DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: In claim 8, line 4, the recitation “based the one of more features” should be corrected to “based on the one or more features. Appropriate correction is required.
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.
Claim(s) 1-2, 6, 8-12, 15, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the US Patent US 11,172,868 by Zheng et al. (Zheng hereafter).
Regarding claim 1, Zheng teaches in Figure 3, a system for determining electrical properties of tissue samples, the system comprising:
a tissue measurement tool comprising at least two electrodes (301, 302) that measure, while operating at a frequency (frequency of the signal source 110, shown in detail in Figure 6), a set of electrical properties corresponding to a section of tissue (the electrodes and amplifier 330 measure the difference of the excitation signal received at the electrodes which is directly related to the section of the tissue adjacent to the electrodes, so as to determine disturbance coefficients and impedance - see for example, col. 13, lines 64-67 and col. 5, lines 17-18), and
a decoupling device (BPF filter 133) connected to the at least two electrodes (connected to electrodes 103 and 104); and
a classification module (134+135+136) that computes, based on the set of electrical properties, at least an electrical impedance of the section of tissue (impedance related to the area of the measurement. See col. 6, lines 1-4 and col. 5, lines 61-65).
As to claim 2, Zheng teaches the system of claim 1, wherein the at least two electrodes are connected in a bipolar configuration (as shown in figure 3, each electrode is connected to a pole signal generator 110).
As to claim 6, Zheng shows in Figure 1, the system of claim 1, further comprising an electrode array (101, 102, 106, 105, 103, 104) that includes the at least two electrodes. It’s noted that the system shown in figure 3 is a representation of one of the modes of operation of the system of figure 1, wherein the configurable analog switches are operated to allow the connection of electrodes to the patient’s head in the manner depicted in Figures 2, 3, 4, 5 and 8. See col. 5, lines 44-46).
Regarding claim 8, Zheng teaches the system of claim 1, wherein the classification module further:
extracts, from the set of electrical properties at frequencies above 1 kHz (see col. 6, line 44 or col. 12, lines 1-3), one or more features (internal tissue condition in the mode shown in Figure 2. See col. 5, lines 54-56); and
determines, based on the one or more features, that the section of the tissue contains cancerous cells (malignant glioma, see col. 8, lines 53-55).
Regarding claim 9, Davalos teaches the system of claim 8 including all structural elements recited as explained above. The examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With reference to claim 9, the recitation: “wherein a section of tissue comprises a portion of an excised tissue sample” appears directed to the preferred or intended manner of operating the claimed system. That is, the claim doesn’t recite additional elements/components not present in the prior art of record, that would allow the system to be used as intended/preferred. Because Zheng teaches all structural elements as recited, and because the assembly may be readily used in a process of determining properties of tissue, the prior art meets the claim.
As to claim 10, Zheng teaches the section of tissue remains attached to a patient, and the set of electrical properties is measured in vivo (see col. 7, line 65, as well as Figure 1: “Head Top” and as implied in col. 1, line 37-38 as well as col. 6, lines 45-47).
Regarding claim 11, Zheng teaches in Figures 1-8, a method for determining electrical properties of tissue samples, the method comprising:
measuring, by a tissue measurement tool (shown in Figure 1; it’s noted that Figure 1 shows a system including configurable analog switches 120 that allow the system to adopt different configurations shown in Figures 2-5. See col. 5, lines 44-46), while operating at a frequency (frequency set by source 110), a set of electrical properties corresponding to a section of tissue (impedances at two locations, see col. 6, lines 1-4), wherein the tissue measurement tool includes:
at least two electrodes (103, 104), and a decoupling device (133) connected to the at least two electrodes (as illustrated in Figure 5); and
computing, by a classification module (134+135+136) based on the set of electrical properties, at least an electrical impedance of the section of tissue (impedance related to the area of the measurement. See col. 6, lines 1-4 and col. 5, lines 61-65).
As to claim 12, Zheng teaches the method of claim 11, further comprising:
extracting, by the classification module, from the set of electrical properties at frequencies above 1 kHz (see col. 6, line 44), one or more features (tissue condition, see col. 8, line 3); and
determining, by the classification module and based the one or more features, that the section of the tissue contains cancerous cells (determining the presence of a malignant glioma, see col. 8, lines 54-55).
As to claim 15, Zheng teaches the system of claim 1, wherein the at least two electrodes are connected in a bipolar configuration (as shown in figure 5, each electrode provides a pole inputted to individual amplifiers so as to provide a bipolar signal to unit 133).
As to claim 17, Zheng shows in Figure 1, the tissue measurement tool further includes an electrode array (101-106) that includes the at least two electrodes.
As to claim 20, Zheng teaches the section of tissue remains attached to a patient, and the set of electrical properties is measured in vivo (see col. 7, line 65, as well as Figure 1: “Head Top” and as implied in col. 1, line 37-38 as well as col. 6, lines 45-47).
Claim(s) 1, 4, 6-7, 11 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the US Patent Application Publication PGPub 2017/0360326 by Davalos et al., (Davalos hereafter).
Regarding claim 1, Davalos teaches in Figures 8 and 14, a system for determining electrical properties of tissue samples, the system comprising:
a tissue measurement tool (600) comprising at least two electrodes (electrode sets 310, see paragraph 0099, line 4-6. The electrodes reside within unit 200, as shown in detail in Figure 8 and 14) that measure, while operating at a frequency (frequency of voltage outputted by unit 700 as directed by waveform generator 680), a set of electrical properties corresponding to a section of tissue (for example, measure high-frequency impedance; see paragraph 0082), and
a decoupling device (630) connected to the at least two electrodes (see paragraph 0112: “the impedance analyzer can contain one or more switches 630, where each switch can be coupled to a single impedance sensor on the electrical conductivity probe 610.”. Inherently, if the switches can couple the sensor to the probe, it can also decouple them); and
a classification module (impedance analyzer 620) that computes, based on the set of electrical properties, at least an electrical impedance of the section of tissue (tissue impedance; see paragraph 0082).
Regarding claim 4, Davalos teaches the decoupling device (630) is capable of decoupling the electrodes from the impedance analyzer (see paragraph 0112; the impedance analyzer can contain one or more switches 630, where each switch can be coupled to a single impedance sensor on the electrical conductivity probe 610.”) Thus, the decoupling device is capable of disconnecting any or all electrodes from the impedance analyzer if needed, and in doing so, reducing all parasitic impedance created/generated in one or more lines 641b, regardless of the lines being exposed to a high frequency signal, including above 20MHz.
** The examiner notes that claim 4 as recited, appears to describe the decoupling device in terms of its intended functionality. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. Since Davalos anticipates all structural elements, and it’s capable of performing the intended functionality as explained above, Davalos anticipates the claim.
As to claim 6, Davalos shows in Figure 8, the system of claim 1, further comprising an electrode array (array of electrodes within 300) that includes the at least two electrodes.
As to claim 7, Davalos shows in Figure 8, teaches the electrodes included in the electrode array are interdigitated (see paragraph 0099, lines 1-5).
Regarding claim 11, Davalos teaches in Figures 8 and 14, a method for determining electrical properties of tissue samples, the method comprising:
measuring, by a tissue measurement tool (60), while operating at a frequency (frequency of voltage outputted by unit 700 as directed by waveform generator 680), a set of electrical properties corresponding to a section of tissue for example, measure high-frequency impedance; see paragraph 0082), wherein the tissue measurement tool includes:
at least two electrodes (electrode sets 310, see paragraph 0099, line 4-6. The electrodes reside within unit 200, as shown in detail in Figure 8 and 14), and
a decoupling device (630; see paragraph 0112: “the impedance analyzer can contain one or more switches 630, where each switch can be coupled to a single impedance sensor on the electrical conductivity probe 610.”. Inherently, if the switches can couple the sensor to the probe, it can also decouple them) connected to the at least two electrodes (as illustrated in Figure 5); and
computing, by a classification module (impedance analyzer 620) based on the set of electrical properties, at least an electrical impedance of the section of tissue (tissue impedance; see paragraph 0082).
As to claim 17, Davalos shows in Figure 8, the system of claim 1, further comprising an electrode array (array of electrodes within 300) that includes the at least two electrodes.
As to claim 18, Davalos shows in Figure 8, teaches the electrodes included in the electrode array are interdigitated (see paragraph 0099, lines 1-5).
Regarding claim 19, Davalos teaches the decoupling device (630) is capable of decoupling the electrodes from the impedance analyzer (see paragraph 0112; the impedance analyzer can contain one or more switches 630, where each switch can be coupled to a single impedance sensor on the electrical conductivity probe 610.”) Thus, the decoupling device is capable of disconnecting any or all electrodes from the impedance analyzer if needed and, in doing so, reducing all parasitic impedance created/generated in one or more lines 641b, regardless of the lines being exposed to a high frequency signal, including above 20MHz.
** The examiner notes that claim 11 as recited, doesn’t describe a “step” in the method (for example, the step of “reducing parasitic impedance using the decoupling device”, it only recites a capability of the decoupling device. As explained above, because Davalos teaches a decoupling device, and the decoupling device is capable of reducing parasitic impedances in one or more lines regardless of the frequency the disconnected lines are exposed to, Davalos anticipates the method.
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.
Claim(s) 3, 5, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng.
As to claims 3 and 16, Zheng substantially teaches all of the recited elements/steps except for explicitly mentioning that an electrical impedance of the decoupling device falls within a linear detection range of the tissue measurement tool.
However, the examiner takes Official Notice to the fact a person having ordinary skill in the art would before the effective filing of the application would have found it obvious to select a decoupling device that has a capability of operation that is linear across a range of values of impedance that the system is intended to be exposed to and/or process. Doing so would ensure the decoupling device output is not clipped and/or outputs a value that isn’t accurate at the high and low ends of the detection range.
Regarding claim 5, Zheng substantially teaches all of the elements disclosed above, including the presence of a wire (112 or 107) that is coupled to the tissue measurement tool. However, Zheng doesn’t explicitly mention the wire being at least 1 meter.
However, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, In re Gardner v. TEC Syst., Inc (see below)
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
It would have been obvious to a person having ordinary skill in the art, before the application was effectively filed, to use a wire that is at least 1 meter long, in order to ensure the source (110) comfortably reaches the analog switches module (120), or to ensure there is enough slack on the wire to allow electrodes (103, 104) to comfortably reach the patient’s head.
Regarding claim 14, Zheng teaches, the method of claim 11, further comprising:
measuring, by the tissue measurement tool while the tissue is absent, an additional set of electrical properties corresponding to the tissue measurement tool; and computing, by the classification module and based on the additional set of electrical properties, an electrical impedance of the tissue measurement tool, wherein the classification module computes the electrical impedance of the section of tissue based on the electrical impedance of the tissue measurement tool (Zheng explains in col. 7, lines 35-64 a process of calibration of the system, where electrical properties such as Zo and Zc are measured and used to compute the impedance of the tool itself; specifically the transmission and receiving impedances).
Although Zheng doesn’t explicitly mention the calibration procedure discussed above is performed while tissue is absent, the examiner takes Official Notice to the fact it would have been obvious to a person having ordinary skill in the art before the application was effectively filed, to calibrate the system using previously measured and stored values of Vtc and Vrc while the system, and specifically the electrodes, are not in contact with the tissue, in order to reduce any influence the tissue itself may have in the calibration process.
Claim(s) 1, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over the US Patent Application Publication PGPub 2021/0174957 by Levedev et al., (Levedev hereafter), in view of Davalos.
Regarding claim 1, Levedev teaches in Figure 11, a system for determining electrical properties of tissue samples, the system comprising:
a tissue measurement tool (100) comprising at least two electrodes (110, 112, 116, 118) that measure, while operating at a frequency (frequency of the signal outputted by generator 108), a set of electrical properties corresponding to a section of tissue (for example, resistivity/intensity of current flow at terminals of the electrodes; see paragraph 0188), and
a classification module (external processing unit not shown in Figure 11; see paragraph 0199) that computes, based on the set of electrical properties, at least an electrical impedance of the section of tissue (tissue impedance; see paragraph 0082 and paragraph 0370).
Levedev substantially teaches all of the recited elements as discussed above, except for explicitly mentioning the presence of a decoupling device connected to the electrodes.
Davalos teaches in Figure 14, the use of a decoupling device (630) that couples/decouples an impedance analyzer from data sensing electrodes (within 200).
It would have been obvious to a person having ordinary skill in the art before the invention was effectively filed, to apply the teaching of decoupling devices as taught by Davalos, in the device of Levedev, in order to provide the system with the ability to quickly disconnect/decouple the electrodes from either unit 114 or 108, in the event the electrodes overheat, thus reducing the likelihood of damage to the tissue under inspection.
As to claims 12, Levedev teaches one or more features (impedance, conductivity of the issue under inspection) may be determined to contain cancerous cells (paragraph 0370).
As to claim 13, Levedev teaches the features include at least one feature at a frequency above 10 Mhz (see paragraph 0133).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- The US Patent US 10,238,447 by Neal II.
- The US Patent Application Publication PGPub 2010/0148798 by Wang et al.
- The US Patent Application Publication PGPub 2013/0211280 by Gregory et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard Isla whose telephone number is (571)272-5056. The examiner can normally be reached Monday-Friday 9a - 5:30p.
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/RICHARD ISLA/ Primary Patent Examiner, Art Unit 2858 June 10, 2026
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