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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 5/6/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Responses to Amendments and Arguments
The amendments filed 2/11/2026 have been entered. Claims 1, 2, 4, 5, 6, 7, 10, 11, 13, 14, 15, 16 and 19 are amended, and claim 20 is added. Claims 1-20 remain pending in the application.
Applicant's amendments and argument filed 2/11/2026 with respect to the rejection of claim 4-7 and 13-16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been fully considered and are persuasive. Thus, the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph have been withdrawn.
Applicant's argument and amendments filed 2/11/2026 with respect to
the rejection of claims 1-3, 8-12 and 17-19 directed to a judicial exception under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, Applicant's amendments have overcome the rejection under 35 U.S.C. 102, but the claims raise the rejection under 35 U.S.C. 103.
On pages 20-22 of Applicant’s response, Applicant alleges that while amended claim 1 uses the small random variations in electronic signals to allow full-span rapid calibration prior to a full stability response from the sensor, the system of Tolmie performs a baseline zero recalibration but must wait for the sensor output to reach full stability, … there is no disclosure in Tolmie of the claimed "estimate a near stabilization point of the sensor readings by identifying at least one sensor reading from the series of sensor readings at which the change in sensor reading from previous sensor readings is less than an internally generated self-referencing threshold relative to said variations; and adjusting, based on the near stabilization point, a parameter in the instrument that represents an association between sensor readings and a known physical quantity", as recited by amended claim 1. … the above-noted subject matter of amended claim 1 is not taught or suggested by Tolmie.
The Examiner respectfully disagrees.
Under the broadest reasonable interpretation, the claimed features recited in claim 1 is indicative of determining variations in electronic signals from the obtained sensor outputs/readings to thereby determine/estimate the stabilization point when the change in the sensor outputs/reading is compared to a predetermined threshold, (especially, the change in sensor reading from previous sensor readings is less than an internally generated self-referencing threshold). Under this interpretation, at least paragraph 0078 teaches monitoring the sensor output for variations and estimating if stable state of the sensor by comparing the sensor output based on the predetermined thresholds to perform the calibration when the sensor output is within the stable threshold. In the estimation step, “less than … threshold” itself is not critical to be distinctly result-effective features but is merely indicative of a condition for performing the estimation, where the condition “less than … threshold” may be selected by routine experimentation and/or a user’s interest/preference in usage of a predetermined threshold. Therefore, the condition “less than … threshold” for performing the estimation is obvious to one of ordinary skill in the art before the effective filing date of the claimed invention which may prompt variations of it for use, as Tolmie teaches estimating if stable state of the sensor by comparing the sensor output based on the predetermined thresholds to perform the calibration when the sensor output is within the stable threshold (see at least paragraph 0078).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 7-12 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tolmie et al. (US PGPUB US 20150233879 A1, hereinafter referred to as “Tolmie” cited in IDS dated 09/25/2024).
Regarding Claim 1, Tolmie teaches a calibration system for calibrating an instrument, the calibration system (Figs. 1A-1B, 100; Para 0006-0009), comprising:
at least one sensor (Figs. 1A-1B, 109, 119; Para 0048);
a processor (Figs. 1A-1B, 145; Para 0048; Para 0042, “a system controller that may comprise one or more processors and memory”); and
a memory (Figs. 1A-1B, 145; Para 0048; Para 0044, “the memory may store a set of machine-executable instructions (or algorithms), when executed by processors”) comprising instructions which, when executed by the processor, configure the processor to:
obtain a series of sensor readings (i.e., offset reading) (Para 0075 teaches zero offset reading of sensor, “perform a baseline calibration and/or time offline can include both the response time of the catalytic type electrochemical sensor required to obtain the zero offset reading (e.g., the output indicative of 0 PPM when the sensor may be at least partially saturated)”;
determine variations between changes in successive sensor readings from the series of sensor readings, said variations being representative of random variations in electronic signals (Para 0078 teaches rate of change and variations of the sensor output, “The rate of change of the NO sensor output can be monitored and compared against predetermined thresholds deemed "stable" …. By monitoring the sensor output for variations over the monitored and/or recorded over a period of time, the calibration may be concluded when the sensor output is within the stable threshold”);
estimate a near stabilization point of the sensor readings by identifying at least one sensor reading from the series of sensor readings at which the change in sensor reading from previous sensor readings is less than an internally generated self-referencing threshold relative to said variations (Para 0078 teaches estimating if stable state of the sensor by comparing the sensor output based on the predetermined thresholds, “The rate of change of the NO sensor output can be monitored and compared against predetermined thresholds deemed "stable" …. If the sensor output (e.g., in microamps or ADC counts) is outside the stable threshold during the monitoring period, monitoring may be continued until the sensor output is within the stable threshold, for example, 1 ADC count variation or less over a 10 second monitoring period. It has been found that, in at least some instances, sensor response to changes in concentration of the target gas (e.g., changes in set dose of NO) may respond more quickly in newer sensors and/or with smaller absolute changes in concentration (e.g., smaller absolute changes in set dose).”); and
adjust, based on the stabilization point, a parameter in the instrument that represents an association between sensor readings and a known physical quantity (Para 0076 and 0078 teach calibrating the sensor by adjusting quantity of the drift (offset) based on zero output (i.e., stabilization point); Para 0078 “The rate of change of the NO sensor output can be monitored and compared against predetermined thresholds deemed "stable" …. By monitoring the sensor output for variations over the monitored and/or recorded over a period of time, the calibration may be concluded when the sensor output is within the stable threshold”; Para 0076, “the quantity of this drift (offset) in the baseline (zero) current output can be determined … the sensor may then require another period of time (e.g., 2 minutes, etc.), where the period of time may be in the range of about 1 to 2 minutes to stabilize to target gas. This drift can then be used to adjust the calibration line offset. By way of example, to determine the quantity of this drift (offset) in the initial baseline current output (4.5 micro amps for 0 PPM of NO), a new baseline current 306 (-1.0 micro amp for 0 PPM of NO) can be determined when exposing the sensor to 0 PPM of NO (ambient air). The now known baseline current shift (e.g., from 0 micro amps to -1 micro amps for 0 PPM of NO) can be applied with the slope of the initial and/or previous calibration line to report the actual NO gas concentration. … the calibration may be concluded when the sensor output is within the stable threshold, which may provide a value within 99% of the full signal”).
Tolmie does not explicitly teach “the change in sensor reading … is less than an internally generated self-referencing threshold” (Emphasis added). It has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Under the broadest reasonable interpretation, the claimed features recited in claim 1 is indicative of determining variations in electronic signals from the obtained sensor outputs/readings to thereby determine/estimate the stabilization point when the change in the sensor outputs/reading is compared to a predetermined threshold, (especially, the change in sensor reading from previous sensor readings is less than an internally generated self-referencing threshold). Under this interpretation, at least paragraph 0078 in Tolmie teaches monitoring the sensor output for variations and estimating if stable state of the sensor by comparing the sensor output based on the predetermined thresholds to perform the calibration when the sensor output is within the stable threshold. In the estimation step, “less than … threshold” itself is not critical to be distinctly result-effective features but is merely indicative of a condition for performing the estimation, where the condition “less than … threshold” may be selected by routine experimentation and/or a user’s interest/preference in usage of a predetermined threshold. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a predetermined threshold for estimating the stable state and calibrating the sensor by adjusting quantity of the drift (offset), as per a user’s interest and routine experimentation, as taught by Tolmie at least at paragraphs 0076 and 0078.
Regarding Claim 2, Tolmie teaches wherein the stabilization point comprises a point where the change in the sensor reading is less than said internally generated self-referencing threshold (Fig. 3, zero drift; Para 0068-0069, 0075 and 0078 teach zero point 302 which is indicative of zero drift (i.e., zero offset reading) not required to compensate the sensor; Para, “calibration point 302 can be determined by exposing NO sensor 108 to ambient source 130 (e.g., conditioned ambient that can have 0 PPM of NO and/or that can be inclusive of environmental temperature and humidity) to establish an output current for a zero concentration of a target gas of interest”; Para 0075 “electrochemical sensor required to obtain the zero offset reading (e.g., the output indicative of 0 PPM when the sensor may be at least partially saturated)”).
Regarding Claim 3, Tolmie teaches wherein the processor is configured to:
update a reading buffer with the series of sensor readings (Para 0078 “The number of counts measured over a period may be stored in memory”);
populate a rolling average of the first differences (RADi) buffer based on the reading buffer data (Para 0078 “the counts generated over 10 seconds summed and averaged”);
estimate a standard deviation (ADC count variation) of a last N sample RADi readings (Note that, under the broadest reasonable interpretation, this limitation is indicative of a process estimating sensor outputs, which is taught by at least Para 0078 “If the sensor output (e.g., in microamps or ADC counts) is outside the stable threshold during the monitoring period, monitoring may be continued until the sensor output is within the stable threshold, for example, 1 ADC count variation or less over a 10 second monitoring period”);
retrieve a standard deviation (ADC count variation) from a previous N sample of RADi readings prior to the last N RADi readings (Para 0078 “If the sensor output (e.g., in microamps or ADC counts) is outside the stable threshold during the monitoring period, monitoring may be continued until the sensor output is within the stable threshold, for example, 1 ADC count variation or less over a 10 second monitoring period”);
determine an interval where stable readings would fall; and determine a count of RADi buffer entries in the interval (Para 0078 “The number of counts measured over a period may be stored in memory”).
Regarding Claim 7, Tolmie teaches wherein the processor is configured to determine that the last N sample of RADi readings is extreme when the count is less than or equal to said extreme threshold count value (Para 0108 teaches the system controller to determine that the sensor output (i.e., last N sample of RADi readings) is extreme (i.e., outside of the range expected due to drift) when the sensor output is greater than an expected output threshold (i.e., a first threshold)).
Tolmie does not explicitly teach wherein the frequency is ranged less than or equal to a threshold. It has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 optimum or workable ranges of the sensor output (i.e., count) taught by Tolmie to be in the claimed range in order to determine if the N sample of the RADi readings is extreme as per a user’s interest and routine experimentation.
Regarding Claim 8, Tolmie teaches wherein the processor is configured to: associate a physical quantity with the sensor output as identified through the calibration process (Note that, under the broadest reasonable interpretation, this limitation may be indicative of a calibration/compensation process to apply or determine the sensor output, which is taught by paragraph 0076, “the quantity of this drift (offset) in the baseline (zero) current output can be determined by exposing the sensor (e.g., NO sensor) to a known 0 PPM concentration of the gas of interest (e.g., NO) … The now known baseline current shift (e.g., from 0 micro amps to -1 micro amps for 0 PPM of NO) can be applied with the slope of the initial and/or previous calibration line to report the actual NO gas concentration”).
Regarding Claim 9, Tolmie teaches wherein the processor is configured to: associate a target value with the sensor output as identified through the calibration process (Note that, under the broadest reasonable interpretation, this limitation may be indicative of a calibration/compensation process to apply or determine a target value of the sensor output, which is taught by paragraph 0076, “the quantity of this drift (offset) in the baseline (zero) current output can be determined by exposing the sensor (e.g., NO sensor) to a known 0 PPM concentration of the gas of interest (e.g., NO) … The now known baseline current shift (e.g., from 0 micro amps to -1 micro amps for 0 PPM of NO) can be applied with the slope of the initial and/or previous calibration line to report the actual NO gas concentration”).
Regarding Claim 10, it is a method type claim and has similar limitations as of a part of claim 1 above. Therefore, it is rejected under the same rationale as of claim 1 above.
Regarding Claim 11, it is dependent on claim 10 and has similar limitations as of claim 2 above. Therefore, it is rejected under the same rationale as of claim 2 above.
Regarding Claim 12, it is dependent on claim 10 and has similar limitations as of claim 3 above. Therefore, it is rejected under the same rationale as of claim 3 above.
Regarding Claim 16, it is a method type claim having similar limitations as of claim 7 above. Therefore, it is rejected under the same rationale as of claim 7 above.
Regarding Claim 17, it is dependent on claim 10 and has similar limitations as of claim 8 above. Therefore, it is rejected under the same rationale as of claim 8 above.
Regarding Claim 18, it is dependent on claim 10 and has similar limitations as of claim 9 above. Therefore, it is rejected under the same rationale as of claim 9 above.
Regarding Claim 19, it is a system type claim having similar limitations as of claim 1 above. Therefore, it is rejected under the same rationale as of claim 1 above.
Regarding Claim 20, Tolmie teaches wherein said near stabilization point is less than 99% of the span between the sensor reading when no target gas is present and when the sensor is exposed to the target gas (Para 0076 and 0078 teach calibrating the sensor by adjusting quantity of the drift (offset) based on zero output (i.e., stabilization point); Para 0078 “The rate of change of the NO sensor output can be monitored and compared against predetermined thresholds deemed "stable" …. By monitoring the sensor output for variations over the monitored and/or recorded over a period of time, the calibration may be concluded when the sensor output is within the stable threshold”; Para 0076, “the quantity of this drift (offset) in the baseline (zero) current output can be determined … the sensor may then require another period of time (e.g., 2 minutes, etc.), where the period of time may be in the range of about 1 to 2 minutes to stabilize to target gas. This drift can then be used to adjust the calibration line offset. By way of example, to determine the quantity of this drift (offset) in the initial baseline current output (4.5 micro amps for 0 PPM of NO), a new baseline current 306 (-1.0 micro amp for 0 PPM of NO) can be determined when exposing the sensor to 0 PPM of NO (ambient air). The now known baseline current shift (e.g., from 0 micro amps to -1 micro amps for 0 PPM of NO) can be applied with the slope of the initial and/or previous calibration line to report the actual NO gas concentration. … the calibration may be concluded when the sensor output is within the stable threshold, which may provide a value within 99% of the full signal”; Para 0109, “as the vast majority (e.g., 99%, etc.) of all deliveries of therapeutic gas may be less than a set dose of NO at about 50 PPM, then using a calibration schedule based on an absolute change in set dose of 50 PPM addresses the worst case scenario as well as provides the benefit of reduced sensor time offline”).
Examiner Notes
Claims 4-6 and 13-15 may not be taught by the prior arts.
Claims 4-6 and 13-15 would be allowable to include all of the limitations of the base claim and any intervening claims.
The following is an examiner's statement for the reasons for allowance:
Regarding claim 4, the prior art does not teach or suggest, in combination with the rest of the limitations of Claim 4,
"wherein the processor is configured to set the estimate of the standard deviation equal to a resolution value of the sensor reading when the standard deviation from the previous N sample of RADi readings prior to the last N RADi readings is less than the resolution value of the sensor reading".
Regarding claim 5, the prior art does not teach or suggest, in combination with the rest of the limitations of Claim 5,
"wherein the processor is configured to determine that the last N sample of RADi readings is stable when: the count is greater than an extreme threshold count value; the count is greater than a stable threshold count value; andthere is no extreme RADi entry in the last N sample RADi readings, wherein the processor is configured to determine that a RADi entry in the last N sample of RADi readings is extreme when the RADi entry is outside of said interval".
Regarding claim 6, the prior art does not teach or suggest, in combination with the rest of the limitations of Claim 6,
"wherein the processor is configured to determine that the last N sample of RADi readings is unstable when: the count is greater than an extreme threshold count value; the count is greater than a stable threshold count value; andthere is at least one extreme RADi entry in the last N sample RADi readings, wherein the processor is configured to determine that a RADi entry in the last N sample of RADi readings is extreme when the RADi entry is outside of said interval".
Claim 13 would be allowable due to the same reason of claim 4 set forth above.
Claim 14 would be allowable due to the same reason of claim 5 set forth above.
Claim 15 would be allowable due to the same reason of claim 6 set forth above.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
GARCIA et al. (WO 2017044654 A1, cited in IDS dated 09/25/2024) teaches a method of calibrating an analyte concentration sensor within a biological system, using only a signal from the analyte concentration sensor, where at a steady state, the analyte concentration value within the biological system is known, comprising: a. on a monitoring device, detecting when an analyte concentration value as measured by an analyte concentration sensor indwelling in a biological system constitutes a first repeatable event; and b. on the monitoring device or on a device or server operatively coupled to the monitoring device, correlating a measurement of the analyte concentration value when the biological system is at the detected first repeatable event to the known analyte concentration value, and where it further comprises recalibrating the analyte concentration sensor by correlating a sensor reading when the biological system is at the detected second repeatable event to the known analyte concentration value at a time when a sensor reading is substantially stable, or within a predetermined range of readings for a threshold period of time, whereby an occurrence of unexpected jumps in readings is reduced.
Aguiar et al. (US 20200184236 A1) teaches validating calibration of a system of sensors having several types of sensors, where an object may be configured to have a substantially reflective portion such that the sensors can isolate the substantially reflective portion, and their sensor data can be compared to determine, if the detected locations of the substantially reflective portion by each sensor are aligned, and where for calibrating a system of sensors, an object having known calibration features can be used and detected by each sensor, and the detected data can be compared to known calibration data associated with the object to determine if each sensor is correctly calibrated.
Katz et al. (US 20150193983 A1) teaches calibrating components of VR system simultaneously to (1) adjust calibrations to adjust the estimated positions so a relative distance between the adjusted estimated positions of observed locators and positions of their corresponding model locaters is less than a threshold value; and (2) adjust the estimated positions of the reference point determined from the fast calibration data such that a relative distance between the estimated positions of the reference point and positions of a model reference point determined from the model locators is less than the threshold value.
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 BYUNG RO LEE whose telephone number is (571)272-3707. The examiner can normally be reached on Monday-Friday 8:30am-4:00pm.
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, Lee Rodak can be reached on (571) 270-5628. The fax phone number for the organization where this application or proceeding is assigned is 571-273-2555.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BYUNG RO LEE/Examiner, Art Unit 2858
/LEE E RODAK/Supervisory Patent Examiner, Art Unit 2858
Prosecution Insights