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 .
Preliminary Remarks
The amendment filed on 02/18/2026 has been entered. Claims 1-12 have been amended, claims 13-15 are withdrawn from consideration, and claims 16-20 have been added. Therefore, claims 1-20 remain pending in the application.
Claim Objections
The claim objections cited in the Office Action mailed on 11/20/2025 is withdrawn, since applicant has amended the claims to overcome the cited objections.
Claim Rejections - 35 USC § 112
Applicant has amended claims 1, 9, and 10 to overcome the 112(b) rejection of the claims cited in the previously mailed Office Action.
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.
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 1-8, 10-12, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0349874A1-Jaques et al. (hereinafter Jaques), and further in view of US 2019/0358633 A1-Collins (has an effective filing date as of the provisional application).
Regarding claim 1, Jaques discloses a system for performing cell culture (abstract; para. [0021], lines 1-10) comprising a bioreactor (abstract, para. [0021], lines 1-2; para. [0079], line 3, bioreactor vessel 1, Fig. 1A) a holding tank (bioprocessing container 100, para. [0079], line 3-4, Fig. 1A), a device for producing liquid media for cell cultures (bioprocessing container 100, para. [0079], line 3-4, Fig. 1A) and a control system (controller, para. [0041], lines 7-8; and lines 11-12) connected to the bioreactor, the holding tank and the device for producing liquid media for cell cultures, wherein the liquid media are produced by dissolving ingredients in water (an agitation system configured to suspend any desired components contained within the bioprocess container (para. [0170], lines 1-3), the device for producing liquid media for cell cultures comprising a mixing vessel for holding and mixing a watery formulation (vessel 100, Fig. 1A); an agitator (impellers 6 and 7, para. [0079], line 12, Fig. 1A) for mixing the watery formulation in the mixing vessel; at least one pH meter (pH sensor, para. [0041], line 4; and lines 1-3) in the mixing vessel or in fluid connection with the mixing vessel; a dosing apparatus connected to the mixing vessel for filling a specific amount of at least one solid ingredient or of at least one mixture of solid ingredients into the mixing vessel (the controller facility for dosing a single addition, repeated on multiple days during the fermentation may be performed (para. [0290], lines 8-11); a flow generating apparatus (pump, para. [0192], lines 3-6) for generating or allowing a flow of the watery formulation from the mixing vessel; Jaques discloses the control system being connected to the pH meter (abstract, para. [0041], lines 7-9), such that the measured values of the pH meter are accessible by the control system, the control system being connected to the water supply to control the amount of water being filled into the mixing vessel (para. [0041], lines 10-12), the control system being connected to the base supply to control the amount of base or watery base being filled into the mixing vessel, the control system being connected to the acid supply to control the amount of acid or watery acid being filled into the mixing vessel (para. [0041], lines 10-12). Further, Jaques discloses the control system being connected to the dosing apparatus to control the amount of the at least one ingredient or the at least one mixture of ingredients being filled into the mixing vessel (para. [0290], lines 8-11), wherein the control system is programmed to control the dosing apparatus, the water supply, the base supply, the acid supply, and preferably the flow generating apparatus, depending from the measured values of at least one of the pH meter (para. [0041], lines 7-14), and, if present, of a dissolution sensor in the mixing vessel, and wherein the bioreactor and the mixing vessel of the device for producing liquid media for cell cultures are connected via at least a pipeline or tube (tubes 15, para. [0079], lines 18-19) which is interrupted by at least one holding tank. However, Jacques does not explicitly teach a water supply, a base supply, and an acid supply.
For claim 1, Collins teaches a system and method for automated and closed cell culture system; the system includes a disposable assembly, actuators, sensors, software/firmware and smart device (abstract and para. [0005], lines 1-5) and Collins teaches multiple reagent containers (para. [0157], lines 4-8), which reads on the instant claim limitation of multiple containers for a water supply, a base supply, and an acid supply.
It would have been obvious to one of ordinary skill, in the art at the time, to further include of multiple containers for a water supply, a base supply, and an acid supply as taught by Collins. Further, Collins teaches the multiple containers with different fluids deliver different reagents to the cell culture vessel (para. [0171], lines 40-42).
Regarding claim 2, Jaques teaches at least one sterile filter is arranged in said pipeline or tube (17 are the inline sterile filters, para. [0079], line 25, Fig. 1A).
Regarding claim 3, Jaques teaches the system comprises a signal receiving unit which is able to receive a signal from the bioreactor (signals can be provided for temperature measurement and control, data logging and alarms, para. [0280], lines 1-5), and the control system is programmed to control the flow of the watery formulation in response to the signal received from the bioreactor via the signal receiving unit (the controller may be any type of processing hardware, such as a processor or a computing device, configured to control and execute various instructions for one or more components and/or related equipment associated with the single-use bioreactor, para. [0251], lines 1-6).
Regarding claim 4, Jaques teaches the bioreactor comprises a controller (para. [0251], lines 1-3; para. [0041], lines 1-12) and a signal sending unit which sends a signal to the signal receiving unit if the amount of watery formulation drops below a certain value or fresh watery formulation is needed (signals can be provided for temperature measurement and control, data logging and alarms, para. [0280], lines 1-5).
Regarding claim 5, Jaques teaches the holding tank comprises a controller (para. [0041], lines 7-14) and a signal sending unit (signals can be provided for temperature measurement and control, data logging and alarms, para. [0280], lines 1-5) which sends a signal to the signal receiving unit if the amount of watery formulation drops below a certain value or fresh watery formulation is needed and the control system is programmed to control the production of the watery formulation in response to the signal received from the holding tank via the signal receiving unit.
Regarding claim 6, Jaques teaches the bioreactor is operated in perfusion mode (perfusion mode—para. [0119], lines 1-4).
Regarding claim 7, Jaques teaches at least one dissolution sensor (a dissolved carbon dioxide sensor or a dissolved oxygen sensor—para. [0041], lines 4-6) for detecting the presence of undissolved ingredients in the watery formulation, wherein the control system (para. [0041], lines 1-4; and lines 4-6) is connected to the at least one dissolution sensor, such that the measured values of the at least one dissolution sensor are accessible by the control system.
Regarding claim 8, Jaques teaches the device comprising at least one sensor for measuring the electrical conductivity (sensor for measuring a parameter within the hollow enclosure—para. [0041], lines 1-4) of the watery formulation, wherein the at least one sensor for measuring the electrical conductivity of the watery formulation is located in the mixing vessel (para. [0041], lines 3-4, within the hollow enclosure) and/or in a pipe for conducting the flow from the mixing vessel, wherein the control system is connected to the at least one sensor for measuring the electrical conductivity of the watery formulation, such that the measured values of the at least one sensor for measuring the electrical conductivity of the watery formulation are accessible by the control system (sensor for measuring a parameter within the hollow enclosure—para. [0041], lines 1-4) and the control system is able to control at least the flow generating apparatus depending from the measured values of the at least one sensor for measuring the electrical conductivity of the watery formulation (sensor for measuring a parameter within the hollow enclosure—para. [0041], lines 1-4),
Jaques teaches and/or a sensor for measuring the osmolarity of the watery formulation (the bioreactor system can further include at least one sensor in operative association with the bioprocess container for monitoring at least one parameter within the hollow enclosure (para. [0041], lines 1-4), wherein the sensor for measuring the osmolarity of the watery formulation is located in the mixing vessel (para. [0041], lines 1-4) and/or in a pipe for conducting the flow from the mixing vessel, wherein the control system (para. [0041], lines 7-14) being connected to the sensor for measuring the osmolarity of the watery formulation, such that the measured values of the sensor for measuring the osmolarity of the watery formulation are accessible by the control system and the control system is able to control at least the flow generating (pump, para. [0192], lines 3-6) apparatus depending from the measured values of the sensor for measuring the osmolarity of the watery formulation and/or a sensor for level indication of the watery formulation inside the mixing vessel, wherein the control system being connected to the sensor for level indication (para. [0041],lines 7-14), such that the measured values of the sensor for level indication are accessible by the control system and the control system is able to control at least the flow generating apparatus depending from the measured values of the sensor for level indication and/or a volume sensor and/or a liquid level sensor to measure the volume of watery formulation in the mixing vessel,
Jaques teaches wherein the control system being connected to the volume sensor (para. [0041], lines 7-12) and/or the liquid level sensor to control the amount of watery formulation in the mixing vessel and being programmed (controller—para. [0251], lines 1-5) to fill water and/or the at least one ingredient or the at least one mixture of ingredients into the mixing vessel depending from the measured value of the volume sensor and/or the liquid level sensor and/or at least one weight sensor (load cell, para. [0037], lines 1-3) to measure the weight of content in the mixing vessel and/or the amount of the at least one ingredient or of the at least one mixture of ingredients to be filled into the mixing vessel by the dosing apparatus, wherein the control system (para. [0041], lines 1-6) being connected to the at least one weight sensor to control the amount of watery formulation in the mixing vessel and being programmed to fill water and/or the at least one ingredient or the at least one mixture of ingredients into the mixing vessel depending from the measured value of the at least one weight sensor and/or the control system being connected to the at least one weight sensor to control the weight (para. [0041], lines 1-6) of the at least one ingredient or of the at least one mixture of ingredients to be filled into the mixing vessel by the dosing apparatus and being programmed (controller—para. [0251], lines 1-5) to fill water and/or additional of the at least one ingredient or the at least one mixture of ingredients into the mixing vessel (the controller facility for dosing a single addition, repeated on multiple days during the fermentation may be performed (para. [0290], lines 8-11) depending from the weight measured by the at least one weight sensor.
Regarding claim 10, Jaques teaches whereby the control system comprises one or more of the following programming: - the control system is programmed to control the agitator depending from the measured values of at least one of the pH meter and/or, if present, of the dissolution sensor, and/or of the at least one sensor for measuring the electrical conductivity of the watery formulation and/or of the sensor for measuring the osmolarity of the watery formulation and/or a time information given by the timing element (para. [0251], lines 1-8); - the control system is programmed to produce at least two different types of liquid media for the growth of at least two different cell cultures or different process phases of the same cell culture process; the control system is programmed to start the production of a new batch of liquid media triggered via a signal or a request to the control system via at least one interface.
Regarding claim 11, Jaques teaches whereby all pipes and containers coming in contact with the watery formulation of the system are single-use parts (single-use bioreactor which includes a bioprocess container, a shell, at least one agitator, at least one sparger , at least one gas filter inlet port for the sparger(s) and headspace overlay, at least one fill port, at least one, para. [0027]).
Regarding claim 12, Jaques teaches whereby the flow of the watery formulation from the mixing vessel generated or allowed by the flow generating apparatus flows into the holding tank and/or into the bioreactor (pump, para. [0192], lines 3-6), whereby the control system is connected to a signal receiving unit (signals can be provided for temperature measurement and control, data logging and alarms, para. [0280], lines 1-5), which is able to receive a signal from the bioreactor and/or the holding tank, and the control system is programmed (controller—para. [0251], lines 1-5) to control the flow of the watery formulation in response to the signal received from the bioreactor and/or the holding tank via the signal receiving unit.
Regarding claim 16, Jaques teaches wherein the control system is programmed to control the flow generating apparatus (the controller can be configured to receive information from the at least one sensor and, based on the information, to control a fluid supply for varying a flow rate of a fluid from the fluid supply into the hollow enclosure of the bioprocess container, para. [0041], lines 8-12).
Regarding claim 20, Jaques teaches the invention discussed in claim 9. Further, Jaques teaches a single-use bioreactor of the present disclosure would have integrated media and feed preparation to perfusion (para. [0023], lines 7-9). However, Jaques does not explicitly teach a pumping device.
For claim 20, Collins teaches various pumping mechanisms—pumping from media/reagent containers to cell culture container (para. [0015], lines 2-3), which reads on the instant claim limitation of a pumping device.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a pumping device as taught by Collins, because Collins there are provided methods for carrying out pumping from media/reagent containers to cell culture container while avoiding any leaking of fluids from the cell container to waste by pumping in pulses and waiting between trains of pulses (para. [0015], lines 2-6).
Claims 9 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over by US 2017/0349874A1-Jaques et al. (hereinafter Jaques), in view of US 2019/0358633 A1-Collins (has an effective filing date as of the provisional application), as applied to claim 1 above, and further in view of a different embodiment of Jaques-US 2017/0349874A1.
Regarding claim 9, modified Jaques teaches the invention discussed above in claim 1. Further, Jaques teaches a flow generating apparatus and a pumping device. Further, Jaques teaches a holding tank and a mixing vessel, also discussed above. However, Jaques does not teach a controllable valve for controlling the flow.
For claim 9, a different embodiment of Jaques teaches a fluid control device may comprise a one-way valve (para. [0035], lines 8-9)where the fluid control device only permits fluid to flow out and also prevents fluid from flowing the opposite direction, which reads on the instant claim limitation of a controllable valve for controlling the flow.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the bioreactor of modified Jaques to further include a controllable valve for controlling the flow as taught by a different embodiment of Jaques. Further, the different embodiment of Jaques teaches a fluid control device that only permits fluid to flow out of the fluid outlet and prevents fluid flow in an opposite direction (para. [0035], lines 5-7).
Regarding claim 17, Jaques teaches wherein the control system is programmed to control the dosing apparatus, the water supply, the base supply, the acid supply, and optionally the flow generating apparatus, depending from the measured values of the pH meter (the controller can be configured to receive information from multiple sensors in order to control multiple parameters within the bioreactor, para. [0048], lines 1-3).
Regarding claim 18, Jaques teaches wherein the control system is programmed to control the dosing apparatus, the water supply, the base supply, the acid supply, and optionally the flow generating apparatus, depending from the measured values of the dissolution sensor (the controller can be configured to receive information from multiple sensors in order to control multiple parameters within the bioreactor, para. [0048], lines 1-3; also, it should be noted the dissolution sensor is not required, as cited in claim 1).
Regarding claim 19, Jaques teaches wherein the flow of the formulation is driven by gravity (the device comprises the ability to hold a formulation and unless impeded, the natural gravitational force would still likely occur, further, Jaques teaches the bioprocess container can have a top , a bottom , and at least one side wall therebetween . The bioprocess chamber can define a hollow enclosure for receiving a culture media, para. [0040], lines 4-7).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the current rejection above pertains to new reference(s) relied upon to address the newly amended claim limitations; the arguments filed rely on the reference or combination of references not currently being used in the present Office Action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./ Examiner, Art Unit 1799
/MICHAEL L HOBBS/ Primary Examiner, Art Unit 1799