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 statements (IDS) submitted on 01/22/26 and 11/28/23 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on January 22, 2026, amended claims 1, 3, 8 and 9 have has been entered. New claims 21-31 have been added.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but were not persuasive
Applicant argues Rogers does not teach a microfluidic module that routes a mixture of biomarkers bound to labeled detection reagents to a detection reservoir. Examiner disagrees and notes that Rogers teaches fluorescent probes installed in each reservoir are dissolved by incoming sweat and react with their targets [par. 529] Rogers also teaches the chambers are used for electrochemical sensing [par. 460]. An additional embodiment of Rogers teaches the use of redox mediators for efficiently shuttling electrons from the enzyme’s active site to the current collector [par. 458]. Therefore, this equates to a microfluidic module that routes a mixture of biomarkers bound to labeled detection reagents to a detection reservoir, when taking into consideration broadest reasonable interpretation.
Applicant argues Rogers does not teach a bioaffinity sensor. Examiner notes that Rogers teaches the chambers are used for colorimetric and electrochemical sensing [par. 460]. Further, Rogers teaches the use of this with the biofuel cell based electrochemical sensors [par. 462] that utilize redox mediators [ par. 458, 466]. Therefore, this equates to a bioaffinity sensor when taking into consideration broadest reasonable interpretation.
Lastly, Applicant argues Rogers does not teach a reagent reservoir configured to refresh the sweat sample with the labeled detection reagents. Examiner notes that Rogers teaches that the sweat sample enters the device through the bursting valves, which Examiner interprets to be the reagent reservoir, route sweat through the device [par. 460]. Additionally, the chambers use electrochemical sensing [par. 460]. Rogers also teaches fluorescent probes installed in each reservoir are dissolved by incoming sweat and react with their targets [par. 529]. Further, these systems are all connected [par. 460]. Therefore, this equates to a reagent reservoir configured to refresh the sweat sample with the labeled detection reagents, when taking into consideration broadest reasonable interpretation.
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, 5, 8, 9, 21, 22 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (U.S. Patent Application Publication 2020/0155047A1) Heikenfeld (U.S. Patent Application Publication 2020/0138347A1)
Rogers was applied in the Applicant’s IDS
Rogers and Heikenfeld were applied in the previous office action
Regarding claim 1, Rogers teaches a wearable biosensor device [fig. 1a, element 10], comprising: an configured to stimulate production of a sweat sample from skin of a user, the sweat sample including biomarkers [par. 445, 502]; a microfluidic module [fig. 1a, element 10; par. 401] comprising labeled detection reagents [par. 27, 401, 529] and a detection reservoir [fig. 1c, element 60], the microfluidic module configured to collect the sweat sample, mix the sweat sample with labeled detection reagents to obtain a mixture including the biomarkers bound to the labeled detection reagents, and route the mixture to a detection reservoir [fig. 1c, element 60; par. 20 “Any of the microfluidic systems may be described as having the plurality of reservoir chambers chemically decoupled from each other for independent biofluid property detection”; Examiner notes reservoir chambers also function has detection chambers] of the microfluidic module [par. 15, 17, 27, 401]; and a sensor assembly [fig. 1c, element 80; par. 15, 401] comprising a bioaffinity sensor configured to quantify the biomarkers of the mixture in the detection reservoir to determine a concentration of the biomarkers present in the sweat sample [par. 17 “any of the microfluidic systems may have a first microfluidic network configured to monitor a biofluid parameter…; biofluid analyte concentration; biomarker presence or absence”],
A second embodiment of Rogers teaches the bioaffinity sensor comprising an electrode functionalized to bind to the biomarkers of the mixture [par. 451].
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 Rogers, to incorporate the bioaffinity sensor comprising an electrode functionalized to bind to the biomarkers of the mixture, for determining concentration, as evidence by Rogers [par. 451].
However, Rogers does not teach an iontophoresis module
Heikenfeld teaches an iontophoresis module [par. 91]
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 Rogers, to incorporate an iontophoresis module, for increasing sweat concentration, as evidence by Heikenfeld [par. 91].
Regarding claim 5, Rogers further teaches the microfluidic module comprises: an inlet [fig. 1c, element 50] for collecting the sweat sample [par. 401,; a reagent reservoir [fig. 1c, element 60] including the labeled detection reagents, the reagent reservoir configured to refresh the sweat sample with the labeled detection reagents [par. 27, 401, 529]; a mixing channel [fig. 1c, element 70; Examiner notes sweat enters the device through the bursting valves] for mixing the sweat sample refreshed with the labeled detection reagents to form the mixture including the labeled detection reagents bound to the biomarkers [par. 328, 367, 401, 402, 428]; the detection reservoir [fig. 1c, element 60; par. 20 “Any of the microfluidic systems may be described as having the plurality of reservoir chambers chemically decoupled from each other for independent biofluid property detection”; Examiner notes reservoir chambers also function has detection chambers] for receiving the mixture from the mixing channel [par. 238, 367, 401, 402, 428]; and an outlet [fig. 1c, element 90] for providing an outflow of the sweat sample from the detection reservoir [par. 66, 328, 401]
Regarding claim 8, Embodiment 3 of Rogers teaches the wearable biosensor device comprises: a disposable patch including the microfluidic module, and the sensor assembly, the disposable patch comprising an adhesive to directly adhere the disposable patch to the skin [fig. 20A; par. 460]; and a flexible printed circuit board (FPCB) coupled to the patch, the FPCB configured to receive signals from the sensor assembly and power the wearable biosensor device [fig. 20; par. 460].
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 Rogers, to incorporate the wearable biosensor device comprises: a disposable patch including the iontophoresis module, the microfluidic module, and the sensor assembly, the disposable patch comprising an adhesive to directly adhere the disposable patch to the skin; and a flexible printed circuit board (FPCB) coupled to the patch, the FPCB configured to receive signals from the sensor assembly and power the wearable biosensor device, for allowing reuse of the electronics and replacement of the microfluidics, as evidence by Embodiment 3 of Rogers [par. 462].
However, Rogers does not teach an iontophoresis module
Heikenfeld teaches an iontophoresis module [par. 91]
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 Rogers, to incorporate an iontophoresis module, for increasing sweat concentration, as evidence by Heikenfeld [par. 91].
Regarding claim 9, Embodiment 3 of Rogers further teaches the FPCB is reusable and configured to removably couple to the patch [par. 461, 462]; and the FPCB comprises a processor configured to perform in situ signal processing of signals received from the sensor assembly, and a wireless communication module configured to wirelessly communicate, in real-time, with a mobile device [par. 461, 462]
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 Rogers, to incorporate the FPCB is reusable and configured to removably couple to the patch; and the FPCB comprises a processor configured to perform in situ signal processing of signals received from the sensor assembly, and a wireless communication module configured to wirelessly communicate, in real-time, with a mobile device, for allowing reuse of the electronics and replacement of the microfluidics and wireless data extraction, as evidence by Embodiment 3 of Rogers [par. 462].
Regarding claim 21, Embodiment 4 of Rogers teaches the labeled detection reagents comprise electroactive label molecules; and the bioaffinity sensor is configured to measure an amount of the electroactive label molecules present at a surface of the electrode to determine the concentration of the biomarkers present in the sweat sample [par. 458, 459, Examiner notes the redox mediators, which are the electroactive labels, are used for detecting the analyte]
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 Rogers, to incorporate the labeled detection reagents comprise electroactive label molecules; and the bioaffinity sensor is configured to measure an amount of the electroactive label molecules present at a surface of the electrode to determine the concentration of the biomarkers present in the sweat sample, for efficiently shuttling electrons from the enzyme's active site to the current collector, as evidence by Embodiment 4 of Rogers [par. 458].
Regarding claim 22, Embodiment 4 of Rogers further teaches wherein the electroactive label molecules are redox molecules [par. 458, 459]
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 Rogers, to incorporate the electroactive label molecules are redox molecules, for efficiently shuttling electrons from the enzyme's active site to the current collector, as evidence by Embodiment 4 of Rogers [par. 458].
Regarding claim 30, Rogers further teaches the detection reservoir comprises electrolytes [par. 91; Examiner notes that since the sweat sample that contains electrolytes is in the detection reservoir, it would inherently comprise electrolytes].
Regarding claim 31, embodiment 5 of Rogers teaches the mixing channel has a serpentine shape [fig. 4, element 30; par. 401, 506].
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 Rogers, to incorporate the mixing channel has a serpentine shape, for allowing for stretchable material, as evidence by Embodiment 5 of Rogers [par. 388].
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers and Heikenfeld and in further view of Bullington (U.S. Patent Application Publication 2021/0178389A1).
Bullington was applied in the Applicant’s IDS and the previous office action
Regarding claim 2, Rogers and Heikenfeld teach wearable biosensor device, as disclosed above.
However, Rogers and Heikenfeld do not teach the labeled detection reagents comprise first nanoparticles conjugated with detection antibodies that bind to the biomarkers; and a surface of the electrode comprises second nanoparticles conjugated with capture antibodies that bind to the biomarkers.
Bullington teaches the labeled detection reagents comprise first nanoparticles conjugated with detection antibodies that bind to the biomarkers [par. 87, 91]; and a surface of the electrode comprises second nanoparticles conjugated with capture antibodies that bind to the biomarkers [par. 87, 91].
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 Rogers and Heikenfeld, to incorporate the labeled detection reagents comprise first nanoparticles conjugated with detection antibodies that bind to the biomarkers; and a surface of the electrode comprises second nanoparticles conjugated with capture antibodies that bind to the biomarkers, for the advantages including, ease of fabrication, simplicity, low cost, rapid fabrication, and use of minimal additives and/or chemicals, as evidence by Bullington [par. 88].
Regarding claim 3, Bullington further teaches the first nano particles and second nanoparticles are gold nanoparticles [par. 89]; and the biomarkers comprise protein biomarkers or hormone biomarkers [par. 43].
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 Rogers and Heikenfeld, to incorporate the first nano particles and second nanoparticles are gold nanoparticles; and the biomarkers comprise protein biomarkers or hormone biomarkers, for creating a strong bond, as evidence by Bullington [par. 89].
Claims 4, 23 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers and Heikenfeld and in further view of Wei (U.S. Patent Application Publication 2010/0330706A1).
Wei was applied in the previous office action
Regarding claim 4, Rogers and Heikenfeld teach a wearable biosensor device, as disclosed above.
However, Rogers and Heikenfeld do not teach the bioaffinity sensor is configured to quantify the biomarkers of the mixture to determine the concentration with a sensitivity of 1 micromole or less, 100 nanomoles or less, 10 nanomoles or less, 1 nanomole or less, 100 picomoles or less, or 10 picomoles or less.
Wei teaches the bioaffinity sensor is configured to quantify the biomarkers of the mixture to determine the concentration with a sensitivity of 1 micromole or less, 100 nanomoles or less, 10 nanomoles or less, 1 nanomole or less, 100 picomoles or less, or 10 picomoles or less [par. 92].
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 Rogers and Heikenfeld, to incorporate the bioaffinity sensor is configured to quantify the biomarkers of the mixture to determine the concentration with a sensitivity of 1 micromole or less, 100 nanomoles or less, 10 nanomoles or less, 1 nanomole or less, 100 picomoles or less, or 10 picomoles or less, for better detection, as evidence by Wei [par. 92].
Regarding claim 23, Wei further teaches the biomarkers are inflammatory biomarkers [par. 24]; the labeled detection reagents further comprise first nanoparticles conjugated with detection antibodies that bind to the inflammatory biomarkers; and a surface of the electrode comprises second nanoparticles conjugated with capture antibodies that bind to the inflammatory biomarkers [par. 8, 9, 43]
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 Rogers and Heikenfeld, to incorporate the biomarkers are inflammatory biomarkers; the labeled detection reagents further comprise first nanoparticles conjugated with detection antibodies that bind to the inflammatory biomarkers; and a surface of the electrode comprises second nanoparticles conjugated with capture antibodies that bind to the inflammatory biomarkers, as the capture moieties determine sensor sensitivity, as evidence by Wei [par. 74].
Regarding claim 26, Wei further teaches the first nanoparticles and second nanoparticles are gold nanoparticles [par. 40, 68].
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 Rogers and Heikenfeld, to incorporate the first nanoparticles and second nanoparticles are gold nanoparticles, as is a common nanoparticle material, as evidence by Wei [par. 40, 68].
Regarding claim 27, Wei further teaches the biomarkers are protein biomarkers or hormone biomarkers [par. 17]; and the bioaffinity sensor is configured to quantify the protein biomarkers or hormone biomarkers of the mixture to determine the concentration with a sensitivity of 100 picomoles or less [par. 92]
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 Rogers and Heikenfeld, to incorporate the biomarkers are protein biomarkers or hormone biomarkers; and the bioaffinity sensor is configured to quantify the protein biomarkers or hormone biomarkers of the mixture to determine the concentration with a sensitivity of 100 picomoles or less, for better detection, as evidence by Wei [par. 92].
Regarding claim 28, Wei further teaches the bioaffinity sensor is configured to quantify the protein biomarkers or hormone biomarkers of the mixture to determine the concentration with a sensitivity of 10 picomoles or less [par. 92].
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 Rogers and Heikenfeld, to incorporate the bioaffinity sensor is configured to quantify the protein biomarkers or hormone biomarkers of the mixture to determine the concentration with a sensitivity of 10 picomoles or less, for better detection, as evidence by Wei [par. 92].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers and Heikenfeld and in further view of DeFranks (U.S. Patent Application Publication 2019/0365328A1).
DeFranks was applied in the previous office action
Regarding claim 6, Rogers and Heikenfeld teach a wearable biosensor device, as disclosed above.
Embodiment 2 of Rogers teaches the sensor assembly further comprises: a temperature sensor configured to measure a temperature of the skin [par. 384]; and a pH sensor configured to measure a pH level of the sweat sample [par. 384].
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 Rogers, to incorporate the sensor assembly further comprises: a temperature sensor configured to measure a temperature of the skin; and a pH sensor configured to measure a pH level of the sweat sample, as these are common useful device components for sensing, as evidence by Embodiment 2 of Rogers [par. 384]
However, Rogers does not teach an ionic strength sensor configured to measure an ionic strength of the sweat sample; wherein the wearable biosensor device is configured to calibrate readings from the bioaffinity sensor based on measurements made by the temperature sensor, the ionic strength sensor, and the pH sensor
Heikenfeld teaches an ionic strength sensor configured to measure an ionic strength of the sweat sample [par. 85]
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 Rogers, to incorporate an ionic strength sensor configured to measure an ionic strength of the sweat sample, for predetermining target analyte concentration, as evidence by Heikenfeld [par. 85].
DeFranks teaches wherein the wearable biosensor device is configured to calibrate readings from the bioaffinity sensor based on measurements made by the temperature sensor, the ionic strength sensor, and the pH sensor [par. 35, 36]
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 Rogers and Heikenfeld, to incorporate an ionic strength sensor configured to measure an ionic strength of the sweat sample, for to ensure stability against these variations, as evidence by DeFranks [par. 36].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers and Heikenfeld and in further view of Taghipour (U.S. Patent Application Publication 2023/0309868A1).
Taghipour was applied in the previous office action
Regarding claim 7, Rogers and Heikenfeld teach a wearable biosensor device, as disclosed above, and the multiplexed sensor array including the bioaffinity sensor, the temperature sensor, the ionic strength sensor, and the pH sensor [par. 384].
However, Rogers and Heikenfeld donot teach the sensor assembly comprises a multiplexed sensor array fabricated using laser-engraved graphene (LEG)
Taghipour teaches the sensor assembly comprises a multiplexed sensor array fabricated using laser-engraved graphene (LEG) [par. 28, 125]
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 Rogers and Heikenfeld, to incorporate the sensor assembly comprises a multiplexed sensor array fabricated using laser-engraved graphene (LEG), for the advantage of providing the sensing nodes with the ability to be regenerated in situ, as evidence by Taghipour [par. 125].
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers, Heikenfeld and Wei and in further view of Dubrovsky (U.S. Patent Application Publication 2024/0206783 A1).
Regarding claim 24, Rogers, Heikenfeld and Wei teach a wearable biosensor device, as disclosed above.
However, Rogers, Heikenfeld and Wei do not teach the inflammatory biomarkers are C-reactive proteins
Dubrovsky teaches the inflammatory biomarkers are C-reactive proteins [par. 286-289, 557]
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 Rogers, Heikenfeld and Wei, to incorporate the inflammatory biomarkers are C-reactive proteins, for using the sensor to correlate lifestyle to inflammation, as evidence by Dubrovsky [par. 282].
Regarding claim 25, Embodiment 4 of Rogers teaches the electroactive label molecules are redox molecules [par. 458, 459].
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 Rogers, to incorporate the electroactive label molecules are redox molecules, for efficiently shuttling electrons from the enzyme's active site to the current collector, as evidence by Embodiment 4 of Rogers [par. 458].
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers and Heikenfeld and in further view of Wei and Dubrovsky
Regarding claim 29, Rogers and Heikenfeld teach a wearable biosensor device, as disclosed above.
However, Rogers and Heikenfeld do not teach the biomarkers are C-reactive proteins; and the bioaffinity sensor is configured to quantify the C-reactive proteins of the mixture to determine the concentration with a sensitivity of 10 picomoles or less.
Wei teaches the biomarkers are reactive proteins [par. 17]; and the bioaffinity sensor is configured to quantify the reactive proteins of the mixture to determine the concentration with a sensitivity of 10 picomoles or less [par. 92].
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 Rogers and Heikenfeld, to incorporate the biomarkers are reactive proteins; and the bioaffinity sensor is configured to quantify the reactive proteins of the mixture to determine the concentration with a sensitivity of 10 picomoles or less, for better detection, as evidence by Wei [par. 92].
Dubrovsky teaches the biomarkers are C-reactive proteins [par. 286-289, 557]
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 Rogers, Heikenfeld and Wei, to incorporate the biomarkers are C-reactive proteins, for using the sensor to correlate lifestyle to inflammation, as evidence by Dubrovsky [par. 282].
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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