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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 4-13) in the reply filed on 7/16/2026 is acknowledged.
Claims 14-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/16/2026.
Claim Objections
Claims 10 and 11 are objected to because of the following informalities:
-Claim 10, Line 2: “stores” should be corrected to “is configured to store”.
-Claim 11, Line 3: Between “the” and “to”, “sensor” should be inserted.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5-7, 9 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by European Patent No. 1838356 B1 to Burbank et al. (hereinafter “Burbank”).
Regarding claim 1, Burbank discloses a peritoneal dialysis system (see Figure 19A) comprising:
a water purifier (1295, 1300, 1305)(see paragraph 72; Figure 19A);
a disposable set (1303)(see paragraph 73; Figure 19A) including
a water line (1370) in fluid communication with the water purifier (see paragraphs 72, 75; Figure 19A),
a drain line (1345) for draining from the disposable set (see paragraph 74; Figure 19A, 19G, 19J), and
a disposable container (1, 1317)(see paragraphs 39, 7; Figures 4 and 19A) including at least one chamber (see paragraph 39; Figure 19A), the disposable container including at least one concentrate ("concentrate ") in one of the at least one chamber (see paragraph 39, Figure 19A), and the disposable container positioned and arranged to hold a dialysis fluid prepared by mixing ("mixed") water ("water") from the water purifier and the at least one concentrate (see paragraphs 39, 73-75; Figure 19A);
a control unit ("controller") in communication with at least one sensor (1322), for detecting a first property of water from the water purifier (see paragraph 87; Figure 19A) and a second property of the dialysis fluid (see paragraph 74; Figure 19A).
Regarding claim 2, Burbank discloses a conductivity sensor (1322) (see paragraph 74; Figure 19A).
Regarding claim 5, Burbank discloses that the sensor (1322) is at least partially housed within the disposable set (1303)(see Figure 19A).
Regarding claim 6, Burbank discloses a weighing scale (see paragraph 75: “weighing the batch container”) or a heater (1452)(see paragraph 92; Figure 22).
Regarding claim 7, Burbank discloses a cycler configured to (i) mix water from the water purifier and the at least one concentrate to form a dialysis fluid and (ii) deliver the dialysis fluid to a patient (see paragraphs 75, 103; Figures 19A-19B).
Regarding claim 9, Burbank discloses that the control unit (1810) is part of the cycler (see paragraph 103; Figure 28).
Regarding claim 11, Burbank discloses that the control unit is programmed to compare a sensed value for at least one of the conductivity of the water from the water purifier or the conductivity of the dialysis fluid sensed by the sensor to a setpoint value (see paragraphs 74, 87).
Regarding claim 12, Burbank discloses that one of the at least one chamber (1313) of the disposable set is adapted for receiving used dialysis fluid from a patient drain (see paragraph 74; Figure 19A).
Regarding claim 13, Burbank discloses that the disposable set includes a pumping tube (1546) for operation with a peristaltic pump (1544)(see paragraph 93; Figure 23).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burbank.
Burbank discloses the peritoneal dialysis system of claim 1 as described above.
Claim 4 differs from Burbank in reciting that the sensor is housed within the water purifier.
Burbank discloses that the conductivity sensor is used to test the quality of the treatment fluid and purified water in the discharge line (see paragraph 74).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to rearrange the conductivity sensor in the water purifier to check the quality of purified water, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank as applied to claim 7 or 1 respectively above, and further in view of US 2019/0262525 A1 to Wyeth et al. (hereinafter “Wyeth”).
Burbank discloses the peritoneal dialysis system of claim 1 or 7 as described above.
Burbank discloses a heater (1452) for heating fluid in the batch bag (1444)(see paragraph 92; Figure 22).
Claim 8 differs from Burbank in reciting that the cycler includes a heating pan configured to hold the disposable container and to heat an area within the disposable container.
Wyeth teaches a peritoneal dialysis system comprising a heating pan (770) configured to hold the disposable container (732) and to heat an area within the disposable container (732) (see paragraph 191; Figure 17A).
It would have been obvious to a person of ordinary skill in the art to substitute a heater of Burbank for a heating pan of Wyeth for heating the fluid in the disposable container.
Claim 10 differs from Burbank in reciting that the control unit stores a look-up table with at least one setpoint value for at least one of the conductivity of the water from the water purifier or the conductivity of the dialysis fluid.
Wyeth teaches a peritoneal dialysis system comprising the control unit stores a look-up table with at least one setpoint value for at least one of the conductivity of the water from the water purifier or the conductivity of the dialysis fluid (see paragraph 186; Figure 15E).
It would have been obvious to a person of ordinary skill in the art to modify Burbank to incorporate the control unit to store a look-up table with at least one setpoint value for at least one of the conductivity of the water from the water purifier or the conductivity of the dialysis fluid for the benefit of calculating a new quantity of concentrate to be calculated from the given water quantity and the calculated concentration of a first concentrate as suggested by Wyeth (see paragraph 186).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1772
JK
7/30/26
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