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 .
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.
Claim(s) 1, 2, 5-9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiacotti et al. (US 2013/0200005A1).
Regarding claim 1, Mangiacotti teaches a system (refer fig. 1, 2) comprising:
a tangential flow filtration (TFF) module (106) comprising a feed inlet (refer conduit 2 providing feed to module 106), a retentate outlet (connected to conduit 3), and a permeate outlet (connected to conduit 5),
wherein the feed inlet of the TFF module is fluidly connected to an outlet of a first feed unit (feed is supplied from 102) to receive a feed stream, and the permeate outlet of the TFF module is fluidly connected to a permeate collection module (112);
a backpressure regulator (108), wherein an inlet of the backpressure regulator is fluidly connected to the retentate outlet of the TFF module (refer fig. 1), and an outlet of the backpressure regulator is fluidly connected to an inlet of the first feed unit (refer fig. 1 indicating outlet of 108 is connected to reservoir 102);
a first sensor configured to measure a flow rate at the permeate outlet of the TFF module (refer paragraph [0040] disclosing a plurality of sensors including flow rate sensor on permeate flow); and
a control unit (122) electrically connected to the backpressure regulator (108) and the first sensor (refer [0035], [0047]), and configured to control the backpressure regulator to adjust a transmembrane pressure (TMP) of the TFF module (refer [0042] disclosing controlling valve 108 with PID controller 126 to maintain a user selected TMP setpoint; refer also [0047] disclosing “putting the TMP valve 108 into automatic with a predefined recipe driven TMP pressure setpoint and waiting for the recipe target ultra violet sensor value to be met”. It should be noted to ). Mangiacotti also teaches (refer [0035]) maintaining user selected flow rate at the disposable flow sensor.
Regarding the limitation of control unit configured to control the backpressure regulator to adjust a transmembrane pressure based on the flow rate measured by the first sensor (flow sensor) and maintaining a first substantially constant flow rate at the permeate outlet of the TFF module, Mangiacotti discloses (as discussed above) a control unit that is connected to the backpressure valve, flow rate sensor, and feed pump and also discloses a program to control TMP by adjusting backpressure valve, controlling feed pump, and monitoring and setting permeate flow. Selecting whether to make user selected flow rate to be a constant value or a variable value, would have been an obvious matter of choice to one of ordinary skill in the art because Mangiacotti discloses that the main pump 104 is controlled with PID controller to maintain a user selected permeate flow rate (refer [0035]).
Regarding claim 2, Mangiacotti teaches limitations of claim 1 as set forth above. Mangiacotti further teaches that the control of the backpressure regulator increases a pressure at the retentate outlet of the TFF module in response to a decrease of the flow rate measured by the first sensor (Refer [0047] disclosing “the process includes the steps of putting the main pump 104 in automatic with a predefined recipe driven flow rate setpoint and then waiting for the main pump flow rate to stabilize at or near the setpoint. The next step is putting the TMP valve 108 into automatic with a predefined recipe driven TMP pressure setpoint and waiting for the recipe target ultra violet sensor value to be met.”).
Regarding claim 5, Mangiacotti teaches limitations of claim 1 as set forth above. In fig. 1, Mangiacotti teaches a single TFF unit (refer 106).
Regarding claims 6-7, Mangiacotti teaches limitations of claim 1 as set forth above. In fig. 1, Mangiacotti teaches two TFF units arranged in parallel, wherein each of the two TFF units comprises individual fluid inlet connected to feed inlet of the TFF module, individual retentate outlet connected to retentate outlet of the TFF module, individual permeate outlet connected to the permeate outlet of the TFF module and a plurality of valves corresponding to the inlets and outlets. Providing connections to additional units, valves, pumps, and sensors to the control unit would have been obvious to one of ordinary skill in the art to enable control of TMP and flow rate.
Regarding claims 8-9, Mangiacotti teaches limitations of claim 6 as set forth above. selecting whether to provide a single unit or a plurality of units within a unit would have been an obvious matter of choice to one of ordinary skill in the art.
Regarding claim 20, Mangiacotti teaches limitations of claim 1 as set forth above. Mangiacotti further teaches that the system comprises a feed pump(104) fluidly connected to the feed inlet of the TFF module (106), and fluidly connected to the outlet of the first feed unit (Refer fig. 1).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiacotti et al. (US 2013/0200005A1), in view of Herczeg et al. (US 2020/0016520A1).
Regarding claims 3-4, Mangiacotti teaches limitations of claim 2 as set forth above. Mangiacotti discloses controlling of TMP valve 108 with a PID controller and that the TMP valve is controlled to maintain a user selected TMP setpoint, and also teaches predefine recipe driven flow rate setpoint (refer [0047]). Since Mangiacotti teaches setting flow rate setpoint to a user defined value, adjusting pump and valves to achieve the flow rate set point would have been obvious to one of ordinary skill in the art. It is well known in the art that increasing transmembrane pressure results in increase in permeate flow. Refer [0062] of Herczeg. Therefore, it would have been obvious to one of ordinary skill in the art to increase TMP to increase permeate flow and decrease TMP to decrease permeate flow.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiacotti et al. (US 2013/0200005A1), in view of ISHII et al. (US 2023/0285903A1), and Herczeg et al. (US 2020/0016520A1).
Regarding claims 10-13, Mangiacotti teaches limitations of claim 6 as set forth above. Mangiacotti teaches providing a pressure sensor (refer PA in fig. 2) to measure pressure at feed inlet of the TFF module. Mangiacotti does not teach providing individual pressure sensors to measure pressure at each of the retentate outlets. However, providing additional sensors at each of inlets and outlets would have been obvious because ISHII teaches a filtration system comprising two filters units (4 and 5) arranged in parallel wherein each of the filter units comprises a feed inlet, a permeate outlet and a retentate outlet (refer fig. 1), wherein each of the feed inlet and retentate outlet comprises a pressure sensor for measuring pressure, and each of the permeate outlet comprises a flow rate sensor for measuring permeate flow rate (refer fig. 1).
Mangiacotti discloses controlling of TMP valve 108 with a PID controller and that the TMP valve is controlled to maintain a user selected TMP setpoint, and also teaches predefine recipe driven flow rate setpoint (refer [0047]). Since Mangiacotti teaches setting flow rate setpoint to a user defined value, adjusting pump and valves to achieve the flow rate set point would have been obvious to one of ordinary skill in the art. It is well known in the art that increasing transmembrane pressure results in increase in permeate flow. Refer [0062] of Herczeg. Therefore, it would have been obvious to one of ordinary skill in the art to increase TMP to increase permeate flow and decrease TMP to decrease permeate flow.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiacotti et al. (US 2013/0200005A1), in view of Capron et al. (US 2024/0140989A1).
Regarding claim 15, Mangiacotti teaches limitations of claim 1 as set forth above. Mangiacotti does not teach that the the feed inlet of the TFF module is fluidly connected to the outlet of the first feed unit through a fourth valve, and fluidly connected to an outlet of a buffer module through a fifth valve; and the control unit is electrically connected to the fourth valve and the fifth valve and is further configured to control the fourth valve and the fifth valve to draw either the feed stream from the first feed unit or a buffer stream from the buffer module for flowing through the TFF module.
Capron teaches a filtration system comprising a filter unit connected to a feed tank and a buffer tank (refer fig. 1), wherein outlets of the feed tank and buffer tank comprises a valve controlling output of the tank (refer fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of Mangiacotti to include a buffer tank and valves at outlets of the feed tank and buffer tank to enable control of output of the tanks to the filter unit as taught by Capron. Mangiacotti teaches connecting valves, pumps and sensors to control unit (refer rejection of claim 1 above). Connecting additional valves to the control unit would have been obvious to one of ordinary skill in the art to enable automatic control of valves.
Regarding claim 15, Mangiacotti teaches limitations of claim 14 as set forth above. Limitations of claim 15 are reciting a manner of operating the system without imparting additional structure. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiacotti et al. (US 2013/0200005A1), in view of Capron et al. (US 2024/0140989A1), and Xu et al. (US 2024/0069001A1).
Regarding claim 16-18, Mangiacotti teaches limitations of claim 1 as set forth above. Mangiacotti does not teach that the system comprises a plurality of feed units, wherein the plurality of feed units comprises the first feed unit and a second feed unit, wherein each respective feed unit in the first and second feed units comprises: a corresponding fourth valve connecting a corresponding individual outlet of the respective feed unit with the feed inlet of the TFF module; a corresponding sixth valve connecting a corresponding individual inlet of the respective feed unit with a source module; a corresponding seventh valve connecting the corresponding individual inlet of the respective feed unit with a buffer module; a corresponding eighth valve connecting the corresponding individual inlet of the respective feed unit with the outlet of the backpressure regulator; and a corresponding fifth sensor configured to measure an amount of a fluid contained in the respective feed unit, wherein the control unit is electrically connected to the corresponding fourth, sixth, seventh and eighth valves and the corresponding fifth sensor of each of the first and second feed units, and configured to (i) determine whether the amount of the fluid contained in the first feed unit is below a predetermined amount; and (ii) control, if it is determined that the amount of the fluid contained in the first feed unit is below the predetermined amount, the corresponding fourth, sixth, seventh and eighth valves of each of the first and second feed units to draw the feed stream from the second feed unit in the plurality of feed units; wherein the control unit is further configured to: (iii) control, if it is determined that the amount of the fluid contained in the first feed unit is below the predetermined amount, the corresponding fourth, sixth, seventh and eighth valves of each of the first and second feed units to flush the first feed unit with a buffer stream from the buffer module; wherein the control unit is further configured to:(iv) control, if it is determined that the amount of the fluid contained in the first feed unit is below the predetermined amount, the corresponding fourth, sixth, seventh and eighth valves of each of the first and second feed units to replenish the first feed unit with a feed fluid from the source module.
Capron teaches a filtration system comprising a filter unit connected to a feed tank (break tank) and a plurality of additional tanks (refer WFI and buffer concentrate), wherein outlets of each of the tanks comprises a valve controlling output of the tank (refer fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of Mangiacotti to include feed tank and additional tanks, each including a valve to control output of the tanks to the filter unit as taught by Capron. Mangiacotti teaches connecting valves, pumps and sensors to control unit (refer rejection of claim 1 above). Connecting additional valves to the control unit would have been obvious to one of ordinary skill in the art to enable automatic control of valves.
Use of weight sensor to determine amount of feed in a tank is disclosed by Xu (refer sensor 174 for tank 104). Use of a known sensor (such as weight sensor) to determine amount of contents of tanks in the system of modified Mangiacotti would have been obvious to one of ordinary skill in the art to monitor contents of the tanks.
A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). Whether the tanks contain feed solution or buffer solution or other liquid does not impart patentability to the claims claiming tanks containing Feed, buffer, and/or source. Selecting which liquid to be placed in which container and controlling output of the liquid from a system that is capable of individually controlling output of the tanks to the filter unit would have been an obvious matter of choice to one of ordinary skill in the art.
Regarding claim 19, modified Mangiacotti teaches limitations of claim 16 as set forth above. Capron further teaches providing additional pumps connected to additional tanks (refer fig. 1) facilitating supply of contents of the tanks to the filter unit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dixon et al. (US 2023/0072711) teaches a system comprising a TFF module producing permeate, retentate and having a plurality of sensors including permeate flow rate sensor.
SIBILIA et al. (US 2022/0395770) teaches a system comprising a TFF module producing permeate, retentate and having a plurality of sensors including permeate flow rate sensor.
Magazov et al. (US 20200276538) teaches a control system and a control method for automated controlling of a crossflow filtration system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRANAV PATEL whose telephone number is (571)272-5142. The examiner can normally be reached M-F 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at (571) 270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PRANAV N PATEL/Primary Examiner, Art Unit 1777
Prosecution Insights