurostimulation with optical and electrical signals, discloses a method and apparatus for treating tissue in vivo. Wells discloses wherein a device is a lead (Fig. 7A; para. [0098]: "probe 720") having proximal (Fig. 7A; the end of 720 towards 722) and distal ends (Fig. 7; the end of 720 away from 722), the proximal end configured for attachment to an implantable pulse generator ( Fig. 7A/B; electric pulse generator shown as an input on the right end of probe 720; para. [102]) and the distal end comprising the electrode (Fig. 7; para. [0098]: "electrodes 723 and electrodes 725 shown in FIG. 7A") and a plurality of optical devices (Fig. 7B; para. [0092]: " …in some embodiments, nerve-interface unit 720 includes a first plurality of fine-pitched optical emitters 732 on one side (e.g., the lower middle) of unit 720 ") located at a first longitudinal position (para. [0091]: " In some embodiments, by providing a plurality of such finely pitched electrodes on opposite sides of nerve 11 as well as spaced longitudinally along the nerve 11, the direction across and along the nerve can be precisely controlled.") along the lead such that each optical device provides a spatially selective optical output. (para. (100): "Recently, for some embodiments, hybrid neural stimulation combining optical and electrical techniques was shown to provide spatially selective activation of nerve fibers.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Flaherty to further include the lead and electrodes, as disclosed by Wells. One of ordinary skill would recognize that the method and lead device of Wells would improve the method of Flaherty by increasing efficacy, precision, treatment, and diagnosis of nervous tissue (see Wells para. [0031]). Therefore, it would have been obvious to combine the method and lead device of Wells with the method of Flaherty.
Regarding claim 5, Flaherty, in combination with Wells, discloses the method of claim 4 (see 103 rejection above). Wells further discloses wherein the lead (Fig. 7A; para. [0098]: "probe 720") comprises a plurality of segmented electrodes (Fig. 7A/B; electrodes 724 are shown in mutliple segments) distributed in a set at a second longitudinal position along the lead (Fig. 7A/B shows the electrodes segmented with distances between each electrode 724 and distributed along the lead 720 longitudinally), the set allowing a directional electrical signal to be defined (par. [0092]: "In some embodiments, by providing a plurality of such finely pitched electrodes on opposite sides of nerve 11 as well as spaced longitudinally along the nerve 11, the direction across and along the nerve can be precisely controlled"; The electrodes along the length of probe 720 would be provide a directional signal), and the first electrode and the first optical device are spatially aligned with one another along the lead (Fig. 7B; electrodes 724 and optical emitters 732 are shown in a parallel alignment).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Flaherty to further include the lead and spatially arranged electrodes, as disclosed by Wells. One of ordinary skill would recognize that the method and lead device of Wells would improve the method of Flaherty by increasing efficacy, precision, treatment, and diagnosis of nervous tissue (see Wells para. [0031]). Therefore, it would have been obvious to combine the method and lead device of Wells with the method of Flaherty.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 10576283 B2, "Flaherty") in view of Moffitt et al. (US 20220266014 A1, "Moffitt").
Regarding claim 6, Flaherty teaches the method of claim 1 (see 102 rejection above). However, Flaherty does not expressly teach wherein the optical modulation comprises optical energy having a wavelength in the range of about 600 to 1000 nanometers.
Moffitt, in the same field of endeavor of stimulating brain stimulation (specifically, the Nucleus Basalis of Meynert), discloses methods and systems for using an implantable stimulation lead. Moffitt discloses wherein the optical modulation comprises optical energy having a wavelength in the range of about 600 to 1000 nanometers. (para. [0118]: "[0118] Any suitable wavelength, wavelength range, or combination of wavelengths can be emitted by the light delivery elements 970. In at least some embodiments, a lead 912 can include light delivery elements 970 that emit different wavelengths of light or are capable of delivering multiple wavelengths of light. In at least some embodiments, at least one of the light delivery elements 970 of a lead 912 is capable of emitting light having at least one wavelength in a range of 600 to 850 nm or in a range of 620 to 720 nm.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Flaherty to further include the ranges of wavelength delivered by a light delivery (optical device) as disclosed by Moffitt. One of ordinary skill would recognize that the disclosed wavelength ranges would improve the method of Flaherty by including methods for achieving a halting or reduction in degeneration of neurons in the Nucleus Basalis of Meynert, and by increasing the production of acetylcholine (see Moffit para. [0122]). Therefore, it would have been obvious to combine the method and wavelength parameters of Moffitt in the method of Flaherty.
Regarding claim 7, Flaherty teaches the method of claim 1 (see 102 rejection above). However, Flaherty does not expressly teach wherein the electrical signal is generated at a frequency in the range of about 20 to 80 Hz, for about 5 to about 30 seconds, followed by about 30 to about 55 seconds of rest.
Moffitt discloses wherein the electrical signal is generated at a frequency in the range of about 20 to 80 Hz, for about 5 to about 30 seconds, followed by about 30 to about 55 seconds of rest. (para.[0092]: "For example, a 60 second cycle may include 20 seconds of stimulation and 40 seconds of no stimulation resulting in a stimulation duty cycle ratio of 1:2. The duration of the cycle can be any suitable number including, but not limited to, 5, 10, 15, 20, 30, or 45 seconds or 1, 2, 5, 10, 15, 30, or 60 minutes or more, or the like. The duty cycle ratio can be any suitable ratio including, but not limited to, a ratio in a range from 1:5 to 5:1 or from 1:3 to 3:1 or from 1:5 to 1:1."; para. [0094]: "As an example, stimulation to one of the stimulation regions 762 can be delivered at a pulse rate of 20 Hz during 20 seconds of a 60 second cycle (for a duty cycle ratio of 1:2)…").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Flaherty to further include the stimulation parameters disclosed by Moffitt. One of ordinary skill would recognize that the disclosed parameters would improve the method of Flaherty by including methods for achieving a halting or reduction in degeneration of neurons in the Nucleus Basalis of Meynert, and by increasing the production of acetylcholine (see Moffit para. [0122]). Therefore, it would have been obvious to combine the method and parameters of Moffitt in the method of Flaherty.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th), 8am – noon (F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Additionally, SPE Carl Layno may be reached at (571) 272-4949.
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/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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