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 .
Election/Restrictions
1. Applicant’s election of claims 1-9 and 12-20 in the reply filed on 04/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
2. Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 7, “the light emission state” lacks antecedent basis since it has yet to be claimed. It should be amended to “a light emission state” since it has yet to be claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claim(s) 1-9, 12-17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suehara (US 20190150801 A1).
In regards to claim 1, Suehara discloses a measurement probe (Abstract discloses a measurement device) comprising:
an elongated body configured to be inserted into a catheter (Par. 0195-0196 teach a catheter that has an elongated tube), the catheter including a flow path (Par. 0197 teaches the elongate tube allows fluid to flow);
a sensor fixed to the elongated body and configured to detect a state of a fluid flowing in the flow path (Par. 0203 teaches an oxygen sensor that can detect oxygen in the fluid, i.e. a state of the fluid); and
a sensor holding portion configured to hold the sensor at a predetermined position when the elongated body is inserted into the catheter (Par. 0203 teaches the oxygen sensor is fixed/held at a specific portion of the catheter)
In regards to claim 2, Suehara discloses the measurement probe according to claim 1, wherein an output of the sensor is configured to change depending on an oxygen partial pressure in the fluid, a carbon dioxide partial pressure in the fluid, a hydrogen ion index of the fluid, an amount of potassium ions in the fluid, an amount of sodium ions in the fluid, an amount of chlorine ions in the fluid, a temperature of the fluid, or a flow rate of the fluid (Par. 0203 teaches the sensor detects oxygen in the urine – the output would change depending on if there is oxygen or not (See also Fig 6). Par. 0202 and 0209 also teach temperature and fluid flow rate sensors) .
In regards to claim 3, Suehara discloses the measurement probe according to claim 1, wherein the sensor holding portion is configured to abut against an end of the flow path (Par. 0203 and Fig 2 teach the oxygen sensor [20a] being fixed in a way that allows it to come in contact with the fluid flow).
In regards to claim 4, Suehara discloses the measurement probe according to claim 1, wherein the sensor includes a light emitter configured to emit light when the light emitter comes into contact with a component to be measured (Par. 0204-0205 teaches that the oxygen sensor comprises a fluorescent body that can emit fluorescent light); and
the elongated body includes a light guide configured to guide radiation light emitted from the light emitter (Par. 0204-205 teaches an optical fiber, i.e. light guide, that guides the fluorescent irradiated light)
In regards to claim 5, Suehara discloses the measurement probe according to claim 4, wherein the radiation light is fluorescence (Par. 0205).
In regards to claim 6, Suehara discloses the measurement probe according to claim 4, further comprising: a light shield configured to prevent light excluding the radiation light from entering the light guide (Par. 0205 teaches a coating, i.e. shield, that can block ambient light without blocking the fluorescent light).
In regards to claim 7, Suehara discloses the measurement probe according to claim 4, wherein the light emission state of the light emitter is configured to change depending on each of a plurality of measurement items (Par. 0229 teaches that the light emission is decreased based on data from the oxygen sensor).
In regards to claim 8, Suehara discloses the measurement probe according to claim 1, further comprising:
a plurality of the sensors fixed to the elongated body (Par. 0202-203 and 0209 teach there being multiple sensors on the body such as oxygen sensor, temperature sensor, and flow rate sensor); and
wherein the plurality of the sensors are fixed at different positions or a same position along a longitudinal direction of the elongated body (Fig 2 shows the sensors are places at different positions on the body, [reference characters 22a, 44, and 76]).
In regards to claim 9, Suehara discloses the measurement probe according to claim 1, wherein the catheter is a bladder indwelling catheter having a urine passage, and the elongated body is configured to be inserted into the urine passage (Par. 0195 teaches a urethral catheter that is taking in urine)
In regards to claim 12, Suehara discloses a measurement system comprising: a measurement probe (Abstract discloses a measurement device) comprising, the measurement probe includes:
an elongated body configured to be inserted into a catheter, the catheter having a flow path (Par. 0195-0196 teach a catheter that has an elongated tube. Par. 0197 teaches fluid flow/path);
a sensor fixed to the elongated body and configured to detect a state of a fluid flowing in the flow path (Par. 0203 teaches an oxygen sensor that can detect oxygen in the fluid, i.e. a state of the fluid); and
a sensor holding portion configured to hold the sensor at a predetermined position when the elongated body is inserted into the catheter (Par. 0203 teaches the oxygen sensor is fixed/held at a specific portion of the catheter); and
a measurement device (Par. 0228-229 teach the measurement system), the measurement device includes:
a data acquisition unit configured to acquire data from the sensor held by the sensor holding portion (Par. 0229 teaches a control unit that acquires sensor data from all of the sensor – such as the temperature, flow state, and oxygen sensors);
a determination unit configured to determine a condition of a patient in which the catheter is indwelled based on the acquired data (Par. 0231-234 teach taking in the sensor data and then determining if a user is in a first, second, or third, stake of acute kidney impairment (AKI)) and
a display unit configured to display the determined condition (Par. 0236 teaches displaying this information on a display).
In regards to claim 13, Suehara discloses the measurement system according to claim 12, wherein the sensor includes a light emitter configured to emit light when the sensor comes into contact with a component to be measured (Par. 0204-0205 teaches that the oxygen sensor comprises a fluorescent body that can emit fluorescent light);
the measurement probe includes a light guide configured to guide radiation light emitted from the light emitter (Par. 0204-205 teaches an optical fiber, i.e. light guide, that guides the fluorescent irradiated light);
the measurement device includes:
a light source configured to irradiate the light emitter with excitation light via the light guide (Par. 0015 teaches irradiating the light emitter with exciting light); and
a light receiver configured to receive the radiation light guided by the light guide (Par. 0214 teaches a light detection portion);
an optical analyzer configured to analyze the radiation light; and the data acquisition unit is configured to acquire data related to a light emission state of the light emitter from the optical analyzer (Par. 0214 discloses that there is a photodiode for detecting the light emitted and that the light information can be converted into a digital value and sent to the control unit for analysis).
In regards to claim 14, Suehara discloses the measurement system according to claim 13, further comprising: a light shield configured to prevent light excluding the radiation light from entering the light guide (Par. 0205 teaches a coating, i.e. shield, that can block ambient light without blocking the fluorescent light).
In regards to claim 15, Suehara discloses the measurement system according to claim 13, wherein the radiation light is fluorescence (Par. 0205).
In regards to claim 16, Suehara discloses the measurement system according to claim 13, wherein the sensor includes a plurality of the light emitters respectively corresponding to a plurality of measurement items (Par. 0205 and 0214 teach there being a plurality of light emitters such as a fluorescence emitter and a light diode); and
the light guide is configured to guide beams of the radiation light respectively emitted from the plurality of the light emitters in a mixed state (Par. 0204-205 teaches an optical fiber, i.e. light guide, that guides the light).
In regards to claim 17, Suehara discloses the measurement system according to claim 13, further comprising: a plurality of the sensors (Par. 0202-203 and 0209 teach there being multiple sensors such as oxygen sensor, temperature sensor, and flow rate sensor); and
wherein the light guide is configured to guide beams of the radiation light respectively emitted from the light emitters of the plurality of the sensors in a mixed state (Par. 0204-205 teaches an optical fiber, i.e. light guide, that guides the light).
In regards to claim 20, Suehara discloses the measurement system according to claim 12, wherein the catheter has a non-communicating conduit that is disposed in parallel with the flow path and does not communicate with the flow path; and the measurement system further comprising a non-wetted sensor inserted through the non-communicating conduit (Par. 0252-253 and Fig 13a show a sensor lumen that is parallel with the flow path [which flows through reference character 30] and is partitioned so that there is no fluid communication and the sensor remains dry)
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.
4. Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suehara and in view of Yelin (US 20150011896 A1).
In regards to claim 18, Suehara discloses the measurement system according to claim 16, except for wherein the measurement device includes: a spectroscopic unit configured to spectrally disperse the radiation light; and a plurality of the optical analyzers configured to analyze beams of light dispersed by the spectroscopic unit.
However, in the same field of endeavor, Yelin discloses catheter systems for emitting light to vessels, such as those in the urinary tract (Abstract and Par. 0003, 0137) wherein the system spectrally disperses the illuminated light which can then be processed (Par. 0119) in order to view the particles inside the vessel for flow cytometry purposes (Par. 0119)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Suehara and modified them by having the system spectrally disperse the illuminated light, as taught and suggested by Yelin, in order to view the particles inside the vessel for flow cytometry purposes (Par. 0119 of Yelin).
5. Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suehara and in view of Altschul (US 20180256208 A1).
In regards to claim 19, Suehara discloses the measurement system according to claim 16, except for wherein the measurement device includes a filter configured to transmit a specific band of the radiation light; and the optical analyzer is configured to analyze light transmitted through the filter.
However, in the same field of endeavor, Altschul discloses an analyte urinary monitoring system (Abstract and Par. 0054) wherein the system comprises a filter for filtering the light into different wavelengths and wherein this light is analyzed (Par. 0089-0090) in order to select the appropriate filter for desired wavelength (Par. 0089).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Suehara and modified them by having the system apply filters, as taught and suggested by Altschul, in order to select the appropriate filter for desired wavelength (Par. 0089 of Altshul).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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