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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/18/2023, 07/15/2024, 01/28/2025, and 03/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 18 is objected to because of the following informalities:
In claim 18, line 12, “that t by end” should read “that by end”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the predicted value" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, Examiner currently interprets claim 20 to be dependent on claim 19, as the predicted clearance value was previously introduced in claim 19.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
In January, 2019 (updated October 2019), the USPTO released new examination guidelines setting forth a two-step inquiry for determining whether a claim is directed to non-statutory subject matter. According to the guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that claim 1 is directed toward non-statutory subject matter, as shown below:
STEP 1: Does claim 1 fall within one of the statutory categories? Yes. The claims are directed toward a computer-implemented method executable by a processor of a dialysis machine (claim 1), a dialysis system (claim 10), and one or more computer readable media (claim 18).
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? Yes, the claims are directed to an abstract idea.
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 1:
A computer-implemented method executable by a processor of a dialysis machine, the method comprising:
determining, based on a prescription received from an external source, a treatment time of a dialysis treatment for a patient;
[…]
predicting, based on (i) the treatment time, (ii) the amount of bicarbonate left in the bicarbonate source, and (iii) the dialysate flow rate, that by end of the dialysis treatment no more than a specific threshold amount of bicarbonate will be left in the bicarbonate source, and in response,
determining that a clearance value during the treatment is or will be higher than a specific threshold clearance value.
Claim 10:
A dialysis system comprising:
[…]
determining, based on a prescription received from an external source, a treatment time of a dialysis treatment for a patient;
predicting, based on (i) the treatment time, (ii) the amount of bicarbonate left in the bicarbonate source, and (iii) the dialysate flow rate, that by end of the dialysis treatment no more than a specific threshold amount of bicarbonate will be left in the bicarbonate source, and in response,
determining that a clearance value during the treatment is or will be higher than a specific threshold clearance value.
Claim 18:
One or more computer readable media storing instructions that are executable by a processing device, and upon such execution cause the processing device to perform operations comprising:
determining, based on a prescription received for a patient from an external source, a treatment time of a dialysis treatment for the patient;
predicting, based on (i) the treatment time, (ii) the amount of bicarbonate left in the bicarbonate source, and (iii) the dialysate flow rate, that t by end of the dialysis treatment no more than a specific threshold amount of bicarbonate will be left in the bicarbonate source, and in response;
determining that a clearance value during the treatment is or will be higher than a specific threshold clearance value.
The examiner submits that the foregoing bolded limitations constitute mental processes because under its broadest reasonable interpretation, the claims cover a judgment or evaluation that can be practicably performed in the human mind. As such, claim 1, 10, and 18 recite an abstract idea.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Claim 1:
A computer-implemented method executable by a processor of a dialysis machine, the method comprising: determining, based on a prescription received from an external source, a treatment time of a dialysis treatment for a patient; receiving, from a first sensor of the dialysis machine, an amount of bicarbonate left in a bicarbonate source attached to the dialysis machine; receiving, from at least one second sensor of the dialysis machine, a dialysate flow rate of dialysate running in the machine, the dialysate comprising bicarbonate pumped out of the bicarbonate source; and predicting, based on (i) the treatment time, (ii) the amount of bicarbonate left in the bicarbonate source, and (iii) the dialysate flow rate, that by end of the dialysis treatment no more than a specific threshold amount of bicarbonate will be left in the bicarbonate source, and in response, determining that a clearance value during the treatment is or will be higher than a specific threshold clearance value, and sending, to a balancing system that receives the dialysate, an instruction to change a switching rate to reduce the dialysate flow rate to a reduced rate, the balancing system being part of the dialysis machine, wherein the reduced rate results in reducing a rate of bicarbonate pumped out of the bicarbonate source while maintaining a clearance value at no less than the clearance threshold value.
The examiner submits that the above identified additional limitations do not integrate the previously discussed abstract idea into a practical application. The bolded limitations are not an exemplary consideration that indicate an abstract idea having been integrated into practical application. Said limitations are claimed generically and does no more than generally link the use of a judicial exception a particular technological environment, i.e. generally linking the controller to execute the abstract idea which does not add significantly more or limit the claim meaningfully. In addition, said limitation amounts to mere updating intangible data, i.e. a signal, that has yet to show any physical outcomes to the medical device. Thus, it is a form of extra solution activity. This analysis is also applied to the substantially similar limitations of claim 10 and 18.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claim does not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above. Applicant simply appends a routine and convention activity, i.e., a first sensor and a second sensor, previously known to the industry, as evidenced by Yuds et al. US 2019/0388600 A1, as cited in the IDS, in Par. 6 – “Current machines test depletion of bicarbonate using conductivity sensors” and “Current machines... to determine the proper volume of container, the patient or operator must consult a manual for a table that provides an approximate depletion time based on the prescribed flow rate”, specified at a high level of generality as described in Par. 46 and 54 of Applicant’s PG-Pub, to the abstract idea, which indicative that an inventive concept may not be present. The function of the controller, oxygenator, and pump is claimed in a generic manner of their intended use and does not amount to significantly more to the abstract idea. This analysis is also applied to the substantially similar limitations of claim 10 and 18.
Conclusion
Thus, since claims 1, 10, and 18 are: (a) directed towards abstract ideas, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that claim 1, 10, and 18 are directed towards non-statutory subject matter.
Dependent claims 2-9, 11-17, and 19-20 do not recite any further limitations that cause the claim to be patent eligible. The limitations of the dependent claims are directed towards additional aspects of the judicial exception and/or additional elements that do not integrate the judicial exception into a practical application.
As such, claims 1-20 are rejected under 35 U.S.C 101 as being drawn to an abstract idea without significantly more, and thus are ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 7, 10-12, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yuds et al. US 2019/0388600 A1 (hereinafter Yuds), as cited in the IDS, in view of Hogard et al. US 2020/0061273 A1 (hereinafter Hogard), as cited in the IDS.
Regarding claim 1, Yuds discloses a computer-implemented method (Par. 25-28) executable by a processor 114 (Fig. 1 – processor 114) of a dialysis machine 100 (Fig. 1 – dialysis system 100), the method comprising:
determining, based on a prescription received from an external source, a treatment time of a dialysis treatment for a patient (Par. 42 – “the dialysis machine is also configured to detect the time at which bicarbonate concentrate will be depleted… and the prescription inputted into the dialysis machine. The prescription includes…, treatment time…”);
receiving, from a first sensor 414 (Fig. 4 – conductivity sensor 414) of the dialysis machine 100 (Fig, 1), an amount of bicarbonate left in a bicarbonate source 408 (Fig. 4 – container 408, and Par. 52 – “The conductivity sensor 414 is configured to sense the conductivity of a fluid in the line downstream of the outlet 410 and is connected to the processor. The conductivity sensor is sends signals containing conductivity information to the processor. The conductivity information can be used to determine when Bicarbonate levels are below a threshold, for example 20% depleted”) attached to the dialysis machine 100 (Fig. 1);
receiving, from at least one second sensor 418 (Fig. 4 – flow rate sensor 418) of the dialysis machine 100 (Fig. 1), a dialysate flow rate of dialysate running in the machine 100 (Fig. 1, and Par. 52), the dialysate comprising bicarbonate pumped out of the bicarbonate source 408 (Fig. 4, and Par. 6 – “The dialysis machine then moves the saturated bicarbonate solution to mix with acid solution and additional substances in a chamber, to create dialysate”); and
predicting, based on (i) the treatment time, (ii) the amount of bicarbonate left in the bicarbonate source, and (iii) the dialysate flow rate (Fig. 6, and Par. 58), that by end of the dialysis treatment no more than a specific threshold amount of bicarbonate will be left in the bicarbonate source (Par. 52 – “The conductivity information can be used to determine when Bicarbonate levels are below a threshold, for example 20% depleted”), and in response,
determining that a clearance value (Fig. 5 – “dialysis flow Qd”) during the treatment is or will be higher than a specific threshold clearance value (Fig. 5, and Par. 56 – “The table 500 is used to manually finding the depletion time by first knowing the volume of the container 504, and using the level of bicarbonate and the flow rate”; thus the running clearance value can be compared against said Table 500 to determine if it is higher than the flow rate established in the Table 500), and
sending an instruction to change a switching rate (Par. 65 – “If the depletion time is less than the treatment time, the operator will be notified 812 and prompted to change the container, adjust the prescription, or continue with treatment”, wherein the prescription has been established in Par. 42 to include a flow rate).
However, Yuds does not disclose sending, to a balancing system that receives the dialysate, an instruction to reduce the dialysate flow rate to a reduced rate, the balancing system being part of the dialysis machine, wherein the reduced rate results in reducing a rate of bicarbonate pumped out of the bicarbonate source while maintaining a clearance value at no less than the clearance threshold value.
Hogard, in the same field of endeavor of dialysis systems and methods (Title), teaches sending, to a balancing system 226+227 (Fig. 16 – dialysate pump 226 and used dialysate pump 227, and Par. 151 – “dynamic balancing”) that receives the dialysate (Par. 151), an instruction 2014 (Fig. 20) to reduce the dialysate flow rate to a reduced rate (Par. 134 – “at step 2014 of flowchart 2000, the dialysate flow rate can be reduced to a flow rate”), the balancing system being part of the dialysis machine (Fig. 16, and Par. 146 – subsystem 164 is a part of the dialysis delivery system),
wherein the reduced rate results in reducing a rate of bicarbonate pumped out of the bicarbonate source (Fig. 14, Fig. 20, and Par. 130 – “the dialysis system of the present disclosure can conserve dialysate concentrate by actively monitoring the amount of dialysate used during therapy and modulating the dialysate flow rate to lower the consumption of acid and bicarbonate concentrates”, and Par. 131 – “Depending on treatment goal, running at a lower dialysate flow rate may be appropriate”) while maintaining a clearance value at no less than the clearance threshold value (Par. 131 – “The onboard monitoring of dialysate consumption, and real-time dialysate flow rate control, allows for laissez faire dialysis treatments while retaining appropriate device efficiency”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yuds to further incorporate and send instruction to a balancing system to lower the bicarbonate consumption while maintaining clearance as taught by Hogard, in order to conserve dialysate concentrate, such as bicarbonate concentrates (Par. 130 of Hogard) and in order to provide a gentler physiological effect on the body via lower rates for patients dialyzing at night (Par. 131 of Hogard).
Regarding claim 2, Yuds in view of Hogard discloses the invention of claim 1. Yuds in view of Hogard further discloses wherein the determined clearance value is or is determined based on a current clearance value of the treatment (Par. 56 of Yuds and as discussed in claim 1, “The table 500 is used to manually finding the depletion time by first knowing the volume of the container 504, and using the level of bicarbonate and the flow rate”; thus the running clearance value can be compared against said Table 500 to determine if it is higher than the flow rate established in the Table 500).
However, Yuds in view of Hogard does not currently disclose the method further comprises determining the current clearance value by: receiving, from multiple third sensors, measurements of respective conductivity values of the dialysate running to or from a dialyzer of the dialysis machine; and calculating the current clearance value based on the received conductivity values.
Hogard, in the same field of endeavor of dialysis systems and methods (Title), teaches the method further comprises determining the current clearance value (Par. 121 – “…to measure solute clearance”) by: receiving, from multiple third sensors 196 (Fig. 14 – conductivity sensors 196, and Par. 121 – “subsystem can include on or more conductivity sensors 196…”), measurements of respective conductivity values of the dialysate (Fig. 14, and Par. 141 – “conductivity sensors 196 to monitor the fluid during the dialysate preparation”) running to the dialysis machine (Fig. 14 – “”to Ultrafilter and Dialyzer”); and
calculating the current clearance value based on the received conductivity values (Par. 121 – “subsystem can include on or more conductivity sensors 196 configured to measure the conductivity of water flowing through the subsystem to measure solute clearance”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yuds in view of Hogard to further incorporate multiple sensors to measure conductivity values and calculate clearance values as taught by Hogard, in order to monitor the fluid during the dialysate preparation (Par. 141 of Hogard) and confirm that the composition is correct (Par. 141 of Hogard).
Regarding claim 7, Yuds in view of Hogard discloses the invention of claim 1. Yuds in view of Hogard further discloses wherein the instruction to change (Par. 65 of Yuds) the switching rate comprises a rate reduction amount for the switching rate (Par. 130 of Hogard – “the dialysis system of the present disclosure can conserve dialysate concentrate by actively monitoring the amount of dialysate used during therapy and modulating the dialysate flow rate to lower the consumption of acid and bicarbonate concentrates”, and Fig. 20 of Hogard, step 20, a reduction from 300 ml/min to 100 ml/min).
Once the modification is made as discussed in claim 1, the reduced rate of Hogard will be incorporated into the method of Yuds, including the rate reduction amount. Thus, the limitation is met.
Regarding claim 10, Yuds discloses a dialysis system 100 (Fig. 1 – dialysis system 100) comprising:
a dialyzer 112 (Fig. 1 – dialyzer 112);
a first sensor 414 (Fig. 4 – conductivity sensor 414) operatively connected to a bicarbonate source 408 (Fig. 4 – container 408, and Par. 52 – “The container 408, as described in FIG. 2, contains bicarbonate powder”) attached to the dialysis machine 100 (Fig. 1, Par. 52 discusses that the dialysis flow line 400 of dialysis machine), and configured to measure an amount of bicarbonate left in the bicarbonate source 408 (Fig. 4, and Par. 52 – “The conductivity sensor 414 is configured to sense the conductivity of a fluid in the line downstream of the outlet 410 and is connected to the processor. The conductivity sensor is sends signals containing conductivity information to the processor. The conductivity information can be used to determine when Bicarbonate levels are below a threshold, for example 20% depleted”);
a fluid line 400 (Fig. 4 – dialysis flow line 400) for passing dialysate from the bicarbonate source 408 (Fig. 4) to a system 422 (Fig. 4 – bicarbonate pump 422, and Par. 52 – “a dialysis flow line 400 including… a bicarbonate pump 422 leading to a dialyzer 112”);
a second sensor 418 (Fig. 4 – flow rate sensor 418) configured to measure a dialysate flow rate of dialysate running in the fluid line 400 (Fig. 4), the dialysate comprising bicarbonate pumped out of the bicarbonate source 408 (Fig. 4, and Par. 6 – “The dialysis machine then moves the saturated bicarbonate solution to mix with acid solution and additional substances in a chamber, to create dialysate”);
the system 422 (Fig. 4) configured to transfer clean dialysate from the fluid line 400 (Fig. 4) to the dialyzer 122 (Fig. 1, and Par. 52 – “a dialysis flow line 400 including… a bicarbonate pump 422 leading to a dialyzer 112”); and
a processor 114 (Fig. 1 – processor 114) configured to perform operations comprising:
determining, based on a prescription received from an external source, a treatment time of a dialysis treatment for a patient (Par. 42 – “the dialysis machine is also configured to detect the time at which bicarbonate concentrate will be depleted… and the prescription inputted into the dialysis machine. The prescription includes…, treatment time…”);
receiving, from the first sensor 414 (Fig. 4), the amount of bicarbonate left in the bicarbonate source 408 (Fig. 4 – container 408, and Par. 52 – “The conductivity sensor 414 is configured to sense the conductivity of a fluid in the line downstream of the outlet 410 and is connected to the processor. The conductivity sensor is sends signals containing conductivity information to the processor. The conductivity information can be used to determine when Bicarbonate levels are below a threshold, for example 20% depleted”);
receiving, from the second sensor 418 (Fig. 4), the dialysate flow rate (Par. 52);
predicting, based on (i) the treatment time, (ii) the amount of bicarbonate left in the bicarbonate source, and (iii) the dialysate flow rate (Fig. 6, and Par. 58), that by end of the dialysis treatment no more than a specific threshold amount of bicarbonate will be left in the bicarbonate source (Par. 52 – “The conductivity information can be used to determine when Bicarbonate levels are below a threshold, for example 20% depleted”), and in response,
determining that a clearance value (Fig. 5 – “dialysis flow Qd”) during the treatment is or will be higher than a specific threshold clearance value (Fig. 5, and Par. 56 – “The table 500 is used to manually finding the depletion time by first knowing the volume of the container 504, and using the level of bicarbonate and the flow rate”; thus the running clearance value can be compared against said Table 500 to determine if it is higher than the flow rate established in the Table 500), and
sending an instruction to change the switching rate (Par. 65 – “If the depletion time is less than the treatment time, the operator will be notified 812 and prompted to change the container, adjust the prescription, or continue with treatment”, wherein the prescription has been established in Par. 42 to include a flow rate).
However, Yuds does not disclose a balancing system, the balancing system configured to drain used dialysate from the dialyzer to a drainage, wherein the balancing system comprises a switch with a status that changes with a switch rate, wherein a change in the switch rate causes a change in the dialysis flow rate running through the fluid line; and sending, to the balancing system, an instruction to reduce the dialysate flow rate to a reduced rate, wherein the reduced rate results in reducing a rate of bicarbonate pumped out of the bicarbonate source while maintaining a clearance value at no less than the threshold clearance value.
Hogard, in the same field of endeavor of dialysis systems and methods (Title), teaches a balancing system 226+227 (Fig. 16 – dialysate pump 226 and used dialysate pump 227, and Par. 151 – “dynamic balancing”), the balancing system 226+227 (Fig. 16) configured to drain used dialysate from the dialyzer 126 (Fig. 16 – dialyzer 126) to a drainage (Fig. 16 – the used dialysate pump 227 is capable of draining a used dialysate from the dialyzer), wherein the balancing system 226+227 (Fig. 16) comprises a switch 177 (Fig. 16 – valves 177) with a status that changes with a switch rate (Par. 146 –“…one or more actuators or valves 177 that can be controlled to allow dialysate to pass through the dialyzer 126”), wherein a change in the switch rate causes a change in the dialysis flow rate running through the fluid line (Par. 146); and
sending, to a balancing system 226+227 (Fig. 16 – dialysate pump 226 and used dialysate pump 227, and Par. 151 – “dynamic balancing”), an instruction 2014 (Fig. 20) to reduce the dialysate flow rate to a reduced rate (Par. 134 – “at step 2014 of flowchart 2000, the dialysate flow rate can be reduced to a flow rate”), the balancing system being part of the dialysis machine (Fig. 16, and Par. 146 – subsystem 164 is a part of the dialysis delivery system),
wherein the reduced rate results in reducing a rate of bicarbonate pumped out of the bicarbonate source (Fig. 14, Fig. 20, and Par. 130 – “the dialysis system of the present disclosure can conserve dialysate concentrate by actively monitoring the amount of dialysate used during therapy and modulating the dialysate flow rate to lower the consumption of acid and bicarbonate concentrates”, and Par. 131 – “Depending on treatment goal, running at a lower dialysate flow rate may be appropriate”) while maintaining a clearance value at no less than the clearance threshold value (Par. 131 – “The onboard monitoring of dialysate consumption, and real-time dialysate flow rate control, allows for laissez faire dialysis treatments while retaining appropriate device efficiency”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yuds to further incorporate and send instruction to a balancing system to lower the bicarbonate consumption while maintaining clearance as taught by Hogard, in order to conserve dialysate concentrate, such as bicarbonate concentrates (Par. 130 of Hogard) and in order to provide a gentler physiological effect on the body via lower rates for patients dialyzing at night (Par. 131 of Hogard).
Regarding claim 11, Yuds in view of Hogard discloses the invention of claim 10. However, Yuds in view of Hogard does not disclose further comprising multiple third sensors operatively connected to the fluid line of the dialysis machine, the third sensors being configured to measure respective conductivity values of the dialysate running to or from the dialyzer.
Hogard, in the same field of endeavor of dialysis systems and methods (Title), teaches further comprising multiple third sensors 196 (Fig. 14 – conductivity sensors 196, and Par. 121 – “subsystem can include on or more conductivity sensors 196…”) operatively connected to the fluid line of the dialysis machine (Fig. 14 shows a subsystem of the dialysis delivery system).
the third sensors 196 (Fig. 14, and Par. 141) being configured to measure respective conductivity values of the dialysate running to (Fig. 14, and Par. 141 – “conductivity sensors 196 to monitor the fluid during the dialysate preparation”) the dialyzer (Fig. 14 – ”to Ultrafilter and Dialyzer”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yuds in view of Hogard to further incorporate multiple sensors to measure conductivity values as taught by Hogard, in order to further monitor the fluid during the dialysate preparation (Par. 141 of Hogard).
Regarding claim 12, Yuds in view of Hogard discloses the invention of claim 11. Yuds in view of Hogard further discloses wherein the determined clearance value is or is determined based on a current clearance value of the treatment (Par. 56 of Yuds and as discussed in claim 1, “The table 500 is used to manually finding the depletion time by first knowing the volume of the container 504, and using the level of bicarbonate and the flow rate”; thus the running clearance value can be compared against said Table 500 to determine if it is higher than the flow rate established in the Table 500), and the operations further comprise determining the current clearance value (Par. 121 of Hogard – “…to measure solute clearance”) by:
receiving, from the multiple third sensors, the respective conductivity values 196 (Fig. 14 of Hogard – conductivity sensors 196, and Par. 121 of Hogard – “subsystem can include on or more conductivity sensors 196…”).
Examiner notes that once the modification is made as discussed in claim 11, the third sensors 196 of Hogard will be incorporated into the device of Yuds, including the function of measuring conductivity values. Thus, the limitation is met.
However, Yuds in view of Hogard does not currently disclose calculating the current clearance value based on the received conductivity values.
Hogard, in the same field of endeavor of dialysis systems and methods (Title), teaches calculating the current clearance value based on the received conductivity values (Par. 121 – “subsystem can include on or more conductivity sensors 196 configured to measure the conductivity of water flowing through the subsystem to measure solute clearance”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yuds in view of Hogard to further incorporate calculating clearance values as taught by Hogard, in order to monitor the fluid during the dialysate preparation (Par. 141 of Hogard) and confirm that the composition is correct (Par. 141 of Hogard).
Regarding claim 17, Yuds in view of Hogard discloses the invention of claim 10. Yuds in view of Hogard further discloses wherein the instruction to change (Par. 65 of Yuds) the switching rate comprises a rate reduction amount for the switching rate (Par. 130 of Hogard – “the dialysis system of the present disclosure can conserve dialysate concentrate by actively monitoring the amount of dialysate used during therapy and modulating the dialysate flow rate to lower the consumption of acid and bicarbonate concentrates”, and Fig. 20, step 20, a reduction from 300 ml/min to 100 ml/min).
Once the modification is made as discussed in claim 10, the reduced rate of Hogard will be incorporated into the method of Yuds, including the rate reduction amount. Thus, the limitation is met.
Regarding claim 18, Yuds discloses one or more computer readable media storing instructions (Par. 72 – “Computer readable media suitable for storing computer program instructions”) that are executable by a processing device 114 (Fig. 1 – processor 114, and Par. 72 – “The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry”), and upon such execution cause the processing device 114 (Fig. 1) to perform operations comprising:
determining, based on a prescription received for a patient from an external source, a treatment time of a dialysis treatment for the patient (Par. 42 – “the dialysis machine is also configured to detect the time at which bicarbonate concentrate will be depleted… and the prescription inputted into the dialysis machine. The prescription includes…, treatment time…”);
receiving, from a first sensor 414 (Fig. 4 – conductivity sensor 414) of the dialysis machine 100 (Fig. 1), an amount of bicarbonate left in a bicarbonate source 408 (Fig. 4, and Par. 52 – “The conductivity sensor 414 is configured to sense the conductivity of a fluid in the line downstream of the outlet 410 and is connected to the processor. The conductivity sensor is sends signals containing conductivity information to the processor. The conductivity information can be used to determine when Bicarbonate levels are below a threshold, for example 20% depleted”) attached to the dialysis machine 100 (Fig. 1, Par. 52 discusses that the dialysis flow line 400 of dialysis machine);
receiving, from at least one second sensor 418 (Fig. 4 – flow rate sensor 418) of the dialysis machine 100 (Fig. 1), a dialysate flow rate of dialysate running in the machine 100 (Fig. 1, and Par. 52), the dialysate comprising bicarbonate pumped out of the bicarbonate source 408 (Fig. 4, and Par. 6 – “The dialysis machine then moves the saturated bicarbonate solution to mix with acid solution and additional substances in a chamber, to create dialysate”);
predicting, based on (i) the treatment time, (ii) the amount of bicarbonate left in the bicarbonate source, and (iii) the dialysate flow rate (Fig. 6, and Par. 58), that by end of the dialysis treatment no more than a specific threshold amount of bicarbonate will be left in the bicarbonate source (Par. 52 – “The conductivity information can be used to determine when Bicarbonate levels are below a threshold, for example 20% depleted”), and in response;
determining that a clearance value (Fig. 5 – “dialysis flow Qd”) during the treatment is or will be higher than a specific threshold clearance value (Fig. 5, and Par. 56 – “The table 500 is used to manually finding the depletion time by first knowing the volume of the container 504, and using the level of bicarbonate and the flow rate”; thus the running clearance value can be compared against said Table 500 to determine if it is higher than the flow rate established in the Table 500); and
sending an instruction to change a switching rate (Par. 65 – “If the depletion time is less than the treatment time, the operator will be notified 812 and prompted to change the container, adjust the prescription, or continue with treatment”, wherein the prescription has been established in Par. 42 to include a flow rate).
However, Yuds does not disclose sending, to a balancing system that receives the dialysate, an instruction to reduce the dialysate flow rate to a reduced rate, the balancing system being part of the dialysis machine, wherein the reduced rate results in reducing a rate of bicarbonate pumped out of the bicarbonate source while maintaining a clearance value at no less than the threshold clearance value.
Hogard, in the same field of endeavor of dialysis systems and methods (Title), teaches sending, to a balancing system 226+227 (Fig. 16 – dialysate pump 226 and used dialysate pump 227, and Par. 151 – “dynamic balancing”) that receives the dialysate (Par. 151), an instruction 2014 (Fig. 20) to reduce the dialysate flow rate to a reduced rate (Par. 134 – “at step 2014 of flowchart 2000, the dialysate flow rate can be reduced to a flow rate”), the balancing system being part of the dialysis machine (Fig. 16, and Par. 146 – subsystem 164 is a part of the dialysis delivery system),
wherein the reduced rate results in reducing a rate of bicarbonate pumped out of the bicarbonate source (Fig. 14, Fig. 20, and Par. 130 – “the dialysis system of the present disclosure can conserve dialysate concentrate by actively monitoring the amount of dialysate used during therapy and modulating the dialysate flow rate to lower the consumption of acid and bicarbonate concentrates”, and Par. 131 – “Depending on treatment goal, running at a lower dialysate flow rate may be appropriate”) while maintaining a clearance value at no less than the clearance threshold value (Par. 131 – “The onboard monitoring of dialysate consumption, and real-time dialysate flow rate control, allows for laissez faire dialysis treatments while retaining appropriate device efficiency”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yuds to further incorporate and send instruction to a balancing system to lower the bicarbonate consumption while maintaining clearance as taught by Hogard, in order to conserve dialysate concentrate, such as bicarbonate concentrates (Par. 130 of Hogard) and in order to provide a gentler physiological effect on the body via lower rates for patients dialyzing at night (Par. 131 of Hogard).
Claims 3, 4, 6, 13, 14, 16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yuds in view of Hogard as applied to claim 1, claim 10, and claim 18 above, and further in view of Childers et al. US 2010/0010426 A1 (hereinafter Childers), as cited in the IDS.
Regarding claim 3, Yuds in view of Hogard discloses the invention of claim 1. However, Yuds in view of Hogard does not disclose wherein the determined clearance value is a future clearance value, and the method further comprises predicting the future clearance value by: calculating multiple clearance values for the treatment over a time period during the treatment, each clearance value in the multiple clearance values being calculated based on respective conductivity values of the dialysate at a respective time during the time period, predicting, based on a trend in the multiple clearance values and the current clearance value, a future clearance value for a time before the treatment ends.
Childers, in the same field of endeavor of dialysis system (Title), teaches wherein the determined clearance value is a future clearance value (Par. 11 – “predicted clearance”), and the method further comprises predicting the future clearance value by:
calculating multiple clearance values for the treatment over a time period during the treatment (Par. 11 – “One possibility is to develop and store an algorithm either in the APD machine itself… The algorithm can employ a three-pore model, for example, which adds predicted clearances across three different sized pores in the patient's peritoneal membrane”), each clearance value in the multiple clearance values being calculated based on respective conductivity values of the dialysate at a respective time during the time period (Par. 11 – “Flow of toxins through large pores, small pores and micro-pores in the blood vessels of the peritoneal membrane are summed… In each case, an osmotic gradient drives the toxins from the patient's blood to the dialysate”).
predicting, based on a trend in the multiple clearance values and the current clearance value, a future clearance value for a time before the treatment ends (Par. 11 – “Using the predicted clearances and the three-pore model, the system of the present disclosure outputs a plurality of acceptable regimens for the patient” and Par. 13 – “chemical analysis performed on dialysate samples to accurately predict the patient's clearances”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yuds in view of Hogard to further incorporate a step of predicting future clearance as taught by Childers, in order to accurately predict the patient’s clearances for urea removed, Kt/V, pKt/v, creatinine removed, CCr, pCCr, glucose absorption and total effluent even better (Par. 13 of Childers). The prediction algorithm also outputs acceptable regimes for the patients (Par. 11 of Childers.)
Regarding claim 4, Yuds in view of Hogard in view of Childers discloses the invention of claim 3. The combination further discloses further comprising generating the instruction (Par. 65 of Yuds) to the balancing system 226+227 (Fig. 16 of Hogard) based on the predicted future clearance value (Par. 11 of Childers; Examiner notes that once the modification is made as discussed in claim 1, the method of Yuds in view of Hogard will generate an instruction to the balancing system to maintain the a clearance value; therefore, it has to be based on the predicted future clearance value as modified by Childers in claim 3; thus, the limitation is met), wherein the instruction includes a reduction value in the switching rate (Par. 130 of Hogard – “the dialysis system of the present disclosure can conserve dialysate concentrate by actively monitoring the amount of dialysate used during therapy and modulating the dialysate flow rate to lower the consumption of acid and bicarbonate concentrates”, and Par. 131 of Hogard – “Depending on treatment goal, running at a lower dialysate flow rate may be appropriate”).
However, the combination does not disclose wherein the reduction value depends on a difference between the predicted future clearance value and the specific threshold clearance value such that a higher difference causes a higher reduction value.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have reasonably deduced that the more the predicted clearance value of the combination deviates from the threshold value, the faster the bicarbonate amount will deplete. Therefore, in order to “maintain a clearance value at a no less than the clearance threshold value” as claimed and established in claim 1 above, it is within the ambit of a skilled artisan to reduce the flow rate to slow down dialysate flow, thus lowering the clearance value and preventing the predicted clearance value to exceed the threshold clearance value. Thus, the limitation is met.
Regarding claim 6, Yuds in view of Hogard in view of Childers discloses the invention of claim 3. The combination further discloses further comprising sending the predicted future clearance value to be presented on a display (Fig. 7A of Childers shows potential regimen outcomes of clearance parameters).
Once the modification is made as discussed in claim 3, the step of predicting clearance values of Childers will be incorporated into the method of Yuds in view of Hogard, including the display of predicted values. Thus, the limitation is met.
Regarding claim 13, Yuds in view of Hogard discloses the invention of claim 10. However, Yuds in view of Hogard does not disclose wherein the determined clearance value is a future clearance value, and the operations further comprise predicting the future clearance value by: calculating multiple clearance values for the treatment over a time period during the treatment, each clearance value in the multiple clearance values being calculated based on respective conductivity values of the dialysate at a respective time during the time period; and predicting, based on a trend in the multiple clearance values and the current clearance value, a future clearance value for a time before the treatment ends.
Childers, in the same field of endeavor of dialysis system (Title), teaches wherein the determined clearance value is a future clearance value (Par. 11 – “predicted clearance”), and the operations further comprise predicting the future clearance value by:
calculating multiple clearance values for the treatment over a time period during the treatment (Par. 11 – “One possibility is to develop and store an algorithm either in the APD machine itself… The algorithm can employ a three-pore model, for example, which adds predicted clearances across three different sized pores in the patient's peritoneal membrane”), each clearance value in the multiple clearance values being calculated based on respective conductivity values of the dialysate at a respective time during the time period (Par. 11 – “Flow of toxins through large pores, small pores and micro-pores in the blood vessels of the peritoneal membrane are summed… In each case, an osmotic gradient drives the toxins from the patient's blood to the dialysate”); and
predict