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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 28-29, 34-35, 37-39, 43, 48, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/098510 A1 (Hagl) (cited by Applicant) (Paragraph references are with respect to the previously-provided machine translation) in view of US 2006/0133960 A1 (Ahmad) (previously cited) and US 2009/0204008 A1 (Beilin).
With regards to claims 28 and 43, Hagl teaches a measuring device and method for measuring an intensive measurand comprising one of a concentration of a substance emitted by a body by diffusion or a temperature of the body (Fig. 2 and ¶ [0081] depict a sensor arrangement 10), comprising: at least one measuring chamber having at least one opening (Fig. 2 and ¶ [0081] depict a measuring chamber 3 designed as a separation column having bottom and top openings), the at least one opening being placeable on the body to be examined (¶ [0084] depicts the distances of the sensors 4a-4d from the measuring object being defined by the thickness of the supports, thereby indicating that the opening of the supports are configured to be placed on the measuring object; also see analogous Fig. 1 and ¶ [0075] which depict an opening formed on the front side 36 of the measuring chamber 3, which is placed on a measuring object), at least three sensors for measuring the intensive measurand are arranged in the measuring chamber (Fig. 2 and ¶ [0082] depict different sensors 4a-4d being arranged in the measuring chamber 3), the sensors being arranged at different distances from the body to be examined during measurement (Fig. 2 and ¶ [0084] depict different distances between the measuring object and the sensors 4a-4d).
The above embodiment is silent with regards to an evaluating device configured to receive values measured by each of the at least three sensors,
In the same field of endeavor of substance detection, Hagl teaches an embodiment comprising an evaluating device configured to receive values measured by each sensor (¶ [0075] of Hagl teaches a processing unit 40 for receiving values recorded by the sensors 4a, 4b). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 2 of Hagl to incorporate an evaluating device configured to receive values measured by each of the sensors as taught by ¶ [0075] of Hagl. The motivation would have been to provide processing circuitry for performing the measurement of the substances.
The above combination is silent with regards to whether the evaluating device is configured to determine a total value for the intensive measurand from the values measured by the at least three sensors, wherein a calculation rule is stored in the evaluating device, wherein the evaluating device is configured to, based on the calculation rule, determine the total value for the intensive measurand; and wherein the evaluating device is configured to determine the total value for the intensive measurand on the basis of the calculation rule. The examiner notes that “total value” is being interpreted to correspond to “a value determined from all measured values”, as indicated in paragraph [0040] of the application as published.
In the same field of endeavor of substance detection, Ahmad teaches determining a total value for the intensive measurand from the values measured by a plurality of sensors (¶ [0093] teaches averaging voltages of multiple thermopiles linked in arrays, wherein the thermopiles are configured to detect the same analyte; ¶ [0095] discloses the microprocessor converts the voltage to the concentration of the analyte), wherein a calculation rule is stored in the evaluating device, wherein the evaluating device is configured to, based on the calculation rule, determine the total value for the intensive measurand (¶ [0095] discloses the microprocessor converts the voltage to the concentration of the analyte, wherein the conversion may be programmed by use of a calibration curve, look-up table, or other method); and wherein the total value for the intensive measurand is an estimated value which the evaluating device is configured to determine on the basis of the calculation rule (¶ [0095] discloses the microprocessor converts the voltage to the concentration of the analyte, wherein the conversion may be programmed by use of a calibration curve, look-up table, or other method). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the evaluating device of the above combination to incorporate determining a total value for the intensive measurand from the values measured by the at least three sensors, wherein a calculation rule is stored in the evaluating device, wherein the evaluating device is configured to, based on the calculation rule, determine the total value for the intensive measurand; and wherein the evaluating device is configured to determine the total value for the intensive measurand on the basis of the calculation rule as taught by Ahmad. The motivation would have been to reduce the net effect of noise (¶ [0093] of Ahmad).
The above combination is silent with regards to whether the evaluating device is configured to determine the total value for the intensive measurand on the basis of the calculation rule by using a plurality of measurements to predict a convergence value for the intensive measurand, and using the convergence value in the calculation rule
In a system relevant to the problem of predicting convergence of measurement parameters, Beilin teaches using a plurality of measurements to predict a convergence value for the intensive measurand (¶ [0053] depict prediction of a stable final temperature based on the rate of change and elapsed time of the measurement), and using the convergence value in the calculation rule (¶ [0054] discloses using a plurality of temperature readings to determine a steady state temperature, wherein statistical analysis includes determining an arithmetic mean). Although Beilin is directed to the determination of a final temperature, the mathematical analysis of Beilin (i.e., prediction based on the rate of change and elapsed time of the measurement and determination of an arithmetic mean) is capable of being applied to the determination of the diffusion-based concentration of Hagl in view of Ahmad because both rely upon the same underlying physical characteristics involving diffusion. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation rule of the above combination to incorporate, based on the teachings of Beilin, using a plurality of measurements to predict a convergence value for the intensive measurand, and using the convergence value in the calculation rule. The motivation would have been to provide a more robust and/or accurate value of the measurand by accounting for noisy and/or spurious values.
With regards to claim 29, the above combination teaches or suggests the measuring chamber comprises at least two openings (Fig. 2 of Hagl depicts bottom and top openings).
With regards to claim 34 and 48, the above combination teaches or suggests a model function is stored in the evaluating device or in a downstream separate evaluating unit for the approximate simulation of the real course of an intensive measurand to be determined (¶¶ [0149]-[0150] of Hagl discloses determining total concentration based on the equations, ¶ [0075] of Hagl discloses a processing unit 40 for determining content of the substance in the measuring chamber, thereby indicating that the processing unit stores the model for determining concentration).
With regards to claim 35, the above combination teaches or suggests the measuring chamber comprises at least one sidewall and the at least three sensors are arranged on the at least one sidewall at different distances from the body to be examined (Fig. 2 of Hagl depicts the sensors 4a-4d being arranged on the sidewalls at different distances from the opening).
With regards to claim 37, the above combination is silent with regards to whether the measuring chamber has a round cross-section
In the same field of endeavor of substance monitoring, Hagl teaches another embodiment in which the measuring chamber has a round cross-section (¶ [0090] of Hagl discloses the measuring chamber 3 having a circular cross-section). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cross-section of the measuring chamber of the above combination to be circular. Because both cross-sections are capable of being used for determining concentrations of substances, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 38, the above combination teaches or suggests the at least three sensors are arranged in at least three rows, the at least three rows being arranged at different distances from the body to be examined and at least one sensor of the at least three sensors being arranged per row (Fig. 2 and ¶ [0081] of Hagl depict the sensors 4a-4d being arranged on supports 22a-22d being arranged on top of each other).
With regards to claim 39, the above combination teaches or suggests the at least three sensors are configured to measure the concentration of a substance emitted by the body by diffusion (¶ [0075] of Hagl discloses a processing unit 40 for determining content of the substance in the measuring chamber; ¶¶ [0003], [0025], [0242] of Hagl disclose measuring substances released from the body through the skin).
With regards to claim 50¸the above combination teaches or suggests the concentration of the substance emitted by the body by diffusion is the intensive measurand (¶ [0075] of Hagl discloses a processing unit 40 for determining content of the substance in the measuring chamber; ¶¶ [0003], [0025], [0242] of Hagl disclose measuring substances released from the body through the skin).
With regards to claim 51, the above combination teaches or suggests the method further comprises measuring at least three points which are at a different distance from the body, at least three values of temperature, and/or at least three values of relative humidity (Fig. 2 and ¶ [0081] of Hagl depict the sensors 4a-4d being arranged on supports 22a-22d being arranged on top of each other and are at different distances from the body).
Claims 31, 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Hagl in view of Ahmad and Beilin, as applied to respective claims 28 and 43 above, and further in view of US 2013/0197332 A1 (Lucisano) (previously cited).
With regards to claim 31 and 45, the above combination is silent with regards to whether the calculation rule stored in the evaluating device weights the values measured by the at least three sensors differently to determine the total value for the intensive measurand.
In the same field of endeavor of substance monitoring, Lucisano teaches weighting values measured by sensors differently to determine a total value for an intensive measurand (¶ [0072] discloses determining a weighted average value using a multiplicity of detectors). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation rule of the above combination to incorporate, based on the teachings of Lucisano, weighting the values measured by the at least three sensors differently to determine the total value for the intensive measurand. The motivation would have been to minimize the effects of variations of performance by individual detectors (see ¶ [0072] of Lucisano).
With regards to claim 46, the above combination teaches or suggests the weights the values measured by the sensors differently to determine the total value for the intensive measurand (see the above combination in view of Lucisano).
The above combination is silent with regards to the measured values of the sensors that are arranged closer to the body to be examined are weighted higher.
The weighting would depend up the factors of desired accuracy. As such, the weighting is a results-effective variable that would have been optimized through routine experimentation based on the desired accuracy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the weighting, so as to obtain the desired accuracy. In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the calculations such that the measured values of the sensors that are arranged closer to the body to be examined are weighted higher. See MPEP 2144.05 (II) (A).
Claims 32 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Hagl in view of Ahmad and Beilin, as applied to respective claims 28 and 43 above, and further in view of US 2003/0216627 A1 (Lorenz) (previously cited)
With regards to claim 32 and 47, the above combination is silent with regards to whether the evaluating device is configured to use a robust estimator when determining the total value of the intensive measurand on the basis of the calculation rule.
In the same field of endeavor of substance measurement, Lorenz teaches determining a total value using a robust estimator (¶ [0083] discloses that measurements are averaged using either a mean calculation or a robust estimate of the mean (e.g., trimmed mean)). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the total value of the above combination such that it is determined using a robust estimator as taught by Lorenz. The motivation would have been to provide a more robust or accurate determination of the total value.
Claims 36 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Hagl in view of Ahmad and Beilin, as applied to claim 28 above, and in view of US 4,066,068 A (Nilsson) (Previously-cited).
With regards to claim 36 , the above combination teaches or suggests that the measuring chamber comprises at least one sidewall and at least three sensors arranged in relation to the sidewalls (Fig. 2 of Hagl depicts the sidewalls of the measuring chamber in relation to sensors 4a-4d).
The above combination is silent with regards to the at least three sensors are arranged spaced from the sidewall in the central area of the measuring chamber at different distances from the body to be examined.
In the same field of endeavor of monitoring a substance diffused from a dermal surface, Nilsson teaches sensors are arranged spaced from the sidewall in the central area of the measuring chamber at different distances from the body to be examined (Figs. 1-2 depict sensors 6-9 spaced from the wall of the protective capsule and at different heights relative to skin). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the placement of the sensors of Hagl such that they are spaced from the sidewall in the central area of the measuring chamber as taught by Nilsson. Because both placements are capable of being used for determining parameters of diffused substances within a chamber (Fig. 2 of Hagl and Figs. 1-2 of Nilsson), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 40, the above combination is silent with regards to whether the at least three sensors measuring the concentration of the substance emitted by diffusion are additionally configured to measure the temperature and/or relative humidity, or wherein the measuring device further comprises at least three temperature sensors and/or sensors for measuring relative humidity for measuring the temperature and/or relative humidity, which are arranged at different distances from the body to be examined during measurement.
In the same field of endeavor of monitoring a substance diffused from a dermal surface, Nilsson teaches sensing an amount of liquid and convection heat emitted form a surface by diffusion by using temperature sensors and/or sensors for measuring relative humidity, which are arranged at different distances from the body to be examined during measurement (Figs. 1-3 depict temperature sensor members 6, 7 being thermistors RTA RTB also being arranged at with the other sensors 8, 9 at different distances from the body). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing arrangement of Hagl such that each of the sensors 4a-4d of Hagl are accompanied with temperature and/or humidity sensors as taught by Nilsson. The motivation would have been to account for temperature and humidity fluctuations in the determination of the concentration (see Col. 1, lines 16-33 of Nilsson), thereby providing a more accurate diagnostic analysis.
With regards to claim 41, the above combination teaches or suggests wherein the evaluating device is configured to receive the measured values for the temperature and/or relative humidity and is configured to determine a total temperature value and/or total value for relative humidity based on said values for the temperature and/or relative humidity (Fig. 3 of Nilsson depicts receiving the temperature signal values at 24; Col. 5, lines 1-16 and 31-36 of Nilsson disclose determining a signal value of either difference in partial pressure or temperature difference).
The examiner notes that “total temperature value” and “total value for relative humidity” are being interpreted to correspond to “a value determined from all measured values”, as indicated in paragraph [0040] of the application as published.
With regards to claim 42, the above combination teaches or suggests the temperature sensors and/or sensors for relative humidity are arranged on the sidewall (Fig. 1 of Nilsson depicts the temperature and relative humidity sensors being arranged on the sidewalls of the chamber).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Hagl in view of Ahmad and Beilin, as applied to claim 48 above, and in view of US 2003/0135120 A1 (Parks) (previously cited)
With regards to claim 49, the above combination is silent with regards to a value for the intensive measurand for a specific distance from a surface of the body that was not measured directly by one of the at least three sensors can be determined.
In a system related to the problem of interpolating values using a plurality of sensors, Parks teaches a value for the intensive measurand for a specific location that was not measured directly by one a plurality of can be determined (Abstract, ¶ [0131], ¶ [0270] teaches interpolating values for sensors for which no values were detected and interpolating values for locations between sensors to increase the spatial resolution of values visually indicated on a temporal plot and/or a profile plot). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing of Hagl to incorporate a value for the intensive measurand for a specific distance from a surface of the body that was not measured directly by one of the at least three sensors can be determined as taught by Parks. The motivation would have been to provide a more complete diagnostic analysis of the subject and/or increase the spatial resolution of the values.
Claims 52 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Hagl in view of Ahmad and Beilin, as applied to claim 43 above, and further in view of US 2020/0146596 A1 (Shah) (previously-cited).
With regards to claim 52, the above combination is silent with regards to determining a diffusion rate for a corresponding measurand from a gradient ∇ c(z) of a measured intensive measurand c(z) based on Fick's law.
In the same field of endeavor of monitoring an analyte concentration, Shah teaches determining a diffusion rate for a corresponding measurand from a gradient ∇ c(z) of a measured intensive measurand c(z) based on Fick's law (¶ [0061]-[0063]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing of Hagl of the above combination to incorporate determining a diffusion rate for a corresponding measurand from a gradient ∇ c(z) of a measured intensive measurand c(z) based on Fick's law as taught by Shah. The motivation would have been to provide a more complete diagnostic analysis of the patient.
With regards to claim 54, the above combination teaches or suggests the intensive measurand is a substance concentration and the diffusion rate is a substance quantity per time and per area (¶¶ [0061]-[0063] of Shah teaches the flux and substance concentration) .
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Hagl in view of Ahmad, Beilin, and Shah, as applied to claim 52 above, and further in view of US 6,694,977 B1 (Federowicz) (previously cited)
With regards to claim 53, the above combination is silent with regards to whether the intensive measurand is the temperature and the diffusion rate is the heat loss.
In a system related to the problem of determining heat transfer parameters, Federowicz teaches the intensive measurand is the temperature and the diffusion rate is the heat loss (Col. 21, line 61 to Col. 22, line 25). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing of the above combination to incorporate the intensive measurand is the temperature and the diffusion rate is the heat loss as taught by Federowicz. The motivation would have been to provide a more complete diagnostic analysis of the patient.
Response to Arguments
Claim Objections
In view of the claim amendments filed 10/22/2025, the claim objections were withdrawn.
Claim Rejections under 35 U.S.C. §112(b) and (d)
In view of the claim amendments filed 10/22/2025, the claim rejections under 35 U.S.C. §112(b) and (d) were withdrawn.
Claim Rejections under 35 U.S.C. §103
There are new grounds of rejections under 35 U.S.C. §103 necessitated by the claim amendments filed 10/22/2025. A new grounds of rejection is made in view of Beilin. Specifically, the previously applied prior combination does not disclose whether the evaluating device is configured to determine the total value for the intensive measurand on the basis of the calculation rule by using a plurality of measurements to predict a convergence value for the intensive measurand, and using the convergence value in the calculation rule. Beilin teaches this feature in ¶¶ [0053], [0054], which provides the benefit of providing a more robust and/or accurate value of the measurand by accounting for noisy and/or spurious values. Therefore, the previously applied rejection under 35 U.S.C. §103 has been modified to incorporate the teachings of Beilin.
To the extent that the Applicant's arguments are applicable to the current rejections, the Examiner makes the following comments.
Applicant's arguments filed 10/22/2025 have been fully considered but they are not persuasive.
Applicant asserts:
PNG
media_image1.png
272
642
media_image1.png
Greyscale
This argument is not persuasive. The claim language recites “at least one opening being placeable on the body to be examined”. Fig. 2 and ¶ [0081] of Hagl depict a measuring chamber 3 designed as a separation column having bottom and top openings. The Examiner asserts that the top and bottom openings are capable of being placed on a body because there are no features which prevent the potential placement of the openings on the body. The claim limitation does not recite any further features which preclude such an interpretation. Therefore, Hagl teaches the claim limitation. Additionally, ¶ [0084] of Hagl teaches the distances of the sensors 4a, 4b, ... from the measuring object can be determined by the defined thicknesses of the supports 22a to 22d, which indicates that the opening and one of the supports is placed on the measuring object. Analogous Fig. 1 and ¶ [0075] depict an opening formed on the front side 36 of the measuring chamber 3, which is placed on a measuring object. ¶ [0025] indicates that the measuring object relates to the skin of the subject.
Applicant’s arguments with regards to the dependent claims are not persuasive because the arguments regarding the independent claims are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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, Jacqueline Cheng can be reached at (571) 272-5596. 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.
/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791