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 03/18/2022
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/14/2022, 01/28/2026 and 02/06/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 6 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the at least one of the plurality of adjacently disposed hydrogel elements”. It is unclear from the claim language if “the plurality of adjacently disposed hydrogel elements” refers back to the first or second hydrogel elements or is a new term being defined.
Claim 6 recites the limitation "a non-gel element communicating with at least one of the plurality of connected hydrogel”. It is unclear from the claim language how the non-gel element is communicating. Examiner is interpreting the claim as follows
“a non-gel element coupled with at least one of the plurality of connected hydrogel”.
Claim 7 recites the limitation "a medical device communicating with at least one of the plurality of adjacently disposed hydrogel elements”. It is unclear from the claim language how the medical device is communicating with disposed hydrogel elements, does the hydrogel elements have communication modules to achieve this communication. Examiner is interpreting the claim as follows
“a medical device coupled with at least one of the plurality of adjacently disposed hydrogel elements”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
To determine if a claim is directed to patent ineligible subject matter, the Court has guided the Office to apply the Alice/Mayo test, which requires:
1. Determining if the claim falls within a statutory category;
2A. Determining if the claim is directed to a patent ineligible judicial exception consisting of a law of nature, a natural phenomenon, or abstract idea; and
Step 2A is a two-prong inquiry. MPEP 2106.04(II)(A). Under the first prong, examiners evaluate whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. Abstract ideas include mathematical concepts, certain methods of organizing human activity, and mental processes. MPEP 2106.04(a)(2). The second prong is an inquiry into whether the claim integrates a judicial exception into a practical application. MPEP 2106.04(d).
2B. If the claim is directed to a judicial exception, determining if the claim recites limitations or elements that amount to significantly more than the judicial exception. (See MPEP 2106).
Claims 1-9 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite a mental process and a mathematical calculation; see MPEP 2106.04(a)(2)(I) and MPEP 2106.04(a)(2)(III).
Step 1:
Claims 1-8 are directed to the statutory category of composition of matter.
Claim 1 Step 2A prong 1:
For the sake of identifying the abstract ideas, a copy of the claim is provided below. Abstract ideas are bolded.
A hydrogel phantom, comprising:
a plurality of connected hydrogel elements, a first one of the hydrogel elements having a first electrical impedance and a second one of the hydrogel elements having a second impedance with the first impedance different from the second impedance.
The limitations “a first one of the hydrogel elements having a first electrical impedance and a second one of the hydrogel elements having a second impedance with the first impedance different from the second impedance” are an abstract ideas because it is directed to a mathematical model. The limitation, as drafted and under broadest reasonable interpretation, “can be performed using mathematical equations” MPEP 2106.04(a)(2)(I). Also, the limitation, as drafted and under broadest reasonable interpretation, “can be performed in the human mind or by a human using a pen and paper”. MPEP 2106.04(a)(2)(III). For example, a human could, mentally or on paper, observe, evaluate or analyze to make the determination of a model and its output.
The limitations “a plurality of connected hydrogel elements,”, is an abstract idea because it is directed to a mental process. The limitation, as drafted and under broadest reasonable interpretation, “can be performed in the human mind or by a human using a pen and paper”. MPEP 2106.04(a)(2)(III). For example, a human could, write a desired outcome.
Claim 1 Step 2A prong 2:
Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present general field of use or insignificant extra-solution activity. In particular, the claim recites the additional limitations:
“A hydrogel phantom” (general field of use – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
Claim 1 Step 2B:
The Examiner must consider whether each claim limitation individually or as an ordered combination amount to significantly more than the abstract idea. This analysis includes determining whether an inventive concept is furnished by an element or a combination of elements that are beyond the judicial exception. For limitations that were categorized as “apply it” or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations considered directed towards field of use or insignificant extra-solution activity. See MPEP 2106.04(d) referencing MPEP 2106.05(h) and MPEP2106.05(g).
Considering the claim limitations as an ordered combination, claim 1 does not include significantly more than the abstract idea.
Claim 2 further recites: “wherein the plurality of connected hydrogel elements are in the form of a patient's body part” These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. The additional feature(s) are considered to further clarify the what are elements under step 2A prong 1 of the abstract idea analysis. MPEP 2106.04(a)(2)(III). Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 3 recites “wherein at least one of the hydrogel elements is in the form of a tumor, and the at least one of the plurality of adjacently disposed hydrogel elements has an impedance mimicking the impedance of the tumor” These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. The additional feature(s) are considered to further clarify the elements under step 2A prong 1 of the abstract idea analysis, or alternatively, the limitation is considered to further define the mathematical formula. MPEP 2106.04(a)(2)(I) and MPEP 2106.04(a)(2)(III). Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 4 recites “wherein the plurality of connected hydrogel elements are in the shape of a human head” This limitation is considered to be a field of use limitation, because it defines the type of shape that is being considered. see MPEP 2106.05(d) referencing MPEP 2106.05(h).
These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 5 recites “wherein each of the plurality of connected hydrogel elements include a predetermined ratio of a first component and a second component” This limitation is considered to be a field of use limitation, because it defines the type of data that is being considered. see MPEP 2106.05(d) referencing MPEP 2106.05(h).
These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 6 recites “further comprising a non-gel element communicating with at least one of the plurality of connected hydrogel elements” These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. The additional feature(s) are considered to further clarify the type of elements under step 2A prong 1 of the abstract idea analysis, MPEP 2106.04(a)(2)(III). Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 7 recites “wherein the non-gel element is a medical device communicating with at least one of the plurality of adjacently disposed hydrogel elements” This limitation is considered to be a field of use limitation, because it defines the object that are being considered. see MPEP 2106.05(d) referencing MPEP 2106.05(h).
These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible
Claim 8 recites “wherein the non-gel element is implanted within the plurality of adjacently disposed hydrogel elements” This limitation is considered to be a field of use limitation, because it defines the parameters that are being considered. see MPEP 2106.05(d) referencing MPEP 2106.05(h).
These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible
Regarding claims 9 and 20 are rejected under 35 U.S.C. 101
Claim 9 is directed to the statutory category of process.
Claim 1 Step 2A prong 1:
For the sake of identifying the abstract ideas, a copy of the claim is provided below. Abstract ideas are bolded.
A method, comprising:
receiving a 3-dimensional model of an object, the 3-dimensional model having a plurality of 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; and
operating a gel application system to create a hydrogel phantom with the 3-dimensional model, by creating hydrogel elements within the hydrogel phantom corresponding to voxels within the 3-dimensional model.
The limitations “operating a gel application system to create a hydrogel phantom with the 3-dimensional model, by creating hydrogel elements within the hydrogel phantom corresponding to voxels within the 3-dimensional model” are an abstract ideas because it is directed to a mathematical model. The limitation, as drafted and under broadest reasonable interpretation, “can be performed using mathematical equations” MPEP 2106.04(a)(2)(I). Also, the limitation, as drafted and under broadest reasonable interpretation, “can be performed in the human mind or by a human using a pen and paper”. MPEP 2106.04(a)(2)(III). For example, a human could, mentally or on paper, observe, evaluate or analyze to make the determination of a model and its output.
Claim 1 Step 2A prong 2:
Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present general field of use or insignificant extra-solution activity. In particular, the claim recites the additional limitations:
“A method, comprising: ” (general field of use – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
“receiving a 3-dimensional model of an object, the 3-dimensional model having a plurality of 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” (general field of use and data gathering – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
Claim 1 Step 2B:
The Examiner must consider whether each claim limitation individually or as an ordered combination amount to significantly more than the abstract idea. This analysis includes determining whether an inventive concept is furnished by an element or a combination of elements that are beyond the judicial exception. For limitations that were categorized as “apply it” or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations considered directed towards field of use or insignificant extra-solution activity. See MPEP 2106.04(d) referencing MPEP 2106.05(h) and MPEP2106.05(g).
Considering the claim limitations as an ordered combination, claim 9 does not include significantly more than the abstract idea.
Claim 20 is directed to the statutory category of process.
Claim 1 Step 2A prong 1:
For the sake of identifying the abstract ideas, a copy of the claim is provided below. Abstract ideas are bolded.
A method, comprising:
attaching field-generating pads to a hydrogel phantom at pre-determined locations based on a computer simulation, the hydrogel phantom having a plurality of hydrogel elements, a first one of the hydrogel elements having a first electrical impedance and a second one of the hydrogel elements having a second impedance with the first impedance different from the second impedance;
applying an alternating electric field to the hydrogel phantom with the field generating pads;
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; and,
comparing the actual TTField intensity to an estimated TTField intensity obtained from the computer simulation.
The limitations “comparing the actual TTField intensity to an estimated TTField intensity obtained from the computer simulation” are an abstract ideas because it is directed to a mathematical model. The limitation, as drafted and under broadest reasonable interpretation, “can be performed using mathematical equations” MPEP 2106.04(a)(2)(I). Also, the limitation, as drafted and under broadest reasonable interpretation, “can be performed in the human mind or by a human using a pen and paper”. MPEP 2106.04(a)(2)(III). For example, a human could, mentally or on paper, observe, evaluate or analyze to make the determination of a model and its output.
Claim 1 Step 2A prong 2:
Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present general field of use or insignificant extra-solution activity. In particular, the claim recites the additional limitations:
“A method, comprising: ” (general field of use – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
“attaching field-generating pads to a hydrogel phantom at pre-determined locations based on a computer simulation, the hydrogel phantom having a plurality of hydrogel elements, a first one of the hydrogel elements having a first electrical impedance and a second one of the hydrogel elements having a second impedance with the first impedance different from the second impedance” (general field of use and data gathering – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
“applying an alternating electric field to the hydrogel phantom with the field generating pads” (general field of use and data gathering – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
“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” (general field of use and data gathering – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
Claim 1 Step 2B:
The Examiner must consider whether each claim limitation individually or as an ordered combination amount to significantly more than the abstract idea. This analysis includes determining whether an inventive concept is furnished by an element or a combination of elements that are beyond the judicial exception. For limitations that were categorized as “apply it” or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations considered directed towards field of use or insignificant extra-solution activity. See MPEP 2106.04(d) referencing MPEP 2106.05(h) and MPEP2106.05(g).
Considering the claim limitations as an ordered combination, claim 20 does not include significantly more than the abstract idea.
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.
Claims 1-2, 4-10 and 12-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyunwoo Yuk, NPL “Hydrogel bioelectronics”, Chen Soc Rev, Published: 26 November 2018, (hereafter Yuk).
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 impedance with the first impedance different from the second impedance (Page 1650, Table 4, Impedance, different hydrogel impedance).
Regarding claim 2. Yuk teaches the hydrogel phantom of claim 1, wherein the plurality of connected hydrogel elements are in the form of a patient's body part (Page 1651, Fig 7, plurality of hydrogel placed on a body part).
Regarding claim 4. Yuk teaches the hydrogel phantom of claim 1, wherein the plurality of connected hydrogel elements are in the shape of a human head (Page 1651, Fig 7C, electrodes in the shape of a human head).
Regarding claim 5. Yuk teaches 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 (Page 1651, Fig 7D, electrodes shape have proportion of 1.
Regarding claim 6. Yuk teaches the hydrogel phantom of claim 1, further comprising a non-gel element communicating with at least one of the plurality of connected hydrogel elements (Page 1651, Fig 7D, connected to the electronic device).
Regarding claim 7. Yuk teaches the hydrogel phantom of claim 6, wherein the non-gel element is a medical device communicating with at least one of the plurality of adjacently disposed hydrogel elements (Page 1651, Fig 7D, electrodes are connected to the electronic device).
Regarding claim 8. Yuk teaches the hydrogel phantom of claim 6, wherein the non-gel element is implanted within the plurality of adjacently disposed hydrogel elements (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 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).
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 impedance with the first impedance different from the second 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).
Regarding claim 12 Yuk teaches 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 (Page 1648, col 2, equation 9, high efficiency, thus a loss is incurred in the hydrogel).
Regarding claim 13 Yuk teaches 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 (Page 1645, Fig 2D, recording electrode, records an electrical property)(Page 1651, Fig 7, Multiple electrodes).
Regarding claim 14 Yuk teaches 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 (Page 1652, Fig 9, measures at least one property).
Regarding claim 15 Yuk teaches 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 (Page 1648, col 2, SNR is a function of temperature).
Regarding claim 16 Yuk teaches 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 one or more sensor to determine an electrical property related to the alternating electric field passing through the particular portion of the hydrogel phantom (Page 1645, Fig 2D, recording electrode, Vrec).
Regarding claim 17 Yuk teaches 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 one or more sensor to determine a magnetic property related to the alternating electric field passing through the particular portion of the hydrogel phantom (Page 1646, Col 2, Maxwells equations provide the simplified relationship between Ve and J, where conductivity is accounted).
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 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 Mari Lehti-Polojarvi. NPL “Electrical Impedance tomography applied to stem cells in hydrogel scaffold”, Published: June 4, 2014 (hereafter Lehti).
Regarding claim 3. Yuk teaches 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 adjacently disposed hydrogel elements has an impedance mimicking the impedance (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 teaches 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 (Page 1651, fig 7, applying the electrodes for treatment).
Yuk 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 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 teaches the method of claim 14, wherein applying an alternating electric field includes applying treating field to the hydrogel phantom with the field generating pads (Page 1651, fig 7, applying the electrodes for treatment).
Yuk 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 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 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)(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 pre-determined locations based on a computer simulation (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 impedance with the first impedance different from the second 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); and,.
Yuk does not teach comparing the actual TTField intensity to an estimated TTField intensity obtained from the computer simulation.
Lehti teaches 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).
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 compared the simulated field impedance to the measured field impedance because by comparing an error can be estimated thus providing guidance as to the validity of the model (Lehti, Page 26, sec 3.1.5)
Conclusion
The prior art made of record, listed on PTO-892, and not relied upon is considered pertinent to applicant's disclosure.
Song, Discloses simulating in vivo tumor angiogenesis, using hydrogels and their design parameters, to create a microvessel model to capture the native angiogenesis process.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGEL JAVIER CALLE whose telephone number is (571)272-0463. The examiner can normally be reached Monday - Friday 7:30 a.m. - 5 p.m..
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/A.C./Examiner, Art Unit 2189
/REHANA PERVEEN/Supervisory Patent Examiner, Art Unit 2189