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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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:
magnetic field generating device first appearing in claim 1 (corresponding structure disclosed as at least one electromagnetic coil and/or at least one permanent magnet: specification, pg. 4, lines 19-24)
controlling arrangement first appearing in claim 1 (corresponding structure disclosed as a microcontroller: specification, pg. 6, lines 1-2)
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 § 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 2-4, 6, and 10-18 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 2 recites the limitation “the controlling arrangement” while parent claim 1 recites “at least one controlling arrangement”. It is unclear which of the previously recited “at least one” controlling arrangement applicant intends to reference in claim 2.
The same issue appears in claims 3, 4, 10, 13, 17, and 18.
Claim 3 recites the limitation “the carrier frequencies” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites “the time-varying magnetic field”, while parent claim 1 recites “time-varying magnetic fields”. There is insufficient antecedent basis for this limitation in the claim.
The same issue appears in claim 10.
Claim 11 recites the limitation “the same carrier frequency” in multiple instances of the claim. There is insufficient antecedent basis for these limitations in the claim.
Claim 15 recites the limitation “the carrier frequency”. There is insufficient antecedent basis for this limitation in the claim.
There is insufficient antecedent basis for this limitation in claim 16.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to “[a] computer program product comprising program code”, which in its broadest reasonable interpretation, amounts to software per se. Thus, the claim is non-statutory. See MPEP 2106.03(I). To overcome this rejection, the examiner suggests amending the preamble to specify the computer program product is embodied on a non-transitory computer readable medium.
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, 2, 5, 8, 10, 13, 14, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/155407 (Velasco Valcke).
Regarding claim 1, Velasco Valcke teaches a system for stimulation of biological tissue (abstract; pg. 9, lines 5-8; Figure 17), comprising at least two magnetic field generating devices (1) for generating time-varying magnetic fields, wherein the magnetic field generating devices are to be arranged relative to the tissue in such a way that their time-varying magnetic fields at least partially overlap in the tissue (pg. 9, lines 13; pg. 14, lines 9 and 12-27; Figure 1); and at least one controlling arrangement (21) for controlling the at least two magnetic field generating devices, wherein the controlling arrangement is configured to control at least one of the at least two magnetic field generating devices in such a way that the time-varying magnetic field generated by the at least one device is phase modulated (pg. 9, lines 9-18; Figure 17; phase modulated, pg. 12, lines 12-18).
Regarding claim 2, Velasco Valcke teaches the controlling arrangement (21) is configured to control the at least one magnetic field generating device (1) in such a way that the time-varying magnetic field generated by the device is frequency modulated (pg. 12, lines 12-18; Figure 1).
Regarding claim 5, Velasco Valcke teaches the modulation is at least partially sinusoidal (pg. 27, lines 25-30; Figure 5B).
Regarding claim 8, Velasco Valcke teaches at least one of the magnetic field generating devices comprises or consist of at least one electromagnetic coil (pg. 14, lines 9-14; Figure 1).
Regarding claim 10, Velasco Valcke teaches the at least two magnetic field generating devices (1) belong to a first group of devices and the system comprises a second group of devices that contains at least two magnetic field generating devices for generating time- varying magnetic fields, wherein the controlling arrangement (21) is configured to control at least one of the two magnetic field generating devices of the second group in such a way that the time-varying magnetic field generated by the device is modulated (activating each transducer, pg. 12, lines 28-31; modulated, pg. 13, lines 6-10; pg. 14, lines 15-27; Figure 1).
Regarding claims 13 and 14, Velasco Valcke teaches the controlling arrangement (21) comprises a programmable unit (pg. 11, lines 1-9; pg. 12, lines 28-31); wherein the programmable unit (21) generates at least one control signal for controlling the time-varying magnetic fields generated by the at least two magnetic generating devices (1) (“the computing unit (21) implements the method for tissue stimulation”, pg. 9, lines 9-19).
Regarding claim 16, Velasco Valcke teaches the carrier frequency of at least one of the time-varying magnetic field is below 1MHz, below 900 kHz, below 500 kHz, below 200 kHz, below 100 kHz, below 50 kHz, or below 10 kHz (“carrier signal…a fixed frequency of 500 Hz”, pg. 27 lines 25-30).
Regarding claim 18, Velasco Valcke teaches a computer program product comprising program code having instructions which - when executed by a programmable unit of the controlling arrangement of the system of any of the preceding claim 1 - will cause the controlling arrangement to control the at least two magnetic field generating devices of the system in such a way that each of them generates a time-varying magnetic field, wherein the time-varying magnetic field of at least one of the devices is phase modulated (see discussion for claim 1; “computing unit (21) implements the method for tissue stimulation”, pg. 9, lines 9-19; activation “signals are generated by a computing unit or by a signals generator or combinations of these, according to programs”, pg. 12, lines 18-19; program, pg. 12, lines 28-31).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/155407 (Velasco Valcke) in view of RU 2012387 (Chajchuk et al., see attached machine translation).
Regarding claim 3, Velasco Valcke teaches all the limitations of claim 1. Velasco Valcke does not explicitly specify the controlling arrangement is configured to control the at least two magnetic field generating devices in such a way that the carrier frequencies of at least two of the time-varying magnetic fields generated by the devices are identical.
However, Chajchuk teaches a system for stimulation of biological tissue (abstract), comprising: at least two magnetic generating devices (3) for generating time-varying magnetic fields; and at least one controlling arrangement (4) for controlling the at least two magnetic field generating devices, wherein the controlling arrangement is configured to control the at least two magnetic field generating devices in such a way that the carrier frequencies of at least two of the time-varying magnetic fields generated by the devices are identical (one oscillation generator 4 producing phase-modulated signal for each inductor 3: translation, pg. 2, paragraph 4). 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 controlling arrangement of Velasco Valcke to control the at least two magnetic field generating devices in such a way that the carrier frequencies of at least two of the time-varying magnetic fields generated by the devices are identical as taught by Chajchuk in order to produce the same stimulation signal from each magnetic field generating device to meet the user’s needs.
Claims 4, 7, 11, 12, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/155407 (Velasco Valcke).
Regarding claim 4, Velasco Valcke teaches all the limitations of claim 1. Velasco Valcke teaches “the parameters of each activation signal such as frequency, phase, amplitude, duty cycle, can be modified” (pg. 10, lines 7-9). Velasco Valcke does not expressly teach the controlling arrangement is configured to adjust the ratio of the amplitudes of the time-varying magnetic fields generated by the at least two magnetic field generating devices. 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 controlling arrangement to adjust the ratio of the amplitudes of the time-varying magnetic fields generated by the at least two magnetic field generating devices in light of the teachings of Velasco Valcke in order to adjust the resulting electromagnetic stimulus to meet the individual treatment needs of the patient (pg. 10, lines 7-9).
Regarding claim 7, Velasco Valcke teaches all the limitations of claim 1. Velasco Valcke teaches the modulation is a phase modulation (pg. 12, line 16), wherein activation signals are “applied to each transducer at a determined time, sequentially, out of phase in relation to the other activation signal or to various stimulation signals, randomly, or according to a program established for each one of the transducers” (pg. 12, lines 28-31). Velasco Valcke does not expressly specify the program includes a phase modulation comprising a switch from a first state in which the time-varying magnetic fields have opposite phases to a second state in which the time-varying magnetic fields are in phase. 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 phase modulation of Velasco Valcke to switch from a first state in which the time-varying magnetic fields have opposite phases to a second state in which the time-varying magnetic fields are in phase in light of the teachings of Velasco Valcke in order to produce stimulation to meet the needs of the individual patient.
Regarding claim 11, Velasco Valcke teaches all the limitations of claim 1. Velasco Valcke teaches the magnetic fields generated by the magnetic field generating devices (1) of the first group have a carrier frequency and the magnetic fields generated by the magnetic field generating devices (1) of the second group have a carrier frequency (col. 9, line 23-col. 10, line 6; col. 12, lines 11-19; pg. 27, lines 25-30). Velasco Valcke does not specify the carrier frequencies are different. 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 carrier frequency of each group of magnetic field generating devices such that the carrier frequency of a first group is different from that of a second group in light of the teachings of Velasco Valcke in order to produce stimulation that meets the needs of the individual patient.
Regarding claim 12, Velasco Valcke teaches all the limitations of claim 11. Velasco Valcke teaches the difference between the carrier frequencies of the first and second group is at least 0.2 kHz, at least 0.5 kHz or at least 1 kHz (pg. 26, lines 3-7; pg. 27, lines 25-30).
Regarding claim 15, Velasco Valcke teaches all the limitations of claim 1. Velasco Valcke does not expressly state the carrier frequency, as cited, of at least one of the time-varying magnetic fields is at least 1 kHz.
However, Velasco Valcke teaches an alternative embodiment wherein the carrier frequency is at least 1 kHz (between 0.1 Hz and 1000 kHz for both the carrier signal (9) and the modulating signal (8), pg. 26, lines 6-7). 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 carrier frequency to be at least 1 kHz as taught by Velasco Valcke in order to meet the treatment needs of an individual patient (pg. 26, lines 8-9).
Regarding claim 17, Velasco Valcke teaches all the limitations of claim 1. Valcke teaches the modulation is a phase modulation (pg. 12, line 16), wherein activation signals are “applied to each transducer at a determined time, sequentially, out of phase in relation to the other activation signal or to various stimulation signals, randomly, or according to a program established for each one of the transducers” (pg. 12, lines 28-31). Velasco Valcke does not expressly teach the controlling arrangement is configured to control the at least two magnetic field generating devices in such a way that the time-varying magnetic field generated by one of the magnetic field generating devices is phase modulated, while the time-varying magnetic field generated by the other magnetic field generating device is unmodulated. 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 controlling arrangement to control the at least two magnetic field generating devices in such a way that the time-varying magnetic field generated by one of the magnetic field generating devices is phase modulated, while the time-varying magnetic field generated by the other magnetic field generating device is unmodulated in light of the teachings of Velasco Valcke in order to produce stimulation to meet the needs of the individual patient.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/155407 (Velasco Valcke) in view of U.S. Patent No. 5,480,373 (Fischer et al.).
Regarding claim 6, Velasco Valcke teaches all the limitations of claim 1. Velasco Valcke does not teach the frequency of the modulation is lower than a third or fifth of the frequency of the time-varying magnetic field.
However, Fischer teaches a system for stimulation of biological tissue (abstract), comprising: at least two magnetic field generating devices (15) for generating phase-modulated time-varying magnetic fields, wherein the frequency of the modulation is lower than a third or a fifth of the frequency of each time-varying magnetic field (“frequency of the basis pulses is between 100 and 1000 Hz, col. 8, lines 66-67; modulation frequency of 0.5 to 35 Hz, col. 9, lines 37-32). 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 Velasco Valcke such that the frequency of the modulation is lower than a third or a fifth of the frequency of each time-varying magnetic field as taught by Fischer, in order to produce an electromagnetic field suitable for tissue stimulation, in accordance with the individual needs of the patient.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/155407 (Velasco Valcke) in view of U.S. Patent No. 4,818,697 (Liboff et al.).
Regarding claim 9, Velasco Valcke teaches all the limitations of claim 1. Velasco Valcke does not teach at least one of the magnetic field generating devices comprises or consist of at least one rotatable permanent magnet.
However, Liboff teaches a system for stimulation of biological tissue, comprising: at least two magnetic field generating devices comprising at least one rotatable permanent magnet (col. 3, lines 53-57). 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 magnetic field generating devices of Velasco Valcke to include at least one rotatable permanent magnet as taught by Liboff, as Liboff teaches “coils…or any other arrangement of electrical coils or permanent magnets” may be used to “create a net magnetic flux density” for stimulation (col. 3, lines 53-66).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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