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 .
Response to Arguments
Applicant's amendments and arguments filed July 27, 2026 have been fully considered.
The indefiniteness rejections have been withdrawn.
The prior art rejections have been maintained and updated.
In the response, it was argued that “neither Anderson nor Benton alone or in combination teaches or suggests determining a flow rate based on (i) a volume of available spent dialysis fluid, (ii) a length of time available to produce a desired amount of diluted concentrate fluid, and (iii) distributing the available volume over the available time period” (see Response pages 9-10). It is noted that independent claim 1 was amended to recite this new limitation. It is acknowledged that US 097 in view of US 693 does not disclose the newly amended limitation. However, the upon further consideration, a new ground(s) of rejection is made. The new grounds of rejection relies upon newly cited prior art.
It is noted that in the June 10, 2026 Office Action, the language of claim 32 was deemed indefinite. Claim 32 had recited “control the flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of the diluted concentrate fluid; and control the flow rate of the dialysis concentrate fluid into the draw side based on a volume of dialysis concentrate fluid needed to produce the desired amount of diluted concentrate fluid and the length of the time period, to provide the desired amount of diluted concentrate fluid at the end of the time period” and for the sake of compact prosecution, control of the flow rate of the spent dialysis fluid may be based on volume of available spent dialysis fluid or the length of a time. Thus, the language of newly amended claim 31 is deemed to be presented for the first time for consideration.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 31-43 and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020174097 A1 (hereinafter WO 097) in view of US 2018/0243693 A1 (hereinafter US 693) and US 5326476 A (hereinafter US 476).
Regarding claim 31, WO 097 discloses an apparatus for producing dialysis fluid (see WO 097 abstract, figures 1-7, 9, claim 14; page 5 line 27 – page 6 line 1; page 11 lines 20-25; page 19 line 29 – page 30 line 18; page 21 lines 8 – page 22 line 15; page 28 line 16 – page 29 line 14). Statements in the preamble reciting the purpose or intended use of the claimed invention which do not result in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art do not limit the claim and do not distinguish over the prior art apparatus (or process). See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) and cases cited therein, as it has been held that the recitation of a new intended use for an old product does not make a claim to that old product patentable. In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). See also MPEP § 2111.02, §2112.02 and 2114-2115. Nevertheless, WO 097 discloses an apparatus for producing dialysis fluid (see WO 097 page 8 lines 1-5; page 14 lines 15-23).
WO 097 discloses a draw fluid path including at least one concentrate connector, each connector configured to be connected to a source of dialysis concentrate fluid (see WO 097 concentrated dialysate being within a container, as illustrated in figures 1-2, enters the system via a pipeline/tube that connects the outlet of the container to the draw input side of the forward osmosis unit; figures 1-7, page 12 lines 20-23; page 15 lines 22 – page 16 line 30; page 28 lines 18-22; page 29 lines 5-7).
The term “concentrate connectors” is understood to be any device, element or object that achieves a connection between a source of dialysis concentrate fluid to the draw fluid path. Herein, WO 097 necessarily discloses at least one concentrate connector since the concentrated dialysate enters the pipeline/tube and flows through the draw fluid path from the source. The Examiner notes that “a source of dialysis concentrate fluid” is not an element of the claimed apparatus.
WO 097 discloses a feed fluid path including a connector configured to be connected to a source of spent dialysis fluid (see WO 097 spent dialysate, either from the dialyzer or within a container, as illustrated in figures 1-2, enters the system via a pipeline/tube that connects from the outlet of the dialyzer or container to the feed pump then to the feed input side of the forward osmosis unit; figures 1-7, page 8 lines 1-2; page 20 lines 1 – 16 & 26-31; page 28 lines 18-22; page 28 line 29 – page 29 line 5; page 29 lines 19-20).
The term “connector” is understood to be any device, element or object that achieves a connection between a source of spent dialysis fluid to the feed fluid path. Herein, WO 097 necessarily discloses a connector since the spent dialysis fluid enters the pipeline/tube and flows through the feed fluid path from the source. The Examiner notes that “a source of spent dialysis fluid” is not an element of the claimed apparatus.
WO 097 discloses a forward osmosis (FO-) unit including a feed side and a draw side separated by a FO- membrane; the feed side included in the feed fluid path and the draw side included in the draw fluid path, wherein the FO-unit is configured to receive a dialysis concentrate fluid at the draw side and to receive the spent dialysis fluid at the feed side, wherein water is transported from the spent dialysis fluid to the dialysis concentrate fluid through the FO-membrane via an osmotic pressure difference between the draw side and the feed side, thereby diluting the dialysis concentrate fluid into a diluted dialysis concentrate fluid and dewatering the spent dialysis fluid into a dewatered spent dialysis fluid (see WO 097 draw solution/concentrate fluid is passed from the draw fluid path to the draw side of the FO unit and feed solution/spent dialysis fluid is passed from the feed fluid path to the feed side of the FO unit; the FO apparatus, which may comprise more than one forward osmosis module/unit, wherein each forward osmosis module/unit comprises a membrane module comprising a membrane capable of allowing water to pass and rejecting certain solutes; figures 1-7 and page 6 line 28 – page 7 line 14; page 11 line 17 – page 12 line 11; page 14 line 25 – page 17 line 29; page 20 lines 7-16; page 21 lines 11-16; page 28 lines 16 – page 29 line 11; page 29 line 16 – page 31 line 4).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of WO 097 is substantially identical to the claimed FO-unit of the present application, and therefore, the structure of WO 097 is presumed inherently capable of receiving dialysis concentrate fluid at the draw side and to receiving the spent dialysis fluid at the feed side, wherein water is transported from the spent dialysis fluid to the dialysis concentrate fluid through the FO-membrane via an osmotic pressure difference between the draw side and the feed side, thereby diluting the dialysis concentrate fluid into a diluted dialysis concentrate fluid and dewatering the spent dialysis fluid into a dewatered spent dialysis fluid.
WO 097 discloses achieving a transmembrane pressure (TMP) difference across the membrane of the forward osmosis membrane (see WO 097 page 18 lines 23-31) and discloses using a pump to supply spent dialysate with a hydrostatic pressure before the spent dialysate enters the inlet of the forward osmosis apparatus (see WO 097 figure 5 and page 30 lines 20-23).
WO 097 does not disclose the A) claimed “at least one property sensor configured to sense one or more properties of the diluted dialysis concentrate fluid and/or the dewatered spent dialysis fluid” limitation, B) claimed “at least one pressure sensor configured to sense one or more pressures indicative of a hydrostatic pressure difference between the draw side and the feed side” limitation and the C) claimed “a control arrangement configured to cause a flow of the dialysis concentrate fluid into the draw side to be provided, cause a flow of the spent dialysis fluid into the feed side to be provided, cause a hydrostatic pressure difference between the draw side and the feed side with at least one pressure pump to be provided, and control a flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of a diluted concentrate fluid, by distributing the volume over the length of the time period, so as to yield the diluted dialysis concentrate fluid” limitation.
US 693 discloses method and systems for dewater a solution by forward osmosis, wherein the systems and methods operate with a pressurized draw stream and systems are configured to “facilitate methods for membrane integrity monitoring and/or providing enhanced purification” (see US 693 paragraph 0024; see also US 693 abstract and figures 1, 4, 5; claims 1, 27, 48 and paragraphs 0007-009). US 693 discloses the system 500 can include one or more sensors 160 or sensing devices configured to detect one or more markers in at least one of the feed stream 112, the feed concentrate 116, the draw stream 122, or the RO permeate 156. The one or more sensors 160 can be operably coupled to the first side 115 of the FO element 110, an output of the first side of the FO element (e.g., to monitor the feed concentrate 116)” (see US 693 paragraph 0071; see also US 693 paragraphs 0073-0078, 0080, 0081) and
at least some of the one or more sensors 160 can be configured as pressure sensors (e.g., pressure transducers) to detect the pressure in one or more portions of the system. The pressure sensors can be disposed in one or more locations in both of the first side 115 (e.g., feed side) and the second side 125 (e.g., draw side) effective to monitor the difference in hydrostatic pressures between the first side 115 and the second side 125. The pressure sensors can be configured to continuously, intermittently, or instantly monitor the hydrostatic pressure of the first and second sides (and/or a hydrostatic pressure differential therebetween) and communicate the detected pressures to the controller 170 (e.g., collectively a pressure monitoring system)
(see US 693 paragraph 0071; see also US 693 paragraphs 0077, 0078, 0081, 0112).
US 693 discloses that “the positive draw-to-feed hydrostatic pressure differential can be monitored and verified by an independent pressure monitoring system” (see US 693 paragraph 0041; see also US 693 paragraphs 0076, 0077, 0079). US 693 discloses that the hydrostatic pressure can be applied to the forward osmosis unit to provide a higher hydrostatic pressure in the draw side of an FO element in comparison to the feed side and that when there is a breached membrane, this will assist with preventing contamination of the draw stream with the feed stream (see US 693 paragraphs 0021, 0025-0026). US 693 discloses having the draw stream at a higher hydrostatic pressure than the feed stream achieves a positive hydrostatic pressure against the draw side of the FO unit and that “operating the draw stream at a higher hydrostatic pressure than the feed stream pushes the draw stream against the FO membrane to provide a pressure barrier between the feed stream and draw stream effective to prevent or limit leaks into the draw stream from the feed stream” (see US 693 paragraph 0057; see also US 693 paragraphs 0032, 0040, 0042, 0044, 0046, 0047, 0057, 0067, 0077, 0079). US 693 discloses that the feed stream and draw stream may comprise one or more of a tank, a pressurized pump, a valve, a pipe, a conduit, a hose, a temperature control element (see US 693 paragraph 0040).
US 693 discloses that a controller can control the opening or closing of “one or more valves or deactivate or adjust (e.g., decrease or increase pressure produced by) one or more pumps responsive to receiving a sensing signal from the sensor” (see US 693 paragraph 0076; see also US 693 paragraph 0084, 0087). US 693 discloses the pressure regulation system comprises at least one pump and a controller that “can be used to regulate the pressure of the feed stream, the draw stream, the diluted draw stream, or any other solutions in the system” (see US 693 paragraph 0079). US 693 discloses that the pressure regulation system communicates with the pressure sensor(s)/pressure monitoring system (see US 693 paragraphs 0071, 0076, 0077, 0079, 0083-0086, 0112-0014 and figures 5-8). US 693 discloses that the “the pressure regulation system is configured to selectively control (e.g., increase, decrease, initiate, or terminate) the hydrostatic pressure or flow rate of the feed stream, draw stream, or diluted draw stream in one or more portions of the system responsive to the monitoring system” (see US 693 paragraph 0079; see also US 693 paragraphs 0083-0084).
US 693 is considered to be analogous to the claimed invention because it is in the same field of endeavor, i.e. forward osmosis system, dewatering of a fluid.
A) Regarding the claimed “at least one property sensors configured to sense one or more properties of the diluted dialysis concentrate fluid and/or the dewatered spent dialysis fluid” limitation.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method and system of WO 097 by incorporating the at least one sensor, as disclosed in US 693, because it will assist in providing one of ordinary skill in the art with information about the operating conditions of the system and/or because it would assist with monitoring at least one feed stream, the feed concentrate, the draw stream, the feed side of the FO apparatus, the draw side of the FO apparatus and/or the outlet of the FO apparatus.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method and system of WO 097 by incorporating the at least one sensor, as disclosed in US 693, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. provide one of ordinary skill in the art with data about the operating condition(s) of the system.
B) Regarding the claimed “at least one pressure sensor configured to sense one or more pressures indicative of a hydrostatic pressure difference between the draw side and the feed side” limitation.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method and system of WO 097 by incorporating the at least one pressure sensor, as disclosed in US 693, because it would provide one of ordinary skill in the art with additional information about the operating conditions of the system and/or because it would assist with monitoring the difference in hydrostatic pressure/transmembrane pressure (TMP) difference between the feed side 115 and the draw side of the FO apparatus of WO 097 (see WO 097 page 18 lines 23-31, page 30 lines 20-23 and figure 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method and system of WO 097 by incorporating the at least one pressure sensor, as disclosed in US 693, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. measure the pressure in the system.
C) Regarding the claimed “a control arrangement configured to cause a flow of the dialysis concentrate fluid into the draw side to be provided, cause a flow of the spent dialysis fluid into the feed side to be provided, cause a hydrostatic pressure difference between the draw side and the feed side with at least one pressure pump to be provided, and control a flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of a diluted concentrate fluid, by distributing the volume over the length of the time period, so as to yield the diluted dialysis concentrate fluid” limitation.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method and system of WO 097 by incorporating the pressure regulation system, comprising at least one pump and a controller, along with sensor(s), valve(s) and the pressure sensor(s)/pressure monitoring system, as disclosed in US 693, because it will assist in controlling the operating of the system of WO 097 in view of US 693, which can include flow rate of the various fluids throughout the system (see US 693 paragraphs 0079, 0083-0086) and/or increasing or decreasing the hydrostatic pressure/transmembrane pressure (TMP) difference (see US 693 paragraphs 0071, 0079, 0083-0086).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the method and system of WO 097 by incorporating the pressure regulation system, comprising at least one pump and a controller, along with sensor(s), valve(s) and the pressure sensor(s)/pressure monitoring system, as disclosed in US 693, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. control various operating parameters of the system, including flow rate and hydrostatic pressure.
It is noted that the as-originally filed specification discloses a “control arrangement 50 is arranged to control the apparatus 1 to perform a plurality of procedures. The control arrangement 50 includes a control unit 30, a valve arrangement 20 (20a-20p) and at least one pump 6, 7, 10, 23, 29, 32” (see as-originally filed specification page 11 lines 4-6). Herein, WO 097 in view of US 693 is deemed to disclose a control arrangement since the system/apparatus comprises at least one pump, a controller and a valve.
WO 097 in view of US 693 does not disclose control a flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of a diluted concentrate fluid, by distributing the volume over the length of the time period.
US 476 discloses methods for operational instructions related to a hemodialysis machine (see US 476 abstract and claims 1-6). US 476 discloses a controller programmed to determine a flow rate based upon the volume of a material being used and a time period for operating (see US 476 col 10 lines 7-12; col 11 lines 59-66; col 16 lines 49-64; col 17 line 29-32 & lines 65-68; col 18 lines 3-5 & 8-36 (US 476 discloses that flow is controlled wherein “Since the flow equalizer volume is calibrated and the end-of-stroke time is controlled, the UF/PROP system 516 can accurately control the dialysate flow rate to the user-entered value” (see US 476 col 18 lines 33-36).).
US 476 is considered to be analogous to the claimed invention because it is in the same field of endeavor, i.e. hemodialysis therapy, dialysis machine, dialysis method, forming dialysate and/or concentrate dialysate/spent dialysate.
US 476 “[a] reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.” See MPEP 2141.01(a). US 476 is reasonably pertinent to the problem faced by the inventor, i.e. controlling the movement of fluid within an apparatus/system and/or reducing amount of dialysis fluid being transported (see Applicant’s specification, abstract and page 3).), because US 476 is directed towards a method and/or machine for controlling the movement of fluid(s) through an apparatus/system and the forming a dialysate solution (see US 476 claims 4 & 5; col 32 lines 48-51).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the controller of WO 097 in view of US 693, which controls at least one pump, valve(s) and the pressure sensor(s)/pressure monitoring system, with a program or algorithm, as discloses in US 476, which includes a program to determine a flow rate based upon the volume of a material being used and a time period for operating, because WO 097 in view of US 693 discloses a control arrangement/controller for controlling flow rate of spent dialysis fluid but does not disclose a program for determining flow rate and US 476 provides a method or algorithm for determining flow rate.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the controller of WO 097 in view of US 693, which controls at least one pump, valve(s) and the pressure sensor(s)/pressure monitoring system, with a program or algorithm, as discloses in US 476, which includes a program to determine a flow rate based upon the volume of a material being used and a time period for operating, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. determine a flow rate.
One of ordinary skill in the art, such as a chemical engineer with a Bachelors of Science, would have the capacity to modify a controller to include a program or algorithm to determine and/or control the flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of a diluted concentrate fluid, by distributing the volume over the length of the time period.
Hence, WO 097 in view of US 693 and US 476 is deemed to disclose an apparatus for producing dialysis fluid, the apparatus comprising a draw fluid path including at least one concentrate connector, each connector configured to be connected to a source of dialysis concentrate fluid; a feed fluid path including a connector configured to be connected to a source of spent dialysis fluid; a forward osmosis (FO-) unit including a feed side and a draw side separated by a FO- membrane, the feed side included in the feed fluid path and the draw side included in the draw fluid path, wherein the FO-unit is configured to receive a dialysis concentrate fluid at the draw side and to receive the spent dialysis fluid at the feed side, wherein water is transported from the spent dialysis fluid to the dialysis concentrate fluid through the FO-membrane via an osmotic pressure difference between the draw side and the feed side, thereby diluting the dialysis concentrate fluid into a diluted dialysis concentrate fluid and dewatering the spent dialysis fluid into a dewatered spent dialysis fluid; at least one property sensor configured to sense one or more properties of the diluted dialysis concentrate fluid and/or the dewatered spent dialysis fluid; at least one pressure sensor configured to sense one or more pressures indicative of a hydrostatic pressure difference between the draw side and the feed side; and a control arrangement configured to cause a flow of the dialysis concentrate fluid into the draw side to be provided, cause a flow of the spent dialysis fluid into the feed side to be provided, cause a hydrostatic pressure difference between the draw side and the feed side with at least one pressure pump to be provided, and control a flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of a diluted concentrate fluid, by distributing the volume over the length of the time period , so as to yield the diluted dialysis concentrate fluid.
The Examiner notes that “a source of dialysis concentrate fluid”/”a dialysis concentrate fluid”, “a source of spent dialysis fluid”/“spent dialysis fluid”, “water”, “diluted dialysis concentrate fluid” and/or “the dewatered spent dialysis fluid” are not elements of the claimed apparatus. Nonetheless, as established above, WO 097 in view of US 693 and US 476 is deemed “a source of dialysis concentrate fluid”/”a dialysis concentrate fluid”, “a source of spent dialysis fluid”/“spent dialysis fluid”, “water”, “diluted dialysis concentrate fluid” and/or “the dewatered spent dialysis fluid”.
The Examiner notes that the term “control arrangement” is defined by functional language and not by a structural element(s). Herein, the Examiner understands the combination of the controller, at least one pump and valve(s) of WO 097 in view of US 693 and US 476 to be a control arrangement that is configured to cause a flow of the dialysis concentrate fluid into the draw side to be provided, cause a flow of the spent dialysis fluid into the feed side to be provided, cause a hydrostatic pressure difference between the draw side and the feed side with at least one pressure pump to be provided, and control a flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of a diluted concentrate fluid, by distributing the volume over the length of the time period, so as to yield the diluted dialysis concentrate fluid.
The Examiner holds that WO 097 in view of US 693 and US 476 is deemed to disclose “at least one pressure pump” since the pump is capable of generating a force to move fluid through the system.
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of WO 097 in view of US 693 and US 476 is substantially identical to the claimed A) at least one property sensor, B) at least one pressure sensor, and C) control arrangement of the present application, and therefore, the structure of WO 097 in view of US 693 and US 476 is presumed inherently capable of A) sensing one or more properties of the diluted dialysis concentrate fluid and/or the dewatered spent dialysis fluid, B) sensing one or more pressures indicative of a hydrostatic pressure difference between the draw side and the feed side and C) cause a flow of the dialysis concentrate fluid into the draw side to be provided, cause a flow of the spent dialysis fluid into the feed side to be provided, cause a hydrostatic pressure difference between the draw side and the feed side with at least one pressure pump to be provided, and control a flow rate of spent dialysis fluid into the feed side based on a volume of available spent dialysis fluid and a length of a time period available to produce a desired amount of a diluted concentrate fluid, by distributing the volume over the length of the time period, so as to yield the diluted dialysis concentrate fluid.
Regarding claim 32, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 does not disclose control the flow rate of the dialysis concentrate fluid into the draw side based on both a volume of dialysis concentrate fluid needed to produce the desired amount of the diluted concentrate fluid and the length of the time period, by distributing said volume over said length of the time period, to provide the desired amount of the diluted concentrate fluid at the end of the time period.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the controller of WO 097 in view of US 693 and US 476, which controls at least one pump, valve(s) and the pressure sensor(s)/pressure monitoring system, with a program or algorithm, as discloses in US 476, which includes a program to determine a flow rate based upon the volume of a material being used and a time period for operating, because WO 097 in view of US 693 and US 476 discloses a control arrangement/controller for controlling flow rate of dialysis concentrate fluid but does not disclose a program for determining flow rate and US 476 provides a method or algorithm for determining flow rate.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the controller of WO 097 in view of US 693 and US 476, which controls at least one pump, valve(s) and the pressure sensor(s)/pressure monitoring system, with a program or algorithm, as discloses in US 476, which includes a program to determine a flow rate based upon the volume of a material being used and a time period for operating, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. determine a flow rate.
One of ordinary skill in the art, such as a chemical engineer with a Bachelors of Science, would have the capacity to modify a controller to include a program or algorithm to determine and/or control the flow rate of the dialysis concentrate fluid into the draw side based on both a volume of dialysis concentrate fluid needed to produce the desired amount of the diluted concentrate fluid and the length of the time period, by distributing said volume over said length of the time period, to provide the desired amount of the diluted concentrate fluid at the end of the time period.
Regarding claim 33, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 discloses the control arrangement is further configured to control the hydrostatic pressure difference with the at least one pressure pump based on the one or more properties of diluted dialysis concentrate and/or dewatered spent dialysis fluid, and the sensed one or more pressures indicative of the hydrostatic pressure difference (see rejection of claim 31; see also US 693 paragraph 0076).
Regarding claim 34, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 33. Further, WO 097 in view of US 693 and US 476 discloses the control arrangement is further configured to control the hydrostatic pressure difference with the at least one pressure pump based on the sensed one or more pressures to achieve a predetermined hydrostatic pressure difference (see rejection of claim 31; see also US 693 paragraph 0076).
It is understood that “predetermined hydrostatic pressure difference” may be any hydrostatic pressure difference. Herein, there must necessarily be a value within the prior art. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
Regarding claim 35, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 34. Further, WO 097 in view of US 693 and US 476 discloses the predetermined hydrostatic pressure difference is a maximum allowed hydrostatic pressure difference (see rejection of claim 34).
Regarding claim 36, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 33. Further, WO 097 in view of US 693 and US 476 discloses the control arrangement is further configured to control the hydrostatic pressure difference based on a property of diluted dialysis concentrate and/or dewatered spent dialysis fluid, to make the property equal to a target value of the property (see rejection of claims 1, 33 and 34).
It is understood that “target value of the property” may be any value of any property. Herein, there must necessarily be a value within the prior art. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
Regarding claim 37, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 32. Further, WO 097 in view of US 693 and US 476 does not disclose the control arrangement is further configured to control the flow rate of dialysis concentrate fluid using a concentrate pump and control the flow rate of diluted dialysis concentrate fluid using a second pressure pump of the at least one pressure pump, such that the flow rate of diluted dialysis concentrate fluid equals an inlet flow rate of dialysis concentrate fluid to the draw side times a target dilution factor.
However, WO 097 in view of US 693 and US 476 discloses a control arrangement that is capable of controlling a pump (see rejection of claim 31).
WO 097 discloses several pump limitations, including “a pump for pumping the concentrated dialysate to the forward osmosis unit, or a pump for suction of the diluted dialysate from the forward osmosis unit” (see WO 097 page 22 lines 4-7; page 45 lines 20-23); “suitable pump is a peristaltic pump, however other pumps of the positive displacement type may also be used” (see WO 097 page 15 lines 17-20), and feed and draw pumps (see WO 097 page 36 lines 4-6; page 38 lines 4-14/Table 2.
US 693 discloses control arrangement controls flow rate and/or hydrostatic pressure (see US 693 claim 58; paragraphs 0040, 0076-0077, 0079, 0083-0084, 0086) and controls pressurized pumps (see US 693 paragraphs 0040, 0046, 0061, 0062, 0065).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the control arrangement of WO 097 in view of US 693 and US 476 to control each of the pumps in the system, as disclosed in US 693, which would necessarily include “a pump for pumping the concentrated dialysate to the forward osmosis unit, or a pump for suction of the diluted dialysate from the forward osmosis unit” (see WO 097 page 22 lines 4-7; page 45 lines 20-23), peristaltic pump or other pumps of the positive displacement type (see WO 097 page 15 lines 17-20), feed and draw pump(s) and pressurized pumps (US 693 paragraphs 0040, 0046, 0061, 0062, 0065), because it would assist with streamlining the system by having one control unit to control all elements of the system and/or one of ordinary skill in the art would desire automating a system to have one controller element for each pump of the system (see MPEP 2144.04, III).
Hence, WO 097 in view of US 693 and US 476 is deemed to disclose the control arrangement is further configured to control the flow rate of dialysis concentrate fluid using a concentrate pump (such as a feed pump) and control the flow rate of diluted dialysis concentrate fluid using a second pressure pump of the at least one pressure pump (such as a pressurized pump), such that the flow rate of diluted dialysis concentrate fluid equals an inlet flow rate of dialysis concentrate fluid to the draw side times a target dilution factor.
It is understood that “target dilution factor” may be any dilution factor. Herein, there must necessarily be a value within the prior art. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
Regarding claim 38, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 37. Further, WO 097 in view of US 693 and US 476 discloses the control arrangement is further configured to control a ratio between the concentrate pump and the second pressure pump based on a property of diluted dialysis concentrate, to make the property equal to a target value of the property (see rejection of claims 31, 37).
It is understood that “target value of the property” may be any value. Herein, there must necessarily be a value within the prior art. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
Regarding claim 39, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 38. Further, WO 097 in view of US 693 and US 476 discloses the control arrangement is further configured to control the flow rate of spent dialysis fluid into the feed side and/or control the flow rate of the dialysis concentrate fluid into the draw side, based on the sensed one or more pressures indicative of the hydrostatic pressure difference, such that the hydrostatic pressure difference is kept below or on a maximum allowed hydrostatic pressure difference (see rejection of claims 31, 33, 36, 37).
It is understood that “maximum allowed hydrostatic pressure difference” may be any value. Herein, there must necessarily be a value within the prior art. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
Regarding claim 40, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 discloses the at least one property sensor are configured to sense one or more of a concentration of the diluted dialysis concentrate, concentration of the dewatered spent dialysis fluid, a flow rate of the diluted dialysis concentrate or a flow rate of the dewatered spent dialysis fluid (see rejection of claim 31; see US 693 figure 5, paragraphs 0071-0077).
Regarding claim 41, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 discloses the at least one pressure pump comprise a first pressure pump arranged for operating on the dewatered spent dialysis fluid inputted from the feed side (see rejection of claim 31; see US 693 paragraphs 0040, 0046, 0067, 0074).
It is noted that the pressurized pump on the feed stream source would apply pressure to the fluid on feed side of the FO unit and would necessarily also apply pressure to the output of the feed side of the FO unit.
Regarding claim 42, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 41. Further, WO 097 in view of US 693 and US 476 does not disclose the first pressure pump is configured to pump in either an upstream direction and a downstream direction (see rejection of claims 31, 33, 34).
Even if WO 097 in view of US 693 and US 476 does not disclose the first pressure pump is configured to pump in either an upstream direction and a downstream direction, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the pressure pump of the feed stream of WO 097 in view of US 693 and US 476 to operate in a bi-directional fashion because it would assist with achieving a desired flow rate and/or hydrostatic pressure.
Regarding claim 43, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 discloses the at least one pressure pump comprise a second pressure pump arranged for operating on the diluted dialysis fluid outputted from the draw side (see rejection of claim 31; see US 693 paragraphs 0040, 0046, 0067, 0074). It is noted that the pressurized pump on the draw stream source would apply pressure to the fluid on draw side of the FO unit and would necessarily also apply pressure to the output of the draw side of the FO unit.
Regarding claim 45, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 does not disclose at least one of the at least one pressure pump is a volumetric pump.
However, WO 097 in view of US 693 and US 476 discloses a “suitable pump is a peristaltic pump, however other pumps of the positive displacement type may also be used” for the movement of fluid through the system” (see WO 097 page 15 lines 18-20).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to either the peristaltic pump or another positive displacement type pump in the system of WO 097 in view of US 693 and US 476, as disclosed in WO 097, because it would assist with the movement of fluid through the system and WO 097 in view of US 693 and US 476 does not disclose a specific example of a pressurized pump and/or reasonably expect the resulting apparatus to work as the prior art intended, i.e. move fluid through the system.
Regarding claim 46, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 does not disclose the control arrangement is configured to control a flow rate of a second or third concentrate so as to flow into the diluted concentrate fluid to form a dialysis fluid
However, WO 097 in view of US 693 and US 476 discloses the addition of a second concentrate, such as sodium bicarbonate, that flows into the diluted concentrate fluid to form a dialysis fluid (see WO 097 figures 1, 7, page 19 lines 1-17; page 21 line 30 – page 22 line 2; page 23 line 16-18). WO 097 in view of US 693 and US 476 discloses the use of a pump, sensor and control unit in order to control flow rate of a fluid in a system (see rejection of claim 31; US 693 claim 58; paragraphs 0040, 0076, 0077, 0079, 0083).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of WO 097 in view of US 693 and US 476 by incorporating monitoring and regulating elements, such as a sensor, at least one pump and the controller, as discloses in US 693, into the pipeline for the addition of a second concentrate, such as sodium bicarbonate, as disclosed in WO 097, because it would assist with controlling the addition of a second concentrate, such as sodium bicarbonate, into the diluted concentrate fluid and thereby assisting with the forming of a dialysis fluid.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of WO 097 in view of US 693 and US 476 by incorporating monitoring and regulating elements, such as a sensor and at least one pump, which are controlled by the controller, as discloses in US 693, into the pipeline for the addition of a second concentrate, such as sodium bicarbonate, as disclosed in WO 097, since it has been held that mere duplication of an element of an apparatus involves only routine skill in the art. MPEP 2144.04.VI.B. There is no patentable significance of an additional sensor and pump, which predictable provides one of ordinary skill in the art with additional information regarding the operating system and the movement of fluid through a system, respectively, and does not produce any new and/or unexpected results.
Regarding claim 47, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 discloses the apparatus is configured to provide pure water into the diluted concentrate fluid to form a dialysis fluid (see WO 097 figures 1, 9).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over WO 097 in view of US 693 and US 476 as applied to claim 31 above, and further in view of US 20180354831 A1 (see US 831).
Regarding claim 44, WO 097 in view of US 693 and US 476 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 and US 476 does not disclose at least one of the at least one pressure pump is a non-volumetric pump.
US 831 discloses a method and system of purifying wastewater with a forward osmosis unit (see US 831 abstract, figures 1-2 and paragraphs 0008-0010). US 831 discloses that the system comprises a recirculation pump, such as a centrifugal pump or other suitable corrosion resistant pump, that is capable of pumping fluid from a feed stream through the membrane of an FO unit (see US 831 paragraph 0025 and figure 1).
US 831 is considered to be analogous to the claimed invention because it is in the same field of endeavor, i.e. forward osmosis system.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify and/or substitute at least one of the pressurized pumps of WO 097 in view of US 693 and US 476 by incorporating a centrifugal pump, as disclosed in US 831, because it would assist with the movement of fluid through the system and WO 097 in view of US 693 and US 476 does not disclose a specific example of a pressurized pump.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify and/or substitute at least one of the pressurized pumps of WO 097 in view of US 693 and US 476 by incorporating a centrifugal pump, as disclosed in US 831, because it would assist with reducing corrosion in the system.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify and/or substitute at least one of the pressurized pumps of WO 097 in view of US 693 and US 476 by incorporating a centrifugal pump, as disclosed in US 831, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. move fluid through the system.
Other Applicable Prior Art
All other art cited not detailed above in a rejection is considered relevant to at least some portion or feature of the current application and is cited for possible future use for reference. Applicant may find it useful to be familiar with all cited art for possible future rejections or discussion.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BERNADETTE K MCGANN whose telephone number is (571)272-5367. The examiner can normally be reached M-F 7:00 am -3:30 pm (EST).
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/BERNADETTE KAREN MCGANN/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
