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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 2, 2025 has been entered.
Response to Arguments
Applicant's arguments filed October 2, 2025 have been fully considered, but are found unpersuasive. Amendments to the current set of claims have changed the scope of the claimed invention, resulting in a slight modification of the previous prior art rejection.
On pages 6-7 of the Remarks section as indicated by the page number at the bottom of each page, Applicant argues that the previous prior art rejection does not disclose the claimed invention or the newly added limitation that the heater is downstream from the sterilization module. Applicant asserts that primary reference Jansson et al., (“Jansson”, WO 00/57935A1), does not disclose this feature because its heating bath 364 and heat exchanger 360, which correspond to the claimed heater, are “both within the sterilization module 300” in Figure 4 or 4a of Jansson, and concludes that the disclosed heater cannot be downstream of the sterilization module as claimed, because they are inside it. The Examiner notes that this remark is unpersuasive because the term “sterilization module” is very broad, and does not require any specific or explicit structure beyond carrying out sterilization. The Examiner has already relied upon a subset of the sterilization module 300, which in Jansson is a large multi-component system, of Jansson as the claimed sterilization module, such as disinfection heater 330 and/or heating coil 363, because disinfection results in the same effect as sterilization. In this manner, the heater 364 and heat exchangers 360 and 362 are clearly downstream of the disinfection heater 330, and exchangers 360/362 are downstream of both of disinfection heater 330 and heating coil 363. For this reason, the Examiner finds Applicant’s remarks unpersuasive.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
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, 5-7, 9-12, 17, 19 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al., (“Jansson”, WO00/57935A1), in view of Kamen et al., (“Kamen”, US 2008/0208111).
Claims 1 & 5-7 are directed to a temperature regulation system for use in peritoneal dialysis, an apparatus type invention group.
Regarding Claims 1 & 5-7, Jansson discloses a temperature regulation system, (Apparatus 100, Control 104, Thermal Control/Sterilization Module 300, See Figures 1, 1a & 2 and See page 35, lines 11-21, page 37, lines 5-14), for use in peritoneal dialysis, (See page 33, lines 35-38), comprising:
a first fluid line fluidly connectable to a dialysate generation system, (Thermal Control/Sterilization Module 300 has Line 4a leading to Concentrate Mixing Module 400, See Figures 2 & 4a); the dialysate generation system comprising a water source, (Water Source 1, See Figure 3, and See page 43, lines 15-19), and at least one first osmotic agent source, (Glucose 420, See Figure 5 and See page 63, lines 1-9 and page 91, lines 25-31, page 92, lines 3-6), and a sterilization module having one or more sterilization components, (Disinfection Heater 330 and Heating Coil 363, See Figure 4a, See page 53, lines 10-16, See page 92, lines 19-36; The Examiner interprets that “normal operation” includes both the process of sterilizing the water, adding concentrate to the water to make dialysate, and then sterilizing the dialysate again before use. Thus, the Examiner takes the position that ‘normal operation’ is broad enough such that every component in the sterilization module 300 will act upon the fluid at some point during the process);
wherein the at least one first osmotic agent source is a reservoir configured to contain at least a solid form of a glucose, (Glucose 420, See Figure 5 and See page 63, lines 1-9 and page 91, lines 25-31, page 92, lines 3-6),
wherein the at least one first osmotic agent source has an inlet and an outlet, (Filter 438 at top of Line 436 is an inlet, and exit out of Glucose Source 420 in Line 436 is an outlet, See Figure 5);
wherein the inlet and the outlet of the at least one first osmotic agent source is a same fluid line, (Filter 438 at top of Line 436 is an inlet, and exit out of Glucose Source 420 in Line 436 is an outlet, (Line 436 has both an inlet/outlet), See Figure 5);
the first fluid line including a heater, (Heater 364a, See Figures 2, 4a, or Heater 364, See Figure 4, and See page 92, lines 11-21, or Heat Exchanger 360/362, See Figure 4/4a, See page 53, lines 10-16, and See page 59, lines 34-38), and at least a first temperature sensor, wherein the first temperature sensor is located between the heater and the at least one first osmotic agent source, (Temperature Sensor 379 between Glucose 420 to Line 4b to Heater 364, See Figure 4, or Temperature Sensor 370 between Glucose 420 to Heat Exchanger 360/362, See Figure 4a, See page 53, lines 10-16, and See page 59, lines 34-38),
wherein the heater is located downstream from the sterilization module, (Any of Heater 364/364a or Heater Exchangers 360/362 are downstream of Disinfection Heater 330, See Figure 4 or 4a);
the first fluid line fluidly connectable to an integrated cycler, and a second temperature sensor, (Second part of Line 8a having Temperature Sensors 372 which later leads to Cycler Module 600, See Figures 4 & 7, See page 59, lines 34-38, See page 60, lines 1-12);
a control system in communication with the first temperature sensor, the second temperature sensor, and the heater; wherein the control system is configured to: receive from the first temperature sensor, a signal correlative to a measured temperature of a water from the water source; and heat the water based on the measured temperature to a temperature of greater than 41 oC, (See page 53, lines 10-16, See page 55, lines 20-32, page 59, lines 27-38, page 60, lines 1-12, and See page 61, lines 19-23, See page 74, lines 4-14; The system confirms that the temperature is at least 41 deg. C, 150 deg. C), in heating bath 364), such that, when the water is added to the at least one first osmotic agent source to dissolve the glucose, a dissolution time of the glucose is minimized, (See page 91, lines 25-31);
Modified Jansson does not disclose that the integrated cycler has the second temperature sensor.
Kamen discloses a temperature regulation system where the integrated cycler has the second temperature sensor, (See paragraph [0012], and Thermal Sensor 6014, See Figure 14, See paragraph [0124], Kamen). 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 temperature regulation system of modified Jansson by incorporating that the integrated cycler has the second temperature sensor as in Kamen in order to provide “an accurate measurement apparatus that can measure the temperature…where such dialysate is contained in and/or flowing through a disposable cassette such that part or all of the sensor apparatus can be reused and need not be disposed of along with the disposable cassette”, (See paragraph [0011], Kamen).
Additional Disclosures Included:
Claim 5: The temperature regulation system of claim 1, the dialysate generation system fluidly connectable to a disinfectant source, (Water Preparation Module 200 fluidly connected to Concentrate Mixing Module 400 via Line 3 or via lines 2a/c to Heating Module 300 and Line 4a to Concentrate Mixing Module 400, See page 104, lines 12-22, lines 32-38, page 105, lines 23-38, page 106, lines 28-38, page 107, lines 1-17, Jansson).
Claim 6: The temperature regulation system of claim 5, the dialysate generation system fluidly connectable to a waste line, (Line 15 from Concentrate Module 400 to Module 500, See Figure 2 & 5, Jansson); the waste line fluidly connectable to the integrated cycler, (Module 500 with Line 15 is connected via Lines 14a/b from Cycler Module 600, See Figures 2, 6/7 and See page 42, line 38, page 43, lines 1-5, Jansson).
Claim 7: The temperature regulation system of claim 6, further comprising a system pump; the system pump recirculating fluid from the disinfectant source, through the dialysate generation system and the temperature regulation system, (Water Preparation Module 200 fluidly connected to Concentrate Mixing Module 400 via Line 3 or via lines 2a/c and Pump 452 to Heating Module 300 and Line 4a to Concentrate Mixing Module 400 and Line 4b to Heating Module 300 again, and See page 104, lines 12-22, lines 32-38, page 105, lines 23-38, page 106, lines 28-38, page 107, lines 1-17, Jansson).
Claims 9-12 are directed to a method, a method type invention group.
Regarding Claims 9-12, modified Jansson discloses a method for using the temperature regulation system of claim 1, (See rejection of Claim 1 above), comprising the steps of:
a) generating a peritoneal dialysate with the peritoneal dialysate generation system, (Concentrate Mixing Module 400, See Figures 2 & 4, and See page 39, lines 28-34, page 40, lines 37-38, Jansson);
b) pumping the peritoneal dialysate through the temperature regulation system of claim 1, (Line 4b from Concentrate Module 400 to Heating/Sterilization Module 300, See Figures 2, 4 & 5 and See page 39, lines 31-34, page 53, lines 24-28, Jansson), (Temperature Sensors 370 and Heat Exchangers 360/362/Bath 364, See Figure 4a, See page 59, lines 34-38, Jansson);
c) pumping the peritoneal dialysate into the integrated cycler through the second fluid line, (Line 4a is later fluidly connected to Line 8a which connects to Cycler Module 600, See Figures 2 & 4a, See page 60, lines 8-12, Jansson);
d) measuring a temperature of the peritoneal dialysate in a second fluid line, (Line 4a is later fluidly connected to Line 8a having Temperature Sensors 372, See Figure 4a, See page 60, lines 1-12, Jansson); and
e) heating the peritoneal dialysate downstream of a connection between the water source and each of the at least one first osmotic agent source with the heater to a desired temperature as measured by the first temperature sensor and/or the second temperature sensor, (Heat Exchanger 360 and Temperature Sensors 370/372, See page 60, lines 1-12, and See page 61, lines 19-23, Jansson).
Additional Disclosures Included:
Claim 10: The method of claim 9, wherein the desired temperature as measured by the first temperature sensor is between around 25 oC and around 40 oC, (See page 59, lines 34-38, page 60, lines 1-12, Jansson; The desired temperature disclosed anticipates the claimed range at 37 oC).
Claim 11: The method of claim 9, wherein the desired temperature as measured by the second temperature sensor is between around 25 oC and around 40 oC, (See page 59, lines 34-38, page 60, lines 1-12, Jansson; The desired temperature disclosed anticipates the claimed range at 37 oC).
Claim 12: The method of claim 9, further comprising a step of pumping the peritoneal dialysate from the integrated cycler into a peritoneal cavity of a patient, (Cycler 600 to Patient, See Figure 2 & 7 and See page 42, lines 4-18, and page 96, lines 26-37, Jansson).
Claim 13: The method of claim 12, further comprising a step of generating an alarm, (See page 35, lines 33-36, Jansson), if a temperature of the peritoneal dialysate as measured by the first temperature sensor and/or the second temperature sensor is outside of a predetermined range, (See paragraph [0137], Kamen).
Claim 14: The method of claim 12, further comprising stopping the step of pumping the peritoneal dialysate from the integrated cycler into the peritoneal cavity of the patient, (See page 96, lines 26-37, See page 92, lines 3-10, Jansson) if a temperature of the peritoneal dialysate as measured by the first temperature sensor and/or the second temperature sensor is outside of a predetermined range, (See paragraph [0137], Kamen).
Claim 15: The method of claim 13, wherein the predetermined range as measured by the first temperature sensor is between around 25 oC and around 40 oC, (See page 59, lines 34-38, page 60, lines 1-12, See page 92, lines 3-10, Jansson; The desired temperature disclosed anticipates the claimed range at 37 oC).
Claim 16: The method of claim 13, wherein the predetermined range as measured by the second temperature sensor is between around 25 oC and around 40 oC, (See page 59, lines 34-38, page 60, lines 1-12, See page 92, lines 3-10, Jansson; The desired temperature disclosed anticipates the claimed range at 37 oC).
Claims 17, 19 & 20 are directed to a method of disinfecting a peritoneal dialysis system, a method type invention group.
Regarding Claims 17, 19 & 20, modified Jansson discloses a method of disinfecting a peritoneal dialysis system, (See page 101, lines 9-27, Jansson), using the temperature regulation system of claim 1, (See rejection of Claim 1 above), the method comprising the steps of:
a) fluidly connecting a disinfectant source to the first fluid line of the dialysate generation system, (Cleaning Agent 410 connected via Valve 480 to Line 4a in Concentrate Mixing Module 400, See Figure 5b, and See page 107, lines 30-38, page 108, lines 1-12; See page 92, lines 3-10; Alternatively Water Supply from Water Connection 2c to Mixing Module 400, See Figure 2 & 5b, and See page 104, lines 12-22, Jansson);
b) fluidly connecting the first fluid line to a second fluid line, (Line 4b to Line 8a, See Figures 2, 4 & 5b, and See page 107, lines 31-38, page 108, lines 1-29, See page 92, lines 3-10, Jansson);
c) recirculating a disinfectant solution through the peritoneal dialysis system, (Cleaning Fluid circulates through Concentrate Module 400, Thermal Module 300, Cycler 600, See Figure 2, and See page 107, lines 31-38, page 108, lines 1-29, See page 92, lines 3-10, Jansson);
d) measuring a temperature of the disinfectant solution in the peritoneal dialysis system, (See page 62, lines 11-20, See page 92, lines 3-10, Jansson); and
e) heating the disinfectant solution downstream of a connection between the water source and each of the at least one first osmotic agent source source to a desired temperature as measured by the first temperature sensor and/or the second temperature sensor, (See page 62, lines 11-20, See page 104, lines 12-22, lines 32-38, page 105, lines 23-38, page 106, lines 28-38, page 107, lines 1-17; and See page 109, lines 31-38, page 110, lines 1-6, See page 92, lines 3-10, Jansson).
Additional Disclosures Included:
Claim 19: The method of claim 17, wherein the desired temperature as measured by the second temperature sensor is equal to or greater than around 80 oC, (See page 109, lines 31-38, page 110, lines 1-6, See page 92, lines 3-10, Jansson).
Claim 20: The method of claim 17, wherein the disinfectant solution is a citric acid solution, (See page 108, lines 27-29, See page 92, lines 3-10, Jansson).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al., (“Jansson”, WO00/57935A1), in view of Kamen et al., (“Kamen”, US 2008/0208111), in further view of Kelly, (US 2005/0171501).
Claim 4 is directed to a method, a method type invention group.
Regarding Claim 4, modified Jansson discloses the temperature regulation system of claim 1, but does not explicitly disclose in the specified combination wherein at least one of the one or more sterilization components of the sterilization module is an ultrafilter.
Kelly discloses a dialysis system, (See paragraph [0075], Kelly), with at least one of the one or more sterilization components of the sterilization module that is an ultrafilter, (See paragraph [0059]-[0061]).
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 wherein at least one of the one or more sterilization components of the sterilization module is an ultrafilter as in Kelly because the ultrafilters therein undergo the bubble test, (See paragraph [0059], Kelly), as in Burbank, (See paragraph [0112], Burbank), for ensuring integrity, (See paragraph [0061], Kelly), in which it will “remove virtually, if not all, bacteria and endotoxin” for the treated fluid, (See paragraph [0059], Kelly).
Claims 18 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al., (“Jansson”, WO00/57935A1), in view of Kamen et al., (“Kamen”, US 2008/0208111), in further view of Grant et al., (“Grant”, US 2010/0051529).
Claims 18 & 19 are directed to a method of disinfecting a peritoneal dialysis system, a method type invention group.
Regarding Claim 18, modified Jansson discloses the method of claim 17, wherein there is a desired temperature as measured by the first temperature sensor, (See page 62, lines 11-20, See page 92, lines 3-10, Jansson; All of the temperature sensors in the overall system are maintained at a certain temperature to attain disinfection), but does not disclose that the desired temperature is equal to or greater than around 80 oC.
Grant discloses a method of disinfecting a dialysis system, (See Abstract and See paragraph [0085], Grant), wherein a desired temperature is equal to or greater than around 80 oC, (See paragraph [0085], Grant; A disclosed temperature range of at least 90 degrees Celsius anticipates the claimed range at 90 degrees Celsius and above).
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 disinfecting a dialysis system of modified Jansson by incorporating that the desired temperature is equal to or greater than around 80 oC as in Grant since this temperature is “able to cause disinfection or sterilization”, (See paragraph [0085], Grant), in the first place.
Alternatively, in the event that the step of sterilization as claim mapped to in Claim 19 does not explicitly read upon the claimed disinfection process in the earlier rejection of Claim 19, Jansson discloses a desired temperature as measured by the second temperature sensor, (See page 62, lines 11-20; All of the temperature sensors in the overall system are maintained at a certain temperature to attain disinfection), but does not explicitly disclose that this desired temperature during the disinfection step is equal to or greater than around 80 oC.
Grant discloses a method of disinfecting a dialysis system, (See Abstract and See paragraph [0085], Grant), wherein a desired temperature is equal to or greater than around 80 oC, (See paragraph [0085], Grant; A disclosed temperature range of at least 90 degrees Celsius anticipates the claimed range at 90 degrees Celsius and above).
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 disinfecting a dialysis system of modified Jansson by incorporating that the desired temperature is equal to or greater than around 80 oC as in Grant since this temperature is “able to cause disinfection or sterilization”, (See paragraph [0085], Grant), in the first place.
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 on M-F, 9AM-5PM.
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/JONATHAN M PEO/ Primary Examiner, Art Unit 1779