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 .
Election/Restrictions
Applicant’s election without traverse of Species II (claims 3-5, 14) in the reply filed on 7/15/2026 is acknowledged.
Claims 2, 6-13 and 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/15/2026.
Specification
The disclosure is objected to because of the following informalities:
-Paragraph [0048}, Line 13: “FIGURES” should be corrected to “DRAWINGS”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1, Line 8 as two conditional “when” clauses which are indefinite as to which condition is being claimed. For examination purpose, “when desired to stop the PD fluid pump” is read as “to stop the PD fluid pump”.
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.
Claim 14 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2015/0057601 A1 to Ly et al. (hereinafter “Ly”).
Ly discloses (see Figure 3; paragraphs 0076-0079, 0110-0115, 0130-0138) a peritoneal dialysis (PD) system comprising:
a PD fluid pump including a reciprocating member (piston: 133A, 133B) having a home position (see paragraph 0076);
at least one pressure sensor (151A, 151B) positioned and arranged along an open fluid line to sense the pressure of PD fluid pumped by the PD fluid pump, wherein the pressure of PD fluid changes in a pattern according to movement of the reciprocating member; and
a control unit (139) configured to detect the position (including the home position) of the pump piston using data from a pressure sensor and to stop the pump when required (see paragraphs 0076-0079). Furthermore, the control unit is configured to use a feature in (implicit) the pattern to determine when the reciprocating member is in the home position (see paragraphs 0076-0079).
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 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ly.
Regarding claim 1, Ly discloses (see Figure 3; paragraphs 0076-0079, 0110-0115, 0130-0138) a peritoneal dialysis (PD) system comprising:
a PD fluid pump including a reciprocating member (piston: 133A, 133B) having a home position (see paragraph 0076);
at least one pressure sensor (151A, 151B) positioned and arranged along an open fluid line to sense the pressure of PD fluid pumped by the PD fluid pump, wherein the pressure of PD fluid changes in a pattern according to movement of the reciprocating member; and
a control unit (139) configured to detect the position (including the home position) of the pump piston using data from a pressure sensor and to stop the pump when required (see paragraphs 0076-0079). Furthermore, the control unit is configured to use a feature in (implicit) the pattern to determine when the reciprocating member is in the home position (see paragraphs 0076-0079).
Claim 1 differs from Ly in reciting the control unit configured "to stop the PD fluid pump when the reciprocating member is in the home position”.
Although Ly does not directly and unambiguously disclose that the control unit is configured to stop the PD fluid pump when the reciprocating member is in the home position, Ly teaches that the control unit is configured to control the pump actuation and that this is directly dependent on the position of the pump piston that has been detected (see paragraphs 0076-0079; paragraph [0077]: “When the pump chamber 138A, 138B has been isolated… the pressure sensors 151A, 151B detects the reference pressure (e.g. 300 mbar), which is indicative of liquid (rather than air) being pressurized within the pump chamber 138A, 138B , the control unit 139 determines the position of the piston 133A, 133B that corresponds to that pressure”).
Hence, it would have been obvious to a person of ordinary skill in the art to modify the PD system of Ly to stop the PD fluid pump when the reciprocating member is in the home position to accurately determine the theoretical volume of dialysate in the pump chambers (see paragraph 0078).
Regarding claim 3, Ly discloses that the at least one pressure sensor (151A, 151B) is positioned and arranged to take the pressure of PD fluid along an open fluid line, wherein the pressure of PD fluid changes in a pattern according to movement of the reciprocating member, and wherein a feature in the pattern is related the home position (see Figure 3; paragraphs 0076-0079).
Regarding claim 4, Ly discloses that the open fluid line is used during a PD treatment, the at least one pressure sensor (151A, 151B) taking the pressure of PD fluid during the PD treatment (see Figure 3; paragraphs 0076-0079).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ly as applied to claim 1 above, and further in view of US 2024/0197973 A1 to Pettersson et al. (hereinafter “Pettersson”).
Ly discloses the PD system as described above and further discloses that the control unit (139) is connected to the pressure sensors (151A, 151B) to the stepper motors (e.g., the drivers of the stepper motors) that drives the pistons (133A, 133B) and to the encoders that monitor rotation of the lead screws of the stepper motors such that the control unit 139 can receive signals from and transmit signals to those components of the system (see paragraph 0076).
Claim 5 differs from Ly in reciting that the control unit is configured to take PD fluid pressure readings from the at least one pressure sensor at a sample rate of 50 to 500 Hz.
Pettersson discloses PD system comprising one or more pressure sensors located to sense the PD fluid pressure in the used PD fluid lumen of the dual lumen patient line to estimate the PD fluid pressure using an output provided by a driver of a motor that is used to drive the PD fluid pump (see paragraph 0018) wherein the controller e.g., processor is configured to receive a plurality of output signals at a specified rate between 50 Hz and 1000 Hz for sampling between 1 and 100 output signals (see paragraphs 0025-0026). 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).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to take PD fluid pressure readings from the at least one pressure sensor at a sample rate of 50 to 500 Hz depending on desired frequency of pressure readings, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
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 1772
JK
8/4/26
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