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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/24/2026 has been entered.
Response to Arguments
Applicant's arguments filed 05/26/2026 with respect to the rejections in view of the previously presented prior art of Chang have been fully considered but they are not persuasive.
Applicant argues that Chang fails to disclose or suggest “applying the alternating electric field to the target region of the subject’s body at a first frequency while increasing an intensity of the alternating electric field from zero to a target intensity” and argues that the Office Action presents an inherency argument in its assertion that “it can be appreciated that in order to reach a target intensity, the intensity of the field must start at zero.”
Applicant cites MPEP 2112(IV) for support that “the fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic.” Examiner respectfully argues that this assertion of the MPEP is not relevant to the rejection being made. The argument presented in the Office Action that, in order to reach a target intensity, the intensity of the electric field must necessarily start at zero and increase, is predicated upon the fact that at a time before an alternating electric field is applied, the intensity of the electric field is zero. When the alternating electric current is applied, the resulting electric field has a target intensity. Therefore, it is impossible to have an electric field having a target intensity without, at one point, having no electric field, or in other words, an electric field with an intensity of zero. Even if the increase from zero to the target intensity happens near-instantaneously, it does not negate the fact that the electric field intensity in the area it was applied began at zero and ended at a target intensity.
Additionally, Applicant cites paragraph [0014] of Chang and argues that Chang teaches starting at a lower frequency and then changing to a higher frequency. Examiner points to Chang paragraphs [0014-0016] in their entirety in which Chang discloses multiple configurations at which the electric fields may be applied. In paragraph [0014] as cited by the Applicant, Chang discloses a first frequency between 50 and 500 kHz and a second frequency between 50 and 500 kHz, so either the first or second frequency may be higher. This is further supported in paragraph [0016] where Chang discloses multiple options for the first and second frequencies including wherein the first frequency is between 250 kHz and 350 kHz, and the second frequency is between 150 kHz and 250 kHz; the first frequency is between 125 kHz and 175 kHz, and the second frequency is between 75 kHz and 125 kHz; or the first frequency is between 75 kHz and 175 kHz, and the second frequency is between 100 kHz and 300 kHz.
Applicant argues that the dimming up period in applying an AC voltage waveform helps avoid electrosensation, however this limitation is not present in the claims and therefore is not considered when examining the claimed invention.
With this in consideration, Examiner maintains the rejections over Chang. However, for the sake of compact prosecution, Examiner offers a rejection of the claims under 35 USC 102 or 103 over Chang in view of Armstrong (US 20070097593 A1) detailed below.
Applicant’s arguments, see Remarks dated 05/26/2026 with respect to the rejection of claim 20 over Chang in view of Goldwasser have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Chang in view of Armstrong (US 20070097593 A1) detailed below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 8-12, and 19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Chang et al (US 20200254242 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Chang et al (US 20200254242 A1) in view of Armstrong (US 20070097593 A1).
Regarding claim 1, Chang teaches a method to treat a target region of a subject's body with an alternating electric field (see [abstract]; using alternating electric fields to increase permeability of cell membrane for the delivery of therapy), the method comprising:
applying the alternating electric field to the target region of the subject's body at a first frequency while increasing an intensity of the alternating electric field from zero to a target intensity (see [0010]; the alternating electric field has a field strength of at least 1 V/cm RMS, it can be appreciated that in order to reach a target intensity, the intensity of the field must start at zero),
wherein the alternating electric field is applied to the subject's body through electrodes positioned on the subject's skin (see [0015]; a set of electrodes configured for affixation to the subject’s body, [0104]; positioning electrodes on the subject’s skin); and
changing the frequency of the alternating electric field from the first frequency to a target frequency (see [0008-0009]; application of a first alternating field at a first frequency, the first frequency may be between 250kHz and 350kHz, at a first period of time) while maintaining the alternating electric field at the target intensity (see [0114]; in vivo experiment where cells were subjected to an alternating electric field with a field strength of 1.62 V/cm EMS at different frequencies),
wherein the target frequency and the target intensity have a known efficacy for treating the target region of the subject's body with the alternating electric field (see [0008-0009]; application of a second alternating electric field at a second frequency, at a second period of time, wherein the second alternating electric field reduces viability of cancer cells); and
wherein the first frequency is greater than the target frequency (see [0016]; the first frequency is between 250 kHz and 350 kHz, and the second frequency is between 150 kHz and 250 kHz).
Although Examiner maintains that in order to apply the electric field as taught by Chang at a target intensity, the electric field must start at zero before it can achieve the target intensity, for the sake of compact prosecution, Examiner offers the following rejection under 35 USC 103 using support from Armstrong (US 20070097593 A1).
Armstrong teaches a method for applying stimulation to a target area of a patient wherein applying the stimulation signal at a target frequency/intensity comprises a ramping portion in which the signal is applied at a first frequency while increasing the intensity of the signal from zero to a target frequency over a period of time (see Armstrong Fig. 2, [0038-0039]; a ramping-up or ramping-down portion where characteristics of the signal may be adjusted during a specified ramping portion, which occurs before or after a stimulation portion, the characteristics of the ramp-up and/or ramp-down signals may include an amplitude, a rate of change of the amplitude, a time period of a rate of change of the amplitude, a pulse width, a rate of change of the pulse width, a time period of a rate of change of the pulse width, a frequency, a rate of change of the frequency, a time period of a rate of change of the frequency, and/or a duration of a time period of the ramp-up and/or ramp-down portions).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Chang’s method for treating a region of a subject’s body using a signal having a target intensity and frequency with Armstrong’s ramping-up period wherein the signal goes from zero to a target intensity. One of ordinary skill in the art would have been motivated to make this modification in order to avoid an undesired reaction or side effect experienced from the patient that may occur from a sudden burst of energy applied to the patient (Armstrong [0005]).
Regarding claim 8, Chang teaches the method of claim 1, further comprising: after a first period of time, halting application of the alternating electric field to complete a first duty cycle of the alternating electric field (see [0014-0017]; the alternating field is applied for an interval of time where the interval of time is at least 12 hours);
applying one or more subsequent duty cycles of the alternating electric field, each subsequent duty cycle following a similar pattern of intensities and frequencies as the first duty cycle (see [0014-0016]; the controller is programmed to switch the control input back and forth between the first state and the second state).
Regarding claim 9, Chang teaches the method of claim 1, wherein the target frequency is approximately 50 kHz to approximately 500 kHz (see [0016]; the second frequency is between 150 kHz and 250 kHz).
Regarding claim 10, Chang teaches the method of claim 1, wherein the first frequency is at least approximately 10 kHz higher than the target frequency (see Chang [0016]; the first frequency is between 250 kHz and 350 kHz, and the second frequency is between 150 kHz and 250 kHz, therefore having a first frequency at least approximately 10 kHz higher than the target).
Regarding claim 11, Chang teaches the method of claim 1, wherein the target intensity is approximately 0.1 V/cm to approximately 10.0 V/cm (see [0007]; the alternating field may have a field strength between 1 and 4 V/cm, [0114]; alternating electric field with a field strength of 1.62 V/cm RMS at different frequencies).
Regarding claim 12, Chang teaches an apparatus for treating a target region of a subject's body with an alternating electric field (see [0014]; an apparatus for treating a tumor in a subject’s body), the apparatus comprising:
a first pair of transducers configured to be positioned on the subject's skin to apply a first alternating electric field to a target region of the subject's body (see [0015]; a set of electrodes configured for affixation to the subject’s body, [0105]; for example, if the target cells are located in the subject’s lungs, one pair of electrodes could be positioned on the front and back of the subject’s thorax);
a voltage generator coupled to the first pair of transducers and capable of providing a first voltage to the first pair of transducers for applying the first alternating electric field (see [0014-0015]; an AC voltage generator connected to a set of electrodes to apply an electric field to the target tissue); and
a controller coupled to the voltage generator (see [0014]; the apparatus comprising a controller), the controller comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the controller to instruct the voltage generator to generate the first voltage according to a first waveform (see [0014-0017]; the controller is configured to output a first or second frequency based on the control input to the control module and the programmed instructions) having:
an initial ramp-up period during which an amplitude of the first waveform increases from zero to a target amplitude while a frequency of the first waveform is at a first frequency (see [0010]; the alternating electric field has a field strength of at least 1 V/cm RMS, it can be appreciated that in order to reach a target intensity, the intensity of the field must start at zero); and
a sustained intensity period (see [0114]; in vivo experiment where cells were subjected to an alternating electric field with a field strength of 1.62 V/cm EMS at different frequencies) during which the frequency of the first waveform changes to a target frequency lower than the first frequency while the amplitude of the first waveform remains at the target amplitude (see [0016]; the first frequency is between 250 kHz and 350 kHz, and the second frequency is between 150 kHz and 250 kHz).
Although Examiner maintains that in order to apply the electric field as taught by Chang at a target intensity, the electric field must start at zero before it can achieve the target intensity, for the sake of compact prosecution, Examiner offers the following rejection under 35 USC 103 using support from Armstrong (US 20070097593 A1).
Armstrong teaches a method for applying stimulation to a target area of a patient wherein applying the stimulation signal at a target frequency/intensity comprises a ramping portion in which the signal is applied at a first frequency while increasing the intensity of the signal from zero to a target frequency over a period of time (see Armstrong Fig. 2, [0038-0039]; a ramping-up or ramping-down portion where characteristics of the signal may be adjusted during a specified ramping portion, which occurs before or after a stimulation portion, the characteristics of the ramp-up and/or ramp-down signals may include an amplitude, a rate of change of the amplitude, a time period of a rate of change of the amplitude, a pulse width, a rate of change of the pulse width, a time period of a rate of change of the pulse width, a frequency, a rate of change of the frequency, a time period of a rate of change of the frequency, and/or a duration of a time period of the ramp-up and/or ramp-down portions).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Chang’s method for treating a region of a subject’s body using a signal having a target intensity and frequency with Armstrong’s ramping-up period wherein the signal goes from zero to a target intensity. One of ordinary skill in the art would have been motivated to make this modification in order to avoid an undesired reaction or side effect experienced from the patient that may occur from a sudden burst of energy applied to the patient (Armstrong [0005]).
Regarding claim 19, Chang teaches the apparatus of claim 12, wherein the voltage generator (see [0014-0015]; AC voltage generator) is coupled to the first pair of transducers (see [0014-0015]; a set of electrodes coupled to the AC voltage generator) and capable of providing a third voltage to the first pair of transducers for applying a third alternating electric field to a target region of the subject's body (see [0014-0017]; the AC voltage generator is capable of operating at at least one additional frequency when the control input is in at least one additional state), and
the instructions, when executed by the one or more processors, cause the controller to instruct the voltage generator to generate the third voltage (see [0123]; the AC voltage generator may be configured to output one or more additional frequencies based on a signal from the control input) according to a second waveform having:
an initial ramp-up period during which an amplitude of the second waveform increases from zero to the target amplitude (see [0010]; the alternating electric field has a field strength of at least 1 V/cm RMS, it can be appreciated that in order to reach a target intensity, the intensity of the field must start at zero); while a frequency of the second waveform is at a frequency lower than the first frequency (see [0016]; the first frequency is between 250 kHz and 350 kHz, and the second frequency is between 150 kHz and 250 kHz); and
a sustained intensity period during which the frequency of the second waveform is at the target frequency while the amplitude of the second waveform remains at the target amplitude (see [0114]; in vivo experiment where cells were subjected to an alternating electric field with a field strength of 1.62 V/cm EMS at different frequencies).
Although Examiner maintains that in order to apply the electric field as taught by Chang at a target intensity, the electric field must start at zero before it can achieve the target intensity, for the sake of compact prosecution, Examiner offers the following rejection under 35 USC 103 using support from Armstrong (US 20070097593 A1).
Armstrong teaches a method for applying stimulation to a target area of a patient wherein applying the stimulation signal at a target frequency/intensity comprises a ramping portion in which the signal is applied at a first frequency while increasing the intensity of the signal from zero to a target frequency over a period of time (see Armstrong Fig. 2, [0038-0039]; a ramping-up or ramping-down portion where characteristics of the signal may be adjusted during a specified ramping portion, which occurs before or after a stimulation portion, the characteristics of the ramp-up and/or ramp-down signals may include an amplitude, a rate of change of the amplitude, a time period of a rate of change of the amplitude, a pulse width, a rate of change of the pulse width, a time period of a rate of change of the pulse width, a frequency, a rate of change of the frequency, a time period of a rate of change of the frequency, and/or a duration of a time period of the ramp-up and/or ramp-down portions).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Chang’s method for treating a region of a subject’s body using a signal having a target intensity and frequency with Armstrong’s ramping-up period wherein the signal goes from zero to a target intensity. One of ordinary skill in the art would have been motivated to make this modification in order to avoid an undesired reaction or side effect experienced from the patient that may occur from a sudden burst of energy applied to the patient (Armstrong [0005]).
Claims 6, 7, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (US 20200254242 A1), optionally in view of Armstrong (US 20070097593 A1), and in view of Schmidt et al (US 20190117973 A1).
Regarding claim 6, Chang teaches the method of claim 1. Chang is silent regarding wherein changing the frequency of the alternating electric field is performed gradually over a period of time during application of the alternating electric field.
Schmidt teaches a method for treating cancerous tumors (Schmidt [0006]), via the implementation of an alternating electric field to a targeted area (Schmidt [0121]), wherein changing the frequency of the alternating electric field is performed gradually over a period of time during application of the alternating electric field (see Schmidt Fig. 15, [0120, 0122]; plot 1502 shown sweeping through a range of frequencies gradually).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alternating electric field as taught by Chang with the gradual change of frequencies as taught by Schmidt. One of ordinary skill in the art would have been motivated to make this modification in order to seamlessly transition from a first frequency to a second frequency via sweeping through the frequency ranges, wherein the sweeping may be performed indefinitely (Schmidt [0122]). It can also be appreciated that in the scenario of transitioning from one frequency to a second frequency, there are only a limited number of ways to get from one to the other (e.g. instantaneous, gradual, stepwise), so it would have been obvious to one of ordinary skill in the art to try the gradual approach of the present claim, having a reasonable expectation of success. See MPEP 2143(I)(E).
Regarding claim 7, Chang and Schmidt teach the method of claim 6. Chang further teaches wherein: the alternating electric field is applied using a voltage generated according to an AC voltage waveform (see Chang [0014]; AC voltage generator capable of applying electric field to target area according to control program). Chang is silent regarding changing the frequency of the alternating electric field is performed in a stepwise manner with each shift happening at a different zero crossing of the AC voltage waveform.
Schmidt teaches wherein the alternating electric field is applied using a voltage generated according to an AC voltage waveform (see Schmidt Fig. 15, [0122]; alternating electric field, AC voltage waveform 1502), and
changing the frequency of the alternating electric field is performed in a stepwise manner with each shift happening at a different zero crossing of the AC voltage waveform (see Schmidt [0120]; stepping through one or more frequencies sequentially).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alternating electric field as taught by Chang with the stepwise transition between frequencies as taught by Schmidt. One of ordinary skill in the art would have been motivated to make this modification in order to sequentially transition from one frequency to the next (Schmidt [0120]). It can also be appreciated that in the scenario of transitioning from one frequency to a second frequency, there are only a limited number of ways to get from one to the other (e.g. instantaneous, gradual, stepwise), so it would have been obvious to one of ordinary skill in the art to try the stepwise approach of the present claim, having a reasonable expectation of success. See MPEP 2143(I)(E).
Regarding claim 17, Chang teaches the apparatus of claim 12. Chang is silent regarding wherein the frequency of the first waveform changes gradually from the first frequency to the target frequency.
Schmidt further teaches wherein the frequency of the first waveform changes gradually from the first frequency to the target frequency (see Schmidt Fig. 15, [0120, 0122]; plot 1502 shown sweeping through a range of frequencies gradually).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alternating electric field as taught by Chang with the gradual change of frequencies as taught by Schmidt. One of ordinary skill in the art would have been motivated to make this modification in order to seamlessly transition from a first frequency to a second frequency via sweeping through the frequency ranges, wherein the sweeping may be performed indefinitely (Schmidt [0122]). It can also be appreciated that in the scenario of transitioning from one frequency to a second frequency, there are only a limited number of ways to get from one to the other (e.g. instantaneous, gradual, stepwise), so it would have been obvious to one of ordinary skill in the art to try the gradual approach of the present claim, having a reasonable expectation of success. See MPEP 2143(I)(E).
Regarding claim 18, Chang and Schmidt teach the apparatus of claim 17. Chang is silent regarding wherein the frequency of the first waveform changes in a stepwise manner with each shift happening at a different zero crossing of the first waveform.
Schmidt teaches wherein the frequency of the first waveform changes in a stepwise manner with each shift happening at a different zero crossing of the first waveform (see Schmidt [0120]; stepping through one or more frequencies sequentially).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alternating electric field as taught by Chang with the stepwise transition between frequencies as taught by Schmidt. One of ordinary skill in the art would have been motivated to make this modification in order to sequentially transition from one frequency to the next (Schmidt [0120]). It can also be appreciated that in the scenario of transitioning from one frequency to a second frequency, there are only a limited number of ways to get from one to the other (e.g. instantaneous, gradual, stepwise), so it would have been obvious to one of ordinary skill in the art to try the stepwise approach of the present claim, having a reasonable expectation of success. See MPEP 2143(I)(E).
Claims 2, 4, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (US 20200254242 A1), optionally in view of Armstrong (US 20070097593 A1), and in view of Giladi et al (US 20170281934 A1).
Regarding claim 2, Chang teaches the method of claim 1. They are silent regarding wherein changing the frequency of the alternating electric field is performed instantly at one time during application of the alternating electric field.
However, Giladi teaches a system for treating cancer cells in a target region by imposing an alternating electric field (Giladi [Abstract]) wherein changing the frequency of the alternating electric field is performed instantly at one time during application of the alternating electric field (see Giladi Fig. 8, [0047]; the electric field has two frequencies, anti-mitosis and anti-motility, that are switched between instantaneously at each time t0, t1, t2, etc).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of delivering an alternating electric field by instantaneously changing frequencies as taught by Giladi. One of ordinary skill in the art would have been motivated to make this modification in order to have two distinct phases of the alternating electric fields having different effects on the target region, in this case an anti-mitosis phase and an anti-mobility phase that are mutually exclusive with respect to time (Giladi [0057]).
Regarding claim 4, Chang teaches the method of claim 1. They are silent regarding wherein changing the frequency of the alternating electric field is performed in less than a period of 200 ms. Giladi teaches an instantaneous changing of the frequencies (see Giladi Fig. 8, [0047]; the electric field has two frequencies, anti-mitosis and anti-motility, that are switched between instantaneously at each time t0, t1, t2, etc), but is also silent regarding the period of change being less than 200ms.
However, it can be appreciated that the general conditions of the claim, changing the frequencies of an alternating electric field in a near-instantaneous time period, were disclosed in the prior art of Giladi. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to change the frequencies in a period less than 200ms, 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.
Regarding claim 13, Chang teaches the apparatus of claim 12. They are silent regarding wherein the frequency of the first waveform changes instantly from the first frequency to the target frequency.
However, Giladi teaches wherein the frequency of the first waveform changes instantly from the first frequency to the target frequency (see Giladi Fig. 8, [0047]; the electric field has two frequencies, anti-mitosis and anti-motility, that are switched between instantaneously at each time t0, t1, t2, etc).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of delivering an alternating electric field by instantaneously changing frequencies as taught by Giladi. One of ordinary skill in the art would have been motivated to make this modification in order to have two distinct phases of the alternating electric fields having different effects on the target region, in this case an anti-mitosis phase and an anti-mobility phase that are mutually exclusive with respect to time (Giladi [0057]).
Regarding claim 15, Chang teaches the apparatus of claim 12. The are silent regarding wherein the frequency of the first waveform changes from the first frequency to the target frequency in less than 200 ms. Giladi teaches an instantaneous changing of the frequencies (see Giladi Fig. 8, [0047]; the electric field has two frequencies, anti-mitosis and anti-motility, that are switched between instantaneously at each time t0, t1, t2, etc), but is also silent regarding the period of change being less than 200ms.
However, it can be appreciated that the general conditions of the claim, changing the frequencies of an alternating electric field in a near-instantaneous time period, were disclosed in the prior art of Giladi. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to change the frequencies in a period less than 200ms, 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.
Claims 3, 5, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (US 20200254242 A1), optionally in view of Armstrong (US 20070097593 A1), and in view of Giladi et al (US 20170281934 A1) and Goldwasser et al (US 20170224990 A1).
Regarding claims 3 and 5, Chang and Giladi teach the method of claims 2 and 4 wherein the alternating electric field is applied using a voltage generated according to an AC voltage waveform (see Chang [0014]; AC voltage generator).
They are silent regarding changing the frequency of the alternating electric field is performed at a time corresponding to a zero crossing of the AC voltage waveform.
However, Goldwasser teaches a system for electrical stimulation via an alternating electric field (Goldwasser [0020]), wherein the modulation of the parameters including frequency are modified in order to reduce discomfort to the patient (Goldwasser [1024]). It can therefore be appreciated that, prior to the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to change the frequency of the alternating electric field at the time in which the least amount of discomfort or shock was felt by the patient. Since it has been held that where the general conditions of a claim are disclosed in the prior art, wherein Goldwasser specifies the modulation of waveform frequency to allow habituation to reduce irritation or discomfort (Goldwasser [1019]), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 14 and 16, Chang and Giladi teach the apparatus of claims 12 and 15. They are silent regarding wherein the frequency of the first waveform changes at a zero crossing of the first waveform.
However, Goldwasser teaches a system for electrical stimulation via an alternating electric field (Goldwasser [0020]), wherein the modulation of the parameters including frequency are modified in order to reduce discomfort to the patient (Goldwasser [1024]). It can therefore be appreciated that, prior to the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to change the frequency of the alternating electric field at the time in which the least amount of discomfort or shock was felt by the patient. Since it has been held that where the general conditions of a claim are disclosed in the prior art, wherein Goldwasser specifies the modulation of waveform frequency to allow habituation to reduce irritation or discomfort (Goldwasser [1019]), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (US 20200254242 A1) in view of Armstrong (US 20070097593 A1).
Regarding claim 20, Chang teaches a method to treat a target region of a subject's body with an alternating electric field (see [abstract]; using alternating electric fields to increase permeability of cell membrane for the delivery of therapy), the method comprising:
applying the alternating electric field to the target region of the subject's body at a frequency and an intensity (see [0007]; applying an alternating electric field having a frequency between 210 and 400 kHz, in these instances the alternating electric field may have a field strength of at least 1 V/cm RMS), wherein the frequency is a first frequency, wherein the intensity is a first intensity, and
wherein the alternating electric field is applied to the subject's body through electrodes positioned on the subject's skin (see [0015]; a set of electrodes configured for affixation to the subject’s body, [0104]; positioning electrodes on the subject’s skin); and
decreasing the frequency of the alternating electric field from the first frequency to a target frequency (see [0008-0009]; application of a first alternating field at a first frequency, the first frequency may be between 250kHz and 350kHz, at a first period of time, and applying a second alternating field at a second frequency at a second period of time, the second frequency may be between 150 kHz and 250 kHz),
wherein the target frequency and the target intensity have a known efficacy for treating the target region of the subject's body with the alternating electric field (see [0008-0009]; application of a second alternating electric field at a second frequency, at a second period of time, wherein the second alternating electric field reduces viability of cancer cells); and
wherein the first frequency is greater than the target frequency (see [0016]; the first frequency is between 250 kHz and 350 kHz, and the second frequency is between 150 kHz and 250 kHz).
Chang teaches wherein the alternating electric field is applied at a target intensity, however Chang is silent regarding wherein the alternating electric field is first applied at a first intensity, wherein the first intensity is a non-zero intensity, and increasing the intensity from the first intensity to the target intensity while decreasing the frequency from the first frequency to a target frequency.
Armstrong teaches a method for applying stimulation to a target area of a patient wherein applying the stimulation signal at a target frequency/intensity comprises a ramping portion in which the signal is applied at a first frequency while increasing the intensity of the signal from zero to a target frequency over a period of time (see Armstrong Fig. 2, [0038-0039]; a ramping-up or ramping-down portion where characteristics of the signal may be adjusted during a specified ramping portion, which occurs before or after a stimulation portion, the characteristics of the ramp-up and/or ramp-down signals may include an amplitude, a rate of change of the amplitude, a time period of a rate of change of the amplitude, a pulse width, a rate of change of the pulse width, a time period of a rate of change of the pulse width, a frequency, a rate of change of the frequency, a time period of a rate of change of the frequency, and/or a duration of a time period of the ramp-up and/or ramp-down portions).
Armstrong also teaches wherein during the ramping-up or ramping-down portions, various components of characteristics of the signal may be adjusted, wherein the characteristics may include an amplitude, a rate of change of the amplitude, a time period of a rate of change of the amplitude, a pulse width, a rate of change of the pulse width, a time period of a rate of change of the pulse width, a frequency, a rate of change of the frequency, a time period of a rate of change of the frequency, and/or a duration of a time period of the ramp-up and/or ramp-down portions (Armstrong [0039]), and
wherein a first ramping portion of a first electrical signal comprises a first characteristic as listed above where the first characteristic has a first value and a second (target) value (Armstrong, Claim 16); and
wherein the first ramping portion also includes a second characteristic as listed above where the second characteristic has a first value and a second (target) value (Armstrong, Claim 22).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Chang’s method for treating a region of a subject’s body using a signal having a target intensity and frequency with Armstrong’s ramping-up period wherein the signal goes from a first intensity to a target intensity while the frequency goes from a first frequency to a target frequency. One of ordinary skill in the art would have been motivated to make this modification in order to avoid an undesired reaction or side effect experienced from the patient that may occur from a sudden burst of energy applied to the patient (Armstrong [0005]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Charlesworth et al (US 20150328461 A1) which teaches methods and apparatuses for amplitude-modulated ensemble waveforms for neurostimulation.
Armstrong et al (US 20070100377 A1) which teaches a system for providing multiple signal modes for a medical device.
Palti (US 20070225766 A1) teaches a system for optimizing characteristics of an electric field to increase the field’s effect on proliferating cells.
Schmidt et al (US 20200338344 A1) teaches a system for electrical stimulation for cancer treatment with internal and external electrodes.
Kronberg (US 20040267333 A1) teaches an apparatus and method for bioelectric stimulation, healing acceleration, pain relief, or pathogen devitalization.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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