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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 16, 2025 has been entered.
Response to Arguments
Applicant's arguments filed December 16, 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, but a modification of the previous prior art rejection still reads upon the claims, using newly found secondary reference Gerber et al., (“Gerber”, US 2012/0277552).
On pages 6-7 of the Remarks section as indicate by the page number at the bottom of each page, Applicant discusses the previous 103 rejections, arguing that the previous prior art references used do not disclose the newly added limitations to independent Claims 1 or 10. The Examiner notes that newly found secondary reference Gerber et al., (“Gerber”, US 2012/0277552), discloses these added limitations and has been combined with the previous prior art references, as demonstrated in the prior art rejection section below. Thus, these remarks are moot.
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) 1 & 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al., (“Jansson”, WO00/57935A1), in view of Cichello et al., (“Cichello”, US 2009/0008306), in further view of Ritson et al., (“Ritson”, WO 2018/035520), in further view of Gerber et al., (“Gerber”, US 2012/0277552).
Claims 1 & 6-9 are directed to a method of providing dialysis therapy, a method type invention group.
Regarding Claims 1 & 6-9, Jansson discloses a method of providing dialysis therapy, (See Abstract), comprising the steps of: fluidly coupling a disposable container to a dialysis machine with a single connection interface, (Disposable Concentrate Container 402 connects to Manifold 404 of Module 400 inside Dialysis Apparatus 100, See Figure 1, 5 & 15, See page 30, lines 1-4, page 31, lines 35-38, page 32, lines 1-10 and See page 41, lines 20-24, page 62, lines 35-38, page 66, lines 25-31, page 69, lines 11-16), the disposable container including at least one compartment having a powdered dialysis fluid component therein and at least one compartment having a liquid dialysis fluid component therein, (Compartments 416, 408, 410, 420, 418, 412 & 414 in Container 402, See Figure 5, 10 & 11, See page 62, lines 35-38, page 63, lines 1-9, See page 8, lines 28-31, page 23, lines 14-20); connecting a tubing set of the dialysis machine to a patient, (Dialysis Machine 100 includes Cycler Module 600 connecting to Patient 50 via Patient Fill/Drain Connections 9a/9b, See Figure 1 & 2, page 42, lines 4-37); attaching a connector-side interface of the disposable container to a corresponding machine-side interface on the dialysis machine, (Chassis 401 of Container 402 to Manifold 404, See Figure 5, 15, See page 66, lines 25-31, page 68, lines 16-38, page 69, lines 11-32, Jansson) to cause a valve opening member of the container-side connector interface to open a valve in a singular outlet channel of the machine-side connector interface, (Cleaning Agent Valve 480 or Disinfection Valve 498, See Figure 15, 11 & 5, and See page 104, lines 32-38, page 105, lines 1-14, and See page 107, lines 30-38, page 108, lines 1-29; alternatively Air Vent Valve 496 is opened after rinsing/disinfection is finished, See Figure 15 & 5, See page 76, lines 6-38, page 77, lines 1-3); delivering fluid through the valve in the singular outlet channel of the machine-side connector interface into an inlet channel of the container-side connector interface and the at least one compartment of the disposable container having the powdered dialysis fluid component, (See page 38, lines 19-24, page 41, lines 7-12); providing dialysis fluid in real-time from the disposable container to the dialysis machine through one or more inlet channels in the machine-side connector interface, (At least Channels 430 fluidly connected to Line 4a into Machine 100, See Figure 5, See page 67, lines 4-10, page 77, lines 34-38, page 78, lines 1-6, See page 39, lines 6-31, See page 74, lines 4-12, lines 22-25, lines 35-38, page 75, line 1, and; See page 41, lines 20-24); and initiating dialysis therapy with the dialysis fluid, (See page 52, lines 12-19, See page 60, lines 9-11).
Jansson does not explicitly disclose that the tubing set is a blood tubing set, or delivering purified water through the singular outlet channel of the machine-side connector interface, and the valve opening member engaging with to open the valve when attaching the interface.
Cichello discloses a method of providing dialysis therapy, (See Abstract, Cichello), in which its tubing set is a blood tubing set, (Lines 48a/b to and from Patient 14, See Figure 1, See paragraph [0081], Cichello). Additional features of this embodiment are included as part of the overall combination and are claim mapped to in the Additional Disclosures section below.
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 method of providing dialysis therapy of Jansson by incorporating that the tubing set is a blood tubing set as in Cichello in order to enable the dialysis machine to switch from a peritoneal dialysis mode to a hemodialysis mode to “provide an opportunity to the patient to alternate between PD [peritoneal dialysis], HD [hemodialysis] and/or HDF [hemodiafiltration]”, because “alternating therapies provides two primary advantages, namely preserving maximum residual renal function in PD and obtaining maximum urea clearance through HD and/or HDF”, (See paragraph [0015], Cichello).
Modified Jansson does not disclose delivering purified water through a singular outlet channel of the machine-side connector interface, and the valve opening member engaging with to open the valve when attaching the interface
Ritson discloses a method for delivering purified water through a singular outlet channel of the machine-side connector interface using a valve and valve opening member, and the valve opening member engaging with to open the valve when attaching the interface, (Single outlet and inlet into Concentrate Disposable, See Figure 7, See paragraphs [0007], [0008]; See paragraph [0044], Ritson).
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 method of modified Jansson by incorporating delivering purified water through a singular outlet channel of the machine-side connector interface and the valve opening member engaging with to open the valve when attaching the interface as in Ritson in order to provide “minimal connection points” that “can be easily installed for automated mixing and movement of fluids”, (See paragraph [0027], Ritson), that will “automate and improve the performance, efficiency and safety of dialysis therapy”, (See paragraph [0025], Ritson).
Modified Jansson does not disclose detecting an electrolyte level in the patient’s blood with a sensor, adjusting a supply ratio of the powdered dialysate component and the liquid dialysate component based on the detected electrolyte level; and providing the dialysate fluid based on the supply ratio.
Gerber discloses detecting an electrolyte level in the patient’s blood with a sensor, adjusting a supply ratio of the powdered dialysate component and the liquid dialysate component based on the detected electrolyte level; and providing the dialysate fluid based on the supply ratio, (See paragraph [0050], [0008] & [0009], Gerber).
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 method of modified Jansson by incorporating detecting an electrolyte level in the patient’s blood with a sensor, adjusting a supply ratio of the powdered dialysate component and the liquid dialysate component based on the detected electrolyte level; and providing the dialysate fluid based on the supply ratio as in Gerber because “by monitoring pH or electrolytes, a more appropriate initial dialysate or replacement fluid may be used, or the fluid may be adjusted during a session, to enhance patient safety”, (See paragraph [0006], Gerber).
Additional Disclosures Included:
Claim 6: The method of claim 2, wherein adjusting the proportioning further comprises increasing a concentration of at least one of the powdered dialysis fluid component or the liquid dialysis fluid component from the disposable container, (See page 60, lines 1-9, See page 81, lines 1-7, Jansson; Examiner interprets a condition of the patient to also include the patient’s individual prescription such that when adding the various dialysis components to water, it increases the components to a final prescribed level).
Claim 7: The method of claim 6, wherein increasing the concentration further comprises increasing a proportion of fluid from the at least one compartment having the powdered dialysis fluid component, (See page 60, lines 1-9, See page 81, lines 1-7, Jansson; Examiner interprets a condition of the patient to also include the patient’s individual prescription such that when adding the various dialysis components to water, it increases the components to a final prescribed level).
Claim 8: The method of claim 6, wherein increasing the concentration further comprises increasing a proportion of fluid from the at least one compartment having the liquid dialysis fluid component, See page 60, lines 1-9, See page 81, lines 1-7, and See page 8, lines 28-31, page 23, lines 14-20, Jansson; Examiner interprets a condition of the patient to also include the patient’s individual prescription such that when adding the various dialysis components to water, it increases the components to a final prescribed level).
Claim 9: The method of claim 1, further comprising: decoupling and removing the disposable container from the dialysis machine, (See page 33, lines 22-25, See page 114, lines 1-12); applying a cover to a machine-side connector of the single connection interface, (Manifold Cap 406 engaged to new Container 402, See Figure 16 & 17, See page 72, lines 9-22); and initiating a disinfect cycle through one or more flow paths of the dialysis machine and the machine-side connector, (Cap 406 with Connection 498, See Figures 16 & 17, See page 76, lines 13-36).
Claim(s) 10, 11, 13, 16 & 19-21 is/are rejected under 35 U.S.C. 103 as being obvious over Jansson et al., (“Jansson”, WO00/57935A1), in view of Ritson et al., (“Ritson”, WO 2018/035520), in further view of Gerber et al., (“Gerber”, US 2012/0277552).
Claims 10, 11, 13, 16 & 19-21 are directed to a disposable container configured to facilitate real-time dialysis fluid production, a device or apparatus type invention group.
Regarding Claims 10, 11, 13, 16 & 19-21, Jansson discloses a disposable container configured to facilitate real-time dialysis fluid production, (Disposable Concentrate Container 402, See Figure 1, 5 & 15, See page 32, lines 6-29, Jansson), comprising: at least one powder compartment in the disposable container configured to hold a powdered dialysis fluid component; at least one liquid compartment in the disposable container configured to hold a liquid dialysis fluid component; (Compartments 416, 408, 410, 420, 418, 412 & 414 in Container 402, See Figure 5, 10 & 11, See page 62, lines 35-38, page 63, lines 1-9, See page 8, lines 28-31, page 23, lines 14-20), a container-side connector interface extending from the disposable container, (Chassis 401 extending from Container 402, See Figure 5), and configured to mate with a machine-side connector interface of a dialysis machine, (Chassis 401 of Container 402 to Manifold 404 of Module 400 inside Dialysis Machine 100, See Figure 1, 5, 15, See page 30, lines 1-4, page 31, lines 35-38, page 32, lines 1-10 and See page 41, lines 20-24, page 62, lines 35-38, See page 66, lines 25-31, page 68, lines 16-38, page 69, lines 11-32, Jansson), the container-side connector including a valve opening member associated with an inlet flow path in the container-side connector interface, the valve opening member being configured to interact with the machine-side connector interface to open a valve in a singular outlet channel of the machine-side connector interface, (Cleaning Agent Valve 480 or Disinfection Valve 498, See Figure 15, 11 & 5, and See page 104, lines 32-38, page 105, lines 1-14, and See page 107, lines 30-38, page 108, lines 1-29; alternatively Air Vent Valve 496 is opened after rinsing/disinfection is finished, See Figure 15 & 5, See page 76, lines 6-38, page 77, lines 1-3); the inlet flow path in the container-side connector interface being selectively fluidly coupled to the outlet channel of the machine-side connector interface and to allow for fluid from the dialysis machine through the connector interface to the at least one powder compartment, through the valve in the outlet channel when the container-side connector interface is coupled to the machine-side connector interface, (At least Channels 430 fluidly connected to Line 4a, See Figure 5, See page 67, lines 4-10, page 77, lines 34-38, page 78, lines 1-6, See page 39, lines 6-31, See page 74, lines 4-12, lines 22-25, lines 35-38, page 75, line 1, Jansson; and a plurality of outlet flow paths in the container-side connector interface configured to deliver dialysis fluid from the at least one powder compartment and the at least one liquid compartment to the dialysis machine, (Manifold 404 connects to Container 402 via Channels 426/430/434, See Figure 5, See page 67, lines 4-10, lines 23-29, page 68, lines 28-34, Jansson).
Jansson does not disclose the inlet flow path being a singular inlet flow path being fluidly coupled to the outlet flow path being a singular outlet channel configured to allow for delivery of purified water when the valve is opened by the valve opening member, in which the valve opening member engages with the vale to open the valve when the container-side connector interface is mated to the machine-side connector interface.
Ritson discloses an apparatus the inlet flow path being a singular inlet flow path being fluidly coupled to the outlet flow path being a singular outlet channel configured to allow for delivery of purified water when the valve is opened by the valve opening member, when the valve is opened by the valve opening member, in which the valve opening member engages with the vale to open the valve when the container-side connector interface is mated to the machine-side connector interface, (Single outlet and inlet into Concentrate Disposable, See Figure 7, See paragraphs [0007], [0008]; See paragraph [0044], Ritson).
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 container of Jansson by incorporating the inlet flow path being a singular inlet flow path being fluidly coupled to the outlet flow path being a singular outlet channel configured to allow for delivery of purified water when the valve is opened by the valve opening member when the valve is opened by the valve opening member, in which the valve opening member engages with the vale to open the valve when the container-side connector interface is mated to the machine-side connector interface as in Ritson in order to provide “minimal connection points” that “can be easily installed for automated mixing and movement of fluids”, (See paragraph [0027], Ritson), that will “automate and improve the performance, efficiency and safety of dialysis therapy”, (See paragraph [0025], Ritson).
Modified Jansson does not disclose a sensor configured to detect an electrolyte level in the patient’s blood, and a processor configured to adjust a supply ratio of the powdered dialysate component and the liquid dialysate component during dialysis therapy based on the detected electrolyte level.
Gerber discloses a sensor configured to detect an electrolyte level in the patient’s blood, and a processor configured to adjust a supply ratio of the powdered dialysate component and the liquid dialysate component during dialysis therapy based on the detected electrolyte level, (See paragraph [0050], [0008] & [0009], [0043], Gerber).
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 method of modified Jansson by incorporating a sensor configured to detect an electrolyte level in the patient’s blood, and a processor configured to adjust a supply ratio of the powdered dialysate component and the liquid dialysate component during dialysis therapy based on the detected electrolyte level as in Gerber because “by monitoring pH or electrolytes, a more appropriate initial dialysate or replacement fluid may be used, or the fluid may be adjusted during a session, to enhance patient safety”, (See paragraph [0006], Gerber).
Additional Disclosures Included:
Claim 11: The disposable container of claim 10, wherein the at least one powder compartment comprises a NaCl powder compartment and a NaHCO3 powder compartment, (Sodium Chloride Compartment 414, Sodium Bicarbonate Compartment 412, See Figure 10, See page 65, lines 7-10,11, See page 67, lines 11-16, Jansson).
Claim 13: The disposable container of claim 10, further comprising a diffuser or filter disposed in the outlet flow paths downstream of the at least one powder compartment, (Filter Element 438 from Compartment 420 to Lines 407a/b & Channel 436, See Figures 5, 22 & 23, See page 68, lines 28-37, Jansson).
Claim 16: The disposable container of claim 10, wherein the singular outlet channel of the machine-side connector interface is fluidly coupled to a source of purified water, (At least Channels 430 fluidly connected to Line 4a, See Figure 5, See page 67, lines 4-10, page 77, lines 34-38, page 78, lines 1-6, See page 39, lines 6-31, See page 74, lines 4-12, lines 22-25, lines 35-38, page 75, line 1, Jansson).
Claim 19: The disposable container of claim 10, wherein each of the plurality of outlet flow paths comprises a pump configured to deliver a dialysis fluid from the at least one powder compartment and the at least one liquid compartment to the dialysis machine, (Pump 452 and Pump 446 on Line 4a is fluidly connected to each of Channels 426, 430, 434 etc., See Figure 5, See page 75, lines 2-15, Jansson).
Claim 20: The disposable container of claim 10, wherein each of the plurality of outlet flow paths comprises a flow sensor configured to measure a flow rate of dialysis fluid from the at least one powder compartment and the at least one liquid compartment to the dialysis machine, (Tachometers 454/456 on Pumps 446/452, See Figure 5, See page 75, lines 2-15, Jansson).
Claim 21: The disposable container of claim 10, wherein the at least one powder compartment and the at least one liquid compartment are large enough to generate enough dialysis fluid to support multiple dialysis treatments, (See page 34, lines 22-37, See page 35, lines 18-30, See page 113, lines 30-37; Examiner interprets multiple fill/drain cycles while treating a patient to read upon multiple treatments within one session; also See page 63, lines 18-25).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al., (“Jansson”, WO00/57935A1), in view of Ritson et al., (“Ritson”, WO 2018/035520), in further view of Gerber et al., (“Gerber”, US 2012/0277552), in further view of Kalaskar et al., (“Kalaskar”, US 2020/0282125).
Claim 12 is directed to a disposable container configured to facilitate real-time dialysis fluid production, a device or apparatus type invention group.
Regarding Claim 12, modified Jansson discloses the disposable container of claim 10, wherein the at least one liquid compartment comprises a C6H8O7 compartment, a C6H12O6 compartment, and a MgCl2 compartment, (Glucose Compartment 420, Magnesium Chloride Compartment 418, See Figure 10, Cleaning Agent Compartment 410 can contain Citric Acid, See Figure 10, See page 65, lines 9-14, See page 66, lines 13-16, See page 108, lines 27-29, Jansson).
Modified Jansson does not explicitly disclose that each of these compartments are in liquid form. Jansson suggests providing at least one of its compartments in liquid form, (See page 8, lines 28-31, page 23, lines 14-20).
Kalaskar discloses a container, (Dispenser 202, See Figure 2, See paragraph [0050]), where its compartments are in liquid form, (See paragraphs [0044] & [0050]; Kalaskar presents its concentrates to be alternate forms between liquid and solid, thus Examiner interprets they can be selected as liquid).
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 method of providing dialysis therapy of modified Jansson by incorporating each of the compartments are in liquid form as in Kalaskar so that “based on the prescription, the dialysate mixing system can determine, a…volume of concentrated…solution required for each chemical constituent” so that it “can be automatically dispensed and mixed with purified water…according to the desired dialysate recipe” while being “delivered and stored in…concentrated form, thus requiring minimal storage space and oversight”, (See paragraph [0034], Kalaskar).
Conclusion
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.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779
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