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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 3-5, 7, 10-11 ,13-14, 17-19, and 22) in the reply filed on 07/27/2026 is acknowledged, as well as the election without traverse of
Species 1A (the plurality of planar electrodes are arranged facing towards (or adjacent to) at least one of the second region 102b or the third region 102c),
Species 2A (the three-layer ultrathin cellulose paper 202, folded with both inlet 202a' (for sweat intake) and outlet 202b' (for sweat evaporation)), and
Species 3C (the side view illustrating the kirigami paper fluidic with an additional evaporation pad for improved evaporation rate, in an integrated sweat sensor).
Claim 1, 3-5, 7, 10-11 ,13-14, 17-19, and 22 are pending and under examination and claims 25 and 27-32 are hereby withdrawn.
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 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance,
claim 3 recites the broad recitation “wherein the continuous piece of hydrophilic paper has a thickness ranging from about 0.01 mm to about 0.2 mm”, and the claim also recites “or preferably from about 0.04 mm to about 0.06 mm” which is the narrower statement of the range/limitation,
claim 4 recites the broad recitation “wherein the continuous piece of hydrophilic paper has a porosity larger than 50%”, and the claim also recites “or preferably larger than 60%, or more preferably larger than 70%” which is the narrower statement of the range/limitation,
claim 5 recites the broad recitation “wherein the continuous piece of hydrophilic paper has an average pore size larger than 20 um”, and the claim also recites “or preferably larger than 40 um” which is the narrower statement of the range/limitation,
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1, 7, 10, 14, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bo et al. (CN 109060923).
In re claim 1, Bo discloses a sweat sensing device (fig. 1, combination of 101, 102, 103; [0035]) comprising:
a continuous piece of hydrophilic paper (101; [0035]) comprising
a first region (fig. 2: 201) configured to receive sweat [0035],
a second region (205) opposite to the first region (fig. 2), and
a third region (203) between the first region and the second region (fig. 2),
*the continuous piece of hydrophilic paper being adapted for the received sweat to diffuse laterally along the continuous piece of hydrophilic paper from the first region to the second region via the third region ([0035]: vertically penetrating hydrophilic layer 103 is hydrophilic, and surrounding hydrophobic layer 102 is hydrophobic, resulting in a sample liquid diffusing from the bottom 201 layer to the top 205 layer using the hydrophilic layer 103 as a guide channel; figs. 1-2; [0036]);
a flexible hydrophobic film (fig. 1: 102 is able to bend as shown in fig. 2 and is therefore considered flexible; [0031]) having an opening (fig. 2: when film is folded, there are openings such as under sections 202 and 203, as well as under sections 204 and 205),
the flexible hydrophobic film and the continuous piece of hydrophilic paper being arranged adjacent to each other (fig. 2: when folded, parts of 102 are adjacent with 101; [0035]) with the opening aligned to and exposing the second region (fig. 2: opening under 205 exposed when folded; [0035]); and
a sensor unit (204; [0037]) configured to facilitate a measurement based on the diffused sweat [0037],
wherein the flexible hydrophobic film and the continuous piece of hydrophilic paper are collectively folded in a stacked manner (fig. 2 and fig. 3) such that the sensor unit is sandwiched between the third region and the second region (fig. 2: 204 sandwiched between 203 and 205).
*Regarding the limitations, “the continuous piece of hydrophilic paper being adapted for the received sweat to diffuse laterally along the continuous piece of hydrophilic paper from the first region to the second region via the third region” Examiner asserts that the recited limitations is a recitation of functional language of the claimed invention.
The recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the continuous piece of hydrophilic paper has all the necessary structures directed to the hydrophilic layer and hydrophilic layer to result in the continuous piece of hydrophilic paper being configured for the received sweat diffusing laterally along the continuous piece of hydrophilic paper from the first region to the second region via the third region; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432).
In re claim 7, Bo discloses wherein the sensor unit comprises
a planar substrate (fig. 2: 206 is part of 204); and
a plurality of planar electrodes disposed on the planar substrate ([0038]: 206 comprises electrodes; [0044]).
In re claim 10, Bo discloses wherein the planar substrate comprises
a rigid substrate, or
a flexible substrate ([0035]: paper sheet which includes 204 is flexible to fold the sheet; [0014]), or
a stretchable substrate.
In re claim 14, Bo discloses wherein in the stacked manner (fig. 2), the plurality of planar electrodes is arranged facing towards at least one of the second region or the third region (fig. 2: planar electrodes on 204 are facing third region 203).
In re claim 17, Bo discloses
wherein the first region is extended laterally away from the third region (fig. 2: 201 is extended laterally away from the third region) along a same plane (fig. 2: 201 and 203 are both flat) such that the stacked manner (fig. 3) forms a U- bended shape (fig. 3: 301 and 303 make a U-bended shape when stacked) with the first region providing a sweat collection portion ([0036]: 201 is a sweat collection layer) arranged laterally adjacent to the third region (fig. 3: 301 i.e. 201 is laterally adjacent to third region 303 i.e. 203 when stacked since they are positioned side to side looking from bottom to top of the stacked manner; fig. 2) providing a sensing layer ([0037]: 203 is a swear analysis layer; ), and
the second region providing an evaporation layer ([0045]: 205 is an evaporation layer).
In re claim 18, Bo discloses
wherein the first region and the third region are folded over each other (fig. 3) with corresponding parts of the flexible hydrophobic film facing each other such that the stacked manner forms a continuous zig-zag shape (fig. 3: stacked manner forms a zig-zag shape; fig. 2) with the first region providing a sweat collection layer (see in re claim 17 above),
the third region providing a sensing layer (see in re claim 17 above) and the second region providing an evaporation layer (see in re claim 17 above).
In re claim 19, Bo discloses
further comprising a further flexible hydrophobic film (202) having an aperture (fig. 2: top surface of 202; [0040]: 302 layer on 202 is circular),
the further flexible hydrophobic film and the continuous piece of hydrophilic paper being arranged adjacent to each other ([0040]: top surface 302 would be placed adjacent i.e. on top of the hydrophilic paper; figs. 2-3) with the aperture aligned to and exposing the first region (fig. 2: 302 would be aligned to and exposes 201; fig. 3).
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bo et al. (CN 109060923) in view of Velev et al. (US 2020/0163656).
In re claim 3, Bo fails to disclose wherein the continuous piece of hydrophilic paper has a thickness ranging from about 0.01 mm to about 0.2 mm, or preferably from about 0.04 mm to about 0.06 mm.
Velev teaches an analogous microfluidic device [0006] for monitoring one or more analytes in a fluid [0006], and teaches wherein a continuous piece of hydrophilic ([0006]: hydrophilic substrate) paper [0007] has a thickness ranging from about 0.01 mm to about 0.2 mm [0006].
Velev further teaches that the hydrophilic substrate may have a variety of thicknesses [0055].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the sweat sensing device taught by Bo, to provide wherein the continuous piece of hydrophilic paper has a thickness ranging from about 0.01 mm to about 0.2 mm, as taught by Velev, because the hydrophilic substrate may have a variety of thicknesses.
Further, at the time the instant application was filed it would be obvious to try to provide wherein the continuous piece of hydrophilic paper has a thickness ranging from about 0.01 mm to about 0.2 mm, or preferably from about 0.04 mm to about 0.06 mm. When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed thickness of the continuous piece of hydrophilic paper is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the continuous piece of hydrophilic paper has a thickness ranging from about 0.01 mm to about 0.2 mm, or preferably from about 0.04 mm to about 0.06 mm”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the continuous piece of hydrophilic paper has a thickness ranging from about 0.01 mm to about 0.2 mm, or preferably from about 0.04 mm to about 0.06 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bo et al. (CN 109060923) in view of Yoshimasa et al. (US 2010/0062031).
In re claim 4, Bo fails to disclose wherein the continuous piece of hydrophilic paper has a porosity larger than 50%, or preferably larger than 60%, or more preferably larger than 70%.
Yoshimasa teaches an antibacterial sheet [0014] that dissolves in sweat [0014, 0025] wherein continuous piece of hydrophilic paper ([0018]: base member may be a paper sheet and formed of hydrophilic material) has a porosity larger than 50% ([0018]: porosity is preferably 10-60%).
Yoshimasa further teaches that the porosity of a hydrophilic film may be varied as needed [0018].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the sweat sensing device taught by Bo, to provide wherein the continuous piece of hydrophilic paper has a porosity larger than 50%, as taught by Yoshimasa, because the porosity of a hydrophilic film may be varied as needed.
Further, at the time the instant application was filed it would be obvious to try to provide wherein the continuous piece of hydrophilic paper has a porosity larger than 50%, or preferably larger than 60%, or more preferably larger than 70%. When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed porosity of the continuous piece of hydrophilic paper is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the continuous piece of hydrophilic paper has a porosity larger than 50%, or preferably larger than 60%, or more preferably larger than 70%”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the continuous piece of hydrophilic paper has a porosity larger than 50%, or preferably larger than 60%, or more preferably larger than 70%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bo et al. (CN 109060923) in view of Geiger et al. (US 2010/0267065).
In re claim 5, Bo fails to disclose wherein the continuous piece of hydrophilic paper has an average pore size larger than 20 um, or preferably larger than 40 um.
Geiger teaches an analogous device [0002, 0009] for assessing variables of a fluid [0002] wherein a continuous piece of hydrophilic paper ([0121]: substrate may comprise of areas of various mediums such as a hydrophilic material and a porous medium; [0214]: hydrophilic surface of a capillary reservoir that permits fluid to pass over it) has an average pore size larger than 20 um ([0214]: pore size can be 20 um or more).
Geiger further teaches that different fluids will pass through different pore sizes [0214].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the sweat sensing device taught by Bo, to provide wherein the continuous piece of hydrophilic paper has an average pore size larger than 20 um, as taught by Geiger, because different fluids will pass through different pore sizes.
Further, at the time the instant application was filed it would be obvious to try to provide wherein the continuous piece of hydrophilic paper has an average pore size larger than 20 um, or preferably larger than 40 um. When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed average pore size of the continuous piece of hydrophilic paper is not disclosed as being crucial or unexpected.
Even if the proposed combination fails to yield “wherein the continuous piece of hydrophilic paper has an average pore size larger than 20 um, or preferably larger than 40 um”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the continuous piece of hydrophilic paper has an average pore size larger than 20 um, or preferably larger than 40 um, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bo et al. (CN 109060923) in view of Javey et al. (US 2018/0263539).
In re claim 11, Bo fails to disclose
wherein the rigid substrate comprises polycarbonate or polymethylmethacrylate;
the flexible substrate comprises polyimide, polyamide, polyethylene terephthalate, polyethylene naphthalate, polypropylene, or polyetheretherketone; and
the stretchable substrate comprises polydimethylsiloxane or styrene-ethylene-butylene-styrene.
Javey teaches an analogous wearable biometric monitoring system [0008] for measuring swear of a user [0008] and teaches wherein microsensor arrays [0150] are fabricated on a flexible substrate ([0150]: flexible polyethylene terephthalate (PET) substrate) that comprises of polyethylene terephthalate [0150].
Javey further teaches that the PET substrate forms a stable sensor-skin contact [0058].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the flexible substrate comprises taught by Bo, to provide wherein the flexible substrate comprises polyethylene terephthalate, as taught by the flexible PET substrate of Javey, because doing so forms a stable sensor-skin contact.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bo et al. (CN 109060923) in view of Emaminejad (US 2020/0205721).
In re claim 13, Bo fails to disclose wherein the plurality of planar electrodes comprises multiplexed sensing electrodes.
Emaminejad teaches a wearable device [0005] that is analogous in providing sweat analysis [0005] using a sensing module [0005], and teaches wherein a plurality of planar electrodes ([0011]: sensing compartments which are part of a multiplexed sensing module are interpreted as planar electrodes) comprises multiplexed sensing electrodes ([0011]: each sensing compartment includes a variety of sensors such as for measuring sweat, pH, etc. and are interpreted as multiplexed sensing electrodes).
Emaminejad further teaches that multiplexed sweat analysis allows for various data related to a patient to be measured [0011], for instance their sweat rate [0011], skin temperature [0011], pH [0011], and sweat analyte [0011].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the sweat sensing device taught by Bo, to provide wherein the plurality of planar electrodes comprises multiplexed sensing electrodes, as taught by Emaminejad, because various data related to a patient to be measured, for instance their sweat rate, skin temperature, pH, and sweat analyte.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bo et al. (CN 109060923) in view of Heikenfeld (US 2019/0082999).
In re claim 22, Bo fails to disclose further comprising an external evaporation pad placeable over the opening to enhance passive evaporation of the diffused sweat.
Heikenfeld teaches an analogous health monitoring device [] for continuous health monitoring [] and teaches an external evaporation pad (fig. 11: 1113; [0080]) placeable over an opening (fig. 11: 1110 has a portion between 1122 and 1120 which curves downward and creates a gap (opening) that 1113 is placed on top of) to enhance passive evaporation of the diffused sweat [0080].
Heikenfeld further teaches that the external evaporative textile surface promotes constant promote constant wicking of sweat so a sensor can measure sweat saturation [0080].
The proposed combination would yield wherein the opening portion of Bo (fig. 2: when film is folded, there are openings such as under sections 202 and 203, as well as under sections 204 and 205) includes as external evaporative textile surface that promotes constant wicking of sweat.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the sweat sensing device taught by Bo, to provide external evaporation pad placeable over the opening to enhance passive evaporation of the diffused sweat, as taught by Heikenfeld, because doing so promotes constant promote constant wicking of sweat so a sensor can measure sweat saturation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Kongsuphol et al. (US 2023/0375531) discloses a method of detecting an analyte in a sample (abstract), wherein the sample may be sweat [0047], and teaches a folded and printed cellulose test strip (fig. 9: A; [0172]) with hydrophilic regions [0172].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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