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 .
The following Final Office Action is in response to Applicant’s reply filed on 03/17/2026. Claims 1-20 have been amended. Claims 1-20 are pending and reject as follows.
Claim Rejections - 35 USC § 101
The previous rejection under Claims 1-20 has been addressed and are hereby withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-12, 14-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090070046 A1, Kenjou et al. (hereinafter Kenjou), in view of US 20180085098 A1, Attar (hereinafter Attar), in further view of US 20160000378 A1, Hall et al. (hereinafter Hall).
Regarding Claim 1, 18, and 20, Kenjou discloses an apparatus comprising (Kenjou, [0162] when the daily urinary excretion measurement apparatus of the fourth embodiment is used, the urine can also be collected using a urine collection apparatus which is included in a toilet or a bidet apparatus):
one or more sensors coupled to a toilet bowl (Kenjou, [0162] when creatinine correction is employed, a sensor for measuring the creatinine concentration is used in place of the sensor for measuring the amount of urine and, therefore, the amount of urine is not measured, [0185] The measurement processing is performed by the sodium sensor 302 and the creatinine sensor 303 included in the sensor 3. In the present embodiment, the sodium concentration is detected after the measurement of the electrical conductivity and the creatinine concentration is detected after the optical measurement)
at least one computer processor configured (Kenjou, [0012] the present invention can be realized not only as an apparatus, but also as: a method having the processing units included in the apparatus as its steps; a program causing a computer to execute these steps; a computer-readable recording medium, such as a CD-ROM, which records the program; and; information, data, or a signal showing the program) to:
determining that the urine sample has an elevated creatinine concentration at least partially in response to the derived concentration of creatinine (Kenjou, [0157] A spot urine sample collected in one urine sampling is often concentrated or diluted due to fluid intake or perspiration. For this reason, abnormalities of urine components may be overrated or underrated when an evaluation is made on the basis of the concentration [0171] The creatinine sensor 303 measures the concentration of creatinine in the urine sucked into the sensor); and
Kenjou does not disclose the one or more optical sensors being positioned to receive light from urine disposed in the toilet bowl without requiring any action by a user after emission of the urine;
one or more illumination components configured to illuminate the urine with broadband light;
detect, via the one or more optical sensors, light intensity of the light from the illuminated urine in at least two wavelength bands within a visible-light range that includes a creatinine absorbance peak;
derive a concentration of creatinine by detecting an absorbance peak of the light centered within a predetermined wavelength range between 500 nm and 570 nm relative to at least one other wavelength band;
determine a cause of the elevated creatinine concentration by evaluating one or more additional urine parameters detected by the one or more optical sensors while the urine is disposed in the toilet bowl.
However, Attar teaches the one or more optical sensors being positioned to receive light from urine disposed in the toilet bowl without requiring any action by a user after emission of the urine (Attar, [0119] The testing is automatic and handled by the apparatus, and monitoring of the subject's emissions is seamless to the subject and does not require compliance by the subject, so long no abnormality is detected [0017] receiving light from the toilet bowl using one or more light sensors includes, subsequent to the subject emitting the bodily emission into the toilet bowl, receiving the light from the toilet bowl using one or more light sensors, without requiring any action to be performed by any person subsequent to the emission);
one or more illumination components configured to illuminate the urine with broadband light (Attar, [0140] In general, apparatus 20 typically includes illumination source(s) (i.e., light source(s)) for irradiating biological fluids that are excreted from patient and pass in the toilet bowl water [0141] For some applications, a white light broadband illumination source is used (e.g., white light source 68), and the light detector may comprise at least two light detectors (e.g., two or more of cameras 60, 62, 64, and 66));
detect, via the one or more optical sensors, light intensity of the light from the illuminated urine in at least two wavelength bands within a visible-light range that includes a creatinine absorbance peak (Attar, [0045] the computer processor is configured to detect the one or more spectral components by detecting one or more spectral bands that are centered around a wavelength that is within a range of 530 nm to 785 nm. In some applications, the computer processor is configured to detect the one or more spectral components by detecting one or more spectral bands that are centered around an approximate wavelength selected from the group consisting of: 540 nm, 565 nm, and 575 nm);
derive a concentration of creatinine by detecting an absorbance peak of the light centered within a predetermined wavelength range between 500 nm and 570 nm relative to at least one other wavelength band (Attar, [0157] the received spectrogram was analyzed by calculating two ratios. Ratio 1 was the ratio of the intensity of a 10 nm band centered around 565 nm, to the intensity of a 10 nm band centered around 575 nm (I(565)/I(575)). Ratio 2 was the ratio of the intensity of a 10 nm band centered around 565 nm, to the intensity of a 10 nm band centered around 540 nm (I(565)/I(540)). For the purpose of the experiment, thresholds were set at 1.05 for ratio 1 and 0.8 for ratio 2, such that if ratio 1 would exceed 1.05 and ratio 2 would exceed 0.8, this would be an indication that the sample contains blood. This is because a sample that contains blood would be expected to have a blood signature with a characteristic trough-peak-trough shape at approximately 540 nm (trough), 565 nm (peak) and 575 nm (trough));
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou and Attar teaching because Attar teaches automated optical urine analysis using broadband illumination and spectral detection within visible wavelength ranges, which would have improved Kenjou’s urine monitoring system by enabling non-invasive optical detection and spectral analysis of urine constituents within a toilet bowl environment. A person of ordinary skill in the art would have been motivated to integrate Attar’s optical sensing and spectral analysis techniques into Kenjou in order to improve the accuracy, automation, and functionality of urine constituent detection while achieving results.
Kenjou in view of Attar does not disclose determine a cause of the elevated creatinine concentration by evaluating one or more additional urine parameters detected by the one or more optical sensors while the urine is disposed in the toilet bowl.
However, Hall teaches determine a cause of the elevated creatinine concentration by evaluating one or more additional urine parameters detected by the one or more optical sensors while the urine is disposed in the toilet bowl (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed [0078] In addition to finding new correlations between disease states and alterations in urinary or fecal component concentrations, continuous monitoring of urinary or fecal spectra can be used to identify wavelengths or groups of wavelengths that vary consistently in accordance with changes in an individual's health condition or the molecular makeup of other body systems or fluids [0088] a toilet may provide information about one or more urine and/or fecal analytes, their metabolites and/or related biomarkers; including, but not limited to: amino acids; antioxidants, cancer biomarkers, catecholamines, cholesterol synthesis biomarkers, disease state biomarkers, environmental toxins, enzymes, ethanol, hormones, inflammatory biomarkers, prescription or over-the-counter drugs, illicit drugs, metabolic products, microbial biomarkers, minerals, and/or oxidative stress biomarkers).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar and Hall’s teaching because Hall teaches correlating detected urinary parameters and spectral information with disease states, biomarkers, and health condition analysis, which would have enhanced the combined Kenjou-Attar system by enabling determination of causes associated with elevated creatinine concentrations based on additional urine parameters. A person of ordinary skill in the art would have been motivated to integrate Hall’s health-condition correlation and biomarker evaluation techniques into the combine system in order to improve diagnostic capability, continuous health monitoring, and physiological assessment while yielding results.
Regarding Claim 2, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 1, wherein the one or more sensors are further configured to detect the one or more urine-related parameters relating to the urine (Kenjou, [0098] The urine amount sensor 301 measures the amount of urine sucked into the sensor 3, [0099] The sodium sensor 302 measures a urinary sodium concentration of the urine sucked into the sensor 3).
Kenjou does not disclose without requiring any action to be performed by any person subsequent to emission of the urine into the toilet bowl.
However, Hall teaches without requiring any action to be performed by any person subsequent to emission of the urine into the toilet bowl (Hall, [0058] FIG. 1(A) and FIG. 1(B) depict a toilet-based health analysis system which can be used to quantify the concentrations of a multiplicity of urinary components in an automatable, reagent-free manner which is readily amenable to domestic or other on-site environments, thereby allowing for acquisition of the continuous measurements necessary to assess, monitor and predict the health status of the user).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall shows a toilet-based analysis system that performs measurements automatically without requiring any action from the user after urination. Since Kenjou apparatus is also collecting urine parameters using urine samples, it would be predictable to apply Hall’s automation to improve the user independency. A person of ordinary skill would have recognized that integrating Hall’s teachings into Kenjou system would allow the system to obtain measurements more conveniently and consistently which will improve usability and overall monitoring.
Regarding Claim 3, Kenjou in view of Attar in further view of Hall disclose the apparatus according to claim 1, wherein the one or more sensors comprise one or more light sensors that are configured to detect visible light (Hall, [0061] The light source part 4 comprises a lamp source emitting light of a continuous range of wavelengths, a light-emitting diode array emitting light of a continuous range of wavelengths, a laser unit having a variable oscillation wavelength, or a laser diode array emitting laser beams of measuring wavelengths. The light measuring part 5 is provided with a spectrometer component or interferometer component and a photodetector component comprised of a photodiode, an array type photoreceptor of CCD, a photoreceptor array or a single photoreceptor as a detector), and wherein the at least one computer processor (Hall, [0062] FIG. 2 and FIG. 3 illustrate the system by which absorbance data is transmitted, stored and interpreted, thereby providing continuous health assessment, monitoring and prediction for the user. The system comprises the elements of a toilet body 7, a remote identifying information server 8, a remote data storage and analysis server 9, and an electronic computing device 10 owned and maintained either by the user or a party authorized by the user to receive their health-related information) is configured to derive a concentration of creatinine in the urine (Hall, [0065] the remote data analysis server 9 sorts the spectra data in accordance with the accompanying UIN. Spectra are then evaluated to determine whether or not they meet basic quality parameters. Spectra of sufficient quality undergo algorithmic processing on the basis of the absorbances measured in the toilet body 7 to obtain urinary component concentrations).
detecting an absorbance peak that is centered in a predetermined wavelength range, within the detected visible light (Hall, [0008] toilet stool-based spectroscopic system that analyzes uric component concentrations by measuring urine sample absorbance of select wavelengths of visible or near-infrared light using a rotating filter to selectively expose the sample to a specific set of wavelengths following urine collection in a frontal basin).
Kenjou does not disclose detecting an absorbance peak that is centered in a predetermined wavelength range, within the detected visible light.
However, Attar teaches detecting an absorbance peak that is centered in a predetermined wavelength range (Attar, [0157] the received spectrogram was analyzed by calculating two ratios. Ratio 1 was the ratio of the intensity of a 10 nm band centered around 565 nm, to the intensity of a 10 nm band centered around 575 nm (I(565)/I(575)). Ratio 2 was the ratio of the intensity of a 10 nm band centered around 565 nm, to the intensity of a 10 nm band centered around 540 nm (I(565)/I(540)). For the purpose of the experiment, thresholds were set at 1.05 for ratio 1 and 0.8 for ratio 2, such that if ratio 1 would exceed 1.05 and ratio 2 would exceed 0.8, this would be an indication that the sample contains blood. This is because a sample that contains blood would be expected to have a blood signature with a characteristic trough-peak-trough shape at approximately 540 nm (trough), 565 nm (peak) and 575 nm (trough)), within the detected visible light
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall because Hall teaches obtaining and analyzing visible light absorbance data from urine samples using optical sensing components and processing circuitry to determine concentration. Attar provides a known technique for identifying an absorbance peak centered within a predetermined wavelength range by evaluating spectral intensity characteristics at multiple wavelengths. A person of ordinary skill in the art would have been motivated to integrate Attar’s peak identification technique into the visible light urine analysis system taught by Hall and applied within Kenjou’s urinary monitoring apparatus would have predictably improved the accuracy and reliability of identifying spectral features associated with data present in urine.
Regarding Claim 4, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 1, wherein the apparatus is configured for use with an output device, (Kenjou, [0084] It is preferable that the daily urinary excretion measurement apparatus of the present invention further includes a display unit which displays one of: each amount of the urine component in the plurality of spot urine samples calculated by the urine component calculation unit; and the daily urinary excretion calculated by the daily urinary excretion calculation unit), and at least one the computer processor is further configured to generate an output on the output device indicating a recommendation (Kenjou, [0165] the display unit 207 corresponds to "a display unit which displays an advice when the comparison unit judges that the daily urinary excretion exceeds the standard amount", and displays a health advice on the basis of the calculated daily urinary excretion).
Kenjou does not disclose a response to determining the cause of the predetermined creatinine concentration.
However, Hall teaches a response to determining the cause of the predetermined creatinine concentration (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall describes generating a response based on identifying a cause of abnormal creatinine concentration levels. However, Kenjou systems is capable of displaying recommendations based on the calculated urinary parameters using the computer processor, so combining Hall’s system on identifying the cause of changes of creatinine concentration levels to be displayed in Kenjou system would be a enhancement to Kenjou’s system. A person of ordinary skill in the art would have understood that adding Hall’s system would improve Kenjou’s system by allowing it to provide reasoning for abnormal creatinine concentration and its cause which increases the usefulness of the health information provided to the user with the motivation that Kenjou’s recommendations to not only display abnormal creatinine concentration levels but also identify why the abnormality is occurring. This provides more meaningful, actionable health information to the user, which increases the usefulness and overall performance of the combined system.
Regarding Claim 5, Kenjou in view of Attar in further view of Hall teaches the apparatus of claim 1, wherein the computer processor is further configured to;
detect that the urine has an elevated concentration of urinary NT-titin, (Hall, [0091] In another aspect of the invention, a toilet may be used to detect the presence, type, and/or quantity of specific foods and/or dietary components in urine and/or feces; including, but not limited to: carbohydrate content, fat content, fiber content, protein content and/or mineral content)
determine that the cause of the predetermined creatinine concentration is catabolic processes at least partially in response to detecting that the urine has the elevated concentration of urinary NT-titin (Hall, [0088] The device may also provide information about one or more other aspects of the user's urine and/or feces; including, but not limited to: casts, crystallization, density, fat content, fiber content, microbial content, protein content, radioactivity, red blood cell count, specific gravity, temperature, vitamin content, and/or white blood cell content. Additionally, the apparatus may provide information regarding other aspects of the user's physical and/or physiologic state; including, but not limited to: body weight, body mass index, bioelectric impedance, body fat content, oxygen saturation and/or pulse rate).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall explains that the toilet system can detect multiple urinary components and use those measurements to identify conditions related to NT-titin and other causes. Since Kenjou’s system already collects urine-related parameters and creatinine concentration, applying Hall’s NT-titin analysis to determine whether catabolic processes are contributing to the creatinine levels. A person of ordinary skill would have recognized that integrating Hall’s assessment capabilities into Kenjou’s system would improve the system to be capable of providing more information to the users state.
Regarding Claim 6, Kenjou in view of Attar in further view of Hall discloses the apparatus according to claim 5, wherein the apparatus is configured for use with an output device, (Kenjou, [0084] It is preferable that the daily urinary excretion measurement apparatus of the present invention further includes a display unit which displays one of: each amount of the urine component in the plurality of spot urine samples calculated by the urine component calculation unit; and the daily urinary excretion calculated by the daily urinary excretion calculation unit)
the at least one computer processor is further configured to (Kenjou, [0012] the present invention can be realized not only as an apparatus, but also as: a method having the processing units included in the apparatus as its steps; a program causing a computer to execute these steps; a computer-readable recording medium, such as a CD-ROM, which records the program; and; information, data, or a signal showing the program):
generate an output on the output device indicating an exercise recommendation (Kenjou, [0070] Biological rhythms of urine component excretion are different between a time of day for activities including having meals and exercising and a time of day for sleeping [0165] the display unit 207 corresponds to "a display unit which displays an advice when the comparison unit judges that the daily urinary excretion exceeds the standard amount", and displays a health advice on the basis of the calculated daily urinary excretion).
Kenjou does not disclose determine that the cause of the predetermined creatinine concentration is catabolic processes;
However, Hall teaches determine that the cause (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed) of the predetermined creatinine concentration is catabolic processes (Hall, [0080] continuously monitoring urine and/or feces, it is possible to determine drug usage and metabolism [0089] a toilet may be used to detect the presence and/or concentration of one or more metabolic products in urine and/or feces. Since well over 3,100 metabolites have been identified in urine alone, only a small fraction of the metabolic analytes that may be assessed are listed in Table 1. These metabolites may be the result of amino acid metabolism, antioxidant metabolism, cancer metabolism, cholesterol synthesis, disease activity, enzymatic action, hormone synthesis and metabolism, inflammation, microbial metabolism, oxidative stress or other metabolic processes).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall describes identifying the cause of the change in creatinine concentration within the urine sample tested. However, Kenjou system is already configured to generate recommendations on the output device, and incorporating Hall’s analysis to trigger a recommendation would be a straightforward modification. A person of ordinary skill would have recognized that applying Hall’s interpretation to Kenjou’s output system to enhance the usefulness of the device.
Regarding Claim 7, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 1, wherein the at least one computer processor is further configured to;
detect a specific gravity of the urine (Kenjou, [0213] Also, a weight and a specific gravity of the urine may be measured so that the amount of urine can be measured from the weight and the specific gravity).
Kenjou does not disclose wherein the computer processor is configured to determine the cause of the predetermined creatinine concentration at least partially in response thereto.
However, Hall teaches wherein the computer processor is configured to determine the cause of the predetermined creatinine concentration at least partially in response thereto (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall explains determining the cause of the abnormal creatinine concentration in response to urinary parameter data. However, since Kenjou system is already configured to detect specific gravity and other urine characteristics, and using those measurements to determine the cause as described by Hall. A person of ordinary skill would have recognized that incorporating Hall’s analysis into Kenjou system would allow the device to not only measure gravity but also find the reason for elevated creatinine concentration levels.
Regarding Claim 8, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 7, wherein the at least one computer processor is configured to:
at least partially in response to the detected specific gravity of the urine, determine that the specific gravity of the urine is low (Kenjou, [0213] Also, a weight and a specific gravity of the urine may be measured so that the amount of urine can be measured from the weight and the specific gravity).
Kenjou does not disclose the computer processor is configured to determine that the cause of the predetermined creatinine concentration is kidney dysfunction.
However, Hall teaches the computer processor is configured to determine that the cause of the predetermined creatinine concentration (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed) is kidney dysfunction (Hall, [0076] daily or multi-daily tracking of urinary or fecal components enables pre-symptomatic diagnosis and treatment. For example, kidney stones form subsequent to well-defined changes in urinary components).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall identifies kidney related conditions that can be detected by monitoring changes in urinary data. However, since Kenjou system measures specific gravity and other urine parameters, adding Hall’s analysis to determine whether a specific gravity combined with an creatine concentration level would indicate kidney conditions would also be a straightforward modifications. A person of ordinary skill in the art would have recognized that incorporating Hall’s interpretation of urinary changes into Kenjou’s system would improve the system capabilities and provide more useful information and health advice to the user with the motivation that changes in urinary component concentrations can indicate kidney dysfunction, and applying Hall’s diagnostic interpretation to the urinary measurement already obtained in Kenjou would predictably enhance the system ability to identify abnormalities.
Regarding Claim 9, Kenjou in view of Hall discloses the apparatus of claim 8, wherein;
the apparatus is configured for use with an output device (Kenjou, [0084] It is preferable that the daily urinary excretion measurement apparatus of the present invention further includes a display unit which displays one of: each amount of the urine component in the plurality of spot urine samples calculated by the urine component calculation unit; and the daily urinary excretion calculated by the daily urinary excretion calculation unit); and
the at least one computer processor is further configured to:
generate an output on the output device a recommendation to seek medical attention (Kenjou, [0165] the display unit 207 corresponds to "a display unit which displays an advice when the comparison unit judges that the daily urinary excretion exceeds the standard amount", and displays a health advice on the basis of the calculated daily urinary excretion).
Kenjou does not disclose determine that the cause of the predetermined creatinine concentration is kidney dysfunction.
However, Hall teaches determine that the cause of the predetermined creatinine concentration (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed) is kidney dysfunction (Hall, [0076] daily or multi-daily tracking of urinary or fecal components enables pre-symptomatic diagnosis and treatment. For example, kidney stones form subsequent to well-defined changes in urinary components).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall identifies kidney conditions based on changes in urinary data based on the urine sample attained. However, Kenjou’s system is already configured to display health data and incorporating Hall’s system to find the cause the reason for creatinine concentration levels to be able to apply a recommendation in Kenjou’s display. A person of ordinary skill would have understood that providing a alert in response to detecting kidney conditions improves the overall usefulness of the device.
Regarding Claim 10, Kenjou in view of Attar in further view of Hall teaches the apparatus of claim 7, wherein the at least one computer processor is further configured to:
detect a concentration of urinary NT-titin of urine (Hall, [0091] In another aspect of the invention, a toilet may be used to detect the presence, type, and/or quantity of specific foods and/or dietary components in urine and/or feces; including, but not limited to: carbohydrate content, fat content, fiber content, protein content and/or mineral content);
determine that the concentration of urinary NT-titin and the specific gravity of the urine (Hall, [0088] The device may also provide information about one or more other aspects of the user's urine and/or feces; including, but not limited to: casts, crystallization, density, fat content, fiber content, microbial content, protein content, radioactivity, red blood cell count, specific gravity, temperature, vitamin content, and/or white blood cell content. Additionally, the apparatus may provide information regarding other aspects of the user's physical and/or physiologic state; including, but not limited to: body weight, body mass index, bioelectric impedance, body fat content, oxygen saturation and/or pulse rate) are both within a normal range (Hall, [0066] Urinary component concentrations are then evaluated by the remote data analysis server 9 and classified as “normal” or “abnormal.” The remote data analysis server 9 compares the most recently obtained data associated with a UIN with historical data associated with the same UIN to establish trends over time),
determine that the cause of the predetermined creatinine concentration is dietary (Hall, [0056] the human health property monitoring system of the present invention may track data from a discrete sub-population group comprising a single home, a medical practice group, hospital, school, prison or business group. Sub-populations could also include, for example, sub-populations defined according to age, blood glucose, body-mass index, current and past medications, diagnoses of a particular disease, dietary patterns, elevation, gender, general geographic location, height, independent laboratory results, medical diagnostic test results, medical history, race, temperature, wearable device results, weight, or any other relevant factor related to health or disease states).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall describes determining dietary causes of abnormal urinary creatinine concentration levels from the urine samples. However, Kenjou’s system is already capable of receiving and analyzing data but is not capable of determining causes of changes in the concentration levels. A person of ordinary skill in the art would have recognized that integrating Hall’s teaching with Kenjou’s system would enable the capability of determining the cause of changes in creatinine concentration levels With the motivation to improve the clinical usefulness of Kenjou’s measurements by applying Hall’s dietary-cause analysis so that abnormal NT-titin and specific-gravity values can be interpreted in a more accurate and meaningful way for identifying dietary factors.
Regarding Claim 11, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 7, wherein, at least one computer processor is further configured to:
Determine that the specific gravity of the urine is elevated (Kenjou, [0213] Also, a weight and a specific gravity of the urine may be measured so that the amount of urine can be measured from the weight and the specific gravity); and
Kenjou does not disclose determine that the cause of the predetermined creatinine concentration is either kidney dysfunction or dehydration.
However, Hall teaches determine that the cause of the predetermined creatinine concentration (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed) is either kidney dysfunction or dehydration (Hall, [0076] daily or multi-daily tracking of urinary or fecal components enables pre-symptomatic diagnosis and treatment. For example, kidney stones form subsequent to well-defined changes in urinary components).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teachings to render claim 11 obvious for the same reasons described for claim 8, namely that Hall provides clinical interpretation of urinary component changes that predictably enhance the usefulness and diagnosis capabilities of the measurements collected by Kenjou.
Regarding Claim 12 and 16, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 11, wherein the at least one computer processor is further configured to;
determine a level of protein in the urine (Kenjou, [0198] As a urine component from which a health condition of the user can be detected, protein, salt, uric acid, etc. can be used. As a unit for detecting the concentration of a urine component, various kinds of methods may be used depending on a subject of measurement).
Kenjou does not disclose determine the cause of the predetermined creatinine concentration at least partially in response to the determined level of protein in the urine.
However, Hall teaches determine the cause of the predetermined creatinine concentration at least partially in response to the determined level of protein in the urine (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed, [0088] the device may also provide information about one or more other aspects of the user's urine and/or feces; including, but not limited to: casts, crystallization, density, fat content, fiber content, microbial content, protein content, radioactivity, red blood cell count, specific gravity, temperature, vitamin content, and/or white blood cell content. Additionally, the apparatus may provide information regarding other aspects of the user's physical and/or physiologic state; including, but not limited to: body weight, body mass index, bioelectric impedance, body fat content, oxygen saturation and/or pulse rate).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall describes determining the cause of abnormal creatinine concentration levels in the urine samples. However, Kenjou is already capable of determining parameters such as protein and other urine related parameters but incorporating Hall’s system would include capabilities of determining the cause on why those changes in levels exist. A person of ordinary skill in the art would have recognized that applying Hall’s analysis system in addition to Kenjou’s system would allow the system to attain more parameters which will be more data to accurately define creatinine concentration levels.
Regarding Claim 14, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 12, wherein, the at least one computer processor is further configured to:
determine that the specific gravity of the urine is elevated (Kenjou, [0213] also, a weight and a specific gravity of the urine may be measured so that the amount of urine can be measured from the weight and the specific gravity) and that the level of protein in the urine is elevated (Kenjou, [0198] As a urine component from which a health condition of the user can be detected, protein, salt, uric acid, etc. can be used. As a unit for detecting the concentration of a urine component, various kinds of methods may be used depending on a subject of measurement).
Kenjou does not disclose determine that the cause of the predetermined creatinine concentration is kidney dysfunction.
However, Hall teaches determine that the cause of the predetermined creatinine concentration (Hall, [0076] representative of many other disease states in which symptoms are preceded by changes in urinary or fecal component concentrations; however, without a system for continuous monitoring of these components, these changes are typically only used in confirmatory testing after symptoms have developed) is kidney dysfunction (Hall, [0076] daily or multi-daily tracking of urinary or fecal components enables pre-symptomatic diagnosis and treatment. For example, kidney stones form subsequent to well-defined changes in urinary components).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall explains determining kidney conditions by evaluating changes in the creatinine concentration levels, and other urine related parameters attained by the urine sample. However, Kenjou’s system is capable of also attaining data such as gravity and protein levels but incorporating Hall’s system would allow Kenjou to be able to determine the cause of the changes in the urine data. A person of ordinary skill in the art would have recognized that integrating Hall’s approach into Kenjou’s system would improve the device by allowing it to identifying causes to changes in the concentration levels.
Regarding Claim 15, Kenjou in view of Attar in further view of Hall discloses the apparatus of claim 12, wherein, the at least one computer processor is configured to:
determine that the specific gravity of the urine is elevated (Kenjou, [0213] Also, a weight and a specific gravity of the urine may be measured so that the amount of urine can be measured from the weight and the specific gravity) and that the level of protein in the urine is normal (Kenjou, [0198] As a urine component from which a health condition of the user can be detected, protein, salt, uric acid, etc. can be used. As a unit for detecting the concentration of a urine component, various kinds of methods may be used depending on a subject of measurement), determine that the cause of the predetermined creatinine concentration is dehydration (Kenjou, [0158] The following is a detailed explanation about the method of measuring the concentration of a urine component and the concentration of urinary creatinine at the same time so as to make an evaluation according to the urine-component/creatinine ratio. Creatinine is a dehydration product of creatine, and is not biologically active. Creatinine is produced directly from creatine phosphate and through dehydration of creatine in muscle and nerves within a living body, and is secreted into blood).
Regarding Claim 19, Kenjou in view of Attar in further view of Hall teaches the method of claim 18, further comprising:
performing a comparison (Hall, [0007] Spectral results from the sample are compared to a calibrated chemometric model to generate quantitative measurements of urinary components [0066] Urinary component concentrations are then evaluated by the remote data analysis server 9 and classified as “normal” or “abnormal.” The remote data analysis server 9 compares the most recently obtained data associated with a UIN with historical data associated with the same UIN to establish trends over time) of a first intensity value for a first light spectrum to a second intensity value for a second light spectrum (Hall, [0065] Wavelengths or wavelength regions having absolute values of correlation coefficients of at least 0.4 to a chosen urinary component are regarded as measuring wavelength regions and are selected from the 100 nm to 4,000 nm wavelength range. Additionally, wavelengths or wavelength regions having absolute values of correlation coefficients of at least 0.1 to the presence, absence or severity of the disease, disease state, health risk factor or other health state are regarded as measuring wavelength regions and are selected from the 100 nm to 4,000 nm wavelength range); and
calculating the elevated creatinine concentration based on the comparison (Hall, [0078] In addition to finding new correlations between disease states and alterations in urinary or fecal component concentrations, continuous monitoring of urinary or fecal spectra can be used to identify wavelengths or groups of wavelengths that vary consistently in accordance with changes in an individual's health condition or the molecular makeup of other body systems or fluids).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall teaching because Hall describes comparing intensity values of different light wavelengths to identify correlations between regions and specific urinary changes based off the light data. However, since Kenjou’s system already obtain urine-related measurements and detects creatinine concentration levels, incorporating Hall’s system would provide another way to calculate the creatine concentration level using light sources. A person of ordinary skill in the art would recognize that applying Hall’s wavelength analysis to the provided urine parameters in Kenjou’s system would improve the accuracy of the concentration levels with motivation to improve the reliability and precision of creatinine concentration determinations by incorporating Hall’s proven spectral comparison techniques into Kenjou’s existing urine-analysis framework, thereby providing a predictable enhancement in measurement accuracy using known analytical methods.
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090070046 A1, Kenjou et al. (hereinafter Kenjou), in view of US 20180085098 A1, Attar (hereinafter Attar), in further view of US 20160000378 A1, Hall et al. (hereinafter Hall), in further view of US 20150359522 A1, Recht et al. (hereinafter Recht).
Regarding Claim 13 and 17, Kenjou in view of Attar in further view of Hall disclose the apparatus of claim 12, and wherein the at least one computer processor is further configured to:
determine a level of protein in the urine based on the derived parameter (Kenjou, [0198] As a urine component from which a health condition of the user can be detected, protein, salt, uric acid, etc. can be used. As a unit for detecting the concentration of a urine component, various kinds of methods may be used depending on a subject of measurement).
Kenjou in view of Attar in further view of Hall does not disclose wherein the computer processor is configured to derive a parameter that is indicative of foaming and/or turbidity of the urine
However, Recht teaches wherein the computer processor is configured to derive a parameter that is indicative of foaming and/or turbidity of the urine (Recht, [0112] If the sample contains many red blood cells, it will be cloudy as well as red. Turbidity or cloudiness of a urine sample may be assessed by the testing apparatus. Turbidity or cloudiness may be caused by excessive cellular material or protein in the urine. The detection unit could have the capability of measuring turbidity by backscattered light from the sample).
Before the effective filing date of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine Kenjou in view of Attar in further view of Hall and Recht’s teaching because Recht provides a urine characteristic by evaluating turbidity or cloudiness, which is directly influenced by the proteins in the urine. However, Kenjou system already teaches determining protein levels as part of the urine related parameters collected from the urine sample, so incorporating Recht’s assessment for turbidity or cloudiness would add another measurement for detecting abnormalities in the urine data. A person of ordinary skill in the art would integrate Recht’s assessment into Kenjou’s system to improve overall diagnostic capabilities.
Response to Amendment
35 USC§ 101
Applicant’s arguments with respect to claims 1-20 of the 35 USC§ 101 rejection have been considered and the amendments with respect to claims 1, 18, and 20 addresses the rejection and are hereby withdrawn.
35 USC§ 103
Applicant’s arguments with respect to claim 20 of the 35 USC§ 102
rejection and with respect to claims 1-19 of the 35 USC§ 103 rejection have been fully
considered but are unpersuasive and/or moot in view of the new grounds of rejection as
set forth above over Kenjou in view of Attar in further view of Hall.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM NAGI SHOHATEE whose telephone number is (571)272-6612. The examiner can normally be reached 8am-5pm.
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/IBRAHIM NAGI SHOHATEE/Examiner, Art Unit 2857
/SHELBY A TURNER/Supervisory Patent Examiner, Art Unit 2857
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