DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of group II – claims 94, 103-104, 106-108, 111-115, 117-119, and 121-123 in the reply filed on 08/27/2025 is acknowledged.
Claims 63, 84-86, 127, 128, and 131 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group I and group III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/27/2025.
Claim Objections
Claim 122 is objected to because of the following informalities:
In claim 122, the limitation “wherein the pretreatment or retreatment comprises filtration, adsorption, heating, catalysis, enrichment, concentration, a chemical treatment, an optical treatment, and an electrical treatment” is objected because Examiner cannot reasonably interpret that one pretreatment module can perform all of the recited functions. According to Applicant’s Par. 277 of the PG-Pub, Applicant discusses that “The pretreatment or retreatment includes at least one of a filtration treatment, an adsorption treatment, a heating treatment, a catalytic treatment, an enrichment treatment, a concentration treatment, a chemical treatment, an optical treatment, and an electrical treatment”. For examining purposes, Examiner currently interprets the limitation of claim 122 as recited in the Par. 277 of Applicant’s PG-Pub, which is that the pretreatment or retreatment includes at least one of the listed treatments.
Appropriate correction is required.
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 94, 103, 104, 106, 111-114, 117, and 123 are rejected under 35 U.S.C. 103 as being unpatentable over Wada et al. CN 1845935 A (hereinafter Wada), as cited in the IDS, in view of Crane et al. US 3,795,318 A (hereinafter Crane).
Regarding claim 94, Wada discloses a cycle separation device (Fig. 2 shows a separation system, and Par. 71 in the provided translation – “a separation system”), for performing fluid treatment (Par. 2 in the provided translation – “apparatus for separating biomolecules such as proteins from a solution containing biological components, particularly from human plasma, urine, etc., to prepare a solution having a modified composition of the biological components”), comprising: at least one cycle separation module (see annotated Fig. 2 below), wherein the cycle separation module (see annotated Fig. 2 below) comprises:
a separation pipeline 202 (Fig. 2 – circulation loop 202), having an entrance (Fig. 2 – line 202 on the top) and an exit (Fig. 2 - line 202 on the bottom);
a second separation module 205 (Fig. 2 – second separation membrane module 205), comprising a second separation component (Par. 113 in the provided translation – “the "separation membrane module" refers to a module in which a separation membrane is housed in a casing”); wherein the second separation component (Par. 113 in the provided translation – separation membrane) divides the second separation module 205 (Fig. 2) with at least one second inlet 206 (Fig. 2 – lower tank assembly 206) and at least one second outlet 204 (Fig. 2 – recovery port 204) respectively, and two opposite ends (Fig. 2 – top and bottom end) of the second separation module 205 (Fig. 2) are communicated with the entrance of the separation pipeline 202 (Fig. 2 – the top end of separation membrane module 205 is connected to the top line 202) and the exit of the separation pipeline 202 (Fig 2 – the bottom end of separation membrane module 205 is connected to the bottom line 202) respectively; and
at least one second driving device 203 (Fig. 2 – stage two circulation pump 203), arranged at the separation pipeline 202 (Fig. 2), for driving a fluid in the separation pipeline 202 (Fig. 2) to flow from the entrance of the separation pipeline 202 (Fig. 2 – right arrow on the top line 202 indicating fluid flow) to the exit of the separation pipeline 202 (Fig. 2 – left arrow on the bottom line 202 indicating fluid flow) at a preset flow rate (Examiner contends that a pump has to operate at a certain speed), to dynamically balance a total amount of the fluid in the separation pipeline 202 (Fig. 2) in a cycle separation mode (Par. 230 in the provided translation – “…the solution flows into the second-stage membrane separation unit, is injected into the second-stage separation membrane module 205 (first micromodule (5)), and further circulates in the second-stage solution circulation circuit 202 by the second-stage circulation pump 203”).
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Annotated Fig. 2 of Wada
However, Wada does not disclose the second separation component into a first side and a second side; wherein two opposite ends of the first side of the second separation module are communicated with at least one second inlet and at least one second outlet respectively, and two opposite ends of the second side of the second separation module are communicated with the entrance of the separation pipeline and the exit of the separation pipeline respectively.
Crane, in the same field of endeavor of hemodialysis with permeable membrane (Title), teaches the second separation component 2 (Fig. 1 – permeable membrane 2) into a first side and a second side (Fig. 1 – membrane 2 divides hemodialysis device 1 into two sides); wherein two opposite ends of the first side (Fig. 1 – the right side, a top end and a bottom end) of the separation module 1 (Fig. 1 – hemodialysis device 1) are communicated with at least one second inlet PDi (Fig. 1) and at least one second outlet PDo (Fig. 1) respectively, and two opposite ends of the second side (Fig. 1 – the left side, a top end and a bottom end) of the second separation module 1 (Fig. 1) are communicated with the entrance PBi (Fig. 1) of the separation pipeline and the exit PBo (Fig. 1) of the separation pipeline (Fig. 1 – blood circuit on the blood side of the membrane) respectively.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the separation membrane of Wada that allows for selective filtration of the treated fluid, for the membrane of Crane, since these mechanisms perform the same function of providing separation of certain biological compositions within the treated fluid. Simply substituting one membrane separation means for another would yield the predicable result of allowing a treated fluid to be filtered/separated into different compositions as desired. See MPEP 2143. Once the modification is made as discussed, the membrane dividing into two sides of Crane will be incorporated into the device of Wada, such that its first side will connect with the inlet 206 and outlet 204 of Wada, and its second side will connect with the entrance and exit of the separation pipeline 202 of Wada. Thus, the limitation is met.
Regarding claim 103, Wada in view of Crane discloses the invention of claim 94. Wada in view of Crane further discloses further comprising:
at least one cycle enrichment module (see annotated Fig. 2 of Wada above); wherein the cycle enrichment module (see annotated Fig. 2 of Wada above) comprises:
an enrichment pipeline 102 (Fig. 2 of Wada – circulation loop 102), comprising a first section (Fig. 2 of Wada – line 102 on the top) and a second section (Fig. 2 of Wada – line 102 on the bottom); wherein an entrance of the first section (see annotated Fig. 2 of Wada above) is communicated with at least one first inlet (see annotated Fig. 2 of Wada above – an inlet that leads to the entrance of line 102 on the top), and an exit of the second section (see annotated Fig. 2 of Wada above) is communicated with the first section (see annotated Fig. 2 of Wada above – the exit of line 102 on the bottom recirculates to communicate with line 102 on the top);
at least one first separation module 105 (Fig. 2 of Wada – separation membrane component 105), communicated with an exit of the first section (see annotated Fig. 2 of Wada above – separation membrane component 105 is connected to the annotated exit of the top line 102);
wherein each of the at least one first separation module 105 (Fig. 2 of Wada) comprises a first separation component (Par. 113 of Wada in the provided translation – “the "separation membrane module" refers to a module in which a separation membrane is housed in a casing”); the at least one first separation module 105 (Fig. 2 of Wada) is communicated with an entrance of the second section (see annotated Fig. 2 of Wada above – separation membrane component 105 is connected to the annotated entrance of the bottom line 102), the at least one first separation module 105 (Fig. 2 of Wada) is communicated with at least one first outlet 104 (Fig. 2 of Wada – recovery port 104), and the at least one first inlet (see annotated Fig. 2 of Wada above) is communicated with the separation pipeline 202 (Fig. 2 of Wada) of the cycle separation module (see annotated Fig. 2 of Wada above – the direction of flows starts from the annotated inlet to the loop 202; thus the annotated inlet and pipeline 202 are communicative to each other); and
at least one first driving device 103 (Fig. 2 of Wada – circulation pump 103), arranged at the first section 102 (Fig. 2 of Wada – pump 103 disposed on the top line 102), for driving a fluid to cyclically flow in the enrichment pipeline 102 (Fig. 2 of Wada) to dynamically balance a total amount of the fluid in the enrichment pipeline 102 (Fig. 2 of Wada, and Par. 130 of Wada in the provided translation – “The liquid is transported and circulated in the solution circulation loop 102 formed by the tube using the circulation pump 103”), so that the at least one first separation module 105 (Fig. 2 of Wada) enriches the target substance in a cycle enrichment mode (Fig. 2 of Wada, and Par. 130 of Wada in the provided translation – “This component has a separation membrane with a specific permeability ratio for the first step built in. The liquid is transported and circulated in the solution circulation loop 102 formed by the tube using the circulation pump 103. The permeate that has passed through the separation membrane in the first step is obtained from the first-stage membrane unit treated liquid recovery port 104 serving as the permeate outlet… The target solution is obtained”).
However, Wada in view of Crane currently does not disclose a first separation component to divide a corresponding first separation module into a first side and a second side; wherein the first side of each of the at least one first separation module is communicated with an entrance of the second section, the second side of each of the at least one first separation module is communicated with at least one first outlet.
Crane, in the same field of endeavor of hemodialysis with permeable membrane (Title), teaches a first separation component 2 (Fig. 1 – permeable membrane 2) to divide a corresponding first separation module 1 (Fig. 1 – hemodialysis device 1) into a first side and a second side (Fig. 1 – membrane 2 divides hemodialysis device 1 into two sides);
wherein the first side (Fig. 1 – the right side) of each of the at least one first separation module 1 (Fig. 1) is communicated with an entrance of the second section (Fig. 1 – the right side is communicated with a bottom vertical line), the second side (Fig. 1 – the left side) of each of the at least one first separation module 1 (Fig. 1) is communicated with at least one first outlet PBo (Fig. 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the separation membrane of Wada in view of Crane that allows for selective filtration of the treated fluid, for the membrane of Crane, since these mechanisms perform the same function of providing separation of certain biological compositions within the treated fluid. Simply substituting one membrane separation means for another would yield the predicable result of allowing a treated fluid to be filtered/separated into different compositions as desired. See MPEP 2143. Once the modification is made as discussed, the membrane dividing into two sides of Crane will be incorporated into the device of Wada, such that its first side will connect with the entrance of the second section 102 of Wada, and its second side will connect with the first outlet 104 of Wada. Thus, the limitation is met.
Regarding claim 104, Wada in view of Crane discloses the invention of claim 103. Wada in view of Crane further discloses wherein the first separation component is a porous membrane (Par. 123 of Wada in the provided translation – “a porous membrane having a molecular sieving effect”);
wherein the porous membrane has an average pore diameter or a molecular weight cutoff associated with the target substance (Par. 123 of Wada in the provided translation – “a porous membrane having a molecular sieving effect”)¸ wherein the porous membrane comprises a microfiltration membrane (Par. 227 of Wada in the provided translation – “one micromodule” of Example 2, which corresponds to Fig. 2 according to Par. 71 of Wada in the provided translation).
Regarding claim 106, Wada in view of Crane discloses the invention of claim 103. Wada in view of Crane further discloses wherein the first separation component (Par. 113 of Wada in the provided translation) comprises one or more of a planar membrane, and a hollow fiber membrane (Par. 123 of Wada in the provided translation – “In the concentration step, a porous membrane having a molecular sieving effect, such as a planar filter membrane or a separation membrane such as a hollow fiber membrane, is used to perform concentration using a separation sieve”).
Regarding claim 111, Wada in view of Crane discloses the invention of claim 103. Wada in view of Crane further discloses wherein in the cycle enrichment mode (see annotated Fig. 2 of Wada above, the first cycle), the cycle enrichment module (see annotated Fig. 2 of Wada above) controls a total volume of the fluid introduced into the enrichment pipeline 102 (Fig. 2 of Wada) from the at least one first inlet (see annotated Fig. 2 of Wada above) to be equal to that of a fluid discharged from the enrichment pipeline 102 (Fig. 2 of Wada) by the at least one first outlet 104 (Fig. 2 of Wada, Par. 130 of Wada in the provided translation – “The permeated liquid is injected into the unit of the next process through a tube directly connected to the treated liquid recovery port of the membrane separation unit at the permeate outlet”, and Par. 214 of Wada in the provided translation – “The volume of PBS corresponding to the volume of the filtered solution was added by an injection pump to ensure a constant amount of circulating liquid”).
Regarding claim 112, Wada in view of Crane discloses the invention of claim 103. Wada in view of Crane further discloses wherein the cycle enrichment module (see annotated Fig. 2 of Wada above) controls a ratio of the total volume of the fluid introduced into the enrichment pipeline 102 (Fig. 2 of Wada) per unit time Q1 (Par. 137 of Wada in the provided translation – flow rate Q1 of the liquid flowing into the separation membrane module) to a total volume of a fluid in the enrichment pipeline 102 (Fig. 2 of Wada) to adjust an enrichment efficiency (Par. 137 of Wada in the provided translation discusses the ratio between a flow rate entering the separation membrane module and an exiting flow rate for effective filtration; thus, a ratio between the total volume per unit time and a total volume of fluid can be reasonably deduced by one of ordinary skill in the art).
Regarding claim 113, Wada in view of Crane discloses the invention of claim 103. Wada in view of Crane further discloses wherein the cycle enrichment module (see annotated Fig. 2 of Wada above) comprises a channel-adjusting device 101 (Fig. 2 of Wada – three-way valve 101), arranged at the first section and/or the second section 102 (see annotated Fig. 2 of Wada above – the three-way valve 101 is disposed at the entrance of the first section 102 and the exit of the second section 102), for adjusting a flow direction of a fluid in the enrichment pipeline 102 (Fig. 2 of Wada, and Par. 130 of Wada in the provided translation – “Serum and other biological component detection substances or biological component solutions containing them are injected from the injection pump 100 through the three-phase valve 101 into the first separation membrane component 105”);
wherein the channel-adjusting device 101 (Fig. 2 of Wada) adjusts the flow direction of the fluid in the enrichment pipeline 102 (Fig. 2 of Wada) by:
adjusting the flow direction of the fluid in the enrichment pipeline by adjusting a switching state of the at least one first inlet (see annotated Fig. 2 of Wada above – the three-phase valve 101 can be switched to allow fluid to flow into the direction as indicated by arrows in Fig. 2 of Wada, Par. 130 of Wada in the provided translation – “Serum and other biological component detection substances or biological component solutions containing them are injected… through the three-phase valve 101 into the first separation membrane component 105”, and Par. 230 of Wada in the provided translation – “The serum and diluent (PBS) are injected from the injection pump 100, enter the solution circulation loop 102 through the three-way valve 101”).
Regarding claim 114, Wada in view of Crane discloses the invention of claim 113. Wada in view of Crane further discloses wherein the channel-adjusting device 101 (Fig. 2 of Wada) comprises a first pipeline switch (Fig. 2 of Wada – a valve inherently has a switch) arranged at each of the at least one first inlet (see annotated Fig. 2 of Wada – vale 101 is disposed at the annotated inlet), for controlling a switching state of the corresponding first inlet (see annotated Fig. 2 of Wada) to further control the fluid in the enrichment pipeline 102 (Fig. 2 of Wada, and Par. 130 of Wada in the provided translation) to be a concentration cycle mode (Par. 130 of Wada in the provided translation – a filtration mode) or a cleaning mode (Par. 182 of Wada in the provided translation – “During the filtration process, the original solution at the module outlet is discarded without return by switching the valve for discarding the solution located in the middle of the solution circulation loop”).
Regarding claim 117, Wada in view of Crane discloses the invention of claim 113. Wada in view of Crane further discloses wherein the enrichment pipeline 102 (Fig. 2 of Wada) is switched to a concentration cycle mode (Par. 130 of Wada in the provided translation – “Serum and other biological component detection substances or biological component solutions containing them are injected from the injection pump 100 through the three-phase valve 101 into the first separation membrane component 105”, which only flows biological component solutions) or a dilution mode (Par. 133 of Wada in the provided translation – “a dilution liquid inlet, which is arranged at a position upstream of the above-mentioned target liquid inlet for separation, or at a position in the middle of the above-mentioned solution circulation loop”, which flows dilution liquid into the pipeline) through the channel-adjusting device 101 (Fig. 2 of Wada, Par. 133 of Wada in the provided translation, Par. 213 of Wada in the provided translation – “…the micromodule (1) is connected to a three-way valve provided in the middle of the solution circulation circuit of the micromodule (2). Then, these tubes and the two modules were filled with PBS to prepare a system in which two stages of micromodules were connected in series as shown in FIG. 2”), to adjust a separation efficiency of the at least one first separation module 105 (Fig. 2 of Wada, and Par. 214 of Wada in the provided translation – “The volume of PBS corresponding to the volume of the filtered solution was added by an injection pump to ensure a constant amount of circulating liquid”).
Regarding claim 123, Wada in view of Crane discloses the invention of claim 94. Wada in view of Crane further discloses wherein the cycle separation device (Fig. 2 of Wada) is an extracorporeal cycle device (Par. 118 of Wada in the provided translation – “artificial kidney”, “dialysis module”); wherein the extracorporeal cycle device is a hemodialysis device or an extracorporeal peritoneal dialysis device (Par. 118 of Wada in the provided translation – “artificial kidney”, “dialysis module”).
Claims 107, 108, and 122 are rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Crane as applied to claim 103 and 94 above, and further in view of Greenberg et al US 2013/0178834 A1 (hereinafter Greenberg).
Regarding claim 107, Wada in view of Crane discloses the invention of claim 103. However, Wada in view of Crane does not disclose wherein each of the at least one first separation module is a tangential flow filtration module.
Greenberg, in the same field of endeavor of cell separation (Par. 75), teaches wherein the separation module is a tangential flow filtration module (Par. 75 – “The cell separation and pathogen removal module” and “separation utilizes tangential flow… methods”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the separation mechanism of Wada in view of Crane that allows the targeted substances to be filtered and separated, for the tangential flow separation mechanism of Greenberg since these mechanisms perform the same function of performing substance separation. Simply substituting one separation return means for another would yield the predicable result of separating a treated fluid. See MPEP 2143.
Regarding claim 108, Wada in view of Crane in view of Greenberg discloses the invention of claim 107. The combination further discloses wherein the at least one first driving device 105 (Fig. 2 of Wada) controls a flow rate in the first section 102 (Fig. 2 of Wada) to be above a preset threshold (Par. 137 of Wada in the provided translation – “The flow rate Q1 of the biological component-containing solution flowing into the module is the flow rate of the liquid flowing into the module and flowing in the circuit, and is preferably greater than the flow rate Q2 at which the separated liquid is transported”), so that the target substance in the first separation module 105 (Fig. 2 of Wada) flows from the exit of the first section 102 (see annotated Fig. 2 of Wada above) to the entrance of the second section 102 (see annotated Fig. 2 of Wada above – arrows indicating the direction fluid where fluid flows from the top line 102, past the circulation pump 103, and to the bottom line 102); wherein the preset threshold is determined based on a cavity structure of the at least one first separation module 105 (Fig. 2 of Wada, and Par. 137 of Wada in the provided translation – “The flow rate Q1 of the biological component-containing solution flowing into the module is the flow rate of the liquid flowing into the module and flowing in the circuit, and is preferably greater than the flow rate Q2 at which the separated liquid is transported. This is because it is considered… to prevent clogging of membrane pores, and the like”).
Regarding claim 122, Wada in view of Crane discloses the invention of claim 94. Wada in view of Crane does not disclose further comprising: at least one treatment module, for performing pretreatment or retreatment on the fluid in the cycle separation device; wherein the pretreatment or retreatment comprises filtration, adsorption, heating, catalysis, enrichment, concentration, a chemical treatment, an optical treatment, and an electrical treatment.
Greenberg, in the same field of endeavor of cell separation (Par. 75), teaches further comprising: at least one treatment module (Fig. 1 – “treatment module”), for performing pretreatment on the fluid in the cycle separation device (Fig. 1 – “separation module”; the “treatment module” is placed upstream of the “separation module”); wherein the pretreatment comprises filtration, adsorption, heating, catalysis, enrichment, concentration, a chemical treatment (Fig. 4 - “pharmaceutical module”), an optical treatment (Fig. 5 – “radiation module”), and an electrical treatment (Fig. 7 – “pulsed electrical field module”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wada in view of Crane to further include a pretreatment as taught by Greenberg, in order to tailor the treatment to a specific disease or infection (Abstract of Greenberg) or to a specific patient (Par. 62 of Greenberg). Thus, it allows accurately identification and specific attack to the pathogens (Par. 62 of Greenberg).
Claim 115 is rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Crane as applied to claim 114 above, and further in view of Brugger et al. US 2020/0030518 A1 (hereinafter Brugger).
Regarding claim 115, Wada in view of Crane discloses the invention of claim 114. Wada in view of Crane further discloses wherein the channel-adjusting device further comprises at least one adjusting pipeline and at least one second pipeline switch arranged at the at least one adjusting pipeline so that an entrance of a cleaning solution and an exit of a waste fluid are formed in the enrichment pipeline.
Brugger, in the same field of endeavor of extracorporeal blood treatment (Par. 2), teaches wherein the channel-adjusting device 380 (Fig. 3A-3C – four-way valve 380) further comprises at least one adjusting pipeline 384 (Fig. 3A – port 384) and at least one second pipeline switch (Fig. 3A – the middle shaded section and top shaded section of rotating element 382) arranged at the at least one adjusting pipeline 384 (Fig. 3A – said shaded sections are arranged at the top port 384) so that an entrance 386 and an exit 386 are formed in the enrichment pipeline (Fig. 3A – valve 380 forms two channels).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the three-valve mechanism of Wada in view of Crane that allows the fluid to be introduced and recirculate or exit, for the four-way valve mechanism of Brugger since these mechanisms perform the same function of directing fluid flow within a blood treatment device. Simply substituting one valve means for another would yield the predicable result of allowing fluids to flow to and from the circuit. See MPEP 2143. Given that the device of Wada in view of Crane has an inflow of PBS (see claim 14), the modification by Brugger will allow inflow and outflow of fluid to enter and exit from ports 384, in this instant case, PBS solution; thus, the limitation of “an entrance of a cleaning solution and an exit of a waste fluid are formed in the enrichment pipeline” is met.
Claims 118 and 119 are rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Crane as applied to claim 103 above, and further in view of Roberts et al. US 2012/0271227 A1 (hereinafter Roberts).
Regarding claim 118, Wada in view of Crane discloses the invention of claim 103. However, Wada in view of Crane does not disclose wherein the cycle enrichment module further comprises an air inlet-outlet, arranged at the first section and/or the second section, for adjusting a state of air inside the enrichment pipeline and an air pressure inside the enrichment pipeline.
Roberts, in the same field of endeavor of dialysis methods and apparatus (Title), teaches wherein the cycle enrichment module 1 (Fig. 1 – artificial kidney 1) further comprises an air inlet-outlet 65 (Fig. 1 – gas removal unit 65), arranged at the second section 125 (Fig. 1 – fluid conduit 125), for adjusting a state of air inside the enrichment pipeline 112-136 (Fig. 1 and Par. 53 – fluid conduits of artificial kidney 1) and an air pressure inside the enrichment pipeline 112-136 (Fig. 1, Par. 53, and Par. 68 – “the gas removal unit 65 should be interpreted as merely a vent”, “the gas removal unit 65 should be interpreted as comprising such filter(s). Valves 62, 64 controls flow of fluid into and out of the storage module, respectively. An additional pump (not shown) can also be used”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the enrichment pipeline of Wada in view of Crane to further include an air inlet-outlet arranged at the second section as taught by Roberts, in order to remove problematic gases produced within the pipeline during treatment, such as carbon dioxide (Par. 68 of Roberts.
Regarding claim 119, Wada in view of Crane discloses the invention of claim 103. However, Wada in view of Crane does not disclose wherein the cycle enrichment module further comprises at least one collection device, arranged at the first section and/or the second section, for adjusting a volume of the enrichment pipeline to collect the target substance, or for collecting bubbles.
Roberts, in the same field of endeavor of dialysis methods and apparatus (Title), teaches wherein the cycle enrichment module 1 (Fig. 1 – artificial kidney 1) further comprises at least one collection device 60 (Fig. 1 – storage module 60), arranged at the second section 125 (Fig. 1 – fluid conduit 125), for adjusting a volume of the enrichment pipeline 112-136 (Fig. 1, and Par. 53 – fluid conduits of artificial kidney 1) to collect the target substance (Par. 67 – “where intermittent processing is desired, the storage module 60 advantageously retains the processed (or semi-processed) fluid until it is reintroduced”), or for collecting bubbles (Fig. 1 – storage module 60 communicates with gas removal unit 65 via fluid conduit 126B, thus storage module 60 can also store bubbles until further venting).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the enrichment pipeline of Wada in view of Crane to further include a collection device arranged at the second section as taught by Roberts, in order to intermittently store and reintroduce the processed fluid into the circuit (Par. 67 of Roberts), thereby providing selective volume control of the fluid within the pipeline.
Claim 121 is rejected under 35 U.S.C. 103 as being unpatentable over Wada in view of Crane as applied to claim 103 above, and further in view of Brotherton et al. US 2005/0236329 A1 (hereinafter Brotherton).
Regarding claim 121, Wada in view of Crane discloses the invention of claim 103. However, Wada in view of Crane does not disclose wherein the cycle enrichment module further comprises a flow rate detection device, for detecting a dynamic state inside the enrichment pipeline to generate information for adjusting an internal working state of the enrichment pipeline.
Brotherton, in the same field of endeavor of extracorporeal filtration (Abstract), teaches wherein the cycle enrichment module 50 (Fig. 3 – recirculation circuit 50) further comprises a flow rate detection device (Par. 55 – “Recirculation circuit 50 may further comprise various other components as indicated in FIG. 3... As set forth above, some embodiments may employ dynamically activated valve assemblies, which may be selectively adjusted to control flow rates precisely; appropriate sensors, such as… flow meters”), for detecting a dynamic state inside the enrichment pipeline to generate information for adjusting an internal working state of the enrichment pipeline (Par. 55; Examiner also contends that flow meter/sensors are known in the art for sensing and providing information regarding the flow within the circuit; thus, the limitation is met).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kelly et al. US 2019/0167887 A1
Levin et al. US 2012/0277673 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781