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 .
Response to Amendment
2. This action is responsive to the amendments filed 6/3/2026. Claims 1 and 13 have been amended. Claim 3 was canceled. No claims were newly added.
Response to Arguments
3. Applicant’s arguments filed on 6/3/2026 with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant argues that A) Axelgaard does not teach or suggest wherein at least 50% of a total number of electrode elements in the array are peripheral electrode elements and B) The amendments overcome the double patenting rejection.4. In response to A), the examiner respectfully disagrees.
As noted in paragraphs 0044-0046 of Axelgaard, the arrangement of electrodes can be modified in a multitude of ways including removing/severing an electrode from the configuration. Thus, severing an innermost (non-peripheral) electrode would result in a configuration of 6 non-peripheral and 6 peripheral electrodes locations (i.e. at least 50% of a total number of electrode elements in the array are peripheral electrode elements). Therefore, Axelgaard teaches the scope of the limitations as currently claimed. 5. In response to B), the examiner respectfully agrees. In light of the amendments and applicant’s remarks, the double patenting rejection is withdrawn.
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 1-2, 4-10, 12-14, 16 and 21-24 are rejected under 35 U.S.C 103 as being unpatentable over Axelgaard et al. (US Pub.: 2011/0301683 A1, – Previously Cited) and further in view of Palti et al. (US Patent No.: 8,244,345 B2, – Previously Cited).
Regarding claim 1, Axelgaard teaches a transducer apparatus for delivering tumor treating fields to a subject's body (e.g. paragraph 0001, – using electrodes to perform electrical stimulation for treatment. Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the transducer apparatus (e.g. Fig. 5) comprising:
an array of electrode elements (e.g. Fig. 5 – electrodes 140 and 142), configured to deliver tumor treating fields to the subject's body (e.g. paragraph 0001, – electrodes applying electrical stimulation; Examiner notes that this limitation contains functional language and it is the Examiner’s position that Axelgaard’s electrodes are capable of delivering tumor treating fields), the array comprising all electrode elements present on the transducer apparatus (e.g. Fig. 5 – electrodes 140 and 142),
the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g. Fig. 7; paragraph 0036);
wherein, when viewed from a direction perpendicular to the face of the array, at least 50% of a total number of the electrode elements of the array are peripheral electrode elements defining an outer perimeter of the array (e.g. Fig. 5; paragraphs 0044-0046), the peripheral electrode elements substantially surrounding all other electrode elements of the array (e.g. Fig. 5 – electrodes 140 surrounding electrodes 142);
for each pair of adjacent peripheral electrode elements along the outer perimeter, a distance between the pair of adjacent peripheral electrode elements is not more than 25% greater than a distance between any other pair of adjacent peripheral electrode elements (e.g. Fig. 5, – the illustrated electrodes 140 are disposed to form a regular (equilateral and equiangular) hexagon thus the distance between any two adjacent peripheral electrode elements in the hexagon is the same. See annotated Fig. 5 below); and for each peripheral electrode element, an angle formed between the peripheral electrode element and its two adjacent peripheral electrode elements along the outer perimeter is greater than 90 degrees and less than 180 degrees, the angle facing interior to the array (e.g. Fig. 5 – the regular hexagon configuration is equidistant and equiangular and thus each of its interior angles is 120 degrees).
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However, Axelgaard does not explicitly teach and wherein the array of electrode elements is configured to deliver tumor treating fields to the subject's body at frequencies in a range of from 50 kHz to 500 kHz and/or at an electric field intensity in a range of from 1 V/cm to 4 V/cm.
Palti, in a same field of endeavor of electrical stimulation, discloses wherein the array of electrode elements is configured to deliver tumor treating fields to the subject's body at frequencies in a range of from 50 kHz to 500 kHz and/or at an electric field intensity in a range of from 1 V/cm to 4 V/cm (e.g. column 6 lines 59-67, – delivering frequencies of 50 kHz to 500 kHz; column 20 lines 57-61).
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 Axelgaard to include wherein the array of electrode elements is configured to deliver tumor treating fields to the subject's body at frequencies in a range of from 50 kHz to 500 kHz and/or at an electric field intensity in a range of from 1 V/cm to 4 V/cm, as taught and suggested by Palti, in order to enhance the ability to disrupt cellular structures by breaking the bridge membranes of dividing cells (Palti, column 6, lines 39-50).
Regarding claim 2, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein the outer perimeter either extends through, or touches the outermost edge of, each of the peripheral electrode elements (e.g. Fig. 5; paragraphs 0042-0043).
Regarding claim 4, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein the array comprises at least five peripheral electrode elements (e.g. Fig. 5 – six peripheral electrodes 140).
Regarding claim 5, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein, for each pair of adjacent peripheral electrode elements along the outer perimeter, a distance between the pair of adjacent peripheral electrode elements is not more than 10% greater than a distance between any other pair of adjacent peripheral electrode elements (e.g. Fig. 5 – the illustrated electrodes 140 are disposed to form an equilateral and equiangular (i.e. regular) hexagon thus the distance between any two adjacent peripheral electrodes in the hexagon is the same).
Regarding claim 6, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein, for each distance between the pair of adjacent peripheral elements along the outer perimeter, the distance is from a centroid of a first peripheral electrode element to a centroid of a second adjacent peripheral electrode element (e.g. Fig. 5 – the illustrated electrodes 140 are disposed to form an equilateral and equiangular (i.e. regular) hexagon thus the distance between any two adjacent peripheral electrodes in the hexagon is the same).
Regarding claim 7, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein, for each distance between a pair of adjacent peripheral elements along the outer perimeter, the distance is a shortest distance from an edge of a first peripheral electrode element to an edge of a second adjacent peripheral electrode element (e.g. Fig. 5 – the peripheral electrode elements 140 are equidistant and equiangular).
Regarding claim 8, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein the angle formed between at least one peripheral electrode element and its two adjacent peripheral electrode elements along the outer perimeter is between 108 degrees and 162 degrees and/or greater than 120 degrees and less than or equal to 150 degrees (e.g. Fig. 5 – the regular hexagon configuration is equidistant and equiangular and thus each of its interior angles is 120 degrees). Regarding claim 9, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein for each peripheral electrode element, the angle is measured between a first line connecting a centroid of the peripheral electrode element to a centroid of a first adjacent peripheral electrode element and a second line connecting the centroid of the peripheral electrode element to a centroid of a second adjacent peripheral electrode element (e.g. Fig. 5 – all of the peripheral electrode elements in the regular hexagon configuration are equidistant and equiangular).
Regarding claim 10, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein each of the electrode elements in the array, individually, has a shape selected from: disk-shaped or substantially disk-shaped; square, rectangular or hexagonal shape; substantially square, rectangular or hexagonal shape with one or more rounded corners; triangular shape; substantially triangular shape with rounded corners; truncated triangular shape; substantially truncated triangular shape with rounded corners; wedge shape; substantially wedge shape with rounded corners; truncated wedge shape; or substantially truncated wedge shape with rounded corners (e.g. Fig. 5 – electrodes 140 and 142 are substantially disk-shaped).
Regarding claim 12, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein the outer perimeter extends through at least a majority of the peripheral electrode elements or is disposed along and touches an outermost edge of at least a majority of the peripheral electrode elements (e.g. Fig. 5 – outer perimeter at least extends through/touches the peripheral electrodes 140).
Regarding claim 13, Axelgaard teaches a transducer apparatus for delivering tumor treating fields to a subject's body (e.g. paragraph 0001, – using electrodes to perform electrical stimulation for treatment. Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the transducer apparatus (e.g. Fig. 5) comprising:
an array of electrode elements (e.g. Fig. 5 – electrodes 140 and 142), configured to deliver tumor treating fields to the subject's body (e.g. paragraph 0001, – electrodes applying electrical stimulation; Examiner notes that this limitation contains functional language and it is the Examiner’s position that Axelgaard’s electrodes are capable of delivering tumor treating fields), the array comprising all electrode elements present on the transducer apparatus (e.g. Fig. 5 – electrodes 140 and 142),
the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g. Fig. 7; paragraph 0036);
wherein, when viewed from a direction perpendicular to the face of the array, an outer perimeter substantially surrounding the array of electrode elements is entirely convex in shape (e.g. Fig. 5 – outer perimeter is polygonal shape with rounded corners);
the outer perimeter either extends through, or touches the outermost edge of, at least five of the electrode elements of the array (e.g. Fig. 5; paragraphs 0044-0045), the at least five electrode elements extended through or touched by the outer perimeter being peripheral electrode elements of the array (e.g. Fig. 5 – six peripheral electrodes 140; paragraphs 0042-0043), at least 50% of a total number of electrode elements of the array are peripheral electrode elements (e.g. Fig. 5; paragraphs 0044-0046);
and the peripheral electrode elements of the array are spaced from each other along the perimeter with a variation in the spacing between adjacent peripheral electrode elements of less than 25% (e.g. Fig. 5, – the illustrated electrodes 140 are disposed to form a regular (equilateral and equiangular) hexagon thus the distance between any two adjacent peripheral electrode elements in the hexagon is the same. See annotated Fig. 5 above as applied to claim 1).
However, Axelgaard does not explicitly teach and wherein the array of electrode elements is configured to deliver tumor treating fields to the subject's body at frequencies in a range of from 50 kHz to 500 kHz and/or at an electric field intensity in a range of from 1 V/cm to 4 V/cm.
Palti, in a same field of endeavor of electrical stimulation, discloses wherein the array of electrode elements is configured to deliver tumor treating fields to the subject's body at frequencies in a range of from 50 kHz to 500 kHz and/or at an electric field intensity in a range of from 1 V/cm to 4 V/cm (e.g. column 6 lines 59-67, – 50 kHz to 500 kHz; column 20 lines 57-61).
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 Axelgaard to include wherein the array of electrode elements is configured to deliver tumor treating fields to the subject's body at frequencies in a range of from 50 kHz to 500 kHz and/or at an electric field intensity in a range of from 1 V/cm to 4 V/cm, as taught and suggested by Palti, in order to enhance the ability to disrupt cellular structures by breaking the bridge membranes of dividing cells (Palti, column 6, lines 39-50).
Regarding claim 14, Axelgaard in view of Palti teaches the transducer apparatus of claim 13 as discussed above, and Axelgaard further teaches wherein the array does not have three or more peripheral electrode elements disposed adjacent each other and aligned with each other such that a straight line passes through a centroid of each of the three or more peripheral electrode elements (e.g. Fig. 5 – electrodes 140; paragraphs 0042, 0044).
Regarding claim 16, Axelgaard in view of Palti teaches the transducer apparatus of claim 13 as discussed above, and Axelgaard further teaches wherein the convex outer perimeter has a regular polygon shape, a substantially regular polygonal shape with rounded or curved vertices, an irregular polygon shape, or an irregular polygonal shape with rounded or curved vertices (e.g. Fig. 5, – substantially regular polygon shape with rounded or curved vertices; paragraphs 0042; 0044).
Regarding claim 21, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein an X-axis and a Y-axis of the array are perpendicular to each other and intersect each other at a centroid of the array and in the plane of the array, wherein the array of electrode elements has symmetry with respect to the X-axis, the Y-axis, or both the X-axis and the Y-axis (e.g. Fig. 5; paragraph 042).
Regarding claim 22, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above, and Axelgaard further teaches wherein the transducer apparatus is configured for placement on a head, thorax, torso or thigh of the subject (e.g. paragraph 0036).
Regarding claim 23, Axelgaard in view of Palti teaches the transducer apparatus of claim 13 as discussed above, and Axelgaard further teaches wherein an X-axis and a Y-axis of the array are perpendicular to each other and intersect each other at a centroid of the array and in the plane of the array, wherein the array of electrode elements has symmetry with respect to the X-axis, the Y-axis, or both the X-axis and the Y-axis (e.g. Fig. 5; paragraph 042).
Regarding claim 24, Axelgaard in view of Palti teaches the transducer apparatus of claim 13 as discussed above, and Axelgaard further teaches wherein the transducer apparatus is configured for placement on a head, thorax, torso or thigh of the subject (e.g. paragraph 0036).
Claim 11 is rejected under 35 U.S.C 103 as being unpatentable over Axelgaard and further in view of Palti and further in view of Palti et al. (US Pub.: 2013/0190847 A1, hereafter referred to as “Palti ‘847” – Previously Cited).
Regarding claim 11, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above. However, Axelgaard in view of Palti does not explicitly teach wherein each electrode element in the array comprises a ceramic disk.
Palti ‘847, in a same field of endeavor of electrical stimulation, discloses wherein each electrode element in the array comprises a ceramic disk (e.g. abstract, paragraph 0015).
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 combination of Axelgaard and Palti to include a ceramic disk for each electrode element in the array, as taught and suggested by Palti ‘847, in order to increase the dielectric breakdown voltage as well as enhance the insulation of the electrodes (Palti ‘847, paragraph 0015).
Claim 15 is rejected under 35 U.S.C 103 as being unpatentable over Axelgaard and further in view of Palti and further in view of Eckhouse et al. (US Pub.: 2013/0226269 A1, – Previously Cited).
Regarding claim 15, Axelgaard in view of Palti teaches the transducer apparatus of claim 1 as discussed above. However, Axelgaard in view of Palti does not explicitly teach wherein the convex outer perimeter is substantially circular, oval, ovaloid, ovoid, or elliptical.
Eckhouse, in a same field of endeavor of electrical stimulation, discloses wherein the convex outer perimeter is substantially circular, oval, ovaloid, ovoid, or elliptical (e.g. paragraph 0031, – substantially circular).
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 combination of Axelgaard and Palti to incorporate wherein the convex outer perimeter is substantially circular, oval, ovaloid, ovoid, or elliptical, as taught and suggested by Eckhouse, because it is a simple substitution of one known shape used for a transducer apparatus for another in order to obtain the predictable results of effective electrical stimulation.
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 DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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