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
The Amendments filed 09/23/2025 have been entered.
Claim 1 has thereby been amended.
Claims 1-24 are being examined in this office action.
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.
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.
Claims 1-5, 7, 11-13, 16, 19-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chamney (US 20200353148) in view of Neftel (US 20180117234).
Regarding claim 1, Chamney discloses an intraperitoneal pressure ("IPP")-intraperitoneal volume ("IPV") correlation system comprising: a fluid container including dialysate (Fig. 4: 400); a dialysis machine fluidly coupled to the fluid container (Fig. 4: A), the dialysis machine including at least one pump (para. [0049], sentence 1); an in-line pressure sensor fluidly coupled to the dialysis machine (Fig. 5: 54) and configured to transmit IPP measurement output data (Fig. 5: Pip equating to IPP; page 3, para. [0059]); at least one clamp or valve fluidly located between the dialysis machine and the in-line pressure sensor (Fig. 9: clamps 97-1 and 97-2 located between machine/load cell 95 and the sensor located at 92a); a catheter fluidly coupling the in-line pressure sensor to a peritoneal cavity of a patient (Fig. 5: 52); and a computer communicatively coupled to the in-line pressure sensor (page 3, para. [0049], last sentence; page 3, para. [0055], sentences 1-2), the computer including an application stored in a memory device which when executed by a processor of the computer (page 3, para. [0053], last sentence), causes the computer to: determine or receive an indication of a maximum fill volume of the dialysate to be pumped into the peritoneal cavity of the patient for a fill or a drain phase of a dialysis cycle (page 7, para. [0120], sentence 1), determine a plurality of iterations to achieve the maximum fill volume and a volume of the dialysate to be pumped for each of the iterations (page 1, para. 0007], sentence 1; page 2, para. [0016]), for each iteration cause the dialysis machine to pump the dialysate to the peritoneal cavity of the patient based on the determined volume for that iteration (page 3, para. [0056], sentence 1), cause the dialysis machine to stop pumping the dialysate when the determined volume is reached (page 2, para. [0026]), cause the at least one clamp or valve to be closed to isolate pressure from the dialysis machine (page 6, paras. [0109] and [0112], last two sentences, clamp is immediately closed after open interval), record IPP measurement output data from the pressure sensor (page 3, para. [0056], sentence 1, and para. [0059]; IPP determined immediately after fill clamp is closed during drain open interval [para. 112]), record or determine a total accumulated fill volume (page 3, para. [0056], sentences 2-4), create a data point corresponding to a correlation between the IPP measurement output data and the total accumulated fill volume (page 3, para. [0056], last sentence), and release the at least one clamp or valve to enable pumping of the dialysate for a next iteration (page 6, para. [0112]), and after the plurality of iterations are complete, create a patient model that provides a personalized correlation between IPP measurement output data and total accumulated fill volumes up to the maximum fill volume using the created data points (Fig. 2; page 3, para. [0056], last sentence). However, although Chamney discloses the dialysis system with a pump and also the locations of the clamps along the fluid lines, Chamney fails to explicitly disclose the clamps being located between the pump and the pressure sensor.
Neftel teaches an analogous peritoneal dialysis system and method, which has the clamp or valve (Fig. 2: 306; para. [0044]) fluidly located between the at least one pump (Fig. 2: 307; para. [0045]) of the dialysis machine and the in-line pressure sensor (Fig. 2: 309; para. [0046]; Fig. 2: 306 located in between 307 and 309). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this explicit teaching by Neftel to arrange the Chamney clamps 97-1 and 97-2 in between the pump and the in-line pressure sensor, in order to accurately isolate and measure the pressure at the patient’s peritoneal cavity and not at the pump.
Regarding claim 2, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein execution of the application is further configured to cause the computer to: after the fill phase of the dialysis cycle, cause the dialysis machine to perform a dwell phase (Fig. 10; page 6, para. [0112]); record periodic measurements of IPP measurement output data from the pressure sensor during the dwell phase (page 6, para. [0112], sentence 4; page 7, para. [0126], sentence 4); and create data points for the patient model corresponding to a correlation between the periodic measurements of IPP measurement output data and the maximum fill volume over a time duration corresponding to the dwell phase (Fig. 12: 27).
Regarding claim 3, Chamney in view of Neftel teaches the system of claim 2, as described above, wherein the application is configured to adjust the patient model using information indicative of ultrafiltration accumulation in the peritoneal cavity of the patient during the dwell phase (pages 7-8, para. [0135]), and wherein the information indicative of ultrafiltration accumulation in the peritoneal cavity of the patient during the dwell phase is used to determine an optimal ultrafiltration time for a PD treatment dwell phase (page 2, para. [0017], sentence 1).
Regarding claim 4, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the application is further configured to use the data points of the patient model to: determine a regression curve through the data points (Figs. 11 and 12: solid line curve fit; page 7, para. [0124], sentence 2); and determine prediction intervals for the regression curve specifying a range in which IPP measurement output data will fall when making a new prediction (Fig. 15: variability 151).
Regarding claim 5, Chamney in view of Neftel teaches the system of claim 4, as described above, wherein the application is further configured to use the regression curve to determine an upper prediction limit (Fig. 15: top of 151).
Regarding claim 7, Chamney in view of Neftel teaches the system of claim 5, as described above, wherein the application is further configured to: determine or receive information indicative of an upper IPP limit for the patient (Fig. 15: top of 151); and determine a recommended maximum fill volume range having an upper bound corresponding to an IPV at an intersection of the upper IPP limit and the upper prediction limit (para. [0122], sentences 6-8; Fig. 15; Fig. 12: 128).
Regarding claim 11, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the dialysate has a first concentration of dextrose or glucose and the dialysis cycle is a first dialysis cycle, and wherein the application is configured to perform at least one addition dialysis cycle for dialysates having at least one different concentration of dextrose or glucose to obtain additional data points for the patient model (Chamney: page 8, para. [0135], last sentence).
Regarding claim 12, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the dialysis cycle is a first dialysis cycle, and wherein the application is configured to perform at least one addition dialysis cycle to obtain additional data points for the patient model (page 7, paras. [0124] and [0127]).
Regarding claim 13, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the dialysis machine is a peritoneal dialysis machine (page 3, para. [0062]).
Regarding claim 16, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the application is configured to zero the pressure sensor to atmospheric pressure (page 3, para. [0055], last two sentences; page 4, para. [0073], sentence 2).
Regarding claim 19, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the application is further configured to determine the maximum fill volume by receiving information indicative of the maximum fill volume (page 7, para. [0120], sentence 1), and wherein the application is further configured to determine the plurality of iterations by receiving information indicative of the plurality of iterations (page 2, para. [0016]).
Regarding claim 20, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the computer is communicatively coupled to the dialysis machine (page 3, para. [0049], last sentence), and wherein the application is further configured to transmit instructions to the dialysis machine to cause the dialysis machine to pump the dialysate to the peritoneal cavity of the patient (page 3, para. [0056], sentence 1) and cause the dialysis machine to stop pumping the dialysate when the determined volume is reached (page 2, para. [0026]).
Regarding claim 21, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the computer is communicatively coupled to the dialysis machine (page 3, para. [0049], last sentence), and wherein the application is further configured to receive the total accumulated fill volume from the dialysis machine (page 3, para. [0056], sentences 2-4).
Regarding claim 22, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein at least one of the in-line pressure sensor or the computer is integrated with the dialysis machine (page 3, para. [0049], last sentence).
Regarding claim 24, Chamney in view of Neftel teaches the system of claim 1, as described above, wherein the IPP measurement output data includes a pressure signal (page 8, para. [0140]), and the application is further configured to: sample the IPP measurement output data to extract the recorded IPP measurement output data (page 10, para. [0178], last sentence, and para. [[0179]).
Claims 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chamney (US 20200353148) in view of Neftel (US 20180117234) in further view of Burbank (US 9907897).
Regarding claim 6, Chamney in view of Neftel teaches the system of claim 5, as described above, wherein the application is further configured to: determine or receive information indicative of an upper IPP limit for the patient (Fig. 15: top of 151); the upper IPP limit in relation to the upper prediction limit to enable a maximum fill volume for a peritoneal dialysis treatment for the patient to be determined (Fig. 15; page 7, para. [0122], sentences 6-8). However, Chamney fails to explicitly disclose that the upper IPP limit and upper prediction limit are displayed in the patient model.
Burbank teaches an analogous peritoneal dialysis system which includes a display for the output data and patient projections (906D). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Chamney system by incorporating the display interface taught by Burbank in order to provide visual outputs of the Chamney patient model and upper/predictive pressure and volume limits.
Regarding claim 8, Chamney discloses the system of claim 5, as described above, but fails to disclose a treatment server communicatively coupled to the application.
Burbank teaches an analogous peritoneal dialysis system comprising a treatment server (col. 17, line 67 – col. 18, line 3) communicatively coupled to the application, the treatment server configured to: receive, from the application, output data. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Chamney system by incorporating the server taught by Burbank in order to provide a more secure means of storage and processing of the output data, for long-term and future use (col. 24, lines 10-12). By incorporating the external server taught by Burbank into the Chamney system, the server would receive and store the patient model with the regression curve, the prediction intervals, and the upper prediction limit output by Chamney.
Regarding claim 9, Chamney in view of Neftel teaches in view of Burbank teaches the system of claim 8, as described above, wherein the treatment server is configured to: store the data output by the Chamney system, including the recommended maximum fill volume to an electronic treatment prescription (Chamney: page 1, para. [0012] and page 7, para. [0120], sentence 1); and transmit the electronic treatment prescription to a dialysis machine associated with the patient (Chamney: page 8, para. [0135], last sentence).
Regarding claim 10, Chamney in view of Neftel teaches in view of Burbank teaches the system of claim 9, as described above, wherein the upper IPP limit is based on at least one of a patient age, a patient height, a patient weight, a patient health, a time on dialysis, a patient position (Chamney: page 7, paras. [0122] and [0123]), or a patient gender.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chamney (US 20200353148) in view of Neftel (US 20180117234) in further view of Yuds (US 20200338250).
Regarding claim 14, Chamney in view of Neftel teaches the system of claim 1, as described above, but fails to explicitly disclose the location of the in-line sensor being positioned at the midline of the patient.
Yuds teaches an analogous insertion tubing with integrated sensors for peritoneal dialysis, wherein the in-line sensor (360) is positioned at a midline of the patient (Fig. 2B). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chamney with the placement of the in-line sensor at the midline of the patient as taught by Yuds, in order to provide a standard placement ensured at the peritoneum, and to allow for the patient to comfortably assume a side position if desired without compressing the insertion site (Fig. 1: 115).
Regarding claim 15, Chamney in view of Neftel teaches in view of Yuds teaches the system of claim 14, as described above, wherein the application is configured to output a pressure output from the pressure sensor (Chamney: page 3, para. [0059]; 54) to enable raising or lowering of the pressure sensor for positing at the midline of the patient (Yuds: Fig. 2B).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chamney (US 20200353148) in view of Neftel (US 20180117234) in further view of Chaudhuri (US 20190318818).
Regarding claim 17, Chamney in view of Neftel teaches the system of claim 1, as described above, but fails to disclose an additional physiological sensor for measuring an additional physiological patient parameter.
Chaudhuri teaches an analogous peritoneal dialysis system further comprising a physiological sensor configured to measure a physiological parameter of the patient (1240; page 14, para. [0126]), wherein the data related to the physiological parameter received is associated with and used to adjust patient parameters and data (page 15, para. [0137]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Chamney system by incorporating the respiratory sensor taught by Chaudhuri, in order to account and adjust for the variations in IPP caused by the patient’s respiration, in a more accurate and real-time manner than a non-patient-specific predictive algorithm (Chamney: page 7, paras. [0131] and [0132]). By incorporating the physiological sensor and associated data processing taught by Chaudhuri into the Chamney system, the data point of the patient model created during the iteration for subsequent adjustment of at least one of a regression curve, prediction intervals, or an upper prediction limit determined from the patient model output by Chamney would be associated or updated with the additional physiological data outputs taught by Chaudhuri.
Regarding claim 18, Chamney in view of Neftel teaches the system of claim 1, as described above, but fails to disclose an additional physiological sensor for measuring an additional physiological patient parameter.
Chaudhuri teaches an analogous peritoneal dialysis system further comprising a physiological sensor configured to measure a physiological parameter of the patient (1240; page 14, para. [0126]), wherein the data related to the physiological parameter received is associated with and used to adjust patient parameters and data (page 15, para. [0137]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Chamney system by incorporating the motion sensor taught by Chaudhuri, in order associate the physiological parameter to the corresponding patient model to address changes in intraperitoneal volume due to ultrafiltration and changes in a transport capacity specific to a peritoneal membrane of the patient caused by the patient’s change in posture in real-time opposed to post-processing (Chamney: page 8, paras. [0149] and [0150]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Chamney (US 20200353148) in view of Neftel (US 20180117234) in further view of Elbadry (US 20190358387).
Regarding claim 23, Chamney in view of Neftel teaches the system of claim 1, as described above, but fails to disclose an integrity test of filtering the IPP data with patient movement or breathing data.
Elbadry teaches an analogous peritoneal dialysis system with data processing, wherein the application is further configured to perform an integrity test by: filtering the measurement output data (page 40, para. [0271], sentence 6); receiving patient movement or breathing data (page 40, para. [0271], sentences 4-5); comparing the filtered IPP measurement output data to the patient movement or breathing data (page 40, para. [0271], sentence 6); and providing an indication of an issue with the IPP measurement output data after detecting a deviation in a correlation between the filtered IPP measurement output data and the patient movement or breathing data (page 40, para. [0271], sentence 7). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Chamney system by incorporating the data filtering using movement data taught by Elbadry in order to eliminate the false IPP measurements caused by movement and output accurate patient IPP data (Chamney: page 8, para. [0147]).
Response to Arguments
Applicant’s arguments, filed 09/23/2025, with respect to the rejections of independent claim 1 by Chamney, have been fully considered and are persuasive in view of the newly amended claims. However, upon further consideration, a new ground of rejection in light of the change in scope of independent claim 1 is made by Chamney in view of Neftel, as described above, which teaches all limitations of the amended claims, including the newly amended limitation of the clamps being positioned between the pump and the sensor.
As described in the rejections above, Neftel teaches a system with clamps arranged on a line between the dialysis pump and the pressure sensor, and would have been obvious for one of ordinary skill in the art to have incorporated into the Chamney system and methods.
For these reasons, claims 1-24 stand rejected as recited in the rejections above.
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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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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