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 .
DETAILED ACTION
The following NON-FINAL Office Action is in response to application 18/235,318.
This communication is the first action on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/17/2023 and 09/05/2025 has been considered by the examiner.
Drawings
The drawings were received on 08/17/2023. These drawings are acceptable.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. A subject matter eligibility analysis is set forth below. See MPEP 2106.
Specifically, representative Claim 1 recites:
An apparatus comprising:
one or more sensors coupled to a toilet bowl and configured to detect one or more urine-related parameters relating to urine, and
at least one computer processor configured to:
receive the one or more urine-related parameters from the one or more sensors,
determine whether the urine has a predetermined creatinine concentration based on the one or more urine-related parameters, and
determine a cause of the predetermined creatinine concentration based on the one or more urine-related parameters.
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements.”
Similar limitations comprise the abstract idea of Method Claim 18 and comprises:
detecting one or more urine-related parameters relating to a urine sample;
determining whether the urine sample has an elevated creatinine concentration; and
determining a cause of the elevated creatinine concentration.
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements.”
Similar limitations comprise the abstract idea of Apparatus Claim 20 and comprises:
one or more light sensors that are configured to receive light from a toilet bowl, while a subject's urine is disposed within the toilet bowl; and
a computer processor configured to:
determine light intensities of at least two spectral bands within the received light that are within a predetermined range, by analyzing the received light;
determine a ratio of the intensities of the at least two spectral bands within the received light; and
in response thereto, determine that the subject has elevated creatinine within their urine.
Under Step 1 of the analysis, claim 1 belongs to a statutory category, namely it is an apparatus claim. Likewise, claim 18 is a method claim and claim 20 is also an apparatus claim.
Under Step 2A, prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04, subsection II, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
In the instant case, claim 1 is found to recite at least one judicial exception (i.e. abstract idea), that being a Mental Process and a Mathematical Concept. This can be seen in the claim limitations of “determine whether the urine has a predetermined creatinine concentration based on the one or more urine-related parameters”, and “determine a cause of the predetermined creatinine concentration based on the one or more urine-related parameters” which is the judicial exception of a mental process because these limitations are merely data observations, evaluations, and/or judgements in order to analyze urine characteristics and make diagnostic inferences regarding creatinine concentration and its potential causes and is capable of being performed mentally and/or with the aid of pen and paper. Additionally, the aforementioned limitations recite mathematical calculations, e.g. see Spec. [0114]-[0118] describing the control system calculating ratios of light intensities between different wavelength ranges, comparing those values to predetermined ranges, and determine whether an elevated creatinine concentration is met.
Similar limitations comprise the abstract ideas of Claim 18 and 20.
Step 2A, prong 2 of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception(s) into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
In addition to the abstract ideas recited in claim 1, the claimed apparatus recites additional elements including “one or more sensors coupled to a toilet bowl and configured to detect one or more urine-related parameters relating to urine” and “at least one computer processor configured to: receive the one or more urine-related parameters from the one or more sensors” however these elements are found to be data gathering and output steps, which are recited at a high level of generality, and thus merely amount to “insignificant extra-solution” activity(ies). See MPEP 2106.05(g) “Insignificant Extra-Solution Activity,”. Furthermore, the claim recites “receive the one or more urine-related parameters” are performed by a “computer processor” however this is found to be equivalent to adding the words “apply it” and mere instructions to apply a judicial exception on a general purpose computer does not integrate the abstract idea into a practical application. See MPEP 2106.05(f).
Method claim 18 recites the same additional elements as claim 1. Also, Apparatus Claim 20 recites the same additional elements as claim 1 and also recites “a computer processor configured to: determine light intensities of at least two spectral bands within the received light that are within a predetermined range, by analyzing the received light” however the use of a generic toilet-mounted sensing system to perform the data gathering via sensors and processors is similarly found to be insignificant extra-solution activity. The recited components merely serve as tools for detecting and processing information, and do not represent any improvements for the functioning of the computer, or sensors, or processor. Rather, these elements simply limit the abstract idea to a particular field of use, analyzing urine characteristics in a toilet is just served as a source of collecting data. See MPEP 2106.05(h): “For instance, a data gathering step that is limited to a particular data source (such as the Internet) or a particular type of data (such as power grid data or XML tags) could be considered to be both insignificant extra-solution activity and a field of use limitation.” Apparatus claim 20 also recites that “a computer processor configured to:” is used for “determining” creatinine within their urine however, the apparatus is merely general purpose computer hardware and/or software components used as a tool to “apply” the abstract idea in a technological environment.
The generic data gathering, processing, and output steps, are recited at such a high level of generality (e.g. using “sensors” and “computer processor”) that it represents no more than mere instructions to apply the judicial exceptions on a computer. It can also be viewed as nothing more than an attempt to generally link the use of the judicial exceptions to the technological environment of a computer. Noting MPEP 2106.04(d)(I): “It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point")”.
Thus, under Step 2A, prong 2 of the analysis, even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception. No specific practical application is associated with the claimed system. For instance, nothing is done with the result of the analysis beyond merely identifying whether the urine has an elevated creatinine concentration and its potential cause.
Under Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as described above with respect to Step 2A Prong 2, merely amount to a general purpose computer system that attempts to apply the abstract idea in a technological environment, limiting the abstract idea to a particular field of use, and/or merely performs insignificant extra-solution activit(ies) (claims 1, 18 and 20). Such insignificant extra-solution activity, e.g. data gathering and output, when re-evaluated under Step 2B is further found to be well-understood, routine, and conventional as evidenced by MPEP 2106.05(d)(II) (describing conventional activities that include transmitting and receiving data over a network, electronic recordkeeping, storing and retrieving information from memory, and electronically scanning or extracting data from a physical document).
Therefore, similarly the combination and arrangement of the above identified additional elements when analyzed under Step 2B also fails to necessitate a conclusion that claim 1, as well as claim 18 and 20, amount to significantly more than the abstract idea.
With regards to the dependent claims, claims 2-17 and 19, merely further expand upon the algorithm/abstract idea and do not set forth further additional elements that integrate the recited abstract idea into a practical application or amount to significantly more. Therefore, these claims are found ineligible for the reasons described for claims 1, 18 and 20. Specifically:
With respect to dependent claims 2-3, 5, 7, 8, and 12, specifically, the claims further recite that one or more sensors are configured to detect urine parameters such as light intensity or specific gravity, and derive a creatinine concentration from those parameters. The claims do not specify any improvement to the sensor technology, measurement techniques, or the data acquisition process, but rather apply known sensing operations in their ordinary function. Therefore, these elements fail to integrate the abstract idea into a practical application or amount to significantly more. See MPEP 2106.05(d)(f).
With respect to dependent claim 19, specifically, the claim recites performing a comparison between intensity values of two light spectra and calculating an elevated creatinine concentration based on that comparison. This step performs a mathematical operation applied to acquired data and represents a data analysis form that can be performed mentally or by a generic computer. The claim does not provide any improvement to the mathematical method itself, or computer functionality. Accordingly, the claim fails to amount to significantly more than the abstract idea. See MPEP 2106.05(f).
With respect to dependent claims 12-17, specifically, the claims further recite determining additional parameters such as protein, turbidity and/or foaming, and detecting urinary NT-titin, and their causes. These claims do not provide any improvement to the calculation itself or to the underlying apparatus performing it. As such, it does not amount to significant more than the abstract idea. See MPEP 2106.05(f).
With respect to dependent claims 10-11, specifically, the claims further recite generating or displaying outputs or recommendations based on the analysis, such as identifying conditions, and recommend medical attention. The claims do not provide any technological improvement in how the results of the analysis. The claims do not provide any technological improvement in how the results are displayed, stored, or transmitted but simply use a generic computer function to present information to users. Therefore, these limitations are considered insignificant and fail to transform the abstract idea.
Accordingly, for the reasons above and those discussed in relation to independent claim 1, 18, and 20, the dependent claims are insufficient to integrate the claimed abstract ideas into a practical application or significant more.
Claim Rejections - 35 USC § 102
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 20 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 20160000378 A1, Hall et al.
Regarding Claim 20, Hall discloses an apparatus comprising:
one or more light sensors that are configured to receive light from a toilet bowl, while a subject's urine is disposed within the toilet bowl (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
a computer processor (Hall, [0017] a computer processor configured to determine a statistically significant attribute of the longitudinal data) configured to:
determine light intensities of at least two spectral bands within the received light that are within a predetermined range, by analyzing the received light (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);
determine a ratio of the intensities of the at least two spectral bands within
the received light (Hall, [0061] The urine sample cell 6 is not restricted to a single optical path length, but can be provided with continuously or step-wisely differing optical path lengths chosen in a manner that optimizes the signal-to-noise ratio for a given wavelength or set of wavelengths. Additionally, measuring time may be used to improve signal-to-noise ratio for a given wavelength, set of wavelengths, or the spectra as a whole and may be chosen from the time range of 10 to 1,800,000 ms); and
in response thereto, determine that the subject has elevated creatinine within their urine (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).
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 1-2, 4-12, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090070046 A1, Kenjou et al. (hereinafter Kenjou) in view of US 20160000378 A1, Hall et al. (hereinafter Hall).
Regarding Claim 1, 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) and configured to detect one or more urine-related parameters relating to urine (Kenjou, [0162] the daily urinary excretion measurement method based on the urine amount measurement is employed, the user needs to collect all the urine excreted each time and measure the amount of urine), and
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:
receive the one or more urine-related parameters from the one or more sensors (Kenjou, [0177] From the creatinine concentration received from the creatinine sensor 303 and the sodium concentration received from the sodium sensor 302, the urine component calculation unit 411 calculates a ratio between the amount of sodium and the amount of creatinine in the spot urine sample);
determine whether the urine has a predetermined creatinine concentration based on the one or more urine-related parameters (Kenjou, [162] 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. Instead, the concentration of creatinine in the spot urine sample is measured and, from this result, a daily creatinine excretion is estimated and the urine component amount is accordingly corrected), and
Kenjou does not disclose determine a cause of the predetermined creatinine concentration based on the one or more urine-related parameters.
However, Hall teaches determine a cause of the predetermined creatinine concentration based on the one or more urine-related parameters (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 and Hall’s teaching because Hall explains how determining a cause for an abnormal data such as creatinine from urine samples is useful for determining changes in a patient health. Kenjou’s system on the other hand collects urine related parameters and checking creatinine levels, so adding Hall’s cause finding step would apply an improvement. A person of ordinary skill would have recognized that applying Hall’s analysis to the data produced by Kenjou apparatus would make the system more useful by identifying why the creatinine concentration is abnormal and would be a predictable combination of both systems (e.g. Kenjou discusses providing health related advice and messages based on the urinary measurements and calculations, see at least [0087]).
Regarding Claim 2, Kenjou in view of Hall discloses the apparatus according to claim 1, wherein the one or more sensors are 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 and Hall’s 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 4, Kenjou in view of Hall discloses the apparatus according to 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 the computer processor is 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 and Hall’s 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, Hall in further view of Kenjou teaches the apparatus according to claim 1, wherein the computer processor is 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), and is configured to 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 and Hall’s 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 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), and wherein, the computer processor is configured to 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 a response to determining that the cause of the predetermined creatinine concentration is catabolic processes.
However, Hall teaches a response to determining 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 and Hall’s 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 Hall discloses the apparatus according to claim 1, wherein the computer processor is 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 and Hall’s 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 Hall discloses the apparatus according to claim 7, wherein, at least partially in response to determining 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 and Hall’s 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 according to 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 computer processor is 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 a response to determining that the cause of the
predetermined creatinine concentration is kidney dysfunction.
However, Hall teaches a response to determining 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 and Hall’s 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, Hall in further view of Kenjou teaches the apparatus according to claim 7, wherein the 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), and at least partially in response to determining 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), the computer processor is configured to 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 and Hall’s 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 Hall discloses the apparatus according to claim 7, wherein, at least partially in response to determining 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).
Kenjou does not disclose the computer processor is configured to determine that the cause of the predetermined creatinine concentration is either kidney dysfunction or dehydration.
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 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 the teachings of Kenjou and Hall 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 Hall discloses the apparatus according to claim 11, wherein the computer processor is 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 a configuration to determine the cause of the
predetermined creatinine concentration at least partially in response thereto.
However, Hall teaches a configuration 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 and Hall’s 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 Hall discloses the apparatus according to claim 12, wherein, at least partially in response to determining 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 a computer processor is configured to determine that the cause of the predetermined creatinine concentration is kidney dysfunction.
However, Hall teaches a 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 and Hall’s 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 Hall discloses the apparatus according to claim 12, wherein, at least partially in response to determining 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), the computer processor is configured to 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 18, Kenjou discloses a method comprising:
detecting one or more urine-related parameters relating to a urine sample (Kenjou, [0162] the daily urinary excretion measurement method based on the urine amount measurement is employed, the user needs to collect all the urine excreted each time and measure the amount of urine);
determining whether the urine sample has an elevated creatinine concentration (Kenjou, [162] 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. Instead, the concentration of creatinine in the spot urine sample is measured and, from this result, a daily creatinine excretion is estimated and the urine component amount is accordingly corrected); and
Kenjou does not disclose determining a cause of the elevated creatinine concentration.
However, Hall teaches determining a cause of the elevated 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 and Hall’s teaching because Hall describes determining the cause of an elevated creatine concentration level based on the urine sample attained. However, Kenjou’s method attains urine related parameters and determines the level of creatinine concentration but does not determine the reason it is at such level. A person of ordinary skill in the art would integrate both systems as it will allow the system to provide additional post analysis to the user.
Regarding Claim 19, Hall in further view of Kenjou 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 and Hall’s 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 3, 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 20160000378 A1, Hall et al. (hereinafter Hall), in further view of US 20150359522 A1, Recht et al. (hereinafter Recht).
Regarding Claim 3, Hall in view of Kenjou 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).
Hall in view of Kenjou does not disclose detecting an absorbance peak that is centered in a predetermined wavelength range, within the detected visible light.
However, Recht teaches detecting an absorbance peak that is centered in a predetermined wavelength range (Recht, [0097] The combined light source 1511 emits combined excitation light 1511a that includes first excitation light and second excitation light. The first and second excitation light may be combined using collimating lenses and a beam splitter. First excitation light is centered at or peaks at a first wavelength λ1, and second light is centered at or peaks at a second wavelength λ2. A third light source 1514 may emit third excitation light 1514a that is centered at or peaks at a third wavelength λ3), 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 Hall in view of Kenjou and Recht’s teaching because Recht provides a technique for identifying peaks centered at predetermined wavelength ranges within the detected light. However, Hall discloses collecting and processing visible light data from the urine samples but does not specify using or finding absorbance peak from wavelength-centered light data from the urine samples. A person of ordinary skill in the art would recognize that incorporating Recht’s absorbance peak approach into hall’s existing system would improve the accuracy, strength, and sensitivity of the light data related to the urine sample.
Regarding Claim 13 and 17, Kenjou in view of Hall disclose the apparatus according to claim 12, and wherein the computer processor is 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 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 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclose:
-US 20210186434 A1, describing systems and methods for detecting infection in the patient by illuminating patient’s urine. The reference teaches urine monitoring done by one or more sensors and correlating those measurements with potential infection states.
-US 20180184972 A1, describing a spectrometry based system for analyzing body fat levels using spectral data acquired from one or more spectrometers. The reference describes a handheld device used for obtaining information, measurements, and evaluating data. The teachings relate to optical analysis using wavelengths of biological samples like urine.
-US 5772606 A, describing a method and apparatus for simultaneously measuring multiple urine samples in a clinical setting. The reference performs testing for evaluating glucose, bilirubin, proteins, ketone bodies, and other analytes in a single operation. The system improves diagnostic workflow by enabling rapid multi-parameter testing versus the conventional test strips or chromatographic methods. The reference highlights the challenges of accurate urine analysis in a high throughput environments like a hospital.
Conclusion
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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