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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the flow path switching mechanism defined by a disposable fluid circuit removably engaged with the valve network of amended claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2015/0005699 to Burbank et al. (“Burbank”) in view of U.S. Patent Publication No. 2013/0172803 to Olde et al. (“Olde”), U.S. Patent No. 2015/0027951 to Wallace et al. (“Wallace”), and U.S. Patent Publication No. 2012/0185267 to Kamen et al. (“Kamen”).
Regarding claim 1, Burbank teaches a peritoneal dialysis system (Fig. 6A) comprising a cycler component, wherein the cycler component includes a pump ([0084], pump in 616) and a valve network (732A-H, Fig. 7A), a flow path switching mechanism defined by a disposable fluid circuit (700) removably (by virtue of being disposable) engaged with the valve network of the cycler component (Fig. 7A) and adapted to define multiple flow paths interconnecting a patient access line (650, Fig. 6K), at least one fluid line (642/724), and a drain line (618/712), via the valve network opening and closing selected fluid lines of the disposable fluid circuit ([0104]), at least one pressure sensor (613/614) configured to measure a fluid pressure and located at one or more locations, said locations including a proximal end of the patient access line (614) or a distal end of the patient access line (613), and a controller (610) capable of controlling the pump and the flow path switching mechanism to perform cycler-assisted peritoneal dialysis treatment, the controller applying a closed-loop control on the pump based on a pressure feedback signal from the pressure sensor indicating the fluid pressure in the patient access line ([0057], flow rate is controlled by a continuous feedback loop using pressure sensor information), the controller is configured to apply the closed-loop control on the pump during a drain cycle of the cycler-assisted peritoneal dialysis treatment ([0062], “during fill and drain operations”), and the controller is configured to control the pump, to drain a patient’s peritoneal cavity based on the pressure feedback signal from the at least one pressure sensor ([0062]), but does not teach the pressure feedback signal being an envelope of a signal from the at least one pressure sensor, draining at a constant pressure, and stopping at a predetermined lower value
Olde teaches using an envelope of a signal from at least one pressure sensor ([0116]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an envelope of the signal from a pressure sensor as taught by Olde as the information used for the pressure feedback signal of Burbank to yield the predictable result of providing pressure sensor data. Pressure sensor data can be obtained in many different ways, Olde merely teaches one example of providing pressure sensor data which uses an envelope of the measurement data.
Wallace teaches draining while maintaining a constant pressure ([0082]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Burbank and Olde to drain at a constant pressure as taught by Wallace for the predictable result of maintaining a consistent drain volume output which promotes efficient drainage operations.
Kamen teaches stopping a pump when the controller determines that a pump rate reaches a predetermined minimum value ([0522). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Burbank, Olde, and Wallace to stop when the pump reaches a predetermine minimum value to stop the of infusion fluid to the patient if a fault or error code exists ([0522]) to ensure patient safety.
Regarding claim 2, Burbank, Olde, Wallace, and Kamen teach the peritoneal dialysis system of claim 1 as shown above, Burbank further teaching the controller is configured to apply the closed-loop control on the pump during a fill cycle of the cycler-assisted peritoneal dialysis treatment ([0057], “during filling”).
Regarding claim 3, Burbank, Olde, Wallace, and Kamen teach the peritoneal dialysis system of claim 2 as shown above, Burbank further teaching controlling the pump to fill a patient’s peritoneal cavity ([0004]) based on the pressure feedback signal from the pressure sensor ([0062]) and then to stop the pump when a defined volume of fluid has been delivered ([0205] & [0217]), but does not teach filling at a constant pressure.
Wallace further teaching controlling a pump to fill while maintaining a constant pressure ([0091]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have controlled the pump of Burbank and Olde to fill at a constant pressure as taught by Wallace in order to provide more stable conditions to improve flow balance accuracy ([0091]).
Regarding claim 7, Burbank, Olde, Wallace, and Kamen teach the peritoneal dialysis system of claim 1 as shown above, Burbank further teaching the pump is a peristaltic pump ([0094]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Burbank, Olde, Wallace, and Kamen as applied to claim 1 as shown above, and further in view of U.S. Patent Publication No. 2020/0368418 to Yuds et al. (“Yuds”).
Regarding claim 6, Burbank, Olde, Wallace, and Kamen teach the peritoneal dialysis system of claim 1 as shown above including a controller, but does not show controlling the rate based on a comfort level set by a user.
Yuds teaches controlling a rate of the pump based on a comfort level set by a user ([0054], patient comfort feedback mechanism). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Burbank, Olde, Wallace, and Kamen to allow pump rate adjustments based on a comfort level set by a user for the predictable result of advantageously giving the user control to enhance comfort which allows for greater tolerance by the user in order to continue and enhance treatment overall.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Burbank, Olde, Wallace, and Kamen as applied to claim 1 as shown above, and further in view of U.S. Patent Publication No. 2014/0319035 to Burbank et al. (“Burbank ‘035”).
Regarding claim 8, Burbank, Olde, Wallace, and Kamen teach the peritoneal dialysis system of claim 1 as shown above, but do not teach the air detector.
Burbank ‘035 teaches an air detector on the patient access line ([0029]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burbank, Olde, Wallace, and Kamen to include an air detector as taught by Burbank ‘035 for the predictable result of allowing the system to detect potential leaks which could significantly affect patient care and treatment.
Claims 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank, Olde, Wallace, and Kamen as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2005/0075624 to Miesel and U.S. Patent Publication No. 2020/0352441 to Soykan et al. (“Soykan”).
Regarding claim 48, Burbank, Olde, Wallace, and Kamen teach the peritoneal dialysis system according to claim 1 as shown above, but do not teach the audio events and the microphone.
Misel teaches temporarily ignoring changes in pressure detected by at least one pressure sensor as a result of an audio event ([0088], the audio event is coughing, which is disregarded in the pressure data as a transient event). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Burbank, Olde, Wallace, and Kamen to ignore changes due to an audio even as taught by Miesel to yield the predictable result of avoiding transient events which would give false pressure readings.
Soykan teaches a microphone, wherein the controller is configured to monitor an audio signal captured by the microphone, to identify audio events based on the audio signal ([0057] and Fig. 5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a microphone to create an audio signal corresponding to the audio event of Misel as taught by Soykan to yield the predictable result of providing a means to capture the audio signal corresponding to coughing. Misel already shows the use of coughing data, Soykan simply shows one art-recognized example of obtaining coughing data, namely a microphone.
Regarding claim 49, Burbank, Olde, Wallace, Kamen, Misel, and Soykan teach the peritoneal dialysis system according to claim 48 as shown above, Misel previously teaching the audio events include coughing or sneezing by a patient ([0088] as shown above). Once combined the captured audio signals would be for the patient connected to the patient access line.
Response to Arguments
Applicant’s arguments and with respect to drawing objections have been fully considered and are not persuasive. Applicant argues that the disposable fluid circuit is reference numeral 416. Examiner respectfully disagrees. The recitation cited by Applicant in context states “[t]he fluid circuit with pump and valve network 416 is a fluid circuit element. Every recitation of reference numeral 416 is identified as the valve network, not the fluid circuit. According to the specification, the fluid circuit element appears to encompass the pump, the valve network, as well as sensors, actuators, and additional pumps. Therefore, element 416 alone is not the fluid circuit, it is only the valve network which may or may not be part of the fluid circuit. Examiner requests identification in the drawings of exactly which elements make up the disposable fluid circuit and/or the flow path switching mechanism.
Examiner further notes that elements which appear to be part of the fluid circuit as described in the specification appear to be separately claimed. For example, the pressure sensor and pump appear to be part of the fluid circuit as described in the specification, however, the pressure sensor and pump are claimed separately from the disposable fluid circuit. If the pressure sensor and pump are intended to be part of the fluid circuit as the specification appears to support, then the claims should reflect such an understanding. Clarification is requested.
Applicant’s arguments and amendments with respect to the art rejection of claim 1 have been fully considered and are not persuasive. Applicant argues that Kamen does not teach maintaining a constant pressure. Examiner submits that Kamen is not being relied upon to teach maintaining a constant pressure thereby rendering the argument moot. Applicant argues that Kamen does not teach stopping the pump when the pump rate remains at a predetermined lower value that is higher than said predetermined value for at least a predetermined interval of time. Examiner submits that such a limitation is an alternative reason for stopping the pump and that Kamen is being relied upon for the other alternative, thereby rendering the argument moot. Applicant argues that Kamen does not teach stopping the pump when a pump rate reaches a minimum value and that at most, Kamen merely teaches delivering a prescribed volume by counting motor strokes. Examiner respectfully disagrees. Paragraph [0522] is not merely concerned with delivering a prescribed volume. Kamen states “the infusion rate as measured is outside of a predetermined range or is beyond a threshold, and can communicate a stop comment to the pump to stop the pump” [0522]. A predetermined range would include a predetermined maximum and minimum, and Kamen clearly states that the pump would be stopped if the infusion rates is outside that range, which includes being below a predetermined minimum. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation is found in Kamen itself, when delivering fluids to a patient, great care must be taken to follow the correct dosage and rate in order to best treat the patient. The reality is that problems do occur, and safety measures are necessary to ensure proper patient care. In the instant case, Kamen shows an old and well-known safety or “watchdog” system that monitors delivery rates to ensure they stay within a specified range and will stop delivery if the rate goes outside that range in paragraph [0522]. Such safety mechanisms are often a necessity in any type of fluid delivery system. The rejection stands.
Conclusion
THIS ACTION IS MADE FINAL. 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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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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