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 arguments filed December 23, 2025 have been fully considered but they are not persuasive. Amendments to the current set of claims have changed the scope of the claimed invention, resulting in a modification of the previous prior art rejection.
On page 10 of the Remarks section, as indicated by the page number at the bottom of each page, Applicant discusses the previous objection and 112 rejections and the amendments made in response. Examiner has withdrawn them as a result.
On pages 10-17, Applicant argues against the previous 103 prior art rejection of independent Claim 31 using primary reference Burbank et al., (“Burbank”, US 2008/0230450), and secondary reference Jansson et al., (“Jansson”, WO 00/57935). On pages 10-14, Applicant summarizes the disclosure of Burbank. Then, on pages 14-15, Applicant argues that the current invention is directed toward deliberately operating a hemodialysis machine in a non-treatment mode to produce dialysis fluid online, and not for immediate patient therapy but for controlled filling of more or more containers. Applicant argues that the claimed invention has its dialysis machine receiving the water and dialysate components, and directly mixes the dialysate components, and sends the resultant dialysate out of the machine to be stored for later use. Applicant argues that Burbank has its machine, the treatment machine, downstream of all of the discussed components rather than between them. In response, the Examiner notes that newly found secondary reference Burbank et al., (“Burbank 2”, US 2014/0018727), has a mixing or cycler interface that receives both water and dialysate components to make dialysate that it later delivers to the batch container, (Cycler 788 is interposed between Water purifier 790 and the rest of the tubing set/equipment such as Glucose 760/Electrolyte 762/Batch 764/Fluid Circuit Unit 758, See Figure 7B & 7C, See paragraphs [0100] & [0101], Burbank 2). While the original primary reference Burbank does not explicitly demonstrate its module 1315 as the claimed machine, the structural demonstration and relationship of the different components in relation to the cycler 788 is made clear in Burbank 2. Thus, the Examiner finds Applicant’s remark here directed toward Burbank moot.
On pages 15-16, Applicant continues to argue that the treatment machine of original Burbank is different from the claimed dialysis machine of the current invention. The Examiner notes that the cycler module in Burbank 2 which holds the interfaces through which the different components connect and carry fluids to mix is considered to read upon the claimed dialysis machine instead. Applicant also argues that the structural positioning of original Burbank is different from that of the current invention. Again, the Examiner points to Burbank 2 to demonstrate the structural positioning which reads upon the claimed invention, (Cycler 788 is interposed between Water purifier 790 and the rest of the tubing set/equipment such as Glucose 760/Electrolyte 762/Batch 764/Fluid Circuit Unit 758, See Figure 7B & 7C, See paragraphs [0100] & [0101], Burbank 2).
Finally, on page 16, Applicant argues that original Burbank teaches away from having the dialysis machine operate in a non-treatment mode. The Examiner notes that mixing the dialysate by the machine of Burbank 2 takes place without requiring treatment to take place. Rather, the movement of the different fluid components takes place in the interface 758 directly connected to cycler module 788 in which they are sent to batch container 764 for storing dialysate for later use in therapy, (See Figure 7B/7C, and See paragraphs [0101], [0100], Burbank 2). Thus, the Examiner takes the position that Burbank in combination with Burbank 2 does not teach away when it generates dialysate for later use after sending it to a batch container. The Examiner finds this argument unpersuasive.
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.
Claim(s) 31-39, 47-49 & 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al., (“Burbank”, US 2008/0230450), in view of Jansson et al., (“Jansson”, WO 00/57935), in further view of Burbank et al., (“Burbank 2”, US 2014/0018727).
Regarding Claims 31-39, 47-49 & 51, Burbank discloses a dialysis fluid generation system, (See Abstract, Burbank), comprising: water purification equipment configured to provide purified water, (One of Pretreatment Module 1295, or UV/Pump Module 1300 or Resin Module 1305, See Figure 19A, See paragraph [0130]); a tubing set for use during treatment provided with: at least one container for storing dialysis fluid, (Batch Container 1317, See Figure 19A, See paragraph [0130]), a reusable filter upstream from the at least one container, (Another of Pretreatment Module 1295, or UV/Pump Module 1300 or Resin Module 1305, See Figure 19A, See paragraph [0130]), an outlet line leading from the reusable filter to the at least one container, (Line 1361 to Path Selector 1315 and Line 1369/1366, See Figure 19A, See paragraph [0130]-[0132]), an inlet line leading to the reusable filter, (Lines including Line 1360 from Modules 1295/1300/1305, See Figure 19A); and an inlet connector configured to connect to the dialysis machine or to a fluid line of the dialysis machine, (Connector 1344Q, See Figure 19A, See paragraph [0131] & [0151], Burbank), and at least one disposable filter provided as a set with the at least one container, (LTF Module 1305 includes Ultrafilters, See Figure 24 and Figures 2A/8a, applies to Figure 19, See paragraph [0155]), wherein the at least one disposable filter is located upstream of and/or downstream from the at least one container, (Module 1305 is upstream of Batch Container 1317, See Figure 19A, See paragraph [0130]-[0132]); an additional container containing a first concentrate and containing a second concentrate comprising a buffer, (See paragraphs [0131], [0133] & [0136]); and a dialysis machine configured for online production of the dialysis fluids and in fluid communication with the water purification equipment, (Module 1315 and Treatment Machine 1312 are in fluid communication with One of Modules 1295/1300/1305, See Figure 19A, See paragraph [0130]-[0132]), the dialysis machine including: an inlet port to receive the purified water from the water purification equipment, a first concentrate inlet port connected to the first container containing the first concentrate, a second concentrate inlet port connected to the additional container containing the additional/second concentrate, a dialysis fluid outlet port or a fluid line connected to the inlet connector of the inlet line of the tubing set to provide the dialysis fluid to the tubing set, (Module 1315 includes connector/port from Line 1370 (water), connector/port from Line 1366 (first concentrate), connector/port from Line 1369 (second concentrate), Line 1364 to dialysate fluid for use, See Figure 19A, See paragraph [0130]-[0132]), at least one mixing pump for mixing the first concentrate and the second concentrate with the purified water to form the dialysis fluid within the dialysis machine, (See paragraphs [0133]-[0136]), a dialysis fluid pump for delivering the dialysis fluid to the outlet port or the fluid line and to the at least one container for storing the dialysis fluid, (Dialysate Pump 1464, See Figure 22, See paragraph [0156] & [0155]), and a control unit configured to control the at least one mixing pump to form the dialysis fluid and control the dialysis fluid pump to deliver the dialysis fluid to the at least one container for storing the dialysis fluid, (Controller 1497, See Figures 19B-19J, See paragraph [0156]), the tubing set being arranged to transfer the dialysis fluid from the dialysis machine to the at least one container for storing the dialysis fluid, (See paragraph [0156] and See paragraphs [0133]-[0136]); wherein the dialysis machine is operated in a non-treatment mode while receiving the purified water from the water purification equipment, and mixing the purified water with the first concentrate and with the second concentrate to form the dialysis fluid, (Module 1315 is operating to direct fluid to mix and direct dialysate, not dialysis treatment, See Figures 19A, 24 & 22, See paragraph [0156] and See paragraphs [0133]-[0136]), and wherein the tubing set is removable from the dialysis machine, (See paragraph [0151], Burbank).
Burbank does not disclose the additional container being a first container and a second container, the first concentrate from the first container and the second concentrate from the second container, or wherein the dialysis machine is interposed between the water purification equipment and the tubing set.
Jansson discloses the additional container being a first container and a second container, the first concentrate from the first container and the second concentrate from the second container, (Compartments 408-420, See Figure 5, See page 66, lines 25-38, page 67, lines 1-32, Jansson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Burbank by incorporating the additional container being a first container and a second container and the first concentrate from the first container and the second concentrate from the second container as in Jansson so that it “can be used to make the formulation required by a patient and based on a prescription determined in advance of treatment” and “the prescribing process is separated from the delivery process, giving medical practitioners greater freedom to vary a prescription”, (See page 28, lines 16-25, Jansson).
Modified Burbank does not disclose wherein the dialysis machine is interposed between the water purification equipment and the tubing set.
Burbank 2 discloses wherein the dialysis machine is interposed between the water purification equipment and the tubing set, (Cycler 788 is interposed between Water purifier 790 and the rest of the tubing set/equipment such as Glucose 760/Electrolyte 762/Batch 764/Fluid Circuit Unit 758, See Figure 7B & 7C, See paragraphs [0100] & [0101], Burbank 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the dialysis fluid generation system of modified Burbank by incorporating wherein the dialysis machine is interposed between the water purification equipment and the tubing set as in Burbank 2 in order to provide “an integrated disposable fluid circuit…that allow accurate filing and draining control with high safety margins”, (See paragraph [0011], Burbank 2).
Additional Disclosures Included:
Claim 32: The dialysis fluid generation system of claim 31, the outlet line includes an outlet connector configured to connect to a mating connector of the at least one container, (Connector 1344E, See Figure 19A, Burbank).
Claim 33: The dialysis fluid generation system of claim 31, wherein the reusable filter is provided in a first sterilized package, (See paragraph [0131]), and wherein the outlet line, the at least one disposable filter, and the at least one container are provided in a second sterilized package, (See paragraphs [0069], [0070] & [0099], Burbank).
Claim 34: The dialysis fluid generation system of claim 31, wherein the reusable filter is an ultrafilter or a dialyzer, (Ultrafilters 1035A/B, See Figure 8A, See paragraph [0077]; and LTF Module 1305 includes Ultrafilters, See Figure 24 and Figures 2A/8a, applies to Figure 19, See paragraph [0155]), and wherein the dialysis fluid generation system includes a priming line leading from the ultrafilter, (Vents 1047 and/or Lines in between Ultrafilters 1035A/B, See Figure 8A, paragraph [0077], [0080], [0081], Burbank).
Claim 35: The dialysis fluid generation system of claim 31, wherein the at least one disposable filter is located upstream from the at least one container to further purify the dialysis fluid for use as replacement fluid, (Another of Pretreatment Module 1295, or UV/Pump Module 1300 or Resin Module 1305, See Figure 19A, See paragraph [0130]), an outlet line leading from the reusable filter to the at least one container, (Line 1361 to Path Selector 1315 and Line 1369/1366, See Figure 19A, See paragraph [0130]-[0132], Burbank).
Claim 36: The dialysis fluid generation system of claim 31, wherein the control unit is configured to perform a pressure integrity test on the reusable filter, (See paragraph [0066], [0106] or [0149], Burbank).
Claim 37: The dialysis fluid generation system of claim 31, wherein the reusable filter comprises at least one blocked connector , (Vents 1047 along Ultrafilters 1035A/B, See Figure 8A, See paragraph [0077], Burbank), so that the dialysis fluid delivered from the dialysis machine to the reusable filter is forced through pores of a plurality of membranes housed by the reusable filter for filtration of the dialysis fluid, (See paragraph [0017], [0077], Burbank).
Claim 38: The dialysis fluid generation system of claim 37, wherein the at least one blocked connector of the reusable filter and the outlet line leading from the reusable filter to the at least one container are separated by the plurality of membranes housed by the reusable filter for filtration of the dialysis fluid, (Vent 1047 between Ultrafilters 1035A/B, See Figure 8A, See paragraph [0077], Burbank).
Claim 39: The dialysis fluid generation system of claim 37, wherein the tubing set includes an inlet line leading to the reusable filter, (Line leading to Ultrafilters 1035A/B, See Figure 8A, See paragraph [0077], Burbank), and wherein the at least one blocked connector of the reusable filter and the inlet line are located on a same side of the reusable filter with respect to the plurality of membranes housed by the reusable filter, (Vent 1047 between Ultrafilters 1035A/B, See Figure 8A, See paragraph [0077], Burbank).
Claim 47: The dialysis fluid generation system of claim 31, wherein the first concentrate is an acid and the buffer in the second concentrate is bicarbonate, (See paragraph [0136], Burbank), the dialysis fluid being hemodialysis fluid or replacement fluid, (See paragraph [0099], Burbank).
Claim 48: The dialysis fluid generation system of claim 31, wherein the water purification equipment includes at least one of (i) a central water purification station configured to feed a plurality of dialysis machines; or (ii) a form of purification selected from the group consisting of: reverse osmosis, ultraviolet radiation, electrodionizaion, ultrafiltration, ion- exchange resins, heat disinfection, distillation, and/or forward osmosis, (UV/Pump Module 1300 or LTF Module 1035, See Figure 19A, See paragraph [0130], Burbank).
Claim 49: The dialysis fluid generation system of claim 31, wherein the at least one container for storing dialysis fluid comprises a plurality of containers, the control unit is further configured to enable an operator to enter at least one of (i) a volume of dialysis fluid per container or (ii) a number of the plurality of containers to be filled with dialysis fluid, (See paragraph [0114], [0118], Burbank).
Claim 51: The dialysis fluid generation system of claim 31, wherein the dialysis machine includes at least one conductivity sensor outputting to the control unit as feedback to form the dialysis fluid, (See paragraph [0054], Burbank).
Claim(s) 40 & 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al., (“Burbank”, US 2008/0230450), in view of Jansson et al., (“Jansson”, WO 00/57935), in further view of Burbank et al., (“Burbank 2”, US 2014/0018727), in further view of Ericson et al., (“Ericson”, US 2003/0019276).
Regarding Claim 40, modified Burbank discloses the dialysis fluid generation system of claim 31, wherein the dialysis machine comprises a pressure transducer, (Pressure Transducers 1015/1025, See Figure 1B and Figure 13A/B, See paragraph [0074], Burbank), the tubing set further including a pressure transmission line in fluid communication with the at least one container, (See paragraph [0161], Burbank), the pressure transmission line configured to provide a dialysis fluid pressure to the pressure transducer of the dialysis machine, (See paragraph [0161], Burbank), but does not disclose the control unit configured to determine a characteristic change in dialysis fluid pressure to stop the dialysis fluid pump from delivering the dialysis fluid to the at least one container.
Ericson discloses the control unit configured to determine a characteristic change in dialysis fluid pressure to stop the dialysis fluid pump from delivering the dialysis fluid to the at least one container, (See paragraph [0007] & [0009], Ericson; the machine will stop, indicating fluid movement stops, and a characteristic change (static) in pressure is applied).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating the control unit configured to determine a characteristic change in dialysis fluid pressure to stop the dialysis fluid pump from delivering the dialysis fluid to the at least one container as in Ericson for “testing differential pressure sensors”, (See Abstract, Ericson), to “reliably monitor the pressure” so that “operation of the sensors [is] trouble-free”, (See paragraph [0008], Ericson).
Additional Disclosures Included:
Claim 41: The dialysis fluid generation system of claim 40, wherein the characteristic change in the dialysis fluid pressure is a characteristic change in a static dialysis fluid pressure, (See paragraph [0007] & [0009], Ericson; the machine will stop, indicating fluid movement stops, and a characteristic change (static) in pressure is applied).
Claim(s) 42-46, 50 & 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al., (“Burbank”, US 2008/0230450), in view of Jansson et al., (“Jansson”, WO 00/57935), in further view of Burbank et al., (“Burbank 2”, US 2014/0018727), in further view of Biewer et al., (“Biewer”, US 2019/0083693).
Regarding Claim 42, modified Burbank discloses the dialysis fluid generation system of claim 31, but does not disclose wherein the at least one container includes a first container and a second container placed fluidly in series with the first container.
Biewer discloses a dialysis system wherein the at least one container includes a first container and a second container placed fluidly in series with the first container, (Dialysate Containers 425, See Figure 4A/B, See paragraph [0046], Biewer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating the at least one container includes a first container and a second container placed fluidly in series with the first container as in Biewer because “it is understood that a treatment regimen may need more…dialysate containers” and “that the individual patient treatment regimen and total dialysate volume….may dictate how many…dialysate containers are connected to the dialysis machine”, (See paragraph [0046], Biewer).
Regarding Claim 43, modified Burbank discloses the dialysis fluid generation system of claim 31, but does not disclose wherein the at least one container includes a first container and a second container placed fluidly in parallel with the first container.
Biewer discloses a dialysis system wherein the at least one container includes a first container and a second container placed fluidly in series with the first container, (Dialysate Containers 425, See Figure 4A/B, See paragraph [0046] & [0055] & [0056], Biewer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating the at least one container includes a first container and a second container placed fluidly in series with the first container as in Biewer because “it is understood that a treatment regimen may need more…dialysate containers” and “that the individual patient treatment regimen and total dialysate volume….may dictate how many…dialysate containers are connected to the dialysis machine”, (See paragraph [0046], Biewer). Additionally, the second container “may act as a holding reservoir for diverted dialysate and allow the temporarily unusable dialysate to later be used in the treatment”, (See paragraph [0053], Biewer).
Regarding Claim 44, modified Burbank discloses the dialysis fluid generation system of claim 31, but does not disclose wherein the at least one container includes a first container, a second container, and a third container, wherein the second container is placed fluidly in series with the first container and the third container is placed fluidly in parallel with the first container.
Biewer discloses wherein the at least one container includes a first container, a second container, and a third container, wherein the second container is placed fluidly in series with the first container and the third container is placed fluidly in parallel with the first container, (3 Dialysate Containers 425, rightmost one downstream (series) with leftmost one, middle one is provided in parallel, See Figure 4A/B, See paragraph [0046] & [0055] & [0056], Biewer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating wherein the at least one container includes a first container, a second container, and a third container, wherein the second container is placed fluidly in series with the first container and the third container is placed fluidly in parallel with the first container as in Biewer because “it is understood that a treatment regimen may need more…dialysate containers” and “that the individual patient treatment regimen and total dialysate volume….may dictate how many…dialysate containers are connected to the dialysis machine”, (See paragraph [0046], Biewer). Additionally, the second container “may act as a holding reservoir for diverted dialysate and allow the temporarily unusable dialysate to later be used in the treatment”, (See paragraph [0053], Biewer).
Regarding Claim 45, modified Burbank discloses the dialysis fluid generation system of claim 31, wherein the system further includes a standalone valve station for selectively opening or occluding the first and second filling tubes, (Filter Circuit 1315 and Valves 1412/1414/1416/1418, See paragraph [0156], Burbank), but does not disclose wherein the at least one container includes a first container and a second container for receiving the dialysis fluid, the system further including a first filling tube leading to the first container and a second filling tube leading to the second container.
Biewer discloses wherein the at least one container includes a first container and a second container for receiving the dialysis fluid, the system further including a first filling tube leading to the first container and a second filling tube leading to the second container, (Lines leading to and from Dialysate Containers 425, See Figure 4A/B, See paragraphs [0053] & [0055], Biewer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating wherein the at least one container includes a first container, a second container, and a third container, wherein the second container is placed fluidly in series with the first container and the third container is placed fluidly in parallel with the first container as in Biewer because “it is understood that a treatment regimen may need more…dialysate containers” and “that the individual patient treatment regimen and total dialysate volume….may dictate how many…dialysate containers are connected to the dialysis machine”, (See paragraph [0046], Biewer). Additionally, the second container “may act as a holding reservoir for diverted dialysate and allow the temporarily unusable dialysate to later be used in the treatment”, (See paragraph [0053], Biewer).
Additional Disclosures Included:
Claim 46: The dialysis fluid generation system of claim 45, wherein the standalone valve station is in wired or wireless communication with the control unit of the dialysis machine for commanding the standalone valve station, (Filter Circuit 1315 and Valves 1412/1414/1416/1418, See paragraph [0156], [0066], [0102], Burbank).
Regarding Claim 50, modified Burbank discloses the dialysis fluid generation system of claim 31, but does not disclose further comprising a recirculation container in recirculation fluid communication with the dialysis machine to enable operation of the dialysis machine in the non-treatment mode, wherein the dialysis machine includes a bypass mode that uses the recirculation container to recirculate dialysis fluid through the dialysis machine.
Biewer discloses further comprising a recirculation container in recirculation fluid communication with the dialysis machine via a first recirculation line and a second recirculation line to enable operation of the dialysis machine in the non-treatment mode, each of the first and second recirculation lines connecting the dialysis machine with the recirculation container so that the first recirculation line is configured to send the dialysis fluid from the dialysis machine to the recirculation container while the second recirculation line is configured to withdraw the dialysis fluid from the recirculation container and brings the dialysis fluid back to the dialysis machine, wherein the dialysis machine includes a bypass mode that uses the recirculation container to recirculate the dialysis fluid through the dialysis machine, (3 Dialysate Containers 425 connected via lines 420 and 430, rightmost one downstream (series) with leftmost one, See Figure 4A/B, See paragraph [0046] & [0055] & [0056], Biewer; rightmost one receives dialysate too hot and thus is recirculated until it is ready for re-use).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating further comprising a recirculation container in recirculation fluid communication with the dialysis machine via a first recirculation line and a second recirculation line to enable operation of the dialysis machine in the non-treatment mode, each of the first and second recirculation lines connecting the dialysis machine with the recirculation container so that the first recirculation line is configured to send the dialysis fluid from the dialysis machine to the recirculation container while the second recirculation line is configured to withdraw the dialysis fluid from the recirculation container and brings the dialysis fluid back to the dialysis machine, wherein the dialysis machine includes a bypass mode that uses the recirculation container to recirculate the dialysis fluid through the dialysis machine as in Biewer because “it is understood that a treatment regimen may need more…dialysate containers” and “that the individual patient treatment regimen and total dialysate volume….may dictate how many…dialysate containers are connected to the dialysis machine”, (See paragraph [0046], Biewer). Additionally, the second container “may act as a holding reservoir for diverted dialysate and allow the temporarily unusable dialysate to later be used in the treatment”, (See paragraph [0053], Biewer).
Regarding Claim 52, modified Burbank discloses the dialysis fluid generation system of claim 31, but does not disclose further comprising a return line from the at least one container to the dialysis machine for testing the dialysis fluid, wherein the return line comprises a fluid connection to the at least one container at one end and a return line connector at the other end for enabling the dialysis fluid to be returned to the dialysis machine.
Biewer discloses further comprising a return line from the at least one container to the dialysis machine for testing the dialysis fluid, wherein the return line comprises a fluid connection to the at least one container at one end and a return line connector at the other end for enabling the dialysis fluid to be returned to the dialysis machine, (Line 420, fluid flows from dialysate container to Machine 405 and is returned to another dialysate container if it is unusable after being tested for temperature, See Figures 4A/4B, See paragraphs [0055]-[0058], Biewer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating further comprising a return line from the at least one container to the dialysis machine for testing the dialysis fluid, wherein the return line comprises a fluid connection to the at least one container at one end and a return line connector at the other end for enabling the dialysis fluid to be returned to the dialysis machine as in Biewer to “act as a holding reservoir for diverted dialysate and allow the temporarily unusable dialysate to later be used in the treatment”, (See paragraph [0053], Biewer), when “the diverted dialysate is an acceptable temperature”, (See paragraph [0055], Biewer).
Claim(s) 53-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al., (“Burbank”, US 2008/0230450), in view of Jansson et al., (“Jansson”, WO 00/57935), in further view of Burbank et al., (“Burbank 2”, US 2014/0018727), in further view of Kalaskar et al., (“Kalaskar”, US 2020/0282125).
Regarding Claim 53, modified Burbank discloses the dialysis fluid generation system of claim 31, but does not disclose wherein the at least one container includes a first chamber and a second chamber, the control unit being configured to: control the at least one mixing pump to form a first solution with water and the first concentrate; control the at least one mixing pump to form a second solution with water and the second concentrate, (See page 67, lines 11-32, and See page 24, lines 37-38, page 25, lines 1-10, Jansson); and control the dialysis fluid pump to deliver the first solution and the second solution to the at least one container, (See page 75, lines 36-38, page 76, lines 1-12, Jansson), but does not disclose wherein the at least one container includes a first chamber and a second chamber or delivering solutions to each chamber.
Kalaskar discloses wherein the at least one container includes a first chamber and a second chamber and delivering solutions to each chamber, (Mixing Chamber with two compartments, See Figure 1, See paragraph [0053], Kalaskar).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of modified Burbank by incorporating wherein the at least one container includes a first chamber and a second chamber and delivering solutions to each chamber as in Kalaskar in order to “continually adjust a next dialysate batch’s recipe and task its dialysate mixing system to follow the prescribed recipe”, (See paragraph [0033], Kalaskar).
Additional Disclosures Included:
Claim 54: The dialysis fluid generation system of claim 53, wherein the at least one container includes a first container and a second container having first and second chambers, (Mixing Chamber with two compartments, See Figure 1, See paragraph [0053], Kalaskar), and wherein the control unit is configured to deliver the first solution to the first chamber of each of the first and second containers and the second solution to the second chamber of each of the first and second containers, (Mixing Chamber with two compartments, See Figure 1, See paragraph [0053], Kalaskar), and wherein the first solution is an acid solution and the second solution is a buffer solution, (See paragraph [0136], Burbank; and Compartments 408-420, See Figure 5, See page 66, lines 25-38, page 67, lines 1-32, Jansson).
Claim 55: The dialysis fluid generation system of claim 53, wherein the tubing set includes a first filling line leading to the first chamber of the at least one container and a second filling line leading to a second chamber of the at least one container, (Mixing Chamber with two compartments, See Figure 1, See paragraph [0053], Kalaskar; and See paragraph [0136], Burbank; and Compartments 408-420, See Figure 5, See page 66, lines 25-38, page 67, lines 1-32, Jansson).
Claim 57: The dialysis fluid generation system of claim 53, wherein the at least one disposable filter is located upstream from the at least one container, (Another of Pretreatment Module 1295, or UV/Pump Module 1300 or Resin Module 1305, all upstream from Batch Container 1317, See Figure 19A, See paragraph [0130]), and configured to further purify the first solution and the second solution for use as replacement fluid after mixing, (See paragraphs [0070] & [0099], Burbank).
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al., (“Burbank”, US 2008/0230450), in view of Jansson et al., (“Jansson”, WO 00/57935), in further view of Kalaskar et al., (“Kalaskar”, US 2020/0282125), in further view of Burbank et al., (“Burbank 2”, US 2014/0018727), in further view of Elisabettini et al., (“Elisabettini”, US 2003/0138501).
Regarding Claim 56, modified Burbank discloses the dialysis fluid generation system of claim 53, but does not disclose wherein the first and second chambers of the at least one container are separated by at least one frangible seal, the frangible seal openable to allow the first solution to mix with the second solution.
Elisabettini discloses wherein the first and second chambers of the at least one container are separated by at least one frangible seal, the frangible seal openable to allow the first solution to mix with the second solution, (See paragraph [0034], Elisabettini).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the dialysis fluid generation system of modified Burbank by incorporating wherein the first and second chambers of the at least one container are separated by at least one frangible seal, the frangible seal openable to allow the first solution to mix with the second solution as in Elisabettini so that “this would necessarily ensure that the patient is not overloaded with sodium through the administration of, for example, the bicarbonate concentrate which can be directly coupled to the patient”, (See paragraph [0047], Elisabettini).
Claim(s) 58 & 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al., (“Burbank”, US 2008/0230450), in view of Jansson et al., (“Jansson”, WO 00/57935), in further view of Burbank et al., (“Burbank 2”, US 2014/0018727), in further view of Engeln, (US 2022/0241481).
Regarding Claims 58 & 59, modified Burbank discloses the dialysis fluid generation system of claim 31, but does not disclose further comprising a label printer configured to print a label for placement on the at least one container, the label comprising dialysis fluid information including one or more of: a date that the dialysis fluid is prepared, a time that the dialysis fluid is prepared, an expiration period or date, a type or formulation of the dialysis fluid, a quantity of the dialysis fluid, machine identification that prepared the dialysis fluid, operator identification, or a lot number.
Engeln discloses further comprising a label printer configured to print a label for placement on the at least one container, the label comprising dialysis fluid information including one or more of: a date that the dialysis fluid is prepared, a time that the dialysis fluid is prepared, an expiration period or date, a type or formulation of the dialysis fluid, a quantity of the dialysis fluid, machine identification that prepared the dialysis fluid, operator identification, or a lot number, (See paragraph [0059] & [0062], Engeln).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the dialysis fluid generation system of modified Burbank by incorporating further comprising a label printer configured to print a label for placement on the at least one container, the label comprising dialysis fluid information including one or more of: a date that the dialysis fluid is prepared, a time that the dialysis fluid is prepared, an expiration period or date, a type or formulation of the dialysis fluid, a quantity of the dialysis fluid, machine identification that prepared the dialysis fluid, operator identification, or a lot number as in Engeln in order to “signal to the user whether the dialysis concentrate has the correct density and thus a complete dissolution of the dry concentrate has taken place”, (See paragraph [0032], Engeln).
Additional Disclosures Included:
Claim 59: The dialysis fluid generation system of claim 58, wherein the label printer is provided by the dialysis machine and the control unit is configured to cause the label printer to print the label during or after delivery of the dialysis fluid from the dialysis fluid pump to the at least one container, (See paragraphs [0032], [0059] & [0062], Engeln).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at 571-270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN M PEO/Primary Examiner, Art Unit 1779