DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 06/09/2025. As directed by the amendment: claims 1, 12-13, and 15 have been amended, claims 11 and 17 have been cancelled, and no new claims have been added. Thus, claims 1-10, 12-16, and 18-20 are presently pending in this application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Office Action mailed on 04/03/2025.
Response to Arguments
Applicant's arguments on p.3-4 of “Remarks,” filed 06/09/2025, have been fully considered but they are not persuasive.
In response to the applicant’s argument that Hall in view of Ovchinnikov fails to disclose or teach the limitations of claims 11 and 17, the examiner respectfully disagrees. The applicant argues Ovchinnikov does not look for specific frequencies in a pressure signal that are correlated with a patient’s internal pressure. Examiner emphasizes that the limitations of claims 11 and 17 were rejected with Hall in combination with the teachings of Ovchinnikov. Hall provides the explicit teaching of determining which pressure measurements from a pressure signal are indicative of an intraperitoneal pressure using signal conditioning (see para. 0170). Examiner discussed in the previous office action that Ovchinnikov teaches filtering internal pressure signals using frequencies for specific events such as removing artifacts caused by motion or noise rather than specifically filtering for the internal pressure measurements, but examiner emphasizes that Ovchinnikov was utilized as a teaching for using the frequency domain to filter out specific events in a pressure signal. The combination of Hall explicitly disclosing signal processing to isolate intraperitoneal pressure measurements from artifacts in a signal with the signal processing methods of Ovchinnikov using the frequency domain would render the claim limitations obvious. Therefore, the rejection is maintained.
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(s) 1, 5-10, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (U.S Patent Pub. No. 20100204765 A1, “Hall”) in view of Ovchinnikov et al. (U.S Patent Pub. No. 20180207330 A1, “Ovchinnikov”).
Regarding claim 1, Hall discloses (Claim 1) a medical fluid delivery system (10 in at least Fig. 1A-1B) comprising: a medical fluid handling device (130 and 50) including a patient line (42) for being placed in fluid communication with a patient (see Fig. 1A-1B and para. 0076 and 0078 – system 10 for delivery of a fluid to a peritoneal cavity comprises a lavage administration set [LAS] 130 couples to a patient catheter 50, LAS 130 comprises patient lines 42 which are in fluid communication with the patient catheter 50); and a medical fluid delivery machine (40) including a pump actuator (90a and 90b) for actuating the medical fluid handling device (130 and 50) to move medical fluid into or out of the medical fluid handling device (130 and 50, see Fig. 1A and para. 0076, 0124, and 0129 – main unit 40 comprises the pumps 90a and 90b which provide pressure to actuate fluid flow from reservoir 70 into LAS 130 and out of catheter 50 to the body cavity), a pressure sensor (120b) positioned and arranged to sense pressure of the medical fluid (see para. 0111 – pressure sensors 120b may be located within a pressure measurement chamber 55 in the catheter 50, see para. 0079 – pressure sensors 120b are capable of sensing the pressure of the fluid or infusate 20 within the system 10), and a control unit (41) in signal communication with the pressure sensor (120b) and control communication with the pump actuator (90a and 90b, see para. 0113 – main unit 41 comprises controller 41 which receives signals from pressure sensor 120b, see para. 0129 – controller 41 sends control signals to pumps 90a and 90b), the control unit (41) programmed to perform a routine during pumping in which the control unit (41) (i) determines if at least one signal reading or a component of the at least one signal reading from the pressure sensor (120b) is indicative of a pressure within the patient (see para. 0094, 0113, and 0169-0170– controller 41 executes an electronic instruction set which upon receiving a signal from the pressure sensor 120b performs signal conditioning on the sensor data to remove artifacts and narrow in on the signals indicative of intraperitoneal pressure), and (ii) determines from the at least one pressure signal reading or component reading indicative of the pressure in the patient whether to continue pumping or stop pumping (see para. 0094 and 0113 – after the controller 41 receives the signal from the pressure sensor 120b, the controller 41 utilizes the pressure signal in a feedback loop to determine if the measured signal varies from a selected threshold and controls the pumps 90a and 90b to increase, decrease, or shut off accordingly), wherein the control unit (41) is configured to determine the at least one signal reading or the component of the at least one signal reading is indicative of the pressure within the patient (see para. 0094, 0113, and 0169-0170– controller 41 executes an electronic instruction set which upon receiving a signal from the pressure sensor 120b performs signal conditioning on the sensor data to remove artifacts and narrow in on the signals indicative of intraperitoneal pressure).
However, Hall fails to disclose the limitations of (Claim 1) wherein the control unit is configured to determine the at least one signal reading or the component of the at least one signal reading is indicative of the pressure within the patient by: converting the sensed pressure of the medical fluid from a time dependent signal into a frequency domain; and determining at least one of the frequencies of the sensed pressure of the medical fluid in the frequency domain corresponds to the pressure within the patient. Examiner notes Hall discloses a method for signal conditioning which isolates the pressure measurements related to cavity pressures from artifacts such as patient breathing, motion, etc., but Hall is silent to the details of the signal conditioning method (see para. 0169-0170).
Ovchinnikov discloses frequency-domain signal processing of continuously monitoring pressure sensor signals in fluid flow in phacoemulsification systems; however, the signal processing of continuously-monitored, pressure sensor signals in a body cavity would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of signal processing of continuously-monitored, pressure sensor signals in the peritoneal cavity. Ovchinnikov teaches (Claim 1) wherein the control unit (360) is configured to determine the at least one signal reading or the component of the at least one signal reading is indicative of a specific event by: converting the sensed pressure of the medical fluid from a time dependent signal into a frequency domain; and determining at least one of the frequencies of the sensed pressure of the medical fluid in the frequency domain corresponds to the specific event (see para. 0039-0041 – controller 360 includes a processor that performs FFTs on the pressure measurements of the irrigation fluid to convert them from the time-domain to the frequency-domain to then more easily determine which pressure measurement is indicative of a specific event based upon the pre-determined frequency characteristics for the specific events). Examiner notes Ovchinnikov discloses that the frequency characteristics of specific events such as motion of the equipment, noise, post-occlusion surge, or water hammer are pre-determined through simulations to then use these frequency characteristics to characterize the pressure measurements in the frequency-domain (see para. 0040-0041).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit routine step (i) taught by Hall to incorporate converting the sensed pressure of the medical fluid from a time dependent signal into a frequency domain and determine at least one of the frequencies of the sensed pressure of the medical fluid in the frequency domain corresponds to a specific event as taught by Ovchinnikov. The motivation for this modification is Ovchinnikov teaches that performing a fast Fourier transforms on the pressure signals to convert them into the frequency domain allows the controller to more easily differentiate between pressure-related events by using their pre-determined characteristics frequencies to distinguish therebetween and thus the controller can response appropriately to control the device according to the differentiated pressure measurements (see para. 0039-0041).
Regarding claim 5, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses (Claim 5) wherein the pressure sensor (120b) is a micromechanical ("MEMS") sensor (see para. 0098 – pressure sensor 120b may be a MEMS based strain gauge).
Regarding claim 6, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses the limitations of (Claim 6) wherein the control unit (41) is programmed to perform at least (i) or (ii) (see para. 0094, 0113, and 0169-0170– controller 41 executes an electronic instruction set which upon receiving a signal from the pressure sensor 120b performs signal conditioning on the sensor data to remove artifacts and narrow in on the signals indicative of intraperitoneal pressure, and then the controller 41 utilizes the pressure signal in a feedback loop to determine if the measured signal varies from a selected threshold and controls the pumps 90a and 90b to increase, decrease, or shut off accordingly).
In modified Hall, Ovchinnikov discloses (Claim 6) wherein the control unit (360) is programmed to perform at least (i) or (ii) in a frequency domain (see Fig. 3 and para. 0033-0034 – fluidics subsystem 110 comprises a controller 360 which is operable to communicate with pressure sensor 365 located within hand piece 112 for sensing fluid pressure representative with the surgical site and operable to control the driving device 372 for driving the fluids, see para. 0039-0040 – controller 360 includes a processor that performs a fast Fourier transform [FFT] on the pressure measurements to convert them from the time domain to the frequency-domain to then more easily determine which pressure measurement is indicative of a specific event, examiner notes that this process carried out by controller 360 would be analogous to step [i] for determining if a signal reading is indicative of a specific pressure).
Regarding claim 7, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses (Claim 7) wherein determining from the at least one pressure signal reading or component of the at least one pressure signal reading whether to continue pumping or stop pumping includes evaluating a change in the at least one pressure signal reading or component of the at least one pressure signal reading (see para. 0094 and 0113 – after the controller 41 receives the signal from the pressure sensor 120b, the controller 41 utilizes the pressure signal in a feedback loop to determine if the measured signal varies from a selected threshold and controls the pumps 90a and 90b to increase, decrease, or shut off accordingly).
Regarding claim 8, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses (Claim 8) wherein the control unit (41) includes at least one of at least one processor, at least one memory, or at least one delegate controller (see para. 0094 – controller 41 comprises a computer processor).
Regarding claim 9, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses (Claim 9) the medical fluid delivery system (10) of Claim 1, wherein the pressure within the patient is an intraperitoneal pressure ("IPP") (see para. 0079 – pressure sensors 120b can detect pressure information such as intraperitoneal pressure).
Regarding claim 10, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses (Claim 10) wherein the pressure sensor (120b) and the control unit (41) are configured to record a continuous or semi-continuous measurement of the pressure of the medical fluid (see para. 0113 and 0151 – the sensors of the system 10 continually monitor the pressure within the system such as intraperitoneal pressure or fluid pressure with the signals being continually analyzed by the controller 41).
Regarding claim 14, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses (Claim 14) wherein the control unit (41) is configured to determine to stop pumping when the at least one pressure signal reading or component reading indicative of the pressure in the patient is indicative that a peritoneal cavity of the patient is full or near to full with the medical fluid (see para. 0113 – controller 41 controls the infusion of pumps 90a and 90b to shut off infusion when the pressure signal varies from a selected threshold, the selected threshold is indicative of a pressure value that would cause over-pressurization of the peritoneal cavity).
Regarding claim 15, Hall discloses the limitations of (Claim 15) a medical fluid delivery method comprising: causing a pump actuator (90a and 90b), included within a medical fluid delivery machine (40), to actuate a medical fluid handling device (130 and 50) to move medical fluid into or out of the medical fluid handling device (130 and 50, see Fig. 1A and para. 0076, 0124, and 0129 – main unit 40 comprises the pumps 90a and 90b which provide pressure to actuate fluid flow from reservoir 70 into LAS 130 and out of catheter 50 to the body cavity), the medical fluid handling device (130 and 50) including a patient line (42) for being placed in fluid communication with a patient (see Fig. 1A-1B and para. 0076 and 0078 – system 10 for delivery of a fluid to a peritoneal cavity comprises a lavage administration set [LAS] 130 couples to a patient catheter 50, LAS 130 comprises patient lines 42 which are in fluid communication with the patient catheter 50); recording, via a pressure sensor (120b) positioned and arranged within the medical fluid handling device (130 and 50, see Fig. 3A and see para. 0111 – pressure sensors 120b may be located within a pressure measurement chamber 55 in the catheter 50), pressure of the medical fluid during actuation of the medical fluid handling device (130 and 50, see Fig. 1A-1B and para. 0079 – pressure sensors 120b measure pressure of the medical fluid or infusate 20 of the system during use); determining, via a control unit (41), when at least one signal reading or a component of the at least one signal reading from the pressure sensor (120b) is indicative of a pressure within the patient (see para. 0094, 0113, and 0169-0170– controller 41 executes an electronic instruction set which upon receiving a signal from the pressure sensor 120b performs signal conditioning on the sensor data to remove artifacts and narrow in on the signals indicative of intraperitoneal pressure); and determining, via the control unit (41), whether to continue pumping with the pump actuator (90a and 90b) or stop pumping using the at least one pressure signal reading or component reading indicative of the pressure in the patient (see para. 0094 and 0113 – after the controller 41 receives the signal from the pressure sensor 120b, the controller 41 utilizes the pressure signal in a feedback loop to determine if the measured signal varies from a selected threshold and controls the pumps 90a and 90b to increase, decrease, or shut off accordingly)
However, Hall fails to disclose the limitations of (Claim 15) converting, via the control unit, the sensed pressure of the medical fluid from a time dependent signal into a frequency domain; and determining, via the control unit, at least one of the frequencies of the sensed pressure of the medical fluid in the frequency domain corresponds to the pressure within the patient.
Ovchinnikov teaches (Claim 15) converting, via the control unit (360), the sensed pressure of the medical fluid from a time dependent signal into a frequency domain; and determining, via the control unit (360), at least one of the frequencies of the sensed pressure of the medical fluid in the frequency domain corresponds to a specific event (see para. 0039-0041 – controller 360 includes a processor that performs FFTs on the pressure measurements of the irrigation fluid to convert them from the time-domain to the frequency-domain to then more easily determine which pressure measurement is indicative of a specific event based upon the pre-determined frequency characteristics for the specific events). Examiner notes Ovchinnikov discloses that the frequency characteristics of specific events such as motion of the equipment, noise, post-occlusion surge, or water hammer are pre-determined through simulations to then use these frequency characteristics to characterize the pressure measurements in the frequency-domain (see para. 0040-0041).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit routine taught by Hall to incorporate converting the sensed pressure of the medical fluid from a time dependent signal into a frequency domain and determine at least one of the frequencies of the sensed pressure of the medical fluid in the frequency domain corresponds to a specific event as taught by Ovchinnikov. The motivation for this modification is Ovchinnikov teaches that performing a fast Fourier transforms on the pressure signals to convert them into the frequency domain allows the controller to more easily differentiate between pressure-related events by using their pre-determined characteristics frequencies to distinguish therebetween and thus the controller can response appropriately to control the device according to the differentiated pressure measurements (see para. 0039-0041).
Regarding claim 16, modified Hall discloses the method of claim 15, as discussed above. In modified Hall, Hall discloses (Claim 16) wherein the control unit (41) is configured to determine to stop pumping when the at least one pressure signal reading or component reading indicative of the pressure in the patient is indicative that a peritoneal cavity of the patient is full or near to full with the medical fluid (see para. 0113 – controller 41 controls the infusion of pumps 90a and 90b to shut off infusion when the pressure signal varies from a selected threshold, the selected threshold is indicative of a pressure value that would cause over-pressurization of the peritoneal cavity).
Claim(s) 2, 4, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Ovchinnikov as applied to claim 1 and 15, respectively, and further in view of Burbank et al. (U.S Patent Pub. No. 20140018727 A1, “Burbank”).
Regarding claim 2, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall disclosesHall the limitations of (Claim 2) wherein the medical fluid handling device (130 and 50) further includes a patient transfer set (140) for connecting to a patient's indwelling catheter (50, see Fig. 1A and para. 0078-0079 – LAS 130 comprises a hub 140 which connects tubing to the catheter 50).
However, modified Hall fails to disclose (Claim 2) wherein the pressure sensor is placed within the patient transfer set. Examiner notes the pressure sensor 120b may be attached to the hub 140 (see para. 0079).
Burbank discloses a peritoneal dialysis system with a pressure detection device. Burbank teaches (Claim 2) wherein the medical fluid handling device (60) further includes a patient transfer set (46 and 47) for connecting to a patient's indwelling catheter (see Fig. 2B and para. 0056 – peritoneal dialysis tubing set 60 couples to a cycler similarly to the set illustrated in Fig. 1, set 60 comprising a fill/drain line 47 and catheter connector 46 which are interpreted as the patient transfer set), and wherein the pressure sensor (45) is placed within the patient transfer set (46 and 47, see Fig. 2B and para. 0056 – pressure transducer 45 may be a strain gauge that is built into a wall of the fill/drain line 47 and thus is interpreted as being within the fill/drain line 47).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the pressure sensor located in the catheter or attached to the connector hub of the transfer set taught by modified Hall with a pressure sensor located within the patient line as taught by Burbank. Burbank discloses a peritoneal dialysis system comprising a medical fluid delivery machine in the form of a cycler which fluidly communicates with a disposable peritoneal dialysis tubing set interpreted as the medical fluid handling device, and wherein a pressure transducer is positioned and arranged within the fill line. Burbank discloses in alternative embodiments that the pressure detection device 110 may be located at the end of the fill line 112, alternatively adjacent the patient in the patient catheter 114 itself (see para. 0050), or alternatively be formed within the drain/fill line (see para. 0056). One of ordinary skill in the art could have substituted the known pressure sensor of modified Hall for the pressure sensor within the fill line as taught by the embodiment of Fig. 2B of Burbank, and the results of the substitution would have been predictable as Burbank teaches a pressure detection device that may be located in alternative placements within the medical fluid handling device. Further, the motivation for this modification is that Burbank teaches a pressure sensor that takes pressure readings close to the patient to reduce the error in pressure measurement of the peritoneal cavity due to either pressure loss in the fill line during filling of the cavity or due to height level differences causing gravitational head pressure (see para. 0050).
Regarding claim 4, modified Hall discloses the system of claim 1, as discussed above.
However, modified Hall fails to disclose (Claim 4) wherein the pressure sensor is placed within the patient line.
Burbank teaches (Claim 4) wherein the pressure sensor (45) is placed within the patient line (47, see Fig. 2B and para. 0056 – fill/drain line 47 is interpreted as a patient line which connects the dialysis system to the patient catheter, pressure transducer 45 may be a strain gauge that is built into a wall of the fill/drain line 47 and thus is interpreted as being within the fill/drain line 47).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the pressure sensor located in the catheter or attached to the connector hub of the transfer set taught by modified Hall with a pressure sensor located within the patient line as taught by Burbank. Burbank discloses a peritoneal dialysis system comprising a medical fluid delivery machine in the form of a cycler which fluidly communicates with a disposable peritoneal dialysis tubing set interpreted as the medical fluid handling device, and wherein a pressure transducer is positioned and arranged within the fill line. Burbank discloses in alternative embodiments that the pressure detection device 110 may be located at the end of the fill line 112, alternatively adjacent the patient in the patient catheter 114 itself (see para. 0050), or alternatively be formed within the drain/fill line (see para. 0056). One of ordinary skill in the art could have substituted the known pressure sensor of modified Hall for the pressure sensor within the fill line as taught by the embodiment of Fig. 2B of Burbank, and the results of the substitution would have been predictable as Burbank teaches a pressure detection device that may be located in alternative placements within the medical fluid handling device. Further, the motivation for this modification is that Burbank teaches a pressure sensor that takes pressure readings close to the patient to reduce the error in pressure measurement of the peritoneal cavity due to either pressure loss in the fill line during filling of the cavity or due to height level differences causing gravitational head pressure (see para. 0050).
Regarding claim 18, modified Hall discloses the method of claim 15, as discussed above. In modified Hall, Hall discloses the limitations (Claim 18) wherein the medical fluid handling device (130 and 50) further includes a patient transfer set (140) for connecting to a patient's indwelling catheter (50, see Fig. 1A and para. 0078-0079 – LAS 130 comprises a hub 140 which connects tubing to the catheter 50).
However, modified Hall fails to disclose (Claim 18) wherein the pressure sensor is placed within the patient transfer set. Examiner notes the pressure sensor 120b may be attached to the hub 140 (see para. 0079).
Burbank teaches (Claim 18) wherein the medical fluid handling device (60) further includes a patient transfer set (46 and 47) for connecting to a patient's indwelling catheter (see Fig. 2B and para. 0056 – peritoneal dialysis tubing set 60 couples to a cycler similarly to the set illustrated in Fig. 1, set 60 comprising a fill/drain line 47 and catheter connector 46 which are interpreted as the patient transfer set), and wherein the pressure sensor (45) is placed within the patient transfer set (46 and 47, see Fig. 2B and para. 0056 – pressure transducer 45 may be a strain gauge that is built into a wall of the fill/drain line 47 and thus is interpreted as being within the fill/drain line 47).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the pressure sensor located in the catheter or attached to the connector hub of the transfer set taught by modified Hall with a pressure sensor located within the patient line as taught by Burbank. Burbank discloses a peritoneal dialysis system comprising a medical fluid delivery machine in the form of a cycler which fluidly communicates with a disposable peritoneal dialysis tubing set interpreted as the medical fluid handling device, and wherein a pressure transducer is positioned and arranged within the fill line. Burbank discloses in alternative embodiments that the pressure detection device 110 may be located at the end of the fill line 112, alternatively adjacent the patient in the patient catheter 114 itself (see para. 0050), or alternatively be formed within the drain/fill line (see para. 0056). One of ordinary skill in the art could have substituted the known pressure sensor of modified Hall for the pressure sensor within the fill line as taught by the embodiment of Fig. 2B of Burbank, and the results of the substitution would have been predictable as Burbank teaches a pressure detection device that may be located in alternative placements within the medical fluid handling device. Further, the motivation for this modification is that Burbank teaches a pressure sensor that takes pressure readings close to the patient to reduce the error in pressure measurement of the peritoneal cavity due to either pressure loss in the fill line during filling of the cavity or due to height level differences causing gravitational head pressure (see para. 0050).
Regarding claim 20, modified Hall discloses the method of claim 15, as discussed above.
However, modified Hall fails to disclose (Claim 20) wherein the pressure sensor is placed within the patient line.
Burbank teaches (Claim 20) wherein the pressure sensor (45) is placed within the patient line (47, see Fig. 2B and para. 0056 – fill/drain line 47 is interpreted as a patient line which connects the dialysis system to the patient catheter, pressure transducer 45 may be a strain gauge that is built into a wall of the fill/drain line 47 and thus is interpreted as being within the fill/drain line 47).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the pressure sensor located in the catheter or attached to the connector hub of the transfer set taught by modified Hall with a pressure sensor located within the patient line as taught by Burbank. Burbank discloses a peritoneal dialysis system comprising a medical fluid delivery machine in the form of a cycler which fluidly communicates with a disposable peritoneal dialysis tubing set interpreted as the medical fluid handling device, and wherein a pressure transducer is positioned and arranged within the fill line. Burbank discloses in alternative embodiments that the pressure detection device 110 may be located at the end of the fill line 112, alternatively adjacent the patient in the patient catheter 114 itself (see para. 0050), or alternatively be formed within the drain/fill line (see para. 0056). One of ordinary skill in the art could have substituted the known pressure sensor of modified Hall for the pressure sensor within the fill line as taught by the embodiment of Fig. 2B of Burbank, and the results of the substitution would have been predictable as Burbank teaches a pressure detection device that may be located in alternative placements within the medical fluid handling device. Further, the motivation for this modification is that Burbank teaches a pressure sensor that takes pressure readings close to the patient to reduce the error in pressure measurement of the peritoneal cavity due to either pressure loss in the fill line during filling of the cavity or due to height level differences causing gravitational head pressure (see para. 0050).
Claim(s) 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Ovchinnikov as applied to claims 1 and 15, respectively, and further in view of Plahey et al. (U.S Patent Pub. No. 20060195064 A1, “Plahey”).
Regarding claim 3, modified Hall discloses the system of claim 1, as discussed above.
However, modified Hall fails to disclose (Claim 3) wherein the medical fluid handling device further includes a pumping cassette, and wherein the pressure sensor is placed within the pumping cassette. Examiner notes Hall discloses that the pumps 90a and 90b can be configured to interface a pump cassette portion of the catheter (see para. 0129), but is silent to how the administration set 130 and catheter 50 would interface with such a cassette portion.
Plahey discloses a portable peritoneal dialysis apparatus having a main housing and cassette (see para. 0030). Plahey teaches (Claim 3) wherein the medical fluid handling device (see Fig. 9) further includes a pumping cassette (87, see Fig.9 and para. 0049 – medical fluid handling device is being interpreted as the cassette 28 and coupled fluid lines seen in Fig. 1), and wherein the pressure sensor (P) is placed within the pumping cassette (28, examiner notes the medical fluid handling device is being interpreted as having components of the pressure sensors and thus a component of the fluid handling device such as a pumping cassette comprises components of the pressure sensors, see Fig. 4 and para. 0050-0051 – cassette 28 comprises pressure sensing areas “P” that are the components for the system of pressure transducers 33 which together indirectly detect the pressure and vacuum within the patient’s peritoneum).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporate the administration set taught by modified Hall into a pumping cassette as taught by Plahey, and further simply substituted the pressure sensor attached to the patient line or within the catheter with a pressure sensor located within the pumping cassette as taught by Plahey. Plahey discloses a portable peritoneal dialysis system comprising a medical fluid delivery machine in the form of a main housing which fluidly communicates with a disposable pumping cassette interpreted as the medical fluid handling device, and wherein a pressure transmitting components of the sensor are positioned and arranged within pumping cassette. Plahey discloses that the pressure sensing areas “P” for measuring pressure within the pump chambers may be located within the pumping cassette (see para. 0050). One of ordinary skill in the art could have substituted the known pressure sensor of modified Hall for the pressure sensor within the pumping cassette as taught by Plahey and the results of the substitution would have been predictable as Plahey teaches pressure sensors that are located within the pumping cassette to indirectly detect the pressure and vacuum within the patient’s peritoneum by sensing the fluid pressure within the pump chambers A and B (see para. 0050).
Regarding claim 19, modified Hall discloses the method of claim 15, as discussed above.
However, modified Hall fails to disclose (Claim 19) wherein the medical fluid handling device further includes a pumping cassette, and wherein the pressure sensor is placed within the pumping cassette. Examiner notes Hall discloses that the pumps 90a and 90b can be configured to interface a pump cassette portion of the catheter (see para. 0129), but is silent to how the administration set 130 and catheter 50 would interface with such a cassette portion.
Plahey teaches (Claim 19) wherein the medical fluid handling device (see Fig. 9) further includes a pumping cassette (87, see Fig.9 and para. 0049 – medical fluid handling device is being interpreted as the cassette 28 and coupled fluid lines seen in Fig. 1), and wherein the pressure sensor (P) is placed within the pumping cassette (28, examiner notes the medical fluid handling device is being interpreted as having components of the pressure sensors and thus a component of the fluid handling device such as a pumping cassette comprises components of the pressure sensors, see Fig. 4 and para. 0050-0051 – cassette 28 comprises pressure sensing areas “P” that are the components for the system of pressure transducers 33 which together indirectly detect the pressure and vacuum within the patient’s peritoneum).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporate the administration set taught by modified Hall into a pumping cassette as taught by Plahey, and further simply substituted the pressure sensor attached to the patient line or within the catheter with a pressure sensor located within the pumping cassette as taught by Plahey. Plahey discloses a portable peritoneal dialysis system comprising a medical fluid delivery machine in the form of a main housing which fluidly communicates with a disposable pumping cassette interpreted as the medical fluid handling device, and wherein a pressure transmitting components of the sensor are positioned and arranged within pumping cassette. Plahey discloses that the pressure sensing areas “P” for measuring pressure within the pump chambers may be located within the pumping cassette (see para. 0050). One of ordinary skill in the art could have substituted the known pressure sensor of modified Hall for the pressure sensor within the pumping cassette as taught by Plahey and the results of the substitution would have been predictable as Plahey teaches pressure sensors that are located within the pumping cassette to indirectly detect the pressure and vacuum within the patient’s peritoneum by sensing the fluid pressure within the pump chambers A and B (see para. 0050).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Ovchinnikov as applied to claim 1 above, and further in view of Banet et al. (U.S Patent Pub. No. 20090018409 A1, “Banet”).
Regarding claim 12, modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses the limitations of (Claim 12) wherein the control unit (41) is configured to determines the sensed pressure of the medical fluid corresponds to pressure within the patient (see para. 0094, 0113, and 0169-0170– controller 41 executes an electronic instruction set which upon receiving a signal from the pressure sensor 120b would first comprise determining which sensor the data was received from indicating a step of determining if the received signal is a pressure signal from sensor 120b which is a pressure indicative of an intraperitoneal pressure, controller 41 then performs signal conditioning on the sensor data to remove artifacts and narrow in on the signals indicative of intraperitoneal pressure).
In modified Hall, Ovchinnikov discloses the limitations (Claim 12) wherein the control unit is further configured to determine at least one of the frequencies of the sensed pressure of the medical fluid in the frequency domain corresponds to a specific event (see para. 0039-0041 – controller 360 includes a processor that performs FFTs on the pressure measurements of the irrigation fluid to convert them from the time-domain to the frequency-domain to then more easily determine which pressure measurement is indicative of a specific event based upon the pre-determined frequency characteristics for the specific events). Examiner notes Ovchinnikov discloses that the frequency characteristics of specific events such as motion of the equipment, noise, post-occlusion surge, or water hammer are pre-determined through simulations to then use these frequency characteristics to characterize the pressure measurements in the frequency-domain (see para. 0040-0041).
However, modified Hall fails to disclose the limitations of (Claim 12) using at least one of a low-pass filter, a high-pass filter, a Twin T Active Notch filter, or a bandpass filter on the sensed pressure of the medical fluid in the frequency domain before determining at least one of the frequencies corresponds to pressure within the patient.
Banet discloses frequency-domain signal processing of continuously monitoring acoustic sensor signals during respiration to determine respiration rate; however, the signal processing of continuously-monitored, sensor signals in a high noise environment would have been reasonably pertinent and one in the art would have consulted such art and applied its teaching when faced with solving the problem of signal processing of continuously-monitored, pressure sensor signals in the peritoneal cavity. Banet teaches (Claim 12) using at least one of a low-pass filter, a high-pass filter, a Twin T Active Notch filter, or a bandpass filter on the sensed signal in the frequency domain before determining at least one of the frequencies corresponds to a specific event (see Fig. 7A-7F and para. 0049-0053 – the software based algorithm, shown in Fig. 7A-7F, digitally filters an acoustic waveform comprised of acoustic sensor signals collected from patch sensors placed on a patient’s upper body, the algorithm first converts the time dependent signal 110 to the frequency domain signal 111 using a fast Fourier transform, a digital bandpass filter is then applied to the frequency dependent signal 111 to eliminate extraneous frequencies not related to respiration such as noise, room lights, electrical equipment, and other artifacts, the bandpass filter is applied to the waveform before the finalized determination of the frequency that corresponds to the respiration rate).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit routine comprising a FFT taught by modified Hall to incorporate a filtering step after the FFT but before determining at least one of the frequencies corresponds to a specific event as taught by Banet. The motivation for this modification is Banet teaches applying a bandpass filter to the frequency-domain waveform to precisely filter out chosen frequencies that are not associated with the desired event such as noise and other artifacts (see para. 0050-0051).
Regarding claim 13 modified Hall discloses the system of claim 1, as discussed above. In modified Hall, Hall discloses the limitations of (Claim 13) wherein the control unit is further configured to determine the sensed pressure that represents the pressure within the patient (see para. 0094, 0113, and 0169-0170– controller 41 executes an electronic instruction set which upon receiving a signal from the pressure sensor 120b would first comprise determining which sensor the data was received from indicating a step of determining if the received signal is a pressure signal from sensor 120b which is a pressure indicative of an intraperitoneal pressure, controller 41 then performs signal conditioning on the sensor data to remove artifacts and narrow in on the signals indicative of intraperitoneal pressure).
However, modified Hall fails to disclose the limitations (Claim 13) wherein the control unit is further configured to convert the sensed pressure of the medical fluid in the frequency domain to a value that represents the pressure within the patient.
Banet teaches (Claim 13) wherein the control unit is further configured to convert the sensed pressure of the medical fluid in the frequency domain to a value that represents the pressure within the patient (see Fig. 4 and para. 0033 – patch sensor 42a functions in a system with a body-worn unit that comprises circuitry being interpreted as the control unit, see Fig. 7A-7F and 0049-0053 – the software based algorithm, shown in Fig. 7A-7F and performed by the body-worn unit of Fig. 4, digitally filters an acoustic waveform comprised of acoustic sensor signals collected from patch sensor 42a placed on a patient’s upper body, the algorithm first converts the time dependent signal 110 to the frequency domain signal 111 using a fast Fourier transform, a digital bandpass filter is then applied to the frequency dependent signal 111 to eliminate extraneous frequencies not related to respiration, multiple filtering iterations are then carried out to eventually yield a time-dependent waveform 114 which is further converted into a train 115 of values that represent respiratory rate). Examiner notes Banet discloses a signal processing algorithm that converts a continuous, time-dependent, sensor signal into the frequency domain and eventually outputs a waveform of values that are representative of a desired parameter.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit routine comprising a FFT taught by modified Hall to incorporate converting the signal in the frequency domain to a value representative of the specific event as taught by Banet. The motivation for this modification is Banet teaches a signal processing algorithm that easily filters out sensor signals unrelated to the desired parameter using the frequency domain and outputs a waveform of values that can be easily analyzed to determine the desired parameter (see para. 0051-0053).
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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/K.M.T./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783