DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Emaminejad, et al. application filed with the Office on 3 July 2024.
Claims 1-18 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 the US National Stage Application of an International Patent Application, PCT/US2023/010142, filed on 4 January 2023, which claims priority to a US Provisional Patent Application, 63/296,447, filed on 4 January 2023. Thus, the instant application has an effective filing date of 4 January 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 3 July 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
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 2, 3, 15, 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a US Patent Application Publication assigned to The Trustees of Columbia University in the City of New York, et al. (US 2021/0223240 A1; hereinafter, “Columbia”).
As per claim 2, Columbia discloses a device comprising:
a flexible or stiff field-effect transistor (FET) biosensor array (sensor for detecting target molecule in sample using a field-effect transistor; claim 1) including:
a cortisol aptamer or an aptamer for another biomarker coupled to a thin-film ln2O3 FET (the direct-binding phenylalanine aptamers can be integrated with thin-film metal-oxide field-effect transistors (FETs). Wherein thin-film ln2O3 FETs were covalently modified with dopamine or serotonin aptamers via silane chemistry; FIG. 10; paragraphs [0138], [0195]).
As per claim 3, Columbia discloses the device of claim 2. Columbia further discloses wherein cortisol levels or other biomarker levels (FET can measure glucose levels (biomarker level); paragraph [0082]) are determined via molecular recognition by the aptamer wherein binding is transduced to electrical signals on the FET (FET can detect a target molecule or analyte through signal transduction and amplification. Wherein the signal transduction and amplification can be based on electrostatic gating of semiconductor channels by target-receptor complexes to produce changes in semiconductor transconductance; paragraph [0062]).
As per claim 15, Columbia discloses a method of operating a biosensor comprising: preparing an aptamer-FET sensing interface (sensor includes an aptamer, where aptamer is FET; paragraph [0009]; claims 1 and 2);
translating target binding events into measurable surface charge perturbations (Over 30 min, the baseline current in 1 x aCSF, "artificial cerebrospinal fluid", minimally fluctuated, indicative of minimal perturbation of transistor signals by solution ions. Wherein aptamers include target molecules that can selectively bind to capture regions, and respond by an increase in fluorescence or by changes in FET response, or by other spectroscopic signal changes; abstract; FIG. 21; paragraphs [0092], [0162]); and
measuring the perturbations as changes in effective VGS and subsequently IDS (Source-drain current (IDs) transfer curves were obtained by sweeping the gate-bias voltage (VGs); FIG. 21; paragraphs [0160] and [0162]).
As per claim 16, Columbia discloses the method of claim 15. Columbia further discloses wherein the target binding events include exposure to human sweat or other retrievable biofluids (FETs can detect target analyte in sample, where sample can be blood or urine ( other retrievable biofluids ); paragraph [0075]).
As per claim 18, Columbia discloses the method of claim 15. Columbia further discloses wherein the target binding events (FET comprises responses to recognition events from target-receptor interactions (target binding events); paragraph [0188]) include exposure to cortisol or other biomarkers (paragraph [0082]).
Claim Rejections - 35 USC § 103
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Columbia in view of a published International Patent Application assigned to the Purdue Research Foundation Limited, et al. (WO 2020/069318 A1; hereinafter, “Purdue”).
As per claim 1, Columbia discloses a method of aptamer-FET sensing (a field-effector transistor and an oligonucleotide attached to the field-effect transistor; claim 1) comprising:
preparing a stem-loop aptamer (oligonucleotide is an aptamer, wherein aptamer is a stem-loop aptamer; claims 2 and 4) that contains oligonucleotide sequences with consecutive bases (aptamer includes sequences with consecutive bases; FIG. 2A; claim 17); and
configuring the stem-loop aptamer (a stem-loop aptamer; claim 4) to bind to a substance (aptamers can be identified to bind to target analytes including steroids, disclosed in a long list, (a substance); paragraph [0068]; claim 18) with a dissociation constant between about 1 x 10-8 M to about 1 x 10-4 M, wherein the stem-loop aptamer has at least four times higher binding affinity for a substance compared to other molecules present (consecutive bases identical at least 80% to CGTGTG or 80% to GTGTCC and the stem-loop aptamer binds to glucose with a dissociation constant between about l x l0-5 M to about 50 x 10-3 M, wherein the stem-loop aptamer has at least five-times higher (at least four times higher) binding affinity to glucose compared to non-glucose molecules (other molecules present); claim 18).
Columbia does not disclose wherein the substance is cortisol and wherein it is compared to other steroid molecules present in retrievable biofluids.
Purdue discloses an aptamer that binds to cortisol (cortisol binding aptamer; title; abstract), and wherein cortisol is present in retrievable biofluids (sample is analyzed for cortisol, wherein sample is a biological sample of bodily fluid (retrievable biofluids); page 2, lines 1-5; page 6, lines 17-24).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Columbia invention to provide wherein the substance is cortisol and wherein it is compared to other steroid molecules present in retrievable biofluids, as taught by Purdue, in order to provide a method for recognition of increased cortisol levels, wherein cortisol is known to be associated with stress (Purdue reference, page 1, lines 16-17).s
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Columbia in view of published paper by Pillai, et al. (“Advances in Medical Wearable Biosensors: Design, Fabrication and Materials Strategies in Healthcare Monitoring”, Molecules, 27(1): p. 165, Dec 2021; hereinafter, “Pillai”).
As per claim 4, Columbia discloses the FET biosensor array of claim 2.
Columbia does not disclose a smartwatch or other wearable device based on the FET biosensor array of claim 2.
Pillai discloses a wearable device based on a FET biosensor array (wearable biosensor that include field-effect-transistors; page 17, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Columbia invention to provide a wearable device based on a FET biosensor array, as taught by Pillai, in order to provide personal healthcare monitoring (Pillai reference; abstract).
As per claim 5, Columbia and Pillai, in combination, disclose the smartwatch or other wearable device of claim 4. Columbia further discloses including a custom, multichannel, self-referencing, autonomous source measurement unit or other measurement unit (A sensor that includes an aptamer. Wherein the aptamer can selectively detect the target molecule and allow a direct measurement (other measurement unit) of the target molecule without dilution of the sample and without additional labeling reagents; paragraph [0014]; claims 1 and 2) enabling seamless, real-time, continuous cortisol or other biomarker measurements (Wherein the aptamer can selectively detect the target molecule and allow a direct measurement of the target molecule ( other biomarker measurements) without dilution of the sample and without additional labeling reagents; paragraph [0014]: claims 1 and 2) in biofluids including sweat, saliva, interstitial fluid, tears, urine, or blood (FETs can detect target analyte in sample, where sample can be blood or urine; paragraph [0075]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over a published International Patent Application assigned to 3M Innovation Properties Company, et al. (WO 2021/124165 A1; hereinafter, “3M”) in view of a published paper by Sheibani, et al. (“Extended gate field-effect-transistor for sensing cortisol stress hormone” Communications materials, 2(1): p. 10, Jan 2021; hereinafter, “Sheibani”).
As per claim 6, 3M discloses a device for wearable sensing applications (medical wearables including sweat sensors: page 6, lines 20-22), comprising:
a substrate embedded in a microfluidic device to form a skin-adherable biofluid sampling, routing, and analysis module (directing sweat through a continuous microfluidic channel in a device adhered or mechanically attached to the skin. Wherein sweat sensor is capable of analysis; page 6, lines 23-25; page 7, lines 6-8).
3M does not teach a cortisol-aptamer-FET sensor.
Sheibani discloses a cortisol-aptamer-FET sensor (field-effect-transistor for sensing cortisol stress hormone; title; abstract; Fig. 1 ).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the 3M invention to provide a cortisol-aptamer-FET sensor, as taught by Sheibani, in order to provide a device capable of sensing stress levels in an individual (Sheibani reference, abstract).
As per claim 7, 3M and Sheibani, in combination, disclose the device of claim 6.
3M further discloses wherein the substrate comprises a flexible polyimide substrate or a substrate comprising another flexible material (adhesive layer that includes a film. Wherein film is polymeric film is flexible, and further wherein substrate is a medical wearable; abstract; page 4, lines 11-12; page 6, lines 20-22).
As per claim 8, 3M and Sheibani, in combination, disclose the device of claim 6.
3M does not disclose wherein the sensor comprises an aptamer-FET array.
Sheibani discloses a sensor including an aptamer-FET array (using the array of FETs of fabricated chip sensor; title; page 8, first paragraph; Fig. 4h).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the 3M invention to provide a sensor including an aptamer-FET array, as taught by Sheibani, in order to provide a device that has been previously known to be capable of measuring levels of cortisol related to stress within a subject (Sheibani reference, abstract).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Columbia in view of a published paper by Klinghammer, et al. (“Nanosensor-Based Real-Time Monitoring of Stress Biomarkers in Human Salvia Using a Portable Measurement System” ACS Sensors, 5(12): p. 4081-4091, Dec 2020; hereinafter, “Klinghammer”).
As per claim 17, Columbia discloses the method of claim 15. Columbia discloses target binding events (target molecule can selectively bind to the capture region of the aptamer; abstract).
Columbia does not disclose wherein the target binding events include exposure to human saliva.
Klinghammer discloses exposure to human saliva (Nanosensor-Based Real-Time Monitoring of Stress Biomarkers in Human Saliva Using a Portable Measurement System; title).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Columbia invention to provide wherein the target binding events include exposure to human saliva, as taught by Klinghammer, in order to provide a easily obtainable patient sample.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over 3M in view of Sheibani as applied to claim 6 above, and further in view of a published paper by Analog Devices (“ADI Multichannel Source Measurement Unit (SMU) Solution”, 2021, 6 pages; hereinafter, “Analog”).
As per claim 9, 3M and Sheibani, in combination, disclose the device of claim 6.
3M does not further comprise an on-board multi-channel source measurement unit (SMU).
Analog discloses a multi-channel source measurement unit (SMU) (multichannel source measurement unit; title; page 1, first column, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the 3M invention to provide an on-board multi-channel source measurement unit (SMU), as taught by Analog, in order to provide a unit capable of measuring a signal while outputting a signal (Analog reference, page 1, first column, first paragraph).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over 3M in view of Sheibani as applied to claim 6 above, and further in view of Columbia.
As per claim 10, 3M and Sheibani, in combination, disclose the device of claim 6.
3M does not disclose wherein the sensor comprises quasi-2D FETs employing ln2O3 or another inorganic semiconductor or graphene fabricated on hard or soft substrates.
Columbia discloses a sensor comprising quasi-2D FETs employing ln2O3 (the field-effect transistor can be a quasi-two-dimensional field-effect transistor. Wherein field-effect transistors (FETs) were fabricated with ultrathin ln2O3; paragraphs [0013] and [0152]; claim 6).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the 3M invention to provide wherein the sensor comprises quasi-2D FETs employing ln2O3, as taught by Columbia, in order to provide enabled signal transduction and amplification under biologically relevant conditions (Columbia reference, paragraph [0191]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Columbia in view of 3M and in view of a published paper by Pasahan (“Sensor applications of polyimides”, High Performance Polymers–Polyimides Based–From Chemistry to Applications. InTech: Croatia, Rijeka. 2012 Dec 19:199-214; hereinafter, “Pasahan”).
As per claim 11, Columbia discloses a method of fabricating a device (fabricate FET sensors; paragraph [0154]), comprising: forming a layer of thin-film ln2O3 via spin coating or other methods of deposition (field-effect transistors (FETs) were fabricated with ultrathin (4 nm) ln2O3 semiconductor films; paragraph [0152]);
patterning the ln2O3 layer to form channel regions (To enhance channel surface-to-volume ratios, field-effect transistors (FETs) were fabricated with ultrathin (4 nm) ln2O3 semiconductor films; paragraph [0152]); and
forming source and drain contacts (lnterdigitated source and drain electrodes were patterned on top of ln2O3; paragraph [0152]).
Columbia does not disclose a device for wearable sensing applications and polyimide.
3M discloses a device for wearable sensing applications (medical wearables including sweat sensors; page 6, lines 20-22) and polyimide (film includes polyimide; (within long list); claim 18).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Columbia invention to provide a device for wearable sensing applications, as taught by 3M, in order to provide personalized healthcare monitoring (3M reference page 1, lines 6-9).
Pasahan discloses polyimide sensors (polyimide-modified electrodes are widely used in the field of sensor and biosensor; page 3, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Columbia invention to provide polyimide, as taught by Pasahan, in order to provide electrodes that are widely used within the field of sensors and biosensors (Pasahan reference, page 3, first paragraph).
As per claim 12, Columbia, 3M, and Pasahan, in combination, disclose the method of claim 11. Columbia further discloses wherein patterning is performed by photolithography (patterned by standard photolithography; paragraph [0152]) or other chemical patterning methods and reactive ion etching.
As per claim 13, Columbia, 3M, and Pasahan, in combination, disclose the method of claim 11. Columbia further discloses wherein forming source and drain contacts includes patterning interdigitated Au/Ti or other metal electrodes (Au layer patterned as interdigitated electrodes; paragraph [0237]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Columbia in view of 3M & Pasahan as applied to claim 11 above, and further in view of a published paper by S.Y. Xiao, et al. (“Novel Fabrication Process of MEMS Devices on Polyimide Flexible Substrate”, Microelectronic Engineering, 85(2): p. 452-7, Feb 2008; hereinafter, “Xiao”).
As per claim 14, Columbia, 3M, and Pasahan, in combination, disclose the method of claim 11.
Columbia does not disclose wherein the polyimide comprises a flexible substrate.
Xiao discloses wherein a polyimide comprises a flexible substrate (polyimide flexible substrate; page 2, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Columbia invention to provide a polyimide comprises a flexible substrate, as taught by Xiao, in order to provide a more robust, lighter weight, lower cost, device that offers better flexibility to absorb the stress within the system (Xiao reference, page 1, first paragraph).
Interview with the Examiner
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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:
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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.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795