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 .
Election/Restrictions
Claims 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/02/2026. Claims 1-16 remain pending in the application.
Response to Amendment
The amendment filed 08/05/2026 has been entered. Amendments to claims 1,2, 4, 6, 8, 10-11, 13, cancellation of claims 5 and 12 are acknowledged. Claims 1-4, 6-11, and 13-22 remain pending in the application, claims 17-22 are withdrawn from consideration.
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.
Claim(s) 1-2, 6-9, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanati-Nezhad et al. (US 20250090049 A1) in view of Beech et al. (US 20210285936 A1, as cited by applicant’s IDS filed 09/05/2024), hereinafter Beech.
Regarding claim 1, Sanati-Nezhad discloses a wearable biosensor device (title), comprising: a microfluidic module configured to collect a sweat sample from skin of a user ([0026]: “and microfluidic wearable design that may enable a reliable and evaporation-free collection and/or storage of human sweat”), route the sweat sample to a sensing reservoir (Fig 2, [0031]: “fluid collection device comprises a main channel configured to gather collected sweat from the subject's skin”), and route additional sweat away from the sensing reservoir when the sensing reservoir is filled ([0041]: "The rectangular chambers act as stop valves after main channel filling with sweat with hydrophobic surfaces”) and a sensor assembly configured to quantify a biomarker contained in the sweat sample in the sensing reservoir to determine a concentration of the biomarker present in the sweat sample ([0041]: "a sensor is provided over the main channel, for example using a printable ink, to enable the wearable device to sense one or more biomarkers associated with stress, for example cortisol", [0095]: “can differentiate the biomarkers concentrations in sweat”), the sensor assembly comprising a biorecognition interface having a surface functionalized with an aptamer that binds to the biomarker ([0086-0087]: "wherein the sensing electrodes are functionalized (read for binding of capture molecules)… wherein the bioreceptor (capture molecule) could be… aptamer, enabling highly selective detection of target biomolecule or bioparticle in the sweat.");
While Sanati-Nezhad further discloses the sensor assembly further comprises a working electrode ([0065]: “with one or more electrodes, such as miniaturized, flexible, and multiplexed screen-printed electrodes … single-point sensing of one or multiple target biomolecules and/or bioparticles in the collected sweat;”), they fail to disclose the surface of the biorecognition interface is further functionalized with a labeled molecule containing an electroactive label, wherein the biorecognition interface is configured to release the labeled molecule in response to the aptamer binding to the biomarker; and a working electrode having a surface that faces the surface of the biorecognition interface and forms a second wall of the sensing reservoir opposite the first wall, the surface of the working electrode functionalized to bind to the labeled molecule released from the biorecognition interface.
Beech discloses a sensor assembly comprising a working electrode (Fig 5 element 530B, [0049]: “electrode 530B”); biorecognition interface having a surface that forms a first wall of the sensing reservoir (Fig 2A element 212), the surface containing an electroactive label (Fig 2A element 250, [0009]: “an electroactive redox moiety”, and further in Fig 6 element 630A); in response to the aptamer binding to the biomarker, the biorecognition interface is configured to release the labeled molecule ([0033]: "Upon interaction with the analyte, the aptamer changes shape to bind with the analyte, causing the aptamer to break away from the docking structure", Fig 2A to 2B); and a working electrode having a surface that faces the surface of the biorecognition interface and forms a second wall of the sensing reservoir opposite the first wall ([0050]: “depicts a variation of the embodiment described in relation to FIG. 5. In this embodiment, instead of a second electrode 530B, the device has a pair of electrodes 632, 634”, Fig 6 wherein element 632 is opposite to 630A), the surface of the working electrode is functionalized to bind to the labeled molecule released from the biorecognition interface (Fig 5 530B as connected to 550, wherein the figure 5 depicts the labeled molecule disclosed by Fig 2A/B per [0047]: “The aptamer sensing elements may be arranged in any manner described in the previous embodiments”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the wearable biosensor disclosed by Sanati-Nezhad to include the labeled molecule containing an electroactive label and in response to the aptamer binding to the biomarker, the biorecognition interface is configured to release the labeled molecule as disclosed by Beech in order to improve selective binding of the aptamers to a target biomarker and produce a reliably detectable signal via detachment (Beech [0007]).
Regarding claim 2, Sanati-Nezhad discloses wherein the microfluidic module comprises: an inlet for collecting the sweat sample ([0006]: “a main channel configured to collect sweat”); the sensing reservoir; an outlet for providing an outflow of the additional sweat, the outlet fluidically positioned between the inlet and the sensing reservoir ([0041]: "The rectangular chambers act as stop valves after main channel filling with sweat with hydrophobic surfaces and change in geometry (cross section and angles) in order to keep the liquid in the main channel for sensing and recording data", Fig 2 vents); and a first microvalve fluidically positioned between the inlet and the outlet ([0032]: " further comprises at least one stop valve configured to control flow through the device, and/or to measure the timing/rate of flow through the device"), the first microvalve configured to change from a closed state to an open state after the sensing reservoir is filled, to reroute the additional sweat to the outlet while biosensing of the sweat sample is performed ([0041]: " The stop valves are configured to let the sweat in after specific time for flowing towards outlets and thus providing continuous sweat flow into the device.").
Regarding claim 6, Beech further discloses the aptamer comprises first single-stranded deoxyribonucleic acid (ssDNA) selective to the biomarker ([0035]: "aptamer 240 selected to bind to a target analyte, and may also include one or more linker nucleotide sections"); the labeled molecule comprises second ssDNA ([0034]: "The docking structure 220 can include a 9 to 12 base nucleotide sequence that is selected to be complementary with a nucleotide sequence on the analyte capture complex 212,"); and the surface of the working electrode is functionalized with third ssDNA configured to hybridize to the second ssDNA (Fig 2A element 220, [0009]: “molecular docking structure attached to the electrode”).
Regarding claim 7, Beech further discloses wherein: the first ssDNA is hybridized to the second ssDNA as a partially hybridized sequence (Fig 2A); and in a presence of the biomarker, the first ssDNA is configured to release the second ssDNA from the surface of the biorecognition interface due to a higher affinity of the first ssDNA to the biomarker than the partially hybridized sequence (Fig 2A, [0033]: " Upon interaction with the analyte, the aptamer changes shape to bind with the analyte, causing the aptamer to break away from the docking structure", [0037]: " the aptamer 240 physically changes its three dimensional structure to bind with the analyte. As the aptamer interacts with the analyte, the second linker 244B moves into physical proximity to the first linker 242B. The physical proximity of the complementary linkers causes the first linker to break free from the docking sequence 220 and to bind with the second linker.").
Regarding claim 8, Beech further discloses wherein: the sensor assembly further comprises a counter electrode ([0050]: “, the device has a pair of electrodes 632, 634 located downstream of the first electrode 630A”); and the wearable biosensor device is configured to apply an electric field between the counter electrode and the working electrode to promote transport of the labeled molecule to the working electrode (claim 12: "wherein the second electrode further comprises a pair of electrodes configured to create an electric field across a cross-section of the channel.").
Regarding claim 9, Sanati-Nezhad further discloses further comprising a flexible printed circuit board (FPCB) electrically coupled to the sensor assembly ([0046]: “the device itself may comprise one or more integrated circuits”, the FPCB configured to apply the electric field as a bias potential between the counter electrode and the working electrode ([0037]: “and configured to record electrical signals from the biosensor and to analyze the signals to enable digital monitoring of the sweat, and optionally transmit the results”).
Regarding claim 15, Sanati-Nezhad discloses the biomarker is a first type of biomarker; the sweat sample further comprises a second type of biomarker different from the first type of biomarker ([0088]: “wherein the assembled fluid device and biosensor can simultaneously collect the sweat and detect multiple biomarkers.”); the surface of the biorecognition interface is further functionalized with a second aptamer that binds to the second type of biomarker ([0087]: “wherein the bioreceptor (capture molecule) could be antibody, enzyme, or aptamer, enabling highly selective detection of target biomolecule or bioparticle in the sweat.”); and the sensor assembly is further configured to quantify the second type of biomarker of the sweat sample in the sensing reservoir to determine a concentration of the second type of biomarker present in the sweat sample ([0095]: “, where the chip can differentiate the biomarkers concentrations in sweat generated from endocrine glands or apocrine glands.”).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanati-Nezhad in view of Beech in view of Lee et al. (US 20170130187 A1), hereinafter Lee.
Regarding claim 3, Sanati-Nezhad as modified by Beech discloses the wearable biosensor device of claim 1, but fails to disclose wherein the first microvalve is a first capillary bursting valve (CBV), the first CBV having a burst pressure (BP) that is configured to be exceeded after the sensing reservoir is filled.
Lee discloses wherein a microfluidic device (title) wherein a first microvalve is a first capillary bursting valve (CBV) ([0013]: " the one or more microvalves are capillary burst valves”), the first CBV having a burst pressure (BP) that is configured to be exceeded after the sensing reservoir is filled ([0013]: "wherein a flow of flowable material passing from the inlet region toward the downstream compartment is at least partially diverted by at least one of the microvalves into at least one of the reservoirs as a result of a pressure increase in the microfluidic channel ").
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known stop valve disclosed by Sanati-Nezhad with the known CBV disclosed by Lee for the predictable result of controlling flow.
Regarding claim 4, Sanati-Nezhad discloses the microfluidic module further comprises a second CBV (Fig 2 delay valve, as modified above), the second CBV fluidically positioned after the sensing reservoir (Fig 2); and the second CBV is configured to be in a closed state after the sensing reservoir is filled ([0041]: “The rectangular chambers act as stop valves after main channel filling with sweat with hydrophobic surfaces and change in geometry (cross section and angles) in order to keep the liquid in the main channel for sensing and recording data.”).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanati-Nezhad in view of Beech in further view of Murphy et al. (WO 2023017721 A1), hereinafter Murphy.
Regarding claim 10, Sanati-Nezhad in view of Beech discloses the wearable sensor of claim 5. Beech further discloses wherein the surface of the working electrode comprises: one or more layers of gold nanoparticles (AuNPs) ([0034]: “The electrode 230 may be comprised of gold,”). However, they fail to disclose one or more layers of MXene formed over the one or more layers of AuNPs.
Murphy discloses one or more layers of MXene formed over one or more layers of AuNPs ([0066]: “A slurry in which the MXene particles were dispersed in water at a concentration of 10 mg/mL was prepared. The slurry prepared above was spray-coated on a gold-deposited slide glass (on a gold-deposited surface), and dried in a vacuum oven (350 mm Torr) at 70°C overnight to form a conductive film of MXene particles on the gold-deposited slide glass… Thus, a biosignal sensing electrode sample was produced”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the electrode disclosed by Sanati-Nezhad as modified by Beech to include the MXene layer as disclosed by Murphy in order to improve the sensitivity of the electrode (Murphy [0003]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanati-Nezhad in view of Beech in further view of Heikenfeld (US 20200138347 A1).
Regarding claim 11, Sanati-Nezhad in view of Beech discloses the wearable biosensor of claim 5, but fails to disclose wherein the biomarker is a reproductive hormone.
Heikenfeld discloses an aptamer biosensor wherein the biomarker is a reproductive hormone ([0078]: “Sensor 920 is for estrogen, and sensor 922 is for progesterone, both of which have electrochemical aptamer-based sensors configured to operate at the analytes' natural concentration ranges found in biofluid”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the wearable biosensor disclosed by Sanati-Nezhad as modified by Beech to include detection of reproductive hormones as disclosed by Heikenfeld in order to obtain a more robust data set.
Sanati-Nezhad further discloses the sensor assembly is configured to quantify the reproductive hormone to determine the concentration of the reproductive hormone with a sensitivity of 1 picomole ([0084]: “wherein the biosensors can detect enzymes and proteins in the sweat within the detection range of 1 pg/mL to 10 ng/ml”, as modified by Heikenfeld above). However, Sanati-Nezhad does not explicitly disclose the sensitivity being 1 picomole or less.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of Sanati-Nezhad from between 1 picomole or less as applicant appears to have placed no criticality on the claimed range (applicant’s specification para [0097]: “a sensitivity of 100 picomoles or less, 10 picomoles or less, or even less than 1 picomole”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanati-Nezhad in view of Beech in further view of Heikenfeld in further view of Hianik et al. (“Influence of ionic strength, pH and aptamer configuration for binding affinity to thrombin”, as cited by applicant’s IDS filed 09/05/2024).
Sanati-Nezhad in view of Beech discloses the wearable sensor of claim 5, but fails to disclose wherein the sensor assembly further comprises: an ionic strength sensor configured to measure an ionic strength of the sweat sample; and a pH sensor configured to measure a pH level of the sweat sample.
Heikenfeld discloses an ionic strength sensor configured to measure an ionic strength of the sweat sample ([0085]: “the device measures the ionic strength”, [0004]: “fluid sensing device capable of collecting a biofluid sample, such as … sweat,”); and a pH sensor configured to measure a pH level of the sweat sample ([0113]: “a pH sensor”, [0004]: “fluid sensing device capable of collecting a biofluid sample, such as … sweat,”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the wearable biosensor as disclosed by Santani-Nezhad as modified by Beech to include the ionic sensor and pH sensor as disclosed by Heikenfeld in order to obtain a more robust data set.
Santani-Nezhad as modified by Beech and Heikenfeld fails to disclose wherein the wearable biosensor device is configured to calibrate readings from the working electrode based on measurements made by the ionic strength sensor and the pH sensor.
Hianik disclose calibration of readings from a working electrode based on measurements made by an ionic strength sensor and a pH sensor (abstract: “analyzed how the method of immobilization of aptamer to a solid support, the aptamer configuration as well as variation in ionic strength and pH will affect the binding of thrombin to the aptamer.”, conclusion: “. Increased ionic strength resulted in a decrease of the sensitivity of the aptamer to the thrombin… Best sensitivity was obtained for pH 7.4–7.5, while increase or decrease of pH resulted in decrease of sensitivity of the aptamer sensor.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the biosensor disclosed by Sanati-Nezhad in view of Beech and Heikenfeld to include the calibration disclosed by Hianik in order to account for the impact of pH and ionic strength on aptamer sensor efficacy (Hianik conclusion).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanati-Nezhad in view of Beech in view of Makinen et al. (US 20240260860 A1).
Santani-Nezhad discloses the wearable biosensor of claim 1 and further discloses a wherein the wearable biosensor device comprises: a disposable patch ([0011]: “the wearable apparatus comprises a smart patch”) the microfluidic module (Fig 31), and the sensor assembly (Fig 31), the disposable patch comprising an adhesive to directly adhere the disposable patch to the skin ([0045]: “the device is attached to the user using a medical adhesive”).
Santani-Nezhad fails to disclose an iontophoresis module that stimulates production of the sweat sample and a FPCB coupled to the disposable patch, the FPCB configured to receive signals from the sensor assembly and power the wearable biosensor device, wherein the FPCB is configured to be worn around a finger of the user.
Makinen discloses an iontophoresis module that stimulates production of the sweat sample ([0113]: “the wearable device 104 may perform iontophoresis, where an electrical current/voltage is used to stimulate sweat glands to produce sweat that may be collected”) and a FPCB coupled to the disposable patch ([0045]: “include one or more printed circuit boards (PCBs), such as flexible PCB (e.g., polyimide)”), the FPCB configured to receive signals from the sensor assembly and power the wearable biosensor device ([0045]: “the electronics/battery 210 may include surface mounted devices (e.g., surface-mount technology (SMT) devices) on a flexible PCB… the one or more substrates (e.g., one or more flexible PCBs) may include electrical traces that provide electrical communication between device electronics”), wherein the FPCB is configured to be worn around a finger of the user ([0018]: “such as a ring computing device (hereinafter “ring”) configured to be worn on a user's 102 finger,”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the wearable biosensor disclosed by Santani-Nezhad to include the iontophoresis module disclosed by Makinen in order to improve the rate of sweat collection. It would additionally have obvious to include the FCPB configured to be worn around a user’s finger as disclosed by Makinen in order to allow for less interference during physical activity (Makinen [0099]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanati-Nezhad in view of Beech in view Heikenfeld.
Sanati-Nezhad as modified by Beech discloses the wearable biosensor of claim 15, wherein: the first type of biomarker is a first type of female reproductive hormone; and the second type of biomarker is a second type of female reproductive hormone.
Heikenfeld discloses a aptamer biosensor wherein a first type of biomarker is a first type of female reproductive hormone and a second type of biomarker is a second type of female reproductive hormone ([0078]: “Sensor 920 is for estrogen, and sensor 922 is for progesterone, both of which have electrochemical aptamer-based sensors configured to operate at the analytes' natural concentration ranges found in biofluid”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the wearable biosensor disclosed by Sanati-Nezhad to include detection of reproductive hormones as disclosed by Heikenfeld in order to obtain a more robust data set.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/05/2025, with respect to the rejection(s) of claim(s) 1,2, and 15 under 35 U.S.C. § 102 have been fully considered and are persuasive. Specifically, as acknowledged by the office action filed 05/05/2026, Sanati-Nezhad does not teach every element disclosed by claim 5 which has been incorporated into claim 1. Therefore, the rejection has been withdrawn. However, a new ground(s) of rejection is made in view of 35 U.S.C. § 103 (see above). Sanati-Nezhad in view of Beech discloses the elements of claim 5, as stated in the previous office action and again above. Furthermore, while applicant states that Sanati-Nezhad does not disclose the limitation of claim 2 on page 8, no explanation is provided as to how the limitation differs. Sanati-Nezhad discloses rerouting of sweat periodically to provide continuous flow ([0041]: "thus providing continuous sweat flow into the device."), which thus occurring while the biosensing is performed. As such the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mallires et al. (US 20230301552 A1) – discloses a working electrode functionalized with an aptamer binding complex
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 2:00 - 6:00 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
