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 .
Response to Amendment
This office action is in response to the amendment filed on 10/01/2025. Per the amendment claims 1-6 and 9-20 are as currently amended; and claims 7 and 8 are as previously presented. As such, claims 1-20 are pending in the instant application. The amendments to the specification and drawings have been considered and entered in the instant application.
All objections and rejections pursuant to 35 U.S.C. 112(b) made in the Office Action mailed on 07/01/2025 are withdrawn in light of the amendments.
Claim Objections
Claims are objected to because of the following informalities:
Claim 3, lines 5-6: “of a recipient” should read “of the recipient” for clarity.
Claim 5, lines 5-6: “of a recipient” should read “of the recipient” for clarity.
Claim 12, line 5: “to a recipient” should read “to the recipient” for clarity.
Claim 13, lines 5-6: “of a recipient” should read “of the recipient” for clarity.
Claim 14, line 5: “to a recipient” should read “to the recipient” for clarity.
Claim 15, lines 4-5: “of a recipient” should read “of the recipient” for clarity.
Claim 16, line 5: “to a recipient” should read “to the recipient” for clarity.
Claim 16, lines 7-8: “of a recipient” should read “of the recipient” for clarity.
Claim 18, line 5: “to a recipient” should read “to the recipient” for clarity.
Claim 19, line 5: “to a recipient” should read “to the recipient” for clarity.
Claim 20, line 5: “to a recipient” should read “to the recipient” for clarity.
Claim 20, line 7: “of a recipient” should read “of the recipient” for clarity.
Appropriate correction is required.
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, 4, 5, 11, 14, 15, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaudhry et al. (US 20200360635 A1).
Regarding claim 1, Chaudhry et al. discloses ventilator (Fig. 2; Abstract), comprising:
a positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9) having a drive motor (electric motor 240; Fig. 2) and configured to output a predetermined volume of inspiratory gas for each rotation of an output shaft of the drive motor ([0022], lines 9-14); and
a control unit (Fig. 3) having a controller (108; Figs. 2, 3) comprising a memory (304; Fig. 3) and a processor (processing unit 302; Fig. 3), the control unit (Fig. 3) disposed in electrical communication with the drive motor (electric motor 240; [0031], lines 12-15) and with the at least one pressure sensor (204; [0038], lines 6-7), the controller (108; Figs. 2, 3) configured to:
receive an operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27), and
transmit a drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17) to adjust a number of rotations of the output shaft based upon the operation signal ([0027], lines 2-6, where it is readily understood by one of ordinary skill in the art that a change in rotary speed represents a change in a number of rotations of an output shaft of the rotary pump within a given time period) to control inspiratory gas volume ([0022], lines 18-21).
Regarding claim 4, Chaudhry et al. further discloses the claimed invention as set forth in claim 1, wherein:
when receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27), the controller (108; Figs. 2, 3) is configured to receive the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) identifying an initial inspiration gas delivery rate (flow signal indicates the flow rate of the medical gas, [0042], lines 7-9) and a target inspiratory pressure value ([0043], lines 1-6, where the second value is a predetermined value of the pressure or flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100) for provision to a recipient ([0044], lines 1-5); and
when transmitting the drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17), the controller (108; Figs. 2, 3) is configured to:
transmit a velocity control signal (first control signal; [0040], lines 1-3) to the drive motor (electric motor 240 of rotary pump 104; [0040], lines 1-3; [0031], lines 12-17) to set the rotational speed of the output shaft to correspond to the initial inspiration gas delivery rate ([0040], lines 4-13),
receive a pressure sensor signal from a pressure sensor ([0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying a recipient inspiratory pressure value ([0038], lines 7-9),
compare the recipient inspiratory pressure value with the target inspiratory pressure value (pressure signal of pressure sensor 204 and/or flow signal from flow sensor 202 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure and/or the flow rate of the medical gas supplied to the patient to change the pressure or the flow rate of the drive gas to a second value, where the second value of the drive gas is a predetermined value of the pressure and/or flow rate of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of the gas supplied to the patient is implicitly compared to the predetermined pressure value of the medical gas), and
when the recipient inspiratory pressure value is unequal to the target inspiratory pressure value, transmit an adjusted velocity control signal to the drive motor to adjust the rotational speed of the output shaft (in PCV mode, controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas from the first value to the second value, [0043], lines 1-2 & lines 12-15; the second control signal is transmitted to the electric motor 240 and varies the rotary speed of the rotary pump 104 to increase or decrease the pressure of the drive gas to maintain the predetermined pressure value of the medical gas, [0043], lines 15-end of paragraph).
Regarding claim 5, Chaudhry et al. further discloses the claimed invention as set forth in claim 4, wherein when receiving the pressure sensor signal (pressure signal from pressure sensor 204), the controller (108; Figs. 2, 3) is further configured to:
receive the pressure sensor signal from the pressure sensor (pressure signal from pressure sensor 204; [0038], lines 6-7), the pressure sensor signal identifying an initial inspiratory pressure of a recipient ([0038], lines 1-4);
compare an initial inspiratory pressure value of the pressure sensor signal to a baseline pressure value (pressure signal of pressure sensor 204 and/or flow signal from flow sensor 202 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure and/or the flow rate of the medical gas supplied to the patient to change the pressure or the flow rate of the drive gas to a second value, where the second value of the drive gas is a predetermined value of the pressure and/or flow rate of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of gas supplied is implicitly compared to the predetermined pressure value of the medical gas); and
in response to detecting the pressure value identifying an inspiratory pressure decrease relative to the baseline pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 for increase or decrease the pressure; hence, the controller 108 implicitly identifies a decreased pressure value):
transmit the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to set the rotational speed of the output shaft to correspond to the initial inspiration gas delivery rate (the second control signal changes the pressure of the drive gas to a second value, where the second value corresponds to a predetermined value of the medical gas, [0043], lines 1-5; [0043], lines 13-end of paragraph),
receive an updated pressure sensor signal from the pressure sensor (controller 108 receives a pressure signal from pressure sensor at the end of the inspiration time, [0045], lines 1-3), the updated pressure sensor signal identifying an updated recipient inspiratory pressure value ([0038], lines 1-4),
compare the updated recipient inspiratory pressure value from the updated pressure sensor signal with the target inspiratory pressure value (controller 108 generates a third control signal based on the pressure of the medical gas supplied to the patient 102, [0045], lines 4-6; controller 108 transmits the third control signal to the rotary pump 104 to change the pressure of the drive gas to the third value, where the third value of the drive gas is the same as the PEEP value or a desired pressure value of the medical gas supplied to the patient, [0046], lines 1-9; hence, the pressure of the gas supplied to the patient is implicitly compared to the PEEP value or desired pressure value of the medical gas), and
when the updated recipient inspiratory pressure value from the updated pressure sensor signal is unequal to the target inspiratory pressure value, transmit the adjusted velocity control signal to the drive motor to adjust the rotational speed of the output shaft (third control signal can be a PWM signal to vary the speed of the rotary pump 104 to vary the pressure of the drive gas to be equal to the third value, where the third value is the PEEP value or the desired pressure value of the medical gas supplied to the patient 102, [0046], lines 6-end of paragraph).
Regarding claim 11, Chaudhry et al. further discloses in a ventilator (ventilator system 100; Abstract), a method of providing an inspiration gas to a recipient ([0001], lines 3-5), comprising:
receiving an operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27); and
transmitting a drive motor control signal to a drive motor of the ventilator (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17) to adjust a number of rotations of an output shaft based upon the at least one of the operation signal ([0027], lines 2-6, where it is readily understood by one of ordinary skill in the art that a change in rotary speed represents a change in a number of rotations of an output shaft of the rotary pump within a given time period) to control at least inspiratory gas volume ([0022], lines 18-21).
Regarding claim 14, Chaudhry et al. further discloses the claimed invention as set forth in claim 11, wherein:
receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) comprises receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) identifying an initial inspiration gas delivery rate (flow signal indicates the flow rate of the medical gas, [0042], lines 7-9) and a target inspiratory pressure value ([0043], lines 1-6, where the second value is a predetermined value of the pressure or flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100) for provision to a recipient ([0044], lines 1-5); and
transmitting the drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17) comprises:
transmitting a velocity control signal (first control signal; [0040], lines 1-3) to the drive motor (electric motor 240 of rotary pump 104; [0040], lines 1-3; [0031], lines 12-17) to set the rotational speed of the output shaft to correspond to the initial inspiration gas delivery rate [0040], lines 4-13),
receiving a pressure sensor signal from a pressure sensor ([0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying a recipient inspiratory pressure value ([0038], lines 7-9),
comparing the recipient inspiratory pressure value with the target inspiratory pressure value (pressure signal of pressure sensor 204 and/or flow signal from flow sensor 202 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure and/or the flow rate of the medical gas supplied to the patient to change the pressure or the flow rate of the drive gas to a second value, where the second value of the drive gas is a predetermined value of the pressure and/or flow rate of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of the gas supplied to the patient is implicitly compared to the predetermined pressure value of the medical gas), and
when the recipient inspiratory pressure value is unequal to the target inspiratory pressure value, transmitting an adjusted velocity control signal to the drive motor to adjust the rotational speed of the output shaft (in PCV mode, controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas from the first value to the second value, [0043], lines 1-2 & lines 12-15; the second control signal is transmitted to the electric motor 240 and varies the rotary speed of the rotary pump 104 to increase or decrease the pressure of the drive gas to maintain the predetermined pressure value of the medical gas, [0043], lines 15-end of paragraph).
Regarding claim 15, Chaudhry et al. further discloses the claimed invention as set forth in claim 14, wherein receiving the pressure sensor signal (pressure signal from pressure sensor 204) comprises:
receiving the pressure sensor signal from the pressure sensor (pressure signal from pressure sensor 204; [0038], lines 6-7), the pressure sensor signal identifying an initial inspiratory pressure of a recipient ([0038], lines 1-4);
comparing an initial inspiratory pressure value of the pressure sensor signal to a baseline pressure value (pressure signal of pressure sensor 204 is received by the controller 108, where the controller 108 generates a second control signal based on the pressure of the medical gas supplied to the patient to change the pressure of the drive gas to a second value, where the second value of the drive gas is a predetermined value of the pressure of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of gas supplied is implicitly compared to the predetermined pressure value of the medical gas); and
in response to detecting the pressure value identifying an inspiratory pressure decrease relative to the baseline pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 for increase or decrease the pressure; hence, the controller 108 implicitly identifies a decreased pressure value):
transmitting the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104, [0043], lines 15-17) to set rotational speed of the output shaft to correspond to the initial inspiration gas delivery rate (the second control signal changes the pressure of the drive gas to a second value, where the second value corresponds to a predetermined value of the medical gas, [0043], lines 1-5; [0043], lines 13-end of paragraph),
receiving an updated pressure sensor signal from the pressure sensor (controller 108 receives a pressure signal from pressure sensor at the end of the inspiration time, [0045], lines 1-3), the updated pressure sensor signal identifying an updated recipient inspiratory pressure value ([0038], lines 1-4),
comparing the updated recipient inspiratory pressure value from the updated pressure sensor signal with the target inspiratory pressure value (controller 108 generates a third control signal based on the pressure of the medical gas supplied to the patient 102, [0045], lines 4-6; controller 108 transmits the third control signal to the rotary pump 104 to change the pressure of the drive gas to the third value, where the third value of the drive gas is the same as the PEEP value or a desired pressure value of the medical gas supplied to the patient, [0046], lines 1-9; hence, the pressure of the gas supplied to the patient is implicitly compared to the PEEP value or desired pressure value of the medical gas), and
when the updated recipient inspiratory pressure value from the updated pressure sensor signal is unequal to the target inspiratory pressure value, transmitting the adjusted velocity control signal to the drive motor to adjust the rotational speed of the output shaft (third control signal can be a PWM signal to vary the speed of the rotary pump 104 to vary the pressure of the drive gas to be equal to the third value, where the third value is the PEEP value or the desired pressure value of the medical gas supplied to the patient 102, [0046], lines 6-end of paragraph).
Regarding claim 17, Chaudhry et al. further discloses a ventilator system (100; Abstract), comprising: a ventilator (Figs. 1, 2), comprising:
a positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9) having a drive motor (electric motor 240; Fig. 2) and configured to output a predetermined volume of inspiratory gas for each rotation of an output shaft of the drive motor ([0022], lines 9-14), and
a control unit (Fig. 3) having a controller (108; Figs. 2, 3) comprising a memory (304; Fig. 3) and a processor (processing unit 302; Fig. 3), the
control unit (Fig. 3) disposed in electrical communication with the drive motor (electric motor 240; [0031], lines 12-15), the controller (108; Figs. 2, 3) configured to:
receive an operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27), and
transmit a drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17) to adjust a number of rotations of the output shaft based upon the at least one of the operation signal ([0027], lines 2-6, where it is readily understood by one of ordinary skill in the art that a change in rotary speed represents a change in a number of rotations of an output shaft of the rotary pump within a given time period) to control inspiratory gas volume ([0022], lines 18-21); and
a patient circuit (conduit 228) disposed in fluid communication with the ventilator (Fig. 1), the patient circuit (conduit 228) configured to direct inspiration gas from the ventilator toward a recipient (conduit 228 directs gas to the patient 102; Figs. 1, 2; [0035], lines 2-5).
Regarding claim 19, Chaudhry et al. further discloses the claimed invention as set forth in claim 17, wherein:
when receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27), the controller (108; Figs. 2, 3) is configured to receive the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) identifying an initial inspiration gas delivery rate (flow signal indicates the flow rate of the medical gas, [0042], lines 7-9) and a target inspiratory pressure value ([0043], lines 1-6, where the second value is a predetermined value of the pressure or flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100) for provision to a recipient ([0044], lines 1-5); and
when transmitting the drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17), the controller (108; Figs. 2, 3) is configured to:
transmit a velocity control signal (first control signal; [0040], lines 1-3) to the drive motor (electric motor 240 of rotary pump 104; [0040], lines 1-3; [0031], lines 12-17) to set the rotational speed of the output shaft to correspond to the initial inspiration gas delivery rate ([0040], lines 4-13),
receive a pressure sensor signal from a pressure sensor ([0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying a recipient inspiratory pressure value ([0038], lines 7-9),
compare the recipient inspiratory pressure value with the target inspiratory pressure value (pressure signal of pressure sensor 204 and/or flow signal from flow sensor 202 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure and/or the flow rate of the medical gas supplied to the patient to change the pressure or the flow rate of the drive gas to a second value, where the second value of the drive gas is a predetermined value of the pressure and/or flow rate of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of the gas supplied to the patient is implicitly compared to the predetermined pressure value of the medical gas), and
when the recipient inspiratory pressure value is unequal to the target inspiratory pressure value, transmit an adjusted velocity control signal to the drive motor to adjust the rotational speed of the output shaft (in PCV mode, controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas from the first value to the second value, [0043], lines 1-2 & lines 12-15; the second control signal is transmitted to the electric motor 240 and varies the rotary speed of the rotary pump 104 to increase or decrease the pressure of the drive gas to maintain the predetermined pressure value of the medical gas, [0043], lines 15-end of paragraph).
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 2, 3, 12, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhry et al. (US 20200360635 A1) as applied to claims 1, 11, and 17 above, and further in view of Nitta (US 20210128851 A1).
Regarding claim 2, Chaudhry et al. further discloses the claimed invention as set forth in claim 1, wherein:
when receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27), the controller (108; Figs. 2, 3) is configured to receive the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) identifying a target inspiration gas volume value (patient-specific target tidal volume input by a clinician, [0039], lines 4-12) and a target inspiration gas delivery rate ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100) value for provision to a recipient ([0044], lines 1-5); and
when transmitting the drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17), the controller (108; Figs. 2, 3) is configured to transmit a velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to adjust the rotational speed of the output shaft to correspond to the target inspiration gas delivery rate value ([0043], lines 1-12, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100). Chaudhry et al. fails to explicitly disclose the transmitting of a volume control signal to the drive motor (electric motor 240 of rotary pump 104) to adjust a number of rotations of the output shaft to correspond to the target inspiration gas volume value.
However, Nitta teaches a respiratory assistance device (1; Figs. 1A, 1B) with a control unit (380; Fig. 1B) that adjusts the number of revolutions of an air blower (120; Fig. 1) to adjust the ventilation system’s flowrate to be equal to the prescribed flow rate input from a doctor ([0090], lines 16-23). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Chaudhry et al. with Nitta such that, the controller (108; Figs. 2, 3) is also configured to transmit a volume control signal to the drive motor (electric motor 240 of rotary pump 104; [0040], lines 1-3) to adjust a number of rotations of the output shaft to correspond to the target inspiration gas volume value ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100; control unit 108 sends signal to electric motor 240 of rotary pump 104 to adjust number of rotations of the output shaft of rotary pump 104, Nitta: [0090], lines 16-23) to deliver gas at a desired flow rate to the patient.
Regarding claim 3, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 2, wherein when receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27), the controller (108; Figs. 2, 3) is further configured to:
receive a pressure sensor signal from a pressure sensor (pressure signal from pressure sensor 204; [0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying an initial inspiratory pressure of a recipient ([0038], lines 1-4);
compare a pressure value of the pressure sensor signal to a baseline pressure value (pressure signal of pressure sensor 204 and/or flow signal from flow sensor 202 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure and/or the flow rate of the medical gas supplied to the patient to change the pressure or the flow rate of the drive gas to a second value, where the second value of the drive gas is a predetermined value of the pressure and/or flow rate of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of gas supplied is implicitly compared to the predetermined pressure value of the medical gas); and
in response to detecting an inspiratory pressure decrease between the pressure value and the baseline pressure value of the pressure sensor signal ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 for increase or decrease the pressure; hence, the controller 108 implicitly identifies a decreased pressure value), transmit the volume control signal to the drive motor (electric motor 240 of rotary pump 104; [0040], lines 1-3) to adjust the number of rotations of the output shaft to correspond to the target inspiration gas volume value ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100; control unit 108 sends signal to electric motor 240 of rotary pump 104 to adjust number of rotations of the output shaft of rotary pump 104, Nitta: [0090], lines 16-23) and transmit the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to adjust the rotational speed of the output shaft to correspond to the target inspiration gas delivery rate value ([0043], lines 1-12, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100).
Regarding claim 12, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 11, wherein:
receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) comprises receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) identifying a target inspiration gas volume value (patient-specific target tidal volume input by a clinician, [0039], lines 4-12) and a target inspiration gas delivery rate value ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100) for provision to a recipient ([0044], lines 1-5); and
transmitting the drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17) comprises transmitting a volume control signal to the drive motor (electric motor 240 of rotary pump 104; [0040], lines 1-3) to adjust a number of rotations of the output shaft to correspond to the target inspiration gas volume value ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100; control unit 108 sends signal to electric motor 240 of rotary pump 104 to adjust number of rotations of the output shaft of rotary pump 104, Nitta: [0090], lines 16-23) and to transmit a velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to adjust the rotational speed of the output shaft to correspond to the target inspiration gas delivery rate value ([0043], lines 1-12, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100).
Regarding claim 13, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 12, comprising:
receiving a pressure sensor signal from a pressure sensor (pressure signal from pressure sensor 204; [0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying an initial inspiratory pressure of a recipient ([0038], lines 1-4);
comparing a pressure value of the pressure sensor signal to a baseline pressure value of the pressure sensor signal (pressure signal of pressure sensor 204 and/or flow signal from flow sensor 202 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure and/or the flow rate of the medical gas supplied to the patient to change the pressure or the flow rate of the drive gas to a second value, where the second value of the drive gas is a predetermined value of the pressure and/or flow rate of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of gas supplied is implicitly compared to the predetermined pressure value of the medical gas); and
in response to detecting an inspiratory pressure decrease between the pressure value and the baseline pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 for increase or decrease the pressure; hence, the controller 108 implicitly identifies a decreased pressure value), transmit the volume control signal to the drive motor (electric motor 240 of rotary pump 104; [0040], lines 1-3) to adjust the number of rotations of the output shaft to correspond to the target inspiration gas volume value ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100; control unit 108 sends signal to electric motor 240 of rotary pump 104 to adjust number of rotations of the output shaft of rotary pump 104, Nitta: [0090], lines 16-23) and transmit the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to adjust the rotational speed of the output shaft to correspond to the target inspiration gas delivery rate value ([0043], lines 1-12, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100).
Regarding claim 18, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 17, wherein:
when receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27), the controller (108; Figs. 2, 3) is configured to receive the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) identifying a target inspiration gas volume value (patient-specific target tidal volume input by a clinician, [0039], lines 4-12) and a target inspiration gas delivery rate value ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100) for provision to a recipient ([0044], lines 1-5); and
when transmitting the drive motor control signal to the drive motor (controller 108 transmits a second control signal to the electric motor 240 of rotary pump 104, [0043], lines 1-2 & lines 15-17), the controller (108; Figs. 2, 3) is configured to transmit a volume control signal to the drive motor to adjust a number of rotations of the output shaft to correspond to the target inspiration gas volume value ([0043], lines 1-6, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100; control unit 108 sends signal to electric motor 240 of rotary pump 104 to adjust number of rotations of the output shaft of rotary pump 104, Nitta: [0090], lines 16-23) and to transmit a velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to adjust the rotational speed of the output shaft to correspond to the target inspiration gas delivery rate value ([0043], lines 1-12, where the second value is a predetermined value of the flow rate of the medical gas and is provided by a clinician or operator of the ventilation system 100).
Claims 6, 7, 9, 10, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudhry et al. (US 20200360635 A1) as modified above, and further in view of Chang (US 20160287824 A1).
Regarding claim 6, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 1, but fails to explicitly disclose an operation signal that identifies a constant inspiration gas pressure value.
However, Chang teaches a target parameter value (i.e., a target pressure value or target flow rate) can be a constant target value (i.e., a constant pressure value or constant flow rate) ([0272], lines 1-8). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Chaudhry et al. with Chang such that the controller (108; Figs. 2, 3) is configured to:
when receiving the operation signal, receive the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27, where a predetermined pressure value of medical gas is input to the ventilation system 100 by a clinician or an operator as pre-stored data, [0043], lines 1-6) identifying a constant inspiration gas pressure value ([0043], lines 1-6, where the predetermined pressure value is a target inspiration gas pressure value, Chang: [0272], lines 1-8) for provision to a recipient ([0044], lines 1-5);
receive a pressure sensor signal from a pressure sensor ([0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying a gas pressure of a recipient ([0038], lines 7-9);
compare a pressure value of the pressure sensor signal to the constant inspiration gas pressure value (pressure signal of pressure sensor 204 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure of the medical gas supplied to the patient to change the pressure of the drive gas to a second value, where the second value of the drive gas is a predetermined, or target, value of the pressure of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of the gas supplied to the patient is implicitly compared to the predetermined, or target, pressure value of the medical gas);
in response to detecting a pressure decrease between the pressure value of the pressure sensor signal and the constant inspiration gas pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 for increase or decrease the pressure; hence, the controller 108 implicitly identifies a decreased pressure value), transmit the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to increase the rotational speed of the output shaft ([0043], lines 17-20); and
in response to detecting a pressure increase between the pressure value of the pressure sensor signal and the constant inspiration gas pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 to increase or decrease the pressure; hence, the controller 108 implicitly identifies an increased pressure value), transmit the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to decrease the rotational speed of the output shaft ([0043], lines 17-22, where the rotary speed can be varied, so it can be increased or decreased, hence the second control signal can decrease the rotary speed, [0029], lines 6-8) to more effectively deliver the desired pressure of gas to the patient.
Regarding claim 7, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 1, but fails to explicitly disclose the positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9) is configured as a reciprocating pump.
However, Chang teaches a ventilator with a positive displacement pump that is configured as a reciprocating positive displacement pump ([0137], lines 6-9). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Chaudhry et al. with Chang, such that the positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9) is configured as a reciprocating pump (Chang: [0137], lines 6-9) to provide consistent delivery of fixed volume of gas to the ventilation system.
Regarding claim 9, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 1, but fails to disclose a selector device disposed in fluid communication with the positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9), the selector device configured to allow flow of at least one of air and oxygen into the positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9).
However, Chang teaches a ventilator (Fig. 2) comprising an oxygen control valve (9; Fig. 2) in fluid communication with a pump (8; Fig. 2), where the oxygen control valve (9; Fig. 2) is configured to allow flow of oxygen into the pump (8; [0255], lines 5-6; [0254], lines 1-3). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Chaudhry et al. with Chang, such that a selector device (Chang: oxygen control valve 9; Fig. 2) disposed in fluid communication with the positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9; Chang: Fig. 2), the selector device (Chang: oxygen control valve 9; Fig. 2) configured to allow flow of at least one of air and oxygen into the positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9; Chang: [0255], lines 5-6; [0254], lines 1-3) to control and modulate the flow of at least oxygen through the ventilation system (Chang: [0255], lines 5-6).
Regarding claim 10, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 9, but does not disclose an oxygen sensor disposed in fluid communication with the inspiratory gas, the oxygen sensor configured to measure a percentage of oxygen within the inspiration gas provided by the positive displacement pump.
However, another embodiment of Chang teaches an oxygen sensor (20; Fig. 3) in fluid communication with oxygen within the mixing chamber (19; Fig. 3; [0265], lines 4-6), where the oxygen sensor (20; Fig. 3) is configured to measure a percentage, or fraction, of oxygen within the oxygen in the mixing chamber (Fig. 3; [0176], lines 5-8) provided by the pump (8; Fig. 3). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Chaudhry et al. with Chang, such that an oxygen sensor (Chang: 20; Fig. 3) is disposed in fluid communication with the inspiratory gas (Chang: Fig. 3; [0265], lines 4-6), the oxygen sensor (Chang: 20; Fig. 3) configured to measure a percentage of oxygen within the inspiration gas (Chang: Fig. 3; [0176], lines 5-8) provided by the positive displacement pump (rotary pump 104; Fig. 2; [0022], lines 7-9; Chang: Fig. 3) to communicate the oxygen concentration to a controller of the ventilator system and ensure the desired oxygen content is delivered to the patient (Chang: [0177], lines 3-5; [0265], lines 4-9).
Regarding claim 16, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 11, wherein:
receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27) comprises:
receiving the operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27, where a predetermined pressure value of medical gas is input to the ventilation system 100 by a clinician or an operator as pre-stored data, [0043], lines 1-6) identifying a constant inspiration gas pressure value ([0043], lines 1-6, where the predetermined pressure value is a target inspiration gas pressure value, Chang: [0272], lines 1-8) for provision to a recipient ([0044], lines 1-5);
receiving a pressure sensor signal from a pressure sensor ([0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying a gas pressure of a recipient ([0038], lines 7-9);
comparing a pressure value of the pressure sensor signal to the constant inspiration gas pressure value (pressure signal of pressure sensor 204 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure of the medical gas supplied to the patient to change the pressure of the drive gas to a second value, where the second value of the drive gas is a predetermined, or target, value of the pressure of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of the gas supplied to the patient is implicitly compared to the predetermined, or target, pressure value of the medical gas);
in response to detecting a pressure decrease between the pressure value of the pressure sensor signal and the constant inspiration gas pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 for increase or decrease the pressure; hence, the controller 108 implicitly identifies a decreased pressure value), transmitting the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to increase the rotational speed of the output shaft ([0043], lines 17-20); and
in response to detecting a pressure increase between the pressure value of the pressure sensor signal and the constant inspiration gas pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 to increase or decrease the pressure; hence, the controller 108 implicitly identifies an increased pressure value), transmitting the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to decrease the rotational speed of the output shaft ([0043], lines 17-22, where the rotary speed can be varied, so it can be increased or decreased, hence the second control signal can decrease the rotary speed, [0029], lines 6-8).
Regarding claim 20, Chaudhry et al. as modified further discloses the claimed invention as set forth in claim 17, wherein the controller (108; Figs. 2, 3) is configured to:
when receiving the operation signal, receive an operation signal (flow signal from flow sensor 202 and pre-stored data; [0024], lines 17-27, where a predetermined pressure value of medical gas is input to the ventilation system 100 by a clinician or an operator as pre-stored data, [0043], lines 1-6) identifying a constant inspiration gas pressure value ([0043], lines 1-6, where the predetermined pressure value is a target inspiration gas pressure value, Chang: [0272], lines 1-8) for provision to a recipient ([0044], lines 1-5);
receive a pressure sensor signal from a pressure sensor ([0038], lines 6-7), the pressure sensor signal (pressure signal from pressure sensor 204) identifying a gas pressure of a recipient ([0038], lines 7-9);
compare a pressure value of the pressure sensor signal to the constant inspiration gas pressure value (pressure signal of pressure sensor 204 are received by the controller 108, where the controller 108 generates a second control signal based on the pressure of the medical gas supplied to the patient to change the pressure of the drive gas to a second value, where the second value of the drive gas is a predetermined, or target, value of the pressure of the medical gas; [0042], lines 4-12; [0043], lines 1-5; hence, the pressure of the gas supplied to the patient is implicitly compared to the predetermined, or target, pressure value of the medical gas);
in response to detecting a pressure decrease between the pressure value and the constant inspiration gas pressure value([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 for increase or decrease the pressure; hence, the controller 108 implicitly identifies a decreased pressure value), transmit the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to increase the rotational speed of the output shaft ([0043], lines 17-20); and
in response to detecting a pressure increase between the pressure value and the constant inspiration gas pressure value ([0043], lines 1-15, where the controller 108 transmits the second control signal to the rotary pump 104 to change the pressure of the drive gas and vary the rotary speed of the rotary pump 104 to increase or decrease the pressure; hence, the controller 108 implicitly identifies an increased pressure value), transmit the velocity control signal (second control signal; [0042], last line of paragraph) to the drive motor (electric motor 240 of rotary pump 104; [0043], lines 15-17) to decrease the rotational speed of the output shaft ([0043], lines 17-22, where the rotary speed can be varied, so it can be increased or decreased, hence the second control signal can decrease the rotary speed, [0029], lines 6-8).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chaudhry et al. (US 20200360635 A1) as modified above, and further in view of Doo et al. (US 20170348505 A1).
Regarding claim 8, Cha