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 Arguments
Applicant’s arguments, see page 8, filed 28NOV2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. The “top” is not a defined location in reference to any other components of the device as claimed and allows for a broad interpretation of locations. Additionally, altering the location of a transducer/sensor is generally considered to be obvious barring any mandatory structural requirements or interactions. A new ground(s) of rejection is made in view of US 20100286559 A1 (Paz et al.) in view of US 7132041 B2 (Deng et al.), US 3809478 A (Talbot), US 20210311018 A1 (Harrington et al.), and US 20240180467 A1 (Levine et al.).
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 (i.e., changing from AIA to pre-AIA ) 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, 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, 8, 10, 11, 15, 16, 21-26, 28, 29, 32, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100286559 A1 (Paz et al.) in view of US 7132041 B2 (Deng et al.), US 3809478 A (Talbot), US 20210311018 A1 (Harrington et al.), and US 20240180467 A1 (Levine et al.).
Regarding claim 1, Paz teaches a system for performing urinalysis of a transurethral patient (Fig. 1A), comprising:
a tubing set (108) configured to receive urine from a urine drainage catheter (102) [0115], the tubing set including a chamber (1208) in fluid communication with a lumen of the tubing set (Fig. 12A) [0251];
a detector assembly (at least 110, 112, 114 and 116) operatively coupled with the tubing set (Fig. 1A), wherein the detector assembly comprises:
a light source (emitter) [0257, 0258] configured to project a coherent light beam through the urine sample within the chamber (1208), and
a light receiver (sensor) [0257, 0258] configured to:
collect light exiting the urine sample, and
provide electrical signals to the module in accordance with characteristics of the collected light, the electrodes [0259] necessarily outputting an electrical signal; and
a urinalysis module (150) coupled with the detector assembly, wherein the system is configured to perform urinalysis of a urine sample contained within the chamber [0115, 0251];
the electrical signals which include color signals defined by refracted light exiting the sample [0256], the output considered to correspond to a color composition of the urine sample [0128] (color detection and output of color sensors as described in [0256] being considered to provide an output corresponding to the measured color).
Paz further teaches the detector assembly (at least 110, 112, 114 and 116) comprises a urine sensor configured to provide an electrical signal (the electrodes being considered to provide an electrical signal) to the module (150) and measuring parameters such as flow [0216] or detecting a stoppage in flow [0221], but fails to teach indicating when the chamber is full of urine, vertical flow of urine within the chamber, or disposal of a pressure transducer at the top of the chamber.
Deng teaches a method for analyzing a fluid test sample through use of an electrode (Abstract) wherein the device used provides indication when the chamber is full of the sample liquid (Col. 4: ll. 31-36).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the detector assembly of Paz to incorporate the fill sensor providing a chamber volume reading of Deng to ensure the electrode is adequately contacting the test liquid (Deng Col. 4: ll. 33-36), thereby ensuring the chamber is full of urine.
Talbot teaches a system for optical detection of particulates in a liquid (Col. 1: ll. 11-13) wherein windows (51 and 52) allow detection without impacting flow (Col. 4: ll. 37-39) and is therefore considered to be applicable. Talbot teaches vertical flow of the fluid being measured (Col. 4: ll. 41-44).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Paz in view of Deng to incorporate the vertical flow of Talbot to prevent particles from settling on the detection windows (Col. 4: ll. 41-44).
Harrington teaches a system for performing urinalysis (200) (Fig. 2), wherein the electrical signals include color signals defined by refracted light exiting the sample ([0012] describing light emitting devices and Fig. 2 showing light entering the sample and leaving it, which would necessarily result in refraction), the color signals correspond to a color composition of the urine sample (the signals being a voltage correlated to the optical radiation detected [0015]); wherein
the urine sensor includes a pressure transducer (218) [0018] disposed at the top of the chamber (being considered the “top” as seen in Fig. 2), but fails to explicitly state the pressure transducer configured to detect a liquid pressure of the urine within the chamber resulting from contact of the urine with the pressure transducer.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Paz in view of Deng, Talbot, and Harrington with the osmolality measuring of Harrington to improve the ability of the system to estimate biomarkers and physiological parameters [Harrington 0010].
Levine teaches a system for performing urinalysis of a transurethral patient [Abstract], comprising a pressure transducer configured to detect a liquid pressure of the urine within the chamber resulting from contact of the urine with the pressure transducer [0267].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the undisclosed operation of the pressure transducer of Paz in view of Deng, Talbot, and Harrington with the pressure transducer operation as described by Levine as a simple substitution of one known means of pressure measurement for another with a reasonable expectation of accurately monitoring urine conditions MPEP 2143 I.
Regarding claim 2, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the module (150) is configured to render urinalysis information on a display (142) [0216].
Regarding claim 3, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the tubing set (108) is coupled with a catheter (102) inserted into the patient, as seen in Fig. 1A.
Regarding claim 5, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the tubing set (108) comprises a chamber (1208) (Fig. 12A) configured to contain the urine sample [0251], wherein the chamber is disposed in line with the tubing set (Fig. 12A).
Regarding claim 7, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the tubing set (108) comprises a chamber (1208) (Fig. 12A) configured to contain the urine sample [0251] wherein chamber is a tubular cuvette defining a lumen having an inlet and an outlet (Fig. 12A), a cuvette being defined as “a straight-sided, optically clear container for holding liquid samples” (Oxford Languages).
Regarding claim 8, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the tubing set (108) comprises a chamber (1208) (Fig. 12A) configured to contain the urine sample [0251] wherein the chamber comprises transparent parallel walls [0257, 0258] disposed on opposite sides of the lumen (Fig. 12A).
Regarding claim 10, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the detector assembly comprises: a light source (emitter) [0257, 0258] configured to project a coherent light beam through the urine sample within the chamber (1208), and a light receiver (sensor) [0257, 0258] configured to: collect light exiting the urine sample, and provide electrical signals to the module in accordance with characteristics of the collected light, the electrodes [0259] necessarily outputting an electrical signal, the device performing analysis based on light scattering or laser diffraction [0258] and is therefore considered to teach the electrical signals include scattering signals defined in accordance with dynamic light scattering of the light beam.
Regarding claim 11, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 10.
Paz further teaches the scattering signals described in claims 9 and 10 correspond to sizes of suspended particles within the sample [0258].
Regarding claim 15, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the detector assembly (1200) (Fig. 12A) [0251] is selectively attachable to and detachable from the tubing set (108), via connectors (1210) and (1212) [0252].
Regarding claim 16, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches an electrode (Fig. 1D) [0129] wherein the detector assembly comprises a detector housing (the exterior) configured to shield the light receiver from external light [0147].
Regarding claim 21, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 10.
Paz further teaches the module (150) comprises a console including one or more processors [0256] and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, is configured to perform operations corresponding to performance of the urinalysis of the urine sample disposed within the tubing set (Graphs 5-10) [0222].
Regarding claim 22, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz further teaches measurements may be performed with the start or stop of flow [0259] and is therefore considered to teach the operations comprise: commencing the urinalysis upon an indication from the urine sensor of the presence of the urine within the chamber; and ceasing the urinalysis upon an indication from the urine sensor of the absence of the urine within the chamber.
Regarding claim 23, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz further teaches measurements may be performed with the start or stop of flow [0259] and is therefore considered to teach the operations further comprise: commencing the urinalysis upon an indication from the urine sensor that the urine is flowing through the chamber; and ceasing the urinalysis upon an indication from the urine sensor that the urine is not flowing through the chamber.
Regarding claim 24, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz further teaches the operations further comprise ceasing the urinalysis upon completion of a defined set of urinalysis processes [0259].
Regarding claim 25, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz further teaches the operations further comprise correlating the color composition [0256], but fails to teach the color is with the CIE L*a*b* color space.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the color detection to include the CIE L*a*b* color space as it would be obvious to try when choosing from the finite number of identified methods of color identification MPEP 2143 I.
Regarding claim 26, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz further teaches the scattering signals correspond to sizes of suspended particles within the sample [0258].
Regarding claim 28, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz further teaches the operations further comprise: comparing a characteristic value of the urinalysis with an alarm limit stored in memory; and as a result of the comparison, generating an alarm if the characteristic value exceeds the alarm limit [0244].
Regarding claim 29, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz further teaches the operations further comprise: comparing a measured value of a urine characteristic with an expected value range stored in memory, and as a result of the comparison, providing notification to the user that urine collection and comprehensive testing is recommended if the measured value is outside of the expected range [0100-0101] (Figs. 2, 3).
Regarding claim 32, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz further teaches the system is designed to display urinary parameters in real time and may be integrated into a hospital systems [0086] as well as noting that parameters such as heart rate and blood pressure are monitored in hospitals [0018]. As Paz teaches integrating the urinalysis system into hospital systems, the system is considered to fulfill the claimed requirement that the module is communicatively coupled with a heart rate monitor, a blood pressure monitor, and/or a pulse oximeter, and the operations further comprise rendering a heart rate, blood pressure, and/or an oxygen saturation level on the display.
Regarding claim 41, the device of Claim 1 fails to teach the electrical signals include color signals defined by refracted light exiting the sample, the color signals correspond to a color composition of the urine sample, the system determines an osmolality of the sample based on the color composition of the urine sample, and the system determines the osmolality of the sample based on the color composition in accordance with the CIE L*a*b* color space.
Harrington teaches a system for performing urinalysis (200) (Fig. 2), wherein the electrical signals include color signals defined by refracted light exiting the sample ([0012] describing light emitting devices and Fig. 2 showing light entering the sample and leaving it, which would necessarily result in refraction), the color signals correspond to a color composition of the urine sample (the signals being a voltage correlated to the optical radiation detected [0015]), the system determines an osmolality of the sample based on the color composition of the urine sample (the spectrometer measuring the optical signal and determining osmolality [0016]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Paz in view of Deng, Talbot, and Harrington with the osmolality measuring of Harrington to improve the ability of the system to estimate biomarkers and physiological parameters [Harrington 0010].
Paz further teaches the operations further comprise correlating the color composition [0256], but fails to teach the color is with the CIE L*a*b* color space.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the color detection to include the CIE L*a*b* color space as it would be obvious to try when choosing from the finite number of identified methods of color identification MPEP 2143 I.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Deng, Talbot, and Harrington and further in view of US 20170284925 A1 (Spangenberg et al.).
Regarding claim 6, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz fails to teach the tubing set comprises a pair of diverter valves configured to selectively direct urine flow through: the chamber when actuated to a first state, and a chamber-bypass tube when actuated to an alternative second state.
Spangenberg teaches an apparatus for analyzing urine (Fig. 3) wherein the tubing set (at least 15) may further comprise at least one valve for bypassing the analysis flow path [0032].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Paz in view of Deng, Talbot, and Harrington to incorporate the bypass line and associated valving of Spangenberg to improve flushing of the system [Spangenberg 0032].
Claim(s) 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Deng, Talbot, and Harrington and further in view of US 20180110913 A1 (Loderer et al.).
Regarding claims 17 and 18, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 16.
Paz fails to teach the detector housing is selectively attachable to and detachable from the detector assembly or the detector housing comprises a latch configured to secure the detector housing in a closed state.
Loderer teaches a detector system (Fig. 1) for use on liquids in a tubing set (T) wherein the housing (7) is selectively attachable to and detachable from the detector assembly (3), the detector housing further comprising a latch (79) configured to secure the detector housing in a closed state [0053].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Paz in view of Deng, Talbot, and Harrington with the latching housing of Loderer to ensure the system is secured in place [Loderer 0053].
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Deng, Talbot, and Harrington and further in view of US 20090149776 A1 (Adams).
Regarding claim 27, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 26.
Paz further teaches measuring particle size [0258], but fails to teach the operations further comprise processing the particle size distribution to identify one or more of proteins, albumin, bacteria, red blood cells, white blood cells, crystals, casts, or sediments.
Adams teaches an optical sensor for a urine detection system (Fig. 1) wherein measuring the particle size is used to identify one or more of proteins, albumin, bacteria, red blood cells, white blood cells, crystals, casts, or sediments [0007].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Paz in view of Deng, Talbot, and Harrington to incorporate the particle size detection systems taught by Adams to detect the presence of an infection in the user [Adams 0007].
The combined device of Paz in view of Deng, Talbot, and Adams is therefore considered to teach the operations further comprise processing the particle size distribution to identify one or more of proteins, albumin, bacteria, red blood cells, white blood cells, crystals, casts, or sediments.
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Paz in view Deng and Talbot and further in view of US 6315955 B1 (Klein).
Regarding claim 30, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 21.
Paz fails to teach the operations further comprise adjusting an intensity of the light beam.
Klein teaches a detection system for use on liquids (Fig. 12) wherein the operations comprise adjusting an intensity of the light beam (Col. 7: l. 64- Col. 8: l. 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the detection light of Paz in view of Deng, Talbot, and Harrington with the adjustable intensity of Klein to increase accuracy and efficiency (Klein Col. 7: l. 66 – Col. 8: l. 2).
Claim(s) 31 is rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Deng, Talbot, and Harrington and further in view of US 20210100533 A1 (Seres et al.).
Regarding claim 31, Paz in view of Deng, Talbot, and Harrington teaches the system according to claim 1.
Paz fails to teach the detector assembly is coupled with the module via a wireless connection.
Seres teaches a system for performing urinalysis [Abstract] wherein the detector assembly is coupled with the module via a wireless connection [0009].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Paz in view of Deng, Talbot, and Harrington to incorporate the wireless connection of Seres to allow for remote access by clinicians [Seres 0009].
The combined device is therefore considered to teach the tubing set comprises a pair of diverter valves configured to selectively direct urine flow through: the chamber when actuated to a first state, and a chamber-bypass tube when actuated to an alternative second state.
Claim(s) 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Deng, Talbot, Harrington, Adams, and further in view of US 20170119300 A1 (Conner).
Regarding claims 42 and 43, Paz in view of Deng, Talbot, Harrington, and Adams teaches the system according to claim 27.
Paz further teaches the scattering signals correspond to sizes of suspended particles within the sample [0258], but fails to teach the detection of albumin within the urine sample.
Conner teaches a urine analysis system [Abstract] for determining a concentration of albumin within the urine sample (Claim 5);
comparing the determined concentration with an expected range of albumin (noted in Tables 1, 3, and 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Claim 27 to incorporate the albumin detection and system alerts of Conner to provide earlier detection and indication of conditions or complications in the patient’s urine [Conner 0009].
As Conner teaches alerting the user upon detection of monitored conditions [0042], the combined device is considered to teach comparing the determined concentration with an expected range of albumin stored in the non-transitory computer-readable medium; and as a result of the comparison, providing a notification when the determined concentration exceeds the expected range.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781