The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive.
The applicant argues that the Armstrong reference is not analogous art, stating that Armstrong fails both prongs of the analogous art test. The examiner respectfully disagrees for the reason that follow.
On pages 9-10 of the remarks, the applicant argues that Armstrong is not from the same field of endeavor. The examiner respectfully disagrees with this argument because both the claimed invention and the Armstrong reference are in the medical field, and are more narrowly both within the field of electrical stimulation for medical purposes, which is the same field of endeavor. Contrarily, the applicant very narrowly explains the supposed fields of endeavor for each of the instant application and the Armstrong reference. "The field of endeavor is ‘not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field." (quoting Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001, 120 USPQ2d 1593, 1597 (Fed. Cir. 2016)) – see MPEP 2141.01(a)(I).
Even assuming that the above response is not persuasive, the examiner respectfully disagrees with the arguments on pages 10-13 in which the applicant argues that the Armstrong reference does not face the same problem to be solved as the instant application (i.e., the second prong of the analogous art test). On page 10, the applicant characterizes the instant application’s problem to be solved from passages in paragraphs 6 and 31 of the specification, which generally relates to reducing or eliminating “electrosensation”. This is same problem to be solved by Armstrong. The applicant argues that Armstrong is nor related to this problem, simply because Armstrong is not applying electrical stimulation therapy for the same intended purpose as the claimed invention (i.e., TTFields), nor at the same frequency (i.e., 50 kHz – 1 MHz). This is an unreasonably narrow characterization, and essentially amounts to the argument that “Armstrong is not applicable as a reference under 35 USC 102”, which is not the test for analogous art. Contrary to the arguments posed by the applicant (e.g., specifically those on page 12), one of ordinary skill in the art would find the disclosure of Armstrong relevant in the attempt to reduce or eliminate electrosensation. Armstrong teaches “a sudden burst of energy provided by the stimulation signal may not be tolerated well by the patient's body. For example, a sudden initiation of an electrical signal may cause an undesired reaction or side effect (e.g., pain)… In an attempt to alleviate such problems, designers have provided for a ramping time period immediately before and/or after the delivery of the therapeutic electrical signal” (see paragraphs 5-6). This is the same problem faced by the inventors in the instant application, and is explicitly the problem to be solved as stated by the applicant when paragraphs 6 and 31 are cited on page 10. Therefore, even if it is not found persuasive that Armstrong is in the same field of endeavor as the instant application and claims, the problem to be solved is one in the same. One of ordinary skill in the art would understand that applying electricity to a human body with a sudden increase or jolt from zero to a higher final energy level may cause pain, even if not directly applied to a nerve. One of ordinary skill in the art would look to Armstrong to teach that providing “a ramping time period immediately before and/or after the delivery of the therapeutic electrical signal” would alleviate electrosensations (see paragraph 6 of Amrstrong), and this is exactly what the inventors have done in the instant application.
With the above response in mind, where the applicant’s arguments on pages 14-15 stating that improper hindsight may not be used, it is noted that no such process took place and improper hindsight is of no relevance, since it is clear from the above that Armstrong is analogous art for the reasons it has been incorporated into the rejections, with evidence from Armstrong itself that would lead one of ordinary skill in the art to incorporate a ramp up and/or ramp down time period at the beginning and the end of application of electrical stimulation to the human body.
For at least the reasons above, the applicant’s arguments are not persuasive and the following rejections apply.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-13 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Palti (US Patent Pub. No. 2006/0167499) in view of Wasserman (US Patent Pub. No. 2021/0203250), and further in view of Armstrong (US Patent Pub. No. 2007/0097593).
Regarding claim 1, Palti discloses a method of selectively destroying or inhibiting the growth of rapidly dividing cells located within a target region of a subject’s body (see Title – “Treating a tumor or the like with electric fields at different orientations”, noting that tumors are “the growth of rapidly dividing cells” and the treating thereof is “destroying or inhibiting”), comprising the steps of:
Imposing an AC electric field in the target region with a field orientation that rotates with respect to the target region (see Abstract – “The selective destruction of rapidly dividing cells can therefore be accomplished by imposing an AC electric field in a target region… The field may also be rotated through 360o by applying AC waveforms with different phases to the electrodes.”), wherein the electric field has a frequency between 50 kHz and 1 MHz (see paragraph 27 – “The electronic apparatus includes a generator that generates an alternating voltage waveform at frequencies in the range from about 50 kHz to about 500 kHz.”).
However, Palti does not discuss patient discomfort or electro-sensation related to the initial onset of electric field applied to the patient, or specifically to an amplitude increase over the course of at least 0.1 seconds.
Wasserman teaches a high voltage, high efficiency sine wave generator that prevents spikes during amplitude adjustments and switching of channels (see Title). In paragraphs 137-139, there is a discussion related to Figures 14-16B. Particularly, Wasserman states that “FIG. 14 is a timing diagram that shows the sequencing between the two directions LR and AP that was used in the original Optune®.” Wasserman discusses the issue of switching when one sinusoid is at a peak, as illustrated in Figure 15. “Because such a spike 532 could cause the subject to experience an uncomfortable sensation, the original Optune® was designed to prevent such spikes from occurring. More specifically, this was accomplished by ramping down the output voltage of the AC voltage generator 20 from its steady-state value to zero V during the 100 ms interval that preceded each OFF state, then ramping the output voltage back up to its steady-state value during the 100 ms interval that followed each OFF state, as depicted in FIG. 16A, trace 540. The ramp rate was about 1 V/ms, which was sufficiently slow to avoid spikes that might be noticeable to a patient” (see paragraph 138, emphasis added). It is noted that “ramping the output voltage back up to its steady-state value during the 100 ms interval” means ramping up during a time period of 0.1s.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a ramp up during a time period of 0.1 seconds, as taught by Wasserman, and to incorporate this into the channel switching generator in Palti in order to prevent the subject from experiencing an uncomfortable sensation (see paragraph 138 of Wasserman, as quoted above).
While Palti teaches a rotating electric field via electrodes located around a periphery of a patient’s torso or limb, and Wasserman teaches a ramp up and ramp down period between the transition of each electrode, the stated time period of the ramp up/down in Wasserman is taught explicitly as being 0.1 s (i.e., 100 ms).
Armstrong teaches a variable output ramping for an implantable medical device (see Title). Similar to Wasserman, Armstrong teaches a ramping-up portion and a ramping-down portion with a therapeutic portion therebetween (see Figure 2), which is provided for the same reasons as Wasserman (i.e., “a sudden initiation of an electrical signal may cause an undesired reaction or side effect (e.g., pain)” – see paragraph 5). “FIG. 6A illustrates a ramp-up signal portion that has a first duration (e.g., a 3 second duration). In this example, the latter portion of the duration may necessitate a "tapering-off" in the slope of the rate-of-rise. FIG. 6B illustrates a ramp-up signal portion that has a shorter duration (e.g., a 1 second duration)” (see paragraph 59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a ramping-up portion for a time period sufficient to reach a therapeutic stimulation signal without causing discomfort to the patient whether it be 0.1 second (as in Wasserman) or 1 second or 3 seconds (as taught in Armstrong), as this would have been obvious to try a length of time greater than 0.1 seconds since the result of pain or sensation would occur with a faster ramp up time, not a slower ramp up time (“in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions” – see MPEP 2144.05(II)(B)). Additionally, Armstrong states that “a physician may analyze a patient's progress and may determine that an alteration of the ramping-up/down signals may be desirable to improve efficacy of the therapy” (see paragraph 75), and therefore it would have been obvious to one of ordinary skill in the art that the ramping up/down signals, including duration, should be adjustable depending on the patient and treatment being delivered.
Regarding claim 2, Palti teaches that “the electric field intensity in the tissue to be treated is in the range of about 0.1 V/cm to about 10 V/cm” (see paragraph 90), which range includes 1 V/cm as claimed.
Regarding claim 3, Palti teaches that “the electric energy generated by the source reaches the vicinity of the body via a conductor and is transmitted from it through air or some other electric insulating material to the human body” (see paragraph 9). Additionally, paragraph 11 teaches that “the electric fields are high frequency alternating fields applied to the body by means of insulated electrodes.” Also see Figures 10 and 12, illustrating insulated electrodes.
Regarding claim 5, Palti teaches that “the electric field intensity in the tissue to be treated is in the range of about 0.1 V/cm to about 10 V/cm” (see paragraph 90), which range includes 5 V/cm as claimed.
Regarding claim 6, Palti teaches that “the electric field intensity in the tissue to be treated is in the range of about 0.1 V/cm to about 10 V/cm” (see paragraph 90), which range includes 5 V/cm as claimed. Additionally, paragraph 90 of Palti teaches that “The generator 210 generates an alternating voltage waveform at frequencies in the range from about 50 kHz to about 500 kHz (preferably from about 100 kHz to about 300 kHz) (i.e., the TC fields)”, which range overlaps the range of 80 kHz to 300 kHz as claimed. With regard to the claim limitation of a ramp up time of at least 0.3 seconds, it is re-iterated that the addition of Armstrong teaches a ramp up time of greater than 0.3 seconds.
Regarding claim 7, Palti teaches in paragraph 90 that “The generator 210 generates an alternating voltage waveform at frequencies in the range from about 50 kHz to about 500 kHz (preferably from about 100 kHz to about 300 kHz) (i.e., the TC fields)”, which range overlaps the range of 80 kHz to 300 kHz as claimed.
Regarding claim 8, Palti teaches that “in the case of glioma, field frequencies of 100, 150, 170, 200, 250, and 300 kHz may be applied during the first, second, third, fourth, fifth, and sixth minutes of treatment, respectively. That cycle of frequencies would then repeat during each successive six minutes of treatment” (see paragraph 126). This teaches that the AC electric field therapy is being applied for up to six minutes intervals, which means that the peak level is maintained for that period of time, even though the orientation of that field may be shifting within that time period. Viewed another way, the treatment being applied for six minutes results in a cumulative time period of greater than 100 seconds for which the final level is applied to the patient.
Regarding claim 9, Palti teaches that “Two approaches may be used to obtain a rotating field that rotates in a continuous manner (as opposed to a step-wise manner). One approach, which is usually not practical for in-vivo application, is to physically rotate the electrodes themselves. The other, more preferred, approach is to use 3 or more electrodes that surround the target region, and to simultaneously drive those electrodes with electric potentials in synchrony with one another, but with phase shifts between the driving signals” (see paragraph 165, emphasis added).
Regarding claim 10, it can be seen in Figure 16B of Wasserman that the ramp up period (and the ramp down period) are linear.
Regarding claim 11, Palti claims the following in claim 19:
“An apparatus for selectively destroying or inhibiting the growth of rapidly dividing cells located within a target region of a patient, the apparatus comprising:
at least three insulated electrodes, wherein each of the electrodes has a surface configured for placing against the patient's body; and
an AC voltage source having at least three outputs, each output being electrically connected to a respective one of the electrodes…”, which is identical to lines 1-7 of claim 11 with the addition of “insulated electrodes”.
In addition, Palti claims in claim 21 that “the frequency of the electric field is between about 50 kHz and about 500 kHz”, which overlaps with the claimed range of 50 kHz – 1 MHz.
However, Palti does not discuss patient discomfort or electro-sensation related to the initial onset of electric field applied to the patient, or specifically to an amplitude increase over the course of at least 0.1 seconds, nor that the final level is 50 V RMS.
Wasserman teaches a high voltage, high efficiency sine wave generator that prevents spikes during amplitude adjustments and switching of channels (see Title). In paragraphs 137-139, there is a discussion related to Figures 14-16B. Particularly, Wasserman states that “FIG. 14 is a timing diagram that shows the sequencing between the two directions LR and AP that was used in the original Optune®.” Wasserman discusses the issue of switching when one sinusoid is at a peak, as illustrated in Figure 15. “Because such a spike 532 could cause the subject to experience an uncomfortable sensation, the original Optune® was designed to prevent such spikes from occurring. More specifically, this was accomplished by ramping down the output voltage of the AC voltage generator 20 from its steady-state value to zero V during the 100 ms interval that preceded each OFF state, then ramping the output voltage back up to its steady-state value during the 100 ms interval that followed each OFF state, as depicted in FIG. 16A, trace 540. The ramp rate was about 1 V/ms, which was sufficiently slow to avoid spikes that might be noticeable to a patient” (see paragraph 138, emphasis added). It is noted that “ramping the output voltage back up to its steady-state value during the 100 ms interval” means ramping up during a time period of 0.1s.
Additionally, it is noted that in Figure 16B, the peak voltage is +/- 80 volts. The AC voltage shown in Figure 16B of Wasserman equates to approximately 56.57 V RMS, based on the RMS Voltage Calculator at https://www.omnicalculator.com/physics/rms-voltage with “Characteristic Voltage” set to “Peak Voltage (Vp)”, “Voltage” set to “80”, and “Wave Offset (V0)” set to zero.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a ramp up during a time period of 0.1 seconds, as taught by Wasserman, and to incorporate this into the channel switching generator in Palti in order to prevent the subject from experiencing an uncomfortable sensation (see paragraph 138 of Wasserman, as quoted above).
While Palti teaches a rotating electric field via electrodes located around a periphery of a patient’s torso or limb, and Wasserman teaches a ramp up and ramp down period between the transition of each electrode, the stated time period of the ramp up/down in Wasserman is taught explicitly as being 0.1 s (i.e., 100 ms).
Armstrong teaches a variable output ramping for an implantable medical device (see Title). Similar to Wasserman, Armstrong teaches a ramping-up portion and a ramping-down portion with a therapeutic portion therebetween (see Figure 2), which is provided for the same reasons as Wasserman (i.e., “a sudden initiation of an electrical signal may cause an undesired reaction or side effect (e.g., pain)” – see paragraph 5). “FIG. 6A illustrates a ramp-up signal portion that has a first duration (e.g., a 3 second duration). In this example, the latter portion of the duration may necessitate a "tapering-off" in the slope of the rate-of-rise. FIG. 6B illustrates a ramp-up signal portion that has a shorter duration (e.g., a 1 second duration)” (see paragraph 59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a ramping-up portion for a time period sufficient to reach a therapeutic stimulation signal without causing discomfort to the patient whether it be 0.1 second (as in Wasserman) or 1 second or 3 seconds (as taught in Armstrong), as this would have been obvious to try a length of time greater than 0.1 seconds since the result of pain or sensation would occur with a faster ramp up time, not a slower ramp up time (“in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions” – see MPEP 2144.05(II)(B)). Additionally, Armstrong states that “a physician may analyze a patient's progress and may determine that an alteration of the ramping-up/down signals may be desirable to improve efficacy of the therapy” (see paragraph 75), and therefore it would have been obvious to one of ordinary skill in the art that the ramping up/down signals, including duration, should be adjustable depending on the patient and treatment being delivered.
Regarding claim 12, Palti teaches that “in the case of glioma, field frequencies of 100, 150, 170, 200, 250, and 300 kHz may be applied during the first, second, third, fourth, fifth, and sixth minutes of treatment, respectively. That cycle of frequencies would then repeat during each successive six minutes of treatment” (see paragraph 126). This teaches that the AC electric field therapy is being applied for up to six minutes intervals, which means that the peak level is maintained for that period of time, even though the orientation of that field may be shifting within that time period. Viewed another way, the treatment being applied for six minutes results in a cumulative time period of greater than 30 seconds for which the final level is applied to the patient.
Regarding claim 13, discusses dielectric constants in paragraph 96, including discussions of various thicknesses creating different dielectric constants such as 2-3, or some as much as 20-50. Then, in paragraph 99 Palti states “Since the thin insulating layer can be very vulnerable, etc., the insulation can be replaced by very high dielectric constant insulating materials, such as titanium dioxide (e.g., rutile), the dielectric constant can reach values of about 200. There a number of different materials that are suitable for use in the intended application and have high dielectric constants.” This teaching of using titanium dioxide and achieving a “dielectric constant [that] can reach values of about 200” reads on “insulating material having a dielectric constant of at least 20”, as claimed. It is also re-iterated that claim 19 of Palti teaches electrodes, which inherently have a conductive substrate, and that they are “insulated electrodes”.
Regarding claim 16, Palti teaches in paragraph 90 that “The generator 210 generates an alternating voltage waveform at frequencies in the range from about 50 kHz to about 500 kHz (preferably from about 100 kHz to about 300 kHz) (i.e., the TC fields)”, which range overlaps the range of 80 kHz to 300 kHz as claimed.
Regarding claim 17, Palti teaches the following in paragraph 168, “For example, three electrodes may be physically positioned around the target mass spaced 120o apart, and driven by three sinusoids that are phase-shifted by 120o with respect to each other … to create a similar rotating field.”
Regarding claim 18, Palti teaches in paragraphs 166-167 and with regard to Figure 32A, “Assuming that we have a body 1610 containing a target mass 1612, a preferred placement for the electrodes is to place a first pair one pair of electrodes 1620 on opposite sides of the body 1610, and another pair of electrodes 1630 on opposite sides of the body 1610, offset by 90o from the first set of electrodes 1620. … When both sets of outputs are sinusoids with the same frequency and the first set of outputs is shifted in phase by 90o from the second set of outputs, the field will rotate in the target area 1612 within the body 1610.”
Regarding claim 19, it is noted that claim 27 of Palti states, nearly verbatim, the limitations of claim 19. Aside from the claim language of Palti, Palti teaches “FIG. 33 depicts another set of waveforms that can be used to rotate the field, for the same electrode arrangement that is shown FIG. 32A. In this case the voltage sources produce alternating waveforms 1670, 1680, the amplitude of each being modulated at some chosen frequency that is much lower than the frequency of the waveforms being modulated. The two modulating waveforms 1675, 1685 are provided with a phase shift between them.” When looking at Figure 33, it can be seen that the modulating waveforms 1675, 1685 is “at least ten times lower” frequency than the waveforms being modulated 1670, 1680.
Regarding claim 20, it can be seen in Figure 16B of Wasserman that the ramp up period (and the ramp down period) are linear.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Wasserman and Armstrong as applied to claim 11 above, and further in view of Lee et al. (US Patent Pub. No. 2021/0308476).
Regarding claim 14, Palti in combination with Wasserman and Armstrong is described above with regard to claim 1. Palti teaches a rotating electric field via electrodes located around a periphery of a patient’s torso or limb; Wasserman teaches a ramp up and ramp down period between the transition of each electrode and explicitly shows a final level of 80 V in Figure 16B; and Armstrong teaches alternative time periods for the ramp up; however, none of these references explicitly teach a final level of at least 100 V RMS.
Lee teaches “a cancer treatment device which includes a first electrode and a second electrode, which are electrically connected to a signal generator and face each other with a target area therebetween… A cancer cell is present in the target area. The signal generator applies an AC voltage between the first electrode and the second electrode to generate an electric field between the first electrode and the second electrode” (see Abstract). In paragraph 41, Lee teaches that “The control unit 102 may determine an amplitude, a frequency, etc. of the waveform transmitted from the waveform generating unit 101. … The amplitude of the waveform may be determined as greater than about 0 V/cm and less than or equal to about 100 V/cm.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a final level of 100 V/cm, as taught by Lee, with the system and methods of Palti as combined with Wasserman and Armstrong, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233 – see MPEP 2144.05 (II)(A)).
Regarding claim 15, Palti teaches in paragraph 90 that “The generator 210 generates an alternating voltage waveform at frequencies in the range from about 50 kHz to about 500 kHz (preferably from about 100 kHz to about 300 kHz) (i.e., the TC fields)”, which range overlaps the range of 80 kHz to 300 kHz as claimed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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