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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/09/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18, and all claims depending therefrom, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the limitation “the sixth port of the plurality of port” lacks antecedent basis in the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hopping (US Pub. No. 2005/0209563 A1, hereinafter “Hopping”) in view of Jensen et al (U.S. Pub. 2020/0033897 A1, hereinafter “Jensen”).
Regarding claim 1, Hopping discloses a system, comprising:
a dialysis system 10 (Fig. 1) comprising a receiving component (a housing that encloses the processor and accepts a cassette; para [0058]),
a peritoneal dialysis cassette 50 (Fig. 1) configured to be inserted into the receiving compartment to the dialysis system, the peritoneal dialysis cassette comprising:
a body (i.e., the housing of the cassette 50);
a membrane 102 (Figs. 6, 7, 10-15) on a side of the body;
a plurality of fluid channels (i.e., cassette flow paths including flow paths 114 and flow paths 110/26, see para [0206]) defined by an area between the membrane and the body (para [0164], [0173]; Figs. 4, 6; i.e., cassette flow paths are formed by rigid vertical walls of cassette 50 and membrane 102);
a plurality of ports 118-130 (Fig. 4 and para [0109]);
wherein the plurality of ports is fluidly connected to the plurality of fluid channels (para [0109]; [0247]; Figs. 24A-24C);
one or more pinch valve positions (i.e., position of valves 26, 44, 36, 30, and 42;Fig. 4) for placement of a pinch valve (104/26, 104/44, 104/36, 104/30, 104/42) in the plurality of fluid channels (Fig. 3) to selectively direct fluid from at least a first specified port (i.e., one of bulkhead ports 118-130) of the plurality of ports to a second port (i.e., another of bulkhead ports 118-130) of the plurality of ports (paras [0167], [0172]); and
a pump (casing 78 containing tubing 76, along with peristaltic roller system 100) fluidically connectable to the plurality of ports of the peritoneal dialysis system (i.e., the ports connect to the tubing 76 which assists in pumping the fluid to achieve the desired pressure).
But Hopping does not appear to disclose that the pump is not located within the peritoneal cassette (instead, Hopping discloses that the pump casing portion 78 is part of the cassette 50; para [0110]).
However, to position the pump outside the cassette was well-known in the art. For instance, Jensen teaches a hemodialysis system in the analogous art to Applicant’s invention, comprising a cassette 1104 (Figs. 30 and 52) which is fluidly connected to an external pump (Figs. 1, 30 and 42; pump includes tubing 1160 which fluidly connects to the cassette via fluid hubs 1138 of the cassette).
A skilled artisan would have found it obvious at the time of the invention to modify the system of Hopping so that the pump is provided outside the cassette, as doing so was well-known in the art, as a matter of engineering choice. The design of either an integrated pump or an external pump would work equally well, and the use of an external pump could have numerous advantages including the ability to remove a used cassette without requiring disposing of the pump itself.
Regarding claim 2, Hopping, in view of Jensen, discloses the system of claim 1, and Hopping further discloses a conductivity sensor (56) in a fluid line (28, 54, or 68) fluidly connecting the external pump to either the first or second port of the plurality of ports (para [0175]; respective one of bulkhead connectors 128, 126, or 124 to which tubes 28, 54, or 68 are coupled to) (para [0223]; Fig. 19A; i.e., fluidly coupled via fluidly coupling through cassette flow paths to hollow male elements 96, 98 to the respective bulkhead port)
Regarding claim 3, Hopping, in view of Jensen, discloses the system of claim 1, and Hopping further discloses an air bubble detector (222) in a fluid line (para [0235], [0238]) fluidly connecting the external pump to either the first or second port of the plurality of ports (Figs. 20, 21; i.e., fluidly coupled via fluidly coupling through cassette flow paths to hollow male elements 96, 98 to the respective bulkhead port).
Regarding claim 4, Hopping, in view of Jensen, discloses the peritoneal dialysis cassette of claim 1, and Hopping further discloses improving volumetric accuracy of the pump by accounting for variables including fluid temperature with sensors 116 (para [0275]) for but does not disclose at least one temperature sensor in the peritoneal dialysis cassette.
However, Jensen also discloses a peritoneal dialysis cassette for use in a system with a heater assembly, wherein Jensen further discloses that the fluid cassette comprises conductivity sensors 203 to detect the fluid temperature and provide temperature-compensated conductivity measurements (para [0101]). Therefore, since both Hopping and Jensen discloses a peritoneal dialysis cassette for use in a system with a heater assembly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hopping with the feature of at least one temperature sensor in the peritoneal dialysis cassette as disclosed by Jensen to provide for temperature-compensated measurements and also as a safety check so that the final temperature of the dialysate exiting the system is at an appropriate temperature (para [0101] of Jensen).
Regarding claim 5, Hopping, in view of Jensen, discloses the system of claim 1, and Hopping further discloses at least one pressure sensor (106) in the peritoneal dialysis cassette (para [0177]; since chamber 106 contacts pressure sensor 116 to determine pressure in a similar manner as membrane surfaces at positions 114, 115 of the instant invention).
Regarding claim 2, Hopping, in view of Jensen, discloses the system of claim 1, and Hopping further discloses:
a first peritoneal dialysis fluid source (22) fluidly connectable to a third port (128) of the plurality of ports (para [0100], Figs. 1, 4, 7; i.e., since bag 22 is coupled via line 28 and line 28 is coupled to bulkhead port 126);
a peritoneal dialysis fluid bag (16) fluidly connectable to a fourth port (126) of the plurality of ports (para [0100]; Figs. 1, 4, 7; i.e., since bag 16 is coupled via line 54 and line 54 is coupled to bulkhead port 126); and
a control system (60) (para [0098], [0106]; Figs. 2, 3) in communication with one or more pinch valves (104/26, 104/44, 104/36, 104/30, 104/42) each pinch valve of the one or more pinch valves is configured to be positioned at one of the one or more pinch valve positions (para [0167]-[0168], [0172]);
the control system programmed to control the one or more pinch valves to selectively direct fluid through the peritoneal dialysis cassette (para [0030]; [0167]-[0168]; i.e., controller or microprocessor in actuator unit 60 is programmed to operate the valves and pump). It is noted that bulkhead ports 118-124 or 130 are interpreted as the claimed first and second ports since bulkhead ports 126 and 128 are interpreted as the claimed third and fourth ports.
Regarding claim 7, Hopping, in view of Jensen, discloses the system of claim 6, and Hopping further discloses at least a second peritoneal dialysis fluid source (14) fluidly connectable to a fifth port (124) of the plurality of ports (para [0100]; Figs. 1, 4, 7; i.e., since bag 14 is coupled via line 20 and line 20 is coupled to bulkhead port 124); the control system programmed to control the one or more pinch valves to selectively direct fluid from the first peritoneal dialysis fluid source to the peritoneal dialysis fluid bag and selectively direct fluid from the second peritoneal dialysis fluid source to the peritoneal dialysis fluid bag (para [0030]; [0167]-[0168]; i.e., controller or microprocessor in actuator unit 60 is programmed to operate the valves and pump to direct fluid toward chamber and flow paths in the direction of port 126 coupled to bag 16).
Regarding claim 8, Hopping, in view of Jensen, discloses the system of claim 6, and Hopping further discloses a fifth port (130) of the plurality of ports fluidly connectable to a patient line (12) (para [0247], [0252]); the control system programmed to control the one or more pinch valves to selectively direct fluid from the peritoneal dialysis fluid bag into the patient line (para [0030]; [0167]-[0168]; i.e., controller or microprocessor in actuator unit 60 is programmed to operate the valves and pump to direct fluid to patient line 12).
Regarding claim 9, Hopping, in view of Jensen, discloses the system of claim 6, and Hopping further discloses a fifth port (118) of the plurality of ports fluidly connectable to a drain line (32) (para [0100], [0102]); the control system programmed to control the one or more pinch valves to selectively direct fluid from the peritoneal dialysis fluid bag into the drain line (para [0030]; [0167]-[0168]; i.e., controller or microprocessor in actuator unit 60 is programmed to operate the valves and pump to direct fluid to bag 24).
Regarding claim 10, Hopping, in view of Jensen, discloses the system of claim 8, and Hopping further discloses a sixth port 118 of the plurality of ports fluidly connectable to a drain line (32) (para [0100], [0102]); the control system programmed to control the one or more pinch valves to selectively direct fluid from the patient line into the drain line (para [0030]; [0167]-[0168]; i.e., controller or microprocessor in actuator unit 60 is programmed to operate the valves and pump to direct fluid to bag 24).
Regarding claims 11 and 12, Hopping, in view of Jensen, discloses the system of claim 6, and Hopping further discloses two of bulkhead ports 118-124, 130 being interpreted as the claimed first and second ports and the fifth port may be a third one of bulkhead ports 118-124, and 130 and that cassette 50 may be modified to define suitable configuration (para [0173]). Moreover, while Hopping discloses that it is known in the art for sensors to be employed for monitoring ammonia (para [0011]) and the dialysate collected for integrity test (para [0021]) to provide safety check (para [0232]), Hopping does not explicitly disclose that the fifth port of the plurality of ports fluidly connected to a sampling line (as per claim 11) fluidly connected to a sampling bag (as per claim 12).
However, Jensen discloses a peritoneal dialysis system comprising a cassette 1104 with a plurality of fluid channels, a plurality of ports 1140, and one or more pinch valve positions; a first peritoneal dialysis fluid source 306; a peritoneal dialysis fluid bag 304; a control system 161; and one or more pinch valves (V1-V7) (Fig. 30; para [0133]); and a fluid line coupling to ammonia detector 121 is a sampling line since the line having its fluid characteristic measured, see [0085], [0101]) fluidly connected to a sampling bag (303) (para [0101] and [0121]; i.e., since NH detects the level of ammonia downstream of sorbent cartridge 303, sorbent cartridge 303 is a container into which fluid to be analyzed can be collected). Jensen discloses the sampling test for determining the concentration of ammonium in the dialysate and sorbent cartridge 303 for removal of the ammonium (para [0118]) so that the concentration of ammonium is within an acceptable threshold; paras [0121]-[0122]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hopping with the feature of a fifth port of the plurality of ports fluidly connected to a sampling line (as per claim 11) fluidly connected to a sampling bag (as per claim 12) as disclosed by Jensen so as to check that the composition of the dialysate is within acceptable thresholds (para [0122] of Jensen and para [0011] of Hopping).
Regarding claim 13, Hopping, in view of Jensen, discloses the system of claim 6, and Hopping further discloses further comprising a conductivity sensor 56 in a fluid line (28, 54, or 68) fluidly connecting the external pump to either the first or second port of the plurality of ports (para [0175]; respective one of bulkhead connectors 128, 126, or 124 to which tubes 28, 54, or 68 are coupled to) (para [0223]; Fig. 19A; i.e., fluidly coupled via fluidly coupling through cassette flow paths to hollow male elements 96, 98 to the respective bulkhead port).
Regarding claim 14, Hopping, in view of Jensen, discloses the system of claim 12, wherein Hopping further discloses comprising a sixth port 130 of the plurality of ports fluidly connectable to a patient line 12 (para [0247], [0252]); wherein the control system is programmed to control the one or more pinch valves to selectively direct fluid from the fourth port of the plurality of ports to the sixth port of the plurality of ports (para [0030]; [0167]-[0168]; i.e., controller or microprocessor in actuator unit 60 is programmed to operate the valves and pump to direct fluid to patient line 12 from bag 16).
Regarding claim 15. Hopping, in view of Jensen, discloses the system of claim 11, wherein Hopping further discloses comprising an air bubble detector (222) in a fluid line (para [0235], [0238]) fluidly connecting the external pump to either the first or second port of the plurality of ports (Figs. 20, 21; i.e., fluidly coupled via fluidly coupling through cassette flow paths to hollow male elements 96, 98 to the respective bulkhead port).
Regarding claim 16. Hopping, in view of Jensen, discloses the system of claim 15, further comprising a sixth port 130 of the plurality of ports fluidly connectable to a patient line 12 (para [0247], [0252]); wherein the control system is programmed to control the one or more pinch valves to selectively direct fluid from the fourth port of the plurality of ports to the sixth port of the plurality of ports (para [0030] and [0167]-[0168]; i.e., controller or microprocessor in actuator unit 60 is programmed to operate the valves and pump to direct fluid to patient line 12 from bag 16).
Regarding claim 17, Hopping, in view of Jensen, discloses a method of using the system of claim, and Hopping further discloses the steps of: pumping fluid from a third port 128 of the plurality of ports fluidly connected to a peritoneal dialysis fluid source 22, through the peritoneal dialysis cassette to a fourth port 126 of the plurality of ports fluidly connected to a peritoneal dialysis fluid bag 16 (para [0167]-[0168], [0172]; see also para [0100], Figs. 1, 4, 7 for bulkhead ports 128, 126 and bags 22, 16).
Regarding claim 18, Hopping, in view of Jensen, discloses the method of claim 17, and Hopping further discloses the step of pumping fluid from the peritoneal dialysis fluid bag into a patient line 12 fluidly connected to a fifth port 130 of the plurality of ports (para [0247], [0252]); the patient line fluidly connectable to a catheter (para [0024], [0005]-[00011]; i.e., since implanted catheters are known to be implanted to be coupled to peritoneal dialysis systems for delivering dialysate and draining fluids during treatment); and pumping fluid from the patient line into the sixth port 18 of the plurality of ports fluidly connectable (para [0100], [0102]).
Regarding claim 19, Hopping, in view of Jensen, discloses the method of claim 18, and Hopping further discloses the step of measuring at least one fluid characteristic of fluid (i.e., conductivity or air detection) in a fluid line fluidly connecting the external pump to either the first or second port of the plurality of ports prior to pumping the fluid to the patient line (paras [0223]-[0224] disclose conductivity; paras [0230]-[0239] disclose air detection).
Regarding claim 20, Hopping, in view of Jensen, discloses the method of claim 19, and Hopping further discloses the fluid line fluidly connecting the external pump to either the first or second port of the plurality of ports comprises at least a conductivity sensor and an air bubble detector (para [0223]-[0224] disclose conductivity; [0230]-[0239] disclose air bubble detection).
Response to Arguments
Applicant’s arguments with respect to the previous 35 U.S.C. 112(b) rejections were considered; the amendments to the claims were sufficient to overcome the previously applied 35 U.S.C. 112(b) rejections.
Applicant’s arguments with respect to the amended claims have been considered but are moot in view of the new grounds of rejection necessitated by Applicant’s amendments.
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/03/2026
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