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 § 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.
Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0129927 A1 to Sendelius et al. (hereinafter “Sendelius”) in view of US 2022/0280703 A1 to Bonczar et al. (hereinafter “Bonczar”).
Sendelius discloses a peritoneal dialysis (PD) system (see abstract; fig. 1-5; paragraphs [0135]-[0143]) comprising:
a housing (300);
a PD fluid pump (450) housed by the housing;
an inline heater (302) in fluid communication with the PD fluid pump;
a temperature sensor (303, 313); and
a control unit, the PD fluid pump and the inline heater being under control of the control unit (112), the control unit configured to:
receive a temperature signal from the temperature sensor (paragraphs [0136]-[0137]), and
perform a heat disinfection sequence in which the control unit causes the PD fluid pump to pump disinfection fluid in a forward direction, while the inline heater heats the disinfection fluid (paragraphs [0139]-[0143]).
Sendelius further discloses that a feed forward control of the heater takes into account the temperature and the flow rate of the disinfection liquid (see paragraphs [0139]-[0140]).
Claims 1-2 and 12 differ from the system of Sendelius in that the control unit is configured to cause the PD fluid pump to pump disinfection fluid in a reverse direction.
Bonczar discloses a dialysis system (see fig. 1-4; paragraphs [0088]-[0089]), wherein during heat disinfection a fluid pump (304) is driven in a forward direction and a reverse direction.
It would be obvious to the person skilled in the art to modify the control unit to be configured to cause the PD fluid pump to pump disinfection fluid in a reverse direction to heat and maintain disinfection temperature of the disinfection fluid through the inline heater.
Regarding claims 3 and 13, Sendelius teaches a temperature sensor (303) located upstream of the inline heater (302) when the disinfection fluid is flow from right to left.
Regarding claim 4, Sendelius teaches that the temperature signal is used as a closed loop feedback to the control unit for controlling the inline heater (see paragraphs [0139]-[0140]).
Regarding claims 5 and 18, Sendelius teaches a temperature sensor (313) and a second temperature sensor (303) located downstream of the inline heater (302) wherein the temperature signal from the second temperature sensor (303) is used as a closed loop feedback to the control unit for controlling the inline heater (see figure 5; paragraphs [0136]-[137], [139]-[140]).
Regarding claims 6 and 11, Sendelius teaches that the disinfection temperature is within a range of 70 to 95 degree Celsius which includes 85 degree Celsius. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 7-9 and 19-20, Sendelius teaches that the control unit is configured to cause the PD fluid pump to pump the disinfection fluid for a time duration for the recirculation or a predetermined temperature to be achieved during recirculation based on the measured temperature and the measured flow rate of the disinfection fluid implicitly a number of pump strokes (see paragraphs [0139]-[0140]).
Regarding claims 14-15, Sendelius teaches a flow meter (410) (see figure 5; paragraph [0138]).
Regarding claim 16, Sendelius teaches the feed forward algorithm (see Equation (1) in paragraph [0141]).
Regarding claim 17, Sendelius teaches that the disinfection temperature is within a range of 70 to 95 degree Celsius which includes 85 degree Celsius. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/John Kim/Primary Examiner, Art Unit 1777
JK
1/7/26