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 filed July 24, 2026 have been fully considered but they are not persuasive. Amendments to the current set of claims, particularly independent Claims 1 & 14, have changed the scope of the claimed invention. However, the previous prior art rejection still reads upon the present claimed invention in a modified interpretation.
On page 6 of the Remarks section, as indicated by the page number at the bottom of each page, Applicant discusses the status of the current application.
Then, on pages 6-10, Applicant then argues against the 103 prior art rejection of independent Claim 1, asserting that the combination of primary reference Metzner et al., (“Metzner”, US 4,797,191), and secondary references Merchant et al., (“Merchant”, US 2020/0030515), and Metzner et al., (“Metzner 2”, US 4,995,959), do not disclose the presently claimed invention of Claim 1. First, Applicant recites and summarizes the features of independent Claim 1. Specifically, Applicant argues that the newly added limitation “convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system” is not disclosed in primary reference Metzner. The Examiner notes that Metzner is not relied upon to disclose this limitation in the present prior art rejection, so this remark is piecemeal analysis, and thus moot.
Next, Applicant argues that secondary reference Merchant does not disclose this limitation either. The Examiner notes that Merchant is not relied upon to disclose this limitation in the present prior art rejection, so this remark is piecemeal analysis, and thus moot.
On pages 8-10, Applicant then argues that secondary reference Metzner 2 does not disclose the added limitation. Here, Applicant asserts that the previously cited passages in Metzner 2 describe conveying calibration fluid into the sensing channel and exit channel after conveying sample fluid to the waste container. However, the Examiner notes that newly cited passages from Metzner 2 make clear the connection between the positioning of the valve arrangement in Metzner 2 and the conveying of the sample fluid through the bypass line without entering the inlet/exit of the sensor channel/module, (Sample fluid from Container 15 (already made equivalent to a treatment system from Merchant above) through connecting line 21 so routing the fluid from the starting point of the Channel 24 (sensor module) to an end point of the module, See Figure 1, See column 4, lines 37-43, Metzner 2). In particular, the Examiner indicates that the sample fluid is directed through connecting line 21 (bypass line) to waste container 4 without entering and exiting the sensing channel 24 (module), which reads upon this limitation as claimed. The Examiner also notes that the treatment system feature has already been modified and disclosed by secondary reference Merchant, making the waste container equivalent to treating and re-using the waste fluid. Thus, the Examiner maintains and concludes that this interpretation of Metzner 2 reads upon the added limitation in question, finding Applicant’s argument here unpersuasive.
The same remarks above apply to Applicant’s comments regarding independent Claim 14, which has been rejected in the same manner indicated above.
The remainder of the remarks are directed to dependent claims without any specific arguments made against the rejections for these claims and their disclosures. Thus, these remarks are moot.
The Examiner has also reviewed the status of co-pending applications as indicated by Applicant on page 11 of the Remarks.
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) 1-8, 10, 12-14 & 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Metzner et al., (“Metzner”, US 4,797,191), in view of Merchant et al., (“Merchant”, US 2020/0030515), in further view of Metzner et al., (“Metzner 2”, US 4,995,959).
Claims 1-8, 10, 12 & 13 are directed to a fluid sensor system, an apparatus type invention group.
Regarding Claims 1-8, 10, 12 & 13, Metzner discloses a fluid sensor system, the fluid sensor system comprising: a sensor module comprising a sensing channel in communication with an exit channel and configured to receive a sample fluid, (Electrode Block 22 and Flow Channel 24 with inherent inlet/outlet, See Figure 1, See column 4, lines 37-47), two or more calibration compartments, (Vessels 50 & 52, See Figure 1, See column 4, lines 59-63), and a sensing element configured to interact with the sample fluid in the sensing channel, (Electrode Block 22 has four different electrode sections with Channel 24 running therethrough; alternatively Sensors 70, 72, 74 & 76 all interact upstream/downstream of Channel 24, See Figure 1, See column 4, lines 37-47, See column 5, lines 42-68); and a reader electrically and mechanically coupled to the sensor module, (Electrode Connection Unit 94 and Control Device 90, See Figure 1, See column 6, lines 5-26), the reader comprising a controller configured to control operation of the fluid sensor system, (Electrode Connection Unit 94 and Control Device 90, See Figure 1, See column 6, lines 5-26), and a valve between a reservoir and the sensor module, wherein in a first position of the valve, the valve is configured to convey the sample fluid into the sensing channel and the exit channel, (Valve 58 between Container 62 and Electrode Block 22, See Figure 1).
Metzner does not explicitly disclose that the fluid sensor system performs in-line monitoring and wherein the fluid sensor system is configured to connect in-line with the reservoir that is a treatment system, the fluid is conveyed from the reservoir into the sensor module, a bypass pathway, wherein, in a second position of the valve, the valve is configured to simultaneously: convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel and to convey the sample fluid into the bypass pathway and back into the treatment system.
Merchant discloses a fluid sensor system that performs in-line monitoring and wherein the fluid sensor system is configured to connect in-line with the reservoir that is a treatment system, (See paragraphs [0065], [0123], [0161], Merchant) the fluid is conveyed from the reservoir into the sensor module, (Sensor/Electrode 380 to Valve 320 to Sorbent Cartridge 332 to Compartment 338 and returned back to Sensor/Electrode 380 via Dialysis Machine 302, See Figure 6D, See paragraph [0107], [0109]). Additional features of this embodiment are included as part of the overall combination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fluid sensor system of Metzner by incorporating the fluid sensor system performs in-line monitoring and wherein the fluid sensor system is configured to connect in-line with the reservoir that is a treatment system the fluid is conveyed from the reservoir into the sensor module as in Merchant because “ion-selective electrodes can be used to measure or otherwise sense potassium concentrations in blood, dialysate, or both”, (See paragraph [0161], Merchant), in which it “can, if desired be configured as part of the extracorporeal blood circuit disposable tubing system”, (See paragraph [0065], Merchant), in order to perform “a dialysis treatment on a patient, sensing a concentration of potassium…during the treatment, and modifying the dialysis treatment based on the sensed concentration”, (See paragraph [0042], Merchant), so that it will “guard against too sudden a change in blood potassium concentration during dialysis treatments”, (See paragraph [0005], Merchant).
Modified Metzner does not disclose a bypass pathway, wherein, in a second position of the valve, the valve is configured to simultaneously: convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel, and convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system.
Metzner 2 discloses a fluid sensor system with, a bypass pathway, (Line 21 is separate from Channel 24 and either channel 25/26, See Figure 1, See column 4, lines 6-25, Metzner), the valve is configured to simultaneously: convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel, (See column 4, lines 59-66, Metzner 2), and convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system, (Sample fluid from Container 15 (already made equivalent to a treatment system from Merchant above) through connecting line 21 so routing the fluid from the starting point of the Channel 24 (sensor module) to an end point of the module, See Figure 1, See column 4, lines 37-43, Metzner 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fluid sensor system of modified Metzner by incorporating a bypass pathway, wherein, in a second position of the valve, the valve is configured to simultaneously: convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel and convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system as in Metzner 2 so “the sample line” is “washed through at the same time” and “is ultimately pumped clear of the fluid which it contains, (See column 4, lines 66-68, and column 5, lines 7-8, Metzner 2).
Additional Disclosures Included:
Claim 2: The fluid sensor system of Claim 1, wherein the sensing element comprises a plurality of transducers, (Electrode Block 22 has four different electrode sections with Channel 24 running therethrough; alternatively Sensors 70, 72, 74 & 76 all interact upstream/downstream of Channel 24, See Figure 1, Metzner, See column 4, lines 37-47, See column 5, lines 42-68).
Claim 3: The fluid sensor system of Claim 2, wherein the plurality of transducers are configured to interact with the sample fluid and transmit a signal indicative of a particular constituent component of the sample fluid, (Electrode Block 22 with four sections part of Measuring Unit 20, See Figure 1, See column 6, lines 27-41, Metzner, See column 6, lines 5-38).
Claim 4: The fluid sensor system of Claim 1, wherein the sensing element comprises at least three transducers, (Electrode Block 22 has four different electrode sections with Channel 24 running therethrough; alternatively Sensors 70, 72, 74 & 76 all interact upstream/downstream of Channel 24, See Figure 1, Metzner, See column 4, lines 37-47).
Claim 5: The fluid sensor system of Claim 1, wherein the two or more calibration compartments comprises a first calibration compartment configured to store a first calibration fluid, (Vessels 50 & 52, See Figure 1, See column 4, lines 59-61, See column 3, lines 28-30, See column 6, lines 67-68, column 7, lines 1-15, Metzner).
Claim 6: The fluid sensor system of Claim 5, wherein the two or more calibration compartments comprises a second calibration compartment configured to store a second calibration fluid different from the first calibration fluid, (Vessels 50 & 52, See Figure 1, See column 4, lines 59-61, See column 3, lines 28-30, See column 6, lines 67-68, column 7, lines 1-15, Metzner).
Claim 7: The fluid sensor system of Claim 1, wherein the reader is connectible to an external device and configured to send measurement results to the external device, (See paragraph [0152], Merchant).
Claim 8: The fluid sensor system of Claim 1, further comprising a fluid pathway having a fluid inlet and a fluid outlet, the sensing channel is connected to a portion of the fluid pathway between the fluid inlet and the fluid outlet, (Line 32 and Discharge Line 54, See column 4, lines 48-68, See Figure 1, Metzner).
Claim 10: The fluid sensor system of Claim 8, wherein an exit channel downstream of the sensing element is connected to the fluid pathway, (Discharge Line 54 is part of overall pathway combining Lines 54 and 32, See Figure 1, See column 4, lines 48-68, Metzner).
Claim 12: The fluid sensor system of Claim 1, further comprising a waste compartment positioned downstream of and connected to the sensing element by way of an exit channel, (Waste Container 62 connected to Electrode Block 22 via Discharge Line 54, See Figure 1, See column 5, lines 22-25, Metzner), wherein in the second position of the valve, the valve is configured to direct the calibration fluid to the waste compartment after the calibration fluid has passed through the sensing element, (See column 4, lines 65-68, column 5, lines 1-2, Metzner 2).
Claim 13: The fluid sensor system of Claim 1, wherein a sample exit channel downstream of the sensing element is connected to the treatment system through a fluid outlet of the fluid sensor system, (Potassium Sensors 818A/B on line with inlet/outlet connected to extracorporeal circuit, See Figure 8, See paragraph [0131], Merchant).
Claims 14 & 16-20 are directed to a fluid sensor system, an apparatus system group.
Regarding Claims 14 & 16-20, Metzner discloses a method of monitoring a sample fluid, the method comprising: connecting a sensor module, wherein the sensor module comprises a sensing channel in fluid communication with an exit channel and configured to receive the sample fluid, (Electrode Block 22 and Flow Channel 24 with inherent inlet/outlet, See Figure 1) and a sensing element, (Electrode Block 22 has four different electrode sections with Channel 24 running therethrough; alternatively Sensors 70, 72, 74 & 76 all interact upstream/downstream of Channel 24, See Figure 1); providing the sample fluid to the sensing element to thereby cause the sample fluid to interact with the sensing element, (Electrode Block 22 has four different electrode sections with Channel 24 running therethrough; alternatively Sensors 70, 72, 74 & 76 all interact upstream/downstream of Channel 24, See Figure 1); transmitting a signal indicative of a particular constituent component of the sample fluid by the sensing element to a reader electrically and mechanically coupled to the sensor module, (Electrode Connection Unit 94 and Control Device 90, See Figure 1); and calibrating the sensing element using a calibration fluid stored in two or more calibration compartments, (Electrode Block 22 has four different electrode sections with Channel 24 running therethrough; alternatively Sensors 70, 72, 74 & 76 all interact upstream/downstream of Channel 24, See Figure 1), and a valve between a reservoir and the sensor module, wherein in a first position of the valve, the valve is configured to convey the sample fluid from the reservoir into the sensing channel and the exit channel, (Valve 58 between Container 62 and Electrode Block 22, See Figure 1).
Metzner does not explicitly disclose connecting the sensor module in-line with a treatment system, and that the sample fluid is from the reservoir that is a treatment system, a bypass pathway, wherein, in a second position of the valve, the valve is configured simultaneously: to convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel and convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system.
Merchant discloses a method connecting the sensor module in-line with a treatment system, and that the sample fluid is from the treatment system, (See paragraphs [0065], [0123], [0161], Merchant), the fluid is conveyed from the reservoir into the sensor module, (Sensor/Electrode 380 to Valve 320 to Sorbent Cartridge 332 to Compartment 338 and returned back to Sensor/Electrode 380 via Dialysis Machine 302, See Figure 6D, See paragraph [0107], [0109]). Additional features of this embodiment are included as part of the overall combination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Metzner by incorporating connecting the sensor module in-line with a treatment system, and that the sample fluid is from the treatment system the fluid is conveyed from the reservoir into the sensor module as in Merchant because “ion-selective electrodes can be used to measure or otherwise sense potassium concentrations in blood, dialysate, or both”, (See paragraph [0161], Merchant), in which it “can, if desired be configured as part of the extracorporeal blood circuit disposable tubing system”, (See paragraph [0065], Merchant), in order to perform “a dialysis treatment on a patient, sensing a concentration of potassium…during the treatment, and modifying the dialysis treatment based on the sensed concentration”, (See paragraph [0042], Merchant), so that it will “guard against too sudden a change in blood potassium concentration during dialysis treatments”, (See paragraph [0005], Merchant).
Modified Metzner does not disclose a bypass pathway, wherein, in a second position of the valve, the valve is configured simultaneously: to convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel and convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system.
Metzner 2 discloses a method, with, a bypass pathway, (Line 21 is separate from Channel 24 and either channel 25/26, See Figure 1, See column 4, lines 6-25, Metzner), the valve is configured to simultaneously: convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel, (See column 4, lines 59-66, Metzner 2), and convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system, (Sample fluid from Container 15 (already made equivalent to a treatment system from Merchant above) through connecting line 21 so routing the fluid from the starting point of the Channel 24 (sensor module) to an end point of the module, See Figure 1, See column 4, lines 37-43, Metzner 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Metzner by incorporating a bypass pathway, wherein, in a second position of the valve, the valve is configured to simultaneously: convey calibration fluid from at least one of the two or more calibration compartments into the sensing channel and the exit channel and convey the sample fluid from the treatment system into the bypass pathway and directly from a fluid inlet of the sensor module to a fluid outlet of the sensor module without routing the sample fluid to the sensing element and back into the treatment system as in Metzner 2 so “the sample line” is “washed through at the same time” and “is ultimately pumped clear of the fluid which it contains, (See column 4, lines 66-68, and column 5, lines 7-8, Metzner 2).
Additional Disclosures Included:
Claim 16: The method of Claim 14, wherein the sensing element comprises a plurality of transducers, (Electrode Block 22 has four different electrode sections with Channel 24 running therethrough; alternatively Sensors 70, 72, 74 & 76 all interact upstream/downstream of Channel 24, See Figure 1, See column 4, lines 37-47, See column 5, lines 42-68, Metzner).
Claim 17: The method of Claim 14, wherein the calibration fluid is stored in a first calibration compartment of the two or more calibration compartments, and a second calibration fluid is stored in a second calibration compartment of the two or more calibration compartments, (Vessels 50 & 52, See Figure 1, See column 4, lines 59-61, See column 3, lines 28-30, See column 6, lines 67-68, column 7, lines 1-15, Metzner).
Claim 18: The method of Claim 14, wherein the sensor module comprises a waste compartment positioned downstream of the sensing element and configured to receive the calibration fluid that has passed through the sensing element, (Waste Container 62 connected to Electrode Block 22 via Discharge Line 54, See Figure 1, See column 5, lines 22-25, Metzner), and wherein in the second position of the valve, the valve is configured to direct the calibration fluid to the waste compartment after the calibration fluid has passed through the sensing element, (See column 4, lines 65-68, column 5, lines 1-2, Metzner 2).
Claim 19: The method of Claim 14, further comprising calibrating the sensor module after providing the sample fluid to the sensing element, (Vessels 50 & 52, See Figure 1, See column 4, lines 59-61, See column 3, lines 28-44, Metzner).
Claim 20: The method of Claim 19, further comprising providing a second sample fluid from the treatment system to the sensing element to thereby interact the second sample fluid with the sensing element, (See column 3, lines 28-44, Metzner; and See paragraph [0130], Merchant; Examiner interprets continuously measuring the potassium of the fluid over time using the sensor module to read upon measuring at least a second portion or sample of fluid during that time; also Metzner discloses repeating the cycle again).
Claim(s) 11 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Metzner et al., (“Metzner”, US 4,797,191), in view of Merchant et al., (“Merchant”, US 2020/0030515), in further view of Metzner et al., (“Metzner 2”, US 4,995,959), in further view of Kelly et al., (“Kelly”, US 2013/0199998).
Claim 11 is directed to a fluid sensor system, an apparatus type invention group.
Regarding Claim 11, modified Metzner discloses the fluid sensor system of Claim 8, wherein the fluid inlet or the fluid outlet comprises an adapter configured to couple to the treatment system, (Cannula Adaptor 16 connected to Line 32 and Flow Channel 24, See Figure 1, See column 4, lines 64-67, Metzner).
Modified Metzner does not disclose that the adapter is a Luer lock.
Kelly discloses a treatment system in which an adapter is a Luer lock, (See paragraph [0181]. [0274], Kelly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the fluid sensor system of modified Metzner by incorporating that the adapter is a Luer lock as in Kelly in order to use adapters that are “quick connectors, such as luer connectors, that are large and operable with little force and dexterity”, (See paragraph [0274], Kelly).
Claim 15 is directed to a fluid sensor system, an apparatus type invention group.
Regarding Claim 15, modified Metzner discloses the method of Claim 14, wherein a fluid inlet and a fluid outlet of the sensor module connect to the treatment system by way of an adapter, (Cannula Adaptor 16 connected to Line 32 and Flow Channel 24, See Figure 1, See column 4, lines 64-67, Metzner).
Modified Metzner does not disclose that the adapter is a Luer lock.
Kelly discloses a treatment system in which an adapter is a Luer lock, (See paragraph [0181]. [0274], Kelly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Metzner by incorporating that the adapter is a Luer lock as in Kelly in order to use adapters that are “quick connectors, such as luer connectors, that are large and operable with little force and dexterity”, (See paragraph [0274], Kelly).
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 JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779
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