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 .
Election/Restrictions
2. Restriction to one of the following inventions was required under 35 U.S.C. 121:
I. Claims 1-11 and 15-19, drawn to a method and system for establishing a model for sensing ions in a solution, by applying an ion-sensitive field-effective transistor (ISFET) in machine learning for ion detection in a training solution, classified in G16C 20/70 (Machine learning, data mining, or chemometrics) or G06N 20/00 (Machine learning).
II. Claims 12-14 and 20-23, drawn to a method and system for sensing ions in a solution, using an ion-sensitive field-effect transistor (ISFET) to sense an ion type and an ion concentration of a solution to be tested, classified in G01N 27/414 (Ion-sensitive or chemical field-effect transistors, i.e., ISFETS or CHEMFETS).
3. Applicant's election with traverse of Invention II in the reply filed on June 11, 2026 is acknowledged. The traversal is on the ground(s) that the elected and non-elected claims can be examined together without imposing a serious burden on the Examiner, as the differences among the methods for establishing the model and the methods for sensing the solution would not impose a serious burden if the groups are examined together. This is not found persuasive because the inventions have acquired a separate status in the art in view of their different classification, where it is clear that building a model (in the claims of Invention I) would require a different field of search and separate references than a physical process of sensing ions in a solution including driving gate pins on an ISFET (in the claims of Invention II). The inventions have also acquired a separate status in the art due to their recognized divergent subject matter, as Invention I is related to machine learning to establish a model and describes adjusting an environmental parameter and loading environmental parameters and training features into a machine learning model (which is not found in Invention II), whereas Invention II is related to configuring a solution to be tested and using a gate pin driven bias to generate a virtual sensor to verify an already established model (which is not found in Invention I). The separate inventions would necessarily require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) due to their divergent subject matter, and would require separate primary art references and diverging additional references to address. The Examiner respectfully maintains that there would be a serious burden as there are two separate inventions to address individually if all the claims were to be considered.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
4. Claim 20 is objected to because of the following informalities: a) In claim 20 on pg. 5 line 17, please change "a computer, comprising" to:
--a computer, comprising:--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
5. 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)(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.
6. Claim(s) 20-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bradbury et al. (US Pat. Pub. 2024/0345020, hereinafter "Bradbury").
In regards to claim 20, Bradbury teaches a system for sensing ions in a solution, configured to sense a plurality of ion types and an ion concentration of a solution to be tested (Bradbury abstract, paragraph [0023], and paragraph [0025] teach a sensor device system for sensing an analyte (including specific types of ions present bodily fluid or body tissue) and its concentration from a sample comprising a solution (such as calibration solutions, reference solutions, etc.), where the sensing is performed using a field effect transistor), the system comprising:
a sensor (Bradbury abstract teaches a sensor device comprising the field effect transistor), comprising:
a first transmission interface, configured to transmit a feature to be verified (Bradbury Fig. 1 Item 136 and paragraph [0151] teaches at least one wire connected to the sensor device field effect transistor, where the wire acts as a first transmission interface to transmit a measured feature from the sensing electrode of the sensor device); and
an ion-sensitive field-effect transistor (ISFET) (Bradbury paragraph [0038] teaches where the field effect transistor may be an "ion-sensitive field effect transistor" (ISFET) that is sensitive to a particular type of ionic species), electrically connected to the first transmission interface (Bradbury Fig. 1 Item 136 teaches where the first transmission interface wires are electrically connected to the source 116 and drain 118 of the ISFET), the solution to be tested being configured at a gate pin of the ISFET (Bradbury paragraphs [0029] and [0038] teach configuring the solution to be in physical contact with a gate electrode and channel of the ISFET), and the ISFET driving the gate pin based on a bias parameter (Bradbury paragraphs [0037], [0043], and [0055] teach applying (driving) a voltage or electrical potential (bias parameter) via the gate electrode (gate pin) of the ISFET) to obtain the feature to be verified corresponding to the solution to be tested (Bradbury paragraphs [0058] and [0175] teach obtaining an optimization criterion as a feature to be verified (such as sensitivities and/or signal-to-noise ratio for each of the different values of the applied gate potential) corresponding to the solution to be tested (see paragraph [0168]); and
a computer (Bradbury paragraphs [0044], [0070], and [0080] teach a computer), comprising
a storage unit, configured to store an ion detection model (Bradbury paragraph [0044] teaches a memory storage for storing information determined by a processing unit of the computer, and paragraph [0064] teaches an ion detection model that is trained, suggesting storage of the model in the storage unit that stores information (including trained data) processed by the processing unit of the computer);
a second transmission interface, connected to the first transmission interface through signals and configured to transmit the feature to be verified (Bradbury Fig. 1 Item 136 teaches at least one wire 136 coming out of the control device 146 as a second transmission interface connected to the same wire as the first transmission interface to propagate signals to the first transmission interface, and paragraph [0043] teaches where the output from the control device 146 is an analog output for applying at least one potential to transmit the feature to be verified); and
a processing unit, electrically connected to the storage unit (Bradbury paragraph [0044] teaches where a processing unit is electrically connected to the storage unit) and the second transmission interface (Bradbury Fig. 1 Item 136 and 160 teaches where the processing unit is electrically connected to the second transmission interface wires coming out of the control device), the processing unit loading the feature to be verified into the ion detection model to obtain the ion types and the ion concentration of the solution to be tested (Bradbury paragraph [0064]-[0066] and [0070] teach a computer (processor)-implemented step ii which further comprises performing a calibration that loads the feature to be verified into an ion detection model for relating a measured signal value to a specific concentration of the analyte (ion); Bradbury paragraphs [0050] and [0053] teach loading the optimization criterion (feature to be verified) to obtain the set of selected operation parameters for applying to the field effect transistor for carrying out a step iii of carrying out an actual detection of the ion type and ion concentration of the solution to be tested).
In regards to claim 21, Bradbury teaches the system for sensing ions in a solution wherein the ISFET is any one of a dual gate ISFET, a fin FET, a nanowire FET, or a silicon-on-insulator FET (Bradbury Fig. 1 teaches where the ISFET can be a dual gate ISFET having two gates 120 and 134, or Bradbury paragraph [0038] teaches a silicon-on-insulator type FET where a silicon layer may form part of a gate electrode of the ISFET resting over an insulating dielectric) .
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bradbury et al. (US Pat. Pub. 2024/0345020, hereinafter "Bradbury") as modified by van Rooyen (US Pat. Pub. 2016/0265047, hereinafter "Rooyen").
In regards to claim 12, Bradbury teaches a method for sensing ions in a solution, using an ion-sensitive field-effect transistor (ISFET) to sense an ion type and an ion concentration of a solution to be tested (Bradbury abstract, paragraph [0023], and paragraph [0025] teach a method of sensing an analyte (including a specific type of ion present bodily fluid or body tissue) and its concentration from a sample comprising a solution (such as calibration solutions, reference solutions, etc.), where the sensing is performed using a field effect transistor; Bradbury paragraph [0038] teaches where the field effect transistor may be an "ion-sensitive field effect transistor" (ISFET) that is sensitive to a particular type of ionic species), the method comprising:
configuring the solution to be tested at the ISFET (Bradbury paragraphs [0029] and [0038] teach configuring the solution to be in physical contact with a gate electrode and channel of the ISFET);
driving, by the ISFET, a gate pin of the ISFET based on a bias parameter to generate a virtual sensor (Bradbury paragraphs [0037], [0043], and [0055] teach applying (driving) a voltage or electrical potential (bias parameter) via the gate electrode (gate pin) of the ISFET, and Bradbury paragraph [0175] teaches selecting different values for the gate potential as part of an optimization algorithm to generate a virtual sensor in a factory calibration setting for determining an optimized gate potential);
obtaining, by the virtual sensor, a feature to be verified corresponding to the solution to be tested (Bradbury paragraphs [0058] and [0175] teach obtaining, by the virtual sensor (as generated by the optimization algorithm selecting different values for the gate potential), an optimization criterion as a feature to be verified (such as sensitivities and/or signal-to-noise ratio for each of the different values of the gate potential) corresponding to the solution to be tested (see paragraph [0168]); and
receiving, by a computer, the feature to be verified (Bradbury paragraphs [0048] and [0051] teach a step ii of receiving the optimization criterion such as the signal-to-noise ratio as a feature to be verified in order to select a set of operation parameters to use, and paragraphs [0070], [0080], and [0166] teach a computer carrying out step ii which includes receiving the optimization parameter), and loading the feature to be verified into an ion detection model to obtain the ion type and the ion concentration of the solution to be tested (Bradbury paragraph [0064]-[0066] teaches where step ii further comprises performing a calibration that loads the feature to be verified into an ion detection model for relating a measured signal value to a specific concentration of the analyte (ion); Bradbury paragraphs [0050] and [0053] teach loading the optimization criterion (feature to be verified) to obtain the set of selected operation parameters for applying to the field effect transistor for carrying out a step iii of carrying out an actual detection of the ion type and ion concentration of the solution to be tested).
Bradbury fails to expressly teach a back gate pin of the ISFET.
Rooyen paragraph [0014] teaches that when a MOSFET is used in solution as a biosensor, it is referred to as an ISFET. Rooyen paragraph [0039] teaches where a gate voltage may be applied to the chemically sensitive field effect transistor through a top (or front) and/or back of the device, and hence a suitably configured device may be adapted as a front and/or back-gated device that may be further configured as a solution gate for measuring ion concentrations in a solution.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Rooyen to specify a back gate pin of the ISFET because it is well known to apply gate voltages to either the front or back of the ISFET gate device. Therefore, it would only be a matter of ordinary skill to specify applying a gate voltage to a back gate pin of the ISFET as one of the established configurations for measuring ion concentrations in a solution.
In regards to claim 13, Bradbury teaches the method for sensing ions in a solution as explained according to claim 12 above. Bradbury fails to expressly teach wherein the step of configuring the solution to be tested at the ISFET comprises: configuring the solution to be tested at a front gate pin of the ISFET.
Rooyen paragraph [0014] teaches that when a MOSFET is used in solution as a biosensor, it is referred to as an ISFET. Rooyen paragraph [0039] teaches where a gate voltage may be applied to the chemically sensitive field effect transistor through a top (or front) and/or back of the device, and hence a suitably configured device may be adapted as a front and/or back-gated device that may be further configured as a solution gate for measuring ion concentrations in a solution.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Rooyen to specify a front gate pin of the ISFET because it is well known to apply gate voltages to either the front or back of the ISFET gate device. Therefore, it would only be a matter of ordinary skill to specify applying a gate voltage to a front gate pin of the ISFET as one of the established configurations for measuring ion concentrations in a solution.
In regards to claim 14, Bradbury teaches the method for sensing ions in a solution wherein the feature to be verified comprises a drain current versus gate voltage transfer curve (ID−VFG), a source current, a source current two-dimensional feature, or a combination thereof of the ISFET (Bradbury paragraph [0175] teaches where the feature to be verified (sensitivity and signal-to-noise ratio) is based on at least a drain current versus gate voltage transfer curve (see also paragraph [0063]) or an optimized drain-source current).
Bradbury fails to expressly teach a front gate voltage.
Rooyen paragraph [0014] teaches that when a MOSFET is used in solution as a biosensor, it is referred to as an ISFET. Rooyen paragraph [0039] teaches where a gate voltage may be applied to the chemically sensitive field effect transistor through a top (or front) and/or back of the device, and hence a suitably configured device may be adapted as a front and/or back-gated device that may be further configured as a solution gate for measuring ion concentrations in a solution.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Rooyen to specify a front gate pin of the ISFET because it is well known to apply gate voltages to either the front or back of the ISFET gate device. Therefore, it would only be a matter of ordinary skill to specify applying a gate voltage to a front gate pin of the ISFET as one of the established configurations for measuring ion concentrations in solution, in order to obtain a front gate voltage as part of the transfer curve.
9. Claim(s) 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bradbury et al. (US Pat. Pub. 2024/0345020, hereinafter "Bradbury") as applied to claim 20 above, and further in view of van Rooyen (US Pat. Pub. 2016/0265047, hereinafter "Rooyen").
In regards to claim 22, Bradbury teaches the system for sensing ions in a solution as explained according to claim 20 above. Bradbury fails to expressly teach wherein the solution to be tested is configured at a front gate pin of the ISFET.
Rooyen paragraph [0014] teaches that when a MOSFET is used in solution as a biosensor, it is referred to as an ISFET. Rooyen paragraph [0039] teaches where a gate voltage may be applied to the chemically sensitive field effect transistor through a top (or front) and/or back of the device, and hence a suitably configured device may be adapted as a front and/or back-gated device that may be further configured as a solution gate for measuring ion concentrations in a solution.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Rooyen to specify a front gate pin of the ISFET because it is well known to apply gate voltages to either the front or back of the ISFET gate device. Therefore, it would only be a matter of ordinary skill to specify applying a gate voltage to a front gate pin of the ISFET as one of the established configurations for measuring ion concentrations in a solution.
In regards to claim 23, Bradbury teaches the system for sensing ions in a solution, wherein the feature to be verified comprises a drain current versus gate voltage transfer curve (ID−VFG), a source current, a source current two-dimensional feature, or a combination thereof of the ISFET (Bradbury paragraph [0175] teaches where the feature to be verified (sensitivity and signal-to-noise ratio) is based on at least a drain current versus gate voltage transfer curve (see also paragraph [0063]) or an optimized drain-source current).
Bradbury fails to expressly teach a front gate voltage.
Rooyen paragraph [0014] teaches that when a MOSFET is used in solution as a biosensor, it is referred to as an ISFET. Rooyen paragraph [0039] teaches where a gate voltage may be applied to the chemically sensitive field effect transistor through a top (or front) and/or back of the device, and hence a suitably configured device may be adapted as a front and/or back-gated device that may be further configured as a solution gate for measuring ion concentrations in a solution.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further combine the teachings of Rooyen to specify a front gate pin of the ISFET because it is well known to apply gate voltages to either the front or back of the ISFET gate device. Therefore, it would only be a matter of ordinary skill to specify applying a gate voltage to a front gate pin of the ISFET as one of the established configurations for measuring ion concentrations in a solution, in order to obtain a front gate voltage as part of the transfer curve.
Pertinent Art
10. Applicants are directed to consider additional pertinent prior art included on the Notice of References Cited (PTOL 892) attached herewith. The Examiner has pointed out particular references contained in the prior art of record within the body of this action for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply. Applicant, in preparing the response, should consider fully the entire reference as potentially teaching all or part of the claimed invention, as well as the context of the of the passage as taught by the prior art or disclosed by the Examiner. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
C. Nemirovsky et al. (US Pat. Pub. 2013/0056353) discloses Ion Sensitive Detector.
D. Kawahara et al. (US Pat. Pub. 2016/0245777) discloses Biomolecule Measuring Device.
E. Imai (US Pat. Pub. 2017/0269024) discloses Semiconductor Device.
F. Chiang et al. (US Pat. Pub. 2020/0173958) discloses High Sensitivity ISFET Sensor.
G. Remes et al. (US Pat. Pub. 2023/0369036) discloses Systems and Methods of Ion Population Regulation In Mass Spectrometry.
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL D LEE whose telephone number is (571)270-1598. The examiner can normally be reached on M to F, 9:30 am to 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arleen Vazquez can be reached at 571-272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL D LEE/Primary Examiner, Art Unit 2857 7/24/2026
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