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 as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 720 (in Fig. 7); 812 (in Fig. 8); 1800 (in Fig. 18).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 11-13, 16, 19-22 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chamney (US 20200353148).
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); 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]); 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 at least one clamp or valve to be actuated to isolate pressure from the dialysis machine (page 6, paras. [0109] and [0112]), record IPP measurement output data from the pressure sensor (page 3, para. [0056], sentence 1, and para. [0059]), 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).
Regarding claim 2, Chamney discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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]).
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 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chamney (US 20200353148) in view of Burbank (US 9907897).
Regarding claim 6, Chamney discloses 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 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 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 Yuds (US 20200338250).
Regarding claim 14, Chamney discloses 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 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 Chaudhuri (US 20190318818).
Regarding claim 17, Chamney discloses 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 discloses 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 Elbadry (US 20190358387).
Regarding claim 23, Chamney discloses 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]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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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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/K.A.W./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783