DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Hodges, et al. application filed with the Office on 7 April 2025.
Claims 1, 2, 4, 5, 7, 10, 11, 13, 14, 16, 17, 19, 20, 24, 26, 28, 30, 31, 34, and 37 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a US National Stage Application arising from an International Patent Application, PCT/AU2023/050717, filed on 1 August 2023, which claim priority to a US Provisional Patent Application, 63/414,975, filed on 11 October 2022. Thus, the effective filing date of the present application is 11 October 2022.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted regarding the present application filed on 7 April 2025, 15 July 2026 and 28 July 2026, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been 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 16 and 17 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.
Instant claim 16 recites, “… the second current value, the third current value and the fourth current value …”, and is drawn dependent from clam 10. There is insufficient antecedent basis for this limitation in the claim.
Instant claim 17 recites, “… the second current value, the third current value and the fourth current value …”, and is drawn dependent from clam 10. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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, 11, 13, 14, 24, 28 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by an International Application published under the Patent Cooperation Treaty to Wang, et al. (WO 2021/119546 A1; hereinafter, “Wang”).
Regarding claim 1, Wang discloses electrochemical sensing, and in particular to methods, systems, materials and devices for label-free, continuous real-time monitoring of biomarkers in a biofluid ([0002]; which reads upon the instantly claimed, “[a] method for determining an amount of an analyte in a fluid”). Wang teaches square-wave voltammetry (SWV) uses a square wave superimposed over a staircase function to provide a sweeping measurement that provides two sampling instances per potential ([0046]; which reads on “applying a first change in potential …”), and aptamer sequences tethered to the Au wire of the electrode probe structure 137 can be tailored to bind to an analyte different from the target analyte which is specific to the aptamer sequences that are tethered to the Au wire of the electrode probe structure 127([0047]; which reads on “… an electrochemical sensor working electrode, the electrode having associated therewith (i) a binding element …”). Wang additionally teaches aptamers functionalized by a redox reporter molecule (e.g. methylene blue or anthraquinone) (which reads on “… (ii) an associated redox-active species spatially constrained within a layer adjacent to the electrode surface”). Wang further teaches: Square-wave voltammetry (SWV) uses a square wave superimposed over a staircase function to provide a sweeping measurement that provides two sampling instances per potential. As a result of this sampling technique, the contribution to the total current that results from non-faradic currents is minimized ([0046]; which reads on “measuring current values resulting from at least the application of the first charge in potential at a plurality of time points”). Wang teaches: Aptamers functionalized by a redox reporter molecule (e.g., methylene blue or anthraquinone) can specifically and reversibly bind to a compound of interest, upon which a folding in the conformation of the electrode-bound aptamer occurs. This binding-induced folding can lead to a change in the electron transfer characteristics of the redox molecule that is corresponding to the concentration of the target compound of interest and is detected using electrochemical detection techniques such as square wave voltammetry (SWV) implemented for aptamer-functionalized electrodes of the sensor device 100 ([0042]; which reads on “determining a distribution of the redox-active species by reference to the measured current values; and determining the amount of an analyte bound to the binding element using the determined distribution of the redox-active species”).
Regarding claims 2 and 28, Wang teaches square-wave voltammetry (SWV) uses a square wave superimposed over a staircase function to provide a sweeping measurement that provides two sampling instances per potential ([0046]; wherein the staircase function is a step-wise change in potential).
Regarding claim 4, Wang teaches selective binding of the target biomarker to the aptamer sequence would bring the redox reporter closer to the surface of the Au wire of the electrode probe structure 127 to facilitate electron transfer between the reporter molecule and the electrode probe structure 127 ([0041]).
Regarding claims 10, 11, 13 and 14, Wang teaches square-wave voltammetry (SWV) uses a square wave superimposed over a staircase function to provide a sweeping measurement that provides two sampling instances per potential. As a result of this sampling technique, the contribution to the total current that results from non-faradic currents is minimized. Like CV, the current is plotted as a function of potential ([0046]).
Regarding claim 24, Wang teaches Square-wave voltammetry (SWV) uses a square wave superimposed over a staircase function to provide a sweeping measurement that provides two sampling instances per potential ([0046]).
Regarding claim 37, Wang teaches aptamer sequences tethered to the Au wire of the electrode probe structure 137 can be tailored to bind to an analyte different from the target analyte which is specific to the aptamer sequences that are tethered to the Au wire of the electrode probe structure 127([0047]; which reads on “… a working electrode having associated therewith (i) a binding element …”). Wang additionally teaches aptamers functionalized by a redox reporter molecule (e.g. methylene blue or anthraquinone) (which reads on “… (ii) an associated redox-active species spatially constrained within a layer adjacent to the electrode surface”). Wang further teaches the electronic device 200 includes a processor 220 configured to process data, a memory 210 in communication with the processor 220 configured to store data, and an input/output (I/O) communication interface (or unit) 230 configured to interface the processor 220 and/or the memory 210 to other elements of the electronic device 200 as well as to various modules, units, or devices, including the device 100 and/or external computing devices, data storage devices, or communication devices, for example ([0060]; which reads on “a microprocessor-based controller”). Wang discloses electrochemical sensing, and in particular to methods, systems, materials and devices for label-free, continuous real-time monitoring of biomarkers in a biofluid ([0002]; which reads upon the instantly claimed, “[a] method for determining an amount of an analyte in a fluid”). Wang teaches square-wave voltammetry (SWV) uses a square wave superimposed over a staircase function to provide a sweeping measurement that provides two sampling instances per potential ([0046]; which reads on “applying a first change in potential …”), and aptamer sequences tethered to the Au wire of the electrode probe structure 137 can be tailored to bind to an analyte different from the target analyte which is specific to the aptamer sequences that are tethered to the Au wire of the electrode probe structure 127([0047]; which reads on “… an electrochemical sensor working electrode, the electrode having associated therewith (i) a binding element …”). Wang additionally teaches aptamers functionalized by a redox reporter molecule (e.g. methylene blue or anthraquinone) (which reads on “… (ii) an associated redox-active species spatially constrained within a layer adjacent to the electrode surface”). Wang further teaches: Square-wave voltammetry (SWV) uses a square wave superimposed over a staircase function to provide a sweeping measurement that provides two sampling instances per potential. As a result of this sampling technique, the contribution to the total current that results from non-faradic currents is minimized ([0046]; which reads on “measuring current values resulting from at least the application of the first charge in potential at a plurality of time points”). Wang teaches: Aptamers functionalized by a redox reporter molecule (e.g., methylene blue or anthraquinone) can specifically and reversibly bind to a compound of interest, upon which a folding in the conformation of the electrode-bound aptamer occurs. This binding-induced folding can lead to a change in the electron transfer characteristics of the redox molecule that is corresponding to the concentration of the target compound of interest and is detected using electrochemical detection techniques such as square wave voltammetry (SWV) implemented for aptamer-functionalized electrodes of the sensor device 100 ([0042]; which reads on “determining a distribution of the redox-active species by reference to the measured current values; and determining the amount of an analyte bound to the binding element using the determined distribution of the redox-active species”).
Allowable Subject Matter
Claims 5, 7, 19, 20, 26, 30, 31 and 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Wang does not anticipate nor render obvious the following limitations: mass transport of the redox-active species through the layer adjacent to the electrode surface (claim 5); applying an initial potential (claim 7); generating at least one current ratio (claims 19 and 20); estimating the capacitive charging current (claim 26); or combining selected currents (claims 30, 31 and 34).
Interview with the Examiner
If at any point during the prosecution it is believe an interview with the Examiner would further the prosecution of an application, please consider this option.
The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
The AIR form can be filled out online, and is automatically forwarded to the Examiner, who will call to confirm a requested time and date, or set up a mutually convenient time for the interview. The form can be found at:
https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3
Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J. Christopher Ball/ Primary Examiner, Art Unit 1795
Prosecution Insights