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 .
Claim Status
Claim amendments submitted on June 10th, 2026 have been entered. Claims 1, 3-4, 6-11, and 14 are currently pending and under consideration. Claims 1, 3, 4, and 10-11 have been amended. Claims 2, 5, 12, and 13 remain cancelled.
Response to Arguments
Applicant's arguments filed June 10th, 2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument pertaining to Larsson and Linder, while examiner agrees that Larsson and Linder fail to disclose the limitation of “to constantly maintain the predetermined constant pressure on the ventilation side” as recited by the amended claims, the below rejection of claims does not rely upon Larsson or Linder to teach this limitation but rather utilizes the teachings of Barnitz et al. (U.S. Patent No. 5,624,394) to teach this limitation as detailed below.
Regarding applicants’ argument pertaining to Sorenson, the current rejection no longer relies upon Sorenson and as such these arguments are considered moot.
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.
Claim(s) 1, 3, 4, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsson (U.S. Publication 2007/0078444) in view of Barnitz et al. (U.S. Patent No. 5,624,394).
Regarding claim 1, Larsson discloses a medical suction device (Fig. 2) with a medical suction pump 1 for generating a suction pressure (¶0019 suction source), which is connected at
a suction side (side of lumen 3) to a drainage container 2 communicating with a suction line 3 comprising a proximal end adapted to be arranged in a human body (Abstract, human body cavity),
a ventilation side (side of lumen 5) comprising a ventilation line 5 the proximal end of which communicates with the distal end of the suction line (proximal end in communication with proximal end of line 3 which is in communication with distal end of line 3) and the distal end of which is provided with a controllable (¶0027 controller opens and closes valve) ventilation valve 7,
a patient pressure sensor 6 assigned to the ventilation side, and
a control unit 9 controllably connected to the ventilation valve and the patient pressure sensor (¶0022 controller in communication with all of these elements, suction pump, first pressure sensor, second pressure sensor), characterized-in-that the control unit being adapted to set the ventilation valve for regulating a pressure on the ventilation side (¶0027 controller is a knob for changing the suction power, knob would set the predetermined constant pressure, pressure changes detected by first pressure sensor cause controller to open valve and then when clot has been removed controller automatically decreases suction power to normal drainage power and closes the valve thus the ventilation valve is set to regulate the predetermined constant pressure on the ventilation side) and to selectively supply a medium to a target area (¶0027 controller selectively opens valve 7 which supplies air flow through tubing to target area of clot rather than pulling suction from patient end), wherein the control unit is adapted to set the ventilation valve to regulate a predetermined constant pressure on the ventilation side as a set value (¶0027 controller is a knob for changing the suction power, knob would set the predetermined constant pressure, pressure changes detected by first pressure sensor cause controller to open valve and then when clot has been removed controller automatically decreases suction power to normal drainage power and closes the valve thus the ventilation valve is set to regulate the predetermined constant pressure on the ventilation side), wherein the control unit is further adapted to set the ventilation valve to regulate a predetermined constant pressure on the ventilation side as a set value in coordination with the control of suction pressure by operating the suction pump (¶0024 suction power of suction pump is increased to increase the pressure difference between the pressure in the drainage lumen and the atmosphere in order to suck the clot in direction of container) and the medical suction device comprising a catheter (¶0019 catheter means comprises drainage lumen 3, and auxiliary lumen 5 comprising:
a suction lumen (suction lumen 3 travels along body of catheter and then splits from catheter toward 2 as seen in Fig. 2), a proximal end of which provides a proximal end of the suction line (proximal end of catheter 4 provides proximal end of suction line to the patient), and
a ventilation lumen (auxiliary lumen 5 travels along body of catheter and then splits from catheter toward valve 7 as seen in Fig. 2), the proximal end of which provides the proximal end of the ventilation line (proximal end of catheter 4 provides proximal end of auxiliary line 5 to the patient) wherein the proximal end of the ventilation line and the proximal end of the suction line are short-circuited to each other within the catheter (Fig. 2 shows short circuiting of dividing wall between 5 and 3 such that ventilation line is open to suction line at proximal end).
Larsson does not expressly disclose the control unit being adapted to set the ventilation valve at a predetermined constant pressure on the ventilation side, setting the ventilation valve at the predetermined constant pressure on the ventilation side, or the control unit being further adapted t to control the ventilation valve to constantly maintain the predetermined constant pressure on the ventilation side in coordination with the control of the suction pressure generated by the suction pump such that at the proximal end of the ventilation line there is provided a constant suction pressure, the level of which is kept constant by controlling the ventilation valve to constantly maintain the predetermined constant pressure on the ventilation side.
However, Barnitz, in the same field of endeavor of medical suction devices, teaches a system comprising a control unit (Fig. 3, 24) controllably connected to a ventilation valve (Col. 3 lines 17-30 control signal from control means is transmitted to pressure adjusting assembly, via assembly control means 26) and a pressure sensor (Col. 3 lines 3-16, control means is connected to pressure sensor), the control unit being adapted to set a ventilation valve at a predetermined constant pressure (Col 4 line 52 maintain discloses pressure to be maintained and thus kept constant; Col. 3 lines 3-17 signal generating means generates a control signal representing the difference between the pressure in vacuum line and a desired operating pressure, and assembly control is provided to operate pressure adjusting assembly selectively, in response to the signal from the signal generating means to vary the pressure in the vacuum line, Col. 4 lines 28-42 system control means compares this pressure signal to a first value to determine if the pressure in vacuum line is above or below a desired operating pressure; and if the actual pressure in the vacuum line is above or below that desired operating pressure, then signal generating means generates an output signal representing the difference between the desired operating pressure and the actual pressure…how that pressure should be adjusted, either by adjusting valve; Col. 4 lines 57-65 processor 38 transmits the control signal to assembly control means that signal is received by valve control processor. Processor then transmits a signal to valve driver which in turn transmits a signal to valve actuator to operate valve to increase or decrease the amount of fluid conducted through the valve and, in this way, to increase or decrease the pressure in the vacuum line), and to selectively supply a medium to a target area (Col. 4 lines 57-65 increase or decrease the amount of fluid conducted through the valve), wherein the control unit is adapted to set the ventilation valve at the predetermined constant pressure on the tubing line (Col. 5 lines 18-25 system control means continues to produce a control signal and the pressure in the vacuum line continues to be adjusted until that pressure equals the desired pressure),
Wherein the control unit is further adapted to control the ventilation valve to maintain the predetermined constant pressure on the tubing line side in coordination with the control of the suction pressure generated by the suction pump such that there is provided a constant suction pressure, the level of which is kept constant by controlling the ventilation valve to constantly maintain the predetermined constant pressure, for the purpose of reaching and maintaining a desired operating pressure (Col. 4 lines 28-55 determine if the pressure in vacuum line is above or below a desired operating pressure; Col. 4 line 49 maintain).
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 the valve and control device of Larsson such as to be capable of controlling the valve and pump as taught by Barnitz for the purpose of reaching and maintaining a desired operating pressure (Col. 4 lines 28-55 determine if the pressure in vacuum line is above or below a desired operating pressure; Col. 4 line 49 maintain).
Furthermore Larsson teaches in ¶0002 that the negative pressure applied has to be chosen carefully since excessive pressure may damage delicate tissues in the body cavity, thus one of ordinary skill in the art before the effective filing date of the claimed invention would have been further motivated to apply the teachings of Barnitz in combination with the disclosure of Larsson for the purpose of providing greater control of the negative pressure applied to the body cavity in which the device is deployed.
Larsson in view of Barnitz fails to disclose “constantly” maintaining the predetermined constant pressure as the language suggests a constant monitoring of the pressure to enact control of the valve to compensate.
However, the control system taught by Barnitz suggest the control means generating control signals based on the receipt of pressure signals sensed by the pressure sensor 22 with the pressure sensor being comprised of a transducer that generates an electric signal having a voltage representing or proportional to the pressure in the vacuum line (Col. 4 lines 21-27). The function of a transducer based pressure sensor would inherently continually provide pressure values as long as electrical power is provided to the sensor. Furthermore, Barnitz teaches the control means continuing to produce a control signal until the pressure equals the desired operating pressure suggesting that the pressure sensor is continually sending pressure values to the control means (Col. 5 lines 18-25).
As such, One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious for the teaching of Barnitz of maintaining of the desired value to have been continual, i.e. constant, as the disclosure of Barnitz suggests that the pressure sensor is continually, and thus constantly, sending measured pressure values based on Barnitz disclosure of the control signal continuing to be produced until the actual and the desired pressures match.
Regarding claim 3, Larsson in view of Barnitz suggest the medical suction device according to claim 1. Larsson further discloses the control unit controllably communicates with the suction pump and a suction pressure sensor assigned to the suction side, and the control unit is adapted to increase the suction pressure in the event of clogging of the suction line and to regulate the pressure on the ventilation side with the predetermined constant pressure as a set value as a controlled variable (¶0027 pressure changes caused by clots causes controller to automatically open the valve and increase the suction power/pressure, returns to normal drainage power and closes valve after second pressure sensor indicates clot has been removed thus regulating the pressure on the ventilation side with the predetermined constant pressure as a set value as a controlled variable).
Regarding claim 4, Larsson in view of Barnitz suggest the medical suction device according to claim 1. Barnitz further suggests the valve being formed by a proportional valve (Col. 4 lines 11-20 proportional valve).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve of Larsson during the proposed modification of Larsson with the teaching of Barnitz of claim 1 for the purpose of providing a valve that is capable of being selectively controlled in the manner suggested by Barnitz in order to enact the purpose reaching and maintaining a desired operating pressure (Col. 4 lines 28-55 of Barnitz determine if the pressure in vacuum line is above or below a desired operating pressure; Col. 4 line 49 of Barnitz maintain) and providing greater control of the negative pressure applied to the body cavity in which the device is deployed, as detailed above in claim 1.
Regarding claim 11, Larsson discloses a method (¶0027) for controlling a medical suction pump 1 for generating a suction pressure (¶0019 suction source) on a suction side (side of 3) comprising:
a suction line 3 which has a proximal end adapted to be arranged in a human body (Abstract, human body cavity), and the distal end of which communicates with the suction pump 1 via a drainage container 2, wherein
on a ventilation side (side of line 5) a ventilation line 5 is provided, the proximal end of which communicates with the proximal end of the suction line (proximal end in communication with proximal end of line 3 which is in communication with distal end of line 3), wherein in the method the pressure on the ventilation side is set at a predetermined constant pressure (¶0027 controller is a knob for changing the suction power, knob would set the predetermined constant pressure, pressure changes detected by first pressure sensor cause controller to open valve and then when clot has been removed controller automatically decreases suction power to normal drainage power and closes the valve thus the ventilation valve is set to regulate the predetermined constant pressure on the ventilation side).
wherein the setting of the predetermined constant pressure occurs with a predetermined constant pressure on the ventilation side (¶0027 controller is a knob for changing the suction power, knob would set the predetermined constant pressure, pressure changes detected by first pressure sensor cause controller to open valve and then when clot has been removed controller automatically decreases suction power to normal drainage power and closes the valve thus the ventilation valve is set to regulate the predetermined constant pressure on the ventilation side), wherein a control unit is adapted to control the ventilation valve to regulate a predetermined constant pressure on the ventilation side as a set value in coordination with the control of suction pressure by operating the suction pump (¶0024 suction power of suction pump is increased to increase the pressure difference between the pressure in the drainage lumen and the atmosphere in order to suck the clot in direction of container).
Larsson does not expressly disclose the control unit being further adapted to control the ventilation valve to constantly maintain the predetermined constant pressure on the ventilation side in coordination with the control of the suction pressure generated by the suction pump such that at the proximal end of the ventilation line there is provided a constant suction pressure, the level of which is kept constant by controlling the ventilation valve to constantly maintain the predetermined constant pressure on the ventilation side.
However, Barnitz, in the same field of endeavor of medical suction devices, teaches a system comprising a control unit (Fig. 3, 24) controllably connected to a ventilation valve (Col. 3 lines 17-30 control signal from control means is transmitted to pressure adjusting assembly, via assembly control means 26) and a pressure sensor (Col. 3 lines 3-16, control means is connected to pressure sensor), the control unit being adapted to set a ventilation valve at a predetermined constant pressure (Col 4 line 52 maintain discloses pressure to be maintained and thus kept constant; Col. 3 lines 3-17 signal generating means generates a control signal representing the difference between the pressure in vacuum line and a desired operating pressure, and assembly control is provided to operate pressure adjusting assembly selectively, in response to the signal from the signal generating means to vary the pressure in the vacuum line, Col. 4 lines 28-42 system control means compares this pressure signal to a first value to determine if the pressure in vacuum line is above or below a desired operating pressure; and if the actual pressure in the vacuum line is above or below that desired operating pressure, then signal generating means generates an output signal representing the difference between the desired operating pressure and the actual pressure…how that pressure should be adjusted, either by adjusting valve; Col. 4 lines 57-65 processor 38 transmits the control signal to assembly control means that signal is received by valve control processor. Processor then transmits a signal to valve driver which in turn transmits a signal to valve actuator to operate valve to increase or decrease the amount of fluid conducted through the valve and, in this way, to increase or decrease the pressure in the vacuum line), and to selectively supply a medium to a target area (Col. 4 lines 57-65 increase or decrease the amount of fluid conducted through the valve), wherein the control unit is adapted to set the ventilation valve at the predetermined constant pressure on the tubing line (Col. 5 lines 18-25 system control means continues to produce a control signal and the pressure in the vacuum line continues to be adjusted until that pressure equals the desired pressure),
Wherein the control unit is further adapted to control the ventilation valve to maintain the predetermined constant pressure on the tubing line side in coordination with the control of the suction pressure generated by the suction pump such that there is provided a constant suction pressure, the level of which is kept constant by controlling the ventilation valve to constantly maintain the predetermined constant pressure, for the purpose of reaching and maintaining a desired operating pressure (Col. 4 lines 28-55 determine if the pressure in vacuum line is above or below a desired operating pressure; Col. 4 line 49 maintain).
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 the valve and control device of Larsson such as to be capable of controlling the valve and pump as taught by Barnitz for the purpose of reaching and maintaining a desired operating pressure (Col. 4 lines 28-55 determine if the pressure in vacuum line is above or below a desired operating pressure; Col. 4 line 49 maintain).
Furthermore Larsson teaches in ¶0002 that the negative pressure applied has to be chosen carefully since excessive pressure may damage delicate tissues in the body cavity, thus one of ordinary skill in the art before the effective filing date of the claimed invention would have been further motivated to apply the teachings of Barnitz in combination with the disclosure of Larsson for the purpose of providing greater control of the negative pressure applied to the body cavity in which the device is deployed.
Larsson in view of Barnitz fails to disclose “constantly” maintaining the predetermined constant pressure as the language suggests a constant monitoring of the pressure to enact control of the valve to compensate.
However, the control system taught by Barnitz suggest the control means generating control signals based on the receipt of pressure signals sensed by the pressure sensor 22 with the pressure sensor being comprised of a transducer that generates an electric signal having a voltage representing or proportional to the pressure in the vacuum line (Col. 4 lines 21-27). The function of a transducer based pressure sensor would inherently continually provide pressure values as long as electrical power is provided to the sensor. Furthermore, Barnitz teaches the control means continuing to produce a control signal until the pressure equals the desired operating pressure suggesting that the pressure sensor is continually sending pressure values to the control means (Col. 5 lines 18-25).
As such, One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious for the teaching of Barnitz of maintaining of the desired value to have been continual, i.e. constant, as the disclosure of Barnitz suggests that the pressure sensor is continually, and thus constantly, sending measured pressure values based on Barnitz disclosure of the control signal continuing to be produced until the actual and the desired pressures match.
Claim(s) 7-9, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsson (U.S. Publication 2007/0078444) in view of Barnitz et al. (U.S. Patent No. 5,624,394) and Ehlert (U.S. Publication 2014/0213992).
Regarding claims 7-9, Larsson in view of Barnitz suggest the medical suction device of claim 1. Larsson in view of Sorensen neither disclose nor suggest a measuring line laid parallel to the suction line and the ventilation line and communicating proximally with at least one of the suction line or the ventilation line
Ehlert discloses a medical suction device (Fig. 1) with a medical suction pump (¶0021 suction pump) for generating a suction pressure (¶0021 vacuum source), which is connected at
a suction side (side of line 23) to a drainage container 3 communicating with a suction line 2 comprising a proximal end adapted to be arranged in a human body 1,
a ventilation side (side of lumen 13 leading to 15) comprising a ventilation line (line 13 toward element 15) the proximal end of which communicates with the distal end of the suction line (proximal end at 5 in communication with distal end of 2 at container 3) and the distal end of which is provided with a controllable (¶0058 control device reads out the signals from the sensors and controls the valve 12) ventilation valve 12,
a patient pressure sensor 31, and
a control unit 7 controllably connected to the ventilation valve (¶0058 controls valve 12) and the patient pressure sensor (¶0065 control device periodically compares pressure values determined by pressure sensor 31), characterized-in-that the control unit being adapted to set the ventilation valve for regulating a pressure on the ventilation side (¶0059 opens the vent valve as soon as pressure is above atmospheric pressure) and to selectively supply a medium to a target area ( ¶0058 control of vent valve selectively supplies medium of gaseous constituents of container to target area of atmosphere).
[claim 7] a measuring line 33 laid parallel to the suction and the ventilation lines and communicating proximally with the suction line (communicates at proximal end to 2’ which communicates to 2 through pleural cavity of patient), [claim 8] a controllable valve 32 controllably connected to the control unit 7 distally assigned to the measuring line, [claim 9] the patient pressure sensor 31 being assigned to the measuring line 33, a suction pressure sensor 22 assigned to the suction line (assigned to line 23 in communication with vacuum and thus in communication with suction line 2) and a further sensor 12 determining the pressure in the ventilation line (line 13 toward 15) assigned to the ventilation line, and wherein the patient pressure sensor 31, the suction pressure sensor 22, and the further sensor are controllably connected to the control unit (Fig. 1 lines from control unit 7 show connections to sensors).
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 the system of Larsson in view of Barnitz to have included the measuring line with controllable valve and patient pressure sensor as taught by Ehlert for the purpose of providing an ancillary line that does not have suction applied to it in order to measure the pressure value to which the patient is being subjected too at the site of suction rather than the pressure within the system. This would have the benefit of being able to further regulate the system based on the patient applied pressure so that the patient site does not receive too much pressure as well as indicated any malfunction if there is a large difference between patient site suction and the systems suction (¶0065 if these deviate markedly from each other, this indicates a malfunction, and the control device outputs a corresponding alarm signal).
Regarding claim 14, Larsson in view of Barnitz and Ehlert suggest the medical suction device according to claim 7. Ehlert further suggests wherein, upon clogging of the suction line, the measuring line serves as a fluid-carrying line (¶0065 flushing valve 32 opened to allow fluid to flow through line 33 such that air is sucked through the ancillary line 2’ into suction line 2 and removes any blockages/clogging from the lines) for the purpose of removing any blockages/clogging from the lines. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further utilized the measuring line as a fluid-carrying line for the purpose of removing any blockages/clogging from the lines (¶0065 of Ehlert).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsson (U.S. Publication 2007/0078444) in view of Barnitz et al. (U.S. Patent No. 5,624,394) and Schon et al. (U.S. Publication 2003/0153898).
Regarding claim 6, Larsson in view of Barnitz suggest the medical suction device according to claim 1. Larsson further discloses a ventilation hose 5 connected to a ventilation interface of the suction pump (connected to element 2 which interfaces with the suction pump).
Larsson does not expressly disclose a connector with a catheter interface for connecting the suction lumen and the ventilation lumen of the catheter, a suction hose interface communicating with the suction lumen for connecting a suction hose communicating the drainage container, and a ventilation hose interface communicating with the ventilation lumen for connecting a ventilation hose connected to a ventilation interface of the suction pump.
However, Schon in the same field of endeavor of medical catheters, discloses a connector 18 with a catheter interface (portion in which proximal ends 28 and 30 terminate within hub 18) for connecting two lumens of a catheter and hose interfaces for connecting two separate hoses (20 and 22) to corresponding lumens (24 and 26) of the catheter 5 for the purpose of providing a bonding point in which tubes can be releasably attached to allow for a transition from a state in which the lumens are included in a unitary structure to a point at which the tubing splits into two separate lumens (¶0021) and providing a reinforced area for termination of the lumens (¶0065).
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 the device of Larsson to have included a connector comprising a catheter interface and a suction and ventilation hose interface, as taught by Schon for the purpose of reinforcing the point at which the ventilation side and the suction side of Larsson split from a unitary construction to separate tubing (¶0065) as well as allowing for releasable attachment of the unitary portion from the split portion of the ventilation and suction flow pathway (¶0021).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linder et al. (U.S. Publication 2014/0100540) in view of Barnitz et al. (U.S. Patent No. 5,624,394).
Regarding claim 10, Linder discloses a medical suction pump (Fig. 2) for generating a suction pressure (¶0066 suction pump, arrow of Fig. 3 shows suction of fluid through suction tube 3), with a pump housing 20 in which a negative pressure generating means is accommodated (Fig. 2 shows element 1 within housing),
the suction side of which is connected to a suction interface (see illustrative diagram of Fig. 2 below) to which a drainage container which can be detachably connected to the pump housing can be connected (¶0065 exchangeable collecting container), and
a controllable ventilation valve 7,
the ventilation side of which is connected to a ventilation interface (see illustrative diagram of Fig. 2 below) exposed on the outside of the pump housing (see Fig. 2), to which a ventilation hose 5 can be connected, a patient pressure sensor 6 , and with
a control unit which is controllably connected to the ventilation valve and the patient pressure sensor, and the control unit is adapted to set the ventilation valve for regulating a pressure on the ventilation side (¶0067 control device receives signals from pressure gauges and controls the valve 7).
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Illustrative diagram of Fig. 2 of Linder et al. (U.S. Publication 2014/0100540).
and the medical suction device comprising a catheter 4 comprising:
a suction lumen (suction lumen 3 travels along body of catheter and then splits from catheter toward 2 as seen in Fig. 3), a proximal end of which provides a proximal end of the suction line (proximal end of catheter 4 provides proximal end of suction line to the patient), and
a ventilation lumen (auxiliary lumen 5 travels along body of catheter and then splits from catheter toward valve 7 as seen in Fig. 3), the proximal end of which provides the proximal end of the ventilation line (proximal end of catheter 4 provides proximal end of auxiliary line 5 to the patient) wherein the proximal end of the ventilation line and the proximal end of the suction line are short-circuited to each other within the catheter (Fig. 3 shows short circuiting of dividing wall between 5 and 3 such that ventilation line is open to suction line at proximal end).
Linder does not expressly disclose the patient pressure sensor being provided between the ventilation valve and the ventilation interface, or the control unit being adapted to set the ventilation valve at a predetermined constant pressure on the ventilation side, setting the ventilation valve at the predetermined constant pressure on the ventilation side, or the control unit being further adapted to control the ventilation valve to constantly maintain the predetermined constant pressure on the ventilation side in coordination with the control of the suction pressure generated by the suction pump such that at the proximal end of the ventilation line there is provided a constant suction pressure, the level of which is kept constant by controlling the ventilation valve to constantly maintain the predetermined constant pressure on the ventilation side.
Regarding the patent sensor location, 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 rearranged the patient pressure sensor to be provided between the ventilation valve and the ventilation interface since this claimed position of the patient pressure sensor does not change the patient pressure sensor’s ability to sense the pressure in the ventilation line Since applicant has not given any criticality as to why the claimed position of the patient pressure sensor has any critical importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144.
Regarding the control unit and valve, however, Barnitz, in the same field of endeavor of medical suction devices, teaches a system comprising a control unit (Fig. 3, 24) controllably connected to a ventilation valve (Col. 3 lines 17-30 control signal from control means is transmitted to pressure adjusting assembly, via assembly control means 26) and a pressure sensor (Col. 3 lines 3-16, control means is connected to pressure sensor), the control unit being adapted to set a ventilation valve at a predetermined constant pressure (Col 4 line 52 maintain discloses pressure to be maintained and thus kept constant; Col. 3 lines 3-17 signal generating means generates a control signal representing the difference between the pressure in vacuum line and a desired operating pressure, and assembly control is provided to operate pressure adjusting assembly selectively, in response to the signal from the signal generating means to vary the pressure in the vacuum line, Col. 4 lines 28-42 system control means compares this pressure signal to a first value to determine if the pressure in vacuum line is above or below a desired operating pressure; and if the actual pressure in the vacuum line is above or below that desired operating pressure, then signal generating means generates an output signal representing the difference between the desired operating pressure and the actual pressure…how that pressure should be adjusted, either by adjusting valve; Col. 4 lines 57-65 processor 38 transmits the control signal to assembly control means that signal is received by valve control processor. Processor then transmits a signal to valve driver which in turn transmits a signal to valve actuator to operate valve to increase or decrease the amount of fluid conducted through the valve and, in this way, to increase or decrease the pressure in the vacuum line), and to selectively supply a medium to a target area (Col. 4 lines 57-65 increase or decrease the amount of fluid conducted through the valve), wherein the control unit is adapted to set the ventilation valve at the predetermined constant pressure on the tubing line (Col. 5 lines 18-25 system control means continues to produce a control signal and the pressure in the vacuum line continues to be adjusted until that pressure equals the desired pressure),
Wherein the control unit is further adapted to control the ventilation valve to maintain the predetermined constant pressure on the tubing line side in coordination with the control of the suction pressure generated by the suction pump such that there is provided a constant suction pressure, the level of which is kept constant by controlling the ventilation valve to constantly maintain the predetermined constant pressure, for the purpose of reaching and maintaining a desired operating pressure (Col. 4 lines 28-55 determine if the pressure in vacuum line is above or below a desired operating pressure; Col. 4 line 49 maintain).
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 the valve and control device of Linder such as to be capable of controlling the valve and pump as taught by Barnitz for the purpose of reaching and maintaining a desired operating pressure (Col. 4 lines 28-55 determine if the pressure in vacuum line is above or below a desired operating pressure; Col. 4 line 49 maintain).
Linder in view of Barnitz fails to disclose “constantly” maintaining the predetermined constant pressure as the language suggests a constant monitoring of the pressure to enact control of the valve to compensate.
However, the control system taught by Barnitz suggest the control means generating control signals based on the receipt of pressure signals sensed by the pressure sensor 22 with the pressure sensor being comprised of a transducer that generates an electric signal having a voltage representing or proportional to the pressure in the vacuum line (Col. 4 lines 21-27). The function of a transducer based pressure sensor would inherently continually provide pressure values as long as electrical power is provided to the sensor. Furthermore, Barnitz teaches the control means continuing to produce a control signal until the pressure equals the desired operating pressure suggesting that the pressure sensor is continually sending pressure values to the control means (Col. 5 lines 18-25).
As such, One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious for the teaching of Barnitz of maintaining of the desired value to have been continual, i.e. constant, as the disclosure of Barnitz suggests that the pressure sensor is continually, and thus constantly, sending measured pressure values based on Barnitz teaching of the control signal continuing to be produced until the actual and the desired pressures match.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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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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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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