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 .
Examiner Note
Claims dated 02/16/2026 are annotated in a manner that is not clearly understood. For example claim 2 includes annotation such as “[,]” which includes both underline annotation to indicate addition of text and also the annotation “[]” to delete albeit deletion being incorrectly and incompletely indicated. Claims presented in Preliminary Amendment dated 02/16/2026 are thus non-compliant per 37 CFR 1.121.
Examiner suggests Applicants follow claim amendment manner of making amendments recommendation as enumerated in MPEP 714 (c) and II. MANNER OF MAKING AMENDMENTS UNDER 37 CFR 1.121 section C. Amendments to the Claims.
In the interest of furthering prosecution, elected claims as presented in claims dated 08/26/2022 are being examined on the merits in the current Office Action.
Restriction/Election
Applicant’s election without traverse of claim 1-21 and 26-43 drawn to Group II and magnetic stimulation species A in the reply filed on 02/10/2026 is acknowledged.
Examiner notes that claims 34-42 are drawn to non-elected electrical stimulation species B and thus, are being withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Thus, claim 22-25 and 34-42 are being withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/02/2011.
Currently, claims 1-21 and 26-33 and 43 are being examined on the merits as being drawn to Group II and magnetic stimulation species A in this Office Action.
Specification
The disclosure is objected to because of the following informalities:
“…The neuromodulation can inhibit or enhance neuronal-synaptic transmission or muscle-synaptic transmission between neuron and muscle fibers The variable pulse electric or magnetic stimulation varies based on one or more mean and standard deviations of biological variables… “ in abstract needs to be corrected. A suggested correction is --The neuromodulation can inhibit or enhance neuronal-synaptic transmission or muscle-synaptic transmission between neuron and muscle fibers. The variable pulse electric or magnetic stimulation varies based on one or more mean and standard deviations of biological variables--.
“The presentation application claims benefit to Provisional application Ser. 63/238,218 filed Aug. 29, 1921 which is incorporated herein by reference” on page 1 needs to be corrected. A suggested correction is --The presentation application claims benefit to Provisional application Ser. 63/238,218 filed Aug. 29, 1921 which is incorporated herein by reference.-
At least first occurrence of the acronym/abbreviation “TTL” needs to be expanded in the disclosure.
“A 41-year-old male experienced deep sea scuba diver involved in a dive greater than 150 feet below the surface of the ocean resurfaced too quickly that resulted in paralysis from his waist down for a period of 7.5 years” in page 8 needs to be corrected. A suggested correction is -- A 41-year-old male [[experienced]] deep sea scuba diver involved in a dive greater than 150 feet below the surface of the ocean resurfaced too quickly that resulted in paralysis from his waist down for a period of 7.5 years--.
“When the power source (not shown) is turned on, an electric current pass through the coiled wires producing a magnetic field” in page 9 needs to be corrected. A suggested correction is -- When the power source (not shown) is turned on, an electric current passes through the coiled wires producing a magnetic field--.
“FIG. 5 shows a permanent magnetic stimulation device of the present invention that contains a permanent magnetic 51 and a power source 52 When the power source is turned on, the permanent magnet rotates to produce a magnetic field” in page 10 needs to be corrected. A suggested correction is -- FIG. 5 shows a permanent magnetic stimulation device of the present invention that contains a permanent magnetic 51 and a power source 52. When the power source is turned on, the permanent magnet rotates to produce a magnetic field--.
Appropriate correction is required.
Specification lacks any line or paragraph numbers making it hard to reference. One of line or paragraph numbers is requested.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 26 “the area” needs to be corrected. A suggested correction is – [[the]] an area – in light of lack of any antecedent for the term “area” in the claim.
Each of claims 1-7, 9-26 and 28-43 recite “wherein” clauses which need to be corrected to include a “,” before “wherein”. For example amend claim 1 “applying magnetic stimulation to the patient wherein the magnetic stimulation comprises variable magnetic pulses” to -- applying magnetic stimulation to the patient, wherein the magnetic stimulation comprises variable magnetic pulses--, amend claim 2 “method claim 1 wherein the variable magnetic pulses are random” to -- method claim 1, wherein the variable magnetic pulses are random--.
Claims 5, 12 , 15-17, 21, 26, 31 include numerous acronyms/abbreviations. At least first occurrence of each acronym/abbreviation should be spelled out in full.
Claim 26 needs to corrected to include a “.” at the end of the claim.
Claim 5 recites “a frequency range of from 30 to 150 Hz and a wide pulse interval of from 33.3 msec to 6.7 msec” which needs to be corrected. A suggested correction is -- a frequency range of [[from]] 30 to 150 Hz and a wide pulse interval of [[from]] 33.3 msec to 6.7 msec – or -- a frequency range [[of]] from30 to 150 Hz and a wide pulse interval [[of]] from 33.3 msec to 6.7 msec –.
Claim 19 “the magnetic pulses in a preferred pattern of noise” needs to be corrected. A suggested correction is -- the magnetic pulses are in a preferred pattern of noise--.
Claim 21 “frequency range of from 30 to 150 Hz and a pulse interval of from 33.3 msec to 6.7 msec” needs to be corrected. A suggested correction is -- frequency range [[of]] from 30 to 150 Hz and a pulse interval [[of]] from 33.3 msec to 6.7 msec—or --frequency range of [[from]] 30 to 150 Hz and a pulse interval of [[from]] 33.3 msec to 6.7 msec--.
Claim 26 “a wide frequency range of from 30 to 150 Hz and a wide pulse interval of from 33.3 msec to 6.7 msec” needs to be corrected. A suggested correction is -- a wide frequency range [[of]] from 30 to 150 Hz and a wide pulse interval [[of]] from 33.3 msec to 6.7 msec--.
Claim 27 “method of claim 26 the magnetic stimulation has a white noise pattern” needs to be corrected. A suggested correction is -- method of claim 26, wherein the magnetic stimulation has a white noise pattern--.
Clam 29 line 2 recites “a patient” needs to be corrected. A suggested correction is –[[a]] the patient—in light of its antecedent in claim 29 line 1.
Claim 29 is objected to missing steps (a-d). Please note, claim 29 includes steps (e-h) and appears to be missing steps (a-d).
Claim 9 line 1 “method claim 8” needs to be corrected to -- method of claim 8--.
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.
Claims 2, 4-7, 9-17, 19-21, 27, 29-33, 43 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.
Each of claim 15 and claim 29 recite “biometric character of a patient” and “biometric data set” which renders the claims unclear. More specifically, it is unclear as to what is meant by “biometric character of a patient” and “biometric data set” in the context used in the respective claims.
Each of claim 15 and claim 29 recites “mean and standard deviations of the biological variables” which renders this claim unclear. More specifically, since mean and standard deviation are computed from numeric values and not variables, it is unclear as to what is meant by “mean and standard deviations of the biological variables” in the context used. It is unclear as to how variables are used to generate mean and standard deviations here.
Each of claim 9 and claim 12 recite the limitation " the variable magnetic pulses ". There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation " the magnetic pulses ". There is insufficient antecedent basis for this limitation in the claim.
Claim 15 in lines 9-10 recites “the biological variables”. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 in lines 9-10 recites “the biological variables”. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “the magnetic pulses”. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 in line 1 recites “the white noise”. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “variable magnetic pulses are random” which renders this claim unclear. More specifically, in the context used, it is unclear as to in what manner are the pulses random i.e. frequency, duration, amplitude or the target they are applied to or something else.
Each of claim 16-17 recite the limitation "the biometric character". There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “pink noise”, “violet noise”, “blue noise”, “brown noise” or “red noise” which renders this claim unclear. More specifically, it is unclear as to what is meant by “pink noise”, “violet noise”, “blue noise”, “brown noise” or “red noise” . Still more specifically, in the context used, it is unclear as to what distinguishes one category from the other i.e. amplitude, frequency, wavelength, duration or subject’s response or something else.
Claim 11 recites “pink noise”, “violet noise”, “blue noise”, “brown noise” or “red noise” which renders this claim unclear. More specifically, it is unclear as to what is meant by “pink noise”, “violet noise”, “blue noise”, “brown noise” or “red noise” . Still more specifically, in the context used, it is unclear as to what distinguishes one category from the other i.e. amplitude, frequency, wavelength, duration or subject’s response or something else.
Claim 9 recites “variable magnetic pulses are random” which renders this claim unclear. More specifically, in the context used, it is unclear as to in what manner are the pulses random i.e. frequency, duration, amplitude or the target they are applied to or something else.
Claim 31 in line 1 recites “the variables” which renders this claim unclear. More specifically, it is unclear as to whether claim 31 line 1 “the variables” is referencing claim 29 line 6 “one or more variables” and/or claim 29 line 10 “biological variables”.
Dependent claims 5-7, 11-14, 16-17, 19-20, 30-33, 43 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 5-7, 11-14, 16-17, 19-20, 30-33, 43 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16-17, and 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph for the following reasons:
Each of claims 16-17 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. More specifically, each of claims 16-17 recite “the biometric character” and thus each is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Dependent claims 19-20 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(d) issue in their respective base claims. Consequently, dependent claims 19-20 are also rejected under 35 U.S.C. 112(d) 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 page 5-8, page 10.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 15, 29-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Phillips et al. (Pub. No.: US 20210146151 A1, hereinafter referred to as “Phillips”).
As per independent Claim 1, Phillips discloses a method of masking a signal at a peripheral neuromuscular junction (NMJ) in a patient (Phillips in at least abstract, [0004], [0006-0010], [0019-0020], [0028], [0037], [0074-0078], [0119], [0147], [0274], [0298-0300], [0303-0308], [0321], [0571], [0631] for example discloses relevant subject-matter. More specifically, Phillips in at least [0006-0007], [0013-0015], [0274], [0119] for example discloses method of at least partially masking a signal at a peripheral neuromuscular junction (NMJ) in a patient. See at least Phillips [0006] “methods of treating a subject, comprising determining the intrinsic frequency (f) of the subject within the specified EEG band by: obtaining EEG data of the subject's brain… if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject.”; [0119] “applying of the magnetic field is to the motor cortex of the subject”) which comprises applying magnetic stimulation to the patient wherein the magnetic stimulation comprises variable magnetic pulses (Phillips in at least [0007], [0009-0010], [0019-0020] for example discloses applying magnetic stimulation to the patient wherein the magnetic stimulation comprises variable magnetic pulses. See at least Phillips [0007] “using a Transcranial Magnetic Stimulation (TMS) device for influencing an intrinsic frequency of a subject within a specified EEG band”; [0009] “the magnetic field is generated by a Transcranial Magnetic Stimulation device which generates the magnetic field using an electromagnetic coil”; [0010] “a frequency of the magnetic field with the specified EEG band is from about 0.5 Hz to about 100 Hz”; [0019] “pulsed magnetic fields may be intermittently applied or delivered a target nerve, muscle or tissue without causing habituation of the target nerve, muscle or tissue. Such intermittent magnetic fields may be used to treat chronic conditions, e.g., chronic pain, without causing habituation.”).
As per dependent Claim 2, Phillips further discloses method wherein the variable magnetic pulses are random (Phillips in at least [0010], [0020] for example discloses the variable magnetic pulses within specified EEG band are random. See at least Phillips [0010] “a frequency of the magnetic field with the specified EEG band is from about 0.5 Hz to about 100 Hz”; [0020] “the EEG band is the alpha band, and the mean frequency ranges from about 8 Hz to about 13 Hz”).
As per dependent Claim 3, Phillips further discloses method wherein the magnetic pulses are delivered in a designed pattern of noise (Phillips in at least [0020], [0147] for example discloses the magnetic pulses are delivered in a designed pattern of noise. See Phillips [0020] “the EEG band is the alpha band, and the mean frequency ranges from about 8 Hz to about 13 Hz”; [0147] “devices comprise a white noise generator”).
As per dependent Claim 4, Phillips further discloses method wherein the pattern of noise is white noise, pink noise, violet noise, blue noise, brown noise or red noise (Phillips in at least [0020], [0147] for example discloses the pattern of noise is white noise, pink noise, violet noise, blue noise, brown noise or red noise. See at least Phillips [0020] “the EEG band is the alpha band, and the mean frequency ranges from about 8 Hz to about 13 Hz”; [0147] “devices comprise a white noise generator”).
As per dependent Claim 5, Phillips further discloses method wherein the variable magnetic pulses are a heterogenous mixture of magnetic pulses over a frequency range of from 30 to 150 Hz and a wide pulse interval of from 33.3 msec to 6.7 msec (Phillips in at least [0010] discloses wherein the variable magnetic pulses are a heterogenous mixture of magnetic pulses over a frequency range of from 30 to 150 Hz and a wide pulse interval of from 33.3 msec to 6.7 msec. See at least Phillips [0010] “a frequency of the magnetic field with the specified EEG band is from about 0.5 Hz to about 100 Hz”).
As per dependent Claim 6, Phillips further discloses method wherein the stimulation masks neuronal transmission (Phillips in at least [0006], [0274] for example discloses stimulation masks neuronal transmission. See at least Phillips [0006] “methods of treating a subject, comprising determining the intrinsic frequency (f) of the subject within the specified EEG band by: obtaining EEG data of the subject's brain… performing a Fast Fourier Transformation, X(f), on the EEG data; and achieving a fitted Gaussian curve, A(f), of the EEG data…the first standard of deviation, and the first mean frequency are replaced with a second gain, a second standard of deviation, and a second mean frequency, respectively, until the three parameters are optimized, comparing the intrinsic frequency from step (a) to an average intrinsic frequency of a healthy population database; if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject”;).
As per dependent Claim 7, Phillips further discloses method wherein the magnetic stimulation is used to treat pain (Phillips in at least [0013-0015] for example discloses magnetic stimulation is used to treat pain. See at least Phillips [0014] “method is adapted to improve neuropathic pain”; [0015] “method is adapted to improve a neurological disorder, wherein the neurological disorder comprises at least one of…lower back pain, neck pain, other generalized neuropathic pain…a complex regional pain syndrome.”).
As per independent Claim 15, Phillips discloses a method of magnetic neuromodulation in a patient (Phillips in at least abstract, [0004], [0006-0010], [0019-0020], [0028], [0037], [0074-0078], [0119], [0147], [0274], [0298-0300], [0303-0308], [0321], [0571], [0631] for example discloses relevant subject-matter. More specifically, Phillips in at least [0006-0007], [0013-0015], [0119], [0274] for example discloses method of magnetic neuromodulation in a patient. See at least Phillips [0006] “methods of treating a subject, comprising determining the intrinsic frequency (f) of the subject within the specified EEG band by: obtaining EEG data of the subject's brain… shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject.”;) which comprises:
a. measuring a biometric character of a patient resulting in a biometric data set (Phillips in at least [0006], [0274] for example discloses measuring a biometric character of a patient resulting in a biometric data set. See at least Phillips [0006] “obtaining EEG data of the subject's brain”),
b. comparing the biometric data set of (a) with a normative database to determine if the patient needs neuromodulation (Phillips in at least [0006] for example discloses comparing the biometric data set of (a) with a normative database to determine if the patient needs neuromodulation. See at least Phillips [0006] “ if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject.”),
c. analyzing the biometric data set to identify characteristics of distribution probabilities of one or more variables resulting in mean and standard deviation of pulse period values (Phillips in at least [0006] for example analyzing the biometric data set to identify characteristics of distribution probabilities of one or more variables resulting in mean and standard deviation of pulse period values. See at least Phillips [0006] “obtaining EEG data of the subject's brain; removing any DC component in the signal; performing a Fast Fourier Transformation, X(f), on the EEG data; and achieving a fitted Gaussian curve, A(f), of the EEG data… estimating a first mean frequency, a first standard of deviation, and first gain for the first optimizing loop, shifting the gain, G, up or down slightly from the first gain, determining a new gain resulting in a better fit than that of the first gain, shifting the standard of deviation, d, up or down slightly from the first standard of deviation, determining a new standard of deviation resulting in a better fit than that of the first standard of deviation, shifting the mean frequency, s, up or down slightly from the first mean frequency, determining a new mean frequency resulting in a better fit than that of the first mean frequency, and repeating steps 2), 3), and 4), in which the first gain, the first standard of deviation, and the first mean frequency are replaced with a second gain, a second standard of deviation, and a second mean frequency, respectively, until the three parameters are optimized, comparing the intrinsic frequency from step (a) to an average intrinsic frequency of a healthy population database; if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject”),
d. administering magnetic stimulation to the patient wherein the magnetic stimulation comprises variable pulses based on one or more mean and standard deviations of the biological variables selected from the group consisting of an EEG, an EMG or a spinal cord electric pulse frequency measurement (Phillips in at least [0006] for example discloses administering magnetic stimulation to the patient wherein the magnetic stimulation comprises variable pulses based on one or more mean and standard deviations of the biological variables selected from the group consisting of an EEG, an EMG or a spinal cord electric pulse frequency measurement. See at least Phillips [0006] “performing a Fast Fourier Transformation, X(f), on the EEG data; and achieving a fitted Gaussian curve, A(f), of the EEG data… estimating a first mean frequency, a first standard of deviation, and first gain for the first optimizing loop, shifting the gain, G, up or down slightly from the first gain, determining a new gain resulting in a better fit than that of the first gain, shifting the standard of deviation, d, up or down slightly from the first standard of deviation, determining a new standard of deviation resulting in a better fit than that of the first standard of deviation, shifting the mean frequency, s, up or down slightly from the first mean frequency, determining a new mean frequency resulting in a better fit than that of the first mean frequency, and repeating steps 2), 3), and 4), in which the first gain, the first standard of deviation, and the first mean frequency are replaced with a second gain, a second standard of deviation, and a second mean frequency, respectively, until the three parameters are optimized, comparing the intrinsic frequency from step (a) to an average intrinsic frequency of a healthy population database; if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject”).
As per independent Claim 29, Phillips discloses a method of magnetic neuromodulation in a patient (Phillips in at least abstract, [0004], [0006-0010], [0019-0020], [0028], [0037], [0074-0078], [0119], [0147], [0274], [0298-0300], [0303-0308], [0321], [0571], [0631] for example discloses relevant subject-matter. More specifically, Phillips in at least [0006-0007], [0013-0015], [0119], [0274] for example discloses method of magnetic neuromodulation in a patient. See at least Phillips [0006] “methods of treating a subject, comprising determining the intrinsic frequency (f) of the subject within the specified EEG band by: obtaining EEG data of the subject's brain… shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject.”;) which comprises:
e. measuring a biometric character of a patient resulting in a biometric data set (Phillips in at least [0006], [0274] for example discloses measuring a biometric character of a patient resulting in a biometric data set. See at least Phillips [0006] “obtaining EEG data of the subject's brain”),
f. comparing the biometric data set of (a) with a normative database to determine if the patient needs neuromodulation (Phillips in at least [0006] for example discloses comparing the biometric data set of (a) with a normative database to determine if the patient needs neuromodulation. See at least Phillips [0006] “ if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject.” ),
g. analyzing the biometric data set to identify characteristics of distribution probabilities of one or more variables resulting in mean and standard deviation of pulse period values (Phillips in at least [0006] for example analyzing the biometric data set to identify characteristics of distribution probabilities of one or more variables resulting in mean and standard deviation of pulse period values. See at least Phillips [0006] “obtaining EEG data of the subject's brain; removing any DC component in the signal; performing a Fast Fourier Transformation, X(f), on the EEG data; and achieving a fitted Gaussian curve, A(f), of the EEG data… estimating a first mean frequency, a first standard of deviation, and first gain for the first optimizing loop, shifting the gain, G, up or down slightly from the first gain, determining a new gain resulting in a better fit than that of the first gain, shifting the standard of deviation, d, up or down slightly from the first standard of deviation, determining a new standard of deviation resulting in a better fit than that of the first standard of deviation, shifting the mean frequency, s, up or down slightly from the first mean frequency, determining a new mean frequency resulting in a better fit than that of the first mean frequency, and repeating steps 2), 3), and 4), in which the first gain, the first standard of deviation, and the first mean frequency are replaced with a second gain, a second standard of deviation, and a second mean frequency, respectively, until the three parameters are optimized, comparing the intrinsic frequency from step (a) to an average intrinsic frequency of a healthy population database; if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject”),
h. administering magnetic stimulation to the patient wherein the magnetic stimulation comprises variable pulses based on one or more mean and standard deviations of the biological variable (Phillips in at least [0006] for example discloses administering magnetic stimulation to the patient wherein the magnetic stimulation comprises variable pulses based on one or more mean and standard deviations of the biological variable. See at least Phillips [0006] “performing a Fast Fourier Transformation, X(f), on the EEG data; and achieving a fitted Gaussian curve, A(f), of the EEG data… estimating a first mean frequency, a first standard of deviation, and first gain for the first optimizing loop, shifting the gain, G, up or down slightly from the first gain, determining a new gain resulting in a better fit than that of the first gain, shifting the standard of deviation, d, up or down slightly from the first standard of deviation, determining a new standard of deviation resulting in a better fit than that of the first standard of deviation, shifting the mean frequency, s, up or down slightly from the first mean frequency, determining a new mean frequency resulting in a better fit than that of the first mean frequency, and repeating steps 2), 3), and 4), in which the first gain, the first standard of deviation, and the first mean frequency are replaced with a second gain, a second standard of deviation, and a second mean frequency, respectively, until the three parameters are optimized, comparing the intrinsic frequency from step (a) to an average intrinsic frequency of a healthy population database; if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject; and if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject”).
As per dependent Claim 30, Phillips further discloses method wherein the standard deviation is from 0.1 to 10.0 standard deviations (Phillips in at least [0321] for example discloses standard deviation is from 0.1 to 10.0 standard deviations. See at least Phillips [0321] “shifting the standard of deviation comprises a shift from the first standard deviation of at least one of about 0.005, about 0.01, about 0.02, about 0.05, about 0.1, about 0.2, about 0.5, about 0.6, about 0.7, about 0.75, about 0.8, about 0.9, about 1.0, about 1.1, about 1.2, about 1.5, about 1.75, about 2 and about 2.5. As used herein, the term “about” when used in reference to standard deviation can mean variations of 1%, 10%, 20%, 25%, 50%, 1%-5%, 1%-10%, 5% to 10%, 10% to 20%, 10% to 50%, 10% to 25%, and/or 25% to 50%.”).
As per dependent Claim 31, Phillips further discloses method wherein the variables comprise a pulse period variable or a biometric of heart rate variability, EEG variability, EMG variably or spinal cord measurement variability (Phillips in at least [0006] for example discloses variables comprise a pulse period variable or a biometric of heart rate variability, EEG variability, EMG variably or spinal cord measurement variability. See at least Phillips [0006] “methods of treating a subject, comprising determining the intrinsic frequency (f) of the subject within the specified EEG band by: obtaining EEG data of the subject's brain”).
As per dependent Claim 32, Phillips further discloses method wherein the neuromodulation inhibits NMJ transmission between neurons and muscle fibers (Phillips in at least [0006], [0013], [0015], [0305] for example discloses neuromodulation inhibits NMJ transmission between neurons and muscle fibers. See at least [0006] “comparing the intrinsic frequency from step (a) to an average intrinsic frequency of a healthy population database; if the intrinsic frequency from step (a) is higher than the average intrinsic frequency of the healthy population database, shifting down the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency lower than the intrinsic frequency of the subject”; [0013] “method improves a disorder selected from the group consisting of … fibromyalgia… fibromyalgia is considered a musculoskeletal disease and/or a neuropsychiatric condition”; [0015]“ method is adapted to improve a neurological disorder, wherein the neurological disorder comprises at least one of… a spinal cord disorder, a peripheral nervous system disorder…a seizure disorder, a movement disorder… lower back pain, neck pain, other generalized neuropathic pain… regional pain syndrome.”; [0305] “certain types of neurologic disorders may be treated with the devices and methods provided herein. Neurological disorders can be categorized according to the primary location affected… peripheral nervous system (PNS) disorders”).
As per dependent Claim 33, Phillips further discloses method wherein the neuromodulation enhances synaptic transmission between neurons (Phillips in at least [0006], [0014-0015], [0305] for example discloses the neuromodulation enhances synaptic transmission between neurons. See at least Phillips [0006] “comparing the intrinsic frequency from step (a) to an average intrinsic frequency of a healthy population database; … if the intrinsic frequency from step (a) is lower than the average intrinsic frequency of the healthy population database, shifting up the intrinsic frequency of the subject by applying a magnetic field close to a head of the subject, wherein said magnetic field has a frequency higher than the intrinsic frequency of the subject” ; [0014] “method is adapted to improve neuropathic pain, wherein the neuropathic pain comprises at least one of: occipital neuralgia”; [0015] “method is adapted to improve a neurological disorder, wherein the neurological disorder comprises at least one of: a brain neurological disorder… a cranial nerve disorder, an autonomic nervous system disorder”; [0305] “certain types of neurologic disorders may be treated with the devices and methods provided herein. Neurological disorders can be categorized according to the primary location affected…between central nervous system (CNS) disorders”).
Claims 8-14, 16-17, 18-21, 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho (Pub. No.: US 20190308029 A1, hereinafter referred to as “Ho”).
As per independent Claim 8, Ho discloses a method of enhancing a neuronal-synaptic signal in a patient (Ho in at least abstract, fig. 1-2, [0002-00007], [0011-0019] for example discloses relevant subject-matter. More specifically, Ho in at least abstract, [0002] for example discloses method of enhancing a neuronal-synaptic signal in a patient. See at least [0002] “methods of modulating brain activity with repetitive transcranial magnetic stimulation (rTMS) wherein the rTMS is administered with variable pulse intervals for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved”) which comprises applying variable repetitive transcranial magnetic stimulation (rTMS) to the patient (Ho in at least fig. 1, abstract, [0002], [0005], [0011-0012], [0014] for example discloses applying variable repetitive transcranial magnetic stimulation (rTMS) to the patient. See at least Ho [0005] “brain activity of a mammal is modulated by subjecting the mammal to repetitive transcranial magnetic stimulation (rTMS) with variable pulse intervals determined by individual EEG characteristics for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved”).
As per dependent Claim 9, Ho further discloses method wherein the variable magnetic pulses are random (Ho in at least fig. 1, [0011] discloses variable magnetic pulses are random as they are based on patient’s own EEG. See at least Ho [0011] “an EEG is conducted on a patient experiencing physiological conditions and/or medical conditions in need of treatment. The raw EEG data is analyzed with a wavelet transform algorithm resulting in a unique patient EEG wavelet signal. The pattern of the EEG wavelet signal is used to program the TTL pulses, or other triggers, generated by the rTMS apparatus into variable pulse intervals. rTMS is administered to the patient with variable pulse intervals for a time sufficient to modulate a brain activity which results in an improvement in the physiological condition or the clinical condition being treated”).
As per dependent Claim 10, Ho further discloses method wherein the magnetic pulses are delivered in a pattern of noise (Ho in at least fig. 1, [0011], [0015] discloses aberrant/noisy EEG pattern from a patient in need of treatment. See at least Ho [0011] “an EEG is conducted on a patient experiencing physiological conditions and/or medical conditions in need of treatment. The raw EEG data is analyzed with a wavelet transform algorithm resulting in a unique patient EEG wavelet signal. The pattern of the EEG wavelet signal is used to program the TTL pulses, or other triggers, generated by the rTMS apparatus into variable pulse intervals.”).
As per dependent Claim 11, Ho further discloses method wherein the pattern of noise is white noise, pink noise, violet noise, blue noise, brown noise or red noise (This claim is being interpreted in light of instant application specification as-filed page 5-8. Ho in at least [0005], [0011-0012], [0015] discloses wherein the pattern of noise is white noise, pink noise, violet noise, blue noise, brown noise or red noise. See at least Ho [0005] “brain activity to be modulated can be any one or more desired frequency bandwidth(s) and includes the brain frequency bandwidth of 3-7 Hz, the brain frequency bandwidth of 8-13 Hz, the brain frequency bandwidth of 15-20 Hz, and the brain frequency bandwidth of 35-45 Hz and any sub-bandwidth group within those ranges. If a frequency bandwidth between 8-13 Hz is targeted to treat a patient, the actual bandwidth used to treat that patient can be narrowed within that bandwidth range depending on the variation of patient's EEG oscillation intervals, such as, for example, 105 ms-110 ms, ie a frequency bandwidth between 9.1-9.5 Hz. Success in the modulation is achieved when the targeted frequency bandwidth has an increase in amplitude or relative power density in addition to improvement in symptoms associated with the clinical and physiological conditions being treated.”).
As per dependent Claim 12, Ho further discloses method wherein the variable magnetic pulses are a heterogenous mixture of magnetic pulses over a frequency range of from 0.1 to 15 Hz and a wide pulse interval of from 10,000 msec to 66.7 msec (Ho in at least [0005], [0011-0012], [0015] discloses wherein the variable magnetic pulses are a heterogenous mixture of magnetic pulses over a frequency range of from 0.1 to 15 Hz and a wide pulse interval of from 10,000 msec to 66.7 msec. See at least Ho [0005] “brain activity to be modulated can be any one or more desired frequency bandwidth(s) and includes the brain frequency bandwidth of 3-7 Hz, the brain frequency bandwidth of 8-13 Hz, the brain frequency bandwidth of 15-20 Hz, and the brain frequency bandwidth of 35-45 Hz and any sub-bandwidth group within those ranges. If a frequency bandwidth between 8-13 Hz is targeted to treat a patient, the actual bandwidth used to treat that patient can be narrowed within that bandwidth range depending on the variation of patient's EEG oscillation intervals, such as, for example, 105 ms-110 ms, ie a frequency bandwidth between 9.1-9.5 Hz. Success in the modulation is achieved when the targeted frequency bandwidth has an increase in amplitude or relative power density in addition to improvement in symptoms associated with the clinical and physiological conditions being treated.” ).
As per dependent Claim 13, Ho further discloses method wherein the stimulation enhances transmission of signals between neurons (Ho in at least [0002], [0005-0006], [0011-0012] for example discloses stimulation is based on clinical condition targeted which encompasses stimulation that enhances transmission of signals between neurons. See at least Ho [0011] “EEG is conducted on a patient experiencing physiological conditions and/or medical conditions in need of treatment. The raw EEG data is analyzed with a wavelet transform algorithm resulting in a unique patient EEG wavelet signal… rTMS is administered to the patient with variable pulse intervals for a time sufficient to modulate a brain activity which results in an improvement in the physiological condition or the clinical condition being treated…variable pulse intervals are employed in an rTMS protocol used for a time sufficient to modulate a brain activity resulting in an improvement in a physiological condition or a clinical condition… variable pulse interval settings are achieved by programming the rTMS apparatus with the patient's EEG signal extracted by wavelet analysis to provide magnetic stimulation with variable pulse intervals. The specific brain activity, or brain wave frequency bandwidth, to be modulated is dictated by the patient's EEG… maximum intensity setting of the magnetic pulses is generally limited to the patient's motor threshold or lower.”).
As per dependent Claim 14, Ho further discloses method wherein the magnetic stimulation is used to treat psychological disorders or physical conditions (Ho in at least [0006]).
As per dependent Claim 16, Ho further discloses method wherein the biometric character is an EEG (Ho in at least [0005], [0011]. See Ho at least [0011] “variable pulse interval settings are achieved by programming the rTMS apparatus with the patient's EEG signal extracted by wavelet analysis to provide magnetic stimulation with variable pulse intervals”).
As per independent Claim 18, Ho discloses a method of relieving pain in a patient (Ho in at least abstract, fig. 1-2, [0002-00007], [0011-0019] for example discloses relevant subject-matter. More specifically, Ho in at least abstract, [0002], [0006] for example discloses method of relieving pain in a patient. See at least [0002] “methods of modulating brain activity with repetitive transcranial magnetic stimulation (rTMS) wherein the rTMS is administered with variable pulse intervals for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved”; [0006] “Physiological conditions and medical conditions that can be improved by modulating the brain activity according to the present invention are any conditions where abnormal brain activity contributes to a specific condition. Improvements are seen when the amplitude of the desired or targeted brain wave bands acquire an increase in amplitude or relative power density. Conditions that are treated include but are not limited to … pain… fibromyalgia…Rheumatoid arthritis”) which comprises applying electromagnetic stimulation to the patient wherein the magnetic stimulation comprises variable electromagnetic pulses(Ho in at least fig. 1, abstract, [0002], [0005], [0011-0012], [0014] for example discloses applying variable repetitive transcranial magnetic stimulation (rTMS) to the patient. See at least Ho [0005] “brain activity of a mammal is modulated by subjecting the mammal to repetitive transcranial magnetic stimulation (rTMS) with variable pulse intervals determined by individual EEG characteristics for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved”).
As per dependent Claim 19, Ho further discloses method wherein the magnetic pulses in a preferred pattern of noise (Ho in at least [0002], [0005-0006], [0011-0012] for example discloses magnetic pulses are used for stimulation is based on clinical condition targeted and patient’s own EEG pattern which encompasses the magnetic pulses in a preferred pattern of noise. See at least Ho [0011] “EEG is conducted on a patient experiencing physiological conditions and/or medical conditions in need of treatment. The raw EEG data is analyzed with a wavelet transform algorithm resulting in a unique patient EEG wavelet signal… rTMS is administered to the patient with variable pulse intervals for a time sufficient to modulate a brain activity which results in an improvement in the physiological condition or the clinical condition being treated…variable pulse intervals are employed in an rTMS protocol used for a time sufficient to modulate a brain activity resulting in an improvement in a physiological condition or a clinical condition… variable pulse interval settings are achieved by programming the rTMS apparatus with the patient's EEG signal extracted by wavelet analysis to provide magnetic stimulation with variable pulse intervals. The specific brain activity, or brain wave frequency bandwidth, to be modulated is dictated by the patient's EEG… maximum intensity setting of the magnetic pulses is generally limited to the patient's motor threshold or lower.”).
As per dependent Claim 20, Ho further discloses method wherein the pattern of noise is white noise (This claim is being interpreted in light of instant application specification as-filed page 5-8. Ho in at least [0005], [0011-0012], [0015] discloses wherein the pattern of noise is white noise, pink noise, violet noise, blue noise, brown noise or red noise. See at least Ho [0005] “brain activity to be modulated can be any one or more desired frequency bandwidth(s) and includes the brain frequency bandwidth of 3-7 Hz, the brain frequency bandwidth of 8-13 Hz, the brain frequency bandwidth of 15-20 Hz, and the brain frequency bandwidth of 35-45 Hz and any sub-bandwidth group within those ranges. If a frequency bandwidth between 8-13 Hz is targeted to treat a patient, the actual bandwidth used to treat that patient can be narrowed within that bandwidth range depending on the variation of patient's EEG oscillation intervals, such as, for example, 105 ms-110 ms, ie a frequency bandwidth between 9.1-9.5 Hz. Success in the modulation is achieved when the targeted frequency bandwidth has an increase in amplitude or relative power density in addition to improvement in symptoms associated with the clinical and physiological conditions being treated.”).
As per dependent Claim 21, Ho further discloses method wherein the white noise is a heterogenous mixture of magnetic pulses over a selected frequency range of from 30 to 150 Hz and a pulse interval of from 33.3 msec to 6.7 msec (Ho in at least [0005] for example discloses the white noise is a heterogenous mixture of magnetic pulses over a selected frequency range of from 30 to 150 Hz and a pulse interval of from 33.3 msec to 6.7 msec. See at least Ho [0005] “brain activity of a mammal is modulated by subjecting the mammal to repetitive transcranial magnetic stimulation (rTMS) with variable pulse intervals determined by individual EEG characteristics for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved… wavelet transform algorithm identifies a unique EEG signal pattern for the mammal/patient. The EEG signal pattern is then used to generate a sequence of TTL (transistor-transistor logic) or other triggering pulses to program the rTMS apparatus to provide variable pulse intervals and variable intensities…brain activity to be modulated can be any one or more desired frequency bandwidth(s) and includes …the brain frequency bandwidth of 35-45 Hz and any sub-bandwidth group within those ranges…Success in the modulation is achieved when the targeted frequency bandwidth has an increase in amplitude or relative power density in addition to improvement in symptoms associated with the clinical and physiological conditions being treated.”).
As per independent Claim 26, Ho discloses a method of treating pain in a patient (Ho in at least abstract, fig. 1-2, [0002-00007], [0011-0019] for example discloses relevant subject-matter. More specifically, Ho in at least abstract, [0002], [0006] for example discloses method of relieving pain in a patient. See at least [0002] “methods of modulating brain activity with repetitive transcranial magnetic stimulation (rTMS) wherein the rTMS is administered with variable pulse intervals for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved”; [0006] “Physiological conditions and medical conditions that can be improved by modulating the brain activity according to the present invention are any conditions where abnormal brain activity contributes to a specific condition. Improvements are seen when the amplitude of the desired or targeted brain wave bands acquire an increase in amplitude or relative power density. Conditions that are treated include but are not limited to … pain… fibromyalgia…Rheumatoid arthritis”) which comprises applying transcutaneous magnetic stimulation proximate to the area of the pain (Here, the term “transcutaneous magnetic stimulation” is being broadly yet reasonably interpreted as encompassing magnetic stimulation applied across the depth of the skin which would also encompass rTMS. Ho in at least abstract, [0002], [0005-0006], [0011-0012], [0014] for example discloses comprises applying magnetic stimulation proximate to the area of the pain which is transcutaneous i.e. across the depth of the skin. See at least Ho [0012] “Magnetic coils are placed in close proximity or against a patient's head preferably adjacent to the area of the head where the desired brain frequency wavelengths predominate in the patient's brain… …magnetic coils are positioned adjacent to brain regions that the patient's EEG has identified as having poor coherence, low energy and/or regions that are non-synchronous”) wherein the magnetic stimulation is a heterogenous random mixture of magnetic pulses over a wide frequency range of from 30 to 150 Hz and a wide pulse interval of from 33.3 msec to 6.7 msec, wherein each frequency and pulse interval have an equal opportunity to be selected in each pulse train (Ho in at least [0005], [0007], [0011-0012], [0014] for example discloses the magnetic stimulation is a heterogenous random mixture i.e. dependent on patient’s unique EEG pattern of magnetic pulses over a wide frequency range of from 30 to 150 Hz and a wide pulse interval of from 33.3 msec to 6.7 msec, wherein each frequency and pulse interval have an equal opportunity to be selected in each pulse train as it is dependent on patient’s own heterogenous EEG pattern. See at least Ho [0005] “brain activity of a mammal is modulated by subjecting the mammal to repetitive transcranial magnetic stimulation (rTMS) with variable pulse intervals determined by individual EEG characteristics for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved… wavelet transform algorithm identifies a unique EEG signal pattern for the mammal/patient. The EEG signal pattern is then used to generate a sequence of TTL (transistor-transistor logic) or other triggering pulses to program the rTMS apparatus to provide variable pulse intervals and variable intensities…brain activity to be modulated can be any one or more desired frequency bandwidth(s) and includes …the brain frequency bandwidth of 35-45 Hz and any sub-bandwidth group within those ranges…Success in the modulation is achieved when the targeted frequency bandwidth has an increase in amplitude or relative power density in addition to improvement in symptoms associated with the clinical and physiological conditions being treated.”).
As per dependent Claim 27, Ho further discloses method wherein the magnetic stimulation has a white noise pattern (This claim is being interpreted in light of instant application specification as-filed page 5-8. Ho in at least [0005], [0011-0012], [0015] discloses wherein the pattern of noise is white noise, pink noise, violet noise, blue noise, brown noise or red noise. See at least Ho [0005] “brain activity to be modulated can be any one or more desired frequency bandwidth(s) and includes the brain frequency bandwidth of 3-7 Hz, the brain frequency bandwidth of 8-13 Hz, the brain frequency bandwidth of 15-20 Hz, and the brain frequency bandwidth of 35-45 Hz and any sub-bandwidth group within those ranges. If a frequency bandwidth between 8-13 Hz is targeted to treat a patient, the actual bandwidth used to treat that patient can be narrowed within that bandwidth range depending on the variation of patient's EEG oscillation intervals, such as, for example, 105 ms-110 ms, ie a frequency bandwidth between 9.1-9.5 Hz. Success in the modulation is achieved when the targeted frequency bandwidth has an increase in amplitude or relative power density in addition to improvement in symptoms associated with the clinical and physiological conditions being treated.”).
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 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.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ho.
As per dependent Claim 28, Ho discloses method of claim 26 (see claim 26),
Ho does not necessarily require shingle be the source of pain feature in the applied embodiment.
However, Ho’s disclosure makes obvious method wherein the patient's pain is caused by shingles (Ho’s disclosure in at least abstract, [0002], [0006], [0019] of stimulation to treat patient's pain makes recited subject-matter obvious to PHOSITA to attempt without departing from Ho’s disclosure spirit or essential characteristics. See at least [0002] “methods of modulating brain activity with repetitive transcranial magnetic stimulation (rTMS) wherein the rTMS is administered with variable pulse intervals for a time sufficient to modulate said brain activity wherein an improvement in a physiological condition or a clinical condition is achieved”; [0006] “Physiological conditions and medical conditions that can be improved by modulating the brain activity according to the present invention are any conditions where abnormal brain activity contributes to a specific condition. Improvements are seen when the amplitude of the desired or targeted brain wave bands acquire an increase in amplitude or relative power density. Conditions that are treated include but are not limited to … pain… fibromyalgia…Rheumatoid arthritis”).
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 method of treating pain in a patient as taught by Ho, by extending application to treat pain caused by Shingles, as also made obvious by Ho. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of extending treatment benefits to treat other diseases such as shingles that manifest pain symptoms (Ho, [0006], [0019]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ho in view of Rajguru et al. (Pub. No.: US 20140046423 A1, hereinafter referred to as “Rajguru”).
As per dependent Claim 17, Ho discloses method of claim 13 (see claim 13),
Ho does not explicitly disclose EMG biometric character.
However, in an analogous method of enhancing a neuronal-synaptic signal in a patient field of endeavor, Rajguru discloses a method of enhancing a neuronal-synaptic signal in a patient (Rajguru in at least [0015-0018] for example discloses method of enhancing a neuronal-synaptic signal in a patient. See at least Rajguru [0018] “methods of electromagnetic induction therapy may include one or more of the following steps. A first portion of a patient's body may be positioned relative to or in proximity to an applicator or an applicator may be positioned relative to or in proximity to a first portion of a patient's body, such that a target nerve, muscle or tissue within the first portion of the body is in proximity to one or more conductive coils disposed within or along the applicator. A current may be passed through a coil to generate a magnetic field focused on the target nerve, muscle or tissue. An electrical conduction through the target nerve, a muscular response caused by an electrical conduction through the target nerve or stimulation of a nerve, muscle, or body tissue may be detected by a sensor positioned along a second portion of the body. A signal from the sensor indicative of the electrical conduction or stimulation may be received, which provides feedback about the efficacy of the applied electromagnetic induction therapy. The current may be adjusted by a controller in communication with the conductive coils based on the feedback.”)wherein the biometric character is an EMG (Rajguru in at least [0018], [0210] for example discloses the biometric character is an EMG. See at least Rajguru [0210] “sensors may be utilized, e.g., a three lead EMG…or any sensor for detecting physiologic changes associated with nerve firing and/or muscle contraction. The sensor 342 provides feedback which may be used to monitor and/or control therapy. The sensor 342 may be used to position or optimize therapy”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify biometric character used in the method of enhancing a neuronal-synaptic signal in a patient as taught by Ho, by further including an EMG biometric character, as taught by Rajguru. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage that EMG sensor provides feedback which may be used to monitor and/or control and/or optimize therapy (Rajguru, [0018], [0210]).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Phillips in view of Rajguru.
As per dependent Claim 43, Phillips discloses method of claim 6 (see claim 6 analysis above)
Phillips does not explicitly disclose shingles treatment feature.
However, in an analogous magnetic stimulation field of endeavor, Rajguru discloses magnetic field based treatment method (Rajguru in at least [0015-0018] for example discloses magnetic field based treatment method. See at least Rajguru [0018] “methods of electromagnetic induction therapy may include one or more of the following steps. A first portion of a patient's body may be positioned relative to or in proximity to an applicator or an applicator may be positioned relative to or in proximity to a first portion of a patient's body, such that a target nerve, muscle or tissue within the first portion of the body is in proximity to one or more conductive coils disposed within or along the applicator. A current may be passed through a coil to generate a magnetic field focused on the target nerve, muscle or tissue”), wherein the magnetic stimulation is used to treat shingles (Rajguru in at least [0121] for example discloses magnetic field based treatment wherein the magnetic stimulation is used to treat shingles. See at least Rajguru [0121] “Ailments that may be treated through the use of apparatus and methods as described herein include … post-herpetic neuralgia (pain after shingles)… shingles… therapy is completely non-invasive …therapy can be controlled to optimize the level of therapy delivered according to power consumption and nerve stimulation requirements”).
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 method of masking a signal at a peripheral neuromuscular junction (NMJ) in a patient as taught by Phillips, by extending application to treat shingles, as taught by Rajguru. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of extending treatment benefits to treat other diseases such as shingles (Rajguru, [0121]).
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 20120101366 A1 to Ruohonen use of EMG feedback when magnetically stimulating tissue/nerves similar to that disclosed and claimed.
Prior art US 20090082690 A1to Phillips et al. for disclosing methods of treating a subject, by (a) adjusting output of a magnetic field for influencing an intrinsic frequency of a specified EEG band of the subject toward a pre-selected or target intrinsic frequency of the specified EEG band; and (b) applying said magnetic field close to a head of the subject similar to that disclosed and claimed.
Prior art US 20120053449 A1 to Moses et al. for disclosing use of EMG feedback when magnetically stimulating tissue/nerves similar to that disclosed and claimed. More generally, Moses discloses methods and tools for the design of efficient magnetic stimulators to excite neuronal networks that were not sensitive to stimulation.
Prior art US 20150142082 A1 to Simon et al. for disclosing devices, systems and methods that are used to treat a medical condition, by electrical stimulation of a nerve or nerve ganglion, used in conjunction with biofeedback. The system comprises a stimulator that applies electrical impulses sufficient to modulate a nerve at a target site within the patient. A sensor measures a physiological output from the patient, such as heart rate variability, and a property of the stimulation signal is varied based on the physiological output.
Prior art US 20190082990 A1 to Poltorak for disclosing TMS methods and system to treat neuropathic pain similar to that disclosed.
Prior art US 9308385 B2 to Jin for disclosing modulation of the brain activity of a mammal by subjecting the mammal to repetitive transcranial magnetic stimulation (rTMS) at a frequency of a biological metric for a time sufficient to modulate the brain activity of the mammal similar to that disclosed.
Prior art US 6652443 B1 to Struppler et al. for disclosing EMG based close-loop transcutaneous magnetic stimulation of tissue similar to that disclosed and claimed.
Prior art US 6488617 B1 to Katz for disclosing method and device for the production of a desired brain state in an individual which contain means for monitoring and analyzing the brain state while a set of one or more magnets produce fields that alter this state similar to that disclosed.
Prior art US 20160106994 A1 to Crosby et al. for disclosing a system and method for monitoring progress of TMS treatment via EMG sensors similar to that disclosed.
Prior art US 20190001139 A1 to Mishra et al. for disclosing transcutaneous magnetic field stimulation (TMS) based on EMG sensor feedback similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. 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
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) Form at http://www.uspto.gov/interviewpractice.
/SUNITA REDDY/Primary Examiner, Art Unit 3791