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 .
Response to Amendments
This Office Action is in response to the Amendment filed 5/12/2026. As directed by the Amendment, claims 1, 2, 11, 12, 14-17, and 20 are amended. Claims 1-20 are pending in the application.
The rejections under 35 U.S.C. 112(b) to claims 2 and 16 are withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments, see Remarks, filed 5/12/2026, with respect to the rejections of claims 1-8, 11-18, and 20 under 35 USC § 102 and the rejections of claims 9, 10, and 19 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Marchand et al. (US 20120283529 A1 – Cited by Applicant) (see below under Claim Rejections - 35 USC § 103).
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.
Claims 1-8, 11-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. (Koh, A., Kang, D., Xue, Y., Lee, S., Pielak, R. M., Kim, J., Hwang, T., Min, S., Banks, A., Bastien, P., Manco, M. C., Wang, L., Ammann, K. R., Jang, K.-I., Won, P., Han, S., Ghaffari, R., Paik, U., Slepian, M. J., & Balooch, G. (2016). A Soft, Wearable Microfluidic Device for the Capture, Storage, and Colorimetric Sensing of Sweat. Science Translational Medicine, 8(366), 366ra165. – Cited by Applicant), hereinafter Koh, in view of Marchand et al. (US 20120283529 A1 – Cited by Applicant), hereinafter Marchand.
Regarding claim 1, Koh discloses a detector [see Figs. 1A – 1B], comprising:
a substrate [PDMS microfluidic channel, see in Fig. 1A];
a detector array applied to the substrate [a sealed collection of soft microfluidic channels and reservoirs filled with color-responsive materials for quantitative analysis of sweat volume and chemistry, see on pg. 2, Results, under Soft epidermal microfluidic device for sweat monitoring; colorimetric dye, see in Fig. 1] and configured to detect a parameter of an analyte from a target location of a subject's anatomy [Chloride, lactate, pH glucose, see in Fig. 1B]; and
a target facing component [Adhesive layer, see in Fig. 1A] configured to engage the subject's anatomy [adhesive layer with matching holes bonded to the bottom surface of the device on one side and to the skin on the other, see on pg. 11, section Fabrication of epidermal microfluidic devices with integrated electronics for colorimetric sweat analysis; Backside inlet/harvesting area, see in Fig. 1B];
wherein the substrate is configured to orient the detector array adjacent the target location of the subject's anatomy and expose the detector array to the analyte from the target location [Bonding separate pieces of PDMS formed in this manner defined sealed microfluidic channels and containment reservoirs. Mechanical punches created openings to define the inlets for sweat collection. A separate, double-sided thin adhesive layer with matching holes bonded to the bottom surface of the device on one side and to the skin on the other, see on pg. 11, section Fabrication of epidermal microfluidic devices with integrated electronics for colorimetric sweat analysis; see in Fig. 1D].
Examiner notes that Koh discloses a gas permeable substrate as a part of the detector [see in Fig. 1A]. Koh fails to explicitly disclose that the analyte is gaseous.
However, Marchand discloses detection of a gaseous analyte [the detection of at least one metabolite, only in gas form, resulting from the metabolism or the degradation of the analyte, see in ¶ 0023].
Koh and Marchand are both analogous to the claimed invention because they are in the same field of analyte detectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Koh to incorporate the teachings of Marchand and include that a gaseous analyte can be detected with the disclosed detector in order to detect all targeted analytes, including those that have evaporated from bodily fluid in the detection area.
Regarding claim 2, Koh, as modified, discloses the detector of claim 1, wherein:
the target facing component has a first surface configured to face away from the target location and a second surface opposite of the first surface and configured to face the target location when the target facing component is engaged with the subject's anatomy [Top side, Backside, see in Figs. 1A and 1B]; and
the detector array is applied to the first surface of the substrate [Colorimetric dye adhered to top side, see in Figs. 1A and 1B].
Regarding claim 3, Koh, as modified, discloses the detector of claim 1, wherein the substrate is a hydrophobic, gas permeable material [Examiner notes that PDMS is inherently hydrophobic and gas permeable].
Regarding claim 4, Koh, as modified, discloses the detector of claim 1, wherein the target facing component is flexible [see in Fig. 1E].
Regarding claim 5, Koh, as modified, discloses the detector of claim 1, further comprising: a cover extending over the detector array, secured to the target facing component and the substrate, and defining the opening [PDMS layer, see in Fig. 1A].
Regarding claim 6, Koh, as modified, discloses the detector of claim 5, wherein the cover is transparent and configured such that the detector array is analyzable through the cover [see in Fig. 4C].
Regarding claim 7, Koh, as modified, discloses the detector of claim 1, further comprising: a support extending through the opening and configured to maintain a space between the subject's anatomy and the substrate when the target facing component is engaging the subject's anatomy [adhesive layer with harvesting areas provides support to maintain space between skin and the microfluidic system, see in Fig. 1B].
Regarding claim 8, Koh, as modified, discloses the detector of claim 1, further comprising: tubing configured to facilitate applying a flow of fluid to the opening [microfluidic channel, see in Fig. 1A; Openings defined the sweat harvesting areas (3 mm diameter, corresponding to -10 sweat glands) (34) through which sweat could pass into inlet regions of the overlying soft microfluidic system (Fig.1B). The pressure that drives fluid flow arises from the action of the sweat glands themselves, assisted by capillary effects in the microchannels and the materials embedded within them, see on pg. 2, bottom of Col. 1].
Regarding claim 11, Koh, as modified, discloses the detector of claim 1, wherein: the detector array has a control pattern [reference color markers, see in Figs. 1A and 1B] having a first configuration and a gaseous analyte sensitive pattern [microfluidic system, see in Figs. 1A and 1B] having a second configuration that is substantially similar to the first configuration [Examiner notes that both are in disc form, see in Figs. 1A and 1B]; the control pattern is configured to be non-reactive to the gaseous analyte from the subject; and the analyte sensitive pattern is configured to react to the gaseous analyte from the subject [reference color markers used for control while microfluidic system reacts to analytes, see on pg. 3].
Regarding claim 12, Koh, as modified, discloses a detector device [see in Figs. 1A and 1B] comprising:
a housing component [PDMS microfluidic channel and cover, see in Fig. 1A]; and
a detecting component at least partially covered by the housing component [PDMS microfluidic channel and cover, see in Fig. 1A]; and
wherein the detecting component is configured to detect a parameter of a gaseous analyte [Chloride, lactate, pH Glucose, see in Fig. 1B] from a target location on a subject's anatomy [see Figs. 1D and 5B] and the housing component is flexible [see in Fig. 1E] and configured to define an opening between the target location and the detecting component [Inlet/harvesting area, see in Figs. 1B and 1C].
Regarding claim 13, Koh, as modified, discloses the detector device of claim 12, wherein the housing component includes a target facing component and a cover component coupled to the target facing component [Cover, Microfluidic, adhesive, see in Fig. 1A].
Regarding claim 14, Koh, as modified, discloses the detector device of claim 13, wherein the target facing component is configured to direct a fluid flow including the gaseous analyte from the target location of the subject's anatomy to the detecting component [Bonding separate pieces of PDMS formed in this manner defined sealed microfluidic channels and containment reservoirs. Mechanical punches created openings to define the inlets for sweat collection, see on pg. 11, under section Fabrication of epidermal microfluidic devices with integrated electronics for colorimetric sweat analysis].
Regarding claim 15, Koh, as modified, discloses the detector device of claim 12, wherein the detecting component comprises: a substrate secured to the housing component; and an array of analyte sensitive material applied to the substrate and configured to chemically react to the gaseous analyte [Quantitative colorimetric assay reagents in the reservoirs enabled assessment of pH and the concentration selected essential markers, including glucose, lactate, and chloride, through either enzymatic or chromogenic reactions, see on pg. 2, top of Col. 2].
Regarding claim 16, Koh, as modified, discloses the detector device of claim 12, wherein the detecting component is configured to passively detect the parameter of the gaseous analyte from the target location on the subject's anatomy [Sweat collected from volunteers participating in a competitive long-distance outdoor bicycling race, see on pg. 8, top of Col. 2] .
Regarding claim 17, Koh, as modified, discloses a method of detecting analytes from a target location of a subject's anatomy, the method comprises:
preparing a surface of the target location of the subject's anatomy for detection of a gaseous analyte from the target location [Skin marked with purple ink from pen prior to application of the device, see in Fig. 6D description];
positioning a detector at a desired location [sweat patches were placed on two different geographical body areas (volar arm and lower back), see on pg. 11, first paragraph] and exposing a detecting component of the detector to the gaseous analyte from the target location [Bonding separate pieces of PDMS formed in this manner defined sealed microfluidic channels and containment reservoirs. Mechanical punches created openings to define the inlets for sweat collection. A separate, double-sided thin adhesive layer with matching holes bonded to the bottom surface of the device on one side and to the skin on the other, see on pg. 11, section Fabrication of epidermal microfluidic devices with integrated electronics for colorimetric sweat analysis; see in Fig. 1D] via an opening between the target location and the detecting component [Inlet/harvesting area, see in Figs. 1B and 1C], the detecting component including a substrate and analyte sensitive material applied to a side of the substrate facing away from the target location [PDMS microfluidic channel as substrate, colorimetric dye as analyte sensitive material, colorimetric dye applied to side facing away from adhesive location, see in Fig. 1A]; and
analyzing the analyte sensitive material of the detecting component after the detecting component is exposed to the gaseous analyte from the target location [Recording color changes and converting them into quantitative information were accomplished by digital image capture and analysis. Figure 4A shows frames from a video clip (movie S1) in which the proximity of a smartphone to the device initiated image capture and analysis software automatically using NFC, see on pg. 6, under section NFC interface to a smartphone and image processing and Fig. 4A].
Regarding claim 18, Koh, as modified, discloses the method of claim 17, wherein positioning the detector at the desired location includes securing the detector at the desired location with an adhesive [Adhesive layer, see in Fig. 1A] and the method further comprises: removing the detector after a predetermined time at which the adhesive no longer adheres to the desired location [Examiner notes that removal of the adhesive after a predetermined time at which it no longer adheres to the desired location is an inherent trait of utilizing an adhesive product].
Regarding claim 20, Koh, as modified, discloses the method of claim 17, wherein exposing the detecting component to the gaseous analyte from the target location includes pumping fluid including the gaseous analyte across the detecting component [Openings defined the sweat harvesting areas (3 mm diameter, corresponding to -10 sweat glands) (34) through which sweat could pass into inlet regions of the overlying soft microfluidic system (Fig.1B). The pressure that drives fluid flow arises from the action of the sweat glands themselves, assisted by capillary effects in the microchannels and the materials embedded within them, see on pg. 2, bottom of Col. 1].
Claims 9, 10, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Koh (Koh, A., Kang, D., Xue, Y., Lee, S., Pielak, R. M., Kim, J., Hwang, T., Min, S., Banks, A., Bastien, P., Manco, M. C., Wang, L., Ammann, K. R., Jang, K.-I., Won, P., Han, S., Ghaffari, R., Paik, U., Slepian, M. J., & Balooch, G. (2016). A Soft, Wearable Microfluidic Device for the Capture, Storage, and Colorimetric Sensing of Sweat. Science Translational Medicine, 8(366), 366ra165. – Cited by Applicant) in view of Marchand (US 20120283529 A1 – Cited by Applicant), further in view of Jacobs et al. (US 20150359469 A1 – Cited by Applicant), hereinafter Jacobs.
Regarding claim 9, Koh, as modified, discloses the detector of claim 1.
Koh fails to disclose the detector further comprising a band configured to be worn by the subject against skin of the subject; and wherein the detector array and the substrate are incorporated into the band such that the detector array is exposed to the target location of the subject's anatomy through the substrate when the band is worn by the subject.
However, Jacobs discloses a band configured to be worn by the subject against skin of the subject; and wherein the detector array and the substrate are incorporated into the band such that the detector array is exposed to the target location of the subject's anatomy through the substrate when the band is worn by the subject [see in Figs. 1-3].
Koh and Jacobs are both analogous to the claimed invention because they are in the same field of non-invasively detecting analytes from biological samples. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Koh to incorporate the teachings of Jacobs and include that there is a band configured to be worn by the subject against skin of the subject; and wherein the detector array and the substrate are incorporated into the band such that the detector array is exposed to the target location of the subject's anatomy through the substrate when the band is worn by the subject, in order to add another measure of security to the placement of the detector when placed on the arm.
Regarding claim 10, Koh, as modified, discloses the detector of claim 1.
Koh fails to disclose the detector further comprising a wound dressing configured to cover a portion of the detector array.
However, Jacobs discloses a wound dressing configured to cover a portion of the detector array [a bandage-like patch, see in ¶ 0016 and Figs. 5-7].
Koh and Jacobs are both analogous to the claimed invention because they are in the same field of non-invasively detecting analytes from biological samples. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Koh to incorporate the teachings of Jacobs and include a wound dressing configured to cover a portion of the detector array in order to further secure the detector to the skin with a greater surface area of adhesion.
Regarding claim 19, Koh, as modified, discloses the method of claim 17.
Koh fails to disclose wherein positioning the detector at the desired location includes securing the detector at the desired location includes securing the detector at the desired location with a band.
However, Jacobs discloses positioning the detector at the desired location includes securing the detector at the desired location includes securing the detector at the desired location with a band [see in Figs. 1-3].
Koh and Jacobs are both analogous to the claimed invention because they are in the same field of non-invasively detecting analytes from biological samples. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Koh to incorporate the teachings of Jacobs and include that positioning the detector at the desired location includes securing the detector at the desired location includes securing the detector at the desired location with a band in order to add another measure of security to the placement of the detector when placed on the arm, in addition to the adhesion layer.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HY KHANH DOAN/ Examiner, Art Unit 3791
/TSE CHEN/ Supervisory Patent Examiner, Art Unit 3791
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