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 with traverse of Group 1 (Claims 1-13, and 16) in the reply filed on 20 November 2025, is acknowledged. The traversal is on the ground(s) that there is no serious search burden to search and examine all presented claims. This is not found persuasive because application is filed under the Patent Cooperation Treaty, resulting in the application being considered under unity of invention. MPEP § 1850. Search burden is not considered for unity of invention, but whether the application relates to one invention only or to a group of inventions so linked as to form a single general inventive concept. MPEP § 1850. The sections cited from MPEP 803 relate to US restriction practice and do not apply to Patent Cooperation Treaty applications.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Examiner notes claim 1 recites, “wherein the centrifuge setup is designed to execute a loading cycle, during which cell broth is pumped to the chamber inlet, during which a buffer is pumped to the chamber inlet, and a discharging cycle, during which a buffer is pumped to the chamber outlet” in lines 9-11. Examiner believes between “during which cell broth is pumped to the chamber inlet” and “during which a buffer is pumped to the chamber inlet” reference should be made to the washing cycle. This is based on the description of the washing cycle from the specification of the instant application (pg. 05, line 29 – pg. 06, line 2). Appropriate correction is required.
Claim 5 objected to because of the following informalities: a miscellaneous “(“ in line 2 of the claim. Appropriate correction is required.
Claims 6, 7 and 12-13 objected to because of the following informalities: the claim recites “of the supernatant sensor arrangement.” The supernatant sensor arrangement is previously recited as “the at least one supernatant sensor arrangement” in prior claim. Appropriate correction is required to maintain claim language consistency.
Claims 4, 8-11, and 13 objected to because of the following informalities: the claims recite “the biomass sensor arrangement.” The biomass sensor arrangement is previously recited as “the at least one biomass sensor arrangement” in prior claim. Appropriate correction is required to maintain claim language consistency.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “wherein the centrifuge setup comprises a process control for controlling at least the centrifuge, the liquid pumping arrangement and the valve arrangement” in claim 1.
“A process control” is the process control is a control unit that controls all/most of components and realized as a centralized or decentralized microprocessor that runs software (specification pg. 14, line 29 - pg. 15, line 2) or other equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim1-13 and 16 are 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 1 recites the limitation "a liquid line of the liquid network" in line 15 of the claim. Claim 1 previously recites “a number of liquid lines.” It is unclear of a liquid line is part of the number of liquid lines. Examiner believed a liquid line is part of the number of liquid lines and will be examined as such. Examiner recommends amending the claim to recite “a first liquid line of the number of liquid lines” or an equivalent thereof.
Claims 2-13 and 16 are rejected based on their dependence to claim 1.
Claim 2 recites the limitation "a liquid line of the liquid network" in line 2 of the claim. Claim 1 previously recites “a liquid line of the liquid network.” It is unclear of a liquid line is part of the number of liquid lines. Examiner believed a liquid line is part of the number of liquid lines and will be examined as such. Examiner recommends amending the claim to recite “a second liquid line of the number of liquid lines” or an equivalent thereof.
Claim 2 recites the limitation “an occurrence level” in line 3 of the claim. “An occurrence level” is previously recited in claim 1. It is unclear if these are the same occurrence levels. Examiner believes these are not the same occurrence levels. Examiner recommends amending the claim to recite “an occurrence level of supernatant” or an equivalent thereof.
Claim 3 recites the limitation “a loading cycle” in line 4 of the claim. “A loading cycle” is previously recited in claim 1. It is unclear if these are the same loading cycles. Examiner believes these are the same loading cycles. Examiner recommends amending the claim to recite “ the loading cycle.”
Claim 3 recites the limitation “a waste reception” in lines 10, 16, and 19 of the claim. “A waste reception” is previously recited in the same claim. It is unclear if these are the same waste receptions. Examiner believe they are the same waste receptions. Examiner recommends amending the claim to recite “the waste reception.”
Claim 3 recites the limitation “a buffer source” in line 14 of the claim. “A buffer source” is previously recited in the same claim. It is unclear if these are the same buffer sources. Examiner believes these are the same buffer sources. Examiner recommends amending the claim to recite “the buffer source.”
Claim 3 recites the limitation “a discharging cycle” in line 16 of the claim. “A discharging cycle” is previously recited in claim 1. It is unclear if these are the same discharging cycles. Examiner believes these are the same discharging cycles. Examiner recommends amending the claim to recite “ the discharging cycle.”
Claim 4 recites “a biomass sensor arrangement” in line 1 of the claim. Claim 1 previously recites “at least one biomass sensor arrangement.” Examiner believes these are the same biomass sensor arrangements. Examiner recommends amending the claim to recites “the biomass sensor arrangement” or “the at least one biomass sensor arrangement” or equivalents thereof.
Claim 4 recites the limitation “a biomass filling level” in line 3 of the claim. “A biomass filling level is previously recited in claim 1. Examiner believes these are the same biomass filling levels. Examiner recommends amending claim to recite “the biomass filling level.”
Claim 5 is rejected based on its dependence to claim 4.
Claim 6 recites the limitation "the supernatant sensor arrangement" in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim as claim 6 depends on claim 1 and claim 1 does not recite a supernatant sensor arrangement. Claim 2 recites a supernatant sensor arrangement. Examiner recommends amending the claim the recite “a supernatant sensor arrangement” or changing the claim’s dependency or an equivalent thereof.
Claim 7 is rejected based on its dependency to claim 6.
Claim 8 recites the limitation ““a biomass sensor arrangement” in line 4 of the claim. Claim 1 previously recites “at least one biomass sensor arrangement.” Examiner believes these are the same biomass sensor arrangements. Examiner recommends amending the claim to recites “the biomass sensor arrangement” or “the at least one biomass sensor arrangement” or equivalents thereof.
Claim 8 recites the limitation “an occurrence level of biomass” in line 3-4 of the claim. “An occurrence level of biomass” is previously recited in claim 1. It is unclear if these are the same occurrence levels of biomass. Examiner believes these are the same. Examiner recommends amending the claims to recite “the occurrence level of biomass” or an equivalent thereof.
Claim 9 recites the limitation “the inlet harvest line and the inlet waste line” in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim as claim 6 depends on claim 1 and claim 1 does not recite an inlet harvest line and an inlet waste line. Examiner recommends amending the claim to recite “an inlet harvest line and an inlet waste line” or an equivalent thereof.
Claim 12 recites the limitation “the supernatant sensor arrangement" in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim as claim 12 depends on claim 1 and claim 1 does not recite a supernatant sensor arrangement. Claim 2 recites a supernatant sensor arrangement. Examiner recommends amending the claim the recite “a supernatant sensor arrangement” or changing the claim’s dependency or an equivalent thereof.
Claim 13 recites the limitation “an occurrence level of biomass” in line 3 of the claim. “An occurrence level of biomass” is previously recited in claim 1. It is unclear if these are the same occurrence levels of biomass. Examiner believes these are the same. Examiner recommends amending the claims to recite “the occurrence level of biomass” or an equivalent thereof.
Claim 16 recites the limitation “a centrifuge setup” in line 1 of the claim. Claim 1 previously recites a centrifuge setup. Examiner believes these are the same centrifuge setups. Examiner recommend amending the claim to recite “the centrifuge setup” or an equivalent thereof.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Examiner notes claim 3 is especially lacking in punctuation and formatting resulting in the requirements of the claim being unclear.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta, et. al. (US 20160137976 A1) in view of Ma, et. al. (CN 109401962 A; citations made with respect to provided English machine translation and original copy provided with IDS dated 05 January 2023) and Teixeira, et. al. ("Advances in on-line monitoring and control of mammalian cell cultures: Supporting the PAT initiative;" citations made with respect to attached copy).
Regarding claim 1, Mehta teaches a system to physically manipulate (separate) biomaterials by rotating chamber (Abstract, par. 0081) (centrifuge setup of a bioprocessing installation for the separation of a cell broth by centrifugation). Mehta teaches an embodiment of the system that comprises:
An apparatus 4 that holds rotating chamber 5 with an inlet and an outlet (the top and bottom lines respectively attached to rotating chamber 5 in figure) (Fig. 21-23; par. 0122) (wherein, for the centrifugation, the centrifuge setup comprises a centrifuge, wherein the centrifuge comprises at least one centrifuge chamber with a chamber inlet and a chamber outlet).
The inlet and outlet of the rotating chamber 5 is connected to a series of liquid pathways (the series of solid and dashed lines leading from box to box in the figures) with the flow being driven by bi-directional pump 3 (Fig. 21-23; 0122-0124) (wherein the centrifuge setup comprises a liquid pumping arrangement and a liquid network with a number of liquid lines communicating with the liquid pumping arrangement).
The pathways are paired with a series of valves 15, 17, 21, 24, 27 that are opened and closed to influence the flow of liquid through a predetermined pathway (par. 0122-0125) (wherein the centrifuge setup comprises a valve arrangement, that allows to activate and deactivate at least one of the liquid lines).
The device is driven by a controller (not pictured) that controls the pump(s), flow rate, rotation, and valves (par. 0027-0028; 0144) (wherein the centrifuge setup comprises a process control for controlling at least the centrifuge, the liquid pumping arrangement and the valve arrangement).
Mehta teaches the system has:
a cell capture mode wherein cell containing media flows from the bioreactor 1 to rotating chamber 5 through the inlet (Fig. 21; par. 0122) (execute a loading cycle, during which cell broth is pumped to the chamber inlet)
a media/buffer exchange mode wherein buffer or new media is pumped from the container 22 to rotating chamber 5 through the inlet (Fig. 22; par. 0123) (during which a buffer is pumped to the chamber inlet)
a cell capture mode wherein buffer or new media is pumped from container 26 to rotating chamber 5 through the outlet (Fig. 23; par. 0124) (a discharging cycle, during which a buffer is pumped to the chamber outlet)
Examiner draws attention to the small triangles/arrows along the pathways in Figures 21-23 that indicate the flow path taken and direction in each operating mode.
Finally, Mehta teaches that detectors, like bubble detectors, can be used in the system to trigger next stages of the process (par. 0125). Because Mehta teaches the controller is influenced by the signal from the sensor/detector, that occurrence signal must be calculated by the controller (that the process control calculates an occurrence level… in the respective liquid line based on the sensor signals of the biomass sensor arrangement and the process control controls the valve arrangement and/or the liquid pumping arrangement during the loading cycle and/or the discharging cycle based on the sensor signals of the sensor arrangement).
Examiner notes the loading, washing, and discharging cycles are drawn to the intended use of the flow of liquid through the series of pathways and valves. The prior art made of record, Mehta, teaches a system that has the appropriate vessels connected to the appropriate pathways/liquid lines and valves so that it is capable of performing each of the different cycles without modifying the system's structure.
Mehta is silent to wherein the centrifuge setup comprises a sensor arrangement with at least one biomass sensor arrangement, which biomass sensor arrangement is assigned to a liquid line of the liquid network, that the process control calculates an occurrence level, of biomass in the respective liquid line based on the sensor signals of the biomass sensor arrangement.
Ma teaches a cell preparation and separation system that uses sensors throughout the system (Abstract). Ma teaches a system comprising multiple containers for holding cells, waste, and other liquids associated with cell preparation all connected, a centrifuge tank, and a fluidic network with valves (Fig. 2; par. 0024-0029, 0050, 0056). Ma teaches a first liquid sensor 44 embedded in the fluidic network (Fig. 2) (wherein the centrifuge setup comprises a sensor arrangement with at least one… sensor arrangement, which… sensor arrangement is assigned to a liquid line of the liquid network). Ma teaches including inline liquid sensors regulate the key steps and components of the device ultimately to create an efficient and automated cell preparation system (par. 0022-0023)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the detectors of Mehta to be sensors embedded within the fluidic network lines as taught by Ma in order to fully automate and create a more efficient cell preparation system. Because both systems use a series of fluidic channels and a centrifuge for bioprocessing, modifying the sensors to be embedded within the fluidic lines as provided by Ma, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Mehta in view of Ma is silent to the sensor specifically being a biomass sensor.
Teixeira summarizes the advances made in on-line monitoring of cells in bioprocessing systems (Abstract). Teixeira teaches dielectric capacitance is a well-known technique for monitoring biomass in bioprocessing systems (Table 1, Section 2.4 "Dielectric spectroscopy") (at least one biomass sensor) (an occurrence level, of biomass in the respective liquid line based on the sensor signals of the biomass sensor arrangement). Teixeira teaches dielectric capacitance sensor are especially preferred for monitoring of bioprocessing systems because they offer essentially real-time feedback and control for the systems and they are easily incorporated into systems (pg. 727, col. 2, lines 11-16).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the detectors of Mehta in view of Ma to specifically be biomass sensors as taught by Teixeira in order to receive real-time feedback and control for the system. Because all systems use sensors for analyzing biomass, it would be obvious to try the specific detector of Teixeira because only a finite number of detectors will monitor biomass and therefore would be obvious to try with a reasonable expectation of success. MPEP 2143(I)(E).
Regarding claim 2, modified Mehta in view of Ma teaches a second liquid sensor 45 embedded in a second line of the fluidic network (Ma, Fig. 2). Because supernatant is a liquid it is understood by those of ordinary skill in the art that a liquid sensor can detect the presence of the supernatant (wherein the sensor arrangement comprises at least one supernatant sensor arrangement, which is assigned to a liquid line of the liquid network). Modified Mehta teaches that detectors, like bubble detectors, can be used in the system to trigger next stages of the process (Mehta, par. 0125). In claim 1 above, it is established the detector of Mehta can be modified to be a sensor as provided by Mah; therefore, because Mehta teaches the controller is influenced by the signal from the sensor/detector, that occurrence signal must be calculated by the controller (and that the process control calculates an occurrence level).
Regarding claim 3, modified Mehta teaches a fluidic line connecting bioreactor 1 to the inlet of chamber 5 (see line 2 in Figure 21) (wherein the liquid network comprises an inlet feed line between the chamber inlet and a cell broth source) and a line connecting the chamber 5 outlet to a waste container 23 (see line 6 and 25 in Figure 21) (an outlet waste line between the chamber outlet and a waste reception).
When performing the cell capture mode, as seen in Figure 21 when following the small triangles, cells flow out of bioreactor 1 through pathway 2 and valve 15 by pump 3, until it reached the inlet of chamber 5 (that during a loading cycle the cell broth may be pumped by the liquid pumping arrangement from the cell broth source to the chamber inlet via the inlet feed line) and moves from the outlet of chamber 5 through pathway 6 and 25 and valve 24 to waste container 23 (from the chamber outlet to a waste reception via the outlet waste line) (par. 0122).
Modified Mehta further teaches a new buffer/media container 22 connected to the pump 3 and chamber 5 through pathway 20 and the outlet of chamber 5 through pathway 6 and 25 and valve 24 to waste container 23 (Fig. 22; par. 0123) (that the liquid network comprises an inlet buffer line between the chamber inlet and a buffer source and an outlet waste line between the chamber outlet and a waste reception).
When in the media/buffer exchange mode (seen in Figure 22, following the small triangles) new buffer is pumped from the new media/buffer container 22, to the inlet of chamber 5 and finally to waster container 23 (par. 0123) (that during a washing cycle the buffer may be pumped by the liquid pumping arrangement from the buffer source to the chamber inlet via the inlet buffer line and from the chamber outlet to the waste reception via the outlet waste line).
When in the dispense mode (seen in Figure 23, following the small triangles) new buffer is pumped from new media/buffer container 26 through pathways 28 and 6 through the chamber 5 outlet (that during a discharging cycle the buffer may be pumped from the buffer source to the chamber outlet via the outlet buffer line), through chamber 5 taking the cells in the chamber 5, and finally to dispensed cell harvest container 45 through pathway 2 and 19 (par. 0124) (while the buffer including solid particles, is flowing from the chamber inlet to the cell harvest reception via the inlet cell harvest line).
Regarding claim 4, modified Mehta in view of Ma teaches first sensor 44 is in line between sample container 35 and centrifuge 29 (found within temperature module 48) (Ma, Fig. 2) (wherein a biomass sensor arrangement is located in the inlet feed line). Ma teaches operation step 1 wherein the sample is drawn from the sample container to the centrifuge tank (and that, during the loading cycle) and during that process first sensor 44 monitors the movement of the sample through the fluidic line before a drawing process is stopped (Ma, par. 0063-0064). In other words, the first sensor 44 triggers when to stop the sample drawing process in operation step 1 that fills the centrifuge tank. As established in claim 1 above, the first sensor 44 of Ma can be modified to be a biomass sensor in view of Teixeira. Further, modified Mehta teaches that detectors can be used in the system to trigger next stages of the process (Mehta, par. 0125). Because Mehta teaches the controller is influenced by the signal from the sensor/detector, that occurrence signal must be calculated by the controller. Putting these together, the system of Mehta that includes a processor that converts detector signals to an operational output, the detectors of Mehta are modified in view of Ma to be sensors and specifically biomass sensors in view of Teixeira, in the process of filling the centrifuge tank with the sample, the sensor will monitor the filling process monitoring the biomass level of the sample moved into the centrifuge tank (the process control calculates a biomass filling level of the centrifuge chamber based on the sensor signals of the biomass sensor arrangement).
Regarding claim 5, modified Mehta teaches a cell capture mode wherein cell containing media flows from the bioreactor 1 to rotating chamber 5 through the inlet (Mehta, Fig. 21; par. 0122) (a loading cycle). Modified Mehta in view of Ma teaches the system pumps the liquid from the container holding the sample to the first liquid sensor (Ma; par. 0064) . Ma teaches once the first liquid sensor is triggered by the sample, the drawing of the same is stopped (Ma; par. 0064). Modified Mehta teaches that detectors, like bubble detectors, can be used in the system to trigger next stages of the process (Mehta, par. 0125). Because Mehta teaches the controller is influenced by the signal from the sensor/detector, that occurrence signal must be calculated by the controller as liquid passes through a sensor (wherein a maximum biomass filling level is defined in the process control and that, during the loading cycle, the process control terminates the loading cycle, when the maximum biomass filling level is reached by the calculated biomass filling level).
Regarding claim 6, modified Mehta in view of Ma teaches second liquid sensor 45 is located in the outlet fluid line from the centrifuge tank (surrounded by temperature control unit 48) (Ma, Fig. 2) (wherein the supernatant sensor arrangement is located in the outlet supernatant line). Ma teaches the second liquid sensor 45 analyzes the liquid passing through to be sorted further by a valve (Ma, par. 0064). Modified Mehta teaches that detectors, like bubble detectors, can be used in the system to trigger next stages of the process (Mehta, par. 0125). Because Mehta teaches the controller is influenced by the signal from the sensor/detector, that occurrence signal must be calculated by the controller as liquid passes through a sensor (during the loading cycle, the process control calculates an occurrence level of supernatant in the outlet supernatant line based on the sensor signals of the supernatant sensor arrangement).
Regarding claim 7, modified Mehta in view of Ma teaches the second liquid sensor 45 analyzes the liquid passing through to be sorted further by a valve to be sorting into different collection containers each with their own fluid line(Ma, Fig. 2; par. 0064). As previously stated, because Mehta teaches the controller is influenced by the signal from the sensor/detector, including triggering cycles (Mehta, par. 0125), the controller of Mehta would be able to change valves to control what fluid lines the liquid moves to and terminate and begin cycles (wherein a supernatant switching level is defined in the process control and that, during the loading cycle and/or the washing cycle, the process control switches between the outlet supernatant line and the outlet waste line or another liquid line).
Regarding claim 8, Modified Mehta teaches a fluid line 19 that leads to a cell harvest container 45 and a waste line 23 leading to a waste container 23 (Mehta, Fig.22-23) (the inlet cell harvest line or the inlet waste line). Modified Mehta in view of Ma teaches a first liquid sensor 44 embedded in the fluidic network (Ma, Fig. 2) and Teixeira teaches dielectric capacitance is a well-known technique for monitoring biomass online in bioprocessing systems (Teixeira, Table 1, Section 2.4 "Dielectric spectroscopy") (wherein the centrifuge setup comprises a biomass sensor arrangement of the sensor arrangement). Modified Mehta in view of Ma teaches the second liquid sensor 45 analyzes the liquid passing through to be sorted further by a valve to be sorting into different collection containers each with their own fluid line(Ma, Fig. 2; par. 0064). As previously stated, because Mehta teaches the controller is influenced by the signal from the sensor/detector, including triggering cycles (Mehta, par. 0125), the controller of Mehta would be able to change valves to control what fluid lines the liquid moves to and terminate and begin cycles (during the discharging cycle, the process control calculates an occurrence level of biomass in the inlet cell harvest line or the inlet waste line based on the sensor signals of the biomass sensor arrangement).
Modified Mehta is silent to the sensor arrangement specifically being in the inlet cell harvest line or the inlet waste line.
Modified Mehta in view of Ma teaches a second liquid sensor 45 embedded in a second line of the fluidic network (Ma, Fig. 2). Ma teaches the second liquid sensor 45 analyzes the liquid passing through to be sorted further by a valve to be sorting into different collection containers each with their own fluid line(Ma, Fig. 2; par. 0064). Further, rearranging the parts so that a sensor is located in a different fluidic line that handles biomass matter, does not change the operation and steps of the system to monitor biomass within the system. MPEP § 2144 (VI)(C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling data of the invention to rearrange the location of the biomass sensor to be located in the inlet cell harvest line or the inlet waste line.
Regarding claim 9, modified Mehta in view of Ma teaches the second liquid sensor 45 analyzes the liquid passing through to be sorted further by a valve to be sorting into different collection containers each with their own fluid line(Ma, Fig. 2; par. 0064). As previously stated, because Mehta teaches the controller is influenced by the signal from the sensor/detector, including triggering cycles (Mehta, par. 0125), the controller of Mehta would be able to change valves to control what fluid lines the liquid moves to and terminate and begin cycles (wherein the centrifuge setup comprises a biomass sensor arrangement of the sensor arrangement in the inlet cell harvest line or the inlet waste line and that, during the discharging cycle, the process control calculates an occurrence level of biomass in the inlet cell harvest line or the inlet waste line based on the sensor signals of the biomass sensor arrangement).
Regarding claim 11, modified Mehta in view of Ma teaches a first liquid sensor 44 embedded in the fluidic network (Ma, Fig. 2) and Teixeira teaches dielectric capacitance is a well-known technique for monitoring biomass online in bioprocessing systems (Teixeira, Table 1, Section 2.4 "Dielectric spectroscopy") (wherein the biomass sensor arrangement comprises a biomass sensor, which is realized as a capacitance biomass sensor).
Regarding claim 16, modified Mehta teaches the centrifuge chamber 5 is part of a larger cell culture system, and the cell sample is stored in a bioreactor 1 for processing the cell samples (Mehta, Fig. 21; par. 0103-0104) (a bioprocess installation with a centrifuge setup according to claim 1 and with a cell broth source in the form of a production vessel, or a storage vessel).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta, et. al. (US 20160137976 A1) in view of Ma, et. al. (CN 109401962 A) and Teixeira, et. al. ("Advances in on-line monitoring and control of mammalian cell cultures: Supporting the PAT initiative") as applied to claim 1 above, and further in view of Dadgar, et. al. (WO 2019126212 A1; citations made with respect to attached copy).
Regarding claim 10, modified Mehta in view of Ma teaches a first liquid sensor 44 embedded in the fluidic network (Ma, Fig. 2) and Teixeira teaches dielectric capacitance is a well-known technique for monitoring biomass online in bioprocessing systems (Teixeira, Table 1, Section 2.4 "Dielectric spectroscopy") (wherein the biomass sensor arrangement comprises a biomass sensor).
Modified Mehta is silent to adding a flow sensor in combination.
Dadgar teaches a bioprocessing system controlled by a processor (Abstract). Dadgar teaches the system comprises a series of sensors that send electronic signals back to the electronic components of the system (par. 0112). Dadgar teaches the sensor arrangements exist as assemblies to monitor several components simultaneously, like a presence and flow sensor (par. 0112) (a flow sensor in combination). Dadgar specifically teaches a flow sensor can be a capacitive sensor (par. 0121). Dadgar teaches the addition of the flow sensor allows for the system to be monitored for bubbles or inconsistent flow which can lead to errors in the system (par. 0122).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the capacitive biomass sensor of modified Mehta to further include a flow sensor as taught by Dadgar in order to monitor the system for bubbles or inconsistent flow. Because both systems use sensors to monitor the flow of liquid through the system, modifying the biomass sensor to be coupled with a flow sensor as provided by Dadgar, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta, et. al. (US 20160137976 A1) in view of Ma, et. al. (CN 109401962 A) and Teixeira, et. al. ("Advances in on-line monitoring and control of mammalian cell cultures: Supporting the PAT initiative") as applied to claim 1 above, and further in view of Griffin, et. al. (WO 2019106207 A1; citations made with respect to attached copy).
Regarding claim 12, Modified Mehta in view of Ma teaches a second liquid sensor 45 embedded in a second line of the fluidic network (Ma, Fig. 2). Because supernatant is a liquid it is understood by those of ordinary skill in the art that a liquid sensor can detect the presence of the supernatant (wherein the supernatant sensor arrangement comprises a supernatant sensor).
Modified Mehta is silent to the supernatant sensor being realized as a conductivity sensor.
Griffin teaches a bioprocessing system for sorting and collecting cells (Abstract). Griffin teaches the system comprises sensors to monitor each process the system performs (par. 00246). Griffin teaches conductivity sensors are installed around the circulation loop the fluid takes around the system (par. 00246) (which is realized as a conductivity sensor). Griffin teaches conductivity detectors provide data about the sample fluid in real time (when circulated) instead of during post-collection analysis (par. 000246).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the liquid (supernatant) sensor of modified Mehta to be a conductivity sensor as taught by Griffin in order to provide real-time feedback data on the circulating fluid. Because both systems use sensors to monitor circulating fluid in the system, modify the sensor to be a conductivity sensor as provided by Griffin, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta, et. al. (US 20160137976 A1) in view of Ma, et. al. (CN 109401962 A) and Teixeira, et. al. ("Advances in on-line monitoring and control of mammalian cell cultures: Supporting the PAT initiative") as applied to claim 1 above, and further in view of Griffin, et. al. (WO 2019106207 A1; citations made with respect to attached copy) and Wu, et. al. (“Design of a Conductance and Capacitance Combination Sensor for water holdup measurement in oil–water two-phase flow;” citations made with respect to attached copy)
Regarding claim 13, Modified Mehta in view of Ma teaches a first liquid sensor 44 embedded in the fluidic network and a second liquid sensor 45 embedded in a second line of the fluidic network (Ma, Fig. 2). Modified Mehta in view of Teixeira teaches wherein one sensor uses dielectric capacitance as a well-known technique for monitoring biomass in bioprocessing systems (Teixeira, (Table 1, Section 2.4 "Dielectric spectroscopy") (wherein the biomass sensor and the supernatant sensor) (derives an occurrence level of biomass based on a capacitance measurement).
Modified Mehta is silent to the sensor derives an occurrence level of supernatant based on a conductivity measurement.
Griffin teaches a bioprocessing system for sorting and collecting cells (Abstract). Griffin teaches the system comprises sensors to monitor each process the system performs (par. 00246). Griffin teaches conductivity sensors are installed around the circulation loop the fluid takes around the system (par. 00246) (sensor derives an occurrence level of supernatant based on a conductivity measurement). Griffin teaches conductivity detectors provide data about the sample fluid in real time (when circulated) instead of during post-collection analysis (par. 000246).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the liquid (supernatant) sensor of modified Mehta to be a conductivity sensor as taught by Griffin in order to provide real-time feedback data on the circulating fluid. Because both systems use sensors to monitor circulating fluid in the system, modify the sensor to be a conductivity sensor as provided by Griffin, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Mehta is silent to the sensors (being) provided by a combined sensor with at least two sensor electrodes, the capacitance measurement using the electrodes, and the conductivity measurement using the electrodes.
Wu teaches a sensor that measures capacitance and conductivity in solutions comprising at least two different phases (Abstract). Wu teaches a combined probe that that comprises four conductance probes (electrodes) and two capacitance electrodes (Fig. 1) (a combined sensor with at least two sensor electrodes, the capacitance measurement using the electrodes, and the conductivity measurement using the electrodes). Wu teaches the combined electrode allows for testing of complex samples, specifically samples with different, immiscible phases (pf. 227, section 6 “Conclusions”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the sensors of modified Mehta to be a combined capacitance and conductance electrode sensor as taught by Wu in order to quickly monitor different properties of complex solutions. Because both systems are monitoring the capacitance and conductivity of complex solutions, modifying the sensors to be a combine capacitance and conductivity sensor as provided by Wu, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758