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 .
Response to Arguments
Two sets of arguments are outstanding with regard to the Non-Final Office Action dated 1/27/2026. Applicant’s first set of arguments was filed 7/27/2026, and contains the entirety of Applicant’s substantive arguments regarding the rejections set forth in the Non-Final Office Action dated 1/27/2026. Applicant’s second set of arguments was filed 8/13/2026, and is accompanied by an amendment removing language introduced in the 7/27/2026 amendment which noted as indefinite in the Examiner Interview held 8/13/2026.
Applicant’s arguments filed 8/13/2026 have been fully considered and are persuasive, in that the Examiner agrees with Applicant’s characterization of set forth at Pg. 8, Para. 2 of Applicant’s 8/13/2026 Remarks.
Applicant’s arguments filed 7/27/2026 with respect to the rejection of 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”) have been fully considered and are persuasive. Claim 1 has been amended, inter alia, to clarify the positioning of the plurality of electrodes as “under a patients scalp but above the skull.” The Examiner agrees that this amendment describes a distinct type of stimulation that is different from Huang’s, and as such that the combination of Katnani and Huang does not teach the entirety of amended Claim 1. Claim 1 has additionally been amended to recite “an array of four or more” electrodes rather than the previously recited pair or more of electrodes. The Examiner agrees that the combination of Katnani and Huang does not teach such “an array of four or more” electrodes as claimed. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 and US 2018/0117308 A1.
With respect to Applicant’s arguments filed 7/27/2026 regarding Katnani, Applicant’s arguments are not persuasive to the extent they characterize Katnani’s method as non-amenable to modification for areas other than Katnani’s described deep brain stimulation application. Katnani is relied upon herein for its general teaching of a method for optimizing stimulation to a particular brain region implicated in stroke by observing patient response to stimulation, and adjusting accordingly. Regardless of how the particular brain area stimulated by Katnani is reached (e.g., by implanted deep brain electrodes, transcranially via electric fields, etc.), one of ordinary skill in the art would view Katnani’s methodology as equally applicable, as the responses observed would be similarly indicative across all methods of stimulating the same area.
The Examiner notes that were the outstanding 35 USC 112 issues regarding the term “an array of four or more” to be resolved, the recited array may potentially differentiate Claim 1 from Katnani, depending on what specifically is being done by the array.
Applicant’s arguments filed 7/27/2026 regarding the rejection of dependent Claims 2-14, 18-19 and 21-25 are based on Applicant’s arguments regarding Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 and US 2018/0117308 A1.
Applicant’s arguments filed 7/27/2026 regarding the rejection of Independent Claim 1 under 35 USC 101 have been fully considered and are persuasive. Claim 1 has been amended to require application of stimulation in accordance with the determinations of the recited abstract ideas. The Examiner agrees that these amendments sufficiently integrate the abstract idea into a practical application. The rejection is withdrawn.
Applicant’s arguments filed 7/27/2026 regarding the rejection of dependent Claims 2-14, 18-19 and 21 and 23 are based on Applicant’s arguments regarding Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above. Therefore, the rejection has been withdrawn.
Applicant’s arguments filed 7/27/2026 regarding the objection to Claim 24 for minor informalities have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments have resolved the cited informalities. The objection is withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “under a patient’s scalp” at Ln. 3, but should recite --under the patient’s scalp--. Appropriate correction is required.
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.
Claim 1, and Claims 2-14, 18-19, 21-25 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “delivering first interferential electrical stimulation signals that combine to form at least one beat frequency associated therewith through an array of four or more of the plurality of electrodes.” The Present Specification does not provide support for this limitation, and as such it constitutes new matter.
Applicant’s 7/27/2026 Remarks cite Pg. 18, Ln. 32 through Pg. 19, Ln. 1 in support of the above limitation, which states in pertinent part: “Some examples of electrodes and electrode arrays that may be employed to deliver interferential electrical stimulation to a patient's brain include, but are not limited to, 2 or more stimulation electrodes, or 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, or 36 or more stimulation electrodes in total….” However, no mention is made of “delivering first interferential electrical stimulation signals that combine to form at least one beat frequency associated therewith through an array of four or more of the plurality of electrodes.”
The Present Specification states of the term “beat frequency” that “two frequencies of similar amplitude, but slightly disparate frequencies, can add and subtract to create a beat frequency…” (see Pg. 17, Ln. 18-21 of the Present Specification). Such “an array of four or more” electrodes as recited by Claim 1 is not described to deliver stimulation signals “that combine to form at least one beat frequency.” One of ordinary skill in the art would not understand from the Present Specification what is contemplated by the limitation.
Regarding Claim 2, Claim 2 recites “wherein the interferential electrical stimulation signals are delivered simultaneously through the first array of four or more of the plurality of electrodes.” For similar reasons as explained above with respect to Claim 1, this limitation constitutes new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, and Claims 2-14, 18-19, 21-25 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “delivering first interferential electrical stimulation signals that combine to form at least one beat frequency associated therewith through an array of four or more of the plurality of electrodes.” The Present Specification states of the term “beat frequency” that “two frequencies of similar amplitude, but slightly disparate frequencies, can add and subtract to create a beat frequency…” (see Pg. 17, Ln. 18-21 of the Present Specification). In view of the definition attributed by the Specification to the term “beat frequency,” it is unclear in what sense “an array of four or more” electrodes can be used to deliver “interferential electrical stimulation signals that combine to form at least one beat frequency.” For example, it is unclear whether the limitation is intended to convey that four “frequencies of similar amplitude, but slightly disparate frequencies, … add and subtract to create” a single beat frequency, that two sets of “two frequencies of similar amplitude, but slightly disparate frequencies, can add and subtract to create a beat frequency…,” or something else.
For purposes of this Office Action, the above limitation is being interpreted to mean that signals which could potentially combine are delivered from an array comprising four or more electrodes.
The Examiner further notes that the term “interferential electrical stimulation signals” are being interpreted as the individual signals “having frequencies of similar amplitude, but slightly disparate frequencies, [which] can add and subtract to create a beat frequency” (i.e., as the individual signals which combine and subsequently interfere). This appears consistent with both the Present Specification and the usage of the term elsewhere in the pending claims.
The Examiner notes that Pg. 17, Ln. 18-21 of the Present Specification states that “two frequencies of similar amplitude, but slightly disparate frequencies, can add and subtract to create a beat frequency, which when applied to the human body is referred to herein as interferential stimulation.” Claim 1 uses the term “interferential stimulation” without reference to the particular definition set forth at Claim 1, Ln. 4-5 (quoted above) at several points in the Claim (i.e., Ln. 14, “second interferential stimulation;” and Ln. 21, “repeating delivery of interferential stimulation”). In view of Pg. 17, Ln. 18-21 of the Present Specification, which appears to set forth a specific definition of the term “interferential stimulation,” all such uses of the term “interferential stimulation” are being interpreted similarly to the term “first interferential electrical stimulation” as explained above.
For clarity, the Examiner notes that the foregoing indefiniteness issues are based on an apparent discrepancy between how delivered signals which subsequently interfere and the signal created by that interference are referenced, and more specifically how the “array of four or more electrodes” is described as facilitating this interference.
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 previously cited US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 (“Grossman”) and US 2018/0117308 A1 to Remmert et al. (“Remmert”) as evidenced by Khatoun A. et al., "A Computational Modeling Study to Investigate the Use of Epicranial Electrodes to Deliver Interferential Stimulation to Subcortical Regions," Front. Neurosci., Vol. 15, Article 779271, December 2021 (“Khatoun”).
Regarding Independent Claim 1, Katnani teaches:
A method of electrically stimulating a portion of a patient's brain to treat effects of stroke in the patient, 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.”
(a) positioning a plurality of electrodes [in] the 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”);
Katnani’s Fig. 3A depicts a plurality of electrodes 302 positioned “in” a patient’s skull rather than “under the patient’s scalp but above the skull.”. This deficiency is addressed below.
(b) 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 identifies particular subcortical brain regions as “likely to have been affected by a stroke” and provides a first electrical stimulation to those regions.
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.
(c) monitoring, measuring, sensing and/or recording at least one of verbal responses, motor movement responses in one or more of the patient’s limbs, and muscle twitch responses of the patient in response to delivery of the first … electrical stimulation signals in step (b); (Para. [0055]; Para. [0058]; Paras. [0072] through [0073]; Para. [0085]; Fig. 6, “Acquire Patient Feedback 608;” Paras. [0080] through [0081]);
Katnani’s Paras. [0055] and [0058] describe a closed-loop system which delivers stimulation to a patient while the patient is performing a task, and “gathering and evaluating patient performance” of that task in response to the delivered stimulation. Para [0072], [0073], [0085] and Fig. 6 elaborate upon the described closed loop system.
Paras. [0080] through [0081] describe a particular embodiment of the task wherein “a patient may be directed … to speak” in response to a displayed prompt. The patient’s speech is subsequently evaluated in the manner of Paras. [0055] et seq. Such evaluation equates to “monitoring, measuring, sensing and/or recording at least one of verbal responses, motor movement responses in one or more of the patient’s limbs, and muscle twitch responses of the patient in response to delivery of the first … electrical stimulation signals in step (b)” as claimed.
It is noted that Katnani does not disclose “interferential electrical stimulation” using “an array of four or more” of electrodes. Katnani does, however, disclose the remainder of the claim using non-interferential stimulation and respective differently arranged/placed electrodes. This deficiency is addressed below.
(d) 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]).
As above, it is noted that Katnani does not disclose “interferential electrical stimulation” using “an array of four or more” of electrodes. This deficiency is addressed below.
(e) monitoring, sensing, measuring, and/or recording at least one of verbal responses, motor movement responses in one or more of the patient’s limbs, and muscle twitch responses of the patient in response to delivery of the second … electrical stimulation signals in step (d); (Para. [0055], “…stimulations may be applied to more than one brain tissues or brain regions, and in specific relative timing;” Para. [0055]; Para. [0058]; Paras. [0072] through [0073]; Para. [0085]; Fig. 6, “Acquire Patient Feedback 608;” Paras. [0080] through [0081]; Para. [0076], “…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.”);
As above, it is noted that Katnani does not disclose “interferential electrical stimulation” using “an array of four or more” of electrodes. This deficiency is addressed below.
(f) 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”);
As above, it is noted that Katnani does not disclose “interferential electrical stimulation” using “an array of four or more” of electrodes. This deficiency is addressed below.
(g) monitoring, sensing, measuring and/or recording at least one of verbal responses, motor movement responses in one or more of the patient’s limbs, and muscle twitch responses of the patient in response to each subsequent and sequential delivery of interferential stimulation signals in step (f); (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]);
(h) identifying the one or more … electrodes that provide optimum or desired verbal responses, motor movement responses, and/or muscle twitch responses 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 “identifying” as claimed.
As above, it is noted that Katnani does not disclose “interferential electrical stimulation” using “an array of four or more” of electrodes. This deficiency is addressed below.
and(i) delivering chronic or episodic interferential electrical stimulation signals to the patient through the … electrodes identified in step (h) to treat effects of stroke in the patient; wherein the iteration steps of (b)-(i) are controlled and executed by a stimulation algorithm. (Para. [0084], “The patient may be situated in an environment where a learning task may be administered (for example at home or in a clinic). An automated learning process may then be initiated such that when the patient responds appropriately to the given task, the external equipment automatically commands the implanted device to stimulate the targeted area of the patient's brain.”).
Katnani’s delivery “initiated … when the patients responds appropriately” is periodic.
As above, it is noted that Katnani does not disclose “interferential electrical stimulation” using “an array of four or more” of electrodes. This deficiency is addressed below.
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 ways: (1) Katnani uses implanted electrodes for stimulation; (2) Katnani does not use interferential stimulation; and (3) Katnani does not make use of such “array[s] of four or more” of electrodes as claimed.
Thus, Katnani does not disclose:
positioning a plurality of electrodes under a patient’s scalp but above the skull;
That is, Katnani’s electrodes are positioned “in” the patient’s skull rather than “under a patient’s scalp but above the skull.”
delivering first interferential electrical stimulation signals that combine to form at least one beat frequency associated therewith through an array of four 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.
monitoring, measuring, sensing and/or recording … in response to delivery of the first interferential electrical stimulation signals …
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “array of four or more” of electrodes.
selecting, from among the plurality of electrodes, a second array of four or more of electrodes different from the first array of four 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 “array of four or more” of electrodes.
monitoring, sensing, measuring, and/or recording … in response to delivery of the second interferential electrical stimulation signals in step (d)
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “array of four or more electrodes” 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 arrays of four or more of electrodes, each an array of four or more of electrodes being different from a preceding array of four or more electrodes;
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “array of four or more electrodes” of electrodes.
monitoring, sensing, measuring, and/or recording … in response to delivery of the second interferential electrical stimulation signals in step (f);
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “array of four or more electrodes” of electrodes.
identifying the one or more arrays of four or more electrodes that provide optimum or desired verbal responses, motor movement responses, and/or muscle twitch responses in the patient
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “array of four or more electrodes” of electrodes
delivering chronic or episodic interferential electrical stimulation signals to the patient through the one or more arrays of four or more electrodes identified in step (h) to treat effects of stroke in the patient;
That is, Katnani does not disclose “interferential electrical stimulation” using a respective “array of four or more electrodes” of electrodes.
Grossman describes “Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields” (Title). Grossman is analogous art.
Grossman teaches teaches:
positioning a plurality of electrodes under a patient’s scalp but above the skull; (Pg. 1035, Figure 3 Caption, “(A) 10 Hz stimulation with anesthetized mice bearing two electrodes … placed on the skull surface….”);
That is, Grossman teaches positioning electrodes “under a patient’s scalp but above the skull” in the context of such interferential stimulation as claimed.
delivering first interferential electrical stimulation signals that combine to form at least one beat frequency associated therewith through an array of [two] 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. 1031, Left Column, Third Paragraph, “…we applied TI [(temporal interference)] stimulation transcranially to anesthetized living mice…;” Pg. 1035, Figure 3 Caption, “(A) 10 Hz stimulation with anesthetized mice bearing two electrodes … placed on the skull surface …”);
That is, Grossman teaches such interferential stimulation as claimed applied via paired electrodes.
It is noted that Grossman does not teach “an array of four or more” electrodes, to the extent the term is best understood by the Examiner. This deficiency is addressed below.
Such generation of “at least one beat frequency” as claimed in inherent in interferential stimulation. See Khatoun at Pg. 2, Left Column, Second Paragraph (“…interferential current stimulation (IF), utilizes the concept of wave interference between two sinusoidal stimulation sources of high but slightly different frequencies (e.g., 5,000 and 5,010 Hz) applied to two pairs of TES electrodes. The high frequency fields sum to generate, at a target subcortical region, a low frequency field equivalent to the difference between the two applied high frequencies (i.e., 10 Hz),” referencing Grossman). See Pg. 17, Ln. 18-21 of the Present Specification in support of this interpretation of the term “beat frequency.”
monitoring, measuring, sensing and/or recording … in response to delivery of the first interferential electrical stimulation signals … (Pg. 1029, Summary, “We demonstrate the utility of TI stimulation by stimulating neurons in the hippocampus of living mice without recruiting neurons of the over lying cortex”);
That is, Grossman teaches such interferential stimulation as claimed.
selecting, from among the plurality of electrodes, a second array of [two] or more of electrodes different from the first array of four 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. 1029, Summary; Pg. 1031, Left Column, Third Paragraph; Pg. 1035, Figure 3 Caption);
That is, Grossman teaches such interferential stimulation as claimed applied via paired electrodes.
It is noted that Grossman does not teach “an array of four or more” electrodes, to the extent the term is best understood by the Examiner. This deficiency is addressed below.
monitoring, sensing, measuring, and/or recording … in response to delivery of the second interferential electrical stimulation signals in step (d) (Pg. 1029, Summary; Pg. 1031, Left Column, Third Paragraph; Pg. 1035, Figure 3 Caption);
That is, Grossman teaches such interferential stimulation as claimed
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 arrays of four or more of electrodes, each an array of four or more of electrodes being different from a preceding array of four or more electrodes; (Pg. 1029, Summary; Pg. 1031, Left Column, Third Paragraph; Pg. 1035, Figure 3 Caption);
That is, Grossman teaches such interferential stimulation as claimed applied via paired electrodes.
It is noted that Grossman does not teach “an array of four or more” electrodes, to the extent the term is best understood by the Examiner. This deficiency is addressed below.
monitoring, sensing, measuring, and/or recording … in response to delivery of the second interferential electrical stimulation signals in step (f); (Pg. 1029, Summary; Pg. 1031, Left Column, Third Paragraph; Pg. 1035, Figure 3 Caption);
That is, Grossman teaches such interferential stimulation as claimed applied via paired electrodes.
It is noted that Grossman does not teach “an array of four or more” electrodes, to the extent the term is best understood by the Examiner. This deficiency is addressed below.
delivering chronic or episodic interferential electrical stimulation signals to the patient through the one or more arrays of [two] or more electrodes identified in step (h) to treat effects of stroke in the patient; (Pg. 1029, Summary; Pg. 1031, Left Column, Third Paragraph; Pg. 1035, Figure 3 Caption);
That is, Grossman teaches such interferential stimulation as claimed applied via paired electrodes.
It is noted that Grossman does not teach “an array of four or more” electrodes, to the extent the term is best understood by the Examiner. This deficiency is addressed below.
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 Grossman (i.e., to use electrodes positioned under a patient’s scalp but above the skull in the manner of Grossman) in order to “non-invasively stimulat[e] neurons deep in the brain” (Grossman at Pg. 1038, Right Column, Second Paragraph (“Given the remarkable therapeutic benefits of DBS for patients with otherwise treatment-resistant movement and affective disorders …, the prospects for noninvasive DBS using electricity are potentially exciting. … TI stimulation may thus represent a practical strategy for non-invasively stimulating neurons deep in the brain.”).
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 Grossman (i.e., to use such interferential stimulation as taught by Grossman in the method of Katnani) in order to “non-invasively stimulat[e] neurons deep in the brain” (Grossman at Pg. 1038, Right Column, Second Paragraph (“Given the remarkable therapeutic benefits of DBS for patients with otherwise treatment-resistant movement and affective disorders …, the prospects for noninvasive DBS using electricity are potentially exciting. … TI stimulation may thus represent a practical strategy for non-invasively stimulating neurons deep in the brain.”).
The Examiner notes that such paired electrodes as used by Grossman is implicit in Grossman’s interferential stimulation. See Grossman at Pg. 1032, Right Column, Second Paragraph; Khatoun at Pg. 2, Left Column, Second Paragraph.
The combination of Katnani and Grossman does not disclose such “an array of four or more” electrodes as claimed.
Remmert describes “An electrode for the electrical stimulation of brain tissue or other tissue of a patient is configured for location between skull and scalp of the patient.” Remmert is analogous art.
Remmert teaches:
“an array of four or more” electrodes (Para. [0036], “ The electrode array consists of one central disc-type electrode and at least two, preferentially four secondary disc-type electrodes.”).
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 Grossman with the teachings of Remmert (i.e., to use such an array of four or more electrodes as taught by Remmert in the method of combined Katnani and Grossman) in order to increase efficiency of stimulation (see Remmert at Paras. [0003] through [0005]).
Regarding Claim 2, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Grossman additionally teaches:
wherein the interferential electrical stimulation signals are delivered simultaneously through the first array of four or more of the plurality of electrodes. (Pg. 1037, Figure 4 Caption, “High-frequency stimulating currents … were simultaneously applied…”).
Regarding Claim 3, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Grossman additionally teaches:
wherein at least two different interferential electrical stimulation signals are delivered through at least two arrays of four or more of the plurality of electrodes. (Pg. 1036, Right Column, First Paragraph, “Changing the difference frequency between 1 Hz and 15 Hz changed the motion frequency accordingly…”).
Regarding Claim 4, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Grossman additionally teaches:
wherein the interferential electrical stimulation signals are delivered continuously over a predetermined period of time (Pg. e3, Fourth Paragraph, “10 s intervals of electrical stimulation, with 0.25 s ramp-on and ramp-off periods, were applied interspersed with 10 s rest intervals over a 20 min experimental time course.”).
Regarding Claim 5, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Grossman additionally teaches:
wherein the interferential electrical stimulation signals comprise two signals, three signals, four signals, five signals or six signals (Pg. 1036, Right Column, First Paragraph, “Changing the difference frequency between 1 Hz and 15 Hz changed the motion frequency accordingly…”).
Regarding Claim 6, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Grossman 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. e3, Fourth Paragraph, “10 s intervals of electrical stimulation, with 0.25 s ramp-on and ramp-off periods, were applied interspersed with 10 s rest intervals over a 20 min experimental time course.”).
Regarding Claim 8, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Grossman 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. 1031, Right Column, Second Paragraph, “We found that interferential stimulation (with two sinusoids at 2.01 kHz and 2 kHz, resulting in a Df envelope frequency of 10 Hz) was able to recruit neural firing in synchronization with the envelope.”)
Regarding Claim 9, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Grossman additionally discloses:
further comprising providing the interferential electrical stimulation signals with an amplitude ranging between about 0.5 mA and about 50 mA (Pg. 1030, Figure 1 caption, “I1 and I2 are applied at kHz frequencies f1 (1 mA at 1 kHz in this example, applied across the gray electrodes) and f2 (1 mA at 1.04 kHz, across the blue electrodes)…”)
Regarding Claim 12, the combination of Katnani, Grossman and Remmert 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, Grossman and Remmert 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 between about 0.5 centimeters and about 10 centimeters beneath the patient's skull 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.”)
Regarding Claim 18, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani, Grossman and Remmert does not disclose:
wherein the plurality of electrodes comprise between 6 electrodes and 64 electrodes
However, it would have bene obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Katnani, Grossman and Remmert such that the plurality of electrodes comprise between 6 electrodes and 64 electrodes because such a modification entails a mere duplication of parts, which is a common practices which the court has held normally requires only ordinary skill in the art and hence is considereda routine expedient. MPEP 2144.04(VI)(B).
Regarding Claim 21, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
Katnani additionally teaches:
wherein optimum verbal response of the patient, motor movement responses and/or muscle twitch responses of the patient 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 24, the combination of Katnani, Grossman and Remmert 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 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 configured 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 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)
As explained above in the rejection of Claim 1, Grossman additionally teaches:
configured to be placed under a patient's scalp but above the skull, wherein said plurality includes a first array of at least four of electrodes and a second array of at least four of electrodes that differs from the first array of four or more 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.”);
Grossman additionally teaches positioning electrodes “under a patient’s scalp but above the skull” as claimed at Pg. 1035, Figure 3 Caption.
Grossman teaches such “interferential” electrical stimulation as claimed at Pg. 1031, Left Column, Third Paragraph.
Grossman teaches such a beat frequency as claimed at g. 1031, Left Column, Third Paragraph. See Khatoun at Pg. 2, Left Column, Second Paragraph.
As explained above in the rejection of Claim 1, Remmert additionally teaches such an “an array of four or more” electrodes as claimed at Para. [0036].
Regarding Claim 25, the combination of Katnani, Grossman and Remmert 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 array of four or more (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 previously cited US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 (“Grossman”) and US 2018/0117308 A1 to Remmert et al. (“Remmert”) as evidenced by Khatoun A. et al., "A Computational Modeling Study to Investigate the Use of Epicranial Electrodes to Deliver Interferential Stimulation to Subcortical Regions," Front. Neurosci., Vol. 15, Article 779271, December 2021 (“Khatoun”) 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, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani, Grossman and Remmert 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, Grossman and Remmert 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 previously cited US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 (“Grossman”) and US 2018/0117308 A1 to Remmert et al. (“Remmert”) as evidenced by Khatoun A. et al., "A Computational Modeling Study to Investigate the Use of Epicranial Electrodes to Deliver Interferential Stimulation to Subcortical Regions," Front. Neurosci., Vol. 15, Article 779271, December 2021 (“Khatoun”) 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, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani, Grossman and Remmert 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, Grossman and Remmert 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, Grossman and Remmert renders obvious the entirety of Claim 5 as explained above.
The combination of Katnani, Grossman and Remmert 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, Grossman and Remmert 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 previously cited US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 (“Grossman”) and US 2018/0117308 A1 to Remmert et al. (“Remmert”) as evidenced by Khatoun A. et al., "A Computational Modeling Study to Investigate the Use of Epicranial Electrodes to Deliver Interferential Stimulation to Subcortical Regions," Front. Neurosci., Vol. 15, Article 779271, December 2021 (“Khatoun”) 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, Grossman and Remmert renders obvious the entirety of Claim 9 as explained above.
The combination of Katnani, Grossman and Remmert 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, Grossman and Remmert 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 19 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 (“Grossman”) and US 2018/0117308 A1 to Remmert et al. (“Remmert”) as evidenced by Khatoun A. et al., "A Computational Modeling Study to Investigate the Use of Epicranial Electrodes to Deliver Interferential Stimulation to Subcortical Regions," Front. Neurosci., Vol. 15, Article 779271, December 2021 (“Khatoun”) 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, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani, Grossman and Remmert 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, Grossman and Remmert 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, Grossman and Remmert 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 22 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 (“Grossman”) and US 2018/0117308 A1 to Remmert et al. (“Remmert”) as evidenced by Khatoun A. et al., "A Computational Modeling Study to Investigate the Use of Epicranial Electrodes to Deliver Interferential Stimulation to Subcortical Regions," Front. Neurosci., Vol. 15, Article 779271, December 2021 (“Khatoun”) as applied to Claim 1 above, and further in view of previously cited 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”).
Regarding Claim 22, the combination of Katnani, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani, Grossman and Remmert does not disclose:
wherein the delivery of chronic or episodic interferential electrical stimulation signals in accordance with step (i) is performed for a period of time ranging between about 1 day and about 6 months
Huang teaches:
wherein the delivery of chronic or episodic interferential electrical stimulation signals in accordance with step (i) is performed 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.
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 Katnani, Grossman and Remmert with the teachings of Huang (i.e., to perform Katnani’s stimulation for such a duration as taught by Huang) because such a modification entails mere scaping up of a prior art process capable of being scaled up, and as such constitutes a change in proportion which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. MPEP 2144.04(IV)(A); see also In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2017/0281946 A1 to Katnani et al. (“Katnani”) in view of Grossman N. et al., "Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields," Cell, Volume 169, Issue 6, pg. 1029-1041, e16, June 01, 2017 (“Grossman”) and US 2018/0117308 A1 to Remmert et al. (“Remmert”) as evidenced by Khatoun A. et al., "A Computational Modeling Study to Investigate the Use of Epicranial Electrodes to Deliver Interferential Stimulation to Subcortical Regions," Front. Neurosci., Vol. 15, Article 779271, December 2021 (“Khatoun”) 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, Grossman and Remmert renders obvious the entirety of Claim 1 as explained above.
The combination of Katnani, Grossman and Remmert does not disclose:
further comprising the step of concurrently or subsequently 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 the step of concurrently or subsequently 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, Grossman and Remmert 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
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 CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights