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 .
This Office Action is in response to claims filed on 06/22/2026.
Claims 1-20 are pending.
Claims 1, 3, 6-11, 16-18 and 20 were amended.
Claim Rejections - 35 USC § 112
Applicant’s arguments and amendments, see page 8, filed 06/22/2026, with respect to the claim rejection the amendment has been fully considered and are persuasive. The claim rejection has been withdrawn.
Claim Rejections - 35 USC § 101
Applicant’s arguments and amendments, see pages 8-18, filed 06/22/2026, with respect to the claim rejection the amendment has been fully considered and are persuasive. The claim rejection has been withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s arguments and amendments, see pages 18-19, filed 06/22/2026, with respect to the rejection(s) of claim(s) 1-2, 4-10 and 12-17 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection necessitated by the claim amendment is made in view of Tim Shay, NPL, “Soft electrodes combining hydrogel and liquid metal”, Published: 4 April 2018.
Claim Rejections - 35 USC § 103
Applicant’s arguments and amendments, see pages 19-20, filed 06/22/2026, with respect to the rejection(s) of claim(s) 3, 11 and 18-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection necessitated by the claim amendment is made in view of Tim Shay, NPL, “Soft electrodes combining hydrogel and liquid metal”, Published: 4 April 2018.
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 1-2, 4-10 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hyunwoo Yuk, NPL “Hydrogel bioelectronics”, Chen Soc Rev, Published: 26 November 2018, (hereafter Yuk), in views of Tim Shay, NPL, “Soft electrodes combining hydrogel and liquid metal”, Published: 4 April 2018 (hereafter Shay).
Regarding claim 1. Yuk teaches a hydrogel phantom, comprising:
a plurality of connected hydrogel elements (Page 1651, Fig 7, plurality of hydrogel connected to electrodes), a first one of the hydrogel elements having a first electrical impedance and a second one of the hydrogel elements having a second electrical impedance with the first electrical impedance different from the second electrical impedance (Page 1650, Table 4, Impedance, different hydrogel impedance),.
Yuk does not teach wherein each hydrogel element in the plurality of connected hydrogel elements is connected to another hydrogel element in the plurality of connected hydrogel elements.
Shay teaches wherein each hydrogel element in the plurality of connected hydrogel elements is connected to another hydrogel element in the plurality of connected hydrogel elements (Shay, Page 3299, fig 4, EGain, Acidic Gel, Neutral Gel, Skin, they are connected in series).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk to incorporate the teachings of Shay to connect hydrogel elements with another hydrogel element because it results in better signal to noise ratios, it can be modified without compromising the electrical properties (Shay, Page 3296, abstract).
Regarding claim 2. Yuk and Shay teach the hydrogel phantom of claim 1, wherein the plurality of connected hydrogel elements are in the form of a patient's body part (Yuk, Page 1651, Fig 7, plurality of hydrogel placed on a body part).
Regarding claim 4. Yuk and Shay teach the hydrogel phantom of claim 1, wherein the plurality of connected hydrogel elements are in the shape of a human head (Yuk, Page 1651, Fig 7C, electrodes in the shape of a human head).
Regarding claim 5. Yuk and Shay teach the hydrogel phantom of claim 1, wherein each of the plurality of connected hydrogel elements include a predetermined ratio of a first component and a second component (Yuk, Page 1651, Fig 7D, electrodes shape have proportion of 1.
Regarding claim 6. Yuk and Shay teach the hydrogel phantom of claim 1, further comprising a non-gel element coupled to at least one of the plurality of connected hydrogel elements (Yuk, Page 1651, Fig 7D, connected to the electronic device).
Regarding claim 7. Yuk and Shay teach the hydrogel phantom of claim 6, wherein the non-gel element is a medical device coupled to at least one of the plurality of connected hydrogel elements (Yuk, Page 1651, Fig 7D, electrodes are connected to the electronic device).
Regarding claim 8. Yuk and Shay teach the hydrogel phantom of claim 6, wherein the non-gel element is implanted within the plurality of connected hydrogel elements (Yuk, Page 1651, Fig 7D, electrodes are connected to the electronic device and is placed adjacently to the electrodes).
Regarding claim 9 Yuk teaches a method, comprising:
receiving a 3-dimensional model of an object (Page 1661, fig 21 A, 3D model of an object), the 3-dimensional model having a plurality of voxels (Page 1661, fig 21 B, 3D objects having voxels), with each voxel provided with property information identifying or being usable to determine at least one of an impedance or a resistance for the voxel (Page 1650, table 4, type of interface, having different resistance); and
operating a gel application system to create a hydrogel phantom with the 3-dimensional model, by creating a plurality of hydrogel elements within the hydrogel phantom corresponding to voxels within the 3-dimensional model (Page 1661, fig 21 B, 3D printing of hydrogel into various geometries),
Yuk does not teach wherein each hydrogel element in the plurality of connected hydrogel elements is connected to another hydrogel element in the plurality of connected hydrogel elements.
Shay teaches wherein each hydrogel element in the plurality of connected hydrogel elements is connected to another hydrogel element in the plurality of connected hydrogel elements (Shay, Page 3299, fig 4, EGain, Acidic Gel, Neutral Gel, Skin, they are connected in series).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk to incorporate the teachings of Shay to connect hydrogel elements with another hydrogel element because it results in better signal to noise ratios, it can be modified without compromising the electrical properties (Shay, Page 3296, abstract).
Regarding claim 10 Yuk teaches a method, comprising:
attaching field-generating pads to a hydrogel phantom at particular locations on the hydrogel phantom (Page 1643, fig 1, hydrogel connecting tissue and electronics), the hydrogel phantom having a plurality of connected hydrogel elements (Page 1651, Fig 7A-D, Plurality of hydrogel elements connected), a first one of the hydrogel elements having a first electrical impedance and a second one of the hydrogel elements having a second electrical impedance with the first electrical impedance different from the second electrical impedance (Page 1650, Table 4, type of interface hydrogel having different impedance, Hydrogel coating, ionically hydrogel, nanocomposite hydrogel, polymer hydrogel);
applying an alternating electric field to the hydrogel phantom with the field generating pads (Page 1645, Fig 2C, alternating electric field applied to electrode surface);
measuring of at least one property related to the alternating electric field passing through at least a portion of the hydrogel phantom with a plurality of sensors (Page 1645, Fig 2D, recording electrode)(Page 1647, Table 2, Ve recording); and
performing at least one of the following steps: determining an efficacy of the alternating electric field on a target region within the hydrogel phantom (Page 1652, Fig 9, Stimulation vs Force, difference between hydrogel and metal)(Page 1655, Fig 12C, hydrogel vs commercial electrode); and
modeling the alternating electric field passing through at least a portion of the hydrogel phantom using data measured by the plurality of sensors (Page 1659, Fig 18 B, Electron conduction, is a model of the sensor reading).
Yuk does not teach wherein each hydrogel element in the plurality of connected hydrogel elements is connected to another hydrogel element in the plurality of connected hydrogel elements.
Shay teaches wherein each hydrogel element in the plurality of connected hydrogel elements is connected to another hydrogel element in the plurality of connected hydrogel elements (Shay, Page 3299, fig 4, EGain, Acidic Gel, Neutral Gel, Skin, they are connected in series).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk to incorporate the teachings of Shay to connect hydrogel elements with another hydrogel element because it results in better signal to noise ratios, it can be modified without compromising the electrical properties (Shay, Page 3296, abstract).
Regarding claim 12 Yuk and Shay teach the method of claim 10 further comprising calculating a specific absorption rate of the alternating electric field by the hydrogel phantom based at least in part on the measured at least one property related to the alternating electric field (Yuk, Page 1648, col 2, equation 9, high efficiency, thus a loss is incurred in the hydrogel).
Regarding claim 13 Yuk and Shay teach the method of claim 10 further comprising attaching the plurality of sensors on or within the hydrogel phantom and associated with a particular portion of the hydrogel phantom, each sensor providing at least one property (Yuk, Page 1645, Fig 2D, recording electrode, records an electrical property) (Yuk, Page 1651, Fig 7, Multiple electrodes).
Regarding claim 14 Yuk and Shay teach the method of claim 13 wherein measuring of at least one property related to the alternating electric field further includes measuring at least one of the plurality of sensors to determine the at least one property (Yuk, Page 1652, Fig 9, measures at least one property).
Regarding claim 15 Yuk and Shay teach the method of claim 14 wherein measuring of at least one property related to the alternating electric field further includes measuring at least one of the plurality of sensors to determine a temperature related to the alternating electric field passing through the particular portion of the hydrogel phantom (Yuk, Page 1648, col 2, SNR is a function of temperature).
Regarding claim 16 Yuk and Shay teach the method of claim 14 wherein measuring of at least one property related to the alternating electric field further includes measuring at least one of the plurality of sensors to determine an electrical property related to the alternating electric field passing through the particular portion of the hydrogel phantom (Yuk, Page 1645, Fig 2D, recording electrode, Vrec).
Regarding claim 17 Yuk and Shay teach the method of claim 14 wherein measuring of at least one property related to the alternating electric field further includes measuring at least one of the plurality of sensors to determine a magnetic property related to the alternating electric field passing through the particular portion of the hydrogel phantom (Yuk, Page 1646, Col 2, Maxwells equations provide the simplified relationship between Ve and J, where conductivity is accounted).
Claims 3, 11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hyunwoo Yuk, NPL “Hydrogel bioelectronics”, Chen Soc Rev, Published: 26 November 2018, (hereafter Yuk), in views of Tim Shay, NPL, “Soft electrodes combining hydrogel and liquid metal”, Published: 4 April 2018 (hereafter Shay), in further views of Mari Lehti-Polojarvi. NPL “Electrical Impedance tomography applied to stem cells in hydrogel scaffold”, Published: June 4, 2014 (hereafter Lehti).
Regarding claim 3. Yuk and Shay teach the hydrogel phantom of claim 1, wherein at least one of the hydrogel elements is in the form, and the at least one of the plurality of connected hydrogel elements has an impedance mimicking the impedance (Yuk, Page 1651, Table 4, different impedances for the hydrogels).
Yuk does not teach hydrogel elements in the form of a tumor and hydrogel elements has a impedance mimicking the impedance of the tumor.
Lehti teaches hydrogel elements in the form of a tumor (Page 10, fig 2.5, cell culture, equivalent electrical circuit of a biological cell) and hydrogel elements has a impedance mimicking the impedance of the tumor (Page 10, Fig 2.5, modeling with resistance, capacitance, thus mimicking the impedance of the biological cell).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk to incorporate the teachings of Lehti to model the biological cell as an electrical circuit having impedance because the electrical current behavior of a cell can be explained with an equivalent electrical circuit (Lehti, Page 10, Par 3).
Regarding claim 11 Yuk and Shay teach the method of claim 10, wherein applying an alternating electric field includes applying a treating field to the hydrogel phantom with the field-generating pads (Yuk, Page 1651, fig 7, applying the electrodes for treatment).
Yuk and Shay do not teach applying a tumor treating field.
Lehti teaches applying a tumor treating field (Page 13, sec 2.7.1, sensitivity field, current density field)(Page 15, fig 2.7, current carrying electrodes and its configuration for treatment detection).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk and Shay to incorporate the teachings of Lehti to apply a treatment using the electrical field because the electrical current behavior of a cell can be explained with an equivalent electrical circuit (Lehti, Page 10, Par 3).
Regarding claim 18 Yuk and Shay teach the method of claim 14, wherein applying an alternating electric field includes applying treating field to the hydrogel phantom with the field-generating pads (Yuk, Page 1651, fig 7, applying the electrodes for treatment).
Yuk and Shay does not teach applying a tumor treating field.
Lehti teaches applying a tumor treating field (Page 13, sec 2.7.1, sensitivity field, current density field)(Page 15, fig 2.7, current carrying electrodes and its configuration for treatment detection).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk and Shay to incorporate the teachings of Lehti to apply a treatment using the electrical field because the electrical current behavior of a cell can be explained with an equivalent electrical circuit (Lehti, Page 10, Par 3).
Regarding claim 19 Yuk, Shay and Lehti teach the method of claim 18, wherein modeling the tumor treating field includes determining an efficacy of the alternating electric field on a target region within the hydrogel phantom (Yuk, Page 1652, Fig 9, Stimulation vs Force, difference between hydrogel and metal) (Yuk, Page 1655, Fig 12C, hydrogel vs commercial electrode) (Lehti, Page 10, fig 2.5, cell culture, equivalent electrical circuit of a biological cell).
Regarding claim 20 Yuk teaches a method, comprising:
attaching field-generating pads to a hydrogel phantom at predetermined locations based on a computer simulation (Page 1645, Fig 2B, Bioelectronic device, generating electric potential to have an electric field) (Page 1651, Fig 7, attaching hydrogel),
the hydrogel phantom having a plurality of hydrogel elements (Page 1651, Fig 7, attaching hydrogel having multiple elements),
a first one of the hydrogel elements having a first electrical impedance and a second one of the hydrogel elements having a second electrical impedance with the first electrical impedance different from the second electrical impedance (Page 1650, Table 4, Impedance, different hydrogel impedance),;
applying an alternating electric field to the hydrogel phantom with the field generating pads (Page 1645, Fig 2C, stimulation electrode, Vsti);
measuring TTField intensity related to the alternating electric field passing through at least a portion of the hydrogel phantom to obtain an actual TTField intensity (Page 1645, Fig 2D, Recording electrode, Vrec);
Yuk does not teach the first one of the hydrogel elements connected to the second one of the hydrogel elements.
Shay teaches the first one of the hydrogel elements connected to the second one of the hydrogel elements (Shay, Page 3299, fig 4, EGain, Acidic Gel, Neutral Gel, Skin, they are connected in series).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk to incorporate the teachings of Shay to connect hydrogel elements with another hydrogel element because it results in better signal to noise ratios, it can be modified without compromising the electrical properties (Shay, Page 3296, abstract).
Yuk and Shay do not teach a computer simulation of tumor treating field (TTField) intensity, comparing the actual TTField intensity to an estimated TTField intensity obtained from the computer simulation, validating the computer simulation if a difference between the actual TTField intensity and the estimated TTField intensity is within a predetermined threshold; and calibrating the computer simulation of TTField intensity based on the difference.
Lehti teaches a computer simulation of tumor treating field (TTField) intensity (Page i, abstract, EIT setup is simulated in order to find the optimal electrode locations and resistivity values), comparing the actual TTField intensity to an estimated TTField intensity obtained from the computer simulation (Page 26, fig 3.8, simulated and measured impedance spectrum), validating the computer simulation if a difference between the actual TTField intensity and the estimated TTField intensity is within a predetermined threshold (Page 26, sec 3.1.5, fig 3.8, simulated and measured impedance spectrum, error calculated by an maximum error); and calibrating the computer simulation of TTField intensity based on the difference (Page 45, sec 4.2, the optimal result of this is then used for the other simulations, thus the result of a previous simulation is used).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Yuk and Shay to incorporate the teachings of Lehti to simulate a TTField, compared the simulated field impedance to the measured field impedance, to validate the model by comparing the measured and estimated, calibrate the model using the result of the difference between measured and estimated because by comparing, validating and calibrating, an error can be estimated thus providing guidance as to the validity of the model (Lehti, Page 26, sec 3.1.5).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/A.C./Examiner, Art Unit 2189
/REHANA PERVEEN/Supervisory Patent Examiner, Art Unit 2189
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