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 .
Claim Objections
Claim 14 objected to because of the following informalities:
Claim 14 is currently dependent upon “any of the preceding claims”. All other instances of multiple claim dependency have been removed so it would seem this one was meant to also be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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, 11-13, 15-16, 20, 22 are rejected under 35 U.S.C. 102 (a) (2) as being anticipated by Boyden et al (US 2009/0018384), herein referred to as Boyden.
Regarding Claim 1, Boyden discloses a portable therapeutic device, comprising: an energy storage device coupled to a power supply and configured to store energy received from the power supply (Energy storage device: Figure 1, element 120. Paragraph [0017] “A preferred embodiment comprises a battery, a flyback transformer that permits a DC voltage (e.g., battery) to charge a capacitor, a set of thyristors that optimally allow charging and discharging of the capacitor”), the energy storage device being configured to operate during a predetermined number of charge-discharge cycles, wherein during a charge portion of each charge-discharge cycle, the energy storage device is configured to receive and store energy from the power supply, and during a discharge portion of each charge-discharge cycle, the energy storage device is configured to discharge stored energy (Charge-discharge cycle: Paragraph [0020] “These batteries can fully recharge in as little as 5 minutes, making it simple to operate with rapid cycle times, e.g. on a number of patients, or if the protocol must be repeated several times.” The examiner is interpreting the battery as the power supply.), a magnetic field generation device coupled to the energy storage device and configured to repeatedly generate one or more magnetic field pulses in a plurality of magnetic field pulses during a predetermined period of time (Magnetic Field Generation Device: Figure 1, element 150. Paragraph [0029] “FIGS. 4A and 4B are circuit diagrams of exemplary embodiments of a multiphasic stimulator and a biphasic stimulator, respectively, according to one aspect of the present invention. In FIG. 4A, which is adapted for multiphasic stimulation, energy storage unit 410 (C1) is charged to the appropriate level for the desired pulse strength via the power supply unit. Then the control unit disconnects the power supply unit and closes switch 420 (S1). At this point, energy storage unit 410 and coil 425 (L1) are connected in a LC circuit.” The examiner is interpreting the coil unit as the magnetic field generation device. The examiner is also interpreting the circuit in the prior art as an LC circuit that will pulse at a predetermined frequency for a predetermined period of time. Therefore, the coil unit in the device is configured to repeatedly generate one or more magnetic field pulses in a plurality of magnetic field pulses during a predetermined period of time.), each magnetic field pulse having a predetermined magnetic field strength, during the discharge portion of each charge-discharge cycle of the energy storage device; each magnetic field pulse having a predetermined magnetic field strength, during the discharge portion of each charge-discharge cycle of the energy storage device (Magnetic Field Strength: Paragraph [0035] “In a preferred embodiment, the coil unit comprises a conductive coil that produces a strong magnetic field when the pulse of current generated by the device traverses it.”); each magnetic field pulse having a predetermined magnetic field strength, during the discharge portion of each charge-discharge cycle of the energy storage device; the generated magnetic field pulses being configured to cause generation of an electric field having a predetermined strength, thereby generating a desired therapeutic effect in a subject. (Desired therapeutic effect: Paragraph [0028] “The charge recovery unit is configured to produce the desired stimulation type or pattern. One of the simplest simulation types is biphasic, where the induced current into the brain swings symmetrically in both directions. Multiphasic stimulation is a succession of biphasic stimulations. Also interesting and useful is monophasic stimulation, where the pulsed induced currents are designed to stimulate predominantly in one direction. Several implementations of these stimulation methods are possible. The prototype embodiment has been employed for the following types of stimulation: multiphasic, biphasic (with second inductor to restore polarity), monophasic, and monophasic with shared capacitors.”)
Regarding claim 2, Boyden discloses wherein the energy storage device includes a capacitor. (Paragraph [0022] “The energy storage unit of FIG. 3 comprises capacitor 310 (C1) that stores the energy coming from the power supply unit until it is needed to generate a stimulation pulse and additional circuitry to discharge it and measure its voltage.”)
Regarding claim 3, Boyden discloses wherein the magnetic field generation device includes an inductive coil having a conductive wire, the conductive wire is configured to be wound. (Paragraph [0036] “Optional features of the present invention include, but are not limited to, the capacity to recharge the battery via remote power, such as, but not limited to, through an RF inductive coil, including through the same coil used to do the stimulation, making the coil into an array of coils, each individually actuatable, for more focal stimulation, and replacing the coils with a mesh electrode of copper wires that can go under the hair, for invisible and fashionable wearable brain stimulation.“, coil used for stimulation is an inductive coil, which is a wound conductive wire.)
Regarding claims 4 and 5, Boyden discloses wherein the inductive coil is configured to include a predetermined shape (of claim 4) and wherein the predetermined shape includes at least one of the following: a circular shape, a figure-8 shape, an oval shape, an elliptical shape, a butterfly shape, a double butterfly shape, a triple butterfly shape, an H-coil shape, a regular shape, an irregular shape, and any combination thereof (of claim 5). (Paragraph [0035] “The best designs appear to have a FIG. 8 or similar shape, such as rectangular (where the two loops are rectangular instead of circular)...Many other coil geometries exist, and any coils with the same inductance can be interchanged with one another without alteration of any other part of the circuit, making this also a modular aspect of the circuit.”)
Regarding claim 6, Boyden discloses wherein the wherein the inductive coil includes at least one of the following parameters: a predetermined length, a predetermined number of winding turns of the conductive wire, a predetermined radius of one or more winding turns of the conductive wire, a thickness of the conductive wire, and any combination thereof. (paragraph [0035] “Two model coil designs implemented as prototypes to test the present invention were made of 10-gauge copper magnet wire, insulated with heavy amidester coating, and had two 2.5-15 cm diameter coils arranged in a figure-8.” The examiner is noting that the 10-gauge copper wire has a thickness of approximately 2.5 mm (a “predetermined” thickness) and that the radius of the coil would be 1.5 cm – 7.5 cm (a “predetermined” radius of turns).)
Regarding claim 7, Boyden discloses wherein the predetermined magnetic field strength is determined using at least one of the inductive coil parameters. (Paragraph [0035] “A smaller coil has less flux, and thus requires a higher current to drive; a larger coil requires less current.” The coil parameters inherently dictate the magnetic field strength as noted in paragraph [0040] in the applicant’s disclosed specification where magnetic field strength is calculated using coil parameters such as coil radius in Biot-Savart’s Law. Therefore, the predetermined magnetic field strength is determined using at least one of the inductive coil parameters.)
Regarding claim 11, Boyden discloses wherein the power supply is rechargeable. (Paragraph [0020] “These batteries can fully recharge”.)
Regarding claims 12 and 13, Boyden discloses wherein the magnetic field generation device is configured to generated one or more magnetic field pulses as a result of a predetermined current received from the energy storage device (of claim 12) and wherein the predetermined current being in a range of approximately 800 A to 2500 A (of claim 13). (Paragraph [0020] “For example, one suitable battery configuration is a set of super-high capacity lithium ion batteries that contain storage electrodes comprising sub-100 nanometer active material particles, and can produce 2.3 Amp-hours at 3.3V, in a 70-gram package (e.g., the ANR26650M1 from A123 Systems in the present implementation). These specific batteries can store >20.000 J, enough so that five such batteries can generate O(100) full TMS pulses (100 microseconds, 1000V, 10000 A) even if all the energy is dissipated as heat (and even more if some of the energy is recovered).”)
Regarding claim 15, Boyden discloses further comprising a voltage step-up device coupled to the power supply and the energy storage device and configured to increase voltage being supplied by the power supply to the energy storage device. (Paragraph [0019] “FIG. 2 is a schematic of an exemplary embodiment of a power supply unit using a flyback transformer, according to one aspect of the present invention. This implementation employs flyback transformer 210 (e.g., the 28K074 transformer, which can create up to 4000V at 15 mA) to step up the voltage of a fast oscillating (e.g 15 to 50 kHz), low voltage (e.g. 5 to 25V), moderately high current (100s of mA) waveform 220 and is turned on and off by a microcontroller (PIC).” The examiner is interpreting the flyback transformer as a voltage step up device as it is used to step up the voltage of the power supply.)
Regarding claim 16, Boyden discloses wherein the voltage supplied to the energy storage device is greater than approximately 200 V. (Paragraph [0018] “The power supply unit comprises a controllable device able to generate high voltages in the range of at least 1-3 kV starting from a lower voltage power source, such as, but not limited to, a wall socket, solar panels, or batteries.”)
Regarding claim 20, Boyden discloses wherein the therapeutic effect include a repetitive transcranial magnetic stimulation. (Abstract “A portable modular transcranial magnetic stimulation device.”)
Regarding claim 22, Boyden discloses A method comprising: providing a portable therapeutic device having an energy storage device coupled to a power supply and configured to store energy received from the power supply, the energy storage device being configured to operate during a predetermined number of charge-discharge cycles, wherein during a charge portion of each charge-discharge cycle, the energy storage device is configured to receive and store energy from the power supply, and during a discharge portion of each charge-discharge cycle, the energy storage device is configured to discharge stored energy (Energy Storage Device: Figure 1, element 120. Paragraph [0017] “A preferred embodiment comprises a battery, a flyback transformer that permits a DC voltage (e.g., battery) to charge a capacitor, a set of thyristors that optimally allow charging and discharging of the capacitor.” Paragraph [0020] “These batteries can fully recharge in as little as 5 minutes, making it simple to operate with rapid cycle times, e.g. on a number of patients, or if the protocol must be repeated several times.” The examiner is interpreting the battery as the power supply.); a magnetic field generation device coupled to the energy storage device and configured to repeatedly generate one or more magnetic field pulses in a plurality of magnetic field pulses during a predetermined period of time (Magnetic Field Generation Device: Figure 1, element 150. Paragraph [0029] “FIGS. 4A and 4B are circuit diagrams of exemplary embodiments of a multiphasic stimulator and a biphasic stimulator, respectively, according to one aspect of the present invention. In FIG. 4A, which is adapted for multiphasic stimulation, energy storage unit 410 (C1) is charged to the appropriate level for the desired pulse strength via the power supply unit. Then the control unit disconnects the power supply unit and closes switch 420 (S1). At this point, energy storage unit 410 and coil 425 (L1) are connected in a LC circuit. The energy in energy storage unit 410 will be converted into current in the coil, and back into negative voltage on energy storage unit 410. At that point, D1 430 starts conducting and the process repeats, so that the voltage on energy storage unit 410 is positive again. Now the power supply unit is briefly enabled to replenish the energy loss in the process and bring back energy storage unit 410 to full charge, and the cycle is repeated” The examiner is interpreting the coil unit as the magnetic field generation device. The examiner is also interpreting the circuit in the prior art as an LC circuit that will pulse at a predetermined frequency for a predetermined period of time. Therefore, the coil unit in the device is configured to repeatedly generate one or more magnetic field pulses in a plurality of magnetic field pulses during a predetermined period of time. The examiner is interpreting the cycle of repeatedly charging and discharging to produce the magnetic field pulses as repeatedly generate one or more magnetic field pulses in a plurality of magnetic field pulses during a predetermined period of time.), each magnetic field pulse having a predetermined magnetic field strength, during the discharge portion of each charge-discharge cycle of the energy storage device(Magnetic field strength: Paragraph [0035] “In a preferred embodiment, the coil unit comprises a conductive coil that produces a strong magnetic field when the pulse of current generated by the device traverses it.”); repeatedly generating, using the magnetic field generation device, the one or more magnetic field pulses; and providing the repeatedly generated magnetic field pulses to a subject, and causing generation of an electric field having a predetermined strength, thereby generating a desired therapeutic effect in the subject. (Desired therapeutic effect in the subject: Paragraph [0028] “The charge recovery unit is configured to produce the desired stimulation type or pattern. One of the simplest simulation types is biphasic, where the induced current into the brain swings symmetrically in both directions. Multiphasic stimulation is a succession of biphasic stimulations. Also interesting and useful is monophasic stimulation, where the pulsed induced currents are designed to stimulate predominantly in one direction. Several implementations of these stimulation methods are possible. The prototype embodiment has been employed for the following types of stimulation: multiphasic, biphasic (with second inductor to restore polarity), monophasic, and monophasic with shared capacitors.” Paragraph [0005] “The magnetic stimulation coil unit stores energy received from the energy storage unit as a strong current for application of magnetic stimulation to a patient…. The charge recovery unit converts energy stored as current in the stimulation coil unit back to energy stored as voltage in the energy storage unit, and can be configured to determine the type and pattern of stimulation delivered to the patient. Biphasic, multiphasic, and various types of monophasic stimulators have been implemented.” The examiner is interpreting the magnetic stimulation as the desired therapeutic effect in the subject.)
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.
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.
Claims 8-10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden in view of Saitoh et al (US 2016/0346562), herein referred to as Saitoh.
Regarding claim 8, Boyden fails to teach wherein the predetermined length is in a range of approximately 50 mm to 150 mm.
However, Saitoh teaches a coil device for transcranial magnetic stimulation treatment wherein the coil has a predetermined length in a range of approximately 50 mm to 150 mm. (Paragraph [0042] “Based on the model of FIG. 16 determined as the most effective coil in the analysis with the simplified model, a 20-turn dome-type coil was modeled to have the horizontal length of 112 mm, the vertical length of 39 mm, and the coil width of 97 mm as shown in FIG. 20.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the coil unit taught in Boyden to have the predetermined length taught in Saitoh. Boyden teaches various coil geometries/parameters can be used ([0035]) and Saitoh teaches a coil in the same field of endeavor so it would have been obvious to one skilled in the art before the effective filing date of the claimed invention was filed to substituted the coil of Boyden with the coil of Saitoh as a matter of simple substitution yielding the predictable result of providing transcranial magnetic stimulation. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.II.
Regarding claims 9 and 10, Boyden fails to teach wherein the predetermined strength of the generated electric field is in a range of approximately 50 V/m to 120 V/m (of claim 9) and wherein the predetermined strength of the generated electric field is approximately 65 V/m (of claim 10).
However, Saitoh teaches changing coil design parameters to acquire a desired induced electric field intensity wherein the predetermined strength of the generated electric field falls in a range of approximately 50 V/m to 120 V/m (of claim 9) and wherein the predetermined strength of the generated electric field can be approximately 65 V/m (of claim 10). (Fig 30. Shows testing various coil designs which produce generated electric field strengths varying from 50 V/m to 150 V/m where one of the coil designs produces approximately 65 V/m as seen on the graphs. The examiner is interpreting this as there is an embodiment of this prior art that is capable of producing an electric field with strength of 65 V/m.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the magnetic field taught in Boyden to have the predetermined strength of approximately 65 V/m as taught by Saitoh. Boyden fails to disclose an electric field strength and Saitoh teaches using max electric field strengths ranging from 56-121 V/m (Table 4) for transcranial magnetic stimulation, it would therefore be obvious to apply a field strength within that range such as 65 V/m. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.II.
Regarding claim 14, Boyden fails to teach wherein the one or more magnetic field pulses are generated at a predetermined frequency, the predetermined frequency being determined based on the desired therapeutic effect.
However, Saitoh teaches wherein the one or more magnetic field pulses are generated at a predetermined frequency, the predetermined frequency being determined based on the desired therapeutic effect. (Paragraph [0129] “The alternating current applied to the coil was set to the frequency of 3.4 kHz.”, “The electric conductivity of this brain model was set to 0.11 S/m from the electric conductivity of the grey matter at 3.4 kHz.”, the frequency is being set based on the desired area to be treated, i.e. therapeutic effect. The examiner is interpreting claim 4 as dependent on claim 1.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the magnetic field taught in Boyden to have a predetermined frequency based on a desired therapeutic effect as taught by Saitoh. Boyden teaches a transcranial magnetic stimulation device that is modular so that one can change the properties of the machine ([0004]). It would therefore be obvious to one of ordinary skill in the art to change a property of the machine such as the magnetic field pulse frequency to target the desired area to be treated/the desired therapeutic effect.
Claims 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden in view of Whelan et al (US 2004/0176805), herein referred to as Whelan.
Regarding claim 17, Boyden fails to teach further comprising a printed circuit board for positioning at least one of the power supply, the energy storage device, the magnetic field generation device, and any combination thereof.
However, Whelan teaches a portable electromagnetic stimulation device further comprising a printed circuit board for positioning at least one of the power supply, the energy storage device, the magnetic field generation device, and any combination thereof. (Paragraph [0057] “FIG. 8 depicts an implementation of an enhanced antenna comprising wires 802 wound around an annular ring 804 mounted on a printed circuit board 810. The ring may be a ferrite or magnetic, electrically-insulating ring. The ring may be arranged to support a battery 806 around the periphery. The battery 806 may be held in place by a retaining clip 808 to retain the battery adjacent the printed circuit board 810. Conductors 812 on the printed circuit board may be arranged to function as a main antenna for the therapeutic electromagnetic device and may be coupled to an electromagnetic field generator (not shown) as described above.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the circuit diagrams taught in Boyden to be implemented using a printed circuit board as taught in Whelan. One of ordinary skill in the art would have been able to recognize this method is widely used in the state of electronics today. Additionally, both Boyden and Whelan teach a portable electromagnetic field generating device so modifying the Boyden’s device to use a PCB to position at least one of the components (power supply, conductor, etc.) would have improved the device in a similar way as taught in Whelan.
Regarding claims 18 and 19, Boyden fails to teach wherein the magnetic field pulses are being configured to be applied to the subject from a predetermined distance (of claim 18) and wherein the predetermined distance is in a range of 1.5 cm to 2.5 cm (of claim 19).
However, Whelan teaches wherein the magnetic field pulses are being configured to be applied to the subject from a predetermined distance (of claim 18) and wherein the predetermined distance is in a range of 1.5 cm to 2.5 cm (of claim 19). (Paragraph [0015] “In the methods described herein, positioning a device adjacent a bodily tissue of an individual refers to placing the device close to the skin of the individual (e.g., within 0.5, 1, 2, 3, 4, 5, or 6 inches of the skin) or in contact with the skin.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify the device taught in Boyden to be implemented at the predetermined distances as taught in Whelan. Boyden fails to disclose a range of the magnetic field pulses so it would be obvious to one of ordinary skill in the art to use a well known range for magnetic field pulse application such as taught in Boyden. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the claimed dimensions since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.II.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Boyden in view of Young (US 5707334).
Regarding claim 21, Boyden fails to teach wherein the predetermined magnetic field strength is greater than 100 mT.
However, Young teaches portable transcranial magnetic stimulation device wherein the predetermined magnetic field strength is greater than 100 mT. (Claim 4: the magnetic field strength is about 0.1 to about 4 Tesla)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the application to modify device taught in Boyden to be implemented using the magnetic field strength taught in Whelan. One of ordinary skill in the art would have been able to recognize this magnetic field strength is sufficient to treat subjects with a range of symptoms including mood changes (e.g., ….chronic and recurring depressions) (see column 1, line 20 of Young) which according to the applicant’s specification is the purpose of the claimed device and magnetic field strength.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eriksson et al (US 2018/0361140) teaches a system for facilitating administration of transcranial stimulation. The system includes an electrode, the electrode including a counterpart configured to be attached to a headcap.
Thomas et al (US 2009/0216068) teaches a device for delivering a low frequency magnetic field pulses to affect the physiological and/or neurological conditions of a human and is designed to have anti-depression, analgesic, or anti-anxiety effects.
Hong et al (US 10518098) teaches methods and systems to control magnetic fields and magnetic field induced currents, and more particularly to provide stimulations within a patient's body, such as deep brain stimulation, in a non-invasive manner.
Roth et al (US 10463870) teaches a system and methods for controlling pulse parameters during transcranial magnetic stimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791