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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE 2020 135 023.6, filed on December 29, 2020.
Response to Amendment
In the amendment filed on February 10, 2026, the following has occurred: claim(s) 1-4, 7-10, 12 have been amended and claim(s) 13-14 have been added. Now, claim(s) 1-4, 6-10, 12-14 are pending.
Notice to Applicant
The Examiner has withdrawn the 35 U.S.C. 101 rejection(s) that were previously applied to claims 1-4, 6-10, 12-14. The newly amended claims recite additional elements that improve the operation of a clinic using a plurality of blood treatment machines and a plurality of water preparation systems. The Specification on p. 7, ll. 22-24, p. 8, ll. 1-8 specify that “the control device further comprises a control unit programmed to:” as “The device can, for example, have an operating unit by means of which a user can input control instructions for the at least one blood treatment machine and/or the at least one water preparation system that are then output by the device in accordance with the invention to the at least one blood treatment machine and/or to the at least one water preparation system. The user can thus interact dynamically and directly with a system comprising the at least one blood treatment machine and/or the at least one water preparation system by means of the device in accordance with the invention or can control said system. Alternatively or additionally, the device can furthermore be programmed to actuate an output with respect to the savings potential in costs and/or raw materials and/or energy associated with the output recommendation to optimize the control and/or with a corresponding control instruction to the at least one blood treatment machine and/or the at least one water preparation system. This provides the advantage that the user can directly see whether it is worthwhile to follow the recommendation of the device in accordance with the invention and, for example, to input a corresponding control instruction.” The claims 1-4, 6-10, 12-14 recite additional elements that integrate the recited judicial exception into a practical application. The 35 U.S.C. 101 rejection(s) have been withdrawn.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Claim Objections
Claim 7 objected to because of the following informalities: “the blood treatment machine” in p. 6, ll. 6. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “the first blood treatment machine”.
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.
Claims 1-4, 6-10, 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Nilsson (U.S. Patent Pre-Grant Publication No. 2016/0292377) in view of Reid, Jr. et al. (U.S. Patent Pre-Grant Publication No. 2009/0234262) in view of Akonur et al. (U.S. Patent Pre-Grant Publication No. 2011/0257891) in further view of Bene et al. (U.S. Patent Pre-Grant Publication No. 2013/0317850).
As per independent claim 1, Nilsson discloses a system comprising a blood treatment machine park comprising a plurality of blood treatment machines, a water preparation system park comprising a plurality of water preparation systems, and a control device, the control device comprising a common display device and being configured to display, on the common display device, first data relating to a first blood treatment machine of the plurality of blood treatment machines, and second data relating to a first water preparation system of the plurality of water preparation systems (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting present relevant data to the user to encompass first data relating to the blood treatment machine and second data relating to the water preparation system (extracorporeal blood circuit mechanism ([0028]) and water treatment for the dialysis treatment ([0028]), and interpreting the user interface to encompass the common display device), wherein the control device further comprises a control unit that is programmed to:
consolidate the different data formats of the first data relating to the first blood treatment machine and the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass a control unit that is programmed to consolidate the different data formats ([0033])),
integrate the first data relating to the first blood treatment machine and the second data relating to the first water preparation system (See Paragraphs [0028]-[0029], [0049]: A representing object is arranged to collect information that may be enabled for user interaction with each operation step and represents that as an operation step item for the respective operation step, which the Examiner is interpreting collect information that may be enabled for user interaction to encompass integrate the first data relating to the first blood treatment machine and the second data relating to the first water preparation system as the information is collected for presentation),
display together the first data relating to the first blood treatment machine and the second data relating to the first water preparation system, on the common display device (See Paragraphs [0053]-[0055]: A display control object provides control of what is to be displayed through the UI, which the Examiner is interpreting the display control object to encompass display together the first data relating to the first blood treatment machine and the second data relating to the first water preparation system),
generate indications with respect to an optimized operation of the first blood treatment machine and of the first water preparation system (See Paragraphs [0059]-[0060]: The interaction has called upon displaying of a number of subitems which are displayed, and corresponding check boxes and/or status indicators may also be displayed, which the Examiner is interpreting the indicators to encompass indicators with respect to an optimized operation of the first blood treatment machine and of the first water preparation system as one or more operation step items of said operation step items can be displayed as recommended to be performed next with an indicator representing the recommendation when in another state than the first state ([0041])),
output at least one control instruction to the first blood treatment machine and/or to the first water preparation system, based on a control device determination (See Fig. 1 and Paragraphs [0028]-[0029], [0062]: A controller of the apparatus controls the operation of the functional processes; thus, the process controller may be a joint controller, a multitude of local controllers, or a hierarchy of controllers working together, the functional processes may be water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism, extracorporeal blood circuit mechanism, etc., which the Examiner is interpreting controls the operation of the functional processes to encompass output at least one control instruction to the first blood treatment machine and/or to the first water preparation system, and interpreting the processor has determined this operation substep item as being available only after completion of another operation step or operation substep to encompass a control device determination),
the control instruction is output on the basis of a control or regulation based on the first data relating to the first blood treatment machine and based on the second data relating to the first water preparation system (See Fig. 1 and Paragraphs [0028]-[0029]: Providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting receiving status and measured data from the controller to encompass the first data relating to the first blood treatment machine and/or based on the second data relating to the first water preparation system as the controller can receive data from water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism, extracorporeal blood circuit mechanism, etc.)
While Nilsson discloses the system as described above, Nilsson may not explicitly teach the first blood treatment machine and the first water preparation system are configured to (i) receive the control instruction, and (ii) based on the control instruction, automatically regulate operation of the first blood treatment machine and/or the first water preparation system.
Reid, Jr. teaches a system for the first blood treatment machine and the first water preparation system are configured to (i) receive the control instruction, and (ii) based on the control instruction, automatically regulate operation of the first blood treatment machine and/or the first water preparation system (See Paragraphs [0039]: The control system algorithm can include commands for activating a pump for flushing the dialysis access route when blood flow in the dialysis access route drops below a pre-set level, which the Examiner is interpreting commands to encompass automatically regulate operation of the first blood treatment machine and/or of the first water preparation system when combined with Nilsson’s disclosure of water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Nilsson to include the first blood treatment machine and the first water preparation system are configured to (i) receive the control instruction, and (ii) based on the control instruction, automatically regulate operation of the first blood treatment machine and/or the first water preparation system as taught by Reid, Jr to determine the automatic operation of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson with Reid, Jr. with the motivation of providing dynamic management of therapeutic interventions (See Background of Reid, Jr. in Paragraph [0006]).
While Nilsson/Reid, Jr. discloses the system as described above, Nilsson/Reid, Jr. may not explicitly teach receive, in real time, the first data relating to the first blood treatment machine, in a first data format, and the second data relating to the first water preparation system, in a second data format that is different than the first data format,
the first data relating to the first blood treatment machine comprises data pertaining to respective requirements of the first blood treatment machine,
the second data relating to the first water preparation system comprises data pertaining to an amount of water produced by the first water preparation system and a time period in which the first water preparation system is operated to produce pure water,
the control device is configured to make the control device determination by determining whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet the respective requirements of the first blood treatment machine.
Akonur teaches a system for receive, in real time, the first data relating to the first blood treatment machine, in a first data format, and the second data relating to the first water preparation system, in a second data format that is different than the first data format (See Paragraphs [0170], [0184]: The processor to operate with the display device and the input device to receive data relating to at least one of K.sub.R, K.sub.D, K.sub.M, V.sub.PRE, t.sub.tx, F, C.sub.PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum phosphorus concentration, and blood samples and dialysate samples can be collected, which the Examiner is interpreting blood samples to encompass the first data relating to the first blood treatment machine and interpreting dialysate samples to encompass the second data relating to the first water preparation system),
the first data relating to the first blood treatment machine comprises data pertaining to respective requirements of the first blood treatment machine (See Paragraphs [0102], [0117]: Machine operating parameters that may be entered alternatively or additionally to F and T include blood flowrate, dialysate flowrate, dialysate total volume, ultrafiltration flowrate and ultrafiltration total volume, which the Examiner is interpreting blood flowrate to encompass data pertaining to respective requirements of the first blood treatment machine),
the second data relating to the first water preparation system comprises data pertaining to an amount of water produced by the first water preparation system and a time period in which the first water preparation system is operated to produce pure water (See Paragraphs [0081], [0084]-[0085], [0089], [0105]-[0106]: Running opposite to prediction component, the doctor in optimization component enters desired values for therapy results, e.g., a desired value for urea, e.g., via standard Kt/v, a desired value for phosphorus in, e.g., pre-dialysis phosphorus plasma concentration in milligrams per liter, a desired value for .beta.2-M in, e.g., milligrams per liter, and a desired ultrafiltrate ("UF") removal value, e.g., in liters, UF is generally a machine-controlled function but can affect solute removal, so the input of UF is desirable for optimization, which the Examiner is interpreting a desired UF removal value to encompass an amount of water produced by the first water preparation system, and the therapy duration and blood and dialysate flow rates to encompass the time period in which the first water preparation system is operated to produce pure water),
the control device is configured to make the control device determination by determining whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet the respective requirements of the first blood treatment machine (See Paragraphs [0081], [0084]-[0085], [0089]: The estimated patient parameters are then fed back into the models in prediction component, particularly into the personalized solute flux and volume flux routine, the patient prediction component accepts other known, assumed or calculated (outside of the model) values for the particular solute, such as dialyzer clearance K.sub.D, into personalized solute flux and volume flux routine, which the Examiner is interpreting the therapy duration and blood and dialysate flow rates to encompass the time period in which the first water preparation system is operated to produce pure water, meet the respective requirements of the first blood treatment machine when combined with Nilsson’s disclosure of a functional process may be water treatment for the dialysis treatment ([0028]).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Nilsson/Reid, Jr. to include receive, in real time, the first data relating to the first blood treatment machine, in a first data format, and the second data relating to the first water preparation system, in a second data format that is different than the first data format, the first data relating to the first blood treatment machine comprises data pertaining to respective requirements of the first blood treatment machine, the second data relating to the first water preparation system comprises data pertaining to an amount of water produced by the first water preparation system and a time period in which the first water preparation system is operated to produce pure water, the control device is configured to make the control device determination by determining whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet the respective requirements of the first blood treatment machine as taught by Akonur to determine the operation guidance of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr. with Akonur with the motivation of improving treatment and nutritional regimens for a patient (See Detailed Description of Akonur in Paragraph [0169]).
While Nilsson/Reid, Jr./Akonur discloses the system described above, Nilsson/Reid, Jr./Nilsson/Akonur may not explicitly teach a blood treatment machine park comprising a plurality of blood treatment machines, a water preparation system park comprising a plurality of water preparation systems.
Bene teaches a system for a blood treatment machine park comprising a plurality of blood treatment machines, a water preparation system park comprising a plurality of water preparation systems (See Paragraphs [0108]-[0137], [0250]-[0251]: A system for monitoring a plurality of patients affected by kidney failure over a time frame covering a plurality of blood treatment sessions, the system comprising: a plurality of blood treatment machines for the treatment of the monitored patients, each blood treatment machine including at least one respective control unit and sensors for measuring session parameters, the control unit of each blood treatment machine, which the Examiner is interpreting a plurality of blood treatment machines to encompass the blood treatment machine park comprising a plurality of blood treatment machines including the first blood treatment machine and interpreting the dialysate chamber for each blood treatment machine to encompass the water preparation the water preparation system park comprising a plurality of water preparation systems including the first water preparation system when combined with Akonur’s teachings in Paragraphs [0170], [0184] of “dialysate samples”.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Nilsson/Reid, Jr./Akonur to include a blood treatment machine park comprising a plurality of blood treatment machines, a water preparation system park comprising a plurality of water preparation systems taught by Bene to provide relevant data to the user of Nilsson (Paragraph [0029]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr./Akonur with Bene with the motivation of providing the user with a tool consolidating only relevant information (See Description of Illustrative Embodiments System of Akonur in Paragraph [0366]).
As per claim 2, Nilsson/Reid, Jr./Akonur/Bene discloses the system of claim 1 as described above. Nilsson further teaches wherein the first data and the second data comprise technical data that are provided with a time stamp and that reflect respective states of the first blood treatment machine and the first water preparation system (See Fig. 24 and Paragraphs [0033], [0079]: The operation steps are represented by the operation step items, which may include user understandable information or references to such information, such as operation guidance, parameter setting, status information, etc., and Fig. 24 shows that treatment time can be recorded, which the Examiner is interpreting to encompass a time stamp ([0051]: Status tracking object)), and
the states of the first blood treatment machine and of the first water preparation system independently comprise an operating state (See Fig. 24 and Paragraphs [0033], [0079]: The operation steps are represented by the operation step items, which may include user understandable information or references to such information, such as operation guidance, parameter setting, status information, etc., which the Examiner is interpreting status information to encompass an operating state), a consumption, a machine identification (ID), a location, a routine of a treatment to be carried out, a presetting to take up or to end an operating mode, a measurement value of a fluid, or a combination thereof.
Claim(s) 8 mirrors claim 2 only within (a) different statutory category, and is rejected for the same reason as claim 2.
As per claim 3, Nilsson/Reid, Jr./Akonur/Bene discloses the system of claim 1 as described above. Nilsson/Reid, Jr. may not explicitly teach wherein the requirement of the first blood treatment machine for pure water produced by the first water preparation system is based on the first data relating to the first blood treatment machine, and
the control device is furthermore configured to estimate, on the basis of the second data relating to the first water preparation system, whether the time period in which the first water preparation system is operated for the production of pure water, corresponds to the requirement of the first blood treatment machine.
Akonur teaches a system wherein the requirement of the first blood treatment machine for pure water produced by the first water preparation system is based on the first data relating to the first blood treatment machine (See Paragraphs [0063]-[0065]: The output of estimation component includes a multitude of estimated patient parameters for each solute of concern, which are based on the patient's blood results using models and are therefore specific to the patient, which the Examiner is interpreting a multitude of estimated patient parameters for each solute of concern to encompass the first blood treatment machine for pure water produced by the first water preparation system is based on the first data relating to the first blood treatment machine ([0077], [0144])), and
the control device is furthermore configured to estimate, on the basis of the second data relating to the first water preparation system, whether the time period in which the first water preparation system is operated for the production of pure water, corresponds to the requirement of the first blood treatment machine (See Paragraphs [0081], [0084]-[0085], [0089]: The estimated patient parameters are then fed back into the models in prediction component, particularly into the personalized solute flux and volume flux routine, the patient prediction component accepts other known, assumed or calculated (outside of the model) values for the particular solute, such as dialyzer clearance K.sub.D, into personalized solute flux and volume flux routine, which the Examiner is interpreting the patient prediction component to encompass estimate, on the basis of the second data relating to the first water preparation system, whether the time period in which the first water preparation system is operated for the production of pure water, corresponds to the requirement of the first blood treatment machine as the optimization component can be used to output therapy parameters from optimization component can include therapy duration ("T"), therapy frequency ("F"), blood and dialysate flow rates ("Q.sub.B" and "Q.sub.D", respectively) ([0089]).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Nilsson/Reid, Jr. to include the requirement of the first blood treatment machine for pure water produced by the first water preparation system is based on the first data relating to the first blood treatment machine, and the control device is furthermore configured to estimate, on the basis of the second data relating to the first water preparation system, whether the time period in which the first water preparation system is operated for the production of pure water, corresponds to the requirement of the first blood treatment machine as taught by Akonur to determine the operation guidance of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr. with Akonur with the motivation of improving treatment and nutritional regimens for a patient (See Detailed Description of Akonur in Paragraph [0169]).
Claim(s) 9 mirrors claim 3 only within (a) different statutory category, and is rejected for the same reason as claim 3.
As per claim 4, Nilsson/Reid, Jr./Akonur/Bene discloses the system of claim 1 as described above. Nilsson further teaches wherein the control device is furthermore programmed to output a recommendation to the user to optimize control of the first blood treatment machine and/or control of the first water preparation system, with respect to times of individual operating modes (See Paragraphs [0040]-[0041]: Optionally, one or more operation step items of said operation step items can be displayed as recommended to be performed next with an indicator representing the recommendation when in another state than the first state, i.e. to provide further guidance in sense of the order of taking care of the steps, which the Examiner is interpreting an indicator representing the recommendation when in another state than the first state to encompass o output a recommendation to the user to optimize control of the first blood treatment machine and/or control of the first water preparation system, with respect to times of individual operating modes.)
Claim(s) 10 mirrors claim 4 only within (a) different statutory category, and is rejected for the same reason as claim 4.
As per claim 6, Nilsson/Reid, Jr./Akonur/Bene discloses the system of claims 1 and 4 as described above. Nilsson/Reid, Jr. may not explicitly teach wherein the control device is furthermore programmed to actuate an output with respect to savings potential in: (i) costs, and/or (ii) raw materials, and/or (iii) energy associated with, the generated indications with respect to the output recommendation to optimize the control, and/or with the at least one control instruction.
Akonur teaches a system wherein the control device is furthermore programmed to actuate an output with respect to savings potential in: (i) costs, and/or (ii) raw materials, and/or (iii) energy associated with, the generated indications with respect to the output recommendation to optimize the control, and/or with the at least one control instruction (See Paragraphs [0105]-[0107], [0144]: This model can eventually be used to optimize therapies with a HHD device to remove adequate amounts of phosphorus using minimum necessary volumes of dialysate (i.e., minimized water consumption), which the Examiner is interpreting using minimum necessary volumes of dialysate to encompass a savings potential in raw materials, and the optimization results can be shown on a display (Fig. 8A).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Nilsson/Reid, Jr.to include the control device is furthermore programmed to actuate an output with respect to savings potential in: (i) costs, and/or (ii) raw materials, and/or (iii) energy associated with, the generated indications with respect to the output recommendation to optimize the control, and/or with the at least one control instruction as taught by Akonur to determine the operation guidance of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr. with Akonur with the motivation of improving treatment and nutritional regimens for a patient (See Detailed Description of Akonur in Paragraph [0169]).
As per independent claim 7, Nilsson discloses a method for the coordinated control of first blood treatment machine of a blood treatment machine park, and of a first water preparation system of a water preparation system park, the blood treatment machine park comprising a plurality of blood treatment machines including the first blood treatment machine and the water preparation system park comprising a plurality of water preparation systems including the first water preparation system, the method comprising the steps of:
collating the first data relating to the first blood treatment machine and the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass collating first data relating to the first blood treatment machine and second data relating to the first water preparation system, and the UI controller may form a structure to encompass the second data being of a different format than the first data ([0033]) as the controller of the apparatus controls the operation of the functional processes ([0028]), which receives data from water treatment for the dialysis treatment and extracorporeal blood circuit mechanism);
consolidating different data formats of the first data relating to the first blood treatment machine and of the second data relating to the first water preparation system, on a common display device (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass consolidating different data formats ([0033]));
integrating the consolidated different data formats (See Paragraphs [0028]-[0029], [0049]: A representing object is arranged to collect information that may be enabled for user interaction with each operation step and represents that as an operation step item for the respective operation step, which the Examiner is interpreting collect information that may be enabled for user interaction to encompass integrating the consolidated different data formats as the information is collected for presentation);
displaying the first data relating to the first blood treatment machine and the second data relating to the first water preparation system, on a common display device (See Paragraphs [0053]-[0055]: A display control object provides control of what is to be displayed through the UI, which the Examiner is interpreting the display control object to encompass display the first data relating to the first blood treatment machine and the second data relating to the first water preparation system, on a common display device);
displaying a recommendation to release the output instruction so as to send the output instruction to the first blood treatment machine and/or to the first water preparation system (See Paragraphs [0040]-[0041]: Optionally, one or more operation step items of said operation step items can be displayed as recommended to be performed next with an indicator representing the recommendation when in another state than the first state, i.e. to provide further guidance in sense of the order of taking care of the steps, which the Examiner is interpreting the recommendation to encompass a recommendation to release the output instruction so as to send the output instruction to the first blood treatment machine and/or to the first water preparation system when combined with Reid, Jr.)
While Nilsson discloses the method as described above, Nilsson may not explicitly teach generating an output instruction for automatically regulating control of the first blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a control device determination;
releasing the output instruction in response to the recommendation; and
automatically regulating operation of the first blood treatment machine and/or of the first water preparation system, based on the released output instruction.
Reid, Jr. teaches a method for generating an output instruction for automatically regulating control of the first blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a control device determination (See Paragraphs [0033]-[0034], [0039]: A signal comprising a health intervention command coded to effectuate the interventional response can then be transmitted from the microprocessor to one or more interventional elements within the system, which the Examiner is interpreting a signal comprising a health intervention command coded to encompass an output instruction for automatically regulating control of the first blood treatment machine and/or of the first water preparation system, to optimize operation, when combined with Nilsson’s disclosure of the processor has determined this operation substep item as being available only after completion of another operation step or operation substep in Paragraphs [0062]);
releasing the output instruction in response to the recommendation (See Paragraphs [0033]-[0034]: A signal comprising a health intervention command coded to effectuate the interventional response can then be transmitted from the microprocessor to one or more interventional elements within the system, which the Examiner is interpreting transmitting the signal to encompass releasing the output instruction in response to the recommendation when combined with Nilsson’s disclosure of recommended next operation step ([0066])); and
automatically regulating operation of the first blood treatment machine and/or of the first water preparation system, based on the released output instruction (See Paragraph [0039]: The control system algorithm can include commands for activating a pump for flushing the dialysis access route when blood flow in the dialysis access route drops below a pre-set level, which the Examiner is interpreting commands to encompass automatically regulate operation when combined with Nilsson’s disclosure of water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nilsson to include generating an output instruction for automatically regulating control of the first blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a control device determination; releasing the output instruction in response to the recommendation; and automatically regulating operation of the first blood treatment machine and/or of the first water preparation system, based on the released output instruction as taught by Reid, Jr to determine the automatic operation of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson with Reid, Jr. with the motivation of providing dynamic management of therapeutic interventions (See Background of Reid, Jr. in Paragraph [0006]).
While Nilsson/Reid, Jr. discloses the method as described above, Nilsson/Reid, Jr. may not explicitly teach receiving, in real time, first data relating to the first blood treatment machine and second data relating to the first water preparation system, wherein the second data is in a different format than the first data, and the second data comprises data pertaining to an amount of water produced by the first water preparation system and a time period in which the first water preparation system is operated to produce pure water;
making the control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the first blood treatment machine.
Akonur teaches a method for receiving, in real time, first data relating to the first blood treatment machine and second data relating to the first water preparation system, wherein the second data is in a different format than the first data (See Paragraphs [0170], [0184]: The processor to operate with the display device and the input device to receive data relating to at least one of K.sub.R, K.sub.D, K.sub.M, V.sub.PRE, t.sub.tx, F, C.sub.PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum phosphorus concentration, and blood samples and dialysate samples can be collected, which the Examiner is interpreting blood samples to encompass the first data relating to the first blood treatment machine and interpreting dialysate samples to encompass the second data relating to the first water preparation system, and interpreting the blood samples and dialysate samples to encompass the second data is in a different format than the first data), and the second data comprises data pertaining to an amount of water produced by the first water preparation system and a time period in which the first water preparation system is operated to produce pure water (See Paragraphs [0081], [0084]-[0085], [0089], [0105]-[0106]: Running opposite to prediction component, the doctor in optimization component enters desired values for therapy results, e.g., a desired value for urea, e.g., via standard Kt/v, a desired value for phosphorus in, e.g., pre-dialysis phosphorus plasma concentration in milligrams per liter, a desired value for .beta.2-M in, e.g., milligrams per liter, and a desired ultrafiltrate ("UF") removal value, e.g., in liters, UF is generally a machine-controlled function but can affect solute removal, so the input of UF is desirable for optimization, which the Examiner is interpreting a desired UF removal value to encompass an amount of water produced by the water preparation system, and the therapy duration and blood and dialysate flow rates to encompass the time period in which the first water preparation system is operated to produce pure water);
making the control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the first blood treatment machine (See Paragraphs [0081], [0084]-[0085], [0089]: The estimated patient parameters are then fed back into the models in prediction component, particularly into the personalized solute flux and volume flux routine, the patient prediction component accepts other known, assumed or calculated (outside of the model) values for the particular solute, such as dialyzer clearance K.sub.D, into personalized solute flux and volume flux routine, which the Examiner is interpreting the therapy duration and blood and dialysate flow rates to encompass the time period in which the first water preparation system is operated to produce pure water, meet the respective requirements of the blood treatment machine when combined with Nilsson’s disclosure of a functional process may be water treatment for the dialysis treatment ([0028]).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nilsson/Reid, Jr. to include receiving, in real time, first data relating to the first blood treatment machine and second data relating to the first water preparation system, wherein the second data is in a different format than the first data, and the second data comprises data pertaining to an amount of water produced by the first water preparation system and a time period in which the first water preparation system is operated to produce pure water; making the control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the first blood treatment machine as taught by Akonur to determine the operation guidance of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr. with Akonur with the motivation of improving treatment and nutritional regimens for a patient (See Detailed Description of Akonur in Paragraph [0169]).
While Nilsson/Reid, Jr./Akonur discloses the method described above, Nilsson/Reid, Jr./Nilsson/Akonur may not explicitly teach the blood treatment machine park comprising a plurality of blood treatment machines including the first blood treatment machine and the water preparation system park comprising a plurality of water preparation systems including the first water preparation system.
Bene teaches a method for the blood treatment machine park comprising a plurality of blood treatment machines including the first blood treatment machine and the water preparation system park comprising a plurality of water preparation systems including the first water preparation system (See Paragraphs [0108]-[0137], [0250]-[0251]: A system for monitoring a plurality of patients affected by kidney failure over a time frame covering a plurality of blood treatment sessions, the system comprising: a plurality of blood treatment machines for the treatment of the monitored patients, each blood treatment machine including at least one respective control unit and sensors for measuring session parameters, the control unit of each blood treatment machine, which the Examiner is interpreting a plurality of blood treatment machines to encompass the blood treatment machine park comprising a plurality of blood treatment machines including the first blood treatment machine and interpreting the dialysate chamber for each blood treatment machine to encompass the water preparation the water preparation system park comprising a plurality of water preparation systems including the first water preparation system when combined with Akonur’s teachings in Paragraphs [0170], [0184] of “dialysate samples”.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nilsson/Reid, Jr./Akonur to include the blood treatment machine park comprising a plurality of blood treatment machines including the first blood treatment machine and the water preparation system park comprising a plurality of water preparation systems including the first water preparation system as taught by Bene to provide relevant data to the user of Nilsson (Paragraph [0029]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr./Akonur with Bene with the motivation of providing the user with a tool consolidating only relevant information (See Description of Illustrative Embodiments System of Akonur in Paragraph [0366]).
As per claim 12, Nilsson/Reid, Jr./Akonur/Bene discloses the method of claims 7 and 10 as described above. Nilsson/Reid, Jr. may not explicitly teach wherein the control device is furthermore programmed to actuate an output with respect to savings potential in: (i) costs, and/or (ii) raw materials, and/or (iii) energy associated with, the output recommendation to optimize the control, and/or with a corresponding control instruction to the first blood treatment machine and/or the first water preparation system.
Akonur teaches a system wherein the control device is furthermore programmed to actuate an output with respect to savings potential in: (i) costs, and/or (ii) raw materials, and/or (iii) energy associated with, the output recommendation to optimize the control, and/or with a corresponding control instruction to the first blood treatment machine and/or the first water preparation system (See Paragraphs [0105]-[0107], [0144]: This model can eventually be used to optimize therapies with a HHD device to remove adequate amounts of phosphorus using minimum necessary volumes of dialysate (i.e., minimized water consumption), which the Examiner is interpreting using minimum necessary volumes of dialysate to encompass a savings potential in raw materials, and the optimization results can be shown on a display (Fig. 8A).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nilsson/Reid, Jr.to include the control device is furthermore programmed to actuate an output with respect to savings potential in: (i) costs, and/or (ii) raw materials, and/or (iii) energy associated with, the output recommendation to optimize the control, and/or with a corresponding control instruction to the first blood treatment machine and/or the first water preparation system as taught by Akonur to determine the operation guidance of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr. with Akonur with the motivation of improving treatment and nutritional regimens for a patient (See Detailed Description of Akonur in Paragraph [0169]).
As per claim 13, Nilsson/Reid, Jr./Akonur/Bene discloses the system of claim 1 as described above. Nilsson further teaches wherein the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine, the common display device is configured to display first data relating to the second blood treatment machine and first data relating to the third blood treatment machine, and the control unit is further programmed to:
consolidate the different data formats of the first data relating to the second blood treatment machine and of the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass a control unit that is programmed to consolidate the different data formats ([0033])),
consolidate the different data formats of the first data relating to the third blood treatment machine and of the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass a control unit that is programmed to consolidate the different data formats ([0033])),
integrate the first data relating to the second blood treatment machine and the second data relating to the first water preparation system (See Paragraphs [0028]-[0029], [0049]: A representing object is arranged to collect information that may be enabled for user interaction with each operation step and represents that as an operation step item for the respective operation step, which the Examiner is interpreting collect information that may be enabled for user interaction to encompass integrate the first data relating to the second blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107])),
integrate the first data relating to the third blood treatment machine and the second data relating to the first water preparation system (See Paragraphs [0028]-[0029], [0049]: A representing object is arranged to collect information that may be enabled for user interaction with each operation step and represents that as an operation step item for the respective operation step, which the Examiner is interpreting collect information that may be enabled for user interaction to encompass integrate the first data relating to the third blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107])),
display together the first data relating to the second blood treatment machine and the second data relating to the first water preparation system, on the common display device (See Paragraphs [0053]-[0055]: A display control object provides control of what is to be displayed through the UI, which the Examiner is interpreting the display control object to encompass display together the first data relating to the second blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107])),
display together the first data relating to the third blood treatment machine and the second data relating to the first water preparation system, on the common display device (See Paragraphs [0053]-[0055]: A display control object provides control of what is to be displayed through the UI, which the Examiner is interpreting the display control object to encompass display together the first data relating to the third blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107])),
generate indications with respect to an optimized operation of the second blood treatment machine and of the first water preparation system (See Paragraphs [0059]-[0060]: The interaction has called upon displaying of a number of subitems which are displayed, and corresponding check boxes and/or status indicators may also be displayed, which the Examiner is interpreting the indicators to encompass indicators with respect to an optimized operation of the second blood treatment machine and of the first water preparation system as one or more operation step items of said operation step items can be displayed as recommended to be performed next with an indicator representing the recommendation when in another state than the first state ([0041])),
generate indications with respect to an optimized operation of the third blood treatment machine and of the first water preparation system (See Paragraphs [0059]-[0060]: The interaction has called upon displaying of a number of subitems which are displayed, and corresponding check boxes and/or status indicators may also be displayed, which the Examiner is interpreting the indicators to encompass indicators with respect to an optimized operation of the third blood treatment machine and of the first water preparation system as one or more operation step items of said operation step items can be displayed as recommended to be performed next with an indicator representing the recommendation when in another state than the first state ([0041])),
output at least one control instruction to the second blood treatment machine, based on a second control device determination (See Fig. 1 and Paragraphs [0028]-[0029], [0062]: A controller of the apparatus controls the operation of the functional processes; thus, the process controller may be a joint controller, a multitude of local controllers, or a hierarchy of controllers working together, the functional processes may be water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism, extracorporeal blood circuit mechanism, etc., which the Examiner is interpreting controls the operation of the functional processes to encompass output at least one control instruction to the second blood treatment machine, and interpreting the processor has determined this operation substep item as being available only after completion of another operation step or operation substep to encompass a second control device determination), and
output at least one control instruction to the third blood treatment machine, based on a third control device determination (See Fig. 1 and Paragraphs [0028]-[0029], [0062]: A controller of the apparatus controls the operation of the functional processes; thus, the process controller may be a joint controller, a multitude of local controllers, or a hierarchy of controllers working together, the functional processes may be water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism, extracorporeal blood circuit mechanism, etc., which the Examiner is interpreting controls the operation of the functional processes to encompass output at least one control instruction to the third blood treatment machine, and interpreting the processor has determined this operation substep item as being available only after completion of another operation step or operation substep to encompass a third control device determination),
While Nilsson/Reid, Jr. discloses a system to output at least one control instruction to the third blood treatment machine, based on a third control device determination, Nilsson/Reid, Jr. may not explicitly teach receive, in real time, the first data relating to the second blood treatment machine, in the first data format, and first data relating to the third blood treatment machine, in the first data format,
wherein the control device is configured to make the second control device determination by determining whether the amount of water produced by the first water preparation system, meet respective requirements of the second blood treatment machine, and
the control device is configured to make the third control device determination by determining whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the third blood treatment machine.
Akonur teaches a system for receive, in real time, the first data relating to the second blood treatment machine, in the first data format, and first data relating to the third blood treatment machine, in the first data format (See Paragraphs [0170], [0184]: The processor to operate with the display device and the input device to receive data relating to at least one of K.sub.R, K.sub.D, K.sub.M, V.sub.PRE, t.sub.tx, F, C.sub.PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum phosphorus concentration, and blood samples and dialysate samples can be collected, which the Examiner is interpreting blood samples to encompass the first data relating to the second blood treatment machine, in the first data format, and interpreting blood samples to encompass the first data relating to the third blood treatment machine, in the first data format when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107])),
wherein the control device is configured to make the second control device determination by determining whether the amount of water produced by the first water preparation system, meet respective requirements of the second blood treatment machine (See Paragraphs [0081], [0084]-[0085], [0089]: The estimated patient parameters are then fed back into the models in prediction component, particularly into the personalized solute flux and volume flux routine, the patient prediction component accepts other known, assumed or calculated (outside of the model) values for the particular solute, such as dialyzer clearance K.sub.D, into personalized solute flux and volume flux routine, which the Examiner is interpreting the therapy duration and blood and dialysate flow rates to encompass the time period in which the water preparation system is operated to produce pure water, meet the respective requirements of the second blood treatment machine when combined with Nilsson’s disclosure of a functional process may be water treatment for the dialysis treatment ([0028])), and
the control device is configured to make the third control device determination by determining whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the third blood treatment machine (See Paragraphs [0081], [0084]-[0085], [0089]: The estimated patient parameters are then fed back into the models in prediction component, particularly into the personalized solute flux and volume flux routine, the patient prediction component accepts other known, assumed or calculated (outside of the model) values for the particular solute, such as dialyzer clearance K.sub.D, into personalized solute flux and volume flux routine, which the Examiner is interpreting the therapy duration and blood and dialysate flow rates to encompass the time period in which the water preparation system is operated to produce pure water, meet the respective requirements of the third blood treatment machine when combined with Nilsson’s disclosure of a functional process may be water treatment for the dialysis treatment ([0028]).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Nilsson/Reid, Jr. to include receive, in real time, the first data relating to the second blood treatment machine, in the first data format, and first data relating to the third blood treatment machine, in the first data format, wherein the control device is configured to make the second control device determination by determining whether the amount of water produced by the first water preparation system, meet respective requirements of the second blood treatment machine, and the control device is configured to make the third control device determination by determining whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the third blood treatment machine as taught by Akonur to determine the operation guidance of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr. with Akonur with the motivation of improving treatment and nutritional regimens for a patient (See Detailed Description of Akonur in Paragraph [0169]).
While Nilsson/Reid, Jr./Akonur discloses the system described above, Nilsson/Reid, Jr./Nilsson/Akonur may not explicitly teach wherein the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine, the common display device is configured to display first data relating to the second blood treatment machine and first data relating to the third blood treatment machine.
Bene teaches a system wherein the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine, the common display device is configured to display first data relating to the second blood treatment machine and first data relating to the third blood treatment machine (See Paragraphs [0108]-[0137], [0250]: A system for monitoring a plurality of patients affected by kidney failure over a time frame covering a plurality of blood treatment sessions, the system comprising: a plurality of blood treatment machines for the treatment of the monitored patients, each blood treatment machine including at least one respective control unit and sensors for measuring session parameters, the control unit of each blood treatment machine, which the Examiner is interpreting a plurality of blood treatment machines to encompass a second blood treatment machine and a third blood treatment machine.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Nilsson/Reid, Jr./Akonur to include the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine, the common display device is configured to display first data relating to the second blood treatment machine and first data relating to the third blood treatment machine taught by Bene to provide relevant data to the user of Nilsson (Paragraph [0029]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr./Akonur with Bene with the motivation of providing the user with a tool consolidating only relevant information (See Description of Illustrative Embodiments System of Akonur in Paragraph [0366]).
As per claim 14, Nilsson/Reid, Jr./Akonur/Bene discloses the method of claim 7 as described above. Nilsson further teaches wherein the plurality of blood treatment machines of the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine, and the method further comprises the steps of:
collating the first data relating to the second blood treatment machine and the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass collating first data relating to the second blood treatment machine and second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]), and the UI controller may form a structure to encompass the second data being of a different format than the first data ([0033]) as the controller of the apparatus controls the operation of the functional processes ([0028]), which receives data from water treatment for the dialysis treatment and extracorporeal blood circuit mechanism);
collating the first data relating to the third blood treatment machine and the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass collating first data relating to the third blood treatment machine and second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]), and the UI controller may form a structure to encompass the second data being of a different format than the first data ([0033]) as the controller of the apparatus controls the operation of the functional processes ([0028]), which receives data from water treatment for the dialysis treatment and extracorporeal blood circuit mechanism);
consolidating the different data formats of the first data relating to the second blood treatment machine and of the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass consolidating the different data formats ([0033]));
consolidating the different data formats of the first data relating to the third blood treatment machine and of the second data relating to the first water preparation system (See Paragraphs [0028]-[0029]: The user interface (UI) is connected to the process controller for interchanging of signals, both for providing control data to process controller such that it is able to control the functional processes to make the apparatus perform the desired tasks of the user, and for receiving status and measured data from the controller to be able to adapt behaviour of the UI and/or present relevant data to the user, which the Examiner is interpreting the process controller to encompass consolidating the different data formats ([0033]));
integrating the consolidated different data formats of the first data relating to the second blood treatment machine and of the second data relating to the first water preparation system (See Paragraphs [0028]-[0029], [0049]: A representing object is arranged to collect information that may be enabled for user interaction with each operation step and represents that as an operation step item for the respective operation step, which the Examiner is interpreting collect information that may be enabled for user interaction to encompass integrate the first data relating to the second blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]));
integrating the consolidated different data formats of the first data relating to the third blood treatment machine and of the second data relating to the first water preparation system (See Paragraphs [0028]-[0029], [0049]: A representing object is arranged to collect information that may be enabled for user interaction with each operation step and represents that as an operation step item for the respective operation step, which the Examiner is interpreting collect information that may be enabled for user interaction to encompass integrate the first data relating to the third blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]));
displaying the first data relating to the second blood treatment machine and the second data relating to the first water preparation system, on the common display device (See Paragraphs [0053]-[0055]: A display control object provides control of what is to be displayed through the UI, which the Examiner is interpreting the display control object to encompass display together the first data relating to the second blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]));
displaying the first data relating to the third blood treatment machine and the second data relating to the first water preparation system, on the common display device (See Paragraphs [0053]-[0055]: A display control object provides control of what is to be displayed through the UI, which the Examiner is interpreting the display control object to encompass display together the first data relating to the third blood treatment machine and the second data relating to the first water preparation system when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]));
displaying a recommendation to release the second output instruction so as to send the second output instruction to the second blood treatment machine and/or to the first water preparation system (See Paragraphs [0040]-[0041]: Optionally, one or more operation step items of said operation step items can be displayed as recommended to be performed next with an indicator representing the recommendation when in another state than the first state, i.e. to provide further guidance in sense of the order of taking care of the steps, which the Examiner is interpreting the recommendation to encompass a recommendation to release the second output instruction so as to send the second output instruction to the second blood treatment machine and/or to the first water preparation system when combined with Reid, Jr. and Bene);
displaying a recommendation to release the third output instruction so as to send the third output instruction to the third blood treatment machine and/or to the first water preparation system (See Paragraphs [0040]-[0041]: Optionally, one or more operation step items of said operation step items can be displayed as recommended to be performed next with an indicator representing the recommendation when in another state than the first state, i.e. to provide further guidance in sense of the order of taking care of the steps, which the Examiner is interpreting the recommendation to encompass a recommendation to release the third output instruction so as to send the third output instruction to the third blood treatment machine and/or to the first water preparation system when combined with Reid, Jr. and Bene);
While Nilsson discloses the method as described above, Nilsson may not explicitly teach
generating a second output instruction for automatically regulating control of the second blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a second control device determination;
generating a third output instruction for automatically regulating control of the third blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a third control device determination;
releasing the second output instruction in response to the recommendation to release the second output instruction;
releasing the third output instruction in response to the recommendation to release the third output instruction;
automatically regulating operation of the second blood treatment machine and/or of the first water preparation system, based on the released second output instruction; and
automatically regulating operation of the third blood treatment machine and/or of the first water preparation system, based on the released third output instruction.
Reid, Jr. teaches a method for generating a second output instruction for automatically regulating control of the second blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a second control device determination (See Paragraphs [0033]-[0034], [0039]: A signal comprising a health intervention command coded to effectuate the interventional response can then be transmitted from the microprocessor to one or more interventional elements within the system, which the Examiner is interpreting a signal comprising a health intervention command coded to encompass a second output instruction for automatically regulating control of the second blood treatment machine and/or of the first water preparation system, to optimize operation, when combined with Nilsson’s disclosure of the processor has determined this operation substep item as being available only after completion of another operation step or operation substep in Paragraphs [0062] when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]));
generating a third output instruction for automatically regulating control of the third blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a third control device determination (See Paragraphs [0033]-[0034], [0039]: A signal comprising a health intervention command coded to effectuate the interventional response can then be transmitted from the microprocessor to one or more interventional elements within the system, which the Examiner is interpreting a signal comprising a health intervention command coded to encompass a third output instruction for automatically regulating control of the third blood treatment machine and/or of the first water preparation system, to optimize operation, when combined with Nilsson’s disclosure of the processor has determined this operation substep item as being available only after completion of another operation step or operation substep in Paragraphs [0062] when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]));
releasing the second output instruction in response to the recommendation to release the second output instruction (See Paragraphs [0033]-[0034]: A signal comprising a health intervention command coded to effectuate the interventional response can then be transmitted from the microprocessor to one or more interventional elements within the system, which the Examiner is interpreting transmitting the signal to encompass releasing the second output instruction in response to the recommendation when combined with Nilsson’s disclosure of recommended next operation step ([0066]));
releasing the third output instruction in response to the recommendation to release the third output instruction ((See Paragraphs [0033]-[0034]: A signal comprising a health intervention command coded to effectuate the interventional response can then be transmitted from the microprocessor to one or more interventional elements within the system, which the Examiner is interpreting transmitting the signal to encompass releasing the third output instruction in response to the recommendation when combined with Nilsson’s disclosure of recommended next operation step ([0066]));
automatically regulating operation of the second blood treatment machine and/or of the first water preparation system, based on the released second output instruction (See Paragraphs [0039]: The control system algorithm can include commands for activating a pump for flushing the dialysis access route when blood flow in the dialysis access route drops below a pre-set level, which the Examiner is interpreting commands to encompass automatically regulating operation when combined with Nilsson’s disclosure of water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism); and
automatically regulating operation of the third blood treatment machine and/or of the first water preparation system, based on the released third output instruction (See Paragraphs [0039]: The control system algorithm can include commands for activating a pump for flushing the dialysis access route when blood flow in the dialysis access route drops below a pre-set level, which the Examiner is interpreting commands to encompass automatically regulating operation when combined with Nilsson’s disclosure of water treatment for the dialysis treatment or preparation of dialysis fluid, rinsing mechanism.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nilsson to include generating a second output instruction for automatically regulating control of the second blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a second control device determination; generating a third output instruction for automatically regulating control of the third blood treatment machine and/or of the first water preparation system, to optimize operation, the output instruction being based on a third control device determination; releasing the second output instruction in response to the recommendation to release the second output instruction; releasing the third output instruction in response to the recommendation to release the third output instruction; automatically regulating operation of the second blood treatment machine and/or of the first water preparation system, based on the released second output instruction; and automatically regulating operation of the third blood treatment machine and/or of the first water preparation system, based on the released third output instruction as taught by Reid, Jr to determine the automatic operation of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson with Reid, Jr. with the motivation of providing dynamic management of therapeutic interventions (See Background of Reid, Jr. in Paragraph [0006]).
While Nilsson/Reid, Jr. discloses the method as described above, Nilsson/Reid, Jr. may not explicitly teach receiving, in real time, first data relating to the second blood treatment machine and first data relating to the third blood treatment machine, wherein the second data is in a different format than the first data relating to the second blood treatment machine and in a different format than the first data relating to the third blood treatment machine;
making the second control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the second blood treatment machine;
making the third control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the third blood treatment machine.
Akonur teaches a method for receiving, in real time, first data relating to the second blood treatment machine and first data relating to the third blood treatment machine, wherein the second data is in a different format than the first data relating to the second blood treatment machine and in a different format than the first data relating to the third blood treatment machine (See Paragraphs [0170], [0184]: The processor to operate with the display device and the input device to receive data relating to at least one of K.sub.R, K.sub.D, K.sub.M, V.sub.PRE, t.sub.tx, F, C.sub.PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum phosphorus concentration, and blood samples and dialysate samples can be collected, which the Examiner is interpreting blood samples to encompass the first data relating to the second blood treatment machine and the first data relating to the third blood treatment machine and interpreting the blood samples being measured at different blood treatment machines to encompass the second data is in a different format than the first data relating to the second blood treatment machine and in a different format than the first data relating to the third blood treatment machine when combined with Bene’s teachings of a plurality of blood treatment machines ([0090]-[0107]));
making the second control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the second blood treatment machine (See Paragraphs [0081], [0084]-[0085], [0089]: The estimated patient parameters are then fed back into the models in prediction component, particularly into the personalized solute flux and volume flux routine, the patient prediction component accepts other known, assumed or calculated (outside of the model) values for the particular solute, such as dialyzer clearance K.sub.D, into personalized solute flux and volume flux routine, which the Examiner is interpreting the therapy duration and blood and dialysate flow rates to encompass the time period in which the water preparation system is operated to produce pure water, meet the respective requirements of the second blood treatment machine when combined with Nilsson’s disclosure of a functional process may be water treatment for the dialysis treatment ([0028]));
making the third control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the third blood treatment machine (See Paragraphs [0081], [0084]-[0085], [0089]: The estimated patient parameters are then fed back into the models in prediction component, particularly into the personalized solute flux and volume flux routine, the patient prediction component accepts other known, assumed or calculated (outside of the model) values for the particular solute, such as dialyzer clearance K.sub.D, into personalized solute flux and volume flux routine, which the Examiner is interpreting the therapy duration and blood and dialysate flow rates to encompass the time period in which the water preparation system is operated to produce pure water, meet the respective requirements of the third blood treatment machine when combined with Nilsson’s disclosure of a functional process may be water treatment for the dialysis treatment ([0028]).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nilsson/Reid, Jr. to include receiving, in real time, first data relating to the second blood treatment machine and first data relating to the third blood treatment machine, wherein the second data is in a different format than the first data relating to the second blood treatment machine and in a different format than the first data relating to the third blood treatment machine; making the second control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the second blood treatment machine; making the third control device determination by determining, based on the second data, whether the amount of water produced by the first water preparation system, and the time period in which the first water preparation system is operated to produce pure water, meet respective requirements of the third blood treatment machine as taught by Akonur to determine the operation guidance of Nilsson (Paragraph [0010]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr. with Akonur with the motivation of improving treatment and nutritional regimens for a patient (See Detailed Description of Akonur in Paragraph [0169]).
While Nilsson/Reid, Jr./Akonur discloses the method described above, Nilsson/Reid, Jr./Nilsson/Akonur may not explicitly teach wherein the plurality of blood treatment machines of the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine.
Bene teaches a method wherein the plurality of blood treatment machines of the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine (See Paragraphs [0108]-[0137], [0250]: A system for monitoring a plurality of patients affected by kidney failure over a time frame covering a plurality of blood treatment sessions, the system comprising: a plurality of blood treatment machines for the treatment of the monitored patients, each blood treatment machine including at least one respective control unit and sensors for measuring session parameters, the control unit of each blood treatment machine, which the Examiner is interpreting a plurality of blood treatment machines to encompass a second blood treatment machine and a third blood treatment machine.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nilsson/Reid, Jr./Akonur to include the plurality of blood treatment machines of the blood treatment machine park comprises a second blood treatment machine and a third blood treatment machine taught by Bene to provide relevant data to the user of Nilsson (Paragraph [0029]). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nilsson/Reid, Jr./Akonur with Bene with the motivation of providing the user with a tool consolidating only relevant information (See Description of Illustrative Embodiments System of Akonur in Paragraph [0366]).
Response to Arguments
In the Remarks filed on February 10, 2026, the Applicant argues that the newly amended and/or added claims overcome the 35 U.S.C. 101 rejection(s) and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the 35 U.S.C. 101 rejection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the newly added Claim Objection(s) and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) neither Nilsson, Reid, Jr. et al., nor Akonur et al. discloses or suggests a clinic setting that includes a plurality of blood treatment machines (a blood treatment machine park) and a plurality of water treatment systems (a water treatment system park). Even if Nilsson, Reid, Jr. et al., and Akonur et al. were to have been properly combined, the presently claimed invention would still not have resulted. For this reason alone, the presently claimed invention is neither taught nor suggested by the cited combination of references. In view of the foregoing, it is respectfully submitted that each of claims 1 and 7 is patentably distinguishable from the combination and Nilsson, Reid, Jr. et al., and Akonur et al. Each of claims 1 and 7 defines patentable subject matter and should be found allowable. Each of claims 2-4, 6, 8-10, and 12 depends directly or indirectly from claim 1 or claim 7 and should be allowable for the same reasons why claims 1 and 7 should be allowable, as discussed above. Each of new claims 13 and 14 depends directly from claim 1 or claim 7 and should be allowable for the same reasons why claims 1 and 7 should be allowable, as discussed above. In view of the foregoing, reconsideration and withdrawal of the rejection are respectfully requested.
In response to argument (1), the Examiner finds the Applicant’s argument(s) persuasive. The Examiner has supplemented the combination of Nilsson (U.S. Patent Pre-Grant Publication No. 2016/0292377) in view of Reid, Jr. et al. (U.S. Patent Pre-Grant Publication No. 2009/0234262) in view of Akonur et al. (U.S. Patent Pre-Grant Publication No. 2011/0257891) with Bene et al. (U.S. Patent Pre-Grant Publication No. 2013/0317850) to teach the newly amended claims and added claims as described above in the 35 U.S.C. 103 rejection(s). The 35 U.S.C. 103 rejection(s) stand.
Conclusion
THIS ACTION IS MADE FINAL. 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 Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
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