DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s amendments filed 06/25/2025 have been accepted and entered.
In response to applicant's argument that the applied references fail to teach or suggest “determine a dialysate amount..”, and “quantify the first material consumed…”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Claim Rejections - 35 USC § 103
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 1-4, 6-10, 12-13, 15, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber (US 20150359954 A1) in view of Ballantyne (US 20160058933 A1), further in view of Pudil (US 20180221852 A1).
Regarding Claim 1, Gerber discloses a dialysis system (combination of sorbent dialysis system and dialysis authentication and management system, Fig 19, [abstract]) comprising: a dialysis machine configured to deliver a dialysis treatment to a patient (sorbent dialysis system, Fig 19 ¶[0217]) by at least transferring a dialysate through a dialyzer (dialyzer 10, Fig 19 ¶[0217]), wherein the dialysis machine is configured to recycle the dialysate using a cartridge (sorbent cartridge 17 regenerates dialysate, Fig 19 ¶[0219]); and wherein the dialysis system is configured to consume a first material as the dialysis machine transfers the dialysate through the dialyzer (the system uses consumables during treatment ¶[0003]); a recharger configured to recharge the cartridge following the dialysis treatment (cartridge 17 may be recharged, Fig 19 ¶[0221]); and processing circuitry (processor 140, Fig 1a) configured to: determine a dialysate prescription indicative of a prescribed composition of the dialysate (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings ¶[0098][0100][0122][0137]), and determine, using the dialysate prescription, a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment or the recharger recharging the cartridge (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. The authentication component can be affixed on the dialyzer, cartridge, or recharger ¶[0008][0025][0098][0100][0122][0137]).
Gerber does not explicitly disclose determining a dialysate amount indicative of an amount of the dialysate that was transferred through the dialyzer during delivery of the dialysis treatment, quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input an amount of the first material that would be required to maintain the dialysate amount at the prescribed composition indicated, and determine a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein a processor determines a dialysate amount indicative of an amount of dialysate that was transferred through the dialyzer during the delivery of the dialysis treatment (a processor may calculate a volume of dialysate needed to complete a treatment based on a rate of dialysate use and the treatment duration. The system calculates an amount of remaining dialysate base on the amount of dialysate ingredients 49 that have been used in the treatment, thus the system determines the amount of dialysate that has been transferred through the dialyzer during treatment ¶[0929-0931]), and determine an amount of the first material that would substantially maintain a composition of the dialysate amount (the system may determine the amount of sodium bicarbonate used to maintain the dialysate amount by utilizing measurement 179 and 179 and concentration reference data ¶[0633-0634][0636]) at the prescribed composition indicated by the dialysate prescription (control system may be configured to include a sodium bicarbonate control loop and an acid concentrate control loop to make a dialysate composition surrounding a specific prescription ¶[0636]), and determine a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material (the amount of sodium bicarbonate used in the dialysate may be directly determined by conductivity measurements and on pump-stroke-by-pump stroke basis ¶[0633-0634]) to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (¶[0929]).
Therefore, it would have been obvious to modify the system of Gerber to include determining a dialysate amount indicative of an amount of dialysate that was transferred through the dialyzer during delivery of the dialysis treatment, and determine an amount of a first material that would substantially maintain a composition of the dialysate amount at the prescribed composition indicated by the dialysate prescription, a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material, as taught by Ballantyne to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (as motivated by Ballantyne ¶[0929]).
Gerber/Ballantyne is silent regarding quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition.
However, Pudil teaches a dialysis system, thus from the same field of endeavor, including quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition (The system uses dialysis session parameters (analogous to the dialysate amount; the dialysis session parameters may include dialysate flow rate, e.g., the amount of dialysate pumped through a dialysate flow path in a given period of time, ultrafiltration rate, prescription, total volume treated, total cation and total CO2 pumped through the sorbent module etc. ¶[0008][0010]) to determine the quantity of a sorbent recharge chemical ¶[0007] The control system may inform the user of the correct recharge chemicals to add to achieve a specified concentration, or automatically add the correct amount of chemical ¶[0145])to avoid the need of excess recharge solutions (¶[0002]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber/Ballantyne to include quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition, as taught by Pudil to avoid the need of excess recharge solutions (as motivated by Pudil ¶[0002].
Regarding Claim 2, Gerber discloses that the processing circuitry is configured to track an inventory of consumables associated with the patient based on the quantity of materials consumed (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. An authentication component may be attached to the consumable material 218 of the sorbent cartridge 210, which may be tracked by the processor, Fig 2A ¶[0098][0100][0122][0137][0142]).
Regarding Claim 3, Gerber discloses that the processing circuitry is configured to: determine the inventory of consumables is below or is anticipated to fall below a threshold consumables inventory associated with the patient, wherein the threshold consumables inventory is based on the dialysate prescription, and issue a communication in response to determining the inventory of consumables is below or is anticipated to fall below the threshold consumables inventory (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. Data derived from the authentication component is received by the processor and the state of the rechargeable cartridge is determined based on a predetermined threshold, i.e. the limit of recharging of the rechargeable cartridge. Determinations made by the processor 140 may be displayed on a screen to timely notify a user. ¶[0025-0026][0098-0100][0122][0135][0137]).
Regarding Claim 4, Gerber discloses that the dialysis machine includes a dialysis pump configured to provide a flow rate of the dialysate through the dialyzer (infusate pump 24 necessitates a flow rate, Fig 19 ¶[0219]), and wherein the dialysate amount is based on a flow rate of the dialysate provided by the dialysate pump (dialysate is regenerated after passing through the sorbent cartridge 17 by the infusate pump 24 of infusate system 22 by replenishing lacking ions from the infusate reservoir 23, thus the dialysate amount is dependent on the flow rate of the infusate pump ¶[0219]).
Gerber does not explicitly disclose that the processing circuitry is configured to determine the dialysate amount by integrating the flow rate over a time period of the dialysis treatment.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein the processing circuitry is configured to determine the dialysate amount by integrating the flow rate over a time period of the dialysis treatment (dialysis flow rate over time may be used to determine a remaining amount of dialysate in the tank or the dialysate ingredients. Furthermore, the system measures the flow rate of bicarbonate pump 183 and acid pump 184 to determine the quantity of dialysis ingredients 49 that have been used. ¶[0929-0931], to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (¶[0929]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber so that the processing circuitry is configured to determine the dialysate amount by integrating the flow rate over a time period of the dialysis treatment, as taught by Ballantyne, to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (as motivated by Ballantyne ¶[0929]).
Regarding Claim 6, Gerber discloses that the recharger (recharger 1410, Fig 14) is configured to recharge the cartridge using a quantity of recharge chemicals (cartridge 1400 may be recharged by recharger 1410 ¶[0198]), and wherein the processing circuitry is configured to determine the quantity of recharge chemicals required to recharge the cartridge based on the dialysate amount and the dialysate prescription (based on a determination of the processor, the cartridge is selectively recharged. After recharging, the RFID tag 1402 of the cartridge 1400 is updated to include the date and any other information related to the updated status of the cartridge, including the amount of recharge solution used to recharge the cartridge ¶[0025][0198][0199]).
Regarding Claim 7, Gerber discloses that the processing circuitry is configured to determine the quantity of recharge chemicals by at least identifying a cartridge identifier associated with the cartridge (based on a determination of the processor, the cartridge is selectively recharged. After recharging, the RFID tag 1402 of the cartridge 1400 is updated to include the date and any other information related to the updated status of the cartridge, including the amount of recharge solution used to recharge the cartridge ¶[0025][0198][0199]).
Regarding Claim 8, Gerber discloses that the quantity of materials consumed includes a quantity of cartridges consumed in connection with the dialysis treatment (based on a determination of the processor, the system can track whether a cartridge has reached the limit of recharging, indicating that the cartridge is consumed. Gerber envisions tracking the use of multiple reusable cartridges ¶[0025-0026][0198]).
Regarding Claim 9, Gerber discloses that the processing circuitry is configured to: record a time associated with the recharger recharging the cartridge (based on a determination of the processor, the cartridge is selectively recharged. After recharging, the RFID tag 1402 of the cartridge 1400 is updated to include the date and any other information related to the updated status of the cartridge. ¶[0025][0198]), and include the cartridge in the quantity of materials consumed when a predetermined time period has elapsed since the recorded time (the authentication system can determine the length of time that has elapsed since the cartridge has been used, which can be used to indicate expiration of the cartridge. Gerber envisions tracking the use of multiple reusable cartridges ¶[0189][0198]).
Regarding Claim 10, Gerber discloses that the quantity of materials consumed includes a quantity of dialysate chemical (concentrated ion solution ¶[0219]), wherein the prescribed composition is indicative of a concentration of the dialysate chemical (patient prescription includes system settings for a dialysis session, which would include the concentrated ion solution necessary for recharging the dialysate ¶[0100][0219] the dialysis machine (Fig 19) is configured to add the dialysate chemicals to the dialysate during the dialysis treatment (infusate system 23 adds a concentrated ion solution to dialysate during treatment, Fig 19 ¶[0219]).
Gerber does not explicitly disclose that the processing circuitry is configured to determine the quantity of the dialysate chemical by determining, using the dialysate amount and the dialysate prescription, an amount of the dialysate chemical that would cause the dialysate amount to have the concentration of the dialysate chemical.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein a processor determines the quantity of the dialysate chemical by determining, using the dialysate prescription, an amount of the dialysate chemical that would cause the dialysate amount to have the concentration of the dialysate chemical
(a processor may calculate a volume of dialysate needed to complete a treatment based on a rate of dialysate use and the treatment duration. The system may determine the amount of sodium bicarbonate used to maintain the dialysate amount by utilizing measurement 179 and 179 and concentration reference data ¶[0633-0634][0636]) at the prescribed composition indicated by the dialysate prescription (control system may be configured to include a sodium bicarbonate control loop and an acid concentrate control loop to make a dialysate composition surrounding a specific prescription. The amount of sodium bicarbonate used in the dialysate may be directly determined by conductivity measurements and on pump-stroke-by-pump stroke basis ¶[0633-0634][0636]) to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (¶[0929]).
Therefore, it would have been obvious to modify the system of Gerber so that the processing circuitry determines the quantity of the dialysate chemical by determining, using the dialysate amount and the dialysate prescription, an amount of the dialysate chemical that would cause the dialysate amount to have the concentration of the dialysate chemical, as taught by Ballantyne to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (as motivated by Ballantyne ¶[0929]).
Gerber/Ballantyne is silent whether the quantity of the dialysate chemical is determined by using the dialysate amount to determine an amount of the dialysate chemical that would cause the dialysate amount to have the concentration of the dialysate chemical.
However, Pudil teaches a dialysis system, thus from the same field of endeavor, wherein the quantity of the dialysate chemical is determined by using the dialysate amount to determine an amount of the dialysate chemical that would cause the dialysate amount to have the concentration of the dialysate chemical (The system uses dialysis session parameters (analogous to the dialysate amount; the dialysis session parameters may include dialysate flow rate, e.g., the amount of dialysate pumped through a dialysate flow path in a given period of time, ultrafiltration rate, prescription, total volume treated, total cation and total CO2 pumped through the sorbent module etc. ¶[0008][0010]) to determine the quantity of a sorbent recharge chemical ¶[0007] The control system may inform the user of the correct recharge chemicals to add to achieve a specified concentration, or automatically add the correct amount of chemical ¶[0145])to avoid the need of excess recharge solutions (¶[0002]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber/Ballantyne so that the quantity of the dialysate chemical is determined by using the dialysate amount to determine an amount of the dialysate chemical that would cause the dialysate amount to have the concentration of the dialysate chemical, as taught by Pudil to avoid the need of excess recharge solutions (as motivated by Pudil ¶[0002].
Regarding Claim 12, Gerber discloses that the dialysis system includes a remote device (physician’s remote monitoring device ¶[0160]), the processing circuitry (combination of 140 and physician’s remote monitoring device, Fig 1a ¶[0160]) includes first processing circuitry (140, Fig 1a) and second processing circuitry (clinicians are able to remotely monitor dialysis therapy through the RFID system over a cellular network, which implies processing circuitry at the physician’s monitoring device ¶[0160]), the dialysis machine, the recharger, or the dialysis machine and the recharger include the first processing circuitry (140 may be part of a dialysis component, console, or dialysis cabinet ¶[0135]), the remote device includes the second processing circuitry (clinicians are able to remotely monitor dialysis therapy through the RFID system over a cellular network, which implies processing circuitry at the physician’s monitoring device ¶[0160]), and the first processing circuitry is configured to issue a communication to the second processing circuitry (dialysis component 730, which may include the first processing circuitry 140, transmits information through a mobile host 720 to a user 740. The user’s device would necessarily include the second processing circuitry, Fig 7 ¶[0159-0160]), wherein the communication is indicative of the quantity of materials consumed (the physician can remotely track dialysis components, which would include materials used, such as the reusable modules ¶[0160]).
Regarding Claim 13, Gerber discloses that the processing circuitry is configured to determine a current inventory of consumables using the quantity of materials consumed, (processor 140 may read an authentication component, which may be a patient information storage device 810, which may be utilized by the machine to track treatment parameters such as flow rate and information on consumables used. This would include a quantity of materials used, thus the device is fully capable of determining a current quantity of each consumable used. ¶[0174-0175]).
Gerber is silent whether wherein the current inventory is an inventory of consumables prior to the dialysis treatment less the quantity of materials consumed.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein the current inventory is an inventory of consumables prior to the dialysis treatment less the quantity of materials consumed (current inventory of dialysis ingredients 49 may be determined by the known amount of chemical in a full container prior to treatment minus the amount of chemicals used ¶[0931]) in order to accurately measure the chemicals used to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (as motivated by Ballantyne ¶[0929]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber so that the current inventory is an inventory of consumables prior to the dialysis treatment less the quantity of materials consumed, as taught by Ballantyne in order to accurately measure the chemicals used to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (as motivated by Ballantyne ¶[0929]).
Regarding Claim 15, Gerber discloses that the quantity of materials consumed includes at least one of a quantity of dialyzers consumed during the dialysis treatment or a quantity of one or more tubing sets consumed during the dialysis treatment (use of circuit tubing may be tracked by saving newly generated information regarding usage in the corresponding authentication component ¶[0195]).
Regarding Claim 19, Gerber discloses a method (¶[0006]), comprising: determining, by processing circuitry (140, Fig 1a), a dialysate prescription indicative of a prescribed composition of a dialysate (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings ¶[0098][0100][0122][0137]), wherein a dialysis system (combination of sorbent dialysis system and dialysis authentication and management system, Fig 19, [abstract]) includes a dialysis machine (sorbent dialysis system, Fig 19 ¶[0217]) and a recharger (cartridge 17 may be recharged, Fig 19 ¶[0221]), wherein the dialysis machine is configured to deliver a dialysis treatment to a patient by at least transferring the dialysate through a dialyzer (dialyzer 10, Fig 19 ¶[0217]) and recycling the dialysate using a cartridge (sorbent cartridge 17 regenerates dialysate, Fig 19 ¶[0219]); and wherein the recharger is configured to recharge the cartridge (cartridge 17 may be recharged, Fig 19 ¶[0221]), and wherein the dialysis system is configured to consume a first material as the dialysis machine transfers the dialysate through the dialyzer (the system uses consumables during treatment ¶[0003]); and determining, by the processing circuitry, a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment or the recharger recharging the cartridge, wherein the system circuitry determines the quantity of material consumed based on the dialysate amount and the dialysate prescription (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. The authentication component can be affixed on the dialyzer, cartridge, or recharger, Gerber envisions tracking the use of multiple reusable cartridges ¶[0008][0025][0098][0100][0122][0137][0198]).
Gerber does not explicitly disclose that the processing circuitry determines a dialysate amount indicative of an amount of dialysate that transferred through the dialyzer during the dialysis treatment, and determining, by the processing circuitry, and quantifying, by the processing circuitry, the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain a composition of the dialysate amount at the prescribed composition indicated by the dialysate prescription; and determining, by the processing circuitry, a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein a processor determines a dialysate amount indicative of an amount of dialysate transferred through the dialyzer during the dialysis treatment (a processor may calculate a volume of dialysate needed to complete a treatment based on a rate of dialysate use and the treatment duration. The system calculates an amount of remaining dialysate base on the amount of dialysate ingredients 49 that have been used in the treatment, thus the system determines the amount of dialysate that has been transferred through the dialyzer during treatment ¶[0929-0931]), and determining, by the processing circuitry, an amount of a first material that would substantially maintain a composition of the dialysate amount (the system may determine the amount of sodium bicarbonate used to maintain the dialysate amount by utilizing measurement 179 and 179 and concentration reference data ¶[0633-0634][0636]) at the prescribed composition (control system may be configured to include a sodium bicarbonate control loop and an acid concentrate control loop to make a dialysate composition surrounding a specific prescription ¶[0636]), a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material (the amount of sodium bicarbonate used in the dialysate may be directly determined by conductivity measurements and on pump-stroke-by-pump stroke basis ¶[0633-0634]) to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (¶[0929]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gerber so that the processing circuitry determines a dialysate amount indicative of an amount of the dialysate that transferred through the dialyzer during the dialysis treatment, and determining, by the processing circuitry, an amount of a first material that would substantially maintain a composition of the dialysate amount at the prescribed composition indicated by the dialysate prescription, a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material, as taught by Ballantyne to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (as motivated by Ballantyne ¶[0929]).
Gerber/Ballantyne is silent regarding quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition.
However, Pudil teaches a dialysis system, thus from the same field of endeavor, including quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition (The system uses dialysis session parameters (analogous to the dialysate amount; the dialysis session parameters may include dialysate flow rate, e.g., the amount of dialysate pumped through a dialysate flow path in a given period of time, ultrafiltration rate, prescription, total volume treated, total cation and total CO2 pumped through the sorbent module etc. ¶[0008][0010]) to determine the quantity of a sorbent recharge chemical ¶[0007] The control system may inform the user of the correct recharge chemicals to add to achieve a specified concentration, or automatically add the correct amount of chemical ¶[0145])to avoid the need of excess recharge solutions (¶[0002]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gerber/Ballantyne to include quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition, as taught by Pudil to avoid the need of excess recharge solutions (as motivated by Pudil ¶[0002]).
Regarding Claim 20, Gerber discloses determining, by the processing circuitry, an inventory of consumables associated with the patient based on the quantity of materials consumed (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. An authentication component may be attached to the consumable material 218 of the sorbent cartridge 210, which may be tracked by the processor, Fig 2A ¶[0098][0100][0122][0137][0142]); and determining, by the processing circuitry, the inventory of consumables is below or anticipated to fall below a threshold consumables inventory associated with the patient, wherein the threshold consumables inventory is based on the dialysate prescription; and issuing a communication in response to determining the inventory of consumables is below or anticipated to fall below the threshold consumables inventory (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. Data derived from the authentication component is received by the processor and the state of the rechargeable cartridge is determined based on a predetermined threshold i.e. the limit of recharging of the rechargeable cartridge. Determinations made by the processor 140 may be displayed on a screen to timely notify a user. ¶[0025-0026][0098][0100][0122][0135][0137]).
Regarding Claim 21, Gerber is silent whether the dialysate amount is indicative of a mass or a volume of the dialysate that was transferred through the dialyzer during the dialysis treatment.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein the dialysate amount indicative of an amount of dialysate transferred through the dialyzer during the dialysis treatment (a processor may calculate a volume of dialysate needed to complete a treatment based on a rate of dialysate use and the treatment duration. The system calculates an amount of remaining dialysate base on the amount of dialysate ingredients 49 that have been used in the treatment, thus the system determines the amount of dialysate, which would include the volume, that has been transferred through the dialyzer during treatment ¶[0929-0931]) to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (¶[0929]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber, so that the dialysate amount indicative of an amount of dialysate transferred through the dialyzer during the dialysis treatment, as taught by Ballantyne, to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (¶[0929]).
Regarding Claim 22, Gerber is whether the processing circuitry is configured to monitor one or more parameters of the dialysate to monitor a composition of the dialysate as the dialysate transfers through the dialyzer, wherein the one or more parameters includes at least a pH of the dialysate, and wherein the dialysis system is configured to add the dialysate chemical to the dialysate based on the one or more parameters to substantially maintain the composition of the dialysate at the prescribed composition as the dialysate transfers through the dialyzer.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein the processing circuitry is configured to monitor one or more parameters of the dialysate to monitor a composition of the dialysate as the dialysate transfers through the dialyzer (conductivity and volumetric measurements may be used to monitor the dialysate composition ¶[0400]), wherein the one or more parameters includes at least a pH of the dialysate (pH is a well known characteristic of a dialysate, and is dependent on the amount of sodium bicarbonate in the solution ¶[0241][0906]), and wherein the dialysis system is configured to add the dialysate chemical to the dialysate based on the one or more parameters to substantially maintain the composition of the dialysate at the prescribed composition as the dialysate transfers through the dialyzer (the system allows fluid production parameters to be set, which include the amount of bicarbonate to be added to the dialysate mixture during treatment, thus maintaining the dialysate at the desired composition ¶[0253][0906]) to ensure acceptable dialysate quality is produced and maintained during treatment (¶[0253]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber so that the processing circuitry is configured to monitor one or more parameters of the dialysate to monitor a composition of the dialysate as the dialysate transfers through the dialyzer, wherein the one or more parameters includes at least a pH of the dialysate, and wherein the dialysis system is configured to add the dialysate chemical to the dialysate based on the one or more parameters to substantially maintain the composition of the dialysate at the prescribed composition as the dialysate transfers through the dialyzer, as taught by Ballantyne to ensure acceptable dialysate quality is produced and maintained during treatment (as motivated by Ballantyne ¶[0253]).
Claims 11, 16-18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber (US 20150359954 A1) in view of Ballantyne (US 20160058933 A1), further in view of Pudil (US 20180221852 A1), further in view of Buraczenski (US 20190209764 A1).
Regarding Claim 11, Gerber discloses that the processing circuitry is configured to: determine at least a first quantity of materials consumed during a first dialysis treatment and a second quantity of materials consumed during a second dialysis treatment (authentication component stores treatment information and patient prescription, which includes information on prior sessions, and the processor may optimize settings based on data from the authentication component. Gerber envisions tracking the use of multiple reusable cartridges, which would correspond to a first and second quantity of materials consumed ¶[0014][0016][0198]).
Gerber is silent regarding determining, based on the consumption trend, a future consumables inventory, wherein the future consumables inventory is an estimation of the consumables inventory at a future point in time.
However Buraczenski teaches a communication system for a dialysis machine, thus from the same field of endeavor, which determines, based on the consumption trend, a future consumables inventory, wherein the future consumables inventory is an estimation of an inventory at a future point in time (order management system 170 determines an estimated inventory at the dialysis machine compared to an actual inventory, 170 includes an inventory service 320 that determines ordering trends of a specific item, and may include an order history that is considered for future orders, Fig 4 ¶[0022-0023][0065][0091]) in order to recommend an order to the patient to avoid a current or anticipated shortage of the item (¶[0022-0023]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber to determine, based on the consumption trend, a future consumables inventory, wherein the future consumables inventory is an estimation of an inventory at a future point in time, as taught by Buraczenski in order to recommend an order to the patient to avoid a current or anticipated shortage of the item (as motivated by Buraczenski ¶[0022-0023]). In combination, the cartridges used in the system of Gerber, corresponding to first and second quantity of materials used, would be fully capable of being included in the materials used and estimated by the system of Buraczenski.
Regarding Claim 16 and 23, Gerber discloses a dialysis system (combination of sorbent dialysis system and dialysis authentication and management system, Fig 19, [abstract]) comprising: a dialysis machine configured to deliver a dialysis treatment to a patient (sorbent dialysis system, Fig 19 ¶[0217]) by at least transferring a dialysate through a dialyzer (dialyzer 10, Fig 19 ¶[0217]), wherein the dialysis machine is configured to recycle the dialysate using a cartridge (sorbent cartridge 17 regenerates dialysate, Fig 19 ¶[0219]), and wherein the dialysis system is configured to consume a first material as the dialysis machine transfers the dialysate through the dialyzer (the system uses consumables during treatment ¶[0003]); a recharger configured to recharge the cartridge following the dialysis treatment (cartridge 17 may be recharged, Fig 19 ¶[0221]), wherein the dialysis machine, the recharger, or the dialysis machine and the recharger are located at a first location (dialysis may occur at the user’s home, a clinic, or a mobile setting ¶[0161-0163]); and processing circuitry (140, Fig 1a) configured to: determine a dialysate prescription indicative of a prescribed composition of the dialysate (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings ¶[0098][0100][0122][0137]), determine a quantity of materials consumed during at least one the dialysis machine delivering the dialysis treatment or the recharger recharging the cartridge based on the dialysate amount and the dialysate prescription (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. The authentication component can be affixed on the dialyzer, cartridge, or recharger. Gerber envisions tracking the use of multiple reusable cartridges. ¶[0008][0025][0098][0100][0122][0137][0198]), track an inventory of consumables associated with the patient based on the quantity of materials consumed, compare the inventory of consumables with a threshold consumables inventory associated with the patient, wherein the threshold consumables inventory is based on the dialysate prescription, (140 may determine proper patient information settings from an authentication component, which may include prescription information, treatment history, status of dialysis components, and specific settings. Data derived from the authentication component is received by the processor and the state of the rechargeable cartridge is determined based on a predetermined threshold i.e. the limit of recharging of the rechargeable cartridge. Determinations made by the processor 140 may be displayed on a screen to timely notify a user. ¶[0025-0026][0098][0100][0122][0135][0137]).
Gerber does not explicitly disclose that the processing circuitry determines a dialysate amount indicative of an amount of the dialysate that was transferred through the dialyzer during the dialysis treatment, and determining, by the processing circuitry, and quantifying, by the processing circuitry, the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain a composition of the dialysate amount at the prescribed composition indicated by the dialysate prescription; and determining, by the processing circuitry, a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material; and scheduling a delivery of one or more consumables to the first location from a second location geographically displaced from the first location based on the consumables inventory tracked.
However, Ballantyne teaches control systems for a blood treatment machine, thus from the same field of endeavor, wherein a processor determines a dialysate amount indicative of an amount of dialysate transferred through the dialyzer during the dialysis treatment (a processor may calculate a volume of dialysate needed to complete a treatment based on a rate of dialysate use and the treatment duration. The system calculates an amount of remaining dialysate base on the amount of dialysate ingredients 49 that have been used in the treatment, thus the system determines the amount of dialysate that has been transferred through the dialyzer during treatment ¶[0929-0931]), and determining, by the processing circuitry, an amount of a first material that would substantially maintain a composition of the dialysate amount (the system may determine the amount of sodium bicarbonate used to maintain the dialysate amount by utilizing measurement 179 and 179 and concentration reference data ¶[0633-0634][0636]) at the prescribed composition (control system may be configured to include a sodium bicarbonate control loop and an acid concentrate control loop to make a dialysate composition surrounding a specific prescription ¶[0636]), a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material (the amount of sodium bicarbonate used in the dialysate may be directly determined by conductivity measurements and on pump-stroke-by-pump stroke basis ¶[0633-0634]) to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (¶[0929]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gerber so that the processing circuitry determines a dialysate amount indicative of an amount of the dialysate that transferred through the dialyzer during the dialysis treatment, and determining, by the processing circuitry, an amount of a first material that would substantially maintain a composition of the dialysate amount at the prescribed composition indicated by the dialysate prescription, a quantity of materials consumed during at least one of the dialysis machine delivering the dialysis treatment, wherein the quantity of materials consumed includes the amount of the first material, as taught by Ballantyne to enable the system to automatically adjust dialysate production to reduce potential clogging of the dialyzer fibers and to prevent exhaustion of dialysate during treatment (as motivated by Ballantyne ¶[0929]).
Gerber/Ballantyne is silent regarding quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition, scheduling a delivery of one or more consumables to the first location from a second location geographically displaced from the first location based on the consumables inventory tracked.
However, Pudil teaches a dialysis system, thus from the same field of endeavor, including quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition (The system uses dialysis session parameters (analogous to the dialysate amount; the dialysis session parameters may include dialysate flow rate, e.g., the amount of dialysate pumped through a dialysate flow path in a given period of time, ultrafiltration rate, prescription, total volume treated, total cation and total CO2 pumped through the sorbent module etc. ¶[0008][0010]) to determine the quantity of a sorbent recharge chemical ¶[0007] The control system may inform the user of the correct recharge chemicals to add to achieve a specified concentration, or automatically add the correct amount of chemical ¶[0145])to avoid the need of excess recharge solutions (¶[0002]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gerber/Ballantyne to include quantifying the first material consumed during the dialysis treatment by receiving the dialysate amount as an input and computing, using the input, an amount of the first material that would be required to substantially maintain the dialysate amount at the prescribed composition, as taught by Pudil to avoid the need of excess recharge solutions (as motivated by Pudil ¶[0002]).
Gerber/Ballantyne/Pudil is silent regarding scheduling a delivery of one or more consumables to the first location from a second location geographically displaced from the first location based on the consumables inventory tracked, wherein the delivery of the one or more consumables comprises an amount of the one or more consumables to complete a prescribed dialysis treatment regimen for the patient over a predeter