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 3/23/26. As directed by the amendment: claims 1, 4, 6-8, 11, 12, and 15-18 have been amended, claims 14, 21, and 22 have been cancelled, and no new claims have been added. Thus, claims 1-13 and 15-20 are presently pending in this application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 1-3, 13, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (US 20190022296) in view of Kopperschmidt (US 20090247926).
Regarding claim 1, Ly et al. discloses a medical fluid delivery system comprising: a fluid pump (pistons 133A/B and piston heads 134A/B in pump chambers 138A/B; par. 0076); a pressure sensor (sensors 151A/B) for sensing pressure of fluid pumped by the fluid pump (par. 0076), wherein an output from the pressure sensor varies depending upon whether medical fluid or air is pumped during a pump stroke of the medical fluid pump (par. 0076); and a control unit configured to use the output from the pressure sensor to determine whether medical fluid or air is present during the pump stroke (par. 0076), except for specifically disclosing the control unit configured to analyze peak to peak values of the output from the pressure sensor to determine whether medical fluid or air is present during the pump stroke. However, Kopperschmidt teaches a control unit 22 configured to use the output from the pressure sensor to determine whether medical fluid or air is present during the pump stroke (par. 0030-0031) by analyzing peak to peak values of the output from the pressure sensor (par. 0075-0092). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ly et al. to utilize peak to peak analysis of pressure sensor output, as taught by Kopperschmidt, since Kopperschmidt teaches variability of peaks being associated with the presence of air (see at least fig. 2 and par. 0075-0092).
Regarding claim 2, Ly et al. discloses the control unit is configured to use the output from the pressure sensor to determine whether medical fluid, air, or a mixture of medical fluid and air is present during the pump stroke (at least medical fluid and air from the three alternatives; par. 0076).
Regarding claim 3, Ly et al. discloses the control unit includes an air detection circuit configured to use the output from the pressure sensor to determine whether medical fluid or air is present during the pump stroke (par. 0076).
Regarding claim 13, Ly et al. discloses the control unit includes at least one processor (par. 0076) and at least one memory (par. 0076-0080, 0104, 0131, 0142) configured to use the output from the pressure sensor to determine whether medical fluid or air is present during the pump stroke (par. 0076-0080, 0104, 0131, 0142).
Regarding claim 15, Kopperschmidt further teaches the output from the pressure sensor is a raw output, and wherein the peak to peak values are from the raw output (par. 0075-0085).
Regarding claim 16, Kopperschmidt further teaches the output from the pressure sensor is a sinusoidal output, and wherein the peak to peak values are from the sinusoidal output (par. 0086-0092).
Regarding claim 17, Kopperschmidt further teaches the control unit is configured to determine that air is present during the pump stroke if a threshold decrease in peak to peak values of the output from the pressure sensor is detected (par. 0075-0092).
Regarding claim 18, Kopperschmidt further teaches the control unit is configured to determine that air is present during the pump stroke if a threshold decrease in peak to peak values of the output from the pressure sensor is detected (par. 0075-0092).
Regarding claim 19, Ly et al. discloses the output from the pressure sensor is for an upstream portion of the pump stroke during a patient drain or a patient fill (pressure measured in par. 0076 is upstream from the patient during a fill phase).
Regarding claim 20, Ly et al. discloses the output from the pressure sensor is for a downstream portion of the pump stroke during a patient drain or a patient fill (pressure measured in par. 0076 is downstream from the patient during a drain phase).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. in view of Kopperschmidt, and further in view of Ding et al. (US 20180369477).
Regarding claim 4, Ly et al. as modified by Kopperschmidt teaches the system as claimed, except for the air detection circuit includes a bandpass filter configured to filter unwanted signals from the pressure sensor output to form a filtered output. However, Ding et al. teaches utilizing a bandpass filter during analysis of pressure readings (par. 0091). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ly et al. in view of Kopperschmidt to utilize bandpass filtering of pressure sensor output, as taught by Ding et al., for the purpose of providing sufficient structure to remove noise from the signal generated by the pressure sensor.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. in view of Kopperschmidt and Ding et al., and further in view of Gagel et al. (US 20140166579).
Regarding claim 5, Ly et al., as modified by Kopperschmidt and Ding et al., discloses/teaches the claimed system, including circuitry that compares sensor output vs. values to determine whether medical fluid or air is present (par. 0076-0080), except for specifically disclosing utilizing a comparator for this purpose. However, Gagel et al. teaches utilizing a comparator in order to compare sensed values, including pressure values and microbubble numbers, vs. reference values, in order to detect air. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a comparator, as taught by Gagel et al., in the system of Ly et al. in view of Kopperschmidt and Ding et al., for the purpose of providing sufficient structure in the control circuitry to accomplish the desired comparisons set forth in Ly et al.
Claim(s) 6-9, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. in view of Kopperschmidt, Ding et al., and Gagel et al., and further in view of Georgi (US 4137913).
Regarding claims 6-9, 11, and 12, Ly et al., as modified by Kopperschmidt, Ding et al., and Gagel et al., discloses/teaches the system as claimed, including determining volume of fluid pumped based on revolutions/steps/strokes of the pump during both drain (par. 0131) and fill (par. 0135) phases, wherein the revolutions/steps/strokes measured are those where medical fluid is present as opposed to air (par. 0076), except for specifically disclosing/teaching use of a counter to provide the input of pump revolutions/steps/strokes. However, Georgi teaches utilizing a counter to record pump strokes (col. 4, ln. 9-24), which includes a reset input to reset the count to zero prior to a new cycle of the pump (col. 18, ln. 35-44). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a counter as taught by Georgi in the system of Ly et al., as modified by Kopperschmidt, Ding et al., and Gagel et al., for the purpose of providing the necessary information regarding pump revolutions/steps/strokes required by the methodology of Ly et al.
Claim(s) 10 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. in view of Kopperschmidt, Ding et al., Gagel et al., and Georgi, and further in view of Childers et al. (US 20070276328).
Regarding claim 10, Ly et al., as modified by Kopperschmidt, Ding et al., Gagel et al., and Georgi, discloses/teaches the system as claimed except for subtracting patient fill volume from patient drain volume to determine an amount of ultrafiltration removed from a patient during PD treatment. However, Childers et al. teaches, in a peritoneal dialysis system (abstract), a control unit which control system which calculates the difference between drain and fill fluid to determine ultrafiltrate (par. 0032). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the calculation of ultrafiltrate as taught by Childers et al. in the system of Ly et al., as modified by Kopperschmidt, Ding et al., Gagel et al., and Georgi, for the purpose of providing sufficient structure in the control circuitry to ensure that an appropriate ratio of fluids is managed by the system.
Response to Arguments
Applicant's arguments filed 3/23/26 have been fully considered but they are not persuasive.
Applicant argues, on pages 7-8 of the Remarks, that Kopperschmidt fails to disclose peak to peak analysis as claimed. Examiner respectfully disagrees, noting that the language “peak to peak” as currently claimed is broad enough to encompass the type of analysis/analyses disclosed/taught by Kopperschmidt, which clearly involves analyzing signals with peaks, including divergent peaks such as illustrated in fig. 2. Examiner further notes that both piston based pumping systems and peristaltic systems will involves pulses of flow/pressure.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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