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.
Claims 1-3 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by English translation copy of Japanese Patent Publication No. JP 09-108340 A to Baxter Internation Inc. (hereinafter “Baxter”).
Regarding claim 1, Baxter discloses a peritoneal dialysis ("PD") system (see figures 1-2, 5; overview on pages 1-2; paragraphs 56-71) comprising:
a cycler including
a weigh scale (120, 122),
a chamber ("drainage side chamber" 18 + "dialysate side chamber" 19) positioned to be weighed by the weigh scale (120, 122),
a heater ("silicone rubber-coated heater plate" 30) positioned to heat an inside of the chamber,
a plurality of valves ("drainage bag side electric clamp" 24, "dialysate bag side electric clamp" 26) supported by the chamber or a housing of the cycler,
a pump ("air pump" 100: see figure 5) supported by the chamber or a housing of the cycler, and
a control unit ("control means" 114: see figure 5) operable with the weigh scale, the heater, the plurality of valves and the pump; and
a disposable set (see figure 1) including
a PD fluid container ("dialysis solution bag" 2) sized to fit within the chamber so as to be weighed by the weigh scale and heated by the heater,
a supply line ("tube" 5) in fluid communication with the PD fluid container (2) and extending outside of the chamber,
a drain container ("drain bag" 1) sized to fit within the chamber so as to be weighed by the weigh scale (120),
a drain line ("tube" 4) in fluid communication with the drain container (1) and extending outside of the chamber (18), and
a patient line ("tube" 14) positioned on an opposing side of the pump from the supply line and the drain line (4),
wherein the control unit is configured to operate the plurality of valves (24, 26) and the pump (100) bidirectionally (see figure 5: see arrows in lines connected to air pump 100) to pump (i) used dialysis fluid from the patient line (14), through the drain line (4), to the drain container (1) and (ii) fresh dialysis fluid from the PD fluid container (2), through the supply line (5), and through the patient line (14).
Regarding claims 2-3, Baxter teaches supply line valve ("dialysate bag side electric clamp" 26), drain line valve ("drainage bag side electric clamp" 24), patient line valve ("branched side electric clamp" 44)(see figure 4; paragraphs 57, 59). Electric clamps are solenoid pinch valve.
Regarding claim 11, Baxter teaches that the chamber (19) is configured for the supply line (5) to extend into the chamber for connection to the PD fluid container (2) (see figure 2).
Claims 1-3, 9-18 and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 7,559,913 B1 to Jeppsson et al. (hereinafter “Jeppsson”).
Jeppsson teaches a peritoneal dialysis (“PD”) system (see figures 1, 2 and 9; col. 1, lines 5-8; col. 4, line 47 – col. 6, line 8; col. 8, lines 31-57) comprising:
a cycler (1) including
a weigh scale ("load cells" 10: see figure 9),
a chamber (scales container 6 + "cover" 11: see figure 9) positioned to be weighed by the weigh scale (10),
a heater ("heater foil" 20: see figure 9) positioned to heat an inside of the chamber (6+11),
a plurality of valves ("valve pack" 5: see figure 6) supported by the chamber or a housing of the cycler,
a pump ("air pump" 19: see figure 9) supported by the chamber or a housing of the cycler, and
a control unit (see column 4, lines 28-35) operable with the weigh scale, the heater, the plurality of valves and the pump; and
a disposable set including
a PD fluid container ("heater bag" 27: see figure 2) sized to fit within the chamber (6+11) so as to be weighed by the weigh scale and heated by the heater,
a supply line ("tube" 24a: see figures 1-2) in fluid communication with the PD fluid container (27) and extending outside of the chamber (6+11) (see figure 1),
a drain container ("drain bag" 28: see figure 2) sized to fit within the chamber (6+11) so as to be weighed by the weigh scale,
a drain line ("tube" 24b: see figures 1 and 2) in fluid communication with the drain container (28) and extending outside of the chamber (6+11) (see figure 1), and
a patient line ("tube" 19g: see figure 1) positioned on an opposing side of the pump from the supply line (24a) and the drain line (24b),
wherein the control unit is configured to operate the plurality of valves and the pump bidirectionally to pump (i) used dialysis fluid from the patient line (19g), through the drain line (24b), to the drain container (28) and (ii) fresh dialysis fluid from the PD fluid container (27), through the supply line (24a), and through the patient line (19g) (see column 7, line 27 - column 8, line 19).
Regarding claims 2-3, Jeppsson teaches supply line valve, drain line valve, patient line valve in a valve pack (5) of pinch valves connected to a connection unit (4)(see figure 6; col. 5, line 64 – col. 6, line 55).
Regarding claims 9-10, Jeppsson teaches that supply line (24a) mates with a container line (26) extending from the PD fluid container (27) (see figures 1 and 2).
Regarding claim 11, Jeppsson teaches that the chamber (scales container 6 + "cover" 11: see figure 9) is configured for the supply line (24a) to extend into the chamber for connection to the PD fluid container (27) (see figures 1-2).
Regarding claim 12, Jeppsson teaches a drain container (28) connected to a terminal drain line (19f) (see figures 1 and 2; col. 5, lines 30-32; col. 7, lines 51-54).
Regarding claim 13, Jeppsson teaches that the terminal drain line (19f) is positioned along with the patient line (19g) on the opposing side of the pump from the supply line (24a) and the drain line (24b)(see figure 1).
Regarding claim 14, Jeppsson teaches that terminal drain line (19f) extends to a terminal drain container (16) (extending to a house drain)(see figure 1).
Regarding claim 15, independent claim 15 basically corresponds to independent claim 1, wherein the PD fluid container and drain container of claim 1 are embodied as respectively a fresh PD fluid compartment and a used PD fluid compartment of a (two-chamber) PD fluid container. Jeppsson teaches such a two-chamber PD fluid container ("double bag": see column 5, lines 57-61; see figures 2 and 10) comprising a fresh PD fluid compartment ("heater bag" 27) and a used PD fluid compartment ("drain bag" 28).
Regarding claim 16, Jeppsson teaches that (i) the supply line (24a) mates with a fresh compartment line (26) extending from the fresh PD fluid compartment (27) and (ii) the drain line (24b) mates with a used compartment line (25) extending from the used PD fluid compartment (28)(see figure 2).
Regarding claim 17, Jeppsson teaches that the chamber is configured for (i) the supply line (24a) to extend into the chamber for connection to the fresh PD fluid compartment via fresh compartment line (26) and (ii) the drain line (24b) to extend into the chamber for connection to the used PD fluid compartment via used compartment line (25)(see figure 2).
Regarding claim 18, Jeppsson teaches that the chamber is sized to hold an entire fresh PD fluid volume at a beginning of a treatment and used PD fluid from multiple drains at the end of the treatment (see col. 3, lines 17-28; col. 8, lines 50-56).
Regarding claim 22, independent claim 22 basically corresponds to independent claim 15, wherein the expressions "fresh PD fluid compartment" and a "used PD fluid compartment" are respectively changed into "fresh PD fluid end” and a "used PD fluid end". It is however noted that the "fresh PD fluid compartment" and the used "PD fluid compartment" of the peritoneal dialysis system according to claim 15 each implicitly comprise an "end" where fluid enters/exits the compartment. The scope of claim 22 thus in principle covers that of claim 15. Claim 22 does not exclude that the PD fluid container is actually a two-chamber container, comprising a "fresh PD fluid compartment" with a "fresh PD fluid end" and a "used PD fluid compartment" with a "used PD fluid end". Hence, Jeppsson teaches claim 22.
Regarding claim 23, Jeppsson teaches that (i) the supply line (24a) mates with a fresh compartment line (26) extending from the fresh PD fluid end of the PD fluid compartment (27) and (ii) the drain line (24b) mates with a used compartment line (25) extending from the used PD fluid end of the PD fluid compartment (28)(see figure 2).
Regarding claim 24, Jeppsson teaches that the chamber is configured for (i) the supply line (24a) to extend into the chamber for connection to the fresh PD fluid end of the PD fluid compartment via fresh compartment line (26) and (ii) the drain line (24b) to extend into the chamber for connection to the used PD fluid end of the PD fluid compartment via used compartment line (25)(see figure 2).
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.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Jeppsson.
Jeppsson teaches a peritoneal dialysis (“PD”) system as described above.
Jeppsson teaches supply bags (15a, 15b, 15c, 15d, 15e) and its associated supply lines (19a, 19b, 19c, 19d, 19e)(see figure 1; col. 4, line 47 – col. 5, line 2).
Claim 5 differs from Jeppsson in reciting a second PD fluid container sized to fit within the chamber so as to be weighed by the weigh scale and heated by the heater, and a second supply line in fluid communication with the second PD fluid container and extending outside of the chamber. In essence, claim 5 claims additional PD fluid container and its associated supply line.
Although Jeppsson did not disclose a plurality of PD fluid container and its associated supply line, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). MPEP 2144.04 VI. B.
Regarding claims 6-7, Jeppsson teaches a second PD fluid container (15b) to be placed on top of the first PD fluid container (15a) or adjacent to the first PD fluid container (see figure 1).
Regarding claim 8, Jeppsson teaches that a patient line ("tube" 19g: see figure 1) positioned on an opposing side of the pump from the supply line (24a) and the drain line (24b).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Jeppsson in view of English translation copy of Chinese Patent Publication No. CN 103394141 A to Guosheng et al. (hereinafter “Guosheng”).
Jeppsson teaches a peritoneal dialysis (“PD”) system (see figures 1, 2 and 9; col. 1, lines 5-8; col. 4, line 47 – col. 6, line 8; col. 8, lines 31-57) comprising:
a cycler (1) including
a weigh scale ("load cells" 10: see figure 9),
a chamber (scales container 6 + "cover" 11: see figure 9) positioned to be weighed by the weigh scale (10),
a heater ("heater foil" 20: see figure 9) positioned to heat an inside of the chamber (6+11),
a plurality of valves ("valve pack" 5: see figure 6) supported by the chamber or a housing of the cycler,
a pump ("air pump" 19: see figure 9) supported by the chamber or a housing of the cycler, and
a control unit (see column 4, lines 28-35) operable with the weigh scale, the heater, the plurality of valves and the pump; and
a disposable set including
a PD fluid container ("double bag": see column 5, lines 57-61; see figures 2 and 10) sized to fit within the chamber so as to be weighed by the weigh scale and heated by the heater, the PD fluid container including a fresh PD fluid compartment ("heater bag" 27) and a used PD fluid compartment ("drain bag" 28),
a supply line ("tube" 24a: see figures 1-2) in fluid communication with the PD fluid container (27) and extending outside of the chamber (6+11) (see figure 1),
a drain container ("drain bag" 28: see figure 2) sized to fit within the chamber (6+11) so as to be weighed by the weigh scale,
a drain line ("tube" 24b: see figures 1 and 2) in fluid communication with the drain container (28) and extending outside of the chamber (6+11) (see figure 1), and
a patient line ("tube" 19g: see figure 1) positioned on an opposing side of the pump from the supply line (24a) and the drain line (24b),
wherein the control unit is configured to operate the plurality of valves and the pump bidirectionally to pump (i) used dialysis fluid from the patient line (19g), through the drain line (24b), to the drain container (28) and (ii) fresh dialysis fluid from the PD fluid container (27), through the supply line (24a), and through the patient line (19g) (see column 7, line 27 - column 8, line 19).
Claim 19 differs from Jeppsson in reciting a first one-way valve in fluid communication with the fresh PD fluid compartment, the first one-way valve oriented to open under negative pressure from outside the fresh PD fluid compartment, a second one-way valve in fluid communication with the used PD fluid compartment, the second one-way valve oriented to open under positive pressure from outside the used PD fluid compartment, and a supply/drain line in fluid communication with the first and second one-way valves, the supply/drain line extending outside of the chamber.
Guosheng teaches a peritoneal dialysis ("PD") system (see figures 1-3; paragraphs 31-39) comprising:
a cycler (1) including
a weigh scale (16),
a chamber (volume between cover as shown in figure 1 and top surface of the cycler 1) positioned to be weighed by the weigh scale (16),
a heater (17+3) positioned to heat an inside of the chamber,
a plurality of valves (9, 10) supported by the chamber or a housing of the cycler,
a peristaltic pump (2) supported by the chamber or a housing of the cycler, and
a control unit ("circuit board") operable with the weigh scale, the heater, the plurality of valves (9, 10) and the pump (2); and
a disposable set (see figure 3) including
a PD fluid container ("dialysate bag", connected to "dialysis solution end" 15) and a drain container ("drainage-fluid bag", connected to "drain end" 12) sized to fit within the chamber so as to be weighed by the weigh scale (16) and heated by the heater (17+3), the PD fluid container including a fresh PD fluid compartment and the drain container including a used PD fluid compartment, a first one-way valve ("check-valve" 9) in fluid communication with the fresh PD fluid compartment, the first one-way valve (9) oriented to open under negative pressure from outside the fresh PD fluid compartment (see arrow as shown in figure 3), a second one-way valve (10) in fluid communication with the used PD fluid compartment, the second one-way valve (10) oriented to open under positive pressure from outside the used PD fluid compartment (see arrow as shown in figure 3),
a supply/drain line (portion of the "peristaltic pump flexible pipe" 18 not acted upon by the pump 2 and located on the side near the one-way valves 9 and 10: see figure 1) in fluid communication with the first (9) and second (10) one-way valves, the supply/drain line extending outside of the chamber (see figure 1), and
a patient line (line extending between "peristaltic pump flexible pipe" 18 and "patient end" 14) positioned on an opposing side of the pump (2) from the supply/drain line (portion of the "peristaltic pump flexible pipe" 18 not acted upon by the pump 2 and located on the side near the one-way valves 9 and 10: see figure 1),
wherein the control unit is configured to operate the pump bidirectionally to pump used dialysis fluid from the patient line, through the supply/drain line and the second one-way valve, to the used PD fluid compartment and (ii) fresh dialysis fluid from the fresh PD fluid compartment, through the first one-way valve and the supply/drain line, through the patient line.
It would have been obvious to a person of ordinary skill in the art to incorporate well-known disposable set with a first one-way valve and a second one-way valve respectively in fluid communication with a container volume for fresh PD and a container volume for used PD fluid, wherein the first one-way valve is oriented to open under negative pressure from outside the fresh PD fluid container volume and the second one-way valve is oriented to open under positive pressure from outside the used PD fluid container volume, and including a supply/drain line in fluid communication with the first and second one-way valves, the supply/drain line extending outside of the chamber in the peritoneal system of Jeppsson as an alternative means to operate the peritoneal dialysis system as suggested by Guosheng.
Regarding claim 20, Guosheng teaches the supply/drain line mates with a tee (11: a three way valve) extending to a first port holding the first one-way valve (9) and a second port holding the second one-way valve (10)(see figure 3).
Regarding claim 21, Jeppsson teaches that the chamber is sized to hold an entire fresh PD fluid volume at a beginning of a treatment and used PD fluid from multiple drains at the end of the treatment (see col. 3, lines 17-28; col. 8, lines 50-56).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Jeppsson as applied to claim 1 above and further in view of Guosheng.
Jeppsson teaches a peritoneal dialysis (“PD”) system as described above.
Claim 4 differs from Jeppsson in reciting that the pump is a peristaltic pump, and wherein the disposable set includes a peristaltic pumping tube located between (a) the supply line and the patient line and (b) the drain line and the patient line.
Guosheng teaches (see figures 1-3): a peritoneal dialysis ("PD") system (see figure 1; paragraphs 31-39) as described above including a peristaltic pump (2) supported by the chamber or a housing of the cycler, and a peristaltic pumping tube (18) located between (a) the supply line (15) and the patient line (14) and (b) the drain line (12) and the patient line (14)(see figures 1, 3).
It would have been obvious to a person of ordinary skill in the art to incorporate well-known peristaltic pump and a peristaltic pumping tube of Guosheng for the pump in the peritoneal dialysis system of Jeppsson as an alternative pumping means for fluid flow.
Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Guosheng in view of Jeppsson.
Regarding claim 1, Guosheng discloses (see figures 1-3) a peritoneal dialysis ("PD") system (see figures 1-3; paragraphs 31-39) comprising:
a cycler (1) including
a weigh scale (16),
a chamber (volume between cover as shown in figure 1 and top surface of the cycler 1) positioned to be weighed by the weigh scale (16),
a heater (17+3) positioned to heat an inside of the chamber,
a plurality of valves (9, 10) supported by the chamber or a housing of the cycler,
a pump (2) supported by the chamber or a housing of the cycler, and
a control unit ("circuit board") operable with the weigh scale (16), the heater (17+3), and the pump (2); and
a disposable set (see figure 3) including
a PD fluid container ("dialysate bag", connected to "dialysis solution end" 15) sized to fit within the chamber so as to be weighed by the weigh scale (16) and heated by the heater (17+3),
a supply line (line extending between "dialysis solution end" 15 and "peristaltic pump flexible pipe" 18) in fluid communication with the PD fluid container and extending outside of the chamber (see figure 1),
a drain container ("drainage-fluid bag", connected to "drain end" 12) sized to fit within the chamber so as to be weighed by the weigh scale (16),
a drain line (line extending between "drain end" 12 and "peristaltic pump flexible pipe" 18) in fluid communication with the drain container and extending outside of the chamber (see figure 1), and
a patient line (line extending between "peristaltic pump flexible pipe" 18 and "patient end" 14) positioned on an opposing side of the pump (2) from the supply line (line extending between "dialysis solution end" 15 and "peristaltic pump flexible pipe" 18) and the drain line (line extending between "drain end" 12 and "peristaltic pump flexible pipe" 18),
wherein the control unit is configured to operate the pump (2) bidirectionally ("two-way peristaltic pump" 2) to pump (i) used dialysis fluid from the patient line, through the drain line, to the drain container and (ii) fresh dialysis fluid from the PD fluid container, through the supply line, and through the patient line.
Claim 1 differs from Guosheng in reciting that the control unit is configured to operate the plurality of valves.
The disposable set of the peritoneal dialysis system of Guosheng comprises a check-valve (9) in the supply line and a check valve (10) in the drain line. Check-valve (9) prevents used dialysis fluid from flowing from the patient line to the PD fluid container when the pump is controlled in a clockwise direction. Check-valve (10) prevents used dialysis fluid from flowing from the drain container towards the patient line when the pump is controlled in a counterclockwise direction.
Jeppsson teaches a peritoneal dialysis system as described above comprising a control unit (see column 4, lines 28-35) configured to operate the weigh scale, the heater, the pump and the plurality of pinch valves (see "valve pack" 5 in figure 6) connected to a connection unit (4) (see figure 6; col. 5, line 64 – col. 6, line 55)..
It would have been obvious to a person of ordinary skill in the art to provide well-known controlled valves of Jeppsson at the cycler (e.g. pinch valves) to achieve such flow control in the peritoneal dialysis system of Guosheng.
Regarding claims 2-3, Jeppsson teaches supply line valve, drain line valve, patient line valve in a valve pack (5) of pinch valves connected to a connection unit (4)(see figure 6; col. 5, line 64 – col. 6, line 55).
Regarding claim 4, Guosheng teaches the pump is a peristaltic pump (2), and wherein the disposable set includes a peristaltic pumping tube (18) located between (a) the supply line (15) and the patient line (14) and (b) the drain line (12) and the patient line (14)(see figures 1, 3).
Regarding claim 5-7, Guosheng teaches a second PD fluid container sized to fit within the chamber so as to be weighed by the weigh scale and heated by the heater (17), and a second supply line in fluid communication with the second PD fluid container and extending outside of the chamber and a second PD fluid container to be placed on top of the first PD fluid container or adjacent to the first PD fluid container (see figure 1).
Regarding claim 8, Guosheng teaches that a patient line (14: see figure 1) positioned on an opposing side of the pump (2) from the supply line (15) and the drain line (12).
Regarding claims 9-10, Jeppsson teaches that supply line (24a) mates with a container line (26) extending from the PD fluid container (27) (see figures 1 and 2).
Regarding claim 11, Guosheng teaches that the chamber (volume between cover as shown in figure 1 and top surface of the cycler 1) is configured for the supply line (15) to extend into the chamber for connection to the PD fluid container (dialysate bag) (see figures 1, 3).
Regarding claim 12, Jeppsson teaches a drain container (28) connected to a terminal drain line (19f) (see figures 1 and 2; col. 5, lines 30-32; col. 7, lines 51-54).
Regarding claim 13, Jeppsson teaches that the terminal drain line (19f) is positioned along with the patient line (19g) on the opposing side of the pump from the supply line (24a) and the drain line (24b)(see figure 1).
Regarding claim 14, Jeppsson teaches that terminal drain line (19f) extends to a terminal drain container (16) (extending to a house drain)(see figure 1).
Regarding claim 15, independent claim 15 basically corresponds to independent claim 1 wherein the PD fluid container and drain container of claim 1 are embodied as respectively a fresh PD fluid compartment and a used PD fluid compartment of a (two-chamber) PD fluid container.
Claim 15 differs from Guosheng in reciting that the control unit is configured to operate the plurality of valves and the PD fluid container including a fresh PD fluid compartment and a used PD fluid compartment of a (two-chamber) PD fluid container.
The disposable set of the peritoneal dialysis system of Guosheng comprises a check-valve (9) in the supply line and a check valve (10) in the drain line. Check-valve (9) prevents used dialysis fluid from flowing from the patient line to the PD fluid container when the pump is controlled in a clockwise direction. Check-valve (10) prevents used dialysis fluid from flowing from the drain container towards the patient line when the pump is controlled in a counterclockwise direction.
Jeppsson teaches a peritoneal dialysis system as described above comprising a control unit (see column 4, lines 28-35) configured to operate the weigh scale, the heater, the pump and the plurality of pinch valves (see "valve pack" 5 in figure 6) connected to a connection unit (4) (see figure 6; col. 5, line 64 – col. 6, line 55)..
It would have been obvious to a person of ordinary skill in the art to provide well-known controlled valves of Jeppsson at the cycler (e.g. pinch valves) to achieve such flow control in the peritoneal dialysis system of Guosheng.
Jeppsson teaches a two-chamber PD fluid container ("double bag": see column 5, lines 57-61; see figures 2 and 10) comprising a fresh PD fluid compartment ("heater bag" 27) and a used PD fluid compartment ("drain bag" 28).
It would have been obvious to a person of ordinary skill in the art to provide well-known a two-chamber PD fluid container of Jeppsson in the peritoneal dialysis system of Guosheng to reduce or simplify separate fresh PD fluid container and used PD fluid container into one two-chamber PD fluid container.
Regarding claim 16, Jeppsson teaches that (i) the supply line (24a) mates with a fresh compartment line (26) extending from the fresh PD fluid compartment (27) and (ii) the drain line (24b) mates with a used compartment line (25) extending from the used PD fluid compartment (28)(see figure 2).
Regarding claim 17, Jeppsson teaches that the chamber is configured for (i) the supply line (24a) to extend into the chamber for connection to the fresh PD fluid compartment via fresh compartment line (26) and (ii) the drain line (24b) to extend into the chamber for connection to the used PD fluid compartment via used compartment line (25)(see figure 2).
Regarding claim 18, Jeppsson teaches that the chamber is sized to hold an entire fresh PD fluid volume at a beginning of a treatment and used PD fluid from multiple drains at the end of the treatment (see col. 3, lines 17-28; col. 8, lines 50-56).
Regarding claim 19, Guosheng teaches a peritoneal dialysis ("PD") system (see figures 1-3; paragraphs 31-39) comprising:
a cycler (1) including
a weigh scale (16),
a chamber (volume between cover as shown in figure 1 and top surface of the cycler 1) positioned to be weighed by the weigh scale (16),
a heater (17+3) positioned to heat an inside of the chamber,
a plurality of valves (9, 10) supported by the chamber or a housing of the cycler,
a peristaltic pump (2) supported by the chamber or a housing of the cycler, and
a control unit ("circuit board") operable with the weigh scale, the heater, the plurality of valves (9, 10) and the pump (2); and
a disposable set (see figure 3) including
a PD fluid container ("dialysate bag", connected to "dialysis solution end" 15) and a drain container ("drainage-fluid bag", connected to "drain end" 12) sized to fit within the chamber so as to be weighed by the weigh scale (16) and heated by the heater (17+3), the PD fluid container including a fresh PD fluid compartment and the drain container including a used PD fluid compartment, a first one-way valve ("check-valve" 9) in fluid communication with the fresh PD fluid compartment, the first one-way valve (9) oriented to open under negative pressure from outside the fresh PD fluid compartment (see arrow as shown in figure 3), a second one-way valve (10) in fluid communication with the used PD fluid compartment, the second one-way valve (10) oriented to open under positive pressure from outside the used PD fluid compartment (see arrow as shown in figure 3),
a supply/drain line (portion of the "peristaltic pump flexible pipe" 18 not acted upon by the pump 2 and located on the side near the one-way valves 9 and 10: see figure 1) in fluid communication with the first (9) and second (10) one-way valves, the supply/drain line extending outside of the chamber (see figure 1), and
a patient line (line extending between "peristaltic pump flexible pipe" 18 and "patient end" 14) positioned on an opposing side of the pump (2) from the supply/drain line (portion of the "peristaltic pump flexible pipe" 18 not acted upon by the pump 2 and located on the side near the one-way valves 9 and 10: see figure 1),
wherein the control unit is configured to operate the pump bidirectionally to pump used dialysis fluid from the patient line, through the supply/drain line and the second one-way valve, to the used PD fluid compartment and (ii) fresh dialysis fluid from the fresh PD fluid compartment, through the first one-way valve and the supply/drain line, through the patient line.
Claim 19 differs from Guosheng in reciting that the control unit is configured to operate the plurality of valves and the PD fluid container including a fresh PD fluid compartment and a used PD fluid compartment of a (two-chamber) PD fluid container.
The disposable set of the peritoneal dialysis system of Guosheng comprises a check-valve (9) in the supply line and a check valve (10) in the drain line. Check-valve (9) prevents used dialysis fluid from flowing from the patient line to the PD fluid container when the pump is controlled in a clockwise direction. Check-valve (10) prevents used dialysis fluid from flowing from the drain container towards the patient line when the pump is controlled in a counterclockwise direction.
Jeppsson teaches a peritoneal dialysis system as described above comprising a control unit (see column 4, lines 28-35) configured to operate the weigh scale, the heater, the pump and the plurality of pinch valves (see "valve pack" 5 in figure 6) connected to a connection unit (4) (see figure 6; col. 5, line 64 – col. 6, line 55)..
It would have been obvious to a person of ordinary skill in the art to provide well-known controlled valves of Jeppsson at the cycler (e.g. pinch valves) to achieve such flow control in the peritoneal dialysis system of Guosheng.
Jeppsson teaches a two-chamber PD fluid container ("double bag": see column 5, lines 57-61; see figures 2 and 10) comprising a fresh PD fluid compartment ("heater bag" 27) and a used PD fluid compartment ("drain bag" 28).
It would have been obvious to a person of ordinary skill in the art to provide well-known a two-chamber PD fluid container of Jeppsson in the peritoneal dialysis system of Guosheng to reduce or simplify separate fresh PD fluid container and used PD fluid container into one two-chamber PD fluid container.
Regarding claim 20, Guosheng teaches the supply/drain line mates with a tee (11: a three way valve) extending to a first port holding the first one-way valve (9) and a second port holding the second one-way valve (10)(see figure 3).
Regarding claim 21, Jeppsson teaches that the chamber is sized to hold an entire fresh PD fluid volume at a beginning of a treatment and used PD fluid from multiple drains at the end of the treatment (see col. 3, lines 17-28; col. 8, lines 50-56).
Regarding claim 22, independent claim 22 basically corresponds to independent claim 15, wherein the expressions "fresh PD fluid compartment" and a "used PD fluid compartment" are respectively changed into "fresh PD fluid end” and a "used PD fluid end". It is however noted that the "fresh PD fluid compartment" and the used "PD fluid compartment" of the peritoneal dialysis system according to claim 15 each implicitly comprise an "end" where fluid enters/exits the compartment. Claim 22 does not exclude that the PD fluid container is actually a two-chamber container, comprising a "fresh PD fluid compartment" with a "fresh PD fluid end" and a "used PD fluid compartment" with a "used PD fluid end".
Claim 22 differs from Guosheng in reciting that the control unit is configured to operate the plurality of valves and the PD fluid container including a fresh PD fluid end and a used PD fluid end of a (two-chamber) PD fluid container.
The disposable set of the peritoneal dialysis system of Guosheng comprises a check-valve (9) in the supply line and a check valve (10) in the drain line. Check-valve (9) prevents used dialysis fluid from flowing from the patient line to the PD fluid container when the pump is controlled in a clockwise direction. Check-valve (10) prevents used dialysis fluid from flowing from the drain container towards the patient line when the pump is controlled in a counterclockwise direction.
Jeppsson teaches a peritoneal dialysis system as described above comprising a control unit (see column 4, lines 28-35) configured to operate the weigh scale, the heater, the pump and the plurality of pinch valves (see "valve pack" 5 in figure 6) connected to a connection unit (4) (see figure 6; col. 5, line 64 – col. 6, line 55)..
It would have been obvious to a person of ordinary skill in the art to provide well-known controlled valves of Jeppsson at the cycler (e.g. pinch valves) to achieve such flow control in the peritoneal dialysis system of Guosheng.
Jeppsson teaches a two-chamber PD fluid container ("double bag": see column 5, lines 57-61; see figures 2 and 10) comprising a fresh PD fluid compartment ("heater bag" 27) with implicit fresh PD fluid end and a used PD fluid compartment ("drain bag" 28) with implicit used PD fluid end.
It would have been obvious to a person of ordinary skill in the art to provide well-known a two-chamber PD fluid container with implicit fresh PD fluid end and used PD fluid end of Jeppsson in the peritoneal dialysis system of Guosheng to reduce or simplify separate fresh PD fluid container and used PD fluid container into one two-chamber PD fluid container.
Regarding claim 23, Jeppsson teaches that (i) the supply line (24a) mates with a fresh compartment line (26) extending from the fresh PD fluid end of the PD fluid compartment (27) and (ii) the drain line (24b) mates with a used compartment line (25) extending from the used PD fluid end of the PD fluid compartment (28)(see figure 2).
Regarding claim 24, Jeppsson teaches that the chamber is configured for (i) the supply line (24a) to extend into the chamber for connection to the fresh PD fluid end of the PD fluid compartment via fresh compartment line (26) and (ii) the drain line (24b) to extend into the chamber for connection to the used PD fluid end of the PD fluid compartment via used compartment line (25)(see figure 2).
Allowable Subject Matter
Claims 25-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/John Kim/Primary Examiner, Art Unit 1777
JK
12/11/25