Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I claims 31-47, in the reply filed on May 4, 2026 is acknowledged. Election was made with traverse in the reply filed on May 4, 2026.
Claims 48-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group/species there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 4, 2026.
In the response, it was argued that “the Office Action notes that the special technical feature is a forward osmosis (FO-) unit, which is conveniently disclosed in German Publication No. 102020106751. The Office Action neglects to mention common operations recited in Claims 31 and 48” (see Response page 2). This argument is deemed unpersuasive. Claims 31-47 is directed towards an apparatus. “[i]t is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.” Thus, the noted operations are not a component of the special technical feature.
Claim Interpretation
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). The claimed “control arrangement” limitation is understood as comprising a control unit, at least one valve and at least one pump.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31-47 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 recites “one or more concentrate connectors”. Claim 1 is deemed indefinite because it is unclear how there can be a plurality, i.e. “concentrate connectors”, when there is a singular connector, i.e. “one”. The claimed “one or more property sensors” and the claimed “one or more pressure sensors” are deemed indefinite for similar reasoning. For the sake of compact prosecution, claim 1 is understood as “at least one concentrate connector”, “at least one “property sensor” and “at least one pressure sensor“.
Claims 31-47 are also rejected by virtue of the claim dependency.
Claim 32 recites “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”. Claim 32 is deemed indefinite because it is unclear which element controls “flow rate of spent dialysis fluid” when the “volume of available” and the “length of a time period” differ. Similarly, it is unclear which element controls “flow rate of dialysis concentrate fluid” when “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” differs. Further, it is unclear if the comma between “period” and “to” is present to alter the understanding of what parameters the control of flow rate is based on. 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 and the control of the flow rate of the dialysis concentrate fluid may be based on volume of dialysis concentrate fluid needed or length of the time.
Claim 39 recites “according to any one of claim 38”. Claim 38 is deemed indefinite because it is unclear what “any one of” means. For the sake of compact prosecution, claim 39 is understood as “according to claim 38”.
Claim 41 recites “the one or more pressure pumps comprise a first pressure pump arranged for operating on the spent dialysis fluid outputted from the feed side”. Claim 41 is dependent upon claim 31, which recites “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 … thereby diluting the dialysis concentrate fluid into a diluted dialysis concentrate fluid and dewatering the spent dialysis fluid into a dewatered spent dialysis fluid”. That is, spent dialysis fluid is not outputted from the feed side, but rather dewatered spent dialysis fluid is outputted from the feed side (see as-originally filed specification figures 1 and 4). For the sake of compact prosecution, claim 41 is understood as “operating on the spent dialysis fluid inputted from the feed side”.
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).
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 one or more concentrate connectors, 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 “one or more property sensors configured to sense one or more properties of the diluted dialysis concentrate fluid and/or the dewatered spent dialysis fluid” limitation, B) claimed “one or more pressure sensors 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 one or more pressure pumps to be provided, and control at least one of (i) a flow rate of spent dialysis fluid into the feed side, or (ii) a flow rate of the dialysis concentrate fluid into the draw side or the hydrostatic pressure difference, 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, 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 “one or more 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 one or more sensors, 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 one or more sensors, 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 “one or more pressure sensors 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 one or more pressure sensors, 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 one or more pressure sensors, 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 one or more pressure pumps to be provided, and control at least one of (i) a flow rate of spent dialysis fluid into the feed side, or (ii) a flow rate of the dialysis concentrate fluid into the draw side or the hydrostatic pressure difference, 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, 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 is deemed to disclose the claimed apparatus for producing dialysis fluid, the apparatus comprising a draw fluid path including one or more concentrate connectors, 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; one or more property sensors configured to sense one or more properties of the diluted dialysis concentrate fluid and/or the dewatered spent dialysis fluid; one or more pressure sensors 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 one or more pressure pumps to be provided, and control at least one of (i) a flow rate of spent dialysis fluid into the feed side, or (ii) a flow rate of the dialysis concentrate fluid into the draw side or the hydrostatic pressure difference, 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, 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 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 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 one or more pressure pumps to be provided, and control at least one of (i) a flow rate of spent dialysis fluid into the feed side, or (ii) a flow rate of the dialysis concentrate fluid into the draw side or the hydrostatic pressure difference, 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, so as to yield the diluted dialysis concentrate fluid.
The Examiner holds that WO 097 in view of US 693 is deemed to disclose “one or more pressure pumps” 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 is substantially identical to the claimed A) one or more property sensors, B) one or more pressure sensors, and C) control arrangement of the present application, and therefore, the structure of WO 097 in view of US 693 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 one or more pressure pumps to be provided, and control at least one of (i) a flow rate of spent dialysis fluid into the feed side, or (ii) a flow rate of the dialysis concentrate fluid into the draw side or the hydrostatic pressure difference, 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, so as to yield the diluted dialysis concentrate fluid.
Regarding claim 32, WO 097 in view of US 693 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 discloses the control arrangement is further configured to control the flow rate of spent dialysis fluid into the feed side (see rejection of claim 31).
WO 097 in view of US 693 does not disclose configured to 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.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to control flow rate in the system of WO 097 in view of US 693 based on volume of spent dialysis fluid available because the produced diluted concentrated dialysate can only be diluted from the available spent dialysis fluid and/or if the flow rate is too high, then the available spent dialysis fluid may not be dewatered/produce diluted concentrate fluid and if the flow rate is too low, then the desired amount of the diluted concentrate fluid may not be produced in an efficient time frame. One of ordinary skill in the art would understand that the length of time would be controlled by the flow rate of the fluid through the system.
WO 097 in view of US 693 discloses control the flow rate of the dialysis concentrate fluid into the draw side (see rejection of claim 31). WO 097 in view of US 693 does not disclose 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.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to control flow rate in the system of WO 097 in view of US 693 based on volume of dialysis concentrate fluid needed because it would be wasteful and/or inefficient to produce more diluted concentrate fluid than a patient can use/needs and/or because if the flow rate is too high then the diluted concentrate fluid may not be sufficiently diluted and if the flow rate is too low then the desired amount of the diluted concentrate fluid may not be produced in an efficient time frame. One of ordinary skill in the art would understand that the length of time would be controlled by the flow rate of the fluid through the system.
It is understood that “length of a time period available” may be any time period. It is understood that “desired amount of the diluted concentrate fluid” may be any amount. 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 33, WO 097 in view of US 693 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 discloses the control arrangement is further configured to control the hydrostatic pressure difference with the one or more pressure pumps 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 discloses the invention as discussed above in claim 33. Further, WO 097 in view of US 693 discloses the control arrangement is further configured to control the hydrostatic pressure difference with the one or more pressure pumps 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 discloses the invention as discussed above in claim 34. Further, WO 097 in view of US 693 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 discloses the invention as discussed above in claim 33. Further, WO 097 in view of US 693 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 discloses the invention as discussed above in claim 32. Further, WO 097 in view of US 693 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 one or more pressure pumps, 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 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 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 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 one or more pressure pumps (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 discloses the invention as discussed above in claim 37. Further, WO 097 in view of US 693 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 discloses the invention as discussed above in claim 38. Further, WO 097 in view of US 693 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 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 discloses the one or more property sensors 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 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 discloses the one or more pressure pumps comprise a first pressure pump arranged for operating on the 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 discloses the invention as discussed above in claim 41. Further, WO 097 in view of US 693 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 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 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 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 discloses the one or more pressure pumps 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 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 does not disclose at least one of the one or more pressure pumps is a volumetric pump.
However, WO 097 in view of US 693 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, 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 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 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 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 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 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 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 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 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 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 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 discloses the invention as discussed above in claim 31. Further, WO 097 in view of US 693 does not disclose at least one of the one or more pressure pumps 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 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 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 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 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
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/BERNADETTE KAREN MCGANN/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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