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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-4, 6-12, 14-24, 26-30, 91 and 92) in the reply filed on 12/10/2025 is acknowledged.
Claims 31-35, 38-62, and 81-90 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Claims 1-4, 6-12, 14-24, 26-30, 91 and 92 are examined on the merit.
Claim Objections
Claims 4, 9, 10, 14-19, 24 and 26-29 are objected to because of the following informalities:
Claims 4, 9, 10, 14-16, 18, 19, 24 and 26-28 recite “step” and “steps” which should read “the step” and “the steps”
Claim 17 line 2 recites “the cycle pitch” which should read “a cycle pitch”
Claim 29 lines 1-2 recites “the first” and “the second” which should read “a first” and “a second” respectively.
Appropriate correction is required.
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.
Claims 1-4, 6-10, 12, 17-24, 26-30, 91 and 92 are rejected under 35 U.S.C. 103 as being unpatentable over Weston et al (US 20100298792 A1) in view of Budig (WO 2009003886 A1).
Regarding claim 1, Weston substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a system for treating a wound comprising:
a fluid input (figure 4a [0047] tubing 163 and 166 configured to provide fluid input and arranged upstream of the wound dressing 124) and a fluid output (figure 4a and [0047] tubing 136 and 146 configured to provide fluid output and positioned downstream of the wound dressing 124) for connection to a wound treatment device (figure 4a, wound dressing 124) located at the wound, the fluid input adapted to be fluidly connected to an upstream side of the wound treatment device and the fluid output adapted to be fluidly connected to a downstream side of the wound treatment device.
an air inlet valve (figure 4a, valves 162) upstream of the fluid output;
an actuator to drive the air inlet valve between an open position and a closed position ([0059]-[0064] the valve can be opened or closed by controller to maintained predetermined pressure);
a pump (figure 4a, vacuum pump 130) downstream of the fluid input;
a motor to drive the pump to provide a negative pressure to the wound treatment device ([0011] vacuum pump configured to supply negative pressure to the wound); and
a controller (figure 4a, control device 132) in communication with the actuator and the motor to operate the air inlet valve and the pump ([0050] control device 132 configured to control vacuum pump and any valves including 162); wherein the controller is configured to:
i) open the air inlet valve and operate the pump to maintain a first vacuum pressure at the wound treatment device and introduce air into the wound treatment device (figure 2, [0059]-[0064] the valve 162 can be opened while actuating pump 130 by the control device 132 to maintain the pressure at or below 2B);
ii) close the air inlet valve and operate the pump to maintain a second vacuum pressure at the wound treatment device and remove air and fluid from the wound treatment device (figure 2, [0059]-[0064] the valve 162 can be closed while actuating pump 130 by the control device 132 maintaining the pressure at or above point 2C).;
wherein the first vacuum pressure is less than or equal to the second vacuum pressure (figure 2c, the pressure at point 2B less than the pressure at 2C).
Weston does not the system comprises an actuator to drive the air inlet valve and a motor to drive the pump.
In the same field of endeavor, namely a wound treatment device, Budig teaches the system comprises an actuator (page 13, means of an actuator to move the valve between open and close position) to drive the air inlet valve and a motor to drive the pump (figure 3, motor 120).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, and provides the valve and the pump as claimed, and one of skill in the art motivated to do so, for the purpose of providing the mechanical force required to actuate the valve and to drive the pump.
Regarding claim 2, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein the controller is configured to operate the pump to continuously maintain a negative pressure environment at the wound treatment device when the air valve is open and closed (Weston; figure 2 and [0059]-[0064] The controller configured to continuously actuate the pump 130 to provide positive or negative pressure when the valve 162 is opened or closed).
Regarding claim 3, Weston, as modified by Budig, teaches the system as claimed in claim 2.
The combination further teaches wherein the first and second vacuum pressures provide for effective negative pressure wound therapy (Weston; figure 2 [0010] [0059] maintaining pressure between points 2B and 2C assist with the healing of wound)
Regarding claim 4, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein the controller is configured to repeat the steps i) and ii) to cycle the air inlet valve between the open and closed positions (Weston; figure 2 and [0063] step including opening or closing or valve 162 can be repeated to maintain desired pressure)
Regarding claim 6, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein the controller is configured to operate the pump when the air inlet valve is open to maintain a substantially constant first vacuum pressure (Weston; figure 2 and [0059]-[0064] The controller configured to continuously actuate the pump 130 while opening valve 162 to maintain the pressure at or below 2B during treatment session).
Regarding claim 7, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein the controller is configured to operate the pump with the air inlet valve open so that a flow rate of air into the system through the air inlet valve is equal to a flow rate of the pump (Weston; figure 4a and [0059]-[0064] the pump 130 is a sole pressure source within the system, and the controller is configured to actuate the pump while the valve is opened. Under this configuration, the flow generated by the pump circulates entirely within the system without loss. Accordingly the flow rate of air entering the system is equal to the flow rate produced by the pump).
Regarding claim 8, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein the controller is configured to operate the pump when the air inlet valve is closed to maintain a substantially constant second vacuum pressure (Weston; figure 2 and [0059]-[0064], The controller configured to continuously actuate the pump 130 while closing valve 162 to maintain the pressure at or above 2c during treatment session)
Regarding claim 9 , Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein the controller is configured to: in the step (i), operate the pump with the air inlet valve open so that the system is in an equilibrium state with a zero or constant pressure differential across the treatment device (Weston; figure 4a and [0059]-[0064] opening valve 162 during pump operation may generate a transient pressure differential across the treatment device at beginning, i.e., pressure differential between conduit 166 and 146, but the Weston’s configuration defines a single fluid path that circulates the air within the system, and therefore the pressure differential will relax toward an equilibrium as the air circulates)
Regarding claim 10, Weston, as modified by Budig, teaches the system as claimed in claim 9.
The combination further teaches wherein the controller is configured to: in the step (ii), operate the pump with the air inlet valve closed so that the system is in an equilibrium state with a zero or constant pressure differential across the treatment device (Weston; figure 4a and [0059]-[0064] closing valve 162 during pump operation may generate a transient pressure differential across the treatment device at beginning, i.e., pressure differential between conduit 166 and 146, but the Weston’s configuration defines a single fluid path that circulates the air within the system, and therefore the pressure differential will relax toward an equilibrium as the air circulates).
Regarding claim 12, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein the controller is configured to operate the air inlet valve between open and closed to reduce a density of fluid at the wound to lift the fluid from the wound against gravity (Weston; [0059]-[0064] The control device 132 is configured to open and close the valve. Closing the valve 162 increases the negative pressure within the wound dressing, thereby reduces the density of fluid within the dressing and draws the fluid from the dressing into the canister against gravity)
Regarding claim 17, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination does not expressly teach wherein the air inlet valve is open for at least 10% of the cycle pitch, or at least 20% of the cycle pitch, or at least 30% of the cycle pitch, or at least 40% of the cycle pitch, or at least 50% of the cycle pitch.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, with a reasonable expectation of success, to have the air inlet valve opened for claimed cycle pitch, as a person of ordinary skill has a good reason to peruse the known options (inlet valve can be configured to be opened from 0% to 100% cycle pitch) within his or her technical grasp. If this leads to the anticipated success (providing and maintaining desired negative pressure for wound healing), it is likely that product was not of innovation but of ordinary skill and common sense. In the instant case, the modification involves obvious to try see MPEP 2143.
Regarding claim 18, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein, in the step i), the air inlet valve is open for a sufficient time period so that a volume of air delivered through the system is at least a substantial portion of a total volume of the system. (Weston; figure 2 and [0059]-[0064] opening the inlet valve introduces air into the system that is at least substantial portion of the system volume that place the negative pressure within the system near-atmospheric pressure, i.e., illustrated in figure 2 at point 2C or 2D)
Regarding claim 19, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination does not expressly teach wherein, in step (i), the air inlet valve is open for a sufficient time period so that the volume of air delivered to the system is at least 50%, or at least 100% of the total volume of the system.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, with a reasonable expectation of success, to have the air inlet valve is open for a sufficient time period so that the volume of air delivered to the system is at least 50%, or at least 100% of the total volume of the system, as a person of ordinary skill has a good reason to peruse the known options (the inlet valve can be opened for a set period of time to deliver air from 0% to 100% of the total volume of the system) within his or her technical grasp. If this leads to the anticipated success (providing desired negative pressure for wound healing), it is likely that product was not of innovation but of ordinary skill and common sense. In the instant case, the modification involves obvious to try see MPEP 2143.
Regarding claim 20, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination does not teach wherein the first vacuum pressure is about 30% to 100% of the second vacuum pressure.
In the same field of endeavor, namely a wound treatment device, Budig teaches wherein the first vacuum pressure is about 30% to 100% of the second vacuum pressure (page 4, the processor programed maintained the vacuum within a predetermined pressure, such as 100± 20 mmHg. The first pressure 80 mmHg is about 67% of second pressure 120 mmHg).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, to incorporate the teachings of Budig and provide the controller as claimed for the purpose of improving wound healing as taught by Budig (page 1)
Regarding claim 21, Weston, as modified by Budig, teaches the system as claimed in claim 1
The combination does not tach wherein the first vacuum pressure is about 50 to 100 mmHg.
In the same field of endeavor, namely a wound treatment device, Budig teaches wherein the first vacuum pressure is about 50 to 100 mmHg. (page 4, the processor programed maintained the vacuum within a predetermined pressure, such as 100± 20 mmHg. The first pressure is 80 mmHg).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, to incorporate the teachings of Budig and provide the controller as claimed for the purpose of improving wound healing as taught by Budig (page 1).
Regarding claim 22, Weston, as modified by Budig, teaches the system as claimed in claim 20.
The combination further teaches wherein the second vacuum pressure is about 100 to 150 mmHg (Budig; page 4, the processor programed maintained the vacuum within a predetermined pressure, such as 100± 20 mmHg. The second pressure at 120 mmHg).
Regarding claim 23, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination does not teach wherein the first vacuum pressure is about 10 to 50 mmHg less than the second pressure.
In the same field of endeavor, namely a wound treatment device, Budig teaches wherein the first vacuum pressure is about 10 to 50 mmHg less than the second pressure (page 4, the processor programed maintained the vacuum within a predetermined pressure, such as 100± 20 mmHg. The first pressure 80 mmHg is 40 mmHg less than the second pressure 120 mmHg)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, to incorporate the teachings of Budig and provide the controller as claimed for the purpose of improving wound healing as taught by Budig (page 1)
Regarding claim 24, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination further teaches wherein in step (i) the controller is configured to operate the pump to achieve a vacuum pressure threshold, wherein in step (ii) the controller is configured to operate the pump to achieve a vacuum pressure threshold (Weston; figure 2 and [0059]-[0064] The controller configured to continuously actuate the pump 130 to provide positive or negative pressure to achieve predetermined pressure at points 2B or 2C )
Regarding claim 26, Weston, as modified by Budig, teaches the system as claimed in claim 24.
The combination further teaches wherein the system comprises:
a downstream pressure sensor (figures 4a, pressure sensor 137 in communication with the control device 132) located downstream of the wound treatment device and in communication with the controller, and
the controller is configured to, in step i) operate the pump to achieve the vacuum pressure threshold based on a pressure sensed by the downstream pressure sensor (figure 2 and [0050]-[0051] and [0059]-[0064] negative pressure generated by pump 130 monitored by pressure sensor 137 to maintain predetermined pressure at or below 2B).
Regarding claim 27, Weston, as modified by Budig, teaches the system as claimed in claim 24.
The combination further teaches wherein the system comprises:
an upstream pressure sensor (figure 4a, pressure sensor 165 in communication with the control device 132) located upstream of the wound treatment device and in communication with the controller, and
the controller is configured to, in the step ii), operate the pump to achieve the vacuum pressure threshold based on a pressure sensed by the upstream pressure sensor (figure 2 and [0050]-[0051] and [0059]-[0064] negative pressure generated by pump 130 monitored by pressure sensor to maintain predetermined pressure at or above 2C).
Regarding claim 28, Weston, as modified by Budig, teaches the system as claimed in claim 24.
The combination further teaches wherein the system comprises:
an upstream pressure (figure 4a, sensor 165) sensor located upstream of the wound treatment device and in communication with the controller,
a downstream pressure sensor (figure 4a, sensor 137) located downstream of the wound treatment device and in communication with the controller, and
the controller is configured to, in the step i) operate the pump to achieve a first vacuum pressure threshold based on a pressure sensed by the downstream pressure sensor; and in the step ii), operate the pump to achieve a second vacuum pressure threshold based on a pressure sensed by the upstream pressure sensor (figure 2, [0059]-[0064] the controller operate the pump to maintain negative pressure between upper and lower vacuum pressure threshold at points 2B and 2C based on pressure measurement from pressure sensors 137 and 165).
Regarding claim 29, Weston, as modified by Budig, teaches the system as claimed in claim 24.
The combination further teaches wherein the first vacuum pressure threshold is less than or equal to the second vacuum pressure threshold (Weston; figure 2, the negative maintained within predetermined pressure 2B and 2C, and pressure at point 2B is less than the pressure at 2C)
Regarding claim 30, Weston, as modified by Budig, teaches the system as claimed in claim 24.
The combination further teaches wherein the system comprises an inlet restriction ([0049] filter positioned between the vacuum pump 130 and atmosphere positioned upstream of the upstream pressure sensor 165, the presser sensor 165 measures ambient pressure when valve 162 is open), and the upstream pressure sensor is located upstream of the inlet restriction so that the upstream pressure sensor measures ambient pressure when the air inlet valve is open.
Regarding claim 91, Weston, as modified by Budig, teaches the system as claimed in claim 24.
The combination further teaches wherein the controller is configured to do one or more of the following based on a pressure differential measured across the treatment device (Weston; figure 2, [0059]-[0064] measuring pressure difference between atmospheric pressure and pressure within the system by pressure sensors 137 and 165):
close the air inlet valve when the pressure differential decreases below a lower threshold (Weston; figure 2, [0059]-[0052] closing the valve 162 when the pressure differential below a lower threshold, i.e., when pressure decreased to or below the point 2C);
open the air inlet valve when the pressure differential increases above an upper or maximum threshold (Weston; figure 2, [0059]-[0052] opening the valve 162 when the pressure differential above an upper threshold, i.e., when pressure increased to or above point 2B);
stop the pump when the pressure differential increases above an upper or maximum threshold (Weston; [0060] stopping pump 130 when pressure reaches point 2B);
start the pump when the pressure differential decreases below a lower threshold (Weston; [0063] actuating pump when pressure reaches 2C or 2D).
Regarding claim 92, Weston, as modified by Budig, teaches the system as claimed in claim 24.
The combination further teaches wherein the controller is configured to open or close the air inlet valve and/or operate the pump based on a measured pressure differential across the treatment device (Weston; [0059]-[0064] the controller is configured to open or close the valve 162 to maintain based on the pressure difference between atmospheric pressure and system pressure)
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Weston et al (US 20100298792 A1) in view of Budig (WO 2009003886 A1), and in further view of Luxon et al (US 20180104391 A1).
Regarding claim 14, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination does not teach wherein in the step i) the controller is configured to open the air inlet valve for a predetermined time period.
In the same field of endeavor, namely a device and method for managing chest drainage, Luxon teaches wherein in the step i) the controller is configured to open the air inlet valve for a predetermined time period ([0103] controller may close or open the valve for a set period of time).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, to incorporate the teachings of Luxon and provide the controller as claimed for the purpose of diagnosing blockage within the system as taught by Luxon ([0103])
Regarding claim 15, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination does not teach wherein in the step ii) the controller is configured to close the air inlet valve for a predetermined time period.
In the same field of endeavor, namely a device and method for managing chest drainage, Luxon teaches wherein in the step i) the controller is configured to close the air inlet valve for a predetermined time period ([0103] controller may close or open the valve for a set period of time).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, to incorporate the teachings of Luxon and provide the controller as claimed for the purpose of diagnosing blockage within the system as taught by Luxon ([0103]).
Regarding claim 16, Weston, as modified by Budig, teaches the system as claimed in claim 1.
The combination does not teach wherein in the step i) the controller is configured to open the air inlet valve for at least 10 seconds.
In the same field of endeavor, namely a device and method for managing chest drainage, Luxon teaches wherein in the step i) the controller is configured to open the air inlet valve for at least 10 seconds ([0103] controller may close or open the valve for 10-30 seconds).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weston, as modified by Budig, to incorporate the teachings of Luxon and provide the controller as claimed for the purpose of diagnosing blockage within the system as taught by Luxon ([0103]).
Allowable Subject Matter
Claim 11 is 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: No prior, alone or could be found to teach (claim 1+11) an air inlet valve upstream of the fluid output, wherein the controller is configured to operate the air inlet valve between open and closed to introduces a flow rate of air into the system that generates a bubble flow or slug flow comprising bubbles or slugs of air entrained in fluid flow from the wound treatment device. Weston et al (US 20100298792 A1) and Locke (US 20160325028 A1) appears to be the closest prior art that Weston teaches providing air by opening air inlet valve, and Locke teaches ultrasonic bubble generator that provide micro-bubbles to wound dressing facilitating wound healing. In the examiner’s view, combining the references would not have been obvious because Westons’s air inlet valve is designed to reduce or maintain pressure buildup within the system by vent the pressure build up, while the micro-bubble generator of Locke comes with an instillation fluid source, and therefore the would significantly alter the operation of Weston.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jardret et al (US 20190201595 A1) and Hall et al (US 20110028917 A1) are cited as disclosing a NPWT system comprising fluid input and output which is relatively pertinent to the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/ Examiner, Art Unit 3781