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 .
Information Disclosure Statement
The Information Disclosure Statements filed 03/28/2024 and 08/09/2024 have been considered by the Examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 5: “the MCU control unit ,”. Please remove additional space.
Line 7: “wehrein” should be changed to “wherein”.
Line 10: “wehrein” should be changed to “wherein”.
Lines 17-18: “each respective working cycles” should be changed to “each of respective working cycles”.
Line 18: “the continuous on-time of” should be changed to “the continuous on-time periods of”.
e.g., lines 19-20: “t3” and “t4”. The Examiner questions whether “t3” and “t4” were intended to be deleted throughout the claims like “T1” was in claim 1.
Line 28: “is a set to be a constant value” should be changed to “is set to be a constant value”. Please remove first “a”.
Claim 5 objected to because of the following informalities:
Line 3: “pluse signal” should be changed to “pulse signal”.
Claim 20 objected to because of the following informalities:
Line 6: “each of the second time period T2” should be changed to “each of the second time periods T2”.
Appropriate correction is required.
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 1-21 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 1 recites the limitation “insulated electrodes” in line 13, whereas insulated electrodes was already introduced in claim 1. It is unclear whether the Applicant intended to claim the same or a different insulated electrodes. Consider changing to “the insulated electrodes”.
Claim 1 recites the limitation “insulated electrodes” in line 14, whereas insulated electrodes was already introduced in claim 1. It is unclear whether the Applicant intended to claim the same or a different insulated electrodes. Consider changing to “the insulated electrodes”.
Claim 1 recites the limitation “a constant value” in the 2nd to last and last lines, whereas a constant value was already introduced in claim 1. It is unclear whether the Applicant intended to claim the same or a different constant value. Consider changing to “the constant value”.
Claim 2 recites the limitation "the ratio of the voltage change" in 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the […] disconnection between the MCU control unit and the DC power supply unit" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "disconnection between the MCU control unit and the DC power supply control unit" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “a pulse signal” in line 4, whereas a pulse signal was already introduced in a claim that claim 7 depends from (claim 3). It is unclear whether the Applicant intended to claim the same or a different pulse signal. Consider changing to “the pulse signal”.
Claim 8 recites the limitation “a constant speed” in lines 2-3, whereas a constant speed was already introduced in a claim that claim 8 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different constant speed. Consider changing to “the constant speed”.
Claim 14 recites the limitation “a constant speed” in line 3, whereas a constant speed was already introduced in a claim that claim 14 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different constant speed. Consider changing to “the constant speed”.
Claim 15 recites the limitation "the […] disconnection between the AC voltage control unit and one pair of insulated electrodes" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “insulated electrodes” in line 4, whereas insulated electrodes was already introduced in a claim that claim 15 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different insulated electrodes. Consider changing to “the insulated electrodes”.
Claim 15 recites the limitation “insulated electrodes” in line 7, whereas insulated electrodes was already introduced in a claim that claim 15 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different insulated electrodes. Consider changing to “the insulated electrodes”.
Claim 17 recites the limitation “insulated electrodes” in line 3, whereas insulated electrodes was already introduced in a claim that claim 17 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different insulated electrodes. Consider changing to “the insulated electrodes”.
Claim 17 recites the limitation "the patient’s torso surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “insulated electrodes” in line 7, whereas insulated electrodes was already introduced in a claim that claim 17 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different insulated electrodes. Consider changing to “the insulated electrodes”.
Claim 18 recites the limitation "the duration" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation “a duration” in line 3, whereas a duration was already introduced in claim 18 (line 2). It is unclear whether the Applicant intended to claim the same or a different duration. Consider changing to “the duration”.
The limitation “wherein the first time period T1 and the second time period T2 are same with each other” renders claim 18 (lines 3-4) indefinite. It is unclear whether this limitation is supposed to convey the durations of the first and second time periods are the same.
The limitation “wherein the durations of the switching-on time period t3 and the switching-off time period t4 are both less than 10% of the duration of the first time period T1 or the second time period T2” renders claim 21 (lines 1-3) indefinite. It is unclear whether each of the time periods are less than 10% of the duration or if together the time periods are less than 10% of the duration.
*All other claims are rejected due to their dependency on a rejected claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 221 of copending Application No. 18/696,568 (reference application – hereinafter ‘568 Application). Although the claims at issue are not identical, they are not patentably distinct from each other. It is noted that references to the ‘568 Application are made to the printed publication (US 2025/0229084).
Regarding claims 1-7 and 15-16 of the instant application, claim 221 of the ‘568 Application discloses:
A tumor electric field therapy system comprising an electric field therapy device (Claim 211, lines 1-4) having a plurality of preset system parameters and at least two pairs of insulated electrodes electrically connected to the electric field therapy device (Claim 211, lines 1-4; Claim 213, lines 2-3), wherein the electric field therapy device includes a MCU control unit with a reference voltage (Claim 217, lines 2-3), a direction control unit connected to the MCU control unit (Claim 217, lines 8-9), a DC power control unit electrically connected to the MCU control unit (Claim 217, lines 3-4), and an AC voltage control unit both electrically connected with the direction control unit and the MCU control unit (Claim 217, lines 7-8), and wehrein the MCU control unit is configured to control the AC voltage control unit to generate an alternating electrical signal with an AC voltage according to the system parameters of the electric field therapy device (Claim 211, lines 8-11; Claim 213, lines 2-3), and wehrein the MCU control unit is also configured to drive the direction control unit to cyclically and alternately apply the alternating electrical signal received by the AC voltage control unit to different pairs of insulated electrodes, so as to realize the switching of the alternating electrical signal between different pairs of insulated electrodes (Claim 211, lines 8-18), and wherein the system parameters of the electric field therapy device include an output AC voltage amplitude of the alternating electrical signal stored therein (Claim 213, lines 1-8), and wherein the alternating electrical signal applied to each pair of the insulated electrodes has a continuous on-time period during each respective working cycles (Claim 211, lines 19-25), and wherein each of the continuous on-time of the alternating electrical signal includes an initial switching-on time period t3, an intermediate on-time period and a final switching-off time period t4 (Claim 211, lines 25-28); and wherein the alternating electrical signal has a specific voltage during the intermediate on-time period (Claim 211, lines 29-32) and the specific voltage is equal to or less than a peak of the output AC voltage amplitude of the alternating electrical signal stored in the electric field therapy device (Claim 213, lines 6-8); and wherein during the switching-on time period t3, the MCU control unit controls the DC power control unit to increase the AC voltage value of the alternating electrical signal applied from the AC voltage control unit to the insulated electrodes arranged in pairs from 0 to the specific voltage at a constant speed and a voltage change of the alternating electrical signal applied by the AC voltage control unit per millisecond is a set to be a constant value (Claim 211, lines 33-41); and wherein during the switching-off time period t4, the MCU control unit controls the DC power supply control unit to decrease the AC voltage value of the alternating electrical signal applied from the AC voltage control unit to the insulated electrode arranged in pairs from the specific voltage to 0 at a constant speed (Claim 221, lines 2-10) and a voltage change of the alternating electrical signal applied by the AC voltage control unit per millisecond is set to be a constant value (Claim 211, lines 36-41).
The tumor electric field therapy system according to claim 1, wherein the ratio of the voltage change per millisecond of the alternating electrical signal applied by the AC voltage control unit to the specific voltage is less than 5% (Claim 211, lines 37-41).
The tumor electric field therapy system according to claim 1, wherein the electric field therapy device further includes an inverter boost control unit both connected to the MCU control unit and the DC power supply control unit (Claim 217, lines 5-6) and a filter control unit connected to the inverter boost control unit (Claim 217, lines 6-7), and wherein the system parameters of the electric field therapy device include an electric field frequency and a direction switching period of the alternating electrical signal (Claim 213, lines 2-5), and wherein the MCU control unit generates a pulse signal transmitted to the inverter boost control unit according to the reference voltage thereof (Claim 221, lines 6-10 – DC electric signal, i.e. pulse signal), the electric field frequency of the alternating electrical signal stored in the electric field therapy device and the output AC voltage amplitude of the alternating electrical signal stored in the electric field therapy device (Claim 218, lines 2-4).
The tumor electric field therapy system according to claim 3, wherein the MCU control unit drives the direction control unit to cyclically and alternately switch the alternating electrical signal applied to different pairs of the insulated electrodes through the AC voltage control unit according to the direction switching period of the alternating electrical signal of the electric field therapy device (Claim 213, Claim 221).
The tumor electric field therapy system according to claim 3, wherein the connection and disconnection between the MCU control unit and the DC power supply control unit and whether the pluse signal is applied to the inverter boost control unit or not are controlled by the MCU control unit according to the direction switching period of the alternating electrical signal of the electric field therapy device (Claim 217).
The tumor electric field therapy system according to claim 5, wherein the direction control unit is configured to be switched after the communication between the MCU control unit and the DC power supply control unit is disconnected and the pulse signal transmitted from the MCU control unit to the inverter boost control unit is stopped (Claim 217).
The tumor electric field therapy system according to claim 6, wherein after the direction control unit is switched, the MCU control unit activates the DC power control unit, controls the DC power control unit to output a DC signal to the inverter boost control unit and also outputs a pulse signal to the inverter boost control unit (Claim 219).
The tumor electric field therapy system according to claim 3, wherein the electric field therapy device further includes a first direction switch that is electrically connected to the direction control unit and controls the connection and disconnection between the AC voltage control unit and one pair of insulated electrodes and a second direction switch that is electrically connected to the direction control unit and controls the connection and disconnection between the AC voltage control unit and another pair of insulated electrodes (Claim 217).
The tumor electric field therapy system according to claim 15, wherein the MCU control unit includes a storage module, an execution module communicatively connected with the storage module, a digital-to-analog conversion module (DAC) communicatively connected with the execution module, and a control module that controls the storage module, the execution module and the digital-to-analog conversion module to perform corresponding operations (Claim 218), and wherein the storage module of the MCU control unit, the execution module of the MCU control unit, the digital-to-analog conversion module of the MCU control unit, the control module of the MCU control unit, the DC power supply control unit, the inverter boost control unit and the AC voltage control unit jointly form an AC signal generator, and wherein the storage module of the MCU control unit, the execution module of the MCU control unit, the control module of the MCU control unit, the direction control unit, the first direction switch and the second direction switch both electrically connected to the direction control unit jointly form an AC signal controller (Claim 219).
Claim 221 of the ‘568 Application anticipates instant claims 1-7 and 15-16. Therefore, the instant claims 1-7 and 15-16 are not patentable over claim 221 of the ‘568 Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Palti (US 2007/0225766 – cited on IDS).
Regarding claim 1, Palti teaches (Fig. 5) a tumor electric field therapy system (Par. [0003]; Par. [0016] – FIG. 5 is a block diagram of a system for generating the TTFields in different directions by driving a first electrode pair 11 and a second electrode pair 12 that are positioned about a target) comprising (Fig. 5, # 11 – first electrode pair, 12 – second electrode pair) an electric field therapy device having a plurality of preset system parameters and at least two pairs of insulated electrodes electrically connected to the electric field therapy device (Pars. [0015-0016]), wherein the electric field therapy device includes […] (Fig. 5) a direction control unit (Par. [0016] – system for generating the TTFields in different directions) […], (Fig. 2; Fig. 5, # 43) a DC power control unit (Par. [0016] – a square wave generator 43 generates a square wave that resembles the wave 21 shown in FIG. 2.) […], and (Fig. 5, # 41) an AC voltage control unit […] electrically connected with the direction control unit […] (Par. [0016] – An AC signal generator 41 generates a sinusoid), and wehrein […] (Fig. 5, # 41) the AC voltage control unit to generate an alternating electrical signal with an AC voltage according to the system parameters of the electric field therapy device (Par. [0016] – An AC signal generator 41 generates a sinusoid), and wehrein […], drive (Fig. 5, # 11, 12, 15, 16) the direction control unit to cyclically and alternately apply the alternating electrical signal received by the AC voltage control unit to different pairs of insulated electrodes, so as to realize the switching of the alternating electrical signal between different pairs of insulated electrodes (Par. [0016] – Since the control input for the two amplifiers are out of phase, the amplifiers will alternately drive either the first electrode pair 11 or the second electrode pair 12 to generate either the first field 15 or the second field 16 in the target region), and wherein the system parameters of the electric field therapy device include an output AC voltage amplitude of the alternating electrical signal stored therein (Par. [0015] – The field intensity is preferably at least 1 V/cm, and more preferably between 1 and 10 V/cm.), and wherein (Fig. 6) the alternating electrical signal applied to each pair of the insulated electrodes has a continuous on-time period during each respective working cycles, and wherein each of the continuous on-time of the alternating electrical signal includes an initial switching-on time period t3, an intermediate on-time period and a final switching-off time period t4 (Par. [0017]); and wherein the alternating electrical signal has a specific voltage during the intermediate on-time period and the specific voltage is equal to or less than a peak of the output AC voltage amplitude of the alternating electrical signal stored in the electric field therapy device (Par. [0015] – The field intensity is preferably at least 1 V/cm, and more preferably between 1 and 10 V/cm; claim 1); and wherein (Fig. 2; Figs. 5-6) during the switching-on time period t3, the MCU control unit controls the DC power control unit to increase the AC voltage value of the alternating electrical signal applied from the AC voltage control unit to the insulated electrodes arranged in pairs from 0 to the specific voltage at a constant speed and a voltage change of the alternating electrical signal applied by the AC voltage control unit per millisecond is a set to be a constant value (Par. [0017]); and wherein (Fig. 2; Figs. 5-6) during the switching-off time period t4, the MCU control unit controls the DC power supply control unit to decrease the AC voltage value of the alternating electrical signal applied from the AC voltage control unit to the insulated electrode arranged in pairs from the specific voltage to 0 at a constant speed and a voltage change of the alternating electrical signal applied by the AC voltage control unit per millisecond is set to be a constant value (Par. [0012]; Par. [0017]).
Palti does not explicitly teach the limitation of instant claim 1, that is wherein the system comprises a MCU control unit with a reference voltage, wherein the various electrical components are connected to the MCU control unit. However, Palti does teach that of course, persons skilled in the relevant arts will recognize that a wide variety of other circuits may be used to alternately drive either the first or second pair of electrodes (Par. [0016]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the recited MCU control unit of claim 1 into Palti’s system, since Palti explains that such a circuit for alternately driving the first or second pair of electrodes is a matter that would be obvious to one of ordinary skill in the art (please see Par. [0016] of Palti).
Therefore, claim 1 is unpatentable over Palti.
Regarding claim 2, Palti renders obvious the tumor electric field therapy system according to claim 1, as indicated hereinabove. Palti teaches (Fig. 6) that the rate of turning the field on t3 and off t4 should preferably be done at a rate that is slow relative to the reciprocal of the field frequency (i.e., the period t5), and fast relative to the half cycle duration t1, t2, as seen in FIG. 6 for waveform 61 (Par. [0017]). Palti also teaches that an example of a suitable turn-on rate t3 and turn-on rate t4 is to reach 90% of the steady-state values within about 1-5 ms (Par. [0017]). Palti does not explicitly teach the limitation of instant claim 2, that is wherein the ratio of the voltage change per millisecond of the alternating electrical signal applied by the AC voltage control unit to the specific voltage is less than 5%. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize and arrive at the ratio of the voltage change per millisecond of the alternating electrical signal applied by the AC voltage control unit to the specific voltage is less than 5%, recognizing that the ratio of the voltage change per millisecond of the alternating electrical signal applied by the AC voltage control unit to the specific voltage is directly correlated to avoiding overheating of the tissues by the capacitive currents and dielectric losses in the insulated electrodes, as well as avoiding the generation of spikes during the switching process, which are desirable characteristics, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Therefore, claim 2 is unpatentable over Palti.
Regarding claim 3, Palti renders obvious the tumor electric field therapy system according to claim 1, as indicated hereinabove. Palti also teaches the limitation of instant claim 3, that is wherein the electric field therapy device further includes (Fig. 5, # 44 – inverter, i.e. inverter boost control unit) an inverter boost control unit both connected to the MCU control unit and the DC power supply control unit (Par. [0016]) and (Figs. 5-6) a filter control unit connected to the inverter boost control unit (Par. [0017] – Circuitry for implementing this slow turn on may be implemented using a variety of approaches that will be apparent to persons skilled in the relevant arts, such as using a slow-rising control signal to drive an accurate AM modulator, or by driving a gain control of the amplifier with a square wave and interposing a low pass filter in series with the gain control input.), and wherein (Fig. 2) the system parameters of the electric field therapy device include an electric field frequency and a direction switching period of the alternating electrical signal (Pars. [0011-0012] – The waveforms applied were 100-200 kHz alternating fields modulated to stay On and Off for half cycle durations ranging from 10 ms to 1000 ms; Par. [0015]), and wherein (Fig. 2; Fig. 5, # 42, 43, and 44) the MCU control unit generates a pulse signal transmitted to the inverter boost control unit according to the reference voltage thereof, the electric field frequency of the alternating electrical signal stored in the electric field therapy device and the output AC voltage amplitude of the alternating electrical signal stored in the electric field therapy device (Pars. [0012], [0015-0016] – An inverter 44 inverts this square wave [i.e., pulse signal from square wave generator 43], thereby providing the second wave 22 shown in FIG. 2. The amplifiers 42 amplify the sinusoid when their control input is in one state, and shut off when their control input is in the other state.).
Therefore, claim 3 is unpatentable over Palti.
Regarding claim 4, Palti renders obvious the tumor electric field therapy system according to claim 3, as indicated hereinabove. Palti also teaches the limitation of instant claim 4, that is wherein (Figs. 2 and 5) the MCU control unit drives the direction control unit to cyclically and alternately switch the alternating electrical signal applied to different pairs of the insulated electrodes through the AC voltage control unit according to the direction switching period of the alternating electrical signal of the electric field therapy device (Par. [0012]; Par. [0016] – Since the control input for the two amplifiers are out of phase, the amplifiers will alternately drive either the first electrode pair 11 or the second electrode pair 12 to generate either the first field 15 or the second field 16 in the target region).
Therefore, claim 4 is unpatentable over Palti.
Regarding claim 5, Palti renders obvious the tumor electric field therapy system according to claim 3, as indicated hereinabove. Palti also teaches the limitation of instant claim 5, that is wherein (Fig. 5) the connection and disconnection between the MCU control unit and the DC power supply control unit and whether the pluse signal is applied to the inverter boost control unit or not are controlled by the MCU control unit according to the direction switching period of the alternating electrical signal of the electric field therapy device (Par. [0016]).
Therefore, claim 5 is unpatentable over Palti.
Regarding claim 6, Palti renders obvious the tumor electric field therapy system according to claim 5, as indicated hereinabove. Palti also teaches the limitation of instant claim 6, that is wherein (Fig. 5) the direction control unit is configured to be switched after the communication between the MCU control unit and the DC power supply control unit is disconnected and the pulse signal transmitted from the MCU control unit to the inverter boost control unit is stopped (Par. [0016]).
Therefore, claim 6 is unpatentable over Palti.
Regarding claim 7, Palti renders obvious the tumor electric field therapy system according to claim 6, as indicated hereinabove. Palti also teaches the limitation of instant claim 7, that is wherein (Fig. 5) after the direction control unit is switched, the MCU control unit activates the DC power control unit, controls the DC power control unit to output a DC signal to the inverter boost control unit and also outputs a pulse signal to the inverter boost control unit (Par. [0016]).
Therefore, claim 7 is unpatentable over Palti.
Regarding claim 8, Palti renders obvious the tumor electric field therapy system according to claim 1, as indicated hereinabove. Palti also teaches the limitation of instant claim 8, that is wherein (Fig. 6) the AC voltage of the alternating electrical signal is increased from 0 to the specific voltage at a constant speed with a voltage change of 4V per millisecond during the switching-on time period t3 (Par. [0015] – the field intensity is preferably at least 1 V/cm, and more preferably between 1 and 10 V/cm; Par. [0017] – the rate of turning the field on t3 and off t4 should preferably be done at a rate that is slow relative to the reciprocal of the field frequency (i.e., the period t5), and fast relative to the half cycle duration t1, t2, as seen in FIG. 6 for waveform 61. An example of a suitable turn-on rate t3 and turn-off rate t4 is to reach 90% of the steady-state values within about 1-5 ms; This voltage change required by the claim is achievable given the ranges provided by Palti).
Therefore, claim 8 is unpatentable over Palti.
Regarding claim 9, Palti renders obvious the tumor electric field therapy system according to claim 1, as indicated hereinabove. Palti does not explicitly state the limitation of instant claim 9, that is wherein the switching-on time period t3 is determined as follows: t3=V/ Δ V*t, wherein V is the specific voltage, t is 1 ms, and Δ V is the voltage change of the alternating electrical signal outputted by the AC voltage control unit per millisecond. However, one of ordinary skill in the art would be able to easily arrive at such a straightforward equation for determining the switching-on time period t3 based on simple manipulation of the information provided by Palti in Fig. 6 and Pars. [0015] and [0017].
Therefore, claim 9 is unpatentable over Palti.
Regarding claim 13, Palti renders obvious the tumor electric field therapy system according to claim 1, as indicated hereinabove. Palti does not explicitly state the limitation of instant claim 13, that is wherein the switching-off time period t4 is obtained by the following method: t4=V/ Δ V*t, wherein V is the specific voltage, t is 1 ms, and Δ V is the voltage change of the alternating electrical signal outputted by the AC voltage control unit per millisecond. However, one of ordinary skill in the art would be able to easily arrive at such a straightforward equation for determining the switching-off time period t4 based on simple manipulation of the information provided by Palti in Fig. 6 and Pars. [0015] and [0017].
Therefore, claim 13 is unpatentable over Palti.
Regarding claim 14, Palti renders obvious the tumor electric field therapy system according to claim 1, as indicated hereinabove. Palti also teaches the limitation of instant claim 14, that is wherein (Fig. 6) the AC voltage of the alternating electrical signal is decreased from the specific voltage to 0 at a constant speed with a voltage change of 4V per millisecond during the switching-off time period t4 (Par. [0015] – the field intensity is preferably at least 1 V/cm, and more preferably between 1 and 10 V/cm; Par. [0017] – the rate of turning the field on t3 and off t4 should preferably be done at a rate that is slow relative to the reciprocal of the field frequency (i.e., the period t5), and fast relative to the half cycle duration t1, t2, as seen in FIG. 6 for waveform 61. An example of a suitable turn-on rate t3 and turn-off rate t4 is to reach 90% of the steady-state values within about 1-5 ms; This voltage change required by the claim is achievable given the ranges provided by Palti).
Therefore, claim 14 is unpatentable over Palti.
Regarding claim 15, Palti renders obvious the tumor electric field therapy system according to claim 3, as indicated hereinabove. Palti also teaches the limitation of instant claim 15, that is wherein (Fig. 5, # 42 – direction switches) the electric field therapy device further includes a first direction switch that is electrically connected to the direction control unit and controls the connection and disconnection between the AC voltage control unit and one pair of insulated electrodes and a second direction switch that is electrically connected to the direction control unit and controls the connection and disconnection between the AC voltage control unit and another pair of insulated electrodes (Par. [0016]).
Therefore, claim 15 is unpatentable over Palti.
Claims 10-12 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Palti (US 2007/0225766 – cited on IDS), in view of Wasserman (US 2021/0203250).
Regarding claim 10, Palti renders obvious the tumor electric field therapy system according to claim 1, as indicated hereinabove. Palti does not explicitly teach the limitation of instant claim 10, that is wherein the MCU control unit includes a digital-to-analog conversion module with a DAC data register, and wherein the MCU control unit calculates a voltage output increment of the digital-to-analog conversion module per millisecond based on the reference voltage thereof, the voltage change of the alternating electrical signal outputted by the AC voltage control unit per millisecond, the specific voltage, and the DAC data register value corresponding to the specific voltage.
Wasserman, directed to analogous art, teaches increasing the efficacy of TTFields therapy by using approaches for generating high voltage sinusoidal signals whose output voltage can be adjusted rapidly, without introducing high-frequency artifacts on the output (Title; Abstract). Wasserman also teaches the limitation of instant claim 10, that is wherein (Fig. 1, # 40 – controller, i.e. MCU control unit, 42 – DAC) the MCU control unit includes a digital-to-analog conversion module with a DAC data register (Par. [0065]; Par. [0085]), and wherein the MCU control unit calculates a voltage output increment of the digital-to-analog conversion module per millisecond based on the reference voltage thereof, the voltage change of the alternating electrical signal outputted by the AC voltage control unit per millisecond, the specific voltage, and the DAC data register value corresponding to the specific voltage (Par. [0023] – in some embodiments, withing 5 ms after the electronic switch switches to either the first more or the second mode, the AC voltage generator’s output voltage is at least 80% of the AC voltage generator’s steady state output voltage; Par. [0065]; Pars. [0085-0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Wasserman’s digital-to-analog conversion module and method for calculating the voltage output increment of the digital-to-analog conversion module into Palti’s system, because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing a digital-to-analog controller in order for the control unit to control the amplitude of the output signal (see Par. [0085] of Wasserman).
Therefore, claim 10 is unpatentable over Palti and Wasserman.
Regarding claim 11, Palti, in view of Wasserman, renders obvious the tumor electric field therapy system according to claim 10, as indicated hereinabove. Wasserman teaches the limitations of instant claim 11, that is wherein (Fig. 1, # 42; Fig. 3, # 110, 112) the MCU control unit calculates a voltage output decrement of the digital-to- analog conversion module per millisecond based on the reference voltage thereof, the voltage change of the alternating electrical signal outputted by the AC voltage control unit per millisecond, the specific voltage, and the DAC data register value corresponding to the specific voltage (Pars. [0069] and [0085-0086]).
Therefore, claim 11 is unpatentable over Palti and Wasserman.
Regarding claim 12, Palti, in view of Wasserman, renders obvious the tumor electric field therapy system according to claim 11, as indicated hereinabove. Palti nor Wasserman explicitly teach the limitation of instant claim 12, that is wherein the voltage output increment or decrement per millisecond of the digital-to-analog conversion module is determined by the following method: ΔVDAC=(3.3*1000*Δ V*DAC )/(4096*V), wherein ΔVDAC is the voltage output increment or decrement of the digital-to-analog conversion module per millisecond and measured in millivolts; and the reference voltage of the MCU control unit is 3.3V, and the DAC data register corresponding to the MCU reference voltage value is 4096 and equal to 212 ; ΔV is the voltage change of the alternating electrical signal outputted by the AC voltage control unit per millisecond and measured in volts; V is the specific voltage and measured in volts; DAC is the DAC data register value of the specific voltage in the DAC data register. However, one of ordinary skill in the art would be able to easily arrive at such a straightforward equation for determining the voltage output increment or decrement per millisecond of the digital-to-analog conversion module based on simple manipulation of the information provided by Wasserman in Figs. 1 and 3, and Pars. [0069] and [0085-0086], along with information provided by Palti. One of ordinary skill in the art would have found it obvious to select a reference voltage of 3.3 V and a DAC data register value of 4096, which corresponds to the selection of 4096 (212) bit data register.
Therefore, claim 12 is unpatentable over Palti and Wasserman.
Regarding claim 16, Palti renders obvious the tumor electric field therapy system according to claim 15, as indicated hereinabove. Palti does not explicitly teach the limitations of instant claim 16, that is wherein the MCU control unit includes a storage module, an execution module communicatively connected with the storage module, a digital-to-analog conversion module (DAC) communicatively connected with the execution module, and a control module that controls the storage module, the execution module and the digital-to-analog conversion module to perform corresponding operations, and wherein the storage module of the MCU control unit, the execution module of the MCU control unit, the digital-to-analog conversion module of the MCU control unit, the control module of the MCU control unit, the DC power supply control unit, the inverter boost control unit and the AC voltage control unit jointly form an AC signal generator, and wherein the storage module of the MCU control unit, the execution module of the MCU control unit, the control module of the MCU control unit, the direction control unit, the first direction switch and the second direction switch both electrically connected to the direction control unit jointly form an AC signal controller.
However, in regards to the limitations involving the MCU control unit, storage module, execution module, AC signal generator, and AC signal controller, Palti does suggest such electronic components in their disclosure. For instance, Palti explains that (Fig. 5) of course, persons skilled in the relevant arts will recognize that a wide variety of other circuits may be used to alternately drive either the first or second pair of electrodes (Par. [0016]). Palti further explains that for example, a suitable switching circuit may be provided to route the output of a single amplifier to either the first or second pair of electrodes in an alternating manner, with the switching controlled by a single square wave (Par. [0016]). Palti further teaches (Fig. 6) that circuitry for implementing this slow turn on may be implemented using a variety of approaches that will be apparent to persons skilled in the relevant arts, such as using a slow-rising control signal to drive an accurate AM modulator, or by driving a gain control of the amplifier with a square wave and interposing a low pass filter in series with the gain control input (Par. [0017]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the recited electronic modules of claim 16 into Palti’s system, since Palti explains that such a circuit for alternately driving the first or second pair of electrodes is a matter that would be obvious to one of ordinary skill in the art (please see Par. [0016] of Palti).
With regards to the digital-to-analog conversion module, Wasserman teaches this limitation. Wasserman, directed to analogous art, teaches increasing the efficacy of TTFields therapy by using approaches for generating high voltage sinusoidal signals whose output voltage can be adjusted rapidly, without introducing high-frequency artifacts on the output (Title; Abstract). Wasserman also teaches the limitation of instant claim 16, that is wherein the MCU control unit includes (Fig. 1, # 40 – controller, i.e. MCU control unit, 42 – DAC) a digital-to-analog conversion module (DAC) (Par. [0065]; Par. [0085-0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Wasserman’s digital-to-analog conversion module into Palti’s system, because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired implementing a digital-to-analog controller in order for the control unit to control the amplitude of the output signal (see Par. [0085] of Wasserman).
Therefore, claim 16 is unpatentable over Palti and Wasserman.
Regarding claim 17, Palti, in view of Wasserman, renders obvious the tumor electric field therapy system according to claim 16, as indicated hereinabove. Palti also teaches the limitation of instant claim 17, that is wherein (Figs. 1 and 5, # 11 and 12) at least two pairs of the insulated electrodes include a first pair and a second pair of insulated electrodes disposed on the patient's torso surface (Par. [0018] – used to treat carcinoma or other cancers or other rapidly proliferating cells; Claim 16 – configured for placement against a patient’s body); and wherein the AC signal controller is configured to generate periodic control signals each having a first output state with a duration between 500ms and 980ms and a second output state with a duration between 500ms and 980ms (Par. [0011] – The waveforms applied were 100-200 kHz alternating fields modulated to stay On and Off for half cycle durations ranging from 10 ms to 1000 ms; Claim 1), and wherein (Fig. 5) the AC signal generator generates a first AC signal applied to the first pair of insulated electrodes when the control signal is in the first output state and a second AC signal applied to the second pair of insulated electrodes when the control signal is in the second output state (Par. [0016] – The amplifiers 42 amplify the sinusoid when their control input is in one state, and shut off when their control input is in the other state. Since the control input for the two amplifiers are out of phase, the amplifiers will alternately drive either the first electrode pair 11 or the second electrode pair 12 to generate either the first field 15 or the second field 16 in the target region), and wherein (Fig. 5) the switch between the first AC signal generated between the first pair of insulated electrodes and the second AC signal generated between the second pair of insulated electrodes is achieved through the switch between the first output state and the second output state (Par. [0016]).
Therefore, claim 17 is unpatentable over Palti and Wasserman.
Regarding claim 18, Palti, in view of Wasserman, renders obvious the tumor electric field therapy system according to claim 17, as indicated hereinabove. Palti also teaches (Fig. 2, # 21, 22, t1, t2; Fig. 5) the limitation of instant claim 18, that is wherein the first output state has the duration with a first time period T1, and wherein the second output state has a duration with a second time period T2, and wherein the first time period T1 and the second time period T2 are same with each other (Par. [0012]; Par. [0016]).
Therefore, claim 18 is unpatentable over Palti and Wasserman.
Regarding claim 19, Palti, in view of Wasserman, renders obvious the tumor electric field therapy system according to claim 18, as indicated hereinabove. Palti also teaches the limitation of instant claim 19, that is wherein (Fig. 2) the first time period T1 and the second time period T2 are both 50% of respective operating period (Par. [0012]).
Therefore, claim 19 is unpatentable over Palti and Wasserman.
Regarding claim 20, Palti, in view of Wasserman, renders obvious the tumor electric field therapy system according to claim 18, as indicated hereinabove. Palti also teaches the limitation of instant claim 20, that is wherein (Fig. 2; Fig. 6, # t3 and t4) the first AC signal has an increasing AC voltage amplitude during the switching- on time period t3 and a decreasing AC voltage amplitude in the switching-off time period t4 in each of the first time periods T1; and wherein the second AC signal has an increasing AC voltage amplitude during the switching-on time period t3 and a decreasing AC voltage amplitude during the switching-off time period t4 in each of the second time period T2 (Par. [0012]; Par. [0017] – The rate of turning the field on t3 and off t4 should preferably be done at a rate that is slow relative to the reciprocal of the field frequency (i.e., the period t5), and fast relative to the half cycle duration t1, t2, as seen in FIG. 6 for waveform 61. An example of a suitable turn-on rate t3 and turn-on rate t4 is to reach 90% of the steady-state values within about 1-5 ms).
Therefore, claim 20 is unpatentable over Palti and Wasserman.
Regarding claim 21, Palti, in view of Wasserman, renders obvious the tumor electric field therapy system according to claim 20, as indicated hereinabove. Palti also teaches the limitation of instant claim 21, that is wherein (Figs. 5 and 6) the durations of the switching-on time period t3 and the switching-off time period t4 are both less than 10% of the duration of the first time period T1 or the second time period T2 (Par. [0016] – Palti teaches a preferred embodiment of where the output of the square wave is high between 50 and 250 ms and low for an equal amount of time in every cycle.; Par. [0017] – Palti teaches an example where a suitable turn-on rate t3 and turn-off rate t4 is to reach 90% of the steady-state values within about 1-5 ms.; In this example, the durations of the switching-on time period t3 and the switching-off time period t4 are both less than 10% of the duration of the first time period T1 or the second time period T2).
Therefore, claim 21 is unpatentable over Palti and Wasserman.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shamir (US 2022/0241603)
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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