DETAILED ACTION
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 .
Response to Amendment
In response to amendments, filed November 18, 2025, claim 1 has been amended. No additional claims have been cancelled or added. Claims 1-16, 19-20, and 23-27 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed November 18, 2025, with respect to Drawing objections have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments with respect to the prior art rejections have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Hall (US 20150342574 A1)/Ye (CN 110275033 A)/Amin (US 20190062813 A1). Any arguments still relevant based on the new grounds of rejection are addressed below.
In response to applicant's argument that “a collection port that is an opening” cannot be a channel extending through the housing as described in Hall, Examiner respectfully disagrees. The features upon which applicant relies for differentiation (i.e., the collection port connecting the exterior and interior of the case) 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).
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.
Claim(s) 1-16, 19-20, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall (US 20150342574 A1) in view of Ye (CN 110275033 A) and Amin (US 20190062813 A1).
Regarding claim 1, Hall teaches a urine analysis device (urine capture device 60) comprising:
a case configured to be positioned entirely within a toilet bowl ([0094] “FIG. 7A is a perspective view of a urine capture device 60 having urine capture slit 61 disposed on the inside surface 23 of a toilet, urinal or urine hat”),
the case having a front face for receiving a stream of urine directly from a user urinating on the toilet, a rear face opposite the front face (Fig. 7A, a front face and a rear face are on opposite respective sides of mound 62; [0093] “The urine capture slit may be oriented in any direction suitable for capture of a urine sample. For example, in one aspect of the present invention, the urine capture slit is oriented in a direction substantially parallel to the flow of the urine, thereby maximizing the likelihood that a sufficient amount of urine is captured within the urine capture slit to enable spectroscopic analysis of the urine sample. In another aspect, the narrow slit is oriented in a direction substantially parallel to a flow of flush water, thereby maximizing the likelihood that a urine sample is rinsed from the urine capture slit following capture within the urine capture slit and spectroscopic analysis of the urine sample has been completed. The urine capture slit may, of course, be oriented at any intermediate angle relative to the flow of urine or the flow of flush water.”).
While Hall discloses a collection port that is an opening ([0094] “FIG. 7A is a raised mound 62a and 62b on each side of the urine capture slit 61. The raised mounds 62a and 62b are configured to divert urine flow through the urine capture slit 61.”), Hall fails to disclose a collection port only on the rear face and a test assembly fully contained in the case.
Ye teaches a human urine automatic detection system, comprising a control module, a collecting module, a detecting module, an output module and a cleaning module. Ye discloses and a collection port that is an opening disposed only on the rear face (Pg 4 [8] “Referring to FIG. 3 and the combination shown in FIG. 7, the urine component comprises a collector 110, the collector 110 is provided with a urine collecting mouth 111 [collection port on rear face], urine, piston 112 and inner pipe, the inner pipe is connected with the urine collecting mouth 111 and urine piston 112. wherein the urine collection nozzle 111 is further provided with an upper cover 113 [front face]”).
Therefore, 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 device of Hall to include a collection port that is an opening disposed only on the rear face as disclosed in Ye to control the amount of urine collected (Ye Pg 6 [1]).
However, the combination of Hall/Ye fails to disclose a test assembly fully contained in the case. Amin teaches systems and methods disclosed herein relate to smart toilets (e.g. toilets with integrated stool analysis technology, urinalysis technology, deoxyribonucleic acid (DNA) sequencing technology, and/or logic circuitry which collectively enable the convenient, accessible, and real-time automation of waste analysis and microbiome screening). Amin discloses and a test assembly fully contained in the case and configured to perform an analysis on urine collected through the collection port ([0163] “As shown, the housing 1306 can also include a transmitter/transceiver/antenna 1314. In such case, the device can collect and analyze a waste sample;” [0158] “the disclosed innovation can be embodied in a modular/portable device that can be affixed to the inside of a toilet bowl (e.g., via adhesives, screws, clamping devices, hanging devices, flotation devices, and so on), such that the device is at least partially submerged (or otherwise has physical access to) the toilet water in the toilet bowl. Once affixed to the toilet bowl, the device can perform any and/or all of the above-described waste analysis functionality (e.g., collecting and/or preparing a waste sample via a filtration component, analyzing the sample via a waste analysis component, processing the resulting raw data via a processing component, making diagnoses and/or recommendations via a diagnostic component, notifying the user of the results via a notification component, and so on).”).
Therefore, 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 combination of Hall/Ye to include a test assembly fully contained in the case and configured to perform an analysis on urine collected through the collection port as disclosed in Amin to enable easy implementation of the urine analysis technology via a modular/portable device affixable to a toilet bowl (Amin [0056, 0158]).
Regarding claim 2, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the case is ridge-free (Hall: Fig. 7A; [0089] “The urine capture slit may be disposed within and flush with the surface of a toilet bowl, urinal or urine hat. Alternatively, the urine capture slit may be integrated into a raised mound 62a and 62b that is raised above (i.e., not flush with) the surface of the toilet bowl, urinal or urine hat. As described in more detail below, the raised mound functions to divert the urine specimen and flush water toward the urine capture slit.”).
Regarding claim 3, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the rear face comprises a relief forming a pathway for urine towards the collection port (Hall: [0094] “FIG. 7A is a raised mound 62a and 62b on each side of the urine capture slit 61. The raised mounds 62a and 62b are configured to divert urine flow through the urine capture slit 61.” Ye: urine collecting mouth 111, Fig. 3).
Regarding claim 4, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the collection port is located in a recess (Hall: [0094] “FIG. 7A is a perspective view of a urine capture device 60 having urine capture slit 61 disposed on the inside surface 23 of a toilet, urinal or urine hat. Also shown in FIG. 7A is a raised mound 62a and 62b on each side of the urine capture slit 61. The raised mounds 62a and 62b are configured to divert urine flow through the urine capture slit 61 (wherein it can be temporarily retained for analysis);” Ye: urine collecting mouth 111, Fig. 3).
Regarding claim 5, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 4, wherein the recess extends towards a center of the case over a distance of between 1 and 4cm (Hall: [0092] “In some embodiments, the length, height and width of the raised mound may be approximately the same as or slightly larger than the length, height and width of the urine capture slit, as described above. For example, in some embodiments, the length of the raised mound may range from about 2.5 mm (about 0.1 inches) to about 25 mm (about 1 inches), or from about 2.5 mm (about 0.1 inches) to about 9.5 mm (about 0.375 inches). In one particular embodiment, with length of the raised mound is about 6.35 mm (about 0.25 inches) long. The height of the raised mound may, in some embodiments, range from about 2.5 mm (about 0.1 inches) to about 31.75 mm (about 1.25 inches). In one particular embodiment, the height of the raised mound is about 6.35 mm (about 0.25 inches) long, which is sufficient to allow a spectroscopic optical cable and any necessary support structures to be integrated into the sides of the urine capture slit;” Ye: urine collecting mouth 111, Fig. 3).
Regarding claim 6, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 4, wherein the recess comprises two lateral grooves extending from an edge of the case to a central portion of the recess, the collection port being in the central portion (Hall: [0094] “FIG. 7A is a raised mound 62a and 62b on each side of the urine capture slit 61. The raised mounds 62a and 62b are configured to divert urine flow through the urine capture slit 61 (wherein it can be temporarily retained for analysis);” Ye: urine collecting mouth 111, Fig. 3).
Regarding claim 7, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 6, wherein the central portion has an area of between 3 and 8 cm2 (Hall: [0092] “the length, height and width of the raised mound may be approximately the same as or slightly larger than the length, height and width of the urine capture slit … the length of the raised mound may range from about 2.5 mm (about 0.1 inches) to about 25 mm (about 1 inches) … the width of the raised mound may range from about 50 mm (about 2 inches) to about 125 mm (about 5 inches);” lower end: 2.5mm x 50mm = 125mm2 = 1.25 cm2; upper end: 25mm x 125mm = 3,125mm2 = 31.25cm2; between 3-8 cm2 is within the range of 1.25-31.25 cm2).
Regarding claim 8, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 6, wherein a depth of the two lateral grooves increases from the edge to the central portion (Hall: [0094] “FIG. 7A is a raised mound 62a and 62b on each side of the urine capture slit 61. The raised mounds 62a and 62b are configured to divert urine flow through the urine capture slit 61 (wherein it can be temporarily retained for analysis”).
Regarding claim 9, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 6, wherein the recess has a border that has an inflection between at least one lateral groove of the two lateral grooves and the central portion (Hall: Fig. 7B, urine capture slit 61).
Regarding claim 10, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 9, wherein a distance between the border of the recess and the edge of the case increases from a beginning of the at least one lateral groove to the central portion (Hall: [0094] “FIG. 7A is a raised mound 62a and 62b on each side of the urine capture slit 61.” Ye: urine collecting mouth 111, Fig. 3).
Regarding claim 11, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the collection port is located in the vicinity of a lower end of the case in a normal use position of the urine analysis device (Hall: Figs. 7A-B, urine capture slit 61; [0093] “The urine capture slit may be oriented in any direction suitable for capture of a urine sample. For example, in one aspect of the present invention, the urine capture slit is oriented in a direction substantially parallel to the flow of the urine, thereby maximizing the likelihood that a sufficient amount of urine is captured within the urine capture slit to enable spectroscopic analysis of the urine sample.” Ye: urine collecting mouth 111 below cover 113, Fig. 3).
Regarding claim 12, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the case has a generally circular pebble shape (Hall: Fig. 7A; Ye: Fig. 3, upper cover 113 and urine collecting mouth 111).
Regarding claim 13, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the case comprises a drain port configured to drain urine (Amin: [0132] “Once the medical/clinical tests have been performed by the waste analysis component 408, any remnants of the sample can, in various embodiments, be discarded by being transported to the toilet drain 708 (e.g., flowing from the testing chamber 604, through the outlet 606, and back into the toilet bowl)”).
Regarding claim 14, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the case is made of hydrophilic material that is one of a ceramic, a polyamide, a silicone, and a hydrophilic polymer and/or the case is treated with a hydrophilic surface treatment (Hall: [0091] “the urine capture slit of the present invention has internal sides having a hydrophilic surface that will draw a portion of the urine sample within the urine capture slit by hydrophilic forces. In some embodiments, the urine capture slit will also be comprised of materials that are non-corrosive in an environment exposed to urine and/or feces (which may potentially enter into the urine capture slit). For example, suitable hydrophilic surfaces may comprise such materials as metal, ceramic, or plastic”).
Regarding claim 15, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein a diameter of the case is between 50 mm and 150 mm (Ye: Fig. 3, upper cover 113 and urine collecting mouth 111; Hall: Fig. 7A; [0092] “the width of the raised mound may range from about 50 mm (about 2 inches) to about 125 mm (about 5 inches).”).
Regarding claim 16, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, further comprising a urine presence sensor in a vicinity of the collection port, the urine presence sensor being configured to detect the presence of urine (Hall: [0077] “The present invention contemplates that any suitable type of spectrometer technology or equipment may be utilized that is capable of analyzing components of urine, including organic compounds, as well as inorganic compounds. For example, spectroscopy may be used to detect the presence and quantity of such analytes as blood urea nitrogen (BUN), glucose, creatinine, protein, urea, ketones, oxalate, and albumin. Particular analytes of interest may include metabolites, such as estrone-3-glucuronide (E.sub.1G) a major estrogen metabolite.” [0092] “spectroscopic analysis of the urine;” [0095] “the optical cables 64a and 64b can pass light from the spectrometer for spectroscopic analysis.” [0097] “FIG. 7C further shows an embodiment having a temperature sensor 69 disposed adjacent to or within the urine capture slit 61 for the purpose of determining the temperature of urine passing through the urine capture slit”).
Regarding claim 19, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the test assembly comprises one or more of: a plurality of test strips, a pH measuring device, a spectroscopic measuring device (Amin: [0141] “the waste analysis component 408 can use automated chemical/reagent test strips (e.g., dip sticks) to test the sample for certain chemical properties (e.g., pH, occult blood, proteins, glucose, ketones, and so on);” Hall: [0092] “spectroscopic analysis of the urine;” [0095] “the optical cables 64a and 64b can pass light from the spectrometer for spectroscopic analysis.”).
Regarding claim 20, the combination of Hall/Ye/Amin discloses a method of collecting urine using the urine analysis device according to claims 1, comprising: detecting the presence of urine in the vicinity of the collection port, collecting the urine flowing on the rear face, analyzing the collected urine to establish one or several analysis results (Hall: Fig. 7A, a front face and a rear face are on opposite respective sides of mound 62; [0094] “FIG. 7A is a raised mound 62a and 62b on each side of the urine capture slit 61. The raised mounds 62a and 62b are configured to divert urine flow through the urine capture slit 61 (wherein it can be temporarily retained for analysis);” [0095] “FIG. 7B shows an expanded side view of the urine capture slit 61 … Internal side 63a and 63b will have an aperture 68a and 68b, respectively, through which the optical cables 64a and 64b can pass light from the spectrometer for spectroscopic analysis.” [0097] “FIG. 7C further shows an embodiment having a temperature sensor 69 disposed adjacent to or within the urine capture slit 61 for the purpose of determining the temperature of urine passing through the urine capture slit.” Ye: Pg 4 [8] “Referring to FIG. 3 and the combination shown in FIG. 7, the urine component comprises a collector 110, the collector 110 is provided with a urine collecting mouth 111 [collection port on rear face], urine, piston 112 and inner pipe, the inner pipe is connected with the urine collecting mouth 111 and urine piston 112. wherein the urine collection nozzle 111 is further provided with an upper cover 113”; Pg 4 [2] “the detection module 300 comprises a detection probe seat for of the collected urine to be detected to detect and obtain corresponding detecting report according to the detecting result;” Amin: [0125] “waste collector 501 can include an inlet 602, a testing chamber 604, and an outlet 606”).
Regarding claim 23, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the front face and the rear face are connected by curved edges (Hall: raised mounds 62a and 62b in Fig. 7A).
Regarding claim 24, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 4, wherein the recess is formed on the rear face (Hall: Fig. 7A-B, urine capture slit 61; Ye: urine collecting mouth 111, Fig. 3).
Regarding claim 25, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 15, wherein the diameter of the case is 100 mm (Ye: Fig. 3, upper cover 113 and urine collecting mouth 111; Hall: Fig. 7A; [0092] “the width of the raised mound may range from about 50 mm (about 2 inches) to about 125 mm (about 5 inches).”).
Regarding claim 26, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 16, wherein the urine presence sensor is a temperature sensor (Hall: [0097] “FIG. 7C further shows an embodiment having a temperature sensor 69 disposed adjacent to or within the urine capture slit 61 for the purpose of determining the temperature of urine passing through the urine capture slit”).
Regarding claim 27, the combination of Hall/Ye/Amin discloses the urine analysis device according to claim 1, wherein the test assembly is configured to perform detection and evaluation within the case of one or more analytes of urine collected through the collection port (Ye: Fig. 3, urine collecting mouth 111 and collector 110; Amin: [0126] “any waste in the toilet bowl (e.g., stool, urine, and so on) can flow into the inlet 602, into the testing chamber 604, and out the outlet 606 in the embodiments shown in FIG. 6.” [0163] “As shown, the housing 1306 can also include a transmitter/transceiver/antenna 1314. In such case, the device can collect and analyze a waste sample;” [0158] “the disclosed innovation can be embodied in a modular/portable device that can be affixed to the inside of a toilet bowl (e.g., via adhesives, screws, clamping devices, hanging devices, flotation devices, and so on), such that the device is at least partially submerged (or otherwise has physical access to) the toilet water in the toilet bowl. Once affixed to the toilet bowl, the device can perform any and/or all of the above-described waste analysis functionality (e.g., collecting and/or preparing a waste sample via a filtration component, analyzing the sample via a waste analysis component, processing the resulting raw data via a processing component, making diagnoses and/or recommendations via a diagnostic component, notifying the user of the results via a notification component, and so on).”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791