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 Objections
Claim 24 is objected to because of the following informalities: Claim 24 recites “the sensor for monitoring…” at Ln. 19, but should recite --the sensor further configured for monitoring--. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
The Examiner notes that the Claim 24 limitation “the system is configured to subsequently and sequentially repeat delivery of interferential stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke using different pairs or more of electrodes, each pair or more of electrodes being different from a preceding pair or more of electrodes, thereby to treat stroke in the patient” is being interpreted to mean that treatment is administered in accordance with the optimization method of Claim 1 via the system of Claim 24. This administration of treatment is being interpreted as an additional element sufficient to integrate the recited abstract ideas into a practical application. As such, Claim 24 contains patent eligible subject matter.
Claim 22 recites similar language to that noted above with respect to Claim 24, and contains patent eligible subject matter for the same reasons.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 1-21 and 23 each fall within one of the four categories of statutory subject matter.
Eligibility Step 2A, Prong One
Claims 1-21 and 23 recite abstract ideas:
Regarding Independent Claim 1:
“determining, from among the monitored or measured verbal responses…” recites a mental process when afforded its broadest reasonable interpretation. The claimed determining could practically be performed in the human mind. See MPEP 2106.04(a)(2)(III). For example, a human could observe data reflective of the various responses and exercise judgment to determine which electrode pair provide an optimum response.
“selecting the one or more pairs of electrodes …” recites a mental process when afforded its broadest reasonable interpretation. The claimed selecting could practically be performed in the human mind. See MPEP 2106.04(a)(2)(III). For example, a human could observe data reflective of the various responses, exercise judgment to determine which electrode pair provide an optimum response, and exercise judgment once more to select that electrode pair.
Regarding Claims 2-21, Claims 2-21 depend from and further limit Claim 1, and recite abstract ideas for the same reasons as does Claim 1.
Regarding Claim 23:
“administering physical or occupational therapy to the patient” recites a method of organizing human activity, and more particularly managing personal behavior or relationships or interactions between people when afforded its broadest reasonable interpretation. See MPEP 2106(a)(2)(II). “The sub-grouping ‘managing personal behavior or relationships or interactions between people’ include social activities, teaching, and following rules or instructions.” MPEP 2106(a)(2)(II)(C). Such “administrating physical or occupational therapy to the patient” as claimed amounts to teaching, training or evaluating a patient, and as such is a method of organizing human activity.
Eligibility Step 2A, Prong Two
Claims 1-21 and 23 do not recite additional elements that integrate the judicial exception into a practical application:
Regarding Independent Claim 1:
As a whole, Claim 1 is being interpreted as directed to a closed-loop optimization process. Delivery of stimulation and subsequent collection of information regarding that stimulation are thus being interpreted as data gathering steps upon which the abstract ideas of “determining” and “selecting” optimized electrode pairs are based.
“positioning a plurality of electrodes on a patient's skull” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
“delivering first interferential electrical stimulation signals…”is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
“at least one of monitoring, measuring, sensing and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery …”is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
“selecting, from among the plurality of electrodes, a second pair or more of electrodes different from the first pair or more of electrodes through which to deliver second interferential electrical stimulation signals …” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
“at least one of monitoring, sensing, measuring, and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the second interferential electrical stimulation …”
“subsequently and sequentially repeating delivery of interferential stimulation signals…” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
“at least one of monitoring, sensing, measuring and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient…”is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
Regarding Claims 2-21 and 23, Claims 2-21 and 23 do not recite any additional elements, but instead elaborate upon the additional elements recited by Claim 1.
Eligibility Step 2B
Claims 1-21 and 23 do not amount to significantly more than the abstract ideas recited therein:
Regarding Independent Claim 1:
As noted above, Claim 1 is being interpreted as directed to a closed-loop optimization process when viewed as a whole. The data gathering steps of Claim 1 do not contribute an inventive concept because their use is well-understood, routine and conventional in the art, as elaborated upon below. Such a closed loop process does not contribute an inventive concept as it itself is well-understood, routine and conventional in the art. For example, US 2022/0266027 A1 describes such closed loop process as “well known in the art” at Para. [0121].
“positioning a plurality of electrodes on a patient's skull” does not contribute an inventive concept. Such positioning of electrodes is well-understood, routine and conventional in the art. See, e.g., HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA at Pg. 2, Ln. 2-7.
“delivering first interferential electrical stimulation signals…” does not contribute an inventive concept. Such delivery of interferential stimulation is well-understood, routine and conventional in the art. See, e.g., Huang at Pg. 2, Ln. 13-15.
“at least one of monitoring, measuring, sensing and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery …” does not contribute an inventive concept. Such monitoring, measuring, sensing and recording in the context of a closed loop system is well-understood, routine and conventional in the art. See, e.g., US 2022/0266027 A1 at Para. [0121].
“selecting, from among the plurality of electrodes, a second pair or more of electrodes different from the first pair or more of electrodes through which to deliver second interferential electrical stimulation signals …” does not contribute an inventive concept. Such delivery of interferential stimulation is well-understood, routine and conventional in the art. See, e.g., Huang at Pg. 2, Ln. 13-15.
“at least one of monitoring, sensing, measuring, and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the second interferential electrical stimulation…” does not contribute an inventive concept. Such monitoring, measuring, sensing and recording in the context of a closed loop system is well-understood, routine and conventional in the art. See, e.g., US 2022/0266027 A1 at Para. [0121].
“subsequently and sequentially repeating delivery of interferential stimulation signals…” does not contribute an inventive concept. Such delivery of interferential stimulation is well-understood, routine and conventional in the art. See, e.g., Huang at Pg. 2, Ln. 13-15.
“at least one of monitoring, sensing, measuring and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient…” does not contribute an inventive concept. Such monitoring, measuring, sensing and recording in the context of a closed loop system is well-understood, routine and conventional in the art. See, e.g., US 2022/0266027 A1 at Para. [0121].
Regarding Claims 2-21 and 23, Claims 2-21 and 23 do not recite any additional elements.
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 1-6, 8-9, 12, 14, 16, 18, 20-22 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA1 (“Huang”) as evidenced by hyperphysics.phy-astr.gsu.edu, "Beat Frequency," accessed on 1/20/2026 via The Wayback Machine at https://web.archive.org/web/20230206141408/https://hyperphysics.phy-astr.gsu.edu/hbase/ Sound/beat.html; Feb. 6, 2023.
Regarding Independent Claim 1, Katnani teaches:
A method of electrically stimulating a portion of a patient's brain to treat stroke, the method comprising: (Abstract, “Systems and methods are provided for stimulating the brain of a patient to treat a medical condition;” Para. [0008], “In some applications, selective electrical stimulations triggered at specific time points during task performance may be utilized to treat patients with specific medical conditions, such as patients in recovery from traumatic brain injury (“TBI”) or stroke.”
positioning a plurality of electrodes [in] a patient's skull; (Para. [0062], “The stimulation device 300 can include one or more electrodes, or feedthroughs 302 fitted with a number of electrical contacts 306, or stimulators;” Fig. 3A, “electrodes 302”);
Fig. 3A depicts a plurality of electrodes 302 positioned “in” rather than “on” a patient’s skull. This deficiency is addressed below.
delivering first … electrical stimulation signals … through … the plurality of electrodes to or near a region of the patient's brain that has been identified as having been affected or likely to have been affected by a stroke; (Para. [0087], “In some aspects, appropriately-timed high-frequency stimulation in the caudate, nucleus accumbens, hippocampus, nucleus basalis, mammillary bodies, and other structures, can enhance memory formation and retention, treat brain injuries, or mitigate conditions such as depression or motivational issues. For instance, treatment within those regions may be of great use in treating patients with stroke, traumatic brain injury, memory disorders such as Alzheimer's Disease, or other conditions;” Fig. 6, “Provide a First Electrical Stimulation 606”);
Katnani does not disclose delivery of such “interferential” electrical stimulation as claimed, and thus does not disclose a stimulations whose signals combine in the manner claimed via such an electrode configuration as claimed. This deficiency is addressed below.
at least one of monitoring, measuring, sensing and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the first … electrical stimulation signals through the at least first … electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke; (Para. [0055], “As shown in FIG. 2A, the closed-loop system 200 may generally include a stimulation system 202 coupled to the patient and configured to deliver electrical stimulations to the patient, and a capture system 204 in communication with the stimulation system 202 and configured for gathering and evaluating patient performance, for instance, during a selected task. Specifically, the capture system 204 may generally be configured to receive and process patient input or feedback, and provide triggers or command signals to the stimulation system 202 via wired or wireless connection(s);” Para. [0058], “In some modes of operation of the closed-loop system 200, such as during the rehabilitation of a patient, various behavior or motor tasks may be provided to the patient by the capture system 204 by using audio or visual instructions, or cues. … during or upon completion of a given task, the capture system 204 can provide commands or triggers to the stimulation system 202 to stimulate the patient's brain in order to enable or enhance performance of the current task, or a future task;” Paras. [0072] through [0073]; Para. [0085]; Fig. 6, “Acquire Patient Feedback 608”);
It is noted that Katnani does not disclose “interferential electrical stimulation” using respective “pairs or more” of electrodes. Katnani does, however, disclose the remainder of the claim using non-interferential stimulation and respective electrodes. This deficiency is addressed below.
selecting, from among the plurality of electrodes, a second …electrodes different from the first … electrodes through which to deliver second … electrical stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke; (Para. [0057], “In some aspects, the implantable device 206 may be configured to deliver electrical stimulation to multiple brain regions or tissues, such as the Cd and NAcc, using appropriate stimulations and in specific relative timing;” Para. [0067], “For instance, a first electrical stimulation may be provided to a first location in the patient's brain, such as the NAcc, at a first time point while the patient is performing a task. After or during acquisition of feedback from the patient, a second electrical stimulation may then be provided to a second location in the patient's brain, such as the Cd, where the second electrical stimulation occurs at a second time point relative to the first time point, in accordance with the acquired feedback.”);
Katnani provides synchronized stimulation via two distinct electrodes (see Fig. 1, Fig. 3A) to the caudate nucleus (Fig. 1, “Cd 102”) and to the nuclear accumbens (Fig. 1, “NAcc 104”) (see Paras. [0057] and [0067]).
at least one of monitoring, sensing, measuring, and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the second … electrical stimulation signals through the at least second … of electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke; (Para. [0055], “As shown in FIG. 2A, the closed-loop system 200 may generally include a stimulation system 202 coupled to the patient and configured to deliver electrical stimulations to the patient, and a capture system 204 in communication with the stimulation system 202 and configured for gathering and evaluating patient performance, for instance, during a selected task. Specifically, the capture system 204 may generally be configured to receive and process patient input or feedback, and provide triggers or command signals to the stimulation system 202 via wired or wireless connection(s). … As described, in some aspects, such stimulations may be applied to more than one brain tissues or brain regions, and in specific relative timing;” Para. [0058]; Paras. [0072] through [0073]; Para. [0085]);
subsequently and sequentially repeating delivery of … stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke using different … electrodes, each … electrodes being different from a preceding … electrodes; (Para. [0076], “Following the second trigger, a second stimulation is then provided at a second time point, as indicated by process block 612. … In some aspects, feedback may also be acquired from the patient following the second electrical stimulation at process block 612, and analyzed to determine and report a performance of the patient;” Fig. 6, “Provide a Second Electrical Stimulation 612”);
for each … electrodes through which … electrical stimulation signals are delivered to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, at least one of monitoring, sensing, measuring and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient; (Para. [0076], “In some aspects, feedback may also be acquired from the patient following the second electrical stimulation at process block 612, and analyzed to determine and report a performance of the patient;” Para. [0055]; Para. [0058]; Paras. [0072] through [0073]; Para. [0085]);
determining, from among the monitored or measured verbal responses, motor movement responses, and muscle twitch responses of the patient corresponding to … electrical stimulation signals delivered through the different … electrodes, one or more … electrodes that provide optimum verbal responses, motor movement responses, and muscle twitch responses of the patient, and selecting the one or more … electrodes that provide at least one of optimum verbal responses, motor movement responses, and muscle twitch responses for chronic or episodic … electrical stimulation of the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, thereby to treat stroke in the patient. (Para. [0063], “In some aspects, the operational parameters may be modified based upon a patient feedback or performance, and/or brain region or tissue being stimulated;” Para. [0054], “…it is a discovery of the present disclosure that electrical stimulation applied to multiple brain tissues, in appropriate relative timing, can provide results not expected from separate stimuli. Specifically, appropriately timed NAcc stimulation in relation to stimulation of the Cd, may be performed in order to further enhance learning, motivation and association formations. As detailed below, it is a surprising finding of the present disclosure that electrical stimulation of the NAcc applied at the start interval of a task, combined with electrical stimulation of the Cd applied at the reinforcement interval of a task, enhances the performance of a patient well beyond stimulation of the Cd alone;” Para. [0057]; Para. [0067]; Para. [0123])
Katnani optimizes stimulation by a first electrode at “a first location in the patient's brain, such as the NAcc, Cd, or other location” (Para. [0074]) done in conjunction with a second electrode at “a second location in the patient's brain, such as the NAcc or Cd” (Para. [0076]) (see Paras. [0057], [0067], [0073]). Stimulation is applied by both electrodes, at both locations, at an optimized timing using optimized parameters (see, e.g., Para. [0072]). At a given time, Katnani’s optimized relative timing for stimulation is such “determining” and “selecting” as claimed.
Similarly to the invention of Claim 1, Katnani uses response in a patient performing a task as feedback in a closed loop brain stimulation process for treating stroke. Katnani differs from the invention of Claim 1 in three related ways: (1) Katnani uses implanted electrodes for stimulation; (2) Katnani does not use interferential stimulation; and (3) Katnani does not make use of such “pairs” of electrodes as claimed.
Katnani’s deficiencies are described above as being related. This is because all three differences stem from the fact that Katnani’s electrical stimulation is not transcranial interferential stimulation. As explained below, modification of Katnani such that transcranial interferential stimulation is used remedies all three deficiencies.
Thus, Katnani does not disclose:
positioning a plurality of electrodes on a patient's skull;
That is, Katnani’s electrodes are positioned “in” rather than “on” a patient’s skull.
delivering first interferential electrical stimulation signals that combine to form at least one beat frequency associated therewith through at least a first pair or more of the plurality of electrodes to or near a region of the patient's brain that has been identified as having been affected or likely to have been affected by a stroke;
That is, Katnani does not disclose delivery of such “interferential” electrical stimulation as claimed, and thus does not disclose a stimulations whose signals combine in the manner claimed via such an electrode configuration as claimed.
at least one of monitoring, measuring, sensing and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the first interferential electrical stimulation signals through the at least first pair or more of the plurality of electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “pair or more” of electrodes.
selecting, from among the plurality of electrodes, a second pair or more of electrodes different from the first pair or more of electrodes through which to deliver second interferential electrical stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke;
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “pair or more” of electrodes.
at least one of monitoring, sensing, measuring, and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the second interferential electrical stimulation signals through the at least second pair or more of the plurality of electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke;
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “pair or more” of electrodes.
subsequently and sequentially repeating delivery of interferential stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke using different pairs or more of electrodes, each pair or more of electrodes being different from a preceding pair or more of electrodes;
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “pair or more” of electrodes.
for each pair or more of electrodes through which interferential electrical stimulation signals are delivered to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, at least one of monitoring, sensing, measuring and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient;
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “pair or more” of electrodes.
determining, from among the monitored or measured verbal responses, motor movement responses, and muscle twitch responses of the patient corresponding to interferential electrical stimulation signals delivered through the different pairs or more of electrodes, one or more pairs of electrodes that provide optimum verbal responses, motor movement responses, and muscle twitch responses of the patient, and selecting the one or more pairs of electrodes that provide at least one of optimum verbal responses, motor movement responses, and muscle twitch responses for chronic or episodic interferential electrical stimulation of the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, thereby to treat stroke in the patient
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “pair or more” of electrodes.
Huang describes “Optimization of interf erential stimulation of the human brain with electrode arrays” (Title). Huang is analogous art.
Huang teaches:
positioning a plurality of electrodes on a patient's skull; (Pg. 2, Ln. 2-3, “Transcranial electric stimulation (TES) delivers weak electric current (< 2 mA) to the scalp in order to modulate neural activity of the brain…;” Pg. 2, Ln. 13-16; Pg. 3, Ln. 33-39);
That is, Huang remedies the first of Katnini’s above deficiencies as Huang teaches placement of electrodes on a patient’s skull.
delivering first interferential electrical stimulation signals that combine to form at least one beat frequency associated therewith through at least a first pair or more of the plurality of electrodes to or near a region of the patient's brain that has been identified as having been affected or likely to have been affected by a stroke; (Pg. 2, Ln. 14-16, “Recently Grossman et al. (2017) proposed to stimulate the brain with ‘interferential stimulation’ (IFS), which is well known in physical therapy (Goats, 1990). IFS applies sinusoidal waveforms of similar frequency through two electrode pairs;” Pg. 2, Ln. 31 through Pg. 3, Ln. 33, “Here we present a mathematical formulation of the optimization of IFS, including for the case of more than two electrode pairs. This allows us to systematically optimize the location of electrodes and the strength of injected currents through each electrode;” Pg. 7, Ln. 112-123)
Huang teaches such “interferential” electrical stimulation as claimed at Pg. 2, Ln. 14-16 (as well as throughout the document).
Huang teaches the use of pairs of electrodes in interferential electrical stimulation at Pg. 2, Ln. 14-16 and Pg. 2, Ln. 31 through Pg. 3, Ln. 33.
Huang teaches such a beat frequency as claimed at Pg. 7, Ln. 112-123 by virtue of Huang’s frequencies being different. See hyperphysics.phy-astr.gsu.edu, "Beat Frequency," accessed on 1/20/2026 via The Wayback Machine at https://web.archive.org/web/20230206141408/https://hyperphysics.phy-astr.gsu.edu/hbase/Sound/beat.html; Feb. 6, 2023 at Pg. 1, First Paragraph (“The beat frequency is equal to the absolute value of the difference in frequency between the two waves.”).
at least one of monitoring, measuring, sensing and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the first interferential electrical stimulation signals through the at least first pair or more of the plurality of electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke (Pg. 2, Ln. 14-16; Pg. 2, Ln. 31 through Pg. 3, Ln. 33);
selecting, from among the plurality of electrodes, a second pair or more of electrodes different from the first pair or more of electrodes through which to deliver second interferential electrical stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke; (Pg. 2, Ln. 14-16; Pg. 2, Ln. 31 through Pg. 3, Ln. 33);
at least one of monitoring, sensing, measuring, and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of the second interferential electrical stimulation signals through the at least second pair or more of the plurality of electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke; (Pg. 2, Ln. 14-16; Pg. 2, Ln. 31 through Pg. 3, Ln. 33);
subsequently and sequentially repeating delivery of interferential stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke using different pairs or more of electrodes, each pair or more of electrodes being different from a preceding pair or more of electrodes; (Pg. 2, Ln. 14-16; Pg. 2, Ln. 31 through Pg. 3, Ln. 33);
for each pair or more of electrodes through which interferential electrical stimulation signals are delivered to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, at least one of monitoring, sensing, measuring and recording at least one of verbal responses, motor movement responses, and muscle twitch responses of the patient; (Pg. 2, Ln. 14-16; Pg. 2, Ln. 31 through Pg. 3, Ln. 33);
determining, from among the monitored or measured verbal responses, motor movement responses, and muscle twitch responses of the patient corresponding to interferential electrical stimulation signals delivered through the different pairs or more of electrodes, one or more pairs of electrodes that provide optimum verbal responses, motor movement responses, and muscle twitch responses of the patient, and selecting the one or more pairs of electrodes that provide at least one of optimum verbal responses, motor movement responses, and muscle twitch responses for chronic or episodic interferential electrical stimulation of the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, thereby to treat stroke in the patient (Pg. 2, Ln. 14-16; Pg. 2, Ln. 31 through Pg. 3, Ln. 33);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Katnani with the teachings of Huang (i.e., to use such transcranial interferential stimulation as taught by Huang in the method of Katnani, thereby requiring Katnani’s electrodes to be placed on rather than in a patient’s skull, use of interferential stimulation, and use of such “pairs” of electrodes as claimed) in order to provide stimulation non-invasively (Huang at Abstract).
Regarding Claim 2, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein the interferential electrical stimulation signals are delivered simultaneously through the at least first pair or more of the plurality of electrodes. (Pg. 7, Ln. 112-116, “In inferential stimulation two fields oscillating sinusoidally at similar frequencies interfere to cause an amplitude modulation of the oscillating waveform. As an illustrating example, we show two sinusoidal electric fields E1 and E2 with frequencies f1 = 10 Hz and f2 = 11 Hz in Figure lAB (red and blue curves). These two interfere to generate a modulated waveform referred to as the carrier (Figure lCD, black curve);” Pg. 6, Figure 1 depicts simultaneous delivery of the subject signals to cause the described interference).
Regarding Claim 3, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein at least two different interferential electrical stimulation signals are delivered through at least two pairs or more of the plurality of electrodes (Pg. 7, Ln. 112-123).
Regarding Claim 4, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein the interferential electrical stimulation signals are delivered continuously over a predetermined period of time (Pg. 6, Figure 1 depicts continuous delivery over the period of time graphed).
Regarding Claim 5, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein the interferential electrical stimulation signals comprise two signals, three signals, four signals, five signals or six signals (Pg. 2, Ln. 31 through Pg. 3, Ln. 2, “Here we present a mathematical formulation of the optimization of IFS, including for the case of more than two electrode pairs.”).
Huang’s range of “more than two” overlaps the claimed range of two, three, four, five or six. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. Although Huang’s range of “more than two” does not precisely disclose the claimed range of two, three, four, five or six, it would have been obvious to select any one of two, three, four, five or six from Huang’s disclosure as doing so would be likely to result in success.
Regarding Claim 6, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein the interferential electrical stimulation signals comprise one or more of burst signals, triangular wave signals, sinusoidal wave signals, square wave signals, and ramped signals (Pg. 3, Ln. 33 through 34, “This version of IFS using arrays differs from HD-TES only in that IFS uses two sinusoidal frequencies…”).
Regarding Claim 8, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
further comprising providing the beat frequency associated with the interferential electrical stimulation signals range between about 1 Hz and about 500 Hz (Pg. 7, Ln. 116-117, “The envelope (green) of the modulated 117 carrier oscillates at the difference frequency [delta f] = 1 Hz.”).
Huang’s “1 Hz” lies inside the claimed range between about 1 Hz and about 500 Hz. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05.
Regarding Claim 9, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Katnani additionally discloses:
further comprising providing the interferential electrical stimulation signals with an amplitude ranging between about 0.5 mA and about 50 mA (Claim 6, “wherein the plurality electrical signal pulses are defined by current amplitudes between 0 and 10 milli-Amperes…”)
Katnani’s range of 0 and 10 milli-Amperes lies inside the claimed range of between 0.5 mA and about 50 mA. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05.
Regarding Claim 12, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Katnani additionally teaches
wherein the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke is at or near the motor strip of the cortex of the patient's brain (Para. [0054], “Specifically, appropriately timed NAcc stimulation in relation to stimulation of the Cd, may be performed in order to further enhance learning, motivation and association formations.”)
The NAcc and Cd are near the recited motor strip.
Regarding Claim 14, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke is between about 0.5 centimeters and about 10 centimeters beneath the patient's skull (Pg. 16, Ln. 293 through 296, “The modulation depth of IFS achieves a focal spot that is about 60% the size of that of HD-TES (1.36 cm vs. 2.12 cm at the cortical target, Figure 4; 3.27 cm vs. 5.46 cm at the deep target, Figure 5; all comparison under similar levels of modulation depth).”).
Huang states that Huang’s treatment is suitable from stroke (Pg. 2, Ln. 5), and explains that the depth to which treatment is able to penetrate is between 1.36 cm and 5.46 cm.
Huang’s range of 1.36 cm to 5.46 cm lies inside the claimed range of .5 cm to 10 cm. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. Although Huang’s range of 1.36 cm to 5.46 cm does not precisely disclose the claimed range of .5 cm to 10 cm, it would have been obvious to select any of .5 cm to 10 cm from Huang’s disclosure as doing so would be likely to result in success.
Regarding Claim 16, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein the plurality of electrodes are positioned to stimulate transdermally atop the patient’s skin and skull (Pg. 1, Ln. 2-3).
Regarding Claim 18, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
wherein the plurality of electrodes comprise between 2 electrodes and 64 electrodes (Pg. 2, Ln. 31 through Pg. 3, Ln. 2, “Here we present a mathematical formulation of the optimization of IFS, including for the case of more than two electrode pairs.”).
Huang’s range of “more than two” overlaps the claimed range of between 2 and 64. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. Although Huang’s range of “more than two” does not precisely disclose the claimed range of between 2 and 64, it would have been obvious to select any number between 2 and 64 from Huang’s disclosure as doing so would be likely to result in success.
Regarding Claim 20, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Katnani additionally teaches:
wherein the steps of delivering, monitoring, selecting, and repeating are controlled and executed by a stimulation algorithm and method (Para. [0066], “Specifically, the CPU 308 can be configured to perform a variety functions for controlling the control module 304 using instructions stored in memory 312. In some implementations, the CPU 308 may control the sending and receiving of instructions and operational parameters (for example, via a wireless transcutaneous link in the communication module 312), the storage of the operational parameters and instructions in memory 310, the transmission of the operational parameters to signal generators in the signal generation module 314, the selective triggering of the signal generators to provide electrical stimulations to various brain tissues of a patient, as well as synchronizing various functions using the real-time clock 316.”).
Regarding Claim 21, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Katnani additionally teaches:
wherein optimum verbal response of the patient, optimum movements in the patient’s limb or limbs, or optimum twitches in the patient’s limbs or muscles are determined on the basis of at least one of a range of motion of the limb or limbs, a type of muscular contraction or twitch occurring in the limb or limbs, a direction of motion of the limb or limbs, and a degree, type or volume of the patient’s verbal response to electrical stimulation (Para. [0058], “For example, tasks can include tracking a target displayed on a screen, identifying an object physically or verbally, touching a particular region of a touch screen, identifying an object verbally, using a computer mouse, manipulating objects, and so forth.”).
Regarding Claim 22, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Huang additionally teaches:
further comprising delivering chronic or episodic interferential electrical stimulation signals through the one or more pairs of electrodes that have been determined to provide optimum or desired limb or twitch movements in the patient, thereby to treat stroke in the patient, for a period of time ranging between about 1 day and about 6 months (Paras. [0123]-[0126] describe an example where treatment is administered for two weeks).
Katnani’s period of two weeks lies inside the claimed range of between 1 day and about 6 months. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. Although Katnani’s two weeks does not precisely disclose the claimed range of between 1 day and about 6 months, it would have been obvious to select any length of time between 1 day and about 6 months from Katnani’s disclosure as doing so would be likely to result in success.
Regarding Claim 24, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
Katnani additionally teaches:
A system for electrically stimulating a portion of a patient's brain to treat stroke in accordance with the method of claim 1, (Title, “Systems and methods for patient rehabilitation using brain stimulation”);
the system comprising: plurality of electrodes (Para. [0062], “The stimulation device 300 can include one or more electrodes, or feedthroughs 302 fitted with a number of electrical contacts 306, or stimulators;” Fig. 3A, “electrodes 302”);
a pulse generator, (Para. [0063], “…the stimulation device 300 may also include a control module 304 in communication with the electrical contacts 306 or sensors assembled on the feedthroughs 302. In some aspects, the control module 304 is placed subcutaneously on a patient's skull. The control module 304 may also configured to receive triggers and signals for providing electrical stimulation, for example, communicated by a capture system, as described with reference to FIGS. 2A and 2B. During operation, the control module 304 may be configured control, either individually or as a group, the electrical contacts 306 fitted on the feedthroughs 302 to deliver various electrical stimulations spanning a wide range operational parameters. For instance, electrical stimulations may be pulsed,…”);
at least one lead configured to operably connect the pulse generator to the plurality of electrodes, (Para. [0057], “As such, the implantable device 206 may include multiple implantable components (not shown in FIG. 2B), such as electrodes, or feedthroughs fitted with electrical contacts, stimulators, sensors, and other elements.”);
and a sensor configured to monitor, measure, sense and/or record at least one of (a) verbal responses of the patient (b) motor movements of one or more limbs of the patient, and (c) muscle twitch responses of the patient in response to delivery of said first … electrical stimulation signals … through at least said first … electrodes, (Para. [0059], “…the capture system 204 may also be in the form of, or include, various wearable elements, sensors, or components capable of the above-described functionalities;” Para. [0055]; Para. [0058]; Paras. [0072] through [0073]; Para. [0085]; see rejection of Claim 1, above);
wherein: the pulse generator is configured to deliver the first … electrical stimulation signals through the at least one lead to at least the first… electrodes to a region of the patient's brain that has been identified as having been affected or likely to have been affected by a stroke, (Para. [0057]; Para. [0067]; Paras. [0057] and [0067]; see rejection of Claim 1, above);
the sensor … for monitoring, measuring, sensing and/or recording the at least one of said verbal responses, motor movement responses, and muscle twitch responses of the patient in response to delivery of first … electrical stimulation signals through at least a first … electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke is operably connected to at least one other element in the system, (Para. [0060], “As described, the capture system 204 may be configured provide triggers or command signals to the stimulation system 202 to control delivery of electrical stimulations to a patient. In addition, the capture system 204 may also receive data or information from the stimulation system 202;” Para. [0055]; Para. [0058]; Paras. [0072] through [0073]; Para. [0076]; Para. [0085]; see rejection of Claim 1, above);
the system is configured to select from among the plurality of electrodes said second … electrodes different from the first …electrodes through which to deliver second … electrical stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, (Para. [0057]; Para. [0067]; see rejection of Claim 1, above);
the system and the sensor are configured to at least monitor, sense, measure and/or record at least one of (a) verbal responses, (b)motor movement responses, and (c) muscle twitch responses of the patient in response to delivery of the second … electrical stimulation signals through the at least second … electrodes to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke, (Para. [0055]; Para. [0058]; Paras. [0072] through [0073]; Para. [0085]; see rejection of Claim 1, above);
and the system is configured to subsequently and sequentially repeat delivery of… stimulation signals to the region of the patient's brain that has been identified as having been affected or likely to have been affected by the stroke using different … electrodes, each … electrodes being different from a preceding… electrodes, thereby to treat stroke in the patient. (Para. [0076]; Fig. 6, “Provide a Second Electrical Stimulation 612;” see rejection of Claim 1, above)
Huang additionally teaches:
configured to be placed on a patient's skull including at least a first pair of electrodes and a second pair of electrodes, (Pg. 2, Ln. 14-16, “Recently Grossman et al. (2017) proposed to stimulate the brain with ‘interferential stimulation’ (IFS), which is well known in physical therapy (Goats, 1990). IFS applies sinusoidal waveforms of similar frequency through two electrode pairs;” Pg. 2, Ln. 31 through Pg. 3, Ln. 33, “Here we present a mathematical formulation of the optimization of IFS, including for the case of more than two electrode pairs. This allows us to systematically optimize the location of electrodes and the strength of injected currents through each electrode.”);
As explained above in the rejection of Claim 1, Huang additionally teaches:
Huang teaches such “interferential” electrical stimulation as claimed at Pg. 2, Ln. 14-16 (as well as throughout the document).
Huang teaches the use of pairs of electrodes in interferential electrical stimulation at Pg. 2, Ln. 14-16 and Pg. 2, Ln. 31 through Pg. 3, Ln. 33.
Huang teaches such a beat frequency as claimed at Pg. 7, Ln. 112-123 by virtue of Huang’s frequencies being different. See hyperphysics.phy-astr.gsu.edu, "Beat Frequency," accessed on 1/20/2026 via The Wayback Machine at https://web.archive.org/web/20230206141408/https://hyperphysics.phy-astr.gsu.edu/hbase/Sound/beat.html; Feb. 6, 2023 at Pg. 1, First Paragraph (“The beat frequency is equal to the absolute value of the difference in frequency between the two waves.”).
Regarding Claim 25, the combination of Katnani and Huang renders obvious the entirety of Claim 24 as explained above.
Katnani additionally teaches:
wherein said system further includes instructions loaded into a non-transient memory of the pulse generator that are employed to select the second pair or more of electrodes (Para. [0066], “Specifically, the CPU 308 can be configured to perform a variety functions for controlling the control module 304 using instructions stored in memory 312. In some implementations, the CPU 308 may control the sending and receiving of instructions and operational parameters (for example, via a wireless transcutaneous link in the communication module 312), the storage of the operational parameters and instructions in memory 310, the transmission of the operational parameters to signal generators in the signal generation module 314, the selective triggering of the signal generators to provide electrical stimulations to various brain tissues of a patient, as well as synchronizing various functions using the real-time clock 316.”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA (“Huang”) as applied to Claim 1 above, and further in view of US 2004/0138722 A1 to Carroll et al. (“Carroll ‘722”).
Regarding Claim 7, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani and Huang does not disclose:
further comprising providing the interferential electrical stimulation signals with a carrier frequency ranging between about 1 kHz and about 50 kHz
Carroll ‘722 describes “Surface Stimulation For Tremor Control” (Title). Carroll is analogous art.
Carroll ‘722 teaches:
further comprising providing the interferential electrical stimulation signals with a carrier frequency ranging between about 1 kHz and about 50 kHz (Para. [0012], “ The electrical stimulator may utilize an interferential current that has a base medium frequency alternating current between 1 KHz and 100 KHz.”).
Carroll ‘722’s range of 1 kHz and 100 kHz overlaps the claimed range of 1 kHz to 50 kHz. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. Although Carroll ‘722’s range of 1 kHz and 100 kHz does not precisely disclose the claimed range of kHz to 50 kHz, it would have been obvious to select any frequency between 1 kHz to 50 kHz from Carroll ‘722’s disclosure as doing so would be likely to result in success.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Katnani and Huang with the teachings of Carroll ‘722 (i.e., to use a frequency of between 1 kHz and about 50 kHz in the manner of Carroll ‘722) in order to address motor symptoms of tremor (Carroll ‘722 at Para. [0002]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA (“Huang”) as applied to Claim 1 above, and further in view of US 2015/0005841 A1 to Pal et al. (“Pal”).
Regarding Claim 10, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani and Huang does not disclose:
further comprising providing the interferential electrical stimulation signals with an on duty cycle selected from the group consisting of about 1 second, about 2 seconds, about 5 seconds, about 10 seconds, about 20 seconds, about 30 seconds, and about 1 minutes
Pal describes “Portable transdermal electrical stimulation (TES) applicators for modifying a subject's cognitive state” (Abstract) which stimulate a patient’s brain (Para. [0005]) and make use of interferential stimulation (Para. [0009]). Pal is analogous art.
Pal teaches:
further comprising providing the interferential electrical stimulation signals with an on duty cycle selected from the group consisting of about 1 second, about 2 seconds, about 5 seconds, about 10 seconds, about 20 seconds, about 30 seconds, and about 1 minutes (Para. [0043], “ A wearable transdermal electrical stimulation (TES) applicator for modifying a subject's cognitive state may include: a body adapted to be worn against the subject's skin; a first electrode on the body; a second electrode coupled to the body by a cord; and a TES control module at least partially within the body and comprising a processor, a timer and a waveform generator, wherein the TES control module is adapted to deliver a biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent…”)
A duty cycle of 10% over a period of 10 seconds is a duty cycle of “about 1 second” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Katnani and Huang with the teachings of Pal (i.e., to use such a duty cycle as taught by Pal) in order to enhance the applied stimulation (Pal at Paras. [0051] and [0052]).
Regarding Claim 11, the combination of Katnani and Huang renders obvious the entirety of Claim 5 as explained above.
The combination of Katnani and Huang does not disclose:
further comprising providing the interferential electrical stimulation signals with an off duty cycle selected from the group consisting of about 1 second, about 2 seconds, about 5 seconds, about 10 seconds, about 20 seconds, about 30 seconds, and about 1 minute
Pal describes “Portable transdermal electrical stimulation (TES) applicators for modifying a subject's cognitive state” (Abstract) which stimulate a patient’s brain (Para. [0005]) and make use of interferential stimulation (Para. [0009]). Pal is analogous art.
Pal teaches:
further comprising providing the interferential electrical stimulation signals with an off duty cycle selected from the group consisting of about 1 second, about 2 seconds, about 5 seconds, about 10 seconds, about 20 seconds, about 30 seconds, and about 1 minute (Para. [0043], “ A wearable transdermal electrical stimulation (TES) applicator for modifying a subject's cognitive state may include: a body adapted to be worn against the subject's skin; a first electrode on the body; a second electrode coupled to the body by a cord; and a TES control module at least partially within the body and comprising a processor, a timer and a waveform generator, wherein the TES control module is adapted to deliver a biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent…”)
A duty cycle of 10% over a period of 10 seconds is an off duty cycle of 9 seconds, which is “about 10 second” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Katnani and Huang with the teachings of Pal (i.e., to use such a duty cycle as taught by Pal) in order to enhance the applied stimulation (Pal at Paras. [0051] and [0052]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA (“Huang”) as applied to Claim 1 above, and further in view of US 2023/0110411 A1 to Leuthardt et al. (“Leuthardt”).
Regarding Claim 13, the combination of Katnani and Huang renders obvious the entirety of Claim 9 as explained above.
The combination of Katnani and Huang does not disclose:
wherein the region of the patient's brain that has been affected or likely to have been affected by the stroke is identified using one or more of MRI (magnetic resonance imaging), CT (computed tomography), fMRI (functional MRI), DTI (diffusion tensor imaging) and PET (positron emission tomography) techniques
Leuthardt describes “systems and methods of detecting and affecting motoneuron excitability in a motor-impaired subject” (Para. [0003]). Leuthardt is reasonably pertinent to the problem faced by the inventor, and is thus analogous art. MPEP 2141.01(a).
Leuthardt teaches:
wherein the region of the patient's brain that has been affected or likely to have been affected by the stroke is identified using one or more of MRI (magnetic resonance imaging), CT (computed tomography), fMRI (functional MRI), DTI (diffusion tensor imaging) and PET (positron emission tomography) techniques (Para. [0067], “The patient attributes can further include CT (Computed tomography) imaging of stroke damaged nervous tissue.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Katnani and Huang with the teachings of Leuthardt (i.e., to use computed tomography for identification in the manner of Leuthardt) in order to facilitate generation of appropriate stimulation parameters (Leuthardt at Para. [0067]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA (“Huang”) as applied to Claim 1 above, and further in view of US 2021/0370063 A1 to Abouelsoud (“Abouelsoud”).
Regarding Claim 15, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani and Huang does not disclose:
wherein the plurality of electrodes are positioned subcutaneously between the patient’s skin and skull
Abouelsoud describes a “NEURAL STIMULATION DEVICE” (Title). Abouelsoud is analogous art.
Abouelsoud teaches:
wherein the plurality of electrodes are positioned subcutaneously between the patient’s skin and skull (Para. [0056], “While embodiments have been described herein as transdermal, allowing the headset to be placed on the patient's skin, it should be appreciated that embodiments can also include devices where the electrodes are placed subcutaneously, or sub-cranially.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Katnani and Huang with the teachings of Abouelsoud (i.e., to use such subcutaneously place electrodes as taught by Abouelsoud) because such a modification entails only a simple substitution of one known element for another to obtain predictable results. See MPEP 2143(B)
The prior art contained a method (i.e., the method of combined Katnani and Huang which differs from the claimed device by the substitution of some components (i.e., non-subcutaneous electrodes) with other components (i.e., subcutaneous electrodes).
The substituted components and their functions were known in the art. For example, Abouelsoud teaches use of such subcutaneous electrodes at Para. [0056].
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA (“Huang”) as applied to Claim 1 above, and further in view of US 11123549 B1 to Pannu et al. (“Pannu”)
Regarding Claim 17, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani and Huang does not disclose:
wherein the plurality of electrodes are positioned epidurally or subdurally as regards the patient's skull and brain
Pannu describes “Electrical therapy applied to the brain with increased efficacy and/or decreased undesirable side effects, and associated systems and methods” (Title). Pannu is analogous art.
Pannu teaches:
wherein the plurality of electrodes are positioned epidurally or subdurally as regards the patient's skull and brain (Abstract, “A representative method includes applying a therapy signal to a patient, via at least one electrode at a subdural or epidural location at the patient's brain, to provide effective therapy that reduces or eliminates the effects of a patient disorder.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Katnani and Huang with the teachings of Pannu (i.e., to place electrodes subdurally in the manner of Pannu) because such a modification entails only a simple substitution of one known element for another to obtain predictable results. See MPEP 2143(B)
The prior art contained a method (i.e., the method of combined Katnani and Huang which differs from the claimed device by the substitution of some components (i.e., non-subdurally placed electrodes) with other components (i.e., subdurally placed electrodes).
The substituted components and their functions were known in the art. For example, Pannu teaches use of such subdural electrodes at Abstract.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA (“Huang”) as applied to Claim 1 above, and further in view of US 2011/0106220 A1 to DeGiorgio et al. (“DeGiorgio”).
Regarding Claim 19, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani and Huang does not disclose:
Wherein the plurality of electrodes are mounted on a substrate or patch configured for placement on or in the patient’s skull
DeGiorgio describes “EXTRACRANIAL IMPLANTABLE DEVICES, SYSTEMS AND METHODS FOR THE TREATMENT OF NEUROLOGICAL DISORDERS” (Title). DeGiorgio is analogous art.
DeGiorgio teaches:
wherein the plurality of electrodes are mounted on a substrate or patch configured for placement on or in the patient's skull (Para. [0088], “Transcutaneous electrical stimulation of the supraorbital branch of the trigeminal nerve with round 1.25-inch TENS patch electrodes results in current densities and charge density/phase that are well within the limits of safety.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Katnani and Huang with the teachings of DeGiorgio (i.e., to use such patch mounted electrodes as taught by DeGiorgio) because such a modification entails only a simple substitution of one known element for another to obtain predictable results. See MPEP 2143(B)
The prior art contained a method (i.e., the method of combined Katnani and Huang which differs from the claimed device by the substitution of some components (i.e., non-patch mounted electrodes) with other components (i.e., patch mounted electrodes).
The substituted components and their functions were known in the art. For example, DeGiorgio teaches use of such patch mounted electrodes at Para. [0088].
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA (“Huang”) as applied to Claim 1 above, and further in view of US 2008/0077192 A1 to Harry et al. (“Harry”).
Regarding Claim 23, the combination of Katnani and Huang renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani and Huang does not disclose:
further comprising administering physical or occupational therapy to the patient
Harry describes “SYSTEM AND METHOD FOR NEURO-STIMULATION” (Title) for use in the context of stroke rehabilitation (Para. [0015]). Harry is analogous art.
Harry teaches:
further comprising administering physical or occupational therapy to the patient (Para. [0177], “As described previously, the neuro-stimulation system 2000 may be applied to provide sensory enhancement stimulation during stroke rehabilitation and improve neuroplasticity, i.e. the formation of lasting functional changes in the brain. For instance, the neuro-stimulation system 2000 may be applied to a subject's arm, as illustrated in FIGS. 13A and 13B, while the arm undergoes movement associated with post-stroke rehabilitative physical therapy.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Katnani and Huang with the teachings of Harry (i.e., to additionally administer physical therapy in the manner of Harry) in order to enhance post-stroke rehabilitation (Harry at Para. [0015], “In an exemplary application, the neuro-stimulation system above is employed adjunctive to movement of a body part. For example, such movement may be employed as a part of post-stroke rehabilitative therapy. By applying stimulation from the neuro-stimulation system in proximity to the region of the body affected by stroke, the neuroplastic process (the creation of new sensorimotor pathways that allow healthy areas of the brain to assume the functions of the damaged portion) is enhanced. This therapy is particularly effective when used in conjunction with physical rehabilitation procedures.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 HUANG Y, ET AL., Optimization of interferential stimulation of the human brain with electrode arrays, J Neural Eng. 2020 Jun 22; 1-12. 17(3): IOP Publishing, Philadelphia, PA, USA was disclosed by Applicant in the IDS dated 9/23/2024.