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 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.
Claim 2 and 16 is 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 2 recites the limitation "the first surface of the substrate.” Examiner notes that claim 2 defines a first surface of “the target facing component.” “The substrate is referred to in claim 1 but no particular surface portions are mentioned. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the claim, as written, is not clear in pointing out the subject matter which the inventor regards as the invention, as there appears to be extraneous terms in the claim. In particular, “further comprising: tubing configured to” appear to be the extraneous terms. For purposes of examination, the previously listed terms will be ignored and claim 16 will be interpreted as the following: The detector device of claim 12, wherein the detecting component is configured to passively detect the parameter of the analyte from the target location on the subject's anatomy.
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.
Claims 1-8, 11-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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.
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].
Regarding claim 2, Koh 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 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 discloses the detector of claim 1, wherein the target facing component is flexible [see in Fig. 1E].
Regarding claim 5, Koh 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 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 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 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 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 an 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 analyte from the subject; and the analyte sensitive pattern is configured to react to the analyte from the subject [reference color markers used for control while microfluidic system reacts to analytes, see on pg. 3].
Regarding claim 12, Koh 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 an 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 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 discloses the detector device of claim 13, wherein the target facing component is configured to direct a fluid flow including the 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 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 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 discloses the detector device of claim 12, wherein the detecting component is configured to passively detect the parameter of the 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 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 an 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 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 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 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 discloses the method of claim 17, wherein exposing the detecting component to the analyte from the target location includes pumping fluid including the 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].
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 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 Jacobs et al. (US 20150359469 A1 – Cited by Applicant), hereinafter Jacobs.
Regarding claim 9, Koh 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 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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rogers et al. (US 20180064377 A1)
Rogers et al. (US 20170231571 A1)
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/HY KHANH DOAN/Examiner, Art Unit 3791