DETAILED ACTION
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 .
Response to Amendment
The amendment filed November 24th, 2025 has been entered. Claims 1-6, 8-12, 21-22, 24-25 and 27 remain pending in the application. Claims 13-20 have been cancelled. Applicant’s amendments to the claims have overcome the rejections previously set forth in the Non-Final Office Action mailed July 24th, 2025.
Response to Arguments
Applicant’s arguments with respect to claims 1-6, 8-12, 21-22, 24-25 and 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8-12, 21-22, 24-25, and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “a circuit coupled to the electrode to derive a response current having a magnitude corresponding to an amount of the biochemical present within the sweat, wherein the circuit is configured to derive the response current using a range of voltages applied to the biological surface, the range of voltages defining an electrochemical response of the biochemical”, however the specification does not describe these functions being performed by a circuit. The specification discloses in Paragraph [0089] “system processor 410 generates the biochemical concentration” and “the system processor obtains, generates, or the like, a predetermined relationship between response current and a concentration associated with a particular biochemical”. Therefore the examiner does not believe there is support for reciting a circuit that performs these functions and suggests changing the claim language to recite a processor.
Claims 2-6, 8-12, 21-22, 24-25 and 27 are rejected by virtue of dependency on claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-5, 8, 10-11, 21 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over as being anticipated by Peyser et al. (U.S. PGPub. No. 2007/0027383) herein referred to as “Peyser” in view of Gao et al. (U.S. PGPub. No. 2020/0359942) herein referred to as “Gao”.
Regarding claim 1, Peyser discloses a device (measurement device, Paragraph [0104]) comprising:
an electrode electrically responsive to presence of a biochemical present within sweat (once sweat sample enters the detection chamber from the collection region, a signal may be measured from the electrodes (electrodes 651, Paragraph [0113]), Paragraph [0111], Figure 6);
and one or more biofouling and interferent mitigation layers disposed on the electrode to block transmission of biofouling agents in the sweat to the electrode and the reaction of interferents in the sweat on the electrode (covering the electrode with size- and, or charge-selective membranes can allow passage of hydrogen peroxide, for example, while excluding ascorbate, urate, and other material which can react directly with the sensor to produce a spurious signal, suitable size-selective membranes, for example, include those made of charge-selective membranes such as Nafion, Paragraph [0089]),
wherein the electrode is configured to noninvasively obtain the sweat from a biological surface (the microfluidic collection layer is combined with a sweat-inducing layer , or one or more mechanisms for inducing sweat (non-invasively), Paragraph [0067], non-invasively by collecting sweat from the skin surface using a microfluidic collection device, Paragraph [0116] and Paragraph [0129]).
However Peyser does not explicitly disclose a circuit coupled to the electrode to derive a response current having a magnitude corresponding to an amount of the biochemical present within the sweat, wherein the circuit is configured to derive the response current using a range of voltages applied to the biological surface, the range of voltages defining an electrochemical response of the biochemical.
Gao discloses a lab-on-skin biosensor for detecting target molecule and vital sign monitoring (Abstract, microfluidic sweat sampling, Paragraph [0050]) wherein the biosensor comprises a circuit coupled to the electrode to derive a response current having a magnitude corresponding to an amount of the biochemical present within the sweat (microfluidic sweat sampling, Paragraph [0050], electrode 130 may be coupled to microfluidics layer 110 and may be configured to detect a measurement of an electrical property, the measurement may be recorded and sent to the logic circuit for processing, Paragraph [0058], detect a target molecule through differential pulse voltammetry (DPV) based on the amplitude of the oxidation current peak of the target molecule, Paragraph [0060], generating a concentration curve, see curves 1502, 1504, 1506, in Figure 15), wherein the circuit is configured to derive the response current using a range of voltages applied to the biological surface (detect a target molecule through differential pulse voltammetry (DPV) based on the amplitude of the oxidation current peak of the target molecule, Paragraph [0060]), the range of voltages defining an electrochemical response of the biochemical (DPV peak amplitudes of various target molecules may be used, Paragraph [0060], Figures 3, 4, 15 and 16).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser to incorporate
the teachings of Gao by including a circuit coupled to the electrode to derive a response current having a magnitude corresponding to an amount of the biochemical present within the sweat, wherein the circuit is configured to derive the response current using a range of voltages applied to the biological surface, the range of voltages defining an electrochemical response of the biochemical. The motivation to do so being to detect and measure the concentration of a target molecule (Gao, Paragraph [0065]).
Regarding claim 3, Peyser in view of Gao discloses the device of claim 1.
Peyser further discloses wherein the biofouling and interferent mitigation layers comprise an adsorption layer (covering the electrode with size- and, or charge-selective membranes can allow passage of hydrogen peroxide, for example, while excluding ascorbate, urate, and other material which can react directly with the sensor to produce a spurious signal, suitable size-selective membranes, for example, include those made of charge-selective membranes such as Nafion (seen as an adsorption layer), Paragraph [0089]).
Regarding claim 4, Peyser in view of Gao discloses the device of claim 1.
Peyser further discloses wherein the biofouling and interferent mitigation layers are negatively charged (covering the electrode with size- and, or charge-selective membranes can allow passage of hydrogen peroxide, for example, while excluding ascorbate, urate, and other material which can react directly with the sensor to produce a spurious signal, suitable size-selective membranes, for example, include those made of charge-selective membranes such as Nafion (Nafion is negatively charged), Paragraph [0089]).
Regarding claim 5, Peyser in view of Gao discloses the device of claim 1.
Peyser further discloses wherein the biofouling and interferent mitigation layers comprise Nafion (covering the electrode with size- and, or charge-selective membranes can allow passage of hydrogen peroxide, for example, while excluding ascorbate, urate, and other material which can react directly with the sensor to produce a spurious signal, suitable size-selective membranes, for example, include those made of charge-selective membranes such as Nafion (Nafion is negatively charged), Paragraph [0089]).
Regarding claim 8, Peyser in view of Gao discloses the device of claim 1.
Peyser further discloses wherein the biological surface comprises at least one of animal skin and human skin (a sweat sample is taken from human skin, Paragraph [0106]).
Regarding claim 10, Peyser in view of Gao discloses the device of claim 1.
Peyser further discloses wherein the device further comprises: a microfluidic layer disposed on the biofouling and interferent mitigation layers and including at least one microfluidic channel (sweat sample is collected into the microfluidic collection layer of the patch 614, the collection layer comprises a microfluidic channel which may be a serpentine channel, Paragraph [0106]).
Regarding claim 11, Peyser in view of Gao discloses the device of claim 10.
Peyser further discloses wherein the microfluidic channel includes at least one outlet at a first face of microfluidic layer proximate to the electrode (outlet 618 at a first face of the microfluidic layer 614, proximate to electrodes 651, Figure 6, Paragraph [0107]), and at least one inlet at a second face of the microfluidic layer opposite to the first face (inlet (near 630) is at the opposite side of the first face the microfluidic layer 614, Figure 6).
Regarding claim 21, Peyser in view of Gao discloses the device of claim 1.
Peyser further discloses wherein the biofouling agents comprise at least one of uric acid, tyrosine, tryptophan, ascorbic acid, histidine, and methionine, a protein, a peptide, a lipid, and an amino acid (sensitivity to these electrochemical detectors may be increased by the use of selective membranes to screen interfering substances such as ascorbic acid, uric acid, acetaminophen etc. Paragraph [0088]).
Regarding claim 24, Peyser discloses the device of claim 1.
However Peyser does not explicitly disclose wherein the circuit is operable to sweep voltage including the range of voltages across the electrode to derive the response current.
Gao discloses wherein the circuit is operable to sweep voltage including the range of voltages across the electrode to derive the response current (more than one measurement of an electrical property may be obtained by sweeping electrode 130 such that the multimodal sensing layer 120 may be regenerated during a reading, in some embodiments sweeping electrode 130 allows for continuous detection of a measurement of an electrical property, sweeping electrode 130 may allow for continuous detection of more than one measurement of an electrical property, sweeping electrode 130 may include rapid voltametric and/or amperometric sweeping, Paragraph [0100]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser to incorporate
the teachings of Gao by including wherein the circuit is operable to sweep voltage across the electrode to derive the response current. The motivation to do so being to allow for continuous measurement of an electrical property (Gao, Paragraph [0100]).
Regarding claim 25, Peyser discloses the device of claim 24.
However Peyser does not explicitly disclose wherein the circuit is operable to use pulse voltammetry to derive the response current.
Gao further discloses wherein the circuit of the sensor is operable to use pulse voltammetry to derive the response current (electrode 130 is a chemical sensor that may detect a target molecule through differential pulse voltammetry (DPV) based on the amplitude of the oxidation current peak of the target molecule, Paragraph [0060], example for uric acid using differential pulse voltammetry, Paragraph [0066]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser to incorporate
the teachings of Gao by including wherein the circuit of the sensor is operable to use pulse voltammetry to derive the response current. The motivation to do so being to detect a target molecule based on an amplitude of the oxidation current peak (Gao, Paragraph [0060]).
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Peyser in view of Gao further in view of Arumugam et al. (U.S. PGPub. No. 2015/0250421) herein referred to as “Arumugam”.
Regarding claim 2, Peyser in view of Gao discloses the device of claim 1.
However Peyser in view of Gao does not explicitly disclose wherein the electrode comprises a boron-doped diamond electrode.
Arumugam discloses conductive-diamond micro-electrode sensors and sensor arrays for in vivo chemical sensing (abstract). Arumugam further discloses wherein the electrode comprises a boron-doped diamond electrode (carbon nanotubes have been used on the electrode surface, among the carbon nanomaterials, conductive boron-doped diamond (BDD), in particular, offers excellent chemical, electrochemical, and bio stability, Paragraph [0016]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser in view of Gao to incorporate the teachings of Arumugam by including a boron-doped diamond electrode. The motivation to do so being to provide a conductive electrode that also offers excellent chemical, electrochemical, and biostability as well as chemical inertness, dimensional stability, and excellent biocompatibility (Arumugam, Paragraph [0016]).
Regarding claim 6, Peyser in view of Gao discloses the device of claim 1.
However Peyser in view of Gao does not explicitly disclose wherein the electrode comprises at least one of boron-doped diamond, oxygen-terminated boron-doped diamond, and hydrogen-terminated boron-doped diamond.
Arumugam discloses conductive-diamond micro-electrode sensors and sensor arrays for in vivo chemical sensing (abstract). Arumugam further discloses wherein the electrode comprises a boron-doped diamond electrode (carbon nanotubes have been used on the electrode surface, among the carbon nanomaterials, conductive boron-doped diamond (BDD), in particular, offers excellent chemical, electrochemical, and bio stability, Paragraph [0016]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser in view of Gao to incorporate the teachings of Arumugam by including a boron-doped diamond electrode. The motivation to do so being to provide a conductive electrode that also offers excellent chemical, electrochemical, and biostability as well as chemical inertness, dimensional stability, and excellent biocompatibility (Arumugam, Paragraph [0016]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Peyser in view of Gao further in view of Connor et al. (U.S. PGPub. No. 2017/0027511) herein referred to as “Connor”.
Regarding claim 9, Peyser in view of Gao discloses the device of claim 1.
Peyser discloses wherein the measurement device may be worn over the patch in a bracelet or watch-type configuration (Paragraph [0104]), however, Peyser in view of Gao does not explicitly disclose wherein the device comprises a smartwatch.
Connor discloses a wearable device with a plurality of close-fitting biometric sensors for measuring different parameters of a person including hydration levels, oxygen levels, glucose levels, or heart rate (Abstract). Connor further discloses wherein the device comprises a smartwatch (in an example this device can function as a smart watch, including biometric sensors 4903 and 4905, Figure 49, Paragraph [0331]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser in view of Gao to incorporate the teachings of Connor by including wherein the watch is a smartwatch as the measurement device. The motivation to do so being to utilize a wearable device that keeps the biometric sensors in close, uniform contact with body tissue for consistent operation (Connor, Paragraph [0034]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Peyser in view of Gao further in view of Rogers et al. (U.S. Pat. No. 10,925,523) herein referred to as “Rogers”.
Regarding claim 12, Peyser in view of Gao discloses the device of claim 10.
However, Peyser in view of Gao does not explicitly disclose wherein the microfluidic layer is flexible.
Rogers discloses wherein the microfluidic layer is flexible (the microfluidic system may comprise: a plurality of reservoir networks at least partially embedded in or supported by a flexible substrate (i.e., the microfluidic layer is flexible), Col. 2, lines 38-40).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser in view of Gao to incorporate the teachings of Rogers by including a microfluidic layer comprising at least one flexible layer. The motivation to do so being to mechanically match the substrate to the tissue for establishing conformal contact with the skin of the patient (Rogers, Col. 29, lines 51-56).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Peyser in view of Gao further in view of Leach et al. (U.S. PGPub. No. 2009/0124964) herein referred to as “Leach”.
Regarding claim 22, Peyser in view of Gao discloses the device of claim 1.
However Peyser in view of Gao does not explicitly disclose wherein the biochemical comprises acetaminophen.
Leach discloses a device for continuous analyte measurement (Abstract) wherein the biochemical comprises acetaminophen (detecting of interfering species such as acetaminophen, may be used to determine the stability of the sensor, Paragraph [0150]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser in view of Gao to incorporate the teachings of Leach by including wherein the biochemical comprises acetaminophen. The motivation to do so being to determine the stability of the sensor (Leach, Paragraphs [0150] and [0155]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Peyser in view of Gao further in view of Baig et al. (U.S. PGPub. No. 20160235347) herein referred to as “Baig”.
Regarding claim 27, Peyser in view of Gao discloses the device of claim 1.
However Peyser does not explicitly disclose wherein the processor is further configured to use the range of voltages to reduce distortion caused by interferents in the sweat.
Baig discloses an artificial sensor for detecting analytes (Paragraph [0005]) wherein the processor is further configured to use the characteristic voltage window to reduce distortion caused by interferents in the sweat (a certain potential for example a -1V or a +1V potential (seen as a range of voltages), may be applied to the CLE allowing it to attract interferent species, converting interference species, and repelling interference species, Paragraph [0265], wherein the constant voltage is used for sensing and equilibration, Paragraph [0275]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Peyser in view of Gao to incorporate the teachings of Baig by including wherein the processor is further configured to use the range of voltages to reduce distortion caused by interferents in the sweat. The motivation to do so being to eliminate interference species during sensing (Baig, Paragraph [0284] and claim 7).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794