DETAILED ACTION
This action is responsive to the “AMENDMENT UNDER 37 C.F.R. § 1.111” filed 3 August 2026. The Examiner acknowledges the amendments to claims 27, 29, 31-32, 35-40, and 43, as well as the addition of new claim 47. Claims 27-47 are pending, with claim 44 standing as previously withdrawn.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 29 is/are objected to because of the following informalities:
Claim 29 appears to use “correction quantity characteristic” [line 2] and “correction quantity” [lines 4-5] interchangeably. Each instance should only read one or the other of “correction quantity characteristic” and “correction quantity”.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 35 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 recites the limitation “wherein the case is configured to be removably attached to an inner wall of the toilet by… a hook attached to the rim of the toilet” [lines 1-3], which is considered indefinite, as claim 27 previously recites “the case being configured to be positioned entirely within the toilet bowl so as to note protrude from a rim of the toilet bowl” [lines 5-6, emphasis applied], such that it is unclear how the case may be removably attached to an inner wall of the toilet by a hook attached to the rim of the toilet if the case is configured to not protrude from a rim of the toilet bowl, as the hook is considered to protrude from the rim of the toilet bowl.
Claim Analysis - 35 USC § 101
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 27 recites a judicial exception [“obtain a result… as to a follow-up of the treatment from the analyte concentration of the quantity obtained” (lines 19-20)] at Step 2A Prong 1, which is considered to be an abstract idea that may be performed in the mind or by hand by merely observing known or previously collected data and drawing mental conclusions therefrom. However, the Examiner further notes that claim(s) 27 recites limitations directed towards particular structure and functionality of a urine analysis device [lines 4-8] that is considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 27-28, 31, 35, 37-39, and 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemer (US-20050261605-A1) in view of Mostafa (US-20190033288-A1, cited by Applicant, previously presented) and Infante (US-20190302108-A1).
Regarding claim 27, Shemer teaches
A system comprising a urine analysis device and a processing unit [a first main processing unit (MPU) 24 (Shemer ¶0058)],
wherein the urine analysis device comprises a case [exterior of portable toilet unit 10 (Shemer Fig. 1)] configured to be removably positioned in a toilet bowl of a toilet, the case being configured to be positioned entirely within the toilet bowl, the case comprising a collection port [sampling cell entrance holes 9 (Shemer Fig. 1)] configured to collect urine dripping onto the case and a collection channel in fluid communication with the collection port [inlet 712 (Shemer Fig. 4)], and an analysis module contained within said case [As best seen in FIGS. 1 and 2, portable toilet unit 10 is constructed to be non-permanently attachable, that is removably attachable, to the inside of a toilet 4 (Shemer ¶0057, Fig. 1); The positioning of collection and sampling sub-unit 1 is such that urine from the user directly impinges thereon (Shemer ¶0060); The structure of collection and sampling sub-unit 1 is such as to allow urine to flow from a collection basin 11 through sampling cell entrance holes 9 and from there through a light trap (not shown) to a sampling cell where optical measurements are made (Shemer ¶0063); Reference is made to FIG. 4, which is a schematic illustration of a urine analyzer generally referenced 71 and its optical measurement system. Urine flows from an inlet 712 through a flow conduit 710 in a sampling cell towards an exit 714. A sampling cell 716 is located in urine flow conduit 710, and a sample of the flowing urine collects in the sample cavity 718. The structure and operation of cavity 718 are described in more detail hereinbelow, in connection with FIGS. 6A and 6B (Shemer ¶0070, Fig. 4)],
wherein the system is configured to:
(a) perform at least one analysis for at least one micturition of the user by:
a1) collecting urine from the user urinating in the toilet onto the case, the urine trickling on an outer surface of the case to the collection port and being conveyed through the collection channel to the analysis module of the urine analysis device [Shemer ¶¶0060, 0063], and
a2) analyzing the urine collected by the analysis module of the urine analysis device to obtain an analyte concentration in the collected urine [MPU 24 included in electronics sub-unit 2 of toilet unit 10, best seen in FIG. 3, is the heart of the electronic circuit of toilet unit 10. MPU 24 detects the presence of urine in the sampling cell. Once urine is detected, MPU 24 initiates analyses, typically electrical, temperature and optical analyses, of the sample. Optical analyses are used to calculate the concentration or amount of one or more urine constituents. In other embodiments, sensors capable of measuring other urine properties, such as pH, may be included in collection and sampling sub-unit 1 (Shemer ¶¶0065-0066); Analyzed concentrations of urine constituents such as glucose, ketones, occult blood, electrolytes, and total dissolved solids (TDS), whose changes provide indications of a person's health or body condition, are collected and recorded. It is readily understood that the aforementioned constituents are exemplary only and they are not intended to be limiting (Shemer ¶0015)] or a quantity related by a monotonic function to the analyte concentration in the urine; and
(b) obtain a result by the processing unit [MPU 24 included in electronics sub-unit 2 of toilet unit 10, best seen in FIG. 3, is the heart of the electronic circuit of toilet unit 10. MPU 24 detects the presence of urine in the sampling cell. Once urine is detected, MPU 24 initiates analyses, typically electrical, temperature and optical analyses, of the sample. Optical analyses are used to calculate the concentration or amount of one or more urine constituents (Shemer ¶0065)].
However, Shemer fails to explicitly disclose wherein the claimed system is for monitoring compliance of a user with a treatment comprising regular intake of a drug; wherein the analyte is an active ingredient of the drug or a metabolite of the active ingredient; and wherein the result obtained by the processing unit is a follow-up of the treatment from the analyte concentration or the quantity obtained.
Mostafa discloses systems for monitoring compliance of a user with a treatment comprising regular intake of a drug, wherein Mostafa discloses performing an analysis of collected urine to obtain an analyte concentration in the collected urine or a quantity related by a monotonic function to the analyte concentration in the urine, wherein the analyte is an active ingredient of the drug or a metabolite of the active ingredient [The testing device 24 may include a testing substrate, which may be cartridge based for easy replacement. The testing device 24 may include one or more test cells, each of which may be adapted to detect a unique constituent or property of the bio-fluid, and the concentration or level of the constituent or property (Mostafa ¶0041, Fig. 1); The analytic device 26 may include, e.g., a micro-spectrometer. The analytic device 26 may include a bio-fluid analyzer 200 (shown in FIG. 2), which includes a processor 210 and a transceiver 282 that may initiate testing/analysis (Mostafa ¶0043); The one or more testing substrates 350 may be specific to a user and their needs, and each may have more than one testing cell, each being for a different test. The one or more testing substrates 350 may be prescribed according to the user's testing needs for testing for one or more conditions, unique constituent or property, as shown in relation to TABLE 1 (Mostafa ¶0061); Prescription testing (compliance with medications) (Mostafa Table 1)]; and obtaining a result as to a follow-up of the treatment from the analyte concentration or the quantity obtained [The fluid analytics sensor 316 may comprise an optical spectrometer that measures the colors and intensities related to the concentration of the identified element (Mostafa ¶0044); The processor 210 may control the operational functions of the analysis apparatus 20 including the fluid analytics sensor 316 (Mostafa ¶0045); The BF analyzer 200 may communicate (transmit/receive) instruction and data signal via internal transceiver 282 with the user device 40 (shown in FIG. 1), the data storage and reporting system 50 (shown in FIGS. 1 and 5), and/or the subscriber device 62 (shown in FIG. 1) (Mostafa ¶0050, Fig. 1)].
As Shemer is already directed towards urine analysis over time [A personal database of the urine properties and constituents measured is established for each individual using the toilet or other sanitary installation. Data is analyzed on the basis of the individual's last readings, generally a series of readings (Shemer ¶0016), wherein a series of readings of a measured concentration of a constituent is considered to read on the monotonic function of the analyte concentration in the urine], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer to be employed for monitoring compliance of a user with a treatment comprising regular intake of a drug; wherein the analyte is an active ingredient of the drug or a metabolite of the active ingredient; and wherein the result obtained by the processing unit is a follow-up of the treatment from the analyte concentration or the quantity obtained, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [perform urine analysis to enable assessment of medication compliance] [MPEP § 2143(I)(D)].
However, while Shemer discloses alternative solutions for mounting the case to the toilet bowl of the toilet [The flexible strap represents only one means for removably fastening collection and sampling unit 1 inside a toilet. Other such means may include a rigid structure shaped to be positioned on a toilet so as to removably fasten the collection and sampling sub-unit 1 within a toilet bowl. Additionally, a hook or hanger-like element to which the collection and sampling sub-unit 1 is attached can also be used to position sub-unit 1 within a toilet bowl (Shemer ¶0062)], Shemer fails to explicitly disclose wherein the case is configured to be positioned entirely within the toilet bowl so as to not protrude from a rim of the toilet bowl.
Infante discloses systems for performing urine analysis, wherein Infante discloses devices configured to urinated on and be removably positioned in a toilet via suction cup [This cover also has two circular holes (16) in which a plastic suction cup is installed (17) which allows the user to mount the device on a wall or on the toilet, in order to be hands-free during the assessment process (Infante ¶0030); d) Affix the device onto a wall, or the toilet by using the plastic suction cup (17); e) Dampen the pouch(es) of the strip with your urine, either by placing urine in a recipient or by urinating directly over the strip (Infante ¶¶0036-0037)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer to employ the mounting structure(s) of Infante, as this modification would amount to mere simple substitution of one known element for another with similar expected results [one method/structure for adhering a device to an interior of a toilet bowl for another] [MPEP § 2143(I)(B)]. Based on the position of the case inside the toilet bowl of Shemer [Shemer Fig. 1] and the modification based on the disclosure of Infante, the combination of Shemer in view of Mostafa and Infante is considered to render obvious wherein the case is configured to be positioned entirely within the toilet bowl so as to not protrude from a rim of the toilet bowl, as the modified mounting structure of a suction cup to position the case of Shemer within the toilet bowl is considered to not protrude from the rim of the toilet bowl.
Regarding claim 28, Shemer in view of Mostafa and Infante teaches
The system of claim 27, wherein the processing unit is part of the urine analysis device [In another embodiment of the present invention, the collection and sampling sub-unit and the electronics sub-unit of the toilet unit, as well as the communications link between them, can be integrated into a single unit and non-permanently positioned within a toilet bowl. A hanger-like attachment can be used to hang, suspend or position the integrated toilet unit in the toilet bowl. The integrated unit will be positioned so that the urine from an individual directly impinges thereon. The electronics subunit and communications link of this integrated toilet unit are packaged so that the liquid does not impair function (Shemer ¶0106)].
Regarding claim 31, Shemer in view of Mostafa and Infante teaches
The system of claim 27, wherein, to obtain the result, the processing unit is configured to compare the analyte concentration in the collected urine to at least one predetermined threshold [Shemer ¶0016; wherein any comparative analysis to a previously measured concentration is considered to read on the broadest reasonable interpretation of comparison to “at least one predetermined threshold”].
Regarding claim 35, Shemer in view of Mostafa and Infante teaches
The system of claim 27, wherein the case is configured to be removably attached to an inner wall of the toilet bowl by a suction cup attached to the inner wall [See § 103 modification of claim 27 above; Infante ¶¶0030, 0036-0037] or a hook attached to the rim of the toilet.
Regarding claim 37, Shemer in view of Mostafa and Infante teaches
The system of claim 27.
However, Shemer in view of Mostafa and Infante as presently modified fails to explicitly disclose wherein the urine analysis device comprises a pump for delivering urine from the collection port of the urine analysis device to an injector via the collection channel, the injector being configured to inject a controlled amount of urine onto a test strip.
Mostafa discloses the use of a pump for delivering urine from a collection port to an injector configured to inject a controlled amount of urine onto a test strip [The sample channeling device 22 may be configured to receive a bio-fluid from the bio-fluid collection apparatus 10 and separate the bio-fluid into a plurality of channels, which may be further separated into sub-channels. The sample channeling device 22 may receive a high volume of fluid and output a low volume of fluid to the testing device 24 (Mostafa ¶0040); In the example of the device that includes a test substrate 325, which may be a printed test strip, the test strip may include a plurality of colors, each of which may be associated with a particular element (Mostafa ¶0044); The collected sample may be transported to the BF analysis apparatus 20 (Step 212) and analyzed (Step 213) (Mostafa ¶0063, Figs. 3-4); In FIG. 4 the fluid transfer Step 212 is shown as being carried out by a pump (Mostafa ¶0064, Fig. 4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the urine analysis device comprises a pump for delivering urine from the collection port of the urine analysis device to an injector via the collection channel, the injector being configured to inject a controlled amount of urine onto a test strip, as this modification would amount to mere simple substitution of one known element for another [sensing system and control of depositing liquid for the sensing system for another] [MPEP § 2143(I)(D)].
Regarding claim 39 [written in longhand format to incorporate the subject matter of claim 38 therein], Shemer in view of Mostafa and Infante teaches
The system of claim 27.
However, while Shemer discloses the use of an optical sensor [Collection and sampling sub-unit 1 includes a sampling cell (not shown), which allows optical measurements under dark conditions. The structure of collection and sampling sub-unit 1 is such as to allow urine to flow from a collection basin 11 through sampling cell entrance holes 9 and from there through a light trap (not shown) to a sampling cell where optical measurements are made (Shemer ¶0063)], Shemer in view of Mostafa and Infante fails to explicitly disclose wherein the analysis module comprises a plurality of test strips.
Mostafa discloses an analysis module comprising a plurality of test strips and a corresponding optical sensor [The sample channeling device 22 may be configured to receive a bio-fluid from the bio-fluid collection apparatus 10 and separate the bio-fluid into a plurality of channels, which may be further separated into sub-channels. The sample channeling device 22 may receive a high volume of fluid and output a low volume of fluid to the testing device 24 (Mostafa ¶0040); In the example of the device that includes a test substrate 325, which may be a printed test strip, the test strip may include a plurality of colors, each of which may be associated with a particular element. The intensity of the color(s) may be related to the concentration of the identified element. The fluid analytics sensor 316 may comprise an optical spectrometer that measures the colors and intensities related to the concentration of the identified element (Mostafa ¶0044); a bio-fluid (BF) sample may be received at and collected by the BF collection apparatus 10 (Step 211). The collected sample may be transported to the BF analysis apparatus 20 (Step 212) and analyzed (Step 213) (Mostafa ¶0063); FIG. 4 shows a more detailed block diagram of the method of FIG. 3, including a control Step 216, electric signal channels 201, and BF fluid channels 202. In FIG. 4 the fluid transfer Step 212 is shown as being carried out by a pump, and the control Step 216 controls the cleaning mechanism in Step 215 (Mostafa ¶0064)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the analysis module comprises a plurality of test strips and further employ the optical sensor to analyte the test strips, as this modification would amount to mere simple substitution of one known element for another with similar expected results [structures for containing the collected urine to be sensed via an optical sensor] [MPEP § 2143(I)(B)].
Regarding claim 45, Shemer in view of Mostafa and Infante teaches
The system of claim 27.
However, Shemer in view of Mostafa and Infante as presently modified fails to explicitly disclose wherein the analysis module comprises an electrochemical sensor.
Mostafa wherein an analysis modules comprises an electrochemical sensor [Referring back to FIG. 1, the testing device 24 may include a chemically activated monitoring substrate and/or a plurality of testing cells 326 (FIG. 2D), each of which may comprise a chemical that reacts with a BF constituent in the bio-fluid (e.g., urine) to give a qualitative test result, such as providing indications of conditions or constituents shown in TABLE 1… The BF analyzer 200 may compare concentrations or levels of one or more BF constituents in the bio-fluid with associated BF constituent reference data and output BF constituent analysis data based on the constituent concentration/levels of the one or more BF constituents in the bio-fluid (Mostafa ¶0065)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the analysis module comprises an electrochemical sensor, as this modification would amount to mere simple substitution of one known element for another with similar expected results [sensor for urine constituent concentration analysis for another] [MPEP § 2143(I)(B)].
Regarding claim 46, Shemer in view of Mostafa and Infante teaches
The system of claim 27, wherein the processing unit is part of a remote device [Communications link 3, in other embodiments, may be constructed as a wireless link. The flexible strap then would function solely as means to support and position the two sub-units 1 and 2 of toilet unit 10 in and/or on toilet 4 (Shemer ¶0061), wherein the Examiner notes that the cited portion regarding the flexible strap was only cited to highlight that sub-unit 2 (considered to read on the claimed processing unit) is remote from sub-unit 1 (considered to read on the claimed case)].
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemer in view of Mostafa and Infante, as applied to claim 27 above, in further view of Liu (US-20140273269-A1, previously presented).
Regarding claim 29, Shemer in view of Mostafa and Infante teaches
The system of claim 27.
However, Shemer in view of Mostafa and Infante fails to explicitly disclose wherein the analysis module of the urine analysis device is further configured to measure a correction quantity characteristic of a hydration of the user, and the system is further configured to: a3) obtain a corrected analyte concentration to account for user hydration from the analyte concentration and the correction quantity.
While Shemer broadly discloses measuring concentrations of constituents in urine, Mostafa discloses wherein at least creatinine concentration is specifically measured [Mostafa ¶0041].
Liu discloses systems for analyzing analyte concentrations in urine, wherein Liu discloses correcting a measured analyte concentration to account for user hydration [The disclosed method and device utilizes the principle of lateral flow immunochromatography to measure both urine albumin and urine creatinine in a single assay and determining the albumin-creatinine ratio (ACR) (Liu ¶0056); Creatinine is a byproduct of creatine phosphate in muscle. In a normal functioning body, it is excreted into urine at a constant rate. When albumin is measured simultaneously with creatinine, the result is known as the albumin-creatinine ratio. The use of ACR for determination of albumin in the urine corrects for the concentration of urine due to varying diuretic output and the hydration status of the patient (Liu ¶0003)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the analysis module of the urine analysis device is further configured to measure a correction quantity characteristic of a hydration of the user, and the system is further configured to: a3) obtain a corrected analyte concentration to account for user hydration from the analyte concentration and the correction quantity, so as to account for varying diuretic output and hydration status of the user; and as calculating an albumin-creatinine ratio is considered to be indicative of kidney function and treatment efficacy [The ACR assay serves as an early detection method for kidney damage as well as a monitoring method of treatment efficacy. The ACR assay is frequently used in patients with chronic diseases such as diabetes and hypertension that are at an increased risk of developing kidney failure (Liu ¶0004)].
Regarding claim 30, Shemer in view of Mostafa, Infante, and Liu teaches
The system of claim 29, wherein the analyte concentration is corrected by a creatinine concentration in the collected urine [see § 103 modification above; Liu ¶¶0003, 0056], by a specific gravity of the collected urine, by a urinary flow rate of the micturition, or by the conductivity of the collected urine.
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemer in view of Mostafa and Infante, as applied to claim 31 above, in further view of Tu (US-20180372717-A1, cited by Applicant, previously presented).
Regarding claim 32, Shemer in view of Mostafa and Infante teaches
The system of claim 31.
However, while Shemer and Mostafa are each directed towards analyte concentration assessment of different analytes/constituents over time based on different micturitions in accordance with step a1) and analyzed in accordance with step a2), corresponding to different micturitions of the user when the user follows the treatment in accordance with a prescription [Shemer ¶0016; Mostafa ¶¶0061, 0065; see § 103 modification above in light of Mostafa being directed towards prescription compliance], Shemer in view of Mostafa and Infante fails to explicitly disclose wherein the system is further configured to perform a personalized calibration during which a plurality of analyte concentrations are obtained by the analysis module from urine collected in accordance with step a1) and analyzed in accordance with step a2), corresponding to different micturitions of the user when the user follows the treatment in accordance with a prescription, and wherein the processing unit is configured to calculate the predetermined threshold from the concentrations obtained.
Tu discloses systems for analyzing biomarker concentrations in urine, wherein Tu discloses defining baseline biomarker concentration(s) unique to a patient as a personalized calibration [The system will also analyze the trend over time of the concentration of the biomarker(s) compared to baseline biomarker concentration(s) unique to each patient. As an example, if the change in concentration of a specific biomarker exceeds a threshold compared to the baseline biomarker concentration, the system will automatically detect this trend and notify the patient and clinicians of treatment ineffectiveness and the disease progression (Tu ¶0037)].
As the combination of Shemer in view of Mostafa and Infante is directed towards prescription compliance [see § 103 modification of claim 27 above; Mostafa Table 1], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the system is further configured to perform a personalized calibration during which a plurality of analyte concentrations are obtained by the analysis module from urine collected in accordance with step a1) and analyzed in accordance with step a2), corresponding to different micturitions of the user when the user follows the treatment in accordance with a prescription, and wherein the processing unit is configured to calculate the predetermined threshold from the concentrations obtained, so as to allow for analysis of treatment effectiveness and disease progression.
Regarding claim 33, Shemer in view of Mostafa, Infante, and Tu teaches
The system of claim 32, wherein the predetermined threshold is a lower control limit or an upper control limit calculated on the sample of concentrations obtained in the calibration step [see § 103 modification of claim 32 above; Tu ¶0037, wherein a threshold defined based on the baseline concentration is considered to read on being a lower/upper control limit].
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemer in view of Mostafa and Infante, as applied to claim 27 above, in further view of Salem (US-20150134773-A1).
Regarding claim 34, Shemer in view of Mostafa and Infante teaches
The system of claim 27, wherein the processing unit is configured to send or display a notification a content of the notification depends on a rate of change of the analyte concentration between at least two successive analyses [The central institutional computer uses a software package which collects data, maintains a central database and can provide alerts when an extreme value for a urine constituent or urine property is received for an individual. While the indication, also herein described as an exception report, has been described above as being transmitted to a user through display 6 of wall unit 5, other means of transmittal are also available. Exception reports (or alerts) may be transmitted either as a numerical or textual display on display of wall unit 5 (FIG. 7) an alarm lamp (not shown) on wall unit 5 or elsewhere, or an audio alarm (not shown) on wall unit 5 or elsewhere (Shemer ¶¶0104-0105), wherein any second measurement that results in a measured “extreme value” is considered to read on the notification being dependent on a rate of change between two successive analyses].
However, Shemer in view of Mostafa and Infante fails to explicitly disclose wherein the notification is sent or displayed when the result is that the user has not completed the treatment correctly.
Salem discloses systems and methods for analyzing at least user urine, wherein the analysis of the urine may be used to determine possible medication or supplement overdose [Health markers may also be assessed. Information assessed may include Indication(s) for particular drugs (allergies, etc.),… urine analysis... The system may take these inputs and make relevant determinations including a score, raw data, percentile, chart or graph, measurement of physical or mental response to a medication or supplement, possible medication or supplement overdose symptoms alert, and possible medication or supplement overdose signs alert (Salem ¶0089)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the notification is sent or displayed when the result is that the user has not completed the treatment correctly, as urine analysis may be considered indicative of medication or supplement overdose.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemer in view of Mostafa and Infante, as applied to claim 27 above, in further view of Niu (US-20190302097-A1).
Regarding claim 36, Shemer in view of Mostafa and Infante teaches
The system of claim 27.
However, Shemer in view of Mostafa and Infante fails to explicitly disclose wherein the analysis module comprises a rotatable holder in the form of a hollow cylinder and a plurality of strips, the plurality of strips being fixed in housings located on a circumference of the rotatable holder, said rotatable holder being removable from the urine analysis device.
Niu discloses systems for analyzing concentrations of constituents in urine samples, wherein Niu discloses an analysis module comprising a rotatable holder in the form of a hollow cylinder and a plurality of strips, the plurality of strips being fixed in housings located on a circumference of the rotatable holder, said rotatable holder being removable from the urine analysis device [The detector 8 of the urine analyzer 10 could be stationary, and the micro-fluidic chip 1 was removable, so that we could collect the color data of the test strip 2 in the micro-fluidic chip 1 in turn (Niu ¶0111); As shown in FIG. 13, the micro-fluidic chip was bonded with a basal layer 107, an interlayer 108 and an upper layer 109. The liquid inlet end 5 and the basal layer 107 were made into an assembly unit, the liquid outlet end 4 and the upper layer 109 were made into an assembly unit, and the basal layer 107 also had transparent circular sidewalls 110 that can surround the interlayer 108. The fluid channel 3 was made into the channel 307 on the lower surface of the interlayer 108, the channel 308 on the side surface and the channel 309 on the upper surface. The test strip 2 was located on the side surface of the interlayer 108 and in contact with channel 308. In service use, the urine sample entered micro-fluidic chip 1 from the liquid inlet end 5, it flew into the channel 308 through the channel 307 of the fluid channel 3, and then flew into channel 309, and flew out from the liquid outlet end 4 (Niu ¶0114, Fig. 13)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the analysis module comprises a rotatable holder in the form of a hollow cylinder and a plurality of strips, the plurality of strips being fixed in housings located on a circumference of the rotatable holder, said rotatable holder being removable from the urine analysis device, as this modification would amount to mere simple substitution of one known element for another [structures for containing the collected urine to be sensed via an optical sensor] [MPEP § 2143(I)(D)].
Claim(s) 40-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemer in view of Mostafa and Infante, as applied to claim 27 above, in further view of Bango (US-20060073471-A1, previously presented).
Regarding claim 40, Shemer in view of Mostafa and Infante teaches
The system of claim 27.
However, Shemer in view of Mostafa and Infante as presently modified fails to explicitly disclose wherein the analysis module is adapted to contact the collected urine with a detection compound, and the detection compound is a molecularly imprinted polymer.
Mostafa discloses the use of a testing strip comprising a detection compound to contact collected urine [The test strips 25 may include various chemicals, biomolecules, and substances that may bind to and/or react to a sample (Mostafa ¶0130)].
Infante also discloses the use of a testing strip to chemically analyze a urine sample [The current monitoring strips provide a fast and simple mean to carry out the chemical analysis of the urine sample, something very important to help doctors on their diagnostic procedures. This analysis covers pH, presence of protein, glucose, ketones, hemoglobin, bilirubin, urobilinogen, nitrite, leukocytes and density among others (Infante ¶0010)].
Bango discloses systems and methods for assessing analyte concentration, wherein Bango discloses a urine analysis module adapted to contact urine with a detection compound, wherein the detection compound is a molecularly imprinted polymer [The invention outlines a method for using Molecularly Imprinted Polymers (MIP's) in conjunction with specific, narrow wavelength light sources to non-invasively test for disease precursors (Bango ¶0002); The MIP's will target and concentrate specific molecules to test for the presence of various diseases and ailments (Bango ¶0007); Each discrete region could have a MIP designed for a different molecule; the combination of several regions shown as active will help to determine specific fingerprints of different compounds. As each discrete region glows under the influence of suitable wavelength light (fluoresces), a determination can be made as to the type and concentration of each molecule can be made (Bango ¶0008); FIG. 5 shows several views of a tray that could be used to contain a discrete amount of liquid for testing. The liquid could be urine, and with the help of specially designed MIP's coated onto the base of the tray, a determination can be made as to the molecules contained in the urine (Bango ¶0009, Fig. 5); In addition to having a MIP coated liquid sample tray for sampling liquids, a strip of paper or plastic that is coated with MIP's specific to various target species, such as acetone, ammonia, ethyl alcohol, and dipicolinic acid, to name just a few examples, could be used as an alternative to Litmus paper. The MIP's that are coated on the small strip will react and sequester the targeted chemical compounds and molecular species when dipped into a sample of liquid. The strip coated with MIP's could be coated with a homogenous coating, or covered with a plurality of discrete rows, columns, or checkerboard squares of MIP's--each selective or specific to a definite type of molecular specie. The MIP coated strip would be tested in the same test chamber that both the air bag and liquid sample tray are tested in (Bango ¶0017)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the analysis module is adapted to contact the collected urine with a detection compound, and the detection compound is a molecularly imprinted polymer, as this modification would amount to mere simple substitution of one known element for another [form of the sample for analysis by optical sensor for another] [MPEP § 2143(I)(B].
Regarding claim 41, Shemer in view of Mostafa, Infante, and Bango teaches
The system of claim 30, wherein the molecularly imprinted polymer is incorporated into test strips in solid form [see § 103 modification of claim 40 above; wherein as Bango discloses that the test strip (solid) is coated with the molecularly imprinted polymer, the molecularly imprinted polymer is considered to read on the claimed limitation].
Regarding claim 42, Shemer in view of Mostafa, Infante, and Bango teaches
The system of claim 40, wherein the molecularly imprinted polymer is functionalized with a label configured to activate when the molecularly imprinted polymer is bound to the analyte [Bango ¶0008, wherein the molecularly imprinted polymer fluorescently glowing based on the type/concentration of an analyte in contacted urine is considered to read on a “label configured to activate” based on Applicant’s disclosure of a label being fluorescently detectable (Applicant’s Specification ¶0019)].
Regarding claim 43, Shemer in view of Mostafa, Infante, and Bango teaches
The system of claim 40, wherein the molecularly imprinted polymer is stored in solid form [see § 103 modification of claim 40 above; wherein as Bango discloses that the test strip (solid) is coated with the molecularly imprinted polymer, the molecularly imprinted polymer is considered to read on the claimed limitation] or stored in solution .
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemer in view of Mostafa and Infante, as applied to claim 27 above, in further view of Hall (US-20150342574-A1).
Regarding claim 47, Shemer in view of Mostafa and Infante teaches
The system of claim 27.
However, Shemer in view of Mostafa and Infante fails to explicitly disclose wherein the urine analysis device further comprises a urine detector located in a vicinity of the collection port, and the urine analysis device is configured to initiate the analysis automatically, without intervention by the user, when urine is detected by the urine detector.
Hall discloses systems for performing urine analysis, wherein Hall discloses a urine detector located in a vicinity of a collection port of a urine analysis device, and wherein the urine analysis device is configured to initiate analysis automatically, without intervention by a user, when urine is detected by the urine detector [In another embodiment, the analytic device, such as a spectrometer, functionally coordinates with the fluid level sensor. For example, upon the fluid level reaching a designated level, such as above the point at which the spectrometer is able to take a reading, the spectrometer may be actuated to analyze the urine specimen that has reached the designated level (Hall ¶0043)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Shemer in view of Mostafa and Infante to employ wherein the urine analysis device further comprises a urine detector located in a vicinity of the collection port, and the urine analysis device is configured to initiate the analysis automatically, without intervention by the user, when urine is detected by the urine detector, so as to ensure a sufficient amount of urine for analysis, and so as to enable automation of a manual activity [In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined "old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed." The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.)] [MPEP §2144.04(III)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 3 August 2026, with respect to the previously presented Drawing objections have been fully considered and are persuasive. The Drawing objections have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-8, with respect to the previously presented Specification objections have been fully considered and are persuasive. The Specification objections have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously presented Claim objections have been fully considered and are persuasive. The objection to claim 29 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 29, 31-32, 34, and those dependent therefrom under § 112(b) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-10, with respect to the previously applied rejections under § 101 have been fully considered and are persuasive. The rejections of claims 27-34, 38-39, and 45-46 under § 101 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 10-19, with respect to the rejection(s) of claim(s) 27 and those dependent therefrom under § 102 and § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shemer (US-20050261605-A1) in view of Mostafa (US-20190033288-A1, cited by Applicant, previously presented) and Infante (US-20190302108-A1) with respect to claim 27.
Regarding previously rejected claim 35, the Applicant asserts that claim 35 has been canceled, thus rendering moot the rejection of the claim. However, the Examiner notes that claim 35 has not been presently canceled.
Regarding previously rejected claim 27, the Applicant asserts that Mostafa does not disclose, teach, or suggest amended, as the Applicant notes that Mostafa mounts its apparatus on the rim, on the outside of the bowl [Mostafa ¶¶0055-0056, Figs. 2B-C], as opposed to the claimed removable case containing the analysis module being positioned entirely within the toilet bowl so as to not protrude from the rim. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Shemer (US-20050261605-A1) is presently modified in view of Mostafa (US-20190033288-A1, cited by Applicant, previously presented) and Infante (US-20190302108-A1), wherein the Examiner notes that Infante discloses devices configured to urinated on and be removably positioned in a toilet via suction cup [Infante ¶¶0030, 0036-0037], wherein based on the position of the case inside the toilet bowl of Shemer [Shemer Fig. 1] and the modification based on the disclosure of Infante, the combination of Shemer in view of Mostafa and Infante is considered to render obvious wherein the case is configured to be positioned entirely within the toilet bowl so as to not protrude from a rim of the toilet bowl, as the modified mounting structure of a suction cup to position the case of Shemer within the toilet bowl is considered to not protrude from the rim of the toilet bowl.
Regarding previously rejected claim 27, the Applicant further asserts that Mostafa has no collection port and no urine trickling on an outer surface of the case, as Mostafa discloses a testing substrate driven out of the housing [Mostafa ¶¶0055-0056, 0060], such that Mostafa does not disclose, teach, or suggest (i) a case configured to be positioned entirely within the toilet bowl so as to not protrude from the rim, (ii) a collection port configured to collect urine dripping onto the case, or (iii) urine trickling on an outer surface of the case to the collection port and being conveyed through a collection channel to an analysis module within the case. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Examiner notes that the Applicant’s arguments regarding element (i) were discussed above in the corresponding Examiner’s response, and Shemer as presently applied is considered to teach argued elements (ii) and (iii) [Shemer ¶¶0060, 0063].
Regarding previously rejected claim 32, the Applicant asserts that amended claim 32 requires a plurality of analyte concentrations, obtained by the analysis module from urine collected and analyzed in accordance with steps a1) and a2), corresponding to different micturitions of the user while the user follows the treatment in accordance with a prescription, from which the processing unit calculates the threshold, as opposed to a single measurement as performed by Mostafa [based on the previously presented interpretations of Mostafa in the previously applied rejection of claim 32]. The Applicant also notes that Mostafa teaches the opposite arrangement to the claimed limitations, as Mostafa discloses the use of reference data and not a threshold calculated from the individual user’s own calibration measurements [Mostafa ¶0067]. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 32 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Shemer in view of Mostafa, Infante, and Tu is presently applied to teach the subject matter of claim 32, wherein the Examiner notes that Shemer and Mostafa are each directed towards analyte concentration assessment of different analytes/constituents over time based on different micturitions in accordance with step a1) and analyzed in accordance with step a2), corresponding to different micturitions of the user when the user follows the treatment in accordance with a prescription [Shemer ¶0016; Mostafa ¶¶0061, 0065; see § 103 modification of claim 27 above in light of Mostafa being directed towards prescription compliance], and wherein Tu is further applied, as Tu discloses defining baseline biomarker concentration(s) unique to a patient as a personalized calibration [The system will also analyze the trend over time of the concentration of the biomarker(s) compared to baseline biomarker concentration(s) unique to each patient. As an example, if the change in concentration of a specific biomarker exceeds a threshold compared to the baseline biomarker concentration, the system will automatically detect this trend and notify the patient and clinicians of treatment ineffectiveness and the disease progression (Tu ¶0037)].
Regarding the previously applied rejections of claims 29-30 under § 103, the Applicant asserts that Liu does not remedy the deficiencies of Mostafa noted above, and any proper combination of Mostafa and Liu cannot result in any way in the invention of claim 27, as the Applicant notes that modification of Mostafa’s apparatus to relocate the apparatus would render structural elements of Mostafa purposeless and would place the extending testing substrate inside the bowl where the user cannot void upon it, and thus render Mostafa unsatisfactory for its intended purpose. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 29-30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Examiner further notes that the disclosure of Liu is not specifically applied to teach any structural limitations, and is merely applied to teach the limitations of claims 29-30 regarding a correction quantity characteristic [Tu ¶0056].
Regarding the previously applied rejections of claims 33-34, 36, and 46 under § 103, the Applicant asserts that Tu does not remedy the deficiencies of Mostafa noted above, and Tu further fails to disclose computation of a rate of change between two successive analyses and does not make the content of any notification depend upon such a rate of change, such that the motivation applied “so as to detect trends indicative of efficacy of a treatment” is a reason to detect trends and is not a reason to make the content of a notification depend on a rate of change between successive analyses, such that the motivation is a reason directed to a different feature that does not supply the missing teaching. The Applicant further notes that Tu fails to disclose the rotatable holder in the form of a hollow cylinder and a plurality of strips, wherein said rotatable holder is removable from the urine analysis device, as Tu discloses no housings, no cylinder, and no removability of the disclosed carousel [Tu ¶0142]; and wherein the application of simple substitution rationale is improper, as Mostafa has no rotatable strip holder to be substituted and would require abandoning Mostafa’s extension mechanism and redesign Mostafa’s collection and transportation principle. Regarding claim 34, the Examiner notes that Applicant’s arguments with respect to claim(s) 34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Shemer is considered to disclose wherein content of a notification is dependent on a rate of change of the analyte concentration between at least two successive analyses [Shemer ¶¶0104-0105, wherein any second measurement that results in a measured “extreme value” is considered to read on the notification being dependent on a rate of change between two successive analyses]. Regarding claim 36, the Examiner notes that Applicant’s arguments with respect to claim(s) 36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Shemer in view of Mostafa and Infante is further modified by Niu (US-20190302097-A1), wherein Niu discloses an analysis module comprising a rotatable holder in the form of a hollow cylinder and a plurality of strips, the plurality of strips being fixed in housings located on a circumference of the rotatable holder, said rotatable holder being removable from the urine analysis device [Niu ¶¶0111, 0114, Fig. 13].
Regarding the preciously applied rejections of claims 40-43 under § 103, the Applicant asserts that with respect to claim 42, Bango does not disclose a label and instead discloses wherein the molecularly imprinted polymer region itself that glows [Bango ¶0008], instead of a separate moiety with which the polymer has been functionalized. However, in response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a separate moiety with which the polymer has been functionalized”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, the Examiner’s interpretation of the disclosure of Bango is considered sufficient to read on the claimed limitation.
Regarding new claim 47, the Applicant asserts that Mostafa affirmatively requires the opposite of the language of claim 47, as Mostafa conditions both the initiation of collection and the commencement of analysis on affirmative acts by the user [Mostafa ¶0060], and further notes that Tu likewise describes the patient scanning a hospital barcode identifier on the device before urinating into the collection cup, instead of the claimed limitations directed towards initiating the analysis automatically, without intervention by the user, upon detection of urine at a collection port. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 47 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Shemer in view of Mostafa and Infante is further modified by Hall (US-20150342574-A1), wherein Hall discloses a urine detector located in a vicinity of a collection port of a urine analysis device, and wherein the urine analysis device is configured to initiate analysis automatically, without intervention by a user, when urine is detected by the urine detector [Hall ¶0043].
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.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
