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 .
Specification
The disclosure is objected to because of the following informalities: The specification should be amended to include appropriate section headings. See MPEP 608.01(a).
Appropriate correction is required.
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8 includes the variables “K”, “D” and “K0A” that were deleted in dependent claim. It appears these variables should have been deleted in claim 8 as well. Appropriate correction is required.
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.
Claims 14-18 are 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.
Claim 14 is dependent on claim 1 but refers to “a device for monitoring the blood purification according to claim 1.” Claim 1 is directed to a method for monitoring blood purification.
Claims 15-18 each depend from claim 11 and are directed to “the extracorporeal blood purification device according to claim 11.” However, claim 11 is directed to a device for monitoring blood purification. An extracorporeal blood purification device is only recited in claim 11 as an element the device can be used with.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14-18 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As discussed above, claim 14 depends from claim 1 and recites that the “extracorporeal blood purification device has a device for monitoring the blood purification according to claim 1. The claim does not make it clear that claim 14 includes all the limitations of claim 1 and only includes limitations for a device and not the entire method recited in claim. Similarly claims 15-18 depend from claim 11 and recite the extracorporeal blood purification device of claim 11. Claims 15-18 appear to only recite limitations for the extracorporeal blood purification device in claim 11 and not the entire device recited in claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 8, 11-14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2006/0157413 to Bene et al. (Bene) in view of US Patent Application Publication 2022/0236285 to Kampf et al. (Kampf).
Claims 1 and 11
With regard to wherein the concentration of a substance or a variable correlating with the concentration of a substance is measured with at least one sensor during the blood purification; Bene teaches using measuring means to measure the conductivity of a treatment fluid (pars. 69, 70; Fig. 1, measuring means 17, 18).
With regard to on the basis of the concentration of a substance measured with the at least one sensor or a variable correlating with the concentration of a substance, at least one parameter which is characteristic of the purifying performance of the blood purification unit during the blood purification with the predetermined treatment parameters is determined using a computing and/or evaluation unit; Bene teaches using the measured information to calculate a parameter such as dialysance, clearance or dialsysis dose (pars. 71-77; Fig. 1, controller 2).
With regard to wherein the extracorporeal blood purification device is an extracorporeal haemodialysis device, haemofiltration device or haemo(dia)filtration device; Bene teaches a hemodialyser (par. 59; Fig. 1, blood treatment unit 3).
With regard to the blood purification unit of which has a first compartment and a second compartment which are separated by a semipermeable membrane, wherein the first compartment is part of an extracorporeal blood circuit and the second compartment is part of a dialysis fluid system; Bene teaches that the hemodialyzer includes a blood compartment, a dialysate compartment and a semi-permeable membrane separating the two compartments (par. 59; Fig. 1, blood compartment 4, dialysate compartment 5, semi-permeable membrane 6).
With regard to the at least one sensor is provided for measuring the concentration of a substance or a variable correlating with the concentration of a substance in the extracorporeal blood circuit and/or in the dialysis fluid system; Bene teaches using measuring means to measure the conductivity which corresponds to a concentration of a substance in the treatment fluid (pars. 69, 70; Fig. 1, measuring means 17, 18).
With regard to the parameter which is characteristic of the purifying performance of the blood purification unit is the clearance and/or dialysance and/or the dialysis parameter of the dialysis treatment; Bene teaches using the measured information to calculate a parameter such as dialysance, clearance or dialsysis dose (which corresponds to a parameter of the dialysis treatment) (pars. 71-77; Fig. 1, controller 2).
With regard to wherein actions that are predetermined by the computing and/or evaluation unit are triggered depending on whether the parameter which is characteristic of the purifying performance of the blood purification unit lies within or outside the tolerance range for the expected value, a predetermined treatment parameter being the blood flow; Bene teaches generating an output control signal responsive to comparing the calculated value with a reference value (pars. 78-80).
Bene does not teach that an expected value for the purifying performance of the purification unit, which value is dependent on at least one treatment parameter, is determined using the computing and/or evaluation unit, and in that a tolerance range is determined for the expected value using the computing and/or evaluation unit.
Kampf teaches determining a threshold value based on concentration representing normal subjects of various parts of a population (par. 33, 137, 138). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control, as taught by Bene, to include determining a threshold or range of thresholds, as taught by Kampf, because then control of the treatment would have been more effective (Kampf, pars. 3-6).
Claims 2 and 12
Bene teaches that graphical elements and/or symbols are displayed with a graphical user interface and/or acoustic signals are generated with an acoustic user interface, which interfaces display to the user that the parameter which is characteristic of the purifying performance of the blood purification unit lies within or outside the tolerance range for the expected value (Fig. 8, pars. 73-76).
Claims 3 and 13
Bene teaches that an electrical signal is generated which signals that the parameter which is characteristic of the purifying performance of the blood purification unit is within or outside the tolerance range for the expected value (pars. 71-73, 75).
Claims 8 and 18
Bene teaches that the computing and/or evaluation unit is used to calculate the expected value according to a mathematical model which describes the clearance K and/or dialysance D and/or the dialysis parameter KoA as a function of predetermined treatment parameters (pars. 71-73, 75).
Claim 14
Bene teaches an extracorporeal blood purification device which is designed such that a blood purification unit is used to perform blood purification with predetermined treatment parameters in an extracorporeal blood circuit, wherein in that the extracorporeal blood purification device has a device for monitoring the blood purification (par. 59: Fig. 1, blood treatment unit 3).
Claim(s) 4-7 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bene in view of Kampf as applied to claims 1 and 11 above, and further in view of US Patent Application Publication 2017/0312411 to Maierhofer (Maierhofer).
Claims 4 and 15
Bene and Kampf teach all the limitations of claim 1 upon which claim 4 depends and claim 11 upon which claim 15 depends. Bene and Kampf do not teach that expected values for different treatment parameters are stored in a memory, wherein the relevant expected value for the predetermined treatment parameters is read out from the memory by the computing and/or evaluation unit. Maierhofer teaches storing values to be used for comparison over a plurality of treatment days (par. 77). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control combination, as taught by Bene and Kampf, to include storing values for later comparisons, as taught by Maierhofer, because then the reference values would not have needed to be calculated or obtained for each comparison.
Claims 5 and 16
Bene and Kampf teach all the limitations of claim 1 upon which claim 5 depends and claim 11 upon which claim 16 depends. Bene and Kampf do not teach that the computing and/or evaluation unit is used to calculate the expected value according to a mathematical model which describes the expected value as a function of the predetermined treatment parameters. Maierhofer teaches determining the expected value by the mean value over the individual measured values of the same sensors of different dialysis devices (par. 77). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control combination, as taught by Bene and Kampf, to include storing values for later comparisons, as taught by Maierhofer, because then the reference values would not have needed to be calculated or obtained for each comparison.
Claims 6 and 17
Bene and Kampf teach all the limitations of claim 1 upon which claim 6 depends and claim 11 upon which claim 17 depends. Bene and Kampf do not teach that a parameter which is characteristic of the purifying performance of the blood purification unit is determined during a prior blood purification with the extracorporeal blood purification device and is stored in a memory, wherein the expected value determined during the prior blood purification with the extracorporeal blood purification device is read out from the memory as the expected value for the blood purification of a subsequent blood purification. Maierhofer teaches determining the expected value by the mean value over the individual measured values of the same sensors of different dialysis devices (par. 77). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control combination, as taught by Bene and Kampf, to include using a mean value to determine an expected value, as taught by Maierhofer, because then the reference values would have been calculated with a well known statistical model.
Claim 7
Bene and Kampf teach all the limitations of claim 1 upon which claim 7 depends. Bene and Kampf do not teach that a parameter is determined which is characteristic of the purifying performance of the blood purification unit during blood purification with a different extracorporeal blood purification device than the one to be monitored and is stored in a memory, wherein the expected value determined during a prior blood purification with the different extracorporeal blood purification device is read out from the memory as the expected value for the blood purification with the blood purification device to be monitored. Maierhofer teaches determining the expected value by the mean value over the individual measured values of the same sensors of different dialysis devices (par. 77). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control combination, as taught by Bene and Kampf, to include using different machines to calculate the expected value, as taught by Maierhofer, because then errors in a single machine would have been detected by comparison to a other machines that were operating correctly.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bene in view of Kampf as applied to claim 1 above, and further in view of US Patent Application Publication 2019/0365976 to Tatonetti (Tatonetti).
Claim 9
Bene and Kampf teach all the limitations of claim 1 upon which claim 9 depends. Bene and Kampf do not teach that the computing and/or evaluation unit is a computing and/or evaluation unit which is spatially separated from the blood purification device. Tatonetti teaches executing applications on remote servers to operate hemodialysis machines (pars. 27, 50, 58). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control combination, as taught by Bene and Kampf, to include a remote server, as taught by Tatonetti, because then portable machines would have been more efficiently managed (Tatonetti, par. 1).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bene in view of Kampf and Maierhofer as applied to claim 4 above, and further in view of Tatonetti.
Claim 10
Bene, Kampf and Maierhofer teach all the limitations of claim 4 upon which claim 10 depends. Bene, Kampf and Maierhofer do not teach that the memory is a memory which is spatially separated from the blood purification device. Tatonetti teaches executing applications on remote servers to operate hemodialysis machines (pars. 27, 50, 58). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control combination, as taught by Bene, Kampf and Maierhofer, to include a remote server, as taught by Tatonetti, because then portable machines would have been more efficiently managed (Tatonetti, par. 1).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bene in view of US Patent Application Publication 2021/0196879 to Balter et al. (Balter).
Claim 19
With regard to wherein the blood purification devices each have at least one sensor for determining the concentration of a substance or a variable correlating with the concentration of a substance during the blood purification; Bene teaches using measuring means to measure the conductivity of a treatment fluid (pars. 69, 70; Fig. 1, measuring means 17, 18).
With regard to a computing and/or evaluation unit which is configured such that, on the basis of the concentration of a substance measured with the at least one sensor or a variable correlating with the concentration of a substance, at least one parameter is determined which is characteristic of the purifying performance of the blood purification unit during the blood purification with the predetermined treatment parameters; Bene teaches using the measured information to calculate a parameter such as dialysance, clearance or dialsysis dose (pars. 71-77; Fig. 1, controller 2).
With regard to wherein the extracorporeal blood purification device is an extracorporeal haemodialysis device, haemofiltration device or haemo(dia)filtration device; Bene teaches a hemodialyser (par. 59; Fig. 1, blood treatment unit 3).
With regard to the blood purification unit of which has a first compartment and a second compartment which are separated by a semipermeable membrane, wherein the first compartment is part of an extracorporeal blood circuit and the second compartment is part of a dialysis fluid system; Bene teaches that the hemodialyzer includes a blood compartment, a dialysate compartment and a semi-permeable membrane separating the two compartments (par. 59; Fig. 1, blood compartment 4, dialysate compartment 5, semi-permeable membrane 6).
With regard to and the at least one sensor is provided for measuring the concentration of a substance or a variable correlating with the concentration of a substance in the extracorporeal blood circuit and/or in the dialysis fluid system; Bene teaches using measuring means to measure the conductivity of a treatment fluid (pars. 69, 70; Fig. 1, measuring means 17, 18).
With regard to the parameter which is characteristic of the purifying performance of the blood purification unit is the clearance and/or dialysance and/or the dialysis parameter of the dialysis treatment, a predetermined treatment parameter being the blood flow; Bene teaches using the measured information to calculate a parameter such as dialysance, clearance or dialsysis dose (which corresponds to a parameter of the dialysis treatment) (pars. 71-77; Fig. 1, controller 2).
Bene does not teach at least two blood purification devices, each designed such that blood purification with predetermined treatment parameters is performed by means of a blood purification unit in an extracorporeal blood circuit, wherein the blood purification devices each have a data interface, and comprising a data processing system with which the at least two blood purification devices interact such that data are exchanged via the data interface between the at least two blood purification devices on the one hand and/or between at least one of the blood purification devices and the data processing system, on the other hand; and the blood purification system comprises a computing and/or control unit which is configured such that a parameter which is characteristic of the purifying performance of the blood purification unit, which parameter is determined during a blood purification with one of the at least two blood purification devices, is read into a memory and is read out from the memory by another blood purification device of the at least two blood purification devices as the expected value.
Balter teaches multiple dialysis systems that communicate with a remote device (Fig. 2B, dialysis systems 200, remote device 203; par. 58). Balter teaches that the remote computer may monitor and control the multiple dialysis systems and collect data from the dialysis systems (par. 58). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the blood treatment control, as taught by Bene, to include a remote device to control multiple machines, as taught by Balter, because then multiple machines would have been more easily controlled.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL L BARBEE whose telephone number is (571)272-2212. The examiner can normally be reached M-F: 9-5:30..
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/MANUEL L BARBEE/Primary Examiner, Art Unit 2857
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