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 .
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 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tamura et al. (US 2010/0311150 A1) (hereinafter Tamura) in view of Roger (US 2008/0177222 A1) (hereinafter Roger).
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 using a first load cell or a first weight sensor [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 using a second load cell or a second weight sensor [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);
automatically comparing the mass of the first container with the mass of the second container using a controller; and if the difference between the mass of the first container and the mass of the second container exceeds a threshold, automatically generating a notification indicating that a leak is present using the controller [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).
Tamura additionally teaches that the leakage determination section receives data inputs from at least first and second weight sensors for indicating that the leak is present (Para [0016, 0048], see Claims 1-3 and Fig. 1). Tamura fails to explicitly teach that the leakage determination section is a controller for automatically determining the mass of the first container and the second container using a first load cell or a first weight sensor connected to the controller and a second load cell or a second weight sensor connected to the controller. Roger teaches a method for verifying integrity of a fluidic system comprising automatically determining a mass of a container using a weight sensor connected to a controller for determination of a leakage (Para [0065-0067]). 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 Roger such that the leakage determination section automatically determines the mass of the first container and the second container using a first load cell or a first weight sensor connected to the controller and a second load cell or a second weight sensor connected to the controller, in order to automate the data gathering in the system. Additionally, it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. See In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958).
Regarding claim 2, Tamura in view of Roger 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 Tamura Claim 1).
Regarding claim 5, Tamura in view of Roger 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] (Tamura Para [0048]).
Regarding claim 6, Tamura in view of Roger 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] (Tamura Para [0041]).
Claims 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Tamura in view of Roger as applied to claim 1 above, and further in view of Burchesky et al. (US 2019/0162627 A1) (hereinafter Burchesky).
Regarding claim 3, Tamura in view of Roger 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 in view of Roger 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 in view of Roger 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 in view of Roger 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 in view of Roger 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] (Tamura Para [0048, 0054]). Tamura in view of Roger 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 in view of Roger 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 the transfer flow rate minus the specified leak rate detection threshold, for the predictable result of monitoring for leakage in the closed fluidic system.
Allowable Subject Matter
Claim 21 is allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 21, the closest prior art references, Tamura and Roger, teach certain limitations found in the claim, as described in the rejection of Claim 1 above. The prior art fails to teach or provide motivation for wherein the steps are carried out during a bioprocessing operation, the bioprocessing operation comprising at least one of activation, genetic modification, and/or expansion of a cell population, in combination with the rest of the limitations found in the claim. See Applicant Arguments/Remarks filed on 24 June 2026 – Pgs. 6-8.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, the primary reason for the indication of allowable subject matter is the same as the reasoning provided for claim 21 above. It is noted that claim 7 is a substantial duplicate of claim 21. See Claim objection below.
Claim Objections
Claim 7 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 21. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Arguments
Applicant’s arguments with respect to claim(s) 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.
Applicant’s arguments with respect to the prior art rejection of claim 7 have been fully considered and are persuasive. The rejection of claim 7 has been withdrawn.
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 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
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