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 .
Claim Objections
The claims contain minor informalities.
In claim 142, the language “… and configured to [[calibration]] calibrate the system prior to optical testing …” should be changed for clarity.
In claim 145, the language “… (2) [[a]] an optical detector configured to measure …” should be changed for clarity.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 119 is rejected under 35 U.S.C. 101 because the disclosed invention is inoperative and therefore lacks utility.
Amended claim 119 calls for “… further comprising at least one of an impedance sensor or an acoustic sensor configured to sense if the one or more optical properties of the fluid testing chamber is within the predetermined range.”
The specification describes acoustic sensors (¶ [0204], Flow can be detected optically or acoustically); and
impedance sensors that operate in concert with optical sensors (¶ [0305] In some embodiments, bladder management system 7100 may include one or more impedance sensors (not shown)).
However, this claim implies that the optical properties are tested with an impedance sensor or acoustic sensor. An impedance sensor or acoustic sensor measures different physical properties and therefore cannot measure the testing chamber’s optical properties.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 119 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Amended claim 119 calls for “… further comprising at least one of an impedance sensor or an acoustic sensor configured to sense if the one or more optical properties of the fluid testing chamber is within the predetermined range.”
The specification describes acoustic sensors (¶ [0204], Flow can be detected optically or acoustically, through various means both outside or inside the body); and
impedance sensors that operate in concert with optical sensors (¶ [0305] In some embodiments, bladder management system 7100 may include one or more impedance sensors (not shown) operably and/or electrically coupleable to the optical sensors/PCBs, in an open circuit configuration by default, and configured to interact with fluid (e.g., urine), to thereby close or complete the circuit/electrical coupling with the optical sensors/PCBs, to thereby trigger the optical sensors to test the fluid/urine. Said another way, the one or more impedance sensors can function as spectroscopy triggers to cause the optical sensors to emitter and detect light to test the fluid).
The impedance sensors prompt, trigger or activate the optical sensors, while the optical sensors ultimately measure the optical properties of the fluid testing chamber and its contents. However, the specification does not explain how an impedance sensor or an acoustic sensor can sense the fluid testing chamber’s optical properties.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 111, 113-116, 120, 123-125 and 129 are rejected under 35 U.S.C. 103 as being unpatentable over Recht; Michael I. et al. (US 20150359522 A1) in view of Shemer, Yossef et al. (US 20050261605 A1).
Regarding claim 111, Recht discloses a bladder management system, comprising: a fluid testing chamber configured to reside within a urine collection receptacle (¶ [0001], [0002], [0033], FIG. 1, a non-invasive POC testing method involves receiving 102 urine, e.g., from a person using a toilet, urinal, bladder catheter, or other urine collection device);
the fluid testing chamber having a fluid inlet and a fluid outlet (¶ [0048] FIG. 6 illustrates an apparatus 600 … the chamber apparatus 618 incorporates both a chamber 620 and a diverter 606; ¶ [0049], the urine contained in the chamber 620 is expelled via an exit port 622);
a first optical sensor (¶ [0080], a detection unit comprising an optical flow cytometer; ¶ [0096], The detection unit 1510 shown in FIG. 15 can be used for a compact flow cytometer);
including (1) a first emitter configured to convey first light a first pathlength across the fluid testing chamber (¶ [0096], Combined light source 1511, which provides combined first and second excitation light 1511a, … A third light source 1514 generates third excitation light 1514a; ¶ [0103], input light 1601); and
(2) a first optical detector configured to measure an intensity of the first light as the first light exits the fluid testing chamber, the first light having a first wavelength (¶ [0100] Light emanating from the various micro beads and cells 1505, 1506 is detected by photosensitive detector 1532; ¶ [0104] A first detector 1631 is positioned to sense light 1607a … A second detector 1632 is positioned to sense light 1607b).
Recht teaches the invention substantially as claimed by Applicant with the exception of a second optical sensor configured to measure a different pathlength or wavelength. Shemer discloses a system and method for urinalysis (¶ [0001], [0007], [0053], [0056] FIGS. 1-3 … portable toilet unit 10);
comprising: a fluid testing chamber, the fluid testing chamber having a fluid inlet and a fluid outlet (¶ [0074], Referring again to FIG. 4 … sample cavity 718);
a first optical sensor including (1) a first emitter configured to convey first light a first pathlength across the fluid testing chamber, and (2) a first optical detector configured to measure an intensity of the first light as the first light exits the fluid testing chamber, the first light having a first wavelength (¶ [0074] Referring again to FIG. 4, the light transmitted from source rosette 723 enters through an entry port (not shown) and passes through sample cavity 718 to be emitted through an exit port 731 to be detected, preferably by means of a silicon photo-detector 727 disposed adjacent to exit port 731); and
a second optical sensor including (1) a second emitter configured to convey second light a second pathlength across the fluid testing chamber (¶ [0071] Adjacent to cavity 718 is a light emitting diode (LED) array 720 which preferably incorporates a number of discrete LED emitters 721, each emitting at a different wavelength within the range to be used for the measurement. According to one embodiment, the wavelengths of the LEDs 721 range from 260 nm to 950 nm covering the UV to NIR regions of the spectrum; ¶ [0076], According to this embodiment, illumination and detection is performed sequentially from both sides of sampling cavity 718, with the 5 LED's 721 in each rosette 723. Detector 724 of each rosette collects back-scattered light from its own LED's 721 and transmitted light from the LED's 721 of the opposite rosette 723); and
(2) a second optical detector configured to measure an intensity of the second light as the second light exits the fluid testing chamber, the second light having a second wavelength (¶ [0076], Detector 724 of each rosette collects back-scattered light from its own LED's 721 and transmitted light from the LED's 721 of the opposite rosette 723; ¶ [0039] Light emitting diodes (LEDs) are one type of light source which can be used. A single LED may be used if only one wavelength is required, or a cluster of LEDs, each covering a different part of the electromagnetic spectrum as discussed above, may be used ¶ [0040] Detector--when used herein may refer to a single detector for detecting a single wavelength or a cluster of detectors each detecting different portions of the electromagnetic spectrum; ¶ [0089], According to yet another preferred embodiment of the present invention, transmission detector 958 is replaced by another rosette similar to rosette 723 of FIGS. 4 and 5 including both multiple light sources and a detector, as described above);
at least one of (1) the first pathlength being different from the second pathlength, or (2) the first wavelength being different from the second wavelength (¶ [0071], According to one embodiment, the wavelengths of the LEDs 721 range from 260 nm to 950 nm covering the UV to NIR regions of the spectrum).
Shemer detects multiple constituents in urine by exposing the urine to multiple wavelengths and then performing statistical calculations (¶ [0086], These 20 measurement signals, each at their known wavelength range, are then related, preferably by means of the statistical analysis chemometric-type methods, to a large database of stored spectral curves related to various urine compositions, and from the analysis a unique set of concentrations of the constituents of the urine sample is determined). One would be motivated to modify Recht with Shemer’s dual wavelength optical sensors to measure the concentrations of multiple constituents in urine in order to more accurately diagnose a patient’s condition. Therefore, it would have been obvious to modify Recht with Shemer’s dual wavelength optical sensors in order to more accurately diagnose a patient by more thoroughly analyzing the patient’s urine.
Regarding claims 113-116, Recht does not explicitly disclose an emitter that sterilizes the fluid testing chamber. Shemer discloses an emitter configured to convey light across a fluid testing chamber to sterilize an internal surface of the fluid testing chamber (¶ [0071] Adjacent to cavity 718 is a light emitting diode (LED) array 720 which preferably incorporates a number of discrete LED emitters 721 … the wavelengths of the LEDs 721 range from 260 nm to 950 nm covering the UV to NIR regions of the spectrum; ¶ [0080] j=1-10, representing 10 discrete light sources in the UV, NIR and visible spectrum);
further comprising: a controller operably couplable to the first emitter and the second emitter, the controller configured to send a signal to the first emitter to cause the first emitter to convey light to sterilize a first portion of an internal surface of the fluid testing chamber and to send a signal to the second emitter to cause the second emitter to convey light to sterilize a second portion of the internal surface of the fluid testing chamber (¶ [0074] Referring again to FIG. 4 … Main processing unit 24 passes control information 735 to LED sources 721 via communications link 3 of FIG. 3 … Main processing unit (MPU) 24 also controls the switching order and timing of the LED sources 721);
wherein the first light is ultraviolet (UV) light, visible, or infrared (¶ [0071], the wavelengths of the LEDs 721 range from 260 nm to 950 nm covering the UV to NIR regions of the spectrum);
further comprising a controller operably couplable to the first optical sensor, and configured to send a signal to cause the first emitter to convey the first light to sterilize an internal surface of the fluid testing chamber (¶ [0074] Referring again to FIG. 4 … Main processing unit 24 passes control information 735 to LED sources 721 via communications link 3 of FIG. 3 … Main processing unit (MPU) 24 also controls the switching order and timing of the LED sources 721);
in response to the presence of at least one urinary characteristic (¶ [0014], [0041], [0065]);
further comprising a controller operably couplable to the first optical sensor and the second optical sensor and configured to calibrate the system (¶ [0086] Once these coefficients are known they are stored in main processing unit 24, along with the concentrations of the sample with which they are associated, as a reference database in the computing system memory for use in measurements of unknown samples … This method of calibration and analysis thus allows the use of inexpensive LED's 721 with their non-uniform wide spectral range as light sources).
Shemer constructs an optical sensor from inexpensive LED's (¶ [0086]). Regarding the rationale and motivation to modify Recht with Shemer’s calibration technique and UV LEDs, see the discussion of claim 111 above.
Regarding claims 120 and 124, Recht further discloses a controller operably couplable to the first optical detector and configured to send a signal representative of at least one of a biophysical, chemical, or biochemical characteristic associated with fluid in the fluid testing chamber based on data generated by the first optical detector (¶ [0072], A metering sensor coupled to a processor (not shown) of the apparatus 1100 can be used to coordinate the transfer of urine through the various chambers and components of the apparatus 1100; ¶ [0076], The metering sensor can be coupled to a processor of the testing apparatus; ¶ [0104], Additional electronics, e.g., signal processor and/or analyzer (not shown in FIG. 16), can analyze the electrical signals generated by first 1631 and second detectors to 1632 to determine the color or colors of the object 1605);
further comprising a controller operably couplable to the first optical detector and configured to receive a signal from the first optical detector representative of a plurality of wavelength absorption peaks, the controller configured to send a signal indicating at least one of a presence or an absence of a medical condition based on at least one of plurality of wavelength absorption peaks (¶ [0110], Specific dissolved analytes could be detected by their characteristic absorption or autofluorescence; ¶ [0112], Coloring of urine could be measured by providing multispectral (e.g. “white”) light within the detector and measurement of the absorption spectrum; ¶ [0117], refractive index measurements and free protein absorption measurements (around 280 nm) in the same optical cavity).
Regarding claim 123, Recht further discloses a controller operably couplable to the first optical detector and configured receive a first signal at a first time from the first optical detector and a second signal at a second time after the first time from the first optical detector, and compare the first signal to the second signal to infer presence or absence of a medical condition (¶ [0060], In some embodiments, information generated by the detection unit 830 is stored in memory and may be periodically communicated to a remote system or device via a communication device 840; ¶ [0072], A metering sensor coupled to a processor (not shown) of the apparatus 1100 can be used to coordinate the transfer of urine through the various chambers and components of the apparatus 1100; ¶ [0112], A testing apparatus deployed at a person's toilet can assess the color and volume of urine produced during a 24 hour period (and multiple days) to determine if the color and volume of urine falls within or outside of normal ranges).
Recht discloses a system that periodically records data from a patient and stores it in a remote device. This suggests that Recht’s system monitors a patient and detects trends or patterns in their test results.
Regarding claim 125, Recht further discloses a sensor configured to measure a characteristic of the fluid, the controller configured to send the signal indicating the presence of the medical condition based on the wavelength absorption peak and the characteristic of the fluid, the characteristic including at least one of a flow rate associated with the fluid, a volume associate with the fluid, or a duration of voiding associated with the fluid (¶ [0112], A testing apparatus deployed at a person's toilet can assess the color and volume of urine produced during a 24 hour period (and multiple days) to determine if the color and volume of urine falls within or outside of normal ranges).
Regarding claim 129, Recht discloses a system wherein the first optical sensor is tuned to a first wavelength of light, and the second optical sensor is tuned to a second wavelength of light different from the first wavelength of light (¶ [0097] The combined light source 1511 emits combined excitation light 1511a that includes first excitation light and second excitation light … First excitation light is centered at or peaks at a first wavelength λ1, and second light is centered at or peaks at a second wavelength λ2. A third light source 1514 may emit third excitation light 1514a that is centered at or peaks at a third wavelength λ3 … The first, second, and third light sources are preferably solid-state devices such as laser diodes or LEDs); and
(2) a controller is operably couplable to the first optical sensor and the second optical sensor, and configured to evaluate signals generated by the first optical sensor and the second optical sensor to infer at least one of a presence or an absence of at least one of a biophysical, chemical, or biochemical characteristic associated with the fluid in the fluid testing chamber (¶ [0072], A metering sensor coupled to a processor (not shown) of the apparatus 1100 can be used to coordinate the transfer of urine through the various chambers and components of the apparatus 1100; ¶ [0104], Additional electronics, e.g., signal processor and/or analyzer (not shown in FIG. 16), can analyze the electrical signals generated by first 1631 and second detectors to 1632).
Claims 117 and 121 are rejected under 35 U.S.C. 103 as being unpatentable over Recht and Shemer in view of Peesapati; Sameera Anirudh et al. (US 20210074390 A1).
Regarding claims 117 and 121, Recht and Shemer do not explicitly disclose that the calibration includes adjusting at least one of an output of the emitter or a sensitivity of the optical detector. Peesapati discloses a system
wherein a calibration includes determining if one or more optical properties of the fluid testing chamber is within a predetermined range and adjusting at least one parameter of at least one of the first optical sensor or the second optical sensor in response to determining that the one or more optical properties are not within the predetermined range (¶ [0074] After installing the urinalysis device 102, the urinalysis device 102 is automatically calibrated on a regular basis to generate baseline data);
wherein the calibration includes determining if one or more optical properties of the fluid testing chamber is within a predetermined range, the controller further configured to send an alert indicating that the system needs to be cleaned in response to determining that the one or more optical properties are not within the predetermined range (¶ [0085] FIG. 5 shows another urinalysis device 160 … Like the urinalysis device 102, the urinalysis device 160 is calibrated before use. The baseline, however, is when the device 160 is empty. The biomarker sensor 217 in the cup shaped body 162 calibrates by washing or rinsing the device 160 (rather than through flushing); ¶ [0093] In some implementations, the calibration step and be prompted by a controller of the urinalysis device).
Peesapati automates a calibration routine for a urine testing system. One would be motivated to modify Recht and Shemer with Peesapati’s automated calibration routine to minimize errors from sensor drift or when debris accumulates on the testing chamber. Therefore, it would have been obvious to modify Recht and Shemer with Peesapati’s automated calibration routine in order to more reliably gather data from optical sensors.
Claims 118 and 122 and rejected under 35 U.S.C. 103 as being unpatentable over Recht, Shemer and Peesapati in view of Eliason; Garth et al. (US 20180238845 A1).
Regarding claims 118 and 122, Recht, Shemer and Peesapati do not adjust an output of at least the first emitter or the second emitter. Eliason discloses a calibration including determining if one or more optical properties of a fluid testing chamber is within a predetermined range and adjusting an output of at least a first or second emitter (¶ [0055] An example method 500 … in FIG. 5; ¶ [0056], [0057], At 504, the method 500 includes adjusting the output level of the activated light source; ¶ [0058] Additionally, the output level of the light source may be adjusted based on absorption of the light by the liquid sample).
Eliason adjusts the emitters in order to prevent detectors from saturating (¶ [0058]). Regarding the rationale and motivation to modify Recht, Shemer and Peesapati with Eliason’s calibration technique and emitter adjustment, see the discussion of claim 132.
Claim 128 is rejected under 35 U.S.C. 103 as being unpatentable over Recht and Shemer in view of Chance, Britton (US 20040054290 A1).
Regarding claim 128, Recht and Shemer lack fiber optic cables. Chance discloses a spectrophotometric system for examining biological tissue (¶ [0006], [0007], [0058] Referring to FIG. 1 … system 10; ¶ [0096] Alternatively, spectrophotometer 18 is a phased array system described in the PCT/US95/15694 … FIG. 5B depicts an optical coupler for a measurement using a reflection geometry that was already described for coupling system of FIG. 4A);
comprising a first emitter, wherein the first emitter is coupled to one or more fiber optic cables to transmit sterilizing radiation along a length of the fluid testing chamber and radially about one or more fibers of the one or more fiber optic cables (¶ [0094] As described above, spectrophotometer 18 measures the optical properties of tissue 11 and medium 12. Light guides 20 and 20A are connected to light source 21, and light guide 22 is connected to light detector 23).
Chance illuminates multiple sides of a tissue sample by distributing light sources around a testing chamber. This rejection modifies Recht and Shemer with Chance’s fiber optic cables by producing UV light according to Shemer, and transmitting the light to a test chamber with Chance’s fiber optic cables. One would be motivated to modify Recht and Shemer with Chance’s fiber optic cables to increase the number of readings from a single sample for averaging, in order to reduce random noise in the sensor data. Therefore, it would have been obvious to modify Recht and Shemer with Chance’s fiber optic cables in order to reduce random noise that would otherwise distort a single sensor’s data.
Claims 132-135 and 138 are rejected under 35 U.S.C. 103 as being unpatentable over Recht; Michael I. et al. (US 20150359522 A1) in view of Eliason; Garth et al. (US 20180238845 A1).
Regarding claim 132, Recht discloses a bladder management system, comprising: a fluid testing chamber configured to reside within a urine collection receptacle (¶ [0001], [0002], [0033], FIG. 1, a non-invasive POC testing method involves receiving 102 urine, e.g., from a person using a toilet, urinal, bladder catheter, or other urine collection device);
the fluid testing chamber being fluidically coupled to a fluid inlet and a fluid outlet (¶ [0048] FIG. 6 illustrates an apparatus 600 … the chamber apparatus 618 incorporates both a chamber 620 and a diverter 606; ¶ [0049], the urine contained in the chamber 620 is expelled via an exit port 622);
an optical sensor including (1) an emitter configured to convey light across the fluid testing chamber (¶ [0096], Combined light source 1511, which provides combined first and second excitation light 1511a, … A third light source 1514 generates third excitation light 1514a; ¶ [0103], input light 1601); and
(2) an optical detector configured to measure an intensity of the light as it exits the fluid testing chamber (¶ [0100] Light emanating from the various micro beads and cells 1505, 1506 is detected by photosensitive detector 1532; ¶ [0104] A first detector 1631 is positioned to sense light 1607a … A second detector 1632 is positioned to sense light 1607b); and
a controller operably couplable to the emitter and the optical detector (¶ [0074] Referring again to FIG. 4 … Main processing unit 24 passes control information 735 to LED sources 721 via communications link 3 of FIG. 3 … Main processing unit (MPU) 24 also controls the switching order and timing of the LED sources 721).
Recht does not explicitly configure the controller to calibrate the system and adjust the emitter’s output. Eliason discloses a liquid chromatography system (¶ [0002], [0026], [0027] Referring to FIG. 1 … HPLC system 100);
comprising: a fluid testing chamber (¶ [0027], column 150; ¶ [0035] Referring now to FIG. 2, a schematic shows a flow cell 200 … The flow cell 200 may include a chamber 210; ¶ [0040] FIG. 3 illustrates a first embodiment of an integrated illumination-detection flow cell 300);
an optical sensor (¶ [0027], detection system 160);
including (1) an emitter configured to convey light across the fluid testing chamber (¶ [0037], The light entering the chamber originates from a light source (not shown) … a plurality of LEDs, each LED of the plurality of LEDs emitting a light of a different wavelength (for example, 254 nm, 280 nm, 395 nm, 525 nm, etc.); ¶ [0041], Each light source 312 may be a light-emitting diode (LED), wherein each LED in the plurality of diode pairs 311 emits light of a different wavelength (for example, 254 nm, 280 nm, 395 nm, 525 nm, etc.)); and
(2) an optical detector configured to measure an intensity of the light as it exits the fluid testing chamber (¶ [0048] The detection chamber 302 includes one or more photodetectors coupled thereto. As shown, detection chamber 302 is coupled to a calibrated ultraviolet (UV) detector 305 and a calibrated visible light (VIS) detector 304); and
a controller operably couplable to the emitter and the optical detector (¶ [0028] The control system 110 is communicatively coupled to other components of the HPLC system; ¶ [0041], Each LED may be selected and controlled independently to emit light of desired wavelength, for example, by a controller 350); and
configured to calibrate the system prior to optical testing of fluid within the fluid testing chamber, the calibration including determining one or more optical properties of the fluid testing chamber and adjusting an output of the emitter in response to determining the one or more optical properties (¶ [0055] An example method 500 … in FIG. 5; ¶ [0056] The method 500 begins at 502 by activating a light source emitting light of a desired wavelength; ¶ [0057], At 504, the method 500 includes adjusting the output level of the activated light source … the controller may modulate (e.g., increase or decrease) the light emitted by the light source to maintain a constant output of light incident on a liquid sample and/or a flow channel, such as on the first optically transparent wall 319 of the flow channel 306 illustrated in FIGS. 3 and 4; ¶ [0058] Additionally, the output level of the light source may be adjusted based on absorption of the light by the liquid sample inside the flow channel and based on a minimum and a maximum threshold of the detector(s), as indicated at 508).
Eliason adjusts the emitters’ output in order to keep the detectors in their linear range and prevent them from saturating (¶ [0058], In another example, the minimum threshold of each detector may be above the lower limit of detection and the maximum threshold of each detector may be below the saturation point such that the output level is maintained within a linear range of the detectors … The output level of the light source may be adjusted to avoid saturating the UV and/or the VIS detectors).
Eliason does not explicitly limit the calibration step to times prior to optically testing fluid. However, Eliason’s technique continually adjusts the emitters’ output, and can therefore operate at all times, including before the testing fluid enters the testing chamber.
A skilled artisan would have been able to modify Recht with Eliason’s calibration feature by configuring Recht’s controller to monitor the transmitted light intensity and then adjust the emitters’ output accordingly. One would be motivated to modify Recht with Eliason’s calibration feature to more accurately detect transmitted light, without saturating the detectors. Therefore, it would have been obvious to modify Recht with Eliason’s calibration feature in order to more accurately detect light in the detector’s linear region.
Regarding claim 134, Recht discloses that the optical sensor is a first optical sensor, the system further comprising at least one of a second optical sensor, an impedance sensor, or an acoustic sensor, configured to sense if the one or more optical properties of the fluid testing chamber is within the predetermined range (¶ [0104] A first detector 1631 is positioned to sense light 1607a … A second detector 1632 is positioned to sense light 1607b).
Regarding claim 135, Recht further discloses that the controller is configured to send a signal representative of at least one of presence or absence of at least one of a biophysical, chemical, or biochemical characteristic associated with fluid in the fluid testing chamber based on data generated by the optical detector (¶ [0072], A metering sensor coupled to a processor (not shown) of the apparatus 1100 can be used to coordinate the transfer of urine through the various chambers and components of the apparatus 1100; ¶ [0076], The metering sensor can be coupled to a processor of the testing apparatus; ¶ [0104], Additional electronics, e.g., signal processor and/or analyzer (not shown in FIG. 16), can analyze the electrical signals generated by first 1631 and second detectors to 1632 to determine the color or colors of the object 1605).
Regarding claim 138, Recht further discloses a controller configured receive a first signal at a first time from the optical detector and a second signal at a second time after the first time from the optical detector, and compare the first signal to the second signal to infer at least one of a presence or an absence of a medical condition (¶ [0060], In some embodiments, information generated by the detection unit 830 is stored in memory and may be periodically communicated to a remote system or device via a communication device 840; ¶ [0072], A metering sensor coupled to a processor (not shown) of the apparatus 1100 can be used to coordinate the transfer of urine through the various chambers and components of the apparatus 1100; ¶ [0112], A testing apparatus deployed at a person's toilet can assess the color and volume of urine produced during a 24 hour period (and multiple days) to determine if the color and volume of urine falls within or outside of normal ranges).
Recht discloses a system that periodically records data from a patient and stores it in a remote device. This suggests that Recht’s system monitors a patient and detects trends or patterns in their test results.
Claim 136 is rejected under 35 U.S.C. 103 as being unpatentable over Recht and Eliason in view of Peesapati; Sameera Anirudh et al. (US 20210074390 A1).
Regarding claim 136, Recht and Eliason do not send an alert indicating that the system needs to be cleaned. Peesapati discloses a calibration that includes determining if one or more optical properties of a fluid testing chamber is within a predetermined range, a controller further configured to send an alert indicating that the system needs to be cleaned in response to determining that the one or more optical properties are not within the predetermined range (¶ [0085] FIG. 5 shows another urinalysis device 160 … Like the urinalysis device 102, the urinalysis device 160 is calibrated before use. The baseline, however, is when the device 160 is empty. The biomarker sensor 217 in the cup shaped body 162 calibrates by washing or rinsing the device 160 (rather than through flushing); ¶ [0093] In some implementations, the calibration step and be prompted by a controller of the urinalysis device).
Peesapati automates a calibration routine for a urine testing system. Regarding the rationale and motivation to modify Recht and Eliason with Peesapati’s automated calibration routine and cleaning prompt, see the discussion of claim 115 above.
Claims 139 and 140 are rejected under 35 U.S.C. 103 as being unpatentable over Recht and Eliason in view of Shemer, Yossef et al. (US 20050261605 A1).
Regarding claims 139 and 140, Recht and Eliason do not explicitly disclose an emitter that sterilizes the fluid testing chamber or an impedance sensor. Shemer discloses an emitter configured to convey light across a fluid testing chamber to sterilize an internal surface of the fluid testing chamber (¶ [0071] Adjacent to cavity 718 is a light emitting diode (LED) array 720 which preferably incorporates a number of discrete LED emitters 721 … the wavelengths of the LEDs 721 range from 260 nm to 950 nm covering the UV to NIR regions of the spectrum; ¶ [0080] j=1-10, representing 10 discrete light sources in the UV, NIR and visible spectrum); and
an impedance sensor configured to indicate when urine has entered the system, the emitter configured to emit the light in response to the indication by the impedance sensor (¶ [0014], light transmission and/or absorbance and/or reflectance and by measurement of electrical conductivity; ¶ [0065] 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).
Shemer analyzes urine along a broader range of wavelengths in order to identify more analytes, and also avoids errors by confirming the presence of urine before scanning the testing chamber. Regarding the rationale and motivation to modify Recht and Eliason with Shemer’s additional wavelengths and impedance sensor, see the discussion of claim 111 above.
Claims 145-148 are rejected under 35 U.S.C. 103 as being unpatentable over Recht; Michael I. et al. (US 20150359522 A1) in view of Elia; Liron et al. (US 20170035342 A1).
Regarding claim 145, Recht discloses a bladder management system, comprising: a fluid testing chamber configured to reside within a urine collection receptacle (¶ [0001], [0002], [0033], FIG. 1, a non-invasive POC testing method involves receiving 102 urine, e.g., from a person using a toilet, urinal, bladder catheter, or other urine collection device);
the fluid testing chamber having a fluid inlet and a fluid outlet (¶ [0048] FIG. 6 illustrates an apparatus 600 … the chamber apparatus 618 incorporates both a chamber 620 and a diverter 606; ¶ [0049], the urine contained in the chamber 620 is expelled via an exit port 622);
an optical sensor (¶ [0080], a detection unit comprising an optical flow cytometer; ¶ [0096], The detection unit 1510 shown in FIG. 15 can be used for a compact flow cytometer);
including (1) an emitter configured to convey light across the fluid testing chamber (¶ [0096], Combined light source 1511, which provides combined first and second excitation light 1511a, … A third light source 1514 generates third excitation light 1514a; ¶ [0103], input light 1601); and
(2) a optical detector configured to measure an intensity of the light as it exits the fluid testing chamber (¶ [0100] Light emanating from the various micro beads and cells 1505, 1506 is detected by photosensitive detector 1532; ¶ [0104] A first detector 1631 is positioned to sense light 1607a … A second detector 1632 is positioned to sense light 1607b);
a controller operably coupleable to the optical sensor (¶ [0074] Referring again to FIG. 4 … Main processing unit 24 passes control information 735 to LED sources 721 via communications link 3 of FIG. 3 … Main processing unit (MPU) 24 also controls the switching order and timing of the LED sources 721).
Recht’s controller does not explicitly identify a trend for an individual based on first and second characteristics. Elia discloses systems and methods for point of care urine analysis (¶ [0002], [0083], FIG. 1, which is a block diagram of components of a system 100);
comprising: a fluid testing chamber (¶ [0111], FIG. 4, which is a schematic of an exemplary urine analyzer 401; ¶ [0112], a transparent (or translucent) inspection capsule 411; ¶ [0125], FIG. 6A, which is a schematic of an exemplary drip chamber (e.g., 106 described with reference to FIG. 1), and/or inspection capsule (e.g., 411 described with reference to FIG. 4), …transparent walls 606; ¶ [0159], FIG. 9, which is a schematic of an implementation of constituent measuring elements 116 based on a rotating apparatus 900; ¶ [0180] With reference to analyzer 1200A … urine sample 1204);
an optical sensor including (1) an emitter configured to convey light across the fluid testing chamber (¶ [0179], Analyzers 1200A-B include a tunable source 1201A-B capable of emitting a range of wavelengths); and
(2) a optical detector configured to measure an intensity of the light as it exits the fluid testing chamber (¶ [0180], detector 1202);
a controller operably coupleable to the optical sensor and configured to: (1)(2) receive and evaluate first and second signals at first and second times from the optical sensor and infer at least one of a presence or an absence of at least one of a biophysical, chemical, or biochemical first characteristic associated with fluid in the fluid testing chamber, the signal based on an intensity of the light measured by the optical detector during first and second time periods (¶ [0180], a detector 1202 that outputs a signal that may be analyzed to estimate the concentration of constituents in the urine; ¶ [0181], a detector 1202B that outputs a signal that may be analyzed to estimate the concentration of constituents in the urine (e.g., osmolarity and/or osmolality) by constituent code 122B executed by processing unit 120);
(3) associate the first and second signals with an individual and identify a trend for that individual based on the first and second characteristics, and (4) send a signal representative of the trend (¶ [0193] At 214, the calculated urinary flow rate and/or the estimated concentration of urinary constituent(s) is presented on a display (e.g., user interface 128), optionally within a GUI; ¶ [0194], The trend may be updated based on the new measurement … A trend line may be plotted on the GUI to visually indicate the future prediction of the values; ¶ [0198] At 216, an alert is generated … when the trend is indicating that the urine output flow rate is predicted to fall out of the safe range in a predefine time (e.g., in 1-2 hours), … when the osmolality and/or osmolarity of the urine is out of a predefined range (or trending out of the range), and/or when the concentration of one or more urinary constituents are out of a predefined range (or trending out of the range)).
Elia detects changes in a patient’s physiology and proactively warns a caregiver about the patient’s status (¶ [0049], The real-time data … provide treatment to the patient sooner … and/or prevent the patient from deteriorating … with earlier treatment; ¶ [0054], The predictive trend may predict early progression to abnormal health states, for example, progression to AKI; ¶ [0064], The estimation may be used to predict beforehand that the patient urine flow rate and/or concentration of urinary constituents are trending towards leaving a safe predefined range). One would be motivated to modify Recht with Elia’s trend calculation to more quickly warn a caregiver against problems or diseases. Therefore, it would have been obvious to modify Recht with Elia’s trend calculation in order to predict problems well in advance, when a caregiver can intervene.
Regarding claims 146-148, Recht does not explicitly detect a trend. Elia discloses a system wherein the controller is configured to infer a presence or an absence of a medical condition based on the trend (¶ [0051] Optionally the trend is indicative of acute kidney injury (AKI); ¶ [0054], The predictive trend may predict early progression to abnormal health states, for example, progression to AKI);
wherein the first signal is representative of a first plurality of wavelength absorption peaks, and the second signal is representative of a second plurality of wavelength absorption peaks (¶ [0173] Alternatively, in another implementation, source 1081 is a tunable source that is adjustable to emit a selected wavelength … The signals may be sequentially analyzed to identify each constituent corresponding to the selected wavelength; ¶ [0179], Analyzers 1200A-B include a tunable source 1201A-B capable of emitting a range of wavelengths, for example, a vertical-external-cavity surface-emitting-laser (VECSEL));
wherein the fluid inlet, fluid testing chamber, and fluid outlet are collectively configured to maintain within the volume of the fluid testing chamber a volume of fluid sufficient for optical testing of the fluid (¶ [0183], Optionally, each new drop of urine displaces a corresponding volume from the chamber (e.g., out through outlet 1208), maintaining the chamber in a filled state).
Elia warns a caregiver in advance about a patient’s condition (¶ [0049], [0054],[0064]). Regarding the rationale and motivation to modify Recht with Elia’s trend calculations, see the discussion of claim 145 above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 111, 114, 116-120, 122 and 129-130 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 7, 10, 11, 17 and 22 of Arevalos; Christopher Alex et al. (US 11865270 B2).
Regarding pending claim 111, Arevalos claims all limitations in patented claims 1, 11 and 22, namely a bladder management system (claim 1, A system configured to reside within a urine collection receptacle);
comprising: a body (claim 1, a body housing a fluid testing chamber);
configured to reside within a urine collection receptacle (claim 1, A system configured to reside within a urine collection receptacle); and
housing a fluid testing chamber, the fluid testing chamber being fluidically coupled to a fluid inlet and a fluid outlet (claim 1, the fluid testing chamber being fluidically coupled to a fluid inlet and a fluid outlet);
an optical sensor including (1) an emitter configured to convey light across the fluid testing chamber (claim 1, a first optical sensor disposed within the body and including (1) a first emitter configured to convey via a first path a first light across the fluid testing chamber); and
(2) an optical detector configured to measure an intensity of the light as it exits the fluid testing chamber (claim 1, (2) a first optical detector configured to measure an intensity of the first light as the first light exits the fluid testing chamber); and
a sensor configured to sense a presence of at least one urinary characteristic within the fluid testing chamber (claim 11, a sensor configured to indicate when urine has entered the system);
the fluid inlet, fluid testing chamber, and fluid outlet collectively configured to maintain within the volume of the fluid testing chamber a volume of fluid sufficient for optical testing of the fluid (claim 1, the fluid capturing funnel and the fluid testing chamber being collectively configured to maintain within the volume of the fluid testing chamber a volume of fluid sufficient for optical testing of the fluid); and
first and second detectors configured to measure light at first and second different wavelengths (claim 22, (2) a second optical detector arranged to measure an intensity of the light from only the second emitter as the light exits the inner volume of the fluid testing chamber, the first wavelength being different than the second wavelength).
Regarding pending claim 114, Arevalos does not explicitly claim that the light emitted by the emitter is ultraviolet (UV) light, visible, or infrared. However, Arevalos claims that the emitter comprises an LED (claim 10, wherein the first emitter includes a light-emitting diode (LED) and the second emitter includes an LED).
This claim covers all possibilities for the wavelengths that LEDs emit. As known in the art, LEDs are sold commercially that emit light in UV, visible or infrared wavelengths. A skilled artisan would have been able to modify Arevalos’s claims by selecting any commercially available LED which emits light in UV, visible or infrared wavelengths.
Regarding pending claim 120, Arevalos does not explicitly claim a controller that sends a signal representative of a biophysical, chemical, or biochemical characteristic based on the optical detector’s data. However, Arevalos claims a controller that measures and adjusts the emitter’s output or the detector’s sensitivity (claim 17). Arevalos suggests that the controller also communicates information from the optical sensors, because the system wirelessly transmits information (claim 7, further comprising a transmitter configured to wirelessly transmit a signal representative of the intensity to a receiver external to the body). Configuring the controller to handle all of the system’s operations would have been obvious since one electronic microcontroller can be programmed to implement all these features.
Regarding pending claim 129, Arevalos claims that the optical sensor is a first optical sensor (claim 1, a first optical sensor … including (1) a first emitter … and (2) a first optical detector);
the system further comprising (1) a second optical sensor (claim 1, a second optical sensor … including (1) a second emitter … and (2) a second optical detector); and
(2) a controller operably couplable to the first optical sensor and the second optical sensor, and configured to evaluate signals generated by the first optical sensor and the second optical sensor to infer at least one of a presence or an absence of at least one of a biophysical, chemical, or biochemical characteristic associated with the fluid in the fluid testing chamber (claim 7, further comprising a transmitter configured to wirelessly transmit a signal representative of the intensity to a receiver external to the body).
Wherein the first optical sensor is tuned to a first wavelength of light and the second optical sensor is tuned to a second different wavelength of light (claim 22, a first optical sensor … and a second optical sensor … the first wavelength being different than the second wavelength).
Arevalos claims a wireless transmitter (claim 7), and further discloses a feature that selectively activates the system only when urine has entered the system (claim 11, further comprising a sensor configured to indicate when urine has entered the system, the first optical sensor and the second optical sensor configured to test the urine only in response to the indication). This implies that the Arevalos’s system includes a controller.
Regarding pending claims 116-119, 122, and 130, Arevalos claims all limitations in patented claims 1 and 17 as shown in table 1.
Table 1: Arevalos double patenting
Pending claim
Arevalos
Pending claim
Arevalos
116
17
130
1
117
17
118
17
119
17
122
17
Allowable Subject Matter
Claims 126, 127 and 141-144 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant' s arguments filed 16 March 2026 regarding the rejection of claims 111, 113-130, 132, 134-136 and 138-140 as amended, under 35 USC § 103 over Recht, Shemer, Peesapati and Chance, have been fully considered and are partly persuasive.
After further consideration, the amended claims 111, 113-125, 128-130, 132, 134-136, 138-140 and 145-148 and are rejected on new grounds under 35 USC § 103 over Recht, Shemer, Peesapati, Chance Eliason and Elia (see above).
Applicant submits that Amended independent claims 111, 132, 141, 145 and their dependent claims are patentable (remarks p. 13-14). Examiner responds that the new references Eliason and Elia teach features of the amended and new claims as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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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 extension fee 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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