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 .
Specification
Examiner suggests applicant to change “FIGURES” to “DRAWINGS” in line 10 of paragraph [0066].
Claim Objections
Claim 16 is objected to because of the following informalities:
-Claim 16, Line 14: “if” should be corrected to “is”.
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 1-9, 11, 16-19 and 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chinese Patent Publication No. CN 112569418 A to Luo et al. (hereinafter “Luo”).
Regarding claims 1 and 18, Luo discloses a peritoneal dialysis system (see figure 1; paragraph 44) comprising:
a cycler (50a) including
a peristaltic pump actuator (paragraph 77: peristatic pump actuator),
a weigh scale (96a-96d in figure 9; paragraph 67);
a first valve (84 in figure 3; paragraph 51);
a second valve (86 in figure 3; paragraph 51);
a third valve (90 in figure 3; paragraph 54);
a disposable set including
a peristaltic pump tube (34 in figures 2, 5; paragraphs 46, 74) operable with the peristaltic pump actuator (paragraph 74), and
a heating container (containers 22a, 22b on heating plate 94 in figures 1, 9; paragraph 65) in operable communication with the weigh scale (96a-96d in figure 9; paragraph 66); and
Luo discloses in paragraph 21: “One or more weighing sensors mav also be provided, which output to the control unit to monitor the weight of one or more fresh dialvsate containers, thereby determining how much fresh dialysate has been delivered to the patient. In one embodiment, a weighing sensor supports a heating plate, on which one or more fresh dialysate containers are placed. The control unit can be programmed to monitor the output of the weighing sensor, and calculate the volume of dialvsate delivered to and removed from the patient bv calculating the pumped stroke and knowing the pumped stroke volume, as a cross-check with the weighing sensor output and determine the amount of additional fluid in the form of ultrafiltration (''UF'') that has been removed from the patient”. Furthermore, Luo discloses in paragraph 67: “In system 10a, weighing sensors 96a to 96d only measure filling containers 22a and 22, because there are no discharge containers 122a and 122b. Here, UF can be determined by calculating the stroke volume of the platen pump 80 used to deliver and receive dialysis fluid from the patient, multiplying the stroke volume by the volume of each stroke to determine the total volume of fresh fluid delivered and the total volume of used fluid removed and subtracting the former from the latter to determine the UF. Here, the weight determined bv weighing sensors 96a to 96d can be used to cross-check the determination of stroke volume.”
Hence, Luo teaches a control unit (60) configured to (i) cause the peristaltic pump actuator to operate at a rotational speed to deliver an amount of fluid to the heating container, (ii) record a weight of the amount of fluid from the weigh scale, and (iii) determine at least one of a mass rate or volume rate for the rotational speed using the recorded weight (claim 1) and a control unit (60) configured to (i) cause the pump actuator to actuate the pumping portion at a strokes per minute (“SPM”) to deliver an amount of fluid to the heating container, (ii) record a weight of the amount of fluid from the weigh scale, and (iii) determine at least one of a mass rate or volume rate for the SPM using the recorded weight (claim 18).
Regarding claim 2, Luo discloses that at least one of (i) the fluid is dialysis fluid, purified water or concentrate, or (ii) the control unit (60) is provided with the cycler (50a) (figure 2; paragraph 44).
Regarding claim 3, Luo discloses that the control unit is further configured to use the at least one of the mass rate or volume rate for the rotational speed to determine a mass or volume of used dialysis fluid removed in a prior drain operated at the rotational speed (paragraph 21).
Regarding claim 4, Luo discloses that the control unit is configured to perform (i) to (iii) after each of a plurality of patient drains (paragraphs 21, 67).
Regarding claim 5, recitation of “the amount of fluid entering the heating container during (i) is supplied as a sample taken from dialysis fluid provided during a patient fill to the patient” is an intended use of the apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding claim 6, recitation of “the amount of fluid entering the heating container during (i) is supplied via a heating container replenishing sequence” is an intended use of the apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding claim 7, Luo discloses that the cycler (50a) further includes a pressure sensor (78), wherein the control unit (60) records at least one reading from the pressure sensor during (i), the at least one reading associated with the rotational speed (figures 2-3; paragraph 48).
Regarding claim 8, Luo discloses that the control unit (60) is further configured to monitor at least one reading from the pressure sensor (78) during a prior drain while actuating the peristaltic pump tube (34) at the rotational speed (figures 2-3; paragraph 48).
Regarding claim 9, Luo discloses that the control unit is configured to determine a transformation function that relates flowrate or mass rate as a function of the rotational speed and the at least one reading from the pressure sensor (paragraphs 21, 48, 67).
Regarding claim 11, Luo discloses that the control unit is configured to apply the transformation function to at least one rotational speed used during a prior drain (paragraphs 21, 48, 67).
Regarding claim 16, Luo further discloses that the cycler (50a) further includes a pressure sensor (78) and the disposable set further includes a patient line (32) in fluid communication with the peristaltic pump tube (34 in figures 2, 5; paragraphs 46, 74) and the control unit (60) configured to (iv) record a pressure of the fluid from the pressure sensor, and (v) determine a transformation function that relates flowrate or mass rate as a function of the rotational speed and the recorded pressure (see paragraph 48: “Pressure sensor 78 is alternately arranged with pump actuator, wherein the force provided by the pump is associated with the pressure of the dialysate flowing in the patient line 32 via the control unit 60”. So the pressure is also used by the control unit in a transformation function (correlation) or the flow rate and rotational speed.
Regarding claim 17, Luo discloses that the control unit is configured to apply the transformation function to at least one rotational speed used during a prior drain (paragraphs 21, 48, 67).
Regarding claim 19, peristaltic pump strokes implicitly depend on rotational movement.
Regarding claim 24, Luo discloses that the cycler further includes a pressure sensor, and wherein the control unit records at least one reading from the pressure sensor during (i), the at least one reading associated with the SPM (figures 2-3; paragraph 48).
Regarding claim 25, Luo discloses that the control unit is configured to determine a transformation function that relates flowrate or mass rate as a function of the SPM and the at least one reading from the pressure sensor (paragraphs 21, 48, 67).
Regarding claim 26, Luo discloses that the control unit is configured to apply the transformation function to at least one SPM used during a prior drain (paragraphs 21, 48, 67).
Claims 10, 12-15 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Luo.
Luo discloses the peritoneal dialysis system of claims 1 and 18.
Claim 10 differs from Luo in reciting that the transformation function is provided as a lookup table or an algorithm. However, the use of a lookup table or algorithm is common practice for cross-checking and would have been obvious to a person of ordinary skill in the art.
Claims 12-15 and 20-23 are mere alternatives of the capability of the control unit for achieving desired volume infusion or removal in peritoneal dialysis system and would have been obvious to a person of ordinary skill in the art.
Response to Arguments
Applicant’s arguments with respect to claims 1-26 have been considered but are moot because newly claimed recitations of “a first valve”, “a second valve” and “a third valve” in claims 1 and 18 are taught in Luo as described above.
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 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 1777
JK
7/15/26
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