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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: figure 2B includes the following reference character “221” not mentioned in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The disclosure in at least [0021] includes expanded terms with corresponding abbreviation surrounded by “,” instead of parenthesis for example as in para. [0021] “The interval between two pulses of a pulse pair, or inter-stimulus interval, the ISI, may be 1 to 5 milliseconds, ms,” which needs to be corrected. A suggested correction for [0021] is -- The interval between two pulses of a pulse pair, or inter-stimulus interval, the ISI, may be 1 to 5 milliseconds[[, ms,]] (ms)- -.
“…The variation of interval between pulses of the pulse pair, or interpulse interval, may be used to determine an optimal interpulse interval for an individual. For example for an individual on certain day” in para.[0022] is not comprehensible and needs to be corrected.
“In general, pulse pairs comprise may comprise pulse triplets or pulse quadruplets” in [0027] needs to be corrected to --In general, pulse pairs [[comprise]] may comprise pulse triplets or pulse quadruplets--.
“Delaying or advancing the start of the next pulse train may be done with a selected time adjustment to synchronize with brain activity by up to + −3 seconds relative to the nominal inter-train interval” in [0030] needs to be corrected. A suggested correction is --Delaying or advancing the start of the next pulse train may be done with a selected time adjustment to synchronize with brain activity by up to [[+ −3]] +/- 3 seconds relative to the nominal inter-train interval--.
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. In this case, the abstract is objected to for including the form and legal phraseology often used in patent claims.
“This enables adapting timing interval parameters of a TMS session to the brain on person 170” in [0031] needs to be corrected. A suggested correction is --This enables adapting timing interval parameters of a TMS session to the brain [[on]] of person 170--.
“The efficacy of TMS to induce MEPs has been shown to increase by when using facilitatory paired-pulse TMS, ppTMS, instead of single-pulses” in [0035] needs to be corrected. A suggested correction is -- The efficacy of TMS to induce MEPs has been shown to increase by [[when]] using facilitatory paired-pulse TMS, ppTMS, instead of single-pulses--.
“1, 4 . . . 1,7 ms” in [0036], [0038] needs to be corrected to fill in “…” so the specification provides proper support for the claims. Additionally, it is not clear if Applicant is attempting to disclose permutation of ranges such as 1-7 ms or whether in light of other parameters enumerated in instant application specification as-filed [0021-0022], Applicant intended to state 1.4 ms.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claims 1, 3-5 , 14-15 are objected to for include numerous acronyms/abbreviations. At least first occurrence of each acronym/abbreviation should be spelled out in full.
Claim 1 lines 1-2 “An apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation, TMS” needs to be corrected. A suggested correction is -- An apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation[[, TMS]] (TMS) --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1 line 1 “the delivery”. There is insufficient antecedent basis for this limitation in the claim.
Claims 1 line 10 recites “the interval” in the limitation “the interval between bursts being 80 to 500 ms” . There is insufficient antecedent basis for “the interval” limitation in the claim.
Claims 1 line 11 recites “the interval” in the limitation “the interval between pulses of the at least one pulse pair is 1 to 5 ms” . There is insufficient antecedent basis for “the interval” limitation in the claim.
Claims 1 line 12 recites “the interval” in the limitation “the interval between pulse trains is 1 to 60 seconds” . There is insufficient antecedent basis for “the interval” limitation in the claim.
Each of claims 2-5 recites limitation encompassing the term “preferably” which renders respective claim unclear. The use of the word preferably in the claim language renders the respective claim indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention since it raises a "range within a range" or "broader limitation followed by narrow limitation" indefiniteness type issue. For example with respect to claim 5 , it is not clear whether you have to have any value within the specified range (10 to 30 ms) to meet the claim or whether you have to have the specific value (20 ms) that follows the word "preferably."
Regarding claim 5 and claim 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 6, the phrase "for example" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 recitation “1 to 2, 8 ms …. 1, 2 to 1, 7 ms” renders this claim unclear. More specifically, it is not clear as to whether claim 3 is attempting to recite 1 to 2 ms, 1 to 8 ms, 1 to 7 ms, 2 to 7 ms or in light of instant application specification as-filed [0021-0022], Applicant intended to recite 2.8 ms …. 1.2 to 1.7 ms.
Claim 14 recitation “the interval between pulses of one of the pulse pairs being 1,4 ms and the interval between pulses of the other pulse pair being 1,6 ms” renders this claim unclear in light of instant application specification as-filed [0021-0022]. More specifically, it is unclear as to whether Applicant intending to recite 1.4 ms…1.6 ms or whether Applicants is attempting to recite 1ms, 4 ms….1ms, 6 ms.
Dependent claims 2-15 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-15 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed para. [0027] and [0056-0061].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (Pub. No.: US 20080200749 A1, hereinafter referred to as "Zheng").
As per independent Claim 1, Zheng discloses an apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation, TMS (Zheng in at least abstract, [0001], [0003-0024], fig. 1, 3, [0052-0055] for example discloses relevant subject-matter. More specifically, Zheng in at least fig. 1, 3, abstract, [0009], [0046], [0048] for example discloses apparatus (fig. 1) for the delivery of a session of therapeutic transcranial magnetic stimulation), the apparatus comprising at least one processing core, at least one memory including computer program code, the at least one memory and the computer program code being configured to, with the at least one processing core (Zheng in at least fig. 1, 3, [0009], [0046]), cause the apparatus at least to:
define a session of transcranial magnetic stimulation, TMS, the session of TMS comprising a plurality of pulse trains, each pulse train comprising at least one burst and each burst comprising at least one pulse pair (Zheng in at least [0023], [0052]), and
send signals configured to cause delivery of the session of TMS (Zheng in at least fig. 1, [0046]), wherein
each pulse train comprises 5 to 20 bursts, the interval between bursts being 80 to 500 ms (Zheng in at least [0052]. See Zheng [0052] “inter-train frequency of 5 Hz”),
the interval between pulses of the at least one pulse pair is 1 to 5 ms (Zheng in at least [0052]. See Zheng [0052] “an intra-train frequency of 558 Hz’).
Zheng does not necessarily require interval between pulse trains is 1 to 60 seconds feature in the applied embodiment.
However, Zheng discloses alternate embodiments that disclose the interval between pulse trains is 1 to 60 seconds (Zheng in at least [0052]. See Zheng [0052] “Trains of magnetic stimulation may be outputted intermittently such as for 2 seconds, for example, in every 10 seconds”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interval between pulse trains used by the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng , in a manner that the interval between pulse trains is 1 to 60 seconds, as also taught by Zheng . A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of allowing users to set different magnetic stimulation parameters in accordance with medical requirements such as application for treating nervous or psychiatric diseases or improving brain function (Zheng, [0052]).
As per dependent Claim 2, Zheng as a whole further discloses apparatus wherein there are at least 8 pulse trains, preferably 10 to 40 pulse trains, more preferably 20 pulse trains delivered within 3 to 15 minutes, preferably within 8 minutes (Zheng at least [0040] and [0052]. see at least Zheng [0040] “pulse wave form with high frequency and small interval … adding up to 75 trains”).
As per dependent Claim 3, Zheng as a whole further discloses the apparatus wherein the interval between pulses of the at least one pulse pair is 1 to 5 ms, preferably 1 to 2, 8 ms, more preferably 1, 2 to 1, 7 ms(Zheng at least [0052]).
As per dependent Claim 4, Zheng as a whole further discloses apparatus wherein the interval between bursts is 100 to 300 ms, preferably 140 to 200 ms, more preferably 150 to 160 ms(Zheng at least [0052]).
Claims 7-8, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Jung et al. (Pub.: “N. Jung, B. Gleich, N. Gattinger, C. Höss, C. Haug, H. Siebner, V. Mall, “FV 5 Quadri-pulse theta burst stimulation using ultra-high frequency bursts at I-wave periodicity induces direction dependent bi-directional plasticity in human primary motor cortex, Clinical Neurophysiology, Volume 128, Issue 10, 2017, Page e308”, hereinafter referred to as “Jung”).
As per dependent Claim 7, Zheng discloses apparatus of claim 1 (see claim 1),
Zheng does not explicitly disclose pulse pairs comprise pulse triplets or pulse quadruplets.
However, in an analogous therapeutic transcranial magnetic stimulation field of endeavor, Jung discloses an apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation (Jung in col. 1 “quadri-pulse theta burst stimulation… TMS was applied by a custom-made magnetic stimulator”) wherein the pulse pairs comprise pulse triplets or pulse quadruplets(Jung in col. 1 “quadri-pulse theta burst stimulation.. QTBS consisted of repeated bursts of four biphasic TMS pulses (duration: 160 s) separated by ISI of 1.5 ms (666 Hz) and inter-burst intervals of 200 ms. (5 Hz)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse pairs used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, in a manner that the pulse pairs comprise pulse triplets or pulse quadruplets, as taught by Jung. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of targeting and enhancing desired brain targets via brain plasticity-inducing capability (Jung, col. 1).
As per dependent Claim 8, Zheng discloses the apparatus of claim 1 (see claim 1)
Zheng does not explicitly disclose bi-phasic pulse pairs feature.
However, in an analogous therapeutic transcranial magnetic stimulation field of endeavor, Jung discloses the apparatus wherein the pulse pairs are bi-phasic pulse pairs(Zheng, col. 1 “biphasic TMS pulses”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse pairs used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, in a manner that the pulse pairs are bi-phasic pulse pairs, as taught by Jung. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of targeting and enhancing desired brain targets via brain plasticity-inducing capability (Jung, col. 1).
As per dependent Claim 15, Zheng discloses apparatus of claim 1 (see claim 1)
Zheng does not explicitly disclose wherein the apparatus is further caused to receive real-time representations of brain activity, wherein at least one of: the initial pulse in at least one pulse train and at least some intervals, are selected based at least partly on the real-time representations of brain activity.
However, in an analogous therapeutic transcranial magnetic stimulation field of endeavor, Jung discloses apparatus wherein the apparatus is further caused to receive real-time representations of brain activity, such as EEG readings, wherein at least one of: the initial pulse in at least one pulse train and at least some intervals, are selected based at least partly on the real-time representations of brain activity (Jung, “methods”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, in a manner that apparatus is further caused to receive real-time representations of brain activity, wherein at least one of: the initial pulse in at least one pulse train and at least some intervals, are selected based at least partly on the real-time representations of brain activity, as taught by Jung. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of customize stimulation to physiological response (Jung, col. 1).
Claims 5-6, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Grill et al. (Pub. No.: WO 2014130071 A1, hereinafter referred to as “Grill”).
As per dependent Claim 5, Zheng discloses apparatus of claim 1 (see claim 1), wherein each burst comprises a plurality of pulse pairs, such as 2 to 3 pulse pairs (Zheng in at least [0023], [0052]. See at least Zheng [0023] “at least two wave forms”).
Zheng does not explicitly disclose wherein the interval between pulse pairs being 10 to 30 ms.
However, in an analogous therapeutic brain stimulation field of endeavor, Grill discloses apparatus for the delivery of a therapeutic session (Grill in at least [0010] fig. 4-5, [0072-0074] for example discloses relevant subject-matter. More specifically, Grill in at least [0010], [0072-0073] discloses apparatus/pulse generator for the delivery of a therapeutic session. See at least Grill [0072] “stimulation waveform pattern or train generated by the pulse generator … waveform comprises repeating non-regular (i.e., not constant) pulse patterns or trains, in which the interval between electrical pulses (the inter- pulse intervals or IPI) changes or varies over time.”) wherein each burst comprises a plurality of pulse pairs, such as 2 to 3 pulse pairs, the interval between pulse pairs being 10 to 30 ms, preferably 20 ms(Grill in at least fig. 4-5, [0073-0074] for example discloses each burst comprises a plurality of pulse pairs, such as 2 to 3 pulse pairs, the interval between pulse pairs being 10 to 30 ms, preferably 20 ms. See at least Grill [0073] “repeating non-regular (i.e., not constant) pulse patterns or trains can take a variety of different forms… inter-pulse intervals can be linearly cyclically ramped over time in non-regular temporal patterns (growing larger and/or smaller or a combination of each over time); or be periodically embedded in non-regular temporal patterns comprising clusters or groups of multiple pulses (called n-lets), wherein n is two or more. For example, when n=2, the n-let can be called a doublet; when n=3, the n-let can be called a triplet; when n=4, the n-let can be called a quadlet; and so on.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interval between pulse pairs used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, such that the interval between pulse pairs being 10 to 30 ms, as taught by Grill. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of using stimulation patterns or trains that produce desired or greater relief of symptoms (Grill, [0010]). A person of ordinary skill would have also been motivated to do so, with a reasonable expectation of success, for the advantage of also for making possible a reduction in the intensity of side effects, as well as an increase in the dynamic range between the onset of the desired clinical effect(s) and side effects, thereby increasing the clinical efficacy (Grill, [0072]).
As per dependent Claim 6, the combination of Zheng and Grill as a whole further discloses apparatus wherein the interval between pulse pairs varies within the session, for example, within an individual burst or between bursts(Grill in at least fig. 4-5, [0073-0074] for example discloses the interval between pulse pairs varies within the session. See at least Grill [0073] “repeating non-regular (i.e., not constant) pulse patterns or trains can take a variety of different forms… inter-pulse intervals can be linearly cyclically ramped over time in non-regular temporal patterns (growing larger and/or smaller or a combination of each over time); or be periodically embedded in non-regular temporal patterns comprising clusters or groups of multiple pulses (called n-lets), wherein n is two or more. For example, when n=2, the n-let can be called a doublet; when n=3, the n-let can be called a triplet; when n=4, the n-let can be called a quadlet; and so on.”).
As per dependent Claim 9, Zheng discloses apparatus of claim 1 (see claim 1)
Zheng does not explicitly disclose or require the interval between pulses of the at least one pulse pair varies within the session.
However, in an analogous therapeutic brain stimulation field of endeavor, Grill discloses apparatus for the delivery of a therapeutic session (Grill in at least [0010] fig. 4-5, [0072-0074] for example discloses relevant subject-matter. More specifically, Grill in at least [0010], [0072-0073] discloses apparatus/pulse generator for the delivery of a therapeutic session. See at least Grill [0072] “stimulation waveform pattern or train generated by the pulse generator … waveform comprises repeating non-regular (i.e., not constant) pulse patterns or trains, in which the interval between electrical pulses (the inter- pulse intervals or IPI) changes or varies over time.”)
wherein the interval between pulses of the at least one pulse pair varies within the session(Grill, fig. 4-5 [0010], [0073-0074] for example discloses interval between pulses of the at least one pulse pair varies within the session. [0073] “repeating non-regular (i.e., not constant) pulse patterns or trains can take a variety of different forms… inter-pulse intervals can be linearly cyclically ramped over time in non-regular temporal patterns (growing larger and/or smaller or a combination of each over time); or be periodically embedded in non-regular temporal patterns comprising clusters or groups of multiple pulses (called n-lets), wherein n is two or more. For example, when n=2, the n-let can be called a doublet; when n=3, the n-let can be called a triplet; when n=4, the n-let can be called a quadlet; and so on.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interval between pulses of the at least one pulse pair used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, in a manner that the interval between pulses of the at least one pulse pair varies within the session, as taught by Grill. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of deriving stimulation patterns or trains that produce desired or greater relief of symptoms (Grill, [0010]).
As per dependent Claim 10, Zheng discloses apparatus of claim 1 (see claim 1).
Zheng does not explicitly disclose or require the interval between pulse trains varies within the session.
However, in an analogous therapeutic brain stimulation field of endeavor, Grill discloses apparatus for the delivery of a therapeutic session (Grill in at least [0010] fig. 4-5, [0072-0074] for example discloses relevant subject-matter. More specifically, Grill in at least [0010], [0072-0073] discloses apparatus/pulse generator for the delivery of a therapeutic session. See at least Grill [0072] “stimulation waveform pattern or train generated by the pulse generator … waveform comprises repeating non-regular (i.e., not constant) pulse patterns or trains, in which the interval between electrical pulses (the inter- pulse intervals or IPI) changes or varies over time.”)
wherein the interval between pulse trains varies within the session(Grill, fig. 4-5, [0010], [0073-0074] for example discloses the interval between pulse trains varies within the session. [0073] “repeating non-regular (i.e., not constant) pulse patterns or trains can take a variety of different forms… inter-pulse intervals can be linearly cyclically ramped over time in non-regular temporal patterns (growing larger and/or smaller or a combination of each over time); or be periodically embedded in non-regular temporal patterns comprising clusters or groups of multiple pulses (called n-lets), wherein n is two or more. For example, when n=2, the n-let can be called a doublet; when n=3, the n-let can be called a triplet; when n=4, the n-let can be called a quadlet; and so on.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interval between pulse trains used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, in a manner that the interval between pulse trains varies within the session, as taught by Grill. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of deriving stimulation patterns or trains that produce desired or greater relief of symptoms (Grill, [0010]).
As per dependent Claim 11, Zheng discloses apparatus of claim 1(see claim 1).
Zheng does not explicitly disclose the number of bursts within a pulse train varies within the session.
However, in an analogous therapeutic brain stimulation field of endeavor, Grill discloses apparatus for the delivery of a therapeutic session (Grill in at least [0010] fig. 4-5, [0072-0074] for example discloses relevant subject-matter. More specifically, Grill in at least [0010], [0072-0073] discloses apparatus/pulse generator for the delivery of a therapeutic session. See at least Grill [0072] “stimulation waveform pattern or train generated by the pulse generator … waveform comprises repeating non-regular (i.e., not constant) pulse patterns or trains, in which the interval between electrical pulses (the inter- pulse intervals or IPI) changes or varies over time.”)
wherein the number of bursts within a pulse train varies within the session(Grill, fig. 4-5, [0010], [0073-0074] for example discloses number of bursts within a pulse train varies within the session. [0073] “repeating non-regular (i.e., not constant) pulse patterns or trains can take a variety of different forms… inter-pulse intervals can be linearly cyclically ramped over time in non-regular temporal patterns (growing larger and/or smaller or a combination of each over time); or be periodically embedded in non-regular temporal patterns comprising clusters or groups of multiple pulses (called n-lets), wherein n is two or more. For example, when n=2, the n-let can be called a doublet; when n=3, the n-let can be called a triplet; when n=4, the n-let can be called a quadlet; and so on.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bursts within a pulse train used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, in a manner that the number of bursts within a pulse train varies within the session, as taught by Grill. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of deriving stimulation patterns or trains that produce desired or greater relief of symptoms (Grill, [0010]).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Neuvonen et al. (Pub. No.: US 20150018692 A1, hereinafter referred to as “Neuvonen”).
As per dependent Claim 12, Zheng discloses apparatus of claim 1(see claim 1)
Zheng does not explicitly disclose wherein the second pulse in each pulse pair is from 50% to 180% of the amplitude of the first pulse.
However, in an analogous therapeutic transcranial magnetic stimulation field of endeavor, Neuvonen discloses an apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation (Neuvonen in at least abstract, fig. 1-2, [0001], [0007], [0009], [0021], [0043] for example discloses relevant subject-matter. More specifically, Neuvonen in at least abstract, fig. 1-2, [0001], [0007]. See at least Neuvonen [0007] “Transcranial Magnetic Stimulation (TMS) utilizing a bi-phasic double pulse pair from a TMS coil device to stimulate a subject”)
wherein the second pulse in each pulse pair is from 50% to 180% of the amplitude of the first pulse(Neuvonen, fig. 1-2, [0011]. See at least Neuvonen [0011] “the second pulse of the bi-phasic double pulse pair is between 5-50%, preferably between 10-20% lower than the first pulse of the bi-phasic double pulse pair”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify amplitude pulse parameter of the pulse pair used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, such that the second pulse in each pulse pair is from 50% to 180% of the amplitude of the first pulse, as taught by Neuvonen. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of obtaining measurements responsive to stimulation is simpler and more accurate as the number and intensity of stimulation can be reduced compared to standard single pulse stimulation (Neuvonen, abstract, [0005]).
As per dependent Claim 13, Zheng discloses apparatus of claim 1 (see claim 1).
Zheng does not explicitly disclose wherein the first pulse and second pulse of each pulse pair vary in amplitude relative to each other
However, in an analogous therapeutic transcranial magnetic stimulation field of endeavor, Neuvonen discloses an apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation (Neuvonen in at least abstract, fig. 1-2, [0001], [0007], [0009], [0021], [0043] for example discloses relevant subject-matter. More specifically, Neuvonen in at least abstract, fig. 1-2, [0001], [0007]. See at least Neuvonen [0007] “Transcranial Magnetic Stimulation (TMS) utilizing a bi-phasic double pulse pair from a TMS coil device to stimulate a subject”)
wherein the first pulse and second pulse of each pulse pair vary in amplitude relative to each other(Neuvonen, fig. 1-2, [0011]. See at least Neuvonen [0011] “the second pulse of the bi-phasic double pulse pair is between 5-50%, preferably between 10-20% lower than the first pulse of the bi-phasic double pulse pair”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify amplitude pulse parameter of the pulse pair used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, such that the first pulse and second pulse of each pulse pair vary in amplitude relative to each other, as taught by Neuvonen. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of obtaining measurements responsive to stimulation is simpler and more accurate as the number and intensity of stimulation can be reduced compared to standard single pulse stimulation (Neuvonen, abstract, [0005]).
As per dependent Claim 14, Zheng discloses apparatus of claim 1 (see claim 1).
Zheng does not explicitly disclose the interval between pulses of one of the pulse pairs being 1.4 ms and the interval between pulses of the other pulse pair being 1.6 ms.
However, in an analogous therapeutic transcranial magnetic stimulation field of endeavor, Neuvonen discloses an apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation (Neuvonen in at least abstract, fig. 1-2, [0001], [0007], [0009], [0021], [0043] for example discloses relevant subject-matter. More specifically, Neuvonen in at least abstract, fig. 1-2, [0001], [0007]. See at least Neuvonen [0007] “Transcranial Magnetic Stimulation (TMS) utilizing a bi-phasic double pulse pair from a TMS coil device to stimulate a subject”)
wherein there are at least two pulse pairs in a burst, the interval between pulses of one of the pulse pairs being 1.4 ms and the interval between pulses of the other pulse pair being 1.6 ms(Neuvonen, fig. 1-2, [0009], [0021]. See at least Neuvonen [0021] “interpulse interval t.sub.c for double pulses is often selected based on expected physiological effects. … double pulses used in transcranial magnetic stimulation can have can interpulse intervals ranging from, for instance, 1-20 milliseconds, corresponding to repetition frequency of 50 Hz-1000 Hz” ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the interval between pulses of the pulse pairs used in the apparatus for the delivery of a session of therapeutic transcranial magnetic stimulation as taught by Zheng, such that the interval between pulses of one of the pulse pairs being 1.4 ms and the interval between pulses of the other pulse pair being 1.6 ms, as taught by Neuvonen. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of eliciting targeted and desired physiological effects (Neuvonen, , [0009], [0021]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20150073495 A1 to Grill Jr. et al. for disclosing systems and methods for stimulation of neurological tissue generate stimulation trains with temporal patterns of stimulation, in which the interval between electrical pulses (the inter-pulse intervals) changes or varies over time similar to that disclosed. More specifically, Grill discloses the non-regular (i.e., not constant) pulse patterns or trains that embody features of the invention provide a lower average frequency.
Prior art US 20210353205 A1 to Fogel et al. discloses EEG feedback based TMS similar to that disclosed. More specifically, Fogel discloses systems and a computer implemented method for classifying a brain status of a subject, from a neural activity response of the subject to an induced TMS stimulation; the method comprising: constructing a machine learning classifier (MLC) configured to classify a subjects brain status; training the MLC using a training set, the training set comprising pairs of training output-classification vectors and their corresponding training input vectors, all extracted from a database of subjects with known brain status classifications; and applying the trained MLC on an input vector comprising features extracted from a tested-subjects brain neural activity response to the induced TMS stimulation, to obtain an output classification vector for the tested-subjects brain status.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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