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.
Claims 1-12 and 14-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by European Patent No. 2252347 B1 to Wang et al. (hereinafter “wang”).
Regarding claim 1, Wang discloses a peritoneal dialysis system (10) (see paragraphs 30-45, 88-131 and figures 1-4, 42-44) comprising:
a cycler (14) including
an actuation surface (148) including a port (see figure 42: port connecting to line L0),
a pneumatic valve manifold (X1, X2, X3 in figure 42; see paragraphs 88, 131) fluidly coupled to the port (see figure 42),
an air pump (e.g. "piston pump") positioned and arranged to directly supply pneumatic pressure to the port via the pneumatic valve manifold (see paragraph 98; figure 42; see paragraphs 42-44 the pneumatic pressure will be directly provided to the flexible sheet 15, the intermediate sheet 148 does not hinder or contradict this; paragraph 61), without intervening pneumatic storage (see paragraph 98: pressure tanks are only optional),
a pneumatic pressure sensor ("pressure sensor") positioned and arranged to detect pneumatic pressure (see paragraph 98), and
a control unit (16) configured to use an output of the pneumatic pressure sensor as feedback to adjust the air pump according to a set pneumatic pressure (see paragraph 88); and
a disposable set (12) including a pod pump ("pump") having a flexible sheet (15), one side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure from the port via the air pump and pneumatic valve manifold (see paragraphs 42-44; figure 42).
Regarding claim 2, Wang teaches that the air pump is configured to supply positive and negative pneumatic pressure (see paragraph 98).
Regarding claim 3, Wang teaches that the pneumatic valve manifold includes a positive pneumatic valve positioned between the air pump and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and a negative pneumatic valve positioned between the air pump and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and wherein the control unit is configured to open the positive pneumatic valve when the air pump is supplying positive pneumatic pressure and to open the negative pneumatic valve when the air pump is supplying negative pneumatic pressure (see paragraphs 128, 98).
Regarding claim 4, Wang teaches that the pneumatic valve manifold further includes at least one additional pneumatic valve (X2) positioned and arranged to allow a reference chamber to communicate pneumatically with the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure (see figure 42).
Regarding claim 5, Wang teaches that the pressure sensor is a first pressure sensor positioned and is arranged between the pneumatic valve manifold and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and wherein the cycler also includes a second pressure sensor positioned and arranged between the pneumatic valve manifold and the reference chamber (see paragraph 98; figure 42).
Regarding claims 6-7, Wang teaches that the control unit is further configured to use outputs from the first and second pressure sensors in combination with a sequence of the positive pneumatic valve, negative pneumatic valve and the at least one additional pneumatic valve and an ideal gas law equation to compute at least one of (i) an initial dialysis fluid volume in the pod pump after fresh or used dialysis fluid is drawn into the pod pump or (ii) a final dialysis fluid volume in the pod pump after fresh or used dialysis fluid is pumped from the pod
Pump and the control unit is further configured to subtract (ii) from (i) to determine a volume of the fresh or used dialysis fluid pumped from the pod pump (see paragraphs 96-117).
Regarding claim 8, Wang teaches that the control unit is further configured to use at least one of a sensed speed of the air pump or the output of the pneumatic pressure sensor to determine that the flexible sheet has completed (i) drawing fresh or used dialysis fluid into the pod pump or (ii) pumping fresh or used dialysis fluid from the pod pump (see paragraphs 90, 118-125).
Regarding claim 9, Wang teaches that the cycler further includes at least one of (i) a batch or inline dialysis fluid heater (142) under control of the control unit or (ii) an air or priming sensor outputting to the control unit (see paragraph 32; figure 1).
Regarding claims 10-11, Wang teaches that the one side of the flexible sheet is positioned and arranged during operation to receive pneumatic pressure through the actuation surface via the air pump and pneumatic valve manifold disposable set includes a plurality of dialysis fluid lines extending from the pod pump, wherein the cycler includes a plurality of fluid valves provided along the actuation surface for interfacing the plurality of dialysis fluid lines, and wherein the fluid valves are optionally spring actuated to occlude the plurality of dialysis fluid lines (see figures 1-3).
Regarding claim 12, Wang teaches that the disposable cassette (24) includes a fluid contacting rigid plastic shell (18), wherein the flexible sheet (15) is fixed to the fluid contacting rigid plastic shell (see paragraph 41; figure 3).
Regarding claim 14, Wang teaches that the air pump is provided within a noise-reducing enclosure (see paragraph 128).
Regarding claim 15, Wang discloses a peritoneal dialysis system (10) (see paragraphs 30-45, 88-131 and figures 1-4, 42-44) comprising:
a disposable set (12) including a pod pump ("pump") having a flexible sheet (15), one side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure (see paragraphs 42-44; figure 42); and
a cycler (14) including
an actuation surface (148) including a port (see figure 42: port connecting to line L0),
a pneumatic valve manifold (X1, X2, X3 in figure 42; paragraphs 88, 131) fluidly coupled to the port (see figure 42) for directly providing pneumatic pressure to the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure (see paragraphs 42-44; figure 42: the pneumatic pressure will be directly provided to the flexible sheet 15, the intermediate sheet 148 does not hinder or contradict this; paragraph 61),
an air pump (e.g. "piston pump") positioned and arranged to supply pneumatic pressure to the pneumatic valve manifold (see paragraph 98; figure 42) without intervening pneumatic storage (see paragraph 98: pressure tanks are only optional),
a reference chamber ("reference chamber") in pneumatic communication with the pneumatic valve manifold (see figure 42),
a first pneumatic pressure sensor ("pressure sensor") positioned and arranged to detect pneumatic pressure outputted by the air pump (see paragraph 98),
a second pressure sensor ("pressure sensor") positioned and arranged to detect pneumatic pressure within the reference chamber (see paragraph 98), and
a control unit (16) configured to use outputs from the first and second pressure sensors (see paragraph 98) in combination with a sequence of the pneumatic valve manifold (see paragraphs 102-106) and an ideal gas law equation (see paragraph 101) to compute at least one of i) an initial dialysis fluid volume in the pod pump after fresh or used dialysis fluid is drawn into the pod pump (see paragraph 106) or ii) a final dialysis fluid volume in the pod pump after fresh or used dialysis fluid is pumped from the pod pump (see paragraph 106).
Regarding claim 16, Wang teaches that the control unit is further configured to subtract (ii) from (i) to determine a volume of the fresh or used dialysis fluid pumped from the pod pump (see paragraph 106).
Regarding claim 17, Wang teaches that the control unit is further configured to repeat (i) and (ii) and to subtract (ii) from (i) until a prescribed volume of fresh or used dialysis fluid is pumped (see paragraphs 98-99).
Regarding claim 18, Wang teaches that the pneumatic valve manifold includes a positive pneumatic valve positioned between the air pump and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure and a negative pneumatic valve positioned between the air pump and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and at least one additional pneumatic valve positioned and arranged to allow the reference chamber to communicate pneumatically with the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and wherein the control unit is configured to use outputs from the first and second pressure sensors prior to and after the at least one additional pneumatic valve is opened (see paragraphs 128, 98; figure 42).
Regarding claims 19-20, Wang teaches that the sequence of the pneumatic valve manifold includes opening the negative pneumatic valve to draw fresh or used dialysis fluid into the pod pump prior to opening the at least one additional pneumatic valve and the sequence of the pneumatic valve manifold includes opening the positive pneumatic valve to pump fresh or
used dialysis fluid from the pod pump prior to opening the at least one additional pneumatic valve (see paragraphs 128, 98; figure 42).
Regarding claim 21, Wang teaches that the control unit is configured to open the positive pneumatic valve when the air pump is supplying positive pneumatic pressure and to open the negative pneumatic valve when the air pump is supplying negative pneumatic pressure (see paragraphs 128, 98; figure 42).
Claims 1-4, 8-10, 12 and 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0009311 A1 (Wilcox).
Regarding claim 1, Wilcox discloses a peritoneal dialysis system (10) (see paragraphs 60-66, 68, 73; figure 1) comprising:
a cycler (20) including
an actuation surface (60) including a port (68)(see figure 1),
a pneumatic valve manifold (50 in figure 42; see paragraphs 62) fluidly coupled to the port (see figure 1),
an air pump (27) positioned and arranged to directly supply pneumatic pressure to the port via the pneumatic valve manifold (see paragraphs 62, 65; figure 1), without intervening pneumatic storage,
a pneumatic pressure sensor ("pressure sensor" 38a, 38b) positioned and arranged to detect pneumatic pressure (see paragraph 64), and
a control unit (30) configured to use an output of the pneumatic pressure sensor as feedback to adjust the air pump according to a set pneumatic pressure (see paragraphs 61, 64 68); and
a disposable set (100) including a pod pump ("pump") having a flexible sheet (104), one side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure from the port via the air pump and pneumatic valve manifold (see paragraph 66; figure 1).
Regarding claim 2, Wilcox teaches that the air pump (27) is configured to supply positive and negative pneumatic pressure (see paragraph 61).
Regarding claim 3, Wilcox teaches that the pneumatic valve manifold includes a positive pneumatic valve (58) positioned between the air pump (27) and the side of the flexible sheet (104) positioned and arranged during operation to receive pneumatic pressure, and a negative pneumatic valve (58) positioned between the air pump and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and wherein the control unit is configured to open the positive pneumatic valve when the air pump is supplying positive pneumatic pressure and to open the negative pneumatic valve when the air pump is supplying negative pneumatic pressure (see paragraphs 61-63).
Regarding claim 4, Wilcox teaches that the pneumatic valve manifold (50) further includes at least one additional pneumatic valve (58) positioned and arranged to allow a reference chamber to communicate pneumatically with the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure (see paragraphs 62-63; figure 1).
Regarding claim 8, Wilcox teaches that the control unit is further configured to use at least one of a sensed speed of the air pump or the output of the pneumatic pressure sensor to determine that the flexible sheet has completed (i) drawing fresh or used dialysis fluid into the pod pump or (ii) pumping fresh or used dialysis fluid from the pod pump (see paragraphs 90, 68-79).
Regarding claim 9, Wilcox teaches that the cycler further includes at least one of (i) a batch or inline dialysis fluid heater (“heater”) under control of the control unit or (ii) an air or priming sensor outputting to the control unit (see figures 2-6).
Regarding claim 10, Wilcox teaches that the one side of the flexible sheet (104) is positioned and arranged during operation to receive pneumatic pressure through the actuation surface (60) via the air pump (27) and pneumatic valve manifold (50)(see figure 1).
Regarding claim 12, Wilcox teaches that the disposable cassette (100) includes a fluid contacting rigid plastic shell (102), wherein the flexible sheet (104) is fixed to the fluid contacting rigid plastic shell (see paragraph 66; figure 1).
Regarding claim 15, Wilcox discloses a peritoneal dialysis system (10) (see paragraphs 60-66, 68, 73; figure 1) comprising:
a disposable set (100) including a pod pump ("pump") having a flexible sheet (104), one side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure (see paragraph 66; figure 1); and
a cycler (20) including
an actuation surface (60) including a port (68)(see figure 1),
a pneumatic valve manifold (50) (see figure 1; paragraphs 62) fluidly coupled to the port (see figure 1) for directly providing pneumatic pressure to the side of the flexible sheet (104) positioned and arranged during operation to receive pneumatic pressure (see paragraphs 62-65; figure 1),
an air pump (27) positioned and arranged to directly supply pneumatic pressure to the port via the pneumatic valve manifold (50)(see paragraphs 62, 65; figure 1), without intervening pneumatic storage,
a reference chamber (Ref. 1, Ref. 2) in pneumatic communication with the pneumatic valve manifold (50)(see figure 1; paragraph 64),
a first pneumatic pressure sensor ("pressure sensor" 38a, 38b) positioned and arranged to detect pneumatic pressure outputted by the air pump (see paragraph 64),
a second pressure sensor ("pressure sensor" 38c, 38d) positioned and arranged to detect pneumatic pressure within the reference chamber (see paragraph 64), and
a control unit (30) configured to use outputs from the first and second pressure sensors (see paragraph 64) in combination with a sequence of the pneumatic valve manifold (see paragraphs 68-79) and an ideal gas law equation (see paragraph 69) to compute at least one of i) an initial dialysis fluid volume in the pod pump after fresh or used dialysis fluid is drawn into the pod pump (see paragraph 69) or ii) a final dialysis fluid volume in the pod pump after fresh or used dialysis fluid is pumped from the pod pump (see paragraph 69).
Regarding claim 16, Wilcox teaches that the control unit is further configured to subtract (ii) from (i) to determine a volume of the fresh or used dialysis fluid pumped from the pod pump (see paragraph 69).
Regarding claim 17, Wilcox teaches that the control unit is further configured to repeat (i) and (ii) and to subtract (ii) from (i) until a prescribed volume of fresh or used dialysis fluid is pumped (see paragraph 69).
Regarding claim 18, Wilcox teaches that the pneumatic valve manifold includes a positive pneumatic valve positioned between the air pump and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure and a negative pneumatic valve positioned between the air pump and the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and at least one additional pneumatic valve positioned and arranged to allow the reference chamber to communicate pneumatically with the side of the flexible sheet positioned and arranged during operation to receive pneumatic pressure, and wherein the control unit is configured to use outputs from the first and second pressure sensors prior to and after the at least one additional pneumatic valve is opened (see paragraphs 69-72; figures 2-6).
Regarding claims 19-20, Wilcox teaches that the sequence of the pneumatic valve manifold includes opening the negative pneumatic valve to draw fresh or used dialysis fluid into the pod pump prior to opening the at least one additional pneumatic valve and the sequence of the pneumatic valve manifold includes opening the positive pneumatic valve to pump fresh or used dialysis fluid from the pod pump prior to opening the at least one additional pneumatic valve (see paragraphs 69-72; figures 2-6).
Regarding claim 21, Wilcox teaches that the control unit is configured to open the positive pneumatic valve when the air pump is supplying positive pneumatic pressure and to open the negative pneumatic valve when the air pump is supplying negative pneumatic pressure (see paragraphs 69-72; figures 2-6).
.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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wang.
Wang discloses the peritoneal dialysis system of claim 1 as described above.
Wang discloses that the disposable cassette (24) includes flexible membranes (15, 16) sealed together to hold pneumatic rigid plastic shell (18) therebetween and further discloses that membranes need not necessarily be a flexible member (see paragraph 41; figure 3).
Claim 13 differs from Wang in reciting that the disposable cassette includes a pneumatic rigid plastic shell and a fluid contacting rigid plastic shell, which are sealed together to hold the flexible sheet therebetween.
Mere reversal of parts of rigid plastic shell sealed between flexible membranes of Wang to flexible sheet between rigid plastic shells would have been obvious to a person of ordinary skill in the art. See MPEP 2144. VI. A. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/John Kim/Primary Examiner, Art Unit 1777
JK
12/29/25