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 Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaker et al. 2001/0053920
Regarding claim 1, Shaker teaches a device comprising; a catheter unit (apparatus 10, figure 1) comprising: a plurality of balloon components placeable within an esophagus of a patient (balloons 28, 30, and 32, figures 4-6), wherein the plurality of balloon components comprise a measuring balloon (Intrasphincteric ballon 30 is a measuring ballon as it comprises pressure measuring port 36, 0030) and a sealing balloon (esophageal balloon 28), and wherein the plurality of balloon components are operable in a measuring functional mode, wherein, when the plurality of balloon components are operated in the measuring functional mode, the measuring balloon is operable to measure an esophageal pressure of the patient or a thoracic pressure of the patient (0010 and 011 discusses the measuring mode of the measuring balloons); andmode, wherein, when the plurality of balloon components are operated in the sealing functional mode, the sealing balloon seals the esophagus to inhibit secretions from rising through the esophagus (0024 and 0025 discuss the inflation of the balloons); and a controller unit connected to the catheter unit, wherein the controller is configured to control operation of the plurality of balloon components (pump 14 and pressure meter 16).
Regarding claim 2, Shaker teaches the device according to claim 1, wherein the catheter unit comprises a feeding catheter or a decompression catheter, and wherein the catheter unit is insertable into the esophagus (feeding catheter into the esophagus is depicted in figure 3).
Regarding claim 3, Shaker teaches the device according to claim 1, wherein, during the sealing functional mode the sealing balloon seals at least part of esophagus (Depicted in figures 10 and 11).
Regarding claim 4, Shaker teaches the device according to claim 1, wherein a diameter of the sealing balloon exceeds a diameter of a lumen of the esophagus (Depicted in figure 10).
Regarding claim 5, Shaker teaches the device according to claim 1, wherein the sealing balloon has a balloon end that is extended in a proximal direction toward an extracorporeal catheter end (Figure 7 depicts a proximal end of balloon 28 extended in a proximal direction towards the outside of the catheter), and wherein a diameter of the sealing balloon exceeds an outer diameter of a shaft of the catheter unit (Figure 10 also depicts the diameter of the sealing ballon exceeding an outer diameter).
Regarding claim 6, Shaker teaches the device according to claim 1, wherein the sealing balloon has a web-like, partially collapsing inner structure (Collapsing balloon structure depicted from figures 9-12).
Regarding claim 7, Shaker teaches the device according to claim 1, wherein the measuring balloon is positioned in a lower half of the esophagus (Figure 7 depicts measuring balloon 30 placed here).
Regarding claim 8, Shaker teaches the device according to claim 1, wherein the sealing balloon and the measuring balloon are designed as structurally separate and separately fillable components (Depicted in figures 9-12).
Regarding claim 10, Shaker teaches the device according to claim 1, wherein the measuring balloon is situated in series with the sealing balloon (Depicted in figure 8).
Regarding claim 11, Shaker teaches the device according to claim 1, further comprising radiopaque markers on a shaft tube of the catheter unit (0032 states “optional depth markers 45 can be added to the catheter tubing 22 to aid in placement of the compliance balloon catheter 12. For example, it is important not to inflate the gastric balloon 32 before it is completely inside the stomach 23. These markers 45, which can be useful when used with or without an endoscope, can comprise printed numerical or other type of indicia corresponding to the distance to a certain distal point on the compliance balloon catheter, or they can indicate one or more preferred zones corresponding to the desired position of balloon deployment.”).
Regarding claim 12, Shaker teaches the device according to claim 1, wherein, during the measuring functional mode, the measuring balloon assumes a flaccid shape with incomplete, volume- defined filling (0035 discusses a volume based filling of the measuring balloon).
Regarding claim 13, Shaker teaches the device according to claim 1, wherein, during the sealing functional mode, a filling state of the sealing balloon is regulated in a pressure-controlled manner (controlled inflation of balloon 28 is discussed in 0038).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shaker
Regarding claim 9, Shaker teaches the device according to claim 8, however it fails to teach it wherein the measuring balloon is situated concentrically inside the sealing balloon. However, the courts have held that a rearrangement of parts requires only ordinary skill in the art and hence is considered a routine expedient, one of ordinary skill in the art would have the ability to place the measuring balloon 150 concentrically inside of the sealing balloon for the purpose of sealing the area that is also being measured.
Claims 23, 25, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker in view of Malbrain et al. 2008/0077043
Regarding claim 23, Shaker teaches the device according to claim 1, the controller unit (regulator mechanism 0041), but fails to teach at least one electronic pressure-controlling valve that sets a filling pressure in the measuring balloon or the sealing balloon. Malbrain teaches an analogous balloon catheter that does teach at least one electronic pressure-controlling valve that sets the particular filling pressure in the balloon (0061 states “A computer 28 is electrically connected via line 29 to the pressure gauge 24, via line 30 to the first electromagnetic valve 25, via line 31 to the second electromagnetic valve 22 and via line 32 to the electric motor 27. By means of these connections the computer 28 is able to collect pressure readings from the pressure gauge 24, to open and close the first and second valves 25 and 22 and to activate the motor 27 in order to advance or retract the piston of the piston pump 26.”) It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Malbrain and include the electronic pressure controlling valve to set the pressure as it provides a method of starting and stopping inflation of the ballon.
Regarding claim 25, modified Shaker teaches the device according to claim 23, wherein the at least one electronic pressure-controlling valve is comprised of piezoelectronically operating control elements (0061 of Malbrain states “A computer 28 is electrically connected via line 29 to the pressure gauge 24, via line 30 to the first electromagnetic valve 25, via line 31 to the second electromagnetic valve 22 and via line 32 to the electric motor 27. By means of these connections the computer 28 is able to collect pressure readings from the pressure gauge 24, to open and close the first and second valves 25 and 22 and to activate the motor 27 in order to advance or retract the piston of the piston pump 26”).
Regarding claim 27, modified Shaker teaches the device according to claim 23, wherein the at least one electronic pressure controlling valve is connected to one or more external pressure sources (air conduit 23, 0061 of Malbrain)
Regarding claim 28, modified Shaker teaches the device according to claim 23, wherein the controller unit has a module that applies air volume into the measuring balloon, and withdraws air volume from the measuring balloon (Pump 14 of Shaker can apply and withdraw air into the measuring ballon).
Claims 14-16, 22, 24, 51-53, and 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker in view of Gobel et al. 2008/0154191
Regarding claim 14, Shaker teaches the device according to claim 1, but fails to teach wherein the controller unit comprises a selection module that is configured to output an output signal, wherein selection of the measuring functional mode occurs when the output signal has a first logical state, and wherein selection of the sealing functional mode occurs when the output signal has a second logical state. Gobel does teach wherein the controller unit comprises a selection module that is configured to output an output signal (0090 and 0091), wherein selection of the measuring functional mode occurs when the output signal has a first logical state, and wherein selection of the sealing functional mode occurs when the output signal has a second logical state (This would be an inherent quality of the multiple state system as defined in 0090 and 0091 as when either one of measuring or sealing is taking place, it would take priority over the other action). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Gobel and include wherein the controller unit comprises a selection module that is configured to output an output signal, wherein selection of the measuring functional mode occurs when the output signal has a first logical state, and wherein selection of the sealing functional mode occurs when the output signal has a second logical state as this allows for a switching of modes to occur.
Regarding claim 15, modified Shaker teaches the device according to claim 14, wherein the selection module comprises a flip-flop circuit or a bistable toggle circuit (0041 of Gobel states “The feeding pump or regulator mechanism has a display 19 with options for controlling or regulating the feeding rate and other parameters or feedback from sensors: change in pressure (.DELTA.P), actual volume/unit time (V/h), esophageal pressure (P.sub.esophagus), gastric pressure (P.sub.gastric), input mechanism option for .DELTA.P 16, volume 17, and delivery time 18, connection to feeding container 11.”).
Regarding claim 16, modified Shaker teaches the device according to claim 15, wherein an input to the selection module is responsive to a manual input (Inputs of 16, 17, and 18 of Gobel are all manual switches on the regulator as depicted in figure 1).
Regarding claim 22, Shaker teaches the device according to claim 1, but fails to teach wherein, during the sealing functional mode the sealing balloon continuously maintains a target pressure. Gobel does teach wherein, during the sealing functional mode the sealing balloon continuously maintains a target pressure (0027 states “One section provides automated monitoring of the relative gastric and thoracic pressures and control over the inflation of the esophageal balloon so as to ensure a tight seal against the lower esophageal sphincter under feeding conditions”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Gobel and include wherein, during the sealing functional mode the sealing balloon continuously maintains a target pressure as this allows for a controlled inflation to occur.
Regarding claim 24, Shaker teaches the device according to claim 1, but fails to teach wherein the controller unit has a first valve function that supplies volume to the measuring balloon or the sealing balloon, and wherein the controller unit has a second valve function that discharges volume from the measuring balloon or the sealing balloon. Gobel teaches an analogous esophageal catheter that does teach wherein the controller unit has a first valve function (Feeding pump 20 acts as a de facto valve function as it can control the supply of air) that supplies volume to the measuring balloon or the sealing balloon (0013 states “an external pump that regulates air or fluid pressure within said esophageal balloon”), and wherein the controller unit has a second valve function that discharges volume from the measuring balloon or the sealing balloon (0084 states “The air pump may inflate or deflate the esophageal bladder according to certain set parameters.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Gobel and include wherein the controller unit has a first valve function that supplies volume to the measuring balloon or the sealing balloon, and wherein the controller unit has a second valve function that discharges volume from the measuring balloon or the sealing balloon as this allows for a regulation of the inflation of the balloons.
Regarding claim 51, Shaker teaches the device according to claim 1, but fails to teach further comprising an endotracheal tube, wherein the endotracheal tube comprises a tube body through which a lumen passes, wherein a proximal end of the tube body is connectable to a ventilator via one or more ventilation tubes, and wherein a cuff encloses the tube body. Gobel does teach an endotracheal tube (delivery cannula 4), wherein the endotracheal tube comprises a tube body through which a lumen passes (delivery channel 10), wherein a proximal end of the tube body is connectable to a ventilator via one or more ventilation tubes (the proximal end of tube 4 does have the ability to be connected to a ventilator via one or more ventilation tubes (tube for feeding container 11), and wherein a cuff encloses the tube body (Cuff of tube described in 0031). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Gobel and include an endotracheal tube, wherein the endotracheal tube comprises a tube body through which a lumen passes, wherein a proximal end of the tube body is connectable to a ventilator via one or more ventilation tubes, and wherein a cuff encloses the tube body as this allows for a delivery of fluid (0058).
Regarding claim 52, Shaker in view of Gobel teaches the device according to claim 5, wherein the cuff is connected to the controller unit via connecting lines (0031 of Gobel states “The intra-cuff pressure of the tube is also measured by means of a measuring instrument, and the measured values are transmitted by means of a measuring line extending from the cuff of the tube to the ventilator, or to a control device for the pump.”).
Regarding claim 53, Shaker in view of Gobel teaches the device according to claim 52, wherein a module or a function for a dynamically adaptive tracheal sealing of the cuff with respect to a trachea is provided to the controller unit (0031 of Gobel states “The intra-cuff pressure of the tube is also measured by means of a measuring instrument, and the measured values are transmitted by means of a measuring line extending from the cuff of the tube to the ventilator, or to a control device for the pump”) wherein a value of a filling pressure in the cuff is detected (0031 states “To set a desired fill pressure in the gastric probe balloon, a measuring and regulating device is provided, which is integrated with the control device of the pump. For setting a desired fill pressure in the cuff of the tube introduced into the trachea of a patient, it is also proposed that a measuring and regulating device for the fill pressure be provided, which is integrated with the control device of the pump.”).
Regarding claim 56, Shaker teaches a method comprising: a controller unit (pump 14 and pressure meter 16) and a catheter (apparatus 10, figure 1) comprising a plurality of balloon components placeable within an esophagus of a patient wherein the plurality of balloon components comprise a measuring balloon (Intrasphincteric ballon 30 is a measuring ballon as it comprises pressure measuring port 36, 0030) and a sealing balloon wherein the sealing balloon seals the esophagus to inhibit secretions from rising through the esophagus (esophageal balloon 28), wherein, during the measuring functional mode, the measuring balloon is operable to measure an esophageal pressure of the patient or a thoracic pressure of the patient (0010 and 011 discusses the measuring mode of the measuring balloons) but fails to teach generating, by a controller unit, an output signal; and providing, by the controller unit, the output signal to a catheter unit, wherein the plurality of balloon components comprise a measuring balloon and a sealing balloon, wherein, when the output signal has a first logical state, the plurality of balloon components are operated in a measuring functional mode, and wherein the output signal has a second logical state and the plurality of balloon components are operated in a sealing functional mode. Gobel does teach generating, by a controller unit, an output signal; and providing, by the controller unit, the output signal to a catheter unit (0090 and 0091), wherein, when the output signal has a first logical state, the plurality of balloon components are operated in a measuring functional mode, and wherein, when the output signal has a second logical state, the plurality of balloon components are operated in a sealing functional mode (This would be an inherent quality of the multiple state system as defined in 0090 and 0091 as when either one of measuring or sealing is taking place, it would take priority over the other action). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Gobel and include generating, by a controller unit, an output signal; and providing, by the controller unit, the output signal to a catheter unit, wherein the plurality of balloon components comprise a measuring balloon and a sealing balloon, wherein, when the output signal has a first logical state, the plurality of balloon components are operated in a measuring functional mode, and wherein the output signal has a second logical state and the plurality of balloon components are operated in a sealing functional mode as this allows for controlled switching between inflation and measuring states.
Regarding claim 57, modified Shaker teaches the method according to claim 56, wherein, during the measuring functional mode, after initial emptying of the measuring balloon, an injection of a, specified volume of a filling medium into the measuring balloon occurs to convert the measuring balloon into a flaccid, unexpanded filling state (0035 of Shaker discusses a volume based filling of the measuring balloon).
Regarding claim 58, modified Shaker teaches the device method according to claim 56, wherein, during the sealing functional mode, the controller unit supplies volume to from the sealing balloon to continuously hold a set sealing pressure target value (0027 of Shaker states “One section provides automated monitoring of the relative gastric and thoracic pressures and control over the inflation of the esophageal balloon so as to ensure a tight seal against the lower esophageal sphincter under feeding conditions”).
Claims 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker and Gobel in view of Goebel et al. 2009/0120439
Regarding claim 17, modified Shaker teaches the device according to claim 15, but fails to teach wherein an input to the selection module is coupled to a programmable dead time module or a delay module. Goebel does teach wherein an input to the selection module is coupled to a programmable dead time module or a delay module (0035 states “The control unit 7 may further include a manually entered option 11 for a user-determined response delay period to allow for setting a time interval between the detection of respiratory onset and pressure release through the pressure release unit 3.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker with the teachings of Goebel and include a delay module to minimize the amount of breathing work performed by the patient.
Regarding claim 18, modified Shaker teaches the device according to claim 15, but fails to teach wherein a resetting input to the selection module is coupled to a programmable dead time module or a delay module. Goebel does teach wherein a resetting input to the selection module is coupled to a programmable dead time module or a delay module (0035 states “The control unit 7 may further include a manually entered option 11 for a user-determined response delay period to allow for setting a time interval between the detection of respiratory onset and pressure release through the pressure release unit 3.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker with the teachings of Goebel and include a delay module to minimize the amount of breathing work performed by the patient.
Regarding claim 19, modified Shaker teaches the device according to claim 15, but fails to teach wherein multiple input signals that are associated with an input to the selection module are linked via a logical OR gate. Goebel does teach multiple input signals (manual setting option 10) that are associated with an input to the selection module are linked via a logical OR gate (0033 teaches a logic control unit). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker with the teachings of Goebel and include an OR gate to allow for a switching between the two different modes.
Regarding claim 20, modified Shaker in view of Goebel teaches the device according to claim 19, wherein one or more input signal of the multiple input signals are locked by one or more logical blocking signals (0033 of Goebel teaches a logic control unit).
Regarding claim 21, modified Shaker in view of Goebel teaches the device according to claim 20, wherein the one or more logical blocking signals are derived from an input button (0033 of Goebel teaches a logic control unit and manual setting option 11a allows for an adjustment of a pressure release period)
Claim 26, 29-30, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker and Malbrain in view of Gobel
Regarding claim 26, modified Shaker teaches the device according to claim 23 and at least one the electronic pressure-controlling valve (Malbrain 0061), but fails to teach wherein the valve has a sensor function that measures a filling pressure in the measuring balloon or the sealing balloon, in particular via a sensor for the filling pressure in the balloon, the valve controlling the pressure in the balloon in such a way that a predefined filling pressure may be maintained, even continuously, when respiratory-mechanically caused pressure fluctuations occur in the balloon. Gobel does teach wherein the at least one the electronic pressure-controlling valve has a sensor function that measures a filling pressure in the measuring balloon or the sealing balloon (0014 of Gobel states “providing an sensor for monitoring gastric pressure when enteral feeding is in process; receiving a signal that is averaged using a filter algorithm; setting a gradient value that is added to actual gastric pressure, thereby defining a relative level of esophageal pressure applied to seal from gastro-pharyngeal reflux.”), in particular via a sensor for the filling pressure in the balloon, the valve controlling the pressure in the balloon in such a way that a predefined filling pressure may be maintained (0028 of Gobel states “A regulator unit can provide automated regulation of patient feeding rates, and can actively keep the seal pressure of the esophageal balloon in dynamic accordance with the actual intra-gastric pressure, in a fashion that a seal-sufficient pressure gradient between intra-esophageal pressure can be continuously maintained.”), even continuously, when respiratory-mechanically caused pressure fluctuations occur in the balloon (0029 of Gobel states “The pressure within the esophageal bladder prevailing can be ascertained continuously or intermittently; the fluctuations in the intra-thoracic pressure that are transmitted to the balloon of the gastric probe are detected and evaluated and supplied to the ventilator for controlling the breathing gas flow”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker with the teachings of Gobel and include wherein the valve has a sensor function that measures a filling pressure in the measuring balloon or the sealing balloon, in particular via a sensor for the filling pressure in the balloon, the valve controlling the pressure in the balloon in such a way that a predefined filling pressure may be maintained, even continuously, when respiratory-mechanically caused pressure fluctuations occur in the balloon as this allows for the inflation of the balloons to be controlled.
Regarding claim 29, modified Shaker teaches the device according to claim 23, but fails to teach wherein the controller unit has a module that monitors respiratory-mechanically caused pressure fluctuations in a thorax. Gobel teaches an analogous esophageal catheter that does teach wherein the controller unit (Gobel 0041) has a module that monitors respiratory-mechanically caused pressure fluctuations in a thorax (0029 of Gobel states “The pressure within the esophageal bladder prevailing can be ascertained continuously or intermittently; the fluctuations in the intra-thoracic pressure that are transmitted to the balloon of the gastric probe are detected and evaluated and supplied to the ventilator for controlling the breathing gas flow”.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker and include wherein the controller unit has a module that monitors respiratory-mechanically caused pressure fluctuations in a thorax as this allows for a control of the breathing gas flow.
Regarding claim 30, modified Shaker in view of Gobel teaches the device according to claim 29, wherein the controller unit is configured to detect an incipient active respiratory excursion of the thorax to trigger machine-assisted respiration by a ventilator in response to detecting the incipient active respiratory excursion (0029 of Gobel states “the fluctuations in the intra-thoracic pressure that are transmitted to the balloon of the gastric probe are detected and evaluated and supplied to the ventilator for controlling the breathing gas flow”).
Regarding claim 44, modified Shaker in view of Gobel teaches the device according to claim 29, wherein the module correlates one or more electrode signals with, the respiratory-mechanically caused pressure fluctuations in the thorax (0029 of Gobel states “The pressure within the esophageal bladder prevailing can be ascertained continuously or intermittently; the fluctuations in the intra-thoracic pressure that are transmitted to the balloon of the gastric probe are detected and evaluated and supplied to the ventilator for controlling the breathing gas flow.”).
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker, Malbrain, and Gobel in view of Goebel et al.
Regarding claim 45, modified Shaker in view of Gobel teaches the device according to claim 44, but fails to teach wherein the module is configured to identify a pattern sequence for an onset of a neuromuscular breathing activity, wherein the pattern sequence is stored as a reference sequence and used for a correlation in real time with the one or more electrode signals, to generate an early trigger signal for triggering assisted respiration by a ventilator. Goebel does teach (wherein the module is configured to identify a pattern sequence for an onset of a neuromuscular breathing activity, wherein the pattern sequence is stored as a reference sequence and used for a correlation in real time with the one or more electrode signals 0027 states “By triggering ventilator support on the basis of the detection of relative changes in the intra-chest pressure (intra-thoracic pressure) of a patient, patients can be converted to assisted breathing significantly earlier”), to generate an early trigger signal for triggering assisted respiration by a ventilator (0051 state “In order to create the best possible synchronicity between patient breathing activity and ventilator assist, the unit control software may make the release of the triggering impulse dependent upon the fulfillment of certain criteria “). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker with the teachings of Goebel and include wherein the module is configured to identify a pattern sequence for an onset of a neuromuscular breathing activity, wherein the pattern sequence is stored as a reference sequence and used for a correlation in real time with the one or more electrode signals, to generate an early trigger signal for triggering assisted respiration by a ventilator as this allows for a triggering to occur in a manner that does not require any direct communication between the device and the ventilator (0027).
Regarding claim 46, modified Shaker in view of Gobel and Goebel teaches the device according to claim 45, wherein a degree of correlation o for recognizing the onset of the neuromuscular breathing activity is settable, via an input element (0038 of Goebel states “The main unit 2 may also be equipped with an entering option for an auto correlation coefficient (reaching from -1 to +1), chosen by the user, and functioning as a triggering threshold.”).
Claims 31-34, 47-50, and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker in view of Goebel
Regarding claim 31, Shaker teaches the device according to claim 1, but fails to teach wherein the controller unit comprises a comparator module configured to compare a pressure signal associated with the measuring balloon to a magnitude of a pressure reduction that is necessary for triggering a triggering pulse for a ventilator. Goebel teaches an analogous esophageal ballon catheter tubing that does teach a comparator module (0051 unit control software) for comparing the pressure signal to a magnitude of a pressure reduction (0054 states “triggering within that defined pressure range may depend on a certain period of signal stability within that range (neutral or negative slope of pressure curve over a certain period of time)”) that is necessary for triggering a triggering pulse for a ventilator (0055 states “the device may detect and indicate/display tidal support by the ventilator by an increase of intra-thoracic pressure or a certain pressure differential (slope) to be reached. alternatively, within such a defined triggering range and time window, triggering may be released on the basis of curve morphology and an analyzing underlying auto-correlation algorithm.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Goebel and include a comparator module for comparing the pressure signal to a magnitude of a pressure reduction that is necessary for triggering a triggering pulse for a ventilator as this allows for controlled ventilation that prevents unassisted and fatiguing breathing efforts by the patient (0013).
Regarding claim 32, Shaker teaches the device according to claim 1, but fails to teach wherein the controller unit comprises a regulation module that initiates volume compensation in the sealing balloon after a latency time has elapsed, wherein a pressure drop in the sealing balloon occurs during the latency time. Goebel does teach a control or regulation module (Control unit 7) that comprises a regulation module that initiates volume compensation in the sealing balloon after a latency time has elapsed, wherein a pressure drop in the sealing balloon occurs during the latency time (0049 states “By defining the response delay interval between the moment of pressure sensing and the moment of the release of gas from the ventilator tubing, which can be manually set by the therapist, the amount of patient performed WOB 27 during a respiratory cycle can be minimized”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Goebel and include wherein the controller unit comprises a regulation module that initiates volume compensation in the sealing balloon after a latency time has elapsed, wherein a pressure drop in the sealing balloon occurs during the latency time to enable a stable transition from a controlled to a supported ventilation mode.
Regarding claim 33, modified Shaker teaches the device according to claim 32, wherein during the pressure drop in the sealing balloon, a control loop is interrupted until a trigger signal for machine-assisted respiration has been generated (0044 of Goebel states “The pressure drop (or the resulting flow change in the tubing circuit) is sensed by the ventilator or ventilation tubing integrated pressure sensor equipment. If a certain pressure reduction, which has been set by the user as a triggering threshold, has been reached, the ventilator releases the tidal support to the patient initiated breath.”).
Regarding claim 34, Shaker teaches the device according to claim 1, but fails to teach a display device connected to the controller unit, wherein the display device is configured to display a representation of a continuous thoracic pressure signal. Goebel teaches a display device connected to the controller unit, wherein the display device is configured to display a representation of a continuous thoracic pressure signal (0037 states” The unit may optionally be equipped in accordance to the work of breathing (WOB) monitoring function as described in DE 102 13 905 and related U.S. Pat. No. 7,040,321. The WOB option (continuous display of ventilated tidal volume over intra-thoracic sensed pressure) depends on the availability of an additional parameter; the tidal volume being moved in and out of the patients airways. The parameter should be sensed continuously, e.g. by a flow detecting sensor inserted into the ventilation tubing circuit.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker in view of Goebel and include a display device connected to the controller unit, wherein the display device is configured to display a representation of a continuous thoracic pressure signal to provide the clinician with a method of monitoring thoracic pressure.
Regarding claim 47, Shaker teaches the device according to claim 1, but fails to teach wherein a trigger signal is generated for additional machine respiration is transferred to a ventilator as an electrical signal via one or more cables. Goebel does teach wherein a trigger signal is generated for additional machine respiration is transferred to a ventilator as an electrical signal via one or more cables (0033 states “The main unit 2 includes a means for receiving and interpreting the incoming data from the balloon 1 and for sending a signal to and controlling the pressure release unit 3. The interpreting and controlling means may include a pressure transducing module or a signal amplifying input module, a pneumatic pump mechanism, and/or a logic control unit. Thus the main unit 2 integrates parameter input and signal reading options.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Goebel and include wherein a trigger signal is generated for additional machine respiration is transferred to a ventilator as an electrical signal via one or more cables as this allows for positive pressure ventilation of the lungs.
Regarding claim 48, Shaker teaches the device according to claim 1, but fails to teach wherein a trigger signal is generated and is transferred to a ventilator as a pressure signal, and wherein air is discharged from a ventilation tube, leading from the ventilator to the patient, via a pressure relief valve. Goebel does teach a trigger signal that is generated and is transferred to a ventilator as a pressure signal (0035 pressure signal), in that air is discharged from a ventilation tube, leading from the ventilator to the patient (0033 states “The main unit 2 includes a means for receiving and interpreting the incoming data from the balloon 1 and for sending a signal to and controlling the pressure release unit 3. The interpreting and controlling means may include a pressure transducing module or a signal amplifying input module, a pneumatic pump mechanism, and/or a logic control unit. Thus the main unit 2 integrates parameter input and signal reading options.”), via a pressure relief valve (0035 states “The control unit 7 may be operatively connected with the pressure release unit 3 which may include a preferably electromagnetically operated valve mechanism.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Goebel and include wherein a trigger signal is generated and is transferred to a ventilator as a pressure signal, and wherein air is discharged from a ventilation tube, leading from the ventilator to the patient, via a pressure relief valve as this allows for the controlling of a valve to vent gas from the inhalation tubing of the ventilator to trigger an inhalation cycle (abstract).
Regarding claim 49, modified Shaker teaches the device according to claim 48, further comprising a pressure sensor that is connected to the controller unit, wherein the pressure sensor is configured to signal to the controller unit (0040 of Goebel states “in case the ventilator pressure sensor 13 is located adjacent to the patient proximal portion of the tracheal ventilation tube 14 as illustrated in FIG. 3b”) in whether the ventilator has triggered machine-assisted respiration (0048 of Goebel states “thereby generating the required flow or pressure change in the tubing, which in turn triggers the ventilator's tidal support. The main unit senses the onset of ventilator support by an increase in esophageal/tracheal cuff pressure. Once the increase in esophageal/tracheal cuff pressure is sensed, the triggering window and the valve 18 are closed until the pressure returns to the default pressure and optionally stays there for a certain defined period; within that period the slope of delta pressure/delta time should be neutral or negative.”).
Regarding claim 50, modified Shaker teaches the device according to claim 48 wherein the pressure relief valve is situated at a tubular connecting piece (a (Figure 1a of Goebel depicts a tubular connecting piece).
Regarding claim 54, Shaker teaches the device according to claim 1, but fails to teach wherein the controller unit is configured to receive data from a ventilator, wherein the data indicates a volume flow moved from the patient, a volume flow moved to the patient or the pleural pressure. Goebel does teach wherein the controller unit is configured to receive data from a ventilator, wherein the data indicates a volume flow moved from the patient, a volume flow moved to the patient or the pleural pressure (0048 states “at the start of the second respiratory cycle 32 using the inventive device, the intra-thoracic pressure decrease, marking the onset of patient breathing 24, is sensed by the inventive device which releases volume from the patient supplying ventilation tubing via the valve 18 (FIG. 3a), thereby generating the required flow or pressure change in the tubing, which in turn triggers the ventilator's tidal support.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Goebel and include wherein the controller unit is configured to receive data from a ventilator, wherein the data indicates a volume flow moved from the patient, a volume flow moved to the patient or the pleural pressure as this allows for a regulation of assist by the ventilator.
Regarding claim 55, modified Shaker teaches the device according to claim 54, further comprising a display device Configured to display a representation of the data (0010 discuses a curve or data table being generated).
Claims 35-39 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel in view of Hickey et al. 5,570,671
Regarding claim 35, Shaker teaches the device according to claim 1, but fails to teach one or more electrodes situated on the catheter unit, wherein the one or more electrodes are configured to receive electrical signals associated with the patient. Hickey does teach one or more electrodes situated on the catheter unit, wherein the one or more electrodes are configured to receive electrical signals associated with the patient (Column 2 line 66 states “one or more electrodes situated on the catheter unit, wherein the one or more electrodes are configured to receive electrical signals associated with the patient”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Hickey and include one or more electrodes situated on the catheter unit, wherein the one or more electrodes are configured to receive electrical signals associated with the patient as this allows for an esophageal electrocardiogram to be obtained (Column 2 line 66).
Regarding claim 36, modified Shaker teaches the device according to claim 35, wherein the one or more electrodes are situated at a surface of a shaft of the catheter unit, wherein the one or more electrodes are distal to the plurality of balloon components (Depicted in figure 1 of Hickey).
Regarding claim 37, modified Shaker teaches the device according to claim 35, wherein the one or more electrodes are situated at a surface of a shaft of the catheter unit, wherein the one or more electrodes are distributed in an axial direction (Column 6 line 36 of Hickey discusses the use of two electrodes 506 and 508). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Hickey and include wherein the one or more electrodes are situated at a surface of a shaft of the catheter unit, wherein the one or more electrodes are distributed in an axial direction, for the purpose of having multiple locations and types of measurements taken.
Regarding claim 38, modified Shaker teaches the device according to claim 35, a reference electrode that is proximal to other electrodes of the one or more electrodes (Either 506 or 508 of Hickey2 can be used as a reference electrode as “the electrograms may be recorded in terms of distance to the center of the first electrode 506, and a distance equal to half of the distance between the electrode centers added thereto.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shaker with the teachings of Hickey and include a reference electrode as this would provide a base measurement that would aid in eliminating baseline wander (Column 6 line 66)
Regarding claim 39, modified Shaker teaches the device according to claim 35, wherein the one or more electrodes are situated in an area of a shaft of the catheter unit that passes through a diaphragm placement in the esophagus (Electrodes 506 and 508 of Hickey are depicted in this location in figure 13).
Claims 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Shaker and Hickey in view of Goebel et al.
Regarding claim 40, modified Shaker teaches the device according to claim 35, but fails to teach, wherein each electrode of the one or more electrodes is individually contacted via a multicore cable. Goebel does teach wherein each electrode of the one or more electrodes is individually contacted via a multicore cable (0035 states “The transducing module 4 may be equipped with a communication port 6 for connection with a balloon 1 based sensor tube 1a or 1b, or an electric cable, in case an electronic pressure sensor is used on the pressure sensing catheter”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker with the teachings of Goebel and include wherein each electrode of the one or more electrodes is individually contacted via a multicore cable as this is a common method of connection.
Regarding claim 41, modified Shaker teaches the device according to claim 35, but fails to teach wherein the one or more electrodes are connectable to a monitoring module of the controller unit via a cable. Goebel does teach wherein the one or more electrodes are connectable to a monitoring module of the controller unit via a cable (0035 states “the main unit 2 may contain a pressure transducing module 4 and an analog-digital (A/D) converting module 5 converting the analog pressure signal into digitalized data.“, 0035 states “The transducing module 4 may be equipped with a communication port 6 for connection with a balloon 1 based sensor tube 1a or 1b, or an electric cable, in case an electronic pressure sensor is used on the pressure sensing catheter.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Shaker with the teachings of Goebel and include wherein the one or more electrodes are connectable to a monitoring module of the controller unit via a cable as this allows for the regulating of the sensor balloon.
Regarding claim 42, modified Shaker in view of Goebel teaches the device according to claim 41, wherein the monitoring module is configured to perform an autocorrelation function of electrode signals from the one or more electrodes detect cyclically recurring sequences of the electrode signals (0035 of Goebel states “the main unit 2 may contain a pressure transducing module 4 and an analog-digital (A/D) converting module 5 converting the analog pressure signal into digitalized data.“).
Regarding claim 43, modified Shaker in view of Goebel teaches the device according to claim 42, wherein the autocorrelation function correlates a pattern sequence is correlated with subsequent pattern sequences (0038 of Goebel states “The main unit 2 may also be equipped with an entering option for an auto-correlation coefficient (reaching from -1 to +1), chosen by the user, and functioning as a triggering threshold.”).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 56 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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