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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In claim 1, "a high-power switching module" → defined as “a high-power switching module that utilizes a multi-layered printed circuit board (PCB) to implement a circuit for generating high voltage, high pulses to the coil” (see paragraph [0028])
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 5, and 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gleich et al. (US 20160184601 A1).
Regarding claim 1, Gleich et al. teaches a system for administering transcranial magnetic stimulation (“transcranial magnetic stimulation (TMS) is used to stimulate e.g. the human brain”, paragraph [0001]), comprising:
A coil (stimulation coil 4, Fig. 2)
A controller configured to generate low voltage control signals (“control device can…conduct a measurement signal and/or to generate a trigger signal”, control device 3, Fig. 2)
A high-power switching module (pulse generator device 2, Fig. 2) configured to generate a high voltage current delivered to the coil based on the low voltage control signals (“the invention accordingly creates a magnetic stimulator for stimulation of a tissue by a magnetic field with a pulse generator device”, paragraph [0006]), wherein the controller is configured to:
Generate a plurality of bursts of pulses of current through the coil (“pulse generator device which has…a programmable control device which adjusts the pulse generator device in order to generate a complex pulse sequence…applied to a stimulation coil”, paragraph [0006]), wherein a pulse frequency of each burst of pulses is at least 40 Hz (“the magnetic stimulator in accordance with the invention can achieve repeat rates with a frequency of 1000 Hz and higher”, paragraph [0170]) and a number of pulses per burst is at least four (“an I-wave-adapted stimulation at a frequency of 666 Hz, i.e. a 1.5 ms interval between the four pulses”, paragraph [0174])
Regarding claim 5, Gleich et al. teaches the high-power switching module comprising:
A power supply unit (“charging circuit 2a is preferably connected to a power supply”, paragraph [0093]; charging circuit 2a, Fig. 2)
A capacitor (“the pulse generator device 2 contains at least one pulse capacitor which can be charged by a charging circuit to generate a pulse”, paragraph [0089]; capacitors C3-C10, shown in Fig. 7)
A first switch device configured to enable charging of the capacitor by the power supply unit (first switch Q1-Q2, shown in annotated Fig. 7 below)
An insulated gate bipolar transistor (IGBT) (“the different power switches Q1 to Q4 can be actuated via an associated IGBT driver”, paragraph [0107]; switches Q1-Q4, shown in annotated Fig. 7 below)
A diode (diodes D1-D4, shown in annotated Fig. 7 below)
A first resistor connected in series with the diode (first resistor R1, shown in annotated Fig. 7 below)
A second resistor (second resistor R2, shown in annotated Fig. 7 below)
A second switch device connected in series with the second resistor (second switch Q3-Q4, shown in annotated Fig. 7 below) and configured to enable the capacitor to discharge through the second resistor (“pulse capacitor is effected via a further switch and a discharge resistor in a similar manner to the case of the linear charging circuit”, paragraph [0125])
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Regarding claim 9, Gleich et al. teaches wherein the pulse frequency is 45 Hz (“number of pulses output per second, can be adjusted with a range of 0 to 1kHz”, paragraph [0015]).
Regarding claim 10, Gleich et al. teaches the number of pulses per burst is 4 (“an I-wave-adapted stimulation at a frequency of 666 Hz, i.e. a 1.5 ms interval between the four pulses”, paragraph [0174]).
Regarding claim 11, Gleich et al. teaches the number of pulses per burst is 6 (“four to eight pulses, is of relevance for the effects achieved”, paragraph [0172]).
Regarding claim 12, Gleich et al. teaches the pulse frequency is 50 Hz (“number of pulses output per second, can be adjusted with a range of 0 to 1kHz”, paragraph [0015]).
Regarding claim 13, Gleich et al. teaches the plurality of bursts of pulses of current being generated through the coil in a plurality of burst trains (“plurality of pulse trains which each consist of pulse packets which are for their part composed of configurable pulses as can be output to a stimulation coil”, paragraph [0075]), each burst train having a duration of two seconds, wherein one burst train is delivered to the coil every ten seconds (“user can adjust…the period duration of the stimulus or pulse”, paragraph [0154]; shown in Figs. 40A and 40B). It can be configured so that the burst train will have a duration of two seconds and one burst train is delivered to the coil every ten seconds.
Regarding claim 14, Gleich et al. teaches a total number of pulses delivered during a treatment being at least 600 (“number of pulses output per second, can be adjusted”, paragraph [0015]). The number of pulses can be adjusted during treatment to be 600.
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being obvious over Gleich et al. in view of Simon et al. (US 20110152967 A1).
Regarding claim 2, Gleich et al. teaches the low voltage control signals including an enable signal and an inhibit signal (“controllable switch to break and close the oscillation circuit…the pulse capacitor is charged to a desired voltage”, paragraph [0003], Fig. 1, “DC/DC switching regulator”, paragraph [0122]), but does not teach an amplitude signal, and at least one pulse width and frequency signal.
However, Simon et al. teaches a system for administering transcranial magnetic stimulation (“magnetic stimulator coil…for transcranial (TMS)”, paragraph [0083]), including at least one amplitude signal, and at least one pulse width and frequency signal (“parameters of the modulation signal 400 are preferably programmable, such as the frequency, amplitude…pulse width, pulse shape, etc.”, paragraph [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Gleich et al. with the system of Simon et al. and utilizing an amplitude signal, and at least one pulse width and frequency signal in order to allow for the burst of pulses of current to through the coil and to the patient.
Regarding claim 3, Gleich et al. in view of Simon et al. teaches all the limitations of claim 2, including a microcontroller that generates a signal (“microprocessor MP passes a pulse command”, paragraph [0106], Fig. 5) and wherein each pulse width and frequency signal of the at least one pulse width and frequency signal is generated by a gate driver (“amplitude of the oscillation is determined by the charging voltage of the pulse capacitor…current progression is damped by time losses at the power switches”, paragraph [0109], Gleich et al., “maximum switching frequency for the power switches…preferably an IGBT power switch”, paragraph [0105]).
Furthermore, Simon et al. teaches wherein each amplitude signal of the at least one amplitude signal is generated by a digital-to-analog converter (DAC) (“analog-to-digital converters for digitizing externally supplied analog signals”, paragraph [0077]) that converts a pulse width modulation signal generated by a microcontroller into a voltage (“parameters of the modulation signal 400 are preferably programmable, such as…pulse width”, paragraph [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Gleich et al. in view of Simon et al. by allowing for the conversion of digital to analog and converting the pulse width modulation signal into a voltage. It also would have been obvious to one of ordinary skill in the art to include a DAC in order to convert the signals into a voltage, providing a better measure of the signals. okok
Regarding claim 4, Gleich et al. in view of Simon et al. teaches the microcontroller (microprocessor, shown in Fig. 5) being coupled to at least one processor (computer 7, Fig. 1) and a display device (“control device 3 is connected to display elements or display devices”, paragraph [0102]).
Claim 6 is rejected under 35 U.S.C. 103 as being obvious over Gleich et al.
Regarding claim 6, Gleich et al. teaches all the limitations of claim 5, but does not teach the high-power switching module comprising two power supply units and two IGBTs capable to deliver biphasic pulses to the coil.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gleich et al. since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success, such as delivering biphasic pulses to the coil with double the power supply units and IGBT. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 7 is rejected under 35 U.S.C. 103 as being obvious over Gleich et al. in view of Schwarz et al. (US 20200324133 A1).
Regarding claim 7, Gleich et al. teaches all the limitations of claim 5, but does not teach the capacitor, IGBT, the diode, and the first resistor being connected to a multi-layer printed circuit board.
However, Schwarz et al. teaches the IGBT, the diode (“may include any switching device, such as a diode…IGBT”, paragraph [0280]), and the first resistor (“may also include…resistors”, paragraph [0275]) being connected to a multi-layer printed circuit board (“electrodes…may be spaced from each other…by material of a printed circuit board”, paragraph [0217]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Gleich et al. with the circuit board assembly of Schwarz et al. in order to implement a circuit for generating high voltage, high current pulses to the coil. It would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the circuit board by including the capacitor, enabling the higher voltage pulses.
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over Gleich et al. in view of Schwarz et al. and further in view of Mirksy et al. (US 20070080360 A1).
Regarding claim 8, Gleich et al. in view of Schwarz et al. teaches all the limitations of claim 7, but does not teach the specific multiple layers of the circuit board. However, Mirsky et al. teaches the multi-layer printed circuit board including at least seven layers (“several metal layers”, paragraph [0017]) including a top metal layer, a bottom metal layer (“metallization on the top surface of the substrate…metallization on the bottom surface of the substrate”, paragraph [0114]), an interior ground plane metal layer (“an internal aluminum layer (which can be used for power or ground”, paragraph [0031]), and an interior high-voltage plane metal layer (“insulating layer…forms a conduction path itself”, paragraph [0101]), each of the metal layers separated by a dielectric layer (“several metal layers (of conductive traces) separated from one another by layers dielectric material”, paragraph [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Gleich et al. in view of Schwarz et al. with the multi-layer printed circuit board of Mirsky et al. in order to implement a circuit for generating high voltage and current pulses to the coil.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791