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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/21, 12/02/21, 12/07/21, 12/13/22 and 01/12/24 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on July 1, 2026, amended claim 1 has been entered.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered and are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Ohno reference), and updated obviousness rationale.
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 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 1-4, 11, 13, 15, 17-19, 21, 23, 25-27 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala (U.S. Patent Application Document 2017/0251958 A1) in further view of Ohno ("Electrolyte-gated graphene field-effect transistors for detecting pH and protein adsorption." Nano letters 9.9 (2009): 3318-3322), Patolsky (U.S. Patent Application Document 2018/0372678 A1) and Lin (U.S. Patent Application Document 2017/0181669 A1).
Pushpala, Patolsky and Lin were applied in the previous office action
Regarding claim 1, Pushpala teaches a modular sensor [fig. 1 and 24, element 116] comprising: a substrate [fig. 10A, element 91; par. 86]; and one or more sensor elements on the surface of the substrate [par. 45], wherein each of the one or more sensor elements comprises a pair of contact electrodes of a plurality of contact electrodes [par. 65] and a nanoscale material layer in contact with electrodes [par. 93], and wherein the sensor element is configured to detect one or more biomarkers in a biological fluid of a subject [par. 49], and wherein the substrate comprising the one or more sensor elements thereon is configured to be operably and releasably coupled to a device for use as a sensing apparatus [fig. 1, element 190; par. 38].
However, Pushpala does not teach the substrate comprises a first portion functionalized with a hydrophilic material positioned to attract polar fluid towards one or more sensor elements and a second portion, positioned near the one or more sensor elements, functionalized with a hydrophobic material, wherein the first portion and the second portion are configured to facilitate localization of the polar fluid on the one or more sensor elements; wherein the nanoscale material layer serves as an electrically conducting channel between the source and drain electrodes, the field effect transistor being absent a gate electrode distinct from the source electrode and the drain electrode, and wherein the polar fluid localized on the nanoscale material layer induces a gating effect of the field effect transistor that, in operation, modulates a conductance of the electrically conducting channel in response to an ionic concentration of the polar fluid
Ohno teaches the substrate comprises a first portion functionalized with a hydrophilic material positioned to attract polar fluid towards one or more sensor elements [fig. 1b, Examiner notes SiO2 is hydrophilic] and a second portion, positioned near the one or more sensor elements, functionalized with a hydrophobic material [fig. 1b, Examiner notes graphene is hydrophobic], wherein the first portion and the second portion are configured to facilitate localization of the polar fluid on the one or more sensor elements [fig. 1b; pg. 3319: col. 1, par. 1-2; Examiner notes the electrolyte solution acts as the polar fluid];
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, to incorporate the substrate comprises a first portion functionalized with a hydrophilic material positioned to attract polar fluid towards one or more sensor elements and a second portion, positioned near the one or more sensor elements, functionalized with a hydrophobic material, wherein the first portion and the second portion are configured to facilitate localization of the polar fluid on the one or more sensor elements, for better transfer characteristics of GFETs in the electrolyte s, as evidence by Ohno [pg. 3320: col. 1, par. 1]
Ohno further teaches wherein the nanoscale material layer serves as an electrically conducting channel between the source and drain electrodes [fig. 1b; pg. 3319: col. 1, par. 1-2], the field effect transistor being absent a gate electrode distinct from the source electrode and the drain electrode [fig. 1b; pg. 3319: col. 1, par. 1-2], and wherein the polar fluid localized on the nanoscale material layer induces a gating effect of the field effect transistor that, in operation, modulates a conductance of the electrically conducting channel in response to an ionic concentration of the polar fluid [pg. 3319: col. 1, par. 1-2, pg. 3320: col. 1, par. 2-col. 2, par. 1]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, to incorporate wherein the nanoscale material layer serves as an electrically conducting channel between the source and drain electrodes, the field effect transistor being absent a gate electrode distinct from the source electrode and the drain electrode, and wherein the polar fluid localized on the nanoscale material layer induces a gating effect of the field effect transistor that, in operation, modulates a conductance of the electrically conducting channel in response to an ionic concentration of the polar fluid, for better transfer characteristics of GFETs in the electrolyte s, as evidence by Ohno [pg. 3320: col. 1, par. 1]
However, Pushpala does not teach a nanoscale material layer extending on or between and in physical contact with the pair of contact electrodes, wherein the nanoscale material layer connects a first contact electrode of the pair of contact electrodes to a second contact electrode of the pair of contact electrodes.
Patolsky teaches a nanoscale material layer extending on or between and in physical contact with the pair of contact electrodes, wherein the nanoscale material layer connects a first contact electrode of the pair of contact electrodes to a second contact electrode of the pair of contact electrodes [fig. 8A, elements, 40, 42, 44; par. 122]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, to incorporate a nanoscale material layer extending on or between and in physical contact with the pair of contact electrodes, wherein the nanoscale material layer connects a first contact electrode of the pair of contact electrodes to a second contact electrode of the pair of contact electrodes, for providing measurement of a biomarker according to the voltage applied to the nanostructure coupled to each set of electrodes, as evidence by Patolsky [par. 122]
However, Pushpala does not teach a plurality of contact electrodes on the substrate; and wherein the sensor element is configured as a field effect transistor comprising a nanoscale material layer, a source electrode and a drain electrode formed by the pair of contact electrodes
Lin teaches a plurality of contact electrodes on the substrate [par. 234]; and wherein the sensor element is configured as a field effect transistor comprising a nanoscale material layer, a source electrode and a drain electrode formed by the pair of contact electrodes [fig. 28A; par. 26, 234; Claim 32]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, to incorporate a plurality of contact electrodes on the substrate; and wherein the sensor element is configured as a field effect transistor comprising a nanoscale material layer, a source electrode and a drain electrode formed by the pair of contact electrodes, for detection of low-charge, low-molecular-weight molecules, as evidence by Lin [par. 26]
Regarding claim 2, Pushpala further teaches the modular sensor is configured to function as an active sensing unit when electronically coupled to the device [fig. 1 and 10C-E; par. 38].
Regarding claim 3, Pushpala further teaches the modular sensor is configured to fit within a recessed housing on the device [fig. 1; par. 38 and 43]
Regarding claim 4, Pushpala further teaches the modular sensor is protected by the recessed housing [par. 38, 43 and 80].
Regarding claim 11 Pushpala further teaches the plurality of sensor elements is configured to detect one or more biomarkers in a biological fluid of a subject [par. 46]
Regarding claim 13, Pushpala further teaches the biological fluid comprises sweat or interstitial fluid obtained via the surface of the skin [par. 47].
Regarding claim 15, Pushpala further teaches each of the plurality of sensor elements is configured to detect a different biomarker [par. 46 and 48].
Regarding claim 17, Pushpala further teaches the one or more biomarkers comprises an electrolyte, glucose, lactic acid, IL6, a cytokine, HER2, Cortisol, ZAG, cholesterol, vitamins, a protein, a drug molecule, a metabolite, a peptide, an amino acid, a DNA, an RNA, an aptamer, an enzyme, a biomolecule, a chemical molecule, a synthetic molecule, or combinations thereof [par. 46].
Regarding claim 18, Pushpala further teaches the one or more biomarkers comprises one or more of an electrolyte, glucose, and lactic acid [par. 46].
Regarding claim 19, Pushpala further teaches the biological fluid sample comprises sweat, breath, saliva, earwax, urine, semen, blood plasma, a bio-fluid, a chemical fluid, an air sample, a gas sample, or a combination thereof [par. 46].
Regarding claim 21, Pushpala further teaches the plurality of sensor elements is configured to detect the one or more biomarkers when in contact with the biological fluid sample [par. 46 and 61].
Regarding claim 23, Pushpala further teaches the plurality of sensor elements is configured to detect a presence and concentration of the one or more biomarkers substantially in real-time when the device is being worn on the subject or in proximity to the subject [par. 46, 61, 105].
Regarding claim 25, Pushpala further teaches the data indicative of the presence and concentrations of the one or more biomarkers is collected on the device over a time period that the device is being worn on the subject or in proximity to the subject [par. 46 and 105-106].
Regarding claim 26, Pushpala further teaches the modular sensor is configured to be operably and releasably coupled to the device without the use of tools [par. 111, Examiner notes the sensor is coupled to the device magnetically].
Regarding claim 27, Pushpala further teaches the modular sensor is configured to be operably and releasably coupled to the device in less than 10 seconds [par. 111, Examiner notes coupling the sensor to the device magnetically would take less than 10 seconds]
Regarding claim 78, Patolsky further teaches the nanoscale material layer electrically connects a pair of contact electrodes [fig. 8A, elements, 40, 42, 44; par. 122]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, to incorporate the nanoscale material layer electrically connects a pair of contact electrodes, for providing measurement of a biomarker according to the voltage applied to the nanostructure coupled to each set of electrodes, as evidence by Patolsky (par. 122)
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala, Ohno, Patolsky and Lin and in further view of Eid (U.S. Patent Application Document 2018/0026393 A1).
Eid was applied in the previous office action
Regarding claim 5, Pushpala, Ohno, Patolsky and Lin teach a modular sensor, as disclosed above, and the device comprises a magnetic material [par. 111].
However, Pushpala, Ohno, Patolsky and Lin do not teach the substrate comprises a ferrous metal or alloy.
Eid teaches the substrate comprises a ferrous metal or alloy [fig. 1, element 108A-C; par. 15 and 23].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, Ohno, Patolsky and Lin, to incorporate the substrate comprises a ferrous metal or alloy, as these metals create magnetic fields, as evidence by Eid (par. 23).
Regarding claim 6, Eid further teaches the modular sensor is configured to be coupled and held in place on the device via an attractive force between the magnetic material and the ferrous metal or alloy [fig. 1, element 108A-C; par. 15 and 23].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, Ohno, Patolsky and Lin, to incorporate the modular sensor is configured to be coupled and held in place on the device via an attractive force between the magnetic material and the ferrous metal or alloy, for connecting the device, as evidence by Eid (par. 15).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Pushpala, Ohno, Patolsky and Lin and in further view of Rogers (U.S. Patent Application Document 2021/0145352 A1).
Rogers was applied in the previous office action
Regarding claim 22, Pushpala, Ohno, Patolsky and Lin teach a modular sensor, as disclosed above.
However, Pushpala, Ohno, Patolsky and Lin do not teach the plurality of sensor elements is capable of detecting the one or more biomarkers in a non-invasive manner, without requiring penetration of the subject's skin to extract the biological fluid sample.
Rogers teaches the plurality of sensor elements is capable of detecting the one or more biomarkers in a non-invasive manner, without requiring penetration of the subject's skin to extract the biological fluid sample [par. 7].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Pushpala, Ohno, Patolsky and Lin, to incorporate the plurality of sensor elements is capable of detecting the one or more biomarkers in a non-invasive manner, without requiring penetration of the subject's skin to extract the biological fluid sample, for minimizing discomfort of the subject, as evidence by Rogers.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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