DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 1/14/2026 have been fully considered but they are not persuasive.
On p. 8, Applicant argues that the Begtrup reference fails to disclose any impedance measurement, as Begtrup operates under DC conditions, detecting resistance.
The examiner disagrees, as resistance is the DC component of impedance. Impedance is understood as contributions from resistance and reactance used in an AC environment. Therefore, resistance is a portion of impedance data, as asserted by the Examiner. Furthermore, Begtrup does contemplate AC techniques in ¶[0068].
On pp. 8-9, Applicant argues the combination of Begtrup and Kendall fail to teach measuring impedance at first and second time points, to identify a second time point based on a similarity between the first impedance data and the second impedance data.
The rejection is based on Begtrup teaching all of the first and second time points, and identification of a second time point based on a similarity between the first (resistance) data and the second (resistance) data. Kendall is combined with Begtrup to teach total impedance techniques rather than only resistance.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant has refrained from arguing against the combination of Begtrup and Kendall, focusing solely on each individual reference rather than what the art as a whole suggests to a person of ordinary skill in the art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 22-26, 29-32, and 35-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Begtrup et al. (U.S. Patent Application Publication No. 2018/0020966) hereinafter referred to as Begtrup; in view of Kendall et al. (U.S. Patent Application Publication No. 2021/0077019) hereinafter referred to as Kendall.
Regarding claim 22, Begtrup teaches a method, comprising:
directing a sample of bodily fluid (¶[0060] sweat, ¶[0005]) from a sample collection region (Fig. 9, element 932 collection area) of a device to a first electrochemical interface (Fig. 9, electrodes elements 951, 952, 953, 954, 955);
applying a first excitation signal from the first electrochemical interface to a portion of the sample of bodily fluid present at the first electrochemical interface (¶[0060], current is applied when the sweat completes a circuit: “the detection circuit 956 will be completed, and the device will register current across the circuit”);
sensing, at a first time point, a first response signal in response to applying the first excitation signal (¶[0060], current is applied when the sweat completes a circuit: “the detection circuit 956 will be completed, and the device will register current across the circuit”);
measuring, based on the first response signal, a first impedance data related to the portion of the sample of bodily fluid (resistance R1 and R2 in Fig. 9, referring to calculation method in ¶¶[0051-0052] where each channel section filled with sweat represents a resistance that can be calculated from the current measured in the completed circuit);
directing the sample of bodily fluid from the first electrochemical interface through a flow channel to a second electrochemical interface (¶[0060] sweat moves through the channel to each electrode in sequence, Fig. 9);
applying a second excitation signal from the second electrochemical interface to the sample of bodily fluid present at the second electrochemical interface (¶[0060], current is applied when the sweat completes a circuit: “the detection circuit 956 will be completed, and the device will register current across the circuit”);
sensing a second response signal in response to applying the second excitation signal (¶[0060], current is applied when the sweat completes a circuit: “the detection circuit 956 will be completed, and the device will register current across the circuit”);
measuring, based on the second response signal, a second impedance data related to the sample of bodily fluid (resistance R1 and R2 in Fig. 9, referring to calculation method in ¶¶[0051-0052] where each channel section filled with sweat represents a resistance that can be calculated from the current measured in the completed circuit);
comparing the second impedance data to the first impedance data to identify a second time point when the portion of the sample of bodily fluid flows past the second electrochemical interface based on a similarity between the first impedance data and the second impedance data (¶[0051], ¶[0060] register the time required to fill that volume as an increase in current across the circuit); and
determining, based on the first time point, the second time point, a flow rate of the portion of the sample of bodily fluid through the flow channel (¶[0060] sweat rate).
While Begtrup does teach, under BRI, “impedance data related to the sample of bodily fluid” by teaching resistance, Begtrup does not go so far as to teach total impedance, and therefore for compact prosecution, attention is brought to the Kendall reference. Kendall teaches detecting impedance between two electrodes by injecting a signal and measuring the resulting response for monitoring changes in a variety of bioimpedances including sweat and hydration (¶[0147], ¶¶[0150-0151], ¶[0157], ¶[0395]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sweat monitoring of Begtrup to include Kendall’s impedance detection, because Kendall teaches improving signal quality (Kendall ¶¶[0175-0176]).
Regarding claim 23, Begtrup as modified teaches the method of claim 22.
Begtrup teaches further comprising:
obtaining information associated with physiology of a user (¶[0060], ¶[0077]); and
determining, based on the information associated with physiology of the user (¶[0060], and the flow rate of the portion of the sample of bodily fluid (¶[0060]), a property of a source of bodily fluid from which the sample of bodily fluid was collected (¶[0060] sweat rate).
Regarding claim 24, Begtrup as modified teaches the method of claim 23.
Begtrup further teaches wherein the source of bodily fluid is sweat (¶[0060] sweat, ¶[0005]), and the property of the source of bodily fluid is perspiration rate (¶[0060] sweat rate).
Regarding claim 25, Begtrup as modified teaches the method of claim 22.
Begtrup further teaches determining, based on conductivity data related to the portion of the sample of bodily fluid, an osmolality (¶[0065] analyte concentration in mMol, Fig. 11) associated with the portion of the sample of bodily fluid obtaining information associated with physiology of a user (¶[0060], ¶[0077]); and
calculating, based on an osmolality (¶[0065] analyte concentration in mMol, Fig. 11) and the information associated with physiology of the user (¶[0060], ¶[0077]), an electrolyte content associated with a source of bodily fluid from which the sample of bodily fluid was collected (¶[0084]).
While Begtrup does teach, under BRI, “impedance data related to the sample of bodily fluid” by teaching resistance, Begtrup does not go so far as to teach total impedance, and therefore for compact prosecution, attention is brought to the Kendall reference. Kendall teaches detecting impedance between two electrodes by injecting a signal and measuring the resulting response for monitoring changes in a variety of bioimpedances including sweat and hydration (¶[0147], ¶¶[0150-0151], ¶[0157], ¶[0395]) and determining, based on the first impedance data or the second impedance data related to the portion of the sample of bodily fluid, an osmolality associated with the portion of the sample of bodily fluid (¶[0059] ion concentration, ¶¶[0157-0158]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sweat monitoring of Begtrup to include Kendall’s impedance detection, because Kendall teaches improving signal quality (Kendall ¶¶[0175-0176]).
Regarding claim 26, Begtrup as modified teaches the method of claim 22.
Begtrup teaches further comprising:
obtaining information associated with physiology of a user (¶[0060], ¶[0077]);
obtaining information associated with behavior of the user, the behavior being related to fluid intake or fluid outflow (¶[0041] and claim 18 individual’s fluid intake); and
determining, based on at least one of the information associated with physiology of the user (¶[0060], ¶[0077]), information associated with behavior of the user (¶[0041], and claim 18), or the flow rate of the portion of the sample of bodily fluid (¶[0060], ¶[0077]), a rate of change in hydration of the user (¶0041] trend data, target individual’s hydration level over time).
Regarding claim 29, Begtrup as modified teaches the method of claim 22.
Begtrup further teaches wherein the first electrochemical interface includes a first excitation electrode and a first sensing electrode, and the second electrochemical interface includes a second excitation electrode and a second sensing electrode (Fig. 9, plurality of sensing electrodes, interdigitated electrodes).
Begtrup does not specify any particular electrodes as excitation or sensing.
Kendall teaches detecting impedance between two individually addressable electrodes by injecting a signal and measuring the resulting response for monitoring changes in a variety of bioimpedances including sweat and hydration and any electrode can function as a stimulation or measuring electrode (¶[0147], ¶¶[0150-0151], ¶[0157], ¶[0395]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sweat monitoring of Begtrup to include Kendall’s impedance detection, because Kendall teaches improving signal quality (Kendall ¶¶[0175-0176]).
Regarding claim 30, Begtrup as modified teaches the method of claim 29.
Begtrup further teaches wherein the second excitation electrode is the same as the first excitation electrode (Fig. 9, plurality of sensing electrodes, interdigitated electrodes).
Begtrup does not specify any particular electrodes as excitation or sensing.
Kendall teaches detecting impedance between two individually addressable electrodes by injecting a signal and measuring the resulting response for monitoring changes in a variety of bioimpedances including sweat and hydration and any electrode can function as a stimulation or measuring electrode (¶[0147], ¶¶[0150-0151], ¶[0157], ¶[0395]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sweat monitoring of Begtrup to include Kendall’s impedance detection, because Kendall teaches improving signal quality (Kendall ¶¶[0175-0176]).
Regarding claims 31-32, the claims are directed to a method comprising substantially the same subject matter as claims 21-23 and are rejected under substantially the same sections of Begtrup and Kendall.
Regarding claim 35, Begtrup as modified teaches the method of claim 32.
Begtrup teaches further comprising:
receiving information associated with physiology of a user (¶[0060], ¶[0077]);
determining, based on the information associated with physiology of the user (¶[0060], ¶[0077]), and the rate of perspiration (¶[0060] sweat rate), a state of hydration of the user (¶0041] trend data, target individual’s hydration level over time).
Regarding claim 36, Begtrup as modified teaches the method of claim 32.
Begtrup teaches further comprising:
receiving information associated with physiology of a user (¶[0060], ¶[0077]);
determining, based on the information associated with physiology of the user (¶[0060], ¶[0077]), and the rate of perspiration (¶[0060] sweat rate) a loss of electrolytes suffered by the user (¶[0071]).
Regarding claim 37, Begtrup as modified teaches the method of claim 32.
Begtrup teaches further comprising: calculating, based on the perspiration rate (¶[0060] sweat rate), a cumulative fluid loss over a period of time (¶[0071] water loss, ¶[0080] fluid loss).
Regarding claim 38, Begtrup as modified teaches the method of claim 37.
Begtrup teaches further comprising: estimating, based on the cumulative fluid loss over the period of time (¶[0071] water loss, ¶[0080] fluid loss) and information associated with physiology of the user (¶[0060] sweat rate), a full body fluid loss over the period of time (¶[0071] water loss, ¶[0080] fluid loss).
Regarding claim 39, the claim is directed to a method comprising substantially the same subject matter as claim 25 and is rejected under substantially the same sections of Begtrup and Kendall.
Regarding claim 40, Begtrup as modified teaches the method of claim 39.
Begtrup teaches further comprising: calculating, based on the electrolyte content associated with the source of bodily fluid, a cumulative electrolyte loss over a period of time (¶[0071] total electrolyte loss over a plurality of sweat cycles).
Regarding claim 41, Begtrup as modified teaches the method of claim 40.
Begtrup teaches further comprising: estimating, based on the cumulative electrolyte loss over the period of time (¶[0071] total electrolyte loss over a plurality of sweat cycles) and the information associated with physiology of the user (¶[0060] sweat rate), a full body electrolyte loss over the period of time (¶[0071] total electrolyte loss over a plurality of sweat cycles, ¶[0080] whole body totals).
Claim(s) 27 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Begtrup and Kendall as applied to claims 22 and 31 above, and further in view of Harley-Trochimczyk et al. (U.S. Patent Application Publication No. 2019/0227022) hereinafter referred to as Harley.
Regarding claims 27-28, Begtrup as modified teaches the method of claim 22.
Begtrup teaches further comprising:
receiving a temperature associated with the sample of bodily fluid (¶[0075] temperature sensor); and
obtaining information associated with physiology of the user (¶[0060], ¶[0077]).
Begtrup as modified does not teach calculating, based on the temperature, a temperature-corrected first impedance data and a temperature-corrected second impedance data related to the portion of the sample of bodily fluid.
Attention is brought to the Harley reference, which teaches calculating, based on the temperature, a temperature-corrected first impedance data and a temperature-corrected second impedance data related to the portion of the sample of bodily fluid (Fig. 22, ¶[0500] conductance or impedance).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sweat sensor of Begtrup as modified to include temperature compensation, as taught by Harley, because Harley teaches improving the performance of a sensor system by improving accuracy (Harley ¶[0288]).
Regarding claim 33, the claim is directed to a method comprising substantially the same subject matter as claim 27 and is rejected under substantially the same sections of Begtrup, Kendall, and Harley.
Claim(s) 28 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Begtrup and Kendall as applied to claims 22 and 31 above, and further in view of Reifman et al. (U.S. Patent Application Publication No. 2019/0192009) hereinafter referred to as Reifman.
Regarding claim 28, Begtrup as modified teaches the method of claim 22.
Begtrup teaches further comprising:
receiving a temperature associated with a body of a user (¶[0075] temperature sensor); and
obtaining information associated with physiology of the user (¶[0060], ¶[0077]) and the flow rate of the portion of the sample (¶[0060], sweat rate).
Begtrup does not teach determining based on the temperature, the information associated with physiology of the user, and the flow rate of the portion of the sample of bodily fluid, a core body temperature of the user.
Attention is brought to the Reifman reference, which teaches based on the temperature (¶[0025] skin temperature), the information associated with physiology of the user (¶[0025] physiological data), and the flow rate of the portion of the sample of bodily fluid (¶[0040] sweat rate), a core body temperature of the user (¶[0025] core body temperature).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sweat sensor of Begtrup as modified to monitor core body temperature, as taught by Reifman, to alert a monitored user to a dangerous heat injury and help prevent dangerous heat injuries to a user (Reifman ¶[0002]).
Regarding claim 34, the claim is directed to a method comprising substantially the same subject matter as claim 28 and is rejected under substantially the same sections of Begtrup, Kendall, and Reifman.
Conclusion
THIS ACTION IS MADE FINAL. 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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792