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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2006/0189923 A1 to Neftel et al. (hereinafter “Neftel”).
Regarding claim 1, Neftel discloses a peritoneal dialysis ("PD") system (see figures 1-4, 6, 9-11, 15, 20; paragraphs [0101]-[0144]) comprising:
a cycler (51) including
a micropump actuator (shaft 52, rollers 22 and globally the driving zone 41 meant to accommodate the pumping element 1; figures 3, 10; paragraph [0123]),
an inline fluid heater or batch fluid heater (28) (see paragraphs [0110] - [0117]; figures 1a, 1b, 3, 6),
a pressure transducer (pressure sensor)(44)(see fig. 20; paragraph [0137]), and
at least one valve actuator (34)(see fig. 10; paragraph [0123]);
a disposable set (cartridge 2 and tubing; figures 1, 6; paragraph [0101]) including
a micropump head sized and shaped for mating with and being cyclically driven by the micropump actuator (tubing 37, and head part of the pumping element 1, not part of the cycler 51, see figures of the cycler 51 and cartridge 2 and pumping element 1, especially figure 10 where the cavity for the pumping element is centered around shaft 52),
a pressure sensor (pressure sensor formed by several parts, among which the cavity 15) configured to operably communicate with the pressure transducer, at least one fluid valve portion or a portion of at least one fluid line for interfacing with the at least one valve actuator (39)(see figure 11; paragraphs [0124]-[0125]), and
an inline fluid heating pathway or a batch heater container (a cavity (17) including a warmer port (19) and a patient port (16), said patient port (18) of the second hub chamber (8) being connected to said warmer port (19) via said warmer system (28) wherein the warmer port 19 is connected to a warmer 28 (not shown on FIG. 3) via a warmer tube connector 55 and a warmer exit line 30 and the patient port 16 is connected to the patient line 5 and the second hub chamber 8 contains a warmer port 38 connected to a warmer 28 (not shown on FIG. 3) via a warmer tube connector 23 and a warmer enter line 29(see paragraphs [0110]); and
a control unit ("control means" see claims 5 and 6), wherein the disposable set is arranged to allow, and the control unit is programmed to operate the micropump actuator and the at least one valve actuator so that fresh and used dialysis fluid flows through the micropump head in a same direction (see paragraphs[0112]-[0114]),
wherein the inline fluid heater or batch fluid heater of the cycler is positioned and arranged to heat the inline fluid heating pathway or the batch heater container of the disposable set, respectively, when the disposable set is mounted to the cycler (see paragraphs [0101]-[110]).
Regarding claim 2, Neftel teaches implicitly that the micropump actuator and the micropump head are more accurate in the same direction than in a reverse direction (see paragraphs [0112], [0114]).
Regarding claim 3, Neftel teaches that the micropump actuator includes a keyed driver (motor shaft 52 in fig. 10) and the micropump head includes a keyed recess sized and shaped (see a center hole in roller separator 12) for mating with the keyed driver of the micropump actuator (see figs. 10-11; paragraphs [0106], [0123]).
Regarding claims 4-7, Neftel teaches pressure sensor including a fluid pressure chamber having a sealed diaphragm (13) and the cycler including a transmission fluid chamber (44) positioned and arranged to mate with the pressure chamber when the disposable set is mounted to the cycler (see figs. 3, 11, 20; paragraphs [0124]-[0125], [0137]).
Regarding claims 8-9, Neftel teaches valve actuator (43, 39) including a pinch valve (see fig. 10, 12; paragraphs [0123], [0125]).
Regarding claim 11, Neftel teaches that the disposable set being arranged to allow fresh and used dialysis fluid to flow through the micropump head in a same direction includes disposing both a patient line and a drain line of the disposable set, at least during a patient fill phase, downstream of the micropump head (see figs. 1a-1b; paragraphs [0102]-[0103], [0107]-[0108], [0112]).
Response to Arguments
Applicant's arguments filed 1/9/2026 have been fully considered but they are not persuasive.
Applicants argue that Neftel fails to disclose a peritoneal dialysis system with a cartridge having a warmer port since Neftel routes dialysis fluid out of the cartridge to a separate warmer which warms dialysis fluid away from the cartridge. However, Neftel teaches that an inline fluid heating pathway or a batch heater container of the disposable set is positioned and arranged to heat the inline fluid heating pathway or the batch heater container of the disposable set, respectively, when the disposable set is mounted to the cycler since the inline fluid heating pathway or the batch heater container includes a warmer chamber (17), a warmer port (19), warmer (28), a warmer tube connector 55, a warmer exit line 30, a warmer port (38), a warmer tube connector (23) and a warmer enter line 29 (see Fig. 3; paragraphs [0110]; paragraphs [0102]-[0103] for Fig. 1A-1B for using the disposable set when mounted to the cycler). The warmer (28) is part of an inline fluid heating pathway or a batch heater container. Furthermore, warmer (28) heats the inline fluid heating pathway even if Neftel routes dialysis fluid out of the cartridge to a separate warmer.
Conclusion
THIS ACTION IS MADE FINAL. 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
1/26/26