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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11th June 2026 has been entered.
Response to Amendment
Applicant’s amendments filed 11th June 2026 have been entered. Claims 1-61 are pending, with Claims 1-41 previously withdrawn from further consideration. Newly submitted Claims 49-61 are withdrawn from further consideration by election by original presentation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 42 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.
Claim Objections
Claim 42 is objected to because of the following informalities:
Claim 42, ‘defining i) a plurality of inlets, (i) a reservoir, (iii)…’, should likely read ‘defining (i) a plurality of inlets, (ii) a reservoir, (iii)…’.
Appropriate correction is required.
Election/Restrictions
For reference, see Applicant’s election without traverse of originally filed Claims 1-9 in the reply filed on 7th October 2025.
Newly submitted claims 49-55 (Invention II) are directed to an invention that is independent or distinct from the invention originally claimed (Invention I, Claims 42-48) for the following reasons: Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination (Invention I) as claimed does not require the particulars of the subcombination (Invention II) as claimed because can be practiced with a materially different patch that lacks a wireless transceiver or that uses a different sensing modality, while still performing the system-level functions of signal reception, concentration determination, and output. The subcombination has separate utility and can be used with a materially different system (e.g., a dedicated base station/lab analyzer rather than a mobile computing device that stores calibration data and provides a user interface).
Newly submitted claims 56-61 (Invention III) are directed to an invention that is independent or distinct from the invention originally claimed (Invention I, Claims 42-48) for the following reasons: The apparatus of Invention I can be used to practice materially different processes (e.g., static sweat analysis performed once without continuous discharge and refreshed flow, or calibration routines that do not output concentration via a user interface). The process of Invention III can be practiced by a materially different apparatus (e.g., a system in which concentration determination occurs on a remote server rather than on the recited mobile computing device).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 49-61 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 (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 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 42-48 is/ rejected under 35 U.S.C. 103 as being unpatentable over US 20200337641 A1 to Wang et al. (hereinafter, Wang) in view of Gao et al. (hereinafter, Gao) Fully integrated wearable sensor arrays for multiplexed in situ perspiration analysis. Nature. 2016 Jan 28;529(7587):509-514. doi: 10.1038/nature16521. PMID: 26819044; PMCID: PMC4996079.
Regarding Claim 42, Wang discloses a wearable sweat sensor system (Wang: Abstract), comprising: a wearable sweat sensor patch configured to be applied to skin of a subject (Wang: Para. [0010]), the wearable sweat sensor patch comprising:
a sweat sampling and collection structure (Wang: Para. [0045-0049]) defining
(i) a plurality of inlets (Wang: Para. [0046]; Fig. 1B, items 124A-D),
(ii) a reservoir (Wang: Para. [0049]; Fig. 1A, item 123),
(iii) one or more microfluidic channels fluidically coupling the plurality of inlets to the reservoir (Wang: Para. [0049]; Figs 1A & 1B, item 121), and
(iv) an outlet fluidically coupled to the reservoir, wherein the outlet is configured to discharge sweat from the reservoir to permit receipt of refreshed sweat from the plurality of inlets into the reservoir (Wang: Para. [0046], [0049] ‘the opposing end of the channel 121 and/or the one or more outlets are parallel to the skin of the user, enabling previously measured fluid to flow out of the reservoir 123, thereby enabling freshly secreted fluid to enter.’; Figs. 1A & 1B, item 125); and
at least one chemical sensor positioned to contact sweat in the reservoir (Wang: Para. [0045]) and configured to generate an electrical signal indicative of an amount of a target metabolite in the sweat (Wang: Para. [0039], [0042], [0052], [0057]); and
a mobile computing device in communication with the wearable sweat sensor patch (Wang; Para. [0010], [0040], [0138]),
Wang is silent on the specifics regarding the mobile computing device and processing steps.
However, Gao teaches the mobile computing device comprising a wireless transceiver one or more processors, and a non-transitory memory storing instructions that, when executed by the one or more processors, (Gao: Pg. 3-4 ‘The transceiver facilitates wireless data transmission to a Bluetooth-enabled mobile handset with a custom-developed application (Extended Data Fig. 3), containing a user-friendly interface for sharing (through email, SMS, and so on) or uploading the data to cloud servers…’; Note: The mobile handset inherently contains one or more processors and non-transitory memory that store and execute the application instructions), cause the mobile computing device to:
(i) receive the electrical signal via the wireless transceiver (Gao: Pg. 3-4 ‘The transceiver facilitates wireless data transmission to a Bluetooth-enabled mobile handset with a custom-developed application (Extended Data Fig. 3)),
(ii) determine, from the electrical signal using calibration data stored in the non-transitory memory, a concentration of the target metabolite in the sweat (Gao: Pg. 3-4 ‘Figure 1d illustrates the system-level overview of the signal transduction, conditioning, processing, and wireless transmission paths to facilitate multiplexed on-body measurements. The signal-conditioning path for each sensor is implemented with analogue circuits and in relation to the corresponding transduced signal. The circuits are configured to ensure that the final analogue output of each path is finely resolved while staying within the input voltage range of the analogue-to-digital converter. Furthermore, the microcontroller's computational and serial communication capabilities are used to calibrate, compensate, and relay the conditioned signals to an on-board wireless transceiver. The transceiver facilitates wireless data transmission to a Bluetooth-enabled mobile handset with a custom-developed application (Extended Data Fig. 3), containing a user-friendly interface for sharing (through email, SMS, and so on) or uploading the data to cloud servers. The circuit design, calibration, and power delivery diagram of the FISA are described in Methods and Extended Data Figs 4 and 5.’), and
(iii) output the concentration of the target metabolite via a user interface of the mobile computing device (Gao: Pg. 16 Extended Data Figure 3b ‘Real-time data display of sweat analyte levels…’).
The combination involves Wang supplying the physical patch that generates the electrical signal from refreshed sweat in the reservoir. Gao supplies the mobile computing teachings of wireless reception of the signal via Bluetooth, use of stored calibration data (from known concentration standards) to convert the signal into a quantitative metabolite concentration and output that concentration onto the user interface of the mobile computing device.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system of Wang by specifying interconnectivity with a mobile computing device using a custom mobile application as taught by Gao to provide insight to a user’s health state at molecular levels (Gao: Pg. 2).
Regarding Claim 43, Wang in view of Gao discloses the wearable sweat sensor system of claim 42, Wang further discloses wherein the plurality of inlets comprises at least four inlets (Wang: Para. [0046]; Figs. 1A & 1B, item 124A-D).
Regarding Claim 44, Wang in view of Gao discloses the wearable sweat sensor system of claim 42, Wang further discloses wherein the plurality of inlets are positioned relative to the reservoir at an angular span of between 90 degrees and 270 degrees (Wang: Fig. 1B shows the plurality of inlets items 124A-D positioned relative to the reservoir at an angular span of approximately 180 degrees.).
Regarding Claim 45, Wang in view of Gao discloses the wearable sweat sensor system of claim 42, Wang further discloses wherein the one or more microfluidic channels are oriented such that inlet channels are aligned toward the outlet (Wang: Fig. 1A, inlet channels 121 appear to align toward outlet 125).
Regarding Claim 46, Wang in view of Gao discloses the wearable sweat sensor system of claim 42, Wang further discloses wherein the outlet is positioned to discharge sweat away from the plurality of inlets to reduce mixing of discharged sweat with sweat entering the plurality of inlets (Wang: Fig. 1A, outlet is positioned to discharge sweat away from the plurality of inlets. Para. [0049] ‘The fluid then enters into the one or more inlets 124 of the second flexible layer 120 aligned with the one or more holes 131 of the adhesion layer 130. Next, the fluid travels through the channel 121 and into the reservoir 123 and passes over the two or more electrodes 111 of the flexible layer 110, which are aligned with the reservoir 123 of the flexible layer 120. Once the fluid pass over the two or more electrodes 111 (which can include electrode 112), the device 100 is able to detect and/or measure biomarkers in the fluid secreted by the user. The fluid travels out of the reservoir 123 through the opposing end of the channel 121 and exits the device through the one or more outlets 125. In some embodiments, the opposing end of the channel 121 and/or the one or more outlets are parallel to the skin of the user, enabling previously measured fluid to flow out of the reservoir 123, thereby enabling freshly secreted fluid to enter.’).
Regarding Claim 47, Wang in view of Gao discloses the wearable sweat sensor system of claim 42, Wang further discloses wherein the sweat sampling and collection structure is configured such that, after discharge of sweat from the reservoir through the outlet, a refreshed sweat sample fills the reservoir via the plurality of inlets (Wang: Para. [0049] ‘The fluid then enters into the one or more inlets 124 of the second flexible layer 120 aligned with the one or more holes 131 of the adhesion layer 130. Next, the fluid travels through the channel 121 and into the reservoir 123 and passes over the two or more electrodes 111 of the flexible layer 110, which are aligned with the reservoir 123 of the flexible layer 120. Once the fluid pass over the two or more electrodes 111 (which can include electrode 112), the device 100 is able to detect and/or measure biomarkers in the fluid secreted by the user. The fluid travels out of the reservoir 123 through the opposing end of the channel 121 and exits the device through the one or more outlets 125. In some embodiments, the opposing end of the channel 121 and/or the one or more outlets are parallel to the skin of the user, enabling previously measured fluid to flow out of the reservoir 123, thereby enabling freshly secreted fluid to enter.’).
Regarding Claim 48, Wang in view of Gao discloses the wearable sweat sensor system of claim 42, Wang further discloses wherein the at least one chemical sensor comprises an electrochemical sensor (Wang; Para. [0008-0009]).
Conclusion
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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