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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/20/2025 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 10/20/2025. Claim 1 has been amended. Claims 21-22 were newly added.
Response to Arguments
Applicant’s response with respect to art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-9, 11, 14-19, and 21-22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Baldoni et al. (International Publication No.: WO 2020/131857 A1).
Regarding claim 1 Baldoni teaches a transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus (e.g. Fig. 4A; paragraph 0097) comprising:
an array of electrode elements electrically coupled to each other (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2),
the array comprising all electrode elements present on the transducer apparatus, the array configured to be positioned over the subject's body with a face of the array facing the subject's body and configured to deliver tumor treating fields to the subject's body in a range of 50 kHz to 1 MHz (e.g. paragraph 0097, – applying electrical stimulation from 50 kHz to 300 kHz to the patient’s skin. Electrical modulation is used to treat a variety of conditions including cancer);
wherein, when viewed from a direction perpendicular to the face of the array, an outer perimeter of the array substantially tracing the electrode elements of the array has a rounded convex shape (e.g. Fig. 4A, – a circle is a rounded convex shape);
a number of the electrode elements of the array are peripheral electrode elements defining the outer perimeter of the array (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2), the peripheral electrode elements substantially surrounding any other electrode elements of the array (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2 surround EM coils 113);
wherein for each peripheral electrode element, at least a portion of a length of a perimeter of the peripheral electrode element is touching the outer perimeter of the array (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2 each have a length touching the outer perimeter of the array).
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Regarding claim 2, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein the outer perimeter does not have any corners (e.g. Fig. 4A – outer perimeter is a circle; paragraph 0139).
Regarding claim 3, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein the outer perimeter is substantially circular, oval, ovaloid, ovoid, or elliptical (e.g. Fig. 4A – outer perimeter is substantially circular; paragraph 0139).
Regarding claim 4, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein a portion of the outer perimeter is shaped such that every point along the portion of the outer perimeter is equidistant from a point inside the outer perimeter (e.g. Fig. 4A; paragraph 0139).
Regarding claim 5, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein at least one of the electrode elements in the array has a triangular shape, a substantially triangular shape with rounded corners, a truncated triangular shape, a substantially truncated triangular shape with rounded corners, a wedge shape, a substantially wedge shape with rounded corners, a truncated wedge shape, or a substantially truncated wedge shape with rounded corners (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 6, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein at least one of the electrode elements in the array comprises: a first edge extending in a radially outward direction relative to the center portion of the array (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139); a second edge extending in a radially outward direction relative to the center portion of the array (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139); and a rounded edge connecting the first edge to the second edge at an end of the electrode element located radially away from the center portion of the array (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 8, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein at least one electrode element in the array is surrounded by one or more peripheral electrode elements of the array and does not touch the outer perimeter (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2 surround EM coils 113 which does not touch the outer perimeter).
Regarding claim 9, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein for each of the peripheral electrode elements, at least 10% of the length of the perimeter of the peripheral electrode element is touching the outer perimeter (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 11, Baldoni teaches the transducer apparatus of claim 1 as discussed above, and Baldoni further teaches wherein the array of electrode elements are not capacitively coupled (e.g. paragraph 0139).
Regarding claim 14, Baldoni discloses a transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus (e.g. Fig. 4A; paragraph 0097) comprising:
a plurality of electrode elements electrically coupled to each other and forming an array in a plane of the transducer apparatus (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2), the array configured to deliver tumor treating fields to the subject's body (e.g. paragraph 0097, – Electrical modulation is used to treat a variety of conditions including cancer);
wherein, when viewed from a direction perpendicular to the plane: an outer perimeter of the array is defined by a form-fit convex shape surrounding the plurality of electrode elements (e.g. Fig. 4A, – a circle is a rounded convex shape);
and at least 30% of the length of the outer perimeter touches one or more electrode elements of the plurality of electrode elements (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 15, Baldoni teaches the transducer apparatus of claim 14 as discussed above, and Baldoni further teaches wherein the outer perimeter traces one or more curved edges of the one or more electrode elements touching the outer perimeter (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 16, Baldoni teaches the transducer apparatus of claim 14 as discussed above, and Baldoni further teaches wherein for each of the one or more electrode elements touching the outer perimeter, at least 10% of the length of a perimeter of the electrode element is touching the outer perimeter (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 17, Baldoni teaches the transducer apparatus of claim 14 as discussed above, and Baldoni further teaches wherein the outer perimeter has a substantially circular, oval, ovaloid, ovoid, or elliptical shape (e.g. Fig. 4A – outer perimeter is substantially circular; paragraph 0139).
Regarding claim 18, Baldoni discloses a transducer apparatus for delivering tumor treating fields to a subject's body, the transducer apparatus (e.g. Fig. 4A; paragraph 0097) comprising:
an array of electrode elements electrically coupled to each other (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2),
the array comprising all electrode elements present on the transducer apparatus (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2), the array configured to be positioned over the subject's body with a face of the array facing the subject's body and configured to deliver tumor treating fields to the subject's body (e.g. paragraph 0097, – Electrical modulation is used to treat a variety of conditions including cancer);
wherein, when viewed from a direction perpendicular to the face of the array: an outer perimeter circumscribing the array of electrode elements has a substantially circular, oval, ovaloid, ovoid, or elliptical shape (e.g. Fig. 4A – outer perimeter is substantially circular; paragraph 0139);
and at least one electrode element in the array of electrode elements has a curved edge that touches a curved section of the outer perimeter along at least 5% of the length of the outer perimeter (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 19, Baldoni teaches the transducer apparatus of claim 18 as discussed above, and Baldoni further teaches wherein at least 50% of a total number of electrode elements in the array of electrode elements have a curved edge that touches a curved section of the outer perimeter along at least 5% of the length of the outer perimeter (e.g. Fig. 4A, – electrodes 109a1-a2, 109b1-b2, 109c1-c2, and 109d1-d2; paragraph 0139).
Regarding claim 21, Baldoni teaches the transducer apparatus of claim 14 as discussed above, and Baldoni further teaches further comprising: a substrate for attachment to a subject's body (e.g. paragraphs 0099; 0113), wherein the array of electrode elements are disposed in a plane on the substrate (e.g. Fig. 4a; paragraphs 0099; 0113).
Regarding claim 22, Baldoni teaches the transducer apparatus of claim 18 as discussed above, and Baldoni further teaches further comprising: a substrate for attachment to a subject's body (e.g. paragraphs 0099; 0113), wherein the array of electrode elements are disposed in a plane on the substrate (e.g. Fig. 4a; paragraphs 0099; 0113).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10 is rejected under 35 U.S.C 103 as being unpatentable over Baldoni and further in view of Palti et al. (US Pub.: 2013/0190847 A1, – Previously Cited).
Regarding claim 10, Baldoni teaches the transducer apparatus of claim 1 as discussed above. However, Baldoni does not explicitly teach wherein the array of electrode elements are capacitively coupled.
Palti, in the same field of endeavor of electrical stimulation, discloses wherein the array of electrode elements are capacitively coupled (e.g. abstract, paragraph 0015, – electrode comprises a ceramic disc having a dielectric layer and is therefore construed as being capacitively coupled).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Baldoni to include wherein the array of electrode elements are capacitively coupled, as taught and suggested by Palti, in order to increase the dielectric breakdown voltage as well as enhance the insulation of the electrodes (Palti, paragraph 0015).
Claim 12 is rejected under 35 U.S.C 103 as being unpatentable over Baldoni and further in view of Vlach et al. (NPL reference, “Capacitive biopotential electrode with a ceramic dielectric layer”, published, January 2017, – Previously Cited).
Regarding claim 12, Baldoni teaches the transducer apparatus of claim 1 as
discussed above. However, Baldoni does not explicitly teach wherein the electrode elements comprise a ceramic dielectric layer.
Vlach, in a same field of endeavor of biomedical electrodes, discloses wherein the electrode elements comprise a ceramic dielectric layer (e.g. pg. 989).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Baldoni to incorporate a ceramic dielectric layer into the electrode elements in order to increase the input capacitance and, therefore, improve the transmission of low-frequency components without extreme demands on the electronics (Vlach, pg. 989, second column).
Claim 13 is rejected under 35 U.S.C 103 as being unpatentable over Baldoni and further in view of Rubinson et al. (US Pub.: 2013/0001090 A1, – Previously Cited).
Regarding claim 13, Baldoni teaches the transducer apparatus of claim 1 as discussed above.
However, Baldoni does not explicitly teach wherein the electrode elements comprise polymer films.
Rubinson, in a same field of endeavor of electrical stimulation, discloses wherein the electrode elements comprise polymer films (e.g. paragraph 0009, 0098)
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Baldoni to include polymer films on the electrode elements, as taught and suggested by Rubinson, in order to lower the electrical impedance and improve the softness/flexibility of the electrodes (Rubinson, paragraph 0098).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792