DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/13/2025 has been entered.
Response to Amendment
Applicant has amended claims 1-10. The present amendments have overcome all previous claim objections; Examiner accordingly withdraws all previous claim objections. No new matter has been entered. Claims 1-15 remain pending, with claims 12-15 withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wyeth et al. (US 20190262526, henceforth Wyeth) in view of Wang (CN 103751871, henceforth Wang).
Regarding claim 1, Wyeth discloses a peritoneal dialysis system (the chosen embodiment is not shown in any single figure; see the called out figures for relied upon features in the chosen embodiment and see Abstract) comprising, a peritoneal dialysis preparator (containers 734, 736, 738, their respective connectors 730, their respective fluid lines 740, 742, 744, their respective clamps 751, first manifold 758, mixing container 732, and its inlet line 746 and outlet line 750 as shown in fig. 17D make up the claimed preparator); a cycler (waste container 768, module 714 and its components, drain line 756, second manifold 760, fill lines 716 and 755, patient fill line 754, air detector 753, filter 719, air pump 735, and pressure sensor 727 as shown in fig. 17D make up the claimed cycler); and a water purification unit (water filtration system 551 of fig. 22C); the water purification unit fluidly connectable to the peritoneal dialysis preparator (see fig. 17D, the water source 766 which is from water filtration system 551 of fig. 22C is connectable to first manifold 758 via water line 741 as shown and as disclosed in [0193]) and the cycler (see fig. 17D and [0191], since manifolds 758 and 760 are fluidly connected via pump 762 and since manifold 758 of the preparator is fluidly connected to the water purification unit as detailed above, the cycler is fluidly connected to the purified water system via the preparator), the water purification unit being connectable to a water source (source of raw water 556, fig. 22C and [0315]; note that the teachings of [0315] are provided for an alternative embodiment of the water filtration system 551, but are understood to apply to the embodiment of fig. 22C as well) and including at least one pump (pump 552, fig. 22C) for flow of fluid from the water purification unit to a purified water reservoir (see [0315], pump 552 is responsible for pumping fluid to reservoir 581 which is the claimed purified water reservoir), the purified water reservoir being fluidly connectable to the peritoneal dialysis preparator (see fig. 22C, outlet 578 provides a mode for fluid connection of the water filtration system 551 and reservoir 581 to be connected to the called out preparator as in [0327]; thus it is understood that outlet 578 is the fluid line which connects to filter 733 and manifold 758 downstream thereof as shown in fig. 17D), the peritoneal dialysis preparator comprising a plurality of containers (containers 743, 736, and 738, fig. 17D) each containing one or more solutes for dissolution of the one or more solutes (see [0191]; while this is explained for the embodiment of fig. 17A, it is understood to be true for the chosen embodiment of fig. 17D as well since the arrangement of the referred to structures is the same); each container being fluidly connectable to a chamber of the peritoneal dialysis preparator (mixing container 732, fig. 17D; containers 734, 736, and 738 are fluidly connectable to this container via manifolds 758 and 760, see at least [0191], [0198], and [0200]) for receiving a solution of the one or more solutes for preparation of a peritoneal dialysis fluid in the chamber (see [0191], fluid flows from containers 734, 736, 738 through manifolds 758, 760, and into container 732, thus it is for receiving a solution of the solutes for preparation in the chamber as claimed), the cycler fluidly connectable to the peritoneal dialysis preparator (see fig. 17D, the called out cycler and preparator are fluidly connected at least by pump 762, see also [0191]) for receiving the peritoneal dialysis fluid from the peritoneal dialysis preparator (see fig. 17D and [0236], fill line 755 receives fluid from mixing container 732 and first manifold 758 via second manifold 760) for delivery and drainage of the peritoneal dialysis fluid to and from a patient (see [0234]-[0236], the fluid which is received from mixing container 732 and manifold 758 is then further delivered to the patient from manifold 760 and the same fluid line which connects to the patient, patient line 754, is additionally used for drainage as shown in fig. 17D and in [0236]), wherein at least one hydraulic flow generator (pump 585, fig. 22C, which is a hydraulic flow generator as it is an apparatus which creates flow of fluid from reservoir 581 towards the downstream preparator and cycler) is provided in at least one fluid path between the purified water reservoir and the containers (see fig. 22C and see fig. 17D, pump 585 is located in the fluid path which connects reservoir 581 and containers 734, 736, and 738 at manifold 758, thus making it be provided in the flow path between them as claimed), wherein at least one pressure sensor is provided between the water purification unit and the purified water reservoir (first pressure sensor 569, see annotated fig. 22C; this sensor is provided between water filtration system 551 and reservoir 581 as claimed) and a second pressure sensor is provided downstream of the at least one hydraulic flow generator (third pressure sensor 569, see annotated fig. 22C; this sensor is provided at the outflow of pump 585 as shown and is thus downstream of it as claimed), and wherein the system includes a controller (controllers 550 and 576, as shown in fig. 22C, make up a controller where they work in concert via network 1012 as disclosed in [0328]).
Wyeth does not explicitly disclose that the controller is configured to: detect a pressure differential between the at least one pressure sensor and the second pressure sensor; and deactivate the at least one hydraulic flow generator when the detected pressure differential indicates that the purified water reservoir is overfilled. However, Wyeth teaches the use of pressure sensors to determine when to activate or deactivate pumps for filling or draining ([0333]) especially pertaining to the use of multiple pressure sensors and closed loop control of the pressure at different points within the system (see [0333] and [03334]). Wyeth additionally teaches that commands from controllers are configured for pumping water from the purified water reservoir to the preparator and cycler ([0333], “One command may be for the water source to start pumping product water into the connection to the proportioner/cycler”). Wyeth also teaches differential pressure measurements being used (see calibration of [0123]). Additionally, Wang teaches a peritoneal dialysis treatment device (see Title) configured to detect a pressure differential (see highlighted portion of machine translation, pg. 6) between a first and second pressure sensors (see highlighted portion of machine translation, pg. 6, Wang teaches a plurality of pressure sensors which includes at least a first and a second pressure sensor) whereby detection of a predetermined pressure differential controls the flow generator (see highlighted portion of machine translation, pg. 6; Wang teaches adjustment of speed of a flow generator).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wyeth by configuring the controller to compare pressure sensor readings of its first and second pressure sensors to detect a pressure differential between them to deactivate the flow generator when the pressure differential indicates that the reservoir has been overfilled as claimed for the benefit of ensuring the effective volume of the perfusion amount of the next cycle, improving efficiency, and ensuring that excretion speed is within the acceptable range for patient safety (see highlighted portion of machine translation of Wang, pg. 6). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a calculated pressure differential for the control of the flow generator instead of a single pressure measurement as disclosed by Wyeth (see [0327] and [0333]) since the use of a pressure differential or a single pressure measurement could be used interchangeably by one of ordinary skill in the art to provide information about the pressure of a vessel in such a way that the same, predictable result of control of flow generators could be maintained effectively and safely so as not to over pressurize or under pressurize any vessel as desired.
{It is unclear from the disclosure of Wyeth whether or not the pictured pressure sensors (569) are all meant to exist at the same time in an embodiment, or if there is only a single sensor with varying positions for a given embodiment (see Wyeth [0327], there is a reference to “Pressure 569 and temperature 580 sensors may be located at various positions”). If the disclosure is taken to mean that only a single sensor is disclosed for a given embodiment, see below for an addition to the rejection above:
Wyeth as modified does not explicitly disclose an embodiment with the first and second pressure sensors existing at the same time. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included each of the called out pressure sensors shown in Wyeth to provide the maximum amount of data and information about the pressure of the fluid within the tubing at various locations as possible and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.}
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Annotated fig. 22C from Wyeth calling out pressure sensors 569
Regarding claim 2, Wyeth as modified discloses the system wherein the at least one pressure sensor controls filling of the purified water reservoir (see [0327], [0333], and the rejection of claim 1 above, this is considered to be true in view of the use of predefined pressures as measured by the pressure sensors being used for activation and deactivation of pumps).
Regarding claim 3, Wyeth as modified discloses the system wherein the second pressure sensor is provided between the purified water reservoir and the preparator (see figs. 22C and 17D, third pressure sensor 569 as called out in the annotated fig. 22C is provided in the fluid connection between reservoir 581 and outlet 578 which is how water filtration system 551 connects to the proportioning and treatment system for peritoneal dialysis 700D of fig. 17D).
Regarding claim 4, Wyeth as modified discloses the system wherein the at least one hydraulic flow generator is provided between the purified water reservoir and the second pressure sensor (see fig. 22C, pump 585 is in the flow path between third pressure sensor 569 and reservoir 581).
Regarding claim 5, Wyeth as modified discloses the system the second pressure sensor is provided at an outflow of the at least one flow generator (see fig. 22C, third pressure sensor 569 as called out in the annotated fig. 22C is shown at the outflow of pump 585).
Regarding claim 6, Wyeth as modified discloses the system wherein the controller is further configured to detect a pressure differential between the at least one pressure sensor and the second pressure sensors (see the rejection of claim 1 above, this is how the claimed pressure differential is calculated) whereby detection of a second predetermined pressure is configured to cause activation of the at least one hydraulic flow generator (see [0327] and [0333], Wyeth discloses that a threshold can be used to determine starting, or activation, of a pump when a certain pressure threshold is crossed).
While Wyeth as modified does not explicitly disclose that the calculated pressure differential between sensors (see pressure differential between sensors 569 in the rejection of claim 1 above) is used for this activation, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used that pressure differential instead of a single pressure measurement since the use of a pressure differential or a single pressure measurement could be used interchangeably by one of ordinary skill in the art to provide information about the pressure of a vessel in such a way that the same, predictable result of control of flow generators could be maintained effectively and safely so as not to over pressurize or under pressurize any vessel as desired.
Regarding claim 7, Wyeth as modified discloses the system wherein the at least one pressure sensor outputs and the second pressure sensor outputs are transmitted to a microprocessor (see [0319] and [0327], and see [0547]-[0550]).
Regarding claim 8, Wyeth as modified discloses the system further comprising providing a plurality of hydraulic flow or pressure generators (pump 762, fig. 17D and [0198], and air pump 735, fig. 17D) throughout other fluid paths (see fig. 17D, pumps 762 and 735 are provided in or act on paths of fluid flow within the system, such as the path between manifold 758 and manifold 760 or the path of flow at sterilizing filter 719) to provide optimized dissolution of the solutes, optimized mixing of the solution and/or cycling of the peritoneal dialysis fluid (pump 762 is responsible for cycling of fluid as in [0198], and pump 735 is responsible for providing optimized dissolution of solutes where it assists filter 719 in the confirmation of a lack of contaminants which would mean that the solutes are best dissolved since there is nothing else in the solution which would negatively affect the dissolution of solutes).
Regarding claim 9, Wyeth as modified discloses the system wherein the at least one hydraulic flow generator is an actuator (pump 585 is disclosed to be an actuator where it acts on fluid to provide a pressure as in [0327]; since an actuator is defined by Merriam-Webster to be “a mechanical device for moving or controlling something” and pump 585 is a mechanical device which moves and/or controls flow of fluid, it is an actuator as claimed) operable on a fluid line (pump 585 acts on a flow of fluid between outlet 578 and reservoir 581 as shown in fig. 22C).
Regarding claim 10, Wyeth as modified does not explicitly disclose the system wherein the at least one hydraulic flow generator is selected from a hydraulic piston pump and a peristaltic pump. However, Wyeth teaches that its pumps can be peristaltic pumps (see fig. 2D, [0096], [0178], and [0192]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a peristaltic pump for its hydraulic flow generator since peristaltic pumps are taught to be acceptable kinds of pumps used in the system and since using a peristaltic pump for the hydraulic flow generator would have yielded the same, predictable result of a pump which forces fluid along a flow path at a desired rate and in a controlled manner.
Regarding claim 11, Wyeth as modified discloses the system further comprising a disposable dialysis cassette operable within the dialysis system (fluid circuit 701D, see fig. 17D, is disposable as in the Abstract and as in [0192] and is thus considered to be a disposable cassette as claimed – note that while [0192] is described for the embodiment of fig. 17A, it is understood to apply for fig. 17D and the chosen embodiment as well).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the Wyeth reference in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-Th 7:00a-5:00p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783