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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Applicant' s amendment and response filed on 12/22/2025 has been received and entered into the case.
Amendments
In the reply filed 12/22/2025, Applicant has amended claim 1.
Claim Status
Claims 1-11 and 19-31 are pending.
Claims 19-31 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/12/2025.
Claims 1-11 are considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The corresponding signed and initialed PTO form 1449 has been mailed with this action.
New Claim Rejections - 35 USC § 112(a)
NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The new limitation of the last wherein clause “wherein the first pre-programmed corresponding outcome … remains fixed during the execution of the workflow” in the amended claim 1 represents new matter. MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a), pre-AIA first paragraph - written description requirement. In re Rasmussen , 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” Although the basis for this limitation was identified in Applicant’s remarks filed 12/22/2025 as being described “Support for the claim amendments can be found throughout the application as originally filed” (Remarks, p. 6, para 1), a review of the specification by the Examiner did NOT find any specific basis for the recited limitation that the pre-programmed corresponding outcome “remains fixed during the execution of the workflow”. On the contrary, the specification recites “In general, the workcell described herein may measure a first parameter associated with a cell product, compare the first parameter against a first pre-defined condition and, if the first pre-defined condition is met, the workcell may continue with a pre-defined response in accordance with a pre-programmed workflow. If the first pre-defined condition is not met by the first parameter, the workcell may continue with a different pre-defined response in accordance with the pre-programmed workflow” (end of [0072], bolded and underlined by examiner. It is noted that the “pre-defined response” is equivalent to the claimed pre-programmed corresponding outcome). Accordingly, the specification clearly teaches the pre-programmed corresponding outcome is subjected to change based on whether the pre-defined condition is met, and thus it does NOT remain “fixed” during the execution of the workflow.
Withdrawn Claim Rejections - 35 USC § 102
The prior rejection of claims 1-2 and 4-11 under 35 U.S.C. 102 (a)(1) as being anticipated by Sowwan et al. (US PGPub 2022/0127558) has been withdrawn in light of Applicant’s amendment to the claims.
Withdrawn Claim Rejections - 35 USC § 103
The prior rejection of claims 1-11 under 35 U.S.C. 103 as being unpatentable over Sowwan et al. (US PGPub 2022/0127558) has been withdrawn in light of Applicant’s amendment to the claims.
New Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 4-11 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sowwan et al. (US PGPub 2022/0127558. Prior art of record).
With respect to claim 1, Sowwan teaches a method for cell therapy manufacturing using an automated closed apparatus (abstract).
In regard to receiving user input defining (i) a pre-programmed workflow, Sowwan teaches the master controller includes one or more input/output devices, such as cursor control device, keyboard and display and “any of the components may be utilized by the system to receive user input described above” (e.g., [0036]). In the paragraph above (e.g., [0035]), Sowwan teaches “the master controller may be configured to implement the method of FIG. 3 as processor-executable program instructions (e.g., program instructions executable by processor)”. It is noted that Fig. 3 describes a workflow of cell processing steps, from “feed a plurality of initial cells to a master device (302)” to “transfer a subset of initial cells to and from one or more auxiliary devices for processing the subset of initial cells to form a plurality of final cells (304)” and to “transfer the plurality of final cells to an output device (306)”. Thus, Sowwan teaches receiving user input defining (i) a pre-programmed workflow of cell processing steps (e.g., to receive user input to configure program instructions of the method of Fig 3).
Regarding (ii) pre-programmed conditions and pre-programmed corresponding outcomes, Sowwan teaches an example of cell expansion processing step in [0049] including a pre-programmed condition (i.e., “certain cell expansion thresholds”, which is equivalent to a pre-programmed condition defining a threshold value in claims 1 and 6), and a pre-programmed corresponding outcome (i.e., “adjust the experimental conditions (e.g., add nutrients)”, which is equivalent to a pre-programmed corresponding outcome) (see [0049] recited and further discussed below).
In regard to subsequently and automatically executing the workflow, as stated supra, Sowwan teaches “the master controller may be configured to implement the method of FIG. 3 as processor-executable program instructions” (e.g., [0035]), thus teaches the master controller is configured first (by receiving user input of program instructions in [0036]), and then to implement the method of FIG. 3 as processor-executable program instructions (i.e., subsequently and automatically executing the pre-programmed workflow in Fig 3).
In regard to measuring at least one parameter associated with a cell processing step, Sowwan teaches at least one of the one or more auxiliary devices may be configured to perform a measurement process. The one or more auxiliary devices may include one or more sensors to provide data inputs for the master controller (e.g., [0025]), thus teaches measuring at least one parameter associated with at least one cell processing step. Sowwan teaches measuring nutrients and metabolic byproducts (Oxygen, CO2, Glucose, pH, ATP, or the like) in an exemplary cell expansion processing step (see [0049] recited as follows).
“For example, metabolomics can be performed real time on the plurality of initial cells to provide a detailed fingerprint of the biological function of the cells based on the way they are consuming nutrients and producing metabolic byproducts (Oxygen, CO2, Glucose, pH, ATP, or the like), allowing for a prediction of how much the cells will expand as a function of time, and the machine learning techniques may be used to determine how to adjust the experimental conditions (e.g., add nutrients) to meet certain cell expansion thresholds for the plurality of final cells.”
In regard to determining whether a condition is met, as recited above, Sowwan teaches determining (i.e., by using the machine learning techniques) whether a first pre-programmed condition (i.e., “certain cell expansion thresholds”) has been met based upon the measured parameters (i.e., “metabolomics” such as “Oxygen, CO2, Glucose, pH, ATP, or the like”).
In regard to automatically executing a first pre-programmed corresponding outcome selected from the one or more outcomes based on the determination, as stated supra, Sowwan teaches “the machine learning techniques may be used to determine how to adjust the experimental conditions (e.g., add nutrients) to meet certain cell expansion thresholds for the plurality of final cells” ([0049] recited above), thus teaches based on the determination (i.e., the certain cell expansion thresholds have not been met yet), automatically (i.e., by using the machine learning techniques) selecting from the one or more outcomes (i.e., to determine how to adjust the experimental conditions), and executing a first pre-programmed corresponding outcome (i.e., add nutrients), so as to meet the certain cell expansion thresholds.
In regard to the limitation the first pre-programmed corresponding outcome remains fixed during the execution of the workflow, as stated supra, the instant specification does not have support for a “fixed’ outcome, thus the limitation “fixed” is being examined as the corresponding outcome is being pre-programmed before the execution of the workflow. As stated supra, Sowwan teaches “the master controller may be configured to implement the method of FIG. 3 as processor-executable program instructions” (e.g., [0035]), and exemplifies a pre-programmed corresponding outcome (i.e., “adjust the experimental conditions (e.g., add nutrients)”) (see [0049] recited above). Thus, Sowwan teaches the corresponding outcome (e.g., add nutrients) is being pre-programmed (i.e., the master controller is configured first) before the execution of the workflow (i.e., then to implement the method of FIG. 3 as processor-executable program instructions). It is noted that in Sowwan’s teaching “the machine learning techniques may be used to determine how to adjust the experimental conditions (e.g., add nutrients)” ([0049] recited above), the machine learning techniques are used to automatically select and execute the program instructions (i.e., the pre-programmed corresponding outcomes including to add nutrients), which is equivalent to the teaching in instant specification “if the first pre-defined condition is met, the workcell may continue with a pre-defined response in accordance with a pre-programmed workflow. If the first pre-defined condition is not met by the first parameter, the workcell may continue with a different pre-defined response in accordance with the pre-programmed workflow” ([0072], emphasized by examiner).
With respect to claim 2 directed to the set of cell processing steps comprising enrichment, selection, activation, expansion or perfusion, Sowwan teaches the one or more auxiliary devices are configured to perform the following processes: a chemical enrichment process, a cell selection process, an activation, transduction, or transfection process, a perfusion process, and a cell expansion process (e.g., [0026]).
With respect to claim 4 directed to the parameter comprising a pH value or a total cell count value, Sowwan teaches the apparatus comprises one or more sensors for monitoring one or more of O2 levels, pH, CO2 levels, temperature, or pressure (e.g., [0032], [0049]), and teaches a cell count measurement is taken in the input device, the one or more auxiliary devices or the output device (e.g., [0053]).
With respect to claim 5 directed to the parameter being measured at a predetermined time interval, as stated supra, Sowwan teaches at least one of the auxiliary devices may be configured to perform a cell characterization process or other diagnostic or measurement process. The one or more auxiliary devices may include one or more sensors provide data inputs for the master controller (e.g., [0025], [0049]), and the master controller can communicate with the devices, and includes control programs for actuating the devices of the system ([0018]). Thus, Sowwan teaches the master controller has control programs to actuate the auxiliary devices with sensors to perform a measurement process, thus teaches the parameters are measured at a predetermined time interval (i.e., defined in the control programs).
With respect to claim 6 directed to the condition defining a threshold value for the parameter, as stated supra, Sowwan teaches metabolomics of the cells based on the way they are consuming nutrients and producing metabolic byproducts (Oxygen, CO2, Glucose, pH, ATP, or the like) are measured to predict how much the cells will expand as a function of time and to determine how to … meet certain cell expansion thresholds ([0049]), and teaches a cell count measurement is taken in the input device, the one or more auxiliary devices or the output device (e.g., [0053]). Thus, Sowwan teaches the pre-programmed condition defines a threshold value (i.e., “certain cell expansion thresholds” in [0049]).
With respect to claim 7 directed to a cell processing step being executed upon a determination that the measured parameter meets the condition, it is noted that this wherein clause is directed to a contingent limitation based on the limitation that the measured parameter meets the condition. MPEP 2111.04 (II) states “[T]he broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”. Accordingly, the wherein clause in claim 7 does not provide any patentable weight in determining patentability of the claimed method. The method itself (a method for cell processing) is anticipated by the method of Sowwan as discussed above.
With respect to claim 8 directed to the cells being transferred from a first module to a second module upon a determination that the measured parameter meets the condition, it is noted that this wherein clause is directed to a contingent limitation based on the limitation that the measured parameter meets the condition. Accordingly, the wherein clause in claim 8 does not provide any patentable weight in determining patentability of the claimed method. The method itself (a method for cell processing) is anticipated by the method of Sowwan as discussed above.
With respect to claim 9 directed to a notification to a user being generated upon a determination that the measured parameter does not meet the condition, it is noted that this wherein clause is directed to a contingent limitation based on the limitation that the measured parameter does not meet the condition. Accordingly, the wherein clause in claim 9 does not provide any patentable weight in determining patentability of the claimed method. The method itself (a method for cell processing) is anticipated by the method of Sowwan as discussed above.
With respect to claim 10 directed to the workflow being stopped upon a determination that the measured parameter does not meet the condition, it is noted that this wherein clause is directed to a contingent limitation based on the limitation that the measured parameter does not meet the condition. Accordingly, the wherein clause in claim 10 does not provide any patentable weight in determining patentability of the claimed method. The method itself (a method for cell processing) is anticipated by the method of Sowwan as discussed above.
With respect to claim 11 directed to at least one cell processing step being repeated upon a determination that the measured parameter does not meet the condition, it is noted that this wherein clause is directed to a contingent limitation based on the limitation that the measured parameter does not meet the condition. Accordingly, the wherein clause in claim 11 does not provide any patentable weight in determining patentability of the claimed method. The method itself (a method for cell processing) is anticipated by the method of Sowwan as discussed above.
Accordingly, Sowwan anticipates instant claims.
Response to Traversal:
Applicant’s arguments filed on 12/22/2025 are acknowledged.
Applicant first argues that Sowwan, as written in the prior Office action, fails to teach or suggest the amended new limitations (Remarks, p. 6-8).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejection has been withdrawn. However, as necessitated by amendment, a new ground of rejection has been made by re-applying Sowwan to teach the amended limitations, such as user-defined mapping between pre-programmed, fixed conditions and corresponding outcomes for a given step, and subsequently and automatically executing the pre-programmed workflow in the conditional manner, as discussed above.
Applicant further argues that Sowwan's measurements serve a different purpose - providing data for controller operation and, in some cases, for machine-learning-based refinement of process parameters (Remarks, p. 7-8), and argues that Sowwan’s teaching of using machine learning techniques to determine how to adjust conditions is computed during execution, it is not selected from a pre-authored, fixed set of corresponding outcomes defined in advance for the step and in advance of executing the workflow. Put differently, Sowwan's approach is adaptive and generative - computing "how to adjust" - whereas amended claim 1 requires selection and execution of a corresponding outcome from a fixed, pre-programmed set once a condition is satisfied (Remarks, p. 8).
Applicant’s arguments have been fully considered but they are not persuasive.
As discussed above, Sowwan teaches measuring nutrients and metabolic byproducts (Oxygen, CO2, Glucose, pH, ATP, or the like) in an exemplary cell expansion processing step (see [0049] recited above) and teaches “the machine learning techniques may be used to determine how to adjust the experimental conditions (e.g., add nutrients) to meet certain cell expansion thresholds for the plurality of final cells” ([0049] recited above). Thus, Sowwan teaches the exact claimed steps of measuring at least one parameter associated with the at least one cell processing step (e.g., pH value associated with a cell expansion step), determining whether a first pre-programmed condition (i.e., “certain cell expansion thresholds”) has been met based upon the measured parameters (i.e., “metabolomics” such as “Oxygen, CO2, Glucose, pH, ATP, or the like”), and further based on the determination (i.e., the certain cell expansion thresholds have not been met yet), automatically (i.e., by using the machine learning techniques) selecting from the one or more pre-programmed outcomes (i.e., to determine how to adjust the experimental conditions), and executing a first pre-programmed corresponding outcome (i.e., add nutrients), so as to meet the certain cell expansion thresholds.
In response to the argument regarding Sowwan’s machine learning techniques being adaptive and generating while amended claim 1 requires selection from and execution of fixed pre-programmed outcomes (Remarks, p. 8), as a first matter, the instant specification does not have support for a “fixed’ outcome, thus the limitation “fixed” is being examined as the corresponding outcome is being pre-programmed before the execution of the workflow.
As stated supra, Sowwan teaches “the master controller may be configured to implement the method of FIG. 3 as processor-executable program instructions” (e.g., [0035]), and exemplifies a pre-programmed corresponding outcome (i.e., “adjust the experimental conditions (e.g., add nutrients)”) (see [0049] recited above). Thus, Sowwan teaches the corresponding outcome (e.g., add nutrients) is being pre-programmed (i.e., the master controller is configured first) before the execution of the workflow (i.e., then to implement the method of FIG. 3 as processor-executable program instructions).
It is noted that in Sowwan’s teaching “the machine learning techniques may be used to determine how to adjust the experimental conditions (e.g., add nutrients)” ([0049] recited above), the machine learning techniques are used to automatically select and execute the program instructions (i.e., the “fixed” pre-programmed corresponding outcomes including approaches to adjust the experimental conditions, such as adding nutrients), which is equivalent to the teaching of selection and execution in the instant specification “if the first pre-defined condition is met, the workcell may continue with a pre-defined response in accordance with a pre-programmed workflow. If the first pre-defined condition is not met by the first parameter, the workcell may continue with a different pre-defined response in accordance with the pre-programmed workflow” ([0072], emphasized by examiner).
Applicant finally argues that a skilled artisan would not have modified Sowwan to achieve the claimed method, because Sowwan’s method is adaptive, while the instant invention instead requires, for at least one step, user-defined conditions and a fixed set of corresponding outcomes that remain fixed during execution - where the controller selects and executes one of those outcomes upon a condition-met determination (Remarks, p. 8-9, emphasized by examiner).
Applicant’s arguments have been fully considered but they are not persuasive.
The applicant seems to use the terms “adaptive” and “fixed” inconsistently. For example, Sowwan’s method of selecting and executing approaches to adjust the cell expansion conditions, such as adding nutrients, based upon measured parameters, is referred to as being “adaptive”. However, the instant invention “the controller selects and executes one of those outcomes upon a condition-met determination” (which is also based upon measured parameters, see claim 1) is referred to as being “fixed”.
As stated supra, the instant specification does NOT have support for a “fixed’ outcome, thus the limitation “fixed” is being examined as the corresponding outcome is being pre-programmed before the execution of the workflow, which is taught by Sowwan as discussed above.
New 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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sowwan et al. (US PGPub 2022/0127558. Prior art of record).
With respect to claims 1-2 and 4-11, Sowwan anticipates and thus also renders obvious the claimed methodology, as iterated above in the 102 rejection.
Claim 3 is directed to two or more cell processing steps being executed simultaneously.
However, Sowwan is silent on cell processing steps being executed simultaneously.
Nevertheless, Sowwan teaches an automated reconfigurable and modular closed system for cell therapy manufacturing (e.g., [0005]), which allows the one or more auxiliary devices to be configured to be "plug and play" so that the automated closed apparatus may be customized to perform one or more desired process(es) on a variety of cell types for use with a variety of cell therapies ([0023]). Thus, Sowwan teaches the auxiliary devices are modularized and are configured to execute distinct cell processes.
Accordingly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of manufacturing cells for cell therapies comprising automatically executing cell processing steps using modularized auxiliary devices disclosed by Sowwan, by choosing to execute multiple cell processing steps simultaneously as suggested by Sowwan with a reasonable expectation of success. Since Sowwan teaches the auxiliary devices are modularized and configured to execute distinct cell processes on a variety of cell types ([0023]) and suggests to reduce timeline and cost by using the taught apparatus ([0016]), one of ordinary skill in the art would have had a reason to execute multiple cell processing steps in the modularized auxiliary devices simultaneously in order to reduce timeline and cost for manufacturing cells for cell therapies.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 12/22/2025 are acknowledged and have been discussed above.
Maintained Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-11 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8, 13-14, 17-18, 22-23, 25 and 28-29 of US Patent No. 11,701,654 (‘654). Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claims ‘654 recite a system for processing cell products in parallel (reference claims 1-2, 8, 17-18 and 25) that is capable of generating electronic batch records based on process parameters and data collected from sensors during cell process execution within the system, the system comprising one or more processors for automatically adjusting cell process steps within the system according to a measurement of cell process parameters or results including cell numbers, cell density, cell viability, temperature, dissolved oxygen, pH, glucose levels, and volumes of onboard reagent storage and waste (reference claims 6-7, 13-14, 22-23 and 28-29).
However, cited patent system can be obviously used in the instantly claimed method for cell processing.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to use recited system of ‘654 in the instantly claimed method for cell processing with a reasonable expectation of success. One of ordinary skill in the art would have claimed the intended use of the patented system for cell processing because the cited patent recites a system that can be used in a method for cell processing comprising automatically executing a pre-programmed workflow comprising measuring a parameter and determining whether a condition has been met and continuing, modifying or stopping the workflow based upon the determination.
Since the instant application claims are obvious over cited patent claims, said claims are not patentably distinct.
Claims 1-11 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-8, 13-14, 17-18 and 22-23 of US Patent No. 11,826,756 (‘756). Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claims ‘756 recite a system for processing cell products in parallel (reference claims 1-2, 8 and 17-18) that is capable of generating electronic batch records based on process parameters and data collected from sensors during cell process execution within the system, the system comprising one or more processors for automatically adjusting cell process steps within the system according to a measurement of cell process parameters or results including cell numbers, cell density, cell viability, temperature, dissolved oxygen, pH, glucose levels, and volumes of onboard reagent storage and waste (reference claims 6-7, 13-14 and 22-23).
However, cited patent system can be obviously used in the instantly claimed method for cell processing.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to use recited system of ‘756 in the instantly claimed method for cell processing with a reasonable expectation of success. One of ordinary skill in the art would have claimed the intended use of the patented system for cell processing because the cited patent recites a system that can be used in a method for cell processing comprising automatically executing a pre-programmed workflow comprising measuring a parameter and determining whether a condition has been met and continuing, modifying or stopping the workflow based upon the determination.
Since the instant application claims are obvious over cited patent claims, said claims are not patentably distinct.
Claims 1-11 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-15 of US Patent No. 12,350,667 (‘667). Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claims ‘667 recite a system for processing cell products in parallel (reference claim 1) that is configured to generate electronic batch records based on process parameters and data collected during cell processing within the system (reference claim 11) using sensors within the workcell (reference claim 12), the system comprising a processor configured to modify a cell processing operation within the system based on a measurement of one or more cell process parameters or results (reference claim 13) that comprises cell numbers, cell density, cell viability, temperature, dissolved oxygen, pH, glucose levels, and volumes of onboard reagent storage and waste (reference claim 14), and the cell processing operation is automatically modified in real-time (reference claim 15).
However, cited system in ‘667 can be obviously used in the instantly claimed method for cell processing.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to use recited system of ‘667 in the instantly claimed method for cell processing with a reasonable expectation of success. One of ordinary skill in the art would have claimed the intended use of the recited system for cell processing because the recited system can be used in a method for cell processing comprising automatically executing a pre-programmed workflow comprising measuring a parameter and determining whether a condition has been met and continuing, modifying or stopping the workflow based upon the determination.
Since the instant application claims are obvious over cited patent claims, said claims are not patentably distinct.
Response to Traversal:
Applicant’s arguments filed on 12/22/2025 are acknowledged.
Applicant states a terminal disclaimer will be considered filing after receiving an indication that each of the currently rejected claims is allowable.
Applicant’s argument has been fully considered but it is not persuasive.
Applicant is reminded that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer. Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804.I.B.1.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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, James Douglas (Doug) Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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