DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 15-16,18,20-39 have been considered.
The applicant argues that the prior art fails to teach a “software configured to open and close the automated pressure valve in response to both of the detected flow rate of liquid…and the detected negative pressure…” Applicant argues that Karpowicz fails to teach this and thus relies on DeSatnick, where DeSatnick operates independently of a constantly maintained flow rate or volume. The examiner respectfully disagrees. The examiner notes that as previously cited in the prior office action, Karpowicz does disclose that the system and suction pressure are regulated through a controller including a microprocessor, where the microprocessor’s functions include flow monitoring and pressure control (para. 0084). As the device is controlled by a controller and microprocessor it is interpreted that software is used to operate the device. Paragraph 0124, further details that flow and pressure parameters may be used together to control operation of the device. Per paragraph 0124 “When the flow monitor (210) begins to detect a deviation from the reference airflow rate so as to indicate an occlusion, the pressure controller (202) can temporarily reset the pressure setpoint temporarily to a pressure higher than the selected pressure… An occlusion indication will not occur if the pressure pulse is followed by decay in the pressure measured by the pressure transducer (208), because a decay in pressure would indicate a cleared collection line and the absence of an occlusion. Once the flow monitor (210) again detects a normal fluid flow rate, the pressure controller (202) resets the pressure setpoint to the selected pressure.” To the examiner’s understanding the device of Karpowicz discloses that flow is monitored. When the flow deviates from a reference, the controller adjusts parameters, which in turn causes the pump to activate in a pulse to clear a blockage. Then the controller checks the pressure sensor to see if the spike in pressure (caused by pump pulse) decayed, such to indicate that the pathway is no longer blocked. As such it is interpreted that the system of Karpowicz controls this system based on both a flow rate and pressure. Karpowicz however failed to specifically teach a valve that was opened/closed for control. DeSatnick was merely brought in as a teaching reference to show that a controller operated valve for regulating the system would have been obvious to one having ordinary skill in the art to include in the device of Karpowicz.
Applicant further argues that the first sensor of Karpowicz (flow monitor) is positioned in a pump unit and thus not positioned in the flow path. Further applicant points out that the per the office action that said monitor receives info from sensors, but argues that said sensors are used to detect pump motor activity rather than a flow rate of liquid through the flow path. Applicant also argues that the flow monitor is configured to determine airflow and not liquid flowing through the flow path. The examiner disagrees with both arguments. The examiner notes that as detailed in the previous office action and above (per para. 0124) the flow monitor monitors flow within the system and thus is interpreted to at least detect flow in area outside the pump. However, as applicant disagrees, the examiner notes that para. 0129 was previously cited as teaching alternatives to the determining flow, including, for example a proximity sensor including a reed switch, where said embodiments may be placed between the canister and suction source and are thus upstream of the pump. Therefore it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use, for example, a proximity sensor including a reed switch, positioned in the flow line, as the flow monitor, as Karpowicz teaches that said embodiment is a known variant to function in the same manner. Per said modification, the flow pathway is interpreted to be external of the pump section and upstream as it is closes to the dressing.
The examiner further notes that Karpowicz discloses, per para. 0031, that although the term airflow is used, it is known that airflow may include exudates and that “the flow of any of these mixed gases or aerosol suspensions, any of which may include wound exudates, should be considered airflow for purpose of this description. The term "fluid flow" is sometimes used interchangeably with "airflow" to more generally indicate a flow of air, possibly including liquid exudates, in the system.” AS such it is interpreted that the monitor of Karpowicz has at least an indication of liquid flow, as wound exudates and bodily fluids may be present in the suction pathway.
The examiner notes that the same response is provided to the arguments for claim 30 and 36.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 15,18,20-36,39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karpowicz in view of DeSatnick et al. US 4650462, hereafter DeSatnick.
Regarding claim 15, Karpowicz discloses
A system comprising (abstract): an electronic vacuum regulator (EVR) configured to regulate suction pressure applied by a vacuum source at a negative pressure wound dressing (pressure controller (202), para. 0086, figure 6); a flow path extending between an outlet and an inlet, wherein the outlet is configured to fluidically connect to the vacuum source and wherein the inlet is configured to fluidically connect to the negative pressure wound dressing (Fig. 5A, where a flow path can be seen connecting pump unit to a conduit, where conduit connects to container through (54) and where container further connects to the wound site through a second conduit. The examiner notes that although figure 1 teaches a different embodiment of the regulator, this fluid pathway is still seen in the figure); and a first sensor positioned in the flow path, the first sensor configured to: detect a flow rate of liquid flowing through the flow path (flow monitor (210), where per para. 0094 flow monitor receives info from sensors, see also para. 0129 for other variations of the flow monitor including sensors); and transmit a signal representative of the detected flow rate to the EVR (para. 0124, where it is disclosed that pressure controller receives data from the flow monitor to reset pressure setpoints); Karpowicz further discloses a sensor positioned at the negative pressure wound dressing (pressure transducer (208) disclosed to be at the wound site per para. 0086), the second sensor configured to: detect a negative pressure applied at the negative pressure wound dressing (para. 0086); and transmit a signal representative of the detected negative pressure to the EVR (para. 0086, figure 6).
Upon the amendments filed 5/30/25, the examiner notes that Karpowicz discloses a housing (102). However, this embodiment of Karpowicz does not disclose an automated pressure valve, the valve located within the housing, and the control of the pressure valve to automatically regulate the suction pressure. The examiner notes that Karpowicz does however disclose that the system and suction pressure is regulated through a controller including a microprocessor, where the microprocessor’s functions include flow monitoring and pressure control (para. 0084). As the device is controlled by a controller and microprocessor it is interpreted that software is used to operate the device. Paragraph 0124, further details that flow and pressure parameters may be used together to control operation of the device.
Upon the amendments filed 12/16/25, The examiner notes that as detailed in the previous office action and above (per para. 0124) the flow monitor monitors flow within the system and thus is interpreted to at least detect flow in area outside the pump. However, as applicant disagrees, the examiner notes that para. 0129 was previously cited as teaching alternatives to the determining flow, including, for example a proximity sensor including a reed switch, where said embodiments may be placed between the canister and suction source and are thus upstream of the pump. Therefore it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use, for example, a proximity sensor including a reed switch, positioned in the flow line, as the flow monitor, as Karpowicz teaches that said embodiment is a known variant to function in the same manner. Per said modification, the flow pathway is interpreted to be external of the pump section and upstream as it is toward the dressing from the pump.
DeSatnick teaches a fluid treatment system and is thus considered analogous to the claimed invention. DeSatnick teaches that pressure in the system is maintained via a control valve, where a pressure sensor output is sent to a controller, where said controller controls the pressure control valve (column 3, lines 4-20, column 4, lines 26-58). The examiner notes that in both citations, DeSatnick that the controller controls the valve operation to maintain or reach a desired pressure sensed by pressure sensors, and thus the operation is interpreted to be automatic. DeSatnick also teaches that “operation” of the valve is opening and closing (see column 5 lines 41-68 and column 6 lines 1-6). The examiner notes that as understood from the specification of DeSatnick, the valve is located between the outlet the system and the suction source. Therefore to aid in the control of wound pressure, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide valves connected to the pressure controller of Karpowicz, where said valves are automated by the controller. This combination however does not specifically teach that the valves are within the housing of Karpowicz. The examiner notes MPEP section 2144 VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The examiner notes that as the suction source is located within the housing of Karpowicz and fluidly connects to the wound site, and the defined valve functions when located between the wound site and negative pressure, rearranging the location of the valve on the outlet or suction(of DeSatnick) to be within the housing of Karpowicz would be obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention. The examiner notes that this modification would have no apparent change in function of the valve as the valve would still be located along the pathway between the wound and the negative pressure source.
Regarding claim 18, Karpowicz and DeSatnick teach
The system of claim 17, wherein the EVR is configured to regulate suction intermittently by opening and closing the automated pressure valve to increase or decrease suction. The examiner notes that as detailed under the rejection of the claim 15, the valves are controlled by the controller to aid in the control of wound pressure. It is interpreted that said valves would be opened or closed to adjust (raise/lower) the wound pressure, as desired (see column 5 lines 41-68 and column 6 lines 1-6 of DeSatnick).
Regarding claim 20, Karpowicz and DeSatnick teach
The system of claim 15, wherein the EVR comprises an interface for programming a suction pressure applied by a vacuum source at the negative pressure wound dressing (Karpowicz pressure selector dial (206), para. 0083).
Regarding claim 21, Karpowicz and DeSatnick teach
The system of claim 20, wherein the EVR is configured to: compare a programmed suction pressure to one or both of a negative pressure determined from the detected flow rate of liquid flowing through the flow path and the detected negative pressure applied at the negative pressure wound dressing (para. 0088 disclosing the comparison of pressure, para. 0096 for flow rate comparison).
Regarding claim 22, Karpowicz and DeSatnick teach
The system of claim 21, wherein the EVR is further configured to: determine, based on the comparison, presence of a leak in the system; and temporarily increase suction in response to determining the presence of the leak in the system (Karpowicz para. 0096, where a flow rate determined to be higher than normal is indicated (through indicator 232) a leak in the system).
Regarding claim 23, Karpowicz and DeSatnick teach
The system of claim 21, wherein the EVR is configured to: determine, based on the comparison, presence of a leak in the system; and output an alarm in response to determining the presence of the leak in the system (Karpowicz para. 0097, wherein an alarm (238) may be used in addition to flow indicator (232) to indicate abnormal operating conditions, where abnormal operating conditions may include a leak per para 0096).
Regarding claim 24, Karpowicz and DeSatnick teach
The system of claim 21, wherein the EVR is configured to: determine, based on the comparison, a high flow rate condition in the system; and output an alarm in response to determining the high flow rate condition in the system (Karpowicz para. 0096, where a flow rate determined to be higher than normal is indicated (through indicator 232) a leak in the system, and para. 0097, wherein an alarm (238) may be used in addition to flow indicator (232) to indicate abnormal operating conditions).
Regarding claim 25, Karpowicz and DeSatnick teach
The system of claim 15, wherein the EVR is configured to be operable when the vacuum source is a wall vacuum source and operable when the vacuum source is a vacuum motor of the EVR, the vacuum motor of the EVR configured for use as a back-up to the wall vacuum source (Karpowicz para 0074, where the system may be used with a wall suction system or a portable system (as previously detailed under the rejection of claim 15, see figure 6)).
Regarding claim 26, Karpowicz and DeSatnick teach
The system of claim 25, wherein the EVR is configured to be releasably coupled to the wall vacuum source and to the flow path. The examiner notes that as seen in figure 6 and as detailed under para. 0107, the EVR is releasable from the collector (16). As the collector is the connection between the flow path to the wound and the EVR, it is interpreted that the EVR is releasably coupled to the flow path. However, this vacuum source is not a wall source, and is rather a portable source.
Karpowicz discloses, as seen in figure 1, suction regulator (20) seen connected to flow meter (19), and is disclosed to be adjustable per para. 0064. Per para. 0076 components are disclosed to be disconnectable for periodic changeover. Therefore, as Karpowicz teaches that suction regulators are known to be used with wall sources, and that the suction regulator of the embodiment seen in figure 6 allows for external connection (see connection to external components (i.e. power)), it would have been obvious to modify the embodiment of figure 6 to connect to an external vacuum source. However, should applicant disagree, the examiner notes MPEP section 2144.04 VI C. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). As Karpowicz discloses a suction regulator where a controller connects to a vacuum pump, pressure sensor, and flow monitor, where the controller uses data from the sensors and monitors to adjust suction, rearranging the vacuum source to be directly connected to a wall would not have an inherent change in function, as the controller would still be connected to the source and therefore able to control and regulate it. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the vacuum source of figure 6 of Karpowicz to be a wall vacuum source, as said modification would still have the source attached to the controller and therefore still be regulated by the controller, thus having no change in function.
Regarding claim 27, Karpowicz and DeSatnick teach
The system of claim 26, wherein the EVR comprises a connector for coupling to the wall vacuum source, and wherein the connector is configured to be retractable into a housing of the EVR when the vacuum motor of the EVR is in use. The examiner notes that as detailed under the rejection of claim 26 and as seen in figure 1, the regulator describe is used when a wall vacuum source is used and comprises a connector that is releasable from the wall vacuum source. The examiner notes however that said connector is not described to be releasable.
Figure 5A and 5B of Karpowicz, as detailed above, disclose a connecting component (164), in the form of a releasable latch fitting, where said fitting can be seen retracted into the device, and is further interpreted as retractable as the latch may be engaged an released (para. 0107). Therefore as Karpowicz discloses that releasable latch fittings may be used as connections for flow paths, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention to provide a releasable latch fitting (interpreted as retractable) between the regulator and the vacuum source, when the vacuum source is wall vacuum source.
Regarding claim 28, Karpowicz and DeSatnick teach
The system of claim 15, wherein the EVR is configured to regulate suction intermittently in an intermittent suction program whereby the EVR maintains suction throughout the intermittent suction program such that suction is higher than zero during the intermittent suction program even when suction is reduced (Karpowicz para. 0083).
Regarding claim 29, Karpowicz and DeSatnick teach
The system of claim 15, the EVR further comprising a recording system configured to record a rate of fluid removal from a wound over a time period exceeding multiple hours, the rate of fluid removal from the wound determined based on one or both of the detected flow rate of liquid flowing through the flow path and the detected negative pressure applied at the negative pressure wound dressing (Karpowicz para. 0011, 0113,0114, where it is disclosed that a microprocessor capable of functions such as recording various parameters from sensors in time units and providing reports of said record).
Regarding claim 30, Karpowicz discloses
A system comprising: an electronic vacuum regulator (EVR) (figure 6, controller 202) configured to regulate suction pressure applied by a vacuum source at a negative pressure wound dressing para. 0086, the EVR comprising: a housing (unit 102) comprising a first connector for coupling to the vacuum source (figure 6, where controller is seen to be connected to the pump (103). Alternatively the examiner notes that as the unit (102) comprises the pump within it is interpreted that the pump is connected with the housing) and a second connector (164); an interface positioned in the housing for programming a suction pressure applied by a vacuum source at the negative pressure wound dressing (figure 5B, para, 0083, including mode selector switch (204) and pressure selector dial (206)); and tubing configured to provide fluidic communication through a flow path from the second connector of the EVR to the negative pressure wound dressing (164 connects to container 16 through fitting 54, where container connects to tubing (14) and thus to the dressing, see figure 5A); and at least two sensors, each of the at least two sensors configured to: detect a pressure within the system; and transmit a signal representative of the detected pressure to the EVR. The examiner notes that first sensor is interpreted as flow monitor (210), where per para. 0094 discloses that the flow monitor receives info from sensors, see also para. 0129 for other variations of the flow monitor including sensors) and transmit a signal representative of the detected flow rate to the EVR (para. 0124, where it is disclosed that pressure controller receives data from the flow monitor to reset pressure setpoints), and the second sensor is disclosed to be a sensor positioned at the negative pressure wound dressing (pressure transducer (208) disclosed to be at the wound site per para. 0086), the second sensor configured to: detect a negative pressure applied at the negative pressure wound dressing (para. 0086); and transmit a signal representative of the detected negative pressure to the EVR (para. 0086, figure 6). Karpowicz however, fails to teach an automated pressure valve located within the housing and actuated by the EVR to regulate suction by intermittently opening and closing said valve.
Upon the amendments filed 12/16/25, The examiner notes that as detailed in the previous office action and above (per para. 0124) the flow monitor monitors flow within the system and thus is interpreted to at least detect flow in area outside the pump. However, as applicant disagrees, the examiner notes that para. 0129 was previously cited as teaching alternatives to the determining flow, including, for example a proximity sensor including a reed switch, where said embodiments may be placed between the canister and suction source and are thus upstream of the pump and downstream of the dressing. Therefore it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use, for example, a proximity sensor including a reed switch, positioned in the flow line, as the flow monitor, as Karpowicz teaches that said embodiment is a known variant to function in the same manner. Per said modification, the flow pathway is interpreted to be between the dressing and the pump section, thus external to the pump, and is thus both upstream of the pump and downstream of the dressing.
DeSatnick teaches a fluid treatment system and is thus considered analogous to the claimed invention. DeSatnick teaches that pressure in the system is maintained via a control valve, where a pressure sensor output is sent to a controller, where said controller controls the pressure control valve (column 3, lines 4-20, column 4, lines 26-58). The examiner notes that in both citations, DeSatnick that the controller controls the valve operation to maintain or reach a desired pressure sensed by pressure sensors, and thus the operation is interpreted to be automatic. DeSatnick also teaches that “operation” of the valve is opening and closing (see column 5 lines 41-68 and column 6 lines 1-6). The examiner notes that as understood from the specification of DeSatnick, the valve is located between the outlet the system and the suction source. Therefore to aid in the control of wound pressure, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide valves connected to the pressure controller of Karpowicz, where said valves are automated by the controller. This combination however does not specifically teach that the valves are within the housing of Karpowicz.. The examiner notes MPEP section 2144 VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The examiner notes that as the suction source is located within the housing of Karpowicz and fluidly connects to the wound site, and the defined valve functions when located between the wound site and negative pressure, rearranging the location of the valve on outlet or suction line (of DeSatnick) to be within the housing of Karpowicz would be obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention. The examiner notes that this modification would have no apparent change in function of the valve as the valve would still be located along the pathway between the wound and the negative pressure source.
The examiner notes that as detailed under the same rejection, the valves are controlled by the controller to aid in the control of wound pressure. It is taught that said valves would be opened or closed to adjust (raise/lower) the wound pressure, as desired to reach the target pressure (see column 5 lines 41-68 and column 6 lines 1-6 of DeSatnick). Karpowicz discloses that the device may operate in an intermittent mode (Para. 0020, 0083).
Regarding claim 31, Karpowicz and DeSatnick teach
The system of claim 30, wherein the EVR is configured to: receive the signal representative of the detected pressure from each of the at least two sensors; compare at least one of the detected pressures received from each of the at least two sensors to the programmed suction pressure; and adjust the suction pressure applied by the vacuum source based on the comparison (Karpowicz para. 0088 disclosing the comparison of pressure, para. 0096 for flow rate comparison, where both citations disclose that adjustments are made).
Regarding claim 32, Karpowicz and DeSatnick teach
The system of claim 30, wherein the at least two sensors comprise: a first sensor positioned in the tubing and configured to detect a pressure based on a flow rate of a fluid through the tubing; and a second sensor positioned between a wound surface and the negative pressure wound dressing and configured to detect a pressure at the wound surface. The examiner notes that as detailed under the rejection of claim 30, Karpowicz discloses a flow rate sensor and a pressure sensor, where the pressure sensor is located at the wound site. However in said embodiment, the flow rate sensor is not specifically in the tubing. However para. 0129, discloses alternatives to the flow rate sensor previously detailed, where said alternates measure flow directly through devices such as proximity sensors or target meters, placed in various positions within the device. Therefore it would have been obvious to one of ordinary skill in the art to use an alternative flow sensor, such as a target meter or a proximity sensor within the tubing, to directly measure flow data.
Regarding claim 33, Karpowicz and DeSatnick teach
The system of claim 32, wherein the second sensor is configured to be in direct contact with the wound surface (Karpowicz para. 0086, where the sensor is disclosed to be directly within the wound cavity).
Regarding claim 34, Karpowicz and DeSatnick teach
The system of claim 30. Per the rejection of claim 30, DeSatnick teaches a controller connected to a pressure sensor, wherein the controller receives data from the sensor to adjust the therapy of the system to help prevent excess pressurization (see column 5 lines 41-68 and column 6 lines 1-6 of DeSatnick). Karpowicz para. 0086 discloses that a pressure reading from a transducer sends a signal to the controller to regulate the system. Therefore to aid in the control of wound pressure, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide valves connected to the pressure controller of Karpowicz, where said valves are automated by the controller based on data received from a pressure sensor. It is interpreted that said valves would be opened or closed to adjust (raise/lower) the wound pressure, as desired.
Regarding claim 35, Karpowicz and DeSatnick teach
The system of claim 30, wherein the housing further comprises: a memory configured to record the signal representative of the detected pressure transmitted by the at least two sensors (Karpowicz para. 0011, 0113,0114, where it is disclosed that a microprocessor capable of functions such as recording various parameters from sensors in time units and providing reports of said record); a controller configured to use the recorded signals to determine the presence of a leak or a high flow rate in the system para. 0097, wherein an alarm (238) may be used in addition to flow indicator (232) to indicate abnormal operating conditions, where abnormal operating conditions may include a leak per para 0096); and a vacuum motor configured to configured for use as a back-up to a wall vacuum source (para 0074, where the system may be used with a wall suction system or a portable system (as previously detailed under the rejection of claim 15, see figure 6).
Regarding claim 36, Karpowicz discloses
A system comprising (abstract): an electronic vacuum regulator (EVR) configured to regulate suction pressure applied by a vacuum source at a negative pressure wound dressing (pressure controller (202), para. 0086, figure 6), the EVR comprising: a housing (unit 102) comprising a first connector for coupling to the vacuum source (figure 6, where controller is seen to be connected to the pump (103). Alternatively the examiner notes that as the unit (102) comprises the pump within it is interpreted that the pump is connected with the housing) and a second connector (164) ;an interface positioned in the housing for programming a suction pressure applied by the vacuum source at the negative pressure wound dressing (figure 5B, para, 0083, including mode selector switch (204) and pressure selector dial (206)); and tubing configured to provide fluidic communication through a flow path from the second connector of the EVR to the negative pressure wound dressing and tubing configured to provide fluidic communication through a flow path from the second connector of the EVR to the negative pressure wound dressing (164 connects to container 16 through fitting 54, where container connects to tubing (14) and thus to the dressing, see figure 5A); a tubing level sensor configured to be positioned at the tubing, wherein the tubing level sensor is configured to transmit a tubing level signal to the EVR; and a wound level sensor configured to be positioned at a wound level, wherein the wound level sensor is configured to transmit a wound level signal to the EVR. The examiner notes that first sensor is interpreted as flow monitor (210), where per para. 0094 discloses that the flow monitor receives info from sensors, see also para. 0129 for other variations of the flow monitor including sensors) and transmit a signal representative of the detected flow rate to the EVR (para. 0124, where it is disclosed that pressure controller receives data from the flow monitor to reset pressure setpoints) and the second sensor is disclosed to be a sensor positioned at the negative pressure wound dressing (pressure transducer (208) disclosed to be at the wound site or in a conduit between the pump and collector per para. 0086, interpreted as wound level sensor), the second sensor configured to: detect a negative pressure applied at the negative pressure wound dressing (para. 0086); and transmit a signal representative of the detected negative pressure to the EVR (para. 0086, figure 6). Karpowicz however, fails to teach an automated pressure valve located within the housing and actuated by the EVR to regulate suction by intermittently opening and closing said valve.
Upon the amendments filed 12/16/25, The examiner notes that as detailed in the previous office action and above (per para. 0124) the flow monitor monitors flow within the system and thus is interpreted to at least detect flow in area outside the pump. However, as applicant disagrees, the examiner notes that para. 0129 was previously cited as teaching alternatives to the determining flow, including, for example a proximity sensor including a reed switch, where said embodiments may be placed between the canister and suction source and are thus upstream of the pump and downstream of the dressing. Therefore it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use, for example, a proximity sensor including a reed switch, positioned in the flow line, as the flow monitor, as Karpowicz teaches that said embodiment is a known variant to function in the same manner. Per said modification, the flow pathway is interpreted to be between the dressing and the pump section, thus external to the pump. Further, as detailed under the response to arguments, it is interpreted that the sensor is measuring at least some liquid.
DeSatnick teaches a fluid treatment system and is thus considered analogous to the claimed invention. DeSatnick teaches that pressure in the system is maintained via a control valve, where a pressure sensor output is sent to a controller, where said controller controls the pressure control valve (column 3, lines 4-20, column 4, lines 26-58). The examiner notes that in both citations, DeSatnick that the controller controls the valve operation to maintain or reach a desired pressure sensed by pressure sensors, and thus the operation is interpreted to be automatic. DeSatnick also teaches that “operation” of the valve is opening and closing (see column 5 lines 41-68 and column 6 lines 1-6). The examiner notes that as understood from the specification of DeSatnick, the valve is located between the outlet the system and the suction source. Therefore to aid in the control of wound pressure, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide valves connected to the pressure controller of Karpowicz, where said valves are automated by the controller. This combination however does not specifically teach that the valves are within the housing of Karpowicz. The examiner notes MPEP section 2144 VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The examiner notes that as the suction source is located within the housing of Karpowicz and fluidly connects to the wound site, and the defined valve functions when located between the wound site and negative pressure, rearranging the location of the valve on the outlet or suction line (of DeSatnick) to be within the housing of Karpowicz would be obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention. The examiner notes that this modification would have no apparent change in function of the valve as the valve would still be located along the pathway between the wound and the negative pressure source.
The examiner notes that as detailed under the same rejection, the valves are controlled by the controller to aid in the control of wound pressure. It is interpreted that said valves would be opened or closed to adjust (raise/lower) the wound pressure, as desired. Karpowicz discloses that the device may operate in an intermittent mode (Para. 0020, 0083). Should applicant disagree with this interpretation, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as the combination of Karpowicz and DeSatnick teaches a controller coupled with valves configured to aid in the control of wound pressure, and the opening and closing of the valves in response to sensed data is functional language, Karpowicz and DeSatnick teach the claimed limitation.
Regarding claim 37, Karpowicz and DeSatnick teach
The system of claim 36, wherein the second sensor is located between a wound and the negative pressure wound dressing ( per claim 36 rejection pressure transducer (208) disclosed to be at the wound site or in a conduit between the collector and suction source per para. 0086).
Regarding claim 39, Karpowicz and DeSatnick teach
The system of claim 36, wherein the EVR is configured to receive the first signal and the second signal and to direct the automated pressure valve to actuate in response to both the first signal and the second signal. Paragraph 0124 of Karpowicz, details that flow (received from the first sensor), and pressure parameters (received from the second sensor) may be used together to control operation of the device, where as detailed under the rejection of claim 36, the sensors send data to the controller to operate the valve to maintain desired conditions in the system.
Claim 38 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over [Karpowicz in view of DeSatnick and further in view of Vogel CN 101296716.
Regarding claim 38, Karpowicz and DeSatnick teach
The system of claim 36, wherein the first sensor and the second sensor each comprise pressure sensors. Karpowicz does disclose that pressure transducer used in the system may be located between the container and the pump or directly in the wound, per claim 36 rejection. The examiner notes that while the pressure transducer previously disclosed is still interpreted as the second sensor, Karpowicz fails to teach the first sensor being a pressure sensor.
Vogel teaches a wound dressing pressure monitoring system using suction and is thus considered analogous to the claimed invention. Vogel teaches the use of a first pressure sensor and a second pressure sensor, where one embodiment of the sensors has the first sensor coupled to the vacuum pump and measuring the output of the pump (para. 0014), where the second pressure sensor is located at a tank measuring pressure within the tank, where the pump is connected to the tank and the tank is connected with the dressing to provide negative pressure throughout. Therefore Vogel teaches both a first and second sensor, where said sensors send information to an algorithm to control the operation and therefore suction of the pump and system (para.0014). Therefore as Vogel teaches that multiple pressure sensors indicating tubing and wound pressure may be used to control operation of a negative pressure system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the device of Karpowicz with a second pressure sensor located between the canister and the pump as a means to further aid in pressure detection and operation of the system.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781