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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-9 and 11 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2018/0043076 A1 to Gerber et al. (hereinafter “Gerber”).
Regarding claim 1, Gerber discloses a method for determining an appropriate peritoneal dialysis (PD) prescription tailored to meet treatment needs of a patient, the method comprising the steps of;
providing an input computing device (520) configured for receiving health parameters of the patient (see Figure 5),
inputting the patient health parameters into the computing device (see Figure 5; paragraph [0146]: “The computing device 520 can include the one or more processors 522, memory 524, and one or more input/output interfaces 526…can include an input interface to receive parameter input 554”; paragraph [0144]: “Patient parameters can also be input into the system 500 as a parameter input 554”; paragraph [0114]: “patient parameters included in the intersession history can include any data providing medically relevant information about the health status of a patient. For example, a patient physiological parameter can include, but not limited to, blood pressure, blood solute levels, posture or any other medically relevant information. The physiological parameters can encompass information such as age, weight, gender, current drug therapies, smoking habits, diet, etc.”);
providing at least one bag containing an electrolyte solution (512)(see Figure 5; paragraph [0142]: “The concentrate sources 512 can contain one or more solutes for generating the peritoneal dialysate from purified water. The concentrates in the concentrate source 512 are utilized to generate a peritoneal dialysis fluid that matches a dialysis prescription, as described...Table 2 provides non-limiting exemplary ranges of commonly used components of peritoneal dialysate”; Table 2 includes sodium chloride, calcium chloride dehydrate, magnesium chloride hexahydrate, sodium lactate, dextrose monohydrate).
calculating a concentration of electrolytes from the electrolyte solution for a treatment solution based in the patient health parameters (see Figure 5; based on patient parameter input 554 to the computing devic3e 520, new peritoneal dialysis prescription (530) is generated; See Figure 3: “304: Receive Patient Parameters as Parameter Input During Current PD session”, 310: “Determine Adjustment to Generated Fluid for Subsequent PD Session”);
inputting the calculated concentration of electrolytes from the electrolyte solution into an automated peritoneal dialysis (APD) device (see Figure 5: new PD Session Prescription 530 is inputted into APD 516);
mixing the concentration of electrolytes in the APD device into the treatment solution suitable for administration to the patient (see Figure 5; paragraph [0140]: “One or more processors 522 can adjust the dialysis prescription for a current or subsequent session. For example, the processor 522 can control the movement of fluid from the concentrate source to the peritoneal dialysate generation flow path 504 based on the monitored patient parameters”; and,
administering the treatment solution to the patient (see Figure 5: paragraph [0140]: “The integrated cycler 516 can include the effluent line 502, an infusion line 518, and one or more pumps for infusing peritoneal dialysate into the peritoneal cavity 552 of the patient 550 and removing fluid from the peritoneal cavity 552 of the patient 550”).
Regarding claim 2, Gerber teaches that the electrolytes include sodium (see Table 2 in paragraph [0142]).
Regarding claim 3, Gerber teaches inherent removal a determined quantity of sodium from the patient’s blood stream with each treatment in peritoneal dialysis.
Regarding claim 5, Gerber teaches a dextrose solution (see Table 2 in paragraph [0142]).
Regarding claims 9-11, Gerber teaches automatic adjustment of dextrose concentration based on potassium concentration (see paragraph [0125]: “The patient blood solutes can be profiled to control the ultrafiltration rate and solute removal. For example, if a patient has a high blood potassium level, a high ultrafiltration rate may not be desirable, as a high ultrafiltration rate with high potassium can cause irregular heartbeats or other issues. The system can adjust the osmotic agent concentration in the dialysate to use a lower dextrose concentration for the early cycles to reduce the ultrafiltration volume in the earlier cycles, controlling the mass of potassium removed, which is a function of the ultrafiltration volume and potassium blood concentration. As the concentration of potassium decreases during the early cycles of the peritoneal dialysis session, the ultrafiltration volume can be increased by increasing the osmotic agent concentration so that the overall fluid removal goals can be met, while keeping the removal rate of potassium more constant. … The ability of the system illustrated in FIG. 5 to manipulate the osmotic agent concentration for each cycle makes changing the osmotic agent concentration cycle-to-cycle possible. The results on solute removal and overall ultrafiltration achieved with cycle-to-cycle osmotic agent changes can be recorded in the patient history.”).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gerber as applied to claim 2 above and further in view of US 2018/0021501 A1 to Gerber et al. (hereinafter “Gerber ‘501”).
Gerber teaches the method for determining an appropriate peritoneal dialysis (PD) prescription tailored to meet treatment needs of a patient as described above.
Claim 4 differs from Gerber in reciting adding a predetermined quantity of potassium to the patient’s blood stream with each treatment.
Gerber discloses in paragraph [0125] that “As the concentration of potassium decreases during the early cycles of the peritoneal dialysis session, the ultrafiltration volume can be increased by increasing the osmotic agent concentration so that the overall fluid removal goals can be met, while keeping the removal rate of potassium more constant.” This suggests that maintaining certain potassium in the patient is important and critical.
Gerber ‘501 teaches that potassium chloride can be used for hypokalemic patients who don’t receive sufficient potassium through diet (see paragraph [0100]).
Adding a predetermined quantity of potassium to the patient’s blood stream with each treatment of Gerber would have been obvious to a person of ordinary skill in the art to prevent depletion of potassium or hypokalemia.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber as applied to claim 5 above, and further in view of Wang et al., Kidney International, Vol. 52 (1997), pp. 1609-1616 (hereinafter “Wang”).
Gerber teaches the method for determining an appropriate peritoneal dialysis (PD) prescription tailored to meet treatment needs of a patient as described above.
Claims 6-8 differ from Gerber in reciting the input computing device automatically adjusting the dextrose concentration as a function of the sodium concentration.
Gerber teaches that the ability of the system illustrated in FIG. 5 to manipulate the osmotic agent concentration for each cycle makes changing the osmotic agent concentration cycle-to-cycle possible and the osmotic agent concentration is based on potassium concentration (see paragraph [0125]).
Wang teaches that sodium removal depends on glucose concentration as osmotic agent wherein the total removal of sodium (RM) at 360 minutes was significantly higher in the 3.86% and 2.27% solution groups as compared to the 1.36% (see Table 1 in page 1611).
It would have been obvious to a person of ordinary skill in the art to use the knowledge of sodium removal dependency on glucose concentration in Wang to modify the system of Gerber to manipulate the osmotic agent concentration for each cycle makes changing the osmotic agent concentration cycle-to-cycle possible based on sodium concentration with reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2006/0037910 A1 teaches citrate-based dialysate chemical formulations.
US 2018/0361048 A1 teaches therapy calculation 372 based on prescription and solution management 374 (see Figures 46, 48).
US Patent No. 4668400 teaches techniques for predicting the respective concentrations and distributions of diffusible materials in solutions on opposing sides of a semipermeable membrane (see Figures 1A-2F).
US Patent No. 12,064,542 B2 teaches automated peritoneal dialysis treatment using at least two different dialysis fluids containing glucose.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
2/6/26