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 .
Claims 1, 4-18, and 20-23 are examined in this office action.
Claims 2-3 and 19 are cancelled.
Allowable Subject Matter
Claims 17 and 23 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.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to disclose of make obvious the claimed invention including the following features:
Regarding claim 17, wherein the control unit is configured to determine the amount of fresh or used PD fluid discharged from the pump chamber according to the equation:
∆
V
=
[
Ʃ
P
t
f
t
∆
t
R
T
t
]
P
R
T
, wherein R is a constant, f is measured air flowrate, P is measured air pressure and T is measured temperature.
Regarding claim 23, wherein the control unit is configured to integrate outputs from the air flow sensor, the pneumatic pressure sensor and the air temperature sensor over time for determining the an amount of fresh or used PD fluid drawn into the pump chamber according to the equations:
∆
V
f
=
{
[
Ʃ
P
f
t
f
f
t
∆
t
R
T
f
t
]
R
T
f
}
∆
P
f
∆
V
i
=
{
[
Ʃ
P
i
t
f
i
t
∆
t
R
T
i
t
]
R
T
i
}
∆
P
i
, wherein R is a constant, f is measured air flowrate, P is measured air pressure and T is measured temperature.
The combination of the claimed limitations is novel and found to be allowable over the prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant’s claimed invention.
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 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.
Claim(s) 1, 4-9, 11-16, 18, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryant et al. (US Patent No. 5,474,683) in view of Hobot et al. (CA 3063458).
Regarding claim 1, Bryant in view of Hobot discloses a peritoneal dialysis (“PD”) system (Bryant, automated peritoneal dialysis system 10, Fig. 1) comprising:
a disposable set (Bryant, disposable set 12, Fig. 1) including a pump chamber (Bryant, pump chamber P1, Fig. 8B) having a flexible sheet (Bryant, flexible diaphragm 59, Fig. 8), a pneumatic side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure (Bryant, "Further localized application of positive and negative fluid pressures upon the regions of the diaphragm 59 …" - Col. 10 Line 42); and
a cycler (Bryant, cycler 14, Fig. 1) including
an air pump (Bryant, pump 84, Fig. 23) for delivering positive and negative pneumatic pressure to the pump chamber (Bryant, "The pneumatic pressure source 84 comprises a linear vacuum pump and air compressor capable of generating both negative and positive air pressure." - Col. 16 Line 40),
a pneumatic delivery line (Bryant, outlet line 210, Fig. 23) and a pneumatic suction line extending from the air pump (Bryant, inlet line 208, Fig. 23), the pneumatic delivery line and the pneumatic suction line in selective pneumatic communication with the pneumatic side of the flexible sheet (Bryant, "… the cycler 14 applies localized positive and negative fluid pressures to the diaphragm 59 …" - Col. 10 Line 57) ("The pump 84 expels air under positive pressure through an outlet line 210 …" - Col. 18 Line 41, "The negative pressure supply side 206 communicates with the pump inlet line 208 ..." - Col. 18 Line 43),
a pneumatic pressure sensor (Bryant, transducer XP1, Fig. 24) (Bryant, "The transducers 178 are conventional semiconductor piezo-resistance pressure sensors." - Col. Line),
a plurality of fluid valves (Bryant, valve stations V1 to V10, Fig. 8B), and
a control unit (Bryant, controller 16, Fig. 1) configured to integrate outputs from the air flow sensor and the pneumatic pressure sensor over time (Bryant, "the controller 16 measures the air pressure in the pump actuator PA1 (using transducer XP1) …" - Col. 24 Line 13) to determine an amount of fresh or used PD fluid discharged from the pump chamber (Bryant, "The controller 16 calculates the difference between the initial air volume V.sub.i and the final air volume V.sub.f to derive a delivered liquid volume (V.sub.d) ..." - Col. 23 Line 53) under positive pneumatic pressure (Bryant, "The controller operates the network 350 to perform an air volume calculating …during each pump (positive pressure) cycle …" - Col. 23 Line 41) and via an open one of the plurality of fluid valves (Bryant, "The controller 16 opens valve A1 to vent reference chamber VS1 to atmosphere." - Col. 24 Line 2).
Bryant does not expressly disclose an air flow sensor.
Hobot teaches an air flow sensor (flow sensor 108, Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Bryant to include an air flow sensor as taught by Hobot to determine the volume of peritoneal dialysate removed from the patient (Hobot, Para [00116]).
Regarding claim 4, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the cycler (Bryant, cycler 14, Fig. 1) includes a pump actuation chamber (Bryant, pump chamber P1, Fig. 8) covered in operation by the pneumatic side of the flexible sheet (Bryant, "… the flexible diaphragm 59 seats against the upstanding edges 62. The positive force forms peripheral seals about the pump chambers P1 and P2." - Col. 10 Line 35), the pneumatic delivery line (Bryant, outlet line 210, Fig. 23) and pneumatic suction line (Bryant, inlet line 208, Fig. 23) in selective pneumatic communication with the pump actuation chamber (Bryant, "The pump 84 expels air under positive pressure through an outlet line 210 …" - Col. 18 Line 41, "The negative pressure supply side 206 communicates with the pump inlet line 208 ..." - Col. 18 Line 43).
Regarding claim 5, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, further comprising
a pneumatic rigid shell (Bryant, cassette 24, Fig. 8) connected to the pump chamber (Bryant, pump chamber P1, Fig. 8) so as to seal the flexible sheet between the pneumatic rigid plastic shell and the pump chamber (Bryant, "The diaphragms 59/61 are sealed about their peripheries to the peripheral edges of the front and back sides 58/60 of the cassette 24." - Col. 9 Line 28),
wherein the pneumatic delivery line (Bryant, outlet line 210, Fig. 23) and the pneumatic suction line (Bryant, inlet line 208, Fig. 23) are in selective pneumatic communication with a port (Bryant, upper port 64, Fig. 8) provided by the pneumatic rigid plastic shell (Bryant, "The cassette 24 also connects other selected liquid paths only to the upper ports 64(1)/(2) of the pump chambers P1 and P2. These liquid paths can be used to transfer air out of the respective pump chamber P1/P2." - Col. 11 Line 48).
Regarding claim 6, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the pneumatic delivery line (Bryant, outlet line 210, Fig. 23) and the pneumatic suction line (Bryant, inlet line 208, Fig. 23) extend to a common suction line (Bryant, main branch line, 216, Fig. 23),
wherein the pneumatic pressure sensor (Bryant, transducers XNEG, XLPOS, and XHPOS, Fig. 23) are in operable communication with the common pneumatic line (Bryant, Figs. 23 and 24).
Bryant does not disclose the air flow sensor. ‘
Hobot teaches the air flow sensor (flow sensor 108, Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Bryant to include the air flow sensor as taught by Hobot to determine the volume of peritoneal dialysate removed from the patient (Hobot, Para [00116]).
Regarding claim 7, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, further comprising
an air temperature sensor (Bryant, "…temperature sensed by the first sensor in the reference chamber …" - Col. 4 Line 35) (Bryant, reference chambers VS1 and VS2, Fig. 24) in operable communication with the common pneumatic line (Bryant, main branch line 216, Fig. 23), the control unit further configured to integrate outputs from the air temperature sensor (Bryant, "The value of F.sub.t can be computed based upon actual, real time temperature calculations using temperature sensors …" - Col. 26 Line 13) to determine the amount of fresh or used PD fluid that has been discharged from the pump chamber (Bryant, "The controller 16 calculates the difference between the initial air volume V.sub.i and the final air volume V.sub.f to derive a delivered liquid volume (V.sub.d) ..." - Col. 23 Line 53).
Regarding claim 8, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, further comprising
a first pneumatic valve (Bryant, valve C5, Fig. 23) located along the delivery line (Bryant, outlet line 210, Fig. 23) and a second pneumatic valve (Bryant, valve D0, Fig. 23) located along the pneumatic suction line (Bryant, inlet line 208, Fig. 23), the first and second pneumatic valves providing selective pneumatic communication with the pneumatic side of the flexible sheet (Bryant, "… the cycler 14 applies localized positive and negative fluid pressures to the diaphragm 59 …" - Col. 10 Line 57) (Bryant, "The pump 84 expels air under positive pressure through an outlet line 210 …" - Col. 18 Line 41, "The negative pressure supply side 206 communicates with the pump inlet line 208 ..." - Col. 18 Line 43).
Regarding claim 9, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the air pump (Bryant, pump 84, Fig. 23) is pneumatically coupled to positive (Bryant, positive pressure reservoir 220, Fig. 23) and negative pneumatic storage vessels (Bryant, reservoir 214, Fig. 23).
Regarding claim 11, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is configured to integrate outputs from the pneumatic pressure sensor over time for (i) an initial pneumatic pressurization of the pump chamber to determine an initial chamber volume (Bryant, "The controller 16 operates the network 350 to perform the first air volume calculation after the operating pump chamber is filled with the liquid to be pumped (i.e., after its draw cycle). This provides an initial air volume (V.sub.i)." - Col. 23 Line 45) and (ii) a final pneumatic pressurization of the pump chamber to determine a final chamber volume (Bryant, "The controller 16 operates the network 350 to perform the second air volume calculation after moving fluid out of the pump chamber (i.e., after the pump cycle). This provides a final air volume (V.sub.f)." - Col. 23 Line 49), the control unit further configured to determine an amount of fresh or used PD fluid drawn into the pump chamber by subtracting the initial chamber volume from the final chamber volume (Bryant, "The controller 16 calculates the difference between the initial air volume V.sub.i and the final air volume V.sub.f to derive a delivered liquid volume (V.sub.d) …" - Col. 23 Line 53).
Bryant does not expressly disclose the air flow sensor.
Hobot teaches the air flow sensor (flow sensor 108, Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Bryant to include the air flow sensor as taught by Hobot to determine the volume of peritoneal dialysate removed from the patient (Hobot, Para [00116]).
Regarding claim 12, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is configured to cause negative pneumatic pressure to be applied to the pump chamber with one of the plurality of fluid valves opened (Bryant, "By applying negative pressure (through valve A0) to the pump actuator PA1 …" - Col. 21 Line 42) between the initial pneumatic pressurization (Bryant, "…the controller 16 alternates the following sequence 1 and 2: 1. Perform pump chamber P1 draw stroke … actuate valve A0 to supply low-relative negative pressure …" - Col. 33 Line 51) and the final pneumatic pressurization (Bryant, "2. Perform pump chamber P2 draw stroke … actuate valve B4 to supply low-relative negative pressure ..." - Col. 34 Line 11).
Regarding claim 13, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is configured to cause at least one pneumatic line to be vented prior to each of the initial pneumatic pressurization and the final pneumatic pressurization (Bryant, "Preferably, before beginning another pump stroke, the operative pump actuator is vented to atmosphere …" - Col. 25 Line 14).
Regarding claim 14, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is further configured to use (a) the output from the air flow sensor or (b) the amount of fresh or used PD fluid drawn into the pump chamber (Bryant, "The liquid volume delivered (V.sub.d) …" - Col. 25 Line 8) to at least partially determine at least one of (i) a partial or full line occlusion, (ii) a PD fluid container or patient empty condition, or (iii) a presence of air (Bryant, "The controller 16 also monitors the variation of V.sub.d over time to detect the presence of air in the cassette pump chamber P1/P2." - Col. 25 Line 17).
Regarding claim 15, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is configured to use the amount of fresh or used PD fluid discharged from the pump chamber to confirm or fully determine at least one of (i) the partial or full line occlusion (Bryant, "Based upon the liquid volume measurements derived by the measurement network 350, the controller 16 also derives liquid flow rate. Based upon values and changes in derived liquid flow rate, the controller 16 can detect an occluded liquid flow condition." - Col. 30 Line 41), or (ii) the PD fluid container or patient empty condition.
Regarding claim 16, Bryant in view of Hobot disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit is configured to attempt to have fresh or used PD fluid pushed through a same line from which fresh or used PD fluid has just previously been subjected to a fresh or used PD fluid draw to determine between (i) the partial or full line occlusion (Bryant, "When the controller 16 determines that the cassette cannot draw liquid from a given liquid source above the occluded flow rate, the controller 16 determines whether the cassette can move liquid toward the source above the occluded flow rate (i.e., it determines whether the liquid source can serve as a liquid destination). If it can, the controller 16 diagnoses the condition as an empty liquid source condition." - Col. 30 Line 60) , and (ii) the PD fluid container or patient empty condition.
Regarding claim 18, Bryant in view of Hobot disclose a peritoneal dialysis (“PD”) system (Bryant, automated peritoneal dialysis system 10, Fig. 1) comprising:
a disposable set (Bryant, disposable set 12, Fig. 1) including a pump chamber (Bryant, pump chamber P1, Fig. 8B) having a flexible sheet (Bryant, flexible diaphragm 59, Fig. 8), a pneumatic side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure (Bryant, "Further localized application of positive and negative fluid pressures upon the regions of the diaphragm 59 …" - Col. 10 Line 42); and
a cycler (cycler 14, Fig. 1) including
at least one source of positive and negative pneumatic pressure for delivering pneumatic pressure to the pump chamber (Bryant, "The pneumatic pressure source 84 comprises a linear vacuum pump and air compressor capable of generating both negative and positive air pressure." - Col. 16 Line 40),
a pneumatic pressure sensor (Bryant, transducer XP1, Fig.24 ),
a plurality of fluid valves (Bryant, valve stations V1 to V10, Fig. 8B), and
a control unit (Bryant, controller 16, Fig. 1) configured to:
integrate outputs from the air flow sensor and the pneumatic pressure sensor over time (Bryant, "the controller 16 measures the air pressure in the pump actuator PA1 (using transducer XP1) …" - Col. 24 Line 13) for (i) an initial pneumatic pressurization of the pump chamber to determine an initial chamber volume (Bryant, "The controller 16 operates the network 350 to perform the first air volume calculation after the operating pump chamber is filled with the liquid to be pumped (i.e., after its draw cycle). This provides an initial air volume (V.sub.i)." - Col. 23 Line 45) and (ii) a final pneumatic pressurization of the pump chamber to determine a final chamber volume (Bryant, "The controller 16 operates the network 350 to perform the second air volume calculation after moving fluid out of the pump chamber (i.e., after the pump cycle). This provides a final air volume (V.sub.f)." - Col. 23 Line 49), wherein the control unit causes negative pneumatic pressure to be applied to the pump chamber with one of the plurality of fluid valves opened (Bryant, "By applying negative pressure (through valve A0) to the pump actuator PA1 …" - Col. 21 Line 42) between the initial pneumatic pressurization (Bryant, "…the controller 16 alternates the following sequence 1 and 2: 1. Perform pump chamber P1 draw stroke … actuate valve A0 to supply low-relative negative pressure …" - Col. 33 Line 51) and the final pneumatic pressurization (Bryant, "2. Perform pump chamber P2 draw stroke … actuate valve B4 to supply low-relative negative pressure ..." - Col. 34 Line 11), and
determine an amount of fresh or used PD fluid drawn into the pump chamber by subtracting the initial chamber volume from the final chamber volume (Bryant, "The controller 16 calculates the difference between the initial air volume V.sub.i and the final air volume V.sub.f to derive a delivered liquid volume (V.sub.d) ..." - Col. 23 Line 53).
Bryant does not expressly disclose an air flow sensor.
Hobot teaches an air flow sensor (flow sensor 108, Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Bryant to include an air flow sensor as taught by Hobot to determine the volume of peritoneal dialysate removed from the patient (Hobot, Para [00116]).
Regarding claim 20, Bryant in view of Hobot discloses the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is configured to cause at least one pneumatic line to be vented prior to each of the initial pneumatic pressurization and the final pneumatic pressurization (Bryant, "Preferably, before beginning another pump stroke, the operative pump actuator is vented to atmosphere …" - Col. 25 Line 14).
Regarding claim 21, Bryant in view of Hobot discloses the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is further configured to use (a) the output from the air flow sensor (Bryant, "The liquid volume delivered (V.sub.d) …" - Col. Line) or (b) the amount of fresh or used PD fluid drawn into the pump chamber to at least partially determine at least one of (i) a partial or full line occlusion, (ii) a PD fluid container or patient empty condition, or (iii) a presence of air (Bryant, "The controller 16 also monitors the variation of V.sub.d over time to detect the presence of air in the cassette pump chamber P1/P2." - Col. 25 Line 17).
Regarding claim 22, Bryant in view of Hobot discloses the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit is configured to attempt to have fresh or used PD fluid pushed through a same line from which fresh or used PD fluid has just previously been subjected to a fresh or used PD fluid draw to determine between (i) the partial or full line occlusion, and (ii) the PD fluid container or patient empty condition (Bryant, "When the controller 16 determines that the cassette cannot draw liquid from a given liquid source above the occluded flow rate, the controller 16 determines whether the cassette can move liquid toward the source above the occluded flow rate (i.e., it determines whether the liquid source can serve as a liquid destination). If it can, the controller 16 diagnoses the condition as an empty liquid source condition." - Col. 30 Line 60).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryant et al. (US Patent No. 5,474,683) in view of Hobot et al. (CA 3063458) and in further view of Lindo et al. (US Pub No. 20210038798 A1).
Regarding claim 10, Bryant in view of Hobot and Lindo disclose the system (Bryant, automated peritoneal dialysis system 10, Fig. 1) as recited above, wherein
the control unit (Bryant, controller 16, Fig. 1) is configured to integrate outputs from the pneumatic pressure sensor over time (Bryant, "The controller 16 measures the air pressure in the pump actuator PA1 (using transducer XP1) …" - Col. 24 Line 14) using an algorithm derived from the Ideal Gas Law.
Bryant does not expressly disclose integrating outputs from the air flow sensor over time using an algorithm derived from the Ideal Gas Law.
Hobot teaches the air flow sensor (flow sensor 108, Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Bryant to include the air flow sensor as taught by Hobot to determine the volume of peritoneal dialysate removed from the patient (Hobot, Para [00116]).
Bryant does not expressly disclose an algorithm derived from the Ideal Gas Law.
Lindo teaches an algorithm derived from the Ideal Gas Law ("…the automated peritoneal dialysis (APD) device using the Ideal Gas Law to measure the unknown volume of fluid in one or more disposable cassette pump chambers." - Para [0042]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Bryant in view of Bryant to include an algorithm derived from the Ideal Gas Law as taught by Lindo to measure the unknown volume of fluid (Lindo, Para [0024]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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