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 09/10/2025 have been fully considered but they are not persuasive. Amendments to the current set of claims have changed the scope of the claimed invention, resulting in a modification of the previous prior art rejection using newly found secondary reference Troutner et al., (“Troutner”, US 5,442,969).
On page 7 of the Remarks section, as indicated by the page number at the bottom of each page, Applicant summarizes the previous interview. Then, on pages 7-9, Applicant argues against the previous prior art rejections, involving the cited prior art and the claim amendments to independent Claim 1. Applicant also acknowledges that a portion of the claim amendments changed the scope of the claimed invention such that the cited prior art did not disclose that portion. The Examiner finds that new secondary reference Troutner discloses this limitation instead. Next, Applicant argues that previous cited reference Szamosfalvi et al., (“Szamosfalvi”, US 2008/0015487), does not disclose “a ratio, as a function of wavelength, of optical power”, or “fitting the measured spectrum with a combination of signatures, each signature comprising a spectrum”. Applicant argues that the Raman spectroscopy used in Szamosfavli uses light of only a single wavelength, not a plurality of different wavelengths absorbed to different extents by the sample. However, the Examiner notes that the claimed invention does not require multiple wavelengths to be used at the same time or over a time period in order to produce said spectral signature. Claim 1 mentions wavelengths in only one portion “a function of wavelength”, indicating that multiple wavelengths are not required by the claim. The Examiner finds this remark unpersuasive as a result.
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, 6, 8, 10, 12, 15, 18 & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wieringa et al., (“Wieringa”, US 2021/0138132), in view of Szamosfalvi et al., (“Szamosfalvi”, US 2008/0015487), in further view of Troutner et al., (“Troutner”, US 5,442,969).
Regarding Claims 1, 6, 8, 10, 12, 15, 18 & 22, Wieringa discloses a system, (See Figure 1), comprising: a hemodialysis system, (Dialysis Device 100, See Figure 1, See paragraph [0102]), comprising a plurality of conduits including: a received blood conduit, (Conduit from Artery to Dialyzer 106 as part of Blood Flow Channel 102, See Figure 1, See paragraph [0104]), a fresh dialysate conduit, (Conduit from Reservoir to Dialyzer 106 as part of Dialysate Flow Channel 104, See Figure 1, See paragraph [0105]), a spent dialysate conduit, (Conduit from Dialyzer 106 to waste as part of Dialysate Flow Channel 104, See Figure 1, See paragraph [0105]), and a filtered blood conduit, (Conduit from Dialyzer 106 to vein as part of Blood Flow Channel 102, See Figure 1, See paragraph [0104]); a first biomarker sensor optically coupled to the filtered blood conduit, the first biomarker sensor comprising a first spectrophotometer, (Laser Light Source 160, Raman spectrometer 162, See paragraphs [0171], [0175], [0176], “measurements may also be performed on blood flow after the blood flow has passed the dialysis area 106”); and a second biomarker sensor optically coupled to the spent dialysate conduit, the second biomarker sensor comprising a second spectrophotometer, (Laser Light Source 160, Raman spectrometer 162, See paragraph [0171], [0176], “measurements may also be performed on dialysis flow…after the dialysis flow has passed the dialysis area 106”), a third biomarker sensor optically coupled to the received blood conduit, the third biomarker sensor comprising a third spectrophotometer, (Laser Light Source 160, Raman spectrometer 162, See paragraphs [0171], [0175], [0176], “measurement may be performed on blood flow before the blood flow reaches the dialysis area 106”), and a processing circuit configured to control, based on at least one of a signal from the first biomarker sensor, a signal from the second biomarker sensor, a signal from the third biomarker sensor, one or more parameters of the hemodialysis system, (See paragraphs [0177]-[0184]), wherein the first spectrophotometer is coupled to a carrier coupled to a connector of tubing of the filtered blood circuit, (See paragraph [0026]).
Wieringa does not disclose the processing circuit configured: to estimate, from a spectrum measured by the first spectrophotometer, a concentration of a biomarker in the filtered blood conduit or the one or more parameters comprising an effective membrane permeability, wherein the measured spectrum comprises a ratio, as a function of wavelength, of optical power detected by a photodetector of the first spectrophotometer to optical power transmitted by a light source of the first spectrophotometer, wherein the estimate is generated by fitting the measured spectrum with a combination of signatures, each signature comprising a spectrum associated with a corresponding sample of a single biomarker at a set concentration, and wherein the first spectrophotometer is optically coupled to a cartridge, the cartridge comprising a pair of connectors configured to detachably couple the cartridge to a pair of in-line connectors of the tubing.
Szamosfalvi discloses the processing circuit configured: to estimate, from a spectrum measured by the first spectrophotometer, a concentration of a biomarker in the filtered blood conduit, (See paragraph [0940], Szamosfalvi), wherein the estimate is generated by fitting the measured spectrum with a combination of signatures, each signature comprising a spectrum associated with a corresponding sample of a single biomarker at a set concentration, (See paragraph [0940], Szamosfalvi). In another feature of Szamosfalvi, the measured spectrum comprises a ratio, as a function of wavelength, of optical power, (See paragraph [0083], [0829], Szamosfalvi), detected by a photodetector of the first spectrophotometer to optical power transmitted by a light source of the first spectrophotometer, (See paragraph [0829], [0830], Szamosfalvi), the one or more parameters comprising an effective membrane permeability, (See paragraph [0945] and paragraphs [0835], [0920], [0935]; Examiner interprets the sieving coefficient of specific solutes to correspond to the membrane effective permeability for that solute).
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 system of Wieringa by incorporating the processing circuit configured: to estimate, from a spectrum measured by the first spectrophotometer, a concentration of a biomarker in the filtered blood conduit wherein the estimate is generated by fitting the measured spectrum with a combination of signatures, each signature comprising a spectrum associated with a corresponding sample of a single biomarker at a set concentration and the measured spectrum comprises a ratio, as a function of wavelength, of optical power detected by a photodetector of the first spectrophotometer to optical power transmitted by a light source of the first spectrophotometer and the one or more parameters comprising an effective membrane permeability as in Szamosfalvi in order to provide “quantitative detection of an analyte of interest with clinically sufficient precision”, (See paragraph [0940], Szamosfalvi), for “a multitude of analytes…safely and in a sterile fashion”, (See paragraph [0083], Szamosfalvi), and “the clearance of any solute with a known sieving coefficient on the specific type of hemofilter can be easily calculated” which “will be of great value to pharmacists”, (See paragraph [0835], Szamosfalvi).
Modified Wieringa does not disclose wherein the first spectrophotometer is optically coupled to a cartridge, the cartridge comprising a pair of connectors configured to detachably couple the cartridge to a pair of in-line connectors of the tubing.
Womble discloses wherein the first spectrophotometer is optically coupled to a cartridge, (Sensor 130 mounted on Circuit Board 120, See Figure 7, See column 11, lines 20-30, Womble), the cartridge comprising a pair of connectors configured to detachably couple the cartridge to a pair of in-line connectors of the tubing, (Inlet Connector 98 and Exit Connector 100 connected to tubing of fluid on either end, See Figure 7, See column 7, lines 53-66, Womble).
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 system of Wieringa by incorporating wherein the first spectrophotometer is optically coupled to a cartridge, the cartridge comprising a pair of connectors configured to detachably couple the cartridge to a pair of in-line connectors of the tubing as in Womble in order to provide “a non-invasive on-line real time monitoring…while the patient…is attached to the hemodialysis machine”, (See column 4, lines 21-25, Womble), such that “sensing of the fluid flow” will “ensure that sampling of the fluid only occurs during a period of sufficient fluid flow”, (See column 1, lines 26-29, Womble).
Additional Disclosures Included:
Claim 6: The system of claim 1, further comprising a fourth biomarker sensor, coupled to the fresh dialysate conduit, (Laser Light Source 160, Raman spectrometer 162, See paragraphs [0171], [0175], [0176], Wieringa; “measurements may also be performed on dialysate flow before the dialysate flow reaches the dialysis area 106”).
Claim 8: The system of claim 7, wherein the one or more parameters further comprise at least one of a dialysate solute concentration or a fluid flow rate, (See paragraphs [0177]-[0184] Wieringa).
Claim 10: The system of claim 8, wherein the one or more parameters further comprise the dialysate solute concentration, (See paragraph [0177] and [0180] Wieringa).
Claim 12: The system of claim 1, wherein the first biomarker sensor is configured to receive electrical power from the hemodialysis system, (See Figure 1, See paragraphs [0110]-[0114], [0171] Wieringa).
Claim 15: The system of claim 1, further comprising a fourth biomarker sensor comprising a fourth spectrophotometer, (Laser Light Source 160, Raman spectrometer 162, See paragraphs [0171], [0175], [0176], Wieringa; “measurements may also be performed on dialysate flow before the dialysate flow reaches the dialysis area 106”).
Claim 18: The system of claim 1, wherein the biomarker is selected from the group consisting of water, glucose, hemoglobin, creatinine, urea, lactate, ethanol, and methanol, (See paragraphs [0176]-[0179], Wieringa).
Claim 22: The system of claim 8, wherein the one or more parameters further comprise the fluid flow rate, (See paragraphs [0177]-[0184] Wieringa).
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) 2, 16, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wieringa et al., (“Wieringa”, US 2021/0138132), in view of Szamosfalvi et al., (“Szamosfalvi”, US 2008/0015487), in further view of Troutner et al., (“Troutner”, US 5,442,969), in further view of Delbeke et al., (“Delbeke”, US 2012/0226118).
Regarding Claim 2, modified Wieringa discloses the system of claim 1, but does not disclose wherein the first spectrophotometer has an operating wavelength range including a wavelength between 2080 nm and 2400 nm.
Delbeke discloses wherein the first spectrophotometer has an operating wavelength range including a wavelength between 2080 nm and 2400 nm, (See paragraph [0030], Delbeke; anticipates the claimed range from 2080 to 2325 nm).
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 system of modified Wieringa by incorporating wherein the first spectrophotometer has an operating wavelength range including a wavelength between 2080 nm and 2400 nm as in Delbeke because it can “be used in the near infrared radiation wavelength range…where glucose has particular absorption or scattering”, or “other substances, such as…urea…creatinine” for which “similar components…having operability in” a particular wavelength as needed, (See paragraph [0079], Delbeke)
Regarding Claims 19-21, modified Wieringa discloses the system of claim 1, but does not disclose wherein the first spectrophotometer comprises a photonic integrated circuit comprising: a plurality of lasers; a wavelength multiplexer; a power meter; and a wavelength meter, the wavelength multiplexer having an output and a plurality of inputs, each of the inputs of the wavelength multiplexer being connected to a respective laser of the plurality of lasers, the wavelength meter and the power meter being connected to the output of the wavelength multiplexer.
Delbeke discloses wherein the first spectrophotometer comprises a photonic integrated circuit comprising: a plurality of lasers; a wavelength multiplexer; a power meter; and a wavelength meter, the wavelength multiplexer having an output and a plurality of inputs, each of the inputs of the wavelength multiplexer being connected to a respective laser of the plurality of lasers, the wavelength meter and the power meter being connected to the output of the wavelength multiplexer, (See paragraphs 78-95, Figures 1-12).
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 system of modified Wieringa by incorporating wherein the first spectrophotometer comprises a photonic integrated circuit comprising: a plurality of lasers; a wavelength multiplexer; a power meter; and a wavelength meter,the wavelength multiplexer having an output and a plurality of inputs, each of the inputs of the wavelength multiplexer being connected to a respective laser of the plurality of lasers, the wavelength meter and the power meter being connected to the output of the wavelength multiplexer as in Delbeke so that “there is no need for a stimulated flow…to enable sensing” such that “an extraction means…can be avoided, resulting in significant advantages regarding amongst others ease of implantation, mechanical stability, reliability and need for powering” which “is obtainable due to the miniaturization of the sensor used…as photonic integrated circuit”, (See paragraph [0010], Delbeke).
Additional Disclosures Included:
Claim 20: The system of claim 19, wherein the first spectrophotometer has a volume of less than 30 cubic centimeters, (See paragraph [0094], Delbeke; A cylinder with height 0.5-30 mm and diameter from 2-50 mm, in which a height of 0.5 mm and diameter of 2 mm can be selected to compute the volume resulting in pi x (d/2)2 x h or 1.57 mm3 or 0.00157 cm3, anticipating at this value).
Claim 21: The system of claim 20, wherein the first spectrophotometer has a volume of less than 3 cubic centimeters, (See paragraph [0094], Delbeke; A cylinder with height 0.5-30 mm and diameter from 2-50 mm, in which a height of 0.5 mm and diameter of 2 mm can be selected to compute the volume resulting in pi x (d/2)2 x h or 1.57 mm3 or 0.00157 cm3, anticipating at this value).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wieringa et al., (“Wieringa”, US 2021/0138132), in view of Szamosfalvi et al., (“Szamosfalvi”, US 2008/0015487), in further view of Troutner et al., (“Troutner”, US 5,442,969), in further view of Gavin et al., (“Gavin”, US 2008/0125693).
Regarding Claim 23, modified Wieringa discloses the system of claim 10,but does not disclose further comprising a dialysate source including a plurality of reservoirs of different dialysate solutions, each of the reservoirs being connected, through a respective metering valve, to a manifold configured to feed an output of the dialysate source, wherein the processing circuit is configured to control the plurality of metering valves to controllably adjust the dialysate solute concentration.
Gavin discloses further comprising a dialysate source including a plurality of reservoirs of different dialysate solutions, each of the reservoirs being connected, through a respective metering valve, to a manifold configured to feed an output of the dialysate source, wherein the processing circuit is configured to control the plurality of metering valves to controllably adjust the dialysate solute concentration, (Dialysate 105/107 from Bags 104/106, Valves 146, and Cassette 132, See Figure 1 & 4B, See paragraph [0070], [0069], [0054], Gavin).
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 system of modified Wieringa by incorporating further comprising a dialysate source including a plurality of reservoirs of different dialysate solutions, each of the reservoirs being connected, through a respective metering valve, to a manifold configured to feed an output of the dialysate source, wherein the processing circuit is configured to control the plurality of metering valves to controllably adjust the dialysate solute concentration as in Gavin in order to produce “custom dialysate (i.e., dialysates having concentrations of one or more solutes different than those concentrations that are typically found” so that “physicians can prescribe dialysates with solute concentrations that are best-suited for particular patients” so that “the efficiency of the…dialysis treatment can be increased”, (See paragraphs [0041] & [0042], Gavin).
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