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 .
Election/Restrictions
Applicant's election with traverse of Invention I, claims 1-8 in the reply filed on 30 January 2026 is acknowledged. The traversal is on the ground(s) that the special technical feature shared between Group I and Group II is not taught by Tamura. Applicant argues that Tamura does not teach the steps of transferring (a fixed and predetermined) volume from a first container to a second container, comparing the mass in the first and second containers, and generating a notification indicating a leak or blockage is present if a difference therebetween exceeds a threshold. This is not found persuasive. The technical feature shared between Groups I and II is a method for assessing integrity of a bioprocessing system by monitoring mass balance of at least one fluid container in the system with an arbitrary amount of liquid being transferred from one container to another. Group II does not include method steps wherein a fixed and predetermined volume is transferred from a first container to a second container. Group II also does not include method steps of comparing mass in the first and second containers and generating a notification indicating a leak or blockage is present if a difference therebetween exceeds a threshold.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 30 January 2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Tamura et al. (US 2010/0311150 A1) (hereinafter Tamura).
Regarding claim 1, Tamura teaches a method for assessing the integrity of a bioprocessing system [leakage detection; cell processing device] (see Abstract), comprising the steps of:
determining a mass of a first container [weighing the processing containers (first container), the processing liquid container, and the waste liquid container by the weight meters so as to know if their weights are balanced or make any difference before and after the processing liquid or the waste liquid has been supplied or discharged into or from the respective containers] (Para [0015], see Claims 1-3 and Fig. 1);
transferring a volume of fluid from the first container to a second container [discharging liquid from the processing container into the waste containers] (Para [0015, 0054], see Claims 1-3 and Fig. 1);
determining the mass of the second container [weighing the processing containers, the processing liquid container (second container), and the waste liquid container by the weight meters so as to know if their weights are balanced or make any difference before and after the processing liquid or the waste liquid has been supplied or discharged into or from the respective containers] (Para [0015], see Claims 1-3 and Fig. 1);
comparing the mass of the first container with the mass of the second container; and if the difference between the mass of the first container and the mass of the second container exceeds a threshold, generating a notification indicating that a leak is present [leakage determination section determines occurrence of a leakage by comparing a difference in outputs from the weight meters before and after the waste liquid has been discharged from the processing containers, with a difference in outputs from the weight meters before and after the waste liquid has flown into the waste liquid container; leak determination is announced] (Para [0016, 0048], see Claims 1-3 and Fig. 1).
Regarding claim 2, Tamura as applied to claim 1 above teaches the claimed invention, in addition to wherein the first container is a media source bag [decomposition processing container 2a] and the second container is a waste bag [waste liquid containers 5a] (see Claim 1).
Regarding claim 5, Tamura as applied to claim 1 above teaches the claimed invention, in addition to wherein the alert is one of an audible alert and/or a visible alert [determination is announced to the outside through the speaker 19] (Para [0048]).
Regarding claim 6, Tamura as applied to claim 1 above teaches the claimed invention, in addition to wherein the steps are carried out prior to commencement of a bioprocessing operation [cell processing; leakage determination can be carried out before next use of the system] (Para [0041]).
Regarding claim 7, Tamura as applied to claim 1 above teaches the claimed invention, in addition to wherein the steps are carried out during a bioprocessing operation, the bioprocessing operation including at least one of activation, genetic modification and/or expansion of a cell population [cell processing] (Para [0041]).
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 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Tamura as applied to claim 1 above, and further in view of Burchesky et al. (US 2019/0162627 A1) (hereinafter Burchesky).
Regarding claim 3, Tamura as applied to claim 1 above teaches the claimed invention, except for wherein the first container and the second container are the same container, and wherein the step of transferring the volume of fluid from the first container to the second container includes recirculating the volume of fluid. Burchesky teaches a method for assessing the integrity of a bioprocessing system comprising a singular container [120] wherein a mass of the container is compared at an initial time with the mass of the container at an ending time, the fluidic system being capable of recirculating the volume of fluid through valves 151, 152 (Para [0033-0034, 0047-0048], see Fig. 1). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Tamura with Burchesky such that the first container and the second container are the same container, and wherein the step of transferring the volume of fluid from the first container to the second container includes recirculating the volume of fluid, in order to monitor for leakage of a singular container.
Regarding claim 4, Tamura as applied to claim 1 above teaches the claimed invention, except for further maintaining the volume of fluid within the first container for a preset duration; and monitoring a mass of the volume of fluid within the first container at a start and an end of the preset duration; and if a change in mass of the volume of fluid exceed a threshold mass change during the preset duration, generating a notification that a leak is present. Burchesky teaches a method for assessing the integrity of a bioprocessing system comprising maintaining the volume of fluid within a bioprocessing bag for a preset duration and monitoring the mass of the volume of fluid within the container at a start and an end of the preset duration and if a change in mass of the volume of fluid exceeds a threshold mass change during the preset duration, generating a notification that a leak is present (Para [0047-0048]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Tamura with Burchesky such that the method further comprises maintaining the volume of fluid within the first container for a preset duration; and monitoring a mass of the volume of fluid within the first container at a start and an end of the preset duration; and if a change in mass of the volume of fluid exceed a threshold mass change during the preset duration, generating a notification that a leak is present, in order to monitor for leakage in a singular container.
Regarding claim 8, Tamura as applied to claim 1 above teaches the claimed invention, in addition to over a predetermined duration, determining if the ratio between a mass volume absolute variation of the first container and a mass volume absolute variation of the second container is above or below a specified leak rate detection threshold [weight W6 = W2-W3 of the liquid discharged from the processing container 2a; weight W7 = W5-W4 of liquid discharged into the waste containers 5a; if ratio between W7 and W6 is equal to or lower than a predetermined threshold, leakage is determined; determination is announced] (Para [0048, 0054]). Tamura fails to teach determining if the mass volume absolute variation of the first and second containers remains below or above the transfer flow rate minus the specified leak rate detection threshold. Burchesky teaches a method for assessing the integrity of a bioprocessing system wherein the mass volume variation is compared to a transfer flow rate plus a specified calibration constant (Para [0025-0027, 0067-0068]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Tamura with Burchesky such that the method further comprises determining if the mass volume absolute variation of the first container remains below a transfer flow rate plus a specified leak rate detection threshold, and determining if the mass volume absolute variation of the second container stays above or equal to he transfer flow rate minus the specified leak rate detection threshold, for the predictable result of monitoring for leakage in the closed fluidic system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID Z HUANG whose telephone number is (571)270-5360. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM EST.
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/DAVID Z HUANG/ Primary Examiner, Art Unit 2855