DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed on 09 Jun 2026. As directed by the amendment: claims 1, 4, 6-7, 13, 18, and 20 have been amended, claims 3 and 19 have been canceled, and claim 21 has been added. Thus, claims 1-2, 4-18, and 20-21 are presently pending in this application.
Response to Arguments
Claim Support
Applicant cites Figs. 2A-2C and 4A-4C in support of the claim amendments (Remarks, pages 7-8). However, these figures do not appear in the drawings filed 04 Mar 2022.
REJECTIONS RAISED UNDER 35 USC 112
Applicant's arguments filed 09 Jun 2026 have been fully considered but they are not persuasive. The rejection under 35 U.S.C. 112 of claim 14 regarding the limitation “the amplitude” is maintained.
Applicant’s arguments, see Remarks, filed 09 Jun 2026, with respect to the rejections of claims 6-7 and 18 under 35 U.S.C. 112 have been fully considered and are persuasive in light of the claim amendments. The rejections of claims 6-7 and 18 under 35 U.S.C. 112 have been withdrawn.
REJECTIONS RAISED UNDER 35 USC 102
Applicant’s arguments, see Remarks, filed 09 Jun 2026, with respect to the rejections of claims 1, 13, and 20 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Qin et al. (US 20050278001 A1), hereinafter Qin, as explained in further detail below.
REJECTIONS RAISED UNDER 35 USC 103
Applicant’s arguments, see Remarks, filed 09 Jun 2026, with respect to the rejection of claim 18 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Grossman et al. (US 20170216594 A1), hereinafter Grossman, as explained in further detail below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7, 14, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation “the amplitude”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the amplitude” will be interpreted as “an amplitude”.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 8-9, 13, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Publication No. 20020099425 A1, previously cited), hereinafter Johnson, in view of Qin et al. (US 20050278001 A1), hereinafter Qin.
Regarding claim 1, Johnson discloses an apparatus for providing electrostimulation of a biological tissue (Fig. 1, paragraph [0017], apparatus 10), the apparatus comprising:
a first electrical signal provider (Fig. 1, paragraph [0018], electrodes 20 and 22) configured for providing a first alternating electric field in the biological tissue (Fig. 1, paragraph [0017], electrical treatment channel 12), the first alternating electric field having a first frequency (paragraph [0040], "the base frequency for circuit 12 is 1850 Hz");
a second electrical signal provider (Fig. 1, paragraph [0018], electrodes 24 and 26) configured for providing a second alternating electric field in the biological tissue (Fig. 1, paragraph [0017], electrical treatment channel 14), the second alternating electric field having a second frequency (paragraph [0040], "The second frequency, which applies to second channel 14");
wherein the first alternating electric field and the second alternating electric field provide a combined field in the biological tissue (paragraph [0023], "The electrical current provided for each circuit 12, 14, 16, 18 interfere with one another"), and the apparatus further comprises:
a controller (Fig. 4, paragraph [0027], CPU 100) providing variations of at least one of the first frequency and the second frequency to provide first intervals interleaved between second intervals wherein each of the second intervals has a length (paragraph [0042], "apparatus 10 controls the beat frequency to sweep between a selected range of a first value and a second value where the first value is the upper limit and the second value being as low as zero, which means the second frequency would be equal to the first frequency during this sweep operation");
wherein during the first intervals, the first frequency matches the second frequency (paragraph [0042], "the second frequency would be equal to the first frequency") and throughout the second intervals the first frequency is different from the second frequency by a selected beat frequency (paragraph [0040], "two electrical circuits are established that operate at different frequencies from one another ... which establishes a beat difference or frequency") so that the combined field provides a pulsed interferential stimulation signal consisting of a series of pulses (paragraph [0008], "The frequency of each circuit can be varied and a plurality of beat pulses can be generated"), each of the series of pulses having the length and consisting of an alternating electric field at the selected beat frequency (paragraph [0003], "The electrical current is an alternating current and each of the two circuits is operated at a slightly different frequency, which generates a beat frequency within the body where the circuits cross").
Johnson does not explicitly disclose that the selected beat frequency is constant.
However, Qin teaches a multi-mode electrical therapeutic stimulation system (Abstract) wherein the selected beat frequency is constant (paragraph [0087], "The interference frequency can be about 1 Hz to about 150 Hz, as described above, adjustable in one hertz increments"; paragraph [0090], "The output frequency can be adjustable from about 10 Hz to about 80 Hz in 5 Hz increments"; the interference (beat) frequency is constant in periods between frequency adjustments; periods between frequency adjustments can be interpreted as second intervals).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson with the teachings of Qin so that the selected beat frequency is constant, because doing so can be accomplished using digital interface circuitry (Qin, paragraph [0079]), providing greater flexibility, programming options, and ease of use (Qin, paragraph [0012]).
Regarding claim 4, the apparatus of claim 1 is obvious over Johnson and Qin, as explained above. Johnson further discloses that the alternating electric field at the selected beat frequency has a beat period (paragraph [0040], "a beat difference or frequency of 200 Hz" has a beat period of 5 ms).
Johnson does not explicitly disclose that the length is an integer multiple of the beat period.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply pulses with a duration which is an integer multiple of the beat period, because the end of a beat period is when the combined field has ramped down to 0 amplitude, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 5, the apparatus of claim 1 is obvious over Johnson and Qin, as explained above. Johnson further discloses that the variations provide a frequency difference, Δf, selected to provide stimulation of the biological tissue (paragraph [0040], "the difference would be 200 Hz or less, which establishes a beat difference or frequency of 200 Hz or less used in therapeutic treatment"; paragraphs [0040]-[0043]).
Regarding claim 8, the apparatus of claim 1 is obvious over Johnson and Qin, as explained above. Johnson further discloses that:
the first electrical signal provider further comprises a first current source (Fig. 4, paragraph [0033], DAC 110) configured for providing electrical current between a first two electrodes (Fig. 1, paragraph [0018], electrodes 20 and 22), thereby providing the first electric field (Fig. 1, paragraph [0017], electrical treatment channel 12), and
the second electrical signal provider further comprises a second current source (Fig. 4, paragraph [0033], DAC 112) configured for providing electrical current between a second two electrodes (Fig. 1, paragraph [0018], electrodes 24 and 26), thereby providing the second electric field (Fig. 1, paragraph [0017], electrical treatment channel 14).
Regarding claim 9, the apparatus of claim 8 is obvious over Johnson and Qin, as explained above. Johnson further discloses that the first two electrodes and the second two electrodes comprise electrodes configured for implantation on a living biological tissue (paragraph [0019]).
Regarding claim 13, Johnson discloses a method of stimulating biological tissue (paragraph [0018], "the electrical circuit interacts with and stimulates the spinal cord"), the method comprising:
controlling a first alternating current at a first location (paragraph [0008], "The electrodes are placed on sides opposite the patient's spine for optimal treatment") thereby providing a first alternating electric field in the biological tissue (Fig. 1, paragraph [0017], electrical treatment channel 12), the first alternating electric field having a first frequency (paragraph [0040], "the base frequency for circuit 12 is 1850 Hz");
providing a second alternating current at a second location (paragraph [0008], "The electrode on the opposite side can be placed on the hand, shoulder, hip, or other region of the body, so long as it is on the opposite side of the first electrode along a known nerve path between the electrode contact points") thereby providing a second alternating electric field in the biological tissue (Fig. 1, paragraph [0017], electrical treatment channel 14), the second alternating electric field having a second frequency (paragraph [0040], "The second frequency, which applies to second channel 14");
wherein the first alternating electric field and the second alternating electric field combine to provide a combined field in the biological tissue at a third location (paragraph [0023], "The electrical current provided for each circuit 12, 14, 16, 18 interfere with one another"; paragraph [0008], "The electrode on the opposite side can be placed on the hand, shoulder, hip, or other region of the body, so long as it is on the opposite side of the first electrode along a known nerve path between the electrode contact points thereby establishing a current path through the patient's spine"; paragraphs [0024]-[0025]), and the method further comprises:
varying at least one of the first frequency and the second frequency to provide a series of first intervals interleaved between a series of second intervals wherein each second interval has a length (paragraph [0042], "apparatus 10 controls the beat frequency to sweep between a selected range of a first value and a second value where the first value is the upper limit and the second value being as low as zero, which means the second frequency would be equal to the first frequency during this sweep operation");
wherein during the first intervals, the first frequency matches the second frequency (paragraph [0042], "the second frequency would be equal to the first frequency") and throughout the second intervals the first frequency is different from the second frequency by a selected beat frequency (paragraph [0040], "two electrical circuits are established that operate at different frequencies from one another ... which establishes a beat difference or frequency") so that the combined field provides a pulsed interferential stimulation signal consisting of a series of pulses (paragraph [0008], "The frequency of each circuit can be varied and a plurality of beat pulses can be generated"), each of the series of pulses having the length and consisting of an alternating electric field at the selected beat frequency (paragraph [0003], "The electrical current is an alternating current and each of the two circuits is operated at a slightly different frequency, which generates a beat frequency within the body where the circuits cross").
Johnson does not explicitly disclose that the selected beat frequency is constant.
However, Qin teaches a multi-mode electrical therapeutic stimulation system (Abstract) wherein the selected beat frequency is constant (paragraph [0087], "The interference frequency can be about 1 Hz to about 150 Hz, as described above, adjustable in one hertz increments"; paragraph [0090], "The output frequency can be adjustable from about 10 Hz to about 80 Hz in 5 Hz increments"; the interference (beat) frequency is constant in periods between frequency adjustments; periods between frequency adjustments can be interpreted as second intervals).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson with the teachings of Qin so that the selected beat frequency is constant, because doing so can be accomplished using digital interface circuitry (Qin, paragraph [0079]), providing greater flexibility, programming options, and ease of use (Qin, paragraph [0012]).
Regarding claim 15, the method of claim 13 is obvious over Johnson and Qin, as explained above. Johnson further discloses that varying at least one of the first frequency and the second frequency comprises varying the first frequency while keeping the second frequency constant (paragraph [0046], "the first channel can have a fixed base frequency and the second channel has a frequency differential that is either fixed or varied, or pauses at a given frequency relative to the base frequency and can then vary"; paragraph [0008], "The CPU is programmed so that each frequency for each circuit can be varied"; paragraph [0028], "CPU 100 controls power supply 102 to determine ... whether the frequency varies during treatment").
Regarding claim 20, Johnson discloses an electrical signal controller (Fig. 4, paragraph [0027], CPU 100) configured for controlling electrostimulation of biological tissue, the controller being operable to control at least two alternating electrical signals (Fig. 1, paragraph [0017], electrical treatment channels 12 and 14) and being configured to perform a method of stimulating biological tissue (paragraph [0018], "the electrical circuit interacts with and stimulates the spinal cord") comprising:
controlling a first alternating current at a first location (paragraph [0008], "The electrodes are placed on sides opposite the patient's spine for optimal treatment") thereby providing a first alternating electric field in the biological tissue (Fig. 1, paragraph [0017], electrical treatment channel 12), the first alternating electric field having a first frequency (paragraph [0040], "the base frequency for circuit 12 is 1850 Hz");
providing a second alternating current at a second location (paragraph [0008], "The electrode on the opposite side can be placed on the hand, shoulder, hip, or other region of the body, so long as it is on the opposite side of the first electrode along a known nerve path between the electrode contact points") thereby providing a second alternating electric field in the biological tissue (Fig. 1, paragraph [0017], electrical treatment channel 14), the second alternating electric field having a second frequency (paragraph [0040], "The second frequency, which applies to second channel 14");
wherein the first alternating electric field and the second alternating electric field combine to provide a combined field in the biological tissue at a third location (paragraph [0023], "The electrical current provided for each circuit 12, 14, 16, 18 interfere with one another"; paragraph [0008], "The electrode on the opposite side can be placed on the hand, shoulder, hip, or other region of the body, so long as it is on the opposite side of the first electrode along a known nerve path between the electrode contact points thereby establishing a current path through the patient's spine"; paragraphs [0024]-[0025]), and the method further comprises:
varying at least one of the first frequency and the second frequency to provide a series of first intervals interleaved between a series of second intervals wherein each second interval has a length (paragraph [0042], "apparatus 10 controls the beat frequency to sweep between a selected range of a first value and a second value where the first value is the upper limit and the second value being as low as zero, which means the second frequency would be equal to the first frequency during this sweep operation");
wherein during the first intervals, the first frequency matches the second frequency (paragraph [0042], "the second frequency would be equal to the first frequency") and throughout the second intervals the first frequency is different from the second frequency by a selected beat frequency (paragraph [0040], "two electrical circuits are established that operate at different frequencies from one another ... which establishes a beat difference or frequency") so that the combined field provides a pulsed interferential stimulation signal consisting of a series of pulses (paragraph [0008], "The frequency of each circuit can be varied and a plurality of beat pulses can be generated"), each of the series of pulses having the length and consisting of an alternating electric field at the selected beat frequency (paragraph [0003], "The electrical current is an alternating current and each of the two circuits is operated at a slightly different frequency, which generates a beat frequency within the body where the circuits cross").
Johnson does not explicitly disclose that the selected beat frequency is constant.
However, Qin teaches a multi-mode electrical therapeutic stimulation system (Abstract) wherein the selected beat frequency is constant (paragraph [0087], "The interference frequency can be about 1 Hz to about 150 Hz, as described above, adjustable in one hertz increments"; paragraph [0090], "The output frequency can be adjustable from about 10 Hz to about 80 Hz in 5 Hz increments"; the interference (beat) frequency is constant in periods between frequency adjustments; periods between frequency adjustments can be interpreted as second intervals).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson with the teachings of Qin so that the selected beat frequency is constant, because doing so can be accomplished using digital interface circuitry (Qin, paragraph [0079]), providing greater flexibility, programming options, and ease of use (Qin, paragraph [0012]).
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Publication No. 20020099425 A1, previously cited), hereinafter Johnson, in view of Qin et al. (US 20050278001 A1), hereinafter Qin, and further in view of Hansjurgens (US 5573552 A, previously cited).
Regarding claim 2, the apparatus of claim 1 is obvious over Johnson and Qin, as explained above. Although Johnson discloses that the first alternating electric field has an amplitude and the second alternating electric field has an amplitude (paragraphs [0027], 0032], [0035]-[0036], current intensity), Johnson does not explicitly disclose that the apparatus is configured to hold constant the amplitude of the first alternating electric field and the amplitude of the second alternating electric field.
However, Hansjurgens teaches an apparatus for electrotherapeutic applications which operates in the medium frequency range between 1000 Hz and 100,000 Hz, with paired, diametrically opposed electrodes applied in relation to a body part to be treated (column 1, lines 3-7), wherein the apparatus is configured to hold constant the amplitude of the first alternating electric field and the amplitude of the second alternating electric field (column 5, lines 29-30).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson and Qin with the teachings of Hansjurgens so that the first alternating electric field has an amplitude and the second alternating electric field has an amplitude and the apparatus is configured to hold constant the amplitude of the first alternating electric field and the amplitude of the second alternating electric field, because doing so prevents low-frequency irritation of the skin or pain by intensity variations of the stimulation current, decreases the amount of energy lost when the stimulation penetrates the skin, improves depth of penetration of the stimulation, and reduces the amount of sensation that the stimulation evokes (Hansjurgens, column 8, lines 32-51).
Regarding claim 14, the method of claim 13 is obvious over Johnson and Qin, as explained above. Although Johnson discloses that the first alternating electric field has an amplitude and the second alternating electric field has an amplitude (paragraphs [0027], 0032], [0035]-[0036], current intensity), Johnson does not explicitly disclose that the apparatus is configured to hold constant the amplitude of the first alternating electric field and the amplitude of the second alternating electric field.
However, Hansjurgens teaches an apparatus for electrotherapeutic applications which operates in the medium frequency range between 1000 Hz and 100,000 Hz, with paired, diametrically opposed electrodes applied in relation to a body part to be treated (column 1, lines 3-7), wherein the amplitude of the first alternating electric field and the second alternating electric field is held constant during said varying (column 5, lines 29-30).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson and Qin with the teachings of Hansjurgens so that the apparatus is configured to hold constant the amplitude of the first alternating electric field and the amplitude of the second alternating electric field, because doing so prevents low-frequency irritation of the skin or pain by intensity variations of the stimulation current, decreases the amount of energy lost when the stimulation penetrates the skin, improves depth of penetration of the stimulation, and reduces the amount of sensation that the stimulation evokes (Hansjurgens, column 8, lines 32-51).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Publication No. 20020099425 A1, previously cited), hereinafter Johnson, in view of Qin et al. (US 20050278001 A1), hereinafter Qin, and further in view of Wei (US 20130110194 A1, previously cited).
Regarding claim 6, the apparatus of claim 1 is obvious over Johnson and Qin, as explained above. Although Johnson discloses examples of the first frequency and the second frequency (paragraphs [0040]-[0043]), Johnson does not explicitly disclose that these frequencies are greater than any frequency within a natural band of electrically excitable cells of the tissue.
However, Wei teaches a system, devices, and techniques for delivering electrical stimulation therapy (Abstract) wherein the electrical stimulation has a frequency sufficiently high such that the stimulation substantially blocks nerve activity in a manner that prevents the nerve activity from propagating past the nerve location being stimulated (paragraph [0053]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson and Qin with the teachings of Wei so that the first frequency and the second frequency are both greater than any frequency within a natural band of electrically excitable cells of the tissue, because doing so may prevent nerve activity from being propagated across the nerve site when the high frequency stimulation is being delivered (Wei, paragraph [0025]).
Regarding claim 7, the apparatus of claim 6 is obvious over Johnson, Qin, and Wei, as explained above. Johnson further discloses that the biological tissue comprises spinal tissue (paragraph [0018], "the electrical circuit interacts with and stimulates the spinal cord") and the minimum frequency is at least 500 Hz (paragraphs [0040]-[0043] disclose examples where the first and second frequencies are between 1850 and 2850 Hz).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Publication No. 20020099425 A1, previously cited), hereinafter Johnson, in view of Qin et al. (US 20050278001 A1), hereinafter Qin, and further in view of Ahmed et al. (US Publication No. 20130035745 A1, previously cited), hereinafter Ahmed.
Regarding claim 10, the apparatus of claim 1 is obvious over Johnson and Qin, as explained above. Johnson does not explicitly disclose that the pulsed interferential stimulation signal comprises pulses having a duration of at least 5 ms.
However, Ahmed teaches a system configured to apply stimulation to a neural pathway (Abstract) wherein the stimulation pulses have a duration of at least 5 ms (paragraphs [0050], [0055], [0077], [0183], [0230], [0313]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson and Qin with the teachings of Ahmed to apply pulses with a duration of at least 5 ms, because doing so ensures that the electrical signal is sufficient to induce neural signals (Ahmed, paragraph [0183]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply pulses with a duration of at least 5 ms, for the purpose of maintaining safety during use, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 11, the apparatus of claim 1 is obvious over Johnson and Qin, as explained above. Johnson does not explicitly disclose that the pulsed interferential stimulation signal comprises pulses having a duration of less than 150 ms.
However, Ahmed teaches a system configured to apply stimulation to a neural pathway (Abstract) wherein the stimulation pulses have a duration of less than 150 ms (paragraphs [0050], [0055], [0077], [0183], [0230], [0313]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson and Qin with the teachings of Ahmed to apply pulses with a duration of less than 150 ms, because doing so ensures that the electrical signal is sufficient to induce neural signals (Ahmed, paragraph [0183]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply pulses with a duration of less than 150 ms, for the purpose of maintaining safety during use, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 12, the apparatus of claim 11 is obvious over Johnson, Qin, and Ahmed, as explained above. Johnson does not disclose that the pulses have a duration of between 5 ms and 25 ms. However, Ahmed further teaches that the stimulation pulses have a duration is between 5 ms and 25 ms (paragraphs [0050], [0055], [0077], [0183], [0230], [0313]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson with the teachings of Ahmed to apply pulses with a duration of between 5 ms and 25 ms, because doing so ensures that the electrical signal is sufficient to induce neural signals (Ahmed, paragraph [0183]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply pulses with a duration of between 5 ms and 25 ms, for the purpose of maintaining safety during use, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Publication No. 20020099425 A1, previously cited), hereinafter Johnson, in view of Qin et al. (US 20050278001 A1), hereinafter Qin, and further in view of Carroll (US 20170036029 A1, previously cited).
Regarding claim 16, the method of claim 13 is obvious over Johnson and Qin, as explained above. Johnson further discloses that the first location and second location are on the patient's skin (paragraph [0019]). Johnson does not explicitly disclose that at least one of the first location and the second location is in the biological tissue.
However, Carroll teaches a stimulator and a method for the treatment of intractable pain syndromes by interferential electrical stimulation of the spinal cord (Abstract) wherein the electrodes are located in the biological tissue (paragraph [0045], implantable electrodes 108a-d).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson and Qin with the teachings of Carroll so that at least one of the first location and the second location is in the biological tissue, because doing so increases the depth of stimulation and improves directional control (Carroll, paragraph [0039]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US Publication No. 20020099425 A1, previously cited), hereinafter Johnson, in view of Qin et al. (US 20050278001 A1), hereinafter Qin, and further in view of Ting et al. (“A robust ex vivo experimental platform for molecular-genetic dissection of adult human neocortical cell types and circuits.” 2018, previously cited), hereinafter Ting.
Regarding claim 17, the method of claim 13 is obvious over Johnson and Qin, as explained above. Johnson does not explicitly disclose that the biological tissue is ex vivo and/or that the method is not a method of treatment of a living human or animal body by surgery or therapy.
However, Ting teaches an ex vivo patch clamp system (title: “A robust ex vivo experimental platform”, page 3, Patch clamp electrophysiology and live imaging), wherein electrical stimulation is provided to biological tissue (page 8, second to last paragraph, "we performed simultaneous epifluorescence imaging and patch clamp recording and electrical stimulation via the patch pipette to drive neuron firing at frequencies from 1–50 Hz").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson and Qin with the teachings of Ting to perform the method of claim 13 using ex vivo biological tissue because doing so allows for rapid molecular-genetic manipulation (Ting, Abstract) and labeling (Ting, page 2, first paragraph), and for direct measurement of the functional properties of different cell types (Ting, page 1, first paragraph after Abstract).
Claims 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hansjurgens (US 5573552 A, previously cited), in view of Grossman et al. (US 20170216594 A1), hereinafter Grossman.
Regarding claim 18, Hansjurgens discloses a method of providing a pulsed interferential signal (column 9, lines 21-24, interference method) for stimulation of a biological tissue (column 1, lines 6-7, "electrodes applied in relation to a body part to be treated"), the method comprising:
applying a plurality of electric fields to the biological tissue (column 10, lines 14-15, "electrode leads can be applied on the body part to be treated");
frequency modulating at least one of the plurality of electric fields applied to the biological tissue (column 9, lines 21-32) while holding an amplitude of the plurality of electric fields constant (column 5, lines 29-30);
wherein the frequency modulation is controlled to provide a train of pulses (column 2, lines 65-67) and the relative phase of the plurality of electric fields is controlled to shape the pulses (column 8, lines 52-63).
Hansjurgens does not explicitly disclose that the plurality of electric fields are both: (a) in anti-phase at a start of each pulse; and (b) in anti-phase at an end of each pulse.
However, Grossman teaches methods of interferential stimulation (Abstract) wherein the plurality of electric fields are both: (a) in anti-phase at a start of each pulse; and (b) in anti-phase at an end of each pulse (paragraph [0114]), "the phase at the first electrode of the pair is substantially anti-phasic (substantially 180 degrees out-of-phase) from the phase at the second electrode of the pair").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hansjurgens with the teachings of Grossman so that the plurality of electric fields are both: (a) in anti-phase at a start of each pulse; and (b) in anti-phase at an end of each pulse, because doing so allows multiple current waveforms to flow independently inside the tissue, which eliminates (or greatly reduces) crosstalk between the channels and permits triangulation of the currents through the conductive medium away from the path of current to the ground (Grossman, paragraph [0114]).
Regarding claim 21, the method of claim 18 is obvious over Hansjurgens and Grossman, as explained above. Hansjurgens further discloses that the plurality of electric fields are further in phase at a middle of each pulse (column 9, lines 48-65).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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