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 are objected to because of the following informalities:
In Claim 1, the term “a urine collection unit connected to the opening for receiving the sample from the funnel and comprising a light reflective surface” should be replaced with -- a urine collection unit connected to the main opening for receiving the sample from the funnel and comprising a light reflective surface-- for claim consistency.
In Claim 3, the term “wherein the light emitter and the sensor” should be replaced with -- wherein the light emitter and the light sensor -- for claim consistency.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 5-7, 9, and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Recht et al (US 2015/0359522) (“Recht”) in view of Kawamura (US 2001/0031500) and further in view of Pugia et al (US 2013/0041236) (“Pugia”) and further in view of Kulkarni (WO 2021/183678).
Regarding Claim 1, while Recht teaches a urinary measuring device for taking and measuring urine samples, configured to be arranged in a urinary receptacle (Figs. 1 and 4, Abstract, [0043]-[0045] apparatus 400 for capturing and testing urine, [0058] where various embodiments may be arranged in a urinary receptacle / toilet as shown in Fig. 8), the urinary measuring device comprising:
a. a funnel for sample collection, comprising a main opening (Fig. 4, [0043] funnel / capturing arrangement 402, comprising a main opening at the top of the figure);
b. a urine collection unit connected to the main opening for receiving the sample from the funnel and comprising a light reflective surface (Fig. 4, [0044]-[0045] urine collection unit / chamber 420 connecting to the main opening of funnel 402 by way of conduit 404, diverter 406, and conduit 410, the chamber 420 comprises a detection unit 430, [0096]-[0100] A representative detection unit / fluidic device 1520 is shown in Fig. 15 and comprises a light reflective surface in confining member 1522, where emitted light from light sources 1511 and 1514 is transmitted and reflected within the confining member 1522 to a photosensitive detector 1532, this optical sensing being relevant to Fig. 4 is confirmed in [0080]);
c. casings for electronics positioned close to the urine collection unit, the casings for electronics comprising a light emitter arranged for emitting light on the urine collection unit and a light sensor arranged for measuring the light received by reflection from the urine collection unit (Fig. 15, [0096]-[0100] the housing for the light sources 1511, 1514 / light emitter and the photosensitive detector 1532 / light sensor are casings, where the light emitters 1511, 1514 emit light on the urine collection unit 1520 and a light sensor 1532 is arranged for measuring the light received by reflection);
d. a container for collecting fluid overflowing from the urine collection unit, comprising an outlet opening, wherein the outlet opening of the container is configured to allow an outflow (Fig. 4, [0043]-[0044] container / diverter 406 for collecting fluid overflowing from the urine collection unit 420, comprising an outlet opening / conduit 408, wherein the outlet opening of the container 406 is configured to allow an outflow); and
wherein an outlet opening of a container can be configured to allow an outflow smaller than that of the main opening of the funnel to facilitate filling ([0078] where a specifically described diverter 1406 notes that the gathering of a desired volume of a sample may involve utilizing an outlet opening 1412 that is configured to allow an outflow smaller than that of the main opening of the funnel based on the fact that the urine delivered by the inlet port 1405 fills the diverter 1406 despite outflow being allowed), Recht fails to teach this structure being applied in the embodiment of Fig. 4.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the outflow occurring at conduit 408 in Fig. 4 should be smaller than that of the main opening of the funnel in Recht as this can be used to facilitate the filling of a desired sample volume into chambers while also allowing fluid to escape the chambers as necessary.
Yet Recht fails to teach the urine measuring device comprising
c. a casing for electronics positioned close to the urine collection unit, the casing for electronics containing the light emitter and the light sensor.
However Kawamura teaches an optical-based urinalysis system (Abstract, [0017]-[0018]) comprising a measurement system placed in a urinary receptacle and where a light emitter and light sensor of the system are contained in a single casing close to a urine collection unit ([0102]-[0105] system can be arranged in toilet, light emitter / semiconductor lase module 6 and light sensor / photosensor 8 are contained in a single casing / housing 15 close to a urine collection unit / sample cell 10).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the light emitter and light sensor of Recht within a single casing as taught by Kawamura as a singular casing can provide a protective for all of the optical components simultaneously ([0105]).
Yet their combined efforts fail to teach
e. a plurality of electrodes extending inside the container by means of arms.
However Pugia teaches a urine sample analysis system (Abstract, [0030], [0089]) utilizing an overflow chamber to detect when a sample chamber has been completely filled by using a presence detection ([0147], [0165]), where the presence of urine in a chamber can be determined electrically ([0105])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the overflow chamber monitoring of Pugia with the system of Recht as identification of overflow can serve as a notification that the sample within the urine collection unit is ready for monitoring ([0165]), a condition that will not be readily discernable to a user.
Yet their combined efforts fail to teach
e. a plurality of electrodes extending inside the container by means of arms.
However Kulkarni teaches a monitoring of urine samples (Abstract) comprising a container for receiving a urine sample comprising a first embodiment with multiple electrodes extending inside the container by means of arms (Figs. 3A-3B, [0033]) and teaches a second embodiment where electrodes can measure for multiple analytes simultaneously with one urine sample and using a level detection for enabling quantitative and qualitative analysis of analytes ([0032]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the overflow chamber monitoring of Pugia and Recht with arms as taught by Kulkarni as a way to standardize the construction of the invention, ensuring consistency across applications of the invention. Furthermore, it would be obvious to use a plurality of electrodes in the overflow chamber as they can also provide expanded functionality if configured to measure for analytes. Finally, if one desires a level detection within the overflow to chamber to enable both quantitative and qualitative measurements, it would be obvious that electrodes at multiple heights from predetermined arm lengths could act to provide the desired level detection.
Regarding Claim 3, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, wherein the light emitter and the light sensor are located in the casing for electronics for emitting and receiving light with respect to the urine collection unit (See Claim 1 Rejection) and Pugia teaches that the planes perpendicular to the emission and measurement directions of the light sensor and light emitter form at an angle comprised between 90° and 180°, implicated as close to 135° (Fig. 11A, the emission direction due to optical unit 157 and the measurement direction due to optical unit 156 and the corresponding planes perpendicular to these direction form an unstated angle but the horizontal position of the top end of optical unit 156 and the angled position of the top end of optical unit 157 imply a formed angle of about 135°).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to structure the system to have the planes perpendicular to emission and measurement directions of Recht as close to 135° as taught in Pugia as a simple substitution of one placement of the light detector relative to the photosensor (Recht: reflecting light from an opposite sides of the photosensor relative to the urine sample) for another placement (reflecting light from a same side of the photosensor relative to the urine sample) to obtain predictable results of reliable optical sensing of urine characteristics. Furthermore, identifying that optimal angles between the planes perpendicular to the emission and measurement directions form at an angle comprised between 120° and 180° from Pugia’s implied 135° is recognized as an optimization from prior art conditions (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 5, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, wherein the casing for electronics comprises a transparent protector arranged for protecting the light emitter and the sensor against the sample splashing from the urine collection unit (See Claim 1 Rejection, Kawamura teaches that the casing for electronics is a protector for protecting against sample splashing and also notes the need for transparent material to allow light to pass in [0102], indicating that the resin casing has a transparent component at the light emitter and sensor, and thus is transparent protector).
Regarding Claim 6, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, wherein the urine collection unit comprises a surface arranged for maximizing the reflection of an incident light (Fig. 15, [0096]-[0100] surfaces of confining member 1522 maximize reflection of an incident light) and Pugia teaches an optically reflective material can be polymeric or metallic ([0183]). comprising a material selected from one of: ceramic, crystal, glass, porcelain, metal, silicone, wood, stones, polymers, as well as a derivative of these materials ().
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the reflective material of Recht as either metallic or polymeric as taught by Pugia as a way to standardize the construction of the invention, ensuring consistency across applications of the invention.
Regarding Claim 7, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, wherein the device further comprises:
a voltage source connected between the electrodes configured to apply a voltage signal between the electrodes and a current meter configured to measure the current between the electrodes resulting from a voltage signal applied by the voltage source; or
an impedance meter connected to the electrodes, the impedance meter configured to measure the impedance of the fluid present in the container between the electrodes (See Claim 1 Rejection, electrochemical monitoring can be based in impedance so the electrode of Pugia would be connected to an impedance meter).
Regarding Claim 9, Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, and Recht teaches wherein the container further comprises a side outlet opening, arranged at a greater height than that of the outlet opening (Fig. 14, [0078] based on desired emptying and filling of the diverter) and than that of the plurality of electrodes (See Claim 1 Rejection, based on the combination where electrodes are measuring presence of urine early into the filling of overflow chamber, an arm of Kulkarni would extend low into first section 1410 and thus the other outlet ports 1422 and 1432 of Recht would be of a greater height than the outlined outlet opening 1412).
Regarding Claim 12, Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, and Recht teaches that a controller configured to control system components and process information can be utilized ([0076] a processor to control system components, [0104] a processor for processing information), and Kawamura teaches a single computer performing both controlling and analyzing functions ([0045], [0076]), and Pugia teaches a singular device contains the processor, an analyzer, and an actuator system (Fig. 2, [0099]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify that the analysis and control actions in the optical embodiment Recht are performed by a single processor as taught by Kawamura and incorporated into a single device as taught by Pugia as a way to standardize a construction of the urine analyzing systems and extend the protective functionality of Pugia to the processor components as well. Thus, you would arrive at a casing for electronics further comprising a controller/processor configured to control the light emitter and the light sensor and a processor configured to process information from the light emitter and the light sensor.
Regarding Claim 13, Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, and Recht teaches wherein the urinary measuring device further comprises controlling the outflow of water from a water source to the urinary receptacle and wherein the device is configured to control the flow from the water source (Fig. 11, [0033], [0042], [0045], [0071], [0077] the various embodiments may also comprise a connection to a source of cleansing solution, the cleansing solution being water, to pass through the system. The cleansing solution will end back in the urinary receptacle) where valves are outlined as flow control components ([0074]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify that the control of the cleansing solution in Recht is based on the use of valves as taught by as a way to standardize a construction of the urine analyzing systems and provide a missing detail on how a system function may be accomplished.
Regarding Claim 14, Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 13, wherein the urinary measuring device is configured to open the valve when it detects that sample measurement has ended (See Claim 13 Rejection, cleansing operation is conducted after a urine test, where the cleansing operation is outlined as controlled by a valve).
Regarding Claim 15, Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, and Recht teaches a user interface to show information about the condition of the sample to the user ([0041]-[0042) and Pugia teaches wherein the urinary measuring device further comprises a user interface configured to receive identification or anonymous information of a user and to receive information about the urinary sample of the user and to show information ([0080], [0100], [0108] processor and user interface are communicating by input and output, where the initialization of the system includes the user interface receiving code identifying the patient and shows information to the user about recognized initialization)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to expand the capability of Recht’s user interface to include input capability as taught by Pugia as this enables one to correlate urine sample results with a given user (Pugia: [0100]).
Regarding Claim 16, Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, wherein the plurality of electrodes are configured to control the light emitter and light sensor (See Claim 1 Rejection, if analysis is contingent upon a full urine collection unit as measured by electrodes detecting overflow in the overflow container, the plurality of electrodes are configured to control the light emitter and light sensor).
Regarding Claim 17, Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 12, and Recht teaches that a controller configured to control system components and process information can be utilized ([0076] a processor to control system components, [0104] a processor for processing information), and Kawamura teaches a single computer performing both controlling and analyzing functions ([0045], [0076]), and Pugia teaches a singular device contains the processor, an analyzer, and an actuator system (Fig. 2, [0099]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to specify that the analysis and control actions in the optical embodiment Recht are performed by a single processor as taught by Kawamura and incorporated into a single device as taught by Pugia as a way to standardize a construction of the urine analyzing systems and extend the protective functionality of Pugia to the processor components as well. Thus, you would arrive at a controller/processor is configured to control the impedance meter, and wherein the processor is configured to process information from the impedance meter.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Recht in view of Kawamura and further in view of Pugia and further in view of Kulkarni and further in view of Hall et al (US 2020/0390422) (“Hall”) as noted in Applicant IDS dated 12/18/2024.
Regarding Claim 2, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, their combined efforts fail to teach wherein the funnel comprises a filter that at least partially covers the main opening configured to prevent direct urination through the main opening.
However Hall teaches a urine analysis system for a urine receptacle (Abstract) comprising a filter that at least partially covers a port opening configured to prevent unwanted components through the main opening ([0055], [0058] filter such as mesh screen).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the port opening / funnel of Recht to comprise a filter as taught by Hall as this protects the system from unwanted components such as feces or toilet paper. Further, if using a mesh screen as the filter, urine that passed through the mesh screen will not be a direct urination through the main opening.
Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Recht in view of Kawamura and further in view of Pugia and further in view of Kulkarni and further in view of Yano et al (US 2009/0324448) (“Yano”).
Regarding Claim 4, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, their combined efforts fail to teach wherein the casing for electronics comprises a main body, a cover, and a gasket configured to fluidically seal the interface between the main body and the cover.
However Yano teaches a fluid collection and analysis system evaluating urine by optical measurements (Abstract, [0055]) wherein a casing for a system component comprises a main body, a cover, and a gasket configured to fluidically seal the interface between the main body and the cover (Fig. 6, [0094]-[0096] system component is a tank with cleaning solution for maintaining system, where the tank has a main body / body 150, gasket / upper gasket 103, and cover / upper lid 101).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the sealing configuration of Yano instead of the resin structure for the casing of Kawamura as both are forms of sealing a structure in a urine sampling system (Kawamura: resin, Yano: tank with gasket and screws), but Yano’s system still enables one to access an interior of the casing.
Regarding Claim 10, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, and Kulkarni teaches wherein electric cables extend from the arms to a casing for electronics, such that an electrical connection is formed between the electrodes and the electronics in a casing for electronics (See Claim 1 Rejection, Kulkarni, Abstract, cables shown to extend from arms to an electronic reader with a casing), their combined efforts fail to teach wherein electric cables extend from the arms to the casing for electronics through one or more gaskets.
However Yano teaches a fluid collection and analysis system evaluating urine by optical measurements (Abstract, [0055]) wherein a casing for a system component comprises a main body, a cover, and a gasket configured to fluidically seal the interface between the main body and the cover (Fig. 6, [0094]-[0096] system component is a tank with cleaning solution for maintaining system, where the tank has a main body / body 150, gasket / upper gasket 103, and cover / upper lid 101).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the sealing configuration of Yano instead of the resin structure for the casing of Kawamura as both are forms of sealing a structure in a urine sampling system (Kawamura: resin, Yano: tank with gasket and screws), but Yano’s system still enables one to access an interior of the casing. Further, this would cause the electrical cables to extend through gaskets at the top of the casing considering the cables in Kulkarni enter at the top of the reader.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Recht in view of Kawamura and further in view of Pugia and further in view of Kulkarni and further in view of Tu et al (US 2020/0187863) (“Tu”).
Regarding Claim 11, while Recht, Kawamura, Pugia, and Kulkarni teach the urinary measuring device according to claim 1, their combined efforts fail to teach wherein the funnel comprises a handle configured to facilitate the extraction of the urinary measuring device by way of an extraction device.
However Tu teaches a urine collection mechanism for a medical diagnostic system (Abstract) where the urine collection mechanism is mounted with a urine receptacle by a handle ([0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to add a handle to the mounted urine analysis system of Recht as taught by Tu as this provides greater ease and control of the system when compared to a non-handle system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights