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 .
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.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication US 2021/0324318 to Parietti et al. (herein Parietti) as cited on 5/10/24 IDS.
Regarding claim 1, Parietti discloses systems, methods, and apparatuses for facilitating automated modular manufacture of cellular engineering targets (i.e., a method for cell processing) (see [0093]) comprising:
Determining a system configuration of a cell processing system 10 (see Figs. 1-3) configured to process a plurality of cartridges (see [0263-0266]) in parallel (see [0286]), wherein the each of the plurality of cartridges 1100 is configured to carry the cellular engineering target (i.e., cell sample) (see [0025]) and to be loaded into an instrument 300 of a module 208 (i.e., workcell) of the cell processing system 10 (see Figs. 1-3, 11, & 15; [0240]);
Determining a cartridge configuration 1100 for each of the plurality of cartridges (see Figs. 3, 11-12 and 14-22);
Providing a loading schedule for inserting said cartridges into a workcell (see [0262-2063, 0282-0283, 0318]), wherein the loading schedule is based on the system configuration and the cartridge configuration for each of the plurality of cartridges (see Figs. 1-3, 11-12 and 14-22).
Regarding claims 2-3, Parietti discloses the invention of claim 1, and Parietti discloses an incubating time period (see [0169]; a doubling time (see [0172]); time between a round of subculturing (see [0173]); and adjusting system steps based on the time for a particular step to be performed by said system, and loading a module once it becomes empty after completing a task (see [0285-0290]) all of which amounts to time periods that are not available for loading a first cartridge into a workcell and loading a cartridge into a workcell based on a loading schedule.
Regarding claim 4, Parietti discloses the invention of claim 1 and discloses the cell processing system 10 comprising a user interface 278 (see Fig. 2).
Regarding claim 5, Parietti discloses the invention of claim 1 and wherein the system configuration (see Fig. 1) defines a quantity of the instruments 300 (i.e., one or more subsystems) of the cell processing system (see Fig. 3).
Regarding claim 6, Parietti discloses the invention of claim 5 and discloses wherein the one or more subsystems 300 are housed within the workcell 208 of the cell processing system (see Fig. 3).
Regarding claim 7, Parietti discloses the invention of claim 5 and discloses a quality control system (see [0279-0280,0284,0305, 0307, 0313]); a bioprocessing system (see [0022-0024]); and sterility system (see [0025]).
Regarding claim 8, Parietti discloses the invention of claim 5 and discloses various time constraints for various operations of said system (see [0159,0169, 0172-0173]).
Regarding claim 9, Parietti discloses the invention of claim 1 and discloses wherein the cartridge configuration (see Fig. 3) comprises a loading configuration and workflow configuration (see [0099, 0313, and 0350]).
Regarding claim 10, Parietti discloses the invention of claim 1 and discloses managing the overall cycle time of the system which would include the length of time for loading a cartridge into a workcell (see [0093, 0286]).
Regarding claim 11, Parietti discloses the invention of claim 9, and discloses wherein the workflow configuration comprises a simulated cell processing workflow for a cartridge (see Fig. 2), and wherein the simulated cell processing workflow is based on a process design plan for the cartridge ([0025, 0091, 0093, 0101, 0338, and 0141]) and one or more sample intake parameters for the cartridge (see [0159]).
Regarding claim 12, Parietti discloses the invention of claim 11, and discloses wherein the one or more sample intake parameters comprise one or more sample type and/or sample temperature (see [0159]).
Regarding claim 13, Parietti discloses the invention of claim 1 and discloses the system configuration takes into account the overall cycle time of the system, wherein the overall cycle time takes into account that certain processes may take longer than overs (i.e., variability) (see [0093]). The overall cycle time would include the workflow process and cartridge loading.
Regarding claim 14, Parietti discloses the invention of claim 1 and discloses inserting and removing cartridges into and out of the system as desired and controlling the scheduled processing of the cartridge within each module (see [0262-0266]), therefore, Parietti discloses processing one or more cartridges, while one or more cartridges can be stored for a later time (see [0169]).
Regarding claim 15, Parietti discloses the invention of claim 11 and discloses scheduling the first cartridge for processing within the cell processing system based on the loading schedule (see [0285-0290]).
Regarding claim 16, Parietti disclose the method of claim 1 and discloses determining potential imbalances within the system (i.e., amount of contention), wherein the loading schedule is further based on the amount of contention determined (see [0093, 0286]).
Regarding claim 17, Parietti discloses systems, methods, and apparatuses for facilitating automated modular manufacture of cellular engineering targets (i.e., a method for cell processing) (see [0093]) comprising:
loading a plurality of cell samples (see [0147]) into a cell processing system 10 (see Figs. 1-2) for parallel processing (see [0093]), wherein the cell processing system 10 comprises a plurality of instruments 300 (see Fig. 3); and
determining potential imbalances within the system (i.e., amount of contention for each of the plurality of instruments), wherein the amount of contention is based on the number of cell samples that need an instrument during a time period (see [0093, 0286]); and
generating notifications via a user interface (see Fig. 2) and wherein there will be imbalances within the system when there is two or more cell samples to be processed within a given instrument ([0093, 0286]).
Regarding claim 18, Parietti discloses the invention of claim 17 and discloses a prioritized cell sample of the plurality of cell samples to use the instrument based on a weight of instrument contention determined for each cell sample that needs the instrument during the time period (see [0103]).
Regarding claim 19, Parietti discloses the invention of claim 18 and discloses wherein the prioritized cell sample comprises the largest weight of instrument contention (see [0285-0290]) or in other words the system comprises multiple modules for a particular process of a cell sample that will take the longest time period.
Regarding claim 20, Parietti discloses the invention of claim 18 and discloses wherein, for each cell sample, the weight of instrument contention is based on a current cell processing dwell time and a subsequent cell processing operation time (see [0159, 0169, 0172-0173, 0285-0290]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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