DETAILED ACTION
Applicant’s arguments, filed on 05/11/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-23 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 validity of a measurement of a concentration of an intoxicating substance in an 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 a 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 a 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 a 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, an 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 a 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 a 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) the 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 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 an 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 the object approaching the breath analysis device (100) occurs before an 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 a 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 a 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 a peak in the tracer substance by a predetermined factor relating to an expected time delay relating to a 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 an exhaled breath of a user and to 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 a 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 a 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 a 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, an 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 a 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 a 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) a 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 the 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 the 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 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) the 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 parameters: signal slope after an initial ascension, duration of a time period of increasing signal, a signal value associated to an 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 the object approaching the breath analysis device (100) occurs before an 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 a 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 a 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 a 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 a 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 arranged 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 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.”).
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 infrared (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 an 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.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. Applicant argues that Hök does not teach measuring the coverage of the field of view. However, as explained in the 102 rejection above, Hök discloses determining objects that are in the field of view such as a tube and determining features such as the length of the tube, which qualifies as the degree of coverage, as the degree of coverage depends on the size of the tube that is covering the face, therefore this argument is not persuasive ([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.).
Additionally, Applicant argues that Hök does not teach considering how much area any of the elements cover, however the determination of area is not a limitation in the claims, and therefore this argument is not applicable.
Applicant also argues that since Gimbel discloses wherein the breath sample is given via mouthpiece, that the coverage measurement of the field of view by the subject’s dace is irrelevant. However, Gimbel is not relied upon to teach this limitation, Gimbel is only relied upon to teach an infrared sensor being used, therefore this argument is not persuasive.
Additionally, Applicant argues that Gimbel’s imaging device cannot measure the coverage by the object of the field of view because it examines the skin of the user. However, Gimbel uses the IR scanner to determine if the correct area of the face is being recorded, therefore this scanner is also used to determine if the correct area of the skin is not being recorded.
Additionally, Gimbel is simply used to teach that another type of sensor can be used to measure the face of the user, which, as stated in the 103 rejection, can be a simple substitution of camera types from Hök.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights