DETAILED ACTION
Applicant’s arguments, filed 11/12/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has canceled claim 18 and added claims 21-22.
Claims 1, 3-8, 14-17, and 19-22 are the current claims hereby under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
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 § 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, 4, 14-15, 17, and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz (US 10034625 – cited by Applicant).
Regarding claim 1, Schwartz teaches a wearable sweat sensor for detecting one or more analytes in human sweat (Col 9, lines 6-23) comprising:
an optical module comprising a pulse oximeter having at least one light source and at least one light detector attached to a support (Col 12, lines 15-20);
at least one sensor layer, to contact the human sweat on a surface of skin of a user (Figs. 3A-C, assay component 330 contacting skin 305; Col 23, lines 12-14), the at least one sensor layer being optically coupled to the optical module and, having optical absorbance properties that are dependent on a concentration of a target analyte of said one or more analytes (Col 4, lines 1-7); and
one or more processors in communication with the optical module (Fig. 1, controller 150 and processor 186) and being configured to:
cause light from the at least one light source to be transmitted towards, and/or through, the at least one sensor layer (Col 12, lines 18-20);
obtain, from the at least one light detector, one or more optical signals reflected and/or transmitted from the at least one sensor layer (Col 12, lines 18-20); and
determine, from at least one wavelength component of the one or more optical signals, a target analyte concentration (Col 1, lines 59-61).
Regarding claim 4, Schwartz further teaches wherein the one or more processors are further configured to determine, from the one or more optical signals, a heart rate, in addition to determining the target analyte concentration (Col 3, lines 49-51).
Regarding claim 14, Schwartz further teaches a plurality of sensor layers each being configured to detect a different target analyte of said one or more analytes (Col 6, lines 4-9; Col 1, line 62 – Col 2, line 3).
Regarding claim 15, Schwartz further teaches wherein at least one of said sensor layers comprises a plurality of regions each being configured to detect a different target analyte of said one or more analytes (Col 12, lines 52-67).
Regarding claim 17, Schwartz further teaches wherein the at least one sensor layer comprises a plurality of regions each having different thickness and/or surface texture (Col 6, lines 10-27).
Regarding claim 19, Schwartz further teaches wherein the at least one sensor layer forms a protective layer of the pulse oximeter (Fig. 2B, protective layer 263).
Regarding claim 20, Schwartz further teaches comprising one or more of a band, clip, and adhesive layer for attachment of the support to the user (Col 4, lines 45-48).
Regarding claim 21, Schwartz teaches a wearable sweat sensor for detecting one or more analytes in human sweat, comprising:
an optical module comprising a pulse oximeter having at least one light source and at least one light detector attached to a support (Col 12, lines 15-20);
a sensor layer to contact the human sweat on a surface of skin of a user (Figs. 3A-C, assay component 330 contacting skin 305; Col 23, lines 12-14), the at least one sensor layer being optically coupled to the optical module and, having optical absorbance properties that are dependent on a concentration of a target analyte of said one or more analytes (Col 4, lines 1-7);
a processor in communication with the optical module and being configured to use light transmitted from the light source and impinging the at least one sensor layer to determine a target analyte concentration therefrom (Fig. 1, controller 150 and processor 186); and
wherein the sensor layer comprises a plurality of regions each being configured to detect a different target analyte of said one or more analytes (Col 12, lines 52-67).
Regarding claim 22, Schwartz teaches a method for detecting one or more analytes in human sweat, comprising:
using an optical module comprising a pulse oximeter having at least one light source and at least one light detector attached to a support, the at least one light source generating light therefrom (Col 12, lines 15-20);
using at least one sensor layer configured to be worn by a user, the sensor layer configured to contact the human sweat on a surface of skin of the user (Figs. 3A-C, assay component 330 contacting skin 305; Col 23, lines 12-14), the at least one sensor layer being optically coupled to the optical module and having optical absorbance properties that are dependent on a concentration of a target analyte of said one or more analytes (Col 4, lines 1-7); and
using at least one processor in communication with the optical module (Fig. 1, controller 150 and processor 186) to:
cause the light from the at least one light source to be transmitted towards and into, and/or through, the at least one sensor layer (Col 12, lines 18-20);
obtain, from the at least one light detector, one or more optical signals reflected and/or transmitted from the at least one sensor layer (Col 12, lines 18-20); and
determine, from at least one wavelength component of the one or more optical signals, a target analyte concentration (Col 1, lines 59-61).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 3, 5, 7-8, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz as applied to claim 1 above, and further in view of Kim (US 11471133 – previously cited).
Regarding claim 3, Schwartz discusses modifying the wavelength of light depending on the substrate (Col 4, lines 1-7); however, fails to explicitly disclose using multiple light sources.
However, Kim teaches a sweat sensor for measuring analyte concentrations in the blood that uses a light source array (Fig. 1, light source array 121) that may emit light of different wavelengths (Col 4, lines 52-54) towards a sweat sensing layer (Fig. 1, sweat collector 110; Col 6, lines 17-28). One of ordinary skill in the art would have been capable of applying light sources emitting different wavelengths to a known sweat analyte sensor that was ready for improvement and the results would have been predictable to one of ordinary skill in the art.
Schwartz and Kim are considered analogous to the claimed invention because they are in the same field of sweat sensors. One of ordinary skill in the art would have been capable of applying light sources emitting different wavelengths to a known sweat analyte sensor that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schwartz to incorporate the teachings of Kim.
Regarding claim 5, Kim further discloses wherein the optical module comprises a plurality of light detectors configured to detect light at different wavelengths (Col 5, lines 4-6; Col 6, lines 36-45).
Regarding claim 7, Kim further discloses wherein one of said analytes is hydrogen ions and wherein at least one sensor layer comprises a pH-sensitive polymer layer (Col 4, lines 22-28; Col 6, lines 17-28).
Regarding claim 8, Kim discloses a pH-sensitive polymer layer for detecting hydrogen ions, but fails to explicitly disclose use of polyaniline. One of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp as there are only a finite number of pH-sensitive polymers, and would have been able to narrow the use of polymers.
Regarding claim 16, Schwartz as modified discloses wherein the wavelength components comprise a red component (Col 4, lines 4-7 [Schwartz]) and an infrared component (Col 4, lines 52-63 [Kim]). Examiner notes that Schwartz discloses that the wavelength may be visible or infrared light, and Kim introduces two or more wavelengths, but only explicitly states near infrared.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz as applied to claim 1 above, and further in view of Clarke (US 5054487 – previously cited).
Regarding claim 6, Schwartz discloses measuring concentration of analytes in sweat as disclosed above, but fails to determine concentrations based on a ratio of wavelength components of the signal.
However, Clarke teaches a method of determining concentration of analytes using a ratio of two different wavelengths (Col 3, line 61 – Col 4, line 4), and one of ordinary skill in the art would have been capable of applying this known method of measuring analyte concentrations to the sweat sensor of Schwartz and the results would have been predictable to one of ordinary skill in the art.
Schwartz and Clarke are considered analogous to the claimed invention because they are in the same field of analyte measurement. One of ordinary skill in the art would have been capable of applying this known method of measuring analyte concentrations to the sweat sensor of Schwartz and the results would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schwartz to incorporate the teachings of Clarke.
Response to Arguments
Applicant's arguments, see page 7, filed 11/12/2025, with respect to the 35 USC §112(b) rejections have been fully considered and are persuasive. Applicant has clarified that the light source and detector are parts of the pulse oximeter. The rejection of the claims has been withdrawn.
Applicant's arguments, see page 8, filed 11/12/2025, with respect to the 35 U.S.C. §102(a)(1) and §103 rejections have been fully considered but they are not persuasive.
Applicant asserts that Schwartz fails to disclose integration with a pulse oximeter. Examiner respectfully disagrees. Without any specific recitation of processing of photoplethysmogram data, the pulse oximeter merely serves as a light source and detector. Schwartz teaches using a light source and detector to detect analytes of sweat. Additionally, Schwartz teaches measuring a heart rate, a well-known feature/measurement of pulse oximeters. Thus, Schwartz reads on this limitation.
Applicant further asserts that Schwartz does not teach a sensor layer having optical absorbance properties dependent on a concentration of a target analyte. Examiner respectfully disagrees.
Applicant asserts that the sensor layer of Schwartz does not undergo optical absorbance properties by itself, rather it requires an “assay component” or “external binding” to produce a detectable change in optical properties. However, Schwartz states otherwise. For example, as pointed out in the rejection of claim 1 above, the substrate, upon interaction with an analyte, may undergo a change in an optical property, such as optical absorption, reflectivity, or fluorescence. Although, in some embodiments, Schwartz discloses having bio-interactive electronics, assay components, and/or conjugated aptamers, they are embedded within the substrate. Thus, the substrate has optical absorbance properties that are dependent on a concentration of an analyte. These changes are directly measured by the light source/photodetector that are placed over the substrate that contains the assay components.
Examiner notes that the sensor layer as claimed does not exclude having “external” components. Examiner also points out that the instant application has embodiments and claims (claim 17) wherein the sensor layer comprises a dopant to facilitate detection of the different analytes.
Thus, claims 1, 3-8, 14-17, and 19-20 stand rejected. Newly added claims 21-22 are rejected as above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791