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 .
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites that “the microfluidic layer comprises a passive flow control capillary burst valve”; as this is further defining the contents of this layer the claim should recite that the layer further comprises this valve.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5, 10, 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 now recites that a single real-time measurement is collected by detecting a change in impedance “as sweat flows” and to use “the change in impedance measurements” to determine a flow rate. It is entirely unclear how many measurements are performed at any given time – a single measurement, as per “the real-time measurement”, or measurement of at least two values of impedance, to allow determination of a change between the two, or a plurality of measurements of impedance over time. Clarification is required.
Claim 5 now recites that “the real-time measurement collected by the electronics include a first real-time measurement” and the electronics further collect “a second real-time measurement”. The first clause of this is grammatically incorrect, and it is unclear if the intent is for the device of claim 1 to be configured to obtain a plurality of measurements, one of which is this “first” measurement and another which is the second measurement, or if the singular real-time measurement is the first measurement and then the second measurement is not included as part of the real-time measurement. Clarification is required.
Claim 10 still defines that the microfluidic layer comprises a microfluidic layer; it is unclear if the intent is for the device to comprise two microfluidic layers, possibly one within the other, or if claim 10 merely defines the material which the single microfluidic layer is comprised of; for the purposes of examination the claim will be treated as the latter but clarification is required.
Claim 12 recites that “the passive flow control capillary burst valve and the swelling hydrogel valve cooperate to capture sweat into each reservoir”. Per claim 11, the device comprises a plurality of burst valves, one associated with each reservoir, such that claim 12’s reference to “the” burst valve is unclear. Further, as only the first reservoir is defined as having a hydrogel burst valve, it is not possible to treat the claim as though this refers to the burst valve and hydrogel valve for each of the reservoirs. It is unclear how many valves of each type are being referred to and how they interact. Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7, 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cheng (US 2025/0120616).
Regarding claim 1, Cheng discloses a biosensor device comprising:
a first layer that couples the biosensor device to skin of a user (paragraph [0133], “a bottom layer that can pliably attach to the skin”);
a microfluidic layer coupled to the first layer (paragraph [0133], “a microfluidic channel layer”), wherein:
the microfluidic layer is configured to sequentially capture and store liquid collected from the skin of the user into discrete reservoirs (paragraph [0133], “multiple sensing chambers with hydrophobic valves, the sweat can be sequentially collected into each sensing chamber along the microfluidic channel at different times”);
the discrete reservoirs include a first reservoir configured to collect a first sample of the liquid, wherein the first sample of the liquid does not enter any other ones of the discrete reservoirs (paragraph [0133], “multiple sensing chambers with hydrophobic valves, the sweat can be sequentially collected into each sensing chamber along the microfluidic channel at different times”);
the discrete reservoirs include a second reservoir configured to collect a second sample of the liquid after the first sample is collected into the first reservoir, wherein the liquid from the skin collected into the second reservoir is directed to flow into the second reservoir so as to bypass the first reservoir (paragraph [0133], “multiple sensing chambers with hydrophobic valves, the sweat can be sequentially collected into each sensing chamber along the microfluidic channel at different times”); and
the microfluidic layer includes at least one valve configured to prevent the second sample collected into the second reservoir from contaminating the first sample collected into the first reservoir (paragraph [0133], “hydrophobic valves”);
a first sensor comprising laser induced graphene electrodes (figure 51), wherein the first sensor is configured to facilitate monitoring of a biological state or condition associated with the liquid collected from the skin of the user (paragraph [0133], “real-time sweat sampling and glucose analysis”); and
electronics coupled to the laser induced graphene electrodes of the first sensor that are configured to collect a real-time measurement of the biological state or condition (paragraph [0133], “real-time sweat sampling and glucose analysis”; paragraph [0113]).
Regarding claim 2, Cheng further discloses that:
the liquid collected from the skin of the user comprises sweat (paragraph [0133]);
the first sensor implements a sweat sensor (paragraph [0133]);
and the electronics collects the real-time measurement by detecting a change in impedance across the laser induced graphene electrodes as sweat flows over the first sensor (paragraph [0126]).
Regarding claim 7, Cheng further discloses that the laser induced graphene electrodes are formed on a polyimide film that that has been carbonized by a laser to form a graphite/graphene-like planar geometry (paragraph [0088]).
Regarding claim 8, Cheng further discloses that the first sensor comprises at least three laser induced graphene electrodes defining a working electrode, a reference electrode, and a counter electrode (paragraphs [0087]-[0088]), wherein:
platinum is deposited on the counter electrode (paragraph [0090]);
Ag/AgCl is provided on the reference electrode (figure 51); and
the working electrode is platinized, functionalized with an amine binding chemistry, and is bonded to a biorecognition element (paragraph [0090], [0122]-[0126]).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Emaminejad (US 2021/0076991).
Regarding claim 3, Cheng further discloses that the liquid collected from the skin of the user comprises sweat (paragraph [0133]) and the first sensor comprises a sweat sensor (paragraph [0133]); Cheng does not further disclose that the electrodes comprise a pair of parallel band electrodes that align along the first reservoir; the electronics collect real-time measurements by detecting a change in impedance across the laser induced graphene electrodes as sweat flows over the first sensor; and the electronics determine from the change in impedance measurements a flow rate of sweat into the first reservoir.
Emaminejad teaches a biosensor device comprising a microfluidic layer with a reservoir and a sweat sensor comprising electrodes (paragraph [0018]),
where the electrodes comprise a pair of parallel band electrodes that align along the reservoir (figure 3);
electronics collect real-time measurements by detecting a change in impedance across the electrodes as sweat flows over the sweat sensor (paragraph [0018]); and
the electronics determine from the change in impedance measurements a flow rate of sweat into the first reservoir (paragraph [0018]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Cheng with the electrodes configured as parallel band electrodes to use impedance measurements from these to measure the flow rate of the sweat, as taught by Emaminejad, in order to provide a measure of the amount a user is sweating.
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Mishra (US 2021/0290156).
Regarding claim 3, Cheng further discloses that the liquid collected from the skin of the user comprises sweat (paragraph [0133]) and the first sensor comprises a sweat sensor (paragraph [0133]); Cheng does not further disclose that the electrodes comprise a pair of parallel band electrodes that align along the first reservoir; the electronics collect real-time measurements by detecting a change in impedance across the laser induced graphene electrodes as sweat flows over the first sensor; and the electronics determine from the change in impedance measurements a flow rate of sweat into the first reservoir.
Mishra teaches a biosensor device comprising a microfluidic layer with a reservoir and a sweat sensor comprising electrodes (paragraphs [0057]-[0058], [0104]-[0105]),
where the electrodes comprise a pair of parallel band electrodes that align along the reservoir (elements 120, 320);
electronics collect real-time measurements by detecting a change in impedance across the electrodes as sweat flows over the sweat sensor (paragraph [0073]); and
the electronics determine from the change in impedance measurements a flow rate of sweat into the first reservoir (paragraph [0073]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Cheng with the electrodes configured as parallel band electrodes to use impedance measurements from these to measure the flow rate of the sweat, as taught by Mishra, in order to provide a measure of the amount a user is sweating.
Regarding claims 4 and 5, Cheng further discloses that the first sensor comprises a sweat sensor (paragraph [0133]) and the device further comprising a second sensor that implements a sweat sensor, the second sensor comprising laser induced graphene electrodes (paragraph [0133]) and facilitating monitoring of a biological state or condition associated with the liquid collected from the skin of the user (paragraph [0133]) including recording a chronological time stamp associated with fluid flowing into each reservoir (paragraph [0133]); Cheng does not disclose that the first reservoir and the second reservoir each form a serpentine pattern and the laser induced graphene electrodes of the first sensor comprise a first pair of parallel band electrodes that align along the serpentine pattern of the first reservoir, the second sensor’s electrodes being implemented as a second pair of parallel band electrodes that align along the serpentine pattern of the second reservoir, wherein the electronics collect a first real-time measurement by detecting a change in impedance across the first pair of parallel band electrodes as sweat flows over the first sensor and is collected into the first reservoir, the electronics record a volumetric flow rate of sweat flowing into the first reservoir, the electronics collect a second real-time measurement by detecting a change in impedance across the second pair of parallel band electrodes as sweat flows over the second sensor and is collected into the second reservoir, and the electronics record a volumetric flow rate of sweat flowing into the second reservoir.
Mishra teaches a biosensor device comprising a microfluidic layer with a serpentine reservoir (figure 5A) and a sweat sensor comprising electrodes (paragraphs [0057]-[0058], [0104]-[0105]),
where the electrodes comprise a pair of parallel band electrodes that align along the reservoir (elements 120, 320);
and electronics collect real-time measurements by detecting a change in impedance across the electrodes as sweat flows over the sweat sensor and recording a volumetric flow rate of sweat in the reservoir (paragraph [0073]); as modifying Cheng, which has at least two reservoirs with electrodes, Mishra’s teaching of the serpentine reservoir and parallel band electrodes recording flow rate would thus be applied to each reservoir resulting in a second serpentine reservoir, second flow rate sensors, and second flow rate determination.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Cheng with reservoirs being serpentine, as taught by Mishra, in order to conserve space, and the electrodes configured as parallel band electrodes to use impedance measurements from these to measure the flow rate of the sweat, as also taught by Mishra, in order to provide a measure of the amount a user is sweating.
Regarding claim 6, Cheng further discloses that the liquid collected from the skin of the user comprises sweat (paragraph [0133]) and the first sensor comprises a sweat sensor (paragraph [0133]); Cheng does not further disclose that the laser induced graphene electrodes comprise a pair of parallel band electrodes, the electronics collect real-time measurements by detecting a change in impedance across the laser induced graphene electrodes as sweat flows over the first sensor, and the pair of parallel band electrodes of the first sensor form a closed loop such that an initial resistance across the pair of electrodes is not infinite.
Mishra teaches a biosensor device comprising a microfluidic layer with a reservoir and a sweat sensor comprising electrodes (paragraphs [0057]-[0058], [0104]-[0105]),
where the electrodes comprise a pair of parallel band electrodes that align along the reservoir (elements 120, 320);
electronics collect real-time measurements by detecting a change in impedance across the electrodes as sweat flows over the sweat sensor (paragraph [0073]); and the pair of parallel band electrodes form a closed loop (paragraphs [0081]-[0084]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Cheng with the electrodes configured as parallel band electrodes to use impedance measurements from these to measure the flow rate of the sweat, as taught by Mishra, in order to provide a measure of the amount a user is sweating. Mishra does not explicitly teach an initial resistance across the pair of electrodes not being infinite, but as there are a finite number of identified, predictable options for the initial resistance (infinite or not infinite), each having a reasonable expectation of success, given that the disclosure of the instant invention describes use of either as being equally successful and useful in the instant invention, see paragraphs [00112], [00192], [00213] as filed, it would be obvious to try making the initial resistance not infinite.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Rogers (US 2018/0064377).
Regarding claim 9, Cheng does not disclose that the at least one valve of the microfluidic layer that prevents the second sample collected into the second reservoir from contaminating the first sample collected into the first reservoir comprises a swelling hydrogel valve that contacts the sweat collected into the first reservoir, swells and collapses an inlet channel of the first reservoir. Rogers teaches a biosensor device comprising a microfluidic layer coupled to a first layer, the microfluidic layer configured to sequentially capture and store liquid collected from skin into discrete reservoirs and comprising at least one valve that prevents liquid collected into a second reservoir from contact liquid in a first reservoir, where the valve comprises a swelling hydrogel valve that contacts the sweat collected into the first reservoir, swells and collapses an inlet channel of the first reservoir (paragraphs [0185]-[0187]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Cheng with a swelling hydrogel valve, as taught by Rogers, in order to ensure separation of the liquid based on time of capture.
Regarding claim 10, Cheng further discloses that the microfluidic layer comprises Polydimethylsiloxane (PDMS) (paragraph [0104]); Cheng does not further disclose that the swelling hydrogel valve comprises a sodium acrylate hydrogel that is patterned in a channel of the microfluidic layer and is configured to swell when in contact with a liquid, closing off the channel. Rogers further teaches that the swelling hydrogel valve comprises a sodium acrylate hydrogel that is patterned in a channel of the microfluidic layer and is configured to swell when in contact with a liquid, closing off the channel (paragraphs [0185]-[0187]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Cheng, as modified by Rogers, using a sodium acrylate hydrogel for the swelling hydrogel valve, as further taught by Rogers, as Rogers teaches that this material is “super absorbent” (paragraph [0185]) which would ensure the valve functions as desired.
Regarding claims 11 and 12, Rogers further discloses that the microfluidic layer further comprises at least one passive flow control capillary burst valve (CBV) associated with each discrete reservoir that controls filling of the associated discrete reservoir, wherein the at least one capillary burst valve and the at least one hydrogel valve cooperate to capture sweat into each reservoir (figure 25, showing multiple valves associated with each reservoir; claim 34 sets forth the use of both a hydrogel (SAP) and CBV). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Cheng, as modified by Rogers, further including a CBV for each reservoir where the hydrogel valve and the CBV cooperate to capture sweat in their respective reservoir, as further taught by Rogers, in order to ensure time-sequenced sampling (paragraph [0173]).
Response to Arguments
Applicant's arguments filed 6 August 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant asserts that all issues have been resolved via the amendments to the claims; this is not the case, as set forth above.
Regarding the rejections under Cheng, Applicant argues that Cheng does not disclose a microfluidic layer with a plurality of discrete reservoirs including first and second reservoirs where liquid flowing to the second is configured to bypass the first. As noted by Applicant, Cheng discloses sequential sample collection into a plurality of reservoirs. It is entirely unclear what particular aspect of Cheng’s disclosure of a microfluidic layer with a plurality of reservoirs (paragraph [0133], “multiple sensing chambers”) where after some “first” reservoir is closed via a valve (paragraph [0133], “By exploiting multiple sensing chambers with hydrophobic valves, the sweat can be sequentially collected into each sensing chamber”), fluid is bypassed into a “second” chamber (paragraph [0133], “sweat can be sequentially collected into each sensing chamber along the microfluid channel at different times”) differs from the invention as claimed. Applicant merely asserts that Cheng’s disclosure lacks specifics, but has not pointed to any particular limitation that is not clearly disclosed by Cheng.
The Examiner notes that Applicant does not present any remarks regarding the modifying references or dependent claims beyond referring to the supposed deficiencies of Cheng regarding claim 1; as Cheng clearly discloses all the limitations of that claim, the assertion of deficiency is moot.
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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/KAREN E TOTH/ Examiner, Art Unit 3791
