DETAILED ACTION
Response to Amendment
This Office Action is in response to the amendment filed 05/26/2026. Claims 1, 3-7, 9-12, and 21-22 are acknowledged as pending with claims 1, 4, 6-7, and 10 being currently amended, claims 21-22 being new, and claims 2, 8, and 13-20 being cancelled.
The drawing and claim objections, as well as the rejections under 35 U.S.C. 102(a)(1) and 103 are withdrawn as having been overcome by the amendment. New rejections necessitated by the amendment are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1) and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2026 was filed after the mailing date of the Non-Final Office Action on 01/26/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. (US 6561968) in view of Schneider et al. (US 2013/0317281).
Regarding claim 1, Dissing et al. teaches a magnetic field generation device (Abstract) comprising:
a coil (Col. 4, lines 49-65; Fig. 1B, coils 108-112; Col. 11, lines 38-39); and
a power supply (Col. 12, lines 6-17; Fig. 2 - Pulse generator),
wherein the power supply is configured to apply pulsed current to the coil (Col. 4, lines 54-58; Col. 7, lines 4-9; Col. 12, lines 6-32 and 58-67 and Col. 13, lines 1-10; Fig. 8, wherein the pulse generator is configured to create and drive pulsed currents into the coils), and
wherein the maximum value of a generated magnetic field is 60 mG to 3000 mG (Col. 15, lines 15-26; Fig. 4B, the coils are configured to produce a magnetic field of ~ 1 gauss when positioned 3 cm away from a selected stimulation site and/or organism),
wherein pulsed current is current having substantially a rectangular waveform (Col. 12, lines 17-19 and 43-45),
wherein a pulse width defining an application duration of the current is selected from 2 to 8 msec (Col. 12, lines 6-20).
Dissing et al. fails to specifically teach frequency-modulated current and wherein a frequency defined as the number of pulses applied to the coil per second is selected from 1 Hz to 8 Hz.
Schneider et al. teaches an analogous magnetic field generation device further comprising frequency-modulated current (paras. 0036, 0090, and 0095) and wherein a frequency defined as the number of pulses applied to the coil per second is selected from 1 Hz to 8 Hz (paras. 0033, 0074, and 0095).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have modified the magnetic field generation device of Dissing et al. with frequency-modulated current, wherein the frequency is selected from 1 to 8 Hz of Schneider et al. Neuromodulating brain regions with a low-frequency stimulation may evoke significant analgesia in targeted brain regions (Schneider et al., paras. 0035 and 0072).
Regarding claim 7, Dissing et al. teaches a magnetic field irradiation method for a living body (Abstract; Col. 1, lines 17-24) by using a magnetic field generation device (Fig. 1B) including a coil (Col. 4, lines 49-65; Fig. 1B, coils 108-112; Col. 11, lines 38-39) and a power supply (Col. 12, lines 6-17; Fig. 2 - Pulse generator), the magnetic field irradiation method comprising:
a magnetic field irradiation step of irradiating a living body with a magnetic field having the maximum value of 60 mG to 3000 mG generated by the magnetic field generation device (Col. 15, lines 15-26; Fig. 4B, the coils are configured to produce a magnetic field of ~ 1 gauss when positioned 3 cm away from a selected stimulation site and/or organism),
wherein in the magnetic field irradiation step, the power supply applies pulsed current to the coil (Col. 4, lines 54-58; Col. 7, lines 4-9; Col. 12, lines 6-32 and 58-67 and Col. 13, lines 1-10; Fig. 8, wherein the pulse generator is configured to create and drive pulsed currents into the coils),
wherein pulsed current is current having substantially a rectangular waveform (Col. 12, lines 17-19 and 43-45),
wherein a pulse width defining an application duration of the current is selected from 2 to 8 msec (Col. 12, lines 6-20).
Dissing et al. fails to specifically teach frequency-modulated current and wherein a frequency defined as the number of pulses applied to the coil per second is selected from 1 Hz to 8 Hz.
Schneider et al. teaches an analogous magnetic field irradiation method further comprising frequency-modulated current (paras. 0036, 0090, and 0095) and wherein a frequency defined as the number of pulses applied to the coil per second is selected from 1 Hz to 8 Hz (paras. 0033, 0074, and 0095).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have modified the magnetic field irradiation method of Dissing et al. with frequency-modulated current, wherein the frequency is selected from 1 to 8 Hz of Schneider et al. Neuromodulating brain regions with a low-frequency stimulation may evoke significant analgesia in targeted brain regions (Schneider et al., paras. 0035 and 0072).
Claim(s) 3-5, 9-11, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. in view of Schneider et al., further in view of Mazak (EP 2363168), citing to attached translation.
Regarding claim 3, Dissing et al. in view of Schneider et al. teaches the magnetic field generation device according to claim 1 as stated above. Dissing et al. in view of Schneider et al. fails to teach wherein the power supply is configured to repeatedly apply a cycle in which the frequency increases during a predetermined period, or a cycle in which the frequency decreases during a predetermined period to the coil.
In the same field of endeavor, Mazak teaches wherein the power supply (Fig. 2a, frequency generator ‘a’; Fig. 2B; page 6, para. 6, “An output stage of the generator works with a voltage intermediate circuit and is as in Fig. 2b shown connected exclusively as H-bridge. The power elements, for example MOSFETs or IGBTs, are shown as a switch with associated freewheeling diodes”) is configured to repeatedly apply a cycle in which the frequency increases during a predetermined period (page 7, para. 11, “the frequency is incrementally increased in accordance with the cycle time of a microprocessor control of 1 ms, 10 pulses with the same pulse width result next to each other - both in the positive and in the negative direction. The step size for increasing or decreasing the frequency automatically results from the preselected limit values and from the time for a frequency cycle”; page 8, para. 1, “the frequency cycle can take place with variable pulse number and same time for all frequencies - ie with increasing frequency with higher pulse number - or with the same step size - eg 1 kHz - and same pulse number - eg 10 - for all frequencies. The second setting then gives a frequency cycle of 13.3 s. Both the step size and the number of pulses are again freely selectable quantities”), or
a cycle in which the frequency decreases during a predetermined period to the coil (page 7, para. 10, “A second mode or frequency mode or a second mode of operation allows a corresponding periodic or aperiodic passage through any arbitrary frequency range via corresponding control specifications, wherein the frequency is increased or decreased over corresponding freely selectable time constants”; page 7, para. 11, “the frequency is incrementally increased in accordance with the cycle time of a microprocessor control of 1 ms, 10 pulses with the same pulse width result next to each other - both in the positive and in the negative direction. The step size for increasing or decreasing the frequency automatically results from the preselected limit values and from the time for a frequency cycle”; page 8, para. 1, “the frequency cycle can take place with variable pulse number and same time for all frequencies - ie with increasing frequency with higher pulse number - or with the same step size - eg 1 kHz - and same pulse number - eg 10 - for all frequencies. The second setting then gives a frequency cycle of 13.3 s. Both the step size and the number of pulses are again freely selectable quantities”).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have modified the magnetic field generation device of Dissing et al. in view of Schneider et al. with the frequency generator configured to apply a cycle in which frequency increases of Mazak. Cells often respond well to low-frequency and slowly modulated signals. Additionally, using a frequency generator that allows for a freely adjustable cycle ensures that application-specific limit values are consistently met, resulting in better control over the electromagnetic field produced (Mazak, page 8, para. 6, “The third mode and the third mode of operation, in the form of a magnetic flux mode…”; page 3, paras. 9-10, “It is also advantageous if limit values for all operating modes are freely adjustable. This ensures that application-specific limit values can be reliably met. It is also advantageous if time constants required for the individual operating modes are all freely adjustable. This improves the controllability of the frequency generator and thus of the electromagnetic field to be generated”; page 5, para. 3, “a body and / or cells can respond well to low-range frequencies, ie, slow modulations that increase their responsiveness”).
Regarding claim 4, Dissing et al. in view of Schneider et al., further in view of Mazak teaches the magnetic field generation device according to claim 3 as stated above. Dissing et al. in view of Schneider et al. further teaches a range selected from 1 Hz to 8 Hz (Schneider et al., paras. 0033, 0036, and 0074), or a range selected from 8 Hz to 1 Hz (Schneider et al., paras. 0033, 0036, and 0074).
Dissing et al. in view of Schneider fails to teach wherein during the predetermined period, the frequency increases stepwise, or the frequency decreases stepwise.
Mazak further teaches wherein during the predetermined period, the frequency increases stepwise, or the frequency decreases stepwise (page 8, para. 1, “The frequency cycle can take place with variable pulse number and same time for all frequencies – i.e., with increasing frequency with higher pulse number - or with the same step size – e.g. 1 kHz - and same pulse number – e.g. 10 - for all frequencies. Both the step size and the number of pulses are again freely selectable quantities”).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have further modified the magnetic field generation device of Dissing et al. in view of Schneider et al., further in view of Mazak with the stepwise frequency increase of Mazak. In a stepwise manner, the frequency may be incrementally increased in accordance with the cycle time; furthermore, given the variability of the step size, pulses adjacent to each other could be alternated in a positive and negative direction (Mazak, page 7, para. 11, “The individual pulse widths are representative of a packet of equal pulses. If the first positive pulse corresponds, for example, to a frequency of 10 kHz and the frequency is incrementally increased in accordance with the cycle time of a microprocessor control of 1 ms, 10 pulses with the same pulse width result next to each other - both in the positive and in the negative direction. The step size for increasing or decreasing the frequency automatically results from the preselected limit values and from the time for a frequency cycle”).
Regarding claim 5, Dissing et al. in view of Schneider et al., further in view of Mazak teaches the magnetic field generation device according to claim 4 as stated above. Mazak fails to teach wherein the predetermined period is selected from 2 sec to 8 sec.
Schneider et al. further teaches wherein the predetermined period is selected from 2 sec to 8 sec (Schneider et al., paras. 0033, 0036, and 0074, wherein period is the inverse of frequency, Schneider et al. teaches frequencies at 5 Hz or 2 Hz, therefore, the period may equal 5 sec or 2 sec, respectively).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have further modified the magnetic field generation device of Dissing et al. in view of Schneider et al., further in view of Mazak with the predetermined period of Schneider et al. Neuromodulating brain regions with a low-frequency stimulation and inversely related period may evoke significant analgesia in targeted brain regions (Schneider et al., paras. 0035 and 0072).
Regarding claim 9, Dissing et al. in view of Schneider et al. teaches the magnetic field irradiation method according to claim 7 as stated above. Dissing et al. in view of Schneider et al. fails to teach wherein the power supply is configured to repeatedly apply a cycle in which the frequency increases during a predetermined period, or a cycle in which the frequency decreases during a predetermined period to the coil.
In the same field of endeavor, Mazak teaches wherein the power supply (Fig. 2a, frequency generator ‘a’; Fig. 2B; page 6, para. 6, “An output stage of the generator works with a voltage intermediate circuit and is as in Fig. 2b shown connected exclusively as H-bridge. The power elements, for example MOSFETs or IGBTs, are shown as a switch with associated freewheeling diodes”) is configured to repeatedly apply a cycle in which the frequency increases during a predetermined period (page 7, para. 11, “the frequency is incrementally increased in accordance with the cycle time of a microprocessor control of 1 ms, 10 pulses with the same pulse width result next to each other - both in the positive and in the negative direction. The step size for increasing or decreasing the frequency automatically results from the preselected limit values and from the time for a frequency cycle”; page 8, para. 1, “the frequency cycle can take place with variable pulse number and same time for all frequencies - ie with increasing frequency with higher pulse number - or with the same step size - eg 1 kHz - and same pulse number - eg 10 - for all frequencies. The second setting then gives a frequency cycle of 13.3 s. Both the step size and the number of pulses are again freely selectable quantities”), or
a cycle in which the frequency decreases during a predetermined period to the coil (page 7, para. 10, “A second mode or frequency mode or a second mode of operation allows a corresponding periodic or aperiodic passage through any arbitrary frequency range via corresponding control specifications, wherein the frequency is increased or decreased over corresponding freely selectable time constants”; page 7, para. 11, “the frequency is incrementally increased in accordance with the cycle time of a microprocessor control of 1 ms, 10 pulses with the same pulse width result next to each other - both in the positive and in the negative direction. The step size for increasing or decreasing the frequency automatically results from the preselected limit values and from the time for a frequency cycle”; page 8, para. 1, “the frequency cycle can take place with variable pulse number and same time for all frequencies - ie with increasing frequency with higher pulse number - or with the same step size - eg 1 kHz - and same pulse number - eg 10 - for all frequencies. The second setting then gives a frequency cycle of 13.3 s. Both the step size and the number of pulses are again freely selectable quantities”).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have modified the magnetic field irradiation method of Dissing et al. in view of Schneider et al. with the frequency generator configured to apply a cycle in which frequency increases of Mazak. Cells often respond well to low-frequency and slowly modulated signals. Additionally, using a frequency generator that allows for a freely adjustable cycle ensures that application-specific limit values are consistently met, resulting in better control over the electromagnetic field produced (Mazak, page 8, para. 6, “The third mode and the third mode of operation, in the form of a magnetic flux mode…”; page 3, paras. 9-10, “It is also advantageous if limit values for all operating modes are freely adjustable. This ensures that application-specific limit values can be reliably met. It is also advantageous if time constants required for the individual operating modes are all freely adjustable. This improves the controllability of the frequency generator and thus of the electromagnetic field to be generated”; page 5, para. 3, “a body and / or cells can respond well to low-range frequencies, ie, slow modulations that increase their responsiveness”).
Regarding claim 10, Dissing et al. in view of Schneider et al., further in view of Mazak teaches the magnetic field irradiation method according to claim 9 as stated above. Dissing et al. in view of Schneider et al. further teaches a range selected from 1 Hz to 8 Hz (Schneider et al., paras. 0033, 0036, and 0074), or a range selected from 8 Hz to 1 Hz (Schneider et al., paras. 0033, 0036, and 0074).
Dissing et al. in view of Schneider fails to teach wherein during the predetermined period, the frequency increases stepwise, or the frequency decreases stepwise.
Mazak further teaches wherein during the predetermined period, the frequency increases stepwise, or the frequency decreases stepwise (page 8, para. 1, “The frequency cycle can take place with variable pulse number and same time for all frequencies – i.e., with increasing frequency with higher pulse number - or with the same step size – e.g. 1 kHz - and same pulse number – e.g. 10 - for all frequencies. Both the step size and the number of pulses are again freely selectable quantities”).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have further modified the magnetic field irradiation method of Dissing et al. in view of Schneider et al., further in view of Mazak with the stepwise frequency increase of Mazak. In a stepwise manner, the frequency may be incrementally increased in accordance with the cycle time; furthermore, given the variability of the step size, pulses adjacent to each other could be alternated in a positive and negative direction (Mazak, page 7, para. 11, “The individual pulse widths are representative of a packet of equal pulses. If the first positive pulse corresponds, for example, to a frequency of 10 kHz and the frequency is incrementally increased in accordance with the cycle time of a microprocessor control of 1 ms, 10 pulses with the same pulse width result next to each other - both in the positive and in the negative direction. The step size for increasing or decreasing the frequency automatically results from the preselected limit values and from the time for a frequency cycle”).
Regarding claim 11, Dissing et al. in view of Schneider et al., further in view of Mazak teaches the magnetic field irradiation method according to claim 10 as stated above. Mazak fails to teach wherein the predetermined period is selected from 2 sec to 8 sec.
Schneider et al. further teaches wherein the predetermined period is selected from 2 sec to 8 sec (Schneider et al., paras. 0033, 0036, and 0074, wherein period is the inverse of frequency, Schneider et al. teaches frequencies at 5 Hz or 2 Hz, therefore, the period may equal 5 sec or 2 sec, respectively).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have further modified the magnetic field irradiation method of Dissing et al. in view of Schneider et al., further in view of Mazak with the predetermined period of Schneider et al. Neuromodulating brain regions with a low-frequency stimulation and inversely related period may evoke significant analgesia in targeted brain regions (Schneider et al., paras. 0035 and 0072).
Regarding claim 21, Dissing et al. in view of Schneider et al., further in view of Mazak teaches the magnetic field generation device according to claim 3 as stated above. Mazak fails to teach wherein the predetermined period is selected from 2 sec to 8 sec.
Schneider et al. further teaches wherein the predetermined period is selected from 2 sec to 8 sec (Schneider et al., paras. 0033, 0036, and 0074, wherein period is the inverse of frequency, Schneider et al. teaches frequencies at 5 Hz or 2 Hz, therefore, the period may equal 5 sec or 2 sec, respectively).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have further modified the magnetic field generation device of Dissing et al. in view of Schneider et al., further in view of Mazak with the predetermined period of Schneider et al. Neuromodulating brain regions with a low-frequency stimulation and inversely related period may evoke significant analgesia in targeted brain regions (Schneider et al., paras. 0035 and 0072).
Claim(s) 6, 12, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dissing et al. in view of Schneider et al., further in view of Zabara (US 8,684,901).
Regarding claim 6, Dissing et al. in view of Schneider et al. teaches the magnetic field generation device according to claim 1 as stated above. Dissing et al. in view of Schneider et al. fails to teach wherein the magnetic field generation device is configured to be used for treatment of a mitochondria-related disease.
In the same field of endeavor, Zabara teaches wherein the magnetic field generation device is configured to be used for treatment of a mitochondria-related disease (Col. 20, lines 14-24; Col. 11, lines 8-21; Col. 17, lines 9-29).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have modified the magnetic field generation device of Dissing et al. in view of Schneider et al. with the mitochondria-related disease treatment of Zabara. Apoptosis is primarily initiated in the mitochondria; therefore, to elicit programmed cancer cell death, low-frequency electromagnetic radiation utilizing pulsed magnetic fields may be employed to dislodge cytochrome C held in the inner mitochondrial membrane. This ejection of cytochrome C from the membrane causes apoptosis and eventual cancer cell death (Zabara, Col. 20, lines 14-24; Col. 11, lines 8-21; Col. 17, lines 9-29).
Regarding claim 12, Dissing et al. in view of Schneider et al. teaches the magnetic field irradiation method according to claim 7 as stated above. Dissing et al. in view of Schneider et al. fails to teach wherein the magnetic field irradiation method is used for a method of treating a mitochondria-related disease.
In the same field of endeavor, Zabara teaches wherein the magnetic field irradiation method is used for method of treating a mitochondria-related disease (Col. 20, lines 14-24; Col. 11, lines 8-21; Col. 17, lines 9-29; Fig. 2).
Therefore, it would have obvious to someone of ordinary skill in the art, before, the effective filing date of the claimed invention, to have modified the magnetic field irradiation method of Dissing et al. in view of Schneider et al. with the mitochondria-related disease treatment of Zabara. Apoptosis is primarily initiated in the mitochondria; therefore, to elicit programmed cancer cell death, low-frequency electromagnetic radiation utilizing pulsed magnetic fields may be employed to dislodge cytochrome C held in the inner mitochondrial membrane. This ejection of cytochrome C from the membrane causes apoptosis and eventual cancer cell death (Zabara, Col. 20, lines 14-24; Col. 11, lines 8-21; Col. 17, lines 9-29).
Regarding claim 22, Dissing et al. in view of Schneider et al., further in view of Zabara teaches a method for treating a mitochondria-related disease (Zabara, Claim 14; Fig. 2; Col. 11, lines 8-53; Abstract) using the magnetic field irradiation method according to claim 12.
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.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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