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 .
Drawings
The drawings were received on June 7, 2024. These drawings are acceptable.
Claim Objections
Claim 11 is objected to because of the following informalities: It appears that “a main fluid flow path” in lines 5-6 should be “the main fluid flow path”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: It appears that “a primary sensor” and a secondary sensor” should be “the primary sensor” and “the secondary sensor”. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6, 11-16, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al (WO 2023/174604 A1) (provided by applicant in IDS filed 11/26/2025).
With respect to claim 1 Jannson discloses a fluid monitoring system for determining a property of a test fluid (composition related parameter = CRP; See Figs. 12, 13A, 13B and Pg. 22, line 5 – Pg. 24, line 4), the fluid monitoring system comprising:
a main fluid flow path (first fluid line 4a) through which a test fluid can flow (flow path between water supply device 17 and receiving device 40, See Pg. 23, line 35 for discussion of the “main supply path);
a primary sensor set comprising at least one primary sensor (disposable sensor 122) configured to provide a primary measurement signal indicative of a first property (See Pg. 10, line 26 for discussion of CRP: composition related parameter, e.g. conductivity) of a test fluid (See Pg. 22, line 35 for discussion of the medical fluid or any intermediate fluid) flowing through the main fluid flow path);
a secondary sensor set for use in calibrating the primary sensor set (See Pg. 22, line 27 – Pg. 23, line 17), the secondary sensor set comprising a secondary sensor (CRP sensor 22, See Pg. 10, lines 32-33) configured to provide a secondary measurement signal indicative of the first property of the test fluid, wherein the system is configured such that the secondary sensor set can selectively interact with test fluid (See Fig. 12 for depiction of the interaction between sensor 22 and test fluid when fluid is directed to the drain 16); and
a control unit (See Pg. 22, line 28 for discussion of a control device) configured to:
acquire a first measurement based on the primary measurement signal of the at least one primary sensor ("a second set of CRP values from signal S5' of disposable sensor 122") and acquire a second measurement based on the secondary measurement signal of the secondary sensor (See Pg. 21, lines 32-33 for discussion of "a first set of CRP values from signal S5 of sensor 22"; steps 1312, 1313);
compare the first measurement and the second measurement in a calibration operation to determine an adjustment for calibrating the primary sensor set based on the secondary sensor set (See Pg. 22, lines 36 – Pg. 23, line 2 for discussion of "The control device processes (step 1314) the first and second sets of CRP values to determine a calibration factor for the disposable sensor 122"); and
determine a first property of the test fluid based on (i) a primary measurement signal of at least one primary sensor of the primary sensor set from the first measurement and/or a further measurement and (ii) the adjustment (See Pg. 23, Iines 31-34); Pg. 7, lines 3-8 discloses how the CRP sensor is arranged to measure a composition-related parameter of the medical fluid, such as conductivity).
With respect to claim 2 Jannson discloses that the control unit is configured such that the primary measurement signal used in determining the first property is the primary measurement signal of the first measurement, and wherein determining the first property comprises applying the adjustment to the first measurement (See Pg. 22, lines 5-24).
With respect to claim 3 Jannson discloses that the control unit is configured such that the primary measurement signal used in determining the first property is a primary measurement signal obtained in a further measurement, and wherein the adjustment is used in obtaining the primary measurement signal in the further measurement (See Pg. 22, lines 21-25 and Pg. 23, lines 31-34).
With respect to claim 4 Jannson discloses a secondary fluid flow path arranged to selectively receive a portion of the test fluid from the main fluid flow path, wherein the secondary sensor is configured to detect the first property of the test fluid when provided in the second fluid flow path (See Fig. 4 and Pg. 22, lines 27-33).
With respect to claim 6 Jannson discloses that the control unit is configured to obtain a plurality of measurements based on the primary measurement signal; and wherein the control unit is configured determine a first property of the test fluid for each of the plurality of measurements based on the primary measurement signal for each measurement and the adjustment (See Pg. 23, lines 14-17 and 31-34).
With respect to claim 11 Jannson discloses a method of determining a property of a test fluid (composition related parameter = CRP; See Figs. 12, 13A, 13B and Pg. 22, line 5 – Pg. 24, line 4) provided in a main fluid flow path (first fluid line 4a) of a fluid monitoring system, comprising:
acquiring a first measurement based on a primary measurement signal from a primary sensor (disposable sensor 122) of a primary sensor set comprising at least one primary sensor, wherein the primary measurement signal is indicative of a first property (See Pg. 10, line 26 for discussion of CRP: composition related parameter, e.g. conductivity) of a test fluid flowing through the main fluid flow path (See Pg. 22, line 35 for discussion of the medical fluid or any intermediate fluid);
causing a secondary sensor (CRP sensor 22, See Pg. 10, lines 32-33) of a secondary sensor set to interact with the test fluid and acquiring a second measurement based on a secondary measurement signal from a secondary sensor of a secondary sensor set, wherein the secondary measurement signal is indicative of the first property of the test fluid (See Fig. 12 for depiction of the interaction between sensor 22 and test fluid when fluid is directed to the drain 16);
comparing the first measurement and the second measurement in a calibration operation to determine an adjustment for calibrating the primary sensor set based on the secondary sensor set (See Pg. 22, lines 36 – Pg. 23, line 2 for discussion of "The control device processes (step 1314) the first and second sets of CRP values to determine a calibration factor for the disposable sensor 122"); and
determining a first property of the test fluid based on (i) a primary measurement signal of at least one primary sensor of the primary sensor set from the first measurement and/or a further measurement and (ii) the adjustment (See Pg. 23, Iines 31-34; Pg. 7, lines 3-8 discloses how the CRP sensor is arranged to measure a composition-related parameter of the medical fluid, such as conductivity).
With respect to claim 12 Jannson discloses that determining the first property is based on the primary measurement signal of the first measurement and comprises applying the adjustment to the first measurement (See Pg. 22, lines 5-24).
With respect to claim 13 Jannson discloses that determining the first property is based on a primary measurement signal obtained in a further measurement, and wherein the adjustment is used in obtaining the primary measurement signal in the further measurement (See Pg. 22, lines 21-25 and Pg. 23, lines 31-34).
With respect to claim 14 Jannson discloses providing a secondary fluid flow path arranged to selectively receive a portion of the test fluid from the main fluid flow path, wherein causing a secondary sensor of the secondary sensor set to interact with the test fluid comprises providing a portion of the test fluid from the main fluid flow path into the secondary fluid flow path; and acquiring the second measurement based on a secondary measurement signal from the test fluid when the test fluid is provided in the second fluid flow path (See Fig. 4 and Pg. 22, lines 27-33).
With respect to claim 15 Jannson discloses prior to acquiring the second measurement, calibrating the secondary sensor of the secondary sensor set (See Pg. 22, lines 22-36).
With respect to claim 16 Jannson discloses obtaining a plurality of measurements based on the primary measurement signal, wherein determining a first property of the test fluid comprises determining a first property for each of the plurality of measurements based on the primary measurement signal for each measurement and the adjustment (See Pg. 23, lines 14-17 and 31-34).
With respect to claim 19 Jannson discloses a computer program comprising computer program code configured, when said computer program is run on one or more physical computing devices, to cause said one or more physical computing devices to implement the method according to claim 11 (See Col. 3, lines 13-15 and Col. 11, line 27 – Col. 12, line 12 and rejection of claim 11 above).
With respect to claim 20 Jannson discloses one or more non-transitory computer readable media having a computer program stored thereon, the computer program comprising computer program code which is configured, when said computer program is run on one or more physical computing devices, to cause one or more physical computing devices to implement the method according to claim 11 (See Col. 3, lines 13-15 and Col. 11, line 27 – Col. 12, line 12 and rejection of claim 11 above).
Claim(s) 1, 3, 6, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furuhashi et al (JP 2024/054703 A; reference will be made to attached English translation) (provided by applicant in IDS filed 11/26/2025).
With respect to claim 1 Furuhashi discloses a fluid monitoring system for determining a property of a test fluid (See Fig. 1 and Paras. 0008-0011, 0028-0029, 0032-0038), the fluid monitoring system comprising:
a main fluid flow path (blood circuit = arterial blood circuit 1 and venous circuit 2) through which a test fluid can flow; a primary sensor set comprising at least one primary sensor (flow rate sensor 7) configured to provide a primary-measurement signal indicative of a first property (flow velocity, See Para. 0015) of a test fluid flowing through the main fluid flow path;
a secondary sensor set for use in calibrating the primary sensor set, the secondary sensor set (second detection unit, See Para. 0028) comprising a secondary sensor (arterial pressure sensor 8 and a calculation unit 12, See Para. 0019), configured to provide a secondary measurement signal indicative of the first property (flow velocity) of the test fluid, wherein the system is configured such that the secondary sensor set can selectively interact with test fluid; and
a control unit (control unit 13, See Para. 0011) configured to:
acquire a first measurement based on the primary measurement signal of the at least one primary sensor and acquire a second measurement based on the secondary measurement signal of the secondary sensor (See Para. 0029 for discussion of flow velocity is detected by each of the sensor units at different pump speeds; also see Para. 0032-0033) compare the first measurement and the second measurement in a calibration operation to determine an adjustment for calibrating the primary sensor set based on the secondary sensor set (See Para. 0034-0035); and
determine a first property of the test fluid based on (i) a primary measurement signal of at least one primary sensor of the primary sensor set from the first measurement and/or a further measurement and (ii) the adjustment (See Para. 0037-0038).
With respect to claim 3 Furuhashi discloses that the control unit is configured such that the primary measurement signal used in determining the first property is a primary measurement signal obtained in a further measurement, and wherein the adjustment is used in obtaining the primary measurement signal in the further measurement (See Para. 0038).
With respect to claim 6 Furuhashi discloses that the control unit is configured to obtain a plurality of measurements based on the primary measurement signal; and wherein the control unit is configured determine a first property of the test fluid for each of the plurality of measurements based on the primary measurement signal for each measurement and the adjustment (See Paras. 0038, 0045; feedback control of the blood pump implies measurement of flow velocity at different times during treatment).
With respect to claim 8 Furuhashi discloses that the primary sensor has a first sensing modality and the secondary sensor has a second sensing modality (See Para. 0028 for discussion of how the primary sensor is a flow rate sensor and second sensory is a pressure sensor).
With respect to claim 10 Furuhashi discloses an extracorporeal bodily fluid system (blood purification apparatus depicted in Fig 1; See Para. 0010) comprising a circulatory fluid flow path (path begins at arterial puncture needle a and ends at venous puncture needle b), comprising the fluid monitoring system of claim 1, wherein the main fluid flow path is a circulatory fluid flow path for a bodily fluid (See Fig. 1 and Paras. 0024-0026).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furuhashi et al (JP 2024/054703 A).
Refer above for the disclosure of Furuhashi.
With respect to claim 7 Furhashi fails to disclose at least one further primary sensor and one further secondary sensor. However, it has been held that the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al (WO 2023/174604 A1).
Refer above for the disclosure of Jannson.
With respect to claim 7 Jannson fails to disclose at least one further primary sensor and one further secondary sensor. However, it has been held that the mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art
Allowable Subject Matter
Claims 5, 9, 17, and 18 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest cited prior art of reference fails to disclosure or teach:
a calibration unit, the calibration unit comprising the secondary sensor set and the second fluid flow path, wherein the calibration unit is releasably engageable with the main fluid flow path (claim 5);
that the primary sensor comprises an optical sensor and the secondary sensor comprises an electrode (claim 9);
Providing the primary sensor has a first sensing modality and providing the second sensor has a second sensing modality (claim 17); and
providing an extracorporeal bodily fluid system comprising a circulatory fluid flow path for a bodily fluid defining the main fluid flow path; and providing a bodily fluid to the circulatory fluid flow path, wherein the bodily fluid is the test fluid (claim 18).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 September 5, 2026
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