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 April 27, 2026, claims 1, 3, and 12 have been amended. No additional claims have been cancelled. Claims 28-29 have been added. Claims 1-16, 19-20, and 23-29 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed April 27, 2026, 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)/Amin (US 20190062813 A1)/Giaime (US 20220022850 A1). Any arguments still relevant based on the new grounds of rejection are addressed below.
In response to applicant's argument that Amin fails to disclose a test assembly fully contained in the case in the context of a device positioned entirely within a toilet bowl wherein the interior of the case is impervious to fluid except through the collection port and a drain port, Examiner respectfully disagrees. Amin’s Fig. 13 shows the housing 1306 to be entirely within toilet bowl 1302. A test assembly fully contained in the case is described in Amin [0163] -- the device contained within housing 1306 collects and analyzes a waste sample, and can subsequently transmit resulting raw data to a computing platform and/or the cloud for computational processing. Fig. 13 further shows inlet 1308 and an outlet 1310, which may be interpreted as collection and drain ports, to be the only locations in which the case is pervious to liquid.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's argument that Hall’s architecture would not allow for collection on a rear face or the fully contained test assembly of Amin, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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, and 23-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall (US 20150342574 A1) in view of Amin (US 20190062813 A1) and Giaime (US 20220022850 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 (Fig. 7A; [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.”).
However, Hall fails to disclose a rear face opposite the front face and configured to face an inner wall of the toilet bowl. Amin teaches systems and methods related 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 a rear face opposite the front face and configured to face an inner wall of the toilet bowl (Fig. 13, toilet bowl 1302, hosing 1306; [0158] “the disclosed innovation can be embodied in a modular/portable device that can be affixed to the inside of a 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 apparatus of Hall to include a rear face opposite the front face and configured to face an inner wall of the toilet bowl 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]).
While the combination of Hall/Amin discloses a collection port that is an opening (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.” Amin: Fig. 13, inlet 1308 and/or an outlet 1310), the combination of Hall/Amin fails to disclose a collection port only on the rear face.
Giaime teaches a device comprising a filter part with a receptacle for collecting urine for performing a urine pH analysis. Giaime discloses and a collection port that is an opening disposed only on the rear face and connecting an exterior and an interior of the case (Fig. 4; [0037] “the filter part 1a also comprises a receptacle 3 arranged in the region of the filter 2, so that some urine can be retained, in order to allow analysis of the urinary pH.” [0039] “The filter part 11a comprises a multiplicity of holes distributed to form a filter 12, and may comprise a receptacle 13 for retaining a small amount of urine to perform a urine pH test.”).
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/Amin to include a collection port that is an opening disposed only on the rear face that connects an exterior and an interior of the case as disclosed in Giaime to retain a small amount of urine to perform a urine pH test (Giaime [0039]).
The combination of Hall/Amin/Giaime discloses and a test assembly fully contained in the case and configured to perform an analysis on urine collected through the collection port (Amin: [0158] “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).” [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, and can subsequently transmit resulting raw data to a computing platform and/or the cloud for computational processing (as described above).” Giame: [0045] “According to an embodiment, the lid part 21a has an outer face (upper face in the closed position of the lid part) forming a housing provided to receive a roll 27 of urine pH test strips (FIGS. 9, 10B, 11).” [0047] “The device 1, 10, 20 may be distributed in combination with a waterproof bag in which the patient can place the device 1 after use, urine pH test strips that can be used with the urine retained in the receptacle 3, and a card on which to write identification information and the result of the urine pH test.”).
Regarding claim 2, the combination of Hall/Amin/Giaime 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/Amin/Giaime discloses the urine analysis device according to claim 27, 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.” Giaime: Fig. 1B, filter part 1a, curvature from edge 6a to filter 2).
Regarding claim 4, the combination of Hall/Amin/Giaime 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).” Giaime: Fig. 1B, filter 2 and receptacle 3 in recess of filter part 1a curvature).
Regarding claim 5, the combination of Hall/Amin/Giaime 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.” Giaime: Fig. 4, filter 2).
Regarding claim 6, the combination of Hall/Amin/Giaime 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).”).
Regarding claim 7, the combination of Hall/Amin/Giaime 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; Giaime: [0046] “According to an embodiment, the device 1, 10, 20 is entirely made by molding or 3D printing in a plastic material. It has a length between 8 and 12 cm, a width between 5 and 7 cm, and depth between 1.5 and 5 cm. The holes forming the filter 2, 12, 22 have a width between 0.5 and 1 mm. The receptacle 3, 13, 23 may have a width and a depth between 0.8 and 1.5 cm.”).
Regarding claim 8, the combination of Hall/Amin/Giaime 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;” Giaime: Fig. 1B, filter 2 and receptacle 3 in recess of filter part 1a curvature).
Regarding claim 9, the combination of Hall/Amin/Giaime 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; Giaime: Fig. 1B, filter 2 and receptacle 3 in recess of filter part 1a curvature).
Regarding claim 10, the combination of Hall/Amin/Giaime 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.” Giaime: Fig. 1B, filter 2 and receptacle 3 in recess of filter part 1a curvature).
Regarding claim 11, the combination of Hall/Amin/Giaime 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.” Giaime: Fig. 4, filter 2, receptable 3).
Regarding claim 12, the combination of Hall/Amin/Giaime discloses the urine analysis device according to claim 27, wherein the case has a generally circular pebble shape (Hall: Fig. 7A; Giaime: Fig. 4).
Regarding claim 13, the combination of Hall/Amin/Giaime discloses the urine analysis device according to claim 1, wherein the case comprises a drain port configured to drain urine (Giaime: Fig. 4, filter 2).
Regarding claim 14, the combination of Hall/Amin/Giaime 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/Amin/Giaime discloses the urine analysis device according to claim 1, wherein a diameter of the case is between 50 mm and 150 mm (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).” Giaime: [0046] “According to an embodiment, the device 1, 10, 20 is entirely made by molding or 3D printing in a plastic material. It has a length between 8 and 12 cm, a width between 5 and 7 cm, and depth between 1.5 and 5 cm. The holes forming the filter 2, 12, 22 have a width between 0.5 and 1 mm. The receptacle 3, 13, 23 may have a width and a depth between 0.8 and 1.5 cm.”).
Regarding claim 16, the combination of Hall/Amin/Giaime 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/Amin/Giaime 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 (Giaime: [0045] “According to an embodiment, the lid part 21a has an outer face (upper face in the closed position of the lid part) forming a housing provided to receive a roll 27 of urine pH test strips (FIGS. 9, 10B, 11).” [0047] “The device 1, 10, 20 may be distributed in combination with a waterproof bag in which the patient can place the device 1 after use, urine pH test strips that can be used with the urine retained in the receptacle 3, and a card on which to write identification information and the result of the urine pH test.” Hall: [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.”).
Regarding claim 20, the combination of Hall/Amin/Giaime 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.” Giaime: [0045] “According to an embodiment, the lid part 21a has an outer face (upper face in the closed position of the lid part) forming a housing provided to receive a roll 27 of urine pH test strips (FIGS. 9, 10B, 11).” [0047] “The device 1, 10, 20 may be distributed in combination with a waterproof bag in which the patient can place the device 1 after use, urine pH test strips that can be used with the urine retained in the receptacle 3, and a card on which to write identification information and the result of the urine pH test.”).
Regarding claim 23, the combination of Hall/Amin/Giaime 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; Giaime: Fig. 4).
Regarding claim 24, the combination of Hall/Amin/Giaime 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; Giaime: Fig. 1B, filter part 1a, curvature from edge 6a to filter 2; Fig. 4, filter 2; Fig. 11).
Regarding claim 25, the combination of Hall/Amin/Giaime discloses the urine analysis device according to claim 15, wherein the diameter of the case is 100 mm (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).” Giaime: Fig. 4; [0046] “According to an embodiment, the device 1, 10, 20 is entirely made by molding or 3D printing in a plastic material. It has a length between 8 and 12 cm, a width between 5 and 7 cm, and depth between 1.5 and 5 cm. The holes forming the filter 2, 12, 22 have a width between 0.5 and 1 mm. The receptacle 3, 13, 23 may have a width and a depth between 0.8 and 1.5 cm.”).).
Regarding claim 26, the combination of Hall/Amin/Giaime 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/Amin/Giaime 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 (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;” Amin: Fig. 13, hosing 1306; [0158] “the disclosed innovation can be embodied in a modular/portable device that can be affixed to the inside of a 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).”). Giaime: Fig. 11, [0045] “According to an embodiment, the lid part 21a has an outer face (upper face in the closed position of the lid part) forming a housing provided to receive a roll 27 of urine pH test strips (FIGS. 9, 10B, 11).” [0047] “The device 1, 10, 20 may be distributed in combination with a waterproof bag in which the patient can place the device 1 after use, urine pH test strips that can be used with the urine retained in the receptacle 3, and a card on which to write identification information and the result of the urine pH test.”).
Regarding claim 28, the combination of Hall/Amin/Giaime discloses the urine analysis device according to claim 27, wherein the interior of the case is impervious to fluid except through the collection port and a drain port (Amin: Fig. 13, inlet 1308 and/or an outlet 1310; Giaime: Fig. 4, filter 2).
Regarding claim 29, the combination of Hall/Amin/Giaime discloses the urine analysis device according to claim 3, wherein the relief on the rear face is a recess extending from a peripheral edge of the rear face toward the collection port, the recess directing urine toward the collection port by gravity (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.” Giaime: Fig. 1B, filter part 1a, curvature from edge 6a to filter 2).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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