Prosecution Insights
Last updated: April 19, 2026
Application No. 18/290,479

METHOD AND SYSTEM FOR PREVENTING TAMPERING OF BREATH SAMPLE MEASUREMENTS

Non-Final OA §102§103§112
Filed
Nov 14, 2023
Examiner
MCCORMACK, ERIN KATHLEEN
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Automotive Coalition for Traffic Safety, Inc.
OA Round
1 (Non-Final)
14%
Grant Probability
At Risk
1-2
OA Rounds
3y 10m
To Grant
74%
With Interview

Examiner Intelligence

Grants only 14% of cases
14%
Career Allow Rate
3 granted / 22 resolved
-56.4% vs TC avg
Strong +60% interview lift
Without
With
+60.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
100 currently pending
Career history
122
Total Applications
across all art units

Statute-Specific Performance

§101
10.9%
-29.1% vs TC avg
§103
43.5%
+3.5% vs TC avg
§102
13.5%
-26.5% vs TC avg
§112
32.1%
-7.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 22 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION This action is pursuant to claims filed on 11/14/2023. Claims 1-23 are pending. A first action on the merits of claims 1-23 is as follows. 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 . Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters are used to designate multiple components: Reference character “A” has been used to designate both an arrow in Figure 1B and some other feature in Figure 2a, however it is unclear what feature it is meant to reference in Figure 2a since reference character “A” is not mentioned in the description of Figure 2a; Reference character “T” has been used to designate both the tracer substance in Figure 2a and transmission in Figure 5. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Reference character “V” in Figure 1 does not appear in the specification Reference character “B” in Figure 2a does not appear in the specification Reference character “FoV” in Figure 2b does not appear in the specification Reference character “405b” in Figure 4b does not appear in the specification Reference character “405c” in Figure 4c does not appear in the specification Reference character “λ” in Figure 5 does not appear in the specification Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections Claims 1, 10, 13, and 17 are objected to because of the following informalities: In claim 1, line 15, “background value record” should read “background value, record” In claim 1, line 21, “the user determine” should read “the user, determine” In claim 10, lines 3-4, “to the validate the measurement” should read “to validate the measurement” In claim 10, line 20, “background value record” should read “background value, record” In claim 10, line 26, “the user determine” should read “the user, determine” In claim 13, line 3, “arrange” should read “arranged” In claim 17, line 3, “a 8x8 matrix” should read “an 8x8 matrix” In claim 17, line 3, acronym “IR” should be spelled out when it is first introduced in the claims (that is, “IR” should be “infrared (IR)”) Appropriate correction is required. Claim Rejections - 35 USC § 112 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. Claims 1-23 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 1, the claim recites the limitation “the validity” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Further regarding claim 1, the claim recites the limitation “the exhaled breath” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Further regarding claim 1, the claim recites the limitation “the concentration of a tracer substance” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Further regarding claim 1, the claim recites the limitation “the coverage” in line 10. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Further regarding claim 1, the claim recites the limitation “the degree of coverage” in line 11. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Further regarding claim 1, the claim recites the limitation “the output signal variation” in lines 16-17. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Further regarding claim 1, the claim recites the limitation “the respiratory cycle” in line 20. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Further regarding claim 1, the claim recites the limitation “the relation” in line 27. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are also rejected due to their dependency on claim 1. Regarding claim 2, the claim recites the limitation “a background value” in line 2. It is unclear if this limitation is referring to the background value from claim 1, or a different background value. If it is referring to the background value from claim 1, it needs to refer back to it. If it is referring to a different background value, it needs to be distinguished from the background value from claim 1. For purposes of examination, it is being interpreted as referring to the background value from claim 1. Further regarding claim 2, the claim recites the limitation “the parameters” in line 6. There is insufficient antecedent basis for this limitation in the claim. Further regarding claim 2, the claim recites the limitation “the upper value” in line 8. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 4, the claim recites the limitation “an object” in line 3. It is unclear if this limitation is referring to the object from claim 1, or a different object. If it is referring to the object from claim 1, it needs to refer back to it. If it is referring to a different object, it needs to be distinguished from the object from claim 1. For purposes of examination, it is being interpreted as referring to the object from claim 1. Claims 5-6 are also rejected due to their dependency on claim 4. Further regarding claim 4, the claim recites the limitation “the onset” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Claims 5-6 are also rejected due to their dependency on claim 4. Regarding claim 6, the claim recites the limitation “the time difference” in line 4. There is insufficient antecedent basis for this limitation in the claim. Further regarding claim 6, the claim recites the limitation “the time required for an exhaled breath sample” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 7, the claim recites the limitation “the peak in the line-of-sight detector” in line 4. There is insufficient antecedent basis for this limitation in the claim. Further regarding claim 7, the claim recites the limitation “the time required for an exhaled breath sample” in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 10, the claim recites the limitation “the exhaled breath” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Further regarding claim 10, the claim recites the limitation “the concentration of a tracer substance” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Further regarding claim 10, the claim recites the limitation “the coverage” in line 11. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Further regarding claim 10, the claim recites the limitation “the degree of coverage” in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Further regarding claim 10, the claim recites the limitation “the output signal variation” in lines 21-22. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Further regarding claim 10, the claim recites the limitation “the respiratory cycle” in line 25. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Further regarding claim 10, the claim recites the limitation “the relation” in line 32. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Further regarding claim 10, the claim recites the limitation “the validity” in line 35. There is insufficient antecedent basis for this limitation in the claim. Claims 11-23 are also rejected due to their dependency on claim 10. Regarding claim 11, the claim recites the limitation “an effective field of view” in line 4. It is unclear if this limitation refers to the field of view introduced in claim 10, or a different field of view. If it is referring to the field of view from claim 10, it needs to refer back to it. If it is referring to a different field of view, it needs to be distinguished from the field of view from claim 10. For purposes of examination, it is being interpreted as referring to the field of view from claim 10. Regarding claim 14, the claim recites the limitation “a field of view” in line 3. . It is unclear if this limitation refers to the field of view introduced in claim 10, or a different field of view. If it is referring to the field of view from claim 10, it needs to refer back to it. If it is referring to a different field of view, it needs to be distinguished from the field of view from claim 10. For purposes of examination, it is being interpreted as referring to the field of view from claim 10. Further regarding claim 14, the claim recites the limitation “a typical human face” in line 6. It is unclear what constitutes as a typical human face, and what the area of that would be. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as any area that could be considered a typical human face. Regarding claim 15, the claim recites the limitation “a signal from the line-of-sight detector” in lines 4-5. It is unclear if this is referring to the line-of-sight detector output signal from claim 10, or a different signal. If it is referring to the output signal from claim 10, it needs to refer back to it. If it is referring to a different signal, it needs to be distinguished from the output signal from claim 10. For purposes of examination, it is being interpreted as referring to the output signal from claim 15. Regarding claim 18, the claim recites the limitation “a background value” in line 3. It is unclear if this limitation refers to the background value from claim 10, or a different background value. If it is referring to the background value from claim 10, it needs to refer back to it. If it is referring to a different background value, it needs to be distinguished from the background value from claim 10. For purposes of examination, it is being interpreted as referring to the background value from claim 10. Further regarding claim 18, the claim recites the limitation “the parameters” in line 7. There is insufficient antecedent basis for this limitation in the claim. Further regarding claim 18, the claim recites the limitation “the upper value” in line 9. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 20, the claim recites the limitation “an object” in line 4. It is unclear if this limitation refers to the object in claim 10, or a different object. If it is referring to the object in claim 10, it needs to refer back to it. If it is referring to a different object, it needs to be distinguished from the object from claim 10. For purposes of examination, it is being interpreted as referring to the object from claim 10. Claims 21-22 are also rejected due to their dependency on claim 20. Further regarding claim 20, the claim recites the limitation “the onset” in line 5. There is insufficient antecedent basis for this limitation in the claim. Claims 21-22 are also rejected due to their dependency on claim 20. Regarding claim 22, the claim recites the limitation “the time difference” in line 5. There is insufficient antecedent basis for this limitation in the claim. Further regarding claim 22, the claim recites the limitation “the time required for an exhaled breath sample” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Regarding claim 23, the claim recites the limitation “the peak in the line-of-sight detector output signal” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Further regarding claim 22, the claim recites the limitation “the time required for an exhaled breath sample” in line 7. There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-7, 10-11, 14, and 18-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hök (EP 3106872). Regarding independent claim 1, Hök teaches a method of using a breath analysis device (100) for determining the validity of a measurement of a concentration of an intoxicating substance in the exhaled breath of a user (Abstract: “There is disclosed a tamper evident breath analyser device … An associated method is also disclosed.”), the breath analysis device (100) comprising: - a measuring cell arranged to sample a sensor signal representing the concentration of the intoxicating substance and a sensor signal representing the concentration of a tracer substance ([0040]: “In the illustrated embodiment of the device 1 there is provided a pair of sensors 18, 19 inside the sensor module 3 and to one side of the internal chamber 17 therethrough. One of the sensors 19 is responsive to the volatile substance of interest (for example ethanol in the case of an alcohol breath analyser), and the other sensor 18 is responsive to CO2 which will be used as a tracer substance”); and - a line-of-sight detector with a predetermined field of view and arranged to measure the coverage by an object of the field of view ([0035]: “The inlet region 2 of the device is provided with a small (typically less than 5 mm across in its longest dimension) imaging device 9 which may be a digital device such as a charge-coupled device (CCD) image sensor or a complementary metal-oxide-semiconductor (CMOS) image sensor.”; [0059]: “the image processor 25 will proceed to analyse the images by comparing successive images of the captured series to one another, to thereby systematically identify whether or not a face 14 is present in the imaging sensor's field of view 15 (as denoted at 37), whether or not the subject's mouth 11 is open (as denoted at 38), and whether or not a blocking or disturbing object such as a tube 31 is present between the subject's mouth 11 and the breath analyser device (as denoted at 39), as described above”) and to output a signal representing the degree of coverage ([0063]: “Figure 11 (b) denotes detection by the image processor 25 of the face 14 and/or mouth 11 of the test subject 10. As will therefore be noted, the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device. In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V.”; [0065]: “Figure 11 (d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like”; Figure 11. The degree of coverage is equivalent to classifying the presence of a face and the disturbing objects.), the method comprising the steps of: - (305) monitoring the output signal of the line-of-sight detector (108) ([0052]: “It is envisaged that the imaging device 9 will produce real time image signals with a relatively large bandwidth, including typically more than 100 x 100 pixels at a frame rate of 10 images per second. When activated, the imaging device 9 will capture a plurality of successive images of the test subject's face 14 for temporary storage in the data buffer 22. The image processor 25 may then retrieve the captured images from the data buffer 22 for subsequent comparative analysis. The image processor 25 may thus be provided in the form of a general purpose microprocessor with the capacity to perform algorithms at relatively fast speed. The image processor 25 operates in concert with the image classifier 26, whose function is to classify a breath sample from a test subject 10 as either approved or disapproved on the basis of decision criteria related to the comparative analysis of the captured images of the test subject's face”), and if (310) the output signal deviates from an established background value record (315) the line-of-sight detector output signal as a function of time, the output signal variation being a recorded line-of-sight signal signature ([0063]: “Figure 11 (b) denotes detection by the image processor 25 of the face 14 and/or mouth 11 of the test subject 10. As will therefore be noted, the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device. In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V.”; [0065]: “Figure 11 (d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like”; Figure 11. The presence of the face, as shown in Figure 11b, shows the deviation from the established background value (the value of 0 is the background value which represents no face, and the value of 1 shows the recorded signal as a function of time, which is the signal signature); - (320) monitoring the tracer substance sensor signal and if (325) a peak in the tracer substance is detected, the peak indicating a possible exhalation phase of the respiratory cycle of the user determine (330) a breath concentration value of the intoxicating substance based on the intoxicating substance sensor signal and the tracer substance sensor signal ([0049]: “figure 4(a) graphically shows the variation of the measured concentration of CO2 as a function of time, whilst figure 4(b) graphically shows the variation of the substance of primary interest, in this case ethanol (EtOH), as a function of time during a breath test. Both signals are basically zero at the start of the test, and grow to a maximum during the expiratory phase, before then returning to zero as the sensing unit is ventilated. When the CO2 concentration reaches its maximum, the processor unit's algorithm will assume a dilution ratio of CO2alv / CO2meas and multiply it with the measured ethanol concentration at that time in order to obtain the estimated undiluted EtOH concentration.”; Figure 4); - (335) comparing the recorded line-of-sight signal signature originating from the line-of-sight detector (108) with at least one stored reference signal signature ([0052]: “the imaging device 9 will capture a plurality of successive images of the test subject's face 14 for temporary storage in the data buffer 22. The image processor 25 may then retrieve the captured images from the data buffer 22 for subsequent comparative analysis. The image processor 25 may thus be provided in the form of a general purpose microprocessor with the capacity to perform algorithms at relatively fast speed. The image processor 25 operates in concert with the image classifier 26, whose function is to classify a breath sample from a test subject 10 as either approved or disapproved on the basis of decision criteria related to the comparative analysis of the captured images of the test subject's face”); - (345) comparing the relation between the line-of-sight detector output signal and the tracer substance signal with stored signal relation criteria ([0064]-[0065]: “Figure 11 (c) denotes detection by the image processor 25 of the test subject's mouth 14 opening prior to exhalation of a breath sample, which will of course also occur before the CO2 concentration exceeds the predetermined threshold value V. In this example, the test subject's mouth 14 is detected as opening at approximately 3 seconds. Figure 11 (d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like. In the example illustrated, the blocking object is detected at a time of 2 seconds, which again precedes the point in time at which the CO2 concentration exceeds the predetermined threshold value V. In the case of the type of operating regime described above with reference to figure 9, in which the image processor 25 is prompted to retrieve and analyse the images which have been captured and stored in the data buffer 22 only in response to the breath signal processor 27 determining that the CO2 signal received from the CO2 sensor 18 is representative of the CO2 concentration in the sample exceeding the predetermined threshold value V, it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted Ton the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted tin figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T.”); and wherein - (340, 350, 355) the validity of the measurement of the breath concentration value is confirmed if the recorded line of sight signal signature matches the stored reference signal signature and if the recorded line-of-sight output signal and the tracer substance signal fulfils the stored signal relation criteria (Fig. 10; [0059]: “If no such blocking or disturbing object is identified then the breath sample will be approved (as denoted at 40) and the breath signal processor will be instructed (as denoted at 41) to proceed to calculate the concentration of volatile substance (e.g. ethanol) in the breath sample as previously described. However, if a blocking or disturbing object 31 is detected, then the image processor 25 will return an error signal 42, which may be shown on a display, and will be tasked with identifying a test subject's face 14 again for a subsequent test attempt.”). Regarding claim 2, Hök teaches the method according to claim 1, wherein in the monitoring step (305) a background value of the line-of-sight detector output signal is determined ([0063]: “Figure 11 (b) denotes detection by the image processor 25 of the face 14 and/or mouth 11 of the test subject 10. As will therefore be noted, the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device. In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V.”; [0065]: “Figure 11 (d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like”; Figure 11. The presence of the face, as shown in Figure 11b, shows the deviation from the established background value (the value of 0 is the background value which represents no face, and the value of 1 shows the recorded signal as a function of time)), and in the step (335) of comparing the recorded line of sight signal signature with the stored reference signal signature comprises at least comparing one or a selection of the parameters: signal slope after an initial ascension, duration of a time period of increasing signal, a signal value associated to the upper value (21), duration of the signal at or above a predefined level relating to the upper level (21), and signal slope after a peak or plateau ([0065]: “the blocking object is detected at a time of 2 seconds, which again precedes the point in time at which the CO2 concentration exceeds the predetermined threshold value V. In the case of the type of operating regime described above with reference to figure 9, in which the image processor 25 is prompted to retrieve and analyse the images which have been captured and stored in the data buffer 22 only in response to the breath signal processor 27 determining that the CO2 signal received from the CO2 sensor 18 is representative of the CO2 concentration in the sample exceeding the predetermined threshold value V, it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted T on the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted t in figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time T at which the CO2 concentration is deemed to exceed the predetermined threshold value V.”; Fig, 11. This limitation teaches the parameters of the duration of the signal at or above a predefined level relating to an upper level, as the image processor analyzes the images when the face is present and whether there is a blocking object present.). Regarding claim 3, Hök teaches the method according to claim 1, wherein the stored signal relation criteria comprise a time relation between the line-of-sight detector output signal and the tracer substance signal ([0063]: “In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V”, Figure 11). Regarding claim 4, Hök teaches the method according to claim 3, wherein the time relation criterion requires that an increase in the recorded line-of-sight detector output signal, indicative of an object approaching the breath analysis device (100) occurs before the onset of the peak in the tracer substance signal ([0063]: “In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V”, Figure 11; [0065]: “it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted T on the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted t in figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time T at which the CO2 concentration is deemed to exceed the predetermined threshold value V.”. The device analyzes the images to ensure the face is detected and no blocking objects (which represents the peak in the recorded line-of-sight detector) are detected during the period of time that the tracer substance is detected (which represents the peak in the tracer substance signal within a predetermined time). The device compares the collected images to the tracer substance signal, while determining that there is at least a 1 second delay between when the face is detected and when the exhaled breath is received by the breath analyser device.). Regarding claim 5, Hök teaches the method according to claim 4, wherein the time relation criterion requires that a peak in the recorded line-of-sight detector output signal coincide with the peak in the tracer substance signal within a predetermined time period ([0063]: “In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V”, Figure 11; [0065]: “it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted T on the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted t in figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time T at which the CO2 concentration is deemed to exceed the predetermined threshold value V.”. The device analyzes the images to ensure the face is detected and no blocking objects (which represents the peak in the recorded line-of-sight detector) are detected during the period of time that the tracer substance is detected (which represents the peak in the tracer substance signal within a predetermined time).). Regarding claim 6, Hök teaches the method according to claim 5, wherein the step (345) of comparing the relation between the line-of-sight detector output signal and the tracer substance signal with stored signal relation criteria comprises correcting the time difference of the peak in the line-of-sight detector output signal and the peak in the tracer substance by a predetermined factor relating to an expected time delay relating to the time required for an exhaled breath sample reaching the breath analysis device (100) ([0063]: “the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device”; [0065]: “it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted T on the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted t in figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time T at which the CO2 concentration is deemed to exceed the predetermined threshold value V.”. The device compares the collected images to the tracer substance signal, while determining that there is at least a 1 second delay between when the face is detected and when the exhaled breath is received by the breath analyser device.). Regarding claim 7, Hök teaches the method according to claim 3, wherein the time relation between the line-of-sight detector output signal and the tracer substance signal includes an expected time differences between the peak in the line-of-sight detector output signal and the peak in the tracer substance by a predetermined factor relating to an expected time delay relating to the time required for an exhaled breath sample reaching the breath analysis device (100) ([0063]: “the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device”). Regarding independent claim 10, Hök teaches a breath analysis device (100) arranged to perform a measurement of a concentration of an intoxicating substance in the exhaled breath of a user and to the validate the measurement (Abstract: “There is disclosed a tamper evident breath analyser device”), the breath analysis device (100) comprising: - a measuring cell (102) arranged to sample a sensor signal representing the concentration of the intoxicating substance and a sensor signal representing the concentration of a tracer substance ([0040]: “In the illustrated embodiment of the device 1 there is provided a pair of sensors 18, 19 inside the sensor module 3 and to one side of the internal chamber 17 therethrough. One of the sensors 19 is responsive to the volatile substance of interest (for example ethanol in the case of an alcohol breath analyser), and the other sensor 18 is responsive to CO2 which will be used as a tracer substance”); - a line-of-sight detector (108) with a predetermined field of view and arranged to measure the coverage by an object of the field of view ([0035]: “The inlet region 2 of the device is provided with a small (typically less than 5 mm across in its longest dimension) imaging device 9 which may be a digital device such as a charge-coupled device (CCD) image sensor or a complementary metal-oxide-semiconductor (CMOS) image sensor.”; [0059]: “the image processor 25 will proceed to analyse the images by comparing successive images of the captured series to one another, to thereby systematically identify whether or not a face 14 is present in the imaging sensor's field of view 15 (as denoted at 37), whether or not the subject's mouth 11 is open (as denoted at 38), and whether or not a blocking or disturbing object such as a tube 31 is present between the subject's mouth 11 and the breath analyser device (as denoted at 39), as described above”) and to output a signal representing the degree of coverage ([0063]: “Figure 11 (b) denotes detection by the image processor 25 of the face 14 and/or mouth 11 of the test subject 10. As will therefore be noted, the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device. In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V.”; [0065]: “Figure 11 (d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like”; Figure 11. The degree of coverage is equivalent to classifying the presence of a face and the disturbing objects.); and - a control and signal processing unit (114) in connection with the measuring cell (102) and the line-of-sight detector (108) ([0043]: “As also illustrated schematically in figure 3, the IR source 20, the two sensors 18, 19 and the imaging device 9 are all electrically and operatively connected to a processor unit 21, with the imaging device 9 being connected thereto via a memory buffer 22. The processor unit 21 preferably includes integrated analogue and digital circuit elements for signal processing and control. Preferably one or several microprocessors are included for signal processing and management of signals to a display (not shown) for indication of measurement results.), wherein the breath analysis device (100) is arranged to perform the steps of: - (305) monitoring the output signal of the line-of-sight detector (108) ([0052]: “It is envisaged that the imaging device 9 will produce real time image signals with a relatively large bandwidth, including typically more than 100 x 100 pixels at a frame rate of 10 images per second. When activated, the imaging device 9 will capture a plurality of successive images of the test subject's face 14 for temporary storage in the data buffer 22. The image processor 25 may then retrieve the captured images from the data buffer 22 for subsequent comparative analysis. The image processor 25 may thus be provided in the form of a general purpose microprocessor with the capacity to perform algorithms at relatively fast speed. The image processor 25 operates in concert with the image classifier 26, whose function is to classify a breath sample from a test subject 10 as either approved or disapproved on the basis of decision criteria related to the comparative analysis of the captured images of the test subject's face”), and if (310) the output signal deviates from an established background value record (315) the line-of-sight detector output signal as a function of time, the output signal variation being a recorded line-of-sight signal signature ([0063]: “Figure 11 (b) denotes detection by the image processor 25 of the face 14 and/or mouth 11 of the test subject 10. As will therefore be noted, the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device. In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V.”; [0065]: “Figure 11 (d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like”; Figure 11. The presence of the face, as shown in Figure 11b, shows the deviation from the established background value (the value of 0 is the background value which represents no face, and the value of 1 shows the recorded signal as a function of time, which is the signal signature)); - (320) monitoring the tracer substance sensor signal and if (325) a peak in the tracer substance is detected, the peak indicating a possible exhalation phase of the respiratory cycle of the user determine (330) a breath concentration value of the intoxicating substance based on the intoxicating substance sensor signal and the tracer substance sensor signal ([0049]: “figure 4(a) graphically shows the variation of the measured concentration of CO2 as a function of time, whilst figure 4(b) graphically shows the variation of the substance of primary interest, in this case ethanol (EtOH), as a function of time during a breath test. Both signals are basically zero at the start of the test, and grow to a maximum during the expiratory phase, before then returning to zero as the sensing unit is ventilated. When the CO2 concentration reaches its maximum, the processor unit's algorithm will assume a dilution ratio of CO2alv / CO2meas and multiply it with the measured ethanol concentration at that time in order to obtain the estimated undiluted EtOH concentration.”; Figure 4); - (335) comparing the recorded line-of-sight signal signature originating from the line-of-sight detector (108) with at least one stored reference signal signature ([0052]: “the imaging device 9 will capture a plurality of successive images of the test subject's face 14 for temporary storage in the data buffer 22. The image processor 25 may then retrieve the captured images from the data buffer 22 for subsequent comparative analysis. The image processor 25 may thus be provided in the form of a general purpose microprocessor with the capacity to perform algorithms at relatively fast speed. The image processor 25 operates in concert with the image classifier 26, whose function is to classify a breath sample from a test subject 10 as either approved or disapproved on the basis of decision criteria related to the comparative analysis of the captured images of the test subject's face”); - (345) comparing the relation between the line-of-sight detector output signal and the tracer substance signal with stored signal relation criteria ([0064]-[0065]: “Figure 11 (c) denotes detection by the image processor 25 of the test subject's mouth 14 opening prior to exhalation of a breath sample, which will of course also occur before the CO2 concentration exceeds the predetermined threshold value V. In this example, the test subject's mouth 14 is detected as opening at approximately 3 seconds. Figure 11 {d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like. In the example illustrated, the blocking object is detected at a time of 2 seconds, which again precedes the point in time at which the CO2 concentration exceeds the predetermined threshold value V. In the case of the type of operating regime described above with reference to figure 9, in which the image processor 25 is prompted to retrieve and analyse the images which have been captured and stored in the data buffer 22 only in response to the breath signal processor 27 determining that the CO2 signal received from the CO2 sensor 18 is representative of the CO2 concentration in the sample exceeding the predetermined threshold value V, it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted Ton the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted tin figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T.”); and wherein - (340, 350, 355) the validity of the measurement of the breath concentration value is confirmed if the recorded line of sight signal signature matches the stored reference signal signature and if the recorded line-of-sight output signal and the tracer substance signal fulfils the stored signal relation criteria (Fig. 10; [0059]: “If no such blocking or disturbing object is identified then the breath sample will be approved (as denoted at 40) and the breath signal processor will be instructed (as denoted at 41) to proceed to calculate the concentration of volatile substance (e.g. ethanol) in the breath sample as previously described. However, if a blocking or disturbing object 31 is detected, then the image processor 25 will return an error signal 42, which may be shown on a display, and will be tasked with identifying a test subject's face 14 again for a subsequent test attempt.”). Regarding claim 11, Hök teaches the breath analysis device (100) according to claim 10, wherein the line-of-sight detector (108) is arranged to detect electromagnetic radiation and comprises an aperture determining an effective field of view of the line-of-sight detector (108) ([0035]: “The inlet region 2 of the device is provided with a small (typically less than 5 mm across in its longest dimension) imaging device 9 which may be a digital device such as a charge-coupled device (CCD) image sensor or a complementary metal-oxide-semiconductor (CMOS) image sensor. The imaging device 9 may either be simply mounted externally on the housing 5 of the inlet region 2, or it may alternatively be accommodated in a recess formed in the housing 5 so as to be substantially flush with an outer surface of the inlet region 2 as illustrated in figure 2. As will be noted, the imaging device 9 is positioned so as to face outwardly from the end surface of the inlet region 2 within which the sample inlet port 6 is formed, and in the arrangement illustrated is located adjacent the inlet port 6. The imaging device 9 may be provided in combination with a lens and other standard optical elements to define an appropriate field of view, as will be described in more detail below.”). Regarding claim 14, Hök teaches the breath analysis device (100) according to claim 10, wherein the line-of- sight detector (108) is arranged to have a field of view corresponding to a predefined area at a predefined distance from the breath analysis apparatus, wherein the predefined area is the area of a typical human face of a person using the breath analysis device (100) at the predefined distance, the predefined distance associated with appropriate use of breath analysis device (100) and being between 100-300 mm ([0036]: “Figure 2 illustrates a typical operational position of the breath analyser device 1 relative to a test subject 10 from whom a breath sample is to be provided to the device 1. As will be noted, the device is positioned in spaced relation to the text subject's mouth 11 such that a breath sample exhaled from the test subject's mouth 11 and/or nose 12 (typically at a velocity of 0.5 to 2 m/s) will be directed generally towards the sample inlet port 6 as indicated by airflow arrow 13. It is envisaged that in normal use the device 1 will be positioned or held approximately 10 to 15 cm from the test subject's face 14.”; Fig. 2). Regarding claim 18, Hök teaches the breath analysis device (100) according to claim 10, wherein in the monitoring step (305) a background value of the line-of-sight detector output signal is determined ([0063]: “Figure 11 (b) denotes detection by the image processor 25 of the face 14 and/or mouth 11 of the test subject 10. As will therefore be noted, the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device. In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V.”; [0065]: “Figure 11 (d) denotes detection by the image processor 25 of the test subject's mouth 14 becoming obscured by a blocking or disturbing object such as a length of tubing 31 or the like”; Figure 11. The presence of the face, as shown in Figure 11b, shows the deviation from the established background value (the value of 0 is the background value which represents no face, and the value of 1 shows the recorded signal as a function of time)), and in the step (335) of comparing the recorded line of sight signal signature with the stored reference signal signature comprises at least comparing one or a selection of the parameters: signal slope after an initial ascension, duration of a time period of increasing signal, a signal value associated to the upper value (21), duration of the signal at or above a predefined level relating to the upper level (21), and signal slope after a peak or plateau ([0065]: “the blocking object is detected at a time of 2 seconds, which again precedes the point in time at which the CO2 concentration exceeds the predetermined threshold value V. In the case of the type of operating regime described above with reference to figure 9, in which the image processor 25 is prompted to retrieve and analyse the images which have been captured and stored in the data buffer 22 only in response to the breath signal processor 27 determining that the CO2 signal received from the CO2 sensor 18 is representative of the CO2 concentration in the sample exceeding the predetermined threshold value V, it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted Ton the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted tin figures 11 {b), (c), {d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time Tat which the CO2 concentration is deemed to exceed the predetermined threshold value V.”; Fig, 11. This limitation teaches the parameters of the duration of the signal at or above a predefined level relating to an upper level, as the image processor analyzes the images when the face is present and whether there is a blocking object present.). Regarding claim 19, Hök teaches the breath analysis device (100) according to claim 10, wherein the stored signal relation criteria comprise a time relation between the line-of-sight detector output signal and the tracer substance signal ([0063]: “In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V”, Figure 11). Regarding claim 20, Hök teaches the breath analysis device (100) according to claim 19, wherein the time relation criterion requires that an increase in the recorded line-of-sight detector output signal, indicative of an object approaching the breath analysis device (100) occurs before the onset of the peak in the tracer substance signal ([0063]: “In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V”, Figure 11; [0065]: “it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted T on the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted t in figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time T at which the CO2 concentration is deemed to exceed the predetermined threshold value V.”. The device analyzes the images to ensure the face is detected and no blocking objects (which represents the peak in the recorded line-of-sight detector) are detected during the period of time that the tracer substance is detected (which represents the peak in the tracer substance signal within a predetermined time). The device compares the collected images to the tracer substance signal, while determining that there is at least a 1 second delay between when the face is detected and when the exhaled breath is received by the breath analyser device.). Regarding claim 21, Hök teaches the breath analysis device (100) according to claim 20, wherein the time relation criterion requires that a peak in the recorded line-of-sight detector output signal coincide with the peak in the tracer substance signal within a predetermined time period ([0063]: “In the illustrated example, it will be noted that the test subject's face/mouth is detected approximately 2.6 seconds before the CO2 concentration exceeds the predetermined threshold value V”, Figure 11; [0065]: “it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted T on the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted t in figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time T at which the CO2 concentration is deemed to exceed the predetermined threshold value V.”. The device analyzes the images to ensure the face is detected and no blocking objects (which represents the peak in the recorded line-of-sight detector) are detected during the period of time that the tracer substance is detected (which represents the peak in the tracer substance signal within a predetermined time).). Regarding claim 22, Hök teaches the breath analysis device (100) according to claim 21, wherein the step (345) of comparing the relation between the line-of-sight detector output signal and the tracer substance signal with stored signal relation criteria comprises correcting the time difference of the peak in the line-of-sight detector output signal and the peak in the tracer substance by a predetermined factor relating to an expected time delay relating to the time required for an exhaled breath sample reaching the breath analysis device (100) ([0063]: “the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device” [0065]: “it is therefore proposed that the breath signal processor 27 will be operable to determine the point in time, denoted T on the graph of figure 11 (a) at which the CO2 concentration exceeds the predetermined threshold value V, such that the image processor 25 will, in response thereto, then retrieve from the data buffer 22 a series of images captured by the imaging device 9 which correspond to a predetermined time period (an example of which is denoted t in figures 11 (b), (c), (d)), at least the beginning of which precedes said point in time T. This is effective to ensure that the image processor 25 maybe tasked with analysing the correct series of images, in which it is most likely that a blocking object 31 will be detected in the event of a tampering attempt. In some embodiments it is proposed that this predetermined time period may be at least 2 seconds in duration, and may begin at least 1 second before the point in time T at which the CO2 concentration is deemed to exceed the predetermined threshold value V.”. The device compares the collected images to the tracer substance signal, while determining that there is at least a 1 second delay between when the face is detected and when the exhaled breath is received by the breath analyser device.). Regarding claim 23, Hök teaches the breath analysis device (100) according to claim 19, wherein the time relation between the line-of-sight detector output signal and the tracer substance signal includes an expected time differences between the peak in the line-of-sight detector output signal and the peak in the tracer substance by a predetermined factor relating to an expected time delay relating to the time required for an exhaled breath sample reaching the breath analysis device (100) ([0063]: “the signal displayed in the y-axis goes high (i.e. from 0 to 1 as denoted) when the face and/or mouth is detected, which in this illustrated example occurs at approximately 1 second. As will be appreciated, this precedes the CO2 concentration exceeding the predetermined threshold value V because the test subject's face 14 must enter the imaging device's field of view 15 before the breath sample is received by the breath analyser device”). Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 8 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hök as applied to claims 1 and 10 above, and further in view of Gimbel (US 10506949). Regarding claim 8, Hök teaches the method according to claim 1. However, Hök does not teach wherein the line-of-sight detector (108) is arranged to measure heat radiation. Gimbel discloses a device for determining the level of illicit substances in the breath of a person. Specifically, Gimbel teaches wherein the line-of-sight detector (108) is arranged to measure heat radiation (Column 6, lines 39-40: “a camera unit 16 in the form of an IR (infrared) scanner”). Hök and Gimbel are analogous devices as they are both related to devices that determine the concentration of a substance in a user’s breath. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the use of infrared sensors as the line-of-sight detectors from Gimbel into the method from Hök as it is a suitable sensor that can perform the same detection steps as the sensor from Hök, therefore it would be a simple substitution of the sensors. Regarding claim 12, Hök teaches the breath analysis device (100) according to claim 10. However, Hök does not teach wherein the line-of-sight detector (108) comprises a sensor (111) utilizing infra-red detection and is arranged to measure heat radiation. Gimbel teaches \ wherein the line-of-sight detector (108) comprises a sensor (111) utilizing infra-red detection and is arranged to measure heat radiation (Column 6, lines 39-40: “a camera unit 16 in the form of an IR (infrared) scanner”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the use of infrared sensors as the line-of-sight detectors from Gimbel into the device from Hök as it is a suitable sensor that can perform the same detection steps as the sensor from Hök, therefore it would be a simple substitution of the sensors. Regarding claim 13, the Hök/Gimbel combination teaches the breath analysis device (100) according to claim 12, wherein the sensor (111) of the line-of-sight detector (108) is an active sensor arrange to utilize near infrared reflectance measurements (Hök, [0042]: “the sensors 18, 19 receive an IR beam emitted by the source 20 after reflections against the inner wall of the internal chamber 17”). Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hök as applied to claims 1 and 10 above, and further in view of Goad (WO 2014159663). Regarding claim 9, Hök teaches the method according to claim 1. However, Hök does not teach wherein the breath analysis device (100) further comprises means for measuring ambient temperature, and wherein the output signal from the line-of-sight detector (108) is compensated with the ambient temperature. Goad discloses an anti-circumvention apparatus and methods for use in sobriety testing systems. Specifically, Goad teaches wherein the breath analysis device (100) further comprises means for measuring ambient temperature ([0045]: “Breath temperature circuitry 204 constantly monitors the ambient temperature”; [0007]: “the second sensor is either an infrared thermometer measuring a temperature”), and wherein the output signal from the line-of-sight detector (108) is compensated with the ambient temperature (Claim 1: “sensing with a second sensor for a change from an ambient condition caused by the presence of the human test subject proximate the second sensor; and validating the intoxication test when a change from the ambient condition is detected by the second sensor during the time envelope defined by the first sensor.”). Hök and Goad are analogous devices as they are both related to devices that determine the concentration of a substance in a user’s breath. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the ambient temperature detection from Goad into the method from Hök as it allows the method to measure and compensate for ambient temperature, which can ensure the results provided are the most accurate. Regarding claim 15, Hök teaches the breath analysis device (100) according to claim 10. However, Hök does not teach wherein the breath analysis device (100) further comprises means for measuring ambient temperature, and wherein a signal from the line-of-sight detector (108) is compensated with the ambient temperature. Goad teaches wherein the breath analysis device (100) further comprises means for measuring ambient temperature ([0045]: “Breath temperature circuitry 204 constantly monitors the ambient temperature”; [0007]: “the second sensor is either an infrared thermometer measuring a temperature”), and wherein a signal from the line-of-sight detector (108) is compensated with the ambient temperature (Claim 1: “sensing with a second sensor for a change from an ambient condition caused by the presence of the human test subject proximate the second sensor; and validating the intoxication test when a change from the ambient condition is detected by the second sensor during the time envelope defined by the first sensor.”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the ambient temperature detection from Goad into the device from Hök as it allows the device to measure and compensate for ambient temperature, which can ensure the results provided are the most accurate. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hök as applied to claim 10 above in further view of Nakamura (the abstract of the article “A compact 8x8 infrared array sensor “Grid-EYE””). Regarding claim 16, Hök teaches the breath analysis device (100) according to claim 10. However, Hök does not teach wherein the line-of- sight detector (108) comprises a plurality of sensors (411c,d,e) arranged to provide a corresponding plurality of output signals providing a spatial resolution of the field of view. Nakamura discloses an 8x8 matric of IR photodetectors. Specifically, Nakamura teaches wherein the line-of- sight detector (108) comprises a plurality of sensors (411c,d,e) arranged to provide a corresponding plurality of output signals providing a spatial resolution of the field of view (Abstract: “This paper reports a newly developed compact digital output 8x8 infrared array sensor, named "Grid-EYE"”). Hök and Nakamura are analogous arts as they are both related to sensors used to detect a user. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plurality of sensors from Nakamura into the device from Hök as including multiple sensors can increase the measurement area of the device and provide more measurements, which can improve the visibility of the device. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hök as applied to claim 10 above in further view of Gimbel and Nakamura. Regarding claim 17, Hök teaches the breath analysis device (100) according to claim 10. However, Hök does not teach wherein the line-of- sight detector (108) comprises a 8x8 matrix of IR photodetectors. Gimbel teaches wherein the line-of-sight detector (108) comprises IR photodetectors (Column 6, lines 39-40: “a camera unit 16 in the form of an IR (infrared) scanner”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the use of infrared sensors as the line-of-sight detectors from Gimbel into the device from Hök as it is a suitable sensor that can perform the same detection steps as the sensor from Hök, therefore it would be a simple substitution of the sensors. However, the Hök/Gimbel combination is silent on the structure of the line-of-sight detectors. Nakamura discloses a 8x8 matrix of IR photodetectors (Abstract: “This paper reports a newly developed compact digital output 8x8 infrared array sensor, named "Grid-EYE"”). Gimbel and Hök are analogous arts as they are both related to infrared sensors. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the matrix of IR sensors from Nakamura into the Hök/Gimbel combination as the combination is silent on the structure of the IR sensors, and Nakamura discloses a suitable arrangement in an analogous device. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5. 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 Sims can be reached at 5712727540. 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. /E.K.M./Examiner, Art Unit 3791 /MATTHEW KREMER/Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Nov 14, 2023
Application Filed
Jan 06, 2026
Non-Final Rejection — §102, §103, §112 (current)

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2y 5m to grant Granted Dec 02, 2025
Patent 12419557
PRESSURE SENSOR ARRAY FOR URODYNAMIC TESTING AND A TEST APPARATUS INCLUDING THE SAME
2y 5m to grant Granted Sep 23, 2025
Study what changed to get past this examiner. Based on 3 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
14%
Grant Probability
74%
With Interview (+60.0%)
3y 10m
Median Time to Grant
Low
PTA Risk
Based on 22 resolved cases by this examiner. Grant probability derived from career allow rate.

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