CTFR 18/264,755 CTFR 95417 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims Applicant's arguments, filed 03/02/2026 , 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. Applicants have amended their claims, filed 03/02/2026 , and therefore rejections newly made in the instant office action have been necessitated by amendment. Applicants have amended claims 51-57, 60, and 63-65. Applicants have left claims 58-59, 61-62, and 66-70 as originally filed/previously presented. Claims 51-70 are the current claims hereby under examination. Claim Rejections - 35 USC § 112 - Newly Applied Necessitated by Applicant’s Amendments 07-30-02 AIA 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. 07-34-01 Claims 55 and 59 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. Regarding claim 55, the claim recites “wherein for each reference slope the reference electrochemical signal and reference blood glucose concentration are obtained on different days”. However, claim 51 recites “first and second reference electrochemical signals” and “first and second reference blood glucose concentrations” in relation to the personal slope. In light of the specification, it is currently unclear if “the reference electrochemical signal and reference blood glucose concentration” are the same as, related to, or different from “first and second reference electrochemical signals” and “first and second reference blood glucose concentrations” recited in claim 51. If the recitations are the same, it is further unclear if “the reference electrochemical signal and reference blood glucose concentration” relate to the first or second reference signals/concentrations. For the purposes of examination, “the reference electrochemical signal and reference blood glucose concentration” are being interpreted as any reference signal/concentration. Regarding claim 59, the claim recites “receiving an updated reference blood glucose concentration and an updated reference electrochemical signal”. However, claim 51 has been amended to recite first and second reference electrochemical signals and first and second reference blood glucose concentrations. In light of the specification, it is currently unclear if “an updated reference blood glucose concentration and an updated reference electrochemical signal” is referring to a first, a second, or both of the previously recited reference concentration and signals. For the purposes of examination, “an updated reference blood glucose concentration and an updated reference electrochemical signal” is referring to both a first and second reference blood glucose concentrations and reference electrochemical signals. Claim Rejections - 35 USC § 102 - Withdrawn 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. Response to Arguments Applicant’s arguments, see pages 6-8 of Remarks, filed 03/02/2026, with respect to claims 51, 52, 57-60, 63, and 64 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejection moot. The 102(a)(1) rejection of claims 51, 52, 57-60, 63, and 64 has been withdrawn. Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 51, 52, and 56-62 are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (US 20100063372 A1) (previously cited), hereinafter referred to as Potts, in view of Wang et al. (US 20170325724 A1), hereinafter referred to as Wang, in view of Schoenfisch et al. (US 20170238852 A1) (previously cited), hereinafter referred to as Schoenfisch . The claims are generally directed towards a method for determining a blood glucose concentration of a user from a sweat sample from the user, the method comprising: a) receiving the sweat sample from a fingertip of the user with a porous sweat permeation layer of a biosensing device, wherein the porous sweat permeation layer has a first side and a second side located opposite to the first side, wherein the first side of the porous sweat permeation layer is in contact with a plurality of electrodes, wherein the porous sweat permeation layer is configured to transfer the sweat sample from the fingertip by permeating the sweat sample through the porous sweat permeation layer from the second side to the first side to reach the plurality of electrodes; b) detecting with the plurality of electrodes an electrochemical signal from a reaction with an analyte in the sweat sample; c) converting the electrochemical signal to the blood glucose concentration using a personal slope of a line from a calibration of the biosensing device, wherein the calibration comprises: (i) receiving first and second reference electrochemical signals of first and second reference sweat sample from the fingertip of the user from the biosensing device and first and second reference blood glucose concentrations from first and second reference blood samples from the user from a reference device, and (ii) determining the personal slope of the line for the user based at least on the first and second reference electrochemical signal and the first and second reference blood glucose concentration; and d) providing the blood glucose concentration to the user. Regarding claim 51, Potts discloses a method for determining a blood glucose concentration of a user from a sweat sample from the user (Abstract, “methods … for collecting sweat … sweat may be collected for measuring sweat glucose levels …”), the method comprising: a) receiving the sweat sample from a fingertip of the user with a porous sweat permeation layer of a biosensing device (Fig. 1a-1b, para. [0036], “container may comprise an absorbent material configured to absorb only a fixed amount of sweat”, para. [0038], “fingertip”, para. [0048-0060], “skin patch … microchannels are positioned to direct sweat that has come to the surface of the skin to an opening … direct the sweat towards the opening and into the container …”), wherein the porous sweat permeation layer has a first side and a second side located opposite to the first side (para. [0036], “container may comprise an absorbent material configured to absorb only a fixed amount of sweat” - absorbent material inherently includes two sides ), wherein the porous sweat permeation layer is configured to transfer the sweat sample from the fingertip by permeating the sweat sample through the porous sweat permeation layer from the second side to the first side (para. [0036], “container may comprise an absorbent material configured to absorb only a fixed amount of sweat”); b) detecting with a plurality of electrodes an electrochemical signal from a reaction with an analyte in the sweat sample (para. [0018], “electrodes may be used in conjunction with a measurement device to … measure the sweat glucose level”, para. [0060], “container may comprise one or more enzymes used to measure glucose, such as glucose oxidase … one or more surfaces, including electrodes, may include or be coated with the enzyme or enzymes …”, para. [0066], para. [0086], “one or more electrodes in contact with the container may be coated with an enzyme that reacts with glucose in the sweat …”, para. [0095-0100], “measurement device may be used to measure the amount of glucose in the sweat collected by the skin patch … measurement device may interrogate the skin patch …”); c) converting the electrochemical signal to the blood glucose concentration using a calibration of the biosensing device (para. [0095-0100], “device measures the total quantity of glucose present in a fixed volume, and then converts the glucose measurement into a sweat glucose or blood glucose concentration … contain a calibration algorithm, which relates measured values of detected glucose to blood glucose values … calibration curve may be generated, which relates the measured sweat glucose to blood glucose …”), wherein the calibration comprises: (i) receiving first and second reference electrochemical signals of first and second reference sweat samples from the fingertip of the user from the biosensing device and first and second reference blood glucose concentrations from first and second reference blood samples from the user from a reference device (para. [0098-0099], “performance of multiple capillary blood glucose measurements (e.g., blood sticks) with simultaneous patch measurements … statistically significant number of paired data points … sufficient range of values …”), and (ii) determining the calibration for the user based at least on the first and second reference electrochemical signals and the first and second reference blood glucose concentrations (para. [0098-0099], “calibration curve may be generated, which relates the measured sweat glucose to blood glucose …”); and d) providing the blood glucose concentration to the user (para. [0095], “display, to display data … warning indicators … indicate that a patient’s glucose levels are dangerously high or dangerously low …”). However, Potts does not explicitly disclose the first side of the porous sweat permeation layer is in contact with the plurality of electrodes, and the sweat sample permeates through the porous sweat permeation layer from the second side to the first side to reach the plurality of electrodes. Wang teaches an analogous method for determining a blood glucose concentration of a user from a sweat sample (Abstract, para. [0004]), comprising receiving a sweat sample from a user with a porous sweat permeation layer of a biosensing device (Fig. 1A, element 109, para. [0111], para. [0117]). Wang further teaches the first side of the porous sweat permeation layer is in contact with the plurality of electrodes, and the sweat sample permeates through the porous sweat permeation layer from the second side to the first side to reach the plurality of electrodes (Fig. 1, para. [0009], [0013], [0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the porous sweat permeation layer disclosed by Potts to additionally have the first side of the porous sweat permeation layer is in contact with the plurality of electrodes, and the sweat sample permeate through the porous sweat permeation layer from the second side to the first side to reach the plurality of electrodes, as taught by Wang. This is because Wang teaches a hydrogel configuration over the plurality of electrodes allows for fast transport of analytes, such as glucose, from the users skin to the sensor surface (para. [0119], [0122]). However, modified Potts does not explicitly disclose the use of a personal slope of a line from the calibration to covert the electrochemical signal to the blood glucose concentration, and determining the personal slope of the line for the used based on the first and second reference electrochemical signals and the first and second reference blood glucose concentrations. Schoenfisch teaches an analogous method for calibrating a glucose sensor using reference blood glucose measurements (para. [0050]). Schoenfisch further teaches the use of a personal slope of a line for calibration, and determining the personal slope of the line for the used based on the first and second reference electrochemical signals and the first and second reference blood glucose concentrations (para. [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the calibration to utilize a personal slope of a line from first and second reference electrochemical signals and first and second reference blood glucose concentrations, as taught by Schoenfisch. This is because Schoenfisch teaches a slope of a linear trend line allows for calibration of the biosensing device over a period of time, instead of single point calibration, increasing the calibration accuracy (para. [0050-0051]). Regarding claim 52, modified Potts discloses the method of claim 51, wherein the first reference electrochemical signal and the first reference blood glucose concentration are obtained at substantially the same time (para. [0098-0099], “performance of multiple capillary blood glucose measurements (e.g., blood sticks) with simultaneous patch measurements …”). Regarding claim 56, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the step of converting the electrochemical signal to the blood glucose concentration further comprises using a personal intercept of the line. Schoenfisch further teaches the step of converting the electrochemical signal to the blood glucose concentration further comprises using a personal intercept of the line (para. [0050-0051). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Potts to additionally use a personal intercept of the line, as taught by Schoenfisch. This is because Schoenfisch teaches a slope and an intercept of the slope allows for calibration of the biosensing device to be over a period of time, instead of single point calibration, increasing the calibration accuracy (para. [0050-0051]). Regarding claim 57, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the porous sweat permeation layer comprises a hydrogel. Wang further teaches the porous sweat permeation layer comprises a hydrogel (Fig. 1A, element 109, para. [0111], para. [0117], para. [0119], para. [0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the porous sweat permeation layer taught by modified Potts to explicitly comprise a hydrogel, as taught by Wang. This is because Wang teaches a hydrogel allows for fast transport of analytes, such as glucose, from the users skin to the sensor surface (para. [0119], [0122]). Regarding claim 58, modified Potts discloses the method of claim 51, wherein the method further comprises updating the calibration of the biosensing device after about a week (para. [0099], “patients can perform periodic calibrations checks with single blood glucose measurements, or total recalibrations as desirable or necessary”). Regarding claim 59, modified Potts discloses the method of claim 58, wherein the updating the calibration of the biosensing device comprises receiving an updated reference blood glucose concentration and an updated reference electrochemical signal (para. [0098-0099], “performance of multiple capillary blood glucose measurements (e.g., blood sticks) with simultaneous patch measurements … patients can perform periodic calibrations checks with single blood glucose measurements, or total recalibrations as desirable or necessary”). Regarding claim 60, modified Potts discloses the method of claim 51, wherein the reference device is a glucometer, blood glucose meter, blood analyzer, or continuous glucose monitor (para. [0098], “capillary blood glucose measurements (e.g., blood sticks) …”). Regarding claim 61, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the biosensing device is calibrated to provide a mean absolute relative difference of about 20% or less with respect to output of the reference device. Schoenfisch further teaches the calibration of the glucose sensor is calibrated to provide a mean absolute relative difference of about 20% or less with respect to output of the reference device (para. [0050-0051]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the calibration disclosed by modified Potts to additionally allow for the calibration to provide a mean absolute relative difference of about 20% or less with respect to output of the reference device, as taught by Schoenfisch. This is because Schoenfisch teaches a mean absolute relative difference of about 20% or less meets the International Standards Organization (ISO) criteria for glucose monitor performance (para. [0051]). Regarding claim 62, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the biosensing device is calibrated to determine blood glucose concentrations with an error of less than about 20% relative to reference blood glucose concentrations determined by the reference device for at least about 80% of sweat samples. Schoenfisch further teaches the glucose sensor is calibrated to determine blood glucose concentrations with an error of less than about 20% relative to reference blood glucose concentrations determined by the reference device for at least about 80% of sweat samples (para. [0050-0051]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the calibration taught by modified Potts to additionally be calibrated to determine blood glucose concentrations with an error of less than about 20% relative to reference blood glucose concentrations determined by the reference device for at least about 80% of sweat samples, as taught by Schoenfisch. This is because Schoenfisch teaches a calibration error of less than about 20% relative to a reference blood glucose concentration meets the International Standards Organization (ISO) criteria for glucose monitor performance (para. [0051]) . 07-22-aia AIA Claim s 53 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (US 20100063372 A1) (previously cited), hereinafter referred to as Potts, in view of Wang et al. (US 20170325724 A1), hereinafter referred to as Wang, in view of Schoenfisch et al. (US 20170238852 A1) (previously cited), hereinafter referred to as Schoenfisch , as applied to claim 51 above, and further in view of Shurabura et al. (US 20090240440 A1) (previously cited), hereinafter referred to as Shurabura . Regarding claim 53, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the first reference sweat sample and the first reference blood sample are obtained prior to a meal. Shurabura teaches an analogous method of correlating a non-invasive parameter of a user to a blood glucose measurement (Abstract, para. [0015]). Shurabura teaches receiving reference signals and reference blood glucose concentrations for calibration of a biosensor (Fig. 1, para. [0083-0107]). Shurabura further teaches the reference signals are obtained prior to a meal (para. [0091], para. [0151]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Potts to explicitly obtain the reference samples prior to a meal, as taught by Shurabura. This is because Shurabura teaches glucose levels fluctuate throughout the day, and obtaining a reference before and after a meal allows for more accurate calibration (para. [0091]). Regarding claim 54, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the second reference sweat sample and the second reference blood sample are obtained after eating. Shurabura teaches an analogous method of correlating a non-invasive parameter of a user to a blood glucose measurement (Abstract, para. [0015]). Shurabura teaches receiving reference signals and reference blood glucose concentrations for calibration of a biosensor (Fig. 1, para. [0083-0107]). Shurabura further teaches the reference signals are obtained after a meal (para. [0091], para. [0151]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Potts to explicitly obtain the reference samples after a meal, as taught by Shurabura. This is because Shurabura teaches glucose levels fluctuate throughout the day, and obtaining a reference before and after a meal allows for more accurate calibration (para. [0091]) . 07-22-aia AIA Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (US 20100063372 A1) (previously cited), hereinafter referred to as Potts, in view of Wang et al. (US 20170325724 A1), hereinafter referred to as Wang, in view of Schoenfisch et al. (US 20170238852 A1) (previously cited), hereinafter referred to as Schoenfisch , as applied to claim 51 above, and further in view of Hayter et al. (US 20100081906 A1), hereinafter referred to as Hayter . Regarding claim 55, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the step of determining the personal slope of the line further comprises taking an average of at least two reference slopes, wherein for each reference slope the reference electrochemical signal and reference blood glucose concentration are obtained on different days. Hayter teaches an analogous method of calibrating reference electrochemical signals and reference blood glucose concentrations (Abstract, para. [0036]). Hayter further teaches taking an average of the calibrations, wherein the calibrations are obtained on different days (para. [0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Potts to additionally take an average of at least two reference slopes, wherein for each reference slope the reference electrochemical signal and reference blood glucose concentration are obtained on different days, as taught by Hayter. This is because Hayter teaches previous calibration events can be averaged, which would allow for a more complete calibration (para. [0069]) . 07-22-aia AIA Claim s 63-70 are rejected under 35 U.S.C. 103 as being unpatentable over Potts et al. (US 20100063372 A1) (previously cited), hereinafter referred to as Potts, in view of Wang et al. (US 20170325724 A1), hereinafter referred to as Wang, in view of Schoenfisch et al. (US 20170238852 A1) (previously cited), hereinafter referred to as Schoenfisch , as applied to claim 51 above, and further in view of Javey et al. (US 20180263539 A1) (previously cited), hereinafter referred to as Javey . Regarding claim 63, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the fingertip of the user is cleaned with water about three minutes before being placed in contact with the porous sweat permeation layer. Javey teaches an analogous method of determining a blood glucose concentration of a user from a sweat sample from the user (Abstract, Fig. 1C , para. [0046], para. [0054-0055]). Javey teaches the skin of the user is cleaned with water about three minutes before being placed in contact with the biosensor (para. [0100], [0140], [0167-0168]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Potts to additionally clean the fingertip with water about three minutes before being placed in contact with the porous sweat permeation layer, as taught by Javey. One of ordinary skill in the art would recognize cleaning the site with water and/or alcohol allows for unwanted debris to be removed prior to obtaining measurements results. Regarding claim 64, modified Potts discloses the method of claim 63, wherein the fingertip of the user is placed in contact with the porous sweat permeation layer of the biosensing device for at least about 60 seconds (para. [0036-0037], “absorbent material configured to absorb only a fixed amount of sweat … skin patch is configured to remain in contact with the skin for one minute … or longer …”). Regarding claim 65, modified Potts discloses the method of claim 51, wherein the plurality of electrodes comprise the analyte (para. [0018], “electrodes may be used in conjunction with a measurement device to … measure the sweat glucose level”, para. [0060], “container may comprise one or more enzymes used to measure glucose, such as glucose oxidase … one or more surfaces, including electrodes, may include or be coated with the enzyme or enzymes …”, para. [0066], para. [0086], “one or more electrodes in contact with the container may be coated with an enzyme that reacts with glucose in the sweat …”, para. [0095-0100], “measurement device may be used to measure the amount of glucose in the sweat collected by the skin patch … measurement device may interrogate the skin patch …”). However, modified Potts does not explicitly disclose the plurality of electrodes comprise a conductive polymer and a redox-active material. Javey teaches an analogous method of determining a blood glucose concentration of a user from a sweat sample from the user (Abstract, Fig. 1C , para. [0046], para. [0054-0055]). Javey further teaches the biosensing device comprising a plurality of electrodes comprise a conductive polymer and a redox-active material (para. [0059-0060], para. [0079]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and biosensing device taught by modified Potts to explicitly include a conductive polymer and a redox-active material, as taught by Javey. This is because Javey teaches conductive polymers and redox-active materials allow for more accurate measurements of glucose from a sweat sample (para. [0059-0060]). Regarding claim 66, modified Potts discloses the method of claim 65, wherein at least one of the plurality of electrodes comprises glucose oxidase (para. [0060], “glucose oxidase”, para. [0066], para. [0086]). Regarding claim 67, modified Potts discloses the method of claim 66, wherein the glucose oxidase is configured to react with glucose in the sweat sample (para. [0086], “enzyme that reacts with the glucose in the sweat (e.g., glucose oxidase)”). Regarding claim 68, modified Potts discloses the method of claim 65. However, modified Potts does not explicitly disclose wherein at least one of the plurality of electrodes comprises Prussian blue. Javey further teaches at least one of the plurality of electrodes comprises Prussian blue (para. [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes taught by modified Potts to additionally include Prussia blue, as taught by Javey. This is because Javey teaches the addition of Prussian blue minimizes reduction potentials, improving the sensor (para. [0059]). Regarding claim 69, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein electrochemical signal comprises an electrical current. Javey teaches an analogous method of determining a blood glucose concentration of a user from a sweat sample from the user (Abstract, Fig. 1C , para. [0046], para. [0054-0055]). Javey further teaches the electrochemical signal comprises an electrical current (para. [0059], para. [0064-0066], para. [0081]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biosensing device taught by modified Potts to explicitly have the electrochemical signal as an electrical current, as taught by Javey. This is because Javey teaches producing an electrical current allows for a simple circuit for detecting glucose in a user’s sweat (para. [0059], para. [0081]). Regarding claim 70, modified Potts discloses the method of claim 51. However, modified Potts does not explicitly disclose wherein the electrochemical signal is measured via chronoamperometry. Javey teaches an analogous method of determining a blood glucose concentration of a user from a sweat sample from the user (Abstract, Fig. 1C , para. [0046], para. [0054-0055]). Javey further teaches the electrochemical signal is measured via chronoamperometry (para. [0064-0065], para. [0094]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Potts to additionally have the electrochemical signal measured via chronoamperometry, as taught by Javey. This is because Javey teaches chronoamperometry characterization allows for sensitivities of the glucose sensor to be observed (para. [0065]) . Response to Arguments First, Applicant’s amendments have necessitated new grounds of rejections, as recited above. 07-37 AIA Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive. Applicants have argued on page 7 of Remarks, filed 03/02/2026, that “Potts fails to disclose at least “receiving the sweat sample from a fingertip of the user with a porous sweat permeation layer of a biosensing device …”. The Examiner respectfully disagrees. As recited above, Potts explicitly disclose receiving the sweat sample from a fingertip of the user with a porous sweat permeation layer of a biosensing device (para. [0036], “container may comprise an absorbent material configured to absorb only a fixed amount of sweat”). Applicants have argued on pages 8-9 of Remarks, filed 03/02/2026, that “Potts teaches “once a statistically significant number of paired data points have been acquired having a sufficient range of values (e.g., covering changes in blood glucose of about 200 mg/dl) … a person having ordinary skill in the art would not be motivated to look to Shurabura’s more complex method …”. The Examiner respectfully disagrees. Potts already discloses wanting to receive a statistically significant number of paired data points and having a sufficient range of values of about 200 mg/dl, which suggests collecting data points before and after meals. Therefore, one of ordinary skill in the art would already be motivated to explicitly obtain data points before and after a meal to ensure a sufficient range of values. Further, in response to applicant's argument that one would have to modify Potts by changing sweat glucose to electrical impedance of the wrist and adding steps of obtaining the time-dependence of the electrical impedance, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller , 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As recited above, Shurabura suggests to one of ordinary skill in the art to collect data points before and after a meal to calibrate the biosensor. Applicants have argued on pages 9-10 of Remarks, filed 03/02/2026, that “a person with ordinary skill in the art would not look to Schoenfisch to modify Potts to arrive at the claimed invention, because Schoenfisch is directed to an implanted glucose biosensor”. The Examiner respectfully disagrees. Schoenfisch explicitly disclose calibrating a glucose sensor with reference blood glucose measurements. One of ordinary skill in the art would recognize calibrating any glucose sensor with reference blood glucose measurements using the method of Schoenfisch would yield a predictable level of success. Applicants have argued on pages 11-12 of Remarks, filed 03/02/2026, that “a person having ordinary skill in the art would lack any motivation to modify Potts with Javey, because … Javey’s working examples use head or wrist bands that are not readily adaptable to analysis of a sweat sample … Javey’s working examples are also conducted during station cycling … Javey further is silent regarding conversion of sweat glucose concentration to blood glucose concentration …”. First, Applicants arguments regarding when the biosensor is used, and a sweat glucose concentration is not commensurate in scope with the claimed invention. Second, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller , 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Conclusion 07-40 AIA 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 KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM. 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, Jason M Sims can be reached at (571)272-7540. 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. /K.W.K./Examiner, Art Unit 3791 /JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791 Application/Control Number: 18/264,755 Page 2 Art Unit: 3791 Application/Control Number: 18/264,755 Page 3 Art Unit: 3791 Application/Control Number: 18/264,755 Page 4 Art Unit: 3791 Application/Control Number: 18/264,755 Page 6 Art Unit: 3791 Application/Control Number: 18/264,755 Page 7 Art Unit: 3791 Application/Control Number: 18/264,755 Page 8 Art Unit: 3791 Application/Control Number: 18/264,755 Page 9 Art Unit: 3791 Application/Control Number: 18/264,755 Page 10 Art Unit: 3791 Application/Control Number: 18/264,755 Page 11 Art Unit: 3791 Application/Control Number: 18/264,755 Page 12 Art Unit: 3791 Application/Control Number: 18/264,755 Page 13 Art Unit: 3791 Application/Control Number: 18/264,755 Page 14 Art Unit: 3791 Application/Control Number: 18/264,755 Page 16 Art Unit: 3791 Application/Control Number: 18/264,755 Page 17 Art Unit: 3791 Application/Control Number: 18/264,755 Page 18 Art Unit: 3791 Application/Control Number: 18/264,755 Page 19 Art Unit: 3791 Application/Control Number: 18/264,755 Page 20 Art Unit: 3791 Application/Control Number: 18/264,755 Page 21 Art Unit: 3791 Application/Control Number: 18/264,755 Page 22 Art Unit: 3791
Prosecution Insights