DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed February 17, 2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed November 19, 2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kamen et al. (USPN 5628908) in view of Inoue (JP H08725, with citations to the provided machine English Translation).
Regarding claim 1, Kamen discloses a dialysis system (dialysis system 10) comprising:
a dialysis machine (cycler 14);
at least one fluid supply line (tube 26 and tubes 30/32) connected to a source of dialysis fluid (source solution 20 and heater bag 22; “One tube 26 conveys liquid to and from the heater bag 22.” [Col 10, lines 35-36]; “the tubes 30/32 that carry sterile source liquid into the pump chambers enter through the lower pump chamber ports 66(1)/(2).” [Col 10, lines 62-64]); and
a cassette (cassette 24) for use with the dialysis machine, the cassette comprising:
a frame (Figure 8; “the cassette 24 includes an injection molded body having front and back sides 58 and 60.” [Col 7, lines 38-39]),
at least one pump chamber (pump chambers P1, P2) within the frame (Figure 8),
a first set of valves (valves V1, V3) for routing the dialysis fluid from the at least one fluid supply line to the at least one pump chamber (Figure 32; “Perform pump chamber P1 draw stroke (drawing a volume of heated dialysate into pump chamber P1 from the heater bag)…Open inlet path F1 to pump chamber P1, while closing inlet path F1 to pump chamber P2. Actuate valve CO to supply high-relative negative pressure to valve actuator VA1, opening cassette valve station V1. Actuate valves C1; D1; and D2 to supply high-relative positive pressure to valve actuators VA2; VA3: and VA4, closing cassette valve station V2; V3; and V4.” [Col 31, line 61 – Col 32, line 5]; “2. Perform pump chamber P2 draw stroke (drawing a volume of heated dialysate into pump chamber P2 from the heater bag)…Open inlet path F1 to pump chamber P2, while closing inlet path F1 to pump chamber P1. Actuate valves C0; C1; and D2 to supply high-relative positive pressure to valve actuators VA1; VA2; and VA4, closing cassette valve stations V1; V2; and V4. Actuate valve D1 to supply high-relative negative pressure to valve actuator VA3, opening cassette valve station V3.” [Col 32, line 19-31]),
a second set of valves (valves V7, V8) for routing the dialysis fluid from the at least one pump chamber to a patient line (Figure 32, “performing pump chamber P2 pump stroke (expelling a volume of heated dialysate from pump chamber P2 to the patient)…Close outlet path F5 to pump chamber P1, while opening outlet path F5 to pump chamber P2. Actuate valves C2 to C4 and D3 to D5 to supply high-relative positive pressure to valve actuators VA8 to V10 and VA5 to VA7, closing cassette valve stations V8 to V10 and V5 to V7. Actuate valve D5 to supply high-relative negative pressure to valve actuator VA7, opening cassette valve station V7.” [Col 31, line 61 – Col 32, line 12]; “performing pump chamber P1 pump stroke (expelling a volume of heated dialysate from pump chamber P1 to the patient)…Close outlet path F5 to pump chamber P2, while opening outlet path F5 to pump chamber P1. Actuate valve C2 to supply high-relative negative pressure to valve actuator VA8, opening cassette valve station V8. Actuate valves D3 to D5; C2; and C4 to supply high-relative positive pressure to valve actuators VA5 to VA7; V9; and V10, closing cassette valve stations V5 to V7; V9; and V10.” [Col 32, lines 19-39]), and
a plurality of ports (tube connectors 27/29/31/33/35) communicating with the first and second set of valves (“The first through fifth tube connectors 27 to 35 communicate with interior liquid paths F1 to F5, respectively. These liquid paths F1 to F5 constitute the primary liquid paths of the cassette 24, through which liquid enters or exits the cassette 24.” [Col 9, lines 45-49]), each port comprising an integral spike (structure of tube connectors 27/29/31/33/35; Figure 8).
Kamen fails to explicitly disclose a motorized autoconnection mechanism, wherein the motorized autoconnection mechanism is configured to move the at least one fluid supply line and the patient line automatically so as to be spiked open respectively by the plurality of ports of the cassette.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid supply line (bag-side connector 20 having connection pipe 25) connected to a source of dialysis fluid (“a connection pipe 25 to a connection tube to a dialysis bag.” [0010, Page 3]; “an empty bag and a dialysis bag are connected to the bag-side connector 20 by a Y-shaped tube” [Page 4]); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the motorized autoconnection mechanism is configured to move the at least one fluid supply line automatically so as to be spiked open by the port (Figures 3(a)-(g); “The operation of the automatic connection device 50 will be described. As shown in FIG. 3A…the patient side connector 10 and the bag side connector 20 in a state of being covered with 30 and 40 are holders 55, 57 at predetermined positions. Attach to 6, 57, 58. When the screw rod 51 is rotated to the right with the first stopper 61 protruding, the first gear 52 is rotated on the spot, and the second cap holder 57 and the second connector holder 58 are rotated counterclockwise. Cap 3 of 10, 20 0 and 40 come off (see FIG. 3 (b)). When the first stopper 61 is retracted downward and the screw rod 51 is rotated clockwise, the first gear 52, the second gear Both gears 53 move leftward (see FIG. 3B). When the second gear 53 hits the fourth stopper 64, the second gear 5 3 rotates together with the screw rod 51, and the board 54 moves laterally by meshing with the rack on the back surface of the board 54 (FIG. 3). (C)).When the screw rod 51 is rotated counterclockwise, both the first gear 52 and the second gear 53 move to the right, and when the first gear 52 hits the third stopper 63, the first gear 52 rotates counterclockwise, The holders 57 and 58 rotate clockwise to connect the screw of the connector (see FIG. 3D). In this state, the liquid in the patient's body is drained and the dialysate is injected into the body.” [Page 5]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the dialysis system of Kamen to include a motorized autoconnection mechanism configured to move the at least one fluid supply line and the patient line automatically so as to be spiked open respectively by the plurality of ports of the cassette based on the teachings of Inoue to prevent contamination of the fluid lines and ports by allowing for automatic connection between the fluid lines and the cassette instead of connecting the fluid lines by hand (Inoue [Abstract]).
Regarding claim 2, modified Kamen discloses the dialysis system of Claim 1, wherein the dialysis machine comprises a heater (bag heater module 74).
Regarding claim 3, modified Kamen discloses the dialysis system of Claim 1, wherein the plurality of ports includes a patient outlet port (fifth cassette port 35; Figure 8A) and a drain port (connector 29; Figure 8A), wherein the cassette further comprises a third set of valves (valves V2, V4, V7, V8) for routing the dialysis fluid from the patient outlet port to the drain port (Figure 34, see all of [Col 34, line 1 – Col 35, line 24]).
Modified Kamen fails to explicitly disclose wherein the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid line (bag-side connector 20 having connection pipe 25; “a connection pipe 25 to a connection tube to a dialysis bag.” [0010, Page 3]; “an empty bag and a dialysis bag are connected to the bag-side connector 20 by a Y-shaped tube” [Page 4]); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the motorized autoconnection mechanism is configured to move the at least one fluid line automatically so as to be spiked open by the port (Figures 3(a)-(g); detailed on Page 5 of English Translation and in the rejection of claim 1 above).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the dialysis system of Kamen to include the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively based on the teachings of Inoue to prevent contamination of the fluid lines and ports by allowing for automatic connection between the fluid lines and the cassette instead of connecting the fluid lines by hand (Inoue [Abstract]).
Regarding claim 4, modified Kamen discloses the dialysis system of Claim 1, wherein the plurality of ports includes a patient outlet port (fifth cassette port 35; Figure 8A) and a drain port (connector 29; Figure 8A), wherein the cassette further comprises a third set of valves (valves V7, V8) for routing the dialysis fluid from the patient outlet port to the at least one pump chamber (Figure 34; “Perform pump chamber P1 draw stroke (drawing a volume of spent dialysate into pump chamber P1 from the patient)…(i) Open inlet path F5 to pump chamber P1, while closing inlet path F5 to pump chamber P2. Actuate valve C2 to supply high-relative negative pressure to valve actuator VA8, opening cassette valve station V8. Actuate valves D3 to D5, C3, and C4 to supply high-relative positive pressure to valve actuators VA5 to VA7, VA9 and VA10, closing cassette valve stations V5 to V7, V9, and V10.” [Col 34, lines 33-52]; ”Perform pump chamber P2 draw stroke (drawing a volume of spent dialysate into pump chamber P2 from the patient)…opening inlet path F5 to pump chamber P2. Actuate valve D5 to supply high-relative negative pressure to valve actuator VA7, opening cassette valve station V7. Actuate valves D3; D4 and C2 to C4 to supply high-relative positive pressure to valve actuators VA5; VA6; and. VA8 to VA10, closing cassette valve stations V5, V6, and V8 to V10.” [Col 34, line 60 – Col 35, line 5) and a fourth set of valves (valves V2, V4) for routing the dialysis fluid from the at least one pump chamber to the drain port (Figure 34; “performing pump chamber P2 pump stroke (expelling a volume of spent dialysate from pump chamber P2 to the drain)…Close outlet path F2 to pump chamber P1, while opening outlet path F2 to pump chamber P2. Actuate valves C0; C1; and D1 to supply high-relative positive pressure to valve actuators VA1; VA2 and VA3, closing cassette valve stations V1; V2; and V3. Actuate valve D2 to supply high-relative negative pressure to valve actuator VA4, opening cassette valve station V4o” [Col 34, lines 32-52]; “performing pump chamber P1 pump stroke (expelling a volume of spent dialysate from pump chamber P1 to the drain)…Open outlet path F2 to pump chamber P1, while closing outlet path F2 to pump chamber P2. Actuate valve Cl to supply high-relative negative pressure to valve actuator VA2, opening cassette valve station V2. Actuate valves C0; D1; and D2 to supply high-relative positive pressure to valve actuators VA1; VA3; and VA4, closing cassette valve station V1; V3; and V4.” [Col 34, lines 60 – Col 35, line 12]).
Modified Kamen fails to explicitly disclose wherein the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid line (bag-side connector 20 having connection pipe 25; “a connection pipe 25 to a connection tube to a dialysis bag.” [0010, Page 3]; “an empty bag and a dialysis bag are connected to the bag-side connector 20 by a Y-shaped tube” [Page 4]); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the motorized autoconnection mechanism is configured to move the at least one fluid line automatically so as to be spiked open by the port (Figures 3(a)-(g); detailed on Page 5 of English Translation and in the rejection of claim 1 above).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the dialysis system of Kamen to include the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively based on the teachings of Inoue to prevent contamination of the fluid lines and ports by allowing for automatic connection between the fluid lines and the cassette instead of connecting the fluid lines by hand (Inoue [Abstract]).
Regarding claim 5, modified Kamen discloses the dialysis system of Claim 1, wherein the cassette comprises two pump chambers (pump chambers P1, P2; Figure 8).
Regarding claims 6-7, modified Kamen discloses the dialysis system of Claim 1.
Modified Kamen fails to explicitly teach each of the plurality of ports includes a removable cap covering the integral spike, and wherein the motorized autoconnection mechanism is configured to remove the removable cap covering the integral spike, as required by claim 6; and wherein the removable cap has radial symmetry, as required by claim 7.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid supply line (bag-side connector 20 having connection pipe 25); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the port includes a removable cap (cap 30, removal shown in Figures 3a-3b) covering the integral spike (Figure 3a; “The cap 30 for the patient-side connector is in contact with the inner circumference of the first inner cylinder 11 of the patient-side connector 10.” [Page 3]), and wherein the motorized autoconnection mechanism is configured to remove the removable cap covering the integral spike (Figure 3(b); “When the screw rod 51 is rotated to the right with the first stopper 61 protruding, the first gear 52 is rotated on the spot, and the second cap holder 57 and the second connector holder 58 are rotated counterclockwise. Cap 30 of 10, 20 0 and 40 come off (see FIG. 3 (b)).” [Page 5]); and wherein the removable cap (cap 30) has radial symmetry (Figures 1(c) and 2(c)).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the dialysis system of Kamen to include each of the plurality of ports includes a removable cap having radial symmetry covering the integral spike, and wherein the autoconnection mechanism is configured to remove the removable cap covering the integral spike based on the teachings of Inoue to prevent contamination of the fluid lines and ports both before and after a dialysis procedure (Inoue [Abstract], [Page 5]).
Regarding claim 8, modified Kamen discloses the dialysis system of Claim 1, wherein the frame is made out of a rigid plastic (“The cassette 24 is preferably made of a rigid medical grade plastic material” [Col 7, lines 45-46]).
Regarding claim 9, modified Kamen discloses the dialysis system of claim 1.
Modified Kamen fails to explicitly disclose each port comprises a shroud, the spike recessed within the shroud.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid supply line (bag-side connector 20 having connection pipe 25); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the port comprises a shroud (outer cylinder 12), the spike recessed within the shroud (Figure 1(d)).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the dialysis system of Kamen to include each port comprises a shroud, the spike recessed within the shroud based on the teachings of Inoue to prevent the user from accessing the integral spikes of the ports and prevent contamination of the fluid lines and ports both before and after a dialysis procedure (Inoue [Abstract], [Page 4]).
Regarding claim 10, modified Kamen discloses the dialysis system of claim 1, wherein the ports and spikes are oriented at about ninety degrees to a longitudinal axis of the cassette (Figure 8, showing the tube connectors 27-35 perpendicular to the outer surface of the cassette 24).
Regarding claim 11, modified Kamen discloses the dialysis system of claim 1.
Modified Kamen fails to explicitly disclose the integral spike comprises three diameters along a length of the spike.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid supply line (bag-side connector 20 having connection pipe 25); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11) that comprises three diameters along a length of the spike (Figure 1(d) showing that the inner cylinder 11 has a first inner diameter at its angled tip, a second inner diameter along its body, and a third inner diameter that narrows to the diameter of connecting tube 14).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the dialysis system of Kamen to include the integral spike comprises three diameters along a length of the spike based on the teachings of Inoue to provide a fluid tight connection between the plurality of ports and the fluid lines (Inoue [Page 3]).
Regarding claim 12, Kamen discloses a dialysis system (dialysis system 10) comprising:
a dialysis machine (cycler 14);
at least one fluid supply line (tubes 30/32); and
a cassette (cassette 24) for use with the dialysis machine, the cassette including:
a frame (Figure 8; “the cassette 24 includes an injection molded body having front and back sides 58 and 60.” [Col 7, lines 38-39]),
a heating tube (tube 26),
at least one pump chamber (pump chambers P1, P2) within the frame (Figure 8),
a first set of valves (valves V9, V3, V6, V1) for routing a fluid from the at least one fluid supply line to the heating tube (Figure 33; “As FIG. 33 shows, the replenish heater bag phase involves drawing fresh dialysate into cassette pump chamber P1 through primary liquid path F4 via branch liquid path F8. Then, pump chamber P1 expels the dialysate through primary liquid path F1 via branch liquid path F6.” [Col 32, line 56-60], see all of [Col 32, line 46 – Col 33, lines 67]),
a second set of valves (valves V1, V3) for routing fluid from the heating tube to the at least one pump chamber (Figure 32; “Perform pump chamber P1 draw stroke (drawing a volume of heated dialysate into pump chamber P1 from the heater bag)…Open inlet path F1 to pump chamber P1, while closing inlet path F1 to pump chamber P2. Actuate valve CO to supply high-relative negative pressure to valve actuator VA1, opening cassette valve station V1. Actuate valves C1; D1; and D2 to supply high-relative positive pressure to valve actuators VA2; VA3: and VA4, closing cassette valve station V2; V3; and V4.” [Col 31, line 61 – Col 32, line 5]; “2. Perform pump chamber P2 draw stroke (drawing a volume of heated dialysate into pump chamber P2 from the heater bag)…Open inlet path F1 to pump chamber P2, while closing inlet path F1 to pump chamber P1. Actuate valves C0; C1; and D2 to supply high-relative positive pressure to valve actuators VA1; VA2; and VA4, closing cassette valve stations V1; V2; and V4. Actuate valve D1 to supply high-relative negative pressure to valve actuator VA3, opening cassette valve station V3.” [Col 32, line 19-31]),
a third set of valves (valves V7, V8) for routing the fluid from the at least one pump chamber to a patient line (Figure 32, “performing pump chamber P2 pump stroke (expelling a volume of heated dialysate from pump chamber P2 to the patient)…Close outlet path F5 to pump chamber P1, while opening outlet path F5 to pump chamber P2. Actuate valves C2 to C4 and D3 to D5 to supply high-relative positive pressure to valve actuators VA8 to V10 and VA5 to VA7, closing cassette valve stations V8 to V10 and V5 to V7. Actuate valve D5 to supply high-relative negative pressure to valve actuator VA7, opening cassette valve station V7.” [Col 31, line 61 – Col 32, line 12]; “performing pump chamber P1 pump stroke (expelling a volume of heated dialysate from pump chamber P1 to the patient)…Close outlet path F5 to pump chamber P2, while opening outlet path F5 to pump chamber P1. Actuate valve C2 to supply high-relative negative pressure to valve actuator VA8, opening cassette valve station V8. Actuate valves D3 to D5; C2; and C4 to supply high-relative positive pressure to valve actuators VA5 to VA7; V9; and V10, closing cassette valve stations V5 to V7; V9; and V10.” [Col 32, lines 19-39]), and
a plurality of ports (tube connectors 27/29/31/33/35) communicating with the first set of valves and the third set of valves (“The first through fifth tube connectors 27 to 35 communicate with interior liquid paths F1 to F5, respectively. These liquid paths F1 to F5 constitute the primary liquid paths of the cassette 24, through which liquid enters or exits the cassette 24.” [Col 9, lines 45-49]), each port comprising an integral spike (structure of tube connectors 27/29/31/33/35; Figure 8).
Kamen fails to explicitly disclose a motorized autoconnection mechanism, wherein the motorized autoconnection mechanism is configured to move the at least one fluid supply line and the patient line automatically so as to be spiked open respectively by the plurality of ports of the cassette.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid supply line (bag-side connector 20 having connection pipe 25) connected to a source of dialysis fluid (“a connection pipe 25 to a connection tube to a dialysis bag.” [0010, Page 3]; “an empty bag and a dialysis bag are connected to the bag-side connector 20 by a Y-shaped tube” [Page 4]); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the motorized autoconnection mechanism is configured to move the at least one fluid supply line automatically so as to be spiked open by the port (Figures 3(a)-(g); “The operation of the automatic connection device 50 will be described. As shown in FIG. 3A…the patient side connector 10 and the bag side connector 20 in a state of being covered with 30 and 40 are holders 55, 57 at predetermined positions. Attach to 6, 57, 58. When the screw rod 51 is rotated to the right with the first stopper 61 protruding, the first gear 52 is rotated on the spot, and the second cap holder 57 and the second connector holder 58 are rotated counterclockwise. Cap 3 of 10, 20 0 and 40 come off (see FIG. 3 (b)). When the first stopper 61 is retracted downward and the screw rod 51 is rotated clockwise, the first gear 52, the second gear Both gears 53 move leftward (see FIG. 3B). When the second gear 53 hits the fourth stopper 64, the second gear 5 3 rotates together with the screw rod 51, and the board 54 moves laterally by meshing with the rack on the back surface of the board 54 (FIG. 3). (C)).When the screw rod 51 is rotated counterclockwise, both the first gear 52 and the second gear 53 move to the right, and when the first gear 52 hits the third stopper 63, the first gear 52 rotates counterclockwise, The holders 57 and 58 rotate clockwise to connect the screw of the connector (see FIG. 3D). In this state, the liquid in the patient's body is drained and the dialysate is injected into the body.” [Page 5]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the dialysis system of Kamen to include a motorized autoconnection mechanism configured to move the at least one fluid supply line and the patient line automatically so as to be spiked open respectively by the plurality of ports of the cassette based on the teachings of Inoue to prevent contamination of the fluid lines and ports by allowing for automatic connection between the fluid lines and the cassette instead of connecting the fluid lines by hand (Inoue [Abstract]).
Regarding claim 13, modified Kamen discloses the dialysis system of Claim 12, wherein the plurality of ports comprises a patient outlet port (fifth cassette port 35; Figure 8A) and a drain port (connector 29; Figure 8A), wherein the cassette further includes a fourth set of valves (valves V2, V4, V7, V8) for routing the fluid from the patient outlet port to the drain port (Figure 34, see all of [Col 34, line 1 – Col 35, line 24]).
Modified Kamen fails to explicitly disclose wherein the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid line (bag-side connector 20 having connection pipe 25; “a connection pipe 25 to a connection tube to a dialysis bag.” [0010, Page 3]; “an empty bag and a dialysis bag are connected to the bag-side connector 20 by a Y-shaped tube” [Page 4]); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the motorized autoconnection mechanism is configured to move the at least one fluid line automatically so as to be spiked open by the port (Figures 3(a)-(g); detailed on Page 5 of English Translation and in the rejection of claim 12 above).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the dialysis system of Kamen to include the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively based on the teachings of Inoue to prevent contamination of the fluid lines and ports by allowing for automatic connection between the fluid lines and the cassette instead of connecting the fluid lines by hand (Inoue [Abstract]).
Regarding claim 14, modified Kamen discloses the dialysis system of Claim 12, wherein the plurality of ports includes a patient outlet port (fifth cassette port 35; Figure 8A) and a drain port (connector 29; Figure 8A), wherein the cassette further comprises a fourth set of valves (valves V7, V8) for routing the fluid from the patient outlet port to the at least one pump chamber (Figure 34; “Perform pump chamber P1 draw stroke (drawing a volume of spent dialysate into pump chamber P1 from the patient)…(i) Open inlet path F5 to pump chamber P1, while closing inlet path F5 to pump chamber P2. Actuate valve C2 to supply high-relative negative pressure to valve actuator VA8, opening cassette valve station V8. Actuate valves D3 to D5, C3, and C4 to supply high-relative positive pressure to valve actuators VA5 to VA7, VA9 and VA10, closing cassette valve stations V5 to V7, V9, and V10.” [Col 34, lines 33-52]; ”Perform pump chamber P2 draw stroke (drawing a volume of spent dialysate into pump chamber P2 from the patient)…opening inlet path F5 to pump chamber P2. Actuate valve D5 to supply high-relative negative pressure to valve actuator VA7, opening cassette valve station V7. Actuate valves D3; D4 and C2 to C4 to supply high-relative positive pressure to valve actuators VA5; VA6; and. VA8 to VA10, closing cassette valve stations V5, V6, and V8 to V10.” [Col 34, line 60 – Col 35, line 5) and a fifth set of valves (valves V2, V4) for routing the fluid from the at least one pump chamber to the drain port (Figure 34; “performing pump chamber P2 pump stroke (expelling a volume of spent dialysate from pump chamber P2 to the drain)…Close outlet path F2 to pump chamber P1, while opening outlet path F2 to pump chamber P2. Actuate valves C0; C1; and D1 to supply high-relative positive pressure to valve actuators VA1; VA2 and VA3, closing cassette valve stations V1; V2; and V3. Actuate valve D2 to supply high-relative negative pressure to valve actuator VA4, opening cassette valve station V4o” [Col 34, lines 32-52]; “performing pump chamber P1 pump stroke (expelling a volume of spent dialysate from pump chamber P1 to the drain)…Open outlet path F2 to pump chamber P1, while closing outlet path F2 to pump chamber P2. Actuate valve Cl to supply high-relative negative pressure to valve actuator VA2, opening cassette valve station V2. Actuate valves C0; D1; and D2 to supply high-relative positive pressure to valve actuators VA1; VA3; and VA4, closing cassette valve station V1; V3; and V4.” [Col 34, lines 60 – Col 35, line 12]).
Modified Kamen fails to explicitly disclose wherein the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid line (bag-side connector 20 having connection pipe 25; “a connection pipe 25 to a connection tube to a dialysis bag.” [0010, Page 3]; “an empty bag and a dialysis bag are connected to the bag-side connector 20 by a Y-shaped tube” [Page 4]); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the motorized autoconnection mechanism is configured to move the at least one fluid line automatically so as to be spiked open by the port (Figures 3(a)-(g); detailed on Page 5 of English Translation and in the rejection of claim 12 above).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the dialysis system of Kamen to include the motorized autoconnection mechanism is configured to move a patient outlet line and a drain line automatically so as to be spiked open by the patient outlet port and the drain port, respectively based on the teachings of Inoue to prevent contamination of the fluid lines and ports by allowing for automatic connection between the fluid lines and the cassette instead of connecting the fluid lines by hand (Inoue [Abstract]).
Regarding claim 15, modified Kamen discloses the dialysis system of Claim 12, wherein the cassette comprises two pump chambers (pump chambers P1, P2; Figure 8).
Regarding claims 16-17, modified Kamen discloses the dialysis system of Claim 12.
Modified Kamen fails to explicitly teach each of the plurality of ports includes a removable cap covering the integral spike, and wherein the motorized autoconnection mechanism is configured to remove the removable cap covering the integral spike, as required by claim 16; and wherein the removable cap has radial symmetry, as required by claim 17.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid supply line (bag-side connector 20 having connection pipe 25); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the port includes a removable cap (cap 30, removal shown in Figures 3a-3b) covering the integral spike (Figure 3a; “The cap 30 for the patient-side connector is in contact with the inner circumference of the first inner cylinder 11 of the patient-side connector 10.” [Page 3]), and wherein the motorized autoconnection mechanism is configured to remove the removable cap covering the integral spike (Figure 3(b); “When the screw rod 51 is rotated to the right with the first stopper 61 protruding, the first gear 52 is rotated on the spot, and the second cap holder 57 and the second connector holder 58 are rotated counterclockwise. Cap 30 of 10, 20 0 and 40 come off (see FIG. 3 (b)).” [Page 5]); and wherein the removable cap (cap 30) has radial symmetry (Figures 1(c) and 2(c)).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the dialysis system of Kamen to include each of the plurality of ports includes a removable cap having radial symmetry covering the integral spike, and wherein the motorized autoconnection mechanism is configured to remove the removable cap covering the integral spike based on the teachings of Inoue to prevent contamination of the fluid lines and ports both before and after a dialysis procedure (Inoue [Abstract], [Page 5]).
Regarding claim 18, modified Kamen discloses the dialysis system of Claim 12, wherein the frame is made out of a rigid plastic (“The cassette 24 is preferably made of a rigid medical grade plastic material” [Col 7, lines 45-46]).
Regarding claim 19, modified Kamen discloses the dialysis system of claim 12.
Modified Kamen fails to explicitly disclose each port comprises a shroud, the spike recessed within the shroud.
Inoue teaches a motorized autoconnection mechanism (automatic connecting device 50 having motors 71, 73, 76) for a dialysis system (“a device for automatically connecting a plug for connecting a patient and a dialysis bag used in a continuous peritoneal dialysis method.” [0001, Page 1]); at least one fluid supply line (bag-side connector 20 having connection pipe 25); and a port (patient side connector 10) comprising an integral spike (inner cylinder 11), wherein the port comprises a shroud (outer cylinder 12), the spike recessed within the shroud (Figure 1(d)).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the dialysis system of Kamen to include each port comprises a shroud, the spike recessed within the shroud based on the teachings of Inoue to prevent the user from accessing the integral spikes of the ports and prevent contamination of the fluid lines and ports both before and after a dialysis procedure (Inoue [Abstract], [Page 4]).
Regarding claim 20, modified Kamen discloses the dialysis system of claim 12, wherein the ports and spikes are oriented at about ninety degrees to a longitudinal axis of the cassette (Figure 8, showing the tube connectors 27-35 perpendicular to the outer surface of the cassette 24).
Response to Arguments
Applicant's arguments filed February 17, 2026 have been fully considered but they are not persuasive.
Regarding the argument that Kamen does not disclose “each port comprising an integral spike” as required by independent claims 1 and 12 (Remarks, page 6-8), the examiner respectfully disagrees. As detailed above, Kamen discloses a cassette (24) comprising a plurality of ports (27/29/31/33/35), each port comprising an integral spike (structure of tube connectors 27/29/31/33/35; Figure 8). The structure of tube connectors 27/29/31/33/35 is considered to be an “integral spike” because the structure narrows away from the body of the cassette (Figure 8A) and the structure performs the function of a spike by being inserted into the fluid supply lines and provide fluid connection between the fluid supply lines and the cassette (Figure 3). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “piercing open connections to fluid lines” (Remarks, page 7)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim language as currently presented requires “each port comprising an integral spike” and “the patient line…to be spiked open”. The claims as currently presented do not specify a shape of the integral spikes or specify that the integral spikes pierce a membrane of the fluid supply lines, such as described in [0076] of the present application.
Additionally, regarding the argument that “Inoue is silent about ports with integral spikes” (Remarks, page 6), the examiner respectfully disagrees. As detailed above with respect to the rejections of claims 1, 9, 12, and 19, Inoue discloses a port (10) comprising an integral spike (11), wherein the port comprises a shroud (12), the integral spike recessed within the shroud (Figure 1(d)). At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the ports of Kamen to include each port comprises a shroud, the integral spike recessed within the shroud based on the teachings of Inoue to prevent the user from accessing the integral spikes of the ports and prevent contamination of the fluid lines and ports both before and after a dialysis procedure (Inoue [Abstract], [Page 4]).
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/LOAN B JIMENEZ/Supervisory Patent Examiner, Art Unit 3784