DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to because they are not black and white line drawings (see 37 C.F.R. 1.84). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities:
In claim 6, line 3, “magnetic field generation device is used for treatment” should read “magnetic field generation device configured to be used for treatment”
Appropriate correction is required.
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 (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 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.
Claim(s) 1, 3-4, 7, 9-10, 13, 15, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rauscher et al. (US 4,889,526).
Regarding claim 1, Rauscher et al. teaches a magnetic field generation device (Col. 1, lines 14-15) comprising:
a coil (Col. 24, lines 63-68; Col. 25, lines 2-3); and
a power supply (Fig. 12, battery 102),
wherein the power supply is configured to apply pulsed and frequency-modulated current to the coil (Col. 25, lines 2-16; Col. 25, lines 25-28), and
wherein the maximum value of a generated magnetic field is 60 mG to 3000 mG (Col. 28, lines 25-30).
Regarding claim 3, Rauscher et al. teaches the magnetic field generation device according to claim 1 as stated above wherein the power supply (Col. 31, lines 24-52; Fig. 12) 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. (Col. 25, lines 2-16; Col. 26, lines 30-35; Fig. 8c).
Regarding claim 4, Rauscher et al. teaches the magnetic field generation device according to claim 3 as stated above wherein the frequency is the number of pulses applied to the coil per second (Col. 24, lines 63-68), and wherein during the predetermined period (Col. 25, lines 38-40), the frequency increases stepwise within a range selected from 1 Hz to 8 Hz, or the frequency decreases stepwise within a range selected from 8 Hz to 1 Hz (Col. 17, lines 7-10).
Regarding claim 7, Rauscher et al. teaches a magnetic field irradiation method for a living body (Col. 7, lines 6-23; Col. 11, lines 40-45, “electromagnetic components”; Col. 37, lines 61-68 and Col. 38, lines 1-14) using a magnetic field generation device (Col. 1, lines 14-15) including a coil (Col. 24, lines 63-68; Col. 25, lines 2-3) and a power supply (Fig. 12, battery 102), the magnetic field irradiation method comprising:
a magnetic field irradiation step of irradiation 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. 28, lines 25-30),
wherein in the magnetic field irradiation step, the power supply applies pulsed and frequency-modulated current to the coil (Col. 25, lines 2-16; Col. 25, lines 25-28).
Regarding claim 9, Rauscher et al. teaches the magnetic field irradiation method according to claim 7 wherein the power supply (Col. 31, lines 24-52; Fig. 12) 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. (Col. 25, lines 2-16; Col. 26, lines 30-35; Fig. 8c).
Regarding 10, Rauscher et al. teaches the magnetic field irradiation method according to claim 9 as stated above wherein the frequency is the number of pulses applied to the coil per second (Col. 24, lines 63-68), and wherein during the predetermined period (Col. 25, lines 38-40), the frequency increases stepwise within a range selected from 1 Hz to 8 Hz, or the frequency decreases stepwise within a range selected from 8 Hz to 1 Hz (Col. 17, lines 7-10).
Regarding claim 13, Rauscher et al. teaches the magnetic field generation device according to claim 1 as stated above wherein the pulsed current is current having substantially a rectangular waveform (Col. 2, lines 37-49; Col. 2, lines 66-68).
Regarding claim 15, Rauscher et al. teaches the magnetic field irradiation method according to claim 7 as stated above wherein the pulsed current is current having substantially a rectangular waveform (Col. 2, lines 37-49; Col. 2, lines 66-68).
Regarding claim 18, Rauscher et al. teaches the magnetic field generation device according to claim 13 wherein the power supply (Col. 31, lines 24-52; Fig. 12) 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. (Col. 25, lines 2-16; Col. 26, lines 30-35; Fig. 8c).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 8, 14, 16-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauscher et al. in view of Vasishta (US 2010/0197993).
Regarding claims 2 and 8, Rauscher et al. teaches the magnetic field generation device/irradiation method according to claim 1 or 7 as stated above. Rauscher et al. fails to teach wherein a pulse width of the current is selected from 2 to 8 msec.
Vasishta teaches an analogous magnetic field generation system wherein a pulse width of the current is selected from 2 to 8 msec (para. 086; para. 099, where a specific time duration is assigned to the pulse).
Therefore, it would have been 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/irradiation method of Rauscher et al. with disclosed pulse width current interval of Vasishta. Based on the patient’s disease type, the duration and intensity of treatment is calculated to ensure the patient is receiving the proper care according to their specific ailment. Correspondingly, pulse sequences, frequencies, and counts are adjusted based on the treatment plan. On one occasion, a smaller pulse width may stimulate normalized cellular functions of diseased cells by restoring their transmembrane potential. (Vasishta, paragraphs 0072, 0083, 0117, 0246).
Regarding claims 14 and 16, Rauscher et al. in view of Vasishta teaches the magnetic field generation device/irradiation method according to claims 2 or 8 as stated above wherein the pulsed current is current having substantially a rectangular waveform (Rauscher et al., Col. 2, lines 37-49; Col. 2, lines 66-68).
Regarding claim 17, Rauscher et al. in view of Vasishta teaches the magnetic field generation device according to claim 2 as stated above wherein the power supply (Rauscher et al., Col. 31, lines 24-52; Fig. 12) 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. (Rauscher et al., Col. 25, lines 2-16; Col. 26, lines 30-35; Fig. 8c).
Regarding claim 19, Rauscher et al. in view of Vasishta teaches the magnetic field generation device according to claim 14 as stated above wherein the power supply (Rauscher et al., Col. 31, lines 24-52; Fig. 12) 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. (Rauscher et al., Col. 25, lines 2-16; Col. 26, lines 30-35; Fig. 8c).
Regarding claim 20, Rauscher et al. in view of Vasishta teaches the magnetic field generation device according to claim 17 as stated above wherein the frequency is the number of pulses applied to the coil per second (Rauscher et al., Col. 24, lines 63-68), and wherein during the predetermined period (Rauscher et al., Col. 25, lines 38-40), the frequency increases stepwise within a range selected from 1 Hz to 8 Hz, or the frequency decreases stepwise within a range selected from 8 Hz to 1 Hz (Rauscher et al., Col. 17, lines 7-10).
Claim(s) 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauscher et al. in view of CellVital Clinics (DE 102017002889).
Regarding claims 5 and 11, Rauscher et al. teaches the magnetic field generation device/irradiation method according to claims 4 or 10 as stated above. Rauscher et al. fails to teach wherein the predetermined period is selected from 2 sec to 8 sec.
CellVital Clinics teaches an analogous magnetic field applicator wherein the predetermined period is selected from 2 sec to 8 sec (Claim 4 speaks directly on a pulse series interval of 0.7 to 5.0 sec).
Therefore, it would have been 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/irradiation method of Rauscher et al. with the predetermined period of CellVital Clinics. The low frequency pulsed currents combined with the small predetermined period provides the patient with a painless and concentrated treatment field (CellVital Clinics, the entirety of page 2).
Claim(s) 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauscher et al. in view of Pletnev et al. (WO 2020/021320).
Regarding claims 6 and 12, Rauscher et al. teaches the magnetic field generation device/irradiation method according to claims 1 or 7 as stated above. Rauscher et al. further teaches exciting Purkinje cells to simulate a natural pacemaker (Col. 3, lines 34-37) but does not specifically disclose wherein magnetic field generation device/irradiation method is used for a method of treating a mitochondria-related disease.
Pletnev et al. teaches an analogous magnetic field generation device wherein the magnetic field generation device/irradiation method is used for a method of treating a mitochondria-related disease (para. 022, “tumor cells;” para. 037).
Therefore, it would have been 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/irradiation method of Rauscher et al. with the specified treatment of a mitochondria-related disease of Pletnev et al. When treating a mitochondria-related disease with a magnetic field generator, the treatment’s parameters vary. As such, based on the type and affected area size of a diseased formation, frequency ranges and pulse characteristics are adjusted and optimized to prevent the myotic division of diseased cells (Pletnev et al., paragraphs 003, 026, and 037).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ishikawa et al. (JP 6603812) teaches a cancer treatment apparatus that employs a magnetic field generator and produces high frequencies. Terai et al. (JP 2005137784) teaches a cancer treatment induction heating system; nonetheless, the magnetic field amounts to 5.2 millitesla which is smaller than the claimed invention. Berman et al. (US 2016/0235983) teaches a system for directed energy cranial therapeutics with multiple energy portals capable of emitting energy to the human brain. Novickij et al. (2017) discloses a high power pulsed magnetic field generator with a predefined repetition frequency of 1 Hz – 100 Hz.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791