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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/16/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 has been amended to recite “wherein the providing the content of the mixing container to the medicament user device at the predetermined pressure includes measuring a pressure in a fluid loop that includes the first fluid line, the second fluid line, and a medicament output line that connects the proportioning system to the medicament user device…”. This combination of limitations is not supported by the original disclosure and is considered as new matter. The originally filed disclosure indicates that the fluid loop includes the first and second fluid lines. The medicament output line is not part of the flood loop (“Because conductivity/temperature sensor(s) 159c and 159s are provided on the fluid circuit as shown in FIG. 1A, it is possible to control various valves to establish a loop through which fluid from the mixing container flows while the conductivity of the fluid is tested, but little, if any, fluid is wasted. Various examples of a physical configuration of the fluid circuit are shown in FIGS. 6A and 6B…. peristaltic pump 129 operates to draw fluid through inlet line 123 and to circulate the fluid along line 149 through or past sensor 159c and then through or past sensor 159s… In FIG. 6B, valve 139 is opened, while the other valves remain closed”, (emphasis added) [0045]-[0047]).
As disclosed with respect to the elected embodiments of Figures 8B-8C, the medicament output line is part of the fluid path to the medicament user device. This fluid path includes either the first or second fluid line and the medicament output line, but not the first line, second line, and medicament output line. The Examiner notes that these paths are disclosed as fluid paths/channels from the mixing container to the medicament user ([0080]-[0081]), not the fluid loop (“to make the medicament available to the medicament user 157, clamps 136 and 139 can be opened and the other clamps can be closed and the medicament pump 115 may draw from the mixing container 102 without the assistance of a predefined backpressure, hence without the use of peristaltic pump 129. Alternatively, the peristaltic pump 129 may be run through a circulating path of 149, 123, and 125 with a feedback-controlled clamp 139 according to pressure indicated by pressure sensor 301.”, (emphasis added) [0041]).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the limitation of “operating a pump on the first fluid line to draw a fluid, which includes a portion of the content of the mixing container, out of the mixing container and circulate the fluid in said fluid loop and return the fluid to the mixing container” renders the claim unclear. The limitation suggests that the claimed “fluid” is comprised of a portion of the content of the mixing container and something else. The only fluid in the proportioning system being drawn by the pump and circulated in the fluid loop is the content of the mixing container. For clarity, the Examiner suggests amending the claim to read “operating a pump on the first fluid line to draw a [[fluid, which includes]] portion of the content of the mixing container[[,]] out of the mixing container and circulate the [[fluid]] portion of the content of the mixing container in said fluid loop and return the [[fluid]] portion of the content of the mixing container to the mixing container”.
Regarding claim 17, the limitation of “conveying a second variable quantity of the purified water to the mixing container after the second mixing, wherein the second variable quantity is determined based on the determined concentration of the contents of the mixing container after the second mixing” renders the claim unclear. Claim 9, which claim 17 depends from, does not include “a first variable quantity of the purified water”. Additionally, after the second mixing, there is no step of determining a concentration of the content of the mixing container, as suggested by the claim. After the second mixing, claim 9 includes the limitation of “confirming a final concentration of the content of the mixing container”. For clarity and claim language consistency, the Examiner recommends amending claim 17 to read “…wherein the second variable quantity is determined based on the [[determined]] final concentration of the contents of the mixing container after the second mixing” or similarly.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 9-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth (US 20190262526 A1), including Burbank (US 20150005699 A1) which is incorporated by reference in its entirety, in view of Jonsson (US 5511875 A), and further in view of Burbank ‘263 (US 20090182263 A1).
Regarding claims 9-11 and 13, Wyeth discloses a method of generating a custom mini batch of dialysate with a proportioning system (see [0054], [0241], and [0378] & Fig. 18A), the method comprising: attaching a disposable component to the proportioning system (fluid circuit 701E is being interpreted as the disposable component which is attached to fluid module 723 which is being interpreted as the proportioning system, [0241] & Fig. 18A), the disposable component including a mixing container pre-attached to a first fluid line and to a second fluid line (mixing container 732 preconnected to the remainder of the fluid circuit by inflow and outflow lines 746 and 750, [0243] and [0247] & Fig. 18A);
generating purified water with a water purification system (purified water source 766 and sterilizing filter 733 generate purified water, [0236], [0241], [0262] & Fig. 18A); adding a first quantity of the purified water into the mixing container through the first fluid line (controller 739 pumps 50% of water into the mixing container 732 through inlet line 746, see step S548, [0270] and [0247] & Fig. 18A and 18C; inlet line 746 allows fluid to be pumped into container 732);
after adding the first quantity, conveying a second quantity of a first concentrated medicament into the mixing container through the first fluid line (controller 739 pumps 100% of electrolyte concentrate 736 into mixing container 732 through inlet line 746, see step S552, [0272] & Fig. 18C);
after conveying the second quantity, first mixing content of the mixing container by circulating the content of the mixing container out of the mixing container through the first fluid line and back into the mixing container through the second fluid line (“At S554 the controller 739 mixes the mixing container 732 contents by recirculating through the lines 746 and 750 and the manifolds 758 and 760 using the pump 762”, see step S554, [0273] & Fig. 18A and 18C; “the pump 762 may be run in either direction so that the inlet and outlet lines 746 and 750 can switch roles under control of the controller. Thus, the modifiers “inlet” and “outlet” serve to differentiate the two lines 746 and 750 but are not strictly limiting in terms of structure or function and it should be evident that the functionality of batch preparation, mixing, and treatment can be carried out with the roles of inlet and outlet switched during certain operations”, [0240] & Fig. 18A; recirculation can occur from line 746 to line 750);
after the first mixing, determining a concentration of the content of the mixing container by flowing the content of the mixing container through the second fluid line and past at least one fluid quality sensor fluidly connected to the second fluid line (controller 739 opens a path from mixing container 732 to the drain and pumps a quantity of the contents from container 732 through outlet line 750 to test conductivity to confirm level of dilution of electrolyte, see step S556, [0274] & Fig. 18A and 18C; there being two conductivity sensor 764 that are fluidly connected to line 750 considering line 750 is part of the open flow path connecting container 732 and the drain, Fig. 18A; “conductivity measurement operations, the conductivity and the temperature of the fluid may be converted directly to concentration of the electrolytes in water, or for a fluid that contains both electrolytes and an osmotic agent, to concentration of either the electrolytes or the osmotic agent, or both,” [0171]; the remaining contents return to container 732 considering mixing happens via recirculation between manifolds 758 and 760 via lines 746 and 750, see [0247]);
after the determining, conveying a third quantity of a second concentrated medicament into the mixing container through the first fluid line (controller 739 pumps osmotic agent 738 into mixing container 732 through inlet line 746, see step S560, [0276] & Fig. 18C);
after conveying the third quantity, second mixing the content of the mixing container by circulating the content of the mixing container out of the mixing container through the first fluid line and back into the mixing container through the second fluid line (“At S562, the controller 739 mixes the mixing container 732 contents by recirculating through the lines 746 and 750 and the manifolds 758 and 760 using the pump 762.”, see step S562, [0277] & Fig. 18A and 18D; see description of first mixing above in step S554, the two steps being synonymous);
after the second mixing, confirming a final concentration of the content of the mixing container by flowing the content of the mixing container past said at least one fluid quality sensor (“controller 739 tests conductivity of mixing container 732 contents and passes or fails the batch based on the result,”, step S570 similar to S556, [0281] & Fig. 18D); and after the confirming, providing the content of the mixing container to a medicament user device at a predetermined pressure (patient 718 connected to the system by patient line 754, connector 730, and a catheter, [0243] and [0247] & Fig 18A; inherent that a completed batch would be delivered to a patient, see [0235], [0247], and [0378]; the catheter is being interpreted as a medicament user device; a completed batch is necessarily provided to the user at a pressure - Burbank discloses providing feedback control of the pump using pressure sensors to ensure a limit is not exceed, [0056] and [0114]-[0115] of Burbank), wherein the providing the content of the mixing container to the medicament user device at the predetermined pressure includes measuring a pressure in a fluid loop that includes the first fluid line, the second fluid line, and a medicament output line that connects the proportioning system to the medicament user device (pressure sensor 769 located in the recirculation line comprising lines 746 and 750, manifolds 758 and 760, pumping tube 763, and pump 762, which is being interpreted as the fluid loop, [0244] & Fig. 18A; in order for the completed batch to leave the fluid loop and be delivered to patient 718, the batch would necessarily pass through pressure sensor 769, which measures pressure, see [0244] and [0252] & Fig. 18A; pressure sensor 769 necessarily measures pressure as the completed batch leaves container 732 and is pumped into patient filling line 748, [0213] & Fig. 18A; line 748 is part of the fluid loop as fluid flows through 748 to fill the patient);
operating a pump on the first fluid line to draw a fluid, which includes a portion of the content of the mixing container, out of the mixing container and circulate the fluid in said fluid loop and return the fluid to the mixing container (“the pump 762 may be run in either direction so that the inlet and outlet lines 746 and 750 can switch roles under control of the controller. Thus, the modifiers “inlet” and “outlet” serve to differentiate the two lines 746 and 750 but are not strictly limiting in terms of structure or function and it should be evident that the functionality of batch preparation, mixing, and treatment can be carried out with the roles of inlet and outlet switched during certain operations”, [0240] & Fig. 18A; pump 762, which functionally operates on line 746, can draw fluid out of container 732 through line 746 and return fluid to container 732 through line 750);
regulating a controllable clamp on the second fluid line (clamp 751 on line 750 is under control of controller 739, [0244] & Fig. 18A) via feedback control based on the measured pressure (Burbank discloses pressure transducers 924 and 925 generating pressure signals reflecting pressure on both sides of pump tubing segment 944, the signal sent to a controller 907 which controls valve actuators 928-935, [0114]-[0115] & Fig. 10; module 911 and valve actuators 928-935 regulate flow between the tubing lines 914-917 and patient line 919, [0144] & Fig. 10; “a controller connected to the pressure sensor changes the operation of the peritoneal dialysis machine in response to changes in pressure sensed by the pressure sensor.”, [0010]; “the functions of the actuators 929, 930, 928, 931, 932, 933, 934, and 935 are in some instances reassigned by the command signals of the controller 907.”, [0126] & Fig. 10; see [0244] of Wyeth for disclosure of pressure sensors 769 sending signals corresponding to the pressure to controller 739, which could regulate clamp 721 on line 750, a relationship synonymous to controller 907 regulating actuators 928-935); and opening a batch release clamp on the medicament output line to permit the fluid from the fluid loop to flow to the medicament user device (fill line 748 includes clamp 751 which controls flow through line 748, clamp 751 on line 748 would have to open to release the completed batch to a patient, [0213] and [0236] & Fig. 18A).
However, Wyeth fails to explicitly disclose the flowing the contents past at least one fluid quality sensor and back into the mixing container, maintaining the predetermined pressure in the fluid loop, and permitting the fluid from the fluid loop to flow to the medicament user device at the predetermined pressure.
and the determining of the concentration of the contents of the mixing container includes continuously recirculating at least a portion of the contents of the mixing container past the at least one fluid quality sensor until a value output by the fluid quality sensor reaches a steady state.
However, Jonsson teaches the flowing the contents past at least one fluid quality sensor (conductivity meter 23b, Fig. 6) and back into the mixing container (“...the recirculation circuit 20b may comprise a metering pump 22b to facilitate recirculation of the concentrate solution. A concentration meter 23b may be used to check the concentration of the solution in the recirculation circuit,” Col 8 lines 63-65 & Fig. 6 [and see Col 9 lines 34-39]) and the determining of the concentration of the contents of the mixing container includes continuously recirculating at least a portion of the contents of the mixing container past the at least one fluid quality sensor until a value output by the fluid quality sensor reaches a steady state (the recirculating concentrate solution circulates past meter 23b until the conductivity of the solution is stabilized at a decreased level, this is being interpreted as a steady state, see Col 10 lines 35-43 & Fig. 7).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Wyeth with Jonsson to include the step of flowing the contents past at least one fluid quality sensor and back into the mixing container and continuously recirculating at least a portion of the contents of the mixing container past the at least one fluid quality sensor until a value output by the fluid quality sensor reaches a steady state since such a modification would allow for monitoring of the concentration of the contents during mixing and circulation and yield predictable results pertaining to solution conductivity measurement and control (see Col 9 lines 43-47 and Col 10 lines 35-55 of Jonsson).
As modified, the two conductivity sensors 764 of Wyeth would be included in the recirculation loop - between manifolds 758 and 760, on either line 746 and/or 750. The determination of a concentration of the contents would no longer require the contents to be sent to the drain. Instead, the conductivity sensors 764 would operate like the conductivity meter 23b of Jonsson, measuring conductivity of the solution as it circulates until the solution is stabilized.
Further, Burbank ‘263 teaches a method (abstract) comprising maintaining the predetermined pressure in the fluid loop and permitting the fluid from the fluid loop to flow to the medicament user device at the predetermined pressure (system 1399, which is a configuration of a peritoneal dialysis cycler unit, provides batch preparation and storage, [0137]-[0138]; “The system may perform the functions of creating a batch S174 and holding a batch while maintaining its temperature S176. The system may make the batch available for use by providing the fluid at a predefined pressure S178.”, [0150] & Fig. 19A and 20A; “FIG. 22 is a more detailed description of a batch preparation and treatment system which is consistent with the embodiment of FIG. 19A”, [0163]; “To provide a stable and predictable source fluid pressure, similar to that provided by a fluid bag hung above a treatment device, in a situation where the batch container is below the treatment machine as it is in the preferred embodiment (See FIG. 25), a recycling loop 1462 and 1460 is provided.”, [0169] & Fig. 22; a predetermined pressure is maintained in a fluid loop 1462 and 1460, with the completed batch available for use at the predetermined pressure).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Wyeth, as modified, with Burbank ‘263 to include maintaining the predetermined pressure in the fluid loop and permitting the fluid from the fluid loop to flow to the medicament user device at the predetermined pressure since such a modification would provide means to control the delivery pressure of the fluid to the patient, provide consistent metering, and provide stable and predictable source pressure to ensure safe fluid delivery ([0137]-[0138], [0163]-[0164], and [0169] of Burbank ‘263).
Regarding claim 12, Wyeth, as modified, discloses all the limitations of claim 9. Wyeth further discloses the method further comprising: connecting a first source of the first concentrated medicament to the disposable component with a connector (concentrate container 736 containing the electrolyte concentrate operatively connected to fluid circuit 701E by connector 799, [0241] and [0283] & Fig. 18F); and connecting a second source of the second concentrated medicament to the disposable component with a second connector (concentrate container 738 containing the osmotic agent operatively connected to fluid circuit 701E by another connector 799, [0241] and [0283] & Fig. 18F).
Regarding claim 14, Wyeth, as modified, discloses all the limitations of claim 9. Wyeth further discloses the method further comprising: conveying a variable quantity of the purified water to the mixing container after the first mixing (“At S558 the controller 739 conditionally pumps further water or electrolyte concentrate responsively to the previous conductivity test done at S556”, see [0274]-[0275]), wherein the variable quantity is determined based on the concentration of the content of the mixing container (“At S556 the controller 739... pumps a quantity of its contents sufficient to test conductivity to confirm the level of dilution of electrolyte. Any difference between the actual and expected conductivity measurements is compared to a threshold and if the threshold is exceeded, at S558, additional water or electrolyte concentrate may be added to provide the target ratio,” [0274]). As combined above in claim 9, the controller 739 would not need to pump contents to the drain line and would instead initiate a quantity of the contents to be pumped past sensor 764 for conductivity testing or simply continue the mixing operation.
Regarding claim 15, Wyeth, as modified, discloses all the limitations of claim 14. Wyeth further discloses the method further comprising: further determining a concentration of the content of the mixing container at a time after conveying the variable quantity of the purified water to the mixing container and before conveying the third quantity of the second concentrated medicament to the mixing container (“At S558 the controller 739 conditionally pumps further water [or electrolyte concentrate] responsively to the previous conductivity test done at S556. This process may be iterative to provide, effectively, a titration until the required ratio of electrolyte to water is achieved,” [0275]; conductivity can be retested at S556 until the required ratio is achieved – this is being interpreted as further determining a concentration of the contents at a time after conveying the variable quantity of purified water).
Regarding claim 16, Wyeth, as modified, discloses all the limitations of claim 14. Wyeth further discloses the method wherein the variable quantity of the purified water is less than a difference between the first quantity of the purified water and an estimated total quantity of the purified water required in the custom mini batch of dialysate (“At S566, the controller 739 determines and adds the complement of water depending on the initial amount provided at S548. In the example of 50% water, the 50% balance of water is added. If the quantity of water was adjusted in S558, then the balance is adjusted based on any additional quantity added to the contents of the mixing container 732,” [0279] & Fig. 18D; unless the variable quantity added was the remaining 50% balance of water, which in the provided example is not the case considering the quantity of water was adjusted in S558, then the variable quantity of water is less than 50% of the total water balance).
Regarding claim 17, Wyeth, as modified, discloses all the limitations of claim 9. Wyeth further discloses the method further comprising: conveying a second variable quantity of the purified water to the mixing container after the second mixing, wherein the second variable quantity is determined based on the determined concentration of the contents of the mixing container after the second mixing (“At S566, the controller 739 determines and adds the complement of water depending on the initial amount provided at S548... the balance is adjusted based on any additional quantity added to the contents of the mixing container 732,” [0279]; at S564, controller 379 conducts conductivity test with sensors 764 to determine whether the batch can be passed onto S566, [0278] & Fig. 18D; this determines whether the second variable quantity will be added or not).
Regarding claim 18, Wyeth, as modified, discloses all the limitations of claim 9. Wyeth further discloses the method wherein the providing of the contents of the mixing container to the medicament user device takes place less than an hour after an initiation of production of the custom mini batch of dialysate (“the... embodiments include ones in which the method is performed such that it is completed within... an hour of a start of a peritoneal dialysis treatment,” [0375] and see [0140]).
Regarding claim 19, Wyeth, as modified, discloses all the limitations of claim 9. Wyeth further discloses the method wherein the conveying of the third quantity of the second concentrated medicament to the mixing container comprises conveying the third quantity of the second concentrated medicament to the mixing container in response to the determining of the concentration of the content of the mixing container indicating that there is no gross error in a measurement of the concentration of the content of the mixing container (step S560 does not occur until the conductivity test occurs to confirm proportions, [0275]-[0276] & Fig. 18C; if the proportions are not proper – more water or electrolyte is pumped into mixing container 732 in step S558, Fig. 18C; the determination of proper proportions is being interpreted as an indication of whether or not there is a gross error in measurement of the concentration of the contents; alternately, it is also disclosed that two sensors 764 are provided to be able to provide independent indications of conductivity that can be compared to indicate a bad sensor, which may also be interpreted as a gross error in measurement of the concentration, see [0212]).
Regarding claim 20, Wyeth, as modified, discloses all the limitations of claim 9. Wyeth further discloses the method wherein the first concentrated medicament is an osmotic agent concentrate and the second concentrated medicament is an electrolyte concentrate (as presented in claim 9, the first concentrated medicament is electrolyte concentrate in container 736 and the second concentrated medicament is osmotic agent in container 738; however, in the method of Figures 18B-18D and [0251], it is disclosed that the reverse order of medicament introduction is possible, see S552 and S560 in Fig. 18C & [0272] and [0276]; the order reversal would flip the first and second concentrated medicament - the first concentrated medicament being osmotic agent concentrate and the second concentrated medicament being electrolyte concentrate).
Regarding claim 21, Wyeth, as modified, discloses all the limitations of claim 9. Wyeth, as modified, discloses the method wherein the regulating of the controllable clamp on the second fluid line via the feedback control maintains the predetermined pressure in the fluid loop (clamp 751 on line 750 is under control of controller 739, [0244] & Fig. 18A; “a controller connected to the pressure sensor changes the operation of the peritoneal dialysis machine in response to changes in pressure sensed by the pressure sensor.”, [0010] of Burbank; “the functions of the actuators 929, 930, 928, 931, 932, 933, 934, and 935 are in some instances reassigned by the command signals of the controller 907.”, [0126] & Fig. 10; see [0244] of Wyeth for disclosure of pressure sensors 769 sending signals corresponding to the pressure to controller 739, which could regulate clamp 721 on line 750, a relationship synonymous to controller 907 regulating actuators 928-935; as modified with Burbank ‘263, the controller is configured to maintain the pressure in the fluid loop, [0137]-[0138], [0163]-[0164], and [0169] of Burbank ‘263 and claim 9 above). However, Wyeth fails to explicitly disclose the predetermined pressure being selected to be compatible with a pump in the medicament user device.
However, Burbank ‘263 teaches a method (abstract) wherein the predetermined pressure is selected to be compatible with a pump in the medicament user device (“Pumps 1805 and 1806 may be controlled by a controller 1810 using feedback control based on inlet and outlet pressure sensor readings from pressure sensors 1820, 1825, 1821 and 1826, respectively. In addition, precise inlet and outlet pressure readings combined with a calibration curve for each pump may allow the precise determination of total volume of fluid transferred to and from the patient.”, [0182] & Fig. 28; the pressure of the fluid flowing through the pumps is selected to be compatible with pumps 1805 and 1806).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Wyeth, as modified, with Burbank ‘263 to include the predetermined pressure selected to be compatible with a pump in the medicament user device since such a modification would provide high precision in metering dialysate for treatment ([0182] of Burbank ‘263).
Response to Arguments
Applicant's arguments filed 2/16/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments that Wyeth does not disclose a medicament user device, the Examiner finds that the catheter at the end of patient line 754 is being interpreted as a medicament user device ([0243] and [0247]).
Applicant’s arguments with respect to claim 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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