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
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on March 27, 2026 is acknowledged. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 1-14 are rejected under 35 U.S.C. 103 as obvious over Travers et al. (US Patent Pub. No. 2016/0022986) in view of Kirson (US Patent Pub. No. 2018/0001078)
Regarding claims 1 and 7-8, Travers discloses an insulated electrode system for delivering a plurality of tumor treating electromagnetic fields including an array of electrode elements for proximate location on a body of a patient. Travers teaches an array of elements 52 that are controlled and are dynamically re-assignable to deliver any desirable electrical field (see paragraph 69). The stated solution presented by Travers is “a TTF system that enables the dynamic reassignment of array elements to thereby define any array needed and to apply the field from either sub-array A or B” (see paragraph 27) and “An advantage of the present invention is that each array element in the inventive device can be redirected to either power sub-array A or B and to any array combination desired and to any frequency desired” (see paragraph 35). Figure 17 of Travers illustrates an array of elements 52 attached to a patient’s body to whom treatment is to be applied, and Figures 18-23 illustrate exemplary subarray activations that may be used in one particular treatment (see paragraphs 78-79). Paragraph 78 states in reference to Figures 18-23 that “This particular sequence uses a 6-step firing sequence taking place within a three second time span (0.5 seconds per firing).” Therefore, this teaches that the firings of the exemplary subarrays in each figure are in sequence (i.e., one after another) and non-overlapping. Paragraph 79 then states that “The above process sequence can now be repeated”.
However, Travers does not explicitly teach that the application of an alternating voltage.
Kirson teaches arrays for longitudinal delivery of TTFields to a body (see Title). Among various different arrays that may be placed on the body, Figures 5A-5B and 5C-5D illustrate two versions in which there are a total of six (6) separate arrays, as well as Figures 7A-F illustrating an additional, for which paragraph 82 states that “Combining all three of the electrode configurations FIGS. 7A/B, 7C/D, and 7E/F and cycling the field between those three pairs of electrodes to provide three different field directions can provide excellent field coverage of the upper lobes of the lungs while maintaining patient comfort.” Therefore, it is clear that Kirson teaches the utilization of a plurality of different pairs of electrode arrays to deliver TTFields. Additionally, Kirson teaches that “Tumor Treating Fields (TTFields) are low intensity alternating electric fields (e.g., 1-3 V/cm) in the intermediate frequency range (e.g., 125-250 kHz, or in some cases 100-500 kHz) that target solid tumors by disrupting mitosis. TTFields are typically delivered through two pairs of electrode arrays” (see paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that Travers utilizes an alternating voltage electric field, because Kirson explicitly teaches that this is the definition of TTFields, and both Kirson and Travers are utilizing this electrical stimulation technique for their treatment.
Specifically regarding the configuration of the first through fifth set of one or more electrode elements and their recited usage, below is a reproduction of Figure 17, in which it is illustrated one way in which the system of Travers could be set up to read on the language of claim 1:
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It is re-iterated that the disclosure of Travers teaches explicitly that its system is capable of providing that “each array element in the inventive device can be redirected to either power sub-array A or B and to any array combination desired” (see paragraph 35). By the above configuration, this could provide for simultaneous activation of the notated 1st and 2nd arrays (anterior and posterior), 3rd and 4th arrays (left and right), and the 5th array along with at least one (or more than one) of the 1st-4th arrays. To this end, it is noted that Figure 23 of Travers illustrates the notated 5th array (generally) being utilized with another subset of array elements on the patient’s back.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the system and methods of Travers in the manner as illustrated above, and as claimed, because the system of Travers is explicitly built so that “each array element in the inventive device can be redirected to either power sub-array A or B and to any array combination desired” (see paragraph 35).
Regarding claims 2 and 9, Travers teaches “This particular sequence uses a 6-step firing sequence taking place within a three second time span (0.5 seconds per firing)” (see paragraph 35). Therefore, this teaches that the firings of the exemplary subarrays in each figure are in sequence (i.e., one after another) and non-overlapping.
Regarding claims 3 and 10, Travers states that “The above process sequence can now be repeated” (see paragraph 79). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to repeat an electrical stimulation pattern as many times as is needed to achieve the desired outcome for the particular patient being treated. Additionally, it is noted that Kirson teaches that treatment be repeated at least 10,000 times (see paragraph 73, last sentence).
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Regarding claims 4 and 11, it is noted that the electrode array of Travers is dynamic and may be configured as desired. To this end, the additional interpretation of the array illustrated in Figure 17 is commensurate with the plurality of individual arrays illustrated in Figures 5A and 5B of Kirson (see to the right).
In this second reproduction of Figure 17 of Travers that corresponds more directly to the configuration of Figures 5A and 5B of Kirson, it can be seen that a 5th set is located on the top, back of the patient. Based on Travers’ teaching that “each array element in the inventive device can be redirected to either power sub-array A or B and to any array combination desired” (see paragraph 35), it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize this 5th subarray at the top of the entire array structure along with the notated 1st anterior array, if and when the application of the resulting electric field from those two arrays would result in the desired and necessary treatment for the patient.
Regarding claims 5 and 12, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the 5th subarray, as illustrated in either reproduction of Figure 17 found above, with the notated 1st anterior subarray, 3rd left side subarray and 4th right side subarray, or any combination of subarrays as illustrated or as deemed necessary or desirable, if and when the application of the resulting electric field any such combination of subarrays would result in the desired and necessary treatment for the patient, as this dynamically changeable array system is the entire purpose of the Travers reference.
Regarding claims 6 and 13, the second reproduction of Figure 17 above (i.e., the one presented in the rejection of claim 4) illustrates the 5th subarray positioned on a second posterior surface of the subject’s body (see the top two rows of elements on the back side).
Regarding claim 14, the second reproduction of Figure 17 above (i.e., the one presented in the rejection of claim 4) illustrates the 5th subarray positioned on both a rear portion of the subject’s neck (see the top two rows of elements on the back side) and a front portion o the subject’s torso (see the bottom rows of elements on the front side). It is also noted that these locations of elements are meant to coincide with the elements illustrated in Figures 5A and 5B of Kirson, where array 32 is shown explicitly around the neck (e.g., including the rear of the neck) and array 31 is shown explicitly around the torso (e.g., including the front portion of the subject’s torso).
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Farber et al. (US Patent Pub. No. 2022/0096829) alone.
Regarding claims 1-2 and 7-9, Farber discloses “a method of applying tumor treating fields to a torso of a subject's body, the method including: locating a first transducer at a first location of the subject's body … locating a second transducer at a second location of the subject's body… and inducing an electric field between at least part of the first transducer and at least part of the second transducer” (see Abstract). Figures 4A – 4E illustrate a plurality of transducer sets located at various different locations on the patient’s body. As stated in paragraph 29, “FIGS. 4A-4E depict examples of transducer layouts with one pair of transducers for applying TTFields to the torso of the subject's body. Various combinations of these pairs of transducers or similar pairs of transducers may be used together.” It can be seen that Figure 4A illustrates an anterior array 41A and a posterior array 42A, which reads on the claimed 1st and 2nd sets, respectively. It can also be seen that Figure 4D illustrates a left array 41D and a right array 42D, which reads on the claimed 3rd and 4th sets, respectively. Additionally, Figure 4E illustrates an anterior array 41E, which is identical to anterior array 41A and is therefore considered the 1st set again, and another anterior array 42E, which reads on the claimed 5th set.
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In Figure 1, there is illustrated “an example method 100 of applying TTFields to the torso of a subject's body”. It can be seen that “at step S110, a first electric field is induced between the first transducer and the second transducer for a first time period… At step S112, after the first time period, the generation of the first electric field is ceased. That is, the AC generator stops generating the first AC voltage” (see paragraph 20). “At step S114, a second electric field is induced between the third transducer and the fourth transducer for a second time period… At step S116, after the second time period, the generation of the second electric field is ceased. That is, the AC generator stops generating the second AC voltage. In some embodiments, after the second electric field is ceased, the process automatically repeats (arrow 118) in steps S110, S112, S114, and S116” (see paragraph 21). In other words, each electric field is provided sequentially without overlap between pairs of electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that when there are more than two pairs of electrodes to be used in a therapy, that each of the more than two pairs would also be used sequentially without overlap as is illustrated in the example flowchart of Figure 1, and that this would also repeat as needed until the desired outcome of the therapy is obtained.
Regarding claims 3 and 10, it is noted that the repeating of the therapy, as illustrated by lead line 118, as well as the “no” option off of step S502 in Figure 1 could be repeated as many times as needed to achieve the desired outcome of the therapy, including up to and more than 100 times.
Regarding claims 4 and 11, while array 42E in Figure 4E, which is equated to the 5th set in the above rejection of claim 1 is on the anterior side of the patient, it is noted that Farber states “Various combinations of pairs of transducers as discussed herein, or similar pairs of transducers, may be used together. Various locations of transducers, such as those discussed herein or in other locations, may be used. A transducer may be used in a single pair of transducers or in two or more pairs of transducers” (see paragraphs 29 and 31). Another transducer may be used in another location on the posterior side of the patient without departing from the scope of the disclosed invention of Farber and it would have been obvious to do so based the teachings in paragraphs 29 and 31 (i.e., “A transducer may be used in a single pair of transducers or in two or more pairs of transducers.”). Additionally, utilizing any particularly located 5th set with the 1st set would similarly have been obvious since Farber teaches that “Various combinations of pairs of transducers as discussed herein, or similar pairs of transducers, may be used together.”
Regarding claims 5 and 12, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize any particular pair of electrode sets within the scope of Farber together, since Farber teaches that “Various combinations of pairs of transducers as discussed herein, or similar pairs of transducers, may be used together. Various locations of transducers, such as those discussed herein or in other locations, may be used. A transducer may be used in a single pair of transducers or in two or more pairs of transducers” (see paragraphs 29 and 31). It would be obvious to use any two particular sets of electrodes that provide the necessary treatment to the patient, depending on the location of the tumor(s) and the location of the electrode pairs.
Regarding claims 6 and 13-14, while array 42E in Figure 4E, which is equated to the 5th set in the above rejection of claim 1 is on the anterior side of the patient, it is noted that Farber states “Various combinations of pairs of transducers as discussed herein, or similar pairs of transducers, may be used together. Various locations of transducers, such as those discussed herein or in other locations, may be used. A transducer may be used in a single pair of transducers or in two or more pairs of transducers” (see paragraphs 29 and 31). Another transducer may be used in another location on the posterior side of the patient without departing from the scope of the disclosed invention of Farber and it would have been obvious to do so based the teachings in paragraphs 29 and 31 (i.e., “A transducer may be used in a single pair of transducers or in two or more pairs of transducers.”).
Conclusion
Additional prior art is made of record on the PTO-892 as they are considered pertinent to applicant's disclosure, but not relied upon in the rejections above.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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