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 November 18, 2025 have been fully considered but they are not persuasive. Amendments made to the current set of claims, including the addition of new claim limitations to independent Claims 1 & 22 have changed the scope of the claimed invention, but a modification of the previous prior art rejection reads upon the claims using newly found secondary references Roberts et al., (“Roberts”, US 2012/0271227), and Orhan et al., (Orhan”, US 2012/0273354).
On pages 9-11 of the Remarks section as indicated by the page number at the bottom of each page, Applicant discusses the previous interview summary and then argues against the previous 103 prior art rejection. Applicant argues that the previous combination of references does not disclose the newly added limitations to independent Claim 1 or 22. The Examiner notes that newly found secondary references Roberts and Orhan are relied upon to disclose these added limitations instead, so Applicant’s remarks here are considered moot.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 22 and their dependent claims 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.
Claims 1 & 22 recite the added limitations “wherein the residual osmotic agent is a spent osmotic agent that remains in the spent peritoneal dialysate after a dialysis therapy”, “wherein the sensor is configured to measure a concentration of the residual osmotic agent within the spent dialysate and is located upstream from the concentrate source” and “determining a difference between a dialysate prescription and the concentration of the residual osmotic agent present in the spent peritoneal dialysate”. However, a review of the Specification does not appear to demonstrate these actions or the specific language used here. The Examiner indicates these limitations are considered new matter based on this review.
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 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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-3, 8, 12, 17, 43 & 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman, (US 2010/0312172), in view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Jansson et al., (“Jansson”, WO 00/57935 A1), in further view of Roberts et al., (“Roberts”, US 2012/0271227), in further view of Orhan et al., (Orhan”, US 2012/0273354).
Claims 1-3, 8, 12, 17, 43 & 44 are directed to a system, an apparatus type invention group.
Regarding Claims 1-3, 8, 12, 17, 43 & 44, Hoffman discloses a system, comprising:
a water source, (Tap Water is added to Container 57 at beginning of cycle, indicating a water source, and See Figures 5 & 12, and See paragraphs [0091], [0092] & [0126]);
a waste storage container configured to store spent peritoneal dialysate, (Container 57 stores used dialysate that is later regenerated, and See Figures 5 & 12, and See paragraphs [0091], [0092] & [0126]),
wherein the waste storage container and the water source are different, (Tap water added from source comes from tap, different from Container 57, See Figure 5 & 12, See paragraphs [0091], [0092] & [0126]);
wherein the waste storage container is configured to store a spent peritoneal dialysate, (Container 57 stores used dialysate that is later regenerated, and See Figures 5 & 12, and See paragraphs [0091], [0092] & [0126]),
a peritoneal dialysate regeneration module, (Sorbent Cartridge 64, See Figure 12, and See paragraphs [0126] & [0127]);
a concentrate source; (Glucose Solution Pump 53/Cartridge 73, and Electrolyte Solution Pump 54/Cartridge 74, See Figure 12, and See paragraphs [0127] & [0051]); and
wherein the concentrate source comprises at least one ion concentrate source container containing at least one ion concentrate; and at least one osmotic agent source container comprising at least one osmotic agent, (Glucose Solution Pump 53/Cartridge 73, and Electrolyte Solution Pump 54/Cartridge 74, See Figure 12, and See paragraphs [0127] & [0051]),
a control system, (Control Circuit to which Board 18 and Pump Actuators 27/28 are connected, in turn controlling Pumps 53/54, See Figure 11 & 12, See paragraphs [0124], [0125], [0086] & [0087]);
Hoffman does not disclose a sensor positioned between the peritoneal dialysate regeneration module and the concentrate source; wherein the water source, the waste storage container, the peritoneal dialysate regeneration module, the concentrate source, and the sensor are fluidly connectable to each other via a peritoneal dialysate generation flow path, or wherein the control system is configured to determine a concentration of the residual osmotic agent present in the spent peritoneal dialysate based on a data from the sensor; and adjust an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the spent peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription.
Rohde discloses a sensor positioned between the peritoneal dialysate regeneration module and the concentrate source, (MEMS sensor 33 between Dialysis Fluid Preparation System 34 and Vessel 32, See Figure 3, See paragraph [0049], [0063]); and wherein the water source, the waste storage container, the peritoneal dialysate regeneration module, the concentrate source, and the sensor are fluidly connectable to each other via a peritoneal dialysate generation flow path, (Source 31, Vessel 32, Preparation System 34, Sensor 33 all fluidly connected, See Figure 3; or use Vessels 49a/b, Vessel 42, Preparation System 44, Sensor 43 all on path, See Figure 4, See paragraph [0053]), and a concentration of the residual osmotic agent present in the spent peritoneal dialysate is determined based on a data from the sensor (MEMS sensor 33 between Dialysis Fluid Preparation System 34 and Vessel 32, See Figure 3, See paragraph [0049], [0063]).
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 Hoffman by incorporating a sensor positioned between the peritoneal dialysate regeneration module and the concentrate source; and wherein the water source, the waste storage container, the peritoneal dialysate regeneration module, the concentrate source, and the sensor are fluidly connectable to each other via a peritoneal dialysate generation flow path as in Rohde for “determining a composition of the dialysis fluid”, (See paragraph [0021], Rohde), and “check several parameters” which “are very useful to a patient or to a caregiver….since these measurements are directly related to the quality and make-up of the dialysis solution”, (See paragraph [0060], Rohde), in order to “prepare a customized solution or prescription for each patient”, (See paragraph [0060], Rohde).
Modified Hoffman does not explicitly disclose wherein the control system is configured to determine a concentration of the osmotic agent; and adjust an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the spent peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription.
Jansson discloses wherein the control system is configured to determine a concentration of the osmotic agent; and adjust an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription, (See page 35, lines 11-17, See page 90, lines 4-38, page 91, lines 1-10, 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 method of modified Hoffman by incorporating wherein the control system is configured to determine a concentration of the osmotic agent; and adjust an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription as in Jansson because “there is always a risk of errors and there is a desire to be able to control the glucose concentration”, (See page 90, lines 14-16, Jansson), when “provided a choice of formulations which can be made using the plurality of concentrates and liquid” to “produce peritoneal dialysis fluids of different formulations”, (See page 9, lines 4-9, Jansson).
Modified Hoffman does not explicitly disclose wherein the residual osmotic agent is a spent osmotic agent that remains in the spent peritoneal dialysate after a dialysis therapy; wherein the sensor is configured to measure a concentration of the residual osmotic agent within the spent dialysate and is located upstream from the concentrate source; determine a difference between a dialysate prescription and the concentration of the residual osmotic agent present in the spent peritoneal dialysate, and to adjust based on the difference.
Roberts discloses wherein the residual osmotic agent is a spent osmotic agent that remains in the spent peritoneal dialysate after a dialysis therapy, (Glucose Detector 242 measures glucose in reused dialysate, See Figure 1, See paragraph [0087], Roberts); wherein the sensor is configured to measure a concentration of the residual osmotic agent within the spent dialysate and is located upstream from the concentrate source, (Glucose Detector 242 upstream of Glucose Module 80 and Enrichment Module 90, See Figure 1, See paragraph [0087], Roberts), and determine the concentration of the residual osmotic agent present in the spent peritoneal dialysate, and to adjust based on the concentration present, (See paragraph [0087], Roberts; it selects or adjusts the glucose concentration based on the signals from the glucose detector 242).
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 Hoffman by incorporating wherein the residual osmotic agent is a spent osmotic agent that remains in the spent peritoneal dialysate after a dialysis therapy, wherein the sensor is configured to measure a concentration of the residual osmotic agent within the spent dialysate and is located upstream from the concentrate source and determine a difference between a dialysate prescription and the concentration of the residual osmotic agent present in the spent peritoneal dialysate, and to adjust based on the difference as in Roberts so that “concentrations of…glucose…can all be controlled during treatment, using in-line monitors, all without degradation byproducts”, (See paragraph [0102], Roberts), while using “regenerated dialysate [which] will bring about a two-fold or more increase in dialytic efficiency”, (See paragraph [0075], Roberts). Additional features of this embodiment are included as part of the overall combination.
Modified Hoffman does not explicitly disclose the difference between the dialysate prescription and the concentration present in the spent peritoneal dialysate, and to adjust based on the difference.
Orhan discloses the difference between the dialysate prescription and the concentration present in the spent peritoneal dialysate, and to adjust based on the difference, (See paragraph [0279], Orhan). Additional features of this embodiment are included as part of the overall combination.
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 Hoffman by incorporating the difference between the dialysate prescription and the concentration present in the spent peritoneal dialysate, and to adjust based on the difference as in Orhan so it “allows for a direct calculation of mass transfer…between the patient and the dialysate” thus “providing for the infusion of…infusate at a known rate”, (See paragraph [0279], Orhan), such that the “concentration is appropriately maintained or adjusted”, (See paragraph [0286], Orhan).
Additional Disclosures Included: Claim 2: The system of claim 1, wherein the peritoneal dialysate generation flow path comprises connectors for connection to a cycler, (Dialysis Tube Connector 33 and Tenckhoff Catheter, See Figure 12, and See paragraph [0123], [0126] & [0127], Hoffman). Claim 3: The system of claim 1, further comprising an integrated cycler and a sterilization module, (Sterilizing Filter 50, See Figure 12, and See paragraphs [0127] & [0118]); the integrated cycler comprising a pump, (Pump 48, See Figure 12, and See paragraphs [0126] & [0127], Hoffman), an infusion line, (Line from Sterilizing Filter 50 to 3-way Valve 43 that will eventually lead to Dialysate Connector 33, See Figure 12, and See paragraphs [0126] & [0127], Hoffman), and a drain line, (Line from 3-way Valve 43 that leads back to Fluid Storage Container 57 via Pump 48, See Figure 12, and See paragraphs [0126] & [0127], Hoffman); wherein the infusion line is fluidly connected to the peritoneal dialysate generation flow path downstream of the sterilization module, (Line from Sterilizing Filter 50 to 3-way Valve 43 is downstream of Filter 50, See Figure 12, and See paragraphs [0126] & [0127], Hoffman); and wherein the drain line is fluidly connected to the peritoneal dialysate generation flow path upstream of the peritoneal dialysate regeneration module, (Line from 3-way Valve 43 that leads back to Fluid Storage Container 57 via Pump 48 is upstream from Sorbent 64 since spent fluid to be regenerated will flow out of Storage Container 57 to Sorbent 64, See Figure 12, and See paragraphs [0126] & [0127], Hoffman). Claim 8: the system of claim 1, wherein at least the one ion concentrate comprises two or more selected from the group consisting of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate, (Chambers Sodium Bicarbonate 412, Sodium Chloride 414, Calcium Chloride 416, Magnesium Chloride 418, See Figure 5, See page 64, Table 2, Jansson). Claim 12: The system of claim 1, wherein the control system either (a) comprises a timer, wherein the timer causes the control system to regenerate the spent peritoneal dialysate at a predetermined time; and/or (b) comprises a user interface, wherein the user interface causes the control system to regenerate the spent peritoneal dialysate at a selected time, (See paragraph [0043], Hoffman; The control unit 1 includes a user interface in the sense that a user may press control buttons to turn on/off or start/stop the system. Examiner interprets that the timer is not required because of the alternative language format (either and/or)). Claim 17: The system of claim 1, wherein the peritoneal dialysate regeneration module comprise one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter, an ion exchange resin, and a nanofilter, (Sorbent 64, See Figure 12 & 6, and See paragraphs [0127] & [0101], Hoffman). Claim 43: The system of claim 1, wherein the concentrate source further includes: a plurality of concentrate sensors configured to measure a solute concentration within a fluid, wherein a concentrate sensor of the plurality of concentrate sensors is positioned after each container of the at least one ion concentrate source container and the at least one osmotic agent container and before a second container of the at least one ion concentrate source container and the at least one osmotic agent container, (Glucose Detector 242 before Glucose Module 80, Potassium/Calcium/Magnesium Detectors 252 before Enrichment Module 90, See Figure 1, See paragraph [0088] & [0071], Roberts; Sensors 74/75/76 before Concentrate A/B/C, See Figure 1, See paragraph [0276], Orhan). Claim 44: The system of claim 43 wherein the control system is further configured to determine the solute concentration within the fluid after addition of each of the at least one ion concentrate and the at least one osmotic agent through analysis of data from the plurality of concentrate sensors, (See paragraph [0102], [0088] & [0071], Roberts; See paragraph [0276], Orhan).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman, (US 2010/0312172), in view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Jansson et al., (“Jansson”, WO 00/57935 A1), in further view of Roberts et al., (“Roberts”, US 2012/0271227), in further view of Orhan et al., (Orhan”, US 2012/0273354), and in further view of Peabody et al., (“Peabody 2”, US 4,747,822).
Claim 4 is directed to a system, an apparatus type invention group.
Regarding Claim 4, modified Hoffman discloses the system of claim 1, further comprising a sterilization module, (Sterilizing Filter 50, See Figure 12, and See paragraphs [0127] & [0118]), one or more dialysate containers fluidly connectable to the peritoneal dialysate generation flow path downstream of the sterilization module; (Storage Container 57 is also located downstream of Filter 50 when the dialysate flows back from the patient to the Container 57, See Figure 12, and See paragraphs [0126] & [0127], Hoffman), but does not disclose wherein the one or more dialysate containers are positioned such that the spent peritoneal dialysate in the peritoneal dialysate generation flow path is pumped from the sterilization module and into the one or more dialysate containers prior to being pumped into a peritoneal cavity of a patient.
Peabody 2 discloses a system, (See Abstract, Peabody), wherein its one or more dialysate containers are positioned such that the spent peritoneal dialysate in its peritoneal dialysate generation flow path is pumped from its sterilization module and into the one or more dialysate containers prior to being pumped into a peritoneal cavity of a patient, (Bacterial/Sterilizing Filter 30 to Dialysate Head Vessel 32 or Container 36 to Peritoneal Cavity 15, See Figure 2, and See column 4, lines 17-38, lines 43-57, Peabody 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 system of modified Hoffman by incorporating wherein the one or more dialysate containers are positioned such that the spent peritoneal dialysate in the peritoneal dialysate generation flow path is pumped from the sterilization module and into the one or more dialysate containers prior to being pumped into a peritoneal cavity of a patient as in Peabody so that “a gravity fed system is utilized avoiding the pumping of the fluid through the [peritoneal] cavity”, (See column 2, lines 58-60, Peabody 2). By doing so, there is “a high rate of dialysate exchange and dialysis efficiency in which the danger of peritoneal infection is minimized,” (See column 2, lines 38-41, Peabody 2).
Claims 15 & 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman, (US 2010/0312172), in view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Jansson et al., (“Jansson”, WO 00/57935 A1), in further view of Roberts et al., (“Roberts”, US 2012/0271227), in further view of Orhan et al., (Orhan”, US 2012/0273354), in further view of Burbank et al., (“Burbank”, US 2014/0018727).
Claims 15 & 16 are directed to a system, an apparatus type invention group.
Regarding Claim 15, modified Hoffman discloses the system of claim 1, further comprising a sterilization module, (Sterilizing Filter 50, See Figure 12, and See paragraphs [0127] & [0118]), but does not explicitly disclose wherein the sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a heater, a flash pasteurization module, a microbial filter; and combinations thereof. However, Hoffman states that a biofilm may gradually form on the surfaces of the valves, tubing and the sterilizing filter, and microbes in the biofilm/on the surfaces could excrete endotoxins into the passing dialysate, (See paragraph [0090], Hoffman).
Burbank discloses a system, (See Abstract, Burbank), wherein its sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a heater, a flash pasteurization module, a microbial filter; and combinations thereof, (Ultrafilters 958, See Figure 9, and See paragraphs [0113] & [0118], Burbank).
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 Hoffman by incorporating wherein the sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a heater, a flash pasteurization module, a microbial filter; and combinations thereof as in Burbank because Hoffman states that a biofilm may gradually form on the surfaces of the valves, tubing and the sterilizing filter, and microbes in the biofilm/on the surfaces could excrete endotoxins into the passing dialysate, (See paragraph [0090], Hoffman), so placing two ultrafilters in the system as in Burbank “prevents grow-through contamination of the final product”, (See paragraphs [0113] & [0118], Burbank), keeping the final product of the passing dialysate clean.
Regarding Claim 16, modified Hoffman discloses the system of claim 1, further comprising a sterilization module, (Sterilizing Filter 50, See Figure 12, and See paragraphs [0127] & [0118]), but does not disclose wherein the sterilization module comprises at least one of: a UV light source positioned downstream of at least one of the ultrafilters; at least two ultrafilters; or a combination thereof.
Burbank discloses a system wherein the sterilization module comprises any of: a UV light source positioned downstream of at least one of the ultrafilters; at least two ultrafilters; or a combination thereof, (Ultrafilters 958, See Figure 9, and See paragraphs [0113] & [0118], Burbank).
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 Hoffman by incorporating wherein the sterilization module comprises at least one of: a UV light source positioned downstream of at least one of the ultrafilters; at least two ultrafilters; or a combination thereof as in Burbank because Hoffman states that a biofilm may gradually form on the surfaces of the valves, tubing and the sterilizing filter, and microbes in the biofilm/on the surfaces could excrete endotoxins into the passing dialysate, (See paragraph [0090], Hoffman), so placing two ultrafilters in the system as in Burbank “prevents grow-through contamination of the final product”, (See paragraphs [0113] & [0118], Burbank), keeping the final product of the passing dialysate clean.
Claim(s) 22-24, 29, 34 & 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman, (US 2010/0312172), in view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Jansson et al., (“Jansson”, WO 00/57935 A1), in further view of Roberts et al., (“Roberts”, US 2012/0271227), in further view of Orhan et al., (Orhan”, US 2012/0273354).
Claims 22-24, 29, 34 & 38 are directed to a method, a method type invention group.
Regarding Claims 22-24, 29, 34 & 38, Hoffman discloses a method, comprising the steps of:
pumping a spent peritoneal dialysate from a waste storage container through a peritoneal dialysate generation flow path, (Container 57 stores used dialysate that is later regenerated and sends it further along circuit, and See Figures 5 & 12, and See paragraphs [0091], [0092] & [0126]);
wherein the spent peritoneal dialysate comprises a residual osmotic agent, (Container 57 stores used dialysate that is later regenerated, Glucose is added to dialysate beforehand, and See Figures 5 & 12, and See paragraphs [0091], [0092] & [0126]);
wherein the waste storage container is configured to store the spent peritoneal dialysate, (Container 57 stores used dialysate that is later regenerated, and See Figures 5 & 12, and See paragraphs [0091], [0092] & [0126])); wherein the waste storage container and the water source are different; (Tap water added from source comes from tap, different from Container 57, See Figure 5 & 12, See paragraphs [0091], [0092] & [0126]), a peritoneal dialysate regeneration module; (Sorbent Cartridge 64, See Figure 12, and See paragraphs [0126] & [0127]),
a concentrate source, (Glucose Solution Pump 53/Cartridge 73, and Electrolyte Solution Pump 54/Cartridge 74, See Figure 12, and See paragraphs [0127] & [0051]), wherein the concentrate source comprises:
at least one ion concentrate source container comprising at least one ion concentrate, (Electrolyte Solution Pump 54/Cartridge 74, See Figure 12, and See paragraphs [0127] & [0051]); and
at least one osmotic agent source container comprising at least one osmotic agent, (Glucose Solution Pump 53/Cartridge 73, See Figure 12, and See paragraphs [0127] & [0051]); but does not disclose wherein the peritoneal dialysate generation flow path fluidly connects: a water source; the waste storage container or a sensor, wherein the sensor is positioned between the peritoneal dialysate regeneration module and the concentrate source;
determining a concentration of the residual osmotic agent present in the spent peritoneal dialysate based on a data from the sensor; and
adjusting an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the spent peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription.
Rohde discloses a sensor, wherein the sensor is positioned between the peritoneal dialysate regeneration module and the concentrate source, (MEMS sensor 33 between Dialysis Fluid Preparation System 34 and Vessel 32, See Figure 3, See paragraph [0049], [0063]); wherein the peritoneal dialysate generation flow path fluidly connects: a water source; the waste storage container, (Source 31 consisting of spent dialysate and fresh water, Vessel 32, Preparation System 34, Sensor 33 all fluidly connected, See Figure 3; or use Vessels 49a/b, Vessel 42, Preparation System 44, Sensor 43 all on path, See Figure 4, See paragraph [0053]), determining a concentration of the residual osmotic agent present in the spent peritoneal dialysate based on a data from the sensor (MEMS sensor 33 between Dialysis Fluid Preparation System 34 and Vessel 32, See Figure 3, See paragraph [0049], [0063]).
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 Hoffman by incorporating a sensor, wherein the sensor is positioned between the peritoneal dialysate regeneration module and the concentrate source; determining a concentration of the residual osmotic agent present in the spent peritoneal dialysate based on a data from the sensor as in Rohde for “determining a composition of the dialysis fluid”, (See paragraph [0021], Rohde), and “check several parameters” which “are very useful to a patient or to a caregiver….since these measurements are directly related to the quality and make-up of the dialysis solution”, (See paragraph [0060], Rohde), in order to “prepare a customized solution or prescription for each patient”, (See paragraph [0060], Rohde).
Modified Hoffman does not explicitly disclose adjusting an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the spent peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription.
Jansson discloses adjusting an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the spent peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription, (See page 35, lines 11-17, See page 90, lines 4-38, page 91, lines 1-10, 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 method of modified Hoffman by incorporating adjusting an amount of the at least one osmotic agent added from the at least one osmotic agent source container to the spent peritoneal dialysate based on the concentration of the residual osmotic agent present in the spent peritoneal dialysate and a dialysate prescription as in Jansson because “there is always a risk of errors and there is a desire to be able to control the glucose concentration”, (See page 90, lines 14-16, Jansson), when “provided a choice of formulations which can be made using the plurality of concentrates and liquid” to “produce peritoneal dialysis fluids of different formulations”, (See page 9, lines 4-9, Jansson).
Modified Hoffman does not explicitly disclose wherein the residual osmotic agent is a spent osmotic agent that remains in the spent peritoneal dialysate after a dialysis therapy; wherein the sensor is configured to measure a concentration of the residual osmotic agent within the spent dialysate and is located upstream from the concentrate source; determine a difference between a dialysate prescription and the concentration of the residual osmotic agent present in the spent peritoneal dialysate, and to adjust based on the difference.
Roberts discloses wherein the residual osmotic agent is a spent osmotic agent that remains in the spent peritoneal dialysate after a dialysis therapy, (Glucose Detector 242 measures glucose in reused dialysate, See Figure 1, See paragraph [0087], Roberts); wherein the sensor is configured to measure a concentration of the residual osmotic agent within the spent dialysate and is located upstream from the concentrate source, (Glucose Detector 242 upstream of Glucose Module 80 and Enrichment Module 90, See Figure 1, See paragraph [0087], Roberts), and determine the concentration of the residual osmotic agent present in the spent peritoneal dialysate, and to adjust based on the concentration present, (See paragraph [0087], Roberts; it selects or adjusts the glucose concentration based on the signals from the glucose detector 242).
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 Hoffman by incorporating wherein the residual osmotic agent is a spent osmotic agent that remains in the spent peritoneal dialysate after a dialysis therapy, wherein the sensor is configured to measure a concentration of the residual osmotic agent within the spent dialysate and is located upstream from the concentrate source and determine a difference between a dialysate prescription and the concentration of the residual osmotic agent present in the spent peritoneal dialysate, and to adjust based on the difference as in Roberts so that “concentrations of…glucose…can all be controlled during treatment, using in-line monitors, all without degradation byproducts”, (See paragraph [0102], Roberts), while using “regenerated dialysate [which] will bring about a two-fold or more increase in dialytic efficiency”, (See paragraph [0075], Roberts). Additional features of this embodiment are included as part of the overall combination.
Modified Hoffman does not explicitly disclose the difference between the dialysate prescription and the concentration present in the spent peritoneal dialysate, and to adjust based on the difference.
Orhan discloses the difference between the dialysate prescription and the concentration present in the spent peritoneal dialysate, and to adjust based on the difference, (See paragraph [0279], Orhan). Additional features of this embodiment are included as part of the overall combination.
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 Hoffman by incorporating the difference between the dialysate prescription and the concentration present in the spent peritoneal dialysate, and to adjust based on the difference as in Orhan so it “allows for a direct calculation of mass transfer…between the patient and the dialysate” thus “providing for the infusion of…infusate at a known rate”, (See paragraph [0279], Orhan), such that the “concentration is appropriately maintained or adjusted”, (See paragraph [0286], Orhan).
Additional Disclosures Included: Claim 29: the method of claim 22, wherein the at least one ion concentrate source container comprises at least one o of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate, or any combination thereof, (Chambers Sodium Bicarbonate 412, Sodium Chloride 414, Calcium Chloride 416, Magnesium Chloride 418, See Figure 5, See page 64, Table 2, Jansson). Claim 34: the method of claim 22, wherein the at least one ion concentrate source container comprise two or more ion concentrate sources; and wherein each of the two or more ion concentrates comprise different ion concentrates, (Chambers Sodium Bicarbonate 412, Sodium Chloride 414, Calcium Chloride 416, Magnesium Chloride 418, Powdered Glucose 420, See Figure 5, See page 64, Table 2, Jansson). Claim 38: The method of claim 22, wherein the peritoneal dialysate regeneration module comprises one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter, an ion exchange resin, and a nanofilter, (Sorbent 64, See Figure 12 & 6, and See paragraphs [0127] & [0101], Hoffman).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman, (US 2010/0312172), in view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Jansson et al., (“Jansson”, WO 00/57935 A1), in further view of Roberts et al., (“Roberts”, US 2012/0271227), in further view of Orhan et al., (Orhan”, US 2012/0273354), and in further view of Peabody et al., (“Peabody 2”, US 4,747,822).
Claim 25 is directed to a method, a method type invention group.
Regarding Claim 25, modified Hoffman discloses the method of claim 22, wherein the peritoneal dialysate flow path further fluidly connects a sterilization module, (Sterilizing Filter 50, See Figure 12, and See paragraphs [0127] & [0118]); but does not disclose further comprising the step of pumping the spent peritoneal dialysate in the peritoneal dialysate flow path from the sterilization module into the one or more dialysate containers; and pumping the spent peritoneal dialysate from the one or more dialysate containers into a peritoneal cavity of the patient.
Peabody 2 discloses a method, (See Abstract, Peabody), further comprising one or more dialysate containers located downstream of the sterilization module and the step of pumping the spent peritoneal dialysate in the peritoneal dialysate flow path from the sterilization module into the one or more dialysate containers; and pumping the spent peritoneal dialysate from the one or more dialysate containers into a peritoneal cavity of the patient, (Bacterial/Sterilizing Filter 30 to Dialysate Head Vessel 32 or Container 36 to Peritoneal Cavity 15, See Figure 2, and See column 4, lines 17-38, lines 43-57, Peabody 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 method of modified Hoffman by incorporating one or more dialysate containers located downstream of the sterilization module and further comprising the step of pumping the spent peritoneal dialysate in the peritoneal dialysate flow path from the sterilization module into the one or more dialysate containers; and pumping the spent peritoneal dialysate from the one or more dialysate containers into a peritoneal cavity of the patient as in Peabody 2 so that “a gravity fed system is utilized avoiding the pumping of the fluid through the [peritoneal] cavity”, (See column 2, lines 58-60, Peabody 2). By doing so, there is “a high rate of dialysate exchange and dialysis efficiency in which the danger of peritoneal infection is minimized,” (See column 2, lines 38-41, Peabody 2).
Claim 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman, (US 2010/0312172), i in view of Rohde et al., (“Rohde”, US 2010/0051552), in further view of Jansson et al., (“Jansson”, WO 00/57935 A1), in further view of Roberts et al., (“Roberts”, US 2012/0271227), in further view of Orhan et al., (Orhan”, US 2012/0273354), in further view of Burbank et al., (“Burbank”, US 2014/0018727).
Claim 39 is directed to a method, a method type invention group.
Regarding Claim 39, modified Hoffman discloses the method of claim 25, but does not explicitly disclose wherein the sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a microbial filter; and combinations thereof. However, Hoffman states that a biofilm may gradually form on the surfaces of the valves, tubing and the sterilizing filter, and microbes in the biofilm/on the surfaces could excrete endotoxins into the passing dialysate, (See paragraph [0090], Hoffman).
Burbank discloses a method, (See Abstract, Burbank), wherein its sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a microbial filter; and combinations thereof, (Ultrafilters 958, See Figure 9, and See paragraphs [0113] & [0118], Burbank).
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 Hoffman by incorporating wherein the sterilization module comprises one or more from the group consisting of one or more ultrafilters, a UV light source, a microbial filter; and combinations thereof as in Burbank because Hoffman states that a biofilm may gradually form on the surfaces of the valves, tubing and the sterilizing filter, and microbes in the biofilm/on the surfaces could excrete endotoxins into the passing dialysate, (See paragraph [0090], Hoffman), so placing two ultrafilters in the system as in Burbank “prevents grow-through contamination of the final product”, (See paragraphs [0113] & [0118], Burbank), keeping the final product of the passing dialysate clean.
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 PEO whose telephone number is 571-272-9891. The examiner can normally be reached on MON-FRI 9AM – 5 PM.
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/JONATHAN M PEO/
Primary Examiner, Art Unit 1779