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 .
Specification
The disclosure is objected to because of the following informalities:
Examiner suggests applicant to change “FIGURES” in line 10 of Paragraph [0097] to “DRAWINGS”.
Appropriate correction is required.
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 1-11, 18-19 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0125954 A1 to Mathiot et al. (hereinafter “Mathiot”) in view of European Patent Application No. 0097432 A2 to Dadson et al. (hereinafter “Dadson”).
Regarding claims 1-2, Mathiot discloses a peritoneal dialysis system (10a)(see paragraphs 66-98 and figures 1-4) comprising:
a cycler (20) (see Fig. 1) including
a dialysis fluid pump (see paragraph 67: "pump"),
a plurality of valve actuators ("plural pneumatic valve chambers"), and
a control unit (22) configured to control the dialysis fluid pump (see paragraph 67) and the plurality of valve actuators (see paragraph 67); and
a drain line (56, 114) including a disposable portion (56), a reusable portion (114) (see paragraph 84).
Claims 1-2 differ from the peritoneal dialysis system of Mathiot in reciting that a drip chamber located between the disposable portion and the reusable portion, the drip chamber configured to create an air column that dissuades pathogen migration from the reusable portion to the disposable portion.
Drip chambers are well known in various technical fields including dialysis to offer an efficient way to fluidly separate two portions of a fluid system with the aim to avoid cross contamination originating from one portion of the fluid system.
Dadson teaches a peritoneal dialysis system (see page 7, line 32 - page 15, line 2; claims 7-9; figures 1-5) comprising a drip chamber (74) in the drain line (74) of the peritoneal dialysis system for isolation purposes (see figure 3; page 13, lines 10-14).
It would have been obvious to a person of ordinary skill in the art to include a drip chamber in the drain line of the peritoneal dialysis system of Mathiot as a normal design option to avoid cross contamination originating from one portion of the fluid system.
Regarding claim 3, Mathiot teaches that the dialysis fluid pump includes a pneumatic valve manifold and an air pump positioned and arranged to supply pneumatic pressure to the pneumatic valve manifold (see paragraph 67).
Regarding claim 4, Mathiot teaches that the disposable portion of the drain line (56) is provided as part of a disposable set (40) including a pump actuation portion (44) operable with the dialysis fluid pump, and a valve actuation portion operable with the plurality of valve actuators (46)(see figure 2; paragraphs 71-72).
Regarding claim 5, Mathiot teaches that the pump actuation portion (44) of the disposable set includes a pod pump having a flexible sheet e.g. membrane, one side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure via the air pump and pneumatic valve manifold (see figure 2; paragraph 71).
Regarding claim 6, Mathiot teaches pneumatic valves (see paragraph 71). Pinch valves as pneumatic valves is well known in the art and would have been obvious to a person of ordinary skill in the art.
Regarding claim 7, Mathiot teaches that the valve actuation portion of the disposable set (40) includes a plurality of lines, including the drain line (56), positioned and arranged to be actuated by the pinch valve actuators (see figure 2; paragraphs 71-72).
Regarding claim 8, employing a pneumatic pressure sensor in a pneumatic cycler is well known in the art and would have been obvious to a person of ordinary skill in the art for controlling a cycler.
Regarding claim 9, configuring or choosing the length of fluid lines of reuseable portion and the disposable portion would have been obvious to a person of ordinary skill in the art to optimize the distance among patient, cycler and drain (see Mathiot: figure 1 for reuseable portion (56), the disposable portion (114), patient (P), cycler (10), drain (116)).
Regarding claim 10, Mathiot teaches connectors (80a, 82a, 52) including a drain line connector (58) (see figures 1-2; paragraph 72). Employing connectors to connect to the drip chamber would have been obvious to a person of ordinary skill in the art to avoid touch contamination.
Regarding claim 11, choosing a holder including a clip for holding the drip chamber would have been obvious to a person of ordinary skill in the art to attach the drip chamber to a cycler.
Regarding claims 18-19, disinfectant sponges are as such well known and their use would have been obvious to a person of ordinary skill in the art for disinfection of a medical system.
Regarding claims 22-24, Mathiot teaches caps for any of the lines including a drain line (56) being normally capped (see paragraphs 76, 82).
Claims 12-15 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mathiot in view of Dadson as applied to claim 1 above, and further in view of US 2022/0203005 A1 to Jansson et al. (hereinafter “Jansson”).
Mathiot in view of Dadson teaches the peritoneal dialysis system of claim 1 as described above.
Claim 12 differs from Mathiot in view of Dadson in reciting a sensor outputting to the control unit, the drip chamber positioned and arranged to enable the sensor to sense the air column.
Jansson teaches a peritoneal dialysis system comprising
a cycler (20)(see Fig.1; paragraph 168), a drain line (36), an air trap (60) i.e. drip chamber having an upper level sensor (62a) and a lower level sensor (62b) which outputs to the control unit (100) and the drip chamber positioned and arranged to enable the sensor to sense the air column or fluid level (see figure 2; paragraphs 175-177).
It would have been obvious to a person of ordinary skill in the art to include a sensor in the drip chamber of Mathiot in view of Dadson to control fluid level or air column in the drip chamber for the purpose of filling and draining process.
Regarding claim 13, Jansson teaches that the level sensor is an ultrasonic sensor, optical sensor and/or capacitive sensor (see paragraph 243).
Regarding claim 14, Jansson teaches an upper level sensor (62a) and a lower level sensor (62b) (see figure 2; paragraph 176).
Regarding claim 15, Jansson teaches implicit window in the drip chamber for optical sensor (see paragraph 243).
Claim 20 differs from Mathiot in view of Dadson in reciting the drip chamber includes a port connectable to a pneumatic line for receiving air to help maintain the air column.
Jansson teaches the drip chamber (60) includes a port (54e) connectable to a pneumatic line for receiving air to help maintain the air column (see figure 2; paragraph 177).
It would have been obvious to a person of ordinary skill in the art to include a port connectable to a pneumatic line in the drip chamber of Mathiot in view of Dadson to control fluid level or air column in the drip chamber for the purpose of filling and draining process.
Regarding claim 21, Jansson teaches a hydrophobic vent filter (see paragraph 177).
Allowable Subject Matter
Claims 16-17 are 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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, IN SUK BULLOCK can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/John Kim/Primary Examiner, Art Unit 1777
JK
12/17/25